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COLA Incorporates New Standard Program Requirements that Coincide with Updated CLIA Requirements

ALL COLA LABORATORIES WERE REQUIRED TO IMPLEMENT THE NEW CRITERIA BEGINNING JUNE 1, 2007

COLA was the first organization to be renewed since increased government scrutiny of survey organizations and was given permission to accredit laboratories for the next six years to help labs meet CLIA requirements. The increase in oversight by CMS was driven by a government investigation in 2006 into how some highly publicized laboratory errors had occurred and could have been prevented.

COLA has incorporated new standard program requirements that coincide with updated CLIA requirements and are closely aligned with quality systems methodology. The new standard program requirements are a compilation of 75 new or revised criteria to the previously existing 299 questions. Some of the new program features for laboratories include:

  • Revised quality control requirements.
  • Increased attention to laboratory information systems.
  • New focus on quality assessments activities that span all phases of laboratory testing.
  • Incorporation of quality systems processes to all categories of the laboratory’s path of workflow.
Click here to read the Winter 2007 Insights article: "New Requirements on the Horizon"

Some of the current 299 standard and 108 Immunohematology and Transfusion service criteria have been revised in accordance with revisions to CLIA in 2003. In addition to the revisions, the criteria have been re-formatted to be aligned with Quality Management System methodology (Path of Workflow – Pre-analytic, Analytic and Post Analytic Phases).

Additional Resources

The COLA Symposium for Clinical Laboratories offers a "COLA Users Group" session on Saturday that discusses new and revised COLA criteria and processes. Click here for more information on upcoming symposia.

Special Editions of Insights: The Spring and Summer 2007 editions of the COLA Insights review the changes to COLA criteria. You may access archived editions of the Insights on the Member Site under Educational Resources > COLA Insights.

Reporting Device-Related Adverse Events to the FDA

ALL COLA LABORATORIES WERE REQUIRED TO IMPLEMENT THE NEW CRITERIA BEGINNING JUNE 1, 2007.

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