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HHS/CMS

RIN: 0938-AO34

Publication ID: Fall 2008

Title: Cytology Proficiency Testing (CMS-2252-P)
Abstract: This proposed rule would revise certain Clinical Laboratory Improvement Amendments (CLIA) of 1988 proficiency testing requirements for clinical laboratories offering cytology services and individuals examining gynecological cytology specimens. Revisions would also be made to CMS-approval requirements for programs offering proficiency testing for gynecologic cytology under (CLIA) of 1988 program. Evaluating the competency of each individual who examines gynecologic cytology specimens (pap smears) is required by Federal law and regulations. Identifying these individuals is essential in providing quality patient care.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Proposed Rule Stage
Major: No	Unfunded Mandates: No
CFR Citation: 42 CFR 493
Legal Authority: 42 USC 263a, Clinical Laboratory Improvement Amendments of 1988    42 USC 1395x, secs 1861s(15) to 1861s(17)    of the Social Security Act

Legal Deadline:  None

Timetable: Action Date FR Cite NPRM  01/00/2009

Regulatory Flexibility Analysis Required: Undetermined	Government Levels Affected: None
Small Entities Affected: Businesses	Federalism: Undetermined
Included in the Regulatory Plan: No
RIN Data Printed in the FR: No
Agency Contact: Cheryl B. Wiseman Health Insurance Specialist Department of Health and Human Services Centers for Medicare & Medicaid Services Mail Stop S2-12-25, 7500 Security Boulevard, Baltimore, MD 21244 Phone:410 786-3340 Email: cheryl.wiseman@cms.hhs.gov