Flow Cytometry

CLIA Compliance Manual

Prepared for the International Society for Analytical Cytometry

Table of Contents

Anne Hurley, PhD, MT(ASCP)SC
Denise Zito, B.S., MT(ASCP)SI


The 105th Congress of the United States, convened after the January 1997 inauguration of President Clinton, is set to consider many issues affecting clinical laboratory science in general and cytometry laboratories in particular. Conformation to the provisions of the Clinical Laboratory Improvement Act (CLIA), Medicare fee schedule changes, manpower funding, and reimbursement issues will all come under Congressional scrutiny. 1997 will likely prove a crucial year for clinical laboratories and the health care industry.
Because of this fluid regulatory environment, the Flow Cytometry CLIA Compliance Manual has been written to help make sense of the CLIA requirements and give laboratories a clear format by which to monitor Quality Assurance and Quality Control. This manual outlines compliance requirements for clinical laboratories engaged in the practice of flow cytometry, which is considered "high complexity." Since the legislative requirements are based on the complexity of the laboratory testing, recommendations in this manual apply to high-complexity testing; instructions and forms are provided for complying with the personnel, quality control, proficiency testing, and quality assurance requirements.
We hope the explanations put forth here will help cytometry laboratories meet these regulatory requirements with greater ease, so that they may focus with more clarity on the quality of patients' results.

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CD-ROM Vol 3 was produced by Monica M. Shively and other staff at the Purdue University Cytometry Laboratories and distributed free of charge as an educational service to the cytometry community. If you have any comments please direct them to Dr. J. Paul Robinson, Professor & Director, PUCL, Purdue University, West Lafayette, IN 47907. Phone:(765) 494-0757; FAX (765) 494-0517; Web http://www.cyto.purdue.edu, EMAIL cdrom3@flowcyt.cyto.purdue.edu