[Federal Register Volume 60, Number 1 (Tuesday, January 3, 1995)]
[Notices]
[Pages 130-132]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 94-32203]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
[HSQ-224-N]


CLIA Program: Approval of the Joint Commission on Accreditation 
of Healthcare Organizations As An Accrediting Organization

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

ACTION: Notice.

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SUMMARY: This notice announces the approval of the Joint Commission on 
Accreditation of Healthcare Organizations (JCAHO) as an accrediting 
organization for clinical laboratories under the Clinical Laboratory 
Improvement Amendments (CLIA) program. We have found that the 
accreditation process of this organization provides reasonable 
assurance that the laboratories accredited by it meet the conditions 
required by Federal law and regulations. Consequently, laboratories 
that voluntarily become accredited by JCAHO in lieu of receiving direct 
Federal oversight and continue to meet JCAHO requirements would 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 validation and complaint investigation surveys.

EFFECTIVE DATE: This notice is effective for the period January 3, 1995 
through January 3, 1997.

FOR FURTHER INFORMATION CONTACT: Tracey Mummert, (410) 597-5906.

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 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, 
Public Law 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 licensure requirements.
    On February 28, 1992, we published several final rules in the 
Federal Register (57 FR 7002-7243) that implemented the amendments to 
section 353 of the PHSA. In a subsequent rule published January 19, 
1993 (58 FR 5215), we added ``certificate for physician-performed 
microscopy procedures'' and amended some of the performance 
requirements previously published on February 28, 1992.
    On July 31, 1992, we issued final rules (57 FR 33992), under 
authority found in section 353(e)(2) of the PHSA, that permit 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 of our regulations. Under 
Sec. 493.501(d) of our regulations the approval period may not exceed 
six years.
    In general, the accreditation organization must:
    <bullet> Use inspectors qualified to evaluate laboratory 
performance and agree to inspect laboratories with the frequency 
determined by HHS;
    <bullet> Apply standards and criteria that are equal to or more 
stringent than those condition level requirements established by HHS 
when taken as a whole;
    <bullet> Provide reasonable assurance that these standards and 
criteria are continually met by its accredited laboratories;
    <bullet> Provide HHS, within 30 days, with the name of any 
laboratory that has had its accreditation denied, suspended, withdrawn, 
limited, or revoked;
    <bullet> Notify HHS at least 30 days prior to changing its 
standards; and
    <bullet> If HHS withdraws its approval, notify its accredited 
laboratories of the withdrawal within 10 days of the withdrawal.
    Along with requiring the promulgation of criteria for approving an 
accreditation body and for withdrawing such approval, CLIA requires HHS 
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 HHS 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 any private, nonprofit 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 JCAHO as an Accrediting Organization

    In this notice, we approve JCAHO as an organization that may 
accredit laboratories for purposes of establishing their compliance 
with CLIA requirements for all specialty/subspecialty areas. 
[[Page 131]] 
    As a result of this determination, any laboratory that is 
accredited by JCAHO during the effective time period for an approved 
specialty/subspecialty 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, however, is subject 
to validation and complaint investigation surveys performed by HCFA, or 
by any other Federal or State or local public agency or nonprofit 
private organization which acts in conformance to an agreement with the 
Secretary.

III. Evaluation of the JCAHO Request for Approval as an 
Accreditation Organization under CLIA

    JCAHO has formally applied to HCFA for approval as an accreditation 
organization under CLIA for all specialties and subspecialties. We have 
evaluated the JCAHO application for approval to serve as an accrediting 
organization under CLIA, to determine equivalency with our implementing 
and enforcement 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

    JCAHO has submitted a list of 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, and 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 HCFA; its removal 
or withdrawal of laboratory accreditation procedures; its current list 
of accredited laboratories; and its announced or unannounced inspection 
process.
    The JCAHO accreditation process is more stringent than Federal 
certification requirements in that JCAHO accredits a healthcare 
organization (for example, hospital) as a whole and not just the 
laboratory alone. As such, an organization that loses its JCAHO 
accreditation for reasons other than poor laboratory performance would 
also lose its ability to legally test human specimens under the 
laboratory's existing certificate of accreditation, if JCAHO 
accreditation is being used to meet the CLIA requirements. The 
laboratory would then need to reapply to HHS, within 45 days, for an 
appropriate CLIA certificate to continue to perform laboratory testing.
    JCAHO has additional requirements pertaining to waived testing. 
These requirements address the intended use of the waived test (that 
is, screening, diagnosis, monitoring); identification of individuals 
responsible for test performance and for direction/supervision of 
testing activity; training and competence in test performance; written 
policies and procedures for specimen collection and preservation, 
instrument calibration and performance evaluation, quality control, 
test performance, and remedial action; defined quality control checks; 
and the maintenance of quality control and test records. Sites within 
the organization performing waived testing will be routinely surveyed. 
As set forth at 42 CFR 493.15, CLIA requires only that a laboratory 
follow manufacturer's instructions and does not require routine 
inspections of waived testing.
    We have determined that JCAHO 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.

Subpart H--Participation in Proficiency Testing for Laboratories 
Performing Tests of Moderate or High Complexity, or Both

    JCAHO has revised its requirements to be equivalent to the CLIA 
requirements at Secs. 493.801 through 493.865 on an overall basis.

Subpart J--Patient Test Management for Moderate or High Complexity 
Testing, or Both

    JCAHO has revised its requirements to be equivalent to the CLIA 
requirements at Secs. 493.1101 through 493.1111 on an overall basis.

Subpart K--Quality Control for Tests of Moderate or High Complexity, or 
Both

    The quality control (QC) requirements of the JCAHO have been 
evaluated against the requirements of the CLIA regulations. JCAHO has 
modified its survey process and made revisions to its standards 
encompassing general QC requirements as well as specialty and 
subspecialty QC in order to address some of the more specific QC 
requirements of CLIA. As such, we have determined that JCAHO's 
requirements, when taken as a whole, are equal to or more stringent 
than the CLIA requirements. The specific areas of QC that are more 
stringent are:
    <bullet> Compliance with all Federal, State, and local laws 
including the applicable National Fire Protection Association safety 
code requirements regarding employee and patient health and safety;
    <bullet> Requirements that laboratories must meet JCAHO's QC 
requirements for all waived testing that they perform;
    <bullet> No phase-in of quality control requirements except that 
laboratories performing unmodified, moderate complexity tests may meet 
the calibration requirements of Sec. 493.1202(c);
    <bullet> A requirement that laboratories maintain 
histocompatibility records for 5 years;
    <bullet> A requirement that for mycobacteriology, laboratories 
perform daily QC for fluorochrome acid-fast stains;
    <bullet> A requirement that laboratories perform QC on permanent 
stains in parasitology with each use;
    <bullet> A requirement that for mycology, laboratories perform QC 
using both positive and negative controls each day of use for acid-fast 
stains;
    <bullet> For cytology, JCAHO requires the review of all normal or 
negative gynecological specimens, and encourages the review of all 
abnormal gynecologic specimens received in the laboratory within the 
past 5 years when a current determination of a high grade 
intraepithelial lesion or above exists.

Subpart M--Personnel for Moderate and High Complexity Testing

    JCAHO has revised its requirements to equal the CLIA requirements 
at Secs. 493.1403 through 493.1495 on an overall basis. JCAHO states, 
as general policy under its personnel standards, that the laboratory 
must meet CLIA requirements for personnel qualifications. The CLIA 
requirements for personnel responsibilities are encompassed in the 
revisions made to JCAHO standards.

Subpart P--Quality Assurance for Moderate or High Complexity Testing or 
Both

    JCAHO has revised its requirements to be equivalent to the CLIA 
requirements at Secs. 493.1701 through 493.1721 on an overall basis.

Subpart Q--Inspections

    JCAHO has made revisions to its inspection process, which is 
announced, and will perform on-site [[Page 132]] inspections of the 
laboratory on a biennial basis, to equate to the applicable CLIA 
requirements at Secs. 493.1777. In citing deficiencies, JCAHO uses a 
system of weighting multiple standards that aggregate to a single grid 
element. This system has been somewhat modified for laboratories such 
that weight does not preclude laboratories from correcting any 
deficiencies that relate to CLIA requirements. Therefore, we have 
determined that JCAHO's requirements are equivalent to the requirements 
of this subpart.

Subpart R--Enforcement Procedures for Laboratories

    JCAHO meets the requirements of subpart R to the extent it applies 
to accreditation organizations. JCAHO policy stipulates the action it 
takes when laboratories it accredits do not comply with its essential 
standards. When appropriate, JCAHO will deny, revoke or conditionally 
accredit a laboratory and report that action to HCFA within 30 days. 
JCAHO also provides an appeals process for laboratories that have had 
accreditation denied or revoked.
    Some specific actions JCAHO takes in response to non-compliance or 
violation of essential standards include:
    <bullet> When JCAHO determines that a serious risk of harm 
(immediate jeopardy) situation exists in a JCAHO-accredited laboratory, 
the laboratory must immediately correct the problem that poses the 
risk. Failure to do so will result in a recommendation to the JCAHO 
Accreditation Committee to revoke that facility's accreditation. In 
addition, JCAHO will notify HCFA within 10 days of this determination.
    <bullet> When a JCAHO laboratory is unsuccessful in PT 
participation for a Federally required analyte, subspecialty, and/or 
specialty, the laboratory will be contacted by JCAHO and required to 
initiate corrective actions. Failure to submit an acceptable 
proficiency outlier action report (POA) may result in an unscheduled, 
onsite survey and limitation of the laboratory's scope of accreditation 
for the particular analyte, specialty, and/or subspecialty. To regain 
accreditation, the laboratory must provide JCAHO evidence that it has 
successfully participated in two consecutive PT events.
    We have determined that JCAHO'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

    Federal validation inspections and continuing oversight of JCAHO 
accredited laboratories will be conducted based on the regulations at 
42 CFR 493.507 and 493.509.

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 JCAHO, may be removed by 
HCFA for cause, prior to the end of the effective date of approval. If 
it is determined that JCAHO has failed to adopt requirements that are 
equal to or more stringent than the CLIA requirements, or that systemic 
problems exist in its inspection process, a probationary period, not to 
exceed one year, may be given to allow JCAHO to adopt comparable 
requirements.
    Should circumstances result in JCAHO having its approval withdrawn, 
we will publish a notice in the Federal Register explaining the basis 
for removing its approval.

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

    Dated: December 1, 1994.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 94-32203 Filed 12-30-94; 8:45 am]
BILLING CODE 4120-01-P