CLIA Compliance Manual: Table of Contents

Laboratory Standards and Regulations

Table of Contents

Overview of the Rules Defining the CLIA Federal Regulation

Subpart H: Participation in Proficiency Testing (PT) for Laboratories Performing Tests of Moderate or High Complexity, or Both

Subpart I: Proficiency Testing Programs for Tests of Moderate or High Complexity, or Both

Subpart J: Patient Test Management for Moderate or High Complexity Testing, or Both

Subpart K: Quality Control (QC) for Tests of Moderate or High Complexity, or Both

Subpart M: Personnel for Moderate and High Complexity Testing

Subpart P: Quality Assurance (QA) for Moderate or High Complexity Testing, or Both

Subpart Q: Inspection

Subpart T: Consultations

Flow Cytometry Compliance

I. Introduction

II. Proficiency Testing

A. Approved PT programs
B. Documentation III. Quality Control A. Instruments and Equipment
B. Method Validation
C. Reagent Quality Control
D. Remedial Action for Test Results Reported in Error IV. Quality Assurance Documentation A. Specimens
B. Test Results
C. Personnel
D. Problem Resolution V. The Collection of Standard Forms

Back to standards & regulations

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