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clia accreditation
Alert! Changes to CLIA Accreditation, CLIA Revisions
By R. Lewis Dark | From the Volume XXX No. 2 – January 23, 2023 Issue
MEDICAL LABORATORIES HAVE LIVED WITH THE REGULATIONS FOR THE CLINICAL LABORATORY IMPROVEMENTS AMENDMENTS (CLIA) since they were first implemented in 1992. Over the past 30 years there has been no major revision or updating of CLIA regulations. Nor has there been much change in the long-standing statu…
CAP Introduces Features to Aid CLIA Inspections
By Robert Michel | From the Volume XXVIII, No. 14 – October 18, 2021 Issue
CEO SUMMARY: Clinical labs are changing in multiple ways and the College of American Pathologists regularly revises its CLIA accreditation processes in response to these changes. One such change is the growth in the number of integrated delivery networks that operate multiple hospit…
CLIA Accreditation Market: More Competitive Now?
By Robert Michel | From the Volume XXVIII, No. 10 – July 26, 2021 Issue
CEO SUMMARY: It’s been three decades since compliance with the Clinical Laboratory Improvement Amendments (CLIA) became mandatory. During that time, there has been little competition among the major organizations with deeming status by the Medicare Program to accredit labs to CLIA…
CAP Loses CLIA Accreditation Clients to Joint Commission
By Robert Michel | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
This is an excerpt of a 1,790-word article in the January 19, 2021 issue of THE DARK REPORT (TDR). The full article is available to members of The Dark Intelligence Group. CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA …
2021 Opens with a Major Story … and It’s Not COVID!
By R. Lewis Dark | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
On the pages that follow, you will learn about a major story in the clinical laboratory…
CAP Loses Accreditation Clients to Joint Commission
By Robert Michel | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
CEO SUMMARY: Over the past 18 months, several prominent national health systems decided to shift their CLIA laboratory accreditation services away from the College of American Pathologists and to The Joint Commission. These shifts from one accrediting body to another will involve hu…
Why Are Health Systems Changing CLIA Accreditors?
By Robert Michel | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
CEO SUMMARY: It is uncommon for a major health system to switch its CLIA lab accreditation business from one accrediting body to another. Yet, just in the past 18 months, that decision was made by the Veterans Administration, Ascension Health, and Providence Health. This is an impor…
Understanding Differences Between 2 CLIA Accreditors
By Robert Michel | From the Volume XXVIII, No. 1 – January 19, 2021 Issue
MAJOR CHANGES ARE HAPPENING IN THE COMPETITIVE MARKET for CLIA accreditation of hospital laboratories. Some health systems representing hundreds of hospitals have shifted from using the College of American Pathologists (CAP) to using The Joint Commission (TJC) to meet the accreditation …
Much Disruption for Labs In 2016’s Top 10 Stories
By Robert Michel | From the Volume XXIII, No. 17 – December 19, 2016 Issue
CEO SUMMARY: Within THE DARK REPORT’S list of the Top 10 Lab Industry Stories for 2016 is one story of disruption that might have been one story of disruption about to happen. The disintegration of Theranos during 2016 is the big story about a self-proclaimed disruptor of the lab indust…
First CAP 15189 Accreditation for a Children’s Hospital Lab
By Joseph Burns | From the Volume XXIII No. 13 – September 26, 2016 Issue
CEO SUMMARY: It’s now official. St. Jude Children’s Research Hospital is the first children’s hospital to earn accreditation to ISO 15189 under the College of American Pathologists. What is more interesting, however, is how lab leadership used the quality management system of ISO 15…
CURRENT ISSUE

Volume XXX No. 2 – January 23, 2023
The Dark Report explores the decision by The Joint Commission to no longer accept COLA-accredited facilities at its own accredited organizations, and reprints the letters sent by both TJC and COLA relative to the move. In other news, CLIA changes are coming and The Dark Report has an exclusive interview with a member of the committee studying those potential changes.
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