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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