96-14969. Medicare, Medicaid, and CLIA Programs; Clinical Laboratory Improvement Amendments of 1988 Exemption of Laboratories in the State of Oregon  

  • [Federal Register Volume 61, Number 115 (Thursday, June 13, 1996)]
    [Notices]
    [Pages 30072-30075]
    From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
    [FR Doc No: 96-14969]
    
    
    
    -----------------------------------------------------------------------
    
    DEPARTMENT OF HEALTH AND HUMAN SERVICES
    [HSQ-231-N]
    
    
    Medicare, Medicaid, and CLIA Programs; Clinical Laboratory 
    Improvement Amendments of 1988 Exemption of Laboratories in the State 
    of Oregon
    
    AGENCY: Health Care Financing Administration (HCFA), HHS.
    
    ACTION: Notice.
    
    -----------------------------------------------------------------------
    
    SUMMARY: Section 353(p) of the Public Health Service Act provides for 
    the exemption of laboratories from the requirements of the Clinical 
    Laboratory Improvement Amendments of 1988 (CLIA) when the State in 
    which they are located has requirements equal to or more stringent than 
    those of CLIA. This
    
    [[Page 30073]]
    
    notice grants exemption from CLIA requirements and is applicable only 
    to laboratories located within the State of Oregon that possess a valid 
    State license.
    
    EFFECTIVE DATE: The provisions of this notice are effective on June 13, 
    1996, through December 31, 1999.
    
    FOR FURTHER INFORMATION CALL: Val Coppola, (410) 786-3354.
    
    SUPPLEMENTARY INFORMATION:
    
    I. Background and Legislative Authority
    
        Section 353 of the Public Health Service Act, as amended by the 
    Clinical Laboratory Improvement Amendments of 1988 (CLIA), requires any 
    laboratory that performs tests on human specimens to meet the 
    requirements established by the Department of Health and Human 
    Services. Under the provisions of the sentence following section 
    1861(s)(14) and paragraph (s)(16) of the Social Security Act, any 
    laboratory that also requests to be paid for services furnished to 
    Medicare beneficiaries must meet the requirements of section 353 of the 
    Public Health Service Act. Subject to specified exceptions, 
    laboratories must have a current and valid CLIA certificate to test 
    human specimens to be eligible for payment from the Medicare or 
    Medicaid program. Regulations implementing section 353 of the Public 
    Health Service Act are contained in 42 CFR part 493, Laboratory 
    Requirements.
        Section 353(p) of the Public Health Service Act provides for the 
    exemption of laboratories from CLIA requirements in a State that 
    applies requirements that are equal to or more stringent than those of 
    CLIA. The statute does not specifically require the promulgation of 
    criteria for the exemption of laboratories in a State. The decision to 
    grant CLIA exemption to laboratories within a State is at HCFA's 
    discretion, acting on behalf of the Secretary of Health and Human 
    Services.
        Part 493, subpart E, Accreditation by a Private, Nonprofit 
    Accreditation Organization or Exemption Under an Approved State 
    Laboratory Program implements section 353(p) of the Public Health 
    Service Act. Section 493.513 provides that we may exempt from CLIA 
    requirements, for a period not to exceed 6 years, State licensed or 
    approved laboratories in a State if the State meets specified 
    conditions. Section 493.513(k) provides that we will publish a notice 
    in the Federal Register announcing the names and basis for exemption of 
    States whose laboratories are exempt from meeting the requirements of 
    part 493.
    
    II. Notice of Approval of CLIA Exemption to Laboratories in the 
    State of Oregon
    
        In this notice, we grant CLIA exemption for all specialties and 
    subspecialties to all laboratories located in the State of Oregon that 
    possess a valid license to perform laboratory testing effective June 
    13, 1996, through December 31, 1999.
    
    III. Evaluation of The Oregon State Laboratory Program
    
        The following describes the process we used to determine whether we 
    should grant exemption from CLIA requirements to licensed Oregon 
    laboratories.
    
    A. Requirements for Granting CLIA Exemption
    
        To determine whether we should grant a CLIA exemption to all 
    laboratories within the State of Oregon, we conducted a detailed and 
    indepth comparison of Oregon State's requirements for its laboratories 
    to those of CLIA and evaluated whether Oregon State's standards meet 
    the requirements at Sec. 493.513. In summary, we evaluated whether the 
    State of Oregon--
         Has laws in effect that provide for requirements that are 
    equal to or more stringent than CLIA requirements;
         Has an agency that licenses or approves laboratories 
    meeting State requirements that also meet or exceed CLIA requirements, 
    and would, therefore, meet the condition level requirements of the CLIA 
    regulations;
         Demonstrates that it has enforcement authority and 
    administrative structures and resources adequate to enforce its 
    laboratory requirements;
         Permits us or our agents to inspect laboratories within 
    the State;
         Requires laboratories within the State to submit to 
    inspections by us or our agents as a condition of licensure;
         Agrees to pay the cost of the validation program 
    administered by us and the cost of the State's pro rata share of the 
    general overhead to develop and implement CLIA as specified in 
    Secs. 493.645(a) Fee(s) applicable to accredited laboratories/approved 
    State licensure programs and 493.646(b) Payment of fees; and
         Takes appropriate enforcement action against laboratories 
    found by us or our agents not to be in compliance with requirements 
    comparable to condition level requirements.
        We also evaluated whether the State of Oregon laboratory program 
    meets the requirements and licenses laboratories in accordance with 
    Sec. 493.515, Federal review of laboratory requirements of State 
    laboratory programs.
        As specified in Sec. 493.515, our review of a State laboratory 
    program includes (but is not necessarily limited to) an evaluation of--
         Whether the State's requirements for laboratories are 
    equivalent to or more stringent than the CLIA condition level 
    requirements;
         The State's inspection process requirements to determine--
    
    --The comparability of the full inspection and complaint inspection 
    procedures to our procedures;
    --The State's enforcement procedures for laboratories found to be out 
    of compliance with its requirements; and
    --The ability of the State to provide us with electronic data and 
    reports with the adverse or corrective actions resulting from 
    proficiency testing results that constitute unsuccessful participation 
    in HCFA-approved proficiency testing programs and with other data we 
    determine to be necessary for validation and assessment of the State's 
    inspection process requirements;
    
         The State's agreement to--
    
    --Notify us within 30 days of the action taken against any CLIA-exempt 
    laboratory that has had its licensure or approval withdrawn or revoked 
    or been in any way sanctioned;
    --Notify us within 10 days of any deficiency identified in a CLIA-
    exempt laboratory in cases when the deficiency poses an immediate 
    jeopardy to the laboratory's patients or a hazard to the general 
    public;
    --Notify each laboratory licensed by the State within 10 days of our 
    withdrawal of the exemption;
    --Provide us with written notification of any changes in its licensure 
    (or approval) and inspection requirements;
    --Disclose any laboratory's proficiency testing results in accordance 
    with the State's confidentiality requirements;
    --Take the appropriate enforcement action against laboratories we find 
    not to be in compliance with requirements comparable to condition level 
    requirements and report these enforcement actions to us;
    --Notify us of all newly licensed laboratories, including the 
    specialties and subspecialties for which any laboratory performs 
    testing, within 30 days; and
    --Provide to us, as requested, inspection schedules for validation 
    purposes.
    
    [[Page 30074]]
    
    B. Evaluation of the Oregon State Request for CLIA Exemption
    
        The State of Oregon has formally applied to us for an exemption 
    from the CLIA requirements for laboratories located within the State 
    that possess a valid State license.
        We have evaluated the Oregon State's CLIA exemption application and 
    all subsequent submissions for equivalency against the three major 
    categories of CLIA rules: The implementing regulations, the enforcement 
    regulations, and the deeming/exemption requirements. The statutory 
    requirements pertaining to laboratories in Oregon are found at Chapter 
    438, Clinical Laboratories, in the Oregon Revised Statutes. We found 
    the Laboratory Licensing Section of the Center for Public Health 
    Laboratories, which issues, implements, and enforces regulations 
    specified in the Oregon Administrative Rule, Division 24, Chapter 333, 
    to administer a program that is equal to the CLIA program, taken as a 
    whole. We performed an indepth evaluation of the Oregon application to 
    verify the State's assurance of compliance with the following subparts 
    of part 493.
    
    Subpart E, Accreditation by a Private, Nonprofit Accreditation 
    Organization or Exemption Under an Approved State Laboratory 
    Program
    
        HCFA and the Centers for Disease Control and Prevention staff 
    reviewers have examined the Oregon State application and all subsequent 
    submissions against the exemption requirements that a State must meet 
    in order to be granted CLIA-exempt status (Sec. 493.513 and the 
    applicable parts of Secs. 493.515, 493.517, 493.519, and 493.521, which 
    concern General requirements for CLIA-exempt laboratories; Federal 
    review of laboratory requirements of State laboratory programs; 
    Validation inspections of CLIA-exempt laboratories; Continuing Federal 
    oversight of an approved State laboratory program; and Removal of CLIA 
    exemption and final determinations review). The State has complied with 
    the applicable CLIA requirements for exemption under this subpart.
    
    Subpart H, Participation in Proficiency Testing for Laboratories 
    Performing Tests of Moderate Complexity (Including the 
    Subcategory), High Complexity, or Any Combination of These Tests
    
        The Oregon Administrative Rule requires licensed laboratories 
    within Oregon to enroll and participate in a HCFA-approved proficiency 
    testing program for all tests listed in Subpart I of the CLIA 
    regulations. Oregon has adopted the requirements of Subpart H, 
    Participation in proficiency testing for laboratories performing tests 
    of moderate complexity (including the subcategory), high complexity, or 
    any combination of these tests.
        Therefore, the proficiency testing requirements of Oregon are 
    equivalent to those of CLIA.
    
    Subpart J, Patient Test Management for Moderate Complexity 
    (Including the Subcategory), High Complexity, or Any Combination of 
    These Tests
    
        Oregon has modified its requirements for patient test management to 
    be equal to those of the CLIA regulations.
    
    Subpart K, Quality Control for Tests of Moderate Complexity 
    (Including the Subcategory), High Complexity, or Any Combination of 
    These Tests
    
        The Oregon Administrative Rule recognizes the CLIA categorization 
    of tests and stipulates quality control requirements for moderate 
    complexity (including the subcategory of provider performed 
    microscopy), and high complexity tests that are equivalent to the 
    respective CLIA requirements, taken as a whole.
    
    Subpart M, Personnel for Moderate Complexity (Including the 
    Subcategory) and High Complexity Testing
    
        The personnel requirements of the Oregon Administrative Rule are 
    equivalent to those of CLIA for all levels of testing complexity.
    
    Subpart P, Quality Assurance for Moderate Complexity (Including the 
    Subcategory) or High Complexity Testing, or Any Combination of 
    These Tests
    
        The applicable standards of the Oregon Administrative Rule are 
    equal to the CLIA requirements at Secs. 493.1701 through 493.1721, 
    which address quality assurance.
    
    Subpart Q, Inspection
    
        Oregon laboratories that possess a license for moderate or high 
    complexity testing are routinely inspected on-site, biennially. Routine 
    inspections are usually announced. All complaint inspections are 
    unannounced. The Oregon State Laboratory Licensing Section implements 
    inspection requirements and policies that are equal to those of CLIA.
    
    Subpart R, Enforcement Procedures
    
        We have reviewed documentation of Oregon State's enforcement 
    authority, its administrative structure and the resources used to 
    enforce its standards. The State appropriately applies limitations and 
    revocations of its licenses for laboratories as well as other 
    categories of penalties. Dependent upon probable circumstances, Oregon 
    may impose a directed plan of correction, it may refuse to issue a 
    license or permit, or, if necessary, it could initiate criminal 
    penalties.
        The State of Oregon has provided us with the mechanism it currently 
    uses to monitor the proficiency testing performance of its 
    laboratories. The initial action taken by Oregon State for unsuccessful 
    proficiency testing performance requires the laboratory to determine 
    the cause of the failure, document corrective actions and provide an 
    assurance that patient testing is correctly performed. If no response 
    or an inadequate response is received, procedures to remove the 
    analyte, subspecialty, or specialty from the laboratory's license will 
    be initiated. The State may perform an on-site inspection due to 
    unsuccessful proficiency testing performance.
        The State of Oregon has provided appropriate documentation 
    demonstrating that its enforcement policies and procedures are 
    equivalent to those of CLIA.
    
    IV. Federal Validation Inspections and Continuing Oversight
    
        The Federal validation inspections of CLIA-exempt laboratories, as 
    specified in Sec. 493.517, will be conducted on a representative sample 
    basis as well as in response to substantial allegations of 
    noncompliance (complaint inspections). The outcome of those validation 
    inspections will be our principal means for verifying the 
    appropriateness of the exemption given to laboratories in Oregon. This 
    Federal monitoring is an on-going process. The State of Oregon will 
    provide us with survey findings for each laboratory selected for 
    validation.
    
    [[Page 30075]]
    
    V. Removal of Approval of Oregon State Exemption
    
        We will remove the CLIA exemption of laboratories located in the 
    State of Oregon that possess a valid license if we determine the 
    outcome and comparability review of validation inspections are not 
    acceptable as described under Sec. 493.521 or if the State fails to pay 
    the required fee as stated under Sec. 493.645(a).
    
    VI. Laboratory Data
    
        In accordance with Sec. 493.513(d)(2)(iii), Oregon State will 
    provide us with changes to a laboratory's specialties or subspecialties 
    based on the State's survey and with changes in a laboratory's 
    licensure status.
    
    VII. Required Administrative Actions
    
        CLIA is a user-fee funded program. The registration fee paid by the 
    laboratories is used to cover the cost of the development and 
    administration of the program. However, when a State's application for 
    exemption is approved, we may not charge a fee to laboratories in the 
    State that are covered by the exemption. The State's share of the costs 
    associated with CLIA must be collected from the State. Section 493.645 
    specifies that Health and Human Services assesses fees that a State 
    must pay for the following:
         Costs of Federal inspection of laboratories in the State 
    to verify that standards are enforced in an appropriate manner. The 
    average cost per validation survey nationally is multiplied by the 
    number of surveys that will be conducted.
         Costs incurred for Federal investigations and surveys 
    triggered by complaints that are substantiated. We bill the State for 
    these costs. We anticipate that most of these surveys will be referred 
    to the State and that there will be little Federal activity in this 
    area.
         The State's proportionate share of general overhead costs 
    for the items and services it benefits from and only for those paid for 
    out of registration or certificate fees we collected.
        In order to estimate Oregon State's proportionate share of the 
    general overhead costs, we determined the ratio of laboratories in 
    Oregon State to the total number of laboratories nationally. In that 
    the general overhead costs apply equally to all laboratories, we 
    determined the cumulative overhead costs that should be assumed by the 
    State of Oregon.
        The State of Oregon has agreed to pay us its pro rata share of the 
    overhead costs and anticipated costs of actual validation and complaint 
    investigation surveys. A final reconciliation for all laboratories and 
    all expenses will be made. We will reimburse the State for any 
    overpayment or bill it for any balance.
        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: May 13, 1996.
    Bruce C. Vladeck,
    Administrator, Health Care Financing Administration.
    [FR Doc. 96-14969 Filed 6-12-96; 8:45 am]
    BILLING CODE 4120-01-P
    
    

Document Information

Effective Date:
6/13/1996
Published:
06/13/1996
Department:
Health and Human Services Department
Entry Type:
Notice
Action:
Notice.
Document Number:
96-14969
Dates:
The provisions of this notice are effective on June 13, 1996, through December 31, 1999.
Pages:
30072-30075 (4 pages)
Docket Numbers:
HSQ-231-N
PDF File:
96-14969.pdf