[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]]

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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.

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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