Interpretive Guidelines for Laboratories

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 Clinical Laboratory Improvement Amendments (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.  Refer to the downloads below for the following sections:

1. Policy for Conducting Surveys;
2. Index and Subparts A-H contain the General Provisions, Certificates and Proficiency Testing Sections of the CLIA regulations [Sections 493.1 through 493.865];
3. Subpart J contains the Facility Administration sections of the CLIA regulations [Sections 493.1100 through 493.1105];
4. Subpart K, Part 1, contains the Quality System for Nonwaived Testing; General Laboratory Systems, Preanalytic Systems & Analytic Systems (general requirements) sections of the CLIA regulations [Sections 493.1200 through 493.1256];
5. Subpart K, Part 2, contains the Quality System for Nonwaived Testing; Analytic Systems (specialty and subspecialty requirements) and Postanalytic Systems sections of the CLIA regulations [Sections 493.1261 through 493.1299];
6. Subpart M contains the personnel sections of the CLIA regulations [Sections 493.1351 through 493.1495]; and
7. Subpart Q contains the Inspection section of the CLIA regulations [Sections 493.1771 through 493.1780].

On October 17, 2008, CMS released a Survey and Certification memorandum entitled “Revised CLIA Policy on Quality Control for Commercially Available Microbial Identification Systems”, S&C-09-06.  This memorandum revised the analytic system information for microbial information systems found in CMS' Interpretative Guidelines for Laboratories and Laboratory Surveyors at section 493.1256(e)(1).  Refer to the Related Links Inside CMS section for the memorandum. 

On March 1, 2010, CMS released a Survey and Certification memorandum entitled " Clinical Laboratory Improvement Amendments of 1988 (CLIA) – Issuance of Revised Survey Procedures and Interpretive Guidelines for Laboratories and Laboratory Services in Appendix C of the State Operations Manual to Facilitate the Electronic Exchange of Laboratory Information ", S&C-10-12-CLIA.  This memorandum supports the commitment of the Department of Health and Human Services and CMS to create an environment in which most Americans will have access to health information exchange and Electronic Health Records (EHR) by 2014; revised guidance at  D5305, D5811, and D5813 to offer guidance for the exchange of laboratory information by allowing laboratory results to be sent to the authorized individual and others designated by the authorized person to receive the information; and revised guidance at D3041, D5207, D5301, D5659, D5801, D5809, and D5821 to offer additional guidance when surveying laboratories using Health Information Technology for the electronic exchange of laboratory information.  Refer to the Related Links Inside CMS section for the memorandum.