[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493]
[Page 967-1087]
TITLE 42--PUBLIC HEALTH
CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF
HEALTH AND HUMAN SERVICES (CONTINUED)
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.
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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.
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 CMS 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 Nonwaived Testing
493.801 Condition: Enrollment and testing of samples.
493.803 Condition: Successful participation.
493.807 Condition: Reinstatement of laboratories performing nonwaived
testing.
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.
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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 Nonwaived Testing
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_Facility Administration for Nonwaived Testing
493.1100 Condition: Facility administration.
493.1101 Standard: Facilities.
493.1103 Standard: Requirements for transfusion services.
493.1105 Standard: Retention requirements.
Subpart K_Quality System for Nonwaived Testing
493.1200 Introduction.
493.1201 Condition: Bacteriology.
493.1202 Condition: Mycobacteriology.
493.1203 Condition: Mycology.
493.1204 Condition: Parasitology.
493.1205 Condition: Virology.
493.1207 Condition: Syphilis serology.
493.1208 Condition: General immunology.
493.1210 Condition: Routine chemistry.
493.1211 Condition: Urinalysis.
493.1212 Condition: Endocrinology.
493.1213 Condition: Toxicology.
493.1215 Condition: Hematology.
493.1217 Condition: Immunohematology.
493.1219 Condition: Histopathology.
493.1220 Condition: Oral pathology.
493.1221 Condition: Cytology.
493.1225 Condition: Clinical cytogenetics.
493.1226 Condition: Radiobioassay.
493.1227 Condition: Histocompatibility.
General Laboratory Systems
493.1230 Condition: General laboratory systems.
493.1231 Standard: Confidentiality of patient information.
493.1232 Standard: Specimen identification and integrity.
493.1233 Standard: Complaint investigations.
493.1234 Standard: Communications.
493.1235 Standard: Personnel competency assessment policies.
493.1236 Standard: Evaluation of proficiency testing performance.
493.1239 Standard: General laboratory systems quality assessment.
Preanalytic Systems
493.1240 Condition: Preanalytic systems.
493.1241 Standard: Test request.
493.1242 Standard: Specimen submission, handling, and referral.
493.1249 Standard: Preanalytic systems quality assessment.
Analytic Systems
493.1250 Condition: Analytic systems.
493.1251 Standard: Procedure manual.
493.1252 Standard: Test systems, equipment, instruments, reagents,
materials, and supplies.
493.1253 Standard: Establishment and verification of performance
specifications.
493.1254 Standard: Maintenance and function checks.
493.1255 Standard: Calibration and calibration verification procedures.
493.1256 Standard: Control procedures.
493.1261 Standard: Bacteriology.
493.1262 Standard: Mycobacteriology.
493.1263 Standard: Mycology.
493.1264 Standard: Parasitology.
493.1265 Standard: Virology.
493.1267 Standard: Routine chemistry.
493.1269 Standard: Hematology.
493.1271 Standard: Immunohematology.
493.1273 Standard: Histopathology.
493.1274 Standard: Cytology.
493.1276 Standard: Clinical cytogenetics.
493.1278 Standard: Histocompatibility.
493.1281 Standard: Comparison of test results.
493.1282 Standard: Corrective actions.
493.1283 Standard: Test records.
493.1289 Standard: Analytic systems quality assessment.
Postanalytic Systems
493.1290 Condition: Postanalytic systems.
493.1291 Standard: Test report.
493.1299 Standard: Postanalytic systems quality assessment.
[[Page 970]]
Subpart L [Reserved]
Subpart M_Personnel for Nonwaived 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.
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-P [Reserved]
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.
[[Page 971]]
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.
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 CMS in accordance with this part;
Adverse action means the imposition of a principal or alternative
sanction by CMS.
ALJ stands for Administrative Law Judge.
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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 CMS'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 CMS 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.
Calibration means a process of testing and adjusting an instrument
or test system to establish a correlation between the measurement
response and the concentration or amount of the substance that is being
measured by the test procedure.
Calibration verification means the assaying of materials of known
concentration in the same manner as patient samples to substantiate the
instrument or test system's calibration throughout the reportable range
for patient test results.
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 CMS 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 CMS (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 CMS 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 CMS 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 CMS in accordance with subpart E of this part.
Condition level deficiency means noncompliance with one or more
condition level requirements.
[[Page 973]]
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 CMS, 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 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.
CMS agent means an entity with which CMS 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 CMS 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 CMS agent.
FDA-cleared or approved test system means a test system cleared or
approved by the FDA through the premarket notification (510(k)) or
premarket approval (PMA) process for in-vitro diagnostic use. Unless
otherwise stated, this includes test systems exempt from FDA premarket
clearance or approval.
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.
Nonwaived test means any test system, assay, or examination that has
not been found to meet the statutory
[[Page 974]]
criteria specified at section 353(d)(3) of the Public Health Service
Act.
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 CMS 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 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
CMS, the State survey agency or other CMS 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, CMS or other CMS 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. CMS 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).
Reportable range means the span of test result values over which the
laboratory can establish or verify the accuracy of the instrument or
test system measurement response.
Sample in proficiency testing means the material contained in a
vial, on a
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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 CMS 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 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.
Test system means the instructions and all of the instrumentation,
equipment, reagents, and supplies needed to perform an assay or
examination and generate test results.
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
CMS conducts validation inspections and evaluates the results of the
most recent surveys performed by an accreditation organization or State
laboratory program.
Waived test means a test system, assay, or examination that HHS has
determined meets the CLIA statutory criteria as specified for waiver
under
[[Page 976]]
section 353(d)(3) of the Public Health Service Act.
[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; 68 FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22,
2003]
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 Substance Abuse and Mental Health
Services Administration (SAMHSA), in which drug testing is performed
which meets SAMHSA guidelines and regulations. However, all other
testing conducted by a SAMHSA-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; 68 FR 3702, Jan. 24, 2003]
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.
(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
[[Page 977]]
(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.
(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.
[[Page 978]]
(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 CMS and CDC
of the device/test category. FDA will consult with CDC concerning test
categorization in the following three situations:
(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, CMS, 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
[[Page 979]]
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.
(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, and M of this part.
(2) Be subject to inspection as specified under subpart Q of this
part.
[60 FR 20044, Apr. 24, 1995; 68 FR 50723, Aug. 22, 2003]
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, and Q of
[[Page 980]]
this part. Under a registration certificate or certificate of
compliance, laboratories also performing PPM procedures must meet the
inspection requirements at Sec. Sec. 493.1773 and 493.1777.
(c) If the laboratory also performs waived tests, compliance with
subparts H, J, K, and M of this part is not applicable to the waived
tests. However, the laboratory must comply with the requirements in
Sec. Sec. 493.15(e), 493.1773, and 493.1775.
[60 FR 20044, Apr. 24, 1995, as amended at 68 FR 3702, Jan. 24, 2003; 68
FR 50723, Aug. 22, 2003]
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, and Q of this part.
(c) If the laboratory also performs tests of moderate complexity,
the applicable requirements of subparts H, J, K, M, 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. Sec. 493.1773 and 493.1777.
(d) If the laboratory also performs waived tests, the requirements
of subparts H, J, K, and M are not applicable to the waived tests.
However, the laboratory must comply with the requirements in Sec. Sec.
493.15(e), 493.1773, and 493.1775.
[57 FR 7139, Feb. 28, 1992, as amended at 60 FR 20044, Apr. 24, 1995; 68
FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003]
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 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
[[Page 981]]
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 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 Sec. Sec. 493.35 and 493.37.
[[Page 982]]
(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 nonwaived testing 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.
(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; 68 FR 3702, Jan.
24, 2003]
[[Page 983]]
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, 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.
(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; 68 FR 3702, Jan. 24, 2003]
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
[[Page 984]]
(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, and M of this part; and
(3) Inspection only under the circumstances specified under
Sec. Sec. 493.1773 and 493.1775, 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; 68
FR 3702, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003]
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 Sec. Sec. 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, 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 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
[[Page 985]]
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, as amended at 68 FR 3702, Jan. 24, 2003]
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 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.
[[Page 986]]
(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
(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
[[Page 987]]
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.
(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
[[Page 988]]
(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.
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. CMS 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.
[[Page 989]]
(2) The accreditation program or the State licensure program meets
the requirements of this subpart and is approved by CMS.
(3) The laboratory authorizes the approved accreditation
organization or State licensure program to release to CMS 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 CMS, 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 CMS or a
CMS 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 CMS 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, CMS 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 CMS,
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 CMS for deeming authority, or a State licensure program
that applies or reapplies to CMS for exemption from CLIA program
requirements of licensed or approved laboratories within the State, must
provide the following information:
(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 CMS-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.
[[Page 990]]
(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) CMS action on an application or reapplication. If CMS receives
an application or reapplication from an accreditation organization, or
State licensure program, CMS takes the following actions:
(1) CMS 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) CMS 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) CMS notifies the accreditation organization or State licensure
program indicating whether CMS approves or denies the request for
deeming authority or exemption, respectively, and the rationale for any
denial.
(c) Duration of approval. CMS 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.
CMS'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 CMS, 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 CMS that requires
it to do the following:
(1) Notify CMS 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 CMS 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 CMS, within 30 days, of all newly--
(i) Accredited laboratories (or laboratories whose areas of
specialty/subspecialty testing have changed); or
(ii) Licensed laboratories, including the specialty/subspecialty
areas of testing.
(4) Notify each accredited or licensed laboratory within 10 days of
CMS's withdrawal of the organization's deeming authority or State's
exemption.
(5) Provide CMS 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 Sec. Sec. 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
[[Page 991]]
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 CMS 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, CMS or a
CMS agent monitors corrections, as authorized at Sec. 493.565(d)).
(7) A demonstration of its ability to provide CMS 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 CMS 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 CMS 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 CMS, which
includes, but is not limited to, the following:
(i) PT results that constitute unsuccessful participation in a CMS-
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 CMS 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 Sec. Sec. 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:
(1) Demonstrate to CMS that it has enforcement authority and
administrative structures and resources adequate to enforce its
laboratory requirements.
(2) Permit CMS or a CMS agent to inspect laboratories in the State.
(3) Require laboratories in the State to submit to inspections by
CMS or a CMS 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 Sec. Sec. 493.645(a) and 493.646(b).
(5) Take appropriate enforcement action against laboratories found
by CMS 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 CMS 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 CMS
through electronic transmission of the following:
[[Page 992]]
(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 CMS 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 CMS determines are necessary for validation and
assessment of the State's inspection process requirements.
(11) Agree to provide CMS 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 CMS not to be in compliance with requirements
comparable to condition-level requirements and report these enforcement
actions to CMS.
(14) If approved, reapply to CMS every 2 years to renew its exempt
status and to renew its agreement to pay the cost of the CMS-
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. CMS 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 CMS 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.
Sec. 493.561 Denial of application or reapplication.
(a) Reconsideration of denial. (1) If CMS denies a request for
approval, an accreditation organization or State licensure program may
request, within 60 days of the notification of denial, that CMS
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 CMS's determination to deny its request
for approval or reapproval, it may not submit a new application until
CMS 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.
[[Page 993]]
(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) CMS or a CMS 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) CMS 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) CMS or a CMS 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 CMS or a CMS 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 CMS or a CMS agent conducts a
validation inspection in response to a substantial allegation of
noncompliance, the inspection focuses on any condition-level requirement
that CMS determines to be related to the allegation.
(2) If CMS or a CMS agent substantiates a deficiency and determines
that the laboratory is out of compliance with any condition-level
requirement, CMS or a CMS agent conducts a full CLIA inspection.
(d) Inspection of operations and offices. As part of the validation
review process, CMS 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 CMS or a CMS 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.
(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 CMS or a CMS agent, on a
confidential basis, a copy of the laboratory's most recent full, and any
subsequent partial inspection.
(b) Authorize CMS or a CMS agent to conduct a validation inspection.
[[Page 994]]
(c) Provide CMS or a CMS agent with access to all facilities,
equipment, materials, records, and information that CMS or a CMS agent
determines have a bearing on whether the laboratory is being operated in
accordance with the requirements of this part, and permit CMS or a CMS
agent to copy material or require the laboratory to submit material.
(d) If the laboratory possesses a valid certificate of
accreditation, authorize CMS or a CMS 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 CMS or a CMS 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) CMS 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, CMS 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 CMS, 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, CMS directs the State to take
appropriate enforcement action.
Sec. 493.571 Disclosure of accreditation, State and CMS validation
inspection results.
(a) Accreditation organization inspection results. CMS 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) CMS validation inspection results. CMS may disclose the results
of all validation inspections conducted by CMS 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, CMS reviews the
equivalency of requirements in the following cases:
(1) When CMS promulgates new condition-level requirements.
[[Page 995]]
(2) When CMS 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 CMS determines an earlier review is
required.
(b) Validation review. Following the end of a validation review
period, CMS 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 CMS, 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. CMS
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 CMS, upon request, with
the reapplication materials CMS requests. CMS establishes a deadline by
which the materials must be submitted.
(d) Notice. (1) CMS 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 CMS 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 CMS's review process on which the final
determination is based and a description of the possible actions, as
specified in Sec. 493.575, that CMS 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.
Sec. 493.575 Removal of deeming authority or CLIA exemption and final
determination review.
(a) CMS review. CMS 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. CMS reviews, as appropriate, the criteria
described in Sec. Sec. 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. CMS reviews, as appropriate, the criteria described in
Sec. Sec. 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 CMS'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
[[Page 996]]
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 CMS or a CMS agent for the following periods:
(i) One year for accreditation organizations.
(ii) Two years for State licensure programs.
(b) CMS action after review. Following the review, CMS may take the
following action:
(1) If CMS determines that the accreditation organization or State
has failed to adopt requirements equal to, or more stringent than, CLIA
requirements, CMS may give a conditional approval for a probationary
period of its deeming authority to an organization 30 days following the
date of CMS's determination, or exempt status to a State within 30 days
of CMS'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 CMS determines that there are widespread or systematic
problems in the organization's or State's inspection process, CMS 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. CMS 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. CMS 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 CMS 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 CMS does not affect or limit the conduct of
any validation inspection.
(f) Federal Register notice. CMS 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.
(g) Withdrawal of approval-effect on laboratory status--(1)
Accredited laboratory. After CMS 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 CMS 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
CMS's approval of the program.
(3) Extension. After CMS withdraws approval of an accreditation
organization or State licensure program, CMS 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 CMS or a CMS agent before the initial 60-day period ends.
(h) Immediate jeopardy to patients. (1) If at any time CMS
determines that the continued approval of deeming authority of any
accreditation organization poses immediate jeopardy to the patients of
the laboratories accredited
[[Page 997]]
by the organization, or continued approval otherwise constitutes a
significant hazard to the public health, CMS may immediately withdraw
the approval of deeming authority for that accreditation organization.
(2) If at any time CMS 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, CMS may immediately withdraw
the approval of that State licensure program.
(i) Failure to pay fees. CMS withdraws the approval of a State
licensure program if the State fails to pay the applicable fees, as
specified in Sec. Sec. 493.645(a) and 493.646(b).
(j) State refusal to take enforcement action. (1) CMS may withdraw
approval of a State licensure program if the State refuses to take
enforcement action against a laboratory in that State when CMS
determines it to be necessary.
(2) A laboratory that is in a State in which CMS 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 CMS 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 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.
[[Page 998]]
(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]
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
[[Page 999]]
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
(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 Clinical 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.
[[Page 1000]]
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; 68 FR 3702, Jan. 24, 2003]
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 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
[[Page 1001]]
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.
(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 Nonwaived Testing
Source: 57 FR 7146, Feb. 28, 1992, unless otherwise noted.
[[Page 1002]]
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 CMS; 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. 493.1236(c)(1).
(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 CMS
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.
(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 CMS 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 CMS 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
[[Page 1003]]
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; 68
FR 3702, Jan. 24, 2003]
Sec. 493.803 Condition: Successful participation.
(a) Each laboratory performing nonwaived testing must successfully
participate in a proficiency testing program approved by CMS, 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, CMS imposes sanctions, as specified in subpart R
of this part.
(c) If a laboratory fails to perform successfully in a CMS-approved
proficiency testing program, for the initial unsuccessful performance,
CMS 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 CMS or a CMS 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; 68 FR 3702, Jan. 24, 2003]
Sec. 493.807 Condition: Reinstatement of laboratories performing
nonwaived testing.
(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 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 CMS 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--
[[Page 1004]]
(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 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
[[Page 1005]]
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.
(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.
[[Page 1006]]
(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.
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.
[[Page 1007]]
(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 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
[[Page 1008]]
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 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
[[Page 1009]]
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 CMS 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 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-
[[Page 1010]]
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, CMS 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;
(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
[[Page 1011]]
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
(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
[[Page 1012]]
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 Nonwaived Testing
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 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 Sec. Sec. 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
[[Page 1013]]
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
Sec. Sec. 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 CMS 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 HHS to conduct an annual
evaluation to determine whether the proficiency testing program
continues to meet the requirements of Sec. Sec. 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 Sec. Sec. 493.901 through 493.959 for
approval of the proficiency testing program, CMS 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 Sec. Sec. 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
[[Page 1014]]
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 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
[[Page 1015]]
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 80 percent of ten or more referee laboratories or 80
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 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)x100=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
Sec. Sec. 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 2/3x100=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
[[Page 1016]]
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; 68
FR 3702, Jan. 24, 2003]
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.
(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
[[Page 1017]]
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 80 percent of ten or more referee laboratories or 80 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)x100=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
two of the three antimycobacterial agents, the laboratory's grade would
be \2/3\x100=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; 68
FR 3702, Jan. 24, 2003]
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;
[[Page 1018]]
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 80 percent of ten or more referee laboratories or 80
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 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; 68
FR 3702, Jan. 24, 2003]
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
[[Page 1019]]
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 either 80 percent
of ten or more referee laboratories or 80 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)x100=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.
[57 FR 7151, Feb. 28, 1992, as amended at 68 FR 3702, Jan. 24, 2003]
Sec. 493.919 Virology.
(a) Types of services offered by laboratories. In virology, there
are two types
[[Page 1020]]
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 80 percent of
ten or more referee laboratories or 80 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 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)x100=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.
[57 FR 7151, Feb. 28, 1992, as amended at 68 FR 3702, Jan. 24, 2003]
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
Sec. Sec. 493.923 and 493.927.
[[Page 1021]]
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 80 percent of ten or more referee laboratories or 80 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 <plus-minus> 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
------------------------------------------- x100=Testing event score
Total number of all challenges
------------------------------------------------------------------------
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68
FR 3702, Jan. 24, 2003]
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
[[Page 1022]]
analytes, the program must compare the laboratory's response for each
analyte with the response that reflects agreement of either 80 percent
of ten or more referee laboratories or 80 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<ls-
thn-eq>3 SD.
Alpha-fetoprotein (tumor marker).......... Target value <plus-minus<ls-
thn-eq>3 SD.
Antinuclear antibody...................... Target value <plus-minus<ls-
thn-eq>2 dilutions or
positive or negative.
Antistreptolysin O........................ Target value <plus-minus<ls-
thn-eq>2 dilution or
positive or negative.
Anti-Human Immunodeficiency virus......... Reactive or nonreactive.
Complement C3............................. Target value <plus-minus<ls-
thn-eq>3 SD.
Complement C4............................. Target value <plus-minus<ls-
thn-eq>3 SD.
Hepatitis (HBsAg, anti-HBc, HBeAg)........ Reactive (positive) or
nonreactive (negative).
IgA....................................... Target value <plus-minus<ls-
thn-eq>3 SD.
IgE....................................... Target value <plus-minus<ls-
thn-eq>3 SD.
IgG....................................... Target value <plus-minus<ls-
thn-eq>25%.
IgM....................................... Target value <plus-minus<ls-
thn-eq>3 SD.
Infectious mononucleosis.................. Target value <plus-minus<ls-
thn-eq>2 dilutions or
positive or negative.
Rheumatoid factor......................... Target value <plus-minus<ls-
thn-eq>2 dilutions or
positive or negative.
Rubella................................... Target value <plus-minus<ls-
thn-eq>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 x100=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
------------------------------------------- x100=Testing event score
Total number of all challenges
------------------------------------------------------------------------
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68
FR 3702, Jan. 24, 2003]
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 Sec. Sec. 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
[[Page 1023]]
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 80 percent of ten or more
referee laboratories or 80 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<ls-
thn-eq>20%.
Albumin................................... Target value <plus-minus<ls-
thn-eq>10%.
Alkaline phosphatase...................... Target value <plus-minus<ls-
thn-eq>30%.
Amylase................................... Target value <plus-minus<ls-
thn-eq>30%.
Aspartate aminotransferase (AST/SGOT)..... Target value <plus-minus<ls-
thn-eq>20%.
Bilirubin, total.......................... Target value <plus-minus<ls-
thn-eq>0.4 mg/dL or <plus-
minus<ls-thn-eq>20%
(greater).
Blood gas pO2............................. Target value <plus-minus<ls-
thn-eq>3 SD.
pCO2...................................... Target value <plus-minus<ls-
thn-eq>5 mm Hg or <plus-
minus<ls-thn-eq>8%
(greater).
pH........................................ Target value <plus-minus<ls-
thn-eq>0.04.
Calcium, total............................ Target value <plus-minus<ls-
thn-eq>1.0 mg/dL.
Chloride.................................. Target value <plus-minus<ls-
thn-eq>5%.
Cholesterol, total........................ Target value <plus-minus<ls-
thn-eq>10%.
Cholesterol, high density lipoprotein..... Target value <plus-minus<ls-
thn-eq>30%.
Creatine kinase........................... Target value <plus-minus<ls-
thn-eq>30%.
Creatine kinase isoenzymes................ MB elevated (presence or
absence) or Target value
<plus-minus<ls-thn-eq>3SD.
Creatinine................................ Target value <plus-minus<ls-
thn-eq>0.3 mg/dL or <plus-
minus<ls-thn-eq>15%
(greater).
Glucose (excluding glucose performed on Target value <plus-minus<ls-
monitoring devices cleared by FDA for thn-eq>6 mg/dl or <plus-
home use. minus<ls-thn-eq>10%
(greater).
Iron, total............................... Target value <plus-minus<ls-
thn-eq>20%.
Lactate dehydrogenase (LDH)............... Target value <plus-minus<ls-
thn-eq>20%.
LDH isoenzymes............................ LDH1/LDH2 (+ or -) or Target
value <plus-minus<ls-thn-
eq> 30%.
Magnesium................................. Target value <plus-minus<ls-
thn-eq>25%.
Potassium................................. Target value <plus-minus<ls-
thn-eq>0.5 mmol/L.
Sodium.................................... Target value <plus-minus<ls-
thn-eq>4 mmol/L.
Total Protein............................. Target value <plus-minus<ls-
thn-eq>10%.
Triglycerides............................. Target value <plus-minus<ls-
thn-eq>25%.
Urea nitrogen............................. Target value <plus-minus<ls-
thn-eq>2 mg/dL or <plus-
minus<ls-thn-eq>9%
(greater).
Uric acid................................. Target value <plus-minus<ls-
thn-eq>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 x100=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:
[[Page 1024]]
Number of acceptable responses for all
challenges
------------------------------------------- x100=Testing event score
Total number of all challenges
------------------------------------------------------------------------
[57 FR 7151, Feb. 28, 1992, as amended at 68 FR 3702, Jan. 24, 2003]
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 80 percent of ten or more
referee laboratories or 80 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.
Criteria for Acceptable Performance
The criteria for acceptable performance are--
------------------------------------------------------------------------
Criteria for acceptable
Analyte or test performance
------------------------------------------------------------------------
Cortisol.................................. Target value <plus-minus<ls-
thn-eq>25%.
Free Thyroxine............................ Target value <plus-minus<ls-
thn-eq>3 SD.
Human Chorionic Gonadotropin (excluding Target value <plus-minus<ls-
urine pregnancy tests done by visual thn-eq>3 SD positive or
color comparison categorized as waived negative.
tests).
T3 Uptake................................. Target value <plus-minus<ls-
thn-eq>3 SD.
Triiodothyronine.......................... Target value <plus-minus<ls-
thn-eq>3 SD.
Thyroid-stimulating hormone............... Target value <plus-minus<ls-
thn-eq>3 SD.
Thyroxine................................. Target value <plus-minus<ls-
thn-eq>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 x100=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:
[[Page 1025]]
Number of acceptable responses for all
challenges
------------------------------------------- x100=Testing event score
Total number of all challenges
------------------------------------------------------------------------
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68
FR 3702, Jan. 24, 2003]
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 80 percent of ten or more referee laboratories or 80
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<ls-
thn-eq> 25%.
Blood lead................................ Target Value <plus-minus<ls-
thn-eq>10% or 4 mcg/dL
(greater).
Carbamazepine............................. Target Value <plus-minus<ls-
thn-eq> 25%.
Digoxin................................... Target Value <plus-minus<ls-
thn-eq> 20% or <plus-
minus<ls-thn-eq> 0.2 ng/mL
(greater).
Ethosuximide.............................. Target Value <plus-minus<ls-
thn-eq> 20%.
Gentamicin................................ Target Value <plus-minus<ls-
thn-eq> 25%.
Lithium................................... Target Value <plus-minus<ls-
thn-eq> 0.3 mmol/L or <plus-
minus<ls-thn-eq> 20%
(greater).
Phenobarbital............................. Target Value <plus-minus<ls-
thn-eq> 20%
Phenytoin................................. Target Value <plus-minus<ls-
thn-eq> 25%.
Primidone................................. Target Value <plus-minus<ls-
thn-eq> 25%.
Procainamide (and metabolite)............. Target Value <plus-minus<ls-
thn-eq> 25%.
Quinidine................................. Target Value <plus-minus<ls-
thn-eq> 25%.
Tobramycin................................ Target Value <plus-minus<ls-
thn-eq> 25%.
Theophylline.............................. Target Value <plus-minus<ls-
thn-eq> 25%.
Valproic Acid............................. Target Value <plus-minus<ls-
thn-eq> 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 x100=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
------------------------------------------- x100=Testing event score
Total number of all challenges
------------------------------------------------------------------------
[[Page 1026]]
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68
FR 3702, Jan. 24, 2003]
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 80 percent of ten or more
referee laboratories or 80 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 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 <plus-minus<ls-thn-
eq>3SD based on the
percentage of different
types of white blood cells
in the samples.
Erythrocyte count......................... Target <plus-minus<ls-thn-
eq>6%.
Hematocrit (Excluding spun hematocrits)... Target <plus-minus<ls-thn-
eq>6%.
Hemoglobin................................ Target <plus-minus<ls-thn-
eq>7%.
Leukocyte count........................... Target <plus-minus<ls-thn-
eq>15%.
Platelet count............................ Target <plus-minus<ls-thn-
eq>25%.
Fibrinogen................................ Target <plus-minus<ls-thn-
eq>20%.
Partial thromboplastin time............... Target <plus-minus<ls-thn-
eq>15%.
Prothrombin time.......................... Target <plus-minus<ls-thn-
eq>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:
[[Page 1027]]
Number of acceptable responses for the
analyte x100=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
------------------------------------------- x100=Testing event score
Total number of all challenges
------------------------------------------------------------------------
[57 FR 7151, Feb. 28, 1992, as amended at 58 FR 5229, Jan. 19, 1993; 68
FR 3702, Jan. 24, 2003]
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. Sec.
493.1105(a)(7)(i)(A) and 493.1274(f)(2). 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 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 Sec. Sec. 493.1469 or 493.1483 or functioning as a
[[Page 1028]]
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 intra
epithelial 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
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 Sec. Sec.
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
[[Page 1029]]
(b)(3)(ii)(A) of this section for a description of the response
categories.) For cytotechnologists qualified under Sec. Sec. 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; 68
FR 3702, Jan. 24, 2003]
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 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 analytex100=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:
[[Page 1030]]
Number of acceptable responses for all challengesx100=Testing event
score
-------------------------------------------------------------------------
Total number of all challenges
-------------------------------------------------------------------------
Subpart J_Facility Administration for Nonwaived Testing
Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.
Sec. 493.1100 Condition: Facility administration.
Each laboratory that performs nonwaived testing must meet the
applicable requirements under Sec. Sec. 493.1101 through 493.1105,
unless HHS approves a procedure that provides equivalent quality testing
as specified in Appendix C of the State Operations Manual (CMS Pub. 7).
Sec. 493.1101 Standard: Facilities.
(a) The laboratory must be constructed, arranged, and maintained to
ensure the following:
(1) The space, ventilation, and utilities necessary for conducting
all phases of the testing process.
(2) Contamination of patient specimens, equipment, instruments,
reagents, materials, and supplies is minimized.
(3) Molecular amplification procedures that are not contained in
closed systems have a uni-directional workflow. This must include
separate areas for specimen preparation, amplification and product
detection, and, as applicable, reagent preparation.
(b) The laboratory must have appropriate and sufficient equipment,
instruments, reagents, materials, and supplies for the type and volume
of testing it performs.
(c) The laboratory must be in compliance with applicable Federal,
State, and local laboratory requirements.
(d) Safety procedures must be established, accessible, and observed
to ensure protection from physical, chemical, biochemical, and
electrical hazards, and biohazardous materials.
(e) Records and, as applicable, slides, blocks, and tissues must be
maintained and stored under conditions that ensure proper preservation.
Sec. 493.1103 Standard: Requirements for transfusion services.
A facility that provides transfusion services must meet all of the
requirements of this section and document all transfusion-related
activities.
(a) Arrangement for services. The facility must have a transfusion
service agreement reviewed and approved by the responsible party(ies)
that govern the procurement, transfer, and availability of blood and
blood products.
(b) Provision of testing. The facility must provide prompt ABO
grouping, D(Rho) typing, unexpected antibody detection, compatibility
testing, and laboratory investigation of transfusion reactions on a
continuous basis through a CLIA-certified laboratory or a laboratory
meeting equivalent requirements as determined by CMS.
(c) Blood and blood products storage and distribution. (1) If a
facility stores or maintains blood or blood products for transfusion
outside of a monitored refrigerator, the facility must ensure the
storage conditions, including temperature, are appropriate to prevent
deterioration of the blood or blood product.
(2) The facility must establish and follow policies to ensure
positive identification of a blood or blood product recipient.
(d) Investigation of transfusion reactions. The facility must have
procedures for preventing transfusion reactions and when necessary,
promptly identify, investigate, and report blood and blood product
transfusion reactions to the laboratory and, as appropriate, to Federal
and State authorities.
Sec. 493.1105 Standard: Retention requirements.
(a) The laboratory must retain its records and, as applicable,
slides, blocks, and tissues as follows:
(1) Test requisitions and authorizations. Retain records of test
requisitions and test authorizations, including the patient's chart or
medical record if used as the test requisition or authorization, for at
least 2 years.
(2) Test procedures. Retain a copy of each test procedure for at
least 2 years
[[Page 1031]]
after a procedure has been discontinued. Each test procedure must
include the dates of initial use and discontinuance.
(3) Analytic systems records. Retain quality control and patient
test records (including instrument printouts, if applicable) and records
documenting all analytic systems activities specified in Sec. Sec.
493.1252 through 493.1289 for at least 2 years. In addition, retain the
following:
(i) Records of test system performance specifications that the
laboratory establishes or verifies under Sec. 493.1253 for the period
of time the laboratory uses the test system but no less than 2 years.
(ii) Immunohematology records, blood and blood product records, and
transfusion records as specified in 21 CFR 606.160(b)(3)(ii),
(b)(3)(iv), (b)(3)(v) and (d).
(4) Proficiency testing records. Retain all proficiency testing
records for at least 2 years.
(5) Quality system assessment records. Retain all laboratory quality
systems assessment records for at least 2 years.
(6) Test reports. Retain or be able to retrieve a copy of the
original report (including final, preliminary, and corrected reports) at
least 2 years after the date of reporting. In addition, retain the
following:
(i) Immunohematology reports as specified in 21 CFR 606.160(d).
(ii) Pathology test reports for at least 10 years after the date of
reporting.
(7) Slide, block, and tissue retention--(i) Slides. (A) Retain
cytology slide preparations for at least 5 years from the date of
examination (see Sec. 493.1274(f) for proficiency testing exception).
(B) Retain histopathology slides for at least 10 years from the date
of examination.
(ii) Blocks. Retain pathology specimen blocks for at least 2 years
from the date of examination.
(iii) Tissue. Preserve remnants of tissue for pathology examination
until a diagnosis is made on the specimen.
(b) If the laboratory ceases operation, the laboratory must make
provisions to ensure that all records and, as applicable, slides,
blocks, and tissue are retained and available for the time frames
specified in this section.
[68 FR 3703, Jan. 24, 2003; 68 FR 50723, Aug. 22, 2003]
Subpart K_Quality System for Nonwaived Testing
Source: 68 FR 3703, Jan. 24, 2003, unless otherwise noted.
Sec. 493.1200 Introduction.
(a) Each laboratory that performs nonwaived testing must establish
and maintain written policies and procedures that implement and monitor
a quality system for all phases of the total testing process (that is,
preanalytic, analytic, and postanalytic) as well as general laboratory
systems.
(b) The laboratory's quality systems must include a quality
assessment component that ensures continuous improvement of the
laboratory's performance and services through ongoing monitoring that
identifies, evaluates and resolves problems.
(c) The various components of the laboratory's quality system are
used to meet the requirements in this part and must be appropriate for
the specialties and subspecialties of testing the laboratory performs,
services it offers, and clients it serves.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Sec. 493.1201 Condition: Bacteriology.
If the laboratory provides services in the subspecialty of
Bacteriology, the laboratory must meet the requirements specified in
Sec. Sec. 493.1230 through 493.1256, Sec. 493.1261, and Sec. Sec.
493.1281 through 493.1299.
Sec. 493.1202 Condition: Mycobacteriology.
If the laboratory provides services in the subspecialty of
Mycobacteriology, the laboratory must meet the requirements specified in
Sec. Sec. 493.1230 through 493.1256, Sec. 493.1262, and Sec. Sec.
493.1281 through 493.1299.
[[Page 1032]]
Sec. 493.1203 Condition: Mycology.
If the laboratory provides services in the subspecialty of Mycology,
the laboratory must meet the requirements specified in Sec. Sec.
493.1230 through 493.1256, Sec. 493.1263, and Sec. Sec. 493.1281
through 493.1299.
Sec. 493.1204 Condition: Parasitology.
If the laboratory provides services in the subspecialty of
Parasitology, the laboratory must meet the requirements specified in
Sec. Sec. 493.1230 through 493.1256, Sec. 493.1264, and Sec. Sec.
493.1281 through 493.1299.
Sec. 493.1205 Condition: Virology.
If the laboratory provides services in the subspecialty of Virology,
the laboratory must meet the requirements specified in Sec. Sec.
493.1230 through 493.1256, Sec. 493.1265, and Sec. Sec. 493.1281
through 493.1299.
Sec. 493.1207 Condition: Syphilis serology.
If the laboratory provides services in the subspecialty of Syphilis
serology, the laboratory must meet the requirements specified in
Sec. Sec. 493.1230 through 493.1256, and Sec. Sec. 493.1281 through
493.1299.
Sec. 493.1208 Condition: General immunology.
If the laboratory provides services in the subspecialty of General
immunology, the laboratory must meet the requirements specified in
Sec. Sec. 493.1230 through 493.1256, and Sec. Sec. 493.1281 through
493.1299.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Sec. 493.1210 Condition: Routine chemistry.
If the laboratory provides services in the subspecialty of Routine
chemistry, the laboratory must meet the requirements specified in
Sec. Sec. 493.1230 through 493.1256, Sec. 493.1267, and Sec. Sec.
493.1281 through 493.1299.
Sec. 493.1211 Condition: Urinalysis.
If the laboratory provides services in the subspecialty of
Urinalysis, the laboratory must meet the requirements specified in
Sec. Sec. 493.1230 through 493.1256, and Sec. Sec. 493.1281 through
493.1299.
Sec. 493.1212 Condition: Endocrinology.
If the laboratory provides services in the subspecialty of
Endocrinology, the laboratory must meet the requirements specified in
Sec. Sec. 493.1230 through 493.1256, and Sec. Sec. 493.1281 through
493.1299.
Sec. 493.1213 Condition: Toxicology.
If the laboratory provides services in the subspecialty of
Toxicology, the laboratory must meet the requirements specified in
Sec. Sec. 493.1230 through 493.1256, and Sec. Sec. 493.1281 through
493.1299.
Sec. 493.1215 Condition: Hematology.
If the laboratory provides services in the specialty of Hematology,
the laboratory must meet the requirements specified in Sec. Sec.
493.1230 through 493.1256, Sec. 493.1269, and Sec. Sec. 493.1281
through 493.1299.
Sec. 493.1217 Condition: Immunohematology.
If the laboratory provides services in the specialty of
Immunohematology, the laboratory must meet the requirements specified in
Sec. Sec. 493.1230 through 493.1256, Sec. 493.1271, and Sec. Sec.
493.1281 through 493.1299.
Sec. 493.1219 Condition: Histopathology.
If the laboratory provides services in the subspecialty of
Histopathology, the laboratory must meet the requirements specified in
Sec. Sec. 493.1230 through 493.1256, Sec. 493.1273, and Sec. Sec.
493.1281 through 493.1299.
Sec. 493.1220 Condition: Oral pathology.
If the laboratory provides services in the subspecialty of Oral
pathology, the laboratory must meet the requirements specified in
Sec. Sec. 493.1230 through 493.1256, and Sec. Sec. 493.1281 through
493.1299.
Sec. 493.1221 Condition: Cytology.
If the laboratory provides services in the subspecialty of Cytology,
the laboratory must meet the requirements specified in Sec. Sec.
493.1230 through 493.1256, Sec. 493.1274, and Sec. Sec. 493.1281
through 493.1299.
Sec. 493.1225 Condition: Clinical cytogenetics.
If the laboratory provides services in the specialty of Clinical
cytogenetics,
[[Page 1033]]
the laboratory must meet the requirements specified in Sec. Sec.
493.1230 through 493.1256, Sec. 493.1276, and Sec. Sec. 493.1281
through 493.1299.
Sec. 493.1226 Condition: Radiobioassay.
If the laboratory provides services in the specialty of
Radiobioassay, the laboratory must meet the requirements specified in
Sec. Sec. 493.1230 through 493.1256, and Sec. Sec. 493.1281 through
493.1299.
Sec. 493.1227 Condition: Histocompatibility.
If the laboratory provides services in the specialty of
Histocompatibility, the laboratory must meet the requirements specified
in Sec. Sec. 493.1230 through 493.1256, Sec. 493.1278, and Sec. Sec.
493.1281 through 493.1299.
General Laboratory Systems
Sec. 493.1230 Condition: General laboratory systems.
Each laboratory that performs nonwaived testing must meet the
applicable general laboratory systems requirements in Sec. Sec.
493.1231 through 493.1236, unless HHS approves a procedure, specified in
Appendix C of the State Operations Manual (CMS Pub. 7), that provides
equivalent quality testing. The laboratory must monitor and evaluate the
overall quality of the general laboratory systems and correct identified
problems as specified in Sec. 493.1239 for each specialty and
subspecialty of testing performed.
Sec. 493.1231 Standard: Confidentiality of patient information.
The laboratory must ensure confidentiality of patient information
throughout all phases of the total testing process that are under the
laboratory's control.
Sec. 493.1232 Standard: Specimen identification and integrity.
The laboratory must establish and follow written policies and
procedures that ensure positive identification and optimum integrity of
a patient's specimen from the time of collection or receipt of the
specimen through completion of testing and reporting of results.
Sec. 493.1233 Standard: Complaint investigations.
The laboratory must have a system in place to ensure that it
documents all complaints and problems reported to the laboratory. The
laboratory must conduct investigations of complaints, when appropriate.
Sec. 493.1234 Standard: Communications.
The laboratory must have a system in place to identify and document
problems that occur as a result of a breakdown in communication between
the laboratory and an authorized person who orders or receives test
results.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Sec. 493.1235 Standard: Personnel competency assessment policies.
As specified in the personnel requirements in subpart M, the
laboratory must establish and follow written policies and procedures to
assess employee and, if applicable, consultant competency.
Sec. 493.1236 Standard: Evaluation of proficiency testing performance.
(a) The laboratory must review and evaluate the results obtained on
proficiency testing performed as specified in subpart H of this part.
(b) The laboratory must verify the accuracy of the following:
(1) Any analyte or subspecialty without analytes listed in subpart I
of this part that is not evaluated or scored by a CMS-approved
proficiency testing program.
(2) Any analyte, specialty or subspecialty assigned a proficiency
testing score that does not reflect laboratory test performance (that
is, when the proficiency testing program does not obtain the agreement
required for scoring as specified in subpart I of this part, or the
laboratory receives a zero score for nonparticipation, or late return of
results).
(c) At least twice annually, the laboratory must verify the accuracy
of the following:
(1) Any test or procedure it performs that is not included in
subpart I of this part.
[[Page 1034]]
(2) Any test or procedure listed in subpart I of this part for which
compatible proficiency testing samples are not offered by a CMS-approved
proficiency testing program.
(d) All proficiency testing evaluation and verification activities
must be documented.
Sec. 493.1239 Standard: General laboratory systems quality assessment.
(a) The laboratory must establish and follow written policies and
procedures for an ongoing mechanism to monitor, assess, and, when
indicated, correct problems identified in the general laboratory systems
requirements specified at Sec. Sec. 493.1231 through 493.1236.
(b) The general laboratory systems quality assessment must include a
review of the effectiveness of corrective actions taken to resolve
problems, revision of policies and procedures necessary to prevent
recurrence of problems, and discussion of general laboratory systems
quality assessment reviews with appropriate staff.
(c) The laboratory must document all general laboratory systems
quality assessment activities.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Preanalytic Systems
Sec. 493.1240 Condition: Preanalytic systems.
Each laboratory that performs nonwaived testing must meet the
applicable preanalytic system(s) requirements in Sec. Sec. 493.1241 and
493.1242, unless HHS approves a procedure, specified in Appendix C of
the State Operations Manual (CMS Pub. 7), that provides equivalent
quality testing. The laboratory must monitor and evaluate the overall
quality of the preanalytic systems and correct identified problems as
specified in Sec. 493.1249 for each specialty and subspecialty of
testing performed.
Sec. 493.1241 Standard: Test request.
(a) The laboratory must have a written or electronic request for
patient testing from an authorized person.
(b) The laboratory may accept oral requests for laboratory tests if
it solicits a written or electronic authorization within 30 days of the
oral request and maintains the authorization or documentation of its
efforts to obtain the authorization.
(c) The laboratory must ensure the test requisition solicits the
following information:
(1) The name and address or other suitable identifiers of the
authorized person requesting the test and, if appropriate, the
individual responsible for using 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 imminently life
threatening laboratory results or panic or alert values.
(2) The patient's name or unique patient identifier.
(3) The sex and age or date of birth of the patient.
(4) The test(s) to be performed.
(5) The source of the specimen, when appropriate.
(6) The date and, if appropriate, time of specimen collection.
(7) For Pap smears, the patient's last menstrual period, and
indication of whether the patient had a previous abnormal report,
treatment, or biopsy.
(8) Any additional information relevant and necessary for a specific
test to ensure accurate and timely testing and reporting of results,
including interpretation, if applicable.
(d) The patient's chart or medical record may be used as the test
requisition or authorization but must be available to the laboratory at
the time of testing and available to CMS or a CMS agent upon request.
(e) If the laboratory transcribes or enters test requisition or
authorization information into a record system or a laboratory
information system, the laboratory must ensure the information is
transcribed or entered accurately.
Sec. 493.1242 Standard: Specimen submission, handling, and referral.
(a) The laboratory must establish and follow written policies and
procedures for each of the following, if applicable:
(1) Patient preparation.
(2) Specimen collection.
(3) Specimen labeling, including patient name or unique patient
identifier
[[Page 1035]]
and, when appropriate, specimen source.
(4) Specimen storage and preservation.
(5) Conditions for specimen transportation.
(6) Specimen processing.
(7) Specimen acceptability and rejection.
(8) Specimen referral.
(b) The laboratory must document the date and time it receives a
specimen.
(c) The laboratory must refer a specimen for testing only to a CLIA-
certified laboratory or a laboratory meeting equivalent requirements as
determined by CMS.
(d) If the laboratory accepts a referral specimen, written
instructions must be available to the laboratory's clients and must
include, as appropriate, the information specified in paragraphs (a)(1)
through (a)(7) of this section.
Sec. 493.1249 Standard: Preanalytic systems quality assessment.
(a) The laboratory must establish and follow written policies and
procedures for an ongoing mechanism to monitor, assess, and when
indicated, correct problems identified in the preanalytic systems
specified at Sec. Sec. 493.1241 through 493.1242.
(b) The preanalytic systems quality assessment must include a review
of the effectiveness of corrective actions taken to resolve problems,
revision of policies and procedures necessary to prevent recurrence of
problems, and discussion of preanalytic systems quality assessment
reviews with appropriate staff.
(c) The laboratory must document all preanalytic systems quality
assessment activities.
[68 FR 3703, Jan. 24, 2003; 68 FR 3703, Aug. 22, 2003]
Analytic Systems
Sec. 493.1250 Condition: Analytic systems.
Each laboratory that performs nonwaived testing must meet the
applicable analytic systems requirements in Sec. Sec. 493.1251 through
493.1283, unless HHS approves a procedure, specified in Appendix C of
the State Operations Manual (CMS Pub. 7), that provides equivalent
quality testing. The laboratory must monitor and evaluate the overall
quality of the analytic systems and correct identified problems as
specified in Sec. 493.1289 for each specialty and subspecialty of
testing performed.
Sec. 493.1251 Standard: Procedure manual.
(a) A written procedure manual for all tests, assays, and
examinations performed by the laboratory must be available to, and
followed by, laboratory personnel. Textbooks may supplement but not
replace the laboratory's written procedures for testing or examining
specimens.
(b) The procedure manual must include the following when applicable
to the test procedure:
(1) Requirements for patient preparation; specimen collection,
labeling, storage, preservation, transportation, processing, and
referral; and criteria for specimen acceptability and rejection as
described in Sec. 493.1242.
(2) Microscopic examination, 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 test results for the test system as
established or verified in Sec. 493.1253.
(7) Control procedures.
(8) Corrective action to take when calibration or control results
fail to meet the laboratory's criteria for acceptability.
(9) Limitations in the test methodology, including interfering
substances.
(10) Reference intervals (normal values).
(11) Imminently life-threatening test results, or panic or alert
values.
(12) Pertinent literature references.
(13) The laboratory's system for entering results in the patient
record and reporting patient results including, when appropriate, the
protocol for reporting imminently life-threatening results, or panic, or
alert values.
[[Page 1036]]
(14) Description of the course of action to take if a test system
becomes inoperable.
(c) Manufacturer's test system instructions or operator manuals may
be used, when applicable, to meet the requirements of paragraphs (b)(1)
through (b)(12) of this section. Any of the items under paragraphs
(b)(1) through (b)(12) of this section not provided by the manufacturer
must be provided by the laboratory.
(d) Procedures and changes in procedures must be approved, signed,
and dated by the current laboratory director before use.
(e) The laboratory must maintain a copy of each procedure with the
dates of initial use and discontinuance as described in Sec.
493.1105(a)(2).
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Sec. 493.1252 Standard: Test systems, equipment, instruments,
reagents, materials, and supplies.
(a) Test systems must be selected by the laboratory. The testing
must be performed following the manufacturer's instructions and in a
manner that provides test results within the laboratory's stated
performance specifications for each test system as determined under
Sec. 493.1253.
(b) The laboratory must define criteria for those conditions that
are essential for proper storage of reagents and specimens, accurate and
reliable test system operation, and test result reporting. The criteria
must be consistent with the manufacturer's instructions, if provided.
These conditions must be monitored and documented and, if applicable,
include the following:
(1) Water quality.
(2) Temperature.
(3) Humidity.
(4) Protection of equipment and instruments from fluctuations and
interruptions in electrical current that adversely affect patient test
results and test reports.
(c) Reagents, solutions, culture media, control materials,
calibration materials, and other supplies, as appropriate, must be
labeled to indicate the following:
(1) Identity and when significant, titer, strength or concentration.
(2) Storage requirements.
(3) Preparation and expiration dates.
(4) Other pertinent information required for proper use.
(d) Reagents, solutions, culture media, control materials,
calibration materials, and other supplies must not be used when they
have exceeded their expiration date, have deteriorated, or are of
substandard quality.
(e) Components of reagent kits of different lot numbers must not be
interchanged unless otherwise specified by the manufacturer.
Sec. 493.1253 Standard: Establishment and verification of performance
specifications.
(a) Applicability. Laboratories are not required to verify or
establish performance specifications for any test system used by the
laboratory before April 24, 2003.
(b)(1) Verification of performance specifications. Each laboratory
that introduces an unmodified, FDA-cleared or approved test system must
do the following before reporting patient test results:
(i) Demonstrate that it can obtain performance specifications
comparable to those established by the manufacturer for the following
performance characteristics:
(A) Accuracy.
(B) Precision.
(C) Reportable range of test results for the test system.
(ii) Verify that the manufacturer's reference intervals (normal
values) are appropriate for the laboratory's patient population.
(2) Establishment of performance specifications. Each laboratory
that modifies an FDA-cleared or approved test system, or introduces a
test system not subject to FDA clearance or approval (including methods
developed in-house and standardized methods such as text book
procedures), or uses a test system in which performance specifications
are not provided by the manufacturer must, before reporting patient test
results, establish for each test system the performance specifications
for the following performance characteristics, as applicable:
[[Page 1037]]
(i) Accuracy.
(ii) Precision.
(iii) Analytical sensitivity.
(iv) Analytical specificity to include interfering substances.
(v) Reportable range of test results for the test system.
(vi) Reference intervals (normal values).
(vii) Any other performance characteristic required for test
performance.
(3) Determination of calibration and control procedures. The
laboratory must determine the test system's calibration procedures and
control procedures based upon the performance specifications verified or
established under paragraph (b)(1) or (b)(2) of this section.
(c) Documentation. The laboratory must document all activities
specified in this section.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Sec. 493.1254 Standard: Maintenance and function checks.
(a) Unmodified manufacturer's equipment, instruments, or test
systems. The laboratory must perform and document the following:
(1) Maintenance as defined by the manufacturer and with at least the
frequency specified by the manufacturer.
(2) Function checks as defined by the manufacturer and with at least
the frequency specified by the manufacturer. Function checks must be
within the manufacturer's established limits before patient testing is
conducted.
(b) Equipment, instruments, or test systems developed in-house,
commercially available and modified by the laboratory, or maintenance
and function check protocols are not provided by the manufacturer. The
laboratory must do the following:
(1)(i) Establish a maintenance protocol that ensures equipment,
instrument, and test system performance that is necessary for accurate
and reliable test results and test result reporting.
(ii) Perform and document the maintenance activities specified in
paragraph (b)(1)(i) of this section.
(2)(i) Define a function check protocol that ensures equipment,
instrument, and test system performance that is necessary for accurate
and reliable test results and test result reporting.
(ii) Perform and document the 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.
Sec. 493.1255 Standard: Calibration and calibration verification
procedures.
Calibration and calibration verification procedures are required to
substantiate the continued accuracy of the test system throughout the
laboratory's reportable range of test results for the test system.
Unless otherwise specified in this subpart, for each applicable test
system the laboratory must do the following:
(a) Perform and document calibration procedures--
(1) Following the manufacturer's test system instructions, using
calibration materials provided or specified, and with at least the
frequency recommended by the manufacturer;
(2) Using the criteria verified or established by the laboratory as
specified in Sec. 493.1253(b)(3)--
(i) Using calibration materials appropriate for the test system and,
if possible, traceable to a reference method or reference material of
known value; and
(ii) Including the number, type, and concentration of calibration
materials, as well as acceptable limits for and the frequency of
calibration; and
(3) Whenever calibration verification fails to meet the laboratory's
acceptable limits for calibration verification.
(b) Perform and document calibration verification procedures--
(1) Following the manufacturer's calibration verification
instructions;
(2) Using the criteria verified or established by the laboratory
under Sec. 493.1253(b)(3)--
(i) Including the number, type, and concentration of the materials,
as well as acceptable limits for calibration verification; and
(ii) Including at least a minimal (or zero) value, a mid-point
value, and a maximum value near the upper limit of
[[Page 1038]]
the range to verify the laboratory's reportable range of test results
for the test system; and
(3) At least once every 6 months and whenever any of the following
occur:
(i) 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.
(ii) There is major preventive maintenance or replacement of
critical parts that may influence test performance.
(iii) Control materials reflect an unusual trend or shift, or are
outside of the laboratory's acceptable limits, and other means of
assessing and correcting unacceptable control values fail to identify
and correct the problem.
(iv) The laboratory's established schedule for verifying the
reportable range for patient test results requires more frequent
calibration verification.
Sec. 493.1256 Standard: Control procedures.
(a) For each test system, the laboratory is responsible for having
control procedures that monitor the accuracy and precision of the
complete analytic process.
(b) The laboratory must establish the number, type, and frequency of
testing control materials using, if applicable, the performance
specifications verified or established by the laboratory as specified in
Sec. 493.1253(b)(3).
(c) The control procedures must--
(1) Detect immediate errors that occur due to test system failure,
adverse environmental conditions, and operator performance.
(2) Monitor over time the accuracy and precision of test performance
that may be influenced by changes in test system performance and
environmental conditions, and variance in operator performance.
(d) Unless CMS approves a procedure, specified in Appendix C of the
State Operations Manual (CMS Pub. 7), that provides equivalent quality
testing, the laboratory must--
(1) Perform control procedures as defined in this section unless
otherwise specified in the additional specialty and subspecialty
requirements at Sec. Sec. 493.1261 through 493.1278.
(2) For each test system, perform control procedures using the
number and frequency specified by the manufacturer or established by the
laboratory when they meet or exceed the requirements in paragraph (d)(3)
of this section.
(3) At least once each day patient specimens are assayed or examined
perform the following for--
(i) Each quantitative procedure, include two control materials of
different concentrations;
(ii) Each qualitative procedure, include a negative and positive
control material;
(iii) Test procedures producing graded or titered results, include a
negative control material and a control material with graded or titered
reactivity, respectively;
(iv) Each test system that has an extraction phase, include two
control materials, including one that is capable of detecting errors in
the extraction process; and
(v) Each molecular amplification procedure, include two control
materials and, if reaction inhibition is a significant source of false
negative results, a control material capable of detecting the
inhibition.
(4) For thin layer chromatography--
(i) Spot each plate or card, as applicable, with a calibrator
containing all known substances or drug groups, as appropriate, which
are identified by thin layer chromatography and reported by the
laboratory; and
(ii) Include at least one control material on each plate or card, as
applicable, which must be processed through each step of patient
testing, including extraction processes.
(5) For each electrophoretic procedure include, concurrent with
patient specimens, at least one control material containing the
substances being identified or measured.
(6) Perform control material testing as specified in this paragraph
before resuming patient testing when a complete change of reagents is
introduced;
[[Page 1039]]
major preventive maintenance is performed; or any critical part that may
influence test performance is replaced.
(7) Over time, rotate control material testing among all operators
who perform the test.
(8) Test control materials in the same manner as patient specimens.
(9) When using calibration material as a control material, use
calibration material from a different lot number than that used to
establish a cut-off value or to calibrate the test system.
(10) Establish or verify the criteria for acceptability of all
control materials.
(i) When control materials providing quantitative results are used,
statistical parameters (for example, mean and standard deviation) for
each batch and lot number of control materials must be defined and
available.
(ii) The laboratory may use the stated value of a commercially
assayed control material provided the stated value is for the
methodology and instrumentation employed by the laboratory and is
verified by the laboratory.
(iii) Statistical parameters for unassayed control materials must be
established over time by the laboratory through concurrent testing of
control materials having previously determined statistical parameters.
(e) For reagent, media, and supply checks, the laboratory must do
the following:
(1) Check each batch (prepared in-house), lot number (commercially
prepared) and shipment of reagents, disks, stains, antisera, (except
those specifically referenced in Sec. 493.1261(a)(3)) and
identification systems (systems using two or more substrates or two or
more reagents, or a combination) 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),
test staining materials for intended reactivity to ensure predictable
staining characteristics. Control materials for both positive and
negative reactivity must be included, as appropriate.
(3) Check fluorescent and immunohistochemical stains for positive
and negative reactivity each time of use.
(4) Before, or concurrent with the initial use--
(i) Check each batch of media for sterility if sterility is required
for testing;
(ii) Check each batch of media for its ability to support growth
and, as appropriate, select or inhibit specific organisms or produce a
biochemical response; and
(iii) Document the physical characteristics of the media when
compromised and report any deterioration in the media to the
manufacturer.
(5) Follow the manufacturer's specifications for using reagents,
media, and supplies and be responsible for results.
(f) Results of control materials must meet the laboratory's and, as
applicable, the manufacturer's test system criteria for acceptability
before reporting patient test results.
(g) The laboratory must document all control procedures performed.
(h) If control materials are not available, the laboratory must have
an alternative mechanism to detect immediate errors and monitor test
system performance over time. The performance of alternative control
procedures must be documented.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Sec. 493.1261 Standard: Bacteriology.
(a) The laboratory must check the following for positive and
negative reactivity using control organisms:
(1) Each day of use for beta-lactamase methods other than
Cefinase\TM\.
(2) Each week of use for Gram stains.
(3) When each batch (prepared in-house), lot number (commercially
prepared), and shipment of antisera is prepared or opened, and once
every 6 months thereafter.
(b) For antimicrobial susceptibility tests, the laboratory must
check each batch of media and each lot number and shipment of
antimicrobial agent(s) before, or concurrent with, initial use, using
approved control organisms.
(1) Each day tests are performed, the laboratory must use the
appropriate control organism(s) to check the procedure.
(2) The laboratory's zone sizes or minimum inhibitory concentration
for
[[Page 1040]]
control organisms must be within established limits before reporting
patient results.
(c) The laboratory must document all control procedures performed,
as specified in this section.
Sec. 493.1262 Standard: Mycobacteriology.
(a) Each day of use, the laboratory must check all reagents or test
procedures used for mycobacteria identification with at least one acid-
fast organism that produces a positive reaction and an acid-fast
organism that produces a negative reaction.
(b) For antimycobacterial susceptibility tests, the laboratory must
check each batch of media and each lot number and shipment of
antimycobacterial agent(s) before, or concurrent with, initial use,
using an appropriate control organism(s).
(1) The laboratory must establish limits for acceptable control
results.
(2) Each week tests are performed, the laboratory must use the
appropriate control organism(s) to check the procedure.
(3) The results for the control organism(s) must be within
established limits before reporting patient results.
(c) The laboratory must document all control procedures performed,
as specified in this section.
Sec. 493.1263 Standard: Mycology.
(a) The laboratory must check each batch (prepared in-house), lot
number (commercially prepared), and shipment of lactophenol cotton blue
when prepared or opened for intended reactivity with a control
organism(s).
(b) For antifungal susceptibility tests, the laboratory must check
each batch of media and each lot number and shipment of antifungal
agent(s) before, or concurrent with, initial use, using an appropriate
control organism(s).
(1) The laboratory must establish limits for acceptable control
results.
(2) Each day tests are performed, the laboratory must use the
appropriate control organism(s) to check the procedure.
(3) The results for the control organism(s) must be within
established limits before reporting patient results.
(c) The laboratory must document all control procedures performed,
as specified in this section.
Sec. 493.1264 Standard: Parasitology.
(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 material that will demonstrate staining
characteristics.
(d) The laboratory must document all control procedures performed,
as specified in this section.
Sec. 493.1265 Standard: Virology.
(a) When using cell culture to isolate or identify viruses, the
laboratory must simultaneously incubate a cell substrate control or
uninoculated cells as a negative control material.
(b) The laboratory must document all control procedures performed,
as specified in this section.
Sec. 493.1267 Standard: Routine chemistry.
For blood gas analyses, the laboratory must perform the following:
(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 8 hours of testing
using a combination of control materials that include both low and high
values on each day of testing.
(c) Test one sample of control material each time specimens are
tested unless automated instrumentation internally verifies calibration
at least every 30 minutes.
(d) Document all control procedures performed, as specified in this
section.
[[Page 1041]]
Sec. 493.1269 Standard: Hematology.
(a) For manual cell counts performed using a hemocytometer--
(1) One control material must be tested each 8 hours of operation;
and
(2) Patient specimens and control materials must be tested in
duplicate.
(b) For all nonmanual coagulation test systems, the laboratory must
include two levels of control material each 8 hours of operation and
each time a reagent is changed.
(c) For manual coagulation tests--
(1) Each individual performing tests must test two levels of control
materials before testing patient samples and each time a reagent is
changed; and
(2) Patient specimens and control materials must be tested in
duplicate.
(d) The laboratory must document all control procedures performed,
as specified in this section.
Sec. 493.1271 Standard: Immunohematology.
(a) Patient testing. (1) The laboratory must perform ABO grouping,
D(Rho) typing, unexpected antibody detection, antibody identification,
and compatibility testing by following the manufacturer's instructions,
if provided, and as applicable, 21 CFR 606.151(a) through (e).
(2) The laboratory must determine ABO group by concurrently testing
unknown red cells with, at a minimum, 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.
(3) The laboratory must determine the D(Rho) type by testing unknown
red cells with anti-D (anti-Rho) blood typing reagent.
(b) Immunohematological testing and distribution of blood and blood
products. Blood and blood product testing and distribution must comply
with 21 CFR 606.100(b)(12); 606.160(b)(3)(ii) and (b)(3)(v); 610.40;
640.5(a), (b), (c), and (e); and 640.11(b).
(c) Blood and blood products storage. Blood and blood products must
be stored under appropriate conditions that 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.
(2) Inspections of the alarm system must be documented.
(d) Retention of samples of transfused blood. According to the
laboratory's established procedures, samples of each unit of transfused
blood must be retained for further testing in the event of transfusion
reactions. The laboratory must promptly dispose of blood not retained
for further testing that has passed its expiration date.
(e) Investigation of transfusion reactions. (1) According to its
established procedures, the laboratory that performs compatibility
testing, or issues blood or blood products, must promptly investigate
all transfusion reactions occurring in facilities for which it has
investigational responsibility and make recommendations to the medical
staff regarding improvements in transfusion procedures.
(2) The laboratory must document, as applicable, that all necessary
remedial actions are taken to prevent recurrences of transfusion
reactions and that all policies and procedures are reviewed to assure
they are adequate to ensure the safety of individuals being transfused.
(f) Documentation. The laboratory must document all control
procedures performed, as specified in this section.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Sec. 493.1273 Standard: Histopathology.
(a) As specified in Sec. 493.1256(e)(3), fluorescent and
immunohistochemical stains must be checked for positive and negative
reactivity each time of use. For all other differential or special
stains, a control slide of known reactivity must be stained with each
patient slide or group of patient slides. Reaction(s) of the control
slide with each special stain must be documented.
(b) The laboratory must retain stained slides, specimen blocks, and
tissue remnants as specified in Sec. 493.1105. The remnants of tissue
specimens must be maintained in a manner that ensures proper
preservation of the tissue specimens until the portions submitted for
microscopic examination have been examined and a diagnosis
[[Page 1042]]
made by an individual qualified under Sec. Sec. 493.1449(b), (l), or
(m).
(c) An individual who has successfully completed a training program
in neuromuscular pathology approved by HHS may examine and provide
reports for neuromuscular pathology.
(d) Tissue pathology reports must be signed by an individual
qualified as specified in paragraph (b) or, as appropriate, paragraph
(c) of this section. If a computer report is generated with an
electronic signature, it must be authorized by the individual who
performed the examination and made the diagnosis.
(e) The laboratory must use acceptable terminology of a recognized
system of disease nomenclature in reporting results.
(f) The laboratory must document all control procedures performed,
as specified in this section.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Sec. 493.1274 Standard: Cytology.
(a) Cytology slide examination site. All cytology slide preparations
must be evaluated on the premises of a laboratory certified to conduct
testing in the subspecialty of cytology.
(b) Staining. The laboratory must have available and follow written
policies and procedures for each of the following, if applicable:
(1) All gynecologic slide preparations must be stained using a
Papanicolaou or modified Papanicolaou staining method.
(2) Effective measures to prevent cross-contamination between
gynecologic and nongynecologic specimens during the staining process
must be used.
(3) Nongynecologic specimens that have a high potential for cross-
contamination must be stained separately from other nongynecologic
specimens, and the stains must be filtered or changed following
staining.
(c) Control procedures. The laboratory must establish and follow
written policies and procedures for a program designed to detect errors
in the performance of cytologic examinations and the reporting of
results. The program must include the following:
(1) A review of slides from at least 10 percent of the gynecologic
cases interpreted by individuals qualified under Sec. Sec. 493.1469 or
493.1483, to be negative for epithelial cell abnormalities and other
malignant neoplasms (as defined in paragraph (e)(1) of this section).
(i) The review must be performed by an individual who meets one of
the following qualifications:
(A) A technical supervisor qualified under Sec. Sec. 493.1449(b) or
(k).
(B) A cytology general supervisor qualified under Sec. 493.1469.
(C) A cytotechnologist qualified under Sec. 493.1483 who has the
experience specified in Sec. 493.1469(b)(2).
(ii) Cases must be randomly selected from the total caseload and
include negatives and those from patients or groups of patients that are
identified as having a higher than average probability of developing
cervical cancer based on available patient information.
(iii) The review of those cases selected must be completed before
reporting patient results.
(2) Laboratory comparison of clinical information, when available,
with cytology reports and comparison of all gynecologic cytology reports
with a diagnosis of high-grade squamous intraepithelial lesion (HSIL),
adenocarcinoma, or other malignant neoplasms with the histopathology
report, if available in the laboratory (either on-site or in storage),
and determination of the causes of any discrepancies.
(3) For each patient with a current HSIL, adenocarcinoma, or other
malignant neoplasm, laboratory review of all normal or negative
gynecologic specimens received within the previous 5 years, if available
in the laboratory (either on-site or in storage). If significant
discrepancies are found that will affect current patient care, the
laboratory must notify the patient's physician and issue an amended
report.
(4) Records of initial examinations and all rescreening results must
be documented.
(5) An annual statistical laboratory evaluation of the number of--
(i) Cytology cases examined;
(ii) Specimens processed by specimen type;
(iii) Patient cases reported by diagnosis (including the number
reported
[[Page 1043]]
as unsatisfactory for diagnostic interpretation);
(iv) Gynecologic cases with a diagnosis of HSIL, adenocarcinoma, or
other malignant neoplasm for which histology results were available for
comparison;
(v) Gynecologic cases where cytology and histology are discrepant;
and
(vi) Gynecologic cases where any rescreen of a normal or negative
specimen results in reclassification as low-grade squamous
intraepithelial lesion (LSIL), HSIL, adenocarcinoma, or other malignant
neoplasms.
(6) An evaluation of the case reviews of each individual examining
slides against the laboratory's overall statistical values,
documentation of any discrepancies, including reasons for the deviation
and, if appropriate, corrective actions taken.
(d) Workload limits. The laboratory must establish and follow
written policies and procedures that ensure the following:
(1) The technical supervisor establishes a maximum workload limit
for each individual who performs primary screening.
(i) The workload limit is based on the individual's performance
using evaluations of the following:
(A) Review of 10 percent of the cases interpreted as negative for
the conditions defined in paragraph (e)(1) of this section.
(B) Comparison of the individual's interpretation with the technical
supervisor's confirmation of patient smears specified in paragraphs
(e)(1) and (e)(3) of this section.
(ii) Each individual's workload limit is reassessed at least every 6
months and adjusted when necessary.
(2) The maximum number of slides examined by an individual in each
24-hour period does not exceed 100 slides (one patient specimen per
slide; gynecologic, nongynecologic, or both) irrespective of the site or
laboratory. This limit represents an absolute maximum number of slides
and must not be employed as an individual's performance target. In
addition--
(i) The maximum number of 100 slides is examined in no less than an
8-hour workday;
(ii) For the purposes of establishing workload limits for
individuals examining slides in less than an 8-hour workday (includes
full-time employees with duties other than slide examination and part-
time employees), a period of 8 hours is used to prorate the number of
slides that may be examined. The formula--
[GRAPHIC] [TIFF OMITTED] TR24JA03.000
is used to determine maximum slide volume to be examined;
(iii) Nongynecologic slide preparations made using liquid-based
slide preparatory techniques that result in cell dispersion over one-
half or less of the total available slide may be counted as one-half
slide; and
(iv) Technical supervisors who perform primary screening are not
required to include tissue pathology slides and previously examined
cytology slides (gynecologic and nongynecologic) in the 100 slide
workload limit.
(3) The laboratory must maintain records of the total number of
slides examined by each individual during each 24-hour period and the
number of hours spent examining slides in the 24-hour period
irrespective of the site or laboratory.
(4) Records are available to document the workload limit for each
individual.
(e) Slide examination and reporting. The laboratory must establish
and follow written policies and procedures that ensure the following:
(1) A technical supervisor confirms each gynecologic slide
preparation interpreted to exhibit reactive or reparative changes or any
of the following epithelial cell abnormalities:
(i) Squamous cell.
(A) Atypical squamous cells of undetermined significance (ASC-US) or
cannot exclude HSIL (ASC-H).
(B) LSIL-Human papillomavirus (HPV)/mild dysplasia/cervical
intraepithelial neoplasia 1 (CIN 1).
(C) HSIL-moderate and severe dysplasia, carcinoma in situ (CIS)/CIN
2 and CIN 3 or with features suspicious for invasion.
(D) Squamous cell carcinoma.
(ii) Glandular cell.
[[Page 1044]]
(A) Atypical cells not otherwise specified (NOS) or specified in
comments (endocervical, endometrial, or glandular).
(B) Atypical cells favor neoplastic (endocervical or glandular).
(C) Endocervical adenocarcinoma in situ.
(D) Adenocarcinoma endocervical, adenocarcinoma endometrial,
adenocarcinoma extrauterine, and adenocarcinoma NOS.
(iii) Other malignant neoplasms.
(2) The report of gynecologic slide preparations with conditions
specified in paragraph (e)(1) of this section must be signed to reflect
the technical supervisory review or, if a computer report is generated
with signature, it must reflect an electronic signature authorized by
the technical supervisor who performed the review.
(3) All nongynecologic preparations are reviewed by a technical
supervisor. 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
who performed the review.
(4) Unsatisfactory specimens or slide preparations are identified
and reported as unsatisfactory.
(5) The report contains narrative descriptive nomenclature for all
results.
(6) Corrected reports issued by the laboratory indicate the basis
for correction.
(f) Record and slide retention. (1) The laboratory must retain all
records and slide preparations as specified in Sec. 493.1105.
(2) Slides may be loaned to proficiency testing programs in lieu of
maintaining them for the required 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 these slides.
(3) Documentation of slides loaned or referred for purposes other
than proficiency testing must be maintained.
(4) All slides must be retrievable upon request.
(g) Automated and semi-automated screening devices. When performing
evaluations using automated and semi-automated screening devices, the
laboratory must follow manufacturer's instructions for preanalytic,
analytic, and postanalytic phases of testing, as applicable, and meet
the applicable requirements of this subpart K.
(h) Documentation. The laboratory must document all control
procedures performed, as specified in this section.
68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Sec. 493.1276 Standard: Clinical cytogenetics.
(a) The laboratory must have policies and procedures for ensuring
accurate and reliable patient specimen identification during the process
of accessioning, cell preparation, photographing or other image
reproduction technique, photographic printing, and reporting and storage
of results, karyotypes, and photographs.
(b) The laboratory must have records that document the following:
(1) The media used, reactions observed, number of cells counted,
number of cells karyotyped, number of chromosomes counted for each
metaphase spread, and the quality of the banding.
(2) The resolution is appropriate for the type of tissue or specimen
and the type of study required based on the clinical information
provided to the laboratory.
(3) An adequate number of karyotypes are prepared for each patient.
(c) Determination of sex must be performed by full chromosome
analysis.
(d) The laboratory report must include a summary and interpretation
of the observations, number of cells counted and analyzed, and use the
International System for Human Cytogenetic Nomenclature.
(e) The laboratory must document all control procedures performed,
as specified in this section.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Sec. 493.1278 Standard: Histocompatibility.
(a) General. The laboratory must meet the following requirements:
[[Page 1045]]
(1) An audible alarm system must be used to monitor the storage
temperature of specimens (donor and recipient) and reagents. The
laboratory must have an emergency plan for alternate storage.
(2) All patient specimens must be easily retrievable.
(3) Reagent typing sera inventory prepared in-house must indicate
source, bleeding date and identification number, reagent specificity,
and volume remaining.
(4) If the laboratory uses immunologic reagents (for example,
antibodies, antibody-coated particles, or complement) to facilitate or
enhance the isolation of lymphocytes, or lymphocyte subsets, the
efficacy of the methods must be monitored with appropriate quality
control procedures.
(5) 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 interlaboratory reproducibility.
(b) HLA typing. The laboratory must do the following:
(1) Use a technique(s) that is established to optimally define, as
applicable, HLA Class I and II specificities.
(2) HLA type all potential transplant recipients at a level
appropriate to support clinical transplant protocol and donor selection.
(3) HLA type cells from organ donors referred to the laboratory.
(4) Use HLA antigen terminology that conforms to the latest report
of the World Health Organization (W.H.O.) Committee on Nomenclature.
Potential new antigens not yet approved by this committee must have a
designation that cannot be confused with W.H.O. terminology.
(5) Have available and follow written criteria for the following:
(i) The preparation of cells or cellular extracts (for example,
solubilized antigens and nucleic acids), as applicable to the HLA typing
technique(s) performed.
(ii) Selecting typing reagents, whether prepared in-house or
commercially.
(iii) Ensuring that reagents used for typing are adequate to define
all HLA-A, B and DR specificities that are officially recognized by the
most recent W.H.O. Committee on Nomenclature and for which reagents are
readily available.
(iv) The assignment of HLA antigens.
(v) When antigen redefinition and retyping are required.
(6) Check each HLA typing by testing, at a minimum the following:
(i) A positive control material.
(ii) A negative control material in which, if applicable to the
technique performed, cell viability at the end of incubation is
sufficient to permit accurate interpretation of results. In assays in
which cell viability is not required, the negative control result must
be sufficiently different from the positive control result to permit
accurate interpretation of results.
(iii) Positive control materials for specific cell types when
applicable (that is, T cells, B cells, and monocytes).
(c) Disease-associated studies. The laboratory must check each
typing for disease-associated HLA antigens using control materials to
monitor the test components and each phase of the test system to ensure
acceptable performance.
(d) Antibody Screening. The laboratory must do the following:
(1) Use a technique(s) that detects HLA-specific antibody with a
specificity equivalent or superior to that of the basic complement-
dependent microlymphocytotoxicity assay.
(2) Use a method that distinguishes antibodies to HLA Class II
antigens from antibodies to Class I antigens to detect antibodies to HLA
Class II antigens.
(3) Use a panel that contains all the major HLA specificities and
common splits. If the laboratory does not use commercial panels, it must
maintain a list of individuals for fresh panel bleeding.
(4) Make a reasonable attempt to have available monthly serum
specimens for all potential transplant recipients for periodic antibody
screening and crossmatch.
(5) Have available and follow a written policy consistent with
clinical transplant protocols for the frequency of screening potential
transplant recipient sera for preformed HLA-specific antibodies.
[[Page 1046]]
(6) Check each antibody screening by testing, at a minimum the
following:
(i) A positive control material containing antibodies of the
appropriate isotype for the assay.
(ii) A negative control material.
(7) As applicable, have available and follow written criteria and
procedures for antibody identification to the level appropriate to
support clinical transplant protocol.
(e) Crossmatching. The laboratory must do the following:
(1) Use a technique(s) documented to have increased sensitivity in
comparison with the basic complement-dependent microlymphocytotoxicity
assay.
(2) Have available and follow written criteria for the following:
(i) Selecting appropriate patient serum samples for crossmatching.
(ii) The preparation of donor cells or cellular extracts (for
example, solubilized antigens and nucleic acids), as applicable to the
crossmatch technique(s) performed.
(3) Check each crossmatch and compatibility test for HLA Class II
antigenic differences using control materials to monitor the test
components and each phase of the test system to ensure acceptable
performance.
(f) Transplantation. Laboratories performing histocompatibility
testing for transfusion and transplantation purposes must do the
following:
(1) Have available and follow written policies and protocols
specifying the histocompatibility testing (that is, HLA typing, antibody
screening, compatibility testing and crossmatching) to be performed for
each type of cell, tissue or organ to be transfused or transplanted. The
laboratory's policies must include, as applicable--
(i) Testing protocols for cadaver donor, living, living-related, and
combined organ and tissue transplants;
(ii) Testing protocols for patients at high risk for allograft
rejection; and
(iii) The level of testing required to support clinical transplant
protocols (for example, antigen or allele level).
(2) For renal allotransplantation and combined organ and tissue
transplants in which a kidney is to be transplanted, have available
results of final crossmatches before the kidney is transplanted.
(3) For nonrenal transplantation, if HLA testing and final
crossmatches were not performed prospectively because of an emergency
situation, the laboratory must document the circumstances, if known,
under which the emergency transplant was performed, and records of the
transplant must reflect any information provided to the laboratory by
the patient's physician.
(g) Documentation. The laboratory must document all control
procedures performed, as specified in this section.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Sec. 493.1281 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) The laboratory must have a system to identify and assess patient
test results that appear inconsistent with the following relevant
criteria, when available:
(1) Patient age.
(2) Sex.
(3) Diagnosis or pertinent clinical data.
(4) Distribution of patient test results.
(5) Relationship with other test parameters.
(c) The laboratory must document all test result comparison
activities.
Sec. 493.1282 Standard: Corrective actions.
(a) Corrective action policies and procedures must be available and
followed as necessary to maintain the laboratory's operation for testing
patient specimens in a manner that ensures accurate and reliable patient
test results and reports.
(b) The laboratory must document all corrective actions taken,
including actions taken when any of the following occur:
(1) Test systems do not meet the laboratory's verified or
established performance specifications, as determined
[[Page 1047]]
in Sec. 493.1253(b), which include but are not limited to--
(i) Equipment or methodologies that perform outside of established
operating parameters or performance specifications;
(ii) Patient test values that are outside of the laboratory's
reportable range of test results for the test system; and
(iii) When the laboratory determines that the reference intervals
(normal values) for a test procedure are inappropriate for the
laboratory's patient population.
(2) Results of control or calibration materials, or both, fail to
meet the laboratory's established criteria for acceptability. All
patient test results obtained in the unacceptable test run and since the
last acceptable test run must be evaluated to determine if patient test
results have been adversely affected. The laboratory must take the
corrective action necessary to ensure the reporting of accurate and
reliable patient test results.
(3) The criteria for proper storage of reagents and specimens, as
specified under Sec. 493.1252(b), are not met.
Sec. 493.1283 Standard: Test records.
(a) The laboratory must maintain an information or record system
that includes the following:
(1) The positive identification of the specimen.
(2) The date and time of specimen receipt into the laboratory.
(3) The condition and disposition of specimens that do not meet the
laboratory's criteria for specimen acceptability.
(4) The records and dates of all specimen testing, including the
identity of the personnel who performed the test(s).
(b) Records of patient testing including, if applicable, instrument
printouts, must be retained.
Sec. 493.1289 Standard: Analytic systems quality assessment.
(a) The laboratory must establish and follow written policies and
procedures for an ongoing mechanism to monitor, assess, and when
indicated, correct problems identified in the analytic systems specified
in Sec. Sec. 493.1251 through 493.1283.
(b) The analytic systems quality assessment must include a review of
the effectiveness of corrective actions taken to resolve problems,
revision of policies and procedures necessary to prevent recurrence of
problems, and discussion of analytic systems quality assessment reviews
with appropriate staff.
(c) The laboratory must document all analytic systems quality
assessment activities.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Postanalytic Systems
Sec. 493.1290 Condition: Postanalytic systems.
Each laboratory that performs nonwaived testing must meet the
applicable postanalytic systems requirements in Sec. 493.1291 unless
HHS approves a procedure, specified in Appendix C of the State
Operations Manual (CMS Pub. 7) that provides equivalent quality testing.
The laboratory must monitor and evaluate the overall quality of the
postanalytic systems and correct identified problems as specified in
Sec. 493.1299 for each specialty and subspecialty of testing performed.
Sec. 493.1291 Standard: Test report.
(a) The laboratory must have an adequate manual or electronic
system(s) in place to ensure test results and other patient-specific
data are accurately and reliably sent from the point of data entry
(whether interfaced or entered manually) to final report destination, in
a timely manner. This includes the following:
(1) Results reported from calculated data.
(2) Results and patient-specific data electronically reported to
network or interfaced systems.
(3) Manually transcribed or electronically transmitted results and
patient-specific information reported directly or upon receipt from
outside referral laboratories, satellite or point-of-care testing
locations.
(b) Test report information maintained as part of the patient's
chart or
[[Page 1048]]
medical record must be readily available to the laboratory and to CMS or
a CMS agent upon request.
(c) The test report must indicate the following:
(1) For positive patient identification, either the patient's name
and identification number, or a unique patient identifier and
identification number.
(2) The name and address of the laboratory location where the test
was performed.
(3) The test report date.
(4) The test performed.
(5) Specimen source, when appropriate.
(6) The test result and, if applicable, the units of measurement or
interpretation, or both.
(7) Any information regarding the condition and disposition of
specimens that do not meet the laboratory's criteria for acceptability.
(d) Pertinent ``reference intervals'' or ``normal'' values, as
determined by the laboratory performing the tests, must be available to
the authorized person who ordered the tests and, if applicable, the
individual responsible for using the test results.
(e) The laboratory must, upon request, make available to clients a
list of test methods employed by the laboratory and, as applicable, the
performance specifications established or verified as specified in Sec.
493.1253. In addition, information that may affect the interpretation of
test results, for example 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.
(f) Test results must be released only to authorized persons and, if
applicable, the individual responsible for using the test results and
the laboratory that initially requested the test.
(g) The laboratory must immediately alert the individual or entity
requesting the test and, if applicable, the individual responsible for
using the test results when any test result indicates an imminently
life-threatening condition, or panic or alert values.
(h) When 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(s) of the delayed testing.
(i) If a laboratory refers patient specimens for testing--
(1) The referring laboratory must not revise results or information
directly related to the interpretation of results provided by the
testing laboratory;
(2) 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; and
(3) The authorized person who orders a test must be notified by the
referring laboratory of the name and address of each laboratory location
where the test was performed.
(j) All test reports or records of the information on the test
reports must be maintained by the laboratory in a manner that permits
ready identification and timely accessibility.
(k) When errors in the reported patient test results are detected,
the laboratory must do the following:
(1) Promptly notify the authorized person ordering the test and, if
applicable, the individual using the test results of reporting errors.
(2) Issue corrected reports promptly to the authorized person
ordering the test and, if applicable, the individual using the test
results.
(3) Maintain duplicates of the original report, as well as the
corrected report.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Sec. 493.1299 Standard: Postanalytic systems quality assessment.
(a) The laboratory must establish and follow written policies and
procedures for an ongoing mechanism to monitor, assess and, when
indicated, correct problems identified in the postanalytic systems
specified in Sec. 493.1291.
(b) The postanalytic systems quality assessment must include a
review of the effectiveness of corrective actions taken to resolve
problems, revision of
[[Page 1049]]
policies and procedures necessary to prevent recurrence of problems, and
discussion of postanalytic systems quality assessment reviews with
appropriate staff.
(c) The laboratory must document all postanalytic systems quality
assessment activities.
[68 FR 3703, Jan. 24, 2003; 68 FR 50724, Aug. 22, 2003]
Subpart L [Reserved]
Subpart M_Personnel for Nonwaived 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 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 Sec. Sec. 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, and M of this part.
[57 FR 7172, Feb. 28, 1992, as amended at 68 FR 3713, Jan. 24, 2003; 68
FR 50724, Aug. 22, 2003]
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.
[[Page 1050]]
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
(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
[[Page 1051]]
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 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
[[Page 1052]]
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 meeting the qualifications
of Sec. Sec. 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;
[[Page 1053]]
(5) Ensure that the quality control and quality assessment 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;
(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.
[57 FR 7172, Feb. 28, 1992, as amended at 68 FR 3713, Jan. 24, 2003]
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
[[Page 1054]]
(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 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--
[[Page 1055]]
(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 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
[[Page 1056]]
(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 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
[[Page 1057]]
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 and continue to be certified by a board approved by
HHS; or
(ii) Before February 24, 2003, must have served or be serving as a
director of a laboratory performing high complexity testing and must
have at least--
(A) Two years of laboratory training or experience, or both; and
(B) Two years of laboratory experience directing or supervising high
complexity testing.
(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
(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; 65 FR 82944, Dec. 29, 2000; 68 FR 3713, Jan. 24, 2003]
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 Sec. Sec. 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
[[Page 1058]]
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 assessment 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 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.
[57 FR 7172, Feb. 28, 1992, as amended at 68 FR 3714, Jan. 24, 2003]
Sec. 493.1447 Condition: Laboratories performing high complexity
testing; technical supervisor.
The laboratory must have a technical supervisor who meets the
qualification
[[Page 1059]]
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 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
[[Page 1060]]
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 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
[[Page 1061]]
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 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
[[Page 1062]]
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 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
[[Page 1063]]
(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
(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:
[[Page 1064]]
(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 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
[[Page 1065]]
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:
(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
[[Page 1066]]
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;
(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 Sec. Sec. 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. 493.1274(d) and
(e);
[[Page 1067]]
(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; 68
FR 3714, Jan. 24, 2003]
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]
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
[[Page 1068]]
(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
(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 Sec. Sec. 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 Sec. Sec. 493.1449(b) or 493.1449(l)(1);
(2) In dermatopathology, by an individual who is qualified as a
technical supervisor under Sec. Sec. 493.1449(b) or 493.1449(l) or (2);
(3) In ophthalmic pathology, by an individual who is qualified as a
technical supervisor under Sec. Sec. 493.1449(b) or 493.1449(1)(3); and
(4) In oral pathology, by an individual who is qualified as a
technical supervisor under Sec. Sec. 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,
[[Page 1069]]
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.
(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
[[Page 1070]]
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. 493.1274(c));
(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.
[57 FR 7172, Feb. 28, 1992, as amended at 68 FR 3714, Jan. 24, 2003]
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
[[Page 1071]]
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. 493.1274(c));
(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.
[57 FR 7172, Feb. 28, 1992, as amended at 68 FR 3714, Jan. 24, 2003]
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:
(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
[[Page 1072]]
(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
(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;
[[Page 1073]]
(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;
(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-P [Reserved]
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 Sec. Sec. 493.1775 through 493.1780.
(b) All CLIA-exempt laboratories must comply with the inspection
requirements in Sec. Sec. 493.1773 and 493.1780, when applicable.
[63 FR 26737, May 14, 1998]
[[Page 1074]]
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 CMS or a CMS 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
CMS or a CMS agent to conduct validation and complaint inspections.
(b) General requirements. As part of the inspection process, CMS or
a CMS 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 CMS or a CMS 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 CMS or a CMS 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 CMS or a CMS
agent to make a determination of the laboratory's compliance with the
applicable requirements of this part.
(e) Reinspection. CMS or a CMS 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. CMS or a CMS 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 CMS or a CMS 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]
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, CMS or a CMS 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
[[Page 1075]]
permit an initial inspection to assess the laboratory's compliance with
the requirements of this part before CMS issues a certificate of
compliance.
(2) The inspection may occur at any time during the laboratory's
hours of operation.
(b) Subsequent inspections. (1) CMS or a CMS agent may conduct
subsequent inspections on a biennial basis or with such other frequency
as CMS determines to be necessary to ensure compliance with the
requirements of this part.
(2) CMS 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. CMS or a CMS agent may conduct a
validation inspection of any accredited or CLIA-exempt laboratory at any
time during its hours of operation.
(b) Complaint inspection. CMS or a CMS 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 CMS, 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.
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;
[[Page 1076]]
(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 CMS 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 CMS 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) CMS's decision to
impose sanctions is based on one or more of the following:
(i) Deficiencies found by CMS 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) CMS imposes one or more of the alternative or principal
sanctions specified in Sec. Sec. 493.1806 and 493.1807 when CMS or
CMS's agent finds that a laboratory has condition-level deficiencies.
(c) Imposition of alternative sanctions. (1) CMS may impose
alternative sanctions in lieu of, or in addition to principal sanctions,
(CMS 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) CMS 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. CMS 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 CMS, or its agents:
(1) Whether the deficiencies pose immediate jeopardy.
(2) The nature, incidence, severity, and duration of the
deficiencies or noncompliance.
(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 CMS agents, and to CMS.
(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 CMS 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. CMS 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]
[[Page 1077]]
Sec. 493.1806 Available sanctions: All laboratories.
(a) Applicability. CMS 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. CMS may impose any of the three principal
CLIA sanctions, which are suspension, limitation, or revocation of any
type of CLIA certificate.
(c) Alternative sanctions. CMS 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. CMS 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 CMS 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
CMS suspends or revokes any type of CLIA certificate, CMS concurrently
cancels the laboratory's approval to receive Medicare payment for its
services.
(b) Limitation of any type of CLIA certificate. When CMS limits any
type of CLIA certificate, CMS concurrently limits Medicare approval to
only those 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
CMS or its agency identifies condition level noncompliance in a
laboratory, CMS 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 CMS 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.
[[Page 1078]]
(b) Opportunity to respond. During the period specified in paragraph
(a)(6) of this section, the laboratory may submit to CMS 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. CMS 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 CMS or its agent determines that the deficiencies
pose immediate jeopardy, CMS provides notice at least 5 days before the
effective date of sanction.
(ii) If CMS or its agent determines that the deficiencies do not
pose immediate jeopardy, CMS 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) CMS'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, CMS'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 CMS
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) CMS 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, CMS suspends or limits the laboratory's CLIA
certificate no earlier than 5 days after the date of notice of
suspension or limitation. CMS may later revoke the certificate.
(c) In addition, if CMS 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, CMS 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) CMS may cancel the laboratory's approval to
receive Medicare payment for its services.
(2) CMS may suspend, limit, or revoke the laboratory's CLIA
certificate.
(3) If CMS 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, CMS 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 CMS imposes
alternative sanctions for condition level deficiencies that do not pose
immediate
[[Page 1079]]
jeopardy, and the laboratory does not correct the condition level
deficiencies within 12 months after the last day of inspection, CMS--
(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, CMS 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 CMS 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) CMS cancels the laboratory's approval to receive Medicare
payment for its services.
(2) CMS 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. CMS, the State survey agency or other CMS
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.
(c) Failure to correct deficiencies. If during a visit it is found
that the laboratory has not corrected its deficiencies, CMS 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, CMS 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 Sec. Sec. 493.1814 and 493.1816 apply.
Sec. 493.1826 Suspension of part of Medicare payments.
(a) Application. (1) CMS 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) CMS suspends Medicare payment for those specialities or
subspecialties of tests for which the laboratory is out of compliance
with Federal requirements.
[[Page 1080]]
(b) Procedures. Before imposing this sanction, CMS 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 CMS 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, CMS
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) CMS may suspend payment for all Medicare-
approved laboratory services when the laboratory has condition level
deficiencies.
(2) CMS 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) CMS suspends payment for services furnished on and after the
effective date of sanction.
(b) Procedures. Before imposing this sanction, CMS 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, CMS 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. CMS may impose a directed plan of correction as an
alternative sanction for any laboratory that has condition level
deficiencies. If CMS does not impose a directed plan of correction as an
alternative sanction for a laboratory that has condition 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, CMS--
(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. CMS 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, CMS takes the following
steps--
(i) Directs the laboratory to submit to CMS, the State survey
agency, or other CMS 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 CMS.
(ii) Within 30 calendar days of receipt of the information, may send
to each
[[Page 1081]]
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 CMS imposes a principal
sanction following the imposition of an alternative sanction, and for
which CMS has already obtained a list of laboratory clients, CMS may use
that list to notify the clients of the imposition of the principal
sanction.
(c) Duration of a directed plan of correction. If CMS 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) CMS cancels the laboratory's approval for Medicare payment of
its services, and notifies the laboratory of CMS'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 CMS 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. CMS 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, CMS 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.
(iv) The laboratory's intent or reason for noncompliance.
(v) The accuracy and extent of laboratory records and their
availability to CMS, the State survey agency, or other CMS 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, CMS shifts the penalty amount to the lower
range.
(4) Increased penalty amounts. CMS 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) CMS sends the laboratory written notice, of CMS'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 CMS considered.
(D) The opportunity for responding to the notice in accordance with
Sec. 493.1810(c).
[[Page 1082]]
(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, CMS 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, CMS determines that compliance was achieved before the
revisit. (In this situation, the money penalty stops accruing as of the
date of compliance.)
(iii) CMS 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.
CMS computes the total penalty amount after the laboratory's compliance
is verified or CMS 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.
(2) CMS 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. CMS 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) CMS 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 CMS
and the State.
[[Page 1083]]
(ii) The hourly rate includes salary, fringe benefits, travel, and
other direct and indirect costs approved by CMS.
(b) Procedures. Before imposing this sanction, CMS provides notice
of sanction and opportunity to respond in accordance with Sec.
493.1810.
(c) Duration of sanction. (1) If CMS imposes onsite monitoring, the
sanction continues until CMS 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, CMS 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, CMS 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 Sec. Sec. 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. CMS may initiate adverse action to suspend, limit
or revoke any CLIA certificate if CMS 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 CMS for any
information or work on materials that CMS concludes is necessary to
determine the laboratory's continued eligibility for its CLIA
certificate or continued compliance with performance standards set by
CMS;
(5) Refused a reasonable request by CMS 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 CMS determines that a laboratory has intentionally referred
its proficiency testing samples to another laboratory for analysis, CMS
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, CMS 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, CMS
[[Page 1084]]
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. CMS 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 CMS or a CMS agent
to inspect the laboratory or its operation.
(e) Procedures for revocation. (1) CMS does not revoke any type of
CLIA certificate until after an ALJ hearing that upholds revocation.
(2) CMS 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. CMS 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) CMS always cancels a laboratory's
approval to receive Medicare payment for its services if CMS suspends or
revokes the laboratory's CLIA certificate.
(2) CMS 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 CMS.
(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, CMS
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 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 CMS 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
[[Page 1085]]
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 CMS-approved
accreditation organization is no longer deemed to meet the conditions
set forth in subparts H, J, K, M, 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 CMS 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) CMS 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
CMS or a CMS agent to inspect the laboratory or its operation.
(3) Cancellation of Medicare approval. The effective date of the
cancellation 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 Sec. Sec. 498.22 through 498.25 of this chapter.
(2) Notice of reopening. If CMS reopens an initial or reconsidered
determination, CMS 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
[[Page 1086]]
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 CMS suspends, limits, or
revokes a laboratory's CLIA certificate or cancels the approval to
receive Medicare payment for its services, CMS 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, CMS 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 CMS 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, as amended at 68
FR 3714, Jan. 24, 2003]
Sec. 493.1846 Civil action.
If CMS has reason to believe that continuation of the activities of
any laboratory, including a State-exempt laboratory, would constitute a
significant hazard to the public health, CMS 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 CMS 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 CMS makes available to physicians and to the general
public specific information (including information provided to CMS 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.
[[Page 1087]]
(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 CMS 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 nonwaived testing;
(2) Determination of waived tests;
(3) Personnel standards;
(4) Facility administration and quality systems 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.
(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; 68 FR 3714, Jan. 24, 2003]
PART 494 [RESERVED]