Medicare, Medicaid, and CLIA Programs; Continuing Approval of AABB (Formerly the American Association of Blood Banks as a CLIA Accreditation Organization, 30109-30111 [E8-10769]
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Federal Register / Vol. 73, No. 101 / Friday, May 23, 2008 / Notices
—The Joint Commission’s policies with
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dwashington3 on PRODPC61 with NOTICES
Authority: Section 1865 of the Social
Security Act (42 U.S.C. 1395bb).
(Catalog of Federal Domestic Assistance
Program No. 93.778, Medical Assistance
Program; No. 93.773 Medicare—Hospital
Insurance Program; and No. 93.774,
Medicare—Supplementary Medical
Insurance Program)
Dated: May 1, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E8–10776 Filed 5–22–08; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare and Medicaid
Services
[CMS–2224–N]
RIN 0938–ZA98
Medicare, Medicaid, and CLIA
Programs; Continuing Approval of
AABB (Formerly the American
Association of Blood Banks as a CLIA
Accreditation Organization
Centers for Medicare and
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
SUMMARY: In this notice, we reapprove
and grant AABB (formerly known as the
American Association of Blood Banks)
deeming authority as an accrediting
organization for clinical laboratories
under the Clinical Laboratory
Improvement Amendments of 1988
(CLIA) program. This deeming authority
is granted to AABB for the Blood Bank
and Transfusion Service (BB/TS)
accreditation program and the
Immunohematology Reference
Laboratory (IRL) Program.
DATES: Effective Date: This notice is
effective from May 23, 2008 to May 23,
2014.
FOR FURTHER INFORMATION CONTACT:
Daralyn Hassan, (410) 786–9360.
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 Laboratory
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 may grant deeming
authority to an accreditation
organization that accredits 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
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30109
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 at the frequency
determined by CMS.
• Apply standards and criteria that
are equal to, or more stringent than,
those condition-level requirements
established by CMS.
• 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 of approved
accreditation organizations by
inspecting a representative sample 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 AABB as an
Accreditation Organization
In this notice, we approve AABB as
an organization that may accredit
laboratories for purposes of establishing
their compliance with CLIA
requirements. We have examined the
AABB 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
AABB complies with the applicable
CLIA requirements and grant AABB
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, Virology.
• Diagnostic Immunology, including
Syphilis Serology, General Immunology.
• Chemistry, including Routine
Chemistry, Urinalysis, Toxicology.
• Hematology.
• Immunohematology, including
ABO Group and Rh Group, Antibody
Detection, Antibody Identification,
Compatibility Testing.
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Federal Register / Vol. 73, No. 101 / Friday, May 23, 2008 / Notices
As a result of this determination, any
laboratory that is accredited by AABB
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.
dwashington3 on PRODPC61 with NOTICES
III. Evaluation of AABB Request for
Approval as an Accreditation
Organization Under CLIA
The following describes the process
used to determine that requirements of
the AABB accreditation program are
equal to or more stringent than the CLIA
condition level requirements, and that
AABB has met the requirements of
subpart E of 42 CFR part 493.
AABB formally reapplied to us for
approval as an accreditation
organization under CLIA for the
following specialties and subspecialties:
• Microbiology, including
Bacteriology, Virology.
• Diagnostic Immunology, including
Syphilis Serology, General Immunology.
• Chemistry, including Routine
Chemistry, Urinalysis, Toxicology.
• Hematology.
• Immunohematology, including
ABO Group and Rh Group, Antibody
Detection, Antibody Identification,
Compatibility Testing.
We evaluated the AABB application
to determine compliance with our
implementing and enforcement
regulations, and the deeming/exemption
requirements of the CLIA rules.
We verified that the AABB BB/TS and
IRL accreditation program requirements
and methods require the laboratories it
accredits to be, and that the organization
is, in compliance with 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
AABB submitted the specialties and
subspecialties that it would accredit; a
comparison of its accreditation
requirements to CLIA condition level
requirements; a description of its
inspection process and its 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 CMS; its
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procedures for removing or withdrawing
laboratory accreditation; its current list
of accredited laboratories; and its
announced or unannounced inspection
process.
AABB has additional requirements
pertaining to waived testing. AABB will
routinely inspect laboratories that
perform waived tests that are normally
associated with blood centers and
transfusion services. These laboratories
will be inspected to verify that tests are
performed according to manufacturer’s
instructions. In addition, AABB requires
that there be appropriately qualified
personnel—that is a director, a
supervisor, and testing personnel for
waived testing. Section 493.15 of the
CLIA regulations requires only that a
laboratory follow manufacturer’s
instructions and does not require
routine inspections of waived testing.
Thus the requirements of AABB are
more stringent than the requirements of
the CLIA regulations.
Subpart H—Participation in Proficiency
Testing for Laboratories Performing
Nonwaived Testing
AABB’s requirements are equal to the
CLIA requirements at § 493.801 through
§ 493.865. Both CLIA regulations and
AABB standards require accredited
laboratories to participate in a CMSapproved proficiency testing (PT)
program for any of the tests listed in
subpart I. Additionally, AABB
administers a non-regulated PT program
to challenge the ability of the labs in the
IRL program to resolve complex
serological problems.
Subpart J—Facility Administration for
Nonwaived Testing
AABB requirements are equal to or
more stringent than the CLIA
requirements at § 493.1100 through
§ 493.1105. The following specific
AABB requirements are more stringent
than the requirements of the CLIA
regulations:
• AABB’s record-keeping
requirements are more extensive and
detailed than the CLIA requirements.
For example, AABB requires
laboratories to retain quality assessment
records for 5 years, while the CLIA
regulations require laboratories to retain
those records for only 2 years.
• The IRL standards require
laboratories to maintain an extensive
inventory of rare reagents for resolving
complex serological problems.
Subpart K— Quality System for
Nonwaived Testing
The quality control requirements of
AABB have been evaluated against the
requirements of the CLIA regulations.
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Fmt 4703
Sfmt 4703
AABB, like CLIA, uses a quality system
approach in its requirements for
laboratories. AABB inspectors use
detailed checklists to ensure that
compliance with specific CLIA
requirements is met. AABB
requirements are equal to the CLIA
requirements at § 493.1200 through
§ 493.1299.
Subpart M—Personnel for Nonwaived
Testing
AABB uses the criteria identified in
the CLIA regulations at §§ 493.1441,
493.1447, 493.1453, 493.1459, and
493.1487 (applicable to laboratories
performing high-complexity testing). 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.
Subpart Q—Inspections
We have determined that the AABB
requirements are equal to the CLIA
requirements at § 493.1771 through
§ 493.1780. AABB will continue to
perform onsite inspections every 2
years.
Subpart R—Enforcement Procedures
AABB meets the requirements of
subpart R to the extent that it applies to
accreditation organizations. AABB
policy sets forth the actions the
organization takes when laboratories it
accredits do not comply with its
requirements and standards for
accreditation. When appropriate, AABB
will deny, suspend, or revoke
accreditation in a laboratory accredited
by AABB and report that action to us
within 30 days. AABB also provides an
appeal process for laboratories that have
had accreditation denied, suspended, or
revoked.
We have determined that AABB’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
AABB 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 CMS or our agents, the State survey
agencies, will be our principal means
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Federal Register / Vol. 73, No. 101 / Friday, May 23, 2008 / Notices
for verifying that the laboratories
accredited by AABB 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 AABB, for
cause, before the end of the effective
date of approval. If we determine that
AABB 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 AABB to
adopt comparable requirements.
Should circumstances result in our
withdrawal of the AABB’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.
Authority: Section 353 of the Public Health
Service Act (42 U.S.C. 263a).
Dated: April 11, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E8–10769 Filed 5–22–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
dwashington3 on PRODPC61 with NOTICES
[CMS–7009–N]
Medicare Program; Announcement of
Meeting of the Advisory Panel on
Medicare Education, June 26, 2008
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice of meeting.
AGENCY:
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SUMMARY: In accordance with the
Federal Advisory Committee Act, this
notice announces a meeting of Advisory
Panel on Medicare Education (the
Panel). The Panel advises and makes
recommendations to the Secretary of
Health and Human Services and the
Administrator of the Centers for
Medicare & Medicaid Services on the
effectiveness of consumer education
strategies concerning the Medicare
program. This meeting is open to the
public.
DATES: Meeting Date: June 26, 2008 from
9 a.m. to 3:30 p.m., d.s.t.
Deadline for Meeting Registration,
Presentations and Comments: June 19,
2008, 12 noon, d.s.t.
Deadline for Requesting Special
Accommodations: June 12, 2008, 12
noon, d.s.t.
ADDRESSES: Meeting Location: Four
Points Hotel, 1201 K Street, NW.,
Washington, DC 20005, (202) 349–2205.
Meeting Registration, Presentations,
and Written Comments: Lynne Johnson,
Designated Federal Official, Division of
Forum and Conference Development,
Office of External Affairs, Centers for
Medicare & Medicaid Services, 7500
Security Boulevard, Mailstop S1–05–06,
Baltimore, MD 21244–1850 or contact
Ms. Johnson via e-mail at
Lynne.Johnson@cms.hhs.gov.
Registration: The meeting is open to
the public, but attendance is limited to
the space available. Persons wishing to
attend this meeting must register by
contacting Lynne Johnson at the address
listed in the ADDRESSES section of this
notice or by telephone at (410) 786–
0090, by the date listed in the DATES
section of this notice.
FOR FURTHER INFORMATION CONTACT:
Lynne Johnson, (410) 786–0090. Please
refer to the CMS Advisory Committees’
Information Line (1–877–449–5659 toll
free)/(410–786–9379 local) or the
Internet (https://www.cms.hhs.gov/
FACA/04_APME.asp) for additional
information and updates on committee
activities. Press inquiries are handled
through the CMS Press Office at (202)
690–6145.
SUPPLEMENTARY INFORMATION: Section
9(a)(2) of the Federal Advisory
Committee Act authorizes the Secretary
of Health and Human Services (the
Secretary) to establish an advisory panel
if the Secretary determines that the
panel is ‘‘in the public interest in
connection with the performance of
duties imposed * * * by law.’’ Such
duties are imposed by section 1804 of
the Social Security Act (the Act),
requiring the Secretary to provide
informational materials to Medicare
beneficiaries about the Medicare
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30111
program, and section 1851(d) of the Act,
requiring the Secretary to provide for
‘‘activities * * * to broadly disseminate
information to [M]edicare beneficiaries
* * * on the coverage options provided
under [Medicare Advantage] in order to
promote an active, informed selection
among such options.’’
The Panel is also authorized by
1114(f) of the Act (42 U.S.C. 1311(f))
and section 222 of the Public Health
Service Act (42 U.S.C. 217a). The
Secretary signed the charter establishing
this Panel on January 21, 1999 and
approved the renewal of the charter on
November 14, 2006. The establishment
of the charter and the renewal of the
charter were announced in the February
17, 1999 Federal Register (64 FR 7899),
and the March 23, 2007 Federal
Register (72 FR 13796), respectively.
The Panel advises and makes
recommendations to the Secretary and
the Administrator of the Centers for
Medicare & Medicaid Services (CMS) on
opportunities to enhance the
effectiveness of consumer education
strategies concerning the Medicare
program. The Secretary delegates
authority to the Administrator.
The goals of the Panel are as follows:
• To provide recommendations on
the development and implementation of
a national Medicare education program
that describes the options for selecting
a health plan and prescription drug plan
under Medicare.
• To enhance the Federal
government’s effectiveness in informing
the Medicare consumer, including the
appropriate use of public-private
partnerships.
• To provide recommendations on
how to expand outreach to vulnerable
and underserved communities,
including racial and ethnic minorities,
in the context of a national Medicare
education program.
• To assemble an information base of
best practices for helping consumers
evaluate health plan options and build
a community infrastructure for
information, counseling, and assistance.
The current members of the Panel are:
Anita B. Boles, Executive Director,
Society for the Arts in Healthcare;
Gwendolyn T. Bronson, SHINE/SHIP
Counselor, Massachusetts SHINE
Program; Dr. Yanira Cruz, President and
Chief Executive Officer, National
Hispanic Council on Aging; Clayton
Fong, President and Chief Executive
Officer, National Asian Pacific Center
on Aging; Nan Kirsten-Forte, Executive
Vice President, Consumer Services,
WebMD; Dr. Jessie C. Gruman, President
and Chief Executive Officer, Center for
the Advancement of Health; Dr. David
Lansky, PhD., President and Chief
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]]>Agencies
[Federal Register Volume 73, Number 101 (Friday, May 23, 2008)]
[Notices]
[Pages 30109-30111]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-10769]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare and Medicaid Services
[CMS-2224-N]
RIN 0938-ZA98
Medicare, Medicaid, and CLIA Programs; Continuing Approval of
AABB (Formerly the American Association of Blood Banks as a CLIA
Accreditation Organization
AGENCY: Centers for Medicare and Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: In this notice, we reapprove and grant AABB (formerly known as
the American Association of Blood Banks) deeming authority as an
accrediting organization for clinical laboratories under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA) program. This deeming
authority is granted to AABB for the Blood Bank and Transfusion Service
(BB/TS) accreditation program and the Immunohematology Reference
Laboratory (IRL) Program.
DATES: Effective Date: This notice is effective from May 23, 2008 to
May 23, 2014.
FOR FURTHER INFORMATION CONTACT: Daralyn Hassan, (410) 786-9360.
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 Laboratory 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 may
grant deeming authority to an accreditation organization that accredits
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 at the frequency
determined by CMS.
Apply standards and criteria that are equal to, or more
stringent than, those condition-level requirements established by CMS.
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 of approved
accreditation organizations by inspecting a representative sample 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 AABB as an Accreditation Organization
In this notice, we approve AABB as an organization that may
accredit laboratories for purposes of establishing their compliance
with CLIA requirements. We have examined the AABB 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 AABB complies
with the applicable CLIA requirements and grant AABB 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, Virology.
Diagnostic Immunology, including Syphilis Serology,
General Immunology.
Chemistry, including Routine Chemistry, Urinalysis,
Toxicology.
Hematology.
Immunohematology, including ABO Group and Rh Group,
Antibody Detection, Antibody Identification, Compatibility Testing.
[[Page 30110]]
As a result of this determination, any laboratory that is
accredited by AABB 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 AABB Request for Approval as an Accreditation
Organization Under CLIA
The following describes the process used to determine that
requirements of the AABB accreditation program are equal to or more
stringent than the CLIA condition level requirements, and that AABB has
met the requirements of subpart E of 42 CFR part 493.
AABB formally reapplied to us for approval as an accreditation
organization under CLIA for the following specialties and
subspecialties:
Microbiology, including Bacteriology, Virology.
Diagnostic Immunology, including Syphilis Serology,
General Immunology.
Chemistry, including Routine Chemistry, Urinalysis,
Toxicology.
Hematology.
Immunohematology, including ABO Group and Rh Group,
Antibody Detection, Antibody Identification, Compatibility Testing.
We evaluated the AABB application to determine compliance with our
implementing and enforcement regulations, and the deeming/exemption
requirements of the CLIA rules.
We verified that the AABB BB/TS and IRL accreditation program
requirements and methods require the laboratories it accredits to be,
and that the organization is, in compliance with 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
AABB submitted the specialties and subspecialties that it would
accredit; a comparison of its accreditation requirements to CLIA
condition level requirements; a description of its inspection process
and its 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 CMS;
its procedures for removing or withdrawing laboratory accreditation;
its current list of accredited laboratories; and its announced or
unannounced inspection process.
AABB has additional requirements pertaining to waived testing. AABB
will routinely inspect laboratories that perform waived tests that are
normally associated with blood centers and transfusion services. These
laboratories will be inspected to verify that tests are performed
according to manufacturer's instructions. In addition, AABB requires
that there be appropriately qualified personnel--that is a director, a
supervisor, and testing personnel for waived testing. Section 493.15 of
the CLIA regulations requires only that a laboratory follow
manufacturer's instructions and does not require routine inspections of
waived testing. Thus the requirements of AABB are more stringent than
the requirements of the CLIA regulations.
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
AABB's requirements are equal to the CLIA requirements at Sec.
493.801 through Sec. 493.865. Both CLIA regulations and AABB standards
require accredited laboratories to participate in a CMS-approved
proficiency testing (PT) program for any of the tests listed in subpart
I. Additionally, AABB administers a non-regulated PT program to
challenge the ability of the labs in the IRL program to resolve complex
serological problems.
Subpart J--Facility Administration for Nonwaived Testing
AABB requirements are equal to or more stringent than the CLIA
requirements at Sec. 493.1100 through Sec. 493.1105. The following
specific AABB requirements are more stringent than the requirements of
the CLIA regulations:
AABB's record-keeping requirements are more extensive and
detailed than the CLIA requirements. For example, AABB requires
laboratories to retain quality assessment records for 5 years, while
the CLIA regulations require laboratories to retain those records for
only 2 years.
The IRL standards require laboratories to maintain an
extensive inventory of rare reagents for resolving complex serological
problems.
Subpart K-- Quality System for Nonwaived Testing
The quality control requirements of AABB have been evaluated
against the requirements of the CLIA regulations. AABB, like CLIA, uses
a quality system approach in its requirements for laboratories. AABB
inspectors use detailed checklists to ensure that compliance with
specific CLIA requirements is met. AABB requirements are equal to the
CLIA requirements at Sec. 493.1200 through Sec. 493.1299.
Subpart M--Personnel for Nonwaived Testing
AABB uses the criteria identified in the CLIA regulations at
Sec. Sec. 493.1441, 493.1447, 493.1453, 493.1459, and 493.1487
(applicable to laboratories performing high-complexity testing). 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.
Subpart Q--Inspections
We have determined that the AABB requirements are equal to the CLIA
requirements at Sec. 493.1771 through Sec. 493.1780. AABB will
continue to perform onsite inspections every 2 years.
Subpart R--Enforcement Procedures
AABB meets the requirements of subpart R to the extent that it
applies to accreditation organizations. AABB policy sets forth the
actions the organization takes when laboratories it accredits do not
comply with its requirements and standards for accreditation. When
appropriate, AABB will deny, suspend, or revoke accreditation in a
laboratory accredited by AABB and report that action to us within 30
days. AABB also provides an appeal process for laboratories that have
had accreditation denied, suspended, or revoked.
We have determined that AABB'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 AABB 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
CMS or our agents, the State survey agencies, will be our principal
means
[[Page 30111]]
for verifying that the laboratories accredited by AABB 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 AABB, for cause, before the
end of the effective date of approval. If we determine that AABB 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 AABB to adopt comparable requirements.
Should circumstances result in our withdrawal of the AABB'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.
Authority: Section 353 of the Public Health Service Act (42
U.S.C. 263a).
Dated: April 11, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-10769 Filed 5-22-08; 8:45 am]
BILLING CODE 4120-01-P
