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