[Federal Register Volume 75, Number 154 (Wednesday, August 11, 2010)]
[Notices]
[Page 48698]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2010-19675]
[[Page 48698]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Centers for Medicare & Medicaid Services
[CMS-2363-N]
Medicare, Medicaid and CLIA Programs; COLA (Formerly the
Commission on Office Laboratory Accreditation) Voluntary Withdrawal
From the Specialty of Pathology
AGENCY: Centers for Medicare & Medicaid Services (CMS), HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: This notice announces COLA's voluntary withdrawal from the
specialty of Pathology. COLA is an accreditation organization for
clinical laboratories under the Clinical Laboratory Improvement
Amendments (CLIA) program.
DATES: Effective Date: This notice is effective on August 27, 2010.
FOR FURTHER INFORMATION CONTACT: Raelene Perfetto, (410) 786-6876.
SUPPLEMENTARY INFORMATION:
I. Background
In a Federal Register notice published on February 23, 2007(72 FR
8171), we granted COLA approval as an accreditation organization under
42 CFR part 493 subpart E. The approval was effective from February 23,
2007 until February 25, 2013. During this time, COLA was allowed to
accredit laboratories for purposes of establishing their compliance
with CLIA requirements in the following specialty and subspecialty
areas:
Microbiology, including Bacteriology, Mycobacteriology,
Mycology, Parasitology, Virology.
Diagnostic Immunology, including Syphilis Serology,
General Immunology.
Chemistry, including Routine Chemistry, Urinalysis,
Endocrinology, Toxicology.
Hematology.
Immunohematology, Including ABO Group and Rh Group,
Antibody Detection, Antibody Identification, Compatibility Testing.
Pathology, including Histopathology, Oral Pathology,
Cytology.
In a letter dated June 15, 2010, COLA provided official notice of
its intent to voluntarily withdraw from accreditation in the specialty
of Pathology. This withdrawal was effective June 30, 2010. All
laboratories accredited by COLA in the specialty of Pathology (to
include Histopathology, Oral Pathology or Cytology) will have 60 days
from the date of this Federal Register notice to seek either CLIA
inspection by the State Agency where the laboratory is located or
accreditation with another accrediting organization that is currently
CMS-approved for the specialty of Pathology.
This notice only addresses COLA's accreditation for the specialty
of Pathology. As discussed below, COLA's accreditation status in the
other specialties is not affected by this notice.
II. Provisions of the Notice
This notice announces COLA's withdrawal as an accreditation
organization from the specialty of Pathology. COLA retains deeming
authority as an accreditation organization under 42 CFR part 493
subpart E in a number of specialties. It may continue to accredit
laboratories for purposes of establishing their compliance with CLIA
requirements in the following specialty and subspecialty areas:
Microbiology, including Bacteriology, Mycobacteriology,
Mycology, Parasitology, Virology.
Diagnostic Immunology, including Syphilis Serology,
General Immunology.
Chemistry, including Routine Chemistry, Urinalysis,
Endocrinology, Toxicology.
Hematology.
Immunohematology, including ABO Group and Rh Group,
Antibody Detection, Antibody Identification, Compatibility Testing.
A. Options for Laboratories Testing in Both Pathology and Other
Specialties and Subspecialties
Laboratories currently accredited by COLA and performing testing in
both the specialty of Pathology (to include Histopathology, Oral
Pathology, or Cytology) and the other specialties and subspecialties
for which COLA retains deeming authority may choose one of the
following courses of action:
Remain with COLA for purposes of the accreditation of non-
Pathology specialties and subspecialties only and seek accreditation
services for Pathology from another CMS-approved accrediting
organization. The Certificate of Accreditation (CoA) will remain.
Seek certification for all applicable specialties and
subspecialties from the State Agency where the laboratory is located. A
laboratory may not combine accreditation from a CMS-approved
accrediting organization with a certification from the State Agency
where the laboratory is located. Laboratories must seek a single path,
either accreditation through one or more accreditation organizations
with the appropriate deeming authorities, or certification through the
appropriate State Agency.
B. Options for Laboratories Testing Only in Pathology
Laboratories currently accredited by COLA and performing testing in
only the specialty of Pathology (to include Histopathology, Oral
Pathology or Cytology) have the following options:
Seek CLIA accreditation with another CMS-approved
accrediting organization that currently possesses deeming authority in
the specialty of Pathology.
Seek certification with the State Agency where the
laboratory is located.
III. Collection of Information Requirements
This document does not impose information collection and
recordkeeping requirements. Consequently, it need not be reviewed by
the Office of Management and Budget under the authority of the
Paperwork Reduction Act of 1995.
Authority: Section 353 of the Public Health Service Act (42
U.S.C. 263a).
(Catalog of Federal Domestic Assistance Program No. 93.773,
Medicare--Hospital Insurance Program; No. 93.774, Medicare--
Supplementary Medical Insurance Program; and No. 93.778, Medical
Assistance Program.)
Dated: July 27, 2010.
Donald M. Berwick,
Administrator, Centers for Medicare & Medicaid Services.
[FR Doc. 2010-19675 Filed 8-10-10; 8:45 am]
BILLING CODE 4120-01-P