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College of American Pathologists
Proficiency Testing Ranks High as a CLIA Violation
By Robert Michel | From the Volume XXX, Number 15 – October 23, 2023 Issue
CEO SUMMARY: Proficiency testing (PT) deficiencies are consistently cited by clinical laboratory accreditors during CLIA inspections. Surveyors and inspectors note that labs may mistakenly believe that an 80% score on a PT event is satisfactory. To the contrary, experts advise labs to scr…
Actions Pathologists Can Take to Protect Their Income
By jpschlingman | From the Volume XXX, No. 12 – August 21, 2023 Issue
CEO SUMMARY: Pathology groups may feel their income is under attack from lower Medicare reimbursement rates and rising practice costs. But steps to protect that income can include carefully determin…
Competency Assessments Prove To Be a Nagging CLIA Deficiency
By Scott Wallask | From the Volume XXX, No. 11 – July 31, 2023 Issue
CEO SUMMARY: Competency assessment problems rank high among frequently cited deficiencies during CLIA inspections. Representatives from the CAP, COLA, and The Joint Commission explain what areas to…
CLIA Lab Accreditors Reveal Most Frequent Deficiencies
By Scott Wallask | From the Volume XXX, No. 8 – May 30, 2023 Issue
CEO SUMMARY: CAP, The Joint Commission, COLA, and A2LA took the stage at the recent Executive War College to detail their respective lists of the 10 most often-cited standards during…
Lab Execs Allegedly Lied to FDA about Faulty Tests
By Scott Wallask | From the Volume XXX, No. 7 – May 8, 2023 Issue
CEO SUMMARY: Three former executives of a lab testing company face criminal charges. Federal prosecutors claim that the three plaintiffs who previously worked at Magellan Diagnostics flagrantly hid…
Lab Accreditors CAP and Joint Commission Face Inspector Hiring Pressures
By Robert Michel | From the Volume XXX No. 3 – February 13, 2023 Issue
In an exclusive story, The Dark Report covers the difficulties facing lab accreditors the College of American Pathologists (CAP) and The Joint Commission (TJC) in staffing inspection and survey teams under CLIA. Like the clinical laboratories they accredit to the requirem…
CAP, Joint Commission Under Pressure to Add More Inspectors
By Scott Wallask | From the Volume XXX No. 3 – February 13, 2023 Issue
CEO SUMMARY: Like the clinical laboratories they accredit to the requirements of CLIA, The Joint Commission and College of American Pathologist (CAP) face recruitment and hiring pressures when it comes to their surveyors and inspectors. Labs involved with CAP’s peer inspections ma…
Joint Commission Will Not Accept COLA Accreditation
By Scott Wallask | From the Volume XXX No. 2 – January 23, 2023 Issue
CEO SUMMARY: This may be a first in the 40-year history of CLIA accreditation of clinical laboratories. The Joint Commission (TJC) announced it will no longer recognize COLA’s laboratory accreditation program within “TJC-accredited facilities,” effective Jan 1, 2023. COLA-accredited labs …
January 23, 2023, Intelligence: Late-Breaking Lab News
By Scott Wallask | From the Volume XXX No. 2 – January 23, 2023 Issue
New data from the Association of American Medical Colleges (AAMC) offers further evidence of a decreasing talent pool of pathologists in the United States. Active physicians in anatomic and clinical pathology dropped from 13,201 in 2016 to 12,180 in 2021—a 7.7% decrease, according to the AAM…
Eight Macro Trends for Clinical Labs in 2023
By Robert Michel | From the Volume XXX, No. 1 – January 3, 2023 Issue
CEO SUMMARY: Laboratory administrators and pathologists will want to carefully study eight important trends that will guide their business strategies in 2023. Many of these macro trends center on financial and operational difficulties and ways to steer around these obstacles. Anothe…
CURRENT ISSUE

Volume XXXII, No. 6 – April 21, 2025
Now that a federal judge has vacated the FDA’s LDT rule, The Dark Report analyzes the judgement and notes the various steps the FDA could take in response. Also, lab testing at pharmacies is proving to be less successful than was once anticipated.
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