Policy & Data Reporting Guidance for CMS-2226-F

On January 8, 2004, the memorandum entitled “Clinical Laboratory Improvement Amendments (CLIA) Policy and Data Reporting Guidance for First Survey Cycle Following the Effective Date of CMS-2226-F” was sent to all State Agency Directors.  For a copy of the memorandum, see the link in the Download section below.

This memorandum provided official notification to the State Survey Agencies (SAs) and the Centers for Medicare & Medicaid Services (CMS) regional offices of the date to begin using the revised regulations, interpretive guidelines and survey protocols to implement CMS-2226-F (“Medicare, Medicaid, and CLIA Programs; Laboratory Requirements Relating to Quality Systems and Certain Personnel Qualifications,” 68 FR 3640).  The memorandum contained the following information that are found as downloads below:

• Survey and Certification 03-33 policy letter, dated 08/14/2003;

• Guidance on the laboratory survey protocol for first cycle surveys;

• ASPEN Survey Explorer updates to include the current CLIA regulations and the associated Interpretive Guidelines;

• CLIA Deficiency Crosswalk to accommodate “new” D tags; and

• Special Data Reporting for tracking deficiency citations (Dtag Exclusions).

On July 14, 2005, the CLIA policy letters for first survey cycle following the effective date of CMS-2226-F were revised and are listed in a download below.

Also, listed below as a download are the following:

• a follow-up to last year's QC for the Future Meeting;
• the November 30, 2007 Dear Colleague letter about the adjustment to educational CLIA QC policies; 
• the August 24, 2007 memorandum to State Survey Agency Directors about Continuation and Revision of the Components of the Clinical Laboratory Improvement Amendments (CLIA) Educational Period Regarding Certain Quality Control (QC) Requirements; and
• the attachments to the August 24, 2007 memorandum to the State Agency Directors.