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 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