More Signs of Shifting Sands in the Lab World

By R. Lewis Dark | From the Volume XXXII, No. 15 – October 27, 2025 Issue

If you feel like the ground is shifting under y…

Read More

---

CAP Regains VA Lab Accreditation Contract

By Janette Wider | From the Volume XXXII, No. 15 – October 27, 2025 Issue

CEO SUMMARY: In a blow to The Joint Commission, the US Department of Veterans Affairs has awarded a new clinical laboratory accreditation contract to the College of American Pathologists (CAP). The decision highlights the competition between the two accrediting organizatio…

Read More

---

Accreditors Explain Changes to CLIA Supervisor Qualifications

By Mark Terry | From the Volume XXXII, No. 15 – October 27, 2025 Issue

In December 2023, the Centers for Medicare and Medicaid Services (CMS) announced major updates to the Clinical Laboratory Improvement Amendments (CLIA) personnel regulations, which went into effect on December 28, 2024. During a panel discussio…

Read More

---

June 2, 2025, Intelligence: Late-Breaking Lab News

By Scott Wallask | From the Volume XXXII, No. 8 – June 2, 2025 Issue

Our sibling publication, G2 Intelligence, reported in May about a new Department of Justice (DOJ) memorandum that indicated prosecutors will seek to exercise fairness when deciding how to pursue fraud cases against clinical laboratories and other organizations. The DOJ emphasiz…

Read More

---

LDT Oversight May Fall to Congress, CLIA

By Robert Michel | From the Volume XXXII, No. 7 – May 12, 2025 Issue

CEO SUMMARY: After a federal court struck down the FDA’s final rule on laboratory developed tests, attention has shifted to Congress and CLIA as likely paths forward for oversight. A lack of bipartisan momentum makes new legislation unlikely in the near term. Experts sug…

Read More

---

December 16, 2024, Intelligence Late-Breaking Lab News

By Robert Michel | From the Volume XXXI, No. 17 – December 16, 2024 Issue

Sonic Healthcare Ltd of Sydney, Australia, announced the acquisition of clinical laboratory company LADR (Laboratory Group Dr. Kramer & Colleagues) based in Geesthacht, Germany, on Dec. 9, 2024. The enterprise value of the deal is €423 million (US$446.9 million…

Read More

---

CLIA Lab Directors Must Watch Delegated Duties

By Robert Michel | From the Volume XXX, Number 17 – December 4, 2023 Issue

CEO SUMMARY: Laboratory accredito…

Read More

---

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…

Read More

---

Lab News Briefs: Joint Commission, Bon Secours, Anthem, Walmart

By Scott Wallask | From the Volume XXX, No. 13 – September 11, 2023 Issue

Joint Commission Looks at Cyberattacks The Joint Commission issued a Sentinel Event Alert for hospitals to address cyberattacks. The alert pr…

Read More

---

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…

Read More

---