[Federal Register Volume 60, Number 140 (Friday, July 21, 1995)]
[Notices]
[Pages 37660-37662]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-17981]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[HSQ-228-N]
CLIA Program; Approval of the American Association of Blood Banks
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Notice.
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SUMMARY: This notice announces the approval of the American Association
of Blood Banks (AABB) as an accrediting organization for clinical
laboratories under the Clinical Laboratory Improvement Amendments
(CLIA) program. We have found 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 HHS or
its designee.
EFFECTIVE DATE: This notice is effective for the period July 21, 1995
through July 21, 1997.
FOR FURTHER INFORMATION CONTACT: Tracey Mummert, (410) 597-5906.
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 of the Public Health Service Act
(PHSA), as enacted by the Clinical Laboratories Improvement Act of
1967, and made every laboratory in the United States and its
territories that tests human specimens for health reasons subject to
the requirements established by HHS and Federal regulation whether or
not it participates in the Medicare or Medicaid program. New section
353 requires HHS to establish requirements for any laboratory that
performs tests on human specimens and certify, through issuance of a
certificate, that those laboratories meet the requirements established
by HHS.
Section 6141 of the Omnibus Budget Reconciliation Act of 1989,
Public Law 101-239, amended the Social Security Act (the Act) to
require that laboratories participating in the Medicare program meet
the certificate requirements of section 353 of the PHSA. Subject to
specified exceptions, laboratories must have a current unrevoked and
unsuspended certificate to be eligible for reimbursement in the
Medicare or Medicaid programs, or both. Laboratories that are
accredited by an accreditation organization approved under section
353(e) of the PHSA will automatically be eligible for Medicare and
Medicaid participation as long as they meet applicable State
requirements.
On February 28, 1992, we published several final rules in the
Federal Register (57 FR 7002-7243) that implemented the amendments to
section 353 of the PHSA. Specifically, regulations were established at
42 CFR part 493 that:
Require laboratories to pay fees for issuance of
registration certificates, certificates of waiver, certificates of
accreditation, or other applicable certificates and to fund activities
to determine compliance with our performance requirements.
Specify the performance requirements that apply to
laboratories subject to CLIA and list requirements for laboratories
performing certain limited testing to be eligible for a certificate of
waiver.
Set rules for the enforcement of CLIA requirements on
laboratories that are found not to meet Federal requirements.
On July 31, 1992, we issued final rules (57 FR 33992), under
authority in section 353(e)(2) of the PHSA, that permit us to approve a
private, nonprofit organization as an accreditation organization for
clinical laboratories under the CLIA program if that organization's
requirements for its accredited laboratories are equal to, or more
stringent than, the applicable CLIA program requirements established at
part 493 of our regulations. Therefore, a laboratory accredited by an
approved organization that meets and continues to meet all of the
accreditation organization's requirements is deemed to meet CLIA
condition level requirements. Subpart E of part 493 specifies the
requirements an accreditation organization must meet in order to be
approved. We may approve an accreditation organization under
Sec. 493.501(d) of our regulations for a period not to exceed 6 years.
In general, the accreditation organization must:
Use inspectors qualified to evaluate laboratory
performance and agree to inspect laboratories with the frequency
determined by HHS;
Apply standards and criteria that are equal to, or more
stringent than, those condition level requirements established by HHS
when taken as a whole;
Provide reasonable assurance that these standards and
criteria are continually met by its accredited laboratories;
Provide HHS, within 30 days, with the name of any
laboratory that has had its accreditation denied, suspended, withdrawn,
limited, or revoked;
Notify HHS at least 30 days prior to changing its
standards; and
If HHS withdraws its approval, notify its accredited
laboratories of the withdrawal within 10 days of the withdrawal.
Along with requiring the promulgation of criteria for approving an
accreditation body and for withdrawing such approval, CLIA requires HHS
to annually evaluate the performance of an approved accreditation body
for compliance with the CLIA requirements by inspecting a sufficient
number of laboratories accredited by the organization as well as by any
other means that HCFA determines appropriate. Under section 353(o) of
the PHSA, the Secretary may, by agreement, use the services or
facilities of any other Federal, State or local public agency, or any
private, nonprofit organization to conduct inspections of laboratories
performing clinical testing on human specimens in the United States and
its territories for the purpose of determining compliance with CLIA
requirements.
II. Notice of Approval of AABB as an Accrediting Organization
In this notice, we approve the AABB as an organization that may
accredit laboratories for purposes of establishing their compliance
with CLIA requirements for the following specialty/subspecialty areas:
Immunohematology
Diagnostic Immunology
Hematology
Histocompatibility
Routine Chemistry
Toxicology
As a result of this determination, any laboratory that is
accredited by AABB during the effective time period for an approved
specialty/subspecialty is deemed to meet the CLIA requirements
[[Page 37661]]
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 HCFA, or by
any other Federal or State or local public agency or nonprofit private
organization which acts in conformance to an agreement with the
Secretary.
III. Evaluation of the AABB Request for Approval as an Accreditation
Organization under CLIA
The AABB formally applied to HCFA for approval as an accreditation
organization under CLIA for the specialties of immunohematology,
histocompatibility, hematology, diagnostic immunology and the
subspecialties of routine chemistry and toxicology. We evaluated the
AABB application to determine equivalency with our implementing and
enforcement regulations, and the deeming/exemption requirements of the
CLIA rules. 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, and 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 HCFA, 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, the AABB requires that there
be appropriately qualified personnel, that is, director, supervisor,
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.
We have determined that the AABB has complied with the general
requirements under Sec. 493.501, the applicable parts of Sec. 493.506,
and the CLIA requirements for approval as an accreditation organization
under various subparts of part 493.
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Tests of Moderate or High Complexity, or Both
The AABB requires that its accredited laboratories performing
histocompatibility testing participate in a local, State, or national
PT program or cell exchange for all tests. The CLIA regulations do not
require laboratories that perform histocompatibility testing to
participate in a HCFA-approved PT program. Apart from this more
stringent requirement for PT, the AABB has revised its requirements to
be equivalent to the CLIA requirements at Secs. 493.801 through 493.865
on an overall basis.
Subpart J--Patient Test Management for Moderate or High Complexity
Testing, or Both
The AABB has revised its requirements to be equivalent to the CLIA
requirements at Secs. 493.1101 through 493.1111 on an overall basis.
Subpart K--Quality Control for Tests of Moderate or High Complexity, or
Both
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 requirements as well as specialty and
subspecialty QC in order to address some of the more general QC
requirements of CLIA. As such, we have determined that the AABB's
requirements, when taken as a whole, are equal to or more stringent
than the CLIA requirements. The specific areas of QC that are more
stringent are:
The requirement that laboratories meet the AABB's QC
requirements for all waived testing they perform;
The requirement that laboratories maintain
histocompatibility records for 5 years;
The requirement for compliance with standards for
parentage testing;
The application of all requirements for moderate
complexity testing to testing categorized as provider-performed
microscopy procedures, as of April 25, 1995.
Subpart M--Personnel for Moderate and High Complexity Testing
The AABB has revised its requirements to equal the CLIA
requirements at Secs. 493.1403 through 493.1495 on an overall basis.
The AABB states, as general policy under its personnel standards, 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 P--Quality Assurance for Moderate or High Complexity Testing or
Both
The AABB has revised its requirements to be equivalent to the CLIA
requirements at Secs. 493.1701 through 493.1721 on an overall basis.
One specific area of quality assurance that is more stringent is the
requirement that laboratories maintain quality assurance records for 5
years.
Subpart Q--Inspections
We have determined that the AABB's requirements for inspections are
at least equivalent to the requirements of Secs. 493.1775 through
493.1780 of this subpart.
Subpart R--Enforcement Procedures for Laboratories
The AABB meets the requirements of subpart R to the extent it
applies to accreditation organizations. The AABB policy stipulates the
action it 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 using
the AABB accreditation to meet the CLIA requirements and report that
action to HCFA within 30 days. The AABB also provides an appeals
process for laboratories that have had accreditation denied, suspended
or revoked.
Some specific actions the AABB takes in response to non-compliance
or violation of its requirements or standards for accreditation
include:
When the AABB determines that a serious risk of harm
(immediate jeopardy) exists in an AABB-accredited laboratory, the
laboratory must immediately correct the problem that poses the risk.
Failure to do so will result in a recommendation to the AABB area
chairman to suspend or revoke that facility's accreditation. In
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addition, the AABB will notify HCFA within 10 days of this
determination.
When an AABB laboratory is unsuccessful in PT
participation for a Federally-required analyte, subspecialty, and/or
specialty, the laboratory will be contacted by the AABB and required to
initiate corrective actions. Failure to submit an acceptable plan of
remedial action to correct the problem may result in a focused, onsite
survey or limitation of the laboratory's scope of accreditation for the
particular analyte, specialty, and/or subspecialty. As applicable, to
regain accreditation, the laboratory must provide the AABB with
evidence that it has successfully participated in two consecutive PT
events.
We have determined that the AABB's laboratory enforcement and
appeal policies are essentially equivalent to the requirements of this
part 493 subpart R as they apply to accreditation organizations.
IV. Federal Validation Inspections and Continuing Oversight
The Federal validation inspections and continuing oversight of the
AABB accredited laboratories will be conducted based on the regulations
at Secs. 493.507 and 493.509.
V. Removal of Approval as an Accrediting Organization
Our regulations at Sec. 493.511 provide that we may rescind the
approval of an accreditation organization, such as that of the AABB,
for cause, prior to 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, 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: June 29, 1995
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 95-17981 Filed 7-20-95; 8:45 am]
BILLING CODE 4120-01-P
