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 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
