[Federal Register Volume 72, Number 36 (Friday, February 23, 2007)]
[Notices]
[Pages 8173-8174]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-3030]



[[Page 8173]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

[CMS-2218-N]
RIN 0938-ZA99


Medicare, Medicaid, and CLIA Programs; Approval of the Joint 
Commission (Formerly the Joint Commission on Accreditation of 
Healthcare Organizations) as a CLIA Accreditation Organization

AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.

ACTION: Notice.

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SUMMARY: This notice announces CMS' grant of deeming authority to the 
Joint Commission (formerly the Joint Commission on Accreditation of 
Healthcare Organizations) under the Clinical Laboratory Improvement 
Amendments of 1988 (CLIA) program. We have determined that the 
requirements of the Joint Commission accreditation process are equal to 
or more stringent than the CLIA condition level requirements, and that 
the Joint Commission has met the requirements of subpart E of 42 CFR 
part 493. Consequently, laboratories that are voluntarily accredited by 
the Joint Commission and continue to meet the Joint Commission 
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 Federal validation 
and complaint investigation surveys conducted by us or our designee.

DATES: Effective Date: This notice is effective from February 23, 2007 
to February 23, 2012.

FOR FURTHER INFORMATION CONTACT: Kathleen Todd, (410) 786-3385.

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 Laboratories 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 
approves a grant of deeming authority to an 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 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 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.
     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 by inspecting a 
sufficient number 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 the Joint Commission as an Accreditation 
Organization

    In this notice, we approve the Joint Commission as an organization 
that may accredit laboratories for purposes of establishing their 
compliance with CLIA requirements. We have examined the Joint 
Commission 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 the Joint Commission complied with the applicable CLIA 
requirements and grant the Joint Commission deeming authority as an 
accreditation organization under subpart E, for the period stated in 
the ``Effective Date'' section of this notice for all specialty and 
subspecialty areas under CLIA.
    As a result of this determination, any laboratory that is 
accredited by the Joint Commission 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 the Joint Commission Request for Approval as an 
Accreditation Organization Under CLIA

    The following describes the process used to determine that 
requirements of the Joint Commission accreditation program are equal to 
or more stringent than the CLIA condition level requirements, and that 
the Joint Commission has met requirements of subpart E of 42 CFR part 
493.
    The Joint Commission formally reapplied to us for approval as an 
accreditation organization under CLIA for all specialties and 
subspecialties. We evaluated the Joint Commission application to 
determine compliance with our implementing and enforcement regulations, 
and the deeming/exemption requirements of the CLIA rules.
    We verified that the Joint Commission accreditation program 
requirements and methods require the laboratories it accredits to be, 
and that the organization meets or exceeds 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 Joint Commission submitted the 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 us; its removal 
or withdrawal of laboratory accreditation procedures; its current list

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of accredited laboratories; and its announced or unannounced inspection 
process.
    Our evaluation identified Joint Commission requirements pertaining 
to waived testing that are more stringent than the CLIA requirements. 
The Joint Commission waived testing requirements include the following:
     Defining the extent that waived test results are used in 
patient care.
     Identifying the personnel responsible for performing and 
supervising waived testing.
     Assuring that personnel performing waived testing have 
adequate, specific training and orientation to perform the testing and 
can demonstrate satisfactory levels of performance.
     Making certain that policies and procedures governing 
waived testing-related processes are current and readily available.
     Conducting defined quality control checks.
     Maintaining quality control and test records.
    The CLIA requirements at Sec.  493.15 only require that a 
laboratory follow manufacturer's instructions and obtain a certificate 
of waiver.

Subpart H--Participation in Proficiency Testing for Laboratories 
Performing Nonwaived Testing

    The Joint Commission's requirements are equal to the CLIA 
requirements at Sec.  493.801 through Sec.  493.865.

Subpart J--Facility Administration for Nonwaived Testing

    The Joint Commission requirements are equal to the CLIA 
requirements at Sec.  493.1100 through Sec.  493.1105.

Subpart K--Quality System for Nonwaived Testing

    The Joint Commission requirements are equal to or more stringent 
than the CLIA requirements at Sec.  493.1200 through Sec.  493.1299. We 
have determined that Joint Commission's requirements, when taken as a 
whole, are more stringent than the CLIA requirements. For instance, the 
Joint Commission has control procedure requirements for all waived 
complexity testing performed.

Subpart M--Personnel for Nonwaived Testing

    We have determined that the Joint Commission requirements are equal 
to or more stringent than the CLIA requirements at Sec.  493.1403 
through Sec.  493.1495 for laboratories that perform moderate and high 
complexity testing.

Subpart Q--Inspections

    We have determined that the Joint Commission requirements are equal 
to or more stringent than the CLIA requirements at Sec.  493.1771 
through Sec.  493.1780. The Joint Commission will continue to perform 
onsite inspections every 2 years.

Subpart R--Enforcement Procedures

    The Joint Commssion meets the requirements of subpart R to the 
extent that it applies to accreditation organizations. The Joint 
Commission 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 Joint Commission 
will deny, suspend, or, revoke accreditation in a laboratory accredited 
by the Joint Commission and report that action to us within 30 days. 
The Joint Commission also provides an appeal process for laboratories 
that have had accreditation denied, suspended, or revoked.
    We have determined that the Joint Commission's laboratory 
enforcement and appeal policies are equal to or more stringent than 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 Joint Commission 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 agents, or the State survey agencies, will be 
our principal means for verifying that the laboratories accredited by 
the Joint Commission 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 the Joint Commission, for 
cause, before the end of the effective date of approval. If we 
determine that the Joint Commission 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 the Joint Commission 
to adopt comparable requirements.
    Should circumstances result in our withdrawal of the Joint 
Commission'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.

VII. Executive Order 12866 Statement

    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: December 7, 2006.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E7-3030 Filed 2-22-07; 8:45 am]
BILLING CODE 4120-01-P