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HHS/CMS

RIN: 0938-AO34

Publication ID: Fall 2010

Title: Cytology Proficiency Testing (CMS-2252-F)
Abstract: This rule revises certain Clinical Laboratory Improvement Amendments (CLIA) of 1988, including proficiency testing requirements for clinical laboratories offering cytology services and for individuals examining gynecological cytology specimens (pap smears). Revisions are also made to CMS approval requirements for programs offering proficiency testing for gynecologic cytology. Evaluating the competency of each individual who examines gynecologic cytology specimens is required by Federal law and regulations.
Agency: Department of Health and Human Services(HHS)	Priority: Other Significant
RIN Status: Previously published in the Unified Agenda	Agenda Stage of Rulemaking: Long-Term Actions
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: Action Source Description Date Final  Statutory  MMA Section 902  01/16/2012

Timetable: Action Date FR Cite NPRM  01/16/2009  74 FR 3264    NPRM Comment Period End  03/17/2009     Final Action  To Be Determined

Regulatory Flexibility Analysis Required: No	Government Levels Affected: None
Small Entities Affected: No	Federalism: No
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