[Federal Register Volume 86, Number 58 (Monday, March 29, 2021)]
[Notices]
[Pages 16371-16373]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-06439]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3408-N]


CLIA Program; Announcement of the Re-Approval of the College of 
American Pathologists (CAP) as an Accreditation Organization Under the 
Clinical Laboratory Improvement Amendments of 1988

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This notice announces the application of the College of 
American Pathologists (CAP) for approval as an accreditation 
organization for clinical laboratories under the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) program. We have determined that 
the CAP meets or exceeds the applicable CLIA requirements. In this 
notice, we announce the approval and grant CAP deeming authority for a 
period of 6 years.

DATES: This notice is effective from March 27, 2021 until March 26, 
2027.

FOR FURTHER INFORMATION CONTACT: Cindy Flacks, 410-786-6520.

SUPPLEMENTARY INFORMATION:

I. Background and Legislative Authority

    On October 31, 1988, the Congress enacted the Clinical Laboratory 
Improvement Amendments of 1988 (CLIA) (Pub. L. 100-578). CLIA amended 
section 353 of the Public Health Service Act. We issued a final rule 
implementing the accreditation provisions of CLIA on July 31, 1992 (57 
FR 33992). Under those provisions, we may grant deeming authority to an 
accreditation organization if its requirements for laboratories 
accredited under its program are equal to or more stringent than the 
applicable CLIA program requirements in 42 CFR part 493 (Laboratory 
Requirements). Subpart E of part 493 (Accreditation by a Private, 
Nonprofit Accreditation Organization or Exemption Under an Approved 
State Laboratory Program) specifies the requirements an accreditation 
organization must meet to be approved by CMS as an accreditation 
organization under CLIA.

II. Notice of Approval of CAP as an Accreditation Organization

    In this notice, we approve the College of American Pathologists 
(CAP) as an organization that may accredit laboratories for purposes of 
establishing their compliance with CLIA requirements in all specialties 
and subspecialties. We have examined the initial CAP application and 
all subsequent submissions to determine its accreditation program's 
equivalency with the requirements for approval of an accreditation 
organization under subpart E of part 493. We have determined that the 
CAP meets or exceeds the applicable CLIA requirements. We have also 
determined that the CAP will ensure that its accredited laboratories 
will meet or exceed the applicable requirements in subparts H, I, J, K, 
M, Q, and the applicable sections of R. Therefore, we grant the CAP 
approval as an accreditation organization under subpart E of part 493, 
for the period stated in the DATES section of this notice for all 
specialties and subspecialties under CLIA. As a result of this 
determination, any laboratory that is accredited by the CAP during the 
time period stated in the DATES section of this notice will be deemed 
to meet the CLIA requirements for the listed specialties and 
subspecialties, and therefore, will generally not be subject to routine 
inspections by a state survey agency to determine its compliance with 
CLIA requirements. The accredited laboratory, however, is subject to 
validation and complaint investigation surveys performed by CMS, or its 
agent(s).

III. Evaluation of the CAP Request for Approval as an Accreditation 
Organization Under CLIA

    The following describes the process used to determine that the CAP 
accreditation program meets the necessary requirements to be approved 
by CMS and that, as such, we may approve the CAP as an accreditation 
program with deeming authority under the CLIA program. The CAP formally

[[Page 16372]]

applied to CMS for approval as an accreditation organization under CLIA 
for all specialties and subspecialties.
    In reviewing these materials, we reached the following 
determinations for each applicable part of the CLIA regulations:

A. Subpart E--Accreditation by a Private, Nonprofit Accreditation 
Organization or Exemption Under an Approved State Laboratory Program

    The CAP submitted its mechanism for monitoring compliance with all 
requirements equivalent to condition-level requirements, a list of all 
its current laboratories and the expiration date of their 
accreditation, and a detailed comparison of the individual 
accreditation requirements with the comparable condition-level 
requirements. We have determined that the CAP policies and procedures 
for oversight of laboratories performing all laboratory testing covered 
by CLIA are equivalent to those required by our CLIA regulations in the 
matters of inspection, monitoring proficiency testing (PT) performance, 
investigating complaints, and making PT information available. The CAP 
submitted documentation regarding its requirements for monitoring and 
inspecting laboratories and describing its own standards regarding 
accreditation organization data management, inspection processes, 
procedures for removal or withdrawal of accreditation, notification 
requirements, and accreditation organization resources. We have 
determined that the requirements of the accreditation program submitted 
for approval are equal to or more stringent than the requirements of 
the CLIA regulations.

B. Subpart H--Participation in Proficiency Testing for Laboratories 
Performing Nonwaived Testing

    We have determined that the CAP's requirements are equal to or more 
stringent than the CLIA requirements at Sec. Sec.  493.801 through 
493.865. Consistent with the CLIA requirements, all of the CAP's 
accredited laboratories are required to participate in an HHS-approved 
PT program for tests listed in subpart I. CLIA exempts waived testing 
from PT, whereas the CAP requires its accredited laboratories to 
participate in a PT program for test systems waived under CLIA.

C. Subpart J--Facility Administration for Nonwaived Testing

    The CAP requirements are equal to or more stringent than the CLIA 
requirements at Sec. Sec.  493.1100 through 493.1105. CAP is more 
stringent than CLIA in its specific requirements for the Laboratory 
Information System that include requirements for computer facility, 
hardware and software, system security, patient data, auto 
verification, data retrieval and preservation, interfaces, and 
telepathology.

D. Subpart K--Quality System for Nonwaived Testing

    We have determined that the quality control requirements of the CAP 
are more stringent than the CLIA requirements at Sec. Sec.  493.1200 
through 493.1299. The CAP lists extensive requirements for the 
methodologies of clinical biochemical genetics, molecular pathology and 
flow cytometry, which are presented in separate checklists. The CAP's 
control procedure requirements for molecular testing and 
histocompatibility are more specific and detailed than the CLIA 
requirements for control procedures. Laboratories accredited by the 
CAP, performing waived testing must follow the same requirements that 
apply to non-waived testing for procedure manuals, specimen handling, 
results reporting, instruments, and equipment. Under CLIA, the subpart 
K Quality System requirements do not apply to waived testing.

E. Subpart M--Personnel for Nonwaived Testing

    We have determined that the CAP requirements are equal to or more 
stringent than the CLIA requirements at Sec. Sec.  493.1403 through 
493.1495 for laboratories that perform moderate and high complexity 
testing. For certain types of testing, such as molecular testing, the 
experience requirements for General Supervisor are more closely related 
to the specific testing technology than the CLIA requirements. The CAP 
requires training and annual competency assessment for staff who 
perform waived testing. CLIA regulations do not contain such 
requirements for persons performing waived testing.

F. Subpart Q--Inspection

    We have determined that the CAP inspection requirements are equal 
to or more stringent than the CLIA requirements at Sec. Sec.  493.1771 
through 493.1780. The CAP will continue to conduct biennial onsite 
inspections. During the onsite inspection, the CAP requires that the 
inspector meet with the hospital administrator or medical staff to 
obtain their feedback on the laboratory service. The CAP also requires 
a mid-cycle self-inspection of all accredited laboratories. CLIA 
regulations do not contain these requirements.

G. Subpart R--Enforcement Procedures

    We have determined that the CAP meets the requirements of subpart R 
to the extent that it applies to accreditation organizations. The CAP's 
policy sets forth the actions the organization takes when laboratories 
it accredits do not comply with its requirements and standards for 
accreditation. When appropriate, the CAP will deny, suspend, or revoke 
accreditation in a laboratory accredited by the CAP and report that 
action to us within 30 days. The CAP also provides an appeals process 
for laboratories that have had accreditation denied, suspended, or 
revoked.
    We have determined that the CAP's laboratory enforcement and appeal 
policies are equal to or more stringent than the requirements of part 
493 subpart R as they apply to accreditation organizations.

IV. Federal Validation Inspections and Continuing Oversight

    The federal validation inspections of laboratories accredited by 
the CAP may be conducted on a representative sample basis or in 
response to substantial allegations of noncompliance (that is, 
complaint inspections). The outcome of those validation inspections, 
performed by CMS or our agents, or the state survey agencies, will be 
our principal means for verifying that the laboratories accredited by 
the CAP remain in compliance with CLIA requirements. This federal 
monitoring is an ongoing process.

V. Removal of Approval as an Accrediting Organization

    Our regulations provide that we may rescind the approval of an 
accreditation organization, such as that of the CAP, for cause, before 
the end of the effective date of approval. If we determine that the CAP 
has failed to adopt, maintain and enforce requirements that are equal 
to, or more stringent than, the CLIA requirements, or that systemic 
problems exist in its monitoring, inspection or enforcement processes, 
we may impose a probationary period, not to exceed 1 year, in which the 
CAP would be allowed to address any identified issues. Should the CAP 
be unable to address the identified issues within that timeframe, we 
may, in accordance with the applicable regulations, revoke the CAP's 
deeming authority under CLIA.
    Should circumstances result in our withdrawal of the CAP's 
approval, we will publish a notice in the Federal Register explaining 
the basis for removing its approval.

[[Page 16373]]

VI. Collection of Information Requirements

    This notice does not impose any information collection and record 
keeping requirements subject to the Paperwork Reduction Act (PRA). 
Consequently, it does not need to be reviewed by the Office of 
Management and Budget (OMB) under the authority of the PRA. The 
requirements associated with the accreditation process for clinical 
laboratories under the CLIA program, and the implementing regulations 
in 42 CFR part 493, subpart E, are currently approved under OMB control 
number 0938-0686.

VII. Executive Order 12866 Statement

    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget.
    The Acting Administrator of the Centers for Medicare & Medicaid 
Services (CMS), Elizabeth Richter, having reviewed and approved this 
document, authorizes Lynette Wilson, who is the Federal Register 
Liaison, to electronically sign this document for purposes of 
publication in the Federal Register.

    Dated: March 24, 2021.
Lynette Wilson,
Federal Register Liaison, Centers for Medicare & Medicaid Services.
[FR Doc. 2021-06439 Filed 3-26-21; 8:45 am]
BILLING CODE 4120-01-P