Details:

Personal Author:
Lawson, Herschel W. ; Ridderhof, John C. ; Whalen, Rhonda S.
Lawson, Herschel W. ; Ridderhof, John C. ; Whalen, Rhonda S. Less -
Corporate Authors:
Centers for Disease Control and Prevention (U.S.) ; Centers for Disease Control and Prevention (U.S.), Public Health Practice Program Office., Division of Laboratory Systems. ; National Center for Chronic Disease Prevention and Health Promotion (U.S.), Division of Cancer Prevention and Control.
Centers for Disease Control and Prevention (U.S.) ; Centers for Disease Control and Prevention (U.S.), Public Health Practice Program Office., Division of Laboratory Systems. ; National Center for Chronic Disease Prevention and Health Promotion (U.S.), Division of Cancer Prevention and Control. Less -
Description:
The Papanicolaou test--or Pap smear test--is one of the most effective cancer screening tests available, and its ability to detect premalignant conditions has contributed to the decline in cervical cancer morbidity and mortality in the United States since its development in 1941. The success of this screening test has created confidence among women, health-care providers, and public health officials. However, this screening tool is not perfect: false-negative findings are a special concern because they can delay necessary follow-up of and treatment for women who have cervical cancer precursor lesions or invasive cervical cancer. Recent media attention has focused on cytology laboratories that have been closed as a result of deficiencies (including a high proportion of false-negative reports), and in some states legal action has been taken against individual laboratories. With the advent of revised federal regulations implementing the Clinical Laboratory Improvement Amendments (CLIA) of 1988, scrutiny of the quality of cytology laboratory practice has increased. Between 1992 and 1994, a total of 10 cytology laboratories were closed by regulatory action of the Health Care Financing Administration because they were considered a threat to the public's health. Although such closures represent <1% of CLIA-certified cytology laboratories, the attendant publicity may trigger anxiety among women. Public health officials must respond to those concerns with appropriate clinical and community actions to ensure the health and safety of women whose Pap smears were evaluated by the closed laboratories. There are no published recommendations to help develop a public health response to the regulatory closure of a cervical cytology laboratory. In April 1994, the Association of State and Territorial Public Health Laboratory Directors, through a cooperative agreement with CDC, convened a working group to provide background on the current practice of clinical cervical cytology in the United States, summarize the CLIA regulations that established specific quality assurance standards for this specialty, and recommend actions that a public health agency may initiate to deliver a measured response to laboratory closings and other regulatory sanctions. This report includes this background and summary of the workshop. The working group made three recommendations: (a) public health officials should plan for a cervical cytology laboratory closure, then, when a laboratory is closed by regulatory action, they should (b) assess the severity of the situation and determine an appropriate response and (c) provide accurate, timely information to the public.

Includes bibliographical references (p. 14-15).


Content Notes:
The following CDC staff prepared this report: Herschel W. Lawson, Division of Cancer Prevention and Control, National Center for Chronic Disease Prevention and Health Promotion; John C. Ridderhof, Rhonda S. Whalen, Division of Laboratory Systems, Public Health Practice Program Office.
Subject:
[+]
Cell Biology
False Negative Reactions
Health Facility Closure
Laboratories
Mass Screening
Prevention & Control
Public Health
Quality Control
Standards
Uterine Cervical Neoplasms
Vaginal Smears
Cell Biology/Legislation/United States
Cell Biology/Standards/United States
Laboratories/Legislation/United States
Laboratories/Standards/United States
Uterine Cervical Neoplasms/Prevention & Control
Vaginal Smears/Standards

Series:
MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports ; v. 46, no. RR-17
Pubmed ID:
9409538
Document Type:
Journal Issue
Genre:
Legislation ; Legislation
Legislation ; Legislation Less -
Place as Subject:
United States
Collection(s):
Stephen B. Thacker CDC Library collection
Main Document Checksum:
[+]
urn:sha256:79ba07d915a1e3d27ea7df16c4c04238e1119a0a2015680ced2d4f5288975e57
File Type:

Supporting Files

• No Additional Files

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