CLIA Lab Directors Must Watch Delegated Duties

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

CEO SUMMARY: Laboratory accredito…

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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…

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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…

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CLIA Lab Director Testimony Shows Risks to Pathologists

By Robert Michel | From the Volume XXVIII, No. 15 – November 8, 2021 Issue

CEO SUMMARY: Elizabeth Holmes’ criminal trial is a case study for clinical lab directors in how not to run a medical lab, according to an attorney with 30 years of advising labs on CLIA-enforcement issues. During the trial, federal prosecutors cited the Clinical Laboratory Improve…

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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…

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NILA: CLIA Proposal Doesn’t Address Flaws

By Joseph Burns | From the Volume XXV No. 3 – February 12, 2018 Issue

CEO SUMMARY: For many years, NILA has urged the federal Centers for Medicare and Medicaid Services to make significant changes in CLIA regulations. Yet, in its recent request for information, CMS addressed five specific areas. But the federal agency left out the need for a comprehensive o…

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After Two Decades, CMS Wants to Update CLIA Lab Regulations

By Joseph Burns | From the Volume XXV No. 2 – January 22, 2018 Issue

IN THE FIRST EFFORT OF ITS kIND in more than two decades, the federal Centers for Medicare and Medicaid Services has published a request for information (RFI) in the Federal Register as a first step to revise the CLIA rules it promulgated in 1992. Over the years, CMS has made some m…

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Proposed Bill in Congress Would Regulate LDTs

By Joseph Burns | From the Volume XXIV No. 7 – May 15, 2017 Issue

CEO SUMMARY: As one response to the FDA’s efforts to regulate laboratory-developed tests, some large labs and IVD manufacturers organized the Diagnostic Test Working Group. It has engaged with congressional officials to draft legislation that would establish a risk-based review of both …

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Health Insurers Want More Data On Clinical Utility of Molecular, Genetic Tests

By Joseph Burns | From the Volume XXIV No. 4 – March 13, 2017 Issue

CEO SUMMARY: Genetic tests that lack two essentials are troublesome for the nation’s health insurers. Those essentials are clinical validity and clinical utility. During a recent webinar, two executives from major health insurers stressed the need for genetic testing labs to provide acc…

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FDA Official Outlines Need for Federal Regulation of LDTs

By Robert Michel | From the Volume XXIII No. 14 – October 17, 2016 Issue

AT A CONGRESSIONAL BRIEFING LAST WEEK, a federal official charged with regulating laboratory-developed tests made the case that LDTs are inconsistently reliable and thus put patients at risk, according to MedPage Today. “If you take the same patient sample and you send it to different la…

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