Appendix C
Survey Procedures and Interpretive Guidelines for
Laboratories and Laboratory Services
The items listed below replace the current Publication 7, Appendix C,
Survey Procedures and Interpretive Guidelines for Laboratories and
Laboratory Services. This material was rewritten due to publication of
CMS- 2226-F: 42 CFR 493 Medicare, Medicaid, and CLIA Programs;
Laboratory Requirements Relating to Quality Systems and Certain
Personnel Qualifications; Final Rule on January 24, 2003, with an
effective date of April 24, 2003.
1. Policy for Conducting Surveys PDF
270K
2. Index and Subparts A-H [General
Provisions, Certificates and Proficiency Testing] of the CLIA
regulations - Sections 493.1 through 493.865 PDF 925K
3. Subpart J [Facility Administration]
- Sections 493.1100 through 493.1105 PDF 211K
4. Subpart K, Part 1 [Quality System
for Nonwaived Testing; General Laboratory Systems, Preanalytic Systems
& Analytic Systems (general requirements)] - Sections 493.1200
through 493.1256 PDF 700K
5. Subpart K, Part 2 [Quality System
for Nonwaived Testing; Analytic Systems (specialty and subspecialty
requirements) and Postanalytic Systems] - Sections 493.1261 through
493.1299 PDF 1.2MB
6. Subpart M [Personnel] - Sections
493.1351 through 493.1495 PDF 585K
7. Subpart Q [Inspection] - Sections
493.1771 through 493.1780 PDF 137K
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Last Modified on Thursday, September 16, 2004
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