Laboratory Standards
and Regulations
Introduction
This manual will outline the Clinical Laboratory Improvement Act (CLIA)
compliance requirements for clinical laboratories engaged in the practice
of flow cytometry. The legislation requirements are based on the complexity
of the laboratory testing. Flow cytometry is considered high complexity
testing. The recommendations in this manual will apply to high complexity
testing and will give instructions and forms for complying with the personnel,
quality control, proficiency testing, and quality assurance requirements.
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CD-ROM Vol 4 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 cdrominfo@flowcyt.cyto.purdue.edu