Medicare, Medicaid, and CLIA Programs; Approval of COLA (Formerly the Commission on Office Laboratory Accreditation) as a CLIA Accreditation Organization, 8171-8172 [E7-3025]
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Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices
Authority: Section 1833(t) of the Act (42
U.S.C. 1395l(t)). The Panel is governed by the
provisions of Pub. L. 92–463, as amended (5
U.S.C. Appendix 2).(Catalog of Federal
Domestic Assistance Program No. 93.773,
Medicare-Hospital Insurance; and Program
No. 93.774, Medicare-Supplementary
Medical Insurance Program).
Dated: February 15, 2007.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E7–3040 Filed 2–22–07; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2221–N]
RIN 0938–ZA98
Medicare, Medicaid, and CLIA
Programs; Approval of COLA
(Formerly the Commission on Office
Laboratory Accreditation) as a CLIA
Accreditation Organization
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
cprice-sewell on PROD1PC61 with NOTICES
SUMMARY: In this notice, we grant COLA
(formerly the Commission on Office
Laboratory Accreditation) deeming
authority as an accrediting organization
for clinical laboratories under the
Clinical Laboratory Improvement
Amendments of 1988 (CLIA) program.
We have determined that the
requirements of the COLA accreditation
process are equal to or more stringent
than the CLIA condition level
requirements, and that COLA has met
the requirements of subpart E of 42 CFR
Part 493. Consequently, laboratories that
are voluntarily accredited by COLA and
continue to meet COLA requirements
will be deemed to meet the CLIA
condition-level requirements for
laboratories and therefore are not
subject to routine inspection by State
survey agencies to determine their
compliance with Federal requirements.
They are, however, subject to Federal
validation and complaint investigation
surveys conducted by us or our
designee.
Effective Date: This notice is
effective from February 23, 2007 to
February 25, 2013.
FOR FURTHER INFORMATION CONTACT:
Raelene Perfetto, (410) 786–6876.
SUPPLEMENTARY INFORMATION:
DATES:
VerDate Aug<31>2005
15:07 Feb 22, 2007
Jkt 211001
8171
I. Background and Legislative
Authority
II. Notice of Approval of COLA as an
Accreditation Organization
On October 31, 1988, the Congress
enacted the Clinical Laboratory
Improvement Amendments of 1988
(CLIA), Public Law 100–578. CLIA
replaced in its entirety section 353(e)(2)
of the Public Health Service Act, as
enacted by the Clinical Laboratories
Improvement Act of 1967. We issued a
final rule implementing the
accreditation provisions of CLIA on July
31, 1992, (57 FR 33992). Under the CLIA
program, CMS approves a grant of
deeming authority to an accreditation
organization to accredit clinical
laboratories if the organization meets
certain requirements. An organization’s
requirements for accredited laboratories
must be equal to, or more stringent than,
the applicable CLIA program
requirements in 42 CFR part 493
(Laboratory Requirements). The
regulations in subpart E (Accreditation
by a Private, Nonprofit Accreditation
Organization or Exemption Under an
Approved State Laboratory Program)
specify the requirements an
accreditation organization must meet to
be an approved accreditation
organization. We approve an
accreditation organization for a period
not to exceed 6 years.
In general, the approved accreditation
organization must:
• Use inspectors qualified to evaluate
laboratory performance and agree to
inspect laboratories with the frequency
determined by us.
• Apply standards and criteria that
are equal to, or more stringent than,
those condition-level requirements
established by us.
• Assure that laboratories accredited
by the accreditation organization
continually meet these standards and
criteria.
• Provide us with the name of any
laboratory that has had its accreditation
denied, suspended, withdrawn, limited,
or revoked within 30 days of the action
taken.
• Notify us at least 30 days before
implementing any proposed changes in
its standards.
• If we withdraw our approval, notify
the accredited laboratories of the
withdrawal within 10 days of the
withdrawal.
CLIA requires that we perform an
annual evaluation by inspecting a
sufficient number of laboratories
accredited by an approved accreditation
organization as well as by any other
means that we determine to be
appropriate.
In this notice, we approve COLA
(formerly the Commission on Office
Laboratory Accreditation) as an
organization that may accredit
laboratories for purposes of establishing
their compliance with CLIA
requirements. We have examined the
COLA application and all subsequent
submissions to determine equivalency
with our requirements under subpart E
of part 493 that an accreditation
organization must meet to be approved
under CLIA. We have determined that
COLA complied with the applicable
CLIA requirements and grant COLA
approval as an accreditation
organization under subpart E, as for the
period stated in the ‘‘Effective Date’’
section of this notice for the following
specialty and subspecialty areas:
• 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.
• Pathology, including
Histopathology, Oral Pathology,
Cytology.
As a result of this determination, any
laboratory that is accredited by COLA
during the effective time period for an
approved specialty or subspecialty is
deemed to meet the CLIA requirements
for the laboratories found in part 493 of
our regulations and, therefore, is not
subject to routine inspection 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 us,
or by any other validly authorized agent.
PO 00000
Frm 00023
Fmt 4703
Sfmt 4703
III. Evaluation of COLA Request for
Approval as an Accreditation
Organization Under CLIA
The following describes the process
used to determine that requirements of
the COLA accreditation program are
equal to or more stringent than the CLIA
condition level requirements, and that
COLA has met the requirements of
subpart E of 42 CFR part 493.
COLA formally reapplied to us for
approval as an accreditation
organization under CLIA for the
following specialties and subspecialties:
E:\FR\FM\23FEN1.SGM
23FEN1
8172
Federal Register / Vol. 72, No. 36 / Friday, February 23, 2007 / Notices
• 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.
• Pathology, including
Histopathology, Oral Pathology,
Cytology.
We evaluated the COLA application
to meet or exceed our implementing and
enforcement regulations, and the
deeming/exemption requirements of the
CLIA rules.
We verified that the COLA
accreditation program requirements and
methods require the laboratories it
accredits to be, and that the organization
meets or exceeds the following subparts
of part 493 as explained below:
cprice-sewell on PROD1PC61 with NOTICES
Subpart E—Accreditation by a Private,
Nonprofit Accreditation Organization or
Exemption Under an Approved State
Laboratory Program
COLA submitted the specialties and
subspecialties that it would accredit; a
comparison of individual accreditation
and condition-level requirements; a
description of its inspection process;
proficiency testing (PT) monitoring
process; its data management and
analysis system; a listing of the size,
composition, education and experience
of its inspection teams; its investigative
and complaint response procedures; its
notification agreements with us; its
removal or withdrawal of laboratory
accreditation procedures; its current list
of accredited laboratories; and its
announced or unannounced inspection
process.
Subpart H—Participation in Proficiency
Testing for Laboratories Performing
Nonwaived Testing
COLA’s requirements are equal to the
CLIA requirements at § 493.801 through
§ 493.865. Like CLIA, all of COLA’s
accredited laboratories are required to
participate in a CMS-approved
proficiency test (PT) program for any of
tests listed in subpart I. COLA also
encourages its accredited laboratories to
participate in PT for tests that are
waived under CLIA.
Subpart J—Facility Administration for
Nonwaived Testing
COLA requirements are equal to the
CLIA requirements at § 493.1100
through § 493.1105.
VerDate Aug<31>2005
15:07 Feb 22, 2007
Jkt 211001
Subpart K—Quality System for
Nonwaived Testing
COLA requirements are equal to the
CLIA requirements at § 493.1200
through § 493.1299. COLA makes
educational material available to its
accredited laboratories, which provide
further information on quality
assurance. As part of good laboratory
practice and to ensure accuracy, COLA
encourages development of a QC
program for tests that are waived under
CLIA.
Subpart M—Personnel for Nonwaived
Testing
COLA states as general policy that its
personnel standards for accreditation
are identical to CLIA. A qualified
individual must fulfill the
responsibilities of each required
position in the laboratory. The
laboratory director and laboratory
personnel must meet educational and
experience requirements. Although
certain duties of the laboratory director
may be delegated to qualified
individuals, the laboratory director
remains ultimately responsible. We
have determined that COLA
requirements are equal to the CLIA
requirements at § 493.1403 through
§ 493.1495 for laboratories that perform
moderate and high complexity testing.
Subpart Q—Inspections
We have determined that the COLA
requirements are equal to the CLIA
requirements at § 493.1771 through
§ 493.1780. COLA will continue to
perform onsite inspections every 2
years.
Subpart R—Enforcement Procedures
COLA meets the requirements of
subpart R to the extent that it applies to
accreditation organizations. 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, COLA
will deny, suspend, or, revoke
accreditation in a laboratory accredited
by COLA and report that action to us
within 30 days. COLA also provides an
appeal process for laboratories that have
had accreditation denied, suspended, or
revoked.
We have determined that COLA’s
laboratory enforcement and appeal
policies are equal to 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
COLA accredited laboratories may be
PO 00000
Frm 00024
Fmt 4703
Sfmt 4703
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 us or our agents, the State survey
agencies, will be our principal means
for verifying that the laboratories
accredited by 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 COLA, for
cause, before the end of the effective
date of approval. If we determine that
COLA failed to adopt requirements that
are equal to, or more stringent than, the
CLIA requirements, or that systemic
problems exist in its inspection process,
we may give it a probationary period,
not to exceed 1 year to allow COLA to
adopt comparable requirements.
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 Clinical
Laboratory Improvement Amendments
of 1988 (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: December 7, 2006.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E7–3025 Filed 2–22–07; 8:45 am]
BILLING CODE 4120–01–P
E:\FR\FM\23FEN1.SGM
23FEN1
]]>Agencies
[Federal Register Volume 72, Number 36 (Friday, February 23, 2007)]
[Notices]
[Pages 8171-8172]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E7-3025]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2221-N]
RIN 0938-ZA98
Medicare, Medicaid, and CLIA Programs; Approval of COLA (Formerly
the Commission on Office Laboratory Accreditation) as a CLIA
Accreditation Organization
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In this notice, we grant COLA (formerly the Commission on
Office Laboratory Accreditation) deeming authority as an accrediting
organization for clinical laboratories under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) program. We have determined that
the requirements of the COLA accreditation process are equal to or more
stringent than the CLIA condition level requirements, and that COLA has
met the requirements of subpart E of 42 CFR Part 493. Consequently,
laboratories that are voluntarily accredited by COLA and continue to
meet COLA requirements will be deemed to meet the CLIA condition-level
requirements for laboratories and therefore are not subject to routine
inspection by State survey agencies to determine their compliance with
Federal requirements. They are, however, subject to Federal validation
and complaint investigation surveys conducted by us or our designee.
DATES: Effective Date: This notice is effective from February 23, 2007
to February 25, 2013.
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), Public Law 100-578. CLIA
replaced in its entirety section 353(e)(2) of the Public Health Service
Act, as enacted by the Clinical Laboratories Improvement Act of 1967.
We issued a final rule implementing the accreditation provisions of
CLIA on July 31, 1992, (57 FR 33992). Under the CLIA program, CMS
approves a grant of deeming authority to an accreditation organization
to accredit clinical laboratories if the organization meets certain
requirements. An organization's requirements for accredited
laboratories must be equal to, or more stringent than, the applicable
CLIA program requirements in 42 CFR part 493 (Laboratory Requirements).
The regulations in subpart E (Accreditation by a Private, Nonprofit
Accreditation Organization or Exemption Under an Approved State
Laboratory Program) specify the requirements an accreditation
organization must meet to be an approved accreditation organization. We
approve an accreditation organization for a period not to exceed 6
years.
In general, the approved accreditation organization must:
Use inspectors qualified to evaluate laboratory
performance and agree to inspect laboratories with the frequency
determined by us.
Apply standards and criteria that are equal to, or more
stringent than, those condition-level requirements established by us.
Assure that laboratories accredited by the accreditation
organization continually meet these standards and criteria.
Provide us with the name of any laboratory that has had
its accreditation denied, suspended, withdrawn, limited, or revoked
within 30 days of the action taken.
Notify us at least 30 days before implementing any
proposed changes in its standards.
If we withdraw our approval, notify the accredited
laboratories of the withdrawal within 10 days of the withdrawal.
CLIA requires that we perform an annual evaluation by inspecting a
sufficient number of laboratories accredited by an approved
accreditation organization as well as by any other means that we
determine to be appropriate.
II. Notice of Approval of COLA as an Accreditation Organization
In this notice, we approve COLA (formerly the Commission on Office
Laboratory Accreditation) as an organization that may accredit
laboratories for purposes of establishing their compliance with CLIA
requirements. We have examined the COLA application and all subsequent
submissions to determine equivalency with our requirements under
subpart E of part 493 that an accreditation organization must meet to
be approved under CLIA. We have determined that COLA complied with the
applicable CLIA requirements and grant COLA approval as an
accreditation organization under subpart E, as for the period stated in
the ``Effective Date'' section of this notice for the following
specialty and subspecialty areas:
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.
Pathology, including Histopathology, Oral Pathology,
Cytology.
As a result of this determination, any laboratory that is
accredited by COLA during the effective time period for an approved
specialty or subspecialty is deemed to meet the CLIA requirements for
the laboratories found in part 493 of our regulations and, therefore,
is not subject to routine inspection 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 us, or by any other validly
authorized agent.
III. Evaluation of COLA Request for Approval as an Accreditation
Organization Under CLIA
The following describes the process used to determine that
requirements of the COLA accreditation program are equal to or more
stringent than the CLIA condition level requirements, and that COLA has
met the requirements of subpart E of 42 CFR part 493.
COLA formally reapplied to us for approval as an accreditation
organization under CLIA for the following specialties and
subspecialties:
[[Page 8172]]
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.
Pathology, including Histopathology, Oral Pathology,
Cytology.
We evaluated the COLA application to meet or exceed our
implementing and enforcement regulations, and the deeming/exemption
requirements of the CLIA rules.
We verified that the COLA accreditation program requirements and
methods require the laboratories it accredits to be, and that the
organization meets or exceeds the following subparts of part 493 as
explained below:
Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
COLA submitted the specialties and subspecialties that it would
accredit; a comparison of individual accreditation and condition-level
requirements; a description of its inspection process; proficiency
testing (PT) monitoring process; its data management and analysis
system; a listing of the size, composition, education and experience of
its inspection teams; its investigative and complaint response
procedures; its notification agreements with us; its removal or
withdrawal of laboratory accreditation procedures; its current list of
accredited laboratories; and its announced or unannounced inspection
process.
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
COLA's requirements are equal to the CLIA requirements at Sec.
493.801 through Sec. 493.865. Like CLIA, all of COLA's accredited
laboratories are required to participate in a CMS-approved proficiency
test (PT) program for any of tests listed in subpart I. COLA also
encourages its accredited laboratories to participate in PT for tests
that are waived under CLIA.
Subpart J--Facility Administration for Nonwaived Testing
COLA requirements are equal to the CLIA requirements at Sec.
493.1100 through Sec. 493.1105.
Subpart K--Quality System for Nonwaived Testing
COLA requirements are equal to the CLIA requirements at Sec.
493.1200 through Sec. 493.1299. COLA makes educational material
available to its accredited laboratories, which provide further
information on quality assurance. As part of good laboratory practice
and to ensure accuracy, COLA encourages development of a QC program for
tests that are waived under CLIA.
Subpart M--Personnel for Nonwaived Testing
COLA states as general policy that its personnel standards for
accreditation are identical to CLIA. A qualified individual must
fulfill the responsibilities of each required position in the
laboratory. The laboratory director and laboratory personnel must meet
educational and experience requirements. Although certain duties of the
laboratory director may be delegated to qualified individuals, the
laboratory director remains ultimately responsible. We have determined
that 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.
Subpart Q--Inspections
We have determined that the COLA requirements are equal to the CLIA
requirements at Sec. 493.1771 through Sec. 493.1780. COLA will
continue to perform onsite inspections every 2 years.
Subpart R--Enforcement Procedures
COLA meets the requirements of subpart R to the extent that it
applies to accreditation organizations. 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, COLA will deny, suspend, or, revoke accreditation in a
laboratory accredited by COLA and report that action to us within 30
days. COLA also provides an appeal process for laboratories that have
had accreditation denied, suspended, or revoked.
We have determined that COLA's laboratory enforcement and appeal
policies are equal to 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 COLA accredited laboratories
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
us or our agents, the State survey agencies, will be our principal
means for verifying that the laboratories accredited by 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 COLA, for cause, before the
end of the effective date of approval. If we determine that COLA failed
to adopt requirements that are equal to, or more stringent than, the
CLIA requirements, or that systemic problems exist in its inspection
process, we may give it a probationary period, not to exceed 1 year to
allow COLA to adopt comparable requirements.
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 Clinical Laboratory Improvement Amendments of
1988 (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: December 7, 2006.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E7-3025 Filed 2-22-07; 8:45 am]
BILLING CODE 4120-01-P
