Deeming Notice for American Society for Histocompatibility and Immunogenetics (ASHI) as an Accrediting Organization Under the Clinical Laboratory Improvement Amendments of 1988, 77702-77704 [E8-29659]
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77702
Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Notices
of the following subjects: (1) The
necessity and utility of the proposed
information collection for the proper
performance of the Agency’s function;
(2) the accuracy of the estimated
burden; (3) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (4) the use of
automated collection techniques or
other forms of information technology to
minimize the information collection
burden.
1. Type of Information Collection
Request: Reinstatement without change
of a previously approved collection;
Title of Information Collection:
Certification Statement for Electronic
File Interchange Organizations (EFIOs);
Use: Health care providers can currently
obtain a National Provider Identifier
(NPI) via a paper application or over the
Internet through the National Plan and
Provider Enumeration System (NPPES).
These applications must be submitted
individually, on a per-provider basis.
The Electronic File Interchange (EFI)
process allows provider-designated
electronic file interchange organizations
(EFIOs) to capture multiple providers’
NPI application information on a single
electronic file for submission to NPPES.
This process is also referred to as ‘‘bulk
enumeration.’’ To ensure that the EFIO
has the authority to act on behalf of each
provider and complies with other
Federal requirements, an authorized
official of the EFIO must sign a
certification statement and mail it to the
Centers for Medicare and Medicaid
Services (CMS). Form Number: CMS–
10175 (OMB# 0938–0984); Frequency:
Once; Affected Public: Private Sector—
Business or other for-profits; Number of
Respondents: 300; Total Annual
Responses: 300; Total Annual Hours:
300.
2. Type of Information Collection
Request: New collection; Title of
Information Collection: Disclosure of
Financial Relationships Report
(‘‘DFRR’’); Use: Section 1877(f) of the
Social Security Act requires that each
entity providing covered items or
services for which payment may be
made shall provide the Secretary with
information concerning the entity’s
ownership and investment interests,
and compensation arrangements, in
such form, manner, and at such times as
the Secretary shall specify. The DFRR
collection instrument will be used by
CMS to (1) identify arrangements that
potentially may not be in compliance
with the physician self-referral statute
and implementing regulations; and (2)
to identify examples and areas of noncompliance that may assist us in any
future rulemaking concerning the
reporting requirements and other
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physician self-referral provisions. Form
Number: CMS–10236 (OMB# 0938–
New); Frequency: Once; Affected Public:
Private Sector—Business or other forprofits and Not-for-profit institutions;
Number of Respondents: 400; Total
Annual Responses: 400; Total Annual
Hours: 40,000.
3. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Transmittal and
Notice of Approval of State Plan
Material and Medicaid State Plan—Base
Plan, Attachments and Supplemental
Pages and Supporting Regulations in 42
CFR 430.10–430.20 and 440.167; Use:
The Medicaid State base plan pages and
attachments are documents utilized by
State and territorial agencies which
have the responsibility for
administering the Medicaid program.
The Medicaid State plan is comprised of
‘‘pages’’ and organized by subject matter
which includes Medicaid eligibility
services, payment for services, and
general, financial and personnel
administration. When States seek to
change selected pages of their State
plans, the page(s) are transmitted to
CMS for review and approval by the
CMS Central and Regional Offices prior
to amending its State plan. Form
Number: CMS–179 (OMB# 0938–0193);
Frequency: Once and as needed;
Affected Public: State, Local, or Tribal
Governments; Number of Respondents:
56; Total Annual Responses: 4,681;
Total Annual Hours: 9,271.
To obtain copies of the supporting
statement and any related forms for the
proposed paperwork collections
referenced above, access CMS Web Site
address at https://www.cms.hhs.gov/
PaperworkReductionActof1995, or Email your request, including your
address, phone number, OMB number,
and CMS document identifier, to
Paperwork@cms.hhs.gov, or call the
Reports Clearance Office on (410) 786–
1326.
To be assured consideration,
comments and recommendations for the
proposed information collections must
be received by the OMB desk officer at
the address below, no later than 5 p.m.
on January 20, 2009.
OMB, Office of Information and
Regulatory Affairs, Attention: CMS
Desk Officer, New Executive Office
Building, Room 10235, Washington,
DC 20503, Fax Number: (202) 395–
6974.
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Dated: December 12, 2008.
Michelle Shortt,
Director, Regulations Development Group,
Office of Strategic Operations and Regulatory
Affairs.
[FR Doc. E8–30327 Filed 12–18–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2295–N]
RIN 0938–AP20
Deeming Notice for American Society
for Histocompatibility and
Immunogenetics (ASHI) as an
Accrediting Organization Under the
Clinical Laboratory Improvement
Amendments of 1988
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS.
ACTION: Notice.
SUMMARY: The American Society for
Histocompatibility and Immunogenetics
(ASHI) was granted deeming authority
as an accrediting organization for
clinical laboratories under the Clinical
Laboratory Improvement Amendments
of 1988 (CLIA) program on March 25,
2005. The deeming authority was
granted for the CLIA specialty of
Histocompatibility and the subspecialty
ABO/Rh. In this notice, we approve and
grant ASHI deeming authority for the
additional CLIA subspecialty of General
Immunology.
DATES: Effective Date: This notice is
effective from December 19, 2008 until
March 25, 2011.
FOR FURTHER INFORMATION CONTACT:
Penelope Meyers, (410) 786–3366.
SUPPLEMENTARY INFORMATION:
I. Background
On October 31, 1988, the Congress
enacted the Clinical Laboratory
Improvement Amendments of 1988
(CLIA), Public Law 100–578. CLIA
amended section 353 of the Public
Health Service Act. We issued a final
rule implementing the accreditation
provisions of CLIA on July 31, 1992 (57
FR 33992). Under the CLIA program,
CMS may grant deeming authority to an
accreditation organization that accredits
clinical laboratories if the organization
meets certain requirements. Among
other requirements, an organization’s
requirements for laboratories accredited
under its program must be equal to or
more stringent than the applicable CLIA
program requirements in 42 CFR part
E:\FR\FM\19DEN1.SGM
19DEN1
Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Notices
493 (Laboratory Requirements). This
requirement and others in subpart E of
that part (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 approved
by CMS as an accreditation organization
under CLIA.
II. Notice of Approval of Deeming
Authority for ASHI in the Subspecialty
of General Immunology
In this notice, we approve ASHI as an
organization that may accredit
laboratories for purposes of establishing
their compliance with CLIA
requirements in the subspecialty of
General Immunology. We have
examined the initial ASHI application
and all subsequent submissions to
determine their accreditation program’s
equivalency with the requirements for
approval of an accreditation
organization under subpart E of part
493. We have determined that ASHI
meets or exceeds the applicable CLIA
requirements. We have also determined
that the ASHI program will ensure that
its accredited laboratories will meet or
exceed the applicable requirements in
subparts H, K and M. Therefore, by this
notice we grant ASHI approval as an
accreditation organization under
subpart E of part 493, for the period
stated in the ‘‘Effective Date’’ section of
this notice for the subspecialty area of
General Immunology. As a result of this
determination, any laboratory that is
accredited by ASHI during the time
period stated in the ‘‘Effective Date’’
section of this notice for the approved
subspecialty of General Immunology is
deemed to meet the CLIA requirements
for laboratories found in part 493 of our
regulations and, therefore, is generally
not subject to routine inspections 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
CMS, or its agent(s).
III. Evaluation of ASHI Request for
Approval as an Accreditation
Organization Under CLIA in the
Subspecialty of General Immunology
The following describes the process
used to determine that the ASHI
accreditation program for the
subspecialty of General Immunology
met the necessary requirements to be
approved by CMS, and that, as such,
CMS may approve ASHI as an
accreditation program with deeming
authority under the CLIA program.
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• ASHI formally applied to CMS for
approval as an accreditation
organization under CLIA for the
subspecialty of General Immunology. In
reviewing these materials, CMS found
as follows for each applicable subpart of
the CLIA regulations:
Subpart E—Accreditation by a Private,
Nonprofit Accreditation Organization or
Exemption Under an Approved State
Laboratory Program
ASHI submitted its mechanism for
monitoring compliance with all
requirements equivalent to conditionlevel requirements within the scope of
the subspecialty area of General
Immunology; a list of all its current
laboratories and the expiration date of
their accreditation; and a detailed
comparison of the individual
accreditation requirements with the
comparable condition-level
requirements. ASHI’s proposed policies
and procedures for oversight of
laboratories performing General
Immunology testing would be the same
as those previously approved by CMS
for laboratory oversight in the matters of
inspection, monitoring proficiency
testing (PT) performance, investigating
complaints, and making PT information
available. ASHI’s proposed
requirements for monitoring and
inspecting General Immunology
laboratories would be the same as those
previously approved by CMS for
laboratories in the areas of accreditation
organization data management, the
inspection process, procedures for
removal or withdrawal of accreditation,
notification requirements, and
accreditation organization resources.
The requirements of ASHI are equal to
the requirements of the CLIA
regulations.
ASHI’s application and supplemental
materials demonstrate that ASHI’s
accreditation program for General
Immunology met the subpart E
requirements.
Subpart H—Participation in Proficiency
Testing for Laboratories Performing
Nonwaived Testing
ASHI’s application materials
demonstrate that the requirements in
ASHI’s accreditation program for the
subspecialty of General Immunology are
equal to the CLIA requirements at
§ 493.837. Both CLIA regulations and
ASHI standards require accredited
laboratories to participate in a CMSapproved PT program for any of the
tests listed in subpart I. Additionally,
ASHI’s requirements exceed the CLIA
requirements in that it requires
laboratories to participate in nonregulated PT programs when available.
PO 00000
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Fmt 4703
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77703
ASHI’s application and supplemental
materials demonstrate that ASHI’s
accreditation program for General
Immunology met or exceeds the subpart
H requirements.
Subpart K—Quality System for
Nonwaived Testing
The quality control requirements of
ASHI have been evaluated against the
requirements of the CLIA regulations.
ASHI standards contain additional,
specific quality control requirements for
General Immunology testing. Therefore,
the ASHI requirements are more
stringent than the CLIA requirements at
§ 493.1208.
ASHI’s application and supplemental
materials demonstrate that ASHI’s
accreditation program for General
Immunology exceeds the subpart K
requirements.
Subpart M—Personnel for Nonwaived
Testing
We have determined that the ASHI
requirements are equal to the CLIA
requirements at § 493.1441 through
§ 493.1495 (applicable to laboratories
performing testing in the subspecialty of
General Immunology).
ASHI’s application and supplemental
materials demonstrate that ASHI’s
accreditation program for General
Immunology met the subpart M
requirements.
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 CMS 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 ASHI, for
cause, before the end of the effective
date of approval. If we determine that
ASHI has failed to adopt, maintain and
enforce requirements that are equal to,
or more stringent than, the CLIA
requirements, or that systemic problems
exist in its monitoring, inspection or
enforcement processes, we may impose
a probationary period, not to exceed 1
year, in which ASHI would be allowed
E:\FR\FM\19DEN1.SGM
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77704
Federal Register / Vol. 73, No. 245 / Friday, December 19, 2008 / Notices
to address any identified issues. Should
ASHI be unable to address the identified
issues within that time frame, CMS may,
in accordance with the applicable
regulations, revoke ASHI’s deeming
authority under CLIA.
Should circumstances result in our
withdrawal of 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, and the
implementing regulations in 42 CFR
part 493, subpart E, are currently
approved under OMB control number
0938–0686.
Authority: Section 353(p) of the Public
Health Service Act (42 U.S.C. 263a).
Dated: December 4, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare
& Medicaid Services.
[FR Doc. E8–29659 Filed 12–18–08; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Centers for Medicare & Medicaid
Services
[CMS–2274–N]
RIN 0938–AP09
Medicaid Program; Fiscal Year
Disproportionate Share Hospital
Allotments and Disproportionate Share
Hospital Institutions for Mental
Disease Limits
AGENCY: Centers for Medicare &
Medicaid Services (CMS), HHS
ACTION: Notice.
SUMMARY: This notice announces the
final Federal share disproportionate
share hospital (DSH) allotments for
Federal fiscal year (FFY) 2007 and the
preliminary Federal share DSH
allotments for FFY 2009. This notice
also announces the final FFY 2007 and
the preliminary FFY 2009 limitations on
aggregate DSH payments that States may
make to institutions for mental disease
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17:29 Dec 18, 2008
Jkt 217001
and other mental health facilities. In
addition, this notice includes
background information describing the
methodology for determining the
amounts of States’ FFY DSH allotments.
DATES: Effective Date: This notice is
effective on 60 days after the date of
publication in the Federal Register. The
final allotments and limitations set forth
in this notice are effective for the fiscal
years specified.
FOR FURTHER INFORMATION CONTACT:
Richard Strauss, (410) 786–2019.
SUPPLEMENTARY INFORMATION:
I. Background
A. Disproportionate Share Hospital
Allotments for Federal Fiscal Year 2003
Under section 1923(f)(3) of the Social
Security Act (the Act), States’ Federal
fiscal year (FFY) 2003 disproportionate
share hospital (DSH) allotments were
calculated by increasing the amounts of
the FFY 2002 allotments for each State
(as specified in the chart, entitled ‘‘DSH
Allotment (in millions of dollars),’’
contained in section 1923(f)(2) of the
Act) by the percentage change in the
Consumer Price Index for all Urban
Consumers (CPI–U) for the prior fiscal
year. The allotment, determined in this
way, is subject to the limitation that an
increase to a State’s DSH allotment for
a fiscal year cannot result in the DSH
allotment exceeding the greater of the
State’s DSH allotment for the previous
fiscal year or 12 percent of the State’s
total medical assistance expenditures
for the allotment year (this is referred to
as the 12 percent limit).
Most States’ actual FY 2002
allotments were determined in
accordance with the provisions of
section 1923(f)(4) of the Act. However,
as indicated previously, the calculation
of States’ FFY 2003 allotments was not
based on the actual FFY 2002 DSH
allotments; rather, section 1923(f)(3) of
the Act requires that the States’ FY 2003
allotments be determined using the
amount of the States’ FY 2002
allotments specified in the chart in
section 1923(f)(2) of the Act. The
exception to this is the calculation of
the FFY 2003 DSH allotments for certain
‘‘Low-DSH States’’ (defined in section
1923(f)(5) of the Act). Under the LowDSH State provision, there is a special
calculation methodology for the LowDSH States only. Under this
methodology, the FFY 2003 allotments
were determined by using (that is,
increasing) States’ actual FFY 2002 DSH
allotments (not their FFY 2002
allotments specified in the chart in
section 1923(f)(2) of the Act) by the
percentage change in the CPI–U for the
previous fiscal year.
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Fmt 4703
Sfmt 4703
B. DSH Allotments for FFY 2004
Section 1001(a) of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) (Pub.
L. 108–173, enacted on December 8,
2003) amended section 1923(f)(3) of the
Act to provide for a ‘‘Special,
Temporary Increase in Allotments on a
One-Time, Non-Cumulative Basis.’’
Under this provision, States’ FFY 2004
DSH allotments were determined by
increasing their FFY 2003 allotments by
16 percent, and the fiscal year DSH
allotment amounts so determined were
not subject to the 12 percent limit.
C. DSH Allotments for Non-Low DSH
States for FFY 2005, and Fiscal Years
Thereafter
Under the methodology contained in
section 1923(f)(3)(C) of the Act, as
amended by section 1001(a)(2) of the
MMA, the non-Low-DSH States’ DSH
allotments for FFY 2005 and subsequent
fiscal years continue at the same level
as the States’ DSH allotments for FFY
2004 until a ‘‘fiscal year specified’’
occurs. The ‘‘fiscal year specified’’ is the
first fiscal year for which the Secretary
estimates that a State’s DSH allotment
equals (or no longer exceeds) the DSH
allotment as would have been
determined under the statute in effect
before the enactment of the MMA. We
determine whether the fiscal year
specified has occurred under a special
parallel process. Specifically, under this
parallel process, a ‘‘parallel’’ DSH
allotment is determined for FFYs after
2003 by increasing the State’s DSH
allotment for the previous fiscal year by
the percentage change in the CPI–U for
the prior fiscal year, subject to the 12
percent limit. This is the methodology
as would otherwise have been applied
under section 1923(f)(3)(A) of the Act
notwithstanding the application of the
provisions of MMA. The ‘‘fiscal year
specified,’’ is the fiscal year in which
the parallel DSH allotment calculated
under this special parallel process
finally equals or exceeds the FY 2004
DSH allotment, as determined under the
MMA provisions. Once the fiscal year
specified occurs for a State, that State’s
fiscal year DSH allotment will be
calculated by increasing the State’s
previous actual fiscal year DSH
allotment (which would be equal to the
FY 2004 DSH allotment) by the
percentage change in the CPI–U for the
previous fiscal year, subject to the 12
percent limit. The following example
illustrates how the fiscal year DSH
allotment would be calculated for fiscal
years after FFY 2004.
Example—In this example, we are
determining the parallel FFY 2009 DSH
E:\FR\FM\19DEN1.SGM
19DEN1
]]>Agencies
[Federal Register Volume 73, Number 245 (Friday, December 19, 2008)]
[Notices]
[Pages 77702-77704]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: E8-29659]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2295-N]
RIN 0938-AP20
Deeming Notice for American Society for Histocompatibility and
Immunogenetics (ASHI) as an Accrediting Organization Under the Clinical
Laboratory Improvement Amendments of 1988
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The American Society for Histocompatibility and Immunogenetics
(ASHI) was granted deeming authority as an accrediting organization for
clinical laboratories under the Clinical Laboratory Improvement
Amendments of 1988 (CLIA) program on March 25, 2005. The deeming
authority was granted for the CLIA specialty of Histocompatibility and
the subspecialty ABO/Rh. In this notice, we approve and grant ASHI
deeming authority for the additional CLIA subspecialty of General
Immunology.
DATES: Effective Date: This notice is effective from December 19, 2008
until March 25, 2011.
FOR FURTHER INFORMATION CONTACT: Penelope Meyers, (410) 786-3366.
SUPPLEMENTARY INFORMATION:
I. Background
On October 31, 1988, the Congress enacted the Clinical Laboratory
Improvement Amendments of 1988 (CLIA), Public Law 100-578. CLIA amended
section 353 of the Public Health Service Act. We issued a final rule
implementing the accreditation provisions of CLIA on July 31, 1992 (57
FR 33992). Under the CLIA program, CMS may grant deeming authority to
an accreditation organization that accredits clinical laboratories if
the organization meets certain requirements. Among other requirements,
an organization's requirements for laboratories accredited under its
program must be equal to or more stringent than the applicable CLIA
program requirements in 42 CFR part
[[Page 77703]]
493 (Laboratory Requirements). This requirement and others in subpart E
of that part (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
approved by CMS as an accreditation organization under CLIA.
II. Notice of Approval of Deeming Authority for ASHI in the
Subspecialty of General Immunology
In this notice, we approve ASHI as an organization that may
accredit laboratories for purposes of establishing their compliance
with CLIA requirements in the subspecialty of General Immunology. We
have examined the initial ASHI application and all subsequent
submissions to determine their accreditation program's equivalency with
the requirements for approval of an accreditation organization under
subpart E of part 493. We have determined that ASHI meets or exceeds
the applicable CLIA requirements. We have also determined that the ASHI
program will ensure that its accredited laboratories will meet or
exceed the applicable requirements in subparts H, K and M. Therefore,
by this notice we grant ASHI approval as an accreditation organization
under subpart E of part 493, for the period stated in the ``Effective
Date'' section of this notice for the subspecialty area of General
Immunology. As a result of this determination, any laboratory that is
accredited by ASHI during the time period stated in the ``Effective
Date'' section of this notice for the approved subspecialty of General
Immunology is deemed to meet the CLIA requirements for laboratories
found in part 493 of our regulations and, therefore, is generally not
subject to routine inspections 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 CMS, or its agent(s).
III. Evaluation of ASHI Request for Approval as an Accreditation
Organization Under CLIA in the Subspecialty of General Immunology
The following describes the process used to determine that the ASHI
accreditation program for the subspecialty of General Immunology met
the necessary requirements to be approved by CMS, and that, as such,
CMS may approve ASHI as an accreditation program with deeming authority
under the CLIA program.
ASHI formally applied to CMS for approval as an
accreditation organization under CLIA for the subspecialty of General
Immunology. In reviewing these materials, CMS found as follows for each
applicable subpart of the CLIA regulations:
Subpart E--Accreditation by a Private, Nonprofit Accreditation
Organization or Exemption Under an Approved State Laboratory Program
ASHI submitted its mechanism for monitoring compliance with all
requirements equivalent to condition-level requirements within the
scope of the subspecialty area of General Immunology; a list of all its
current laboratories and the expiration date of their accreditation;
and a detailed comparison of the individual accreditation requirements
with the comparable condition-level requirements. ASHI's proposed
policies and procedures for oversight of laboratories performing
General Immunology testing would be the same as those previously
approved by CMS for laboratory oversight in the matters of inspection,
monitoring proficiency testing (PT) performance, investigating
complaints, and making PT information available. ASHI's proposed
requirements for monitoring and inspecting General Immunology
laboratories would be the same as those previously approved by CMS for
laboratories in the areas of accreditation organization data
management, the inspection process, procedures for removal or
withdrawal of accreditation, notification requirements, and
accreditation organization resources. The requirements of ASHI are
equal to the requirements of the CLIA regulations.
ASHI's application and supplemental materials demonstrate that
ASHI's accreditation program for General Immunology met the subpart E
requirements.
Subpart H--Participation in Proficiency Testing for Laboratories
Performing Nonwaived Testing
ASHI's application materials demonstrate that the requirements in
ASHI's accreditation program for the subspecialty of General Immunology
are equal to the CLIA requirements at Sec. 493.837. Both CLIA
regulations and ASHI standards require accredited laboratories to
participate in a CMS-approved PT program for any of the tests listed in
subpart I. Additionally, ASHI's requirements exceed the CLIA
requirements in that it requires laboratories to participate in non-
regulated PT programs when available.
ASHI's application and supplemental materials demonstrate that
ASHI's accreditation program for General Immunology met or exceeds the
subpart H requirements.
Subpart K--Quality System for Nonwaived Testing
The quality control requirements of ASHI have been evaluated
against the requirements of the CLIA regulations. ASHI standards
contain additional, specific quality control requirements for General
Immunology testing. Therefore, the ASHI requirements are more stringent
than the CLIA requirements at Sec. 493.1208.
ASHI's application and supplemental materials demonstrate that
ASHI's accreditation program for General Immunology exceeds the subpart
K requirements.
Subpart M--Personnel for Nonwaived Testing
We have determined that the ASHI requirements are equal to the CLIA
requirements at Sec. 493.1441 through Sec. 493.1495 (applicable to
laboratories performing testing in the subspecialty of General
Immunology).
ASHI's application and supplemental materials demonstrate that
ASHI's accreditation program for General Immunology met the subpart M
requirements.
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
CMS 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 ASHI, for cause, before the
end of the effective date of approval. If we determine that ASHI has
failed to adopt, maintain and enforce requirements that are equal to,
or more stringent than, the CLIA requirements, or that systemic
problems exist in its monitoring, inspection or enforcement processes,
we may impose a probationary period, not to exceed 1 year, in which
ASHI would be allowed
[[Page 77704]]
to address any identified issues. Should ASHI be unable to address the
identified issues within that time frame, CMS may, in accordance with
the applicable regulations, revoke ASHI's deeming authority under CLIA.
Should circumstances result in our withdrawal of 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, and the implementing regulations in 42 CFR part
493, subpart E, are currently approved under OMB control number 0938-
0686.
Authority: Section 353(p) of the Public Health Service Act (42
U.S.C. 263a).
Dated: December 4, 2008.
Kerry Weems,
Acting Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. E8-29659 Filed 12-18-08; 8:45 am]
BILLING CODE 4120-01-P
