[Federal Register: May 23, 2008 (Volume 73, Number 101)]
[Notices]
[Page 30109-30111]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23my08-64]
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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.
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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