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
| Published date | 29 March 2021 |
| Citation | 86 FR 16371 |
| Record Number | 2021-06439 |
| Section | Notices |
| Court | Centers For Medicare & Medicaid Services |
Federal Register, Volume 86 Issue 58 (Monday, March 29, 2021)
[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
