[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
