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.
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
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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.
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.
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.
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.
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
[[Page 884]]
death, to individuals served by the laboratory or to the health or
safety of the general public. This term is synonymous with imminent and
serious risk to human health and significant hazard to the public
health.
Intentional violation means knowing and willful noncompliance with
any CLIA condition.
Kit means all components of a test that are packaged together.
Laboratory means a facility for the biological, microbiological,
serological, chemical, immunohematological, hematological, biophysical,
cytological, pathological, or other examination of materials derived
from the human body for the purpose of providing information for the
diagnosis, prevention, or treatment of any disease or impairment of, or
the assessment of the health of, human beings. These examinations also
include procedures to determine, measure, or otherwise describe the
presence or absence of various substances or organisms in the body.
Facilities only collecting or preparing specimens (or both) or only
serving as a mailing service and not performing testing are not
considered laboratories.
Midlevel practitioner means a nurse midwife, nurse practitioner, or
physician assistant, licensed by the State within which the individual
practices, if such licensing is required in the State in which the
laboratory is located.
Operator means the individual or group of individuals who oversee
all facets of the operation of a laboratory and who bear primary
responsibility for the safety and reliability of the results of all
specimen testing performed in that laboratory. The term includes--
(1) A director of the laboratory if he or she meets the stated
criteria; and
(2) The members of the board of directors and the officers of a
laboratory that is a small corporation under subchapter S of the
Internal Revenue Code.
Owner means any person who owns any interest in a laboratory except
for an interest in a laboratory whose stock and/or securities are
publicly traded. (That is e.g., the purchase of shares of stock or
securities on the New York Stock Exchange in a corporation owning a
laboratory would not make a person an owner for the purpose of this
regulation.)
Party means a laboratory affected by any of the enforcement
procedures set forth in this subpart, by 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
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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 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,
[[Page 886]]
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.
[57 FR 7139, Feb. 28, 1992, as amended at 57 FR 7236, Feb. 28, 1992; 57
FR 34013, July 31, 1992; 57 FR 35761, Aug. 11, 1992; 58 FR 5220, Jan.
19, 1993; 58 FR 48323, Sept. 15, 1993; 60 FR 20043, Apr. 24, 1995; 63 FR
26732, May 14, 1998]
Sec. 493.3 Applicability.
(a) Basic rule. Except as specified in paragraph (b) of this
section, a laboratory will be cited as out of compliance with section
353 of the Public Health Service Act unless it--
(1) Has a current, unrevoked or unsuspended certificate of waiver,
registration certificate, certificate of compliance, certificate for PPM
procedures, or certificate of accreditation issued by HHS applicable to
the category of examinations or procedures performed by the laboratory;
or
(2) Is CLIA-exempt.
(b) Exception. These rules do not apply to components or functions
of--
(1) Any facility or component of a facility that only performs
testing for forensic purposes;
(2) Research laboratories that test human specimens but do not
report patient specific results for the diagnosis, prevention or
treatment of any disease or impairment of, or the assessment of the
health of individual patients; or
(3) Laboratories certified by the 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]
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
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Act if it restricts the tests that it performs to one or more of the
following tests or examinations (or additional tests added to this list
as provided under paragraph (d) of this section) and no others:
(1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the
following:
(i) Bilirubin;
(ii) Glucose;
(iii) Hemoglobin;
(iv) Ketone;
(v) Leukocytes;
(vi) Nitrite;
(vii) pH;
(viii) Protein;
(ix) Specific gravity; and
(x) Urobilinogen.
(2) Fecal occult blood;
(3) Ovulation tests--visual color comparison tests for human
luteinizing hormone;
(4) Urine pregnancy tests--visual color comparison tests;
(5) Erythrocyte sedimentation rate--non-automated;
(6) Hemoglobin--copper sulfate--non-automated;
(7) Blood glucose by glucose monitoring devices cleared by the FDA
specifically for home use;
(8) Spun microhematocrit; and
(9) Hemoglobin by single analyte instruments with self-contained or
component features to perform specimen/reagent interaction, providing
direct measurement and readout.
(d) Revisions to criteria for test categorization and the list of
waived tests. HHS will determine whether a laboratory test meets the
criteria listed under paragraph (b) of this section for a waived test.
Revisions to the list of waived tests approved by HHS will be published
in the Federal Register in a notice with opportunity for comment.
(e) Laboratories eligible for a certificate of waiver must--
(1) Follow manufacturers' instructions for performing the test; and
(2) Meet the requirements in subpart B, Certificate of Waiver, of
this part.
[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5221, Jan. 19, 1993]
Sec. 493.17 Test categorization.
(a) Categorization by criteria. Notices will be published in the
Federal Register which list each specific test system, assay, and
examination categorized by complexity. Using the seven criteria
specified in this paragraph for categorizing tests of moderate or high
complexity, each specific laboratory test system, assay, and examination
will be graded for level of complexity by assigning scores of 1, 2, or 3
within each criteria. The score of "1" indicates the lowest level of
complexity, and the score of "3" indicates the highest level. These
scores will be totaled. Test systems, assays or examinations receiving
scores of 12 or less will be categorized as moderate complexity, while
those receiving scores above 12 will be categorized as high complexity.
Note: A score of "2" will be assigned to a criteria heading when
the characteristics for a particular test are intermediate between the
descriptions listed for scores of "1" and "3."
(1) Knowledge.
(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
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no special handling, precautions or storage conditions.
(ii) Score 3. (A) Reagents and materials may be labile and may
require special handling to assure reliability; or
(B) Reagents and materials preparation may include manual steps such
as gravimetric or volumetric measurements.
(4) Characteristics of operational steps. (i) Score 1. Operational
steps are either automatically executed (such as pipetting, temperature
monitoring, or timing of steps), or are easily controlled.
(ii) Score 3. Operational steps in the testing process require close
monitoring or control, and may require special specimen preparation,
precise temperature control or timing of procedural steps, accurate
pipetting, or extensive calculations.
(5) Calibration, quality control, and proficiency testing materials.
(i) Score 1. (A) Calibration materials are stable and readily
available;
(B) Quality control materials are stable and readily available; and
(C) External proficiency testing materials, when available, are
stable.
(ii) Score 3. (A) Calibration materials, if available, may be
labile;
(B) Quality control materials may be labile, or not available; or
(C) External proficiency testing materials, if available, may be
labile.
(6) Test system troubleshooting and equipment maintenance.
(i) Score 1. (A) Test system troubleshooting is automatic or self-
correcting, or clearly described or requires minimal judgment; and
(B) Equipment maintenance is provided by the manufacturer, is seldom
needed, or can easily be performed.
(ii) Score 3. (A) Troubleshooting is not automatic and requires
decision-making and direct intervention to resolve most problems; or
(B) Maintenance requires special knowledge, skills, and abilities.
(7) Interpretation and judgment. (i) Score 1. (A) Minimal
interpretation and judgment are required to perform preanalytic,
analytic and postanalytic processes; and
(B) Resolution of problems requires limited independent
interpretation and judgment; and
(ii) Score 3. (A) Extensive independent interpretation and judgment
are required to perform the preanalytic, analytic or postanalytic
processes; and
(B) Resolution of problems requires extensive interpretation and
judgment.
(b) Revisions to the criteria for categorization. The Clinical
Laboratory Improvement Advisory Committee, as defined in subpart T of
this part, will conduct reviews upon request of HHS and recommend to HHS
revisions to the criteria for categorization of tests.
(c) Process for device/test categorization utilizing the scoring
system under Sec. 493.17(a). (1)(i) For new commercial test systems,
assays, or examinations, the manufacturer, as part of its 510(k) and PMA
application to FDA, will submit supporting data for device/test
categorization. FDA will determine the complexity category, notify the
manufacturers directly, and will simultaneously inform both 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
[[Page 889]]
new information not previously submitted in a request for categorization
or recategorization by the same applicant and will not be considered
more frequently than once per year.
(4) If a laboratory test system, assay or examination does not
appear on the lists of tests in the FEDERAL REGISTER notices, it is
considered to be a test of high complexity until PHS, upon request,
reviews the matter and notifies the applicant of its decision. Test
categorization is effective as of the notification to the applicant.
(5) PHS will publish revisions periodically to the list of moderate
and high complexity tests in the FEDERAL REGISTER in a notice with
opportunity for comment.
[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993]
Sec. 493.19 Provider-performed microscopy (PPM) procedures.
(a) Requirement. To be categorized as a PPM procedure, the procedure
must meet the criteria specified in paragraph (b) of this section.
(b) Criteria. Procedures must meet the following specifications:
(1) The examination must be personally performed by one of the
following practitioners:
(i) A physician during the patient's visit on a specimen obtained
from his or her own patient or from a patient of a group medical
practice of which the physician is a member or an employee.
(ii) A midlevel practitioner, under the supervision of a physician
or in independent practice only if authorized by the State, during the
patient's visit on a specimen obtained from his or her own patient or
from a patient of a clinic, group medical practice, or other health care
provider of which the midlevel practitioner is a member or an employee.
(iii) A dentist during the patient's visit on a specimen obtained
from his or her own patient or from a patient of a group dental practice
of which the dentist is a member or an employee.
(2) The procedure must be categorized as moderately complex.
(3) The primary instrument for performing the test is the
microscope, limited to bright-field or phase-contrast microscopy.
(4) The specimen is labile or delay in performing the test could
compromise the accuracy of the test result.
(5) Control materials are not available to monitor the entire
testing process.
(6) Limited specimen handling or processing is required.
(c) Provider-performed microscopy (PPM) examinations. A laboratory
may qualify to perform tests under this section if it restricts PPM
examinations to one or more of the following procedures (or additional
procedures added to this list as provided under paragraph (d) of this
section), waived tests and no others:
(1) All direct wet mount preparations for the presence or absence of
bacteria, fungi, parasites, and human cellular elements.
(2) All potassium hydroxide (KOH) preparations.
(3) Pinworm examinations.
(4) Fern tests.
(5) Post-coital direct, qualitative examinations of vaginal or
cervical mucous.
(6) Urine sediment examinations.
(7) Nasal smears for granulocytes.
(8) Fecal leukocyte examinations.
(9) Qualitative semen analysis (limited to the presence or absence
of sperm and detection of motility).
(d) Revisions to criteria and the list of PPM procedures.
(1) The CLIAC conducts reviews upon HHS' request and recommends to
HHS revisions to the criteria for categorization of procedures.
(2) HHS determines whether a laboratory procedure meets the criteria
listed under paragraph (b) of this section for a PPM procedure.
Revisions to the list of PPM procedures proposed by HHS are published in
the FEDERAL REGISTER as a notice with an opportunity for public comment.
(e) Laboratory requirements. Laboratories eligible to perform PPM
examinations must--
(1) Meet the applicable requirements in subpart C or subpart D, and
subparts F, H, J, K, M, and P of this part.
(2) Be subject to inspection as specified under subpart Q of this
part.
[60 FR 20044, Apr. 24, 1995]
[[Page 890]]
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 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]
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] |