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2021’s Top 10 Lab Stories Confirm Important Trends
By Robert Michel | From the Volume XXVIII, No. 17 – December 20, 2021 Issue
CEO SUMMARY: Much like 2020, the pandemic dominated our new list of the top 10 lab industry stories for 2021. Beyond COVID-19 testing, the virus crept its way into long-term trends, such as pathology jobs and technology innovation. New ways of delivering healthcare will need respons…
Federal Rule to Revise Out-of-Network Billing
By Robert Michel | From the Volume XXVIII, No. 14 – October 18, 2021 Issue
CEO SUMMARY: Remaining out of network with health insurance companies may boost revenue for providers, including anatomic pathologists and emergency room physicians. But the good times may soon end. Last month four federal agencies issued rules that implement new requirements under …
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…
September 27, 2021 Intelligence: Late-Breaking Lab News
By Robert Michel | From the Volume XXVIII, No. 13 – September 27, 2021 Issue
Following the opening of her criminal trial in a Silicon Valley courtroom in recent weeks, Elizabeth Holmes—the disgraced ex-Founder and CEO of Theranos—continues to be the subject of news headlines. Federal prosecutors are calling witnesses to testify. Much of this testimony includes anec…
Comment Period Closing on Federal Surprise Billing Rule
By Robert Michel | From the Volume XXVIII, No. 12 – September 7, 2021 Issue
PATHOLOGY GROUPS AND CLINICAL LABS HAD UNTIL SEPTEMBER 7 to comment on an interim final rule that provides federal protections against surprise billing and limits out-of-network (OON) cost sharing under many of the circumstances in which surprise bills arise most frequently….
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…
CURRENT ISSUE

Volume XXXII, No. 10 – July 14, 2025
This issue is strong on different flavors of enforcement that clinical laboratories, whether they want to or not, will need to contend with. Lab stakeholders provide insights that medical labs need to brace for more action to counter pending test reimbursement rate cuts under PAMA. Also, this issue provides the legal and regulatory landscape for clinical labs’ use of AI and how it evolves with the technology. AI is creating legal uncertainty for clinical labs, especially around data privacy and FDA oversight of AI tools in diagnostics.
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