[Federal Register Volume 69, Number 250 (Thursday, December 30, 2004)]
[Notices]
[Pages 78426-78428]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-28152]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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:
    <bullet> Use inspectors qualified to evaluate laboratory 
performance and agree to inspect laboratories with the frequency 
determined by us.
    <bullet> Apply standards and criteria that are equal to or more 
stringent than those condition-level requirements established by us.
    <bullet> Provide reasonable assurance that its accredited 
laboratories continually meet these standards and criteria.
    <bullet> 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.
    <bullet> Notify us at least 30 days before implementing any 
proposed change in its standards.
    <bullet> 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:
    <bullet> Immunohematology.
    <bullet> General immunology.
    <bullet> Hematology.
    <bullet> Routine chemistry.
    <bullet> 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:
    <bullet> Subpart H, Participation in Proficiency Testing for 
Laboratories Performing Nonwaived Testing.
    <bullet> Subpart J, Facility Administration for Nonwaived Testing.
    <bullet> Subpart K, Quality System for Nonwaived Testing.
    <bullet> Subpart M, Personnel for Nonwaived Testing.
    <bullet> Subpart Q, Inspections.
    <bullet> 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:
    <bullet> The requirement that laboratories meet the AABB's QC 
requirements for all waived testing they perform.
    <bullet> The requirement for compliance with standards for 
parentage testing.
    <bullet> 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]
BILLING CODE 3410-01-P