Announcement of the Re-Approval of the College of American Pathologists (CAP) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988, 16395-16396 [2015-07111]
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16395
Federal Register / Vol. 80, No. 59 / Friday, March 27, 2015 / Notices
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Number of
respondents
21 CFR section
Number of
responses per
respondent
Total
annual
responses
Average
burden per
response
Total hours
610.2 Lot Release Information Submission ....................................
660.6(b) Lot Release Information Submission ................................
660.36(a)(2) and (b) Lot Release Information Submission .............
660.46(b) Lot Release Information Submission ..............................
76
2
1
1
84.54
9
1
1
6,197
18
1
1
3
5
6
5
18,591
90
6
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.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015–07008 Filed 3–26–15; 8:45 am]
BILLING CODE 4164–01–P
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
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
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.
SUMMARY:
This notice is effective from
March 27, 2015, until March 27, 2021.
FOR FURTHER INFORMATION CONTACT:
Melissa Singer, 410–786–0365.
SUPPLEMENTARY INFORMATION:
DATES:
mstockstill on DSK4VPTVN1PROD with NOTICES
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
VerDate Sep<11>2014
20:59 Mar 26, 2015
Jkt 235001
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
PO 00000
Frm 00037
Fmt 4703
Sfmt 4703
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 conditionlevel 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
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
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
§ 493.801 through § 493.865. Like CLIA,
all of the CAP’s accredited laboratories
are required to participate in an HHSapproved 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 § 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.
mstockstill on DSK4VPTVN1PROD with NOTICES
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
§ 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.
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
§ 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
VerDate Sep<11>2014
20:59 Mar 26, 2015
Jkt 235001
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 § 493.1771 through
§ 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.
PO 00000
Frm 00038
Fmt 4703
Sfmt 9990
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
E:\FR\FM\27MRN1.SGM
27MRN1
]]>Agencies
[Federal Register Volume 80, Number 59 (Friday, March 27, 2015)]
[Notices]
[Pages 16395-16396]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[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
