Lab Risk & Compliance
Cyberattack Victims Sue Enzo Biochem and Labcorp
CEO SUMMARY: It’s the latest reminder that clinical laboratories and anatomic pathology groups are at risk for two threats. One threat is a cyberattack that shuts down a lab’s IT system while stealing patient data. The other threat involves lawsui…
FDA Expected to Publish Proposed LDT Rule in August
CEO SUMMARY: Congressional lawmakers and the federal Food and Drug Administration are again eyeing changes that would bring greater oversight to laboratory-developed tests (LDTs). Leaders at clinical laboratories and pathology groups should monitor these proposals, both of which c…
Proposed Electronic Signature Rule Has Compliance Risks
CEO SUMMARY: Proposed HHS rule aims to define and standardize physician electronic signatures. For clinical laboratories, this is important because lab test claims require a signed requisition form. Given …
CLIA Lab Accreditors Reveal Most Frequent Deficiencies
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…
CMS Ends Remote Reading of Pathology Glass Slides
CEO SUMMARY: On the day the federal government ended the public health emergency for SARS-CoV-2, CMS issued an updated FAQ that ended the allowance for remote reviews of glass slides…
Elizabeth Holmes Still Wants ‘To Contribute’ in Healthcare
CLINICL LABORATORY AND ANATOMIC PATHOLOGY PROFESSIONALS have another reason to shake …
Lab Execs Allegedly Lied to FDA about Faulty Tests
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…
Draft Rule Standardizes Electronic Signatures
CEO SUMMARY: Every year, payers refuse laboratory test claims on grounds that the ordering provider’s signature is missing or illegible—a situation that costs clinical labs million of dollars in…
OIG’s Issues New Opinion on Use of Gift Cards for Lab Specimens
CEO SUMMARY: This new Advisory Opinion from the Office of Inspector General (OIG) outlines a narrow situation in which it may be allowable for clinical laboratories to use gift cards to encourage pa…
Six Important Themes to Help Labs Succeed
CEO SUMMARY: Clinical laboratories face business challenges with day-to-day operations, genetic testing, and evolving care delivery models. The 2023 Executive War College on Diagnostics, Clinical Laboratory, and Pathology Management returns on April 25-26 in New Orleans. Participant…
CURRENT ISSUE
Volume XXXI, No. 11 – August 12, 2024
This issue identifies current lab trends as experienced by the two Blood Brothers, Labcorp and Quest Diagnostics, and delves into these trends. Also, a new survey highlights consumer healthcare trends that labs should be aware of.
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