ALL COLA LABORATORIES WILL BE REQUIRED TO IMPLEMENT THE
NEW CRITERIA BEGINNING JUNE 1, 2007
COLA is the first organization to be renewed since increased
government scrutiny of survey organizations and will be 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 will incorporate 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 existing 299 questions. Some of the new program
features for laboratories in 2007 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
Sessions at the Symposium for Clinical Laboratories held in San Diego
Special Edition of Insights
Reporting Device-Related Adverse Events to the FDA
ALL COLA LABORATORIES WILL BE REQUIRED TO IMPLEMENT THE NEW CRITERIA
BEGINNING JUNE 1, 2007.
COLA to Incorporate New Standard Program Requirements that Coincide
with Updated CLIA Requirements
