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 is 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 assessment activities that span all phases of
laboratory testing.
- Incorporation of quality systems processes to all specialties.
A comprehensive communications plan is underway to introduce laboratories to
the new requirements and new program features. Laboratories will have ample
opportunity to be aware of any changes to the criteria that apply to their
operation well before they are surveyed with those criteria. COLA intends to
conduct laboratory surveys based on the new requirements beginning in June 2007.
To assist labs in implementing the new criteria, COLA will offer several
educational products and resources. COLA will begin with the release of a new
COLA Accreditation Manual in March 2007. The manual will detail the new
requirements and will contain an updated self-assessment. The manual will be
available in several formats.
- Electronic version available on the website for members only to download
- Print version that will be sold
- CD ROM that will be mailed to all COLA labs.
Additional Educational Products are in production to compliment the release
of the new COLA Accreditation Manual. These include:
- Special Edition of Insights
Early this spring, the Insights Special Edition, a sixteen page overview of
the criteria changes, will be published. This edition will provide labs with
the new requirements with special articles on areas that have been impacted
the most. These targeted topics will alert readers on what to expect during
the lab's next COLA survey.
- Sessions at the Symposium for Clinical
Professional held in San Diego, California in May 2-5, 2007
All sessions will reflect updated standards and the session for the
"COLA User's Group" will detail the changes and additions to the
COLA criteria such as Equivalent Quality Control and Performance
Specifications.
- CE Express Courses
The CE Express courses will assist labs to earn continuing education units
in new and revised criteria areas such as quality assessment, performance
specifications, calibration/calibration verification, and quality control.
- Updated LabGuides
All of COLA's LabGuides are undergoing revision to reflect the new criteria
and updated CLIA 2003 requirements. As they are available, labs will be able
to download them from the members only website. They will also be available
in hard copy.
Laboratories may continue to follow the current COLA accreditation
criteria until instructed otherwise. COLA surveyors will continue to survey
laboratories according to the current COLA criteria for laboratory on-site
inspections scheduled through May 2007.
There is an increased emphasis on quality and on systemic processes in all
forms of healthcare, and the current focus on quality assessment and quality
systems in labs is just one aspect of this. What it will mean for laboratories
is an emphasis on creating and improving systems that prevent errors, rather
than correcting errors after they happen. It will mean an increased emphasis on
teamwork, and the way all aspects of the lab fit together to produce accurate
test results. At various points, the assessment process may focus on personnel,
equipment, records, purchasing, and customer service, since all of them play a
part in the final results.
Going forward, the on-site survey process will look at whole systems, rather
than single items in isolation. We'll look at the inter-connectedness of
pre-analytic systems, your analytic systems and post-analytic systems.
Laboratories should also expect a reinvigorated focus on lab director
responsibilities in the coming year. CLIA requirements for lab director have not
changed, but in recent years lab directors in certain situations have not
fulfilled their responsibilities. Ultimately the lab director has total
responsibility for oversight of the laboratory. When a lab director is involved
on a day-to-day basis in the laboratory, or has delegated certain
responsibilities to a competent, qualified person, all aspects of laboratory
performance improve.
