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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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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CLIA PT Enforcement Ensnares Top Labs

By Robert Michel | From the Volume XIX No. 11 – August 6, 2012 Issue

CEO SUMMARY: Think it can’t happen to you? Think again. Following self-disclosure of inadvertent referrals of proficiency testing (PT) specimens, the laboratory at Ohio State University Wexner Medical Center (OSUWMC) was visited by officials from the Ohio Department of Health and the Ce…

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Existing CLIA Language Drives PT Enforcement

By Joseph Burns | From the Volume XIX No. 11 – August 6, 2012 Issue

CEO SUMMARY: Revocation of a lab’s CLIA license as penalty for inadvertent errors in handling proficiency tests (PT) is not a new problem. As explained here, most clinical laboratories have appropriate protocols for handling PT samples. But, when errors occur, the Centers for Medicare &…

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CLIA’s Catch-22 Involving Proficiency Testing

By R. Lewis Dark | From the Volume XIX No. 7 – May 14, 2012 Issue

THERE’S A REGULATORY TRAP awaiting the unwary laboratory organization. It involves language in CLIA rules for proficiency testing (PT). All medical directors and lab administrators will want to fully understand the implications of what appears to be an emerging trend in CLIA laboratory enforcement….

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Inadvertent PT “Errors” Trigger CLIA Sanctions

By Joseph Burns | From the Volume XIX No. 7 – May 14, 2012 Issue

CEO SUMMARY: Despite taking appropriate steps to complete proficiency testing (PT), in recent years an unknown number of labs were determined to be in violation of CLIA requirements. Federal regulators are enforcing penalties ranging from suspension of the labs’ licenses to transition t…

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Patient Privacy Laws Create Legal Risk for Labs

By Robert Michel | From the Volume XVII No. 10 – July 12, 2010 Issue

CEO SUMMARY: Before the nation’s healthcare system can achieve the integrated universal EHR, it must fix the crazy contradictions in state and federal laws governing patient privacy. There is discordance between federal law and state law that defines the role and responsibility…

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ISO 15189 Accreditation Requires Specific Steps For Global Recognition

By Robert Michel | From the Volume XVII No. 6 – April 19, 2010 Issue

CEO SUMMARY: This intelligence briefing is the third in an ongoing series about quality management systems (QMS) and their role in advancing the performance of clinical laboratories and improving the quality of the testing services they provide. ISO 15189 is a set of standards for medical…

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Need Rigorous Validation For Home Brew Assays

By Robert Michel | From the Volume XVI No. 3 – February 23, 2009 Issue

CEO SUMMARY: National headlines about erroneous Vitamin D results are a reminder to the lab industry of the imprecision and risks associated with home brew testing. According to one laboratory expert, every laboratory-developed test (LDT) must meet two high standards. On…

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Labs Should Prepare for Tighter CLIA Enforcement

By Robert Michel | From the Volume XV No. 4 – March 24, 2008 Issue

CEO SUMMARY: Lab directors and pathologists should take notice of disturbing new developments in enforcement of CLIA regulations. During the past year, CMS officials have revoked the CLIA certification of several hospital laboratories for what are, essentially, inadvertent violations of p…

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