[Federal Register Volume 63, Number 68 (Thursday, April 9, 1998)]
[Notices]
[Pages 17429-17431]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-9263]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration
[HCFA-2246-N]


Medicare, Medicaid, and CLIA Programs; Clinical Laboratory 
Improvement Amendments of 1988 Continuance of Approval as an 
Accrediting Organization: the Joint Commission on Accreditation of 
Healthcare Organizations, the American Association of Blood Banks, and 
the American Osteopathic Association

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Notice.

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SUMMARY: This notice announces the continued approval of accrediting 
organizations for clinical laboratories under the Clinical Laboratory 
Improvement Amendments (CLIA) program for the following organizations: 
The Joint Commission on Accreditation of Healthcare Organizations 
(JCAHO), the American Association of Blood Banks (AABB), and the 
American Osteopathic Association (AOA). This represents a continuation 
of the initial exemptions published in the Federal Register on--
     January 3, 1995 (60 FR 130)--JCAHO.
     July 21, 1995 (60 FR 37660)--AABB.
     July 21, 1995 (60 FR 37657)--AOA.
    We have found that the accreditation process of these organizations 
provides reasonable assurance that the laboratories accredited by them 
meet the conditions required by Federal law and regulations. 
Consequently, laboratories that voluntarily become accredited by one or 
more of these organizations (as applicable) and continue to meet the 
organization's requirements would meet the CLIA condition level 
requirements for laboratories. Therefore, laboratories accredited by 
one or more of these organizations (as applicable) 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.

EFFECTIVE DATE: This notice is effective on April 9, 1998 through June 
30, 1999 for the JCAHO, and July 21, 2001 for the AABB and the AOA.

FOR FURTHER INFORMATION CONTACT:
Joan Simmons, (410) 786-3408 (JCAHO)
Virginia Wanamaker, (410) 786-3384 (AABB)
Kathleen Todd, (410) 786-3385 (AOA)


[[Page 17430]]


SUPPLEMENTARY INFORMATION:

I. Background and Legislative Authority

    Section 353 of the Public Health Service Act (PHSA), as amended by 
the Clinical Laboratory Improvement Amendments of 1988 (CLIA), requires 
any laboratory that performs tests on human specimens to meet 
requirements established by the Department of Health and Human Services 
(HHS). Under the provisions of sections 1861(s)(14) and (s)(16) of the 
Social Security Act, any laboratory that also wants to be paid for 
services furnished to Medicare beneficiaries must meet the requirements 
of section 353 of the PHSA. Subject to specified exceptions, 
laboratories must have a current and valid CLIA certificate to test 
human specimens or be eligible for payment from the Medicare or 
Medicaid programs. Regulations implementing section 353 of the PHSA are 
contained in 42 CFR part 493. Section 353(e)(2) of the PHSA permits 
HCFA 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 42 CFR part 493.
    Section 493.501 allows us to deem a laboratory to meet the CLIA 
requirements if the accreditation process of the organization 
requesting approval provides reasonable assurance that the laboratories 
accredited by it meet the conditions required by Federal law and 
regulations, including the requirements at Sec. 493.506. Under 
Sec. 493.501, the accreditation organization must also--
     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; 
and
     Provide reasonable assurance that these standards and 
criteria are continually met by its accredited laboratories.
    A laboratory can be accredited if it meets the standards of an 
approved accreditation body and meets the requirements at 
Sec. 493.501(b).

II. Requirements for Granting CLIA Approval

    In order to determine whether we should grant or continue an 
existing CLIA approval to laboratories accredited by a private 
accrediting organization, we conduct a detailed and in-depth comparison 
between the organization's requirements and the CLIA requirements at 
Sec. 493.501 to determine whether the organization meets the CLIA 
requirements.
    As specified at Sec. 493.506, our review of an accrediting 
organization's laboratory program includes (but is not necessarily 
limited to) an evaluation of the following:
     Whether the organization's requirements for laboratories 
are equivalent to, or more stringent than, the CLIA condition level 
requirements.
     The organization's inspection process requirements to 
determine the following:
    + The comparability of the full inspection and complaint inspection 
procedures to those of HCFA;
    + The ability of the organization to provide us with electronic 
data and reports with the adverse or corrective actions resulting from 
proficiency testing (PT) results that constitute unsuccessful 
participation in HCFA-approved PT programs and with other data we 
determine to be necessary for validation and assessment of the 
organization's inspection process requirements.
     The organization's agreement with us to ensure that the 
organization agrees to do the following:
    + Notify us within 30 days of all newly accredited laboratories, 
including the specialties and subspecialties for which any laboratory 
performs testing.
    + Notify us within 30 days of the name of any laboratory that has 
had its accreditation denied, suspended, withdrawn, limited, or 
revoked.
    + Notify us within 10 days of any deficiency identified in an 
accredited laboratory when the deficiency poses an immediate jeopardy 
to the laboratory's patients or a hazard to the general public.
    + Notify us at least 30 days prior to changing its standards.
    + Notify each laboratory accredited by the organization within 10 
days of our withdrawal of approval.
    + Disclose any laboratory's PT results upon the reasonable request 
by any person.
    + Provide us, as requested, with inspection schedules for 
validation purposes.
    Under Sec. 493.501(d), the approval period may not exceed 6 years. 
Section 493.501(e) provides that we publish a notice in the Federal 
Register announcing the names of accrediting organizations whose 
laboratories are deemed as meeting requirements equivalent to those of 
part 493. This notice must describe the basis for granting deeming 
authority to the accreditation organization. In addition, the notice 
must describe how the accreditation organization provides reasonable 
assurance to us that laboratories accredited by it meet CLIA 
requirements equivalent to those specified in part 493 and would, 
therefore, meet the CLIA requirements if, rather than being granted 
deemed status, they had been inspected against CLIA condition level 
requirements.
    We published notices in the Federal Register announcing that the 
JCAHO (January 3, 1995; 60 FR 130), the AABB July 21, 1995; 60 FR 
37660) and the AOA (July 21, 1995; 60 FR 37657) had applied for 
approval of their accreditation program for laboratories under the CLIA 
program; that the evaluation of these organizations' applications 
demonstrated that all requirements for approval were met; and that 
these organizations were granted approval as accreditation 
organizations under CLIA.

III. Evaluation of Requests for Continued CLIA Approval

    The JCAHO, the AABB, and the AOA applied to us for continued 
approval of their laboratory accreditation programs under CLIA. As with 
the initial application, we evaluated the requests for continuation of 
these organizations' approvals for equivalency against the three major 
categories of CLIA rules: The implementing regulations, the enforcement 
regulations, and the deeming/exemption requirements.
    We evaluated the applications to verify these organizations' 
assurances of continued compliance with the following subparts of part 
493: Subpart H, Participation in Proficiency Testing for Laboratories 
Performing Tests of Moderate Complexity (including the Subcategory), 
High Complexity, or any Combination of These Tests; Subpart J, Patient 
Test Management For Moderate Complexity (including the Subcategory), 
High Complexity, or any Combination of These Tests; Subpart K, Quality 
Control for Tests of Moderate Complexity (including the Subcategory), 
High Complexity, or any Combination of These Tests; Subpart M, 
Personnel for Moderate Complexity (including the Subcategory) and High 
Complexity Testing; Subpart P, Quality Assurance for Moderate 
Complexity (including the Subcategory), or High Complexity Testing, or 
any Combination of These Tests; Subpart Q, Inspection; and Subpart R, 
Enforcement Procedures.
    These organizations continue to meet the requirements of subparts 
H, J, K, M, P, Q, and R as they were described in

[[Page 17431]]

the January 3, 1995 and July 21, 1995 Federal Register notices.

IV. Federal Validation Inspections and Continuing Oversight

    Federal validation inspections and continuing oversight of these 
accredited laboratories are conducted based on Secs. 493.507 and 
493.509; that is, they are conducted on a representative sample basis 
as well as in response to substantial allegations of noncompliance 
(complaint inspections). We have conducted Federal validation 
inspections of a sample of these accredited laboratories, as specified 
in Sec. 493.507, and evaluated the findings. The evaluations confirmed 
the satisfactory performance of these organizations as accrediting 
organizations for clinical laboratories under the CLIA program. These 
organizations are maintaining their workloads at the proper level to 
ensure that all laboratories using one or more of these laboratory 
accreditation programs (as applicable) to meet CLIA requirements will 
be inspected in a 24-month cycle. All parameters monitored by HCFA 
staff to date indicate that these organizations are meeting all 
requirements under the CLIA approvals. This Federal monitoring process 
will continue as an ongoing process.
    The CLIA approval of laboratories accredited by these organizations 
may be removed if we determine the outcome and comparability reviews of 
validation inspections are not acceptable as described under 
Sec. 493.511.

V. Approval as an Accrediting Organization

    HCFA grants continuation of the CLIA approval for all specialties 
and subspecialties for which the JCAHO, the AABB, and the AOA were 
previously approved (as noted below) to all laboratories accredited by 
and using one or more of these organizations' laboratory accreditation 
programs (as applicable) to meet CLIA requirements. The CLIA approval 
for these organizations continues until the following dates and for the 
following areas:
     JCAHO--June 30, 1999; all specialties and subspecialties.
     AABB--July 21, 2001; limited to the Immunohematology, 
Diagnostic Immunology, Hematology, Histocompatibility, Routine 
Chemistry, and Toxicology.
     AOA--July 21, 2001; all specialties and subspecialties.

VI. Regulatory Impact Statement

    We generally prepare a regulatory flexibility analysis that is 
consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 
through 612) unless the Secretary certifies that a notice such as this 
would not have a significant economic impact on a substantial number of 
small entities. For purposes of the RFA, we consider all laboratories 
to be small entities.
    Also, section 1102(b) of the Act requires the Secretary to prepare 
a regulatory impact analysis for any notice that may have a significant 
impact on the operations of a substantial number of small rural 
hospitals. Such analysis must conform to the provisions of sections 604 
of the RFA. For purposes of section 1102(b) of the Act, we consider a 
small rural hospital as a hospital that is located outside of a 
metropolitan statistical area and has fewer than fifty beds.
    This notice announces the continuance of the approvals of 
laboratories accredited by one or more of these organizations' 
accreditation programs as meeting the CLIA requirements. These 
organizations have established that their standards in determining 
whether or not to accredit a laboratory are equal to, or more stringent 
than, those of the CLIA program, and also have established that they 
have a comparable program to monitor and evaluate compliance with the 
standards. The effect of the continued approval of these organizations' 
accreditation programs as meeting the CLIA requirements is that 
laboratories will continue to be allowed to use these respective 
accreditation programs to meet the requirements of CLIA with no 
discernable difference in the operations of the program. Consequently, 
we anticipate that our continuation of these organizations' CLIA 
approval will not affect the laboratories or the quality and 
availability of services furnished.
    We have determined, and the Secretary certifies, that this notice 
will not result in a significant impact on a substantial number of 
small entities and will not have a significant effect on the operations 
of a substantial number of small rural hospitals. Therefore, we are not 
preparing analyses for either the RFA or sections 1102(b) of the Act.
    In accordance with the provisions of Executive Order 12866, this 
notice was not reviewed by the Office of Management and Budget.

    Authority: Sec. 353(e)(2) of the Public Health Service Act (42 
U.S.C. 263a).

    Dated: February 17, 1998.
Nancy-Ann Min DeParle,
Administrator, Health Care Financing Administration.
[FR Doc. 98-9263 Filed 4-8-98; 8:45 am]
BILLING CODE 4120-01-P