Medicare, Medicaid, and CLIA Programs; Continuance of the Approval of the American Society for Histocompatibility and Immunogenetics as a CLIA Acreditation Organization, 15327-15329 [05-5595]
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Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices
15327
TABLE 1.—FRAMEWORK FOR EQUIVALENT PROTECTIONS—Continued
Specific protection
Example procedures
45 CFR part 46 subpart A authority
46.111(a)(4) Informed consent will be sought from each prospective
subject or the subject’s legally authorized representative, in accordance with, and to the extent required by § 46.116.
46.116(a)(1–8) Necessary elements of disclosure.
46.116(b)(1–6) Necessary elements of disclosure.
46.116(c)(1–2) Waiver of informed consent.
46.116(d)(1–4) Approval of alternate consent procedures or waiver.
46.117(a) Written informed consent.
Bernard A. Schwetz,
Director, Office for Human Research
Protections.
[FR Doc. 05–5947 Filed 3–24–05; 8:45 am]
BILLING CODE 4150–36–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
The National Center for Chronic
Disease Prevention and Health
Promotion
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention announces the
following meeting.
Name: Interagency Committee on Smoking
and Health.
Time and Date: 9 a.m.–4:30 p.m., April 13,
2005.
Place: Omni Shoreham Hotel, Hampton
Ballroom, 2500 Calvert Street, NW.,
Washington, DC 20008. Telephone: 202–234–
0700.
Status: Open to the public, limited only by
the space available. Those who wish to
attend are encouraged to register with the
contact person listed below. If you will
require a sign language interpreter, or have
other special needs, please notify the contact
person by 4:30 e.s.t. on April 4, 2005.
Purpose: The Interagency Committee on
Smoking and Health advises the Secretary,
Department of Health and Human Services,
and the Assistant Secretary for Health in the
(a) coordination of all research and education
programs and other activities within the
Department and with other Federal, State,
local and private agencies and (b)
establishment and maintenance of liaison
with appropriate private entities, Federal
agencies, and State and local public health
agencies with respect to smoking and health
activities.
Matters to be Discussed: The agenda will
focus on addressing the Global Tobacco
Epidemic.
For Further Information Contact:
Substantive program information as well as
summaries of the meeting and roster of
committee members may be obtained from
the Internet at https://www.cdc.gov/tobacco in
mid-May or from Ms. Monica L. Swann,
Management and Program Analyst, Office on
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Jkt 205001
Smoking and Health, 200 Independence
Avenue, SW., Suite 317B, Washington, DC
20201, (202) 205–8500.
Agenda items are subject to change as
priorities dictate.
The Director, Management Analysis and
Services Office, has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both the Centers for Disease Control and
Prevention and the Agency for Toxic
Substances and Disease Registry.
Dated: March 18, 2005.
Alvin Hall,
Director, Management Analysis and Service
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–5913 Filed 3–24–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Disease Control and
Prevention
Board of Scientific Counselors,
National Center for Infectious Diseases
In accordance with section 10(a)(2) of
the Federal Advisory Committee Act
(Pub. L. 92–463), the Centers for Disease
Control and Prevention (CDC)
announces the following committee
meeting.
Name: Board of Scientific Counselors,
National Center for Infectious Diseases
(NCID).
Times and Dates: 9 a.m.–5:30 p.m., May
12, 2005. 8:30 a.m.–2 p.m., May 13, 2005.
Place: CDC, Auditorium B, Building 1,
1600 Clifton Road, Atlanta, Georgia 30333.
Status: Open to the public, limited only by
the space available.
Purpose: The Board of Scientific
Counselors, NCID, provides advice and
guidance to the Director, CDC, and Director,
NCID, in the following areas: program goals
and objectives; strategies; program
organization and resources for infectious
disease prevention and control; and program
priorities.
Matters To Be Discussed: Agenda items
will include:
1. Opening Session: NCID Update.
2. Futures Initiative Update.
3. Environmental Microbiology.
PO 00000
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4. Development of CDC Research Agenda.
5. Veterinary-Human Public Health
Interface.
6. Global Disease Detection Initiative.
7. Topic Updates.
a. Influenza.
b. Chronic Wasting Disease.
c. Quarantine Update.
8. Board meets with Director, CDC.
Other agenda items include
announcements/introductions; follow-up on
actions recommended by the Board
December 2004; consideration of future
directions, goals, and recommendations.
Agenda items are subject to change as
priorities dictate.
Written comments are welcome and should
be received by the contact person listed
below prior to the opening of the meeting.
Contact Person for More Information: Tony
Johnson, Office of the Director, NCID, CDC,
Mailstop E–51, 1600 Clifton Road, NE.,
Atlanta, Georgia 30333, e-mail
tjohnson3@cdc.gov; telephone 404/498–3249.
The Director, Management Analysis and
Services Office has been delegated the
authority to sign Federal Register notices
pertaining to announcements of meetings and
other committee management activities, for
both CDC and the Agency for Toxic
Substances and Disease Registry.
Dated: March 18, 2005.
Alvin Hall,
Director, Management Analysis and Services
Office, Centers for Disease Control and
Prevention.
[FR Doc. 05–5909 Filed 3–24–05; 8:45 am]
BILLING CODE 4163–18–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2211–N]
Medicare, Medicaid, and CLIA
Programs; Continuance of the
Approval of the American Society for
Histocompatibility and
Immunogenetics as a CLIA
Acreditation Organization
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
E:\FR\FM\25MRN1.SGM
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15328
Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices
SUMMARY: This notice announces the reapproval of the American Society for
Histocompatibility and Immunogenetics
(ASHI) as an accrediting organization
for clinical laboratories under the
Clinical Laboratory Improvement
Amendments of 1988 (CLIA) program.
We have determined that the
accreditation process of this
organization provides reasonable
assurance that the laboratories
accredited by ASHI meet the conditions
required by Federal law and regulations.
Consequently, laboratories that are
voluntarily accredited by ASHI and
continue to meet the ASHI 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 validation
and complaint investigation surveys
conducted by us or our designee.
DATES: Effective Date: This notice is
effective on March 25, 2005. It will
remain in effect for 6 years.
FOR FURTHER INFORMATION CONTACT:
Minnie Christian, (410) 786–3339.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative
Authority
On October 31, 1988, the Congress
enacted the Clinical Laboratory
Improvement Amendments of 1988
(CLIA), Pub. L. 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, we
may approve a private, nonprofit
organization as an approved
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 listed in subpart E
(Accreditation by a Private, Nonprofit
Accreditation Organization or
Exemption Under an Approved State
Laboratory Program) specify the
requirements an 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:
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16:11 Mar 24, 2005
Jkt 205001
• 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 change 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 Continued Approval of
ASHI as an Accreditation Organization
In this notice, we approve ASHI as an
organization that may continue to
accredit laboratories for purposes of
establishing their compliance with CLIA
requirements. We have examined the
ASHI 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
ASHI complied with the applicable
CLIA requirements and grant ASHI
approval as an accreditation
organization under subpart E, for the
period stated in the ‘‘Effective Date’’
section of this notice, for the following
specialty and subspecialty areas:
• Histocompatibility.
• ABO/Rh typing.
As a result of this determination, any
laboratory that is accredited by ASHI
during the effective time period for an
approved specialty or subspecialty
listed above is deemed to meet 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 us, or by any other validly
authorized agent.
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Frm 00053
Fmt 4703
Sfmt 4703
III. Evaluation of the ASHI Request for
Approval as an Accreditation
Organization Under CLIA
The following describes the process
used to determine that the ASHI
provides reasonable assurance that
laboratories it accredits will meet the
applicable requirements of CLIA.
The ASHI formally reapplied to us for
approval as an accreditation
organization under CLIA for the
specialty of Histocompatibility and the
subspecialty of ABO/Rh. We evaluated
the ASHI application to determine
compliance with our implementing and
enforcement regulations, and the
deeming/exemption requirements of the
CLIA rules.
We verified the ASHI’s assurance that
it requires the laboratories it accredits to
be, and that the organization is, in
compliance with 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 ASHI submitted the specialty and
subspecialty 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
of accredited laboratories; and its
announced or unannounced inspection
process.
Subpart H—Participation in Proficiency
Testing for Laboratories Performing
Nonwaived Testing
The ASHI’s requirements are equal to
or more stringent than the CLIA
requirements at § 493.801 through
§ 493.865.
For the specialty of
Histocompatibility, ASHI requires
participation in at least one external PT
program, if available, in
histocompatibility testing with an 80
percent score required for successful
participation and enhanced PT for
laboratories that fail an event. The CLIA
regulations do not contain a
requirement for external PT for the
specicialty of Histocompatibility.
Subpart J—Facility Administration for
Nonwaived Testing
The ASHI requirements are equal to
or more stringent than the CLIA
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Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Notices
requirements at § 493.1100 through
§ 493.1105.
Subpart K—Quality System for
Nonwaived Testing
The ASHI requirements are equal to
or more stringent than the CLIA
requirements at § 493.1200 through
§ 493.1299. For instance, ASHI’s control
procedure requirements for the test
procedures Nucleic Acid Testing and
Flow Cytometry are more specific and
detailed than the CLIA language for
requirements for control procedures.
Sections 493.1256(c)(1) and (c)(2)
require control materials that will detect
immediate errors and monitor accuracy
and precision of test performance that
may be caused by test system failures,
environmental conditions and variance
in operator performance. ASHI
standards provide detailed, specific
requirements for the control materials to
be used to meet these CLIA
requirements.
Subpart M—Personnel for Nonwaived
Testing
We have determined that ASHI
requirements are equal to or more
stringent than the CLIA requirements at
§ 493.1403 through § 493.1495 for
laboratories that perform moderate and
high complexity testing. Experience
requirements for Director, Technical
Supervisor, and General Supervisor
exceed CLIA’s personnel experience
requirements in the specialty of
Histocompatibility.
Subpart Q—Inspections
We have determined that the ASHI
requirements are equal to or more
stringent than the CLIA requirements at
§ 493.1771 through § 493.1780. The
ASHI inspections are more frequent
than CLIA requires. ASHI performs an
onsite inspection every 2 years and
requires submission of a self-evaluation
inspection in the intervening years. If
the self-evaluation inspection indicates
that an onsite inspection is warranted,
ASHI conducts an additional onsite
review. In addition, ASHI inspectors
provide onsite proficiency testing
samples to be processed during the
inspection.
Subpart R—Enforcement Procedures
The ASHI meets the requirements of
subpart R to the extent that it applies to
accreditation organizations. The ASHI
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
ASHI will deny, suspend, or, revoke
accreditation in a laboratory accredited
VerDate jul<14>2003
16:11 Mar 24, 2005
Jkt 205001
by the ASHI and report that action to us
within 30 days. The ASHI also provides
an appeals process for laboratories that
have had accreditation denied,
suspended, or revoked.
We have determined that the ASHI’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
ASHI 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, the State survey
agencies, will be our principal means
for verifying that the laboratories
accredited by ASHI 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 ASHI,
for cause, before the end of the effective
date of approval. If we determine that
the ASHI 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 ASHI
to adopt comparable requirements.
Should circumstances result in our
withdrawal of the ASHI’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.
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Frm 00054
Fmt 4703
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15329
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: March 10, 2005.
Mark B. McClellan,
Administrator, Centers For Medicare &
Medicaid Services.
[FR Doc. 05–5595 Filed 3–24–05; 8:45 am]
BILLING CODE 4121–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–0014–N]
Procedures for Non-Privacy
Administrative Simplification
Complaints Under the Health
Insurance Portability and
Accountability Act of 1996
Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
AGENCY:
SUMMARY: This notice sets forth the
procedures for filing with the Secretary
of the Department of Health and Human
Services a complaint of non-compliance
by a covered entity with certain
provisions of the administrative
simplification rules under 45 CFR parts
160, 162, and 164. It also describes the
procedures the Department employs to
review the complaints. These
procedures are intended to facilitate the
investigation and resolution of these
complaints.
Effective Date: This notice is
effective on April 25, 2005.
FOR FURTHER INFORMATION CONTACT:
Michael Phillips, (410) 786–6713.
ADDRESSES: Complaints may be filed
with CMS in two ways: (1) By Internet
using the Administrative Simplification
Enforcement Tool at https://htct.hhs.gov/.
(2) By mail at: The Centers for Medicare
& Medicaid Services, HIPAA TCS
Enforcement Activities, P.O. Box 8030,
Baltimore, MD 21244–8030.
SUPPLEMENTARY INFORMATION: The
Secretary of Health and Human Services
delegated to the Administrator, Centers
for Medicare & Medicaid Services
(CMS), the authority to investigate
complaints of noncompliance with, and
to make decisions regarding the
interpretation, implementation, and
enforcement of certain regulations
adopting administrative simplification
DATES:
E:\FR\FM\25MRN1.SGM
25MRN1
]]>Agencies
[Federal Register Volume 70, Number 57 (Friday, March 25, 2005)]
[Notices]
[Pages 15327-15329]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 05-5595]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2211-N]
Medicare, Medicaid, and CLIA Programs; Continuance of the
Approval of the American Society for Histocompatibility and
Immunogenetics as a CLIA Acreditation Organization
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
[[Page 15328]]
SUMMARY: This notice announces the re-approval of the American Society
for Histocompatibility and Immunogenetics (ASHI) as an accrediting
organization for clinical laboratories under the Clinical Laboratory
Improvement Amendments of 1988 (CLIA) program. We have determined that
the accreditation process of this organization provides reasonable
assurance that the laboratories accredited by ASHI meet the conditions
required by Federal law and regulations. Consequently, laboratories
that are voluntarily accredited by ASHI and continue to meet the ASHI
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 validation and
complaint investigation surveys conducted by us or our designee.
DATES: Effective Date: This notice is effective on March 25, 2005. It
will remain in effect for 6 years.
FOR FURTHER INFORMATION CONTACT: Minnie Christian, (410) 786-3339.
SUPPLEMENTARY INFORMATION:
I. Background and Legislative Authority
On October 31, 1988, the Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), Pub. L. 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, we may approve a
private, nonprofit organization as an approved 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 listed in subpart E (Accreditation by a
Private, Nonprofit Accreditation Organization or Exemption Under an
Approved State Laboratory Program) specify the requirements an
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 change 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 Continued Approval of ASHI as an Accreditation
Organization
In this notice, we approve ASHI as an organization that may
continue to accredit laboratories for purposes of establishing their
compliance with CLIA requirements. We have examined the ASHI
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 ASHI complied with the applicable CLIA requirements and grant ASHI
approval as an accreditation organization under subpart E, for the
period stated in the ``Effective Date'' section of this notice, for the
following specialty and subspecialty areas:
Histocompatibility.
ABO/Rh typing.
As a result of this determination, any laboratory that is
accredited by ASHI during the effective time period for an approved
specialty or subspecialty listed above is deemed to meet 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 us, or by any other validly
authorized agent.
III. Evaluation of the ASHI Request for Approval as an Accreditation
Organization Under CLIA
The following describes the process used to determine that the ASHI
provides reasonable assurance that laboratories it accredits will meet
the applicable requirements of CLIA.
The ASHI formally reapplied to us for approval as an accreditation
organization under CLIA for the specialty of Histocompatibility and the
subspecialty of ABO/Rh. We evaluated the ASHI application to determine
compliance with our implementing and enforcement regulations, and the
deeming/exemption requirements of the CLIA rules.
We verified the ASHI's assurance that it requires the laboratories
it accredits to be, and that the organization is, in compliance with
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 ASHI submitted the specialty and subspecialty 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 of
accredited laboratories; and its announced or unannounced inspection
process.
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
The ASHI's requirements are equal to or more stringent than the
CLIA requirements at Sec. 493.801 through Sec. 493.865.
For the specialty of Histocompatibility, ASHI requires
participation in at least one external PT program, if available, in
histocompatibility testing with an 80 percent score required for
successful participation and enhanced PT for laboratories that fail an
event. The CLIA regulations do not contain a requirement for external
PT for the specicialty of Histocompatibility.
Subpart J--Facility Administration for Nonwaived Testing
The ASHI requirements are equal to or more stringent than the CLIA
[[Page 15329]]
requirements at Sec. 493.1100 through Sec. 493.1105.
Subpart K--Quality System for Nonwaived Testing
The ASHI requirements are equal to or more stringent than the CLIA
requirements at Sec. 493.1200 through Sec. 493.1299. For instance,
ASHI's control procedure requirements for the test procedures Nucleic
Acid Testing and Flow Cytometry are more specific and detailed than the
CLIA language for requirements for control procedures. Sections
493.1256(c)(1) and (c)(2) require control materials that will detect
immediate errors and monitor accuracy and precision of test performance
that may be caused by test system failures, environmental conditions
and variance in operator performance. ASHI standards provide detailed,
specific requirements for the control materials to be used to meet
these CLIA requirements.
Subpart M--Personnel for Nonwaived Testing
We have determined that ASHI 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. Experience requirements for Director, Technical Supervisor,
and General Supervisor exceed CLIA's personnel experience requirements
in the specialty of Histocompatibility.
Subpart Q--Inspections
We have determined that the ASHI requirements are equal to or more
stringent than the CLIA requirements at Sec. 493.1771 through Sec.
493.1780. The ASHI inspections are more frequent than CLIA requires.
ASHI performs an onsite inspection every 2 years and requires
submission of a self-evaluation inspection in the intervening years. If
the self-evaluation inspection indicates that an onsite inspection is
warranted, ASHI conducts an additional onsite review. In addition, ASHI
inspectors provide onsite proficiency testing samples to be processed
during the inspection.
Subpart R--Enforcement Procedures
The ASHI meets the requirements of subpart R to the extent that it
applies to accreditation organizations. The ASHI 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 ASHI will deny, suspend, or, revoke accreditation in a
laboratory accredited by the ASHI and report that action to us within
30 days. The ASHI also provides an appeals process for laboratories
that have had accreditation denied, suspended, or revoked.
We have determined that the ASHI'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 ASHI 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, the State survey agencies, will be our principal
means for verifying that the laboratories accredited by ASHI 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 ASHI, for cause, before
the end of the effective date of approval. If we determine that the
ASHI 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 ASHI to adopt comparable requirements.
Should circumstances result in our withdrawal of the ASHI'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: March 10, 2005.
Mark B. McClellan,
Administrator, Centers For Medicare & Medicaid Services.
[FR Doc. 05-5595 Filed 3-24-05; 8:45 am]
BILLING CODE 4121-01-P
