[Code of Federal Regulations]
[Title 42, Volume 3]
[Revised as of October 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR493]
[Page 955-1077]
TITLE 42--PUBLIC HEALTH
CHAPTER IV--CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF
HEALTH AND HUMAN SERVICES--(Continued)
PART 493--LABORATORY REQUIREMENTS
Subpart A--General Provisions
Sec.
493.1 Basis and scope.
493.2 Definitions.
493.3 Applicability.
493.5 Categories of tests by complexity.
493.15 Laboratories performing waived tests.
493.17 Test categorization.
493.19 Provider-performed microscopy (PPM) procedures.
493.20 Laboratories performing tests of moderate complexity.
493.25 Laboratories performing tests of high complexity.
[[Page 956]]
Subpart B--Certificate of Waiver
493.35 Application for a certificate of waiver.
493.37 Requirements for a certificate of waiver.
493.39 Notification requirements for laboratories issued a certificate
of waiver.
Subpart C--Registration Certificate, Certificate for Provider-performed
Microscopy Procedures, and Certificate of Compliance
493.43 Application for registration certificate, certificate for
provider-performed microscopy (PPM) procedures, and
certificate of compliance.
493.45 Requirements for a registration certificate.
493.47 Requirements for a certificate for provider-performed microscopy
(PPM) procedures.
493.49 Requirements for a certificate of compliance.
493.51 Notification requirements for laboratories issued a certificate
of compliance.
493.53 Notification requirements for laboratories issued a certificate
for provider-performed microscopy (PPM) procedures.
Subpart D--Certificate of Accreditation
493.55 Application for registration certificate and certificate of
accreditation.
493.57 Requirements for a registration certificate.
493.61 Requirements for a certificate of accreditation.
493.63 Notification requirements for laboratories issued a certificate
of accreditation.
Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
493.551 General requirements for laboratories.
493.553 Approval process (application and reapplication) for
accreditation organizations and State licensure programs.
493.555 Federal review of laboratory requirements.
493.557 Additional submission requirements.
493.559 Publication of approval of deeming authority or CLIA exemption.
493.561 Denial of application or reapplication.
493.563 Validation inspections--Basis and focus.
493.565 Selection for validation inspection--laboratory
responsibilities.
493.567 Refusal to cooperate with validation inspection.
493.569 Consequences of a finding of noncompliance as a result of a
validation inspection.
493.571 Disclosure of accreditation, State and CMS validation inspection
results.
493.573 Continuing Federal oversight of private nonprofit accreditation
organizations and approved State licensure programs.
493.575 Removal of deeming authority or CLIA exemption and final
determination review.
Subpart F--General Administration
493.602 Scope of subpart.
493.606 Applicability of subpart.
493.638 Certificate fees.
493.639 Fee for revised certificate.
493.643 Fee for determination of program compliance.
493.645 Additional fee(s) applicable to approved State laboratory
programs and laboratories issued a certificate of
accreditation, certificate of waiver, or certificate for PPM
procedures.
493.646 Payment of fees.
493.649 Methodology for determining fee amount.
Subpart G [Reserved]
Subpart H--Participation in Proficiency Testing for Laboratories
Performing 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.
[[Page 957]]
493.851 Standard; Hematology.
493.853 Condition: Pathology.
493.855 Standard; Cytology: gynecologic examinations.
493.857 Condition: Immunohematology.
493.859 Standard; ABO group and D (Rho) typing.
493.861 Standard; Unexpected antibody detection.
493.863 Standard; Compatibility testing.
493.865 Standard; Antibody identification.
Subpart I--Proficiency Testing Programs for Tests of Moderate Complexity
(Including the Subcategory), High Complexity, or Any Combination of
These Tests
493.901 Approval of proficiency testing programs.
493.903 Administrative responsibilities.
493.905 Nonapproved proficiency testing programs.
Proficiency Testing Programs by Specialty and Subspecialty
493.909 Microbiology.
493.911 Bacteriology.
493.913 Mycobacteriology.
493.915 Mycology.
493.917 Parasitology.
493.919 Virology.
493.921 Diagnostic immunology.
493.923 Syphilis serology.
493.927 General immunology.
493.929 Chemistry.
493.931 Routine chemistry.
493.933 Endocrinology.
493.937 Toxicology.
493.941 Hematology (including routine hematology and coagulation).
493.945 Cytology; gynecologic examinations.
493.959 Immunohematology.
Subpart J--Patient Test Management for Moderate Complexity (Including
the Subcategory), High Complexity, or Any Combination of These Tests
493.1101 Condition: Patient test management; moderate complexity
(including the subcategory), or high complexity testing, or
any combination of these tests.
493.1103 Standard; Procedures for specimen submission and handling.
493.1105 Standard; Test requisition.
493.1107 Standard; Test records.
493.1109 Standard; Test report.
493.1111 Standard; Referral of specimens.
Subpart K--Quality Control for Tests of Moderate Complexity (Including
the Subcategory), High Complexity, or Any Combination of These Tests
493.1201 Condition: General quality control; moderate complexity
(including the subcategory) or high complexity testing, or any
combination of these tests.
493.1202 Standard; Moderate or high complexity testing, or both:
Effective from September 1, 1992 to December 31, 2002.
493.1203 Standard; Moderate or high complexity testing, or both:
Effective beginning December 31, 2002.
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.
[[Page 958]]
493.1273 Standard; Immunohematological collection, processing, dating
periods, labeling and distribution of blood and blood
products.
493.1275 Standard; Blood and blood products storage facilities.
493.1277 Standard; Arrangement for services.
493.1279 Standard; Provision of testing.
493.1283 Standard; Retention of samples of transfused blood.
493.1285 Standard; Investigation of transfusion reactions.
Subpart L [Reserved]
Subpart M--Personnel for Moderate Complexity (Including the Subcategory)
and High Complexity Testing
493.1351 General.
Laboratories Performing Provider-Performed Microscopy (PPM) Procedures
493.1353 Scope.
493.1355 Condition: Laboratories performing PPM procedures; laboratory
director.
493.1357 Standard; laboratory director qualifications.
493.1359 Standard; PPM laboratory director responsibilities.
493.1361 Condition: Laboratories performing PPM procedures; testing
personnel.
493.1363 Standard; PPM testing personnel qualifications.
493.1365 Standard; PPM testing personnel responsibilities.
Laboratories Performing Moderate Complexity Testing
493.1403 Condition: Laboratories performing moderate complexity testing;
laboratory director.
493.1405 Standard; Laboratory director qualifications.
493.1406 Standard; Laboratory director qualifications on or before
February 28, 1992.
493.1407 Standard; Laboratory director responsibilities.
493.1409 Condition: Laboratories performing moderate complexity testing;
technical consultant.
493.1411 Standard; Technical consultant qualifications.
493.1413 Standard; Technical consultant responsibilities.
493.1415 Condition: Laboratories performing moderate complexity testing;
clinical consultant.
493.1417 Standard; Clinical consultant qualifications.
493.1419 Standard; Clinical consultant responsibilities.
493.1421 Condition: Laboratories performing moderate complexity testing;
testing personnel.
493.1423 Standard; Testing personnel qualifications.
493.1425 Standard; Testing personnel responsibilities.
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.
[[Page 959]]
Subparts N-O [Reserved]
Subpart P--Quality Assurance for Moderate Complexity (Including the
Subcategory) or High Complexity Testing, or Any Combination of These
Tests
493.1701 Condition: Quality assurance; moderate complexity (including
the subcategory) or high complexity testing, or any
combination of these tests.
493.1703 Standard; Patient test management assessment.
493.1705 Standard; Quality control assessment.
493.1707 Standard; Proficiency testing assessment.
493.1709 Standard; Comparison of test results.
493.1711 Standard; Relationship of patient information to patient test
results.
493.1713 Standard; Personnel assessment.
493.1715 Standard; Communications.
493.1717 Standard; Complaint investigations.
493.1719 Standard; Quality assurance review with staff.
493.1721 Standard; Quality assurance records.
Subpart Q--Inspection
493.1771 Condition: Inspection requirements applicable to all CLIA-
certified and CLIA-exempt laboratories.
493.1773 Standard: Basic inspection requirements for all laboratories
issued a CLIA certificate and CLIA-exempt laboratories.
493.1775 Standard: Inspection of laboratories issued a certificate of
waiver or a certificate for provider-performed microscopy
procedures.
493.1777 Standard: Inspection of laboratories that have requested or
have been issued a certificate of compliance.
493.1780 Standard: Inspection of CLIA-exempt laboratories or
laboratories requesting or issued a certificate of
accreditation.
Subpart R--Enforcement Procedures
493.1800 Basis and scope.
493.1804 General considerations.
493.1806 Available sanctions: All laboratories.
493.1807 Additional sanctions: Laboratories that participate in
Medicare.
493.1808 Adverse action on any type of CLIA certificate: Effect on
Medicare approval.
493.1809 Limitation on Medicaid payment.
493.1810 Imposition and lifting of alternative sanctions.
493.1812 Action when deficiencies pose immediate jeopardy.
493.1814 Action when deficiencies are at the condition level but do not
pose immediate jeopardy.
493.1816 Action when deficiencies are not at the condition level.
493.1820 Ensuring timely correction of deficiencies.
493.1826 Suspension of part of Medicare payments.
493.1828 Suspension of all Medicare payments.
493.1832 Directed plan of correction and directed portion of a plan of
correction.
493.1834 Civil money penalty.
493.1836 State onsite monitoring.
493.1838 Training and technical assistance for unsuccessful
participation in proficiency testing.
493.1840 Suspension, limitation, or revocation of any type of CLIA
certificate.
493.1842 Cancellation of Medicare approval.
493.1844 Appeals procedures.
493.1846 Civil action.
493.1850 Laboratory registry.
Subpart S [Reserved]
Subpart T--Consultations
493.2001 Establishment and function of the Clinical Laboratory
Improvement Advisory Committee.
Authority: Sec. 353 of the Public Health Service Act, secs. 1102,
1861(e), the sentence following sections 1861(s)(11) through 1861(s)(16)
of the Social Security Act (42 U.S.C. 263a, 1302, 1395x(e), the sentence
following 1395x(s)(11) through 1395x(s)(16)).
Source: 55 FR 9576, Mar. 14, 1990, unless otherwise noted.
Subpart A--General Provisions
Source: 57 FR 7139, Feb. 28, 1992, unless otherwise noted.
Sec. 493.1 Basis and scope.
This part sets forth the conditions that all laboratories must meet
to be certified to perform testing on human specimens under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA). It implements sections
1861 (e) and (j), the sentence following section 1861(s)(13), and
1902(a)(9) of the Social Security Act, and section 353 of the Public
Health Service Act. This part applies to all laboratories as defined
under ``laboratory'' in Sec. 493.2 of this part. This part also applies
to laboratories seeking payment under the Medicare and Medicaid
programs. The
[[Page 960]]
requirements are the same for Medicare approval as for CLIA
certification.
Sec. 493.2 Definitions.
As used in this part, unless the context indicates otherwise--
Accredited institution means a school or program which--
(a) Admits as regular student only persons having a certificate of
graduation from a school providing secondary education, or the
recognized equivalent of such certificate;
(b) Is legally authorized within the State to provide a program of
education beyond secondary education;
(c) Provides an educational program for which it awards a bachelor's
degree or provides not less than a 2-year program which is acceptable
toward such a degree, or provides an educational program for which it
awards a master's or doctoral degree;
(d) Is accredited by a nationally recognized accrediting agency or
association.
This definition includes any foreign institution of higher education
that HHS or its designee determines meets substantially equivalent
requirements.
Accredited laboratory means a laboratory that has voluntarily
applied for and been accredited by a private, nonprofit accreditation
organization approved by CMS in accordance with this part;
Adverse action means the imposition of a principal or alternative
sanction by CMS.
ALJ stands for Administrative Law Judge.
Alternative sanctions means sanctions that may be imposed in lieu of
or in addition to principal sanctions. The term is synonymous with
``intermediate sanctions'' as used in section 1846 of the Act.
Analyte means a substance or constituent for which the laboratory
conducts testing.
Approved accreditation organization for laboratories means a
private, nonprofit accreditation organization that has formally applied
for and received CMS's approval based on the organization's compliance
with this part.
Approved State laboratory program means a licensure or other
regulatory program for laboratories in a State, the requirements of
which are imposed under State law, and the State laboratory program has
received CMS approval based on the State's compliance with this part.
Authorized person means an individual authorized under State law to
order tests or receive test results, or both.
Challenge means, for quantitative tests, an assessment of the amount
of substance or analyte present or measured in a sample. For qualitative
tests, a challenge means the determination of the presence or the
absence of an analyte, organism, or substance in a sample.
CLIA means the Clinical Laboratory Improvement Amendments of 1988.
CLIA certificate means any of the following types of certificates
issued by CMS or its agent:
(1) Certificate of compliance means a certificate issued to a
laboratory after an inspection that finds the laboratory to be in
compliance with all applicable condition level requirements, or reissued
before the expiration date, pending an appeal, in accordance with
Sec. 493.49, when an inspection has found the laboratory to be out of
compliance with one or more condition level requirements.
(2) Certificate for provider-performed microscopy (PPM) procedures
means a certificate issued or reissued before the expiration date,
pending an appeal, in accordance with Sec. 493.47, to a laboratory in
which a physician, midlevel practitioner or dentist performs no tests
other than PPM procedures and, if desired, waived tests listed in
Sec. 493.15(c).
(3) Certificate of accreditation means a certificate issued on the
basis of the laboratory's accreditation by an accreditation organization
approved by CMS (indicating that the laboratory is deemed to meet
applicable CLIA requirements) or reissued before the expiration date,
pending an appeal, in accordance with Sec. 493.61, when a validation or
complaint survey has found the laboratory to be noncompliant with one or
more CLIA conditions.
(4) Certificate of registration or registration certificate means a
certificate issued or reissued before the expiration date, pending an
appeal, in accordance
[[Page 961]]
with Sec. 493.45, that enables the entity to conduct moderate or high
complexity laboratory testing or both until the entity is determined to
be in compliance through a survey by CMS or its agent; or in accordance
with Sec. 493.57 to an entity that is accredited by an approved
accreditation organization.
(5) Certificate of waiver means a certificate issued or reissued
before the expiration date, pending an appeal, in accordance with
Sec. 493.37, to a laboratory to perform only the waived tests listed at
Sec. 493.15(c).
CLIA-exempt laboratory means a laboratory that has been licensed or
approved by a State where CMS has determined that the State has enacted
laws relating to laboratory requirements that are equal to or more
stringent than CLIA requirements and the State licensure program has
been approved by CMS in accordance with subpart E of this part.
Condition level deficiency means noncompliance with one or more
condition level requirements.
Condition level requirements means any of the requirements
identified as ``conditions'' in subparts G through Q of this part.
Credible allegation of compliance means a statement or documentation
that--
(1) Is made by a representative of a laboratory that has a history
of having maintained a commitment to compliance and of taking corrective
action when required;
(2) Is realistic in terms of its being possible to accomplish the
required corrective action between the date of the exit conference and
the date of the allegation; and
(3) Indicates that the problem has been resolved.
Dentist means a doctor of dental medicine or doctor of dental
surgery licensed by the State to practice dentistry within the State in
which the laboratory is located.
Equivalency means that an accreditation organization's or a State
laboratory program's requirements, taken as a whole, are equal to or
more stringent than the CLIA requirements established by CMS, taken as
whole. It is acceptable for an accreditation organization's or State
laboratory program's requirements to be organized differently or
otherwise vary from the CLIA requirements, as long as (1) all of the
requirements taken as a whole would provide at least the same protection
as the CLIA requirements taken as a whole; and (2) a finding of
noncompliance with respect to CLIA requirements taken as a whole would
be matched by a finding of noncompliance with the accreditation or State
requirements taken as a whole.
CMS agent means an entity with which CMS arranges to inspect
laboratories and assess laboratory activities against CLIA requirements
and may be a State survey agency, a private, nonprofit organization
other than an approved accreditation organization, a component of HHS,
or any other governmental component CMS approves for this purpose. In
those instances where all of the laboratories in a State are exempt from
CLIA requirements, based on the approval of a State's exemption request,
the State survey agency is not the CMS agent.
HHS means the Department of Health and Human Services, or its
designee.
Immediate jeopardy means a situation in which immediate corrective
action is necessary because the laboratory's noncompliance with one or
more condition level requirements has already caused, is causing, or is
likely to cause, at any time, serious injury or harm, or 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
[[Page 962]]
determine, measure, or otherwise describe the presence or absence of
various substances or organisms in the body. Facilities only collecting
or preparing specimens (or both) or only serving as a mailing service
and not performing testing are not considered laboratories.
Midlevel practitioner means a nurse midwife, nurse practitioner, or
physician assistant, licensed by the State within which the individual
practices, if such licensing is required in the State in which the
laboratory is located.
Operator means the individual or group of individuals who oversee
all facets of the operation of a laboratory and who bear primary
responsibility for the safety and reliability of the results of all
specimen testing performed in that laboratory. The term includes--
(1) A director of the laboratory if he or she meets the stated
criteria; and
(2) The members of the board of directors and the officers of a
laboratory that is a small corporation under subchapter S of the
Internal Revenue Code.
Owner means any person who owns any interest in a laboratory except
for an interest in a laboratory whose stock and/or securities are
publicly traded. (That is e.g., the purchase of shares of stock or
securities on the New York Stock Exchange in a corporation owning a
laboratory would not make a person an owner for the purpose of this
regulation.)
Party means a laboratory affected by any of the enforcement
procedures set forth in this subpart, by CMS or the OIG, as appropriate.
Performance characteristic means a property of a test that is used
to describe its quality, e.g., accuracy, precision, analytical
sensitivity, analytical specificity, reportable range, reference range,
etc.
Performance specification means a value or range of values for a
performance characteristic, established or verified by the laboratory,
that is used to describe the quality of patient test results.
Physician means an individual with a doctor of medicine, doctor of
osteopathy, or doctor of podiatric medicine degree who is licensed by
the State to practice medicine, osteopathy, or podiatry within the State
in which the laboratory is located.
Principal sanction means the suspension, limitation, or revocation
of any type of CLIA certificate or the cancellation of the laboratory's
approval to receive Medicare payment for its services.
Prospective laboratory means a laboratory that is operating under a
registration certificate or is seeking any of the three other types of
CLIA certificates.
Rate of disparity means the percentage of sample validation
inspections for a specific accreditation organization or State where
CMS, the State survey agency or other CMS agent finds noncompliance with
one or more condition level requirements but no comparable deficiencies
were cited by the accreditation organization or the State, and it is
reasonable to conclude that the deficiencies were present at the time of
the most recent accreditation organization or State licensure
inspection.
Example: Assume the State survey agency, CMS or other CMS agent
performs 200 sample validation inspections for laboratories accredited
by a single accreditation organization or licensed in an exempt State
during a validation review period and finds that 60 of the 200
laboratories had one or more condition level requirements out of
compliance. CMS reviews the validation and accreditation organization's
or State's 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
[[Page 963]]
event for that specific test, analyte, subspecialty, or specialty.
Reference range means the range of test values expected for a
designated population of individuals, e.g., 95 percent of individuals
that are presumed to be healthy (or normal).
Sample in proficiency testing means the material contained in a
vial, on a slide, or other unit that contains material to be tested by
proficiency testing program participants. When possible, samples are of
human origin.
State includes, for purposes of this part, each of the 50 States,
the District of Columbia, the Commonwealth of Puerto Rico, the Virgin
Islands and a political subdivision of a State where the State, acting
pursuant to State law, has expressly delegated powers to the political
subdivision sufficient to authorize the political subdivision to act for
the State in enforcing requirements equal to or more stringent than CLIA
requirements.
State licensure means the issuance of a license to, or the approval
of, a laboratory by a State laboratory program as meeting standards for
licensing or approval established under State law.
State licensure program means a State laboratory licensure or
approval program.
State survey agency means the State health agency or other
appropriate State or local agency that has an agreement under section
1864 of the Social Security Act and is used by CMS to perform surveys
and inspections.
Substantial allegation of noncompliance means a complaint from any
of a variety of sources (including complaints submitted in person, by
telephone, through written correspondence, or in newspaper or magazine
articles) that, if substantiated, would have an impact on the health and
safety of the general public or of individuals served by a laboratory
and raises doubts as to a laboratory's compliance with any condition
level requirement.
Target value for quantitative tests means either the mean of all
participant responses after removal of outliers (those responses greater
than 3 standard deviations from the original mean) or the mean
established by definitive or reference methods acceptable for use in the
National Reference System for the Clinical Laboratory (NRSCL) by the
National Committee for the Clinical Laboratory Standards (NCCLS). In
instances where definitive or reference methods are not available or a
specific method's results demonstrate bias that is not observed with
actual patient specimens, as determined by a defensible scientific
protocol, a comparative method or a method group (``peer'' group) may be
used. If the method group is less than 10 participants, ``target value''
means the overall mean after outlier removal (as defined above) unless
acceptable scientific reasons are available to indicate that such an
evaluation is not appropriate.
Unsatisfactory proficiency testing performance means failure to
attain the minimum satisfactory score for an analyte, test,
subspecialty, or specialty for a testing event.
Unsuccessful participation in proficiency testing means any of the
following:
(1) Unsatisfactory performance for the same analyte in two
consecutive or two out of three testing events.
(2) Repeated unsatisfactory overall testing event scores for two
consecutive or two out of three testing events for the same specialty or
subspecialty.
(3) An unsatisfactory testing event score for those subspecialties
not graded by analyte (that is, bacteriology, mycobacteriology,
virology, parasitology, mycology, blood compatibility, immunohematology,
or syphilis serology) for the same subspecialty for two consecutive or
two out of three testing events.
(4) Failure of a laboratory performing gynecologic cytology to meet
the standard at Sec. 493.855.
Unsuccessful proficiency testing performance means a failure to
attain the minimum satisfactory score for an analyte, test,
subspecialty, or specialty for two consecutive or two of three
consecutive testing events.
Validation review period means the one year time period during which
CMS conducts validation inspections and
[[Page 964]]
evaluates the results of the most recent surveys performed by an
accreditation organization or State laboratory program.
[57 FR 7139, Feb. 28, 1992, as amended at 57 FR 7236, Feb. 28, 1992; 57
FR 34013, July 31, 1992; 57 FR 35761, Aug. 11, 1992; 58 FR 5220, Jan.
19, 1993; 58 FR 48323, Sept. 15, 1993; 60 FR 20043, Apr. 24, 1995; 63 FR
26732, May 14, 1998]
Sec. 493.3 Applicability.
(a) Basic rule. Except as specified in paragraph (b) of this
section, a laboratory will be cited as out of compliance with section
353 of the Public Health Service Act unless it--
(1) Has a current, unrevoked or unsuspended certificate of waiver,
registration certificate, certificate of compliance, certificate for PPM
procedures, or certificate of accreditation issued by HHS applicable to
the category of examinations or procedures performed by the laboratory;
or
(2) Is CLIA-exempt.
(b) Exception. These rules do not apply to components or functions
of--
(1) Any facility or component of a facility that only performs
testing for forensic purposes;
(2) Research laboratories that test human specimens but do not
report patient specific results for the diagnosis, prevention or
treatment of any disease or impairment of, or the assessment of the
health of individual patients; or
(3) Laboratories certified by the National Institutes on Drug Abuse
(NIDA), in which drug testing is performed which meets NIDA guidelines
and regulations. However, all other testing conducted by a NIDA-
certified laboratory is subject to this rule.
(c) Federal laboratories. Laboratories under the jurisdiction of an
agency of the Federal Government are subject to the rules of this part,
except that the Secretary may modify the application of such
requirements as appropriate.
[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5221, Jan. 19, 1993; 60
FR 20043, Apr. 24, 1995]
Sec. 493.5 Categories of tests by complexity.
(a) Laboratory tests are categorized as one of the following:
(1) Waived tests.
(2) Tests of moderate complexity, including the subcategory of PPM
procedures.
(3) Tests of high complexity.
(b) A laboratory may perform only waived tests, only tests of
moderate complexity, only PPM procedures, only tests of high complexity
or any combination of these tests.
(c) Each laboratory must be either CLIA-exempt or possess one of the
following CLIA certificates, as defined in Sec. 493.2:
(1) Certificate of registration or registration certificate.
(2) Certificate of waiver.
(3) Certificate for PPM procedures.
(4) Certificate of compliance.
(5) Certificate of accreditation.
[60 FR 20043, Apr. 24, 1995]
Sec. 493.15 Laboratories performing waived tests.
(a) Requirement. Tests for certificate of waiver must meet the
descriptive criteria specified in paragraph (b) of this section.
(b) Criteria. Test systems are simple laboratory examinations and
procedures which--
(1) Are cleared by FDA for home use;
(2) Employ methodologies that are so simple and accurate as to
render the likelihood of erroneous results negligible; or
(3) Pose no reasonable risk of harm to the patient if the test is
performed incorrectly.
(c) Certificate of waiver tests. A laboratory may qualify for a
certificate of waiver under section 353 of the PHS Act if it restricts
the tests that it performs to one or more of the following tests or
examinations (or additional tests added to this list as provided under
paragraph (d) of this section) and no others:
(1) Dipstick or Tablet Reagent Urinalysis (non-automated) for the
following:
(i) Bilirubin;
(ii) Glucose;
(iii) Hemoglobin;
(iv) Ketone;
(v) Leukocytes;
(vi) Nitrite;
(vii) pH;
(viii) Protein;
(ix) Specific gravity; and
[[Page 965]]
(x) Urobilinogen.
(2) Fecal occult blood;
(3) Ovulation tests--visual color comparison tests for human
luteinizing hormone;
(4) Urine pregnancy tests--visual color comparison tests;
(5) Erythrocyte sedimentation rate--non-automated;
(6) Hemoglobin--copper sulfate--non-automated;
(7) Blood glucose by glucose monitoring devices cleared by the FDA
specifically for home use;
(8) Spun microhematocrit; and
(9) Hemoglobin by single analyte instruments with self-contained or
component features to perform specimen/reagent interaction, providing
direct measurement and readout.
(d) Revisions to criteria for test categorization and the list of
waived tests. HHS will determine whether a laboratory test meets the
criteria listed under paragraph (b) of this section for a waived test.
Revisions to the list of waived tests approved by HHS will be published
in the Federal Register in a notice with opportunity for comment.
(e) Laboratories eligible for a certificate of waiver must--
(1) Follow manufacturers' instructions for performing the test; and
(2) Meet the requirements in subpart B, Certificate of Waiver, of
this part.
[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5221, Jan. 19, 1993]
Sec. 493.17 Test categorization.
(a) Categorization by criteria. Notices will be published in the
Federal Register which list each specific test system, assay, and
examination categorized by complexity. Using the seven criteria
specified in this paragraph for categorizing tests of moderate or high
complexity, each specific laboratory test system, assay, and examination
will be graded for level of complexity by assigning scores of 1, 2, or 3
within each criteria. The score of ``1'' indicates the lowest level of
complexity, and the score of ``3'' indicates the highest level. These
scores will be totaled. Test systems, assays or examinations receiving
scores of 12 or less will be categorized as moderate complexity, while
those receiving scores above 12 will be categorized as high complexity.
Note: A score of ``2'' will be assigned to a criteria heading when
the characteristics for a particular test are intermediate between the
descriptions listed for scores of ``1'' and ``3.''
(1) Knowledge.
(i) Score 1. (A) Minimal scientific and technical knowledge is
required to perform the test; and
(B) Knowledge required to perform the test may be obtained through
on-the-job instruction.
(ii) Score 3. Specialized scientific and technical knowledge is
essential to perform preanalytic, analytic or postanalytic phases of the
testing.
(2) Training and experience.
(i) Score 1. (A) Minimal training is required for preanalytic,
analytic and postanalytic phases of the testing process; and
(B) Limited experience is required to perform the test.
(ii) Score 3. (A) Specialized training is essential to perform the
preanalytic, analytic or postanalytic testing process; or
(B) Substantial experience may be necessary for analytic test
performance.
(3) Reagents and materials preparation.
(i) Score 1. (A) Reagents and materials are generally stable and
reliable; and
(B) Reagents and materials are prepackaged, or premeasured, or
require no special handling, precautions or storage conditions.
(ii) Score 3. (A) Reagents and materials may be labile and may
require special handling to assure reliability; or
(B) Reagents and materials preparation may include manual steps such
as gravimetric or volumetric measurements.
(4) Characteristics of operational steps. (i) Score 1. Operational
steps are either automatically executed (such as pipetting, temperature
monitoring, or timing of steps), or are easily controlled.
[[Page 966]]
(ii) Score 3. Operational steps in the testing process require close
monitoring or control, and may require special specimen preparation,
precise temperature control or timing of procedural steps, accurate
pipetting, or extensive calculations.
(5) Calibration, quality control, and proficiency testing materials.
(i) Score 1. (A) Calibration materials are stable and readily
available;
(B) Quality control materials are stable and readily available; and
(C) External proficiency testing materials, when available, are
stable.
(ii) Score 3. (A) Calibration materials, if available, may be
labile;
(B) Quality control materials may be labile, or not available; or
(C) External proficiency testing materials, if available, may be
labile.
(6) Test system troubleshooting and equipment maintenance.
(i) Score 1. (A) Test system troubleshooting is automatic or self-
correcting, or clearly described or requires minimal judgment; and
(B) Equipment maintenance is provided by the manufacturer, is seldom
needed, or can easily be performed.
(ii) Score 3. (A) Troubleshooting is not automatic and requires
decision-making and direct intervention to resolve most problems; or
(B) Maintenance requires special knowledge, skills, and abilities.
(7) Interpretation and judgment. (i) Score 1. (A) Minimal
interpretation and judgment are required to perform preanalytic,
analytic and postanalytic processes; and
(B) Resolution of problems requires limited independent
interpretation and judgment; and
(ii) Score 3. (A) Extensive independent interpretation and judgment
are required to perform the preanalytic, analytic or postanalytic
processes; and
(B) Resolution of problems requires extensive interpretation and
judgment.
(b) Revisions to the criteria for categorization. The Clinical
Laboratory Improvement Advisory Committee, as defined in subpart T of
this part, will conduct reviews upon request of HHS and recommend to HHS
revisions to the criteria for categorization of tests.
(c) Process for device/test categorization utilizing the scoring
system under Sec. 493.17(a). (1)(i) For new commercial test systems,
assays, or examinations, the manufacturer, as part of its 510(k) and PMA
application to FDA, will submit supporting data for device/test
categorization. FDA will determine the complexity category, notify the
manufacturers directly, and will simultaneously inform both CMS and CDC
of the device/test category. FDA will consult with CDC concerning test
categorization in the following three situations:
(A) When categorizing previously uncategorized new technology;
(B) When FDA determines it to be necessary in cases involving a
request for a change in categorization; and
(C) If a manufacturer requests review of a categorization decision
by FDA in accordance with 21 CFR 10.75.
(ii) Test categorization will be effective as of the notification to
the applicant.
(2) For test systems, assays, or examinations not commercially
available, a laboratory or professional group may submit a written
request for categorization to PHS. These requests will be forwarded to
CDC for evaluation; CDC will determine complexity category and notify
the applicant, CMS, and FDA of the categorization decision. In the case
of request for a change of category or for previously uncategorized new
technology, PHS will receive the request application and forward it to
CDC for categorization.
(3) A request for recategorization will be accepted for review if it
is based on new information not previously submitted in a request for
categorization or recategorization by the same applicant and will not be
considered more frequently than once per year.
(4) If a laboratory test system, assay or examination does not
appear on the lists of tests in the Federal Register notices, it is
considered to be a test of high complexity until PHS, upon request,
reviews the matter and notifies the applicant of its decision. Test
categorization is effective as of the notification to the applicant.
(5) PHS will publish revisions periodically to the list of moderate
and high complexity tests in the Federal
[[Page 967]]
Register in a notice with opportunity for comment.
[57 FR 7139, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993]
Sec. 493.19 Provider-performed microscopy (PPM) procedures.
(a) Requirement. To be categorized as a PPM procedure, the procedure
must meet the criteria specified in paragraph (b) of this section.
(b) Criteria. Procedures must meet the following specifications:
(1) The examination must be personally performed by one of the
following practitioners:
(i) A physician during the patient's visit on a specimen obtained
from his or her own patient or from a patient of a group medical
practice of which the physician is a member or an employee.
(ii) A midlevel practitioner, under the supervision of a physician
or in independent practice only if authorized by the State, during the
patient's visit on a specimen obtained from his or her own patient or
from a patient of a clinic, group medical practice, or other health care
provider of which the midlevel practitioner is a member or an employee.
(iii) A dentist during the patient's visit on a specimen obtained
from his or her own patient or from a patient of a group dental practice
of which the dentist is a member or an employee.
(2) The procedure must be categorized as moderately complex.
(3) The primary instrument for performing the test is the
microscope, limited to bright-field or phase-contrast microscopy.
(4) The specimen is labile or delay in performing the test could
compromise the accuracy of the test result.
(5) Control materials are not available to monitor the entire
testing process.
(6) Limited specimen handling or processing is required.
(c) Provider-performed microscopy (PPM) examinations. A laboratory
may qualify to perform tests under this section if it restricts PPM
examinations to one or more of the following procedures (or additional
procedures added to this list as provided under paragraph (d) of this
section), waived tests and no others:
(1) All direct wet mount preparations for the presence or absence of
bacteria, fungi, parasites, and human cellular elements.
(2) All potassium hydroxide (KOH) preparations.
(3) Pinworm examinations.
(4) Fern tests.
(5) Post-coital direct, qualitative examinations of vaginal or
cervical mucous.
(6) Urine sediment examinations.
(7) Nasal smears for granulocytes.
(8) Fecal leukocyte examinations.
(9) Qualitative semen analysis (limited to the presence or absence
of sperm and detection of motility).
(d) Revisions to criteria and the list of PPM procedures.
(1) The CLIAC conducts reviews upon HHS' request and recommends to
HHS revisions to the criteria for categorization of procedures.
(2) HHS determines whether a laboratory procedure meets the criteria
listed under paragraph (b) of this section for a PPM procedure.
Revisions to the list of PPM procedures proposed by HHS are published in
the Federal Register as a notice with an opportunity for public comment.
(e) Laboratory requirements. Laboratories eligible to perform PPM
examinations must--
(1) Meet the applicable requirements in subpart C or subpart D, and
subparts F, H, J, K, M, and P of this part.
(2) Be subject to inspection as specified under subpart Q of this
part.
[60 FR 20044, Apr. 24, 1995]
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
[[Page 968]]
this part. Under a registration certificate or certificate of
compliance, laboratories also performing PPM procedures must meet the
inspection requirements at Sec. 493.1777.
(c) If the laboratory also performs waived tests, compliance with
subparts H, J, K, M, and P of this part is not applicable to the waived
tests. However, the laboratory must comply with the requirements in
Secs. 493.15(e) and 493.1775.
[60 FR 20044, Apr. 24, 1995]
Sec. 493.25 Laboratories performing tests of high complexity.
(a) A laboratory must obtain a certificate for tests of high
complexity if it performs one or more tests that meet the criteria for
tests of high complexity as specified in Sec. 493.17(a).
(b) A laboratory performing one or more tests of high complexity
must meet the applicable requirements of subpart C or subpart D, and
subparts F, H, J, K, M, P, and Q of this part.
(c) If the laboratory also performs tests of moderate complexity,
the applicable requirements of subparts H, J, K, M, P, and Q of this
part must be met. Under a registration certificate or certificate of
compliance, PPM procedures must meet the inspection requirements at
Sec. 493.1777.
(d) If the laboratory also performs waived tests, the requirements
of subparts H, J, K, M, and P are not applicable to the waived tests.
However, the laboratory must comply with the requirements in
Secs. 493.15(e) and 493.1775.
[57 FR 7139, Feb. 28, 1992, as amended at 60 FR 20044, Apr. 24, 1995]
Subpart B--Certificate of Waiver
Source: 57 FR 7142, Feb. 28, 1992, unless otherwise noted.
Sec. 493.35 Application for a certificate of waiver.
(a) Filing of application. Except as specified in paragraph (b) of
this section, a laboratory performing only one or more waived tests
listed in Sec. 493.15 must file a separate application for each
laboratory location.
(b) Exceptions. (1) Laboratories that are not at a fixed location,
that is, laboratories that move from testing site to testing site, such
as mobile units providing laboratory testing, health screening fairs, or
other temporary testing locations may be covered under the certificate
of the designated primary site or home base, using its address.
(2) Not-for-profit or Federal, State, or local government
laboratories that engage in limited (not more than a combination of 15
moderately complex or waived tests per certificate) public 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);
[[Page 969]]
(2) Agree to permit announced and unannounced inspections by HHS in
accordance with subpart Q of this part under the following
circumstances:
(i) When HHS has substantive reason to believe that the laboratory
is being operated in a manner that constitutes an imminent and serious
risk to human health.
(ii) To evaluate complaints from the public.
(iii) On a random basis to determine whether the laboratory is
performing tests not listed in Sec. 493.15.
(iv) To collect information regarding the appropriateness of waiver
of tests listed in Sec. 493.15.
(e) Denial of application. If HHS determines that the application
for a certificate of waiver is to be denied, HHS will--
(1) Provide the laboratory with a written statement of the grounds
on which the denial is based and an opportunity for appeal, in
accordance with the procedures set forth in subpart R of this part;
(2) Notify a laboratory that has its application for a certificate
of waiver denied that it cannot operate as a laboratory under the PHS
Act unless the denial is overturned at the conclusion of the
administrative appeals process provided by subpart R; and
(3) Notify the laboratory that it is not eligible for payment under
the Medicare and Medicaid programs.
[57 FR 7142, Feb. 28, 1992, as amended at 58 FR 5222, Jan. 19, 1993; 60
FR 20044, Apr. 24, 1995]
Sec. 493.37 Requirements for a certificate of waiver.
(a) HHS will issue a certificate of waiver to a laboratory only if
the laboratory meets the requirements of Sec. 493.35.
(b) Laboratories issued a certificate of waiver--
(1) Are subject to the requirements of this subpart and
Sec. 493.15(e) of subpart A of this part; and
(2) Must permit announced or unannounced inspections by HHS in
accordance with subpart Q of this part.
(c) Laboratories must remit the certificate of waiver fee specified
in subpart F of this part.
(d) In accordance with subpart R of this part, HHS will suspend or
revoke or limit a laboratory's certificate of waiver for failure to
comply with the requirements of this subpart. In addition, failure to
meet the requirements of this subpart will result in suspension or
denial of payments under Medicare and Medicaid in accordance with
subpart R of this part.
(e)(1) A certificate of waiver issued under this subpart is valid
for no more than 2 years. In the event of a non-compliance determination
resulting in HHS action to revoke, suspend, or limit the laboratory's
certificate of waiver, HHS will provide the laboratory with a statement
of grounds on which the determination of non-compliance is based and
offer an opportunity for appeal as provided in subpart R of this part.
(2) If the laboratory requests a hearing within the time specified
by HHS, it retains its certificate of waiver or reissued certificate of
waiver until a decision is made by an administrative law judge, as
specified in subpart R of this part, except when HHS finds that
conditions at the laboratory pose an imminent and serious risk to human
health.
(3) For laboratories receiving payment from the Medicare or Medicaid
program, such payments will be suspended on the effective date specified
in the notice to the laboratory of a non-compliance determination even
if there has been no appeals decision issued.
(f) A laboratory seeking to renew its certificate of waiver must--
(1) Complete the renewal application prescribed by HHS and return it
to HHS not less than 9 months nor more than 1 year before the expiration
of the certificate; and
(2) Meet the requirements of 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]
[[Page 970]]
Sec. 493.39 Notification requirements for laboratories issued a
certificate of waiver.
Laboratories performing one or more tests listed in Sec. 493.15 and
no others must notify HHS or its designee--
(a) Before performing and reporting results for any test or
examination that is not specified under Sec. 493.15 for which the
laboratory does not have the appropriate certificate as required in
subpart C or subpart D of this part, as applicable; and
(b) Within 30 days of any change(s) in--
(1) Ownership;
(2) Name;
(3) Location; or
(4) Director.
[57 FR 7142, Feb. 28, 1992, as amended at 60 FR 20045, Apr. 24, 1995]
Subpart C--Registration Certificate, Certificate for Provider-performed
Microscopy Procedures, and Certificate of Compliance
Source: 57 FR 7143, Feb. 28, 1992, unless otherwise noted.
Sec. 493.43 Application for registration certificate, certificate for
provider-performed microscopy (PPM) procedures, and
certificate of compliance.
(a) Filing of application. Except as specified in paragraph (b) of
this section, all laboratories performing tests of moderate complexity
(including the subcategory) or high complexity, or any combination of
these tests, must file a separate application for each laboratory
location.
(b) Exceptions. (1) Laboratories that are not at a fixed location,
that is, laboratories that move from testing site to testing site, such
as mobile units providing laboratory testing, health screening fairs, or
other temporary testing locations may be covered under the certificate
of the designated primary site or home base, using its address.
(2) Not-for-profit or Federal, State, or local government
laboratories that engage in limited (not more than a combination of 15
moderately complex or waived tests per certificate) public health
testing may file a single application.
(3) Laboratories within a hospital that are located at contiguous
buildings on the same campus and under common direction may file a
single application or multiple applications for the laboratory sites
within the same physical location or street address.
(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
[[Page 971]]
complexity (other than the subcategory of PPM procedures) or high
complexity, or both; and
(2) For all laboratories that have been issued a certificate of
waiver or certificate for PPM procedures that intend to perform tests of
moderate or high complexity, or both, in addition to those tests listed
in Sec. 493.15(c) or specified as PPM procedures.
(b) HHS will issue a registration certificate if the laboratory--
(1) Complies with the requirements of Sec. 493.43;
(2) Agrees to notify HHS or its designee within 30 days of any
changes in ownership, name, location, director or technical supervisor
(laboratories performing high complexity testing only);
(3) Agrees to treat proficiency testing samples in the same manner
as it treats patient specimens; and
(4) Remits the fee for the registration certificate, as specified in
subpart F of this part.
(c) Prior to the expiration of the registration certificate, a
laboratory must--
(1) Remit the certificate fee specified in subpart F of this part;
(2) Be inspected by HHS as specified in subpart Q of this part; and
(3) Demonstrate compliance with the applicable requirements of this
subpart and subparts H, J, K, M, P, and Q of this part.
(d) In accordance with subpart R of this part, HHS will initiate
suspension or revocation of a laboratory's registration certificate and
will deny the laboratory's application for a certificate of compliance
for failure to comply with the requirements set forth in this subpart.
HHS may also impose certain alternative sanctions. In addition, failure
to meet the requirements of this subpart will result in suspension of
payments under Medicare and Medicaid as specified in subpart R of this
part.
(e) A registration certificate is--
(1) Valid for a period of no more than two years or until such time
as an inspection to determine program compliance can be conducted,
whichever is shorter; and
(2) Not renewable; however, the registration certificate may be
reissued if compliance has not been determined by HHS prior to the
expiration date of the registration certificate.
(f) In the event of a noncompliance determination resulting in an
HHS denial of a laboratory's certificate of compliance application, HHS
will provide the laboratory with a statement of grounds on which the
noncompliance determination is based and offer an opportunity for appeal
as provided in subpart R.
(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
[[Page 972]]
(3) Inspection only under the circumstances specified under
Sec. 493.1776, but are not routinely inspected to determine compliance
with the requirements specified in paragraphs (c) (1) and (2) of this
section.
(d) In accordance with subpart R of this part, HHS will initiate
suspension, limitation, or revocation of a laboratory's certificate for
PPM procedures for failure to comply with the applicable requirements
set forth in this subpart. HHS may also impose certain alternative
sanctions. In addition, failure to meet the requirements of this subpart
may result in suspension of all or part of payments under Medicare and
Medicaid, as specified in subpart R of this part.
(e) A certificate for PPM procedures is valid for a period of no
more than 2 years.
[58 FR 5223, Jan. 19, 1993, as amended at 60 FR 20045, Apr. 24, 1995]
Sec. 493.49 Requirements for a certificate of compliance.
A certificate of compliance may include any combination of tests
categorized as high complexity or moderate complexity or listed in
Sec. 493.15(c) as waived tests. Moderate complexity tests may include
those specified as PPM procedures.
(a) HHS will issue a certificate of compliance to a laboratory only
if the laboratory--
(1) Meets the requirements of Secs. 493.43 and 493.45;
(2) Remits the certificate fee specified in subpart F of this part;
and
(3) Meets the applicable requirements of this subpart and subparts
H, J, K, M, P, and Q of this part.
(b) Laboratories issued a certificate of compliance--
(1) Are subject to the notification requirements of Sec. 493.51; and
(2) Must permit announced or unannounced inspections by HHS in
accordance with subpart Q of this part--
(i) To determine compliance with the applicable requirements of this
part;
(ii) To evaluate complaints;
(iii) When HHS has substantive reason to believe that tests are
being performed, or the laboratory is being operated in a manner that
constitutes an imminent and serious risk to human health; and
(iv) To collect information regarding the appropriateness of tests
listed in Sec. 493.15 or tests categorized as moderate complexity
(including the subcategory) or high complexity.
(c) Failure to comply with the requirements of this subpart will
result in--
(1) Suspension, revocation or limitation of a laboratory's
certificate of 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.
[[Page 973]]
(h) If HHS determines that the application for the renewal of a
certificate of compliance must be denied or limited, HHS will notify the
laboratory in writing of the--
(1) Basis for denial of the application; and
(2) Opportunity for appeal as provided in subpart R of this part.
(i) If the laboratory requests a hearing within the time period
specified by HHS, the laboratory retains its certificate of compliance
or reissued certificate of compliance until a decision is made by an ALJ
as provided in subpart R, except when HHS finds that conditions at the
laboratory pose an imminent and serious risk to human health.
(j) For laboratories receiving payment from the Medicare or Medicaid
program, such payments will be suspended on the effective date specified
in the notice to the laboratory of nonrenewal of the certificate of
compliance even if there has been no appeals decision issued.
[60 FR 20045, Apr. 24, 1995]
Sec. 493.51 Notification requirements for laboratories issued a
certificate of compliance.
Laboratories issued a certificate of compliance must meet the
following conditions:
(a) Notify HHS or its designee within 30 days of any change in--
(1) Ownership;
(2) Name;
(3) Location;
(4) Director; or
(5) Technical supervisor (laboratories performing high complexity
only).
(b) Notify HHS no later than 6 months after performing any test or
examination within a specialty or subspecialty area that is not included
on the laboratory's certificate of compliance, so that compliance with
requirements can be determined.
(c) Notify HHS no later than 6 months after any deletions or changes
in test methodologies for any test or examination included in a
specialty or subspecialty, or both, for which the laboratory has been
issued a certificate of compliance.
[57 FR 7143, Feb. 28, 1992, as amended at 60 FR 20046, Apr. 24, 1995]
Sec. 493.53 Notification requirements for laboratories issued a
certificate for provider-performed microscopy (PPM)
procedures.
Laboratories issued a certificate for PPM procedures must notify HHS
or its designee--
(a) Before performing and reporting results for any test of moderate
or high complexity, or both, in addition to tests specified as PPM
procedures or any test or examination that is not 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
[[Page 974]]
combination of 15 moderately complex or waived tests per certificate)
public health testing may file a single application.
(3) Laboratories within a hospital that are located at contiguous
buildings on the same campus and under common direction may file a
single application or multiple applications for the laboratory sites
within the same physical location or street address.
(c) Application format and contents. The application must--(1) Be
made to HHS on a form or forms prescribed by HHS;
(2) Be signed by an owner or authorized representative of the
laboratory who attests that the laboratory will be operated in
accordance with the requirements established by the Secretary under
section 353 of the Public Health Service Act; and
(3) Describe the characteristics of the laboratory operation and the
examinations and other test procedures performed by the laboratory
including--
(i) The name and total number of tests and examinations performed
annually (excluding waived tests and tests for quality control, quality
assurance or proficiency testing purposes);
(ii) The methodologies for each laboratory test procedure or
examination performed, or both; and
(iii) The qualifications (educational background, training, and
experience) of the personnel directing and supervising the laboratory
and performing the laboratory examinations and test procedures.
(d) Access and reporting requirements. All laboratories must make
records available and submit reports to HHS as HHS may reasonably
require to determine compliance with this section.
[57 FR 7144, Feb. 28, 1992, as amended at 58 FR 5224, Jan. 19, 1993; 58
FR 39155, July 22, 1993; 60 FR 20046, Apr. 24, 1995]
Sec. 493.57 Requirements for a registration certificate.
A registration certificate is required for all laboratories seeking
a certificate of accreditation, unless the laboratory holds a valid
certificate of compliance issued by HHS.
(a) HHS will issue a registration certificate if the laboratory--
(1) Complies with the requirements of Sec. 493.55;
(2) Agrees to notify HHS within 30 days of any changes in ownership,
name, location, director, or supervisor (laboratories performing high
complexity testing only);
(3) Agrees to treat proficiency testing samples in the same manner
as it treats patient specimens; and
(4) Remits the fee for the registration certificate specified in
subpart F of this part.
(b)(1) The laboratory must provide HHS with proof of accreditation
by an approved accreditation program--
(i) Within 11 months of issuance of the registration certificate; or
(ii) Prior to the expiration of the certificate of compliance.
(2) If such proof of accreditation is not supplied within this
timeframe, the laboratory must meet, or continue to meet, the
requirements of Sec. 493.49.
(c) In accordance with subpart R of this part, HHS will initiate
suspension, revocation, or limitation of a laboratory's registration
certificate and will deny the laboratory's application for a certificate
of accreditation for failure to comply with the requirements set forth
in this subpart. In addition, failure to meet the requirements of this
subpart will result in suspension or denial of payments under Medicare
and Medicaid as specified in subpart R of this part.
(d) A registration certificate is valid for a period of no more than
2 years. However, it may be reissued if the laboratory is subject to
subpart C of this part, as specified in Sec. 493.57(b)(2) and compliance
has not been determined by 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
[[Page 975]]
requests a hearing within the time specified by HHS, the laboratory will
retain its registration certificate or reissued registration certificate
until a decision is made by an administrative law judge as provided in
subpart R, unless HHS finds that conditions at the laboratory pose an
imminent and serious risk to human health; and
(5) For those laboratories receiving payment from the Medicare or
Medicaid program, such payments will be suspended on the effective date
specified in the notice to the laboratory of denial of the request even
if there has been no appeals decision issued.
[57 FR 7144, Feb. 28, 1992, as amended at 60 FR 20046, Apr. 24, 1995]
Sec. 493.61 Requirements for a certificate of accreditation.
(a) HHS will issue a certificate of accreditation to a laboratory if
the laboratory--
(1) Meets the requirements of Sec. 493.57 or, if applicable,
Sec. 493.49 of subpart C of this part; and
(2) Remits the certificate of accreditation fee specified in subpart
F of this part.
(b) Laboratories issued a certificate of accreditation must--
(1) Treat proficiency testing samples in the same manner as patient
samples;
(2) Meet the requirements of Sec. 493.63;
(3) Comply with the requirements of the approved accreditation
program;
(4) Permit random sample validation and complaint inspections as
required in subpart Q of this part;
(5) Permit HHS to monitor the correction of any deficiencies found
through the inspections specified in paragraph (b)(4) of this section;
(6) Authorize the accreditation program to release to HHS the
laboratory's inspection findings whenever HHS conducts random sample or
complaint inspections; and
(7) Authorize its accreditation program to submit to HHS the results
of the laboratory's proficiency testing.
(c) A laboratory failing to meet the requirements of this section--
(1) Will no longer meet the requirements of this part by virtue of
its accreditation in an approved accreditation program;
(2) Will be subject to full determination of compliance by HHS;
(3) May be subject to suspension, revocation or limitation of the
laboratory's certificate of accreditation or certain alternative
sanctions; and
(4) May be subject to suspension of payments under Medicare and
Medicaid as specified in subpart R.
(d) A certificate of accreditation issued under this subpart is
valid for no more than 2 years. In the event of a non-compliance
determination as a result of a random sample validation or complaint
inspection, a laboratory will be subject to a full review by HHS in
accordance with Sec. 488.11 of this chapter.
(e) Failure to meet the applicable requirements of part 493, will
result in an action by HHS to suspend, revoke or limit the certificate
of accreditation. HHS will--
(1) Provide the laboratory with a statement of grounds on which the
determination of noncompliance is based;
(2) Notify the laboratory if it is eligible to apply for a
certificate as defined in subpart C of this part; and
(3) Offer an opportunity for appeal as provided in subpart R of this
part.
(f) If the laboratory requests a hearing within the time frame
specified by HHS--
(1) It retains its certificate of accreditation or reissued
certificate of accreditation until a decision is made by an
administrative law judge as provided in subpart R of this part, unless
HHS finds that conditions at the laboratory pose an imminent and serious
risk to human health; and
(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;
[[Page 976]]
(2) Meet the requirements of this subpart; and
(3) Submit the certificate of accreditation fee specified in subpart
F of this part.
(i) If HHS determines that the renewal application for a certificate
of accreditation is to be denied or limited, HHS will notify the
laboratory in writing of--
(1) The basis for denial of the application;
(2) Whether the laboratory is eligible for a certificate as defined
in subpart C of this part;
(3) The opportunity for appeal on HHS's action to deny the renewal
application for certificate of accreditation as provided in subpart R of
this part. If the laboratory requests a hearing within the time frame
specified by HHS, it retains its certificate of accreditation or
reissued certificate of accreditation until a decision is made by an
administrative law judge as provided in subpart R of this part, unless
HHS finds that conditions at the laboratory pose an imminent and serious
risk to human health; and
(4) Suspension of payments under Medicare or Medicaid for those
laboratories receiving payments under the Medicare or Medicaid programs.
[57 FR 7144, Feb. 28, 1992, as amended at 58 FR 5224, Jan. 19, 1993]
Sec. 493.63 Notification requirements for laboratories issued a
certificate of accreditation.
Laboratories issued a certificate of accreditation must:
(a) Notify HHS and the approved accreditation program within 30 days
of any changes in--
(1) Ownership;
(2) Name;
(3) Location; or
(4) Director.
(b) Notify the approved accreditation program no later than 6 months
after performing any test or examination within a specialty or
subspecialty area that is not included in the laboratory's
accreditation, so that the accreditation organization can determine
compliance and a new certificate of accreditation can be issued.
(c) Notify the accreditation program no later than 6 months after of
any deletions or changes in test methodologies for any test or
examination included in a specialty or subspecialty, or both, for which
the laboratory has been issued a certificate of accreditation.
Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
Source: 63 FR 26732, May 14, 1998, unless otherwise noted.
Sec. 493.551 General requirements for laboratories.
(a) Applicability. CMS may deem a laboratory to meet all applicable
CLIA program requirements through accreditation by a private nonprofit
accreditation program (that is, grant deemed status), or may exempt from
CLIA program requirements all State licensed or approved laboratories in
a State that has a State licensure program established by law, if the
following conditions are met:
(1) The requirements of the accreditation organization or State
licensure program are equal to, or more stringent than, the CLIA
condition-level requirements specified in this part, and the laboratory
would meet the condition-level requirements if it were inspected against
these requirements.
(2) The accreditation program or the State licensure program meets
the requirements of this subpart and is approved by CMS.
(3) The laboratory authorizes the approved accreditation
organization or State licensure program to release to CMS all records
and information required and permits inspections as outlined in this
part.
(b) Meeting CLIA requirements by accreditation. A laboratory seeking
to meet CLIA requirements through accreditation by an approved
accreditation organization must do the following:
(1) Obtain a certificate of accreditation as required in subpart D
of this part.
(2) Pay the applicable fees as required in subpart F of this part.
[[Page 977]]
(3) Meet the proficiency testing (PT) requirements in subpart H of
this part.
(4) Authorize its PT organization to furnish to its accreditation
organization the results of the laboratory's participation in an
approved PT program for the purpose of monitoring the laboratory's PT
and for making the annual PT results, along with explanatory information
required to interpret the PT results, available on a reasonable basis,
upon request of any person. A laboratory that refuses to authorize
release of its PT results is no longer deemed to meet the condition-
level requirements and is subject to a full review by CMS, in accordance
with subpart Q of this part, and may be subject to the suspension or
revocation of its certificate of accreditation under Sec. 493.1840.
(5) Authorize its accreditation organization to release to CMS or a
CMS agent the laboratory's PT results that constitute unsuccessful
participation in an approved PT program, in accordance with the
definition of ``unsuccessful participation in an approved PT program,''
as specified in Sec. 493.2 of this part, when the laboratory has failed
to achieve successful participation in an approved PT program.
(6) Authorize its accreditation organization to release to CMS a
notification of the actions taken by the organization as a result of the
unsuccessful participation in a PT program within 30 days of the
initiation of the action. Based on this notification, CMS may take an
adverse action against a laboratory that fails to participate
successfully in an approved PT program.
(c) Withdrawal of laboratory accreditation. After an accreditation
organization has withdrawn or revoked its accreditation of a laboratory,
the laboratory retains its certificate of accreditation for 45 days
after the laboratory receives notice of the withdrawal or revocation of
the accreditation, or the effective date of any action taken by CMS,
whichever is earlier.
Sec. 493.553 Approval process (application and reapplication) for
accreditation organizations and State licensure programs.
(a) Information required. An accreditation organization that applies
or reapplies to CMS for deeming authority, or a State licensure program
that applies or reapplies to CMS for exemption from CLIA program
requirements of licensed or approved laboratories within the State, must
provide the following information:
(1) A detailed comparison of the individual accreditation, or
licensure or approval requirements with the comparable condition-level
requirements; that is, a crosswalk.
(2) A detailed description of the inspection process, including the
following:
(i) Frequency of inspections.
(ii) Copies of inspection forms.
(iii) Instructions and guidelines.
(iv) A description of the review and decision-making process of
inspections.
(v) A statement concerning whether inspections are announced or
unannounced.
(vi) A description of the steps taken to monitor the correction of
deficiencies.
(3) A description of the process for monitoring PT performance,
including action to be taken in response to unsuccessful participation
in a CMS-approved PT program.
(4) Procedures for responding to and for the investigation of
complaints against its laboratories.
(5) A list of all its current laboratories and the expiration date
of their accreditation or licensure, as applicable.
(6) Procedures for making PT information available (under State
confidentiality and disclosure requirements, if applicable) including
explanatory information required to interpret PT results, on a
reasonable basis, upon request of any person.
(b) CMS action on an application or reapplication. If CMS receives
an application or reapplication from an accreditation organization, or
State licensure program, CMS takes the following actions:
(1) CMS determines if additional information is necessary to make a
determination for approval or denial of the application and notifies the
accreditation organization or State to afford it an opportunity to
provide the additional information.
[[Page 978]]
(2) CMS may visit the accreditation organization or State licensure
program offices to review and verify the policies and procedures
represented in its application and other information, including, but not
limited to, review and examination of documents and interviews with
staff.
(3) CMS notifies the accreditation organization or State licensure
program indicating whether CMS approves or denies the request for
deeming authority or exemption, respectively, and the rationale for any
denial.
(c) Duration of approval. CMS approval may not exceed 6 years.
(d) Withdrawal of application. The accreditation organization or
State licensure program may withdraw its application at any time before
official notification, specified at Sec. 493.553(b)(3).
Sec. 493.555 Federal review of laboratory requirements.
CMS's review of an accreditation organization or State licensure
program includes, but is not limited to, an evaluation of the following:
(a) Whether the organization's or State's requirements for
laboratories are equal to, or more stringent than, the condition-level
requirements for laboratories.
(b) The organization's or State's inspection process to determine
the comparability of the full inspection and complaint inspection
procedures and requirements to those of CMS, including, but not limited
to, inspection frequency and the ability to investigate and respond to
complaints against its laboratories.
(c) The organization's or State's agreement with CMS that requires
it to do the following:
(1) Notify CMS within 30 days of the action taken, of any laboratory
that has--
(i) Had its accreditation or licensure suspended, withdrawn,
revoked, or limited;
(ii) In any way been sanctioned; or
(iii) Had any adverse action taken against it.
(2) Notify CMS within 10 days of any deficiency identified in an
accredited or CLIA-exempt laboratory if the deficiency poses an
immediate jeopardy to the laboratory's patients or a hazard to the
general public.
(3) Notify CMS, within 30 days, of all newly--
(i) Accredited laboratories (or laboratories whose areas of
specialty/subspecialty testing have changed); or
(ii) Licensed laboratories, including the specialty/subspecialty
areas of testing.
(4) Notify each accredited or licensed laboratory within 10 days of
CMS's withdrawal of the organization's deeming authority or State's
exemption.
(5) Provide CMS with inspection schedules, as requested, for
validation purposes.
Sec. 493.557 Additional submission requirements.
(a) Specific requirements for accreditation organizations. In
addition to the information specified in Secs. 493.553 and 493.555, as
part of the approval and review process, an accreditation organization
applying or reapplying for deeming authority must also provide the
following:
(1) The specialty or subspecialty areas for which the organization
is requesting deeming authority and its mechanism for monitoring
compliance with all requirements equivalent to condition-level
requirements within the scope of the specialty or subspecialty areas.
(2) A description of the organization's data management and analysis
system with respect to its inspection and accreditation decisions,
including the kinds of routine reports and tables generated by the
systems.
(3) Detailed information concerning the inspection process,
including, but not limited to the following:
(i) The size and composition of individual accreditation inspection
teams.
(ii) Qualifications, education, and experience requirements that
inspectors must meet.
(iii) The content and frequency of training provided to inspection
personnel, including the ability of the organization to provide
continuing education and training to inspectors.
(4) Procedures for removal or withdrawal of accreditation status for
laboratories that fail to meet the organization's standards.
[[Page 979]]
(5) A proposed agreement between CMS and the accreditation
organization with respect to the notification requirements specified in
Sec. 493.555(c).
(6) Procedures for monitoring laboratories found to be out of
compliance with its requirements. (These monitoring procedures must be
used only when the accreditation organization identifies noncompliance.
If noncompliance is identified through validation inspections, CMS or a
CMS agent monitors corrections, as authorized at Sec. 493.565(d)).
(7) A demonstration of its ability to provide CMS with electronic
data and reports in compatible code, including the crosswalk specified
in Sec. 493.553(a)(1), that are necessary for effective validation and
assessment of the organization's inspection process.
(8) A demonstration of its ability to provide CMS with electronic
data, in compatible code, related to the adverse actions resulting from
PT results constituting unsuccessful participation in PT programs as
well as data related to the PT failures, within 30 days of the
initiation of adverse action.
(9) A demonstration of its ability to provide CMS with electronic
data, in compatible code, for all accredited laboratories, including the
area of specialty or subspecialty.
(10) Information defining the adequacy of numbers of staff and other
resources.
(11) Information defining the organization's ability to provide
adequate funding for performing required inspections.
(12) Any facility-specific data, upon request by CMS, which
includes, but is not limited to, the following:
(i) PT results that constitute unsuccessful participation in a CMS-
approved PT program.
(ii) Notification of the adverse actions or corrective actions
imposed by the accreditation organization as a result of unsuccessful PT
participation.
(13) An agreement to provide written notification to CMS at least 30
days in advance of the effective date of any proposed change in its
requirements.
(14) An agreement to disclose any laboratory's PT results upon
reasonable request by any person.
(b) Specific requirements for a State licensure program. In addition
to requirements in Secs. 493.553 and 493.555, as part of the approval
and review process, when a State licensure program applies or reapplies
for exemption from the CLIA program, the State must do the following:
(1) Demonstrate to CMS that it has enforcement authority and
administrative structures and resources adequate to enforce its
laboratory requirements.
(2) Permit CMS or a CMS agent to inspect laboratories in the State.
(3) Require laboratories in the State to submit to inspections by
CMS or a CMS agent as a condition of licensure or approval.
(4) Agree to pay the cost of the validation program administered in
that State as specified in Secs. 493.645(a) and 493.646(b).
(5) Take appropriate enforcement action against laboratories found
by CMS not to be in compliance with requirements equivalent to CLIA
requirements.
(6) Submit for Medicare and Medicaid payment purposes, a list of the
specialties and subspecialties of tests performed by each laboratory.
(7) Submit a written presentation that demonstrates the agency's
ability to furnish CMS with electronic data in compatible code,
including the crosswalk specified in Sec. 493.553(a)(1).
(8) Submit a statement acknowledging that the State will notify CMS
through electronic transmission of the following:
(i) Any laboratory that has had its licensure or approval revoked or
withdrawn or has been in any way sanctioned by the State within 30 days
of taking the action.
(ii) Changes in licensure or inspection requirements.
(iii) Changes in specialties or subspecialties under which any
licensed laboratory in the State performs testing.
(9) Provide information for the review of the State's enforcement
procedures for laboratories found to be out of compliance with the
State's requirements.
(10) Submit information that demonstrates the ability of the State
to provide CMS with the following:
[[Page 980]]
(i) Electronic data and reports in compatible code with the adverse
or corrective actions resulting from PT results that constitute
unsuccessful participation in PT programs.
(ii) Other data that CMS determines are necessary for validation and
assessment of the State's inspection process requirements.
(11) Agree to provide CMS with written notification of any changes
in its licensure/approval and inspection requirements.
(12) Agree to disclose any laboratory's PT results in accordance
with a State's confidentiality requirements.
(13) Agree to take the appropriate enforcement action against
laboratories found by CMS not to be in compliance with requirements
comparable to condition-level requirements and report these enforcement
actions to CMS.
(14) If approved, reapply to CMS every 2 years to renew its exempt
status and to renew its agreement to pay the cost of the CMS-
administered validation program in that State.
Sec. 493.559 Publication of approval of deeming authority or CLIA
exemption.
(a) Notice of deeming authority or exemption. CMS publishes a notice
in the Federal Register when it grants deeming authority to an
accreditation organization or exemption to a State licensure program.
(b) Contents of notice. The notice includes the following:
(1) The name of the accreditation organization or State licensure
program.
(2) For an accreditation organization:
(i) The specific specialty or subspecialty areas for which it is
granted deeming authority.
(ii) A description of how the accreditation organization provides
reasonable assurance to CMS that a laboratory accredited by the
organization meets CLIA requirements equivalent to those in this part
and would meet CLIA requirements if the laboratory had not been granted
deemed status, but had been inspected against condition-level
requirements.
(3) For a State licensure program, a description of how the
laboratory requirements of the State are equal to, or more stringent
than, those specified in this part.
(4) The basis for granting deeming authority or exemption.
(5) The term of approval, not to exceed 6 years.
Sec. 493.561 Denial of application or reapplication.
(a) Reconsideration of denial. (1) If CMS denies a request for
approval, an accreditation organization or State licensure program may
request, within 60 days of the notification of denial, that CMS
reconsider its original application or application for renewal, in
accordance with part 488, subpart D.
(2) If the accreditation organization or State licensure program
requests a reconsideration of CMS's determination to deny its request
for approval or reapproval, it may not submit a new application until
CMS issues a final reconsideration determination.
(b) Resubmittal of a request for approval-- accreditation
organization. An accreditation organization may resubmit a request for
approval if a final reconsideration determination is not pending and the
accreditation program meets the following conditions:
(1) It has revised its accreditation program to address the
rationale for denial of its previous request.
(2) It demonstrates that it can provide reasonable assurance that
its accredited facilities meet condition-level requirements.
(3) It resubmits the application in its entirety.
(c) Resubmittal of request for approval--State licensure program.
The State licensure program may resubmit a request for approval if a
final reconsideration determination is not pending and it has taken the
necessary action to address the rationale for any previous denial.
Sec. 493.563 Validation inspections--Basis and focus.
(a) Basis for validation inspection--(1) Laboratory with a
certificate of accreditation. (i) CMS or a CMS agent may conduct an
inspection of an accredited laboratory that has been issued a
certificate of accreditation on a representative sample basis or in
response to a
[[Page 981]]
substantial allegation of noncompliance.
(ii) CMS uses the results of these inspections to validate the
accreditation organization's accreditation process.
(2) Laboratory in a State with an approved State licensure program.
(i) CMS or a CMS agent may conduct an inspection of any laboratory in a
State with an approved State licensure program on a representative
sample basis or in response to a substantial allegation of
noncompliance.
(ii) The results of these inspections are used to validate the
appropriateness of the exemption of that State's licensed or approved
laboratories from CLIA program requirements.
(b) Validation inspection conducted on a representative sample
basis. (1) If CMS or a CMS agent conducts a validation inspection on a
representative sample basis, the inspection is comprehensive, addressing
all condition-level requirements, or it may be focused on a specific
condition-level requirement.
(2) The number of laboratories sampled is sufficient to allow a
reasonable estimate of the performance of the accreditation organization
or State.
(c) Validation inspection conducted in response to a substantial
allegation of noncompliance. (1) If CMS or a CMS agent conducts a
validation inspection in response to a substantial allegation of
noncompliance, the inspection focuses on any condition-level requirement
that CMS determines to be related to the allegation.
(2) If CMS or a CMS agent substantiates a deficiency and determines
that the laboratory is out of compliance with any condition-level
requirement, CMS or a CMS agent conducts a full CLIA inspection.
(d) Inspection of operations and offices. As part of the validation
review process, CMS may conduct an onsite inspection of the operations
and offices to verify the following:
(1) The accreditation organization's representations and to assess
the accreditation organization's compliance with its own policies and
procedures.
(2) The State's representations and to assess the State's compliance
with its own policies and procedures, including verification of State
enforcement actions taken on the basis of validation inspections
performed by CMS or a CMS agent.
(e) Onsite inspection of an accreditation organization. An onsite
inspection of an accreditation organization may include, but is not
limited to, the following:
(1) A review of documents.
(2) An audit of meetings concerning the accreditation process.
(3) Evaluation of accreditation inspection results and the
accreditation decision-making process.
(4) Interviews with the accreditation organization's staff.
(f) Onsite inspection of a State licensure program. An onsite
inspection of a State licensure program office may include, but is not
limited to, the following:
(1) A review of documents.
(2) An audit of meetings concerning the licensure or approval
process.
(3) Evaluation of State inspection results and the licensure or
approval decision-making process.
(4) Interviews with State employees.
Sec. 493.565 Selection for validation inspection--laboratory
responsibilities.
A laboratory selected for a validation inspection must do the
following:
(a) Authorize its accreditation organization or State licensure
program, as applicable, to release to CMS or a CMS agent, on a
confidential basis, a copy of the laboratory's most recent full, and any
subsequent partial inspection.
(b) Authorize CMS or a CMS agent to conduct a validation inspection.
(c) Provide CMS or a CMS agent with access to all facilities,
equipment, materials, records, and information that CMS or a CMS agent
determines have a bearing on whether the laboratory is being operated in
accordance with the requirements of this part, and permit CMS or a CMS
agent to copy material or require the laboratory to submit material.
(d) If the laboratory possesses a valid certificate of
accreditation, authorize CMS or a CMS agent to monitor the correction of
any deficiencies found through the validation inspection.
[[Page 982]]
Sec. 493.567 Refusal to cooperate with validation inspection.
(a) Laboratory with a certificate of accreditation. (1) A laboratory
with a certificate of accreditation that refuses to cooperate with a
validation inspection by failing to comply with the requirements in
Sec. 493.565--
(i) Is subject to full review by CMS or a CMS agent, in accordance
with this part; and
(ii) May be subject to suspension, revocation, or limitation of its
certificate of accreditation under this part.
(2) A laboratory with a certificate of accreditation is again deemed
to meet the condition-level requirements by virtue of its accreditation
when the following conditions exist:
(i) The laboratory withdraws any prior refusal to authorize its
accreditation organization to release a copy of the laboratory's current
accreditation inspection, PT results, or notification of any adverse
actions resulting from PT failure.
(ii) The laboratory withdraws any prior refusal to allow a
validation inspection.
(iii) CMS finds that the laboratory meets all the condition-level
requirements.
(b) CLIA-exempt laboratory. If a CLIA-exempt laboratory fails to
comply with the requirements specified in Sec. 493.565, CMS notifies the
State of the laboratory's failure to meet the requirements.
Sec. 493.569 Consequences of a finding of noncompliance as a result of
a validation inspection.
(a) Laboratory with a certificate of accreditation. If a validation
inspection results in a finding that the accredited laboratory is out of
compliance with one or more condition-level requirements, the laboratory
is subject to--
(1) The same requirements and survey and enforcement processes
applied to laboratories that are not accredited and that are found out
of compliance following an inspection under this part; and
(2) Full review by CMS, in accordance with this part; that is, the
laboratory is subject to the principal and alternative sanctions in
Sec. 493.1806.
(b) CLIA-exempt laboratory. If a validation inspection results in a
finding that a CLIA-exempt laboratory is out of compliance with one or
more condition-level requirements, CMS directs the State to take
appropriate enforcement action.
Sec. 493.571 Disclosure of accreditation, State and CMS validation
inspection results.
(a) Accreditation organization inspection results. CMS may disclose
accreditation organization inspection results to the public only if the
results are related to an enforcement action taken by the Secretary.
(b) State inspection results. Disclosure of State inspection results
is the responsibility of the approved State licensure program, in
accordance with State law.
(c) CMS validation inspection results. CMS may disclose the results
of all validation inspections conducted by CMS or its agent.
Sec. 493.573 Continuing Federal oversight of private nonprofit
accreditation organizations and approved State licensure
programs.
(a) Comparability review. In addition to the initial review for
determining equivalency of specified organization or State requirements
to the comparable condition-level requirements, CMS reviews the
equivalency of requirements in the following cases:
(1) When CMS promulgates new condition-level requirements.
(2) When CMS identifies an accreditation organization or a State
licensure program whose requirements are no longer equal to, or more
stringent than, condition-level requirements.
(3) When an accreditation organization or State licensure program
adopts new requirements.
(4) When an accreditation organization or State licensure program
adopts changes to its inspection process, as required by
Sec. 493.575(b)(1), as applicable.
(5) Every 6 years, or sooner if CMS determines an earlier review is
required.
(b) Validation review. Following the end of a validation review
period, CMS evaluates the validation inspection results for each
approved accreditation
[[Page 983]]
organization and State licensure program.
(c) Reapplication procedures. (1) Every 6 years, or sooner, as
determined by CMS, an approved accreditation organization must reapply
for continued approval of deeming authority and a State licensure
program must reapply for continued approval of a CLIA exemption. CMS
provides notice of the materials that must be submitted as part of the
reapplication procedure.
(2) An accreditation organization or State licensure program that
does not meet the requirements of this subpart, as determined through a
comparability or validation review, must furnish CMS, upon request, with
the reapplication materials CMS requests. CMS establishes a deadline by
which the materials must be submitted.
(d) Notice. (1) CMS provides written notice, as appropriate, to the
following:
(i) An accreditation organization indicating that its approval may
be in jeopardy if a comparability or validation review reveals that it
is not meeting the requirements of this subpart and CMS is initiating a
review of the accreditation organization's deeming authority.
(ii) A State licensure program indicating that its CLIA exemption
may be in jeopardy if a comparability or validation review reveals that
it is not meeting the requirements of this subpart and that a review is
being initiated of the CLIA exemption of the State's laboratories.
(2) The notice contains the following information:
(i) A statement of the discrepancies that were found as well as
other related documentation.
(ii) An explanation of CMS's review process on which the final
determination is based and a description of the possible actions, as
specified in Sec. 493.575, that CMS may impose based on the findings
from the comparability or validation review.
(iii) A description of the procedures available if the accreditation
organization or State licensure program, as applicable, desires an
opportunity to explain or justify the findings made during the
comparability or validation review.
(iv) The reapplication materials that the accreditation organization
or State licensure program must submit and the deadline for that
submission.
Sec. 493.575 Removal of deeming authority or CLIA exemption and final
determination review.
(a) CMS review. CMS conducts a review of the following:
(1) A deeming authority review of an accreditation organization's
program if the comparability or validation review produces findings, as
described at Sec. 493.573. CMS reviews, as appropriate, the criteria
described in Secs. 493.555 and 493.557(a) to reevaluate whether the
accreditation organization continues to meet all these criteria.
(2) An exemption review of a State's licensure program if the
comparability or validation review produces findings, as described at
Sec. 493.573. CMS reviews, as appropriate, the criteria described in
Secs. 493.555 and 493.557(b) to reevaluate whether the licensure program
continues to meet all these criteria.
(3) A review of an accreditation organization or State licensure
program, at CMS's discretion, if validation review findings,
irrespective of the rate of disparity, indicate widespread or systematic
problems in the organization's accreditation or State's licensure
process that provide evidence that the requirements, taken as a whole,
are no longer equivalent to CLIA requirements, taken as a whole.
(4) A review of the accreditation organization or State licensure
program whenever validation inspection results indicate a rate of
disparity of 20 percent or more between the findings of the organization
or State and those of CMS or a CMS agent for the following periods:
(i) One year for accreditation organizations.
(ii) Two years for State licensure programs.
(b) CMS action after review. Following the review, CMS may take the
following action:
(1) If CMS determines that the accreditation organization or State
has failed to adopt requirements equal to, or more stringent than, CLIA
requirements, CMS may give a conditional approval for a probationary
period of its
[[Page 984]]
deeming authority to an organization 30 days following the date of CMS's
determination, or exempt status to a State within 30 days of CMS's
determination, both not to exceed 1 year, to afford the organization or
State an opportunity to adopt equal or more stringent requirements.
(2) If CMS determines that there are widespread or systematic
problems in the organization's or State's inspection process, CMS may
give conditional approval during a probationary period, not to exceed 1
year, effective 30 days following the date of the determination.
(c) Final determination. CMS makes a final determination as to
whether the organization or State continues to meet the criteria
described in this subpart and issues a notice that includes the reasons
for the determination to the organization or State within 60 days after
the end of any probationary period. This determination is based on an
evaluation of any of the following:
(1) The most recent validation inspection and review findings. To
continue to be approved, the organization or State must meet the
criteria of this subpart.
(2) Facility-specific data, as well as other related information.
(3) The organization's or State's inspection procedures, surveyors'
qualifications, ongoing education, training, and composition of
inspection teams.
(4) The organization's accreditation requirements, or the State's
licensure or approval requirements.
(d) Date of withdrawal of approval. CMS may withdraw its approval of
the accreditation organization or State licensure program, effective 30
days from the date of written notice to the organization or State of
this proposed action, if improvements acceptable to CMS have not been
made during the probationary period.
(e) Continuation of validation inspections. The existence of any
validation review, probationary status, or any other action, such as a
deeming authority review, by CMS does not affect or limit the conduct of
any validation inspection.
(f) Federal Register notice. CMS publishes a notice in the Federal
Register containing a justification for removing the deeming authority
from an accreditation organization, or the CLIA-exempt status of a State
licensure program.
(g) Withdrawal of approval-effect on laboratory status--(1)
Accredited laboratory. After CMS withdraws approval of an accreditation
organization's deeming authority, the certificate of accreditation of
each affected laboratory continues in effect for 60 days after it
receives notification of the withdrawal of approval.
(2) CLIA-exempt laboratory. After CMS withdraws approval of a State
licensure program, the exempt status of each licensed or approved
laboratory in the State continues in effect for 60 days after a
laboratory receives notification from the State of the withdrawal of
CMS's approval of the program.
(3) Extension. After CMS withdraws approval of an accreditation
organization or State licensure program, CMS may extend the period for
an additional 60 days for a laboratory if it determines that the
laboratory submitted an application for accreditation to an approved
accreditation organization or an application for the appropriate
certificate to CMS or a CMS agent before the initial 60-day period ends.
(h) Immediate jeopardy to patients. (1) If at any time CMS
determines that the continued approval of deeming authority of any
accreditation organization poses immediate jeopardy to the patients of
the laboratories accredited by the organization, or continued approval
otherwise constitutes a significant hazard to the public health, CMS may
immediately withdraw the approval of deeming authority for that
accreditation organization.
(2) If at any time CMS determines that the continued approval of a
State licensure program poses immediate jeopardy to the patients of the
laboratories in that State, or continued approval otherwise constitutes
a significant hazard to the public health, CMS may immediately withdraw
the approval of that State licensure program.
[[Page 985]]
(i) Failure to pay fees. CMS withdraws the approval of a State
licensure program if the State fails to pay the applicable fees, as
specified in Secs. 493.645(a) and 493.646(b).
(j) State refusal to take enforcement action. (1) CMS may withdraw
approval of a State licensure program if the State refuses to take
enforcement action against a laboratory in that State when CMS
determines it to be necessary.
(2) A laboratory that is in a State in which CMS has withdrawn
program approval is subject to the same requirements and survey and
enforcement processes that are applied to a laboratory that is not
exempt from CLIA requirements.
(k) Request for reconsideration. Any accreditation organization or
State that is dissatisfied with a determination to withdraw approval of
its deeming authority or remove approval of its State licensure program,
as applicable, may request that CMS reconsider the determination, in
accordance with subpart D of part 488.
Subpart F--General Administration
Source: 57 FR 7138 and 7213, Feb. 28, 1992, unless otherwise noted.
Sec. 493.602 Scope of subpart.
This subpart sets forth the methodology for determining the amount
of the fees for issuing the appropriate certificate, and for determining
compliance with the applicable standards of the Public Health Service
Act (the PHS Act) and the Federal validation of accredited laboratories
and of CLIA-exempt laboratories.
[60 FR 20047, Apr. 24, 1995]
Sec. 493.606 Applicability of subpart.
The rules of this subpart are applicable to those laboratories
specified in Sec. 493.3.
[58 FR 5212, Jan. 19, 1993]
Sec. 493.638 Certificate fees.
(a) Basic rule. Laboratories must pay a fee for the issuance of a
registration certificate, certificate for PPM procedures, certificate of
waiver, certificate of accreditation, or a certificate of compliance, as
applicable. Laboratories must also pay a fee to reapply for a
certificate for PPM procedures, certificate of waiver, certificate of
accreditation, or a certificate of compliance. The total of fees
collected by HHS under the laboratory program must be sufficient to
cover the general costs of administering the laboratory certification
program under section 353 of the PHS Act.
(1) For registration certificates and certificates of compliance,
the costs include issuing the certificates, collecting the fees,
evaluating and monitoring proficiency testing programs, evaluating which
procedures, tests or examinations meet the criteria for inclusion in the
appropriate complexity category, and implementing section 353 of the PHS
Act.
(2) For a certificate of waiver, the costs include issuing the
certificate, collecting the fees, determining if a certificate of waiver
should be issued, evaluating which tests qualify for inclusion in the
waived category, and other direct administrative costs.
(3) For a certificate for PPM procedures, the costs include issuing
the certificate, collecting the fees, determining if a certificate for
PPM procedures should be issued, evaluating which procedures meet the
criteria for inclusion in the subcategory of PPM procedures, and other
direct administrative costs.
(4) For a certificate of accreditation, the costs include issuing
the certificate, collecting the fees, evaluating the programs of
accrediting bodies, and other direct administrative costs.
(b) Fee amount. The fee amount is set annually by HHS on a calendar
year basis and is based on the category of test complexity, or on the
category of test complexity and schedules or ranges of annual laboratory
test volume (excluding waived tests and tests performed for quality
control, quality assurance, and proficiency testing purposes) and
specialties tested, with the amounts of the fees in each schedule being
a function of the costs for all aspects of general administration of
CLIA as set forth in Sec. 493.649 (b) and (c). This fee is assessed and
payable at least biennially. The methodology used
[[Page 986]]
to determine the amount of the fee is found in Sec. 493.649. The amount
of the fee applicable to the issuance of the registration certificate or
the issuance or renewal of the certificate for PPM procedures,
certificate of waiver, certificate of accreditation, or certificate of
compliance is the amount in effect at the time the application is
received. Upon receipt of an application for a certificate, HHS or its
designee notifies the laboratory of the amount of the required fee for
the requested certificate.
[60 FR 20047, Apr. 24, 1995]
Sec. 493.639 Fee for revised certificate.
(a) If, after a laboratory is issued a registration certificate, it
changes its name or location, the laboratory must pay a fee to cover the
cost of issuing a revised registration certificate. The fee for the
revised registration certificate is based on the cost to issue the
revised certificate to the laboratory.
(b) A laboratory must pay a fee to cover the cost of issuing a
revised certificate in any of the following circumstances:
(1) The fee for issuing an appropriate revised certificate is based
on the cost to issue the revised certificate to the laboratory as
follows:
(i) If a laboratory with a certificate of waiver wishes to perform
tests in addition to those listed in Sec. 493.15(c) as waived tests, it
must, as set forth in Sec. 493.638, pay an additional fee for the
appropriate certificate to cover the additional testing.
(ii) If a laboratory with a certificate for PPM procedures wishes to
perform tests in addition to those specified as PPM procedures or listed
in Sec. 493.15(c) as waived tests, it must, as set forth in
Sec. 493.638, pay an additional fee for the appropriate certificate to
cover the additional testing.
(2) A laboratory must pay a fee to cover the cost of issuing a
revised certificate when--
(i) A laboratory changes its name, location, or its director; or
(ii) A laboratory deletes services or wishes to add services and
requests that its certificate be changed. (An additional fee is also
required under Sec. 493.643(d) if it is necessary to determine
compliance with additional requirements.)
[57 FR 7213, Feb. 28, 1992, as amended at 60 FR 20047, Apr, 24, 1995]
Sec. 493.643 Fee for determination of program compliance.
(a) Fee requirement. In addition to the fee required under
Sec. 493.638, a laboratory subject to routine inspections must pay a fee
to cover the cost of determining program compliance. Laboratories issued
a certificate for PPM procedures, certificate of waiver, or a
certificate of accreditation are not subject to this fee for routine
inspections.
(b) Costs included in the fee. Included in the fee for determining
program compliance is the cost of evaluating qualifications of
personnel; monitoring proficiency testing; conducting onsite
inspections; documenting deficiencies; evaluating laboratories' plans to
correct deficiencies; and necessary administrative costs. HHS sets the
fee amounts annually on a calendar year basis. Laboratories are
inspected biennially; therefore, fees are assessed and payable
biennially. If additional expenses are incurred to conduct follow up
visits to verify correction of deficiencies, to impose sanctions, and/or
for surveyor preparation for and attendance at ALJ hearings, HHS
assesses an additional fee to include these costs. The additional fee is
based on the actual resources and time necessary to perform the
activities.
(c) Classification of laboratories that require inspection for
purpose of determining amount of fee. (1) There are ten classifications
(schedules) of laboratories for the purpose of determining the fee
amount a laboratory is assessed. Each laboratory is placed into one of
the ten following schedules based on the laboratory's scope and volume
of testing (excluding tests performed for quality control, quality
assurance, and proficiency testing purposes).
(i) (A) Schedule A Low Volume. The laboratory performs not more than
2,000 laboratory tests annually.
(B) Schedule A. The laboratory performs tests in no more than 3
specialties of service with a total annual volume of more than 2,000 but
not more than 10,000 laboratory tests.
[[Page 987]]
(ii) Schedule B. The laboratory performs tests in at least 4
specialties of service with a total annual volume of not more than
10,000 laboratory tests.
(iii) Schedule C. The laboratory performs tests in no more 3
specialties of service with a total annual volume of more than 10,000
but not more than 25,000 laboratory tests.
(iv) Schedule D. The laboratory performs tests in at least 4
specialties with a total annual volume of more than 10,000 but not more
than 25,000 laboratory tests.
(v) Schedule E. The laboratory performs more than 25,000 but not
more than 50,000 laboratory tests annually.
(vi) Schedule F. The laboratory performs more than 50,000 but not
more than 75,000 laboratory tests annually.
(vii) Schedule G. The laboratory performs more than 75,000 but not
more than 100,000 laboratory tests annually.
(viii) Schedule H. The laboratory performs more than 100,000 but not
more than 500,000 laboratory tests annually.
(ix) Sc