[Federal Register: December 30, 2004 (Volume 69, Number 250)]
[Notices]
[Page 78426-78428]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr30de04-78]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2490-N]
CLIA Program; Continued Approval of the American Association of
Blood Banks for Deeming Authority
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces the re-approval of the American
Association of Blood Banks (AABB) as an accrediting organization for
clinical laboratories under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) program. The initial exemption
[[Page 78427]]
was published in the Federal Register on July 21, 1995. We have
determined that the accreditation process of this organization provides
reasonable assurance that a laboratory accredited by it meets the
conditions required by Federal law and regulations. Consequently,
laboratories that are voluntarily accredited by the AABB and continue
to meet the AABB 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 validation and complaint investigation surveys conducted by us or
our designee.
EFFECTIVE DATE: This notice is effective for the period July 21, 2001
through July 21, 2007.
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), Pub. L. 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 (57 FR 33992) implementing the accreditation provisions of
CLIA on July 31, 1992. Under the CLIA program, we may approve a
private, nonprofit organization as an approved 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 listed in subpart E of part 493 (Accreditation by a
Private, Nonprofit Accreditation Organization or Exemption Under an
Approved State Laboratory Program) specify the requirements an
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.
Provide reasonable assurance that its accredited
laboratories 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 change in its standards.
If we withdraw our approval, notify the accredited
laboratories of the withdrawal within 10 days of the withdrawal.
CLIA requires CMS to 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 appropriate.
II. Notice of Approval of AABB as an Accrediting Organization
In this notice, we approve AABB as an organization that may
continue to 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 complied with the applicable CLIA requirements and grant AABB
approval as an accreditation organization under subpart E, through July
21, 2007, for the following specialties and subspecialty areas:
Immunohematology.
General immunology.
Hematology.
Routine chemistry.
Toxicology.
As a result of this determination, any laboratory that is
accredited by the AABB during the effective time period for an approved
specialty or subspecialty listed above is deemed to meet the CLIA
requirements for laboratories found in part 493 of our regulations for
that specialty or subspecialty 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 the AABB Request for Approval as an Accreditation
Organization under CLIA
The AABB formally applied to us for approval as an accreditation
organization under CLIA for the specialties of immunohematology,
hematology, general immunology, and the subspecialties of routine
chemistry and toxicology. We evaluated the AABB application to
determine compliance with our implementing and enforcement regulations,
and the deeming/exemption requirements of the CLIA rules.
We evaluated the application to verify assurance of the AABB's
compliance with the following subparts of part 493:
Subpart H, Participation in Proficiency Testing for
Laboratories Performing Nonwaived Testing.
Subpart J, Facility Administration for Nonwaived Testing.
Subpart K, Quality System for Nonwaived Testing.
Subpart M, Personnel for Nonwaived Testing.
Subpart Q, Inspections.
Subpart R, Enforcement Procedures.
The AABB meets the requirements for subparts H, J, K, M, Q, and R.
We also verified the organization's assurance that it requires 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
The AABB submitted a list of all 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 CMS; its removal
or withdrawal of laboratory accreditation procedures; its current list
of accredited laboratories; and its announced or unannounced inspection
process.
The AABB has additional requirements pertaining to waived testing.
The AABB will routinely inspect laboratories that perform waived tests
that are normally associated with blood centers and transfusion
services. These laboratories will be inspected for good manufacturing
practices and to verify that tests are performed according to
manufacturer's instructions. In addition, for waived testing, the AABB
requires that there be appropriately qualified personnel that is,
director, supervisor, and testing personnel. Section 493.15 of the CL1A
regulations
[[Page 78428]]
requires only that a laboratory follow manufacturer's instructions and
does not require routine inspections of waived testing. Thus, the
requirements of the AABB are more stringent than the requirements of
the CLIA regulations.
We have determined that the AABB has complied with the requirements
under subpart E of part 493 and that the requirements of the AABB are
equal to or more stringent than the condition-level requirements in
subparts H, J, K, M, Q, and R of part 493.
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
The AABB has revised its requirements to be equal to or more
stringent than the CLIA requirements at Sec. 493.801 through Sec.
493.865.
Subpart J--Facility Administration for Nonwaived Testing
The AABB has revised its requirements to be equal to or more
stringent than the CLIA requirements at Sec. 493.1100 through Sec.
493.1105. For example, the AABB requires laboratories to retain quality
assessment records for five years, while the CLIA regulations require
laboratories to retain these records for only two years.
Subpart K--Quality System for Nonwaived Testing
The quality control (QC) requirements of the AABB have been
evaluated against the requirements of the CLIA regulations. The AABB
has modified its survey process and made revisions to its standards
encompassing general QC as well as specialty and subspecialty QC
requirements in order to reflect the new QC requirements in the CLIA
regulations. As such, we have determined that the AABB's requirements
are equal to or more stringent than the requirements in the CLIA
regulations. The specific requirements that are more stringent than the
requirements of the CLIA regulations are the following:
The requirement that laboratories meet the AABB's QC
requirements for all waived testing they perform.
The requirement for compliance with standards for
parentage testing.
The AABB's requirement that laboratories that perform
provider-performed microscopy procedures must meet the same
certification requirements as all other laboratories that perform
moderate complexity testing.
Subpart M--Personnel for Nonwaived Testing
The AABB has revised its requirements to equal the CLIA
requirements at Sec. 493.1403 through Sec. 493.1495 for laboratories
that perform moderate and high complexity testing. The AABB personnel
standards provide that the laboratory must meet CLIA requirements for
personnel qualifications. The CLIA requirements for personnel
responsibilities are encompassed in the revisions made to the AABB
standards.
Subpart Q--Inspections
We have determined that the AABB's requirements for inspections are
equal to or more stringent than the requirements of Sec. 493.1771
through Sec. 493.1780 of this subpart.
Subpart R--Enforcement Procedures
The AABB meets the requirements of subpart R to the extent it
applies to accreditation organizations. The 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, the AABB will deny, suspend, or revoke accreditation in a
laboratory accredited by the AABB and report that action to CMS within
30 days. The AABB also provides an appeals process for laboratories
that have had accreditation denied, suspended, or revoked.
We have determined that the AABB's laboratory enforcement and
appeal policies are equal to or more stringent than the requirements of
this part 493 subpart R as they apply to accreditation organizations.
IV. Federal Validation Inspection 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
us or our agent, or the State survey agency, will be our principal
means 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 CMS may rescind the approval of an
accreditation organization, such as that of the AABB, for cause, before
the end of the effective date of approval. If we determine that the
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
one year, to allow the 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.
In accordance with the provisions of Executive Order 12866, the
Office of Management and Budget did not review this notice because our
publication of this notice is not a regulatory action under that
Executive Order.
Authority: Section 353 of the Public Health Service Act (42
U.S.C.263a).
Dated: November 16, 2004.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 04-28152 Filed 12-29-04; 8:45 am]
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