48698 Federal Register / Vol. 75, No. 154 / Wednesday, August 11, 2010 / Notices 

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 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Health Resources and Services 

Administration 

National Advisory Council on Migrant 

Health; Notice of Meeting 

In accordance with section 10(a)(2) of 

the Federal Advisory Committee Act 

(Pub. L. 92–463), notice is hereby given 

of the following meeting: 

Name: National Advisory Council on 

Migrant Health. 

Dates and Times: October 19, 2010, 8:30 

a.m. to 5 p.m. October 20, 2010, 8:30 a.m. to 

5 p.m. 

Place: Charleston Marriott Hotel, 170 

Lockwood Boulevard, Charleston, South 

Carolina 29403, Telephone: 800–968–3569, 

Fax: 843–723–0276. 

Status: The meeting will be open to the 

public. 

Purpose: The purpose of the meeting is to 

discuss services and issues related to the 


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