Announcement of the Re-Approval of the Commission on Office Laboratory Accreditation (COLA) as an Accreditation Organization Under the Clinical Laboratory Improvement Amendments of 1988, 12323-12325 [2013-03927]
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sroberts on DSK5SPTVN1PROD with NOTICES
Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices
laws passed since the previous
collection document was approved.
While the OMB control number for this
proposed collection will remain the
same as the previously approved
collection, this proposed collection will
be given a new CMS Form Number.
Form Number: CMS–10430 (OCN:
0938–0702); Frequency: Annually;
Occasionally; Affected Public: Private
Sector; Business or other for-profits and
Not-for-profit institutions, and State,
Local, or Tribal Governments; Number
of Respondents: 8,716; Total Annual
Responses: 39,831,442; Total Annual
Hours: 3,760,422 hours. (For policy
questions regarding this collection
contact Lisa Campbell at 301–492–4114.
For all other issues call 410–786–1326.)
2. Type of Information Collection
Request: Reinstatement with a change of
a previously approved collection; Title:
Medicare Electronic Data Interchange
(EDI) Registration and Electronic Data
Interchange (EDI) Enrollment Form;
Use: The purpose of this collection is to
obtain information that will be
subsequently used during transaction
exchange for identification of Medicare
providers/suppliers and authorization of
requested Electronic Data Interface (EDI)
functions. The EDI Enrollment and the
Medicare Registration Forms are
completed by Medicare providers,
suppliers, or both suppliers and
submitted to Medicare contractors.
Authorization is needed for providers
and suppliers to send and receive
HIPAA standard transactions directly
(or through a designated 3rd party) to
and from Medicare contractors.
Medicare contractors would use the
information for initial set-up and
maintenance of the access privileges.
The use of the standard form provides
an efficient uniform means by which
Medicare captures information
necessary to drive Medicare EDI
security and EDI access privileges. All
EDI providers will complete and sign
the EDI Enrollment Form along with the
Medicare EDI Registration Form. They
will also reconfirm their access
privileges annually.
The information collected will be
uploaded into Medicare contractor
computer systems. Medicare contractors
will store this information in a database
accessed at the time of provider
connection to the Medicare Data
Contractor Network (MDCN). When
authentication is successful and
connectivity is established, transactions
may be exchanged. The information will
be stored in a computer data base and
used to authenticate the user on day-today electronic commerce, support the
submitter and password administration
function, and validate access
VerDate Mar<15>2010
16:18 Feb 21, 2013
Jkt 229001
relationships between providers/
suppliers and their designated EDI
submitter/receiver on a per transaction
basis. Form Number: CMS–10164 (OCN:
0938–0983); Frequency: Once; Affected
Public: Private Sector—Business or
other for-profits, Not for-profit
institutions; Number of Respondents:
240,000; Total Annual Responses:
240,000; Total Annual Hours: 80,000.
(For policy questions regarding this
collection contact Claudette Sikora at
410–786–5618. For all other issues call
410–786–1326.)
3. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection.
Title of Information Collection:
Medicare Credit Balance Reporting
Requirements and Supporting
Regulations in 42 CFR 405.371, 405.378
and 413.20; Use: Section 1815(a) of the
Social Security Act authorizes the
Secretary to request information from
providers which is necessary to
properly administer the Medicare
program. Quarterly credit balance
reporting is needed to monitor and
control the identification and timely
collection of improper payments. The
information obtained from Medicare
credit balance reports will be used by
the contractors to identify and recover
outstanding Medicare credit balances
and by Federal enforcement agencies to
protect Federal funds. The information
will also be used to identify the causes
of credit balances and to take corrective
action. Form Number: CMS–838 (OCN:
0938–0600); Frequency: Yearly; Affected
Public: Private sector—Business or other
for-profits; Number of Respondents:
45,838; Total Annual Responses:
183,352; Total Annual Hours: 550,056.
(For policy questions regarding this
collection contact Milton Jacobson at
410–786–7553. For all other issues call
410–786–1326.)
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS’ Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or
Email your request, including your
address, and phone number as well the
OMB number, and CMS document
identifier, to Paperwork@cms.hhs.gov,
or call the Reports Clearance Office on
(410) 786–1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on March 25, 2013.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS
PO 00000
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12323
Desk Officer, Fax Number: (202) 395–
6974, Email:
OIRA_submission@omb.eop.gov.
Dated: February 19, 2013.
Martique Jones,
Deputy Director, Regulations Development
Group, Office of Strategic Operations and
Regulatory Affairs.
[FR Doc. 2013–04135 Filed 2–21–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3279–N]
Announcement of the Re-Approval of
the Commission on Office Laboratory
Accreditation (COLA) 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 Commission on Office
Laboratory Accreditation (COLA) for
approval as an accreditation
organization for clinical laboratories
under the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) program. We have determined
that COLA meets or exceeds the
applicable CLIA requirements. In this
notice, we announce the approval and
grant COLA deeming authority for a
period of 6 years.
DATES: Effective Date: This notice is
effective from February 22, 2013 to
February 22, 2019.
FOR FURTHER INFORMATION CONTACT:
Raelene Perfetto, (410) 786–6876.
SUPPLEMENTARY INFORMATION:
SUMMARY:
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,
CMS 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
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12324
Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices
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.
sroberts on DSK5SPTVN1PROD with NOTICES
II. Notice of Approval of Commission
on Office Laboratory Accreditation
(COLA) as an Accreditation
Organization
In this notice, we approve COLA as an
organization that may accredit
laboratories for purposes of establishing
their compliance with CLIA
requirements for the following specialty
and subspecialty areas under CLIA:
• Microbiology, including
Bacteriology, Mycobacteriology,
Mycology, Parasitology, Virology.
• Diagnostic Immunology, including
Syphilis Serology, General Immunology.
• Chemistry, including Routine
Chemistry, Urinalysis, Endocrinology,
Toxicology.
• Hematology.
• Immunohematology, including
ABO Group & Rh Group, Antibody
Detection, Antibody Identification,
Compatibility Testing.
We have examined the initial COLA
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 COLA meets or exceeds
the applicable CLIA requirements. We
have also determined that COLA 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 COLA approval as
an accreditation organization under
subpart E of part 493, for the period
stated in the DATES section of this notice
for the submitted specialty and
subspecialty areas under CLIA. As a
result of this determination, any
laboratory that is accredited by COLA
during the time period stated in the
DATES section of this notice will be
deemed to meet the CLIA requirements
for the listed subspecialties and
specialties, 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).
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Jkt 229001
III. Evaluation of the COLA Request for
Approval as an Accreditation
Organization Under CLIA
The following describes the process
used to determine that the COLA
accreditation program meets the
necessary requirements to be approved
by CMS and that, as such, CMS may
approve COLA as an accreditation
program with deeming authority under
the CLIA program. COLA formally
applied to CMS for approval as an
accreditation organization under CLIA
for the following specialties and
subspecialties:
• Microbiology, including
Bacteriology, Mycobacteriology,
Mycology, Parasitology, Virology.
• Diagnostic Immunology, including
Syphilis Serology, General Immunology.
• Chemistry, including Routine
Chemistry, Urinalysis, Endocrinology,
Toxicology.
• Hematology.
• Immunohematology, including
ABO Group & Rh Group, Antibody
Detection, Antibody Identification,
Compatibility Testing.
In reviewing these materials, we
reached the following determinations
for each applicable part of the CLIA
regulations:
testing that are more stringent than
CLIA requirements. The COLA requires
the laboratory director to review quality
control results for waived tests monthly
and also requires that competency be
assessed and documented for personnel
performing waived testing. The CLIA
requirements at § 493.15(e) require
eligible laboratories to follow the
manufacturer’s instructions for
performing tests and obtain a certificate
of waiver as outlined in part 493,
subpart B.
A. Subpart E—Accreditation by a
Private, Nonprofit Accreditation
Organization or Exemption Under an
Approved State Laboratory Program
The COLA 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. The COLA policies and
procedures for oversight of laboratories
performing laboratory testing for the
submitted CLIA specialties and
subspecialties are equivalent to those of
CLIA in the matters of inspection,
monitoring proficiency testing (PT)
performance, investigating complaints,
and making PT information available.
The COLA submitted requirements for
monitoring and inspecting laboratories
in the areas of accreditation
organization, data management, the
inspection process, procedures for
removal or withdrawal of accreditation,
notification requirements, and
accreditation organization resources.
The requirements of the accreditation
programs submitted for approval are
equal to or more stringent than the
requirements of the CLIA regulations.
Our evaluation identified the COLA
requirements pertaining to waived
D. Subpart K—Quality System for
Nonwaived Testing
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B. Subpart H—Participation in
Proficiency Testing for Laboratories
Performing Nonwaived Testing
The COLA’s requirements are equal to
the CLIA requirements at § 493.801
through § 493.865. Like CLIA, all of the
COLA’s accredited laboratories are
required to participate in an HHSapproved PT program for tests listed in
subpart I. The COLA also encourages its
accredited laboratories to participate in
PT for tests that are waived under CLIA.
C. Subpart J—Facility Administration
for Nonwaived Testing
The COLA’s requirements are equal to
the CLIA requirements at § 493.1100
through § 493.1105.
The COLA requirements are equal to
or more stringent than the CLIA
requirements at § 493.1200 through
§ 493.1299. For instance, when a
laboratory establishes performance
specifications for a test not approved by
the Food and Drug Administration
(FDA) or a test that has been approved
by the FDA but modified, the COLA
requires its accredited laboratories to
submit all data obtained for review and
approval by the COLA prior to adding
the test to the laboratory’s menu.
E. Subpart M—Personnel for Nonwaived
Testing
We have determined that the COLA
requirements are equal to the CLIA
requirements at § 493.1403 through
§ 493.1495 for laboratories that perform
moderate and high complexity testing.
F. Subpart Q—Inspections
We have determined that the COLA
requirements are equal to the CLIA
requirements at § 493.1771 through
§ 493.1780. The COLA will continue to
conduct biennial onsite inspections. An
unannounced inspection would be
performed when a complaint, lodged
against a laboratory accredited by the
COLA, indicates that problems may
exist within the laboratory that may
E:\FR\FM\22FEN1.SGM
22FEN1
Federal Register / Vol. 78, No. 36 / Friday, February 22, 2013 / Notices
have a serious or immediate impact on
patient care.
Register explaining the basis for
removing its approval.
G. Subpart R—Enforcement Procedures
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, codified in 42 CFR part 493
subpart E, are currently approved by
OMB under OMB approval number
0938–0686.
The COLA meets the requirements of
subpart R to the extent that it applies to
accreditation organizations. The COLA
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
COLA will deny, suspend, or revoke
accreditation in a laboratory accredited
by the COLA and report that action to
us within 30 days. The COLA also
provides an appeals process for
laboratories that have had accreditation
denied, suspended, or revoked.
We have determined that the COLA’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 COLA
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 COLA remain in
compliance with CLIA requirements.
This federal monitoring is an ongoing
process.
sroberts on DSK5SPTVN1PROD with NOTICES
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 COLA,
for cause, before the end of the effective
date of approval. If we determine that
the COLA 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 COLA would be
allowed to address any identified issues.
Should the COLA be unable to address
the identified issues within that
timeframe, CMS may, in accordance
with the applicable regulations, revoke
COLA’s deeming authority under CLIA.
Should circumstances result in our
withdrawal of the COLA’s approval, we
will publish a notice in the Federal
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16:18 Feb 21, 2013
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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.
Authority: Section 353 of the Public
Health Service Act (42 U.S.C. 263a).
Dated: February 8, 2013.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. 2013–03927 Filed 2–21–13; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–3280–PN]
Medicare and Medicaid Programs;
Application From the Center for
Improvement in Healthcare Quality
(CIHQ) for CMS-Approval of Its
Hospital Accreditation Program
Centers for Medicare &
Medicaid Services, HHS.
ACTION: Proposed notice.
AGENCY:
This proposed notice with
comment period acknowledges the
receipt of an application from the Center
for Improvement in Healthcare Quality
(CIHQ) for recognition as a national
accrediting organization for hospitals
that wish to participate in the Medicare
or Medicaid programs.
DATES: To be assured consideration,
comments must be received at one of
the addresses provided below, no later
than 5 p.m. on March 25, 2013.
ADDRESSES: In commenting, refer to file
code (CMS–3280–PN). Because of staff
and resource limitations, we cannot
accept comments by facsimile (FAX)
transmission.
SUMMARY:
PO 00000
Frm 00036
Fmt 4703
Sfmt 4703
12325
You may submit comments in one of
four ways (choose only one of the ways
listed):
1. Electronically. You may submit
electronic comments on specific issues
in this regulation to https://
www.regulations.gov. Follow the
‘‘Submit a comment’’ instructions.
2. By regular mail. You may mail
written comments to the following
address ONLY: Centers for Medicare &
Medicaid Services, Department of
Health and Human Services, Attention:
CMS–3280–PN, P.O. Box 8016,
Baltimore, MD 21244–8010.
Please allow sufficient time for mailed
comments to be received before the
close of the comment period.
3. By express or overnight mail. You
may send written comments to the
following address ONLY: Centers for
Medicare & Medicaid Services,
Department of Health and Human
Services, Attention: CMS–3280–PN,
Mail Stop C4–26–05, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
4. By hand or courier. Alternatively,
you may deliver (by hand or courier)
your written ONLY to the following
addresses.
a. For delivery in Washington, DC—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, Room 445–G, Hubert
H Humphrey Building, 200
Independence Avenue SW.,
Washington, DC 20201.
(Because access to the interior of the
Hubert H. Humphrey Building is not
readily available to persons without
Federal Government identification,
commenters are encouraged to leave
their comments in the CMS drop slots
located in the main lobby of the
building. A stamp-in clock is available
for persons wishing to retain a proof of
filing by stamping in and retaining an
extra copy of the comments being filed.)
b. For delivery in Baltimore, MD—
Centers for Medicare & Medicaid
Services, Department of Health and
Human Services, 7500 Security
Boulevard, Baltimore, MD 21244–1850.
If you intend to deliver your
comments to the Baltimore address, call
telephone number (410) 786–9994 in
advance to schedule your arrival with
one of our staff members.
Comments erroneously mailed to the
addresses indicated as appropriate for
hand or courier delivery may be delayed
and received after the comment period.
For information on viewing public
comments, see the beginning of the
SUPPLEMENTARY INFORMATION section.
FOR FURTHER INFORMATION CONTACT:
Cindy Melanson, (410) 786–0310.
Patricia Chmielewski, (410) 786–6899.
Monda Shaver, (410) 786–3410.
E:\FR\FM\22FEN1.SGM
22FEN1
]]>Agencies
[Federal Register Volume 78, Number 36 (Friday, February 22, 2013)]
[Notices]
[Pages 12323-12325]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2013-03927]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-3279-N]
Announcement of the Re-Approval of the Commission on Office
Laboratory Accreditation (COLA) 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 Commission on
Office Laboratory Accreditation (COLA) for approval as an accreditation
organization for clinical laboratories under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) program. We have determined that
COLA meets or exceeds the applicable CLIA requirements. In this notice,
we announce the approval and grant COLA deeming authority for a period
of 6 years.
DATES: Effective Date: This notice is effective from February 22, 2013
to February 22, 2019.
FOR FURTHER INFORMATION CONTACT: Raelene Perfetto, (410) 786-6876.
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, CMS 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
[[Page 12324]]
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 Commission on Office Laboratory Accreditation
(COLA) as an Accreditation Organization
In this notice, we approve COLA as an organization that may
accredit laboratories for purposes of establishing their compliance
with CLIA requirements for the following specialty and subspecialty
areas under CLIA:
Microbiology, including Bacteriology, Mycobacteriology,
Mycology, Parasitology, Virology.
Diagnostic Immunology, including Syphilis Serology,
General Immunology.
Chemistry, including Routine Chemistry, Urinalysis,
Endocrinology, Toxicology.
Hematology.
Immunohematology, including ABO Group & Rh Group, Antibody
Detection, Antibody Identification, Compatibility Testing.
We have examined the initial COLA 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 COLA meets or exceeds
the applicable CLIA requirements. We have also determined that COLA
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 COLA approval as an
accreditation organization under subpart E of part 493, for the period
stated in the DATES section of this notice for the submitted specialty
and subspecialty areas under CLIA. As a result of this determination,
any laboratory that is accredited by COLA during the time period stated
in the DATES section of this notice will be deemed to meet the CLIA
requirements for the listed subspecialties and specialties, 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 COLA Request for Approval as an Accreditation
Organization Under CLIA
The following describes the process used to determine that the COLA
accreditation program meets the necessary requirements to be approved
by CMS and that, as such, CMS may approve COLA as an accreditation
program with deeming authority under the CLIA program. COLA formally
applied to CMS for approval as an accreditation organization under CLIA
for the following specialties and subspecialties:
Microbiology, including Bacteriology, Mycobacteriology,
Mycology, Parasitology, Virology.
Diagnostic Immunology, including Syphilis Serology,
General Immunology.
Chemistry, including Routine Chemistry, Urinalysis,
Endocrinology, Toxicology.
Hematology.
Immunohematology, including ABO Group & Rh Group, Antibody
Detection, Antibody Identification, Compatibility Testing.
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 COLA 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. The COLA policies and procedures for oversight of
laboratories performing laboratory testing for the submitted CLIA
specialties and subspecialties are equivalent to those of CLIA in the
matters of inspection, monitoring proficiency testing (PT) performance,
investigating complaints, and making PT information available. The COLA
submitted requirements for monitoring and inspecting laboratories in
the areas of accreditation organization, data management, the
inspection process, procedures for removal or withdrawal of
accreditation, notification requirements, and accreditation
organization resources. The requirements of the accreditation programs
submitted for approval are equal to or more stringent than the
requirements of the CLIA regulations.
Our evaluation identified the COLA requirements pertaining to
waived testing that are more stringent than CLIA requirements. The COLA
requires the laboratory director to review quality control results for
waived tests monthly and also requires that competency be assessed and
documented for personnel performing waived testing. The CLIA
requirements at Sec. 493.15(e) require eligible laboratories to follow
the manufacturer's instructions for performing tests and obtain a
certificate of waiver as outlined in part 493, subpart B.
B. Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
The COLA's requirements are equal to the CLIA requirements at Sec.
493.801 through Sec. 493.865. Like CLIA, all of the COLA's accredited
laboratories are required to participate in an HHS-approved PT program
for tests listed in subpart I. The COLA also encourages its accredited
laboratories to participate in PT for tests that are waived under CLIA.
C. Subpart J--Facility Administration for Nonwaived Testing
The COLA's requirements are equal to the CLIA requirements at Sec.
493.1100 through Sec. 493.1105.
D. Subpart K--Quality System for Nonwaived Testing
The COLA requirements are equal to or more stringent than the CLIA
requirements at Sec. 493.1200 through Sec. 493.1299. For instance,
when a laboratory establishes performance specifications for a test not
approved by the Food and Drug Administration (FDA) or a test that has
been approved by the FDA but modified, the COLA requires its accredited
laboratories to submit all data obtained for review and approval by the
COLA prior to adding the test to the laboratory's menu.
E. Subpart M--Personnel for Nonwaived Testing
We have determined that the COLA requirements are equal to the CLIA
requirements at Sec. 493.1403 through Sec. 493.1495 for laboratories
that perform moderate and high complexity testing.
F. Subpart Q--Inspections
We have determined that the COLA requirements are equal to the CLIA
requirements at Sec. 493.1771 through Sec. 493.1780. The COLA will
continue to conduct biennial onsite inspections. An unannounced
inspection would be performed when a complaint, lodged against a
laboratory accredited by the COLA, indicates that problems may exist
within the laboratory that may
[[Page 12325]]
have a serious or immediate impact on patient care.
G. Subpart R--Enforcement Procedures
The COLA meets the requirements of subpart R to the extent that it
applies to accreditation organizations. The COLA 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 COLA will deny, suspend, or revoke accreditation in a
laboratory accredited by the COLA and report that action to us within
30 days. The COLA also provides an appeals process for laboratories
that have had accreditation denied, suspended, or revoked.
We have determined that the COLA'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 COLA 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 COLA 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 COLA, for cause, before
the end of the effective date of approval. If we determine that the
COLA 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 COLA would be allowed to address any identified issues.
Should the COLA be unable to address the identified issues within that
timeframe, CMS may, in accordance with the applicable regulations,
revoke COLA's deeming authority under CLIA.
Should circumstances result in our withdrawal of the COLA'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 CLIA program, codified in 42 CFR part 493
subpart E, are currently approved by OMB under OMB approval 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.
Authority: Section 353 of the Public Health Service Act (42
U.S.C. 263a).
Dated: February 8, 2013.
Marilyn Tavenner,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2013-03927 Filed 2-21-13; 8:45 am]
BILLING CODE 4120-01-P
