[Code of Federal Regulations]
[Title 42, Volume 3, Parts 430 to End]
[Revised as of October 1, 1999]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493]
[Page 819-941]
PART 493--LABORATORY REQUIREMENTS
Subpart A--General Provisions
Sec.
493.1 Basis and scope.
493.2 Definitions.
493.3 Applicability.
493.5 Categories of tests by complexity.
493.15 Laboratories performing waived tests.
493.17 Test categorization.
493.19 Provider-performed microscopy (PPM) procedures.
493.20 Laboratories performing tests of moderate complexity.
493.25 Laboratories performing tests of high complexity.
Subpart B--Certificate of Waiver
493.35 Application for a certificate of waiver.
493.37 Requirements for a certificate of waiver.
493.39 Notification requirements for laboratories issued a certificate
of waiver.
Subpart C--Registration Certificate, Certificate for Provider-performed
Microscopy Procedures, and Certificate of Compliance
493.43 Application for registration certificate, certificate for
provider-performed microscopy (PPM) procedures, and
certificate of compliance.
493.45 Requirements for a registration certificate.
493.47 Requirements for a certificate for provider-performed microscopy
(PPM) procedures.
493.49 Requirements for a certificate of compliance.
493.51 Notification requirements for laboratories issued a certificate
of compliance.
493.53 Notification requirements for laboratories issued a certificate
for provider-performed microscopy (PPM) procedures.
Subpart D--Certificate of Accreditation
493.55 Application for registration certificate and certificate of
accreditation.
493.57 Requirements for a registration certificate.
493.61 Requirements for a certificate of accreditation.
493.63 Notification requirements for laboratories issued a certificate
of accreditation.
Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
493.551 General requirements for laboratories.
493.553 Approval process (application and reapplication) for
accreditation organizations and State licensure programs.
493.555 Federal review of laboratory requirements.
493.557 Additional submission requirements.
493.559 Publication of approval of deeming authority or CLIA exemption.
493.561 Denial of application or reapplication.
493.563 Validation inspections--Basis and focus.
[[Page 820]]
493.565 Selection for validation inspection--laboratory
responsibilities.
493.567 Refusal to cooperate with validation inspection.
493.569 Consequences of a finding of noncompliance as a result of a
validation inspection.
493.571 Disclosure of accreditation, State and HCFA validation
inspection results.
493.573 Continuing Federal oversight of private nonprofit accreditation
organizations and approved State licensure programs.
493.575 Removal of deeming authority or CLIA exemption and final
determination review.
Subpart F--General Administration
493.602 Scope of subpart.
493.606 Applicability of subpart.
493.638 Certificate fees.
493.639 Fee for revised certificate.
493.643 Fee for determination of program compliance.
493.645 Additional fee(s) applicable to approved State laboratory
programs and laboratories issued a certificate of
accreditation, certificate of waiver, or certificate for PPM
procedures.
493.646 Payment of fees.
493.649 Methodology for determining fee amount.
Subpart G [Reserved]
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Tests of Moderate Complexity (Including the Subcategory),
High Complexity, or Any Combination of These Tests
493.801 Condition: Enrollment and testing of samples.
493.803 Condition: Successful participation.
493.807 Condition: Reinstatement of laboratories performing tests of
moderate complexity (including the subcategory), high
complexity, or any combination of these tests, after failure
to participate successfully.
Proficiency Testing by Specialty and Subspecialty for Laboratories
Performing Tests of Moderate Complexity (Including the Subcategory),
High Complexity, or Any Combination of These Tests
493.821 Condition: Microbiology.
493.823 Standard; Bacteriology.
493.825 Standard; Mycobacteriology.
493.827 Standard; Mycology.
493.829 Standard; Parasitology.
493.831 Standard; Virology.
493.833 Condition: Diagnostic immunology.
493.835 Standard; Syphilis serology.
493.837 Standard; General immunology.
493.839 Condition: Chemistry.
493.841 Standard; Routine chemistry.
493.843 Standard; Endocrinology.
493.845 Standard; Toxicology.
493.849 Condition: Hematology.
493.851 Standard; Hematology.
493.853 Condition: Pathology.
493.855 Standard; Cytology: gynecologic examinations.
493.857 Condition: Immunohematology.
493.859 Standard; ABO group and D (Rho) typing.
493.861 Standard; Unexpected antibody detection.
493.863 Standard; Compatibility testing.
493.865 Standard; Antibody identification.
Subpart I--Proficiency Testing Programs for Tests of Moderate Complexity
(Including the Subcategory), High Complexity, or Any Combination of
These Tests
493.901 Approval of proficiency testing programs.
493.903 Administrative responsibilities.
493.905 Nonapproved proficiency testing programs.
Proficiency Testing Programs by Specialty and Subspecialty
493.909 Microbiology.
493.911 Bacteriology.
493.913 Mycobacteriology.
493.915 Mycology.
493.917 Parasitology.
493.919 Virology.
493.921 Diagnostic immunology.
493.923 Syphilis serology.
493.927 General immunology.
493.929 Chemistry.
493.931 Routine chemistry.
493.933 Endocrinology.
493.937 Toxicology.
493.941 Hematology (including routine hematology and coagulation).
493.945 Cytology; gynecologic examinations.
493.959 Immunohematology.
Subpart J--Patient Test Management for Moderate Complexity (Including
the Subcategory), High Complexity, or Any Combination of These Tests
493.1101 Condition: Patient test management; moderate complexity
(including the subcategory), or high complexity testing, or
any combination of these tests.
493.1103 Standard; Procedures for specimen submission and handling.
493.1105 Standard; Test requisition.
493.1107 Standard; Test records.
493.1109 Standard; Test report.
493.1111 Standard; Referral of specimens.
[[Page 821]]
Subpart K--Quality Control for Tests of Moderate Complexity (Including
the Subcategory), High Complexity, or Any Combination of These Tests
493.1201 Condition: General quality control; moderate complexity
(including the subcategory) or high complexity testing, or any
combination of these tests.
493.1202 Standard; Moderate or high complexity testing, or both:
Effective from September 1, 1992 to December 31, 2000.
493.1203 Standard; Moderate or high complexity testing, or both:
Effective beginning December 31, 2000.
493.1204 Standard; Facilities.
493.1205 Standard; Test methods, equipment, instrumentation, reagents,
materials, and supplies.
493.1211 Standard; Procedure manual.
493.1213 Standard; Establishment and verification of method performance
specifications.
493.1215 Standard; Equipment maintenance and function checks.
493.1217 Standard; Calibration and calibration verification procedures.
493.1218 Standard; Control procedures.
493.1219 Standard; Remedial actions.
493.1221 Standard; Quality control records.
493.1223 Condition: Quality control--specialties and subspecialties for
tests of moderate or high complexity, or both.
493.1225 Condition: Microbiology.
493.1227 Condition: Bacteriology.
493.1229 Condition: Mycobacteriology.
493.1231 Condition: Mycology.
493.1233 Condition: Parasitology.
493.1235 Condition: Virology.
493.1237 Condition: Diagnostic immunology.
493.1239 Condition: Syphilis serology.
493.1241 Condition: General immunology.
493.1243 Condition: Chemistry.
493.1245 Condition: Routine chemistry.
493.1247 Condition: Endocrinology.
493.1249 Condition: Toxicology.
493.1251 Condition: Urinalysis.
493.1253 Condition: Hematology.
493.1255 Condition: Pathology.
493.1257 Condition: Cytology.
493.1259 Condition: Histopathology.
493.1261 Condition: Oral pathology.
493.1263 Condition: Radiobioassay.
493.1265 Condition: Histocompatibility.
493.1267 Condition: Clinical cytogenetics.
493.1269 Condition: Immunohematology.
493.1271 Condition: Transfusion services and bloodbanking.
493.1273 Standard; Immunohematological collection, processing, dating
periods, labeling and distribution of blood and blood
products.
493.1275 Standard; Blood and blood products storage facilities.
493.1277 Standard; Arrangement for services.
493.1279 Standard; Provision of testing.
493.1283 Standard; Retention of samples of transfused blood.
493.1285 Standard; Investigation of transfusion reactions.
Subpart L [Reserved]
Subpart M--Personnel for Moderate Complexity (Including the Subcategory)
and High Complexity Testing
493.1351 General.
Laboratories Performing Provider-Performed Microscopy (PPM) Procedures
493.1353 Scope.
493.1355 Condition: Laboratories performing PPM procedures; laboratory
director.
493.1357 Standard; laboratory director qualifications.
493.1359 Standard; PPM laboratory director responsibilities.
493.1361 Condition: Laboratories performing PPM procedures; testing
personnel.
493.1363 Standard; PPM testing personnel qualifications.
493.1365 Standard; PPM testing personnel responsibilities.
Laboratories Performing Moderate Complexity Testing
493.1403 Condition: Laboratories performing moderate complexity
testing; laboratory director.
493.1405 Standard; Laboratory director qualifications.
493.1406 Standard; Laboratory director qualifications on or before
February 28, 1992.
493.1407 Standard; Laboratory director responsibilities.
493.1409 Condition: Laboratories performing moderate complexity
testing; technical consultant.
493.1411 Standard; Technical consultant qualifications.
493.1413 Standard; Technical consultant responsibilities.
493.1415 Condition: Laboratories performing moderate complexity
testing; clinical consultant.
493.1417 Standard; Clinical consultant qualifications.
493.1419 Standard; Clinical consultant responsibilities.
493.1421 Condition: Laboratories performing moderate complexity
testing; testing personnel.
493.1423 Standard; Testing personnel qualifications.
493.1425 Standard; Testing personnel responsibilities.
[[Page 822]]
Laboratories Performing High Complexity Testing
493.1441 Condition: Laboratories performing high complexity testing;
laboratory director.
493.1443 Standard; Laboratory director qualifications.
493.1445 Standard; Laboratory director responsibilities.
493.1447 Condition: Laboratories performing high complexity testing;
technical supervisor.
493.1449 Standard; Technical supervisor qualifications.
493.1451 Standard; Technical supervisor responsibilities.
493.1453 Condition: Laboratories performing high complexity testing;
clinical consultant.
493.1455 Standard; Clinical consultant qualifications.
493.1457 Standard; Clinical consultant responsibilities.
493.1459 Condition: Laboratories performing high complexity testing;
general supervisor.
493.1461 Standard; General supervisor qualifications.
493.1462 General supervisor qualifications on or before February 28,
1992.
493.1463 Standard; General supervisor responsibilities.
493.1467 Condition: Laboratories performing high complexity testing;
cytology general supervisor.
493.1469 Standard; Cytology general supervisor qualifications.
493.1471 Standard; Cytology general supervisor responsibilities.
493.1481 Condition: Laboratories performing high complexity testing;
cytotechnologist.
493.1483 Standard; Cytotechnologist qualifications.
493.1485 Standard; Cytotechnologist responsibilities.
493.1487 Condition: Laboratories performing high complexity testing;
testing personnel.
493.1489 Standard; Testing personnel qualifications.
493.1491 Technologist qualifications on or before February 28, 1992.
493.1495 Standard; Testing personnel responsibilities.
Subparts N-O [Reserved]
Subpart P--Quality Assurance for Moderate Complexity (Including the
Subcategory) or High Complexity Testing, or Any Combination of These
Tests
493.1701 Condition: Quality assurance; moderate complexity (including
the subcategory) or high complexity testing, or any
combination of these tests.
493.1703 Standard; Patient test management assessment.
493.1705 Standard; Quality control assessment.
493.1707 Standard; Proficiency testing assessment.
493.1709 Standard; Comparison of test results.
493.1711 Standard; Relationship of patient information to patient test
results.
493.1713 Standard; Personnel assessment.
493.1715 Standard; Communications.
493.1717 Standard; Complaint investigations.
493.1719 Standard; Quality assurance review with staff.
493.1721 Standard; Quality assurance records.
Subpart Q--Inspection
493.1771 Condition: Inspection requirements applicable to all CLIA-
certified and CLIA-exempt laboratories.
493.1773 Standard: Basic inspection requirements for all laboratories
issued a CLIA certificate and CLIA-exempt laboratories.
493.1775 Standard: Inspection of laboratories issued a certificate of
waiver or a certificate for provider-performed microscopy
procedures.
493.1777 Standard: Inspection of laboratories that have requested or
have been issued a certificate of compliance.
493.1780 Standard: Inspection of CLIA-exempt laboratories or
laboratories requesting or issued a certificate of
accreditation.
Subpart R--Enforcement Procedures
493.1800 Basis and scope.
493.1804 General considerations.
493.1806 Available sanctions: All laboratories.
493.1807 Additional sanctions: Laboratories that participate in
Medicare.
493.1808 Adverse action on any type of CLIA certificate: Effect on
Medicare approval.
493.1809 Limitation on Medicaid payment.
493.1810 Imposition and lifting of alternative sanctions.
493.1812 Action when deficiencies pose immediate jeopardy.
493.1814 Action when deficiencies are at the condition level but do not
pose immediate jeopardy.
493.1816 Action when deficiencies are not at the condition level.
493.1820 Ensuring timely correction of deficiencies.
493.1826 Suspension of part of Medicare payments.
493.1828 Suspension of all Medicare payments.
[[Page 823]]
493.1832 Directed plan of correction and directed portion of a plan of
correction.
493.1834 Civil money penalty.
493.1836 State onsite monitoring.
493.1838 Training and technical assistance for unsuccessful
participation in proficiency testing.
493.1840 Suspension, limitation, or revocation of any type of CLIA
certificate.
493.1842 Cancellation of Medicare approval.
493.1844 Appeals procedures.
493.1846 Civil action.
493.1850 Laboratory registry.
Subpart S [Reserved]
Subpart T--Consultations
493.2001 Establishment and function of the Clinical Laboratory
Improvement Advisory Committee.
Authority: Sec. 353 of the Public Health Service Act, secs. 1102,
1861(e), the sentence following sections 1861(s)(11) through 1861(s)(16)
of the Social Security Act (42 U.S.C. 263a, 1302, 1395x(e), the sentence
following 1395x(s)(11) through 1395x(s)(16)).
Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.
Subpart A--General Provisions
Source: 57 FR 7139, Feb. 28, 1992, unless otherwise noted.
Sec. 493.1 Basis and scope.
This part sets forth the conditions that all laboratories must meet
to be certified to perform testing on human specimens under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA). It implements sections
1861 (e) and (j), the sentence following section 1861(s)(13), and
1902(a)(9) of the Social Security Act, and section 353 of the Public
Health Service Act. This part applies to all laboratories as defined
under ``laboratory'' in Sec. 493.2 of this part. This part also applies
to laboratories seeking payment under the Medicare and Medicaid
programs. The requirements are the same for Medicare approval as for
CLIA certification.
Sec. 493.2 Definitions.
As used in this part, unless the context indicates otherwise--
Accredited institution means a school or program which--
(a) Admits as regular student only persons having a certificate of
graduation from a school providing secondary education, or the
recognized equivalent of such certificate;
(b) Is legally authorized within the State to provide a program of
education beyond secondary education;
(c) Provides an educational program for which it awards a bachelor's
degree or provides not less than a 2-year program which is acceptable
toward such a degree, or provides an educational program for which it
awards a master's or doctoral degree;
(d) Is accredited by a nationally recognized accrediting agency or
association.
This definition includes any foreign institution of higher education
that HHS or its designee determines meets substantially equivalent
requirements.
Accredited laboratory means a laboratory that has voluntarily
applied for and been accredited by a private, nonprofit accreditation
organization approved by HCFA in accordance with this part;
Adverse action means the imposition of a principal or alternative
sanction by HCFA.
ALJ stands for Administrative Law Judge.
Alternative sanctions means sanctions that may be imposed in lieu of
or in addition to principal sanctions. The term is synonymous with
``intermediate sanctions'' as used in section 1846 of the Act.
Analyte means a substance or constituent for which the laboratory
conducts testing.
Approved accreditation organization for laboratories means a
private, nonprofit accreditation organization that has formally applied
for and received HCFA's approval based on the organization's compliance
with this part.
Approved State laboratory program means a licensure or other
regulatory program for laboratories in a State, the requirements of
which are imposed under State law, and the State laboratory program has
received HCFA approval based on the State's compliance with this part.
Authorized person means an individual authorized under State law to
order tests or receive test results, or both.
[[Page 824]]
Challenge means, for quantitative tests, an assessment of the amount
of substance or analyte present or measured in a sample. For qualitative
tests, a challenge means the determination of the presence or the
absence of an analyte, organism, or substance in a sample.
CLIA means the Clinical Laboratory Improvement Amendments of 1988.
CLIA certificate means any of the following types of certificates
issued by HCFA or its agent:
(1) Certificate of compliance means a certificate issued to a
laboratory after an inspection that finds the laboratory to be in
compliance with all applicable condition level requirements, or reissued
before the expiration date, pending an appeal, in accordance with
Sec. 493.49, when an inspection has found the laboratory to be out of
compliance with one or more condition level requirements.
(2) Certificate for provider-performed microscopy (PPM) procedures
means a certificate issued or reissued before the expiration date,
pending an appeal, in accordance with Sec. 493.47, to a laboratory in
which a physician, midlevel practitioner or dentist performs no tests
other than PPM procedures and, if desired, waived tests listed in
Sec. 493.15(c).
(3) Certificate of accreditation means a certificate issued on the
basis of the laboratory's accreditation by an accreditation organization
approved by HCFA (indicating that the laboratory is deemed to meet
applicable CLIA requirements) or reissued before the expiration date,
pending an appeal, in accordance with Sec. 493.61, when a validation or
complaint survey has found the laboratory to be noncompliant with one or
more CLIA conditions.
(4) Certificate of registration or registration certificate means a
certificate issued or reissued before the expiration date, pending an
appeal, in accordance with Sec. 493.45, that enables the entity to
conduct moderate or high complexity laboratory testing or both until the
entity is determined to be in compliance through a survey by HCFA or its
agent; or in accordance with Sec. 493.57 to an entity that is accredited
by an approved accreditation organization.
(5) Certificate of waiver means a certificate issued or reissued
before the expiration date, pending an appeal, in accordance with
Sec. 493.37, to a laboratory to perform only the waived tests listed at
Sec. 493.15(c).
CLIA-exempt laboratory means a laboratory that has been licensed or
approved by a State where HCFA has determined that the State has enacted
laws relating to laboratory requirements that are equal to or more
stringent than CLIA requirements and the State licensure program has
been approved by HCFA in accordance with subpart E of this part.
Condition level deficiency means noncompliance with one or more
condition level requirements.
Condition level requirements means any of the requirements
identified as ``conditions'' in subparts G through Q of this part.
Credible allegation of compliance means a statement or documentation
that--
(1) Is made by a representative of a laboratory that has a history
of having maintained a commitment to compliance and of taking corrective
action when required;
(2) Is realistic in terms of its being possible to accomplish the
required corrective action between the date of the exit conference and
the date of the allegation; and
(3) Indicates that the problem has been resolved.
Dentist means a doctor of dental medicine or doctor of dental
surgery licensed by the State to practice dentistry within the State in
which the laboratory is located.
Equivalency means that an accreditation organization's or a State
laboratory program's requirements, taken as a whole, are equal to or
more stringent than the CLIA requirements established by HCFA, taken as
whole. It is acceptable for an accreditation organization's or State
laboratory program's requirements to be organized differently or
otherwise vary from the CLIA requirements, as long as (1) all of the
requirements taken as a whole would provide at least the same protection
as the CLIA requirements taken
[[Page 825]]
as a whole; and (2) a finding of noncompliance with respect to CLIA
requirements taken as a whole would be matched by a finding of
noncompliance with the accreditation or State requirements taken as a
whole.
HCFA agent means an entity with which HCFA arranges to inspect
laboratories and assess laboratory activities against CLIA requirements
and may be a State survey agency, a private, nonprofit organization
other than an approved accreditation organization, a component of HHS,
or any other governmental component HCFA approves for this purpose. In
those instances where all of the laboratories in a State are exempt from
CLIA requirements, based on the approval of a State's exemption request,
the State survey agency is not the HCFA agent.
HHS means the Department of Health and Human Services, or its
designee.
Immediate jeopardy means a situation in which immediate corrective
action is necessary because the laboratory's noncompliance with one or
more condition level requirements has already caused, is causing, or is
likely to cause, at any time, serious injury or harm, or death, to
individuals served by the laboratory or to the health or safety of the
general public. This term is synonymous with imminent and serious risk
to human health and significant hazard to the public health.
Intentional violation means knowing and willful noncompliance with
any CLIA condition.
Kit means all components of a test that are packaged together.
Laboratory means a facility for the biological, microbiological,
serological, chemical, immunohematological, hematological, biophysical,
cytological, pathological, or other examination of materials derived
from the human body for the purpose of providing information for the
diagnosis, prevention, or treatment of any disease or impairment of, or
the assessment of the health of, human beings. These examinations also
include procedures to determine, measure, or otherwise describe the
presence or absence of various substances or organisms in the body.
Facilities only collecting or preparing specimens (or both) or only
serving as a mailing service and not performing testing are not
considered laboratories.
Midlevel practitioner means a nurse midwife, nurse practitioner, or
physician assistant, licensed by the State within which the individual
practices, if such licensing is required in the State in which the
laboratory is located.
Operator means the individual or group of individuals who oversee
all facets of the operation of a laboratory and who bear primary
responsibility for the safety and reliability of the results of all
specimen testing performed in that laboratory. The term includes--
(1) A director of the laboratory if he or she meets the stated
criteria; and
(2) The members of the board of directors and the officers of a
laboratory that is a small corporation under subchapter S of the
Internal Revenue Code.
Owner means any person who owns any interest in a laboratory except
for an interest in a laboratory whose stock and/or securities are
publicly traded. (That is e.g., the purchase of shares of stock or
securities on the New York Stock Exchange in a corporation owning a
laboratory would not make a person an owner for the purpose of this
regulation.)
Party means a laboratory affected by any of the enforcement
procedures set forth in this subpart, by HCFA or the OIG, as
appropriate.
Performance characteristic means a property of a test that is used
to describe its quality, e.g., accuracy, precision, analytical
sensitivity, analytical specificity, reportable range, reference range,
etc.
Performance specification means a value or range of values for a
performance characteristic, established or verified by the laboratory,
that is used to describe the quality of patient test results.
Physician means an individual with a doctor of medicine, doctor of
osteopathy, or doctor of podiatric medicine degree who is licensed by
the State to practice medicine, osteopathy, or podiatry within the State
in which the laboratory is located.
Principal sanction means the suspension, limitation, or revocation
of any
[[Page 826]]
type of CLIA certificate or the cancellation of the laboratory's
approval to receive Medicare payment for its services.
Prospective laboratory means a laboratory that is operating under a
registration certificate or is seeking any of the three other types of
CLIA certificates.
Rate of disparity means the percentage of sample validation
inspections for a specific accreditation organization or State where
HCFA, the State survey agency or other HCFA agent finds noncompliance
with one or more condition level requirements but no comparable
deficiencies were cited by the accreditation organization or the State,
and it is reasonable to conclude that the deficiencies were present at
the time of the most recent accreditation organization or State
licensure inspection.
Example: Assume the State survey agency, HCFA or other HCFA agent
performs 200 sample validation inspections for laboratories accredited
by a single accreditation organization or licensed in an exempt State
during a validation review period and finds that 60 of the 200
laboratories had one or more condition level requirements out of
compliance. HCFA reviews the validation and accreditation organization's
or State's inspections of the validated laboratories and determines that
the State or accreditation organization found comparable deficiencies in
22 of the 60 laboratories and it is reasonable to conclude that
deficiencies were present in the remaining 38 laboratories at the time
of the accreditation organization's or State's inspection. Thirty-eight
divided by 200 equals a 19 percent rate of disparity.
Referee laboratory means a laboratory currently in compliance with
applicable CLIA requirements, that has had a record of satisfactory
proficiency testing performance for all testing events for at least one
year for a specific test, analyte, subspecialty, or specialty and has
been designated by an HHS approved proficiency testing program as a
referee laboratory for analyzing proficiency testing specimens for the
purpose of determining the correct response for the specimens in a
testing event for that specific test, analyte, subspecialty, or
specialty.
Reference range means the range of test values expected for a
designated population of individuals, e.g., 95 percent of individuals
that are presumed to be healthy (or normal).
Sample in proficiency testing means the material contained in a
vial, on a slide, or other unit that contains material to be tested by
proficiency testing program participants. When possible, samples are of
human origin.
State includes, for purposes of this part, each of the 50 States,
the District of Columbia, the Commonwealth of Puerto Rico, the Virgin
Islands and a political subdivision of a State where the State, acting
pursuant to State law, has expressly delegated powers to the political
subdivision sufficient to authorize the political subdivision to act for
the State in enforcing requirements equal to or more stringent than CLIA
requirements.
State licensure means the issuance of a license to, or the approval
of, a laboratory by a State laboratory program as meeting standards for
licensing or approval established under State law.
State licensure program means a State laboratory licensure or
approval program.
State survey agency means the State health agency or other
appropriate State or local agency that has an agreement under section
1864 of the Social Security Act and is used by HCFA to perform surveys
and inspections.
Substantial allegation of noncompliance means a complaint from any
of a variety of sources (including complaints submitted in person, by
telephone, through written correspondence, or in newspaper or magazine
articles) that, if substantiated, would have an impact on the health and
safety of the general public or of individuals served by a laboratory
and raises doubts as to a laboratory's compliance with any condition
level requirement.
Target value for quantitative tests means either the mean of all
participant responses after removal of outliers (those responses greater
than 3 standard deviations from the original mean) or the mean
established by definitive or reference methods acceptable for use in the
National Reference System for the Clinical Laboratory (NRSCL) by the
National Committee for the Clinical Laboratory Standards (NCCLS). In
instances where definitive or reference methods are not available
[[Page 827]]
or a specific method's results demonstrate bias that is not observed
with actual patient specimens, as determined by a defensible scientific
protocol, a comparative method or a method group (``peer'' group) may be
used. If the method group is less than 10 participants, ``target value''
means the overall mean after outlier removal (as defined above) unless
acceptable scientific reasons are available to indicate that such an
evaluation is not appropriate.
Unsatisfactory proficiency testing performance means failure to
attain the minimum satisfactory score for an analyte, test,
subspecialty, or specialty for a testing event.
Unsuccessful participation in proficiency testing means any of the
following:
(1) Unsatisfactory performance for the same analyte in two
consecutive or two out of three testing events.
(2) Repeated unsatisfactory overall testing event scores for two
consecutive or two out of three testing events for the same specialty or
subspecialty.
(3) An unsatisfactory testing event score for those subspecialties
not graded by analyte (that is, bacteriology, mycobacteriology,
virology, parasitology, mycology, blood compatibility, immunohematology,
or syphilis serology) for the same subspecialty for two consecutive or
two out of three testing events.
(4) Failure of a laboratory performing gynecologic cytology to meet
the standard at Sec. 493.855.
Unsuccessful proficiency testing performance means a failure to
attain the minimum satisfactory score for an analyte, test,
subspecialty, or specialty for two consecutive or two of three
consecutive testing events.
Validation review period means the one year time period during which
HCFA conducts validation inspections and evaluates the results of the
most recent surveys performed by an accreditation organization or State
laboratory program.
[57 FR 7139, Feb. 28, 1992, as amended at 57 FR 7236, Feb. 28, 1992; 57
FR 34013, July 31, 1992; 57 FR 35761, Aug. 11, 1992; 58 FR 5220, Jan.
19, 1993; 58 FR 48323, Sept. 15, 1993; 60 FR 20043, Apr. 24, 1995; 63 FR
26732, May 14, 1998]
Sec. 493.3 Applicability.
(a) Basic rule. Except as specified in paragraph (b) of this
section, a laboratory will be cited as out of compliance with section
353 of the Public Health Service Act unless it--
(1) Has a current, unrevoked or unsuspended certificate of waiver,
registration certificate, certificate of compliance, certificate for PPM
procedures, or certificate of accreditation issued by HHS applicable to
the category of examinations or procedures performed by the laboratory;
or
(2) Is CLIA-exempt.
(b) Exception. These rules do not apply to components or functions
of--
(1) Any facility or component of a facility that only performs
testing for forensic purposes;
(2) Research laboratories that test human specimens but do not
report patient specific results for the diagnosis, prevention or
treatment of any disease or impairment of, or the assessment of the
health of individual patients; or
(3) Laboratories certified by the National Institutes on Drug Abuse
(NIDA), in which drug testing is performed which meets NIDA guidelines
and regulations. However, all other testing conducted by a NIDA-
certified laboratory is subject to this rule.
(c) Federal laboratories. Laboratories under the jurisdiction of an
agency of the Federal Government are subject to the rules of this part,
except that the Secretary may modify the application of such
requirements as appropriate.
[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5221, Jan. 19, 1993; 60
FR 20043, Apr. 24, 1995]
Sec. 493.5 Categories of tests by complexity.
(a) Laboratory tests are categorized as one of the following:
(1) Waived tests.
(2) Tests of moderate complexity, including the subcategory of PPM
procedures.
(3) Tests of high complexity.
(b) A laboratory may perform only waived tests, only tests of
moderate complexity, only PPM procedures, only tests of high complexity
or any combination of these tests.
[[Page 828]]
(c) Each laboratory must be either CLIA-exempt or possess one of the
following CLIA certificates, as defined in Sec. 493.2:
(1) Certificate of registration or registration certificate.
(2) Certificate of waiver.
(3) Certificate for PPM procedures.
(4) Certificate of compliance.
(5) Certificate of accreditation.
[60 FR 20043, Apr. 24, 1995]
Sec. 493.15 Laboratories performing waived tests.
(a) Requirement. Tests for certificate of waiver must meet the
descriptive criteria specified in paragraph (b) of this section.
(b) Criteria. Test systems are simple laboratory examinations and
procedures which--
(1) Are cleared by FDA for home use;
(2) Employ methodologies that are so simple and accurate as to
render the likelihood of erroneous results negligible; or
(3) Pose no reasonable risk of harm to the patient if the test is
performed incorrectly.
(c) Certificate of waiver tests. A laboratory may qualify for a
certificate of waiver under section 353 of the PHS Act if it restricts
the tests that it performs to one or more of the following tests or
examinations (or additional tests added to this list as provided under
paragraph (d) of this section) and no others:
(1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the
following:
(i) Bilirubin;
(ii) Glucose;
(iii) Hemoglobin;
(iv) Ketone;
(v) Leukocytes;
(vi) Nitrite;
(vii) pH;
(viii) Protein;
(ix) Specific gravity; and
(x) Urobilinogen.
(2) Fecal occult blood;
(3) Ovulation tests--visual color comparison tests for human
luteinizing hormone;
(4) Urine pregnancy tests--visual color comparison tests;
(5) Erythrocyte sedimentation rate--non-automated;
(6) Hemoglobin--copper sulfate--non-automated;
(7) Blood glucose by glucose monitoring devices cleared by the FDA
specifically for home use;
(8) Spun microhematocrit; and
(9) Hemoglobin by single analyte instruments with self-contained or
component features to perform specimen/reagent interaction, providing
direct measurement and readout.
(d) Revisions to criteria for test categorization and the list of
waived tests. HHS will determine whether a laboratory test meets the
criteria listed under paragraph (b) of this section for a waived test.
Revisions to the list of waived tests approved by HHS will be published
in the Federal Register in a notice with opportunity for comment.
(e) Laboratories eligible for a certificate of waiver must--
(1) Follow manufacturers' instructions for performing the test; and
(2) Meet the requirements in subpart B, Certificate of Waiver, of
this part.
[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5221, Jan. 19, 1993]
Sec. 493.17 Test categorization.
(a) Categorization by criteria. Notices will be published in the
Federal Register which list each specific test system, assay, and
examination categorized by complexity. Using the seven criteria
specified in this paragraph for categorizing tests of moderate or high
complexity, each specific laboratory test system, assay, and examination
will be graded for level of complexity by assigning scores of 1, 2, or 3
within each criteria. The score of ``1'' indicates the lowest level of
complexity, and the score of ``3'' indicates the highest level. These
scores will be totaled. Test systems, assays or examinations receiving
scores of 12 or less will be categorized as moderate complexity, while
those receiving scores above 12 will be categorized as high complexity.
Note: A score of ``2'' will be assigned to a criteria heading when
the characteristics for a particular test are intermediate between the
descriptions listed for scores of ``1'' and ``3.''
(1) Knowledge.
[[Page 829]]
(i) Score 1. (A) Minimal scientific and technical knowledge is
required to perform the test; and
(B) Knowledge required to perform the test may be obtained through
on-the-job instruction.
(ii) Score 3. Specialized scientific and technical knowledge is
essential to perform preanalytic, analytic or postanalytic phases of the
testing.
(2) Training and experience.
(i) Score 1. (A) Minimal training is required for preanalytic,
analytic and postanalytic phases of the testing process; and
(B) Limited experience is required to perform the test.
(ii) Score 3. (A) Specialized training is essential to perform the
preanalytic, analytic or postanalytic testing process; or
(B) Substantial experience may be necessary for analytic test
performance.
(3) Reagents and materials preparation.
(i) Score 1. (A) Reagents and materials are generally stable and
reliable; and
(B) Reagents and materials are prepackaged, or premeasured, or
require no special handling, precautions or storage conditions.
(ii) Score 3. (A) Reagents and materials may be labile and may
require special handling to assure reliability; or
(B) Reagents and materials preparation may include manual steps such
as gravimetric or volumetric measurements.
(4) Characteristics of operational steps. (i) Score 1. Operational
steps are either automatically executed (such as pipetting, temperature
monitoring, or timing of steps), or are easily controlled.
(ii) Score 3. Operational steps in the testing process require close
monitoring or control, and may require special specimen preparation,
precise temperature control or timing of procedural steps, accurate
pipetting, or extensive calculations.
(5) Calibration, quality control, and proficiency testing materials.
(i) Score 1. (A) Calibration materials are stable and readily
available;
(B) Quality control materials are stable and readily available; and
(C) External proficiency testing materials, when available, are
stable.
(ii) Score 3. (A) Calibration materials, if available, may be
labile;
(B) Quality control materials may be labile, or not available; or
(C) External proficiency testing materials, if available, may be
labile.
(6) Test system troubleshooting and equipment maintenance.
(i) Score 1. (A) Test system troubleshooting is automatic or self-
correcting, or clearly described or requires minimal judgment; and
(B) Equipment maintenance is provided by the manufacturer, is seldom
needed, or can easily be performed.
(ii) Score 3. (A) Troubleshooting is not automatic and requires
decision-making and direct intervention to resolve most problems; or
(B) Maintenance requires special knowledge, skills, and abilities.
(7) Interpretation and judgment. (i) Score 1. (A) Minimal
interpretation and judgment are required to perform preanalytic,
analytic and postanalytic processes; and
(B) Resolution of problems requires limited independent
interpretation and judgment; and
(ii) Score 3. (A) Extensive independent interpretation and judgment
are required to perform the preanalytic, analytic or postanalytic
processes; and
(B) Resolution of problems requires extensive interpretation and
judgment.
(b) Revisions to the criteria for categorization. The Clinical
Laboratory Improvement Advisory Committee, as defined in subpart T of
this part, will conduct reviews upon request of HHS and recommend to HHS
revisions to the criteria for categorization of tests.
(c) Process for device/test categorization utilizing the scoring
system under Sec. 493.17(a). (1)(i) For new commercial test systems,
assays, or examinations, the manufacturer, as part of its 510(k) and PMA
application to FDA, will submit supporting data for device/test
categorization. FDA will determine the complexity category, notify the
manufacturers directly, and will simultaneously inform both HCFA and CDC
of the device/test category. FDA will consult with CDC concerning test
categorization in the following three situations:
[[Page 830]]
(A) When categorizing previously uncategorized new technology;
(B) When FDA determines it to be necessary in cases involving a
request for a change in categorization; and
(C) If a manufacturer requests review of a categorization decision
by FDA in accordance with 21 CFR 10.75.
(ii) Test categorization will be effective as of the notification to
the applicant.
(2) For test systems, assays, or examinations not commercially
available, a laboratory or professional group may submit a written
request for categorization to PHS. These requests will be forwarded to
CDC for evaluation; CDC will determine complexity category and notify
the applicant, HCFA, and FDA of the categorization decision. In the case
of request for a change of category or for previously uncategorized new
technology, PHS will receive the request application and forward it to
CDC for categorization.
(3) A request for recategorization will be accepted for review if it
is based on new information not previously submitted in a request for
categorization or recategorization by the same applicant and will not be
considered more frequently than once per year.
(4) If a laboratory test system, assay or examination does not
appear on the lists of tests in the Federal Register notices, it is
considered to be a test of high complexity until PHS, upon request,
reviews the matter and notifies the applicant of its decision. Test
categorization is effective as of the notification to the applicant.
(5) PHS will publish revisions periodically to the list of moderate
and high complexity tests in the Federal Register in a notice with
opportunity for comment.
[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993]
Sec. 493.19 Provider-performed microscopy (PPM) procedures.
(a) Requirement. To be categorized as a PPM procedure, the procedure
must meet the criteria specified in paragraph (b) of this section.
(b) Criteria. Procedures must meet the following specifications:
(1) The examination must be personally performed by one of the
following practitioners:
(i) A physician during the patient's visit on a specimen obtained
from his or her own patient or from a patient of a group medical
practice of which the physician is a member or an employee.
(ii) A midlevel practitioner, under the supervision of a physician
or in independent practice only if authorized by the State, during the
patient's visit on a specimen obtained from his or her own patient or
from a patient of a clinic, group medical practice, or other health care
provider of which the midlevel practitioner is a member or an employee.
(iii) A dentist during the patient's visit on a specimen obtained
from his or her own patient or from a patient of a group dental practice
of which the dentist is a member or an employee.
(2) The procedure must be categorized as moderately complex.
(3) The primary instrument for performing the test is the
microscope, limited to bright-field or phase-contrast microscopy.
(4) The specimen is labile or delay in performing the test could
compromise the accuracy of the test result.
(5) Control materials are not available to monitor the entire
testing process.
(6) Limited specimen handling or processing is required.
(c) Provider-performed microscopy (PPM) examinations. A laboratory
may qualify to perform tests under this section if it restricts PPM
examinations to one or more of the following procedures (or additional
procedures added to this list as provided under paragraph (d) of this
section), waived tests and no others:
(1) All direct wet mount preparations for the presence or absence of
bacteria, fungi, parasites, and human cellular elements.
(2) All potassium hydroxide (KOH) preparations.
(3) Pinworm examinations.
(4) Fern tests.
(5) Post-coital direct, qualitative examinations of vaginal or
cervical mucous.
(6) Urine sediment examinations.
(7) Nasal smears for granulocytes.
[[Page 831]]
(8) Fecal leukocyte examinations.
(9) Qualitative semen analysis (limited to the presence or absence
of sperm and detection of motility).
(d) Revisions to criteria and the list of PPM procedures.
(1) The CLIAC conducts reviews upon HHS' request and recommends to
HHS revisions to the criteria for categorization of procedures.
(2) HHS determines whether a laboratory procedure meets the criteria
listed under paragraph (b) of this section for a PPM procedure.
Revisions to the list of PPM procedures proposed by HHS are published in
the Federal Register as a notice with an opportunity for public comment.
(e) Laboratory requirements. Laboratories eligible to perform PPM
examinations must--
(1) Meet the applicable requirements in subpart C or subpart D, and
subparts F, H, J, K, M, and P of this part.
(2) Be subject to inspection as specified under subpart Q of this
part.
[60 FR 20044, Apr. 24, 1995]
Sec. 493.20 Laboratories performing tests of moderate complexity.
(a) A laboratory may qualify for a certificate to perform tests of
moderate complexity provided that it restricts its test performance to
waived tests or examinations and one or more tests or examinations
meeting criteria for tests of moderate complexity including the
subcategory of PPM procedures.
(b) A laboratory that performs tests or examinations of moderate
complexity must meet the applicable requirements in subpart C or subpart
D, and subparts F, H, J, K, M, P, and Q of this part. Under a
registration certificate or certificate of compliance, laboratories also
performing PPM procedures must meet the inspection requirements at
Sec. 493.1777.
(c) If the laboratory also performs waived tests, compliance with
subparts H, J, K, M, and P of this part is not applicable to the waived
tests. However, the laboratory must comply with the requirements in
Secs. 493.15(e) and 493.1775.
[60 FR 20044, Apr. 24, 1995]
Sec. 493.25 Laboratories performing tests of high complexity.
(a) A laboratory must obtain a certificate for tests of high
complexity if it performs one or more tests that meet the criteria for
tests of high complexity as specified in Sec. 493.17(a).
(b) A laboratory performing one or more tests of high complexity
must meet the applicable requirements of subpart C or subpart D, and
subparts F, H, J, K, M, P, and Q of this part.
(c) If the laboratory also performs tests of moderate complexity,
the applicable requirements of subparts H, J, K, M, P, and Q of this
part must be met. Under a registration certificate or certificate of
compliance, PPM procedures must meet the inspection requirements at
Sec. 493.1777.
(d) If the laboratory also performs waived tests, the requirements
of subparts H, J, K, M, and P are not applicable to the waived tests.
However, the laboratory must comply with the requirements in
Secs. 493.15(e) and 493.1775.
[57 FR 7139, Feb. 28, 1992, as amended at 60 FR 20044, Apr. 24, 1995]
Subpart B--Certificate of Waiver
Source: 57 FR 7142, Feb. 28, 1992, unless otherwise noted.
Sec. 493.35 Application for a certificate of waiver.
(a) Filing of application. Except as specified in paragraph (b) of
this section, a laboratory performing only one or more waived tests
listed in Sec. 493.15 must file a separate application for each
laboratory location.
(b) Exceptions. (1) Laboratories that are not at a fixed location,
that is, laboratories that move from testing site to testing site, such
as mobile units providing laboratory testing, health screening fairs, or
other temporary testing locations may be covered under the certificate
of the designated primary site or home base, using its address.
(2) Not-for-profit or Federal, State, or local government
laboratories that engage in limited (not more than a combination of 15
moderately complex or waived tests per certificate) public
[[Page 832]]
health testing may file a single application.
(3) Laboratories within a hospital that are located at contiguous
buildings on the same campus and under common direction may file a
single application or multiple applications for the laboratory sites
within the same physical location or street address.
(c) Application format and contents. The application must--
(1) Be made to HHS or its designee on a form or forms prescribed by
HHS;
(2) Be signed by an owner, or by an authorized representative of the
laboratory who attests that the laboratory will be operated in
accordance with requirements established by the Secretary under section
353 of the PHS Act; and
(3) Describe the characteristics of the laboratory operation and the
examinations and other test procedures performed by the laboratory
including--
(i) The name and the total number of test procedures and
examinations performed annually (excluding tests the laboratory may run
for quality control, quality assurance or proficiency testing purposes;
(ii) The methodologies for each laboratory test procedure or
examination performed, or both; and
(iii) The qualifications (educational background, training, and
experience) of the personnel directing and supervising the laboratory
and performing the laboratory examinations and test procedures.
(d) Access requirements. Laboratories that perform one or more
waived tests listed in Sec. 493.15(c) and no other tests must meet the
following conditions:
(1) Make records available and submit reports to HHS as HHS may
reasonably require to determine compliance with this section and
Sec. 493.15(e);
(2) Agree to permit announced and unannounced inspections by HHS in
accordance with subpart Q of this part under the following
circumstances:
(i) When HHS has substantive reason to believe that the laboratory
is being operated in a manner that constitutes an imminent and serious
risk to human health.
(ii) To evaluate complaints from the public.
(iii) On a random basis to determine whether the laboratory is
performing tests not listed in Sec. 493.15.
(iv) To collect information regarding the appropriateness of waiver
of tests listed in Sec. 493.15.
(e) Denial of application. If HHS determines that the application
for a certificate of waiver is to be denied, HHS will--
(1) Provide the laboratory with a written statement of the grounds
on which the denial is based and an opportunity for appeal, in
accordance with the procedures set forth in subpart R of this part;
(2) Notify a laboratory that has its application for a certificate
of waiver denied that it cannot operate as a laboratory under the PHS
Act unless the denial is overturned at the conclusion of the
administrative appeals process provided by subpart R; and
(3) Notify the laboratory that it is not eligible for payment under
the Medicare and Medicaid programs.
[57 FR 7142, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993; 60
FR 20044, Apr. 24, 1995]
Sec. 493.37 Requirements for a certificate of waiver.
(a) HHS will issue a certificate of waiver to a laboratory only if
the laboratory meets the requirements of Sec. 493.35.
(b) Laboratories issued a certificate of waiver--
(1) Are subject to the requirements of this subpart and
Sec. 493.15(e) of subpart A of this part; and
(2) Must permit announced or unannounced inspections by HHS in
accordance with subpart Q of this part.
(c) Laboratories must remit the certificate of waiver fee specified
in subpart F of this part.
(d) In accordance with subpart R of this part, HHS will suspend or
revoke or limit a laboratory's certificate of waiver for failure to
comply with the requirements of this subpart. In addition, failure to
meet the requirements of this subpart will result in suspension or
denial of payments under Medicare and Medicaid in accordance with
subpart R of this part.
(e)(1) A certificate of waiver issued under this subpart is valid
for no more
[[Page 833]]
than 2 years. In the event of a non-compliance determination resulting
in HHS action to revoke, suspend, or limit the laboratory's certificate
of waiver, HHS will provide the laboratory with a statement of grounds
on which the determination of non-compliance is based and offer an
opportunity for appeal as provided in subpart R of this part.
(2) If the laboratory requests a hearing within the time specified
by HHS, it retains its certificate of waiver or reissued certificate of
waiver until a decision is made by an administrative law judge, as
specified in subpart R of this part, except when HHS finds that
conditions at the laboratory pose an imminent and serious risk to human
health.
(3) For laboratories receiving payment from the Medicare or Medicaid
program, such payments will be suspended on the effective date specified
in the notice to the laboratory of a non-compliance determination even
if there has been no appeals decision issued.
(f) A laboratory seeking to renew its certificate of waiver must--
(1) Complete the renewal application prescribed by HHS and return it
to HHS not less than 9 months nor more than 1 year before the expiration
of the certificate; and
(2) Meet the requirements of Secs. 493.35 and 493.37.
(g) A laboratory with a certificate of waiver that wishes to perform
examinations or tests not listed in the waiver test category must meet
the requirements set forth in subpart C or subpart D of this part, as
applicable.
[57 FR 7142, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993; 60
FR 20045, Apr. 24, 1995]
Sec. 493.39 Notification requirements for laboratories issued a
certificate of waiver.
Laboratories performing one or more tests listed in Sec. 493.15 and
no others must notify HHS or its designee--
(a) Before performing and reporting results for any test or
examination that is not specified under Sec. 493.15 for which the
laboratory does not have the appropriate certificate as required in
subpart C or subpart D of this part, as applicable; and
(b) Within 30 days of any change(s) in--
(1) Ownership;
(2) Name;
(3) Location; or
(4) Director.
[57 FR 7142, Feb. 28, 1992, as amended at 60 FR 20045, Apr. 24, 1995]
Subpart C--Registration Certificate, Certificate for Provider-performed
Microscopy Procedures, and Certificate of Compliance
Source: 57 FR 7143, Feb. 28, 1992, unless otherwise noted.
Sec. 493.43 Application for registration certificate, certificate for
provider-performed microscopy (PPM) procedures, and
certificate of compliance.
(a) Filing of application. Except as specified in paragraph (b) of
this section, all laboratories performing tests of moderate complexity
(including the subcategory) or high complexity, or any combination of
these tests, must file a separate application for each laboratory
location.
(b) Exceptions. (1) Laboratories that are not at a fixed location,
that is, laboratories that move from testing site to testing site, such
as mobile units providing laboratory testing, health screening fairs, or
other temporary testing locations may be covered under the certificate
of the designated primary site or home base, using its address.
(2) Not-for-profit or Federal, State, or local government
laboratories that engage in limited (not more than a combination of 15
moderately complex or waived tests per certificate) public health
testing may file a single application.
(3) Laboratories within a hospital that are located at contiguous
buildings on the same campus and under common direction may file a
single application or multiple applications for the laboratory sites
within the same physical location or street address.
[[Page 834]]
(c) Application format and contents. The application must--(1) Be
made to HHS or its designee on a form or forms prescribed by HHS;
(2) Be signed by an owner, or by an authorized representative of the
laboratory who attests that the laboratory will be operated in
accordance with the requirements established by the Secretary under
section 353 of the Public Health Service Act; and
(3) Describe the characteristics of the laboratory operation and the
examinations and other test procedures performed by the laboratory
including--
(i) The name and total number of test procedures and examinations
performed annually (excluding waived tests or tests for quality control,
quality assurance or proficiency testing purposes);
(ii) The methodologies for each laboratory test procedure or
examination performed, or both;
(iii) The qualifications (educational background, training, and
experience) of the personnel directing and supervising the laboratory
and performing the examinations and test procedures.
(d) Access and reporting requirements. All laboratories must make
records available and submit reports to HHS as HHS may reasonably
require to determine compliance with this section.
[57 FR 7143, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993; 58
FR 39155, July 22, 1993; 60 FR 20045, Apr. 24, 1995]
Sec. 493.45 Requirements for a registration certificate.
Laboratories performing only waived tests, PPM procedures, or any
combination of these tests, are not required to obtain a registration
certificate.
(a) A registration certificate is required--(1) Initially for all
laboratories performing test procedures of moderate complexity (other
than the subcategory of PPM procedures) or high complexity, or both; and
(2) For all laboratories that have been issued a certificate of
waiver or certificate for PPM procedures that intend to perform tests of
moderate or high complexity, or both, in addition to those tests listed
in Sec. 493.15(c) or specified as PPM procedures.
(b) HHS will issue a registration certificate if the laboratory--
(1) Complies with the requirements of Sec. 493.43;
(2) Agrees to notify HHS or its designee within 30 days of any
changes in ownership, name, location, director or technical supervisor
(laboratories performing high complexity testing only);
(3) Agrees to treat proficiency testing samples in the same manner
as it treats patient specimens; and
(4) Remits the fee for the registration certificate, as specified in
subpart F of this part.
(c) Prior to the expiration of the registration certificate, a
laboratory must--
(1) Remit the certificate fee specified in subpart F of this part;
(2) Be inspected by HHS as specified in subpart Q of this part; and
(3) Demonstrate compliance with the applicable requirements of this
subpart and subparts H, J, K, M, P, and Q of this part.
(d) In accordance with subpart R of this part, HHS will initiate
suspension or revocation of a laboratory's registration certificate and
will deny the laboratory's application for a certificate of compliance
for failure to comply with the requirements set forth in this subpart.
HHS may also impose certain alternative sanctions. In addition, failure
to meet the requirements of this subpart will result in suspension of
payments under Medicare and Medicaid as specified in subpart R of this
part.
(e) A registration certificate is--
(1) Valid for a period of no more than two years or until such time
as an inspection to determine program compliance can be conducted,
whichever is shorter; and
(2) Not renewable; however, the registration certificate may be
reissued if compliance has not been determined by HHS prior to the
expiration date of the registration certificate.
(f) In the event of a noncompliance determination resulting in an
HHS denial of a laboratory's certificate of compliance application, HHS
will provide the laboratory with a statement of grounds on which the
noncompliance determination is based and offer an opportunity for appeal
as provided in subpart R.
[[Page 835]]
(g) If the laboratory requests a hearing within the time specified
by HHS, it retains its registration certificate or reissued registration
certificate until a decision is made by an administrative law judge as
provided in subpart R of this part, except when HHS finds that
conditions at the laboratory pose an imminent and serious risk to human
health.
(h) For laboratories receiving payment from the Medicare or Medicaid
program, such payments will be suspended on the effective date specified
in the notice to the laboratory of denial of the certificate application
even if there has been no appeals decision issued.
[57 FR 7143, Feb. 28, 1992, as amended at 58 FR 5223, Jan. 19, 1993; 60
FR 20045, Apr. 24, 1995]
Sec. 493.47 Requirements for a certificate for provider-performed
microscopy (PPM) procedures.
(a) A certificate for PPM procedures is required--
(1) Initially for all laboratories performing test procedures
specified as PPM procedures; and
(2) For all certificate of waiver laboratories that intend to
perform only test procedures specified as PPM procedures in addition to
those tests listed in Sec. 493.15(c).
(b) HHS will issue a certificate for PPM procedures if the
laboratory--
(1) Complies with the requirements of Sec. 493.43; and
(2) Remits the fee for the certificate, as specified in subpart F of
this part.
(c) Laboratories issued a certificate for PPM procedures are subject
to--
(1) The notification requirements of Sec. 493.53;
(2) The applicable requirements of this subpart and subparts H, J,
K, M, and P of this part; and
(3) Inspection only under the circumstances specified under
Sec. 493.1776, but are not routinely inspected to determine compliance
with the requirements specified in paragraphs (c) (1) and (2) of this
section.
(d) In accordance with subpart R of this part, HHS will initiate
suspension, limitation, or revocation of a laboratory's certificate for
PPM procedures for failure to comply with the applicable requirements
set forth in this subpart. HHS may also impose certain alternative
sanctions. In addition, failure to meet the requirements of this subpart
may result in suspension of all or part of payments under Medicare and
Medicaid, as specified in subpart R of this part.
(e) A certificate for PPM procedures is valid for a period of no
more than 2 years.
[58 FR 5223, Jan. 19, 1993, as amended at 60 FR 20045, Apr. 24, 1995]
Sec. 493.49 Requirements for a certificate of compliance.
A certificate of compliance may include any combination of tests
categorized as high complexity or moderate complexity or listed in
Sec. 493.15(c) as waived tests. Moderate complexity tests may include
those specified as PPM procedures.
(a) HHS will issue a certificate of compliance to a laboratory only
if the laboratory--
(1) Meets the requirements of Secs. 493.43 and 493.45;
(2) Remits the certificate fee specified in subpart F of this part;
and
(3) Meets the applicable requirements of this subpart and subparts
H, J, K, M, P, and Q of this part.
(b) Laboratories issued a certificate of compliance--
(1) Are subject to the notification requirements of Sec. 493.51; and
(2) Must permit announced or unannounced inspections by HHS in
accordance with subpart Q of this part--
(i) To determine compliance with the applicable requirements of this
part;
(ii) To evaluate complaints;
(iii) When HHS has substantive reason to believe that tests are
being performed, or the laboratory is being operated in a manner that
constitutes an imminent and serious risk to human health; and
(iv) To collect information regarding the appropriateness of tests
listed in Sec. 493.15 or tests categorized as moderate complexity
(including the subcategory) or high complexity.
(c) Failure to comply with the requirements of this subpart will
result in--
(1) Suspension, revocation or limitation of a laboratory's
certificate of
[[Page 836]]
compliance in accordance with subpart R of this part; and
(2) Suspension or denial of payments under Medicare and Medicaid in
accordance with subpart R of this part.
(d) A certificate of compliance issued under this subpart is valid
for no more than 2 years.
(e) In the event of a noncompliance determination resulting in an
HHS action to revoke, suspend or limit the laboratory's certificate of
compliance, HHS will--
(1) Provide the laboratory with a statement of grounds on which the
determination of noncompliance is based; and
(2) Offer an opportunity for appeal as provided in subpart R of this
part. If the laboratory requests a hearing within 60 days of the notice
of sanction, it retains its certificate of compliance or reissued
certificate of compliance until a decision is made by an administrative
law judge (ALJ) as provided in subpart R of this part, except when HHS
finds that conditions at the laboratory pose an imminent and serious
risk to human health or when the criteria at Sec. 493.1840(a) (4) and
(5) are met.
(f) For laboratories receiving payment from the Medicare or Medicaid
program, such payments will be suspended on the effective date specified
in the notice to the laboratory of a noncompliance determination even if
there has been no appeals decision issued.
(g) A laboratory seeking to renew its certificate of compliance
must--
(1) Complete and return the renewal application to HHS 9 to 12
months prior to the expiration of the certificate of compliance; and
(2) Meet the requirements of Sec. 493.43 and paragraphs (a)(2) and
(b)(2) of this section.
(h) If HHS determines that the application for the renewal of a
certificate of compliance must be denied or limited, HHS will notify the
laboratory in writing of the--
(1) Basis for denial of the application; and
(2) Opportunity for appeal as provided in subpart R of this part.
(i) If the laboratory requests a hearing within the time period
specified by HHS, the laboratory retains its certificate of compliance
or reissued certificate of compliance until a decision is made by an ALJ
as provided in subpart R, except when HHS finds that conditions at the
laboratory pose an imminent and serious risk to human health.
(j) For laboratories receiving payment from the Medicare or Medicaid
program, such payments will be suspended on the effective date specified
in the notice to the laboratory of nonrenewal of the certificate of
compliance even if there has been no appeals decision issued.
[60 FR 20045, Apr. 24, 1995]
Sec. 493.51 Notification requirements for laboratories issued a
certificate of compliance.
Laboratories issued a certificate of compliance must meet the
following conditions:
(a) Notify HHS or its designee within 30 days of any change in--
(1) Ownership;
(2) Name;
(3) Location;
(4) Director; or
(5) Technical supervisor (laboratories performing high complexity
only).
(b) Notify HHS no later than 6 months after performing any test or
examination within a specialty or subspecialty area that is not included
on the laboratory's certificate of compliance, so that compliance with
requirements can be determined.
(c) Notify HHS no later than 6 months after any deletions or changes
in test methodologies for any test or examination included in a
specialty or subspecialty, or both, for which the laboratory has been
issued a certificate of compliance.
[57 FR 7143, Feb. 28, 1992, as amended at 60 FR 20046, Apr. 24, 1995]
Sec. 493.53 Notification requirements for laboratories issued a
certificate for provider-performed microscopy (PPM)
procedures.
Laboratories issued a certificate for PPM procedures must notify HHS
or its designee--
(a) Before performing and reporting results for any test of moderate
or high complexity, or both, in addition to tests specified as PPM
procedures or any test or examination that is not
[[Page 837]]
specified under Sec. 493.15(c), for which it does not have a
registration certificate as required in subpart C or subpart D, as
applicable, of this part; and
(b) Within 30 days of any change in--
(1) Ownership;
(2) Name;
(3) Location; or
(4) Director.
[58 FR 5224, Jan. 19, 1993, as amended at 60 FR 20046, Apr. 24, 1995]
Subpart D--Certificate of Accreditation
Source: 57 FR 7144, Feb. 28, 1992, unless otherwise noted.
Sec. 493.55 Application for registration certificate and certificate of
accreditation.
(a) Filing of application. A laboratory may be issued a certificate
of accreditation in lieu of the applicable certificate specified in
subpart B or subpart C of this part provided the laboratory--
(1) Meets the standards of a private non-profit accreditation
program approved by HHS in accordance with subpart E; and
(2) Files a separate application for each location, except as
specified in paragraph (b) of this section.
(b) Exceptions. (1) Laboratories that are not at fixed locations,
that is, laboratories that move from testing site to testing site, such
as mobile units providing laboratory testing, health screening fairs, or
other temporary testing locations may be covered under the certificate
of the designated primary site or home base, using its address.
(2) Not-for-profit or Federal, State, or local government
laboratories that engage in limited (not more than a combination of 15
moderately complex or waived tests per certificate) public health
testing may file a single application.
(3) Laboratories within a hospital that are located at contiguous
buildings on the same campus and under common direction may file a
single application or multiple applications for the laboratory sites
within the same physical location or street address.
(c) Application format and contents. The application must--(1) Be
made to HHS on a form or forms prescribed by HHS;
(2) Be signed by an owner or authorized representative of the
laboratory who attests that the laboratory will be operated in
accordance with the requirements established by the Secretary under
section 353 of the Public Health Service Act; and
(3) Describe the characteristics of the laboratory operation and the
examinations and other test procedures performed by the laboratory
including--
(i) The name and total number of tests and examinations performed
annually (excluding waived tests and tests for quality control, quality
assurance or proficiency testing purposes);
(ii) The methodologies for each laboratory test procedure or
examination performed, or both; and
(iii) The qualifications (educational background, training, and
experience) of the personnel directing and supervising the laboratory
and performing the laboratory examinations and test procedures.
(d) Access and reporting requirements. All laboratories must make
records available and submit reports to HHS as HHS may reasonably
require to determine compliance with this section.
[57 FR 7144, Feb. 28, 1992, as amended at 58 FR 5224, Jan. 19, 1993; 58
FR 39155, July 22, 1993; 60 FR 20046, Apr. 24, 1995]
Sec. 493.57 Requirements for a registration certificate.
A registration certificate is required for all laboratories seeking
a certificate of accreditation, unless the laboratory holds a valid
certificate of compliance issued by HHS.
(a) HHS will issue a registration certificate if the laboratory--
(1) Complies with the requirements of Sec. 493.55;
(2) Agrees to notify HHS within 30 days of any changes in ownership,
name, location, director, or supervisor (laboratories performing high
complexity testing only);
(3) Agrees to treat proficiency testing samples in the same manner
as it treats patient specimens; and
[[Page 838]]
(4) Remits the fee for the registration certificate specified in
subpart F of this part.
(b)(1) The laboratory must provide HHS with proof of accreditation
by an approved accreditation program--
(i) Within 11 months of issuance of the registration certificate; or
(ii) Prior to the expiration of the certificate of compliance.
(2) If such proof of accreditation is not supplied within this
timeframe, the laboratory must meet, or continue to meet, the
requirements of Sec. 493.49.
(c) In accordance with subpart R of this part, HHS will initiate
suspension, revocation, or limitation of a laboratory's registration
certificate and will deny the laboratory's application for a certificate
of accreditation for failure to comply with the requirements set forth
in this subpart. In addition, failure to meet the requirements of this
subpart will result in suspension or denial of payments under Medicare
and Medicaid as specified in subpart R of this part.
(d) A registration certificate is valid for a period of no more than
2 years. However, it may be reissued if the laboratory is subject to
subpart C of this part, as specified in Sec. 493.57(b)(2) and compliance
has not been determined by HHS before the expiration date of the
registration certificate.
(e) In the event that the laboratory does not meet the requirements
of this subpart, HHS will--
(1) Deny a laboratory's request for certificate of accreditation;
(2) Notify the laboratory if it must meet the requirements for a
certificate as defined in subpart C of this part;
(3) Provide the laboratory with a statement of grounds on which the
application denial is based;
(4) Offer an opportunity for appeal on the application denial as
provided in subpart R of this part. If the laboratory requests a hearing
within the time specified by HHS, the laboratory will retain its
registration certificate or reissued registration certificate until a
decision is made by an administrative law judge as provided in subpart
R, unless HHS finds that conditions at the laboratory pose an imminent
and serious risk to human health; and
(5) For those laboratories receiving payment from the Medicare or
Medicaid program, such payments will be suspended on the effective date
specified in the notice to the laboratory of denial of the request even
if there has been no appeals decision issued.
[57 FR 7144, Feb. 28, 1992, as amended at 60 FR 20046, Apr. 24, 1995]
Sec. 493.61 Requirements for a certificate of accreditation.
(a) HHS will issue a certificate of accreditation to a laboratory if
the laboratory--
(1) Meets the requirements of Sec. 493.57 or, if applicable,
Sec. 493.49 of subpart C of this part; and
(2) Remits the certificate of accreditation fee specified in subpart
F of this part.
(b) Laboratories issued a certificate of accreditation must--
(1) Treat proficiency testing samples in the same manner as patient
samples;
(2) Meet the requirements of Sec. 493.63;
(3) Comply with the requirements of the approved accreditation
program;
(4) Permit random sample validation and complaint inspections as
required in subpart Q of this part;
(5) Permit HHS to monitor the correction of any deficiencies found
through the inspections specified in paragraph (b)(4) of this section;
(6) Authorize the accreditation program to release to HHS the
laboratory's inspection findings whenever HHS conducts random sample or
complaint inspections; and
(7) Authorize its accreditation program to submit to HHS the results
of the laboratory's proficiency testing.
(c) A laboratory failing to meet the requirements of this section--
(1) Will no longer meet the requirements of this part by virtue of
its accreditation in an approved accreditation program;
(2) Will be subject to full determination of compliance by HHS;
(3) May be subject to suspension, revocation or limitation of the
laboratory's certificate of accreditation or certain alternative
sanctions; and
(4) May be subject to suspension of payments under Medicare and
Medicaid as specified in subpart R.
[[Page 839]]
(d) A certificate of accreditation issued under this subpart is
valid for no more than 2 years. In the event of a non-compliance
determination as a result of a random sample validation or complaint
inspection, a laboratory will be subject to a full review by HHS in
accordance with Sec. 488.11 of this chapter.
(e) Failure to meet the applicable requirements of part 493, will
result in an action by HHS to suspend, revoke or limit the certificate
of accreditation. HHS will--
(1) Provide the laboratory with a statement of grounds on which the
determination of noncompliance is based;
(2) Notify the laboratory if it is eligible to apply for a
certificate as defined in subpart C of this part; and
(3) Offer an opportunity for appeal as provided in subpart R of this
part.
(f) If the laboratory requests a hearing within the time frame
specified by HHS--
(1) It retains its certificate of accreditation or reissued
certificate of accreditation until a decision is made by an
administrative law judge as provided in subpart R of this part, unless
HHS finds that conditions at the laboratory pose an imminent and serious
risk to human health; and
(2) For those laboratories receiving payments from the Medicare or
Medicaid program, such payments will be suspended on the effective date
specified in the notice to the laboratory even if there has been no
appeals decision issued.
(g) In the event the accreditation organization's approval is
removed by HHS, the laboratory will be subject to the applicable
requirements of subpart C of this part or Sec. 493.57.
(h) A laboratory seeking to renew its certificate of accreditation
must--
(1) Complete and return the renewal application to HHS 9 to 12
months prior to the expiration of the certificate of accreditation;
(2) Meet the requirements of this subpart; and
(3) Submit the certificate of accreditation fee specified in subpart
F of this part.
(i) If HHS determines that the renewal application for a certificate
of accreditation is to be denied or limited, HHS will notify the
laboratory in writing of--
(1) The basis for denial of the application;
(2) Whether the laboratory is eligible for a certificate as defined
in subpart C of this part;
(3) The opportunity for appeal on HHS's action to deny the renewal
application for certificate of accreditation as provided in subpart R of
this part. If the laboratory requests a hearing within the time frame
specified by HHS, it retains its certificate of accreditation or
reissued certificate of accreditation until a decision is made by an
administrative law judge as provided in subpart R of this part, unless
HHS finds that conditions at the laboratory pose an imminent and serious
risk to human health; and
(4) Suspension of payments under Medicare or Medicaid for those
laboratories receiving payments under the Medicare or Medicaid programs.
[57 FR 7144, Feb. 28, 1992, as amended at 58 FR 5224, Jan. 19, 1993]
Sec. 493.63 Notification requirements for laboratories issued a
certificate of accreditation.
Laboratories issued a certificate of accreditation must:
(a) Notify HHS and the approved accreditation program within 30 days
of any changes in--
(1) Ownership;
(2) Name;
(3) Location; or
(4) Director.
(b) Notify the approved accreditation program no later than 6 months
after performing any test or examination within a specialty or
subspecialty area that is not included in the laboratory's
accreditation, so that the accreditation organization can determine
compliance and a new certificate of accreditation can be issued.
(c) Notify the accreditation program no later than 6 months after of
any deletions or changes in test methodologies for any test or
examination included in a specialty or subspecialty, or both, for which
the laboratory has been issued a certificate of accreditation.
[[Page 840]]
Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
Source: 63 FR 26732, May 14, 1998, unless otherwise noted.
Sec. 493.551 General requirements for laboratories.
(a) Applicability. HCFA may deem a laboratory to meet all applicable
CLIA program requirements through accreditation by a private nonprofit
accreditation program (that is, grant deemed status), or may exempt from
CLIA program requirements all State licensed or approved laboratories in
a State that has a State licensure program established by law, if the
following conditions are met:
(1) The requirements of the accreditation organization or State
licensure program are equal to, or more stringent than, the CLIA
condition-level requirements specified in this part, and the laboratory
would meet the condition-level requirements if it were inspected against
these requirements.
(2) The accreditation program or the State licensure program meets
the requirements of this subpart and is approved by HCFA.
(3) The laboratory authorizes the approved accreditation
organization or State licensure program to release to HCFA all records
and information required and permits inspections as outlined in this
part.
(b) Meeting CLIA requirements by accreditation. A laboratory seeking
to meet CLIA requirements through accreditation by an approved
accreditation organization must do the following:
(1) Obtain a certificate of accreditation as required in subpart D
of this part.
(2) Pay the applicable fees as required in subpart F of this part.
(3) Meet the proficiency testing (PT) requirements in subpart H of
this part.
(4) Authorize its PT organization to furnish to its accreditation
organization the results of the laboratory's participation in an
approved PT program for the purpose of monitoring the laboratory's PT
and for making the annual PT results, along with explanatory information
required to interpret the PT results, available on a reasonable basis,
upon request of any person. A laboratory that refuses to authorize
release of its PT results is no longer deemed to meet the condition-
level requirements and is subject to a full review by HCFA, in
accordance with subpart Q of this part, and may be subject to the
suspension or revocation of its certificate of accreditation under
Sec. 493.1840.
(5) Authorize its accreditation organization to release to HCFA or a
HCFA agent the laboratory's PT results that constitute unsuccessful
participation in an approved PT program, in accordance with the
definition of ``unsuccessful participation in an approved PT program,''
as specified in Sec. 493.2 of this part, when the laboratory has failed
to achieve successful participation in an approved PT program.
(6) Authorize its accreditation organization to release to HCFA a
notification of the actions taken by the organization as a result of the
unsuccessful participation in a PT program within 30 days of the
initiation of the action. Based on this notification, HCFA may take an
adverse action against a laboratory that fails to participate
successfully in an approved PT program.
(c) Withdrawal of laboratory accreditation. After an accreditation
organization has withdrawn or revoked its accreditation of a laboratory,
the laboratory retains its certificate of accreditation for 45 days
after the laboratory receives notice of the withdrawal or revocation of
the accreditation, or the effective date of any action taken by HCFA,
whichever is earlier.
Sec. 493.553 Approval process (application and reapplication) for
accreditation organizations and State licensure programs.
(a) Information required. An accreditation organization that applies
or reapplies to HCFA for deeming authority, or a State licensure program
that applies or reapplies to HCFA for exemption from CLIA program
requirements of licensed or approved laboratories within the State, must
provide the following information:
[[Page 841]]
(1) A detailed comparison of the individual accreditation, or
licensure or approval requirements with the comparable condition-level
requirements; that is, a crosswalk.
(2) A detailed description of the inspection process, including the
following:
(i) Frequency of inspections.
(ii) Copies of inspection forms.
(iii) Instructions and guidelines.
(iv) A description of the review and decision-making process of
inspections.
(v) A statement concerning whether inspections are announced or
unannounced.
(vi) A description of the steps taken to monitor the correction of
deficiencies.
(3) A description of the process for monitoring PT performance,
including action to be taken in response to unsuccessful participation
in a HCFA-approved PT program.
(4) Procedures for responding to and for the investigation of
complaints against its laboratories.
(5) A list of all its current laboratories and the expiration date
of their accreditation or licensure, as applicable.
(6) Procedures for making PT information available (under State
confidentiality and disclosure requirements, if applicable) including
explanatory information required to interpret PT results, on a
reasonable basis, upon request of any person.
(b) HCFA action on an application or reapplication. If HCFA receives
an application or reapplication from an accreditation organization, or
State licensure program, HCFA takes the following actions:
(1) HCFA determines if additional information is necessary to make a
determination for approval or denial of the application and notifies the
accreditation organization or State to afford it an opportunity to
provide the additional information.
(2) HCFA may visit the accreditation organization or State licensure
program offices to review and verify the policies and procedures
represented in its application and other information, including, but not
limited to, review and examination of documents and interviews with
staff.
(3) HCFA notifies the accreditation organization or State licensure
program indicating whether HCFA approves or denies the request for
deeming authority or exemption, respectively, and the rationale for any
denial.
(c) Duration of approval. HCFA approval may not exceed 6 years.
(d) Withdrawal of application. The accreditation organization or
State licensure program may withdraw its application at any time before
official notification, specified at Sec. 493.553(b)(3).
Sec. 493.555 Federal review of laboratory requirements.
HCFA's review of an accreditation organization or State licensure
program includes, but is not limited to, an evaluation of the following:
(a) Whether the organization's or State's requirements for
laboratories are equal to, or more stringent than, the condition-level
requirements for laboratories.
(b) The organization's or State's inspection process to determine
the comparability of the full inspection and complaint inspection
procedures and requirements to those of HCFA, including, but not limited
to, inspection frequency and the ability to investigate and respond to
complaints against its laboratories.
(c) The organization's or State's agreement with HCFA that requires
it to do the following:
(1) Notify HCFA within 30 days of the action taken, of any
laboratory that has--
(i) Had its accreditation or licensure suspended, withdrawn,
revoked, or limited;
(ii) In any way been sanctioned; or
(iii) Had any adverse action taken against it.
(2) Notify HCFA within 10 days of any deficiency identified in an
accredited or CLIA-exempt laboratory if the deficiency poses an
immediate jeopardy to the laboratory's patients or a hazard to the
general public.
(3) Notify HCFA, within 30 days, of all newly--
(i) Accredited laboratories (or laboratories whose areas of
specialty/subspecialty testing have changed); or
[[Page 842]]
(ii) Licensed laboratories, including the specialty/subspecialty
areas of testing.
(4) Notify each accredited or licensed laboratory within 10 days of
HCFA's withdrawal of the organization's deeming authority or State's
exemption.
(5) Provide HCFA with inspection schedules, as requested, for
validation purposes.
Sec. 493.557 Additional submission requirements.
(a) Specific requirements for accreditation organizations. In
addition to the information specified in Secs. 493.553 and 493.555, as
part of the approval and review process, an accreditation organization
applying or reapplying for deeming authority must also provide the
following:
(1) The specialty or subspecialty areas for which the organization
is requesting deeming authority and its mechanism for monitoring
compliance with all requirements equivalent to condition-level
requirements within the scope of the specialty or subspecialty areas.
(2) A description of the organization's data management and analysis
system with respect to its inspection and accreditation decisions,
including the kinds of routine reports and tables generated by the
systems.
(3) Detailed information concerning the inspection process,
including, but not limited to the following:
(i) The size and composition of individual accreditation inspection
teams.
(ii) Qualifications, education, and experience requirements that
inspectors must meet.
(iii) The content and frequency of training provided to inspection
personnel, including the ability of the organization to provide
continuing education and training to inspectors.
(4) Procedures for removal or withdrawal of accreditation status for
laboratories that fail to meet the organization's standards.
(5) A proposed agreement between HCFA and the accreditation
organization with respect to the notification requirements specified in
Sec. 493.555(c).
(6) Procedures for monitoring laboratories found to be out of
compliance with its requirements. (These monitoring procedures must be
used only when the accreditation organization identifies noncompliance.
If noncompliance is identified through validation inspections, HCFA or a
HCFA agent monitors corrections, as authorized at Sec. 493.565(d)).
(7) A demonstration of its ability to provide HCFA with electronic
data and reports in compatible code, including the crosswalk specified
in Sec. 493.553(a)(1), that are necessary for effective validation and
assessment of the organization's inspection process.
(8) A demonstration of its ability to provide HCFA with electronic
data, in compatible code, related to the adverse actions resulting from
PT results constituting unsuccessful participation in PT programs as
well as data related to the PT failures, within 30 days of the
initiation of adverse action.
(9) A demonstration of its ability to provide HCFA with electronic
data, in compatible code, for all accredited laboratories, including the
area of specialty or subspecialty.
(10) Information defining the adequacy of numbers of staff and other
resources.
(11) Information defining the organization's ability to provide
adequate funding for performing required inspections.
(12) Any facility-specific data, upon request by HCFA, which
includes, but is not limited to, the following:
(i) PT results that constitute unsuccessful participation in a HCFA-
approved PT program.
(ii) Notification of the adverse actions or corrective actions
imposed by the accreditation organization as a result of unsuccessful PT
participation.
(13) An agreement to provide written notification to HCFA at least
30 days in advance of the effective date of any proposed change in its
requirements.
(14) An agreement to disclose any laboratory's PT results upon
reasonable request by any person.
(b) Specific requirements for a State licensure program. In addition
to requirements in Secs. 493.553 and 493.555, as part of the approval
and review process, when a State licensure program applies or reapplies
for exemption from the CLIA program, the State must do the following:
[[Page 843]]
(1) Demonstrate to HCFA that it has enforcement authority and
administrative structures and resources adequate to enforce its
laboratory requirements.
(2) Permit HCFA or a HCFA agent to inspect laboratories in the
State.
(3) Require laboratories in the State to submit to inspections by
HCFA or a HCFA agent as a condition of licensure or approval.
(4) Agree to pay the cost of the validation program administered in
that State as specified in Secs. 493.645(a) and 493.646(b).
(5) Take appropriate enforcement action against laboratories found
by HCFA not to be in compliance with requirements equivalent to CLIA
requirements.
(6) Submit for Medicare and Medicaid payment purposes, a list of the
specialties and subspecialties of tests performed by each laboratory.
(7) Submit a written presentation that demonstrates the agency's
ability to furnish HCFA with electronic data in compatible code,
including the crosswalk specified in Sec. 493.553(a)(1).
(8) Submit a statement acknowledging that the State will notify HCFA
through electronic transmission of the following:
(i) Any laboratory that has had its licensure or approval revoked or
withdrawn or has been in any way sanctioned by the State within 30 days
of taking the action.
(ii) Changes in licensure or inspection requirements.
(iii) Changes in specialties or subspecialties under which any
licensed laboratory in the State performs testing.
(9) Provide information for the review of the State's enforcement
procedures for laboratories found to be out of compliance with the
State's requirements.
(10) Submit information that demonstrates the ability of the State
to provide HCFA with the following:
(i) Electronic data and reports in compatible code with the adverse
or corrective actions resulting from PT results that constitute
unsuccessful participation in PT programs.
(ii) Other data that HCFA determines are necessary for validation
and assessment of the State's inspection process requirements.
(11) Agree to provide HCFA with written notification of any changes
in its licensure/approval and inspection requirements.
(12) Agree to disclose any laboratory's PT results in accordance
with a State's confidentiality requirements.
(13) Agree to take the appropriate enforcement action against
laboratories found by HCFA not to be in compliance with requirements
comparable to condition-level requirements and report these enforcement
actions to HCFA.
(14) If approved, reapply to HCFA every 2 years to renew its exempt
status and to renew its agreement to pay the cost of the HCFA-
administered validation program in that State.
Sec. 493.559 Publication of approval of deeming authority or CLIA
exemption.
(a) Notice of deeming authority or exemption. HCFA publishes a
notice in the Federal Register when it grants deeming authority to an
accreditation organization or exemption to a State licensure program.
(b) Contents of notice. The notice includes the following:
(1) The name of the accreditation organization or State licensure
program.
(2) For an accreditation organization:
(i) The specific specialty or subspecialty areas for which it is
granted deeming authority.
(ii) A description of how the accreditation organization provides
reasonable assurance to HCFA that a laboratory accredited by the
organization meets CLIA requirements equivalent to those in this part
and would meet CLIA requirements if the laboratory had not been granted
deemed status, but had been inspected against condition-level
requirements.
(3) For a State licensure program, a description of how the
laboratory requirements of the State are equal to, or more stringent
than, those specified in this part.
(4) The basis for granting deeming authority or exemption.
(5) The term of approval, not to exceed 6 years.
[[Page 844]]
Sec. 493.561 Denial of application or reapplication.
(a) Reconsideration of denial. (1) If HCFA denies a request for
approval, an accreditation organization or State licensure program may
request, within 60 days of the notification of denial, that HCFA
reconsider its original application or application for renewal, in
accordance with part 488, subpart D.
(2) If the accreditation organization or State licensure program
requests a reconsideration of HCFA's determination to deny its request
for approval or reapproval, it may not submit a new application until
HCFA issues a final reconsideration determination.
(b) Resubmittal of a request for approval-- accreditation
organization. An accreditation organization may resubmit a request for
approval if a final reconsideration determination is not pending and the
accreditation program meets the following conditions:
(1) It has revised its accreditation program to address the
rationale for denial of its previous request.
(2) It demonstrates that it can provide reasonable assurance that
its accredited facilities meet condition-level requirements.
(3) It resubmits the application in its entirety.
(c) Resubmittal of request for approval--State licensure program.
The State licensure program may resubmit a request for approval if a
final reconsideration determination is not pending and it has taken the
necessary action to address the rationale for any previous denial.
Sec. 493.563 Validation inspections--Basis and focus.
(a) Basis for validation inspection--(1) Laboratory with a
certificate of accreditation. (i) HCFA or a HCFA agent may conduct an
inspection of an accredited laboratory that has been issued a
certificate of accreditation on a representative sample basis or in
response to a substantial allegation of noncompliance.
(ii) HCFA uses the results of these inspections to validate the
accreditation organization's accreditation process.
(2) Laboratory in a State with an approved State licensure program.
(i) HCFA or a HCFA agent may conduct an inspection of any laboratory in
a State with an approved State licensure program on a representative
sample basis or in response to a substantial allegation of
noncompliance.
(ii) The results of these inspections are used to validate the
appropriateness of the exemption of that State's licensed or approved
laboratories from CLIA program requirements.
(b) Validation inspection conducted on a representative sample
basis. (1) If HCFA or a HCFA agent conducts a validation inspection on a
representative sample basis, the inspection is comprehensive, addressing
all condition-level requirements, or it may be focused on a specific
condition-level requirement.
(2) The number of laboratories sampled is sufficient to allow a
reasonable estimate of the performance of the accreditation organization
or State.
(c) Validation inspection conducted in response to a substantial
allegation of noncompliance. (1) If HCFA or a HCFA agent conducts a
validation inspection in response to a substantial allegation of
noncompliance, the inspection focuses on any condition-level requirement
that HCFA determines to be related to the allegation.
(2) If HCFA or a HCFA agent substantiates a deficiency and
determines that the laboratory is out of compliance with any condition-
level requirement, HCFA or a HCFA agent conducts a full CLIA inspection.
(d) Inspection of operations and offices. As part of the validation
review process, HCFA may conduct an onsite inspection of the operations
and offices to verify the following:
(1) The accreditation organization's representations and to assess
the accreditation organization's compliance with its own policies and
procedures.
(2) The State's representations and to assess the State's compliance
with its own policies and procedures, including verification of State
enforcement actions taken on the basis of validation inspections
performed by HCFA or a HCFA agent.
(e) Onsite inspection of an accreditation organization. An onsite
inspection of an accreditation organization may include, but is not
limited to, the following:
(1) A review of documents.
[[Page 845]]
(2) An audit of meetings concerning the accreditation process.
(3) Evaluation of accreditation inspection results and the
accreditation decision-making process.
(4) Interviews with the accreditation organization's staff.
(f) Onsite inspection of a State licensure program. An onsite
inspection of a State licensure program office may include, but is not
limited to, the following:
(1) A review of documents.
(2) An audit of meetings concerning the licensure or approval
process.
(3) Evaluation of State inspection results and the licensure or
approval decision-making process.
(4) Interviews with State employees.
Sec. 493.565 Selection for validation inspection--laboratory
responsibilities.
A laboratory selected for a validation inspection must do the
following:
(a) Authorize its accreditation organization or State licensure
program, as applicable, to release to HCFA or a HCFA agent, on a
confidential basis, a copy of the laboratory's most recent full, and any
subsequent partial inspection.
(b) Authorize HCFA or a HCFA agent to conduct a validation
inspection.
(c) Provide HCFA or a HCFA agent with access to all facilities,
equipment, materials, records, and information that HCFA or a HCFA agent
determines have a bearing on whether the laboratory is being operated in
accordance with the requirements of this part, and permit HCFA or a HCFA
agent to copy material or require the laboratory to submit material.
(d) If the laboratory possesses a valid certificate of
accreditation, authorize HCFA or a HCFA agent to monitor the correction
of any deficiencies found through the validation inspection.
Sec. 493.567 Refusal to cooperate with validation inspection.
(a) Laboratory with a certificate of accreditation. (1) A laboratory
with a certificate of accreditation that refuses to cooperate with a
validation inspection by failing to comply with the requirements in
Sec. 493.565--
(i) Is subject to full review by HCFA or a HCFA agent, in accordance
with this part; and
(ii) May be subject to suspension, revocation, or limitation of its
certificate of accreditation under this part.
(2) A laboratory with a certificate of accreditation is again deemed
to meet the condition-level requirements by virtue of its accreditation
when the following conditions exist:
(i) The laboratory withdraws any prior refusal to authorize its
accreditation organization to release a copy of the laboratory's current
accreditation inspection, PT results, or notification of any adverse
actions resulting from PT failure.
(ii) The laboratory withdraws any prior refusal to allow a
validation inspection.
(iii) HCFA finds that the laboratory meets all the condition-level
requirements.
(b) CLIA-exempt laboratory. If a CLIA-exempt laboratory fails to
comply with the requirements specified in Sec. 493.565, HCFA notifies
the State of the laboratory's failure to meet the requirements.
Sec. 493.569 Consequences of a finding of noncompliance as a result of
a validation inspection.
(a) Laboratory with a certificate of accreditation. If a validation
inspection results in a finding that the accredited laboratory is out of
compliance with one or more condition-level requirements, the laboratory
is subject to--
(1) The same requirements and survey and enforcement processes
applied to laboratories that are not accredited and that are found out
of compliance following an inspection under this part; and
(2) Full review by HCFA, in accordance with this part; that is, the
laboratory is subject to the principal and alternative sanctions in
Sec. 493.1806.
(b) CLIA-exempt laboratory. If a validation inspection results in a
finding that a CLIA-exempt laboratory is out of compliance with one or
more condition-level requirements, HCFA directs the State to take
appropriate enforcement action.
[[Page 846]]
Sec. 493.571 Disclosure of accreditation, State and HCFA validation
inspection results.
(a) Accreditation organization inspection results. HCFA may disclose
accreditation organization inspection results to the public only if the
results are related to an enforcement action taken by the Secretary.
(b) State inspection results. Disclosure of State inspection results
is the responsibility of the approved State licensure program, in
accordance with State law.
(c) HCFA validation inspection results. HCFA may disclose the
results of all validation inspections conducted by HCFA or its agent.
Sec. 493.573 Continuing Federal oversight of private nonprofit
accreditation organizations and approved State licensure
programs.
(a) Comparability review. In addition to the initial review for
determining equivalency of specified organization or State requirements
to the comparable condition-level requirements, HCFA reviews the
equivalency of requirements in the following cases:
(1) When HCFA promulgates new condition-level requirements.
(2) When HCFA identifies an accreditation organization or a State
licensure program whose requirements are no longer equal to, or more
stringent than, condition-level requirements.
(3) When an accreditation organization or State licensure program
adopts new requirements.
(4) When an accreditation organization or State licensure program
adopts changes to its inspection process, as required by
Sec. 493.575(b)(1), as applicable.
(5) Every 6 years, or sooner if HCFA determines an earlier review is
required.
(b) Validation review. Following the end of a validation review
period, HCFA evaluates the validation inspection results for each
approved accreditation organization and State licensure program.
(c) Reapplication procedures. (1) Every 6 years, or sooner, as
determined by HCFA, an approved accreditation organization must reapply
for continued approval of deeming authority and a State licensure
program must reapply for continued approval of a CLIA exemption. HCFA
provides notice of the materials that must be submitted as part of the
reapplication procedure.
(2) An accreditation organization or State licensure program that
does not meet the requirements of this subpart, as determined through a
comparability or validation review, must furnish HCFA, upon request,
with the reapplication materials HCFA requests. HCFA establishes a
deadline by which the materials must be submitted.
(d) Notice. (1) HCFA provides written notice, as appropriate, to the
following:
(i) An accreditation organization indicating that its approval may
be in jeopardy if a comparability or validation review reveals that it
is not meeting the requirements of this subpart and HCFA is initiating a
review of the accreditation organization's deeming authority.
(ii) A State licensure program indicating that its CLIA exemption
may be in jeopardy if a comparability or validation review reveals that
it is not meeting the requirements of this subpart and that a review is
being initiated of the CLIA exemption of the State's laboratories.
(2) The notice contains the following information:
(i) A statement of the discrepancies that were found as well as
other related documentation.
(ii) An explanation of HCFA's review process on which the final
determination is based and a description of the possible actions, as
specified in Sec. 493.575, that HCFA may impose based on the findings
from the comparability or validation review.
(iii) A description of the procedures available if the accreditation
organization or State licensure program, as applicable, desires an
opportunity to explain or justify the findings made during the
comparability or validation review.
(iv) The reapplication materials that the accreditation organization
or State licensure program must submit and the deadline for that
submission.
[[Page 847]]
Sec. 493.575 Removal of deeming authority or CLIA exemption and final
determination review.
(a) HCFA review. HCFA conducts a review of the following:
(1) A deeming authority review of an accreditation organization's
program if the comparability or validation review produces findings, as
described at Sec. 493.573. HCFA reviews, as appropriate, the criteria
described in Secs. 493.555 and 493.557(a) to reevaluate whether the
accreditation organization continues to meet all these criteria.
(2) An exemption review of a State's licensure program if the
comparability or validation review produces findings, as described at
Sec. 493.573. HCFA reviews, as appropriate, the criteria described in
Secs. 493.555 and 493.557(b) to reevaluate whether the licensure program
continues to meet all these criteria.
(3) A review of an accreditation organization or State licensure
program, at HCFA's discretion, if validation review findings,
irrespective of the rate of disparity, indicate widespread or systematic
problems in the organization's accreditation or State's licensure
process that provide evidence that the requirements, taken as a whole,
are no longer equivalent to CLIA requirements, taken as a whole.
(4) A review of the accreditation organization or State licensure
program whenever validation inspection results indicate a rate of
disparity of 20 percent or more between the findings of the organization
or State and those of HCFA or a HCFA agent for the following periods:
(i) One year for accreditation organizations.
(ii) Two years for State licensure programs.
(b) HCFA action after review. Following the review, HCFA may take
the following action:
(1) If HCFA determines that the accreditation organization or State
has failed to adopt requirements equal to, or more stringent than, CLIA
requirements, HCFA may give a conditional approval for a probationary
period of its deeming authority to an organization 30 days following the
date of HCFA's determination, or exempt status to a State within 30 days
of HCFA's determination, both not to exceed 1 year, to afford the
organization or State an opportunity to adopt equal or more stringent
requirements.
(2) If HCFA determines that there are widespread or systematic
problems in the organization's or State's inspection process, HCFA may
give conditional approval during a probationary period, not to exceed 1
year, effective 30 days following the date of the determination.
(c) Final determination. HCFA makes a final determination as to
whether the organization or State continues to meet the criteria
described in this subpart and issues a notice that includes the reasons
for the determination to the organization or State within 60 days after
the end of any probationary period. This determination is based on an
evaluation of any of the following:
(1) The most recent validation inspection and review findings. To
continue to be approved, the organization or State must meet the
criteria of this subpart.
(2) Facility-specific data, as well as other related information.
(3) The organization's or State's inspection procedures, surveyors'
qualifications, ongoing education, training, and composition of
inspection teams.
(4) The organization's accreditation requirements, or the State's
licensure or approval requirements.
(d) Date of withdrawal of approval. HCFA may withdraw its approval
of the accreditation organization or State licensure program, effective
30 days from the date of written notice to the organization or State of
this proposed action, if improvements acceptable to HCFA have not been
made during the probationary period.
(e) Continuation of validation inspections. The existence of any
validation review, probationary status, or any other action, such as a
deeming authority review, by HCFA does not affect or limit the conduct
of any validation inspection.
(f) Federal Register notice. HCFA publishes a notice in the Federal
Register containing a justification for removing the deeming authority
from an accreditation organization, or the CLIA-exempt status of a State
licensure program.
[[Page 848]]
(g) Withdrawal of approval-effect on laboratory status--(1)
Accredited laboratory. After HCFA withdraws approval of an accreditation
organization's deeming authority, the certificate of accreditation of
each affected laboratory continues in effect for 60 days after it
receives notification of the withdrawal of approval.
(2) CLIA-exempt laboratory. After HCFA withdraws approval of a State
licensure program, the exempt status of each licensed or approved
laboratory in the State continues in effect for 60 days after a
laboratory receives notification from the State of the withdrawal of
HCFA's approval of the program.
(3) Extension. After HCFA withdraws approval of an accreditation
organization or State licensure program, HCFA may extend the period for
an additional 60 days for a laboratory if it determines that the
laboratory submitted an application for accreditation to an approved
accreditation organization or an application for the appropriate
certificate to HCFA or a HCFA agent before the initial 60-day period
ends.
(h) Immediate jeopardy to patients. (1) If at any time HCFA
determines that the continued approval of deeming authority of any
accreditation organization poses immediate jeopardy to the patients of
the laboratories accredited by the organization, or continued approval
otherwise constitutes a significant hazard to the public health, HCFA
may immediately withdraw the approval of deeming authority for that
accreditation organization.
(2) If at any time HCFA determines that the continued approval of a
State licensure program poses immediate jeopardy to the patients of the
laboratories in that State, or continued approval otherwise constitutes
a significant hazard to the public health, HCFA may immediately withdraw
the approval of that State licensure program.
(i) Failure to pay fees. HCFA withdraws the approval of a State
licensure program if the State fails to pay the applicable fees, as
specified in Secs. 493.645(a) and 493.646(b).
(j) State refusal to take enforcement action. (1) HCFA may withdraw
approval of a State licensure program if the State refuses to take
enforcement action against a laboratory in that State when HCFA
determines it to be necessary.
(2) A laboratory that is in a State in which HCFA has withdrawn
program approval is subject to the same requirements and survey and
enforcement processes that are applied to a laboratory that is not
exempt from CLIA requirements.
(k) Request for reconsideration. Any accreditation organization or
State that is dissatisfied with a determination to withdraw approval of
its deeming authority or remove approval of its State licensure program,
as applicable, may request that HCFA reconsider the determination, in
accordance with subpart D of part 488.
Subpart F--General Administration
Source: 57 FR 7138 and 7213, Feb. 28, 1992, unless otherwise noted.
Sec. 493.602 Scope of subpart.
This subpart sets forth the methodology for determining the amount
of the fees for issuing the appropriate certificate, and for determining
compliance with the applicable standards of the Public Health Service
Act (the PHS Act) and the Federal validation of accredited laboratories
and of CLIA-exempt laboratories.
[60 FR 20047, Apr. 24, 1995]
Sec. 493.606 Applicability of subpart.
The rules of this subpart are applicable to those laboratories
specified in Sec. 493.3.
[58 FR 5212, Jan. 19, 1993]
Sec. 493.638 Certificate fees.
(a) Basic rule. Laboratories must pay a fee for the issuance of a
registration certificate, certificate for PPM procedures, certificate of
waiver, certificate of accreditation, or a certificate of compliance, as
applicable. Laboratories must also pay a fee to reapply for a
certificate for PPM procedures, certificate of waiver, certificate of
accreditation, or a certificate of compliance. The total of fees
collected by HHS under the laboratory program must be
[[Page 849]]
sufficient to cover the general costs of administering the laboratory
certification program under section 353 of the PHS Act.
(1) For registration certificates and certificates of compliance,
the costs include issuing the certificates, collecting the fees,
evaluating and monitoring proficiency testing programs, evaluating which
procedures, tests or examinations meet the criteria for inclusion in the
appropriate complexity category, and implementing section 353 of the PHS
Act.
(2) For a certificate of waiver, the costs include issuing the
certificate, collecting the fees, determining if a certificate of waiver
should be issued, evaluating which tests qualify for inclusion in the
waived category, and other direct administrative costs.
(3) For a certificate for PPM procedures, the costs include issuing
the certificate, collecting the fees, determining if a certificate for
PPM procedures should be issued, evaluating which procedures meet the
criteria for inclusion in the subcategory of PPM procedures, and other
direct administrative costs.
(4) For a certificate of accreditation, the costs include issuing
the certificate, collecting the fees, evaluating the programs of
accrediting bodies, and other direct administrative costs.
(b) Fee amount. The fee amount is set annually by HHS on a calendar
year basis and is based on the category of test complexity, or on the
category of test complexity and schedules or ranges of annual laboratory
test volume (excluding waived tests and tests performed for quality
control, quality assurance, and proficiency testing purposes) and
specialties tested, with the amounts of the fees in each schedule being
a function of the costs for all aspects of general administration of
CLIA as set forth in Sec. 493.649 (b) and (c). This fee is assessed and
payable at least biennially. The methodology used to determine the
amount of the fee is found in Sec. 493.649. The amount of the fee
applicable to the issuance of the registration certificate or the
issuance or renewal of the certificate for PPM procedures, certificate
of waiver, certificate of accreditation, or certificate of compliance is
the amount in effect at the time the application is received. Upon
receipt of an application for a certificate, HHS or its designee
notifies the laboratory of the amount of the required fee for the
requested certificate.
[60 FR 20047, Apr. 24, 1995]
Sec. 493.639 Fee for revised certificate.
(a) If, after a laboratory is issued a registration certificate, it
changes its name or location, the laboratory must pay a fee to cover the
cost of issuing a revised registration certificate. The fee for the
revised registration certificate is based on the cost to issue the
revised certificate to the laboratory.
(b) A laboratory must pay a fee to cover the cost of issuing a
revised certificate in any of the following circumstances:
(1) The fee for issuing an appropriate revised certificate is based
on the cost to issue the revised certificate to the laboratory as
follows:
(i) If a laboratory with a certificate of waiver wishes to perform
tests in addition to those listed in Sec. 493.15(c) as waived tests, it
must, as set forth in Sec. 493.638, pay an additional fee for the
appropriate certificate to cover the additional testing.
(ii) If a laboratory with a certificate for PPM procedures wishes to
perform tests in addition to those specified as PPM procedures or listed
in Sec. 493.15(c) as waived tests, it must, as set forth in
Sec. 493.638, pay an additional fee for the appropriate certificate to
cover the additional testing.
(2) A laboratory must pay a fee to cover the cost of issuing a
revised certificate when--
(i) A laboratory changes its name, location, or its director; or
(ii) A laboratory deletes services or wishes to add services and
requests that its certificate be changed. (An additional fee is also
required under Sec. 493.643(d) if it is necessary to determine
compliance with additional requirements.)
[57 FR 7213, Feb. 28, 1992, as amended at 60 FR 20047, Apr, 24, 1995]
[[Page 850]]
Sec. 493.643 Fee for determination of program compliance.
(a) Fee requirement. In addition to the fee required under
Sec. 493.638, a laboratory subject to routine inspections must pay a fee
to cover the cost of determining program compliance. Laboratories issued
a certificate for PPM procedures, certificate of waiver, or a
certificate of accreditation are not subject to this fee for routine
inspections.
(b) Costs included in the fee. Included in the fee for determining
program compliance is the cost of evaluating qualifications of
personnel; monitoring proficiency testing; conducting onsite
inspections; documenting deficiencies; evaluating laboratories' plans to
correct deficiencies; and necessary administrative costs. HHS sets the
fee amounts annually on a calendar year basis. Laboratories are
inspected biennially; therefore, fees are assessed and payable
biennially. If additional expenses are incurred to conduct follow up
visits to verify correction of deficiencies, to impose sanctions, and/or
for surveyor preparation for and attendance at ALJ hearings, HHS
assesses an additional fee to include these costs. The additional fee is
based on the actual resources and time necessary to perform the
activities.
(c) Classification of laboratories that require inspection for
purpose of determining amount of fee. (1) There are ten classifications
(schedules) of laboratories for the purpose of determining the fee
amount a laboratory is assessed. Each laboratory is placed into one of
the ten following schedules based on the laboratory's scope and volume
of testing (excluding tests performed for quality control, quality
assurance, and proficiency testing purposes).
(i) (A) Schedule A Low Volume. The laboratory performs not more than
2,000 laboratory tests annually.
(B) Schedule A. The laboratory performs tests in no more than 3
specialties of service with a total annual volume of more than 2,000 but
not more than 10,000 laboratory tests.
(ii) Schedule B. The laboratory performs tests in at least 4
specialties of service with a total annual volume of not more than
10,000 laboratory tests.
(iii) Schedule C. The laboratory performs tests in no more 3
specialties of service with a total annual volume of more than 10,000
but not more than 25,000 laboratory tests.
(iv) Schedule D. The laboratory performs tests in at least 4
specialties with a total annual volume of more than 10,000 but not more
than 25,000 laboratory tests.
(v) Schedule E. The laboratory performs more than 25,000 but not
more than 50,000 laboratory tests annually.
(vi) Schedule F. The laboratory performs more than 50,000 but not
more than 75,000 laboratory tests annually.
(vii) Schedule G. The laboratory performs more than 75,000 but not
more than 100,000 laboratory tests annually.
(viii) Schedule H. The laboratory performs more than 100,000 but not
more than 500,000 laboratory tests annually.
(ix) Schedule I. The laboratory performs more than 500,000 but not
more than 1,000,000 laboratory tests annually.
(x) Schedule J. The laboratory performs more than 1,000,000
laboratory tests annually.
(2) For purposes of determining a laboratory's classification under
this section, a test is a procedure or examination for a single analyte.
(Tests performed for quality control, quality assurance, and proficiency
testing are excluded from the laboratory's total annual volume). Each
profile (that is, group of tests) is counted as the number of separate
procedures or examinations; for example, a chemistry profile consisting
of 18 tests is counted as 18 separate procedures or tests.
(3) For purposes of determining a laboratory's classification under
this section, the specialties and subspecialties of service for
inclusion are:
(i) The specialty of Microbiology, which includes one or more of the
following subspecialties:
(A) Bacteriology.
(B) Mycobacteriology.
(C) Mycology.
(D) Parasitology.
(E) Virology.
(ii) The specialty of Serology, which includes one or more of the
following subspecialties:
(A) Syphilis Serology.
(B) General immunology
[[Page 851]]
(iii) The specialty of Chemistry, which includes one or more of the
following subspecialties:
(A) Routine chemistry.
(B) Endocrinology.
(C) Toxicology.
(D) Urinalysis.
(iv) The specialty of Hematology.
(v) The specialty of Immunohematology, which includes one or more of
the following subspecialties:
(A) ABO grouping and Rh typing.
(B) Unexpected antibody detection.
(C) Compatibility testing.
(D) Unexpected antibody identification.
(vi) The specialty of Pathology, which includes the following
subspecialties:
(A) Cytology.
(B) Histopathology.
(C) Oral pathology.
(vii) The specialty of Radiobioassay.
(viii) The specialty of Histocompatibility.
(ix) The specialty of Cytogenetics.
(d) Additional fees. (1) If after a certificate of compliance is
issued, a laboratory adds services and requests that its certificate be
upgraded, the laboratory must pay an additional fee if, in order to
determine compliance with additional requirements, it is necessary to
conduct an inspection, evaluate personnel, or monitor proficiency
testing performance. The additional fee is based on the actual resources
and time necessary to perform the activities. HHS revokes the
laboratory's certificate for failure to pay the compliance determination
fee.
(2) If it is necessary to conduct a complaint investigation, impose
sanctions, or conduct a hearing, HHS assesses the laboratory holding a
certificate of compliance a fee to cover the cost of these activities.
If a complaint investigation results in a complaint being
unsubstantiated, or if an HHS adverse action is overturned at the
conclusion of the administrative appeals process, the government's costs
of these activities are not imposed upon the laboratory. Costs for these
activities are based on the actual resources and time necessary to
perform the activities and are not assessed until after the laboratory
concedes the existence of deficiencies or an ALJ rules in favor of HHS.
HHS revokes the laboratory's certificate of compliance for failure to
pay the assessed costs.
[57 FR 7138 and 7213, Feb. 28, 1992, as amended at 60 FR 20047, Apr. 24,
1995]
Sec. 493.645 Additional fee(s) applicable to approved State laboratory
programs and laboratories issued a certificate of
accreditation, certificate of waiver, or certificate for PPM
procedures.
(a) Approved State laboratory programs. State laboratory programs
approved by HHS are assessed a fee for the following:
(1) Costs of Federal inspections of laboratories in that State (that
is, CLIA-exempt laboratories) to verify that standards are being
enforced in an appropriate manner.
(2) Costs incurred for investigations of complaints against the
State's CLIA-exempt laboratories if the complaint is substantiated.
(3) Costs of the State's prorata share of general overhead to
develop and implement CLIA.
(b) Accredited laboratories. (1) In addition to the certificate fee,
a laboratory that is issued a certificate of accreditation is also
assessed a fee to cover the cost of evaluating individual laboratories
to determine overall whether an accreditation organization's standards
and inspection policies are equivalent to the Federal program. All
accredited laboratories share in the cost of these inspections. These
costs are the same as those that are incurred when inspecting
nonaccredited laboratories.
(2) If a laboratory issued a certificate of accreditation has been
inspected and followup visits are necessary because of identified
deficiencies, HHS assesses the laboratory a fee to cover the cost of
these visits. The fee is based on the actual resources and time
necessary to perform the followup visits. HHS revokes the laboratory's
certificate of accreditation for failure to pay the assessed fee.
(c) If, in the case of a laboratory that has been issued a
certificate of accreditation, certificate of waiver, or certificate for
PPM procedures, it is necessary to conduct a complaint investigation,
impose sanctions, or conduct
[[Page 852]]
a hearing, HHS assesses that laboratory a fee to cover the cost of these
activities. Costs are based on the actual resources and time necessary
to perform the activities and are not assessed until after the
laboratory concedes the existence of deficiencies or an ALJ rules in
favor of HHS. HHS revokes the laboratory's certificate for failure to
pay the assessed costs. If a complaint investigation results in a
complaint being unsubstantiated, or if an HHS adverse action is
overturned at the conclusion of the administrative appeals process, the
costs of these activities are not imposed upon the laboratory.
[60 FR 20047, Apr. 24, 1995]
Sec. 493.646 Payment of fees.
(a) Except for CLIA-exempt laboratories, all laboratories are
notified in writing by HHS or its designee of the appropriate fee(s) and
instructions for submitting the fee(s), including the due date for
payment and where to make payment. The appropriate certificate is not
issued until the applicable fees have been paid.
(b) For State-exempt laboratories, HHS estimates the cost of
conducting validation surveys within the State for a 2-year period. HHS
or its designee notifies the State by mail of the appropriate fees,
including the due date for payment and the address of the United States
Department of Treasury designated commercial bank to which payment must
be made. In addition, if complaint investigations are conducted in
laboratories within these States and are substantiated, HHS bills the
State(s) the costs of the complaint investigations.
[57 FR 7138 and 7213, Feb. 28, 1992, as amended at 60 FR 20048, Apr. 24,
1995]
Sec. 493.649 Methodology for determining fee amount.
(a) General rule. The amount of the fee in each schedule for
compliance determination inspections is based on the average hourly rate
(which includes the costs to perform the required activities and
necessary administration costs) multiplied by the average number of
hours required or, if activities are performed by more than one of the
entities listed in paragraph (b) of this section, the sum of the
products of the applicable hourly rates multiplied by the average number
of hours required by the entity to perform the activity. The fee for
issuance of the registration certificate or certificate of compliance is
based on the laboratory's scope and volume of testing.
(b) Determining average hourly rates used in fee schedules. Three
different entities perform activities related to the issuance or
reissuance of any certificate. HHS determines the average hourly rates
for the activities of each of these entities.
(1) State survey agencies. The following costs are included in
determining an average hourly rate for the activities performed by State
survey agencies:
(i) The costs incurred by the State survey agencies in evaluating
personnel qualifications and monitoring each laboratory's participation
in an approved proficiency testing program. The cost of onsite
inspections and monitoring activities is the hourly rate derived as a
result of an annual budget negotiation process with each State. The
hourly rate encompasses salary costs (as determined by each State's
civil service pay scale) and fringe benefit costs to support the
required number of State inspectors, management and direct support
staff.
(ii) Travel costs necessary to comply with each State's
administrative requirements and other direct costs such as equipment,
printing, and supplies. These costs are established based on historical
State requirements.
(iii) Indirect costs as negotiated by HHS.
(2) Federal agencies. The hourly rate for activities performed by
Federal agencies is the most recent average hourly cost to HHS to staff
and support a full time equivalent employee. Included in this cost are
salary and fringe benefit costs, necessary administrative costs, such as
printing, training, postage, express mail, supplies, equipment, computer
system and building service charges associated with support services
provided by organizational components such as a computer center, and any
other oversight activities necessary to support the program.
[[Page 853]]
(3) HHS contractors. The hourly rate for activities performed by HHS
contractors is the average hourly rate established for contractor
assistance based on an independent government cost estimate for the
required workload. This rate includes the cost of contractor support to
provide proficiency testing programs to laboratories that do not
participate in an approved proficiency testing program, provide
specialized assistance in the evaluation of laboratory performance in an
approved proficiency testing program, perform assessments of cytology
testing laboratories, conduct special studies, bill and collect fees,
issue certificates, establish accounting, monitoring and reporting
systems, and assist with necessary surveyor training.
(c) Determining number of hours. The average number of hours used to
determine the overall fee in each schedule is HHS's estimate, based on
historical experience, of the average time needed by each entity to
perform the activities for which it is responsible.
[57 FR 7138 and 7213, Feb. 28, 1992, as amended at 60 FR 20048, Apr. 24,
1995]
Subpart G [Reserved]
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Tests of Moderate Complexity (Including the Subcategory),
High Complexity, or Any Combination of These Tests
Source: 57 FR 7146, Feb. 28, 1992, unless otherwise noted.
Sec. 493.801 Condition: Enrollment and testing of samples.
Each laboratory must enroll in a proficiency testing (PT) program
that meets the criteria in subpart I of this part and is approved by
HHS. The laboratory must enroll in an approved program or programs for
each of the specialties and subspecialties for which it seeks
certification. The laboratory must test the samples in the same manner
as patients' specimens. For laboratories subject to 42 CFR part 493
published on March 14, 1990 (55 FR 9538) prior to September 1, 1992, the
rules of this subpart are effective on September 1, 1992. For all other
laboratories, the rules of this subpart are effective January 1, 1994.
(a) Standard; Enrollment. The laboratory must--
(1) Notify HHS of the approved program or programs in which it
chooses to participate to meet proficiency testing requirements of this
subpart.
(2)(i) Designate the program(s) to be used for each specialty,
subspecialty, and analyte or test to determine compliance with this
subpart if the laboratory participates in more than one proficiency
testing program approved by HCFA; and
(ii) For those tests performed by the laboratory that are not
included in subpart I of this part, a laboratory must establish and
maintain the accuracy of its testing procedures, in accordance with
Sec. 493.1709.
(3) For each specialty, subspecialty and analyte or test,
participate in one approved proficiency testing program or programs, for
one year before designating a different program and must notify HCFA
before any change in designation; and
(4) Authorize the proficiency testing program to release to HHS all
data required to--
(i) Determine the laboratory's compliance with this subpart; and
(ii) Make PT results available to the public as required in section
353(f)(3)(F) of the Public Health Service Act.
(b) Standard; Testing of proficiency testing samples. The laboratory
must examine or test, as applicable, the proficiency testing samples it
receives from the proficiency testing program in the same manner as it
tests patient specimens.
(1) The samples must be examined or tested with the laboratory's
regular patient workload by personnel who routinely perform the testing
in the laboratory, using the laboratory's routine methods. The
individual testing or examining the samples and the laboratory director
must attest to the routine integration of the samples into the patient
workload using the laboratory's routine methods.
[[Page 854]]
(2) The laboratory must test samples the same number of times that
it routinely tests patient samples.
(3) Laboratories that perform tests on proficiency testing samples
must not engage in any inter-laboratory communications pertaining to the
results of proficiency testing sample(s) until after the date by which
the laboratory must report proficiency testing results to the program
for the testing event in which the samples were sent. Laboratories with
multiple testing sites or separate locations must not participate in any
communications or discussions across sites/locations concerning
proficiency testing sample results until after the date by which the
laboratory must report proficiency testing results to the program.
(4) The laboratory must not send PT samples or portions of samples
to another laboratory for any analysis which it is certified to perform
in its own laboratory. Any laboratory that HCFA determines intentionally
referred its proficiency testing samples to another laboratory for
analysis will have its certification revoked for at least one year. Any
laboratory that receives proficiency testing samples from another
laboratory for testing must notify HCFA of the receipt of those samples.
(5) The laboratory must document the handling, preparation,
processing, examination, and each step in the testing and reporting of
results for all proficiency testing samples. The laboratory must
maintain a copy of all records, including a copy of the proficiency
testing program report forms used by the laboratory to record
proficiency testing results including the attestation statement provided
by the PT program, signed by the analyst and the laboratory director,
documenting that proficiency testing samples were tested in the same
manner as patient specimens, for a minimum of two years from the date of
the proficiency testing event.
(6) PT is required for only the test system, assay, or examination
used as the primary method for patient testing during the PT event.
[57 FR 7146, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993]
Sec. 493.803 Condition: Successful participation.
(a) Each laboratory performing tests of moderate complexity
(including the subcategory) and/or high complexity must successfully
participate in a proficiency testing program approved by HCFA, if
applicable, as described in subpart I of this part for each specialty,
subspecialty, and analyte or test in which the laboratory is certified
under CLIA.
(b) Except as specified in paragraph (c) of this section, if a
laboratory fails to participate successfully in proficiency testing for
a given specialty, subspecialty, analyte or test, as defined in this
section, or fails to take remedial action when an individual fails
gynecologic cytology, HCFA imposes sanctions, as specified in subpart R
of this part.
(c) If a laboratory fails to perform successfully in a HCFA-approved
proficiency testing program, for the initial unsuccessful performance,
HCFA may direct the laboratory to undertake training of its personnel or
to obtain technical assistance, or both, rather than imposing
alternative or principle sanctions except when one or more of the
following conditions exists:
(1) There is immediate jeopardy to patient health and safety.
(2) The laboratory fails to provide HCFA or a HCFA agent with
satisfactory evidence that it has taken steps to correct the problem
identified by the unsuccessful proficiency testing performance.
(3) The laboratory has a poor compliance history.
[57 FR 7146, Feb. 28, 1992, as amended at 60 FR 20048, Apr. 24, 1995; 63
FR 26737, May 14, 1998]
Sec. 493.807 Condition: Reinstatement of laboratories performing tests
of moderate complexity (including the subcategory), high
complexity, or any combination of these tests, after failure
to participate successfully.
(a) If a laboratory's certificate is suspended or limited or its
Medicare or Medicaid approval is cancelled or its Medicare or Medicaid
payments are suspended because it fails to participate successfully in
proficiency testing
[[Page 855]]
for one or more specialties, subspecialties, analyte or test, or
voluntarily withdraws its certification under CLIA for the failed
specialty, subspecialty, or analyte, the laboratory must then
demonstrate sustained satisfactory performance on two consecutive
proficiency testing events, one of which may be on site, before HCFA
will consider it for reinstatement for certification and Medicare or
Medicaid approval in that specialty, subspecialty, analyte or test.
(b) The cancellation period for Medicare and Medicaid approval or
period for suspension of Medicare or Medicaid payments or suspension or
limitation of certification under CLIA for the failed specialty,
subspecialty, or analyte or test is for a period of not less than six
months from the date of cancellation, limitation or suspension of the
CLIA certificate.
[58 FR 5228, Jan. 19, 1993, as amended at 60 FR 20048, Apr. 24, 1995]
Proficiency Testing by Specialty and Subspecialty for Laboratories
Performing Tests of Moderate Complexity (Including the Subcategory),
High Complexity, or Any Combination of These Tests
Sec. 493.821 Condition: Microbiology.
The specialty of microbiology includes, for purposes of proficiency
testing, the subspecialties of bacteriology, mycobacteriology, mycology,
parasitology and virology.
Sec. 493.823 Standard; Bacteriology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) Remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two years from
the date of participation in the proficiency testing event.
(e) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.825 Standard; Mycobacteriology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing
[[Page 856]]
program within the time frame specified by the program is unsatisfactory
performance and results in a score of 0 for the testing event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) Remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two years from
the date of participation in the proficiency testing event.
(e) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.827 Standard; Mycology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) Remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two years from
the date of participation in the proficiency testing event.
(e) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.829 Standard; Parasitology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) Remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two years from
the date of participation in the proficiency testing event.
[[Page 857]]
(e) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.831 Standard; Virology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unsatisfactory testing events, remedial action must be
taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the
proficiency testing event.
(e) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.833 Condition: Diagnostic immunology.
The specialty of diagnostic immunology includes for purposes of
proficiency testing the subspecialties of syphilis serology and general
immunology.
Sec. 493.835 Standard; Syphilis serology.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unacceptable testing event score, remedial action must
be taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the
proficiency testing event.
(e) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
[[Page 858]]
Sec. 493.837 Standard; General immunology.
(a) Failure to attain a score of at least 80 percent of acceptable
responses for each analyte in each testing event is unsatisfactory
analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory analyte or test performance or testing
event for reasons other than a failure to participate, the laboratory
must undertake appropriate training and employ the technical assistance
necessary to correct problems associated with a proficiency testing
failure.
(2) For any unacceptable analyte or testing event score, remedial
action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of
participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
or test in two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
(g) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.839 Condition: Chemistry.
The specialty of chemistry includes for the purposes of proficiency
testing the subspecialties of routine chemistry, endocrinology, and
toxicology.
Sec. 493.841 Standard; Routine chemistry.
(a) Failure to attain a score of at least 80 percent of acceptable
responses for each analyte in each testing event is unsatisfactory
analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory analyte or test performance or testing
event for reasons other than a failure to participate, the laboratory
must undertake appropriate training and employ the technical assistance
necessary to correct problems associated with a proficiency testing
failure.
(2) For any unacceptable analyte or testing event score, remedial
action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from
[[Page 859]]
the date of participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
or test in two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
(g) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.843 Standard; Endocrinology.
(a) Failure to attain a score of at least 80 percent of acceptable
responses for each analyte in each testing event is unsatisfactory
analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory analyte or test performance or testing
event for reasons other than a failure to participate, the laboratory
must undertake appropriate training and employ the technical assistance
necessary to correct problems associated with a proficiency testing
failure.
(2) For any unacceptable analyte or testing event score, remedial
action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of
participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
or test in two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
(g) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.845 Standard; Toxicology.
(a) Failure to attain a score of at least 80 percent of acceptable
responses for each analyte in each testing event is unsatisfactory
analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory analyte or test performance or testing
event for reasons other than a failure to participate, the laboratory
must undertake appropriate training and employ the technical assistance
necessary to
[[Page 860]]
correct problems associated with a proficiency testing failure.
(2) For any unacceptable analyte or testing event score, remedial
action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of
participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
or test in two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
(g) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.849 Condition: Hematology.
The specialty of hematology, for the purpose of proficiency testing,
is not subdivided into subspecialties of testing.
Sec. 493.851 Standard; Hematology.
(a) Failure to attain a score of at least 80 percent of acceptable
responses for each analyte in each testing event is unsatisfactory
analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory analyte or test performance or testing
event for reasons other than a failure to participate, the laboratory
must undertake appropriate training and employ the technical assistance
necessary to correct problems associated with a proficiency testing
failure.
(2) For any unacceptable analyte or testing event score, remedial
action must be taken and documented, and the documentation must be
maintained by the laboratory for two years from the date of
participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
in two consecutive events or two out of three consecutive testing events
is unsuccessful performance.
(g) Failure to achieve an overall testing event score of
satisfactory performance for two consecutive testing events or two out
of three consecutive testing events is unsuccessful performance.
Sec. 493.853 Condition: Pathology.
The specialty of pathology includes, for purposes of proficiency
testing, the subspecialty of cytology limited to gynecologic
examinations.
Sec. 493.855 Standard; Cytology: gynecologic examinations.
To participate successfully in a cytology proficiency testing
program for gynecologic examinations (Pap smears), the laboratory must
meet the requirements of paragraphs (a) through (c) of this section.
(a) The laboratory must ensure that each individual engaged in the
examination of gynecologic preparations is enrolled in a proficiency
testing program approved by HCFA by January 1, 1995, if available in the
State in which he or she is employed. The laboratory must ensure that
each individual is tested at least once per year and obtains a passing
score. To ensure this annual testing of individuals, an announced or
unannounced testing event will be conducted on-site in each laboratory
at least once each year. Laboratories will be notified of the time of
each announced on-site testing event
[[Page 861]]
at least 30 days prior to each event. Additional testing events will be
conducted as necessary in each State or region for the purpose of
testing individuals who miss the on-site testing event and for retesting
individuals as described in paragraph (b) of this section.
(b) The laboratory must ensure that each individual participates in
an annual testing event that involves the examination of a 10-slide test
set as described in Sec. 493.945. Individuals who fail this testing
event are retested with another 10-slide test set as described in
paragraphs (b)(1) and (b)(2) of this section. Individuals who fail this
second test are subsequently retested with a 20-slide test set as
described in paragraphs (b)(2) and (b)(3) of this section. Individuals
are given not more than 2 hours to complete a 10-slide test and not more
than 4 hours to complete a 20-slide test. Unexcused failure to appear by
an individual for a retest will result in test failure with resulting
remediation and limitations on slide examinations as specified in
(b)(1), (b)(2), and (b)(3) of this section.
(1) An individual is determined to have failed the annual testing
event if he or she scores less than 90 percent on a 10-slide test set.
For an individual who fails an annual proficiency testing event, the
laboratory must schedule a retesting event which must take place not
more than 45 days after receipt of the notification of failure.
(2) An individual is determined to have failed the second testing
event if he or she scores less than 90 percent on a 10-slide test set.
For an individual who fails a second testing event, the laboratory must
provide him or her with documented, remedial training and education in
the area of failure, and must assure that all gynecologic slides
evaluated subsequent to the notice of failure are reexamined until the
individual is again retested with a 20-slide test set and scores at
least 90 percent. Reexamination of slides must be documented.
(3) An individual is determined to have failed the third testing
event if he or she scores less than 90 percent on a 20-slide test set.
An individual who fails the third testing event must cease examining
gynecologic slide preparations immediately upon notification of test
failure and may not resume examining gynecologic slides until the
laboratory assures that the individual obtains at least 35 hours of
documented, formally structured, continuing education in diagnostic
cytopathology that focuses on the examination of gynecologic
preparations, and until he or she is retested with a 20-slide test set
and scores at least 90 percent.
(c) If a laboratory fails to ensure that individuals are tested or
those who fail a testing event are retested, or fails to take required
remedial actions as described in paragraphs (b)(1), (b)(2) or (b)(3) of
this section, HCFA will initiate intermediate sanctions or limit the
laboratory's certificate to exclude gynecologic cytology testing under
CLIA, and, if applicable, suspend the laboratory's Medicare and Medicaid
payments for gynecologic cytology testing in accordance with subpart R
of this part.
[57 FR 7146, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993; 59
FR 62609, Dec. 6, 1994]
Sec. 493.857 Condition: Immunohematology.
The specialty of immunohematology includes four subspecialties for
the purposes of proficiency testing: ABO group and D (Rho) typing;
unexpected antibody detection; compatibility testing; and antibody
identification.
Sec. 493.859 Standard; ABO group and D (Rho) typing.
(a) Failure to attain a score of at least 100 percent of acceptable
responses for each analyte or test in each testing event is
unsatisfactory analyte performance for the testing event.
(b) Failure to attain an overall testing event score of at least 100
percent is unsatisfactory performance.
(c) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
[[Page 862]]
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(d) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(e)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unacceptable analyte or unsatisfactory testing event
score, remedial action must be taken and documented, and the
documentation must be maintained by the laboratory for two years from
the date of participation in the proficiency testing event.
(f) Failure to achieve satisfactory performance for the same analyte
in two consecutive testing events or two out of three consecutive
testing events is unsuccessful performance.
(g) Failure to achieve an overall testing event score of
satisfactory for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
Sec. 493.861 Standard; Unexpected antibody detection.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unsatisfactory testing event score, remedial action must
be taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the
proficiency testing event.
(e) Failure to achieve an overall testing event score of
satisfactory for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
Sec. 493.863 Standard; Compatibility testing.
(a) Failure to attain an overall testing event score of at least 100
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
[[Page 863]]
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unsatisfactory testing event score, remedial action must
be taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the
proficiency testing event.
(e) Failure to achieve an overall testing event score of
satisfactory for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
Sec. 493.865 Standard; Antibody identification.
(a) Failure to attain an overall testing event score of at least 80
percent is unsatisfactory performance.
(b) Failure to participate in a testing event is unsatisfactory
performance and results in a score of 0 for the testing event.
Consideration may be given to those laboratories failing to participate
in a testing event only if--
(1) Patient testing was suspended during the time frame allotted for
testing and reporting proficiency testing results;
(2) The laboratory notifies the inspecting agency and the
proficiency testing program within the time frame for submitting
proficiency testing results of the suspension of patient testing and the
circumstances associated with failure to perform tests on proficiency
testing samples; and
(3) The laboratory participated in the previous two proficiency
testing events.
(c) Failure to return proficiency testing results to the proficiency
testing program within the time frame specified by the program is
unsatisfactory performance and results in a score of 0 for the testing
event.
(d)(1) For any unsatisfactory testing event for reasons other than a
failure to participate, the laboratory must undertake appropriate
training and employ the technical assistance necessary to correct
problems associated with a proficiency testing failure.
(2) For any unsatisfactory testing event score, remedial action must
be taken and documented, and the documentation must be maintained by the
laboratory for two years from the date of participation in the
proficiency testing event.
(e) Failure to identify the same antibody in two consecutive or two
out of three consecutive testing events is unsuccessful performance.
(f) Failure to achieve an overall testing event score of
satisfactory for two consecutive testing events or two out of three
consecutive testing events is unsuccessful performance.
Subpart I--Proficiency Testing Programs for Tests of Moderate Complexity
(Including the Subcategory), High Complexity, or Any Combination of
These Tests
Source: 57 FR 7151, Feb. 28, 1992, unless otherwise noted.
Sec. 493.901 Approval of proficiency testing programs.
In order for a proficiency testing program to receive HHS approval,
the program must be offered by a private nonprofit organization or a
Federal or State agency, or entity acting as a designated agent for the
State. An organization, Federal, or State program seeking approval or
reapproval for its program for the next calendar year must submit an
application providing the required information by July 1 of the current
year. The organization, Federal, or State program must provide technical
assistance to laboratories seeking to qualify under the program, and
must, for each specialty, subspecialty, and analyte or test for which it
provides testing--
(a) Assure the quality of test samples, appropriately evaluate and
score
[[Page 864]]
the testing results, and identify performance problems in a timely
manner;
(b) Demonstrate to HHS that it has--
(1) The technical ability required to--
(i) Prepare or purchase samples from manufacturers who prepare the
samples in conformance with the appropriate good manufacturing practices
required in 21 CFR parts 606, 640, and 820; and
(ii) Distribute the samples, using rigorous quality control to
assure that samples mimic actual patient specimens when possible and
that samples are homogeneous, except for specific subspecialties such as
cytology, and will be stable within the time frame for analysis by
proficiency testing participants;
(2) A scientifically defensible process for determining the correct
result for each challenge offered by the program;
(3) A program of sufficient annual challenge and with the frequency
specified in Secs. 493.909 through 493.959 to establish that a
laboratory has met minimum performance requirements;
(4) The resources needed to provide Statewide or nationwide reports
to regulatory agencies on individual's performance for gynecologic
cytology and on individual laboratory performance on testing events,
cumulative reports and scores for each laboratory or individual, and
reports of specific laboratory failures using grading criteria
acceptable to HHS. These reports must be provided to HHS on a timely
basis when requested;
(5) Provisions to include on each proficiency testing program report
form used by the laboratory to record testing event results, an
attestation statement that proficiency testing samples were tested in
the same manner as patient specimens with a signature block to be
completed by the individual performing the test as well as by the
laboratory director;
(6) A mechanism for notifying participants of the PT shipping
schedule and for participants to notify the proficiency testing program
within three days of the expected date of receipt of the shipment that
samples have not arrived or are unacceptable for testing. The program
must have provisions for replacement of samples that are lost in transit
or are received in a condition that is unacceptable for testing; and
(7) A process to resolve technical, administrative, and scientific
problems about program operations;
(c) Meet the specific criteria for proficiency testing programs
listed by specialty, subspecialty, and analyte or test contained in
Secs. 493.901 through 493.959 for initial approval and thereafter
provide HHS, on an annual basis, with the information necessary to
assure that the proficiency testing program meets the criteria required
for approval; and
(d) Comply with all applicable packaging, shipment, and notification
requirements of 42 CFR part 72.
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993]
Sec. 493.903 Administrative responsibilities.
The proficiency testing program must--
(a)(1) Provide HHS or its designees and participating laboratories
with an electronic or a hard copy, or both, of reports of proficiency
testing results and all scores for each laboratory's performance in a
format as required by and approved by HCFA for each CLIA-certified
specialty, subspecialty, and analyte or test within 60 days after the
date by which the laboratory must report proficiency testing results to
the proficiency testing program.
(2) Provide HHS with reports of PT results and scores of individual
performance in cytology and provide copies of reports to participating
individuals, and to all laboratories that employ the individuals, within
15 working days of the testing event;
(b) Furnish to HHS cumulative reports on an individual laboratory's
performance and aggregate data on CLIA-certified laboratories for the
purpose of establishing a system to make the proficiency testing
program's results available, on a reasonable basis, upon request of any
person, and include such explanatory information as may be appropriate
to assist in the interpretation of the proficiency testing program's
results;
(c) Provide HHS with additional information and data upon request
and submit such information necessary for
[[Page 865]]
HHS to conduct an annual evaluation to determine whether the proficiency
testing program continues to meet the requirements of Secs. 493.901
through 493.959;
(d) Maintain records of laboratories' performance for a period of
five years or such time as may be necessary for any legal proceedings;
and
(e) Provide HHS with an annual report and, if needed, an interim
report which identifies any previously unrecognized sources of
variability in kits, instruments, methods, or PT samples, which
adversely affect the programs' ability to evaluate laboratory
performance.
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993]
Sec. 493.905 Nonapproved proficiency testing programs.
If a proficiency testing program is determined by HHS to fail to
meet any criteria contained in Secs. 493.901 through 493.959 for
approval of the proficiency testing program, HCFA will notify the
program and the program must notify all laboratories enrolled of the
nonapproval and the reasons for nonapproval within 30 days of the
notification.
Proficiency Testing Programs by Specialty and Subspecialty
Sec. 493.909 Microbiology.
The subspecialties under the specialty of microbiology for which a
program may offer proficiency testing are bacteriology,
mycobacteriology, mycology, parasitology and virology. Specific criteria
for these subspecialties are found at Secs. 493.911 through 493.919.
Sec. 493.911 Bacteriology.
(a) Types of services offered by laboratories. In bacteriology, for
proficiency testing purposes, there are five types of laboratories:
(1) Those that interpret Gram stains or perform primary inoculation,
or both; and refer cultures to another laboratory appropriately
certified for the subspecialty of bacteriology for identification;
(2) Those that use direct antigen techniques to detect an organism
and may also interpret Gram stains or perform primary inoculation, or
perform any combination of these;
(3) Those that, in addition to interpreting Gram stains, performing
primary inoculations, and using direct antigen tests, also isolate and
identify aerobic bacteria from throat, urine, cervical, or urethral
discharge specimens to the genus level and may also perform
antimicrobial susceptibility tests on selected isolated microorganisms;
(4) Those that perform the services in paragraph (a)(3) of this
section and also isolate and identify aerobic bacteria from any source
to the species level and may also perform antimicrobial susceptibility
tests; and
(5) Those that perform the services in paragraph (a)(4) of this
section and also isolate and identify anaerobic bacteria from any
source.
(b) Program content and frequency of challenge. To be approved for
proficiency testing for bacteriology, the annual program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The samples
may be provided to the laboratory through mailed shipments or, at HHS'
option, may be provided to HHS or its designee for on-site testing. For
the types of laboratories specified in paragraph (a) of this section, an
annual program must include samples that contain organisms that are
representative of the six major groups of bacteria: anaerobes,
Enterobacteriaceae, gram-positive bacilli, gram-positive cocci, gram-
negative cocci, and miscellaneous gram-negative bacteria, as
appropriate. The specific organisms included in the samples may vary
from year to year. The annual program must include samples for bacterial
antigen detection, bacterial isolation and identification, Gram stain,
and antimicrobial susceptibility testing.
(1) An approved program must furnish HHS with a description of
samples that it plans to include in its annual program no later than six
months before each calendar year. At least 50 percent of the samples
must be mixtures of the principal organism and appropriate normal flora.
The program must include other important emerging
[[Page 866]]
pathogens (as determined by HHS) and either organisms commonly occurring
in patient specimens or opportunistic pathogens. The program must
include the following two types of samples; each type of sample must
meet the 50 percent mixed culture criterion:
(i) Samples that require laboratories to report only organisms that
the testing laboratory considers to be a principal pathogen that is
clearly responsible for a described illness (excluding immuno-
compromised patients). The program determines the reportable isolates,
including antimicrobial susceptibility for any designated isolate; and
(ii) Samples that require laboratories to report all organisms
present. Samples must contain multiple organisms frequently found in
specimens such as urine, blood, abscesses, and aspirates where multiple
isolates are clearly significant or where specimens are derived from
immuno-compromised patients. The program determines the reportable
isolates.
(2) An approved program may vary over time. For example, the types
of organisms that might be included in an approved program over time
are--
Anaerobes:
Bacteroides fragilis group
Clostridium perfringens
Peptostreptococcus anaerobius
Enterobacteriaceae
Citrobacter freundii
Enterobacter aerogenes
Escherichia coli
Klebsiella pneumoniae
Proteus mirabilis
Salmonella typhimurium
Serratia marcescens
Shigella sonnei
Yersinia enterocolitica
Gram-positive bacilli:
Listeria monocytogenes
Corynebacterium species CDC Group JK
Gram-positive cocci:
Staphylococcus aureus
Streptococcus Group A
Streptococcus Group B
Streptococcus Group D (S. bovis and enterococcus)
Streptococcus pneumoniae
Gram-negative cocci:
Branhamella catarrhalis
Neisseria gonorrhoeae
Neisseria meningitidis
Miscellaneous Gram-negative bacteria:
Campylobacter jejuni
Haemophilis influenza, Type B
Pseudomonas aeruginosa
(3) For antimicrobial susceptibility testing, the program must
provide at least one sample per testing event that includes gram-
positive or gram-negative strains that have a predetermined pattern of
sensitivity or resistance to the common antimicrobial agents.
(c) Evaluation of a laboratory's performance. HHS approves only
those programs that assess the accuracy of a laboratory's responses in
accordance with paragraphs (c) (1) through (7) of this section.
(1) The program determines staining characteristics to be
interpreted by Gram stain. The program determines the reportable
bacteria to be detected by direct antigen techniques or isolation. To
determine the accuracy of a laboratory's response for Gram stain
interpretation, direct antigen detection, identification, or
antimicrobial susceptibility testing, the program must compare the
laboratory's response for each sample with the response which reflects
agreement of either 90 percent of ten or more referee laboratories or 90
percent or more of all participating laboratories.
(2) To evaluate a laboratory's response for a particular sample, the
program must determine a laboratory's type of service in accordance with
paragraph (a) of this section. A laboratory must isolate and identify
the organisms to the same extent it performs these procedures on patient
specimens. A laboratory's performance will be evaluated on the basis of
its final answer, for example, a laboratory specified in paragraph
(a)(3) of this section will be evaluated on the basis of the average of
its scores for paragraphs (c)(3) through (c)(6) as determined in
paragraph (c)(7) of this section.
(3) Since laboratories may incorrectly report the presence of
organisms in addition to the correctly identified principal organism(s),
the grading system must provide a means of deducting credit for
additional erroneous organisms that are reported. Therefore, the total
number of correct responses for organism isolation and identification
submitted by the laboratory divided by the number of organisms present
plus the number of incorrect organisms reported by the laboratory must
be multiplied by 100 to establish a score for
[[Page 867]]
each sample in each testing event. For example, if a sample contained
one principal organism and the laboratory reported it correctly but
reported the presence of an additional organism, which was not
considered reportable, the sample grade would be 1/(1+1) x 100=50
percent.
(4) For antimicrobial susceptibility testing, a laboratory must
indicate which drugs are routinely included in its test panel when
testing patient samples. A laboratory's performance will be evaluated
for only those antibiotics for which service is offered. A correct
response for each antibiotic will be determined as described in
Secs. 493.911(c) (1) using criteria such as the guidelines established
by the National Committee for Clinical Laboratory Standards. Grading is
based on the number of correct susceptibility responses reported by the
laboratory divided by the actual number of correct susceptibility
responses determined by the program, multiplied by 100. For example, if
a laboratory offers susceptibility testing for Enterobacteriaceae using
amikacin, cephalothin, and tobramycin, and the organism in the
proficiency testing sample is an Enterobacteriaceae, and the laboratory
reports correct responses for two of three antimicrobial agents, the
laboratory's grade would be 2/3 x 100=67 percent.
(5) The performance criterion for qualitative antigen tests is the
presence or absence of the bacterial antigen. The score for antigen
tests is the number of correct responses divided by the number of
samples to be tested for the antigen, multiplied by 100.
(6) The performance criteria for Gram stain is staining reaction,
i.e., gram positive or gram negative. The score for Gram stain is the
number of correct responses divided by the number of challenges to be
tested, multiplied by 100.
(7) The score for a testing event in bacteriology is the average of
the scores determined under paragraphs (c)(3) through (c)(6) of this
section kbased on the type of service offered by the laboratory.
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993]
Sec. 493.913 Mycobacteriology.
(a) Types of services offered by laboratories. In mycobacteriology,
there are five types of laboratories for proficiency testing purposes:
(1) Those that interpret acid-fast stains and refer specimen to
another laboratory appropriately certified in the subspecialty of
mycobacteriology;
(2) Those that interpret acid-fast stains, perform primary
inoculation, and refer cultures to another laboratory appropriately
certified in the subspecialty of mycobacteriology for identification;
(3) Those that interpret acid-fast stains, isolate and perform
identification and/or antimycobacterial susceptibility of Mycobacterium
tuberculosis, but refer other mycobacteria species to another laboratory
appropriately certified in the subspecialty of mycobacteriology for
identification and/or susceptibility tests;
(4) Those that interpret acid-fast stains, isolate and identify all
mycobacteria to the extent required for correct clinical diagnosis, but
refer antimycobacterial susceptibility tests to another laboratory
appropriately certified in the subspecialty of mycobacteriology; and
(5) Those that interpret acid-fast stains, isolate and identify all
mycobacteria to the extent required for correct clinical diagnosis, and
perform antimycobacterial susceptibility tests on the organisms
isolated.
(b) Program content and frequency of challenge. To be approved for
proficiency testing for mycobacteriology, the annual program must
provide a minimum of five samples per testing event. There must be at
least two testing events per year. The samples may be provided through
mailed shipments or, at HHS' option, provided to HHS or its designee for
on-site testing events. For types of laboratories specified in
paragraphs (a)(1) and (a) (3) through (5) of this section, an annual
program must include samples that contain species that are
representative of the 5 major groups (complexes) of mycobacteria
encountered in human specimens. The specific mycobacteria included in
the samples may vary from year to year.
[[Page 868]]
(1) An approved program must furnish HHS and its agents with a
description of samples that it plans to include in its annual program no
later than six months before each calendar year. At least 50 percent of
the samples must be mixtures of the principal mycobacteria and
appropriate normal flora. The program must include mycobacteria commonly
occurring in patient specimens and other important emerging mycobacteria
(as determined by HHS). The program determines the reportable isolates
and correct responses for antimycobacterial susceptibility for any
designated isolate.
(2) An approved program may vary over time. For example, the types
of mycobacteria that might be included in an approved program over time
are--
TB
Mycobacterium tuberculosis
Mycobacterium bovis
Group I
Mycobacterium kansasii
Group II
Mycobacterium szulgai
Group III
Mycobacterium avium-intracellulare
Mycobacterium terrae
Group IV
Mycobacterium fortuitum
(3) For antimycobacterial susceptibility testing, the program must
provide at least one sample per testing event that includes
mycobacterium tuberculosis that has a predetermined pattern of
sensitivity or resistance to the common antimycobacterial agents.
(4) For laboratories specified in paragraphs (a)(1) and (a)(2), the
program must provide at least five samples per testing event that
includes challenges that are acid-fast and challenges which do not
contain acid-fast organisms.
(c) Evaluation of a laboratory's performance. HHS approves only
those programs that assess the accuracy of a laboratory's response in
accordance with paragraphs (c)(1) through (6) of this section.
(1) The program determines the reportable mycobacteria to be
detected by acid-fast stain, for isolation and identification, and for
antimycobacterial susceptibility. To determine the accuracy of a
laboratory's response, the program must compare the laboratory's
response for each sample with the response that reflects agreement of
either 90 percent of ten or more referee laboratories or 90 percent or
more of all participating laboratories.
(2) To evaluate a laboratory's response for a particular sample, the
program must determine a laboratory's type of service in accordance with
paragraph (a) of this section. A laboratory must interpret acid-fast
stains and isolate and identify the organisms to the same extent it
performs these procedures on patient specimens. A laboratory's
performance will be evaluated on the basis of the average of its scores
as determined in paragraph (c)(6) of this section.
(3) Since laboratories may incorrectly report the presence of
organisms in addition to the correctly identified principal organism(s),
the grading system must provide a means of deducting credit for
additional erroneous organisms reported. Therefore, the total number of
correct responses submitted by the laboratory divided by the number of
organisms present plus the number of incorrect organisms reported by the
laboratory must be multiplied by 100 to establish a score for each
sample in each testing event. For example, if a sample contained one
principal organism and the laboratory reported it correctly but reported
the presence of an additional organism, which was not present, the
sample grade would be
1/(1+1) x 100=50 percent
(4) For antimycobacterial susceptibility testing, a laboratory must
indicate which drugs are routinely included in its test panel when
testing patient samples. A laboratory's performance will be evaluated
for only those antibiotics for which susceptibility testing is routinely
performed on patient specimens. A correct response for each antibiotic
will be determined as described in Sec. 493.913(c)(1). Grading is based
on the number of correct susceptibility responses reported by the
laboratory divided by the actual number of correct susceptibility
responses as determined by the program, multiplied by 100. For example,
if a laboratory offers susceptibility testing using three
antimycobacterial agents and the laboratory reports correct response for
[[Page 869]]
two of the three antimycobacterial agents, the laboratory's grade would
be \2/3\ x 100=67 percent.
(5) The performance criterion for qualitative tests is the presence
or absence of acid-fast organisms. The score for acid-fast organism
detection is the number of correct responses divided by the number of
samples to be tested, multiplied by 100.
(6) The score for a testing event in mycobacteriology is the average
of the scores determined under paragraphs (c)(3) through (c)(5) of this
section based on the type of service offered by the laboratory.
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993]
Sec. 493.915 Mycology.
(a) Types of services offered by laboratories. In mycology, there
are four types of laboratories for proficiency testing purposes that may
perform different levels of service for yeasts, dimorphic fungi,
dermatophytes, and aerobic actinomycetes:
(1) Those that isolate and identify only yeasts and/or dermatophytes
to the genus level;
(2) Those that isolate and identify yeasts and/or dermatophytes to
the species level;
(3) Those that isolate and perform identification of all organisms
to the genus level; and
(4) Those that isolate and perform identification of all organisms
to the species level.
(b) Program content and frequency of challenge. To be approved for
proficiency testing for mycology, the annual program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The samples
may be provided through mailed shipments or, at HHS' option, may be
provided to HHS or its designee for on-site testing. An annual program
must include samples that contain organisms that are representative of
five major groups of fungi: Yeast or yeast-like fungi; dimorphic fungi;
dematiaceous fungi; dermatophytes; and saprophytes, including
opportunistic fungi. The specific fungi included in the samples may vary
from year to year.
(1) An approved program must, before each calendar year, furnish HHS
with a description of samples that it plans to include in its annual
program no later than six months before each calendar year. At least 50
percent of the samples must be mixtures of the principal organism and
appropriate normal background flora. Other important emerging pathogens
(as determined by HHS) and organisms commonly occurring in patient
specimens must be included periodically in the program.
(2) An approved program may vary over time. As an example, the types
of organisms that might be included in an approved program over time
are--
Candida albicans
Candida (other species)
Cryptococcus neoformans
Sporothrix schenckii
Exophiala jeanselmei
Fonsecaea pedrosoi
Microsporum sp.
Acremonium sp.
Trichophvton sp.
Aspergillus fumigatus
Nocardia sp.
Blastomyces dermatitidis \1\
Zygomycetes sp.
Note: \1\ Provided as a nonviable sample.
(c) Evaluation of a laboratory's performance. HHS approves only
those programs that assess the accuracy of a laboratory's response, in
accordance with paragraphs (c)(1) through (5) of this section.
(1) The program determines the reportable organisms. To determine
the accuracy of a laboratory's response, the program must compare the
laboratory's response for each sample with the response that reflects
agreement of either 90 percent of ten or more referee laboratories or 90
percent or more of all participating laboratories.
(2) To evaluate a laboratory's response for a particular sample, the
program must determine a laboratory's type of service in accordance with
paragraph (a) of this section. A laboratory must isolate and identify
the organisms to the same extent it performs these procedures on patient
specimens.
(3) Since laboratories may incorrectly report the presence of
organisms in addition to the correctly identified principal organism(s),
the grading system must deduct credit for additional
[[Page 870]]
erroneous organisms reported. Therefore, the total number of correct
responses submitted by the laboratory divided by the number of organisms
present plus the number of incorrect organisms reported by the
laboratory must be multiplied by 100 to establish a score for each
sample in each shipment or testing event. For example, if a sample
contained one principal organism and the laboratory reported it
correctly but reported the presence of an additional organism, which was
not present, the sample grade would be 1/(1+1)x100=50 percent.
(4) The score for the antigen tests is the number of correct
responses divided by the number of samples to be tested for the antigen,
multiplied by 100.
(5) The score for a testing event is the average of the sample
scores as determined under paragraph (c)(3) or (c)(4), or both, of this
section.
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5228, Jan. 19, 1993]
Sec. 493.917 Parasitology.
(a) Types of services offered by laboratories. In parasitology there
are two types of laboratories for proficiency testing purposes--
(1) Those that determine the presence or absence of parasites by
direct observation (wet mount) and/or pinworm preparations and, if
necessary, refer specimens to another laboratory appropriately certified
in the subspecialty of parasitology for identification;
(2) Those that identify parasites using concentration preparations
and/or permanent stains.
(b) Program content and frequency of challenge. To be approved for
proficiency testing in parasitology, a program must provide a minimum of
five samples per testing event. There must be at least three testing
events at approximately equal intervals per year. The samples may be
provided through mailed shipments or, at HHS's option, may be provided
to HHS or its designee for on-site testing. An annual program must
include samples that contain parasites that are commonly encountered in
the United States as well as those recently introduced into the United
States. Other important emerging pathogens (as determined by HHS) and
parasites commonly occurring in patient specimens must be included
periodically in the program.
(1) An approved program must, before each calendar year furnish HHS
with a description of samples that it plans to include in its annual
program no later than six months before each calendar year. Samples must
include both formalinized specimens and PVA (polyvinyl alcohol) fixed
specimens as well as blood smears, as appropriate for a particular
parasite and stage of the parasite. The majority of samples must contain
protozoa or helminths or a combination of parasites. Some samples must
be devoid of parasites.
(2) An approved program may vary over time. As an example, the types
of parasites that might be included in an approved program over time
are--
Enterobius vermicularis
Entamoeba histolytica
Entamoeba coli
Giardia lamblia
Endolimax nana
Dientamoeba fragilis
Iodamoeba butschli
Chilomastix mesnili
Hookworm
Ascaris lumbricoides
Strongyloides stercoralis
Trichuris trichiura
Diphyllobothrium latum
Cryptosporidium sp.
Plasmodium falciparum
(3) For laboratories specified in paragraph (a)(1) of this section,
the program must provide at least five samples per testing event that
include challenges which contain parasites and challenges that are
devoid of parasites.
(c) Evaluation of a laboratory's performance. HHS approves only
those programs that assess the accuracy of a laboratory's responses in
accordance with paragraphs (c)(1) through (6) of this section.
(1) The program must determine the reportable parasites. It may
elect to establish a minimum number of parasites to be identified in
samples before they are reported. Parasites found in rare numbers by
referee laboratories are not considered in scoring a laboratory's
performance; such findings are neutral. To determine the accuracy of a
laboratory's response, the program must compare the laboratory's
response with the response that reflects agreement of
[[Page 871]]
either 90 percent of ten or more referee laboratories or 90 percent or
more of all participating laboratories.
(2) To evaluate a laboratory's response for a particular sample, the
program must determine a laboratory's type of service in accordance with
paragraph (a) of this section. A laboratory must determine the presence
or absence of a parasite(s) or concentrate and identify the parasites to
the same extent it performs these procedures on patient specimens.
(3) Since laboratories may incorrectly report the presence of
parasites in addition to the correctly identified principal parasite(s),
the grading system must deduct credit for these additional erroneous
parasites reported and not found in rare numbers by the program's
referencing process. Therefore, the total number of correct responses
submitted by the laboratory divided by the number of parasites present
plus the number of incorrect parasites reported by the laboratory must
be multiplied by 100 to establish a score for each sample in each
testing event. For example, if a sample contained one principal parasite
and the laboratory reported it correctly but reported the presence of an
additional parasite, which was not present, the sample grade would be
1/(1+1) x 100=50 percent.
(4) The criterion for acceptable performance for qualitative
parasitology examinations is presence or absence of a parasite(s).
(5) The score for parasitology is the number of correct responses
divided by the number of samples to be tested, multiplied by 100.
(6) The score for a testing event is the average of the sample
scores as determined under paragraphs (c)(3) through (c)(5) of this
section.
Sec. 493.919 Virology.
(a) Types of services offered by laboratories. In virology, there
are two types of laboratories for proficiency testing purposes--
(1) Those that only perform tests that directly detect viral
antigens or structures, either in cells derived from infected tissues or
free in fluid specimens; and
(2) Those that are able to isolate and identify viruses and use
direct antigen techniques.
(b) Program content and frequency of challenge. To be approved for
proficiency testing in virology, a program must provide a minimum of
five samples per testing event. There must be at least three testing
events at approximately equal intervals per year. The samples may be
provided to the laboratory through mailed shipments or, at HHS's option,
may be provided to HHS or its designee for on-site testing. An annual
program must include viral species that are the more commonly identified
viruses. The specific organisms found in the samples may vary from year
to year. The annual program must include samples for viral antigen
detection and viral isolation and identification.
(1) An approved program must furnish HHS with a description of
samples that it plans to include in its annual program no later than six
months before each calendar year. The program must include other
important emerging viruses (as determined by HHS) and viruses commonly
occurring in patient specimens.
(2) An approved program may vary over time. For example, the types
of viruses that might be included in an approved program over time are
the more commonly identified viruses such as Herpes simplex, respiratory
syncytial virus, adenoviruses, enteroviruses, and cytomegaloviruses.
(c) Evaluation of laboratory's performance. HHS approves only those
programs that assess the accuracy of a laboratory's response in
accordance with paragraphs (c)(1) through (5) of this section.
(1) The program determines the reportable viruses to be detected by
direct antigen techniques or isolated by laboratories that perform viral
isolation procedures. To determine the accuracy of a laboratory's
response, the program must compare the laboratory's response for each
sample with the response that reflects agreement of either 90 percent of
ten or more referee laboratories or 90 percent or more of all
participating laboratories.
[[Page 872]]
(2) To evaluate a laboratory's response for a particular sample, the
program must determine a laboratory's type of service in accordance with
paragraph (a) of this section. A laboratory must isolate and identify
the viruses to the same extent it performs these procedures on patient
specimens.
(3) Since laboratories may incorrectly report the presence of
viruses in addition to the correctly identified principal virus, the
grading system must provide a means of deducting credit for additional
erroneous viruses reported. Therefore, the total number of correct
responses determined by virus culture techniques submitted by the
laboratory divided by the number of viruses present plus the number of
incorrect viruses reported by the laboratory must be multiplied by 100
to establish a score for each sample in each testing event. For example,
if a sample contained one principal virus and the laboratory reported it
correctly but reported the presence of an additional virus, which was
not present, the sample grade would be 1/(1+1) x 100=50 percent.
(4) The performance criterion for qualitative antigen tests is
presence or absence of the viral antigen. The score for the antigen
tests is the number of correct responses divided by the number of
samples to be tested for the antigen, multiplied by 100.
(5) The score for a testing event is the average of the sample
scores as determined under paragraph (c)(3) and (c)(4) of this section.
Sec. 493.921 Diagnostic immunology.
The subspecialties under the specialty of immunology for which a
program may offer proficiency testing are syphilis serology and general
immunology. Specific criteria for these subspecialties are found at
Secs. 493.923 and 493.927.
Sec. 493.923 Syphilis serology.
(a) Program content and frequency of challenge. To be approved for
proficiency testing in syphilis serology, a program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The samples
may be provided through mailed shipments or, at HHS' option, may be
provided to HHS or its designee for on-site testing. An annual program
must include samples that cover the full range of reactivity from highly
reactive to non-reactive.
(b) Evaluation of test performance. HHS approves only those programs
that assess the accuracy of a laboratory's responses in accordance with
paragraphs (b)(1) through (4) of this section.
(1) To determine the accuracy of a laboratory's response for
qualitative and quantitative syphilis tests, the program must compare
the laboratory's response with the response that reflects agreement of
either 90 percent of ten or more referee laboratories or 90 percent or
more of all participating laboratories. The proficiency testing program
must indicate the minimum concentration, by method, that will be
considered as indicating a positive response. The score for a sample in
syphilis serology is the average of scores determined under paragraphs
(b)(2) and (b)(3) of this section.
(2) For quantitative syphilis tests, the program must determine the
correct response for each method by the distance of the response from
the target value. After the target value has been established for each
response, the appropriateness of the response must be determined by
using fixed criteria. The criterion for acceptable performance for
quantitative syphilis serology tests is the target value <SUP>plus-minus</SUP>
1 dilution.
(3) The criterion for acceptable performance for qualitative
syphilis serology tests is reactive or nonreactive.
(4) To determine the overall testing event score, the number of
correct responses must be averaged using the following formula:
Number of acceptable responses for all
challenges
------------------------------------------- x 100=Testing event score
Total number of all challenges
------------------------------------------------------------------------
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
[[Page 873]]
Sec. 493.927 General immunology.
(a) Program content and frequency of challenge. To be approved for
proficiency testing for immunology, the annual program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The annual
program must provide samples that cover the full range of reactivity
from highly reactive to nonreactive. The samples may be provided through
mailed shipments or, at HHS' option, may be provided to HHS or its
designee for on-site testing.
(b) Challenges per testing event. The minimum number of challenges
per testing event the program must provide for each analyte or test
procedure is five. Analytes or tests for which laboratory performance is
to be evaluated include:
Analyte or Test Procedure
Alpha-l antitrypsin
Alpha-fetoprotein (tumor marker)
Antinuclear antibody
Antistreptolysin O
Anti-human immunodeficiency virus (HIV)
Complement C3
Complement C4
Hepatitis markers (HBsAg, anti-HBc, HBeAg)
IgA
IgG
IgE
IgM
Infectious mononucleosis
Rheumatoid factor
Rubella
(c) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
responses in accordance with paragraphs (c)(1) through (5) of this
section.
(1) To determine the accuracy of a laboratory's response for
quantitative and qualitative immunology tests or analytes, the program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 90 percent of ten or more
referee laboratories or 90 percent or more of all participating
laboratories. The proficiency testing program must indicate the minimum
concentration that will be considered as indicating a positive response.
The score for a sample in general immunology is either the score
determined under paragraph (c)(2) or (3) of this section.
(2) For quantitative immunology analytes or tests, the program must
determine the correct response for each analyte by the distance of the
response from the target value. After the target value has been
established for each response, the appropriateness of the response must
be determined by using either fixed criteria or the number of standard
deviations (SDs) the response differs from the target value.
Criteria for Acceptable Performance
The criteria for acceptable performance are--
------------------------------------------------------------------------
Criteria for acceptable
Analyte or test performance
------------------------------------------------------------------------
Alpha-1 antitrypsin....................... Target value <plus-minus>3
SD.
Alpha-fetoprotein (tumor marker).......... Target value <plus-minus>3
SD.
Antinuclear antibody...................... Target value +/-2 dilutions
or positive or negative.
Antistreptolysin O........................ Target value +/-2 dilution
or positive or negative.
Anti-Human Immunodeficiency virus......... Reactive or nonreactive.
Complement C3............................. Target value <plus-minus>3
SD.
Complement C4............................. Target value <plus-minus>3
SD.
Hepatitis (HBsAg, anti-HBc, HBeAg)........ Reactive (positive) or
nonreactive (negative).
IgA....................................... Target value <plus-minus>3
SD.
IgE....................................... Target value <plus-minus>3
SD.
IgG....................................... Target value +/-25%.
IgM....................................... Target value <plus-minus>3
SD.
Infectious mononucleosis.................. Target value +/-2 dilutions
or positive or negative.
Rheumatoid factor......................... Target value +/-2 dilutions
or positive or negative.
Rubella................................... Target value +/-2 dilutions
or immune or nonimmune or
positive or negative.
------------------------------------------------------------------------
(3) The criterion for acceptable performance for qualitative general
immunology tests is positive or negative.
(4) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
Number of acceptable responses for the
analyte x 100=Analyte score for the
------------------------------------------- testing event
Total number of challenges for the analyte
------------------------------------------------------------------------
[[Page 874]]
(5) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
Number of acceptable responses for all
challenges
------------------------------------------- x 100=Testing event score
Total number of all challenges
------------------------------------------------------------------------
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
Sec. 493.929 Chemistry.
The subspecialties under the specialty of chemistry for which a
proficiency testing program may offer proficiency testing are routine
chemistry, endocrinology, and toxicology. Specific criteria for these
subspecialties are listed in Secs. 493.931 through 493.939.
Sec. 493.931 Routine chemistry.
(a) Program content and frequency of challenge. To be approved for
proficiency testing for routine chemistry, a program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The annual
program must provide samples that cover the clinically relevant range of
values that would be expected in patient specimens. The specimens may be
provided through mailed shipments or, at HHS' option, may be provided to
HHS or its designee for on-site testing.
(b) Challenges per testing event. The minimum number of challenges
per testing event a program must provide for each analyte or test
procedure listed below is five serum, plasma or blood samples.
Analyte or Test Procedure
Alanine aminotransferase (ALT/SGPT)
Albumin
Alkaline phosphatase
Amylase
Aspartate aminotransferase (AST/SGOT)
Bilirubin, total
Blood gas (pH, pO2, and pCO2)
Calcium, total
Chloride
Cholesterol, total
Cholesterol, high density lipoprotein
Creatine kinase
Creatine kinase, isoenzymes
Creatinine
Glucose (Excluding measurements on devices cleared by FDA for home use)
Iron, total
Lactate dehydrogenase (LDH)
LDH isoenzymes
Magnesium
Potassium
Sodium
Total Protein
Triglycerides
Urea Nitrogen
Uric Acid
(c) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
responses in accordance with paragraphs (c)(1) through (5) of this
section.
(1) To determine the accuracy of a laboratory's response for
qualitative and quantitative chemistry tests or analytes, the program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 90 percent of ten or more
referee laboratories or 90 percent or more of all participating
laboratories. The score for a sample in routine chemistry is either the
score determined under paragraph (c)(2) or (3) of this section.
(2) For quantitative chemistry tests or analytes, the program must
determine the correct response for each analyte by the distance of the
response from the target value. After the target value has been
established for each response, the appropriateness of the response must
be determined by using either fixed criteria based on the percentage
difference from the target value or the number of standard deviations
(SDs) the response differs from the target value.
Criteria for Acceptable Performance
The criteria for acceptable performance are--
------------------------------------------------------------------------
Criteria for acceptable
Analyte or test performance
------------------------------------------------------------------------
Alanine aminotransferase (ALT/SGPT)....... Target value <plus-
minus>20%.
Albumin................................... Target value <plus-
minus>10%.
Alkaline phosphatase...................... Target value <plus-
minus>30%.
Amylase................................... Target value <plus-
minus>30%.
Aspartate aminotransferase (AST/SGOT)..... Target value <plus-
minus>20%.
Bilirubin, total.......................... Target value <plus-minus>0.4
mg/dL or <plus-minus>20%
(greater).
[[Page 875]]
Blood gas pO2............................. Target value <plus-minus>3
SD.
pCO2...................................... Target value <plus-minus>5
mm Hg or +/-8% (greater).
pH........................................ Target value <plus-
minus>0.04.
Calcium, total............................ Target value <plus-minus>1.0
mg/dL.
Chloride.................................. Target value <plus-minus>5%.
Cholesterol, total........................ Target value <plus-
minus>10%.
Cholesterol, high density lipoprotein..... Target value <plus-
minus>30%.
Creatine kinase........................... Target value <plus-
minus>30%.
Creatine kinase isoenzymes................ MB elevated (presence or
absence) or Target value
<plus-minus>3SD.
Creatinine................................ Target value <plus-minus>0.3
mg/dL or <plus-minus>15%
(greater).
Glucose (excluding glucose performed on Target value <plus-minus>6
monitoring devices cleared by FDA for mg/dl or <plus-minus>10%
home use. (greater).
Iron, total............................... Target value <plus-
minus>20%.
Lactate dehydrogenase (LDH)............... Target value <plus-
minus>20%.
LDH isoenzymes............................ LDH1/LDH2 (+ or -) or Target
value <plus-minus> 30%.
Magnesium................................. Target value <plus-
minus>25%.
Potassium................................. Target value <plus-minus>0.5
mmol/L.
Sodium.................................... Target value <plus-minus>4
mmol/L.
Total Protein............................. Target value <plus-
minus>10%.
Triglycerides............................. Target value <plus-
minus>25%.
Urea nitrogen............................. Target value <plus-minus>2
mg/dL or <plus-minus>9%
(greater).
Uric acid................................. Target value <plus-
minus>17%.
------------------------------------------------------------------------
(3) The criterion for acceptable performance for qualitative routine
chemistry tests is positive or negative.
(4) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
Number of acceptable responses for the
analyte x 100=Analyte score for the
------------------------------------------- testing event
Total number of challenges for the analyte
------------------------------------------------------------------------
(5) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
Number of acceptable responses for all
challenges
------------------------------------------- x 100=Testing event score
Total number of all challenges
------------------------------------------------------------------------
Sec. 493.933 Endocrinology.
(a) Program content and frequency of challenge. To be approved for
proficiency testing for endocrinology, a program must provide a minimum
of five samples per testing event. There must be at least three testing
events at approximately equal intervals per year. The annual program
must provide samples that cover the clinically relevant range of values
that would be expected in patient specimens. The samples may be provided
through mailed shipments or, at HHS' option, may be provided to HHS or
its designee for on-site testing.
(b) Challenges per testing event. The minimum number of challenges
per testing event a program must provide for each analyte or test
procedure is five serum, plasma, blood, or urine samples.
Analyte or Test
Cortisol
Free Thyroxine
Human Chorionic gonadotropin (excluding urine pregnancy tests done by
visual color comparison categorized as waived tests)
T3 Uptake
Triiodothyronine
Thyroid-stimulating hormone
Thyroxine
(c) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
responses in accordance with paragraphs (c)(1) through (5) of this
section.
(1) To determine the accuracy of a laboratory's response for
qualitative and quantitative endocrinology tests or analytes, a program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 90 percent of ten or more
referee laboratories or 90 percent or more of all participating
laboratories. The score for a sample in endocrinology is either the
score determined under paragraph (c)(2) or (c)(3) of this section.
(2) For quantitative endocrinology tests or analytes, the program
must determine the correct response for each analyte by the distance of
the response from the target value. After the target value has been
established for each response, the appropriateness of the response must
be determined by using either fixed criteria based on the percentage
difference from the target value or the number of standard deviations
(SDs) the response differs from the target value.
[[Page 876]]
Criteria for Acceptable Performance
The criteria for acceptable performance are--
------------------------------------------------------------------------
Criteria for acceptable
Analyte or test performance
------------------------------------------------------------------------
Cortisol.................................. Target value +/-25%.
Free Thyroxine............................ Target value +/-3 SD.
Human Chorionic Gonadotropin (excluding Target value +/-3 SD
urine pregnancy tests done by visual positive or negative.
color comparison categorized as waived
tests).
T3 Uptake................................. Target value +/-3 SD.
Triiodothyronine.......................... Target value +/-3 SD.
Thyroid-stimulating hormone............... Target value +/-3 SD.
Thyroxine................................. Target value +/-20% or 1.0
mcg/dL (greater).
------------------------------------------------------------------------
(3) The criterion for acceptable performance for qualitative
endocrinology tests is positive or negative.
(4) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
Number of acceptable responses for the
analyte x 100=Analyte score for the
------------------------------------------- testing event
Total number of challenges for the analyte
------------------------------------------------------------------------
(5) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
Number of acceptable responses for all
challenges
------------------------------------------- x 100=Testing event score
Total number of all challenges
------------------------------------------------------------------------
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
Sec. 493.937 Toxicology.
(a) Program content and frequency of challenge. To be approved for
proficiency testing for toxicology, the annual program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The annual
program must provide samples that cover the clinically relevant range of
values that would be expected in specimens of patients on drug therapy
and that cover the level of clinical significance for the particular
drug. The samples may be provided through mailed shipments or, at HHS'
option, may be provided to HHS or its designee for on-site testing.
(b) Challenges per testing event. The minimum number of challenges
per testing event a program must provide for each analyte or test
procedure is five serum, plasma, or blood samples.
Analyte or Test Procedure
Alcohol (blood)
Blood lead
Carbamazepine
Digoxin
Ethosuximide
Gentamicin
Lithium
Phenobarbital
Phenytoin
Primidone
Procainamide
(and metabolite)
Quinidine
Theophylline
Tobramycin
Valproic Acid
(c) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
responses in accordance with paragraphs (c)(1) through (4) of this
section.
(1) To determine the accuracy of a laboratory's responses for
quantitative toxicology tests or analytes, the program must compare the
laboratory's response for each analyte with the response that reflects
agreement of either 90 percent of ten or more referee laboratories or 90
percent or more of all participating laboratories. The score for a
sample in toxicology is the score determined under paragraph (c)(2) of
this section.
(2) For quantitative toxicology tests or analytes, the program must
determine the correct response for each analyte by the distance of the
response from the target value. After the target value has been
established for each response, the appropriateness of the response must
be determined by using fixed criteria based on the percentage difference
from the target value
Criteria for Acceptable Performance
The criteria for acceptable performance are:
------------------------------------------------------------------------
Criteria for acceptable
Analyte or test performance
------------------------------------------------------------------------
Alcohol, blood............................ Target Value <plus-minus>
25%.
Blood lead................................ Target Value <plus-minus>10%
or 4 mcg/dL (greater).
[[Page 877]]
Carbamazepine............................. Target Value <plus-minus>
25%.
Digoxin................................... Target Value <plus-minus>
20% or <plus-minus> 0.2 ng/
mL (greater).
Ethosuximide.............................. Target Value <plus-minus>
20%.
Gentamicin................................ Target Value <plus-minus>
25%.
Lithium................................... Target Value <plus-minus>
0.3 mmol/L or <plus-minus>
20% (greater).
Phenobarbital............................. Target Value <plus-minus>
20%
Phenytoin................................. Target Value <plus-minus>
25%.
Primidone................................. Target Value <plus-minus>
25%.
Procainamide (and metabolite)............. Target Value <plus-minus>
25%.
Quinidine................................. Target Value <plus-minus>
25%.
Tobramycin................................ Target Value <plus-minus>
25%.
Theophylline.............................. Target Value <plus-minus>
25%.
Valproic Acid............................. Target Value <plus-minus>
25%.
------------------------------------------------------------------------
(3) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
Number of acceptable responses for the
analyte x 100=Analyte score for the
------------------------------------------- testing event
Total number of challenges for the analyte
------------------------------------------------------------------------
(4) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
Number of acceptable responses for all
challenges
------------------------------------------- x 100=Testing event score
Total number of all challenges
------------------------------------------------------------------------
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
Sec. 493.941 Hematology (including routine hematology and coagulation).
(a) Program content and frequency of challenge. To be approved for
proficiency testing for hematology, a program must provide a minimum of
five samples per testing event. There must be at least three testing
events at approximately equal intervals per year. The annual program
must provide samples that cover the full range of values that would be
expected in patient specimens. The samples may be provided through
mailed shipments or, at HHS' option, may be provided to HHS and or its
designee for on-site testing.
(b) Challenges per testing event. The minimum number of challenges
per testing event a program must provide for each analyte or test
procedure is five.
Analyte or Test Procedure
Cell identification or white blood cell differential
Erythrocyte count
Hematocrit (excluding spun microhematocrit)
Hemoglobin
Leukocyte count
Platelet count
Fibrinogen
Partial thromboplastin time
Prothrombin time
(1) An approved program for cell identification may vary over time.
The types of cells that might be included in an approved program over
time are--
Neutrophilic granulocytes
Eosinophilic granulocytes
Basophilic granulocytes
Lymphocytes
Monocytes
Major red and white blood cell abnormalities
Immature red and white blood cells
(2) White blood cell differentials should be limited to the
percentage distribution of cellular elements listed above.
(c) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
responses in accordance with paragraphs (c) (1) through (5) of this
section.
(1) To determine the accuracy of a laboratory's responses for
qualitative and quantitative hematology tests or analytes, the program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 90 percent of ten or more
referee laboratories or 90 percent or more of all participating
laboratories. The score for a sample in hematology is either the score
determined under paragraph (c) (2) or (3) of this section.
(2) For quantitative hematology tests or analytes, the program must
determine the correct response for each analyte by the distance of the
response from the target value. After the target
[[Page 878]]
value has been established for each response, the appropriateness of the
response is determined using either fixed criteria based on the
percentage difference from the target value or the number of standard
deviations (SDs) the response differs from the target value.
Criteria for Acceptable Performance
The criteria for acceptable performance are:
------------------------------------------------------------------------
Criteria for acceptable
Analyte or test performance
------------------------------------------------------------------------
Cell identification....................... 90% or greater consensus on
identification.
White blood cell differential............. Target +/- 3SD based on the
percentage of different
types of white blood cells
in the samples.
Erythrocyte count......................... Target +/-6%.
Hematocrit (Excluding spun hematocrits)... Target +/-6%.
Hemoglobin................................ Target +/-7%.
Leukocyte count........................... Target +/-15%.
Platelet count............................ Target +/-25%.
Fibrinogen................................ Target +/- 20%.
Partial thromboplastin time............... Target +/-15%.
Prothrombin time.......................... Target +/-15%.
------------------------------------------------------------------------
(3) The criterion for acceptable performance for the qualitative
hematology test is correct cell identification.
(4) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
Number of acceptable responses for the
analyte x 100=Analyte score for
------------------------------------------- the testing event
Total number of challenges for the analyte
------------------------------------------------------------------------
(5) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
Number of acceptable responses for all
challenges
------------------------------------------- x 100=Testing event score
Total number of all challenges
------------------------------------------------------------------------
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
Sec. 493.945 Cytology; gynecologic examinations.
(a) Program content and frequency of challenge. (1) To be approved
for proficiency testing for gynecologic examinations (Pap smears) in
cytology, a program must provide test sets composed of 10- and 20-glass
slides. Proficiency testing programs may obtain slides for test sets
from cytology laboratories, provided the slides have been retained by
the laboratory for the required period specified in Sec. 493.1257. If
slide preparations are still subject to retention by the laboratory,
they may be loaned to a proficiency testing program if the program
provides the laboratory with documentation of the loan of the slides and
ensures that slides loaned to it are retrievable upon request. Each test
set must include at least one slide representing each of the response
categories described in paragraph (b)(3)(ii)(A) of this section, and
test sets should be comparable so that equitable testing is achieved
within and between proficiency testing providers.
(2) To be approved for proficiency testing in gynecologic cytology,
a program must provide announced and unannounced on-site testing for
each individual at least once per year and must provide an initial
retesting event for each individual within 45 days after notification of
test failure and subsequent retesting events within 45 days after
completion of remedial action described in Sec. 493.855.
(b) Evaluation of an individual's performance. HHS approves only
those programs that assess the accuracy of each individual's responses
on both 10- and 20-slide test sets in which the slides have been
referenced as specified in paragraph (b)(1) of this section.
(1) To determine the accuracy of an individual's response on a
particular challenge (slide), the program must compare the individual's
response for each slide preparation with the response that reflects the
predetermined consensus agreement or confirmation on the diagnostic
category, as described in the table in paragraph (b)(3)(ii)(A) of this
section. For all slide preparations, a 100% consensus agreement among a
minimum of three physicians certified in anatomic pathology
[[Page 879]]
is required. In addition, for premalignant and malignant slide
preparations, confirmation by tissue biopsy is required either by
comparison of the reported biopsy results or reevaluation of biopsy
slide material by a physician certified in anatomic pathology.
(2) An individual qualified as a technical supervisor under
Sec. 493.1449 (b) or (k) who routinely interprets gynecologic slide
preparations only after they have been examined by a cytotechnologist
can either be tested using a test set that has been screened by a
cytotechnologist in the same laboratory or using a test set that has not
been screened. A technical supervisor who screens and interprets slide
preparations that have not been previously examined must be tested using
a test set that has not been previously screened.
(3) The criteria for acceptable performance are determined by using
the scoring system in paragraphs (b)(3) (i) and (ii) of this section.
(i) Each slide set must contain 10 or 20 slides with point values
established for each slide preparation based on the significance of the
relationship of the interpretation of the slide to a clinical condition
and whether the participant in the testing event is a cytotechnologist
qualified under Secs. 493.1469 or 493.1483 or functioning as a technical
supervisor in cytology qualified under Sec. 493.1449 (b) or (k) of this
part.
(ii) The scoring system rewards or penalizes the participants in
proportion to the distance of their answers from the correct response or
target diagnosis and the penalty or reward is weighted in proportion to
the severity of the lesion.
(A) The four response categories for reporting proficiency testing
results and their descriptions are as follows:
------------------------------------------------------------------------
Category Description
------------------------------------------------------------------------
A................................. Unsatisfactory for diagnosis due to:
(1) Scant cellularity.
(2) Air drying.
(3) Obscuring material (blood,
inflammatory cells, or lubricant).
B................................. Normal or Benign Changes--includes:
(1) Normal, negative or within
normal limits.
(2) Infection other than Human
Papillomavirus (HPV) (e.g.,
Trichomonas vaginalis, changes or
morphology consistent with Candida
spp., Actinomyces spp. or Herpes
simplex virus).
(3) Reactive and reparative changes
(e.g., inflammation, effects of
chemotherapy or radiation).
C................................. Low Grade Squamous Intraepithelial
Lesion--includes:
(1) Cellular changes associated with
HPV.
(2) Mild dysplasia/CIN-1.
D................................. High Grade Lesion and Carcinoma--
includes:
(1) High grade squamous
intraepithelial lesions which
include moderate dysplasia/CIN-2
and severe dysplasia/carcinoma in-
situ/CIN-3.
(2) Squamous cell carcinoma.
(3) Adenocarcinoma and other
malignant neoplasms.
------------------------------------------------------------------------
(B) In accordance with the criteria for the scoring system, the
charts in paragraphs (b)(3)(ii)(C) and (D) of this section, for
technical supervisors and cytotechnologists, respectively, provide a
maximum of 10 points for a correct response and a maximum of minus five
(-5) points for an incorrect response on a 10-slide test set. For
example, if the correct response on a slide is ``high grade squamous
intraepithelial lesion'' (category ``D'' on the scoring system chart)
and an examinee calls it ``normal or negative'' (category ``B'' on the
scoring system chart), then the examinee's point value on that slide is
calculated as minus five (-5). Each slide is scored individually in the
same manner. The individual's score for the testing event is determined
by adding the point value achieved for each slide preparation, dividing
by the total points for the testing event and multiplying by 100.
(C) Criteria for scoring system for a 10-slide test set. (See table
at (b)(3)(ii)(A) of this section for a description of the response
categories.) For technical supervisors qualified under Sec. 493.1449(b)
or (k):
------------------------------------------------------------------------
Examinee's response: A B C D
------------------------------------------------------------------------
Correct response category:
A................................................. 10 0 0 0
B................................................. 5 10 0 0
C................................................. 5 0 10 5
[[Page 880]]
D................................................. 0 5 5 10
------------------------------------------------------------------------
(D) Criteria for scoring system for a 10-slide test set. (See table
at paragraph (b)(3)(ii)(A) of this section for a description of the
response categories.) For cytotechnologists qualified under
Secs. 493.1469 or 493.1483:
------------------------------------------------------------------------
Examinee's response: A B C D
------------------------------------------------------------------------
Correct response category:
A................................................. 10 0 5 5
B................................................. 5 10 5 5
C................................................. 5 0 10 10
D................................................. 0 -5 10 10
------------------------------------------------------------------------
(E) In accordance with the criteria for the scoring system, the
charts in paragraphs (b)(3)(ii)(F) and (G) of this section, for
technical supervisors and cytotechnologists, respectively, provide
maximums of 5 points for a correct response and minus ten (-10) points
for an incorrect response on a 20-slide test set.
(F) Criteria for scoring system for a 20-slide test set. (See table
at paragraph (b)(3)(ii)(A) of this section for a description of the
response categories.) For technical supervisors qualified under
Sec. 493.1449(b) or (k):
------------------------------------------------------------------------
Examinee's response: A B C D
------------------------------------------------------------------------
Correct response category:
A........................................... 5 0 0 0
B........................................... 2.5 5 0 0
C........................................... 2.5 0 5 2.5
D........................................... 0 -10 2.5 5
------------------------------------------------------------------------
(G) Criteria for scoring system for a 20-slide test set. (See table
at (b)(3)(ii)(A) of this section for a description of the response
categories.) For cytotechnologists qualified under Secs. 493.1469 or
493.1483:
------------------------------------------------------------------------
Examinee's response: A B C D
------------------------------------------------------------------------
Correct response category:
A............................................ 5 0 2.5 2.5
B............................................ 2.5 5 2.5 2.5
C............................................ 2.5 0 5 5
D............................................ 0 -10 5 5
------------------------------------------------------------------------
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
Sec. 493.959 Immunohematology.
(a) Types of services offered by laboratories. In immunohematology,
there are four types of laboratories for proficiency testing purposes--
(1) Those that perform ABO group and/or D (Rho) typing;
(2) Those that perform ABO group and/or D (Rho) typing, and
unexpected antibody detection;
(3) Those that in addition to paragraph (a)(2) of this section
perform compatibility testing; and
(4) Those that perform in addition to paragraph (a)(3) of this
section antibody identification.
(b) Program content and frequency of challenge. To be approved for
proficiency testing for immunohematology, a program must provide a
minimum of five samples per testing event. There must be at least three
testing events at approximately equal intervals per year. The annual
program must provide samples that cover the full range of interpretation
that would be expected in patient specimens. The samples may be provided
through mailed shipments or, at HHS' option, may be provided to HHS or
its designee for on-site testing.
(c) Challenges per testing event. The minimum number of challenges
per testing event a program must provide for each analyte or test
procedure is five.
Analyte or Test Procedure
ABO group (excluding subgroups)
D (Rho) typing
Unexpected antibody detection
Compatibility testing
Antibody identification
(d) Evaluation of a laboratory's analyte or test performance. HHS
approves only those programs that assess the accuracy of a laboratory's
response in accordance with paragraphs (d)(1) through (5) of this
section.
(1) To determine the accuracy of a laboratory's response, a program
must compare the laboratory's response for each analyte with the
response that reflects agreement of either 100 percent of ten or more
referee laboratories or 95 percent or more of all participating
laboratories except for unexpected antibody detection and antibody
identification. To determine the accuracy of a laboratory's response for
unexpected antibody detection and antibody
[[Page 881]]
identification, a program must compare the laboratory's response for
each analyte with the response that reflects agreement of either 95
percent of ten or more referee laboratories or 95 percent or more of all
participating laboratories. The score for a sample in immunohematology
is either the score determined under paragraph (d)(2) or (3) of this
section.
(2) Criteria for acceptable performance. The criteria for acceptable
performance are--
------------------------------------------------------------------------
Criteria for acceptable
Analyte or test performance
------------------------------------------------------------------------
ABO group................................. 100% accuracy.
D (Rho) typing............................ 100% accuracy.
Unexpected antibody detection............. 80% accuracy.
Compatibility testing..................... 100% accuracy.
Antibody identification................... 80% accuracy.
------------------------------------------------------------------------
(3) The criterion for acceptable performance for qualitative
immunohematology tests is positive or negative.
(4) To determine the analyte testing event score, the number of
acceptable analyte responses must be averaged using the following
formula:
Number of acceptable responses for the analyte x 100=Analyte score for
the testing event
-------------------------------------------------------------------------
Total number of challenges for the analyte
-------------------------------------------------------------------------
(5) To determine the overall testing event score, the number of
correct responses for all analytes must be averaged using the following
formula:
Number of acceptable responses for all challenges x 100=Testing event
score
-------------------------------------------------------------------------
Total number of all challenges
-------------------------------------------------------------------------
Subpart J--Patient Test Management for Moderate Complexity (Including
the Subcategory), High Complexity, or Any Combination of These Tests
Source: 57 FR 7162, Feb, 28, 1992, unless otherwise noted.
Sec. 493.1101 Condition: Patient test management; moderate complexity
(including the subcategory), or high complexity testing, or
any combination of these tests.
Each laboratory performing moderate complexity (including the
subcategory) or high complexity testing, or any combination of these
tests, must employ and maintain a system that provides for proper
patient preparation; proper specimen collection, identification,
preservation, transportation, and processing; and accurate result
reporting. This system must assure optimum patient specimen integrity
and positive identification throughout the preanalytic (pre-testing),
analytic (testing), and postanalytic (post-testing) processes and must
meet the standards as they apply to the testing performed.
[60 FR 20048, Apr. 24, 1995]
Sec. 493.1103 Standard; Procedures for specimen submission and
handling.
(a) The laboratory must have available and follow written policies
and procedures for each of the following, if applicable: Methods used
for the preparation of patients; specimen collection; specimen labeling;
specimen preservation; conditions for specimen transportation; and
specimen processing. Such policies and procedures must assure positive
identification and optimum integrity of the patient specimens from the
time the specimen(s) are collected until testing has been completed and
the results reported.
(b) If the laboratory accepts referral specimens, written
instructions must be available to clients and must include, as
appropriate, the information specified in paragraph (a) of this section.
(c) Oral explanation of instructions to patients for specimen
collection, including patient preparation, may be used as a supplement
to written instructions where applicable.
[57 FR 7162, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
[[Page 882]]
Sec. 493.1105 Standard; Test requisition.
The laboratory must perform tests only at the written or electronic
request of an authorized person. Oral requests for laboratory tests are
permitted only if the laboratory subsequently requests written
authorization for testing within 30 days. The laboratory must maintain
the written authorization or documentation of efforts made to obtain a
written authorization. Records of test requisitions or test
authorizations must be retained for a minimum of two years. The
patient's chart or medical record, if used as the test requisition, must
be retained for a minimum of two years and must be available to the
laboratory at the time of testing and available to HHS upon request. The
laboratory must assure that the requisition or test authorization
includes--
(a) The patient's name or other unique identifier;
(b) The name and address or other suitable identifiers of the
authorized person requesting the test and, if appropriate, the
individual responsible for utilizing the test results or the name and
address of the laboratory submitting the specimen, including, as
applicable, a contact person to enable the reporting of imminent life
threatening laboratory results or panic values;
(c) The test(s) to be performed;
(d) The date of specimen collection;
(e) For Pap smears, the patient's last menstrual period, age or date
of birth, and indication of whether the patient had a previous abnormal
report, treatment or biopsy; and
(f) Any additional information relevant and necessary to a specific
test to assure accurate and timely testing and reporting of results.
[57 FR 7162, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
Sec. 493.1107 Standard; Test records.
The laboratory must maintain a record system to ensure reliable
identification of patient specimens as they are processed and tested to
assure that accurate test results are reported. These records must
identify the personnel performing the testing procedure. Records of
patient testing, including, if applicable, instrument printouts, must be
retained for at least two years. Immunohematology records and
transfusion records must be retained for no less than five years in
accordance with 21 CFR part 606, subpart I. In addition, records of
blood and blood product testing must be maintained for a period not less
than five years after processing records have been completed, or six
months after the latest expiration date, whichever is the later date, in
accordance with 21 CFR 606.160(d). The record system must provide
documentation of information specified in Sec. 493.1105 (a) through (f)
and include--
(a) The patient identification number, accession number, or other
unique identification of the specimen;
(b) The date and time of specimen receipt into the laboratory;
(c) The condition and disposition of specimens that do not meet the
laboratory's criteria for specimen acceptability; and
(d) The records and dates of all specimen testing, including the
identity of the personnel who performed the test(s), which are necessary
to assure proper identification and accurate reporting of patient test
results.
[57 FR 7162, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
Sec. 493.1109 Standard; Test report.
The laboratory report must be sent promptly to the authorized
person, the individual responsible for using the test results or
laboratory that initially requested the test. The original report or an
exact duplicate of each test report, including final and preliminary
report, must be retained by the testing laboratory for a period of at
least two years after the date of reporting. Immunohematology reports
and transfusion records must be retained by the laboratory for a period
of no less than five years in accordance with 21 CFR part 606, subpart
I. In addition, records of blood and blood product testing must be
maintained for a period not less than five years after processing
records have been completed, or six months after the latest expiration
date, whichever is the later date, in accordance with 21 CFR 606.160(d).
For pathology, test reports must be retained
[[Page 883]]
for a period of at least ten years after the date of reporting. This
information may be maintained as part of the patient's chart or medical
record which must be readily available to the laboratory and to HHS upon
request.
(a) The laboratory must have adequate systems in place to report
results in a timely, accurate, reliable and confidential manner, and,
ensure patient confidentiality throughout those parts of the total
testing process that are under the laboratory's control.
(b) The test report must indicate the name and address of the
laboratory location at which the test was performed, the test performed,
the test result and, if applicable, the units of measurement.
(c) The laboratory must indicate on the test report any information
regarding the condition and disposition of specimens that do not meet
the laboratory's criteria for acceptability.
(d) Pertinent ``reference'' or ``normal'' ranges, as determined by
the laboratory performing the tests, must be available to the authorized
person who ordered the tests or the individual responsible for utilizing
the test results.
(e) The results or transcripts of laboratory tests or examinations
must be released only to authorized persons or the individual
responsible for utilizing the test results.
(f) The laboratory must develop and follow written procedures for
reporting imminent life-threatening laboratory results or panic values.
In addition, the laboratory must immediately alert the individual or
entity requesting the test or the individual responsible for utilizing
the test results when any test result indicates an imminent life-
threatening condition.
(g) The laboratory must, upon request, make available to clients a
list of test methods employed by the laboratory and, in accordance with
Sec. 493.1213, as applicable, the performance specifications of each
method used to test patient specimens. In addition, information that may
affect the interpretation of test results, such as test interferences,
must be provided upon request. Pertinent updates on testing information
must be provided to clients whenever changes occur that affect the test
results or interpretation of test results.
(h) The original report or exact duplicates of test reports must be
maintained by the laboratory in a manner that permits ready
identification and timely accessibility.
[57 FR 7162, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993]
Sec. 493.1111 Standard; Referral of specimens.
A laboratory must refer specimens for testing only to a laboratory
possessing a valid certificate authorizing the performance of testing in
the specialty or subspecialty of service for the level of complexity in
which the referred test is categorized.
(a) The referring laboratory must not revise results or information
directly related to the interpretation of results provided by the
testing laboratory.
(b) The referring laboratory may permit each testing laboratory to
send the test result directly to the authorized person who initially
requested the test. The referring laboratory must retain or be able to
produce an exact duplicate of each testing laboratory's report.
(c) The authorized person who orders a test or procedure must be
notified by the referring laboratory of the name and address of each
laboratory location at which a test was performed.
Subpart K--Quality Control for Tests of Moderate Complexity (Including
the Subcategory), High Complexity, or Any Combination of These Tests
Source: 57 FR 7163, Feb. 28, 1992, unless otherwise noted.
Sec. 493.1201 Condition: General quality control; moderate complexity
(including the subcategory) or high complexity testing, or any
combination of these tests.
(a) Applicability of subpart K of this part. Subpart K is divided
into two sections, general quality control and quality control for
specialties and subspecialties. The quality control requirements are
specified in Secs. 493.1201 through 493.1285 unless--
[[Page 884]]
(1) An alternative procedure specified in the manufacturer's
protocol has been cleared by the Food and Drug Administration (FDA) as
meeting certain CLIA requirements for general quality control and
specialty/subspecialty quality control, and the manufacturer's
instructions contain the following statement,
Unless this device is modified by a laboratory, the laboratory's
compliance with these quality control instructions will satisfy the
applicable requirements of 42 CFR 493.1203(b).
or
(2) HHS approves an equivalent procedure that is specified in
Appendix C of the State Operations Manual (HCFA Pub. 7).
(b) The laboratory must establish and follow written quality control
procedures for monitoring and evaluating the quality of the analytical
testing process of each method to assure the accuracy and reliability of
patient test results and reports. The laboratory must meet the
applicable standards in Secs. 493.1202 through 493.1221 of this subpart,
unless an alternative procedure specified in the manufacturer's protocol
has been cleared by the Food and Drug Administration (FDA) as meeting
certain CLIA requirements for quality control or HHS approves an
equivalent procedure specified in appendix C of the State Operations
Manual (HCFA Pub. 7). HCFA Pub. 7 is available from the Technical
Information Service, U.S. Department of Commerce, 5825 Port Royal Road,
Springfield, VA 22161, telephone number (703) 487-4630.
[58 FR 5230, Jan. 19, 1993, as amended at 60 FR 20048, Apr. 24, 1995]
Sec. 493.1202 Standard; Moderate or high complexity testing, or both:
Effective from September 1, 1992 to December 31, 2000.
(a) For each test of high complexity performed, the laboratory must
meet all applicable standards of this subpart.
(b) For each test of moderate complexity performed using a
standardized method, or method developed in-house, a device not subject
to clearance by the FDA (including any commercially distributed
instrument, kit or test system subject to the Food, Drug and Cosmetic
Act marketed prior to the Medical Device Amendments, Public Law 94-295,
enacted on May 28, 1976, and those identified in 21 CFR parts 862, 864,
and 866 as exempt from FDA premarket review), or using an instrument,
kit or test system cleared by the FDA through the premarket notification
(510(k)) or premarket approval (PMA) process for in-vitro diagnostic use
but modified by the laboratory, the laboratory must meet all applicable
standards of this subpart.
(c) For all other tests of moderate complexity performed using an
instrument, kit or test system cleared by the FDA through the premarket
notification (510(k)) or premarket approval (PMA) process for in-vitro
diagnostic use, the laboratory must--(1) Follow the manufacturer's
instructions for instrument or test system operation and test
performance;
(2) Have a procedure manual describing the processes for testing and
reporting patient test results;
(3) Perform and document calibration procedures or check calibration
at least once every six months;
(4) Perform and document control procedures using at least two
levels of control materials each day of testing;
(5) Perform and document applicable specialty and subspecialty
control procedures as specified under Sec. 493.1223;
(6) Perform and document that remedial action has been taken when
problems or errors are identified as specified in Sec. 493.1219; and
(7) Maintain records of all quality control activities for two
years. Quality control records for immunohematology and blood and blood
products must be maintained as specified in Sec. 493.1221.
[57 FR 7163, Feb. 28, 1992, as amended at 58 FR 5230, Jan. 19, 1993]
Sec. 493.1203 Standard; Moderate or high complexity testing, or both:
Effective beginning December 31, 2000.
For each moderate or high complexity test performed, the laboratory
will be in compliance with this section if it:
(a) Meets all applicable quality control requirements specified in
this subpart when using a standardized method, a method developed in-
house, a device not subject to clearance by the
[[Page 885]]
FDA (including any commercially distributed instrument, kit or test
system subject to the Food, Drug and Cosmetic Act marketed prior to the
Medical Device Amendments, Public Law 94-295, enacted on May 28, 1976,
and those identified in 21 CFR parts 862, 864, and 866 as exempt from
FDA premarket review), a manufacturer's product modified by the
laboratory, or a device (instrument, kit or test system) not cleared by
the FDA as meeting certain CLIA quality control requirements; or
(b) Follows manufacturer's instructions when using a device
(instrument, kit, or test system) cleared by the FDA as meeting the CLIA
requirements for quality control located at Secs. 493.1215, 493.1217,
and 493.1223, and applicable parts of Secs. 493.1205, 493.1211 and
493.1218. In addition, the laboratory must comply with the requirements
of Secs. 493.1204, 493.1213, 493.1219, and 493.1221 and those parts of
Secs. 493.1205, 493.1211, and 493.1218 that are unique to the laboratory
facility and cannot be met by following manufacturer's instructions.
[58 FR 5230, Jan. 19, 1993]
Sec. 493.1204 Standard; Facilities.
The laboratory must provide the space and environmental conditions
necessary for conducting the services offered.
(a) The laboratory must be constructed, arranged, and maintained to
ensure the space, ventilation, and utilities necessary for conducting
all phases of testing, including the preanalytic (pre-testing), analytic
(testing), and postanalytic (post-testing), as appropriate.
(b) Safety precautions must be established, posted, and observed to
ensure protection from physical, chemical, biochemical and electrical
hazards and biohazardous materials.
[57 FR 7163, Feb. 28, 1992, as amended at 58 FR 5230, Jan. 19, 1993]
Sec. 493.1205 Standard; Test methods, equipment, instrumentation,
reagents, materials, and supplies.
The laboratory must utilize test methods, equipment,
instrumentation, reagents, materials, and supplies that provide accurate
and reliable test results and test reports.
(a) Test methodologies and equipment must be selected and testing
performed in a manner that provides test results within the laboratory's
stated performance specifications for each test method as determined
under Sec. 493.1213.
(b) The laboratory must have appropriate and sufficient equipment,
instruments, reagents, materials, and supplies for the type and volume
of testing performed and for the maintenance of quality during the
preanalytic, analytic, and postanalytic phases of testing.
(c) The laboratory must define criteria for those conditions that
are essential for proper storage of reagents and specimens, and accurate
and reliable test system operation and test result reporting.
(1) These conditions include, if applicable--
(i) Water quality;
(ii) Temperature;
(iii) Humidity; and
(iv) Protection of equipment and instrumentation from fluctuations
and interruptions in electrical current that adversely affect patient
test results and test reports.
(2) Remedial actions taken to correct conditions that fail to meet
the criteria specified in paragraph (c)(1) of this section must be
documented.
(d) Reagents, solutions, culture media, control materials,
calibration materials and other supplies, as appropriate, must be
labeled to indicate--
(1) Identity and, when significant, titer, strength or
concentration;
(2) Recommended storage requirements;
(3) Preparation and expiration date; and
(4) Other pertinent information required for proper use.
(e) Reagents, solutions, culture media, control materials,
calibration materials and other supplies must be prepared, stored, and
handled in a manner to ensure that--
(1) Reagents, solutions, culture media, controls, calibration
materials and other supplies are not used when they have exceeded their
expiration date, have deteriorated or are of substandard quality. The
laboratory must comply with the FDA product dating
[[Page 886]]
requirements of 21 CFR 610.53 for blood products and other biologicals,
and labeling requirements, as cited in 21 CFR 809.10 for all other in
vitro diagnostics. Any exception to the product dating requirements in
21 CFR 610.53 will be granted by the FDA in the form of an amendment of
the product license, in accordance with 21 CFR 610.53(d). All exceptions
must be documented by the laboratory; and
(2) Components of reagent kits of different lot numbers are not
interchanged unless otherwise specified by the manufacturer.
[57 FR 7163, Feb. 28, 1992, as amended at 58 FR 5230, Jan. 19, 1993]
Sec. 493.1211 Standard; Procedure manual.
(a) A written procedure manual for the performance of all analytical
methods used by the laboratory must be readily available and followed by
laboratory personnel. Textbooks may be used as supplements to these
written descriptions but may not be used in lieu of the laboratory's
written procedures for testing or examining specimens.
(b) The procedure manual must include, when applicable to the test
procedure:
(1) Requirements for specimen collection and processing, and
criteria for specimen rejection;
(2) Procedures for microscopic examinations, including the detection
of inadequately prepared slides;
(3) Step-by-step performance of the procedure, including test
calculations and interpretation of results;
(4) Preparation of slides, solutions, calibrators, controls,
reagents, stains and other materials used in testing;
(5) Calibration and calibration verification procedures;
(6) The reportable range for patient test results as established or
verified in Sec. 493.1213;
(7) Control procedures;
(8) Remedial action to be taken when calibration or control results
fail to meet the laboratory's criteria for acceptability;
(9) Limitations in methodologies, including interfering substances;
(10) Reference range (normal values);
(11) Imminent life-threatening laboratory results or ``panic
values'';
(12) Pertinent literature references;
(13) Appropriate criteria for specimen storage and preservation to
ensure specimen integrity until testing is completed;
(14) The laboratory's system for reporting patient results
including, when appropriate, the protocol for reporting panic values;
(15) Description of the course of action to be taken in the event
that a test system becomes inoperable; and
(16) Criteria for the referral of specimens including procedures for
specimen submission and handling as described in Sec. 493.1103.
(c) Manufacturers' package inserts or operator manuals may be used,
when applicable, to meet the requirements of paragraphs (b)(1) through
(b)(13) of this section. Any of the items under paragraphs (b)(1)
through (b)(13) of this section not provided by the manufacturer must be
provided by the laboratory.
(d) Procedures must be approved, signed, and dated by the director.
(e) Procedures must be re-approved, signed and dated if the
directorship of the laboratory changes.
(f) Each change in a procedure must be approved, signed, and dated
by the current director of the laboratory.
(g) The laboratory must maintain a copy of each procedure with the
dates of initial use and discontinuance. These records must be retained
for two years after a procedure has been discontinued.
Sec. 493.1213 Standard; Establishment and verification of method
performance specifications.
Prior to reporting patient test results, the laboratory must verify
or establish, for each method, the performance specifications for the
following performance characteristics: accuracy; precision; analytical
sensitivity and specificity, if applicable; the reportable range of
patient test results; the reference range(s) (normal values); and any
other applicable performance characteristic.
(a) The provisions of this section are not retroactive. Laboratories
are not required to verify or establish performance specifications for
any test method
[[Page 887]]
of moderate or high complexity in use prior to September 1, 1992.
(b)(1) Each laboratory that introduces a new procedure for patient
testing using a device (instrument, kit, or test system) cleared by the
FDA as meeting certain CLIA requirements for quality control, must
demonstrate that, prior to reporting patient test results, it can obtain
the performance specifications for accuracy, precision, and reportable
range of patient test results, comparable to those established by the
manufacturer. The laboratory must also verify that the manufacturer's
reference range is appropriate for the laboratory's patient population.
(2) Each laboratory that introduces a new method or device as
specified in either Sec. 493.1202(a) or (b), or Sec. 493.1203(a), must,
prior to reporting patient test results--
(i) Verify or establish for each method the performance
specifications for the following performance characteristics, as
applicable:
(A) Accuracy;
(B) Precision;
(C) Analytical sensitivity;
(D) Analytical specificity to include interfering substances;
(E) Reportable range of patient test results;
(F) Reference range(s); and
(G) Any other performance characteristic required for test
performance.
(ii) Based upon the performance specifications verified or
established in accordance with paragraph (b)(2)(i) of this section,
establish calibration and control procedures for patient testing as
required under Secs. 493.1217 and 493.1218.
(c) The laboratory must have documentation of the verification or
establishment of all applicable test performance specifications.
[57 FR 7163, Feb. 28, 1992, as amended at 58 FR 5230, Jan. 19, 1993]
Sec. 493.1215 Standard; Equipment maintenance and function checks.
The laboratory must perform equipment maintenance and function
checks that include electronic, mechanical and operational checks
necessary for the proper test performance and test result reporting of
equipment, instruments and test systems, to assure accurate and reliable
test results and reports.
(a) Maintenance of equipment, instruments, and test systems. (1) For
manufacturers' equipment, instruments or test systems cleared by the FDA
as meeting certain CLIA requirements for quality control, the laboratory
must--
(i) Perform maintenance as defined by the manufacturer and with at
least the frequency specified by the manufacturer; and
(ii) Document all maintenance performed.
(2) For methods or devices, as specified in either Sec. 493.1202(a)
or (b) or Sec. 493.1203(a), the laboratory must--
(i) Establish a maintenance protocol that ensures equipment,
instrument, and test system performance necessary for accurate and
reliable test results and test result reporting;
(ii) Perform maintenance with at least the frequency specified in
paragraph (a)(2)(i) of this section; and
(iii) Document all maintenance performed.
(b) Function checks of equipment, instruments, and test systems. (1)
For manufacturers' equipment, instruments, or test systems cleared by
the FDA as meeting certain CLIA requirements for quality control, the
laboratory must--
(i) Perform function checks as defined by the manufacturer and with
at least the frequency specified by the manufacturer; and
(ii) Document all function checks performed.
(2) For methods or devices, as specified in either Sec. 493.1202 (a)
or (b) or Sec. 493.1203(a), the laboratory must--
(i) Define a function check protocol that ensures equipment,
instrument, and test system performance necessary for accurate and
reliable test results and test result reporting;
(ii) Perform function checks including background or baseline checks
specified in paragraph (b)(2)(i) of this section. Function checks must
be within the laboratory's established limits before patient testing is
conducted; and
(iii) Document all function checks performed.
[57 FR 7163, Feb. 28, 1992, as amended at 58 FR 5231, Jan. 19, 1993; 58
FR 39155, July 22, 1993]
[[Page 888]]
Sec. 493.1217 Standard; Calibration and calibration verification
procedures.
Calibration and calibration verification procedures are required to
substantiate the continued accuracy of the test method throughout the
laboratory's reportable range for patient test rests. Calibration is the
process of testing and adjusting an instrument, kit, or test system to
provide a known relationship between the measurement response and the
value of the substance that is being measured by the test procedure.
Calibration verification is the assaying of calibration materials in the
same manner as patient samples to confirm that the calibration of the
instrument, kit, or test system has remained stable throughout the
laboratory's reportable range for patient test results. The reportable
range of patient test results is the range of test result values over
which the laboratory can establish or verify the accuracy of the
instrument, kit or test system measurement response. Calibration and
calibration verification must be performed and documented as required in
this section unless otherwise specified in Secs. 493.1223 through
493.1285.
(a) For laboratory test procedures that are performed using
instruments, kits, or test systems that have been cleared by the FDA as
meeting certain CLIA requirements for quality control, the laboratory
must, at a minimum, follow the manufacturer's instructions for
calibration and calibration verification procedures using calibration
materials specified by the manufacturer.
(b) For each method or device, as specified in either Sec. 493.1202
(a) or (b) or Sec. 493.1203(a), the laboratory must--
(1) Perform calibration procedures--
(i) At a minimum, in accordance with manufacturer's instructions, if
provided, using calibration materials provided or specified, as
appropriate, and with at least the frequency recommended by the
manufacturer; and
(ii) In accordance with criteria established by the laboratory, as
required under Sec. 493.1213(b)(2)(i)--
(A) Including the number, type and concentration of calibration
materials, acceptable limits for calibration, and the frequency of
calibration; and
(B) Using calibration materials appropriate for the methodology and,
if possible, traceable to a reference method or reference material of
known value; and
(iii) Whenever calibration verification fails to meet the
laboratory's acceptable limits for calibration verification; and
(2) Perform calibration verification procedures--
(i) In accordance with the manufacturer's calibration verification
instructions when they meet or exceed the requirements specified in
paragraph (b)(2)(ii) of this section; or
(ii) In accordance with criteria established by the laboratory--
(A) Including the number, type, and concentration of calibration
materials, acceptable limits for calibration verification and frequency
of calibration verification;
(B) Using calibration materials appropriate for--
(1) The methodology and, if possible, traceable to a reference
method or reference material of known value; and
(2) Verifying the laboratory's established reportable range of
patient test results, which must include at least a minimal (or zero)
value, a mid-point value, and a maximum value at the upper limit of that
range; and
(C) At least once every six months and whenever any of the following
occur:
(1) A complete change of reagents for a procedure is introduced,
unless the laboratory can demonstrate that changing reagent lot numbers
does not affect the range used to report patient test results, and
control values are not adversely affected by reagent lot number changes;
Note: If reagents are obtained from a manufacturer and all of the
reagents for a test are packaged together, the laboratory is not
required to perform calibration verification for each package of
reagents, provided the packages of reagents are received in the same
shipment and contain the same lot number.
(2) There is major preventive maintenance or replacement of critical
parts that may influence test performance;
(3) Controls reflect an unusual trend or shift or are outside of the
laboratory's acceptable limits and other
[[Page 889]]
means of assessing and correcting unacceptable control values have
failed to identify and correct the problem; or
(4) The laboratory's established schedule for verifying the
reportable range for patient test results requires more frequent
calibration verification than specified in paragraphs (b)(2)(ii)(C) (1),
(2), or (3) of this section; and
(3) Document all calibration and calibration verification procedures
performed.
[58 FR 5231, Jan. 19, 1993]
Sec. 493.1218 Standard; Control procedures.
Control procedures are performed on a routine basis to monitor the
stability of the method or test system; control and calibration
materials provide a means to indirectly assess the accuracy and
precision of patient test results. Control procedures must be performed
as defined in this section unless otherwise specified in Secs. 493.1223
through 493.1285 of this subpart.
(a) For each device cleared by the FDA as meeting certain CLIA
requirements for quality control, the laboratory must, at a minimum,
follow the manufacturer's instructions for control procedures. In
addition, the laboratory must meet the requirements under paragraphs (c)
through (e) of this section and, as applicable, paragraph (f) of this
section.
(b) For each device, as specified in either Sec. 493.1202 (a) or (b)
or Sec. 493.1203(a), the laboratory must evaluate instrument and reagent
stability and operator variance in determining the number, type, and
frequency of testing calibration or control materials and establish
criteria for acceptability used to monitor test performance during a run
of patient specimen(s). A run is an interval within which the accuracy
and precision of a testing system is expected to be stable, but cannot
be greater than 24 hours or less than the frequency recommended by the
manufacturer. For each procedure, the laboratory must monitor test
performance using calibration materials or control materials or a
combination thereof.
(1) For qualitative tests, the laboratory must include a positive
and negative control with each run of patient specimens.
(2) For quantitative tests, the laboratory must include at least two
samples of different concentrations of either calibration materials,
control materials, or a combination thereof with the frequency
determined in Sec. 493.1218(b), but not less frequently than once each
run of patient specimens.
(3) For electrophoretic determinations--
(i) At least one control sample must be used in each electrophoretic
cell; and
(ii) The control sample must contain fractions representative of
those routinely reported in patient specimens.
(4) Each day of use, the laboratory must evaluate the detection
phase of direct antigen systems using an appropriate positive and
negative control material (organism or antigen extract). When direct
antigen systems include an extraction phase, the system must be checked
each day of use using a positive organism.
(5) If calibration materials and control materials are not
available, the laboratory must have an alternative mechanism to assure
the validity of patient test results.
(c) Control samples must be tested in the same manner as patient
specimens.
(d) When calibration or control materials are used, statistical
parameters (e.g., mean and standard deviation) for each lot number of
calibration material and each lot of control material must be determined
through repetitive testing.
(1) The stated values of an assayed control material may be used as
the target values provided the stated values correspond to the
methodology and instrumentation employed by the laboratory and are
verified by the laboratory.
(2) Statistical parameters for unassayed materials must be
established over time by the laboratory through concurrent testing with
calibration materials or control materials having previously determined
statistical parameters.
(e) Control results must meet the laboratory's criteria for
acceptability prior to reporting patient test results.
[[Page 890]]
(f) Reagent and supply checks. (1) The laboratory must check each
batch or shipment of reagents, discs, stains, antisera and
identification systems (systems using two or more substrates) when
prepared or opened for positive and negative reactivity, as well as
graded reactivity if applicable.
(2) Each day of use (unless otherwise specified in this subpart),
the laboratory must test staining materials for intended reactivity to
ensure predictable staining characteristics.
(3) The laboratory must check fluorescent stains for positive and
negative reactivity each time of use (unless otherwise specified in this
subpart).
(4) The laboratory must check each batch or shipment of media for
sterility, if it is intended to be sterile, and sterility is required
for testing. Media must also be checked for its ability to support
growth, and as appropriate, selectivity/inhibition and/or biochemical
response. The laboratory may use manufacturer's control checks of media
provided the manufacturer's product insert specifies that the
manufacturer's quality control checks meet the National Committee for
Clinical Laboratory Standards (NCCLS) for media quality control. The
laboratory must document that the physical characteristics of the media
are not compromised and report any deterioration in the media to the
manufacturer. The laboratory must follow the manufacturer's
specifications for using the media and be responsible for the test
results.
Note: A batch of media (solid, semi-solid, or liquid) consists of
all tubes, plates, or containers of the same medium prepared at the same
time and in the same laboratory; or, if received from an outside source
or commercial supplier, consists of all of the plates, tubes or
containers of the same medium that have the same lot numbers and are
received in a single shipment.
[57 FR 7163, Feb. 28, 1992, as amended at 58 FR 5232, Jan. 19, 1993]
Sec. 493.1219 Standard; Remedial actions.
Remedial action policies and procedures must be established by the
laboratory and applied as necessary to maintain the laboratory's
operation for testing patient specimens in a manner that assures
accurate and reliable patient test results and reports. The laboratory
must document all remedial actions taken when--
(a) Test systems do not meet the laboratory's established
performance specifications, as determined in Sec. 493.1213 of this
section, which include but are not limited to--
(1) Equipment or methodologies that perform outside of established
operating parameters or performance specifications;
(2) Patient test values that are outside of the laboratory's
reportable range of patient test results; and
(3) The determination that the laboratory's reference range for a
test procedure is inappropriate for the laboratory's patient population.
(b) Results of control and calibration materials fail to meet the
laboratory's established criteria for acceptability. All patient test
results obtained in the unacceptable test run or since the last
acceptable test run must be evaluated to determine if patient test
results have been adversely affected and the laboratory must take the
remedial action necessary to ensure the reporting of accurate and
reliable patient test results;
(c) The laboratory cannot report patient test results within its
established time frames. The laboratory must determine, based on the
urgency of the patient test(s) requested, the need to notify the
appropriate individual of the delayed testing; and
(d) Errors in the reported patient test results are detected. The
laboratory must--
(1) Promptly notify the authorized person ordering or individual
utilizing the test results of reporting errors;
(2) Issue corrected reports promptly to the authorized person
ordering the test or the individual utilizing the test results; and
(3) Maintain exact duplicates of the original report as well as the
corrected report for two years.
Sec. 493.1221 Standard; Quality control records.
The laboratory must document and maintain records of all quality
control activities specified in Secs. 493.1202 through 493.1285 of this
subpart and retain records for at least two years.
[[Page 891]]
Immunohematology quality control records must be maintained for a period
of no less than five years. In addition, quality control records for
blood and blood products must be maintained for a period not less than
five years after processing records have been completed, or six months
after the latest expiration date, whichever is the later date, in
accordance with 21 CFR 606.160(d).
Sec. 493.1223 Condition: Quality control--specialties and
subspecialties for tests of moderate or high complexity, or
both.
The laboratory must establish and follow written quality control
procedures for monitoring and evaluating the quality of the analytical
testing process of each method to assure the accuracy and reliability of
patient test results and reports. Except as specified in
Sec. 493.1202(c), the laboratory must meet the applicable general
requirements specified in Secs. 493.1201 through 493.1221. In addition,
the laboratory must meet the applicable requirements of Secs. 493.1225
through 493.1285 unless an alternative procedure specified in the
manufacturer's protocol has been cleared by the Food and Drug
Administration (FDA) as meeting certain CLIA requirements for quality
control or HCFA approves an equivalent procedure specified in appendix C
of the State Operations Manual (HCFA Pub. 7). Failure to meet any of the
applicable conditions in Secs. 493.1225 through 493.1285 will result in
intermediate sanctions, loss of Medicare or Medicaid approval, and/or
revocation of CLIA certification for the entire specialty or
subspecialty to which the condition applies, in accordance with subpart
R of this part.
[58 FR 5232, Jan. 19, 1993]
Sec. 493.1225 Condition: Microbiology.
The laboratory must meet the applicable quality control requirements
in Secs. 493.1201 through 493.1221 and in Secs. 493.1227 through
493.1235 of this subpart for the subspecialties for which it is
certified under the specialty of microbiology.
Sec. 493.1227 Condition: Bacteriology.
To meet the quality control requirements for bacteriology, the
laboratory must comply with the applicable requirements in
Secs. 493.1201 through 493.1221 and with paragraphs (a) through (c) of
this section. All quality control activities must be documented.
(a) The laboratory must check positive and negative reactivity with
control organisms--
(1) Each day of use for catalase, coagulase, beta-lactamase, and
oxidase reagents and DNA probes;
(2) Each week of use for Gram and acid-fast stains, bacitracin,
optochin, ONPG, X, and V discs or strips; and
(3) Each month of use for antisera.
(b) Each week of use, the laboratory must check XV discs or strips
with a positive control organism.
(c) For antimicrobial susceptibility tests, the laboratory must
check each new batch of media and each lot of antimicrobial discs
before, or concurrent with, initial use, using approved reference
organisms.
(1) The laboratory's zone sizes or minimum inhibitory concentration
for reference organisms must be within established limits before
reporting patient results.
(2) Each day tests are performed, the laboratory must use the
appropriate control organism(s) to check the procedure.
Sec. 493.1229 Condition: Mycobacteriology.
To meet the quality control requirements for mycobacteriology, the
laboratory must comply with the applicable requirements in
Secs. 493.1201 through 493.1221 of this subpart and with paragraphs (a)
through (d) of this section. All quality control activities must be
documented.
(a) Each day of use, the laboratory must check the iron uptake test
with at least one acid-fast organism that produces a positive reaction
and with an organism that produces a negative reaction and check all
other reagents or test procedures used for mycobacteria identification
with at least one acid-fast organism that produces a positive reaction.
[[Page 892]]
(b) The laboratory must check fluorochrome acid-fast stains for
positive and negative reactivity each week of use.
(c) The laboratory must check acid-fast stains each week of use with
an acid-fast organism that produces a positive reaction.
(d) For susceptibility tests performed on Mycobacterium tuberculosis
isolates, the laboratory must check the procedure each week of use with
a strain of Mycobacterium tuberculosis susceptible to all
antimycobacterial agents tested.
Sec. 493.1231 Condition: Mycology.
To meet the quality control requirements for mycology, the
laboratory must comply with the applicable requirements in
Secs. 493.1201 through 493.1221 of this subpart and with paragraphs (a)
through (d) of this section. All quality control activities must be
documented.
(a) Each day of use, the laboratory using the auxanographic medium
for nitrate assimilation must check the nitrate reagent with a peptone
control.
(b) Each week of use, the laboratory must check all reagents used
with biochemical tests and other test procedures for mycological
identification with an organism that produces a positive reaction.
(c) Each week of use, the laboratory must check acid-fast stains for
positive and negative reactivity.
(d) For susceptibility tests, the laboratory must test each drug
each day of use with at least one control strain that is susceptible to
the drug. The laboratory must establish control limits. Criteria for
acceptable control results must be met prior to reporting patient
results.
Sec. 493.1233 Condition: Parasitology.
To meet the quality control requirements for parasitology, the
laboratory must comply with the applicable requirements of
Secs. 493.1201 through 493.1221 of this subpart and with paragraphs (a)
through (c) of this section. All quality control activities must be
documented.
(a) The laboratory must have available a reference collection of
slides or photographs, and, if available, gross specimens for
identification of parasites and use these references in the laboratory
for appropriate comparison with diagnostic specimens.
(b) The laboratory must calibrate and use the calibrated ocular
micrometer for determining the size of ova and parasites, if size is a
critical parameter.
(c) Each month of use, the laboratory must check permanent stains
using a fecal sample control that will demonstrate staining
characteristics.
Sec. 493.1235 Condition: Virology.
To meet the quality control requirements for virology, the
laboratory must comply with the applicable requirements in
Secs. 493.1201 through 493.1221 of this subpart and with paragraphs (a)
through (c) of this section. All quality control activities must be
documented.
(a) The laboratory must have available host systems for the
isolation of viruses and test methods for the identification of viruses
that cover the entire range of viruses that are etiologically related to
clinical diseases for which services are offered.
(b) The laboratory must maintain records that reflect the systems
used and the reactions observed.
(c) In tests for the identification of viruses, the laboratory must
simultaneously culture uninoculated cells or cell substrate controls as
a negative control to detect erroneous identification results.
Sec. 493.1237 Condition: Diagnostic immunology.
The laboratory must meet the applicable quality control requirements
in Secs. 493.1201 through 493.1221 and Secs. 493.1239 through 493.1241
of this subpart for the subspecialties for which it is certified under
the specialty of diagnostic immunology.
Sec. 493.1239 Condition: Syphilis serology.
To meet the quality control requirements for syphilis serology, the
laboratory must comply with the applicable requirements in
Secs. 493.1201 through 493.1221 of this subpart and with paragraphs (a)
through (e) of this section. All quality control activities must be
documented.
[[Page 893]]
(a) For laboratories performing syphilis testing, the equipment,
glassware, reagents, controls, and techniques for tests for syphilis
must conform to manufacturers' specifications.
(b) The laboratory must run serologic tests on patient specimens
concurrently with a positive serum control of known titer or controls of
graded reactivity plus a negative control.
(c) The laboratory must employ positive and negative controls that
evaluate all phases of the test system to ensure reactivity and uniform
dosages.
(d) The laboratory may not report test results unless the
predetermined reactivity pattern of the controls is observed.
(e) All facilities manufacturing blood and blood products for
transfusion or serving as referral laboratories for these facilities
must meet the syphilis serology testing requirements of 21 CFR 640.5(a).
Sec. 493.1241 Condition: General immunology.
To meet the quality control requirements for general immunology, the
laboratory must comply with the applicable requirements in
Secs. 493.1201 through 493.1221 of this subpart and with paragraphs (a)
through (d) of this section. All quality control activities must be
documented.
(a) The laboratory must run serologic tests on patient specimens
concurrently with a positive serum control of known titer or controls of
graded reactivity, if applicable, plus a negative control.
(b) The laboratory must employ controls that evaluate all phases of
the test system (antigens, complement, erythrocyte indicator systems,
etc.) to ensure reactivity and uniform dosages when positive and
negative controls alone are not sufficient.
(c) The laboratory may not report test results unless the
predetermined reactivity pattern of the controls is observed.
(d) All facilities manufacturing blood and blood products for
transfusion or serving as referral laboratories for these facilities
must meet--
(1) The HIV testing requirements of 21 CFR 610.45; and
(2) Hepatitis testing requirements of 21 CFR 610.40.
Sec. 493.1243 Condition: Chemistry.
The laboratory must meet the applicable quality control requirements
in Secs. 493.1201 through 493.1221 and Secs. 493.1245 through 493.1249
of this subpart for the subspecialties for which it is certified under
the specialty of chemistry.
Sec. 493.1245 Condition: Routine chemistry.
To meet the quality control requirements for routine chemistry, the
laboratory must comply with the applicable requirements in
Secs. 493.1201 through 493.1221. All quality control activities must be
documented. In addition, for blood gas analyses, the laboratory must--
(a) Calibrate or verify calibration according to the manufacturer's
specifications and with at least the frequency recommended by the
manufacturer;
(b) Test one sample of control material each eight hours of testing;
(c) Use a combination of calibrators and control materials that
include both low and high values on each day of testing; and
(d) Include one sample of calibration material or control material
each time patients are tested unless automated instrumentation
internally verifies calibration at least every thirty minutes.
Sec. 493.1247 Condition: Endocrinology.
To meet the quality control requirements for endocrinology, the
laboratory must comply with the applicable requirements contained in
Secs. 493.1201 through 493.1221 of this subpart. All quality control
activities must be documented.
Sec. 493.1249 Condition: Toxicology.
To meet the quality control requirements for toxicology, the
laboratory must comply with the applicable requirements in
Secs. 493.1201 through 493.1221 of this subpart. All quality control
activities must be documented. In addition, for drug abuse screening
using thin layer chromatography--
[[Page 894]]
(a) Each plate must be spotted with at least one sample of
calibration material containing all drug groups identified by thin layer
chromatography which the laboratory reports; and
(b) At least one control sample must be included in each chamber,
and the control sample must be processed through each step of patient
testing, including extraction procedures.
Sec. 493.1251 Condition: Urinalysis.
Except for those tests categorized as waived, to meet the quality
control requirements for urinalysis, the laboratory must comply with the
applicable requirements in Secs. 493.1201 through 493.1221.
[58 FR 5232, Jan. 19, 1993]
Sec. 493.1253 Condition: Hematology.
To meet the quality control requirements for hematology, the
laboratory must comply with the applicable requirements in
Secs. 493.1201 through 493.1221 of this subpart and with paragraphs (a)
through (d) of this section. All quality control activities must be
documented.
(a) Cell counts performed manually using a hemocytometer must be
tested in duplicate. One control is required for each eight hours of
operation.
(b) For non-manual hematology testing systems, excluding
coagulation, the laboratory must include two levels of controls each
eight hours of operation.
(c) For all non-manual coagulation testing systems, the laboratory
must include two levels of control each eight hours of operation and
each time a change in reagents occurs.
(d) For manual coagulation tests--
(1) Each individual performing tests must test two levels of
controls before testing patient samples and each time a change in
reagents occurs; and
(2) Patient and control specimens must be tested in duplicate.
[57 FR 7163, Feb. 28, 1992, as amended at 58 FR 5232, Jan. 19, 1993]
Sec. 493.1255 Condition: Pathology.
The laboratory must meet the applicable quality control requirements
in Secs. 493.1201 through 493.1221 and Secs. 493.1257 through 493.1261
of this subpart for the subspecialties for which it is certified under
the specialty of pathology. All quality control activities must be
documented.
Sec. 493.1257 Condition: Cytology.
To meet the quality control requirements for cytology, the
laboratory must comply with the applicable requirements in
Secs. 493.1201 through 493.1221 of this subpart and paragraphs (a)
through (g) of this section.
(a) The laboratory must assure that--
(1) All gynecologic smears are stained using a Papanicolaou or
modified Papanicolaou staining method;
(2) Effective measures are taken to prevent cross-contamination
between gynecologic and nongynecologic specimens during the staining
process;
(3) Nongynecologic specimens that have a high potential for cross-
contamination are stained separately from other nongynecologic
specimens, and the stains are filtered or changed following staining;
(4) Diagnostic interpretations are not reported on unsatisfactory
smears; and
(5) All cytology slide preparations are evaluated on the premises of
a laboratory certified to conduct testing in the subspecialty of
cytology.
(b) The laboratory is responsible for ensuring that--
(1) Each individual engaged in the evaluation of cytology
preparations by nonautomated microscopic technique examines no more than
100 slides (one patient per slide, gynecologic or nongynecologic, or
both) in a 24 hour period, irrespective of the site or laboratory. This
limit represents an absolute maximum number of slides and is not to be
employed as a performance target for each individual. Previously
examined negative, reactive, reparative, atypical, premalignant or
malignant gynecologic cases as defined in paragraph (c)(1) of this
section, previously examined nongynecologic cytology preparations, and
tissues patholoty slides examined by a technical supervisor qualified
under Sec. 493.1449 (b) or (k) are not included in the 100 slide limit.
(For this section, all references to technical supervisor refer to
individuals qualified under Secs. 493.1449 (b) and (k).);
[[Page 895]]
(2) For purposes of workload calculations, each slide preparation
(gynecologic and nongynecologic) made using automated, semi-automated,
or other liquid-based slide preparatory techniques which result in cell
dispersion over one-half or less of the total available slide area and
which is examined by nonautomated microscopic technique counts as one-
half slide.
(3) Records are maintained of the total number of slides examined by
each individual during each 24 hour period, irrespective of the site or
laboratory, and the number of hours each individual spends examining
slides in the 24 hour period;
(i) The maximum number of 100 slides described in paragraph (b)(1)
of this section is examined in no less than an 8 hour workday;
(ii) For the purposes of establishing workload limits for
individuals examining slides by nonautomated microscopic technique on
other than an 8 hour workday basis (includes full-time employees with
duties other than slide examination and part-time employees), a period
of 8 hours must be used to prorate the number of slides that may be
examined. Use the formula--
No. of hours examining slides x 100
-------------------------------------------------------------------------
8
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to determine maximum slide volume to be examined.
(c) The individual qualified under Secs. 493.1449 (b) or (k) who
provides technical supervision of cytology must ensure that--
(1) All gynecologic smears interpreted to be showing reactive or
reparative changes, atypical squamous or glandular cells of undetermined
significance, or to be in the premalignant (dysplasia, cervical
intraepithelial neoplasia or all squamous intraepithelial lesions
including human papillomavirus-associated changes) or malignant category
are confirmed by a technical supervisor in cytology. The report must be
signed to reflect the review or, if a computer report is generated with
signature, it must reflect an electronic signature authorized by the
technical supervisor in cytology;
(2) All nongynecologic cytologic preparations are reviewed by the
technical supervisor in cytology. The report must be signed to reflect
technical supervisory review or, if a computer report is generated with
signature, it must reflect an electronic signature authorized by the
technical supervisor;
(3) The slide examination performance of each cytotechnologist is
evaluated and documented, including performance evaluation through the
re-examination of normal and negative cases and feedback on the
reactive, reparative, atypical, malignant or premalignant cases as
defined in paragraph (c)(1) of this section; and
(4) A maximum number of slides, not to exceed the maximum workload
limit described in paragraph (b) of this section is established by the
technical supervisor for each individual examining slide preparations by
nonautomated microscopic technique.
(i) The actual workload limit must be documented for each individual
and established in accordance with the individual's capability based on
the performance evaluation as described in paragraph (c)(3) of this
section.
(ii) Records are available to document that each individual's
workload limit is reassessed at least every 6 months and adjusted when
necessary.
(d) The laboratory must establish and follow a program designed to
detect errors in the performance of cytologic examinations and the
reporting of results.
(1) The laboratory must establish a program that includes a review
of slides from at least 10 percent of the gynecologic cases interpreted
to be negative for reactive, reparative, atypical, premalignant or
malignant conditions as defined in paragraph (c)(1) of this section that
are examined by each individual not qualified under Secs. 493.1449 (b)
or (k). This review must be done by a technical supervisor in cytology,
a cytology general supervisor qualified under Sec. 493.1469, or a
cytotechnologist qualified under Sec. 493.1483 who has the experience
specified in Sec. 493.1469(b)(2).
(i) The review must include negative cases selected at random from
the total caseload and from patients or groups of patients that are
identified as having a
[[Page 896]]
high probability of developing cervical cancer, based on available
patient information;
(ii) Records of initial examinations and rescreening results must be
available; and
(iii) The review must be completed before reporting patient results
on those cases selected.
(2) The laboratory must compare clinical information, when
available, with cytology reports and must compare all malignant and
premalignant (as defined in paragraph (c)(1) of this section) gynecology
reports with the histopathology report, if available in the laboratory
(either on-site or in storage), and determine the causes of any
discrepancies.
(3) For each patient with a current high grade intraepithelial
lesion or above (moderate dysplasia or CIN-2 or above), the laboratory
must review all normal or negative gynecologic specimens received within
the previous five years, if available in the laboratory (either on-site
or in storage). If significant discrepancies are found that would affect
patient care, the laboratory must notify the patient's physician and
issue an amended report.
(4) The laboratory must establish and document an annual statistical
evaluation of the number of cytology cases examined, number of specimens
processed by specimen type, volume of patient cases reported by
diagnosis (including the number reported as unsatisfactory for
diagnostic interpretation), number of gynecologic cases where cytology
and available histology are discrepant, the number of gynecologic cases
where any rescreen of a normal or negative specimen results in
reclassification as malignant or premalignant, as defined in paragraph
(c)(1) of the section, and the number of gynecologic cases for which
histology results were unavailable to compare with malignant or
premalignant cytology cases as defined in paragraph (c)(1) of this
section.
(5) The laboratory must evaluate the case reviews of each individual
examining slides against the laboratory's overall statistical values,
document any discrepancies, including reasons for the deviation, and
document corrective action, if appropriate.
(e) The laboratory report must--
(1) Clearly distinguish specimens or smears, or both, that are
unsatisfactory for diagnostic interpretation; and
(2) Contain narrative descriptive nomenclature for all results.
(f) Corrected reports issued by the laboratory must indicate the
basis for correction.
(g) The laboratory must retain all slide preparations for five years
from the date of examination, or slides may be loaned to proficiency
testing programs, in lieu of maintaining them for this time period,
provided the laboratory receives written acknowledgment of the receipt
of slides by the proficiency testing program and maintains the
acknowledgment to document the loan of such slides. Documentation for
slides loaned or referred for purposes other than proficiency testing
must also be maintained. All slides must be retrievable upon request.
[57 FR 7163, Feb. 28, 1992, as amended at 58 FR 5232, Jan. 19, 1993; 58
FR 39155, July 22, 1993]
Sec. 493.1259 Condition: Histopathology.
To meet the quality control requirements for histopathology, a
laboratory must comply with the applicable requirements in
Secs. 493.1201 through 493.1221 of this subpart and paragraphs (a)
through (e) of this section. All quality control activities must be
documented.
(a) A control slide of known reactivity must be included with each
slide or group of slides for differential or special stains. Reaction(s)
of the control slide with each special stain must be documented.
(b) The laboratory must retain stained slides at least ten years
from the date of examination and retain specimen blocks at least two
years from the date of examination.
(c) The laboratory must retain remnants of tissue specimens in a
manner that assures proper preservation of the tissue specimens until
the portions submitted for microscopic examination have been examined
and a diagnosis made by an individual qualified under Secs. 493.1449(b)
or 493.1449(l)(1) of this part. In addition, an individual who meets the
requirements of Secs. 493.1449(b),
[[Page 897]]
493.1449(l)(1) or 493.1449(l)(2), may examine and provide reports for
specimens for skin pathology; an individual meeting the requirements of
Secs. 493.1449(b) or 493.1449(l)(3) may examine and provide reports for
ophthalmic pathology; an individual meeting the requirements of
Secs. 493.1449(b) or 493.1449(m) may examine and provide reports for
oral pathology specimens.
(d) All tissue pathology reports must be signed by an individual
qualified as specified in paragraph (c) of the section. If a computer
report is generated with an electronic signature, it must be authorized
by the individual qualified as specified in paragraph (c) of this
section.
(e) The laboratory must utilize acceptable terminology of a
recognized system of disease nomenclature in reporting results.
Sec. 493.1261 Condition: Oral pathology.
To meet the quality control requirements for oral pathology, the
laboratory must comply with the applicable requirements in
Secs. 493.1201 through 493.1221 and Sec. 493.1259 of this subpart. All
quality control activities must be documented.
Sec. 493.1263 Condition: Radiobioassay.
To meet quality control requirements for radiobioassay, the
laboratory must comply with the applicable requirements of
Secs. 493.1201 through 493.1221 of this subpart. All quality control
activities must be documented.
Sec. 493.1265 Condition: Histocompatibility.
In addition to meeting the applicable requirements for general
quality control in Secs. 493.1201 through 493.1221, for quality control
for general immunology in Sec. 493.1241 of this subpart and for
immunohematology in Sec. 493.1269 of this subpart, the laboratory must
comply with the applicable requirements in paragraphs (a) through (d) of
this section. All quality control activities must be documented.
(a) For renal allotransplantation, the laboratory must meet the
following requirements:
(1) The laboratory must have available and follow criteria for--
(i) Selecting appropriate patient serum samples for crossmatching;
(ii) The technique used in crossmatching;
(iii) Preparation of donor lymphocytes for crossmatching; and
(iv) Reporting crossmatch results;
(2) The laboratory must--
(i) Have available results of final crossmatches before an organ or
tissue is transplanted; and
(ii) Make a reasonable attempt and document efforts to have
available serum specimens for all potential transplant recipients at
initial typing, for periodic screening, for pre-transplantation
crossmatch and following sensitizing events, such as transfusion and
transplant loss;
(3) The laboratory's storage and maintenance of both recipient sera
and reagents must--
(i) Be at an acceptable temperature range for sera and components;
(ii) Use a temperature alarm system and have an emergency plan for
alternate storage; and
(iii) Ensure that all specimens are properly identified and easily
retrievable;
(4) The laboratory's reagent typing sera inventory (applicable only
to locally constructed trays) must indicate source, bleeding date and
identification number, and volume remaining;
(5) The laboratory must properly label and store cells, complement,
buffer, dyes, etc.;
(6) The laboratory must--
(i) HLA type all potential transplant recipients;
(ii) Type cells from organ donors referred to the laboratory; and
(iii) Have available and follow a policy that establishes when
antigen redefinition and retyping are required;
(7) The laboratory must have available and follow criteria for--
(i) The preparation of lymphocytes for HLA-A, B and DR typing;
(ii) Selecting typing reagents, whether locally or commercially
prepared;
(iii) The assignment of HLA antigens; and
(iv) Assuring that reagents used for typing recipients and donors
are adequate to define all major and International Workshop HLA-A,B and
DR
[[Page 898]]
specificities for which reagents are readily available;
(8) The laboratory must--
(i) Screen potential transplant recipient sera for preformed HLA-A
and B antibodies with a suitable lymphocyte panel on sera collected;
(A) At the time of the recipient's initial HLA typing; and
(B) Thereafter, following sensitizing events and upon request; and
(ii) Use a suitable cell panel for screening patient sera (antibody
screen), a screen that contains all the major HLA specificities and
common splits--
(A) If the laboratory does not use commercial panels, it must
maintain a list of individuals for fresh panel bleeding; and
(B) If the laboratory uses frozen panels, it must have a suitable
storage system;
(9) The laboratory must check--
(i) Each typing tray using--
(A) Positive control sera;
(B) Negative control sera; and
(C) Positive controls for specific cell types when applicable (i.e.,
T cells, B cells, and monocytes); and
(ii) Each compatibility test (i.e. mixed lymphocyte cultures,
homozygous typing cells or DNA analysis) and typing for disease-
associated antigens using controls to monitor the test components and
each phase of the test system to ensure an acceptable performance level;
(10) Compatibility testing for cellularly-defined antigens must
utilize techniques such as the mixed lymphocyte culture test, homozygous
typing cells or DNA analysis;
(11) If the laboratory reports the recipient's or donor's, or both,
ABO blood group and D(Rho) typing, the testing must be performed in
accordance with Sec. 493.1269 of this subpart;
(12) If the laboratory utilizes immunologic reagents (such as
antibodies or complement) to remove contaminating cells during the
isolation of lymphocytes or lymphocyte subsets, the efficacy of the
methods must be verified with appropriate quality control procedures;
(13) At least once each month, the laboratory must have each
individual performing tests evaluate a previously tested specimen as an
unknown to verify his or her ability to reproduce test results. Records
of the results for each individual must be maintained; and
(14) The laboratory must participate in at least one national or
regional cell exchange program, if available, or develop an exchange
system with another laboratory in order to validate inter-laboratory
reproducibility.
(b) If the laboratory performs histocompatibility testing for--
(1) Transfusions and other non-renal transplantation, excluding bone
marrow and living transplants, all the requirements specified in this
section, as applicable, except for the performance of mixed lymphocyte
cultures, must be met;
(2) Bone marrow transplantation, all the requirements specified in
this section, including the performance of mixed lymphocyte cultures or
other augmented testing to evaluate class II compatibility, must be met;
and
(3) Non-renal solid organ transplantation, the results of final
crossmatches must be available before transplantation when the recipient
has demonstrated presensitization by prior serum screening except for
emergency situations. The laboratory must document the circumstances, if
known, under which emergency transplants are performed, and records must
reflect any information concerning the transplant provided to the
laboratory by the patient's physician.
(c) Laboratories performing HLA typing for disease-associated
studies must meet all the requirements specified in this section except
for the performance of mixed lymphocyte cultures, antibody screening and
crossmatching.
(d) For laboratories performing organ donor HIV testing the
requirements of Sec. 493.1241 of this subpart for the transfusion of
blood and blood products must be met.
[57 FR 7163, Feb. 28, 1992, as amended at 58 FR 5233, Jan. 19, 1993]
Sec. 493.1267 Condition: Clinical cytogenetics.
To meet the quality control requirements for clinical cytogenetics,
the laboratory must comply with the applicable requirements of
Secs. 493.1201
[[Page 899]]
through 493.1221 of this subpart and with paragraphs (a) through (d) of
this section. All quality control activities must be documented.
(a) When determination of sex is performed by X and Y chromatin
counts, these counts must be based on an examination of an adequate
number of cells. Confirmatory testing such as full chromosome analysis
must be performed for all atypical results.
(b) The laboratory must have records that reflect the media used and
document the reactions observed, number of cells counted, the number of
cells karyotyped, the number of chromosomes counted for each metaphase
spread, and the quality of the banding; that the resolution is
sufficient to support the reported results; and that an adequate number
of karyotypes are prepared for each patient.
(c) The laboratory also must have policies and procedures for
assuring an accurate and reliable patient sample identification during
the process of accessioning, cell preparation, photographing or other
image reproduction technique, and photographic printing, and storage and
reporting of results or photographs.
(d) The laboratory report must include the summary and
interpretation of the observations and number of cells counted and
analyzed and the use of appropriate nomenclature.
Sec. 493.1269 Condition: Immunohematology.
To meet the quality control requirements for immunohematology, the
laboratory must comply with the applicable requirements in
Secs. 493.1201 through 493.1221 of this subpart and with paragraphs (a)
through (d) of this section. All quality control activities must be
documented.
(a) The laboratory must perform ABO group and D(Rho) typing,
unexpected antibody detection, antibody identification and compatibility
testing in accordance with manufacturer's instructions, if provided, and
as applicable, with 21 CFR part 606 (with the exception of 21 CFR
606.20a, Personnel) and 21 CFR part 640 et seq.
(b) The laboratory must perform ABO group by concurrently testing
unknown red cells with anti-A and anti-B grouping reagents. For
confirmation of ABO group, the unknown serum must be tested with known
A1 and B red cells.
(c) The laboratory must determine the D(Rho) type by testing unknown
red cells with anti-D (anti-Rho) blood grouping reagent.
(d) If required in the manufacturer's package insert for anti-D
reagents, the laboratory must employ a control system capable of
detecting false positive D(Rho) test results.
Sec. 493.1271 Condition: Transfusion services and bloodbanking.
If a facility provides services for the transfusion of blood and
blood products, the facility must be under the adequate control and
technical supervision of the pathologist or other doctor of medicine or
osteopathy meeting the qualifications in subpart M for technical
supervision in immunohematology. The facility must ensure that there are
facilities for procurement, safekeeping and transfusion of blood and
blood products and that blood and blood products must be available to
meet the needs of the physicians responsible for the diagnosis,
management, and treatment of patients. The facility meets this condition
by complying with the standards in Sec. Sec. 493.1273 through 493.1285.
[58 FR 5233, Jan. 19, 1993]
Sec. 493.1273 Standard; Immunohematological collection, processing,
dating periods, labeling and distribution of blood and blood
products.
In addition to the requirements in paragraphs (a) through (d) of
this section, the facility must also meet the applicable quality control
requirements in Secs. 493.1201 through 493.1221 of this part.
(a) Blood and blood product collection, processing and distribution
must comply with 21 CFR part 640 and 21 CFR part 606, and the testing
laboratory must meet the applicable requirements of part 493.
(b) Dating periods for blood and blood products must conform to 21
CFR 610.53.
[[Page 900]]
(c) Labeling of blood and blood products must conform to 21 CFR part
606, subpart G.
(d) Policies to ensure positive identification of a blood or blood
product recipient must be established, documented, and followed.
Sec. 493.1275 Standard; Blood and blood products storage facilities.
(a) The blood and blood products must be stored under appropriate
conditions, which include an adequate temperature alarm system that is
regularly inspected.
(1) An audible alarm system must monitor proper blood and blood
product storage temperature over a 24-hour period; and
(2) Inspections of the alarm system must be documented.
(b) If blood is stored or maintained for transfusion outside of a
monitored refrigerator, the facility must ensure and document that
storage conditions, including temperature, are appropriate to prevent
deterioration of the blood or blood product.
Sec. 493.1277 Standard; Arrangement for services.
In the case of services provided outside the blood bank, the
facility must have an agreement reviewed and approved by the director
that governs the procurement, transfer and availability of blood and
blood products.
Sec. 493.1279 Standard; Provision of testing.
There must be provision for prompt ABO blood group, D(Rho) type,
unexpected antibody detection and compatibility testing in accordance
with Sec. 493.1269 of this subpart and for laboratory investigation of
transfusion reactions, either through the facility or under arrangement
with an approved facility on a continuous basis, under the supervision
of a pathologist or other doctor of medicine or osteopathy meeting the
qualifications of Secs. 493.1449(b) or 493.1449(q).
Sec. 493.1283 Standard; Retention of samples of transfused blood.
According to the facility's established procedures, samples of each
unit of transfused blood must be retained for further testing in the
event of reactions. The facility must promptly dispose of blood not
retained for further testing that has passed its expiration date.
Sec. 493.1285 Standard; Investigation of transfusion reactions.
The facility, according to its established procedures, must promptly
investigate all transfusion reactions occurring in all facilities for
which it has investigational responsibility and make recommendations to
the medical staff regarding improvements in transfusion procedures. The
facility must document that all necessary remedial actions are taken to
prevent future recurrences of transfusion reactions and that all
policies and procedures are reviewed to assure that they are adequate to
ensure the safety of individuals being transfused within the facility.
Subpart L [Reserved]
Subpart M--Personnel for Moderate Complexity (Including the Subcategory)
and High Complexity Testing
Source: 57 FR 7172, Feb. 28, 1992, unless otherwise noted.
Sec. 493.1351 General.
This subpart consists of the personnel requirements that must be met
by laboratories performing moderate complexity testing, PPM procedures,
high complexity testing, or any combination of these tests.
[60 FR 20049, Apr. 24, 1995]
Laboratories Performing Provider-Performed Microscopy (PPM) Procedures
Source: 60 FR 20049, Apr. 24, 1995, unless otherwise noted.
Sec. 493.1353 Scope.
In accordance with Sec. 493.19(b), the moderate complexity
procedures specified as PPM procedures are considered such only when
personally performed
[[Page 901]]
by a health care provider during a patient visit in the context of a
physical examination. PPM procedures are subject to the personnel
requirements in Secs. 493.1355 through 493.1365.
Sec. 493.1355 Condition: Laboratories performing PPM procedures;
laboratory director.
The laboratory must have a director who meets the qualification
requirements of Sec. 493.1357 and provides overall management and
direction in accordance with Sec. 493.1359.
Sec. 493.1357 Standard; laboratory director qualifications.
The laboratory director must be qualified to manage and direct the
laboratory personnel and the performance of PPM procedures as specified
in Sec. 493.19(c) and must be eligible to be an operator of a laboratory
within the requirements of subpart R of this part.
(a) The laboratory director must possess a current license as a
laboratory director issued by the State in which the laboratory is
located, if the licensing is required.
(b) The laboratory director must meet one of the following
requirements:
(1) Be a physician, as defined in Sec. 493.2.
(2) Be a midlevel practitioner, as defined in Sec. 493.2, authorized
by a State to practice independently in the State in which the
laboratory is located.
(3) Be a dentist, as defined in Sec. 493.2.
Sec. 493.1359 Standard; PPM laboratory director responsibilities.
The laboratory director is responsible for the overall operation and
administration of the laboratory, including the prompt, accurate, and
proficient reporting of test results. The laboratory director must--
(a) Direct no more than five laboratories; and
(b) Ensure that any procedure listed under Sec. 493.19(c)--
(1) Is personally performed by an individual who meets the
qualification requirements in Sec. 493.1363; and
(2) Is performed in accordance with applicable requirements in
subparts H, J, K, M, and P of this part.
Sec. 493.1361 Condition: Laboratories performing PPM procedures;
testing personnel.
The laboratory must have a sufficient number of individuals who meet
the qualification requirements of Sec. 493.1363 to perform the functions
specified in Sec. 493.1365 for the volume and complexity of testing
performed.
Sec. 493.1363 Standard: PPM testing personnel qualifications.
Each individual performing PPM procedures must--
(a) Possess a current license issued by the State in which the
laboratory is located if the licensing is required; and
(b) Meet one of the following requirements:
(1) Be a physician, as defined in Sec. 493.2.
(2) Be a midlevel practitioner, as defined in Sec. 493.2, under the
supervision of a physician or in independent practice if authorized by
the State in which the laboratory is located.
(3) Be a dentist as defined in Sec. 493.2 of this part.
Sec. 493.1365 Standard; PPM testing personnel responsibilities.
The testing personnel are responsible for specimen processing, test
performance, and for reporting test results. Any PPM procedure must be--
(a) Personally performed by one of the following practitioners:
(1) A physician during the patient's visit on a specimen obtained
from his or her own patient or from a patient of a group medical
practice of which the physician is a member or employee.
(2) A midlevel practitioner, under the supervision of a physician or
in independent practice if authorized by the State in which the
laboratory is located, during the patient's visit on a specimen obtained
from his or her own patient or from the patient of a clinic, group
medical practice, or other health care provider, in which the midlevel
practitioner is a member or an employee.
(3) A dentist during the patient's visit on a specimen obtained from
his or her own patient or from a patient of a group dental practice of
which the dentist is a member or an employee; and
[[Page 902]]
(b) Performed using a microscope limited to a brightfield or a
phase/contrast microscope.
Laboratories Performing Moderate Complexity Testing
Sec. 493.1403 Condition: Laboratories performing moderate complexity
testing; laboratory director.
The laboratory must have a director who meets the qualification
requirements of Sec. 493.1405 of this subpart and provides overall
management and direction in accordance with Sec. 493.1407 of this
subpart.
Sec. 493.1405 Standard; Laboratory director qualifications.
The laboratory director must be qualified to manage and direct the
laboratory personnel and the performance of moderate complexity tests
and must be eligible to be an operator of a laboratory within the
requirements of subpart R of this part.
(a) The laboratory director must possess a current license as a
laboratory director issued by the State in which the laboratory is
located, if such licensing is required; and
(b) The laboratory director must--
(1) (i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in anatomic or clinical pathology, or both, by the
American Board of Pathology or the American Osteopathic Board of
Pathology or possess qualifications that are equivalent to those
required for such certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have had laboratory training or experience consisting of:
(A) At least one year directing or supervising non-waived laboratory
testing; or
(B) Beginning September 1, 1993, have at least 20 continuing medical
education credit hours in laboratory practice commensurate with the
director responsibilities defined in Sec. 493.1407; or
(C) Laboratory training equivalent to paragraph (b)(2)(ii)(B) of
this section obtained during medical residency. (For example, physicians
certified either in hematology or hematology and medical oncology by the
American Board of Internal Medicine); or
(3) Hold an earned doctoral degree in a chemical, physical,
biological, or clinical laboratory science from an accredited
institution; and
(i) Be certified by the American Board of Medical Microbiology, the
American Board of Clinical Chemistry, the American Board of Bioanalysis,
or the American Board of Medical Laboratory Immunology; or
(ii) Have had at least one year experience directing or supervising
non-waived laboratory testing;
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution;
(ii) Have at least one year of laboratory training or experience, or
both in non-waived testing; and
(iii) In addition, have at least one year of supervisory laboratory
experience in non-waived testing; or
(5)(i) Have earned a bachelor's degree in a chemical, physical, or
biological science or medical technology from an accredited institution;
(ii) Have at least 2 years of laboratory training or experience, or
both in non-waived testing; and
(iii) In addition, have at least 2 years of supervisory laboratory
experience in non-waived testing;
(6) Be serving as a laboratory director and must have previously
qualified or could have qualified as a laboratory director under
Sec. 493.1406; or
(7) On or before February 28, 1992, qualified under State law to
direct a laboratory in the State in which the laboratory is located.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5233, Jan. 19, 1993]
Sec. 493.1406 Standard; Laboratory director qualifications on or before
February 28, 1992.
The laboratory director must be qualified to manage and direct the
laboratory personnel and test performance.
(a) The laboratory director must possess a current license as a
laboratory
[[Page 903]]
director issued by the State, if such licensing exists; and
(b) The laboratory director must:
(1) Be a physician certified in anatomical or clinical pathology (or
both) by the American Board of Pathology or the American Osteopathic
Board of Pathology or possess qualifications that are equivalent to
those required for such certification;
(2) Be a physician who:
(i) Is certified by the American Board of Pathology or the American
Osteopathic Board of Pathology in at least one of the laboratory
specialties; or
(ii) Is certified by the American Board of Medical Microbiology, the
American Board of Clinical Chemistry, the American Board of Bioanalysis,
or other national accrediting board in one of the laboratory
specialties; or
(iii) Is certified by the American Society of Cytology to practice
cytopathology or possesses qualifications that are equivalent to those
required for such certification; or
(iv) Subsequent to graduation, has had 4 or more years of full-time
general laboratory training and experience of which at least 2 years
were spent acquiring proficiency in one of the laboratory specialties;
(3) For the subspecialty of oral pathology only, be certified by the
American Board of Oral Pathology, American Board of Pathology or the
American Osteopathic Board of Pathology or possesses qualifications that
are equivalent to those required for certification;
(4) Hold an earned doctoral degree from an accredited institution
with a chemical, physical, or biological science as a major subject and
(i) Is certified by the American Board of Medical Microbiology, the
American Board of Clinical Chemistry, the American Board of Bioanalysis,
or other national accrediting board acceptable to HHS in one of the
laboratory specialties; or
(ii) Subsequent to graduation, has had 4 or more years of full-time
general laboratory training and experience of which at least 2 years
were spent acquiring proficiency in one of the laboratory specialties;
(5) With respect to individuals first qualifying before July 1,
1971, have been responsible for the direction of a laboratory for 12
months between July 1, 1961, and January 1, 1968, and, in addition,
either:
(i) Was a physician and subsequent to graduation had at least 4
years of pertinent full-time laboratory experience;
(ii) Held a master's degree from an accredited institution with a
chemical, physical, or biological science as a major subject and
subsequent to graduation had at least 4 years of pertinent full-time
laboratory experience;
(iii) Held a bachelor's degree from an accredited institution with a
chemical, physical, or biological science as a major subject and
subsequent to graduation had at least 6 years of pertinent full-time
laboratory experience; or
(iv) Achieved a satisfactory grade through an examination conducted
by or under the sponsorship of the U.S. Public Health Service on or
before July 1, 1970; or
(6) Qualify under State law to direct the laboratory in the State in
which the laboratory is located.
Note: The January 1, 1968 date for meeting the 12 months' laboratory
direction requirement in paragraph (b)(5) of this section may be
extended 1 year for each year of full-time laboratory experience
obtained before January 1, 1958 required by State law for a laboratory
director license. An exception to the July 1, 1971 qualifying date in
paragraph (b)(5) of this section was made provided that the individual
requested qualification approval by October 21, 1975 and had been
employed in a laboratory for at least 3 years of the 5 years preceding
the date of submission of his qualifications.
[58 FR 5233, Jan. 19, 1993]
Sec. 493.1407 Standard; Laboratory director responsibilities.
The laboratory director is responsible for the overall operation and
administration of the laboratory, including the employment of personnel
who are competent to perform test procedures, and record and report test
results promptly, accurate, and proficiently and for assuring compliance
with the applicable regulations.
(a) The laboratory director, if qualified, may perform the duties of
the technical consultant, clinical consultant, and testing personnel, or
delegate these responsibilities to personnel
[[Page 904]]
meeting the qualifications of Secs. 493.1409, 493.1415, and 493.1421,
respectively.
(b) If the laboratory director reapportions performance of his or
her responsibilities, he or she remains responsible for ensuring that
all duties are properly performed.
(c) The laboratory director must be accessible to the laboratory to
provide onsite, telephone or electronic consultation as needed.
(d) Each individual may direct no more than five laboratories.
(e) The laboratory director must--
(1) Ensure that testing systems developed and used for each of the
tests performed in the laboratory provide quality laboratory services
for all aspects of test performance, which includes the preanalytic,
analytic, and postanalytic phases of testing;
(2) Ensure that the physical plant and environmental conditions of
the laboratory are appropriate for the testing performed and provide a
safe environment in which employees are protected from physical,
chemical, and biological hazards;
(3) Ensure that--
(i) The test methodologies selected have the capability of providing
the quality of results required for patient care;
(ii) Verification procedures used are adequate to determine the
accuracy, precision, and other pertinent performance characteristics of
the method; and
(iii) Laboratory personnel are performing the test methods as
required for accurate and reliable results;
(4) Ensure that the laboratory is enrolled in an HHS approved
proficiency testing program for the testing performed and that--
(i) The proficiency testing samples are tested as required under
subpart H of this part;
(ii) The results are returned within the timeframes established by
the proficiency testing program;
(iii) All proficiency testing reports received are reviewed by the
appropriate staff to evaluate the laboratory's performance and to
identify any problems that require corrective action; and
(iv) An approved corrective action plan is followed when any
proficiency testing results are found to be unacceptable or
unsatisfactory;
(5) Ensure that the quality control and quality assurance programs
are established and maintained to assure the quality of laboratory
services provided and to identify failures in quality as they occur;
(6) Ensure the establishment and maintenance of acceptable levels of
analytical performance for each test system;
(7) Ensure that all necessary remedial actions are taken and
documented whenever significant deviations from the laboratory's
established performance specifications are identified, and that patient
test results are reported only when the system is functioning properly;
(8) Ensure that reports of test results include pertinent
information required for interpretation;
(9) Ensure that consultation is available to the laboratory's
clients on matters relating to the quality of the test results reported
and their interpretation concerning specific patient conditions;
(10) Employ a sufficient number of laboratory personnel with the
appropriate education and either experience or training to provide
appropriate consultation, properly supervise and accurately perform
tests and report test results in accordance with the personnel
responsibilities described in this subpart;
(11) Ensure that prior to testing patients' specimens, all personnel
have the appropriate education and experience, receive the appropriate
training for the type and complexity of the services offered, and have
demonstrated that they can perform all testing operations reliably to
provide and report accurate results;
(12) Ensure that policies and procedures are established for
monitoring individuals who conduct preanalytical, analytical, and
postanalytical phases of testing to assure that they are competent and
maintain their competency to process specimens, perform test procedures
and report test results promptly and proficiently, and whenever
necessary, identify needs for remedial training or continuing education
to improve skills;
[[Page 905]]
(13) Ensure that an approved procedure manual is available to all
personnel responsible for any aspect of the testing process; and
(14) Specify, in writing, the responsibilities and duties of each
consultant and each person, engaged in the performance of the
preanalytic, analytic, and postanalytic phases of testing, that
identifies which examinations and procedures each individual is
authorized to perform, whether supervision is required for specimen
processing, test performance or results reporting, and whether
consultant or director review is required prior to reporting patient
test results.
Sec. 493.1409 Condition: Laboratories performing moderate complexity
testing; technical consultant.
The laboratory must have a technical consultant who meets the
qualification requirements of Sec. 493.1411 of this subpart and provides
technical oversight in accordance with Sec. 493.1413 of this subpart.
Sec. 493.1411 Standard; Technical consultant qualifications.
The laboratory must employ one or more individuals who are qualified
by education and either training or experience to provide technical
consultation for each of the specialties and subspecialties of service
in which the laboratory performs moderate complexity tests or
procedures. The director of a laboratory performing moderate complexity
testing may function as the technical consultant provided he or she
meets the qualifications specified in this section.
(a) The technical consultant must possess a current license issued
by the State in which the laboratory is located, if such licensing is
required.
(b) The technical consultant must--
(1) (i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in anatomic or clinical pathology, or both, by the
American Board of Pathology or the American Osteopathic Board of
Pathology or possess qualifications that are equivalent to those
required for such certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least one year of laboratory training or experience, or
both in non-waived testing, in the designated specialty or subspecialty
areas of service for which the technical consultant is responsible (for
example, physicians certified either in hematology or hematology and
medical oncology by the American Board of Internal Medicine are
qualified to serve as the technical consultant in hematology); or
(3)(i) Hold an earned doctoral or master's degree in a chemical,
physical, biological or clinical laboratory science or medical
technology from an accredited institution; and
(ii) Have at least one year of laboratory training or experience, or
both in non-waived testing, in the designated specialty or subspecialty
areas of service for which the technical consultant is responsible; or
(4)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 2 years of laboratory training or experience, or
both in non-waived testing, in the designated specialty or subspecialty
areas of service for which the technical consultant is responsible.
Note: The technical consultant requirements for ``laboratory
training or experience, or both'' in each specialty or subspecialty may
be acquired concurrently in more than one of the specialties or
subspecialties of service, excluding waived tests. For example, an
individual who has a bachelor's degree in biology and additionally has
documentation of 2 years of work experience performing tests of moderate
complexity in all specialties and subspecialties of service, would be
qualified as a technical consultant in a laboratory performing moderate
complexity testing in all specialties and subspecialties of service.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993]
Sec. 493.1413 Standard; Technical consultant responsibilities.
The technical consultant is responsible for the technical and
scientific
[[Page 906]]
oversight of the laboratory. The technical consultant is not required to
be onsite at all times testing is performed; however, he or she must be
available to the laboratory on an as needed basis to provide
consultation, as specified in paragraph (a) of this section.
(a) The technical consultant must be accessible to the laboratory to
provide on-site, telephone, or electronic consultation; and
(b) The technical consultant is responsible for--
(1) Selection of test methodology appropriate for the clinical use
of the test results;
(2) Verification of the test procedures performed and the
establishment of the laboratory's test performance characteristics,
including the precision and accuracy of each test and test system;
(3) Enrollment and participation in an HHS approved proficiency
testing program commensurate with the services offered;
(4) Establishing a quality control program appropriate for the
testing performed and establishing the parameters for acceptable levels
of analytic performance and ensuring that these levels are maintained
throughout the entire testing process from the initial receipt of the
specimen, through sample analysis and reporting of test results;
(5) Resolving technical problems and ensuring that remedial actions
are taken whenever test systems deviate from the laboratory's
established performance specifications;
(6) Ensuring that patient test results are not reported until all
corrective actions have been taken and the test system is functioning
properly;
(7) Identifying training needs and assuring that each individual
performing tests receives regular in-service training and education
appropriate for the type and complexity of the laboratory services
performed;
(8) Evaluating the competency of all testing personnel and assuring
that the staff maintain their competency to perform test procedures and
report test results promptly, accurately and proficiently. The
procedures for evaluation of the competency of the staff must include,
but are not limited to--
(i) Direct observations of routine patient test performance,
including patient preparation, if applicable, specimen handling,
processing and testing;
(ii) Monitoring the recording and reporting of test results;
(iii) Review of intermediate test results or worksheets, quality
control records, proficiency testing results, and preventive maintenance
records;
(iv) Direct observation of performance of instrument maintenance and
function checks;
(v) Assessment of test performance through testing previously
analyzed specimens, internal blind testing samples or external
proficiency testing samples; and
(vi) Assessment of problem solving skills; and
(9) Evaluating and documenting the performance of individuals
responsible for moderate complexity testing at least semiannually during
the first year the individual tests patient specimens. Thereafter,
evaluations must be performed at least annually unless test methodology
or instrumentation changes, in which case, prior to reporting patient
test results, the individual's performance must be reevaluated to
include the use of the new test methodology or instrumentation.
Sec. 493.1415 Condition: Laboratories performing moderate complexity
testing; clinical consultant.
The laboratory must have a clinical consultant who meets the
qualification requirements of Sec. 493.1417 of this part and provides
clinical consultation in accordance with Sec. 493.1419 of this part.
Sec. 493.1417 Standard; Clinical consultant qualifications.
The clinical consultant must be qualified to consult with and render
opinions to the laboratory's clients concerning the diagnosis, treatment
and management of patient care. The clinical consultant must--
(a) Be qualified as a laboratory director under Sec. 493.1405(b)
(1), (2), or (3)(i); or
(b) Be a doctor of medicine, doctor of osteopathy or doctor of
podiatric medicine and possess a license to practice medicine,
osteopathy or podiatry in
[[Page 907]]
the State in which the laboratory is located.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993]
Sec. 493.1419 Standard; Clinical consultant responsibilities.
The clinical consultant provides consultation regarding the
appropriateness of the testing ordered and interpretation of test
results. The clinical consultant must--
(a) Be available to provide clinical consultation to the
laboratory's clients;
(b) Be available to assist the laboratory's clients in ensuring that
appropriate tests are ordered to meet the clinical expectations;
(c) Ensure that reports of test results include pertinent
information required for specific patient interpretation; and
(d) Ensure that consultation is available and communicated to the
laboratory's clients on matters related to the quality of the test
results reported and their interpretation concerning specific patient
conditions.
Sec. 493.1421 Condition: Laboratories performing moderate complexity
testing; testing personnel.
The laboratory must have a sufficient number of individuals who meet
the qualification requirements of Sec. 493.1423, to perform the
functions specified in Sec. 493.1425 for the volume and complexity of
tests performed.
Sec. 493.1423 Standard; Testing personnel qualifications.
Each individual performing moderate complexity testing must--
(a) Possess a current license issued by the State in which the
laboratory is located, if such licensing is required; and
(b) Meet one of the following requirements:
(1) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located or have earned a doctoral, master's, or bachelor's degree in a
chemical, physical, biological or clinical laboratory science, or
medical technology from an accredited institution; or
(2) Have earned an associate degree in a chemical, physical or
biological science or medical laboratory technology from an accredited
institution; or
(3) Be a high school graduate or equivalent and have successfully
completed an official military medical laboratory procedures course of
at least 50 weeks duration and have held the military enlisted
occupational specialty of Medical Laboratory Specialist (Laboratory
Technician); or
(4)(i) Have earned a high school diploma or equivalent; and
(ii) Have documentation of training appropriate for the testing
performed prior to analyzing patient specimens. Such training must
ensure that the individual has--
(A) The skills required for proper specimen collection, including
patient preparation, if applicable, labeling, handling, preservation or
fixation, processing or preparation, transportation and storage of
specimens;
(B) The skills required for implementing all standard laboratory
procedures;
(C) The skills required for performing each test method and for
proper instrument use;
(D) The skills required for performing preventive maintenance,
troubleshooting and calibration procedures related to each test
performed;
(E) A working knowledge of reagent stability and storage;
(F) The skills required to implement the quality control policies
and procedures of the laboratory;
(G) An awareness of the factors that influence test results; and
(H) The skills required to assess and verify the validity of patient
test results through the evaluation of quality control sample values
prior to reporting patient test results.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993]
Sec. 493.1425 Standard; Testing personnel responsibilities.
The testing personnel are responsible for specimen processing, test
performance, and for reporting test results.
(a) Each individual performs only those moderate complexity tests
that
[[Page 908]]
are authorized by the laboratory director and require a degree of skill
commensurate with the individual's education, training or experience,
and technical abilities.
(b) Each individual performing moderate complexity testing must--
(1) Follow the laboratory's procedures for specimen handling and
processing, test analyses, reporting and maintaining records of patient
test results;
(2) Maintain records that demonstrate that proficiency testing
samples are tested in the same manner as patient samples;
(3) Adhere to the laboratory's quality control policies, document
all quality control activities, instrument and procedural calibrations
and maintenance performed;
(4) Follow the laboratory's established corrective action policies
and procedures whenever test systems are not within the laboratory's
established acceptable levels of performance;
(5) Be capable of identifying problems that may adversely affect
test performance or reporting of test results and either must correct
the problems or immediately notify the technical consultant, clinical
consultant or director; and
(6) Document all corrective actions taken when test systems deviate
from the laboratory's established performance specifications.
Laboratories Performing High Complexity Testing
Sec. 493.1441 Condition: Laboratories performing high complexity
testing; laboratory director.
The laboratory must have a director who meets the qualification
requirements of Sec. 493.1443 of this subpart and provides overall
management and direction in accordance with Sec. 493.1445 of this
subpart.
Sec. 493.1443 Standard; Laboratory director qualifications.
The laboratory director must be qualified to manage and direct the
laboratory personnel and performance of high complexity tests and must
be eligible to be an operator of a laboratory within the requirements of
subpart R.
(a) The laboratory director must possess a current license as a
laboratory director issued by the State in which the laboratory is
located, if such licensing is required; and
(b) The laboratory director must--
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in anatomic or clinical pathology, or both, by the
American Board of Pathology or the American Osteopathic Board of
Pathology or possess qualifications that are equivalent to those
required for such certification; or
(2) Be a doctor of medicine, a doctor of osteopathy or doctor of
podiatric medicine licensed to practice medicine, osteopathy or podiatry
in the State in which the laboratory is located; and
(i) Have at least one year of laboratory training during medical
residency (for example, physicians certified either in hematology or
hematology and medical oncology by the American Board of Internal
Medicine); or
(ii) Have at least 2 years of experience directing or supervising
high complexity testing; or
(3) Hold an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited institution
and--
(i) Be certified by the American Board of Medical Microbiology, the
American Board of Clinical Chemistry, the American Board of Bioanalysis,
the American Board of Medical Laboratory Immunology or other board
deemed comparable by HHS; or
(ii) Until December 31, 2000, must have at least--
(A) Two years of laboratory training or experience, or both;
(B) Two years of experience directing or supervising high complexity
testing; and
(C) On December 31, 2000, individuals must meet the qualifications
specified in paragraph (b)(3)(i) of this section;
(4) Be serving as a laboratory director and must have previously
qualified or could have qualified as a laboratory director under
regulations at 42 CFR 493.1415, published March 14, 1990 at 55 FR 9538,
on or before February 28, 1992; or
[[Page 909]]
(5) On or before February 28, 1992, be qualified under State law to
direct a laboratory in the State in which the laboratory is located; or
(6) For the subspecialty of oral pathology, be certified by the
American Board of Oral Pathology, American Board of Pathology, the
American Osteopathic Board of Pathology, or possess qualifications that
are equivalent to those required for certification.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993; 59
FR 62609, Dec. 6, 1994; 62 FR 25858, May 12, 1997; 63 FR 55034, Oct. 14,
1998]
Sec. 493.1445 Standard; Laboratory director responsibilities.
The laboratory director is responsible for the overall operation and
administration of the laboratory, including the employment of personnel
who are competent to perform test procedures, record and report test
results promptly, accurately and proficiently, and for assuring
compliance with the applicable regulations.
(a) The laboratory director, if qualified, may perform the duties of
the technical supervisor, clinical consultant, general supervisor, and
testing personnel, or delegate these responsibilities to personnel
meeting the qualifications under Secs. 493.1447, 493.1453, 493.1459, and
493.1487, respectively.
(b) If the laboratory director reapportions performance of his or
her responsibilities, he or she remains responsible for ensuring that
all duties are properly performed.
(c) The laboratory director must be accessible to the laboratory to
provide onsite, telephone or electronic consultation as needed.
(d) Each individual may direct no more than five laboratories.
(e) The laboratory director must--
(1) Ensure that testing systems developed and used for each of the
tests performed in the laboratory provide quality laboratory services
for all aspects of test performance, which includes the preanalytic,
analytic, and postanalytic phases of testing;
(2) Ensure that the physical plant and environmental conditions of
the laboratory are appropriate for the testing performed and provide a
safe environment in which employees are protected from physical,
chemical, and biological hazards;
(3) Ensure that--
(i) The test methodologies selected have the capability of providing
the quality of results required for patient care;
(ii) Verification procedures used are adequate to determine the
accuracy, precision, and other pertinent performance characteristics of
the method; and
(iii) Laboratory personnel are performing the test methods as
required for accurate and reliable results;
(4) Ensure that the laboratory is enrolled in an HHS-approved
proficiency testing program for the testing performed and that--
(i) The proficiency testing samples are tested as required under
subpart H of this part;
(ii) The results are returned within the timeframes established by
the proficiency testing program;
(iii) All proficiency testing reports received are reviewed by the
appropriate staff to evaluate the laboratory's performance and to
identify any problems that require corrective action; and
(iv) An approved corrective action plan is followed when any
proficiency testing result is found to be unacceptable or
unsatisfactory;
(5) Ensure that the quality control and quality assurance programs
are established and maintained to assure the quality of laboratory
services provided and to identify failures in quality as they occur;
(6) Ensure the establishment and maintenance of acceptable levels of
analytical performance for each test system;
(7) Ensure that all necessary remedial actions are taken and
documented whenever significant deviations from the laboratory's
established performance characteristics are identified, and that patient
test results are reported only when the system is functioning properly;
(8) Ensure that reports of test results include pertinent
information required for interpretation;
(9) Ensure that consultation is available to the laboratory's
clients on matters relating to the quality of the test
[[Page 910]]
results reported and their interpretation concerning specific patient
conditions;
(10) Ensure that a general supervisor provides on-site supervision
of high complexity test performance by testing personnel qualified under
Sec. 493.1489(b)(4);
(11) Employ a sufficient number of laboratory personnel with the
appropriate education and either experience or training to provide
appropriate consultation, properly supervise and accurately perform
tests and report test results in accordance with the personnel
responsibilities described in this subpart;
(12) Ensure that prior to testing patients' specimens, all personnel
have the appropriate education and experience, receive the appropriate
training for the type and complexity of the services offered, and have
demonstrated that they can perform all testing operations reliably to
provide and report accurate results;
(13) Ensure that policies and procedures are established for
monitoring individuals who conduct preanalytical, analytical, and
postanalytical phases of testing to assure that they are competent and
maintain their competency to process specimens, perform test procedures
and report test results promptly and proficiently, and whenever
necessary, identify needs for remedial training or continuing education
to improve skills;
(14) Ensure that an approved procedure manual is available to all
personnel responsible for any aspect of the testing process; and
(15) Specify, in writing, the responsibilities and duties of each
consultant and each supervisor, as well as each person engaged in the
performance of the preanalytic, analytic, and postanalytic phases of
testing, that identifies which examinations and procedures each
individual is authorized to perform, whether supervision is required for
specimen processing, test performance or result reporting and whether
supervisory or director review is required prior to reporting patient
test results.
Sec. 493.1447 Condition: Laboratories performing high complexity
testing; technical supervisor.
The laboratory must have a technical supervisor who meets the
qualification requirements of Sec. 493.1449 of this subpart and provides
technical supervision in accordance with Sec. 493.1451 of this subpart.
Sec. 493.1449 Standard; Technical supervisor qualifications.
The laboratory must employ one or more individuals who are qualified
by education and either training or experience to provide technical
supervision for each of the specialties and subspecialties of service in
which the laboratory performs high complexity tests or procedures. The
director of a laboratory performing high complexity testing may function
as the technical supervisor provided he or she meets the qualifications
specified in this section.
(a) The technical supervisor must possess a current license issued
by the State in which the laboratory is located, if such licensing is
required; and
(b) The laboratory may perform anatomic and clinical laboratory
procedures and tests in all specialties and subspecialties of services
except histocompatibility and clinical cytogenetics services provided
the individual functioning as the technical supervisor--
(1) Is a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(2) Is certified in both anatomic and clinical pathology by the
American Board of Pathology or the American Osteopathic Board of
Pathology or Possesses qualifications that are equivalent to those
required for such certification.
(c) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of bacteriology,
the individual functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or
[[Page 911]]
the American Osteopathic Board of Pathology or possess qualifications
that are equivalent to those required for such certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least one year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of bacteriology; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of bacteriology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of bacteriology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical, or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of bacteriology.
(d) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of
mycobacteriology, the individual functioning as the technical supervisor
must--
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor or
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycobacteriology; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycobacteriology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycobacteriology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycobacteriology.
(e) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of mycology, the
individual
[[Page 912]]
functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycology; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both in high complexity testing within the speciality of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of mycology.
(f) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of parasitology,
the individual functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least one year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of parasitology;
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of parasitology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of parasitology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in
[[Page 913]]
high complexity testing within the specialty of microbiology with a
minimum of 6 months experience in high complexity testing within the
subspecialty of parasitology.
(g) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of virology, the
individual functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of virology; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of virology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of virology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing within the specialty of microbiology
with a minimum of 6 months experience in high complexity testing within
the subspecialty of virology.
(h) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the specialty of diagnostic
immunology, the individual functioning as the technical supervisor
must--
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing for the specialty of diagnostic
immunology; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of diagnostic
immunology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing for the specialty of diagnostic
immunology; or
(5) (i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in
[[Page 914]]
high complexity testing for the specialty of diagnostic immunology.
(i) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the specialty of chemistry, the
individual functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing for the specialty of chemistry; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of chemistry; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing for the specialty of chemistry; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing for the specialty of chemistry.
(j) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the specialty of hematology, the
individual functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least one year of laboratory training or experience, or
both, in high complexity testing for the specialty of hematology (for
example, physicians certified either in hematology or hematology and
medical oncology by the American Board of Internal Medicine); or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of hematology; or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing for the specialty of hematology; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing for the specialty of hematology.
(k)(1) If the requirements of paragraph (b) of this section are not
met and the laboratory performs tests in the subspecialty of cytology,
the individual functioning as the technical supervisor must--
(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
[[Page 915]]
(ii) Meet one of the following requirements--
(A) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(B) Be certified by the American Society of Cytology to practice
cytopathology or possess qualifications that are equivalent to those
required for such certification;
(2) An individual qualified under Sec. 493.1449(b) or paragraph
(k)(1) of this section may delegate some of the cytology technical
supervisor responsibilities to an individual who is in the final year of
full-time training leading to certification specified in paragraphs (b)
or (k)(1)(ii)(A) of this section provided the technical supervisor
qualified under Sec. 493.1449(b) or paragraph (k)(1) of this section
remains ultimately responsible for ensuring that all of the
responsibilities of the cytology technical supervisor are met.
(l) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of histopathology,
the individual functioning as the technical supervisor must--
(1) Meet one of the following requirements:
(i) (A) Be a doctor of medicine or a doctor of osteopathy licensed
to practice medicine or osteopathy in the State in which the laboratory
is located; and
(B) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification;
(ii) An individual qualified under Sec. 493.1449(b) or paragraph
(l)(1) of this section may delegate to an individual who is a resident
in a training program leading to certification specified in paragraph
(b) or (l)(1)(i)(B) of this section, the responsibility for examination
and interpretation of histopathology specimens.
(2) For tests in dermatopathology, meet one of the following
requirements:
(i) (A) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located and--
(B) Meet one of the following requirements:
(1) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2) Be certified in dermatopathology by the American Board of
Dermatology and the American Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(3) Be certified in dermatology by the American Board of Dermatology
or possess qualifications that are equivalent to those required for such
certification; or
(ii) An individual qualified under Sec. 493.1449(b) or paragraph
(l)(2)(i) of this section may delegate to an individual who is a
resident in a training program leading to certification specified in
paragraphs (b) or (l)(2)(i)(B) of this section, the responsibility for
examination and interpretation of dermatopathology specimens.
(3) For tests in ophthalmic pathology, meet one of the following
requirements:
(i)(A) Be a doctor of medicine or doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located and--
(B) Must meet one of the following requirements:
(1) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2) Be certified by the American Board of Ophthalmology or possess
qualifications that are equivalent to those required for such
certitication and have successfully completed at least 1 year of formal
post-residency fellowship training in ophthalmic pathology; or
(ii) An individual qualified under Sec. 493.1449(b) or paragraph
(1)(3)(i) of this section may delegate to an individual who is a
resident in a training program
[[Page 916]]
leading to certification specified in paragraphs (b) or (1)(3)(i)(B) of
this section, the responsibility for examination and interpretation of
ophthalmic specimens; or
(m) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the subspecialty of oral pathology,
the individual functioning as the technical supervisor must meet one of
the following requirements:
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located and--
(ii) Be certified in anatomic pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2) Be certified in oral pathology by the American Board of Oral
Pathology or possess qualifications for such certification; or
(3) An individual qualified under Sec. 493.1449(b) or paragraph (m)
(1) or (2) of this section may delegate to an individual who is a
resident in a training program leading to certification specified in
paragraphs (b) or (m) (1) or (2) of this section, the responsibility for
examination and interpretation of oral pathology specimens.
(n) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the specialty of radiobioassay, the
individual functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing for the specialty of radiobioassay; or
(3)(i) Have an earned doctoral degree in a chemical, physical,
biological or clinical laboratory science from an accredited
institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing within the specialty of radiobioassay;
or
(4)(i) Have earned a master's degree in a chemical, physical,
biological or clinical laboratory science or medical technology from an
accredited institution; and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing for the specialty of radiobioassay; or
(5)(i) Have earned a bachelor's degree in a chemical, physical or
biological science or medical technology from an accredited institution;
and
(ii) Have at least 4 years of laboratory training or experience, or
both, in high complexity testing for the specialty of radiobioassay.
(o) If the laboratory performs tests in the specialty of
histocompatibility, the individual functioning as the technical
supervisor must either--
(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have training or experience that meets one of the following
requirements:
(A) Have 4 years of laboratory training or experience, or both,
within the specialty of histocompatibility; or
(B)(1) Have 2 years of laboratory training or experience, or both,
in the specialty of general immunology; and
(2) Have 2 years of laboratory training or experience, or both, in
the specialty of histocompatibility; or
(2)(i) Have an earned doctoral degree in a biological or clinical
laboratory science from an accredited institution; and
(ii) Have training or experience that meets one of the following
requirements:
[[Page 917]]
(A) Have 4 years of laboratory training or experience, or both,
within the specialty of histocompatibility; or
(B)(1) Have 2 years of laboratory training or experience, or both,
in the specialty of general immunology; and
(2) Have 2 years of laboratory training or experience, or both, in
the specialty of histocompatibility.
(p) If the laboratory performs tests in the specialty of clinical
cytogenetics, the individual functioning as the technical supervisor
must--
(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have 4 years of training or experience, or both, in genetics, 2
of which have been in clinical cytogenetics; or
(2)(i) Hold an earned doctoral degree in a biological science,
including biochemistry, or clinical laboratory science from an
accredited institution; and
(ii) Have 4 years of training or experience, or both, in genetics, 2
of which have been in clinical cytogenetics.
(q) If the requirements of paragraph (b) of this section are not met
and the laboratory performs tests in the specialty of immunohematology,
the individual functioning as the technical supervisor must--
(1)(i) Be a doctor of medicine or a doctor of osteopathy licensed to
practice medicine or osteopathy in the State in which the laboratory is
located; and
(ii) Be certified in clinical pathology by the American Board of
Pathology or the American Osteopathic Board of Pathology or possess
qualifications that are equivalent to those required for such
certification; or
(2)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located; and
(ii) Have at least one year of laboratory training or experience, or
both, in high complexity testing for the specialty of immunohematology.
Note: The technical supervisor requirements for ``laboratory
training or experience, or both'' in each specialty or subspecialty may
be acquired concurrently in more than one of the specialties or
subspecialties of service. For example, an individual, who has a
doctoral degree in chemistry and additionally has documentation of 1
year of laboratory experience working concurrently in high complexity
testing in the specialties of microbiology and chemistry and 6 months of
that work experience included high complexity testing in bacteriology,
mycology, and mycobacteriology, would qualify as the technical
supervisor for the specialty of chemistry and the subspecialties of
bacteriology, mycology, and mycobacteriology.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5234, Jan. 19, 1993]
Sec. 493.1451 Standard: Technical supervisor responsibilities.
The technical supervisor is responsible for the technical and
scientific oversight of the laboratory. The technical supervisor is not
required to be on site at all times testing is performed; however, he or
she must be available to the laboratory on an as needed basis to provide
supervision as specified in (a) of this section.
(a) The technical supervisor must be accessible to the laboratory to
provide on-site, telephone, or electronic consultation; and
(b) The technical supervisor is responsible for--
(1) Selection of the test methodology that is appropriate for the
clinical use of the test results;
(2) Verification of the test procedures performed and establishment
of the laboratory's test performance characteristics, including the
precision and accuracy of each test and test system;
(3) Enrollment and participation in an HHS approved proficiency
testing program commensurate with the services offered;
(4) Establishing a quality control program appropriate for the
testing performed and establishing the parameters for acceptable levels
of analytic performance and ensuring that these levels are maintained
throughout the entire testing process from the initial receipt of the
specimen, through sample analysis and reporting of test results;
(5) Resolving technical problems and ensuring that remedial actions
are taken whenever test systems deviate from the laboratory's
established performance specifications;
[[Page 918]]
(6) Ensuring that patient test results are not reported until all
corrective actions have been taken and the test system is functioning
properly;
(7) Identifying training needs and assuring that each individual
performing tests receives regular in-service training and education
appropriate for the type and complexity of the laboratory services
performed;
(8) Evaluating the competency of all testing personnel and assuring
that the staff maintain their competency to perform test procedures and
report test results promptly, accurately and proficiently. The
procedures for evaluation of the competency of the staff must include,
but are not limited to--
(i) Direct observations of routine patient test performance,
including patient preparation, if applicable, specimen handling,
processing and testing;
(ii) Monitoring the recording and reporting of test results;
(iii) Review of intermediate test results or worksheets, quality
control records, proficiency testing results, and preventive maintenance
records;
(iv) Direct observation of performance of instrument maintenance and
function checks;
(v) Assessment of test performance through testing previously
analyzed specimens, internal blind testing samples or external
proficiency testing samples; and
(vi) Assessment of problem solving skills; and
(9) Evaluating and documenting the performance of individuals
responsible for high complexity testing at least semiannually during the
first year the individual tests patient specimens. Thereafter,
evaluations must be performed at least annually unless test methodology
or instrumentation changes, in which case, prior to reporting patient
test results, the individual's performance must be reevaluated to
include the use of the new test methodology or instrumentation.
(c) In cytology, the technical supervisor or the individual
qualified under Sec. 493.1449(k)(2)--
(1) May perform the duties of the cytology general supervisor and
the cytotechnologist, as specified in Secs. 493.1471 and 493.1485,
respectively;
(2) Must establish the workload limit for each individual examining
slides;
(3) Must reassess the workload limit for each individual examining
slides at least every 6 months and adjust as necessary;
(4) Must perform the functions specified in Sec. 493.1257(c);
(5) Must ensure that each individual examining gynecologic
preparations participates in an HHS approved cytology proficiency
testing program, as specified in Sec. 493.945 and achieves a passing
score, as specified in Sec. 493.855; and
(6) If responsible for screening cytology slide preparations, must
document the number of cytology slides screened in 24 hours and the
number of hours devoted during each 24-hour period to screening cytology
slides.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5235, Jan. 19, 1993]
Sec. 493.1453 Condition: Laboratories performing high complexity
testing; clinical consultant.
The laboratory must have a clinical consultant who meets the
requirements of Sec. 493.1455 of this subpart and provides clinical
consultation in accordance with Sec. 493.1457 of this subpart.
Sec. 493.1455 Standard; Clinical consultant qualifications.
The clinical consultant must be qualified to consult with and render
opinions to the laboratory's clients concerning the diagnosis, treatment
and management of patient care. The clinical consultant must--
(a) Be qualified as a laboratory director under Sec. 493.1443(b)(1),
(2), or (3)(i) or, for the subspecialty of oral pathology,
Sec. 493.1443(b)(6); or
(b) Be a doctor of medicine, doctor of osteopathy, doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5235, Jan. 19, 1993]
[[Page 919]]
Sec. 493.1457 Standard; Clinical consultant responsibilities.
The clinical consultant provides consultation regarding the
appropriateness of the testing ordered and interpretation of test
results. The clinical consultant must--
(a) Be available to provide consultation to the laboratory's
clients;
(b) Be available to assist the laboratory's clients in ensuring that
appropriate tests are ordered to meet the clinical expectations;
(c) Ensure that reports of test results include pertinent
information required for specific patient interpretation; and
(d) Ensure that consultation is available and communicated to the
laboratory's clients on matters related to the quality of the test
results reported and their interpretation concerning specific patient
conditions.
Sec. 493.1459 Condition: Laboratories performing high complexity
testing; general supervisor.
The laboratory must have one or more general supervisors who are
qualified under Sec. 493.1461 of this subpart to provide general
supervision in accordance with Sec. 493.1463 of this subpart.
Sec. 493.1461 Standard: General supervisor qualifications.
The laboratory must have one or more general supervisors who, under
the direction of the laboratory director and supervision of the
technical supervisor, provides day-to-day supervision of testing
personnel and reporting of test results. In the absence of the director
and technical supervisor, the general supervisor must be responsible for
the proper performance of all laboratory procedures and reporting of
test results.
(a) The general supervisor must possess a current license issued by
the State in which the laboratory is located, if such licensing is
required; and
(b) The general supervisor must be qualified as a--
(1) Laboratory director under Sec. 493.1443; or
(2) Technical supervisor under Sec. 493.1449.
(c) If the requirements of paragraph (b)(1) or paragraph (b)(2) of
this section are not met, the individual functioning as the general
supervisor must--
(1)(i) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located or have earned
a doctoral, master's, or bachelor's degree in a chemical, physical,
biological or clinical laboratory science, or medical technology from an
accredited institution; and
(ii) Have at least 1 year of laboratory training or experience, or
both, in high complexity testing; or
(2)(i) Qualify as testing personnel under Sec. 493.1489(b)(2); and
(ii) Have at least 2 years of laboratory training or experience, or
both, in high complexity testing; or
(3)(i) Except as specified in paragraph (3)(ii) of this section,
have previously qualified as a general supervisor under Sec. 493.1462 on
or before February 28, 1992.
(ii) Exception. An individual who achieved a satisfactory grade in a
proficiency examination for technologist given by HHS between March 1,
1986 and December 31, 1987, qualifies as a general supervisor if he or
she meets the requirements of Sec. 493.1462 on or before January 1,
1994.''
(4) On or before September 1, 1992, have served as a general
supervisor of high complexity testing and as of April 24, 1995--
(i) Meet one of the following requirements:
(A) Have graduated from a medical laboratory or clinical laboratory
training program approved or accredited by the Accrediting Bureau of
Health Education Schools (ABHES), the Commission on Allied Health
Education Accreditation (CAHEA), or other organization approved by HHS.
(B) Be a high school graduate or equivalent and have successfully
completed an official U.S. military medical laboratory procedures course
of at least 50 weeks duration and have held the military enlisted
occupational specialty of Medical Laboratory Specialist (Laboratory
Technician).
(ii) Have at least 2 years of clinical laboratory training, or
experience, or both, in high complexity testing; or
[[Page 920]]
(5) On or before September 1, 1992, have served as a general
supervisor of high complexity testing and--
(i) Be a high school graduate or equivalent; and
(ii) Have had at least 10 years of laboratory training or
experience, or both, in high complexity testing, including at least 6
years of supervisory experience between September 1, 1982 and September
1, 1992.
(d) For blood gas analysis, the individual providing general
supervision must--
(1) Be qualified under Secs. 493.1461(b) (1) or (2), or 493.1461(c);
or
(2)(i) Have earned a bachelor's degree in respiratory therapy or
cardiovascular technology from an accredited institution; and
(ii) Have at least one year of laboratory training or experience, or
both, in blood gas analysis; or
(3)(i) Have earned an associate degree related to pulmonary function
from an accredited institution; and
(ii) Have at least two years of training or experience, or both in
blood gas analysis.
(e) The general supervisor requirement is met in histopathology,
oral pathology, dermatopathology, and ophthalmic pathology because all
tests and examinations, must be performed:
(1) In histopathology, by an individual who is qualified as a
technical supervisor under Secs. 493.1449(b) or 493.1449(l)(1);
(2) In dermatopathology, by an individual who is qualified as a
technical supervisor under Secs. 493.1449(b) or 493.1449(l) or (2);
(3) In ophthalmic pathology, by an individual who is qualified as a
technical supervisor under Secs. 493.1449(b) or 493.1449(1)(3); and
(4) In oral pathology, by an individual who is qualified as a
technical supervisor under Secs. 493.1449(b) or 493.1449(m).
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5235, Jan. 19, 1993; 58
FR 39155, July 22, 1993; 60 FR 20049, Apr. 24, 1995]
Sec. 493.1462 General supervisor qualifications on or before February
28, 1992.
To qualify as a general supervisor under Sec. 493.1461(c)(3), an
individual must have met or could have met the following qualifications
as they were in effect on or before February 28, 1992.
(a) Each supervisor possesses a current license as a laboratory
supervisor issued by the State, if such licensing exists; and
(b) The laboratory supervisor--
(1) Who qualifies as a laboratory director under
Sec. 493.1406(b)(1), (2), (4), or (5) is also qualified as a general
supervisor; therefore, depending upon the size and functions of the
laboratory, the laboratory director may also serve as the laboratory
supervisor; or
(2)(i) Is a physician or has earned a doctoral degree from an
accredited institution with a major in one of the chemical, physical, or
biological sciences; and
(ii) Subsequent to graduation, has had at least 2 years of
experience in one of the laboratory specialties in a laboratory; or
(3)(i) Holds a master's degree from an accredited institution with a
major in one of the chemical, physical, or biological sciences; and
(ii) Subsequent to graduation has had at least 4 years of pertinent
full-time laboratory experience of which not less than 2 years have been
spent working in the designated specialty in a laboratory; or
(4)(i) Is qualified as a laboratory technologist under
Sec. 493.1491; and
(ii) After qualifying as a laboratory technologist, has had at least
6 years of pertinent full-time laboratory experience of which not less
than 2 years have been spent working in the designated laboratory
specialty in a laboratory; or
(5) With respect to individuals first qualifying before July 1,
1971, has had at least 15 years of pertinent full-time laboratory
experience before January 1, 1968; this required experience may be met
by the substitution of education for experience.
[58 FR 39155, July 22, 1993]
Sec. 493.1463 Standard: General supervisor responsibilities.
The general supervisor is responsible for day-to-day supervision or
oversight of the laboratory operation and personnel performing testing
and reporting test results.
[[Page 921]]
(a) The general supervisor--(1) Must be accessible to testing
personnel at all times testing is performed to provide on-site,
telephone or electronic consultation to resolve technical problems in
accordance with policies and procedures established either by the
laboratory director or technical supervisor;
(2) Is responsible for providing day-to-day supervision of high
complexity test performance by a testing personnel qualified under
Sec. 493.1489;
(3) Except as specified in paragraph (c) of this section, must be
onsite to provide direct supervision when high complexity testing is
performed by any individuals qualified under Sec. 493.1489(b)(5); and
(4) Is responsible for monitoring test analyses and specimen
examinations to ensure that acceptable levels of analytic performance
are maintained.
(b) The director or technical supervisor may delegate to the general
supervisor the responsibility for--
(1) Assuring that all remedial actions are taken whenever test
systems deviate from the laboratory's established performance
specifications;
(2) Ensuring that patient test results are not reported until all
corrective actions have been taken and the test system is properly
functioning;
(3) Providing orientation to all testing personnel; and
(4) Annually evaluating and documenting the performance of all
testing personnel.
(c) Exception. For individuals qualified under Sec. 493.1489(b)(5),
who were performing high complexity testing on or before January 19,
1993, the requirements of paragraph (a)(3) of this section are not
effective, provided that all high complexity testing performed by the
individual in the absence of a general supervisor is reviewed within 24
hours by a general supervisor qualified under Sec. 493.1461.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5235, Jan. 19, 1993; 60
FR 20050, Apr. 24, 1995]
Sec. 493.1467 Condition: Laboratories performing high complexity
testing; cytology general supervisor.
For the subspecialty of cytology, the laboratory must have a general
supervisor who meets the qualification requirements of Sec. 493.1469 of
this subpart, and provides supervision in accordance with Sec. 493.1471
of this subpart.
Sec. 493.1469 Standard: Cytology general supervisor qualifications.
The cytology general supervisor must be qualified to supervise
cytology services. The general supervisor in cytology must possess a
current license issued by the State in which the laboratory is located,
if such licensing is required, and must--
(a) Be qualified as a technical supervisor under Sec. 493.1449 (b)
or (k); or
(b)(1) Be qualified as a cytotechnologist under Sec. 493.1483; and
(2) Have at least 3 years of full-time (2,080 hours per year)
experience as a cytotechnologist within the preceding 10 years.
Sec. 493.1471 Standard: Cytology general supervisor responsibilities.
The technical supervisor of cytology may perform the duties of the
cytology general supervisor or delegate the responsibilities to an
individual qualified under Sec. 493.1469.
(a) The cytology general supervisor is responsible for the day-to-
day supervision or oversight of the laboratory operation and personnel
performing testing and reporting test results.
(b) The cytology general supervisor must--
(1) Be accessible to provide on-site, telephone, or electronic
consultation to resolve technical problems in accordance with policies
and procedures established by the technical supervisor of cytology;
(2) Document the slide interpretation results of each gynecologic
and nongynecologic cytology case he or she examined or reviewed (as
specified under Sec. 493.1257(d));
(3) For each 24-hour period, document the total number of slides he
or she examined or reviewed in the laboratory as well as the total
number of slides examined or reviewed in any other laboratory or for any
other employer; and
(4) Document the number of hours spent examining slides in each 24-
hour period.
[[Page 922]]
Sec. 493.1481 Condition: Laboratories performing high complexity
testing; cytotechnologist.
For the subspecialty of cytology, the laboratory must have a
sufficient number of cytotechnologists who meet the qualifications
specified in Sec. 493.1483 to perform the functions specified in
Sec. 493.1485.
Sec. 493.1483 Standard: Cytotechnologist qualifications.
Each person examining cytology slide preparations must meet the
qualifications of Sec. 493.1449 (b) or (k), or--
(a) Possess a current license as a cytotechnologist issued by the
State in which the laboratory is located, if such licensing is required;
and
(b) Meet one of the following requirements:
(1) Have graduated from a school of cytotechnology accredited by the
Committee on Allied Health Education and Accreditation or other
organization approved by HHS; or
(2) Be certified in cytotechnology by a certifying agency approved
by HHS; or
(3) Before September 1, 1992--
(i) Have successfully completed 2 years in an accredited institution
with at least 12 semester hours in science, 8 hours of which are in
biology; and
(A) Have had 12 months of training in a school of cytotechnology
accredited by an accrediting agency approved by HHS; or
(B) Have received 6 months of formal training in a school of
cytotechnology accredited by an accrediting agency approved by HHS and 6
months of full-time experience in cytotechnology in a laboratory
acceptable to the pathologist who directed the formal 6 months of
training; or
(ii) Have achieved a satisfactory grade to qualify as a
cytotechnologist in a proficiency examination approved by HHS and
designed to qualify persons as cytotechnologists; or
(4) Before September 1, 1994, have full-time experience of at least
2 years or equivalent within the preceding 5 years examining slide
preparations under the supervision of a physician qualified under
Sec. 493.1449(b) or (k)(1), and before January 1, 1969, must have--
(i) Graduated from high school;
(ii) Completed 6 months of training in cytotechnology in a
laboratory directed by a pathologist or other physician providing
cytology services; and
(iii) Completed 2 years of full-time supervised experience in
cytotechnology; or
(5)(i) On or before September 1, 1994, have full-time experience of
at least 2 years or equivalent examining cytology slide preparations
within the preceding 5 years in the United States under the supervision
of a physician qualified under Sec. 493.1449(b) or (k)(1); and
(ii) On or before September 1, 1995, have met the requirements in
either paragraph (b)(1) or (2) of this section.
[57 FR 7172, Feb. 28, 1992, as amended at 59 FR 685, Jan. 6, 1994]
Sec. 493.1485 Standard; Cytotechnologist responsibilities.
The cytotechnologist is responsible for documenting--
(a) The slide interpretation results of each gynecologic and
nongynecologic cytology case he or she examined or reviewed (as
specified in Sec. 493.1257(d));
(b) For each 24-hour period, the total number of slides examined or
reviewed in the laboratory as well as the total number of slides
examined or reviewed in any other laboratory or for any other employer;
and
(c) The number of hours spent examining slides in each 24-hour
period.
Sec. 493.1487 Condition: Laboratories performing high complexity
testing; testing personnel.
The laboratory has a sufficient number of individuals who meet the
qualification requirements of Sec. 493.1489 of this subpart to perform
the functions specified in Sec. 493.1495 of this subpart for the volume
and complexity of testing performed.
Sec. 493.1489 Standard; Testing personnel qualifications.
Each individual performing high complexity testing must--
(a) Possess a current license issued by the State in which the
laboratory is located, if such licensing is required; and
(b) Meet one of the following requirements:
[[Page 923]]
(1) Be a doctor of medicine, doctor of osteopathy, or doctor of
podiatric medicine licensed to practice medicine, osteopathy, or
podiatry in the State in which the laboratory is located or have earned
a doctoral, master's or bachelor's degree in a chemical, physical,
biological or clinical laboratory science, or medical technology from an
accredited institution;
(2)(i) Have earned an associate degree in a laboratory science, or
medical laboratory technology from an accredited institution or--
(ii) Have education and training equivalent to that specified in
paragraph (b)(2)(i) of this section that includes--
(A) At least 60 semester hours, or equivalent, from an accredited
institution that, at a minimum, include either--
(1) 24 semester hours of medical laboratory technology courses; or
(2) 24 semester hours of science courses that include--
(i) Six semester hours of chemistry;
(ii) Six semester hours of biology; and
(iii) Twelve semester hours of chemistry, biology, or medical
laboratory technology in any combination; and
(B) Have laboratory training that includes either of the following:
(1) Completion of a clinical laboratory training program approved or
accredited by the ABHES, the CAHEA, or other organization approved by
HHS. (This training may be included in the 60 semester hours listed in
paragraph (b)(2)(ii)(A) of this section.)
(2) At least 3 months documented laboratory training in each
specialty in which the individual performs high complexity testing.
(3) Have previously qualified or could have qualified as a
technologist under Sec. 493.1491 on or before February 28, 1992;
(4) On or before April 24, 1995 be a high school graduate or
equivalent and have either--
(i) Graduated from a medical laboratory or clinical laboratory
training program approved or accredited by ABHES, CAHEA, or other
organization approved by HHS; or
(ii) Successfully completed an official U.S. military medical
laboratory procedures training course of at least 50 weeks duration and
have held the military enlisted occupational specialty of Medical
Laboratory Specialist (Laboratory Technician);
(5)(i) Until September 1, 1997--
(A) Have earned a high school diploma or equivalent; and
(B) Have documentation of training appropriate for the testing
performed before analyzing patient specimens. Such training must ensure
that the individual has--
(1) The skills required for proper specimen collection, including
patient preparation, if applicable, labeling, handling, preservation or
fixation, processing or preparation, transportation and storage of
specimens;
(2) The skills required for implementing all standard laboratory
procedures;
(3) The skills required for performing each test method and for
proper instrument use;
(4) The skills required for performing preventive maintenance,
troubleshooting, and calibration procedures related to each test
performed;
(5) A working knowledge of reagent stability and storage;
(6) The skills required to implement the quality control policies
and procedures of the laboratory;
(7) An awareness of the factors that influence test results; and
(8) The skills required to assess and verify the validity of patient
test results through the evaluation of quality control values before
reporting patient test results; and
(ii) As of September 1, 1997, be qualified under
Sec. 493.1489(b)(1), (b)(2), or (b)(4), except for those individuals
qualified under paragraph (b)(5)(i) of this section who were performing
high complexity testing on or before April 24, 1995;
(6) For blood gas analysis--
(i) Be qualified under Sec. 493.1489(b)(1), (b)(2), (b)(3), (b)(4),
or (b)(5);
(ii) Have earned a bachelor's degree in respiratory therapy or
cardiovascular technology from an accredited institution; or
(iii) Have earned an associate degree related to pulmonary function
from an accredited institution; or
[[Page 924]]
(7) For histopathology, meet the qualifications of Sec. 493.1449 (b)
or (l) to perform tissue examinations.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5236, Jan. 19, 1993; 58
FR 39155, July 22, 1993; 60 FR 20050, Apr. 24, 1995]
Sec. 493.1491 Technologist qualifications on or before February 28,
1992.
In order to qualify as high complexity testing personnel under
Sec. 493.1489(b)(3), the individual must have met or could have met the
following qualifications for technologist as they were in effect on or
before February 28, 1992. Each technologist must--
(a) Possess a current license as a laboratory technologist issued by
the State, if such licensing exists; and
(b)(1) Have earned a bachelor's degree in medical technology from an
accredited university; or
(2) Have successfully completed 3 years of academic study (a minimum
of 90 semester hours or equivalent) in an accredited college or
university, which met the specific requirements for entrance into a
school of medical technology accredited by an accrediting agency
approved by the Secretary, and has successfully completed a course of
training of at least 12 months in such a school; or
(3) Have earned a bachelor's degree in one of the chemical,
physical, or biological sciences and, in addition, has at least 1 year
of pertinent full-time laboratory experience or training, or both, in
the specialty or subspecialty in which the individual performs tests; or
(4)(i) Have successfully completed 3 years (90 semester hours or
equivalent) in an accredited college or university with the following
distribution of courses--
(A) For those whose training was completed before September 15,
1963. At least 24 semester hours in chemistry and biology courses of
which--
(1) At least 6 semester hours were in inorganic chemistry and at
least 3 semester hours were in other chemistry courses; and
(2) At least 12 semester hours in biology courses pertinent to the
medical sciences; or
(B) For those whose training was completed after September 14, 1963.
(1) 16 semester hours in chemistry courses that included at least 6
semester hours in inorganic chemistry and that are acceptable toward a
major in chemistry;
(2) 16 semester hours in biology courses that are pertinent to the
medical sciences and are acceptable toward a major in the biological
sciences; and
(3) 3 semester hours of mathematics; and
(ii) Has experience, training, or both, covering several fields of
medical laboratory work of at least 1 year and of such quality as to
provide him or her with education and training in medical technology
equivalent to that described in paragraphs (b)(1) and (2) of this
section; or
(5) With respect to individuals first qualifying before July 1,
1971, the technologist--
(i) Was performing the duties of a laboratory technologist at any
time between July 1, 1961, and January 1, 1968, and
(ii) Has had at least 10 years of pertinent laboratory experience
prior to January 1, 1968. (This required experience may be met by the
substitution of education for experience); or
(6) Achieves a satisfactory grade in a proficiency examination
approved by HHS.
[58 FR 39155, July 22, 1993]
Sec. 493.1495 Standard; Testing personnel responsibilities.
The testing personnel are responsible for specimen processing, test
performance and for reporting test results.
(a) Each individual performs only those high complexity tests that
are authorized by the laboratory director and require a degree of skill
commensurate with the individual's education, training or experience,
and technical abilities.
(b) Each individual performing high complexity testing must--
(1) Follow the laboratory's procedures for specimen handling and
processing, test analyses, reporting and maintaining records of patient
test results;
(2) Maintain records that demonstrate that proficiency testing
samples are tested in the same manner as patient specimens;
[[Page 925]]
(3) Adhere to the laboratory's quality control policies, document
all quality control activities, instrument and procedural calibrations
and maintenance performed;
(4) Follow the laboratory's established policies and procedures
whenever test systems are not within the laboratory's established
acceptable levels of performance;
(5) Be capable of identifying problems that may adversely affect
test performance or reporting of test results and either must correct
the problems or immediately notify the general supervisor, technical
supervisor, clinical consultant, or director;
(6) Document all corrective actions taken when test systems deviate
from the laboratory's established performance specifications; and
(7) Except as specified in paragraph (c) of this section, if
qualified under Sec. 493.1489(b)(5), perform high complexity testing
only under the onsite, direct supervision of a general supervisor
qualified under Sec. 493.1461.
(c) Exception. For individuals qualified under Sec. 493.1489(b)(5),
who were performing high complexity testing on or before January 19,
1993, the requirements of paragraph (b)(7) of this section are not
effective, provided that all high complexity testing performed by the
individual in the absence of a general supervisor is reviewed within 24
hours by a general supervisor qualified under Sec. 493.1461.
[57 FR 7172, Feb. 28, 1992, as amended at 58 FR 5236, Jan. 19, 1993; 60
FR 20050, Apr. 24, 1995]
Subparts N-O [Reserved]
Subpart P--Quality Assurance for Moderate Complexity (Including the
Subcategory) or High Complexity Testing, or Any Combination of These
Tests
Source: 57 FR 7183, Feb. 28, 1992, unless otherwise noted.
Sec. 493.1701 Condition: Quality assurance; moderate complexity
(including the subcategory) or high complexity testing, or any
combination of these tests.
Each laboratory performing moderate complexity (including the
subcategory) or high complexity testing, or any combination of these
tests, must establish and follow written policies and procedures for a
comprehensive quality assurance program that is designed to monitor and
evaluate the ongoing and overall quality of the total testing process
(preanalytic, analytic, postanalytic). The laboratory's quality
assurance program must evaluate the effectiveness of its policies and
procedures; identify and correct problems; assure the accurate, reliable
and prompt reporting of test results; and assure the adequacy and
competency of the staff. As necessary, the laboratory must revise
policies and procedures based upon the results of those evaluations. The
laboratory must meet the standards as they apply to the services
offered, complexity of testing performed and test results reported, and
the unique practices of each testing entity. All quality assurance
activities must be documented.
[60 FR 20050, Apr. 24, 1995]
Sec. 493.1703 Standard; Patient test management assessment.
The laboratory must have an ongoing mechanism for monitoring and
evaluating the systems required under subpart J, Patient Test
Management. The laboratory must monitor, evaluate, and revise, if
necessary, based on the results of its evaluations, the following:
(a) The criteria established for patient preparation, specimen
collection, labeling, preservation and transportation;
(b) The information solicited and obtained on the laboratory's test
requisition for its completeness, relevance, and necessity for the
testing of patient specimens;
(c) The use and appropriateness of the criteria established for
specimen rejection;
[[Page 926]]
(d) The completeness, usefulness, and accuracy of the test report
information necessary for the interpretation or utilization of test
results;
(e) The timely reporting of test results based on testing priorities
(STAT, routine, etc.); and
(f) The accuracy and reliability of test reporting systems,
appropriate storage of records and retrieval of test results.
Sec. 493.1705 Standard; Quality control assessment.
The laboratory must have an ongoing mechanism to evaluate the
corrective actions taken under Sec. 493.1219, Remedial actions.
Ineffective policies and procedures must be revised based on the outcome
of the evaluation. The mechanism must evaluate and review the
effectiveness of corrective actions taken for--
(a) Problems identified during the evaluation of calibration and
control data for each test method;
(b) Problems identified during the evaluation of patient test values
for the purpose of verifying the reference range of a test method; and
(c) Errors detected in reported results.
Sec. 493.1707 Standard; Proficiency testing assessment.
Under subpart H of this part, Proficiency Testing, the corrective
actions taken for any unacceptable, unsatisfactory, or unsuccessful
proficiency testing result(s) must be evaluated for effectiveness.
Sec. 493.1709 Standard; Comparison of test results.
(a) If a laboratory performs the same test using different
methodologies or instruments, or performs the same test at multiple
testing sites, the laboratory must have a system that twice a year
evaluates and defines the relationship between test results using the
different methodologies, instruments, or testing sites.
(b) If a laboratory performs tests that are not included under
subpart I of this part, Proficiency Testing Programs, the laboratory
must have a system for verifying the accuracy of its test results at
least twice a year.
[58 FR 5236, Jan. 19, 1993]
Sec. 493.1711 Standard; Relationship of patient information to patient
test results.
For internal quality assurance, the laboratory must have a mechanism
to identify and evaluate patient test results that appear inconsistent
with relevant criteria such as--
(a) Patient age;
(b) Sex;
(c) Diagnosis or pertinent clinical data, when provided;
(d) Distribution of patient test results when available; and
(e) Relationship with other test parameters, when available within
the laboratory.
Sec. 493.1713 Standard; Personnel assessment.
The laboratory must have an ongoing mechanism to evaluate the
effectiveness of its policies and procedures for assuring employee
competence and, if applicable, consultant competence.
Sec. 493.1715 Standard; Communications.
The laboratory must have a system in place to document problems that
occur as a result of breakdowns in communication between the laboratory
and the authorized individual who orders or receives the results of test
procedures or examinations. Corrective actions must be taken, as
necessary, to resolve the problems and minimize communication
breakdowns.
[58 FR 5236, Jan. 19, 1993]
Sec. 493.1717 Standard; Complaint investigations.
The laboratory must have a system in place to assure that all
complaints and problems reported to the laboratory are documented.
Investigations of complaints must be made, when appropriate, and, as
necessary, corrective actions are instituted.
Sec. 493.1719 Standard; Quality assurance review with staff.
The laboratory must have a mechanism for documenting and assessing
[[Page 927]]
problems identified during quality assurance reviews and discussing them
with the staff. The laboratory must take corrective actions that are
necessary to prevent recurrences.
Sec. 493.1721 Standard; Quality assurance records.
The laboratory must maintain documentation of all quality assurance
activities including problems identified and corrective actions taken.
All quality assurance records must be available to HHS and maintained
for a period of 2 years.
[58 FR 5236, Jan. 19, 1993]
Subpart Q--Inspection
Source: 57 FR 7184, Feb. 28, 1992, unless otherwise noted.
Sec. 493.1771 Condition: Inspection requirements applicable to all
CLIA-certified and CLIA-exempt laboratories.
(a) Each laboratory issued a CLIA certificate must meet the
requirements in Sec. 493.1773 and the specific requirements for its
certificate type, as specified in Secs. 493.1775 through 493.1780.
(b) All CLIA-exempt laboratories must comply with the inspection
requirements in Secs. 493.1773 and 493.1780, when applicable.
[63 FR 26737, May 14, 1998]
Sec. 493.1773 Standard: Basic inspection requirements for all
laboratories issued a CLIA certificate and CLIA-exempt
laboratories.
(a) A laboratory issued a certificate must permit HCFA or a HCFA
agent to conduct an inspection to assess the laboratory's compliance
with the requirements of this part. A CLIA-exempt laboratory and a
laboratory that requests, or is issued a certificate of accreditation,
must permit HCFA or a HCFA agent to conduct validation and complaint
inspections.
(b) General requirements. As part of the inspection process, HCFA or
a HCFA agent may require the laboratory to do the following:
(1) Test samples, including proficiency testing samples, or perform
procedures.
(2) Permit interviews of all personnel concerning the laboratory's
compliance with the applicable requirements of this part.
(3) Permit laboratory personnel to be observed performing all phases
of the total testing process (preanalytic, analytic, and postanalytic).
(4) Permit HCFA or a HCFA agent access to all areas encompassed
under the certificate including, but not limited to, the following:
(i) Specimen procurement and processing areas.
(ii) Storage facilities for specimens, reagents, supplies, records,
and reports.
(iii) Testing and reporting areas.
(5) Provide HCFA or a HCFA agent with copies or exact duplicates of
all records and data it requires.
(c) Accessible records and data. A laboratory must have all records
and data accessible and retrievable within a reasonable time frame
during the course of the inspection.
(d) Requirement to provide information and data. A laboratory must
provide, upon request, all information and data needed by HCFA or a HCFA
agent to make a determination of the laboratory's compliance with the
applicable requirements of this part.
(e) Reinspection. HCFA or a HCFA agent may reinspect a laboratory at
any time to evaluate the ability of the laboratory to provide accurate
and reliable test results.
(f) Complaint inspection. HCFA or a HCFA agent may conduct an
inspection when there are complaints alleging noncompliance with any of
the requirements of this part.
(g) Failure to permit an inspection or reinspection. Failure to
permit HCFA or a HCFA agent to conduct an inspection or reinspection
results in the suspension or cancellation of the laboratory's
participation in Medicare and Medicaid for payment, and suspension or
limitation of, or action to revoke the laboratory's CLIA certificate, in
accordance with subpart R of this part.
[63 FR 26737, May 14, 1998; 63 FR 32699, June 15, 1998]
[[Page 928]]
Sec. 493.1775 Standard: Inspection of laboratories issued a certificate
of waiver or a certificate for provider-performed microscopy
procedures.
(a) A laboratory that has been issued a certificate of waiver or a
certificate for provider-performed microscopy procedures is not subject
to biennial inspections.
(b) If necessary, HCFA or a HCFA agent may conduct an inspection of
a laboratory issued a certificate of waiver or a certificate for
provider-performed microscopy procedures at any time during the
laboratory's hours of operation to do the following:
(1) Determine if the laboratory is operated and testing is performed
in a manner that does not constitute an imminent and serious risk to
public health.
(2) Evaluate a complaint from the public.
(3) Determine whether the laboratory is performing tests beyond the
scope of the certificate held by the laboratory.
(4) Collect information regarding the appropriateness of tests
specified as waived tests or provider-performed microscopy procedures.
(c) The laboratory must comply with the basic inspection
requirements of Sec. 493.1773.
[63 FR 26737, May 14, 1998]
Sec. 493.1777 Standard: Inspection of laboratories that have requested
or have been issued a certificate of compliance.
(a) Initial inspection. (1) A laboratory issued a registration
certificate must permit an initial inspection to assess the laboratory's
compliance with the requirements of this part before HCFA issues a
certificate of compliance.
(2) The inspection may occur at any time during the laboratory's
hours of operation.
(b) Subsequent inspections. (1) HCFA or a HCFA agent may conduct
subsequent inspections on a biennial basis or with such other frequency
as HCFA determines to be necessary to ensure compliance with the
requirements of this part.
(2) HCFA bases the nature of subsequent inspections on the
laboratory's compliance history.
(c) Provider-performed microscopy procedures. The inspection sample
for review may include testing in the subcategory of provider-performed
microscopy procedures.
(d) Compliance with basic inspection requirements. The laboratory
must comply with the basic inspection requirements of Sec. 493.1773.
[63 FR 26738, May 14, 1998]
Sec. 493.1780 Standard: Inspection of CLIA-exempt laboratories or
laboratories requesting or issued a certificate of
accreditation.
(a) Validation inspection. HCFA or a HCFA agent may conduct a
validation inspection of any accredited or CLIA-exempt laboratory at any
time during its hours of operation.
(b) Complaint inspection. HCFA or a HCFA agent may conduct a
complaint inspection of a CLIA-exempt laboratory or a laboratory
requesting or issued a certificate of accreditation at any time during
its hours of operation upon receiving a complaint applicable to the
requirements of this part.
(c) Noncompliance determination. If a validation or complaint
inspection results in a finding that the laboratory is not in compliance
with one or more condition-level requirements, the following actions
occur:
(1) A laboratory issued a certificate of accreditation is subject to
a full review by HCFA, in accordance with subpart E of this part and
Sec. 488.11 of this chapter.
(2) A CLIA-exempt laboratory is subject to appropriate enforcement
actions under the approved State licensure program.
(d) Compliance with basic inspection requirements. CLIA-exempt
laboratories and laboratories requesting or issued a certificate of
accreditation must comply with the basic inspection requirements in
Sec. 493.1773.
[63 FR 26738, May 14, 1998]
Subpart R--Enforcement Procedures
Source: 57 FR 7237, Feb. 28, 1992, unless otherwise noted.
[[Page 929]]
Sec. 493.1800 Basis and scope.
(a) Statutory basis. (1) Section 1846 of the Act--
(i) Provides for intermediate sanctions that may be imposed on
laboratories that perform clinical diagnostic tests on human specimens
when those laboratories are found to be out of compliance with one or
more of the conditions for Medicare coverage of their services; and
(ii) Requires the Secretary to develop and implement a range of such
sanctions, including four that are specified in the statute.
(2) The Clinical Laboratories Improvement Act of 1967 (section 353
of the Public Health Service Act) as amended by CLIA '88--
(i) Establishes requirements for all laboratories that perform
clinical diagnostic tests on human specimens;
(ii) Requires a Federal certification scheme to be applied to all
such laboratories; and
(iii) Grants the Secretary broad enforcement authority, including--
(A) Use of intermediate sanctions;
(B) Suspension, limitation, or revocation of the certificate of a
laboratory that is out of compliance with one or more requirements for a
certificate; and
(C) Civil suit to enjoin any laboratory activity that constitutes a
significant hazard to the public health.
(3) Section 353 also--
(i) Provides for imprisonment or fine for any person convicted of
intentional violation of CLIA requirements;
(ii) Specifies the administrative hearing and judicial review rights
of a laboratory that is sanctioned under CLIA; and
(iii) Requires the Secretary to publish annually a list of all
laboratories that have been sanctioned during the preceding year.
(b) Scope and applicability. This subpart sets forth--
(1) The policies and procedures that HCFA follows to enforce the
requirements applicable to laboratories under CLIA and under section
1846 of the Act; and
(2) The appeal rights of laboratories on which HCFA imposes
sanctions.
Sec. 493.1804 General considerations.
(a) Purpose. The enforcement mechanisms set forth in this subpart
have the following purposes:
(1) To protect all individuals served by laboratories against
substandard testing of specimens.
(2) To safeguard the general public against health and safety
hazards that might result from laboratory activities.
(3) To motivate laboratories to comply with CLIA requirements so
that they can provide accurate and reliable test results.
(b) Basis for decision to impose sanctions. (1) HCFA's decision to
impose sanctions is based on one or more of the following:
(i) Deficiencies found by HCFA or its agents in the conduct of
inspections to certify or validate compliance with Federal requirements,
or through review of materials submitted by the laboratory (e.g.,
personnel qualifications).
(ii) Unsuccessful participation in proficiency testing.
(2) HCFA imposes one or more of the alternative or principal
sanctions specified in Secs. 493.1806 and 493.1807 when HCFA or HCFA's
agent finds that a laboratory has condition-level deficiencies.
(c) Imposition of alternative sanctions. (1) HCFA may impose
alternative sanctions in lieu of, or in addition to principal sanctions,
(HCFA does not impose alternative sanctions on laboratories that have
certificates of waiver because those laboratories are not inspected for
compliance with condition-level requirements.)
(2) HCFA may impose alternative sanctions other than a civil money
penalty after the laboratory has had an opportunity to respond, but
before the hearing specified in Sec. 493.1844.
(d) Choice of sanction: Factors considered. HCFA bases its choice of
sanction or sanctions on consideration of one or more factors that
include, but are not limited to, the following, as assessed by the State
or by HCFA, or its agents:
(1) Whether the deficiencies pose immediate jeopardy.
(2) The nature, incidence, severity, and duration of the
deficiencies or noncompliance.
[[Page 930]]
(3) Whether the same condition level deficiencies have been
identified repeatedly.
(4) The accuracy and extent of laboratory records (e.g., of remedial
action) in regard to the noncompliance, and their availability to the
State, to other HCFA agents, and to HCFA.
(5) The relationship of one deficiency or group of deficiencies to
other deficiencies.
(6) The overall compliance history of the laboratory including but
not limited to any period of noncompliance that occurred between
certifications of compliance.
(7) The corrective and long-term compliance outcomes that HCFA hopes
to achieve through application of the sanction.
(8) Whether the laboratory has made any progress toward improvement
following a reasonable opportunity to correct deficiencies.
(9) Any recommendation by the State agency as to which sanction
would be appropriate.
(e) Number of alternative sanctions. HCFA may impose a separate
sanction for each condition level deficiency or a single sanction for
all condition level deficiencies that are interrelated and subject to
correction by a single course of action.
(f) Appeal rights. The appeal rights of laboratories dissatisfied
with the imposition of a sanction are set forth in Sec. 493.1844.
[57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11, 1992, as amended at 60
FR 20051, Apr. 24, 1995]
Sec. 493.1806 Available sanctions: All laboratories.
(a) Applicability. HCFA may impose one or more of the sanctions
specified in this section on a laboratory that is out of compliance with
one or more CLIA conditions.
(b) Principal sanction. HCFA may impose any of the three principal
CLIA sanctions, which are suspension, limitation, or revocation of any
type of CLIA certificate.
(c) Alternative sanctions. HCFA may impose one or more of the
following alternative sanctions in lieu of or in addition to imposing a
principal sanction, except on a laboratory that has a certificate of
waiver.
(1) Directed plan of correction, as set forth at Sec. 493.1832.
(2) State onsite monitoring as set forth at Sec. 493.1836.
(3) Civil money penalty, as set forth at Sec. 493.1834.
(d) Civil suit. HCFA may bring suit in the appropriate U.S. District
Court to enjoin continuation of any activity of any laboratory
(including a CLIA-exempt laboratory that has been found with
deficiencies during a validation survey), if HCFA has reason to believe
that continuation of the activity would constitute a significant hazard
to the public health.
(e) Criminal sanctions. Under section 353(1) of the PHS Act, an
individual who is convicted of intentionally violating any CLIA
requirement may be imprisoned or fined.
[57 FR 7237, Feb. 28, 1992, as amended at 58 FR 5237, Jan. 19, 1993]
Sec. 493.1807 Additional sanctions: Laboratories that participate in
Medicare.
The following additional sanctions are available for laboratories
that are out of compliance with one or more CLIA conditions and that
have approval to receive Medicare payment for their services.
(a) Principal sanction. Cancellation of the laboratory's approval to
receive Medicare payment for its services.
(b) Alternative sanctions. (1) Suspension of payment for tests in
one or more specific specialties or subspecialties, performed on or
after the effective date of sanction.
(2) Suspension of payment for all tests in all specialties and
subspecialties performed on or after the effective date of sanction.
Sec. 493.1808 Adverse action on any type of CLIA certificate: Effect on
Medicare approval.
(a) Suspension or revocation of any type of CLIA certificate. When
HCFA suspends or revokes any type of CLIA certificate, HCFA concurrently
cancels the laboratory's approval to receive Medicare payment for its
services.
(b) Limitation of any type of CLIA certificate. When HCFA limits any
type of CLIA certificate, HCFA concurrently limits Medicare approval to
only those
[[Page 931]]
specialties or subspecialties that are authorized by the laboratory's
limited certificate.
Sec. 493.1809 Limitation on Medicaid payment.
As provided in section 1902(a)(9)(C) of the Act, payment for
laboratory services may be made under the State plan only if those
services are furnished by a laboratory that has a CLIA certificate or is
licensed by a State whose licensure program has been approved by the
Secretary under this part.
[57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11, 1992]
Sec. 493.1810 Imposition and lifting of alternative sanctions.
(a) Notice of noncompliance and of proposed sanction: Content. If
HCFA or its agency identifies condition level noncompliance in a
laboratory, HCFA or its agent gives the laboratory written notice of the
following:
(1) The condition level noncompliance that it has identified.
(2) The sanction or sanctions that HCFA or its agent proposes to
impose against the laboratory.
(3) The rationale for the proposed sanction or sanctions.
(4) The projected effective date and duration of the proposed
sanction or sanctions.
(5) The authority for the proposed sanction or sanctions.
(6) The time allowed (at least 10 days) for the laboratory to
respond to the notice.
(b) Opportunity to respond. During the period specified in paragraph
(a)(6) of this section, the laboratory may submit to HCFA or its agent
written evidence or other information against the imposition of the
proposed sanction or sanctions.
(c) Notice of imposition of sanction--(1) Content. HCFA gives the
laboratory written notice that acknowledges any evidence or information
received from the laboratory and specifies the following:
(i) The sanction or sanctions to be imposed against the laboratory.
(ii) The authority and rationale for the imposing sanction or
sanctions.
(iii) The effective date and duration of sanction.
(2) Timing. (i) If HCFA or its agent determines that the
deficiencies pose immediate jeopardy, HCFA provides notice at least 5
days before the effective date of sanction.
(ii) If HCFA or its agent determines that the deficiencies do not
pose immediate jeopardy, HCFA provides notice at least 15 days before
the effective date of the sanction.
(d) Duration of alternative sanctions. An alternative sanction
continues until the earlier of the following occurs:
(1) The laboratory corrects all condition level deficiencies.
(2) HCFA's suspension, limitation, or revocation of the laboratory's
CLIA certificate becomes effective.
(e) Lifting of alternative sanctions--(1) General rule. Alternative
sanctions are not lifted until a laboratory's compliance with all
condition level requirements is verified.
(2) Credible allegation of compliance. When a sanctioned laboratory
submits a credible allegation of compliance, HCFA's agent determines
whether--
(i) It can certify compliance on the basis of the evidence presented
by the laboratory in its allegation; or
(ii) It must revisit to verify whether the laboratory has, in fact,
achieved compliance.
(3) Compliance achieved before the date of revisit. If during a
revisit, the laboratory presents credible evidence (as determined by
HCFA or its agent) that it achieved compliance before the date of
revisit, sanctions are lifted as of that earlier date.
Sec. 493.1812 Action when deficiencies pose immediate jeopardy.
If a laboratory's deficiencies pose immediate jeopardy, the
following rules apply:
(a) HCFA requires the laboratory to take immediate action to remove
the jeopardy and may impose one or more alternative sanctions to help
bring the laboratory into compliance.
(b) If the findings of a revisit indicate that a laboratory has not
eliminated the jeopardy, HCFA suspends or limits the laboratory's CLIA
certificate no earlier than 5 days after the date of notice of
suspension or limitation. HCFA may later revoke the certificate.
[[Page 932]]
(c) In addition, if HCFA has reason to believe that the continuation
of any activity by any laboratory (either the entire laboratory
operation or any specialty or subspecialty of testing) would constitute
a significant hazard to the public health, HCFA may bring suit and seek
a temporary injunction or restraining order against continuation of that
activity by the laboratory, regardless of the type of CLIA certificate
the laboratory has and of whether it is State-exempt.
Sec. 493.1814 Action when deficiencies are at the condition level but
do not pose immediate jeopardy.
If a laboratory has condition level deficiencies that do not pose
immediate jeopardy, the following rules apply:
(a) Initial action. (1) HCFA may cancel the laboratory's approval to
receive Medicare payment for its services.
(2) HCFA may suspend, limit, or revoke the laboratory's CLIA
certificate.
(3) If HCFA does not impose a principal sanction under paragraph
(a)(1) or (a)(2) of this section, it imposes one or more alternative
sanctions. In the case of unsuccessful participation in proficiency
testing, HCFA may impose the training and technical assistance
requirement set forth at Sec. 493.1838 in lieu of, or in addition to,
one or more alternative sanctions.
(b) Failure to correct condition level deficiencies. If HCFA imposes
alternative sanctions for condition level deficiencies that do not pose
immediate jeopardy, and the laboratory does not correct the condition
level deficiencies within 12 months after the last day of inspection,
HCFA--
(1) Cancels the laboratory's approval to receive Medicare payment
for its services, and discontinues the Medicare payment sanctions as of
the day cancellation is effective.
(2) Following a revisit which indicates that the laboratory has not
corrected its condition level deficiencies, notifies the laboratory that
it proposes to suspend, limit, or revoke the certificate, as specified
in Sec. 493.1816(b), and the laboratory's right to hearing; and
(3) May impose (or continue, if already imposed) any alternative
sanctions that do not pertain to Medicare payments. (Sanctions imposed
under the authority of section 353 of the PHS Act may continue for more
than 12 months from the last date of inspection, while a hearing on the
proposed suspension, limitation, or revocation of the certificate of
compliance, registration certificate, certificate of accreditation, or
certificate for PPM procedures is pending.)
(c) Action after hearing. If a hearing decision upholds a proposed
suspension, limitation, or revocation of a laboratory's CLIA
certificate, HCFA discontinues any alternative sanctions as of the day
it makes the suspension, limitation, or revocation effective.
[57 FR 7237, Feb. 28, 1992, as amended at 60 FR 20051, Apr. 24, 1995]
Sec. 493.1816 Action when deficiencies are not at the condition level.
If a laboratory has deficiencies, that are not at the condition
level, the following rules apply:
(a) Initial action. The laboratory must submit a plan of correction
that is acceptable to HCFA in content and time frames.
(b) Failure to correct deficiencies. If, on revisit, it is found
that the laboratory has not corrected the deficiencies within 12 months
after the last day of inspection, the following rules apply:
(1) HCFA cancels the laboratory's approval to receive Medicare
payment for its services.
(2) HCFA notifies the laboratory of its intent to suspend, limit, or
revoke the laboratory's CLIA certificate and of the laboratory's right
to a hearing.
Sec. 493.1820 Ensuring timely correction of deficiencies.
(a) Timing of visits. HCFA, the State survey agency or other HCFA
agent may visit the laboratory at any time to evaluate progress, and at
the end of the period to determine whether all corrections have been
made.
(b) Deficiencies corrected before a visit. If during a visit, a
laboratory produces credible evidence that it achieved compliance before
the visit, the sanctions are lifted as of that earlier date.
[[Page 933]]
(c) Failure to correct deficiencies. If during a visit it is found
that the laboratory has not corrected its deficiencies, HCFA may propose
to suspend, limit, or revoke the laboratory's CLIA certificate.
(d) Additional time for correcting lower level deficiencies not at
the condition level. If at the end of the plan of correction period all
condition level deficiencies have been corrected, and there are
deficiencies, that are not at the condition level, HCFA may request a
revised plan of correction. The revised plan may not extend beyond 12
months from the last day of the inspection that originally identified
the cited deficiencies.
(e) Persistence of deficiencies. If at the end of the period covered
by the plan of correction, the laboratory still has deficiencies, the
rules of Secs. 493.1814 and 493.1816 apply.
Sec. 493.1826 Suspension of part of Medicare payments.
(a) Application. (1) HCFA may impose this sanction if a laboratory--
(i) Is found to have condition level deficiencies with respect to
one or more specialties or subspecialties of tests; and
(ii) Agrees (in return for not having its Medicare approval
cancelled immediately) not to charge Medicare beneficiaries or their
private insurance carriers for the services for which Medicare payment
is suspended.
(2) HCFA suspends Medicare payment for those specialities or
subspecialties of tests for which the laboratory is out of compliance
with Federal requirements.
(b) Procedures. Before imposing this sanction, HCFA provides notice
of sanction and opportunity to respond in accordance with Sec. 493.1810.
(c) Duration and effect of sanction. This sanction continues until
the laboratory corrects the condition level deficiencies or HCFA cancels
the laboratory's approval to receive Medicare payment for its services,
but in no event longer than 12 months.
(1) If the laboratory corrects all condition level deficiencies,
HCFA resumes Medicare payment effective for all services furnished on or
after the date the deficiencies are corrected.
(2) [Reserved]
[57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11, 1992]
Sec. 493.1828 Suspension of all Medicare payments.
(a) Application. (1) HCFA may suspend payment for all Medicare-
approved laboratory services when the laboratory has condition level
deficiencies.
(2) HCFA suspends payment for all Medicare covered laboratory
services when the following conditions are met:
(i) Either--
(A) The laboratory has not corrected its condition level
deficiencies included in the plan of correction within 3 months from the
last date of inspection; or
(B) The laboratory has been found to have the same condition level
deficiencies during three consecutive inspections; and
(ii) The laboratory has chosen (in return for not having its
Medicare approval immediately cancelled), to not charge Medicare
beneficiaries or their private insurance carriers for services for which
Medicare payment is suspended.
(3) HCFA suspends payment for services furnished on and after the
effective date of sanction.
(b) Procedures. Before imposing this sanction, HCFA provides notice
of sanction and opportunity to respond in accordance with Sec. 493.1810.
(c) Duration and effect of sanction. (1) Suspension of payment
continues until all condition level deficiencies are corrected, but
never beyond twelve months.
(2) If all the deficiencies are not corrected by the end of the 12
month period, HCFA cancels the laboratory's approval to receive Medicare
payment for its services.
Sec. 493.1832 Directed plan of correction and directed portion of a
plan of correction.
(a) Application. HCFA may impose a directed plan of correction as an
alternative sanction for any laboratory that has condition level
deficiencies. If HCFA does not impose a directed plan of correction as
an alternative sanction for a laboratory that has condition
[[Page 934]]
level deficiencies, it at least imposes a directed portion of a plan of
correction when it imposes any of the following alternative sanctions:
(1) State onsite monitoring.
(2) Civil money penalty.
(3) Suspension of all or part of Medicare payments.
(b) Procedures--(1) Directed plan of correction. When imposing this
sanction, HCFA--
(i) Gives the laboratory prior notice of the sanction and
opportunity to respond in accordance with Sec. 493.1810;
(ii) Directs the laboratory to take specific corrective action
within specific time frames in order to achieve compliance; and
(iii) May direct the laboratory to submit the names of laboratory
clients for notification purposes, as specified in paragraph (b)(3) of
this section.
(2) Directed portion of a plan of correction. HCFA may decide to
notify clients of a sanctioned laboratory, because of the seriousness of
the noncompliance (e.g., the existence of immediate jeopardy) or for
other reasons. When imposing this sanction, HCFA takes the following
steps--
(i) Directs the laboratory to submit to HCFA, the State survey
agency, or other HCFA agent, within 10 calendar days after the notice of
the alternative sanction, a list of names and addresses of all
physicians, providers, suppliers, and other clients who have used some
or all of the services of the laboratory since the last certification
inspection or within any other timeframe specified by HCFA.
(ii) Within 30 calendar days of receipt of the information, may send
to each laboratory client, via the State survey agency, a notice
containing the name and address of the laboratory, the nature of the
laboratory's noncompliance, and the kind and effective date of the
alternative sanction.
(iii) Sends to each laboratory client, via the State survey agency,
notice of the recission of an adverse action within 30 days of the
rescission.
(3) Notice of imposition of a principal sanction following the
imposition of an alternative sanction. If HCFA imposes a principal
sanction following the imposition of an alternative sanction, and for
which HCFA has already obtained a list of laboratory clients, HCFA may
use that list to notify the clients of the imposition of the principal
sanction.
(c) Duration of a directed plan of correction. If HCFA imposes a
directed plan of correction, and on revisit it is found that the
laboratory has not corrected the deficiencies within 12 months from the
last day of inspection, the following rules apply:
(1) HCFA cancels the laboratory's approval for Medicare payment of
its services, and notifies the laboratory of HCFA's intent to suspend,
limit, or revoke the laboratory's CLIA certificate.
(2) The directed plan of correction continues in effect until the
day suspension, limitation, or revocation of the laboratory's CLIA
certificate.
Sec. 493.1834 Civil money penalty.
(a) Statutory basis. Sections 1846 of the Act and 353(h)(2)(B) of
the PHS Act authorize the Secretary to impose civil money penalties on
laboratories. Section 1846(b)(3) of the Act specifically provides that
incrementally more severe fines may be imposed for repeated or
uncorrected deficiencies.
(b) Scope. This section sets forth the procedures that HCFA follows
to impose a civil money penalty in lieu of, or in addition to,
suspending, limiting, or revoking the certificate of compliance,
registration certificate, certificate of accreditation, or certificate
for PPM procedures of a laboratory that is found to have condition level
deficiencies.
(c) Basis for imposing a civil money penalty. HCFA may impose a
civil money penalty against any laboratory determined to have condition
level deficiencies regardless of whether those deficiencies pose
immediate jeopardy.
(d) Amount of penalty--(1) Factors considered. In determining the
amount of the penalty, HCFA takes into account the following factors:
(i) The nature, scope, severity, and duration of the noncompliance.
(ii) Whether the same condition level deficiencies have been
identified during three consecutive inspections.
(iii) The laboratory's overall compliance history including but not
limited to any period of noncompliance that occurred between
certifications of compliance.
[[Page 935]]
(iv) The laboratory's intent or reason for noncompliance.
(v) The accuracy and extent of laboratory records and their
availability to HCFA, the State survey agency, or other HCFA agent.
(2) Range of penalty amount.
(i) For a condition level deficiency that poses immediate jeopardy,
the range is $3,050-$10,000 per day of noncompliance or per violation.
(ii) For a condition level deficiency that does not pose immediate
jeopardy, the range is $50-$3,000 per day of noncompliance or per
violation.
(3) Decreased penalty amounts. If the immediate jeopardy is removed,
but the deficiency continues, HCFA shifts the penalty amount to the
lower range.
(4) Increased penalty amounts. HCFA may, before the hearing, propose
to increase the penalty amount for a laboratory that has deficiencies
which, after imposition of a lower level penalty amount, become
sufficiently serious to pose immediate jeopardy.
(e) Procedures for imposition of civil money penalty--(1) Notice of
intent. (i) HCFA sends the laboratory written notice, of HCFA's intent
to impose a civil money penalty.
(ii) The notice includes the following information:
(A) The statutory basis for the penalty.
(B) The proposed daily or per violation amount of the penalty.
(C) The factors (as described in paragraph (d)(1) of this section)
that HCFA considered.
(D) The opportunity for responding to the notice in accordance with
Sec. 493.1810(c).
(E) A specific statement regarding the laboratory's appeal rights.
(2) Appeal rights. (i) The laboratory has 60 days from the date of
receipt of the notice of intent to impose a civil money penalty to
request a hearing in accordance with Sec. 493.1844(g).
(ii) If the laboratory requests a hearing, all other pertinent
provisions of Sec. 493.1844 apply.
(iii) If the laboratory does not request a hearing, HCFA may reduce
the proposed penalty amount by 35 percent.
(f) Accrual and duration of penalty--(1) Accrual of penalty. The
civil money penalty begins accruing as follows:
(i) 5 days after notice of intent if there is immediate jeopardy.
(ii) 15 days after notice of intent if there is not immediate
jeopardy.
(2) Duration of penalty. The civil money penalty continues to accrue
until the earliest of the following occurs:
(i) The laboratory's compliance with condition level requirements is
verified on the basis of the evidence presented by the laboratory in its
credible allegation of compliance or at the time or revisit.
(ii) Based on credible evidence presented by the laboratory at the
time of revisit, HCFA determines that compliance was achieved before the
revisit. (In this situation, the money penalty stops accruing as of the
date of compliance.)
(iii) HCFA suspends, limits, or revokes the laboratory's certificate
of compliance, registration certificate, certificate of accreditation,
or certificate for PPM procedures.
(g) Computation and notice of total penalty amount--(1) Computation.
HCFA computes the total penalty amount after the laboratory's compliance
is verified or HCFA suspends, limits, or revokes the laboratory's CLIA
certificate but in no event before--
(i) The 60 day period for requesting a hearing has expired without a
request or the laboratory has explicitly waived its right to a hearing;
or
(ii) Following a hearing requested by the laboratory, the ALJ issues
a decision that upholds imposition of the penalty.
(2) Notice of penalty amount and due date of penalty. The notice
includes the following information:
(i) Daily or per violation penalty amount.
(ii) Number of days or violations for which the penalty is imposed.
(iii) Total penalty amount.
(iv) Due date for payment of the penalty.
(h) Due date for payment of penalty. (1) Payment of a civil money
penalty is due 15 days from the date of the notice specified in
paragraph (g)(2) of this section.
[[Page 936]]
(2) HCFA may approve a plan for a laboratory to pay a civil money
penalty, plus interest, over a period of up to one year from the
original due date.
(i) Collection and settlement--(1) Collection of penalty amounts.
(i) The determined penalty amount may be deducted from any sums then or
later owing by the United States to the laboratory subject to the
penalty.
(ii) Interest accrues on the unpaid balance of the penalty,
beginning on the due date. Interest is computed at the rate specified in
Sec. 405.378(d) of this chapter.
(2) Settlement. HCFA has authority to settle any case at any time
before the ALJ issues a hearing decision.
[57 FR 7237, Feb. 28, 1992, as amended at 60 FR 20051, Apr. 24, 1995; 61
FR 63749, Dec. 2, 1996]
Sec. 493.1836 State onsite monitoring.
(a) Application. (1) HCFA may require continuous or intermittent
monitoring of a plan of correction by the State survey agency to ensure
that the laboratory makes the improvements necessary to bring it into
compliance with the condition level requirements. (The State monitor
does not have management authority, that is, cannot hire or fire staff,
obligate funds, or otherwise dictate how the laboratory operates. The
monitor's responsibility is to oversee whether corrections are made.)
(2) The laboratory must pay the costs of onsite monitoring by the
State survey agency.
(i) The costs are computed by multiplying the number of hours of
onsite monitoring in the laboratory by the hourly rate negotiated by
HCFA and the State.
(ii) The hourly rate includes salary, fringe benefits, travel, and
other direct and indirect costs approved by HCFA.
(b) Procedures. Before imposing this sanction, HCFA provides notice
of sanction and opportunity to respond in accordance with Sec. 493.1810.
(c) Duration of sanction. (1) If HCFA imposes onsite monitoring, the
sanction continues until HCFA determines that the laboratory has the
capability to ensure compliance with all condition level requirements.
(2) If the laboratory does not correct all deficiencies within 12
months, and a revisit indicates that deficiencies remain, HCFA cancels
the laboratory's approval for Medicare payment for its services and
notifies the laboratory of its intent to suspend, limit, or revoke the
laboratory's certificate of compliance, registration certificate,
certificate of accreditation, or certificate for PPM procedures.
(3) If the laboratory still does not correct its deficiencies, the
Medicare sanction continues until the suspension, limitation, or
revocation of the laboratory's certificate of compliance, registration
certificate, certificate of accreditation, or certificate for PPM
procedures is effective.
[57 FR 7237, Feb. 28, 1992, as amended at 60 FR 20051, Apr. 24, 1995]
Sec. 493.1838 Training and technical assistance for unsuccessful
participation in proficiency testing.
If a laboratory's participation in proficiency testing is
unsuccessful, HCFA may require the laboratory to undertake training of
its personnel, or to obtain necessary technical assistance, or both, in
order to meet the requirements of the proficiency testing program. This
requirement is separate from the principal and alternative sanctions set
forth in Secs. 493.1806 and 493.1807.
Sec. 493.1840 Suspension, limitation, or revocation of any type of CLIA
certificate.
(a) Adverse action based on actions of the laboratory's owner,
operator or employees. HCFA may initiate adverse action to suspend,
limit or revoke any CLIA certificate if HCFA finds that a laboratory's
owner or operator or one of its employees has--
(1) Been guilty of misrepresentation in obtaining a CLIA
certificate;
(2) Performed, or represented the laboratory as entitled to perform,
a laboratory examination or other procedure that is not within a
category of laboratory examinations or other procedures authorized by
its CLIA certificate;
(3) Failed to comply with the certificate requirements and
performance standards;
(4) Failed to comply with reasonable requests by HCFA for any
information
[[Page 937]]
or work on materials that HCFA concludes is necessary to determine the
laboratory's continued eligibility for its CLIA certificate or continued
compliance with performance standards set by HCFA;
(5) Refused a reasonable request by HCFA or its agent for permission
to inspect the laboratory and its operation and pertinent records during
the hours that the laboratory is in operation;
(6) Violated or aided and abetted in the violation of any provisions
of CLIA and its implementing regulations;
(7) Failed to comply with an alternative sanction imposed under this
subpart; or
(8) Within the preceding two-year period, owned or operated a
laboratory that had its CLIA certificate revoked. (This provision
applies only to the owner or operator, not to all of the laboratory's
employees.)
(b) Adverse action based on improper referrals in proficiency
testing. If HCFA determines that a laboratory has intentionally referred
its proficiency testing samples to another laboratory for analysis, HCFA
revokes the laboratory's CLIA certificate for at least one year, and may
also impose a civil money penalty.
(c) Adverse action based on exclusion from Medicare. If the OIG
excludes a laboratory from participation in Medicare, HCFA suspends the
laboratory's CLIA certificate for the period during which the laboratory
is excluded.
(d) Procedures for suspension or limitation--(1) Basic rule. Except
as provided in paragraph (d)(2) of this section, HCFA does not suspend
or limit a CLIA certificate until after an ALJ hearing decision (as
provided in Sec. 493.1844) that upholds suspension or limitation.
(2) Exceptions. HCFA may suspend or limit a CLIA certificate before
the ALJ hearing in any of the following circumstances:
(i) The laboratory's deficiencies pose immediate jeopardy.
(ii) The laboratory has refused a reasonable request for information
or work on materials.
(iii) The laboratory has refused permission for HCFA or a HCFA agent
to inspect the laboratory or its operation.
(e) Procedures for revocation. (1) HCFA does not revoke any type of
CLIA certificate until after an ALJ hearing that upholds revocation.
(2) HCFA may revoke a CLIA certificate after the hearing decision
even if it had not previously suspended or limited that certificate.
(f) Notice to the OIG. HCFA notifies the OIG of any violations under
paragraphs (a)(1), (a)(2), (a)(6), and (b) of this section within 30
days of the determination of the violation.
Sec. 493.1842 Cancellation of Medicare approval.
(a) Basis for cancellation. (1) HCFA always cancels a laboratory's
approval to receive Medicare payment for its services if HCFA suspends
or revokes the laboratory's CLIA certificate.
(2) HCFA may cancel the laboratory's approval under any of the
following circumstances:
(i) The laboratory is out of compliance with a condition level
requirement.
(ii) The laboratory fails to submit a plan of correction
satisfactory to HCFA.
(iii) The laboratory fails to correct all its deficiencies within
the time frames specified in the plan of correction.
(b) Notice and opportunity to respond. Before canceling a
laboratory's approval to receive Medicare payment for its services, HCFA
gives the laboratory--
(1) Written notice of the rationale for, effective date, and effect
of, cancellation;
(2) Opportunity to submit written evidence or other information
against cancellation of the laboratory's approval.
This sanction may be imposed before the hearing that may be
requested by a laboratory, in accordance with the appeals procedures set
forth in Sec. 493.1844.
(c) Effect of cancellation. Cancellation of Medicare approval
terminates any Medicare payment sanctions regardless of the time frames
originally specified.
Sec. 493.1844 Appeals procedures.
(a) General rules. (1) The provisions of this section apply to all
laboratories and prospective laboratories that are
[[Page 938]]
dissatisfied with any initial determination under paragraph (b) of this
section.
(2) Hearings are conducted in accordance with procedures set forth
in subpart D of part 498 of this chapter, except that the authority to
conduct hearings and issue decisions may be exercised by ALJs assigned
to, or detailed to, the Departmental Appeals Board.
(3) Any party dissatisfied with a hearing decision is entitled to
request review of the decision as specified in subpart E of part 498 of
this chapter, except that the authority to review the decision may be
exercised by the Departmental Appeals Board.
(4) When more than one of the actions specified in paragraph (b) of
this section are carried out concurrently, the laboratory has a right to
only one hearing on all matters at issue.
(b) Actions that are initial determinations. The following actions
are initial determinations and therefore are subject to appeal in
accordance with this section:
(1) The suspension, limitation, or revocation of the laboratory's
CLIA certificate by HCFA because of noncompliance with CLIA
requirements.
(2) The denial of a CLIA certificate.
(3) The imposition of alternative sanctions under this subpart (but
not the determination as to which alternative sanction or sanctions to
impose).
(4) The denial or cancellation of the laboratory's approval to
receive Medicare payment for its services.
(c) Actions that are not initial determinations. Actions that are
not listed in paragraph (b) of this section are not initial
determinations and therefore are not subject to appeal under this
section. They include, but are not necessarily limited to, the
following:
(1) The finding that a laboratory accredited by a HCFA-approved
accreditation organization is no longer deemed to meet the conditions
set forth in subparts H, J, K, M, P, and Q of this part. However, the
suspension, limitation or revocation of a certificate of accreditation
is an initial determination and is appealable.
(2) The finding that a laboratory determined to be in compliance
with condition-level requirements but has deficiencies that are not at
the condition level.
(3) The determination not to reinstate a suspended CLIA certificate
because the reason for the suspension has not been removed or there is
insufficient assurance that the reason will not recur.
(4) The determination as to which alternative sanction or sanctions
to impose, including the amount of a civil money penalty to impose per
day or per violation.
(5) The denial of approval for Medicare payment for the services of
a laboratory that does not have in effect a valid CLIA certificate.
(6) The determination that a laboratory's deficiencies pose
immediate jeopardy.
(7) The amount of the civil money penalty assessed per day or for
each violation of Federal requirements.
(d) Effect of pending appeals--(1) Alternative sanctions. The
effective date of an alternative sanction (other than a civil money
penalty) is not delayed because the laboratory has appealed and the
hearing or the hearing decision is pending.
(2) Suspension, limitation, or revocation of a laboratory's CLIA
certificate--(i) General rule. Except as provided in paragraph
(d)(2)(ii) of this section, suspension, limitation, or revocation of a
CLIA certificate is not effective until after a hearing decision by an
ALJ is issued.
(ii) Exceptions. (A) If HCFA determines that conditions at a
laboratory pose immediate jeopardy, the effective date of the suspension
or limitation of a CLIA certificate is not delayed because the
laboratory has appealed and the hearing or the hearing decision is
pending.
(B) HCFA may suspend or limit a laboratory's CLIA certificate before
an ALJ hearing or hearing decision if the laboratory has refused a
reasonable request for information (including but not limited to billing
information), or for work on materials, or has refused permission for
HCFA or a HCFA agent to inspect the laboratory or its operation.
(3) Cancellation of Medicare approval. The effective date of the
cancellation
[[Page 939]]
of a laboratory's approval to receive Medicare payment for its services
is not delayed because the laboratory has appealed and the hearing or
hearing decision is pending.
(4) Effect of ALJ decision. (i) An ALJ decision is final unless, as
provided in paragraph (a)(3) of this section, one of the parties
requests review by the Departmental Appeals Board within 60 days, and
the Board reviews the case and issues a revised decision.
(ii) If an ALJ decision upholds a suspension imposed because of
immediate jeopardy, that suspension becomes a revocation.
(e) Appeal rights for prospective laboratories--(1) Reconsideration.
Any prospective laboratory dissatisfied with a denial of a CLIA
certificate, or of approval for Medicare payment for its services, may
initiate the appeals process by requesting reconsideration in accordance
with Secs. 498.22 through 498.25 of this chapter.
(2) Notice of reopening. If HCFA reopens an initial or reconsidered
determination, HCFA gives the prospective laboratory notice of the
revised determination in accordance with Sec. 498.32 of this chapter.
(3) ALJ hearing. Any prospective laboratory dissatisfied with a
reconsidered determination under paragraph (e)(1) of this section or a
revised reconsidered determination under Sec. 498.30 of this chapter is
entitled to a hearing before an ALJ, as specified in paragraph (a)(2) of
this section.
(4) Review of ALJ hearing decisions. Any prospective laboratory that
is dissatisfied with an ALJ's hearing decision or dismissal of a request
for hearing may file a written request for review by the Departmental
Appeals Board as provided in paragraph (a)(3) of this section.
(f) Appeal rights of laboratories--(1) ALJ hearing. Any laboratory
dissatisfied with the suspension, limitation, or revocation of its CLIA
certificate, with the imposition of an alternative sanction under this
subpart, or with cancellation of the approval to receive Medicare
payment for its services, is entitled to a hearing before an ALJ as
specified in paragraph (a)(2) of this section and has 60 days from the
notice of sanction to request a hearing.
(2) Review of ALJ hearing decisions. Any laboratory that is
dissatisfied with an ALJ's hearing decision or dismissal of a request
for hearing may file a written request for review by the Departmental
Appeals Board, as provided in paragraph (a)(3) of this section.
(3) Judicial review. Any laboratory dissatisfied with the decision
to impose a civil money penalty or to suspend, limit, or revoke its CLIA
certificate may, within 60 days after the decision becomes final, file
with the U.S. Court of Appeals of the circuit in which the laboratory
has its principal place of business, a petition for judicial review.
(g) Notice of adverse action. (1) If HCFA suspends, limits, or
revokes a laboratory's CLIA certificate or cancels the approval to
receive Medicare payment for its services, HCFA gives notice to the
laboratory, and may give notice to physicians, providers, suppliers, and
other laboratory clients, according to the procedures set forth at
Sec. 493.1832. In addition, HCFA notifies the general public each time
one of these principal sanctions is imposed.
(2) The notice to the laboratory--
(i) Sets forth the reasons for the adverse action, the effective
date and effect of that action, and the appeal rights if any; and
(ii) When the certificate is limited, specifies the specialties or
subspecialties of tests that the laboratory is no longer authorized to
perform, and that are no longer covered under Medicare.
(3) The notice to other entities includes the same information
except the information about the laboratory's appeal rights.
(h) Effective date of adverse action. (1) When the laboratory's
deficiencies pose immediate jeopardy, the effective date of the adverse
action is at least 5 days after the date of the notice.
(2) When HCFA determines that the laboratory's deficiencies do not
pose immediate jeopardy, the effective date of the adverse action is at
least 15 days after the date of the notice.
[57 FR 7237, Feb. 28, 1992; 57 FR 35761, Aug. 11, 1992]
Sec. 493.1846 Civil action.
If HCFA has reason to believe that continuation of the activities of
any laboratory, including a State-exempt
[[Page 940]]
laboratory, would constitute a significant hazard to the public health,
HCFA may bring suit in a U.S. District Court to enjoin continuation of
the specific activity that is causing the hazard or to enjoin the
continued operation of the laboratory if HCFA deems it necessary. Upon
proper showing, the court shall issue a temporary injunction or
restraining order without bond against continuation of the activity.
Sec. 493.1850 Laboratory registry.
(a) Once a year HCFA makes available to physicians and to the
general public specific information (including information provided to
HCFA by the OIG) that is useful in evaluating the performance of
laboratories, including the following:
(1) A list of laboratories that have been convicted, under Federal
or State laws relating to fraud and abuse, false billing, or kickbacks.
(2) A list of laboratories that have had their CLIA certificates
suspended, limited, or revoked, and the reason for the adverse actions.
(3) A list of persons who have been convicted of violating CLIA
requirements, as specified in section 353(1) of the PHS Act, together
with the circumstances of each case and the penalties imposed.
(4) A list of laboratories on which alternative sanctions have been
imposed, showing--
(i) The effective date of the sanctions;
(ii) The reasons for imposing them;
(iii) Any corrective action taken by the laboratory; and
(iv) If the laboratory has achieved compliance, the verified date of
compliance.
(5) A list of laboratories whose accreditation has been withdrawn or
revoked and the reasons for the withdrawal or revocation.
(6) All appeals and hearing decisions.
(7) A list of laboratories against which HCFA has brought suit under
Sec. 493.1846 and the reasons for those actions.
(8) A list of laboratories that have been excluded from
participation in Medicare or Medicaid and the reasons for the exclusion.
(b) The laboratory registry is compiled for the calendar year
preceding the date the information is made available and includes
appropriate explanatory information to aid in the interpretation of the
data. It also contains corrections of any erroneous statements or
information that appeared in the previous registry.
Subpart S [Reserved]
Subpart T--Consultations
Source: 57 FR 7185, Feb. 28, 1992, unless otherwise noted.
Sec. 493.2001 Establishment and function of the Clinical Laboratory
Improvement Advisory Committee.
(a) HHS will establish a Clinical Laboratory Improvement Advisory
Committee to advise and make recommendations on technical and scientific
aspects of the provisions of this part 493.
(b) The Clinical Laboratory Improvement Advisory Committee will be
comprised of individuals involved in the provision of laboratory
services, utilization of laboratory services, development of laboratory
testing or methodology, and others as approved by HHS.
(c) HHS will designate specialized subcommittees as necessary.
(d) The Clinical Laboratory Improvement Advisory Committee or any
designated subcommittees will meet as needed, but not less than once
each year.
(e) The Clinical Laboratory Improvement Advisory Committee or
subcommittee, at the request of HHS, will review and make
recommendations concerning:
(1) Criteria for categorizing tests and examinations of moderate
complexity (including the subcategory) and high complexity;
(2) Determination of waived tests;
(3) Personnel standards;
(4) Patient test management, quality control, quality assurance
standards;
(5) Proficiency testing standards;
(6) Applicability to the standards of new technology; and
(7) Other issues relevant to part 493, if requested by HHS.
[[Page 941]]
(f) HHS will be responsible for providing the data and information,
as necessary, to the members of the Clinical Laboratory Improvement
Advisory Committee.
[57 FR 7185, Feb. 28, 1992, as amended at 58 FR 5237, Jan. 19, 1993; 60
FR 20051, Apr. 24, 1995]
PART 494 [RESERVED]