Details:

Personal Author:
Howerton, Devery A. ; Anderson, Nancy L. ; Bosse, Diane ; Granade, Sharon ; Westbrook, Glennis
Howerton, Devery A. ; Anderson, Nancy L. ; Bosse, Diane ; Granade, Sharon ; Westbrook, Glennis Less -
Corporate Authors:
Centers for Disease Control and Prevention (U.S.), Clinical Laboratory Improvement Advisory Committee. ; Centers for Disease Control and Prevention (U.S.) ; National Center for Health Marketing (U.S.)
Centers for Disease Control and Prevention (U.S.), Clinical Laboratory Improvement Advisory Committee. ; Centers for Disease Control and Prevention (U.S.) ; National Center for Health Marketing (U.S.) Less -
Description:
"Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), simple, low-risk tests can be waived and performed with no routine regulatory oversight in physicians' offices and various other locations. Since CLIA was implemented, waived testing has steadily increased in the United States. Surveys conducted during 1999-2004 by the Centers for Medicare & Medicaid Services and studies funded by CDC during 1999-2003 evaluated testing practices in sites holding a CLIA Certificate of Waiver (CW). Although study findings indicate CW sites generally take measures to perform testing correctly, they raise quality concerns about practices that could lead to errors in testing and poor patient outcomes. These issues are probably caused, in part, by high personnel turnover rates, lack of understanding about good laboratory practices, and inadequate training. This report summarizes study findings and provides recommendations developed by the Clinical Laboratory Improvement Advisory Committee for conducting quality waived testing. These recommendations include considerations before introducing waived testing, such as management responsibility for testing, regulatory requirements, safety, physical and environmental requirements, benefits and costs, staffing, and documentation. They also cover good laboratory practices for the three phases of testing: 1) before testing (test ordering and specimen collection), 2) during testing (control testing, test performance, and result interpretation and recording), and 3) after testing (result reporting, documentation, confirmatory testing, and biohazard waste disposal). They are intended to be used by those who would benefit from improving their knowledge of good laboratory practices. Continued monitoring of waived testing, with a focus on personnel education and training, is needed to improve practices and enhance patient safety as waived testing continues to increase. ... this report presents recommendations developed by the Clinical Laboratory Improvement Advisory Committee (CLIAC) for improving the quality of waived testing." - p. 1.
Content Notes:
prepared by Devery Howerton, Nancy Anderson, Diane Bosse, Sharon Granade, Glennis Westbrook.

Includes bibliographical references (p. 19-20).


Subjects:
[+]
Certification Clinical Laboratory Techniques Laboratory Techniques And Procedures Quality Assurance, Health Care Quality Control Standards
Series:
MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports ; v. 54, no. RR-13
Pubmed ID:
16280973
Document Type:
Journal Issue
Name as Subject:
United States
Collection(s):
Guidelines and Recommendations Stephen B. Thacker CDC Library collection
Main Document Checksum:
[+]
urn:sha256:c82d53b6f059bca7d656ca1ed38b680cbe4e247662145726b0f543dd08281616
Download URL:
https://stacks.cdc.gov/view/cdc/6661/cdc_6661_DS1.pdf
File Type:

Supporting Files

• No Additional Files

More +