97-12959. Approval of the Commission on Office Laboratory Accreditation for Immunohematology.  

  • [Federal Register Volume 62, Number 96 (Monday, May 19, 1997)]
    [Notices]
    [Pages 27262-27265]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 97-12959]
    
    
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    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    
    Health Care Financing Administration
    [HSQ-242-N]
    
    
    Approval of the Commission on Office Laboratory Accreditation for 
    Immunohematology.
    
    AGENCY: Health Care Financing Administration (HCFA), HHS.
    
    ACTION: Notice.
    
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    SUMMARY: This notice announces the approval of the Commission on Office 
    Laboratory Accreditation (COLA), which is an accrediting organization 
    for clinical laboratories under the Clinical Laboratory Improvement 
    Amendments (CLIA) program, for the addition of the full specialty of 
    immunohematology. This approval adds immunohematology to the 
    specialties and subspecialties approved by HCFA in a notice published 
    in the Federal Register on December 23, 1993 (58 FR 68148). We have 
    found that the accreditation process of this organization provides 
    reasonable assurance that the laboratories accredited by it for 
    immunohematology meet the conditions required by Federal law and 
    regulations. Consequently, laboratories that voluntarily become 
    accredited by COLA for the specialty of immunohematology in lieu of 
    receiving direct Federal oversight and continue to meet COLA 
    requirements would meet the CLIA immunohematology condition level 
    requirements for laboratories. These laboratories performing 
    immunohematology testing are not subject to routine inspection by State 
    survey agencies to determine their compliance with applicable Federal 
    requirements. They are, however, subject to validation and complaint 
    investigation surveys.
    
    EFFECTIVE DATE: This notice is effective for the period May 19, 1997 
    through November 1, 1997.
    
    FOR FURTHER INFORMATION CONTACT: Valerie Coppola, (410) 786-3354.
    
    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 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 and whether or not it 
    tests specimens in interstate commerce. New section 353 requires HHS to 
    establish certification requirements for any laboratory that performs 
    tests on human specimens and certify through issuance of a certificate 
    that those laboratories meet the certificate requirements established 
    by HHS.
        Section 6141 of the Omnibus Budget Reconciliation Act of 1989, Pub. 
    L. 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 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) that implemented the amendments to 
    section 353 of the PHSA. The technical and scientific portions of these 
    rules were drafted by the Centers for Disease Control and Prevention 
    (CDC) of the Public Health Service (PHS).
        We established regulations 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
    
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    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; and
         Set forth the rules for the enforcement of CLIA 
    requirements on laboratories that are found not to meet Federal 
    requirements.
        On July 31, 1992, we issued additional final rules (57 FR 33992), 
    under authority found in section 353(e)(2) of the PHSA, that establish 
    that we may 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 of 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 
    would meet CLIA condition level requirements if it were inspected 
    against CLIA regulations. The regulations listed in subpart E of part 
    493 specify 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 six 
    years.
        In general, the accreditation organization must--
         Use inspectors qualified to evaluate laboratory 
    performance and agree to inspect laboratories with the frequency 
    determined by HCFA;
         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 HCFA, within 30 days of the event, with the name 
    of any laboratory that has had its accreditation denied, suspended, 
    withdrawn, limited, or revoked;
         Notify HCFA at least 30 days prior to changing its 
    standards; and
         If HCFA withdraws its approval, notify its accredited 
    laboratories of the withdrawal within ten days of the withdrawal.
        A laboratory can be accredited if it meets the standards of an 
    approved accreditation body and authorizes the accreditation body to 
    submit to HCFA records and other information HCFA may require.
        Along with requiring the promulgation of criteria for approving an 
    accreditation body and for withdrawing such approval, CLIA requires 
    HCFA 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 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 nonprofit private 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 COLA as an Accrediting Organization for 
    the Specialty of Immunohematology
    
        In this notice, we approve COLA as an organization that may 
    accredit laboratories for purposes of establishing their compliance 
    with CLIA requirements for the specialty of immunohematology. HCFA and 
    the CDC have examined the COLA application and all subsequent 
    submissions against the requirements under subpart E of part 493 that 
    an accreditation organization must meet in order to be granted approved 
    status under CLIA for immunohematology. We have determined that COLA 
    has complied with the applicable CLIA requirements as of May 19, 1997 
    and grant HCFA approval to COLA as an accreditation organization under 
    this subpart through November 1, 1997, for the specialty of 
    immunohematology.
        As a result of this determination, any laboratory that is 
    accredited by COLA during this time period for the specialty of 
    immunohematology meets the CLIA requirements for 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 performing 
    immunohematology testing, however, is subject to validation and 
    complaint investigation surveys performed by HCFA, or by any other 
    Federal, State or local public agency, or nonprofit private 
    organization which acts in conformance to an agreement with the 
    Secretary.
    
    III. Evaluation of COLA
    
        The following describes the process we used to find that COLA, as a 
    private, nonprofit organization, provides reasonable assurance that 
    those laboratories it accredits for the specialty of immunohematology 
    will meet the applicable requirements of Federal law and regulations.
    
    A. Requirements for Approving an Accreditation Organization Under CLIA
    
        To determine whether we should grant approval to COLA as a private, 
    nonprofit organization for accrediting laboratories under CLIA for the 
    immunohematology specialty of human specimen testing it requested, we 
    conducted a detailed and in-depth comparison of COLA's requirements for 
    its laboratories to those of CLIA. We evaluated whether COLA's 
    standards are at least as stringent as the applicable requirements of 
    42 CFR part 493 when taken as a whole. In summary, we evaluated whether 
    COLA--
         Provides reasonable assurance to us that it requires the 
    laboratories it accredits to meet requirements that are equal to or 
    more stringent than the CLIA condition level requirements for the 
    requested specialty and would, therefore, meet the condition level 
    requirements of CLIA if those laboratories had not been granted deemed 
    status and had been inspected against condition level requirements; and
         Meets the requirements of Sec. 493.506, which specifies 
    the Federal review and approval requirements of private, nonprofit 
    accreditation organizations.
        As specified in the regulations at Sec. 493.506, our review of a 
    private, nonprofit accreditation organization seeking approved status 
    under CLIA includes, but is not limited to, an evaluation of--
         Whether the organization's requirements for 
    immunohematology for its accredited laboratories are equal to or more 
    stringent than the applicable condition level requirements of the CLIA 
    regulations;
    
         The organization's inspection process to determine:
    --The composition of the inspection teams, qualifications of the 
    inspectors, and the ability of the organization to provide continuing 
    education and training to all of its inspectors;
    --The comparability of the organization's full inspection and complaint 
    inspection requirements to those of HCFA, including, but not limited 
    to, inspection frequency, and the ability to investigate and respond to 
    complaints against its accredited laboratories;
    --The organization's procedures for monitoring laboratories that it has
    
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    found to be out of compliance with its requirements;
    --The ability of the organization to provide HCFA with electronic data 
    and reports that are necessary for effective validation and assessment 
    of the organization's inspection process;
    --The ability of the organization to provide HCFA with electronic data, 
    related to the adverse actions resulting from unsuccessful proficiency 
    testing (PT) participation in HHS approved PT programs, as well as data 
    related to the PT failures, within 30 days of the initiation of the 
    action;
    --The ability of the organization to provide HCFA with electronic data 
    for all its accredited laboratories;
    --The adequacy of numbers of staff and other resources; and
    --The organization's ability to provide adequate funding for performing 
    the required inspections.
    
     The organization's agreement with HCFA that requires it to--
    
    --Notify HCFA of any laboratory that has had its accreditation denied, 
    limited, suspended, withdrawn, or revoked by the accreditation 
    organization, or that has had any other adverse action taken against it 
    by the accreditation organization within 30 days of the action taken;
    --Notify HCFA within ten days of a deficiency identified in an 
    accredited laboratory where the deficiency poses an immediate jeopardy 
    to the laboratory's patients or a hazard to the general public;
    --Notify HCFA of all newly accredited laboratories, or laboratories 
    whose areas of specialty or subspecialty are revised, within 30 days;
    --Notify each laboratory accredited by the organization within ten days 
    of HCFA's withdrawal of recognition of the organization's deeming 
    authority;
    --Provide HCFA with inspection schedules, as requested, for the purpose 
    of conducting onsite validation inspections;
    --Provide HCFA, the State survey agency, or other HCFA agent with any 
    facility-specific data that includes, but is not limited to, PT results 
    that constitute unsuccessful participation in an approved PT program 
    and notification of the adverse actions or corrective actions imposed 
    by the accreditation organization as a result of unsuccessful PT 
    participation;
    --Provide HCFA with written notification at least 30 days in advance of 
    the effective date of any proposed changes in its requirements; and
    --Make available, on a reasonable basis, any laboratory's PT results 
    upon request by any person, with such explanatory information needed to 
    assist in the interpretation of the results.
    
         Laboratories that are accredited by an accreditation 
    organization must--
    
    --Authorize the organization to release to HCFA all records and 
    information required by HCFA as required by Sec. 493.501;
    --Permit inspections as required by the CLIA regulations at part 493, 
    subpart Q;
    --Obtain a certificate of accreditation as required by Sec. 493.632; 
    and
    --Pay the applicable fees as required by Secs. 493.638 and 493.645.
    
    B. Evaluation of the COLA Request for Approval
    
        COLA has formally applied to HCFA for approval as an accreditation 
    organization for the specialty of immunohematology which would be an 
    addition to the specialties and subspecialties approved by HCFA in a 
    notice published in the Federal Register on December 23, 1993 (58 FR 
    68148). We have evaluated the COLA application to determine equivalency 
    with our implementing 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 
    42 CFR part 493 as explained below:
    
    Subpart E--Accreditation by a Private, Nonprofit Accreditation 
    Organization or Exemption Under an Approved State Laboratory Program
    
        COLA has submitted a request for HCFA approval for the specialty of 
    immunohematology to be added to the specialties and subspecialties for 
    which it received approval in December, 1993. COLA had previously 
    submitted a comparison of individual accreditation and condition level 
    requirements, a description of its inspection process, PT monitoring 
    process, and its data management and analysis system. In addition, it 
    had submitted 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. We have determined that COLA 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 for the additional specialty.
    
    Subpart H--Participation in Proficiency Testing for Laboratories 
    Performing Tests of Moderate or High Complexity, or Both
    
        COLA's requirements for PT are equal to those of CLIA. All of 
    COLA's accredited laboratories are required to participate in a HCFA 
    approved PT program for all tests that are not waived. CLIA, however, 
    requires laboratories that perform any of the tests listed in subpart I 
    to participate in a HCFA approved PT program for those tests only, 
    rather than all of the tests they may perform. COLA also encourages its 
    accredited laboratories to participate in PT for tests that are waived 
    under CLIA.
    
    Subpart J--Patient Test Management for Moderate or High Complexity 
    Testing, or Both
    
        COLA requirements are equal to the CLIA requirements at 
    Secs. 493.1101 through 493.1111 on an overall basis for the specialty 
    of immunohematology.
    
    Subpart K--Quality Control for Tests of Moderate or High 
    Complexity, or Both
    
        The quality control requirements of COLA have been evaluated 
    against the applicable requirements of the CLIA regulations for 
    immunohematology. We have determined that COLA's requirements, when 
    taken as a whole, are equal to or more stringent than the CLIA 
    requirements. The specific areas that are more stringent are--
         Safety requirements for moderate and high complexity 
    testing;
         Calibration/recalibration requirements for moderate 
    complexity testing;
         A requirement that the laboratory director sign, review, 
    and approve the procedure manual annually; and
         The use of a negative control for ABO antisera is 
    required.
        COLA recognizes the categorization of tests for quality control 
    purposes.
    
    Subpart M--Personnel for Moderate and High Complexity Testing
    
        COLA states, as general policy under its personnel standards, that 
    the laboratory director and laboratory personnel must meet all Federal 
    and State educational and experience requirements necessary to perform 
    their assigned tasks. It has adopted the Federal personnel requirements 
    for education, training, and experience, and recognizes the various 
    positions and the responsibilities of each of the positions cited in 
    the CLIA regulations.
    
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        All COLA accredited laboratories are currently required to meet 
    these CLIA standards. We have, therefore, found the COLA personnel 
    requirements to be equal to the CLIA personnel requirements.
    
    Subpart P--Quality Assurance for Moderate or High Complexity 
    Testing or Both
    
        We have determined that COLA's requirements for immunohematology 
    are equal to the CLIA requirements of this subpart. COLA also makes 
    educational materials available to its accredited laboratories, which 
    provide further information on quality assurance in the office 
    laboratory.
    
    Subpart Q--Inspections
    
        The COLA inspection process, which is announced and performed on-
    site on a biennial basis, is equal to the applicable CLIA requirements 
    at Secs. 493.1777. Therefore, we have determined that COLA's 
    requirements are equal to the requirements of this subpart.
    
    Subpart R--Enforcement Procedures for Laboratories
    
        COLA meets the requirements of subpart R to the extent it applies 
    to accreditation organizations. COLA policy stipulates the action it 
    takes when laboratories it accredits do not comply with its essential 
    standards pertaining to immunohematology. When appropriate, COLA will 
    deny accreditation to a laboratory and report the denial to HCFA within 
    30 days. COLA also provides an appeals process for laboratories that 
    have had accreditation denied.
        We have determined that COLA's laboratory enforcement and appeal 
    policies are essentially equivalent to the requirements of this subpart 
    as they apply to accreditation organizations.
    
    IV. Federal Validation Inspections and Continuing Oversight
    
        The Federal validation inspections of COLA accredited laboratories, 
    as specified in Sec. 493.507, may be conducted on a representative 
    sample basis or in response to substantial allegations of 
    noncompliance, ``complaint inspections''. The outcome of those 
    validation inspections, performed by HCFA, the State survey agency, or 
    a HCFA agent, will be HCFA's principal means for verifying that the 
    laboratories accredited by COLA remain in compliance with CLIA 
    requirements. This Federal monitoring is an on-going process.
    
    V. Removal of Approval as an Accrediting Organization
    
        Our regulations at Sec. 493.511 provide that the approval of an 
    accreditation organization, such as that of COLA, may be removed by 
    HCFA for cause, prior to the end of the effective date of approval. If 
    validation inspection outcomes and the comparability or validation 
    review produce findings as described at Sec. 493.509(a), HCFA will 
    conduct a review of the accreditation organization's program. A review 
    is also conducted when the validation review findings, irrespective of 
    the rate of disparity (as defined in Sec. 493.2), indicate widespread 
    or systematic problems in the organization's processes. These findings 
    provide evidence that the organization's requirements are no longer 
    equivalent to the CLIA requirements.
        If it is determined that COLA has failed to adopt requirements that 
    are equal to or more stringent than the CLIA requirements, or 
    widespread systemic problems exist in its inspection process, a 
    probationary period, not to exceed one year, may be given to allow COLA 
    to adopt comparable requirements. Based on an evaluation of any of the 
    items stipulated at Sec. 493.511(d), a determination will be made as to 
    whether or not COLA retains its approved status as an accreditation 
    organization under CLIA. If approved status is denied, an accreditation 
    organization such as COLA may resubmit its application when it: (1) Has 
    revised its program to address the rationale for the denial; (2) 
    demonstrated that it can reasonably assure that its accredited 
    laboratories meet CLIA condition level requirements; and (3) resubmits 
    its application for approval as an accreditation organization in its 
    entirety. If, however, an accrediting organization requests 
    reconsideration of an adverse determination in accordance with subpart 
    D of part 488 of our regulations, it may not submit a new application 
    until a final reconsideration determination is issued.
        Should circumstances result in COLA having its approval withdrawn, 
    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: March 16, 1997.
    Bruce C. Vladeck,
    Administrator, Health Care Financing Administration.
    [FR Doc. 97-12959 Filed 5-16-97; 8:45 am]
    BILLING CODE 4120-03-P
    
    
    

Document Information

Effective Date:
5/19/1997
Published:
05/19/1997
Department:
Health Care Finance Administration
Entry Type:
Notice
Action:
Notice.
Document Number:
97-12959
Dates:
This notice is effective for the period May 19, 1997 through November 1, 1997.
Pages:
27262-27265 (4 pages)
Docket Numbers:
HSQ-242-N
PDF File:
97-12959.pdf