[Federal Register: February 23, 2007 (Volume 72, Number 36)]
[Notices]
[Page 8173-8174]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23fe07-56]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2218-N]
RIN 0938-ZA99
Medicare, Medicaid, and CLIA Programs; Approval of the Joint
Commission (Formerly the Joint Commission on Accreditation of
Healthcare Organizations) as a CLIA Accreditation Organization
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
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SUMMARY: This notice announces CMS' grant of deeming authority to the
Joint Commission (formerly the Joint Commission on Accreditation of
Healthcare Organizations) under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) program. We have determined that the
requirements of the Joint Commission accreditation process are equal to
or more stringent than the CLIA condition level requirements, and that
the Joint Commission has met the requirements of subpart E of 42 CFR
part 493. Consequently, laboratories that are voluntarily accredited by
the Joint Commission and continue to meet the Joint Commission
requirements will be deemed to 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 Federal validation
and complaint investigation surveys conducted by us or our designee.
DATES: Effective Date: This notice is effective from February 23, 2007
to February 23, 2012.
FOR FURTHER INFORMATION CONTACT: Kathleen Todd, (410) 786-3385.
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(e)(2) of the Public Health Service
Act, as enacted by the Clinical Laboratories Improvement Act of 1967.
We issued a final rule implementing the accreditation provisions of
CLIA on July 31, 1992, (57 FR 33992). Under the CLIA program, CMS
approves a grant of deeming authority to an accreditation organization
to accredit clinical laboratories if the organization meets certain
requirements. An organization's requirements for accredited
laboratories must be equal to, or more stringent than, the applicable
CLIA program requirements in 42 CFR part 493 (Laboratory Requirements).
The regulations in subpart E (Accreditation by a Private, Nonprofit
Accreditation Organization or Exemption Under an Approved State
Laboratory Program) specify the requirements an accreditation
organization must meet to be an approved accreditation organization. We
approve an accreditation organization for a period not to exceed 6
years.
In general, the approved accreditation organization must:
Use inspectors qualified to evaluate laboratory
performance and agree to inspect laboratories with the frequency
determined by us.
Apply standards and criteria that are equal to, or more
stringent than those condition level requirements established by us.
Assure that laboratories accredited by the accreditation
organization continually meet these standards and criteria.
Provide us with the name of any laboratory that has had
its accreditation denied, suspended, withdrawn, limited, or revoked
within 30 days of the action taken.
Notify us at least 30 days before implementing any
proposed changes in its standards.
If we withdraw our approval, notify the accredited
laboratories of the withdrawal within 10 days of the withdrawal.
CLIA requires that we 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 we
determine to be appropriate.
II. Notice of Approval of the Joint Commission as an Accreditation
Organization
In this notice, we approve the Joint Commission as an organization
that may accredit laboratories for purposes of establishing their
compliance with CLIA requirements. We have examined the Joint
Commission application and all subsequent submissions to determine
equivalency with our requirements under subpart E of part 493 that an
accreditation organization must meet to be approved under CLIA. We have
determined that the Joint Commission complied with the applicable CLIA
requirements and grant the Joint Commission deeming authority as an
accreditation organization under subpart E, for the period stated in
the ``Effective Date'' section of this notice for all specialty and
subspecialty areas under CLIA.
As a result of this determination, any laboratory that is
accredited by the Joint Commission during the effective time period for
an approved specialty or subspecialty is deemed to meet the CLIA
requirements for the 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 us, or by any other validly
authorized agent.
III. Evaluation of the Joint Commission Request for Approval as an
Accreditation Organization Under CLIA
The following describes the process used to determine that
requirements of the Joint Commission accreditation program are equal to
or more stringent than the CLIA condition level requirements, and that
the Joint Commission has met requirements of subpart E of 42 CFR part
493.
The Joint Commission formally reapplied to us for approval as an
accreditation organization under CLIA for all specialties and
subspecialties. We evaluated the Joint Commission application to
determine compliance with our implementing and enforcement regulations,
and the deeming/exemption requirements of the CLIA rules.
We verified that the Joint Commission accreditation program
requirements and methods require the laboratories it accredits to be,
and that the organization meets or exceeds the following subparts of
part 493 as explained below:
Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
The Joint Commission submitted 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; 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 us; its removal
or withdrawal of laboratory accreditation procedures; its current list
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of accredited laboratories; and its announced or unannounced inspection
process.
Our evaluation identified Joint Commission requirements pertaining
to waived testing that are more stringent than the CLIA requirements.
The Joint Commission waived testing requirements include the following:
Defining the extent that waived test results are used in
patient care.
Identifying the personnel responsible for performing and
supervising waived testing.
Assuring that personnel performing waived testing have
adequate, specific training and orientation to perform the testing and
can demonstrate satisfactory levels of performance.
Making certain that policies and procedures governing
waived testing-related processes are current and readily available.
Conducting defined quality control checks.
Maintaining quality control and test records.
The CLIA requirements at Sec. 493.15 only require that a
laboratory follow manufacturer's instructions and obtain a certificate
of waiver.
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
The Joint Commission's requirements are equal to the CLIA
requirements at Sec. 493.801 through Sec. 493.865.
Subpart J--Facility Administration for Nonwaived Testing
The Joint Commission requirements are equal to the CLIA
requirements at Sec. 493.1100 through Sec. 493.1105.
Subpart K--Quality System for Nonwaived Testing
The Joint Commission requirements are equal to or more stringent
than the CLIA requirements at Sec. 493.1200 through Sec. 493.1299. We
have determined that Joint Commission's requirements, when taken as a
whole, are more stringent than the CLIA requirements. For instance, the
Joint Commission has control procedure requirements for all waived
complexity testing performed.
Subpart M--Personnel for Nonwaived Testing
We have determined that the Joint Commission requirements are equal
to or more stringent than the CLIA requirements at Sec. 493.1403
through Sec. 493.1495 for laboratories that perform moderate and high
complexity testing.
Subpart Q--Inspections
We have determined that the Joint Commission requirements are equal
to or more stringent than the CLIA requirements at Sec. 493.1771
through Sec. 493.1780. The Joint Commission will continue to perform
onsite inspections every 2 years.
Subpart R--Enforcement Procedures
The Joint Commssion meets the requirements of subpart R to the
extent that it applies to accreditation organizations. The Joint
Commission policy sets forth the actions the organization takes when
laboratories it accredits do not comply with its requirements and
standards for accreditation. When appropriate, the Joint Commission
will deny, suspend, or, revoke accreditation in a laboratory accredited
by the Joint Commission and report that action to us within 30 days.
The Joint Commission also provides an appeal process for laboratories
that have had accreditation denied, suspended, or revoked.
We have determined that the Joint Commission's laboratory
enforcement and appeal policies are equal to or more stringent than the
requirements of part 493 subpart R as they apply to accreditation
organizations.
IV. Federal Validation Inspections and Continuing Oversight
The Federal validation inspections of Joint Commission accredited
laboratories may be conducted on a representative sample basis or in
response to substantial allegations of noncompliance (that is,
complaint inspections). The outcome of those validation inspections,
performed by us or our agents, or the State survey agencies, will be
our principal means for verifying that the laboratories accredited by
the Joint Commission remain in compliance with CLIA requirements. This
Federal monitoring is an ongoing process.
V. Removal of Approval as an Accrediting Organization
Our regulations provide that we may rescind the approval of an
accreditation organization, such as that of the Joint Commission, for
cause, before the end of the effective date of approval. If we
determine that the Joint Commission failed to adopt requirements that
are equal to, or more stringent than, the CLIA requirements, or that
systemic problems exist in its inspection process, we may give it a
probationary period, not to exceed 1 year to allow the Joint Commission
to adopt comparable requirements.
Should circumstances result in our withdrawal of the Joint
Commission's approval, we will publish a notice in the Federal Register
explaining the basis for removing its approval.
VI. Collection of Information Requirements
This notice does not impose any information collection and record
keeping requirements subject to the Paperwork Reduction Act (PRA).
Consequently, it does not need to be reviewed by the Office of
Management and Budget (OMB) under the authority of the PRA. The
requirements associated with the accreditation process for clinical
laboratories under the Clinical Laboratory Improvement Amendments of
1988 (CLIA) program, codified in 42 CFR part 493 subpart E, are
currently approved by OMB under OMB approval number 0938-0686.
VII. Executive Order 12866 Statement
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: December 7, 2006.
Leslie V. Norwalk,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E7-3030 Filed 2-22-07; 8:45 am]
BILLING CODE 4120-01-P