[Code of Federal Regulations]
[Title 42, Volume 3, Parts 430 to end]
[Revised as of October 1, 1997]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493]
[Page 798-923]
TITLE 42--PUBLIC HEALTH
CHAPTER IV--HEALTH CARE FINANCING ADMINISTRATION, 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.
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.
[[Page 799]]
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
493.501 General requirements for accredited laboratories.
493.503 Proficiency testing requirements of laboratories with deemed
status.
493.504 Revocation of accreditation.
493.506 Federal review and approval of private, nonprofit accreditation
organizations.
493.507 Validation inspections of laboratories with certificates of
accreditation.
493.509 Continuing Federal oversight of private, nonprofit
accreditation organizations.
493.511 Removal of deeming authority and final determination review.
493.513 General requirements for CLIA-exempt laboratories.
493.515 Federal review of laboratory requirements of State laboratory
programs.
493.517 Validation inspections of CLIA-exempt laboratories.
493.519 Continuing Federal oversight of an approved State laboratory
program.
493.521 Removal of CLIA exemption and final determination review.
Subpart F--General Administration
493.602 Scope of subpart.
493.606 Applicability of subpart.
493.638 Certificate fees.
493.639 Fee for revised certificate.
493.643 Fee for determination of program compliance.
493.645 Additional fee(s) applicable to approved State laboratory
programs and laboratories issued a certificate of
accreditation, certificate of waiver, or certificate for PPM
procedures.
493.646 Payment of fees.
493.649 Methodology for determining fee amount.
Subpart G--[Reserved]
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Tests of Moderate Complexity (Including the Subcategory),
High Complexity, or Any Combination of These Tests
493.801 Condition: Enrollment and testing of samples.
493.803 Condition: Successful participation.
493.807 Condition: Reinstatement of laboratories performing tests of
moderate complexity (including the subcategory), high
complexity, or any combination of these tests, after failure
to participate successfully.
Proficiency Testing by Specialty and Subspecialty for Laboratories
Performing Tests of Moderate Complexity (Including the Subcategory),
High Complexity, or Any Combination of These Tests
493.821 Condition: Microbiology.
493.823 Standard; Bacteriology.
493.825 Standard; Mycobacteriology.
493.827 Standard; Mycology.
493.829 Standard; Parasitology.
493.831 Standard; Virology.
493.833 Condition: Diagnostic immunology.
493.835 Standard; Syphilis serology.
493.837 Standard; General immunology.
493.839 Condition: Chemistry.
493.841 Standard; Routine chemistry.
493.843 Standard; Endocrinology.
493.845 Standard; Toxicology.
493.849 Condition: Hematology.
493.851 Standard; Hematology.
493.853 Condition: Pathology.
493.855 Standard; Cytology: gynecologic examinations.
493.857 Condition: Immunohematology.
493.859 Standard; ABO group and D (Rho) typing.
493.861 Standard; Unexpected antibody detection.
493.863 Standard; Compatibility testing.
493.865 Standard; Antibody identification.
[[Page 800]]
Subpart I--Proficiency Testing Programs for Tests of Moderate Complexity
(Including the Subcategory), High Complexity, or Any Combination of
These Tests
493.901 Approval of proficiency testing programs.
493.903 Administrative responsibilities.
493.905 Nonapproved proficiency testing programs.
Proficiency Testing Programs by Specialty and Subspecialty
493.909 Microbiology.
493.911 Bacteriology.
493.913 Mycobacteriology.
493.915 Mycology.
493.917 Parasitology.
493.919 Virology.
493.921 Diagnostic immunology.
493.923 Syphilis serology.
493.927 General immunology.
493.929 Chemistry.
493.931 Routine chemistry.
493.933 Endocrinology.
493.937 Toxicology.
493.941 Hematology (including routine hematology and coagulation).
493.945 Cytology; gynecologic examinations.
493.959 Immunohematology.
Subpart J--Patient Test Management for Moderate Complexity (Including
the Subcategory), High Complexity, or Any Combination of These Tests
493.1101 Condition: Patient test management; moderate complexity
(including the subcategory), or high complexity testing, or
any combination of these tests.
493.1103 Standard; Procedures for specimen submission and handling.
493.1105 Standard; Test requisition.
493.1107 Standard; Test records.
493.1109 Standard; Test report.
493.1111 Standard; Referral of specimens.
Subpart K--Quality Control for Tests of Moderate Complexity (Including
the Subcategory), High Complexity, or Any Combination of These Tests
493.1201 Condition: General quality control; moderate complexity
(including the subcategory) or high complexity testing, or any
combination of these tests.
493.1202 Standard; Moderate or high complexity testing, or both:
Effective from September 1, 1992 to July 31, 1998.
493.1203 Standard; Moderate or high complexity testing, or both:
Effective beginning July 31, 1998.
493.1204 Standard; Facilities.
493.1205 Standard; Test methods, equipment, instrumentation, reagents,
materials, and supplies.
493.1211 Standard; Procedure manual.
493.1213 Standard; Establishment and verification of method performance
specifications.
493.1215 Standard; Equipment maintenance and function checks.
493.1217 Standard; Calibration and calibration verification procedures.
493.1218 Standard; Control procedures.
493.1219 Standard; Remedial actions.
493.1221 Standard; Quality control records.
493.1223 Condition: Quality control--specialties and subspecialties for
tests of moderate or high complexity, or both.
493.1225 Condition: Microbiology.
493.1227 Condition: Bacteriology.
493.1229 Condition: Mycobacteriology.
493.1231 Condition: Mycology.
493.1233 Condition: Parasitology.
493.1235 Condition: Virology.
493.1237 Condition: Diagnostic immunology.
493.1239 Condition: Syphilis serology.
493.1241 Condition: General immunology.
493.1243 Condition: Chemistry.
493.1245 Condition: Routine chemistry.
493.1247 Condition: Endocrinology.
493.1249 Condition: Toxicology.
493.1251 Condition: Urinalysis.
493.1253 Condition: Hematology.
493.1255 Condition: Pathology.
493.1257 Condition: Cytology.
493.1259 Condition: Histopathology.
493.1261 Condition: Oral pathology.
493.1263 Condition: Radiobioassay.
493.1265 Condition: Histocompatibility.
493.1267 Condition: Clinical cytogenetics.
493.1269 Condition: Immunohematology.
493.1271 Condition: Transfusion services and bloodbanking.
493.1273 Standard; Immunohematological collection, processing, dating
periods, labeling and distribution of blood and blood
products.
493.1275 Standard; Blood and blood products storage facilities.
493.1277 Standard; Arrangement for services.
493.1279 Standard; Provision of testing.
493.1283 Standard; Retention of samples of transfused blood.
493.1285 Standard; Investigation of transfusion reactions.
Subpart L--[Reserved]
Subpart M--Personnel for Moderate Complexity (Including the Subcategory)
and High Complexity Testing
493.1351 General.
[[Page 801]]
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-O--[Reserved]
Subpart P--Quality Assurance for Moderate Complexity (Including the
Subcategory) or High Complexity Testing, or Any Combination of These
Tests
493.1701 Condition: Quality assurance; moderate complexity (including
the subcategory) or high complexity testing, or any
combination of these tests.
493.1703 Standard; Patient test management assessment.
493.1705 Standard; Quality control assessment.
493.1707 Standard; Proficiency testing assessment.
493.1709 Standard; Comparison of test results.
493.1711 Standard; Relationship of patient information to patient test
results.
493.1713 Standard; Personnel assessment.
493.1715 Standard; Communications.
[[Page 802]]
493.1717 Standard; Complaint investigations.
493.1719 Standard; Quality assurance review with staff.
493.1721 Standard; Quality assurance records.
Subpart Q--Inspection
493.1775 Condition: Inspection of laboratories issued a certificate of
waiver.
493.1776 Condition: Inspection of laboratories issued a certificate for
PPM procedures.
493.1777 Condition: Inspection of laboratories requesting or issued a
certificate of compliance.
493.1780 Condition: Inspection of accredited and CLIA-exempt
laboratories.
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), and the sentence following sections 1861(s)(11) through
1861(s)(16) of the Social Security Act (42 U.S.C. 263a, 1302, 1395x(e),
and 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
[[Page 803]]
HHS or its designee determines meets substantially equivalent
requirements.
Accredited laboratory means a laboratory that has voluntarily
applied for and been accredited by a private, nonprofit accreditation
organization approved by HCFA in accordance with this part;
Adverse action means the imposition of a principal or alternative
sanction by HCFA.
ALJ stands for Administrative Law Judge.
Alternative sanctions means sanctions that may be imposed in lieu of
or in addition to principal sanctions. The term is synonymous with
``intermediate sanctions'' as used in section 1846 of the Act.
Analyte means a substance or constituent for which the laboratory
conducts testing.
Approved accreditation organization for laboratories means a
private, nonprofit accreditation organization that has formally applied
for and received HCFA's approval based on the organization's compliance
with this part.
Approved State laboratory program means a licensure or other
regulatory program for laboratories in a State, the requirements of
which are imposed under State law, and the State laboratory program has
received HCFA approval based on the State's compliance with this part.
Authorized person means an individual authorized under State law to
order tests or receive test results, or both.
Challenge means, for quantitative tests, an assessment of the amount
of substance or analyte present or measured in a sample. For qualitative
tests, a challenge means the determination of the presence or the
absence of an analyte, organism, or substance in a sample.
CLIA means the Clinical Laboratory Improvement Amendments of 1988.
CLIA certificate means any of the following types of certificates
issued by HCFA or its agent:
(1) Certificate of compliance means a certificate issued to a
laboratory after an inspection that finds the laboratory to be in
compliance with all applicable condition level requirements, or reissued
before the expiration date, pending an appeal, in accordance with
Sec. 493.49, when an inspection has found the laboratory to be out of
compliance with one or more condition level requirements.
(2) Certificate for provider-performed microscopy (PPM) procedures
means a certificate issued or reissued before the expiration date,
pending an appeal, in accordance with Sec. 493.47, to a laboratory in
which a physician, midlevel practitioner or dentist performs no tests
other than PPM procedures and, if desired, waived tests listed in
Sec. 493.15(c).
(3) Certificate of accreditation means a certificate issued on the
basis of the laboratory's accreditation by an accreditation organization
approved by HCFA (indicating that the laboratory is deemed to meet
applicable CLIA requirements) or reissued before the expiration date,
pending an appeal, in accordance with Sec. 493.61, when a validation or
complaint survey has found the laboratory to be noncompliant with one or
more CLIA conditions.
(4) Certificate of registration or registration certificate means a
certificate issued or reissued before the expiration date, pending an
appeal, in accordance with Sec. 493.45, that enables the entity to
conduct moderate or high complexity laboratory testing or both until the
entity is determined to be in compliance through a survey by HCFA or its
agent; or in accordance with Sec. 493.57 to an entity that is accredited
by an approved accreditation organization.
(5) Certificate of waiver means a certificate issued or reissued
before the expiration date, pending an appeal, in accordance with
Sec. 493.37, to a laboratory to perform only the waived tests listed at
Sec. 493.15(c).
CLIA-exempt laboratory means a laboratory that has been licensed or
approved by a State where HCFA has determined that the State has enacted
laws relating to laboratory requirements that are equal to or more
stringent than CLIA requirements and the State licensure program has
been approved by HCFA in accordance with subpart E of this part.
Condition level deficiency means noncompliance with one or more
condition level requirements.
Condition level requirements means any of the requirements
identified as
[[Page 804]]
``conditions'' in subparts G through Q of this part.
Credible allegation of compliance means a statement or documentation
that--
(1) Is made by a representative of a laboratory that has a history
of having maintained a commitment to compliance and of taking corrective
action when required;
(2) Is realistic in terms of its being possible to accomplish the
required corrective action between the date of the exit conference and
the date of the allegation; and
(3) Indicates that the problem has been resolved.
Dentist means a doctor of dental medicine or doctor of dental
surgery licensed by the State to practice dentistry within the State in
which the laboratory is located.
Equivalency means that an accreditation organization's or a State
laboratory program's requirements, taken as a whole, are equal to or
more stringent than the CLIA requirements established by HCFA, taken as
whole. It is acceptable for an accreditation organization's or State
laboratory program's requirements to be organized differently or
otherwise vary from the CLIA requirements, as long as (1) all of the
requirements taken as a whole would provide at least the same protection
as the CLIA requirements taken as a whole; and (2) a finding of
noncompliance with respect to CLIA requirements taken as a whole would
be matched by a finding of noncompliance with the accreditation or State
requirements taken as a whole.
HCFA agent means an entity with which HCFA arranges to inspect
laboratories and assess laboratory activities against CLIA requirements
and may be a State survey agency, a private, nonprofit organization
other than an approved accreditation organization, a component of HHS,
or any other governmental component HCFA approves for this purpose. In
those instances where all of the laboratories in a State are exempt from
CLIA requirements, based on the approval of a State's exemption request,
the State survey agency is not the HCFA agent.
HHS means the Department of Health and Human Services, or its
designee.
Immediate jeopardy means a situation in which immediate corrective
action is necessary because the laboratory's noncompliance with one or
more condition level requirements has already caused, is causing, or is
likely to cause, at any time, serious injury or harm, or death, to
individuals served by the laboratory or to the health or safety of the
general public. This term is synonymous with imminent and serious risk
to human health and significant hazard to the public health.
Intentional violation means knowing and willful noncompliance with
any CLIA condition.
Kit means all components of a test that are packaged together.
Laboratory means a facility for the biological, microbiological,
serological, chemical, immunohematological, hematological, biophysical,
cytological, pathological, or other examination of materials derived
from the human body for the purpose of providing information for the
diagnosis, prevention, or treatment of any disease or impairment of, or
the assessment of the health of, human beings. These examinations also
include procedures to determine, measure, or otherwise describe the
presence or absence of various substances or organisms in the body.
Facilities only collecting or preparing specimens (or both) or only
serving as a mailing service and not performing testing are not
considered laboratories.
Midlevel practitioner means a nurse midwife, nurse practitioner, or
physician assistant, licensed by the State within which the individual
practices, if such licensing is required in the State in which the
laboratory is located.
Operator means the individual or group of individuals who oversee
all facets of the operation of a laboratory and who bear primary
responsibility for the safety and reliability of the results of all
specimen testing performed in that laboratory. The term includes--
(1) A director of the laboratory if he or she meets the stated
criteria; and
(2) The members of the board of directors and the officers of a
laboratory that is a small corporation under subchapter S of the
Internal Revenue Code.
[[Page 805]]
Owner means any person who owns any interest in a laboratory except
for an interest in a laboratory whose stock and/or securities are
publicly traded. (That is e.g., the purchase of shares of stock or
securities on the New York Stock Exchange in a corporation owning a
laboratory would not make a person an owner for the purpose of this
regulation.)
Party means a laboratory affected by any of the enforcement
procedures set forth in this subpart, by HCFA or the OIG, as
appropriate.
Performance characteristic means a property of a test that is used
to describe its quality, e.g., accuracy, precision, analytical
sensitivity, analytical specificity, reportable range, reference range,
etc.
Performance specification means a value or range of values for a
performance characteristic, established or verified by the laboratory,
that is used to describe the quality of patient test results.
Physician means an individual with a doctor of medicine, doctor of
osteopathy, or doctor of podiatric medicine degree who is licensed by
the State to practice medicine, osteopathy, or podiatry within the State
in which the laboratory is located.
Principal sanction means the suspension, limitation, or revocation
of any type of CLIA certificate or the cancellation of the laboratory's
approval to receive Medicare payment for its services.
Prospective laboratory means a laboratory that is operating under a
registration certificate or is seeking any of the three other types of
CLIA certificates.
Rate of disparity means the percentage of sample validation
inspections for a specific accreditation organization or State where
HCFA, the State survey agency or other HCFA agent finds noncompliance
with one or more condition level requirements but no comparable
deficiencies were cited by the accreditation organization or the State,
and it is reasonable to conclude that the deficiencies were present at
the time of the most recent accreditation organization or State
licensure inspection.
Example: Assume the State survey agency, HCFA or other HCFA agent
performs 200 sample validation inspections for laboratories accredited
by a single accreditation organization or licensed in an exempt State
during a validation review period and finds that 60 of the 200
laboratories had one or more condition level requirements out of
compliance. HCFA reviews the validation and accreditation organization's
or State's inspections of the validated laboratories and determines that
the State or accreditation organization found comparable deficiencies in
22 of the 60 laboratories and it is reasonable to conclude that
deficiencies were present in the remaining 38 laboratories at the time
of the accreditation organization's or State's inspection. Thirty-eight
divided by 200 equals a 19 percent rate of disparity.
Referee laboratory means a laboratory currently in compliance with
applicable CLIA requirements, that has had a record of satisfactory
proficiency testing performance for all testing events for at least one
year for a specific test, analyte, subspecialty, or specialty and has
been designated by an HHS approved proficiency testing program as a
referee laboratory for analyzing proficiency testing specimens for the
purpose of determining the correct response for the specimens in a
testing event for that specific test, analyte, subspecialty, or
specialty.
Reference range means the range of test values expected for a
designated population of individuals, e.g., 95 percent of individuals
that are presumed to be healthy (or normal).
Sample in proficiency testing means the material contained in a
vial, on a slide, or other unit that contains material to be tested by
proficiency testing program participants. When possible, samples are of
human origin.
State includes, for purposes of this part, each of the 50 States,
the District of Columbia, the Commonwealth of Puerto Rico, the Virgin
Islands and a political subdivision of a State where the State, acting
pursuant to State law, has expressly delegated powers to the political
subdivision sufficient to authorize the political subdivision to act for
the State in enforcing requirements equal to or more stringent than CLIA
requirements.
State licensure means the issuance of a license to, or the approval
of, a laboratory by a State laboratory program as meeting standards for
licensing or approval established under State law.
[[Page 806]]
State survey agency means the State health agency or other
appropriate State or local agency that has an agreement under section
1864 of the Social Security Act and is used by HCFA to perform surveys
and inspections.
Substantial allegation of noncompliance means a complaint from any
of a variety of sources (including complaints submitted in person, by
telephone, through written correspondence, or in newspaper or magazine
articles) that, if substantiated, would have an impact on the health and
safety of the general public or of individuals served by a laboratory
and raises doubts as to a laboratory's compliance with any condition
level requirement.
Target value for quantitative tests means either the mean of all
participant responses after removal of outliers (those responses greater
than 3 standard deviations from the original mean) or the mean
established by definitive or reference methods acceptable for use in the
National Reference System for the Clinical Laboratory (NRSCL) by the
National Committee for the Clinical Laboratory Standards (NCCLS). In
instances where definitive or reference methods are not available or a
specific method's results demonstrate bias that is not observed with
actual patient specimens, as determined by a defensible scientific
protocol, a comparative method or a method group (``peer'' group) may be
used. If the method group is less than 10 participants, ``target value''
means the overall mean after outlier removal (as defined above) unless
acceptable scientific reasons are available to indicate that such an
evaluation is not appropriate.
Unsatisfactory proficiency testing performance means failure to
attain the minimum satisfactory score for an analyte, test,
subspecialty, or specialty for a testing event.
Unsuccessful participation in proficiency testing means any of the
following:
(1) Unsatisfactory performance for the same analyte in two
consecutive or two out of three testing events.
(2) Repeated unsatisfactory overall testing event scores for two
consecutive or two out of three testing events for the same specialty or
subspecialty.
(3) An unsatisfactory testing event score for those subspecialties
not graded by analyte (that is, bacteriology, mycobacteriology,
virology, parasitology, mycology, blood compatibility, immunohematology,
or syphilis serology) for the same subspecialty for two consecutive or
two out of three testing events.
(4) Failure of a laboratory performing gynecologic cytology to meet
the standard at Sec. 493.855.
Unsuccessful proficiency testing performance means a failure to
attain the minimum satisfactory score for an analyte, test,
subspecialty, or specialty for two consecutive or two of three
consecutive testing events.
Validation review period means the one year time period during which
HCFA conducts validation inspections and evaluates the results of the
most recent surveys performed by an accreditation organization or State
laboratory program.
[57 FR 7139, Feb. 28, 1992, as amended at 57 FR 7236, Feb. 28, 1992; 57
FR 34013, July 31, 1992; 57 FR 35761, Aug. 11, 1992; 58 FR 5220, Jan.
19, 1993; 58 FR 48323, Sept. 15, 1993; 60 FR 20043, Apr. 24, 1995]
Sec. 493.3 Applicability.
(a) Basic rule. Except as specified in paragraph (b) of this
section, a laboratory will be cited as out of compliance with section
353 of the Public Health Service Act unless it--
(1) Has a current, unrevoked or unsuspended certificate of waiver,
registration certificate, certificate of compliance, certificate for PPM
procedures, or certificate of accreditation issued by HHS applicable to
the category of examinations or procedures performed by the laboratory;
or
(2) Is CLIA-exempt.
(b) Exception. These rules do not apply to components or functions
of--
(1) Any facility or component of a facility that only performs
testing for forensic purposes;
(2) Research laboratories that test human specimens but do not
report patient specific results for the diagnosis, prevention or
treatment of any disease or impairment of, or the assessment of the
health of individual patients; or
(3) Laboratories certified by the National Institutes on Drug Abuse
[[Page 807]]
(NIDA), in which drug testing is performed which meets NIDA guidelines
and regulations. However, all other testing conducted by a NIDA-
certified laboratory is subject to this rule.
(c) Federal laboratories. Laboratories under the jurisdiction of an
agency of the Federal Government are subject to the rules of this part,
except that the Secretary may modify the application of such
requirements as appropriate.
[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5221, Jan. 19, 1993; 60
FR 20043, Apr. 24, 1995]
Sec. 493.5 Categories of tests by complexity.
(a) Laboratory tests are categorized as one of the following:
(1) Waived tests.
(2) Tests of moderate complexity, including the subcategory of PPM
procedures.
(3) Tests of high complexity.
(b) A laboratory may perform only waived tests, only tests of
moderate complexity, only PPM procedures, only tests of high complexity
or any combination of these tests.
(c) Each laboratory must be either CLIA-exempt or possess one of the
following CLIA certificates, as defined in Sec. 493.2:
(1) Certificate of registration or registration certificate.
(2) Certificate of waiver.
(3) Certificate for PPM procedures.
(4) Certificate of compliance.
(5) Certificate of accreditation.
[60 FR 20043, Apr. 24, 1995]
Sec. 493.15 Laboratories performing waived tests.
(a) Requirement. Tests for certificate of waiver must meet the
descriptive criteria specified in paragraph (b) of this section.
(b) Criteria. Test systems are simple laboratory examinations and
procedures which--
(1) Are cleared by FDA for home use;
(2) Employ methodologies that are so simple and accurate as to
render the likelihood of erroneous results negligible; or
(3) Pose no reasonable risk of harm to the patient if the test is
performed incorrectly.
(c) Certificate of waiver tests. A laboratory may qualify for a
certificate of waiver under section 353 of the PHS Act if it restricts
the tests that it performs to one or more of the following tests or
examinations (or additional tests added to this list as provided under
paragraph (d) of this section) and no others:
(1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the
following:
(i) Bilirubin;
(ii) Glucose;
(iii) Hemoglobin;
(iv) Ketone;
(v) Leukocytes;
(vi) Nitrite;
(vii) pH;
(viii) Protein;
(ix) Specific gravity; and
(x) Urobilinogen.
(2) Fecal occult blood;
(3) Ovulation tests--visual color comparison tests for human
luteinizing hormone;
(4) Urine pregnancy tests--visual color comparison tests;
(5) Erythrocyte sedimentation rate--non-automated;
(6) Hemoglobin--copper sulfate--non-automated;
(7) Blood glucose by glucose monitoring devices cleared by the FDA
specifically for home use;
(8) Spun microhematocrit; and
(9) Hemoglobin by single analyte instruments with self-contained or
component features to perform specimen/reagent interaction, providing
direct measurement and readout.
(d) Revisions to criteria for test categorization and the list of
waived tests. HHS will determine whether a laboratory test meets the
criteria listed under paragraph (b) of this section for a waived test.
Revisions to the list of waived tests approved by HHS will be published
in the Federal Register in a notice with opportunity for comment.
(e) Laboratories eligible for a certificate of waiver must--
(1) Follow manufacturers' instructions for performing the test; and
(2) Meet the requirements in subpart B, Certificate of Waiver, of
this part.
[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5221, Jan. 19, 1993]
[[Page 808]]
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.
(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
[[Page 809]]
(B) Resolution of problems requires limited independent
interpretation and judgment; and
(ii) Score 3. (A) Extensive independent interpretation and judgment
are required to perform the preanalytic, analytic or postanalytic
processes; and
(B) Resolution of problems requires extensive interpretation and
judgment.
(b) Revisions to the criteria for categorization. The Clinical
Laboratory Improvement Advisory Committee, as defined in subpart T of
this part, will conduct reviews upon request of HHS and recommend to HHS
revisions to the criteria for categorization of tests.
(c) Process for device/test categorization utilizing the scoring
system under Sec. 493.17(a). (1)(i) For new commercial test systems,
assays, or examinations, the manufacturer, as part of its 510(k) and PMA
application to FDA, will submit supporting data for device/test
categorization. FDA will determine the complexity category, notify the
manufacturers directly, and will simultaneously inform both HCFA and CDC
of the device/test category. FDA will consult with CDC concerning test
categorization in the following three situations:
(A) When categorizing previously uncategorized new technology;
(B) When FDA determines it to be necessary in cases involving a
request for a change in categorization; and
(C) If a manufacturer requests review of a categorization decision
by FDA in accordance with 21 CFR 10.75.
(ii) Test categorization will be effective as of the notification to
the applicant.
(2) For test systems, assays, or examinations not commercially
available, a laboratory or professional group may submit a written
request for categorization to PHS. These requests will be forwarded to
CDC for evaluation; CDC will determine complexity category and notify
the applicant, HCFA, and FDA of the categorization decision. In the case
of request for a change of category or for previously uncategorized new
technology, PHS will receive the request application and forward it to
CDC for categorization.
(3) A request for recategorization will be accepted for review if it
is based on new information not previously submitted in a request for
categorization or recategorization by the same applicant and will not be
considered more frequently than once per year.
(4) If a laboratory test system, assay or examination does not
appear on the lists of tests in the Federal Register notices, it is
considered to be a test of high complexity until PHS, upon request,
reviews the matter and notifies the applicant of its decision. Test
categorization is effective as of the notification to the applicant.
(5) PHS will publish revisions periodically to the list of moderate
and high complexity tests in the Federal Register in a notice with
opportunity for comment.
[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993]
Sec. 493.19 Provider-performed microscopy (PPM) procedures.
(a) Requirement. To be categorized as a PPM procedure, the procedure
must meet the criteria specified in paragraph (b) of this section.
(b) Criteria. Procedures must meet the following specifications:
(1) The examination must be personally performed by one of the
following practitioners:
(i) A physician during the patient's visit on a specimen obtained
from his or her own patient or from a patient of a group medical
practice of which the physician is a member or an employee.
(ii) A midlevel practitioner, under the supervision of a physician
or in independent practice only if authorized by the State, during the
patient's visit on a specimen obtained from his or her own patient or
from a patient of a clinic, group medical practice, or other health care
provider of which the midlevel practitioner is a member or an employee.
(iii) A dentist during the patient's visit on a specimen obtained
from his or her own patient or from a patient of a group dental practice
of which the dentist is a member or an employee.
(2) The procedure must be categorized as moderately complex.
(3) The primary instrument for performing the test is the
microscope, limited to bright-field or phase-contrast microscopy.
[[Page 810]]
(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]
Sec. 493.20 Laboratories performing tests of moderate complexity.
(a) A laboratory may qualify for a certificate to perform tests of
moderate complexity provided that it restricts its test performance to
waived tests or examinations and one or more tests or examinations
meeting criteria for tests of moderate complexity including the
subcategory of PPM procedures.
(b) A laboratory that performs tests or examinations of moderate
complexity must meet the applicable requirements in subpart C or subpart
D, and subparts F, H, J, K, M, P, and Q of this part. Under a
registration certificate or certificate of compliance, laboratories also
performing PPM procedures must meet the inspection requirements at
Sec. 493.1777.
(c) If the laboratory also performs waived tests, compliance with
subparts H, J, K, M, and P of this part is not applicable to the waived
tests. However, the laboratory must comply with the requirements in
Secs. 493.15(e) and 493.1775.
[60 FR 20044, Apr. 24, 1995]
Sec. 493.25 Laboratories performing tests of high complexity.
(a) A laboratory must obtain a certificate for tests of high
complexity if it performs one or more tests that meet the criteria for
tests of high complexity as specified in Sec. 493.17(a).
(b) A laboratory performing one or more tests of high complexity
must meet the applicable requirements of subpart C or subpart D, and
subparts F, H, J, K, M, P, and Q of this part.
(c) If the laboratory also performs tests of moderate complexity,
the applicable requirements of subparts H, J, K, M, P, and Q of this
part must be met. Under a registration certificate or certificate of
compliance, PPM procedures must meet the inspection requirements at
Sec. 493.1777.
(d) If the laboratory also performs waived tests, the requirements
of subparts H, J, K, M, and P are not applicable to the waived tests.
However, the laboratory must comply with the requirements in
Secs. 493.15(e) and 493.1775.
[57 FR 7139, Feb. 28, 1992, as amended at 60 FR 20044, Apr. 24, 1995]
[[Page 811]]
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 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]
[[Page 812]]
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 Secs. 493.35 and 493.37.
(g) A laboratory with a certificate of waiver that wishes to perform
examinations or tests not listed in the waiver test category must meet
the requirements set forth in subpart C or subpart D of this part, as
applicable.
[57 FR 7142, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993; 60
FR 20045, Apr. 24, 1995]
Sec. 493.39 Notification requirements for laboratories issued a
certificate of waiver.
Laboratories performing one or more tests listed in Sec. 493.15 and
no others must notify HHS or its designee--
(a) Before performing and reporting results for any test or
examination that is not specified under Sec. 493.15 for which the
laboratory does not have the appropriate certificate as required in
subpart C or subpart D of this part, as applicable; and
(b) Within 30 days of any change(s) in--
(1) Ownership;
(2) Name;
(3) Location; or
(4) Director.
[57 FR 7142, Feb. 28, 1992, as amended at 60 FR 20045, Apr. 24, 1995]
Subpart C--Registration Certificate, Certificate for Provider-performed
Microscopy Procedures, and Certificate of Compliance
Source: 57 FR 7143, Feb. 28, 1992, unless otherwise noted.
Sec. 493.43 Application for registration certificate, certificate for
provider-performed microscopy (PPM) procedures, and
certificate of compliance.
(a) Filing of application. Except as specified in paragraph (b) of
this section, all laboratories performing tests of moderate complexity
(including the subcategory) or high complexity, or
[[Page 813]]
any combination of these tests, must file a separate application for
each laboratory location.
(b) Exceptions. (1) Laboratories that are not at a fixed location,
that is, laboratories that move from testing site to testing site, such
as mobile units providing laboratory testing, health screening fairs, or
other temporary testing locations may be covered under the certificate
of the designated primary site or home base, using its address.
(2) Not-for-profit or Federal, State, or local government
laboratories that engage in limited (not more than a combination of 15
moderately complex or waived tests per certificate) public health
testing may file a single application.
(3) Laboratories within a hospital that are located at contiguous
buildings on the same campus and under common direction may file a
single application or multiple applications for the laboratory sites
within the same physical location or street address.
(c) Application format and contents. The application must--(1) Be
made to HHS or its designee on a form or forms prescribed by HHS;
(2) Be signed by an owner, or by an authorized representative of the
laboratory who attests that the laboratory will be operated in
accordance with the requirements established by the Secretary under
section 353 of the Public Health Service Act; and
(3) Describe the characteristics of the laboratory operation and the
examinations and other test procedures performed by the laboratory
including--
(i) The name and total number of test procedures and examinations
performed annually (excluding waived tests or tests for quality control,
quality assurance or proficiency testing purposes);
(ii) The methodologies for each laboratory test procedure or
examination performed, or both;
(iii) The qualifications (educational background, training, and
experience) of the personnel directing and supervising the laboratory
and performing the examinations and test procedures.
(d) Access and reporting requirements. All laboratories must make
records available and submit reports to HHS as HHS may reasonably
require to determine compliance with this section.
[57 FR 7143, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993; 58
FR 39155, July 22, 1993; 60 FR 20045, Apr. 24, 1995]
Sec. 493.45 Requirements for a registration certificate.
Laboratories performing only waived tests, PPM procedures, or any
combination of these tests, are not required to obtain a registration
certificate.
(a) A registration certificate is required--(1) Initially for all
laboratories performing test procedures of moderate complexity (other
than the subcategory of PPM procedures) or high complexity, or both; and
(2) For all laboratories that have been issued a certificate of
waiver or certificate for PPM procedures that intend to perform tests of
moderate or high complexity, or both, in addition to those tests listed
in Sec. 493.15(c) or specified as PPM procedures.
(b) HHS will issue a registration certificate if the laboratory--
(1) Complies with the requirements of Sec. 493.43;
(2) Agrees to notify HHS or its designee within 30 days of any
changes in ownership, name, location, director or technical supervisor
(laboratories performing high complexity testing only);
(3) Agrees to treat proficiency testing samples in the same manner
as it treats patient specimens; and
(4) Remits the fee for the registration certificate, as specified in
subpart F of this part.
(c) Prior to the expiration of the registration certificate, a
laboratory must--
(1) Remit the certificate fee specified in subpart F of this part;
(2) Be inspected by HHS as specified in subpart Q of this part; and
(3) Demonstrate compliance with the applicable requirements of this
subpart and subparts H, J, K, M, P, and Q of this part.
(d) In accordance with subpart R of this part, HHS will initiate
suspension or revocation of a laboratory's registration certificate and
will deny the laboratory's application for a certificate of compliance
for failure to comply with the requirements set forth in
[[Page 814]]
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]
Sec. 493.47 Requirements for a certificate for provider-performed
microscopy (PPM) procedures.
(a) A certificate for PPM procedures is required--
(1) Initially for all laboratories performing test procedures
specified as PPM procedures; and
(2) For all certificate of waiver laboratories that intend to
perform only test procedures specified as PPM procedures in addition to
those tests listed in Sec. 493.15(c).
(b) HHS will issue a certificate for PPM procedures if the
laboratory--
(1) Complies with the requirements of Sec. 493.43; and
(2) Remits the fee for the certificate, as specified in subpart F of
this part.
(c) Laboratories issued a certificate for PPM procedures are subject
to--
(1) The notification requirements of Sec. 493.53;
(2) The applicable requirements of this subpart and subparts H, J,
K, M, and P of this part; and
(3) Inspection only under the circumstances specified under
Sec. 493.1776, but are not routinely inspected to determine compliance
with the requirements specified in paragraphs (c) (1) and (2) of this
section.
(d) In accordance with subpart R of this part, HHS will initiate
suspension, limitation, or revocation of a laboratory's certificate for
PPM procedures for failure to comply with the applicable requirements
set forth in this subpart. HHS may also impose certain alternative
sanctions. In addition, failure to meet the requirements of this subpart
may result in suspension of all or part of payments under Medicare and
Medicaid, as specified in subpart R of this part.
(e) A certificate for PPM procedures is valid for a period of no
more than 2 years.
[58 FR 5223, Jan. 19, 1993, as amended at 60 FR 20045, Apr. 24, 1995]
Sec. 493.49 Requirements for a certificate of compliance.
A certificate of compliance may include any combination of tests
categorized as high complexity or moderate complexity or listed in
Sec. 493.15(c) as waived tests. Moderate complexity tests may include
those specified as PPM procedures.
(a) HHS will issue a certificate of compliance to a laboratory only
if the laboratory--
(1) Meets the requirements of Secs. 493.43 and 493.45;
(2) Remits the certificate fee specified in subpart F of this part;
and
(3) Meets the applicable requirements of this subpart and subparts
H, J, K, M, P, and Q of this part.
[[Page 815]]
(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
there has been no appeals decision issued.
(g) A laboratory seeking to renew its certificate of compliance
must--
(1) Complete and return the renewal application to HHS 9 to 12
months prior to the expiration of the certificate of compliance; and
(2) Meet the requirements of Sec. 493.43 and paragraphs (a)(2) and
(b)(2) of this section.
(h) If HHS determines that the application for the renewal of a
certificate of compliance must be denied or limited, HHS will notify the
laboratory in writing of the--
(1) Basis for denial of the application; and
(2) Opportunity for appeal as provided in subpart R of this part.
(i) If the laboratory requests a hearing within the time period
specified by HHS, the laboratory retains its certificate of compliance
or reissued certificate of compliance until a decision is made by an ALJ
as provided in subpart R, except when HHS finds that conditions at the
laboratory pose an imminent and serious risk to human health.
(j) For laboratories receiving payment from the Medicare or Medicaid
program, such payments will be suspended on the effective date specified
in the notice to the laboratory of nonrenewal of the certificate of
compliance even if there has been no appeals decision issued.
[60 FR 20045, Apr. 24, 1995]
Sec. 493.51 Notification requirements for laboratories issued a
certificate of compliance.
Laboratories issued a certificate of compliance must meet the
following conditions:
(a) Notify HHS or its designee within 30 days of any change in--
(1) Ownership;
(2) Name;
(3) Location;
(4) Director; or
(5) Technical supervisor (laboratories performing high complexity
only).
(b) Notify HHS no later than 6 months after performing any test or
[[Page 816]]
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.
(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
[[Page 817]]
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 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
[[Page 818]]
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
(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:
[[Page 819]]
(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: 57 FR 34014, July 31, 1992, unless otherwise noted.
Sec. 493.501 General requirements for accredited laboratories.
(a) Deemed status. HCFA may deem a laboratory to meet all the
applicable CLIA program requirements of this Part if the laboratory is
accredited by a private, nonprofit accreditation organization for
laboratories that--
(1) Provides reasonable assurance to HCFA that it requires the
laboratories it accredits to meet all of the requirements equivalent to
the CLIA condition level requirements specified in this part and would,
therefore, meet condition level requirements if those laboratories had
not been granted deemed status and had been inspected against condition
level requirements; and
(2) Meets the requirements of Sec. 493.506 of this subpart.
(b) Laboratory requirements. To be deemed to meet the applicable
CLIA program requirements, a laboratory accredited by a private,
nonprofit accreditation organization must--
(1) Authorize its accreditation organization to release to HCFA all
records and information required by HCFA;
(2) Permit inspections as required by these regulations;
(3) Obtain a certificate of accreditation as required by
Sec. 493.632 of this part; and
(4) Pay the applicable fees as required by Secs. 493.638 and 493.645
of this part.
(c) Application and reapplication process for accreditation
organizations. In applying or reapplying to HCFA for deeming authority,
a private nonprofit accreditation organization must provide the
following information to the Administrator of HCFA--
(1) The specialty(ies) or subspecialty(ies) for which the
organization is requesting ``deeming authority'';
(2) A detailed comparison of individual accreditation requirements
with the comparable condition level requirements; i.e., a crosswalk;
(3) A detailed description of the inspection process, including the
frequency of inspections, copies of inspection forms, instructions, and
guidelines, a description of the review and decision-making process of
accreditation inspections and a description of the steps taken to
monitor the correction of deficiencies;
(4) A description of the process for monitoring proficiency testing
(PT) performance, including action to be taken in response to
unsuccessful participation in an approved PT program;
(5) A description of the accreditation organization's data
management and analysis system with respect to its inspection and
accreditation decisions, including the kinds of routine reports and
tables generated by the system;
(6) Detailed information concerning the personnel who perform
accreditation inspections, including but not limited to the size and
composition of individual accreditation inspection teams, education and
experience requirements that those inspectors must meet and the content
and frequency of the training provided to inspection personnel;
[[Page 820]]
(7) Procedures to investigate and respond to complaints against
accredited laboratories;
(8) A list of any currently accredited laboratories and the
expiration date of each laboratory's accreditation;
(9) Procedures for making PT information available, including
explanatory information required to interpret PT results, on a
reasonable basis, upon request of any person;
(10) Procedures for removal or withdrawal of accreditation status
for laboratories that fail to meet the organization's standards;
(11) A proposed agreement between the accreditation organization and
HCFA with respect to the notification requirements specified in
Sec. 493.506(b)(3) of this subpart; and
(12) Whether accreditation inspections are announced or unannounced.
(d) Application review process. Once HCFA receives an application
for deeming authority from a private nonprofit accreditation
organization--
(1) HCFA will determine if additional information is necessary to
make a determination for approval of the accreditation organization's
application for deeming authority and will so notify the organization
and give it an opportunity to provide the additional information.
(2) HCFA may visit the organization's offices to verify
representations made by the organization in its application, including,
but not limited to, review of documents and interviews with the
organization's staff.
(3) The accreditation organization will receive a formal notice from
HCFA stating whether the request for deeming authority has been approved
or denied and the rationale for any denial.
(4) HCFA may approve an accreditation organization for a period not
to exceed six years.
(5) An accreditation organization may withdraw its application for
approval of deeming authority at any time prior to the official
notification specified in paragraph (d)(3) of this section.
(6) Except as provided in paragraph (d)(8) of this section, any
accreditation organization whose request for approval of deeming
authority is denied may request, within 60 days of the notification of
the denial, that its original application be reconsidered.
(7) Except as provided in paragraph (d)(8) of this section, any
accreditation organization whose request for approval of deeming
authority has been denied may resubmit its application if the
organization--
(i) Has revised its accreditation program to address the rationale
for denial of its previous request;
(ii) Can demonstrate that it can provide reasonable assurance that
its accredited facilities meet condition level requirements; and
(iii) Resubmits the application in its entirety.
(8) If an accreditation organization has requested, in accordance
with part 488, subpart D of this chapter, a reconsideration of HCFA's
determination that its request for deeming approval is denied, it may
not submit a new application for deeming authority until a final
reconsideration determination is issued.
(e) Publication of names of approved accreditation organizations.
HCFA publishes a notice in the Federal Register when it grants deeming
authority to an accreditation organization under paragraph (a) of this
section. The notice--
(1) Names the accreditation organization;
(2) Describes the basis for granting deeming authority to the
accreditation organization;
(3) Describes how the accreditation organization provides reasonable
assurance to HCFA that laboratories accredited by the organization meet
CLIA requirements equivalent to those specified in this part and would,
therefore, meet CLIA requirements if those laboratories had not been
granted deemed status, but had been inspected against condition level
requirements; and
(4) Specifies a term of approval not to exceed six years.
Sec. 493.503 Proficiency testing requirements of laboratories with
deemed status.
(a) General. A laboratory deemed to meet condition level
requirements must meet the proficiency testing (PT) requirements of this
part.
[[Page 821]]
(b) Release of PT results. (1) A laboratory deemed to meet condition
level requirements must 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 a 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.
(2) A laboratory that refuses to authorize the release of its PT
results will no longer be deemed to meet the condition level
requirements and will be subject to full review by HCFA, the State
survey agency, or other HCFA agent in accordance with Sec. 493.1777 of
this chapter and may be subject to the suspension or revocation of its
certificate of accreditation under Sec. 493.1840 of this part.
(3) A laboratory with deemed status that has failed to achieve
successful participation in an approved PT program must authorize its
accreditation organization to release to HCFA its 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 this part. Such a laboratory must
also authorize its accreditation organization to release to HCFA a
notification of the actions taken by the organization as a result of the
unsuccessful participation in a PT program within 30 days of the
initiation of such actions.
(4) HCFA may, on the basis of the notification of adverse actions
received from the accreditation organization, take an adverse action
against a laboratory that fails to participate successfully in an
approved PT program.
Sec. 493.504 Revocation of accreditation.
After a private, nonprofit accreditation organization withdraws or
revokes its accreditation of a laboratory, the certificate of
accreditation required by this part will continue in effect until the
earlier of--
(a) 45 days after the laboratory receives notice of the withdrawal
or revocation of the accreditation; or
(b) The effective date of any action taken by HCFA.
Sec. 493.506 Federal review and approval of private, nonprofit
accreditation organizations.
(a) An accreditation organization may request and may be granted
``deeming authority'' for all specialties and subspecialties or for
specific specialty or subspecialty areas. In the latter case, the
accreditation organization will be accountable for the monitoring of
compliance with all requirements equivalent to condition level
requirements within the scope of the specialty or subspecialty.
(b) HCFA's review of a private, nonprofit accreditation organization
includes, but is not necessarily limited to, an evaluation of the
following--
(1) Whether the accreditation organization's requirements for
laboratories are equal to or more stringent than the condition level
requirements for laboratories;
(2) The accreditation organization's inspection process to
determine--
(i) The composition of the inspection team, qualifications of the
inspectors, and the ability of the organization to provide continuing
education and training to inspectors;
(ii) The comparability of the organization's full inspection and
complaint inspection requirements to those of HCFA, including but not
limited to inspection frequency, and the ability to investigate and
respond to complaints against accredited laboratories;
(iii) The organization's procedures for monitoring laboratories
found to be out of compliance with its requirements. (These monitoring
procedures are to be used only when the accreditation organization
identifies noncompliance. If noncompliance is identified through
validation inspections, HCFA, the State survey agency, or other HCFA
agent monitors corrections as authorized at Sec. 493.507(b)(4) of this
subpart);
(iv) The ability of the organization to provide HCFA with electronic
data and reports, including the crosswalk specified in
Sec. 493.501(c)(2), in ASCII-comparable code that are necessary for
effective validation and assessment of the organization's inspection
process;
[[Page 822]]
(v) The ability of the organization to provide HCFA with electronic
data in ASCII-comparable 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;
(vi) The ability of the organization to provide HCFA with electronic
data in ASCII-comparable code for all accredited laboratories, including
the area of specialty or subspecialty;
(vii) The adequacy of numbers of staff and other resources; and
(viii) The organization's ability to provide adequate funding for
performing required inspections; and
(3) The organization's agreement with HCFA that requires it to:
(i) Notify HCFA of any laboratory accredited by the organization
that has had its accreditation withdrawn, revoked or limited by the
accreditation organization denied, suspended, withdrawn or revoked or
that has had any other adverse action taken against it by the
accreditation organization within 30 days of the action taken;
(ii) Notify HCFA within 10 days of a deficiency identified in an
accredited laboratory where the deficiency poses an immediate jeopardy
to the laboratory's patients or a hazard to the general public;
(iii) Notify HCFA of all newly accredited laboratories (or
laboratories whose areas of specialty or subspecialty are revised)
within 30 days;
(iv) Notify each laboratory accredited by the organization within 10
days of HCFA's withdrawal of recognition of the organization's deeming
authority;
(v) Provide HCFA with inspection schedules, as requested, for the
purpose of conducting onsite validation inspections;
(vi) Provide HCFA, the State survey agency or other HCFA agent with
any facility-specific data to include, but not be limited to, the
following (upon request):
(A) PT results that constitute unsuccessful participation in an
approved PT program; and
(B) Notification of the adverse actions or corrective actions
imposed by the accreditation organization as a result of unsuccessful PT
participation;
(vii) Provide HCFA written notification at least 30 days in advance
of the effective date of any proposed changes in its requirements; and
(viii) Disclose any laboratory's PT results upon the reasonable
request by any person.
Sec. 493.507 Validation inspections of laboratories with certificates
of accreditation.
(a) Basis for inspection. HCFA, the State survey agency, or a HCFA
agent may conduct an inspection of an accredited laboratory that has
been issued a certificate of accreditation. The results of these
inspections will be used to validate the accreditation organization's
accreditation process. These inspections may be conducted on a
representative sample basis or in response to substantial allegations of
noncompliance.
(1) When conducted on a representative sample basis, the inspection
is comprehensive, addressing all condition level requirements, or may be
focused on a specific condition level requirement or requirements, and
the number of laboratories sampled is sufficient to allow a reasonable
estimate of the performance of each accreditation organization.
(2) When conducted in response to a substantial allegation of
noncompliance, HCFA, the State survey agency or other HCFA agent
inspects for any condition level requirement or requirements that HCFA
determines to be related to the allegation. If HCFA, the State survey
agency or other HCFA agent substantiates a deficiency and determines
that the laboratory is out of compliance with any condition level
requirement, HCFA, the State survey agency or other HCFA agent will
conduct a full CLIA inspection.
(b) Effect of selection for inspection. A laboratory selected for
inspection must:
(1) Authorize its accreditation organization to release to HCFA, the
State survey agency or other HCFA agent, on a confidential basis, a copy
of the results of the laboratory's most recent full, and any subsequent
partial, accreditation inspection(s);
(2) Authorize the validation inspection to take place;
[[Page 823]]
(3) Provide HCFA, the State survey agency, or other HCFA agent
access to all facilities, equipment, materials, records and information
that HCFA determines have a bearing on whether the laboratory is being
operated in accordance with the requirements of this part, and permit
HCFA, the State survey agency or other HCFA agent to copy any such
material or require it to be submitted; and
(4) Authorize HCFA, the State survey agency or other HCFA agent to
monitor the correction of any deficiencies found through the validation
inspection.
(c) Refusal to cooperate with the inspection. (1) If a laboratory
selected for inspection fails to comply with the requirements specified
in paragraph (b) of this section it--
(i) Will be subject to full review by HCFA, the State survey agency
or other HCFA agent in accordance with this part; and
(ii) May be subject to suspension, revocation, or limitation of its
certificate of accreditation under this part.
(2) An accredited laboratory will be once again deemed to meet the
condition level requirements by virtue of its accreditation when--
(i) It 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) It withdraws any prior refusal to allow a validation
inspection; and
(iii) HCFA finds that the laboratory meets all the condition level
requirements.
(d) Consequences of a finding of noncompliance. If a validation
inspection results in a finding that the laboratory is out of compliance
with one or more condition level requirements, the laboratory is subject
to the same requirements and survey and enforcement processes applied to
laboratories that are not accredited and that are found out of
compliance following a State agency inspection under this part and to
full review by HCFA, the State survey agency or other HCFA agent in
accordance with this part; i.e., the laboratory will be subject to the
principal and alternative sanctions specified in Sec. 493.1806 of this
part.
(e) Disclosure of accreditation and validation inspection results.
The accreditation inspection results are disclosable to the public only
if they are related to an enforcement action taken by the Secretary. The
results of all validation inspections conducted by HCFA, the State
survey agency or other HCFA agents are disclosable.
(f) Onsite observation of accreditation organization operations. As
part of the validation review process, HCFA may conduct an onsite
inspection of the accreditation organization's operations and offices to
verify the organization's representations and to assess the
organization's compliance with its own policies and procedures. Such an
onsite inspection may include, but is not limited to, the review of
documents, the auditing of meetings concerning the accreditation
process, the evaluation of accreditation inspection results or the
accreditation decision-making process, and interviews with the
organization's staff.
Sec. 493.509 Continuing Federal oversight of private, nonprofit
accreditation organizations.
(a) Comparability review. In addition to reviewing the equivalency
of specified accreditation requirements to the comparable condition
level requirements when an accreditation organization initially applies
to HCFA for ``deeming authority'', HCFA reviews the equivalency of
requirements--
(1) When HCFA promulgates new condition level requirements;
(2) When HCFA identifies accreditation organizations whose
requirements do not continue to be equal to or more stringent than
condition level requirements;
(3) When an accreditation organization adopts new requirements;
(4) When an accreditation organization adopts changes to its
inspection process as required by Sec. 493.511(b); or
(5) Every six years or sooner if HCFA determines the organization
requires an earlier review.
(b) Validation review. Following the end of a validation review
period,
[[Page 824]]
HCFA evaluates the validation inspection results for each approved
accreditation organization.
(c) Reapplication procedures. (1) Every six years, or sooner as
determined by HCFA, an approved accreditation organization must reapply
for continued approval of deeming authority. HCFA will notify the
organization of the materials the organization must submit as part of
the reapplication procedure.
(2) An accreditation organization that is not meeting the
requirements of this subpart, as determined through a comparability or
validation review, must furnish HCFA, upon request and at any time, with
the reapplication materials HCFA requests. HCFA will establish a
deadline by which the materials are to be submitted.
(d) Notice. HCFA provides written notice to the accreditation
organization indicating that its approval may be in jeopardy if a
comparability or validation review reveals that an accreditation
organization is not meeting the requirements of this subpart and that a
deeming authority review is being initiated. The notice contains the
following information--
(1) A statement of the discrepancies that were found as well as
other related documentation;
(2) An explanation of HCFA's review process on which the final
determination will be based and a description of the possible actions as
specified in Sec. 493.511 that may be imposed by HCFA based on the
findings from the comparability or validation review;
(3) A description of the procedures available if the accreditation
organization desires an opportunity to explain or justify the findings
made during the comparability or validation review; and
(4) The reapplication materials the organization must submit and the
deadline for that submission.
Sec. 493.511 Removal of deeming authority and final determination
review.
(a) Deeming authority review. (1) HCFA reviews, as appropriate, the
criteria described in Sec. 493.506 to reevaluate whether the
accreditation organization continues to meet all these criteria. HCFA
conducts a deeming authority review of an accreditation organization's
program if the comparability or validation review produces findings as
described at Sec. 493.509(a) of this subpart.
(2) HCFA conducts, at its discretion, a deeming authority review of
an accreditation organization's program if validation review findings,
irrespective of the rate of disparity, indicate widespread or systematic
problems in the organization's processes that provide evidence that the
organization's requirements, taken as a whole, are no longer equivalent
to CLIA requirements, taken as a whole.
(3) HCFA conducts a deeming authority review whenever validation
inspection results over a one-year period indicate a rate of disparity
of 20 percent or more between the findings of the accreditation
organization and the findings of HCFA, State survey agencies, or other
HCFA agents.
(b) Following the deeming authority review, if HCFA determines that
the accreditation organization has failed to adopt requirements equal to
or more stringent than CLIA requirements, HCFA may give the
accreditation organization a conditional approval effective 30 days
following the date of HCFA's determination of its deeming authority for
a probationary period, not to exceed one year, to adopt comparable
requirements.
(c) Following the deeming authority review, if HCFA determines that
there are widespread systematic problems in the organization's
inspection process, HCFA may give the accreditation organization
conditional approval of its deeming authority during a probationary
period not to exceed one year that is effective 30 days following the
date of HCFA's determination.
(d) Within 60 days after the end of any probationary period, HCFA
will make a final determination as to whether or not an accreditation
organization continues to meet the criteria described at Sec. 493.506 of
this subpart and issues an appropriate notice (including reasons for the
determination) to the accreditation organization. This determination is
based on the evaluation of any of the following:
(1) The most recent validation inspection and review findings as
described at Sec. 493.509(b) of this subpart. In
[[Page 825]]
order for the accreditation organization to continue to have deeming
authority, it must continue to meet the criteria in Sec. 493.506 of this
subpart;
(2) Facility-specific data and other related information;
(3) The accreditation organization's surveyors in terms of
qualifications, ongoing education and training, composition of
inspection team, etc.;
(4) The organization's inspection procedures; and
(5) The organization's accreditation requirements.
(e) HCFA may remove recognition of deeming authority effective 30
days from the date that it provides written notice to the accreditation
organization that its deeming authority will be removed if the
accreditation organization has not made improvements acceptable to HCFA
during the probationary period.
(f) The existence of any validation review, deeming authority
review, probationary status, or any other action by HCFA with respect to
an accreditation organization does not affect or limit the conduct of
any validation inspection of its accredited laboratories.
(g) HCFA will publish a notice in the Federal Register containing a
justification of the basis for removing the deeming authority from an
accreditation organization.
(h) After HCFA withdraws approval of an accreditation organization's
deeming authority, the certificates of accreditation of all affected
laboratories continue in effect for 60 days after the laboratory
receives notification of the withdrawal of approval. HCFA may extend the
period for an additional 60 days for a laboratory if it determines that
the laboratory submitted an application for inspection to another
approved accreditation organization or an application for the
appropriate certificate to HCFA, the State agency, or other HCFA agent
before the initial 60-day period ends.
(i) If at any time HCFA determines that the continued approval of
deeming authority of any accreditation organization poses an immediate
jeopardy to the patients of the laboratories accredited by that
organization, or such continued approval otherwise constitutes a
significant hazard to the public health, HCFA may immediately withdraw
the approval of deeming authority of that accreditation organization.
(j) Any accreditation organization that is dissatisfied with a
determination to withdraw its deeming authority may request a
reconsideration of that determination in accordance with subpart D of
part 488.
[57 FR 34014, July 31, 1992, as amended at 60 FR 20046, Apr. 24, 1995]
Sec. 493.513 General requirements for CLIA-exempt laboratories.
(a) HCFA may exempt from CLIA program requirements, for a period not
to exceed six years, all State-licensed or approved laboratories in a
State if the State--
(1) Has in effect laws that provide for requirements equal to or
more stringent than condition level requirements;
(2) Has an agency that licenses or approves laboratories that meet
requirements equal to or more stringent than the CLIA condition level
requirements specified in this part and would, therefore, meet condition
level requirements if those laboratories had not been exempted from
CLIA, but rather had been inspected for compliance with condition level
requirements;
(3) Meets the requirements and is approved in accordance with
Sec. 493.515 of this subpart;
(4) Demonstrates that it has enforcement authority and
administrative structures and resources adequate to enforce its
laboratory requirements;
(5) Permits HCFA or HCFA agents to inspect laboratories in the
State;
(6) Requires laboratories in the State to submit to inspections by
HCFA or HCFA agents as a condition of licensure or approval;
(7) Agrees to pay the cost of the validation program administered by
HCFA in that State as specified in Secs. 493.645(b) and 493.646 of this
part; and
(8) Takes appropriate enforcement action against laboratories found
by HCFA or HCFA agents not to be in compliance with requirements
equivalent to CLIA requirements.
(b) A laboratory in a State with an approved State laboratory
program must--
[[Page 826]]
(1) Authorize the laboratory program to release to HCFA or HCFA
agent all records and information required by HCFA; and
(2) Permit inspection as required by these regulations.
(c) In applying to HCFA for exemption from the CLIA program, the
State must provide the following information to HCFA--
(1) A detailed comparison of individual licensure or approval
requirements with the comparable condition level requirements; i.e., a
crosswalk;
(2) A detailed description of the inspection process including the
frequency of inspections, copies of inspection forms, instructions and
guidelines, a description of the review and decision-making process of
licensure or approval inspections, whether inspections are announced or
unannounced and a description of the steps taken to monitor the
correction of deficiencies;
(3) A description of the State's enforcement authority,
administrative structure and resources to enforce the State standards;
(4) A description of the process for monitoring proficiency testing
(PT) performance, including action to be taken in response to
unsuccessful participation in a HCFA-approved PT program;
(5) The State's procedures for responding to, and for the
investigation of, complaints against licensed or approved laboratories;
(6) A list of all currently licensed or approved laboratories and
the expiration date of each laboratory's current license or approval;
(7) Procedures under State confidentiality and disclosure
requirements for the release of PT information, including explanatory
information required to interpret PT results; and
(8) For Medicare and Medicaid payment purposes, a list of the
specialties and subspecialties of tests performed by each laboratory.
(d) The State must also submit the following supporting
documentation--
(1) A written presentation that demonstrates the agency's ability to
furnish HCFA with electronic data in ASCII comparable code, including
the crosswalk specified in paragraph (c)(1) of this section;
(2) A statement acknowledging that the State will notify HCFA
through electronic data transmission of--
(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 any such action taken;
(ii) Changes in licensure (or approval) or inspection requirements;
and
(iii) Changes in the specialties or subspecialties under which any
laboratory in the State performs testing.
(e) If HCFA determines that additional information is necessary to
make a determination for approval or denial of the application for
exemption, HCFA will notify the State and afford it an opportunity to
provide the additional information.
(f) HCFA may visit the State laboratory program offices to review
the application of the State's policies and procedures and other
information provided by the State. Such review includes, but is not
limited to, examination of documents and interviews with staff.
(g) HCFA will furnish the State a formal notice stating whether the
request for exemption has been approved or denied and the rationale for
any denial.
(h) Except as provided in paragraph (m) of this section, any State
whose application for approval for exemption, or for renewal of that
approval, from CLIA has been denied may resubmit its request as soon as
the State has taken the necessary action to address the rationale for
any previous denial.
(i) A State may withdraw its request for exempt status at any time
prior to the official notification specified in paragraph (g) of this
section.
(j) Any State whose application for approval for exempt status is
denied may request, within 60 days of the notification of the denial,
that its original application or application for renewal be reconsidered
in accordance with part 488, subpart D of this chapter.
(k) HCFA publishes a notice in the Federal Register when it grants
exemption to a State under paragraph (a) of this section. The notice--
(1) Names the State;
(2) Describes the basis for granting the exemption to the State;
[[Page 827]]
(3) Describes how the laboratory requirements of the State are equal
to or more stringent than those specified in this part; and
(4) Specifies a term of approval not to exceed six years.
(l) A State that has received approval for the exemption of its
laboratories from the CLIA program must reapply to HCFA every two years
for renewal of its exemption status and renew its agreement to pay the
cost of the HCFA administered validation program in that State.
(m) If a State has requested a reconsideration of HCFA's
determination that its request for exemption, or for renewal of its
exemption, of its laboratories from CLIA is denied, it may not resubmit
its request until a final reconsideration determination is issued.
Sec. 493.515 Federal review of laboratory requirements of State
laboratory programs.
(a) HCFA's review of a State laboratory program includes, but is not
necessarily limited to, an evaluation of the following:
(1) Whether the State's requirements for laboratories are equal to
or more stringent than the condition level requirements;
(2) The State's inspection process requirements to determine--
(i) The comparability of the full inspection and complaint
inspection procedures to those of HCFA, including but not limited to
inspection frequency and the ability to investigate and respond to
complaints against licensed or approved laboratories;
(ii) The State's enforcement procedures for laboratories found to be
out of compliance with its requirements;
(iii) The ability of the State to provide HCFA with electronic data
and reports in ASCII-comparable code with the adverse or corrective
actions resulting from PT results that constitute unsuccessful
participation in PT programs and with other data HCFA determines are
necessary for validation and assessment of the State's inspection
process requirements;
(3) The State's agreement with HCFA to--
(i) Notify HCFA within 30 days of the action taken against any CLIA-
exempt laboratory that has had its licensure or approval withdrawn or
revoked or has been in any way sanctioned;
(ii) Notify HCFA within 10 days of any deficiency identified in a
CLIA-exempt laboratory in cases where the deficiency poses an immediate
jeopardy to the laboratory's patients or a hazard to the general public.
(iii) Notify each laboratory licensed by the State within 10 days of
HCFA's withdrawal of the State's exemption;
(iv) Provide HCFA with written notification of any changes in its
licensure (or approved) and inspection requirements;
(v) Disclose any laboratory's PT results in accordance with a
State's confidentiality requirements;
(vi) Take the appropriate enforcement action against laboratories
found by HCFA not to be in compliance with requirements comparable to
condition level requirements and report such enforcement actions to
HCFA;
(vii) Notify HCFA of all newly licensed laboratories, including the
specialties and subspecialties, for which any laboratory performs
testing within 30 days; and subspecialties, for which any laboratory
performs testing within 30 days; and
(viii) Provide HCFA, as requested, inspection schedules for
validation purposes.
Sec. 493.517 Validation inspections of CLIA-exempt laboratories.
(a) Basis for inspection. HCFA or a HCFA agent other than the State
survey agency may conduct an inspection of any laboratory in a State
with an approved laboratory program. The results of these inspections
will be used to validate the appropriateness of the exemption of that
State's licensed or approved laboratories from CLIA program
requirements. These inspections may be conducted on a representative
sample basis or in response to substantial allegations of noncompliance.
(1) When conducted on a representative sample basis, the inspection
may be comprehensive, addressing all condition level requirements, or
may be focused on a specific requirement or requirements. The number of
laboratories sampled is sufficient to allow a
[[Page 828]]
reasonable estimate of the performance of the State.
(2) When conducted in response to a substantial allegation of
noncompliance, HCFA or a HCFA agent inspects for any condition level
requirement or requirements that HCFA determines to be related to the
allegation. If HCFA substantiates a deficiency and determines that the
laboratory is out of compliance with any condition level requirement,
HCFA or other HCFA agent will conduct a full CLIA inspection.
(b) Effect of selection for inspection. A CLIA-exempt laboratory
selected for a validation inspection must--
(1) Authorize the State to release to HCFA or a HCFA agent, on a
confidential basis, a copy of the results of the laboratory's most
recent full, and any subsequent partial, licensure or approval
inspection(s);
(2) Authorize the validation inspection to take place; and
(3) Provide HCFA or a HCFA agent access to all facilities,
equipment, materials, records and information that HCFA determines have
a bearing on whether the laboratory is being operated in accordance with
the requirements of this part and permit HCFA or a HCFA agent to copy
any such materials or to require such copies to be submitted.
(c) Refusal to cooperate with the inspection. If a laboratory
selected for a validation inspection fails to comply with the
requirements specified in paragraph (b) of this section, HCFA will
notify the State.
(d) Consequences of a finding of noncompliance. If a validation
inspection results in a finding that the laboratory is out of compliance
with one or more condition level requirements, HCFA will direct the
State to take the appropriate enforcement action(s).
(e) Disclosure of State and validation inspection results. The
disclosure of State inspection results will be the responsibility of the
approved State laboratory program, in accordance with State law. The
results of all validation inspections conducted by HCFA or other HCFA
agents are disclosable.
(f) Onsite observation of State laboratory program operations. As
part of the validation review process, HCFA may conduct an onsite
inspection of a State's laboratory program offices and operations to
verify the State's representations and to assess the State's compliance
with its own policies and procedures, including verification of State
enforcement actions taken on the basis of validation inspections
performed by HCFA or HCFA agents. Such an onsite inspection may include,
but is not limited to, the review of documents, auditing meetings
concerning the licensure or approval process, the evaluation of State
inspection results and the licensure or approval decision-making
process, and interviews with State employees.
Sec. 493.519 Continuing Federal oversight of an approved State
laboratory program.
(a) Comparability review. In addition to reviewing the equivalency
of specified licensure or approval requirements to the comparable
condition level requirements when a State initially applies to HCFA for
exemption of its licensed or approved laboratories from condition level
requirements, HCFA reviews the equivalency of requirements when--
(1) HCFA promulgates new condition level requirements;
(2) HCFA identifies a State whose requirements do not continue to be
equal to or more stringent than condition level requirements;
(3) A State laboratory program adopts new requirements;
(4) A State laboratory program adopts changes to its inspection
process requirements as required by Sec. 493.521(b); or
(5) Every six years or sooner if HCFA determines the State
laboratory requires an earlier review.
(b) Validation review. Following the end of a validation review
period, HCFA evaluates the validation inspection results for each
approved State laboratory program.
(c) Reapplication procedures. (1) Every six years, or sooner as
determined by HCFA, an approved State laboratory program must reapply
for continued approval of CLIA exemption. HCFA will notify the State of
the materials the State must submit as part of the reapplication
procedure.
[[Page 829]]
(2) A State that is not meeting the requirements of this subpart as
determined through a comparability or validation review must furnish
HCFA, upon request and at any time, with the reapplication materials
HCFA requests. HCFA will establish a deadline by which the materials are
to be submitted.
(d) Notice. HCFA provides written notice to the State, 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. The notice contains the following
information--
(1) A statement of the discrepancies that were found, as well as
other related documentation;
(2) An explanation of HCFA's review process on which the final
determination will be based and a description of the possible actions as
specified in Sec. 493.521 that may be imposed by HCFA based on the
findings from the validation or comparability review;
(3) A description of the procedures available if the State desires
an opportunity to explain or justify the findings made during the
comparability or validation review; and
(4) The reapplication materials the State laboratory program must
submit and the deadline for the submission of those materials.
Sec. 493.521 Removal of CLIA exemption and final determination review.
(a)(1) HCFA conducts a review of a State's laboratory program if the
comparability review produces findings as described at Sec. 493.519(a),
of this subpart. HCFA reviews, as appropriate, the criteria described in
Sec. 493.515 to reevaluate whether the laboratory program continues to
meet all these criteria.
(2) HCFA conducts, at its discretion, an exemption review of an
approved State laboratory program if validation review findings,
irrespective of the rate of disparity, indicate widespread or systematic
problems in t |