80 FR 16395 - Announcement of the Re-Approval of the College of American Pathologists (CAP) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services

Federal Register Volume 80, Issue 59 (March 27, 2015)

Page Range		16395-16396
FR Document		2015-07111

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.

Federal Register, Volume 80 Issue 59 (Friday, March 27, 2015)

[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Pages 16395-16396]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-07111]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-3313-N]


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.

-----------------------------------------------------------------------

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, 2015, until March 27, 
2021.

FOR FURTHER INFORMATION CONTACT: Melissa Singer, 410-786-0365.

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 these 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 areas 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 as an accreditation program with deeming authority under the 
CLIA program. The CAP formally 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's 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 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

[[Page 16396]]

equal to or more stringent than the requirements of the CLIA 
regulations.

B. Subpart H--Participation in Proficiency Testing for Laboratories 
Performing Nonwaived Testing and Listing of Analytes Requiring PT From 
Subpart I

    We have determined that the CAP's requirements are equal to or more 
stringent than the CLIA requirements at Sec.  493.801 through Sec.  
493.865. Like CLIA, 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 CMS-approved 
PT program for test systems waived under CLIA.

C. Subpart J--Facility Administration for Non-Waived Testing

    The CAP requirements are equal to or more stringent than the CLIA 
requirements at Sec.  493.1100 through Sec.  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 QC requirements of CAP are more 
stringent than the CLIA requirements at Sec.  493.1200 through Sec.  
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. CAP laboratories 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.  493.1403 through Sec.  
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 
also applies personnel requirements to waived testing. CLIA regulations 
do not contain personnel requirements for 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.  493.1771 
through Sec.  493.1780. CAP will continue to conduct biennial onsite 
inspections. During the onsite inspection, 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 such requirements are utilized by accreditation 
organizations. CAP 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 
492 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 
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, CMS 
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.

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 Clinical Laboratory Improvement Amendments of 
1988 (CLIA) program, and the implementing regulations in 42 CFR part 
493, subpart E, are currently approved under OMB control number 0938-
0686.

    Dated: March 9, 2015.
Andrew M. Slavitt,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2015-07111 Filed 3-26-15; 8:45 am]
 BILLING CODE 4120-01-P

Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices 16395

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of Total Average
Number of
21 CFR section responses per annual burden per Total hours
respondents respondent responses response

610.2 Lot Release Information Submission .................................... 76 84.54 6,197 3 18,591
660.6(b) Lot Release Information Submission ................................ 2 9 18 5 90
660.36(a)(2) and (b) Lot Release Information Submission ............. 1 1 1 6 6
660.46(b) Lot Release Information Submission .............................. 1 1 1 5 5

Total ............................................................................................ 80 .......................... 6,217 .................... 18,692
1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Dated: March 23, 2015. may grant deeming authority to an requirements. The accredited laboratory,
Leslie Kux, accreditation organization if its however, is subject to validation and
Associate Commissioner for Policy. requirements for laboratories accredited complaint investigation surveys
[FR Doc. 2015–07008 Filed 3–26–15; 8:45 am] under its program are equal to or more performed by CMS, or its agent(s).
stringent than the applicable CLIA
BILLING CODE 4164–01–P III. Evaluation of the CAP Request for
program requirements in 42 CFR part Approval as an Accreditation
493 (Laboratory Requirements). Subpart Organization Under CLIA
DEPARTMENT OF HEALTH AND E of part 493 (Accreditation by a Private,
HUMAN SERVICES Nonprofit Accreditation Organization or The following describes the process
Exemption under an Approved State used to determine that the CAP
Centers for Medicare & Medicaid Laboratory Program) specifies the accreditation program meets the
Services requirements an accreditation necessary requirements to be approved
organization must meet to be approved by CMS as an accreditation program
[CMS–3313–N] with deeming authority under the CLIA
by CMS as an accreditation organization
under CLIA. program. The CAP formally applied to
Announcement of the Re-Approval of
CMS for approval as an accreditation
the College of American Pathologists II. Notice of Approval of CAP as an organization under CLIA for all
(CAP) as an Accreditation Organization Accreditation Organization specialties and subspecialties. In
Under the Clinical Laboratory
reviewing these materials, we reached
Improvement Amendments of 1988 In this notice, we approve the College the following determinations for each
of American Pathologists (CAP) as an applicable part of the CLIA regulations:
AGENCY: Centers for Medicare &
organization that may accredit
Medicaid Services (CMS), HHS. A. Subpart E—Accreditation by a
laboratories for purposes of establishing
ACTION: Notice. their compliance with CLIA Private, Nonprofit Accreditation
requirements in all specialties and Organization or Exemption Under an
SUMMARY: This notice announces the
subspecialties. We have examined the Approved State Laboratory Program
application of the College of American
Pathologists (CAP) for approval as an initial CAP application and all The CAP submitted its mechanism for
accreditation organization for clinical subsequent submissions to determine its monitoring compliance with all
laboratories under the Clinical accreditation program’s equivalency requirements equivalent to condition-
Laboratory Improvement Amendments with the requirements for approval of an level requirements, a list of all its
of 1988 (CLIA) program. We have accreditation organization under current laboratories and the expiration
determined that the CAP meets or subpart E of part 493. We have date of their accreditation, and a
exceeds the applicable CLIA determined that the CAP meets or detailed comparison of the individual
requirements. In this notice, we exceeds the applicable CLIA accreditation requirements with the
announce the approval and grant CAP requirements. We have also determined comparable condition-level
deeming authority for a period of 6 that the CAP will ensure that its requirements. We have determined that
years. accredited laboratories will meet or the CAP’s policies and procedures for
exceed the applicable requirements in oversight of laboratories performing all
DATES: This notice is effective from subparts H, I, J, K, M, Q, and the laboratory testing covered by CLIA are
March 27, 2015, until March 27, 2021. applicable sections of R. Therefore, we equivalent to those required by our
FOR FURTHER INFORMATION CONTACT: grant the CAP approval as an CLIA regulations in the matters of
Melissa Singer, 410–786–0365. accreditation organization under inspection, monitoring proficiency
SUPPLEMENTARY INFORMATION: subpart E of part 493, for the period testing (PT) performance, investigating
stated in the DATES section of this notice complaints, and making PT information
I. Background and Legislative for all specialties and subspecialties available. The CAP submitted
Authority areas under CLIA. As a result of this documentation regarding its
On October 31, 1988, the Congress determination, any laboratory that is requirements for monitoring and
mstockstill on DSK4VPTVN1PROD with NOTICES

enacted the Clinical Laboratory accredited by the CAP during the time inspecting laboratories, and describing
Improvement Amendments of 1988 period stated in the DATES section of this its own standards regarding
(CLIA) (Pub. L. 100–578). CLIA notice will be deemed to meet the CLIA accreditation removal or withdrawal of
amended section 353 of the Public requirements for the listed specialties accreditation, notification requirements,
Health Service Act. We issued a final and subspecialties, and therefore, will and accreditation organization
rule implementing the accreditation generally not be subject to routine resources. We have determined that the
provisions of CLIA on July 31, 1992 (57 inspections by a state survey agency to requirements of the accreditation
FR 33992). Under these provisions, we determine its compliance with CLIA program submitted for approval are

VerDate Sep<11>2014 20:59 Mar 26, 2015 Jkt 235001 PO 00000 Frm 00037 Fmt 4703 Sfmt 4703 E:\FR\FM\27MRN1.SGM 27MRN1

16396 Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices

equal to or more stringent than the General Supervisor are more closely V. Removal of Approval as an
requirements of the CLIA regulations. related to the specific testing technology Accrediting Organization
B. Subpart H—Participation in than the CLIA requirements. The CAP
also applies personnel requirements to Our regulations provide that we may
Proficiency Testing for Laboratories rescind the approval of an accreditation
Performing Nonwaived Testing and waived testing. CLIA regulations do not
contain personnel requirements for organization, such as that of the CAP,
Listing of Analytes Requiring PT From for cause, before the end of the effective
Subpart I waived testing.
date of approval. If we determine that
We have determined that the CAP’s F. Subpart Q—Inspection the CAP has failed to adopt, maintain
requirements are equal to or more and enforce requirements that are equal
stringent than the CLIA requirements at We have determined that the CAP
inspection requirements are equal to or to, or more stringent than, the CLIA
§ 493.801 through § 493.865. Like CLIA, requirements, or that systemic problems
all of the CAP’s accredited laboratories more stringent than the CLIA
requirements at § 493.1771 through exist in its monitoring, inspection or
are required to participate in an HHS- enforcement processes, we may impose
approved PT program for tests listed in § 493.1780. CAP will continue to
conduct biennial onsite inspections. a probationary period, not to exceed 1
Subpart I. CLIA exempts waived testing year, in which the CAP would be
from PT, whereas the CAP requires its During the onsite inspection, CAP
requires that the inspector meet with the allowed to address any identified issues.
accredited laboratories to participate in
hospital administrator or medical staff Should the CAP be unable to address
a CMS-approved PT program for test
to obtain their feedback on the the identified issues within that
systems waived under CLIA.
laboratory service. The CAP also timeframe, CMS may, in accordance
C. Subpart J—Facility Administration requires a mid-cycle self-inspection of with the applicable regulations, revoke
for Non-Waived Testing all accredited laboratories. CLIA the CAP’s deeming authority under
The CAP requirements are equal to or regulations do not contain these CLIA.
more stringent than the CLIA requirements. Should circumstances result in our
requirements at § 493.1100 through withdrawal of the CAP’s approval, we
§ 493.1105. CAP is more stringent than G. Subpart R—Enforcement Procedures
will publish a notice in the Federal
CLIA in its specific requirements for the We have determined that the CAP Register explaining the basis for
Laboratory Information System that meets the requirements of subpart R to removing its approval.
include requirements for computer the extent that such requirements are
facility, hardware and software, system VI. Collection of Information
utilized by accreditation organizations.
security, patient data, auto verification, Requirements
CAP policy sets forth the actions the
data retrieval and preservation,
organization takes when laboratories it This notice does not impose any
interfaces, and telepathology.
accredits do not comply with its information collection and record
D. Subpart K—Quality System for requirements and standards for keeping requirements subject to the
Nonwaived Testing accreditation. When appropriate, the Paperwork Reduction Act (PRA).
We have determined that the QC CAP will deny, suspend, or revoke Consequently, it does not need to be
requirements of CAP are more stringent accreditation in a laboratory accredited reviewed by the Office of Management
than the CLIA requirements at by the CAP and report that action to us and Budget (OMB) under the authority
§ 493.1200 through § 493.1299. The CAP within 30 days. The CAP also provides of the PRA. The requirements associated
lists extensive requirements for the an appeals process for laboratories that with the accreditation process for
methodologies of clinical biochemical have had accreditation denied, clinical laboratories under the Clinical
genetics, molecular pathology and flow suspended, or revoked.
Laboratory Improvement Amendments
cytometry, which are presented in We have determined that the CAP’s of 1988 (CLIA) program, and the
separate checklists. The CAP’s control laboratory enforcement and appeal implementing regulations in 42 CFR
procedure requirements for molecular policies are equal to or more stringent part 493, subpart E, are currently
testing and histocompatibility are more than the requirements of part 492 approved under OMB control number
specific and detailed than the CLIA subpart R as they apply to accreditation 0938–0686.
requirements for control procedures. organizations.
CAP laboratories performing waived Dated: March 9, 2015.
testing must follow the same IV. Federal Validation Inspections and Andrew M. Slavitt,
requirements that apply to non-waived Continuing Oversight Acting Administrator, Centers for Medicare
testing for procedure manuals, specimen & Medicaid Services.
handling, results reporting, instruments, The federal validation inspections of
laboratories accredited by the CAP may [FR Doc. 2015–07111 Filed 3–26–15; 8:45 am]
and equipment. Under CLIA, the
Subpart K Quality System requirements be conducted on a representative BILLING CODE 4120–01–P

do not apply to waived testing. sample basis or in response to
substantial allegations of
E. Subpart M—Personnel for Nonwaived noncompliance (that is, complaint
Testing inspections). The outcome of those
validation inspections, performed by
mstockstill on DSK4VPTVN1PROD with NOTICES

We have determined that the CAP
requirements are equal to or more CMS or our agents, or the state survey
stringent than the CLIA requirements at agencies, will be our principal means
§ 493.1403 through § 493.1495 for for verifying that the laboratories
laboratories that perform moderate and accredited by CAP remain in
high complexity testing. For certain compliance with CLIA requirements.
types of testing, such as molecular This federal monitoring is an ongoing
testing, the experience requirements for process.

VerDate Sep<11>2014 20:59 Mar 26, 2015 Jkt 235001 PO 00000 Frm 00038 Fmt 4703 Sfmt 9990 E:\FR\FM\27MRN1.SGM 27MRN1

Document Created: 2015-12-18 11:36:35
Document Modified: 2015-12-18 11:36:35

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		This notice is effective from March 27, 2015, until March 27, 2021.
Contact		Melissa Singer, 410-786-0365.
FR Citation		80 FR 16395

80 FR 16395 - Announcement of the Re-Approval of the College of American Pathologists (CAP) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988

DEPARTMENT OF HEALTH AND HUMAN SERVICESCenters for Medicare & Medicaid Services

Federal Register Volume 80, Issue 59 (March 27, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services