FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
Lab Compliance Advisor
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Articles and Reports
Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
Medical Laboratory Personnel Shortage Relief Act Aims to Dent the Staffing Crisis
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Enforcement Trends: Opioid Crackdown Zeroes in on Urine Drug Testing-Today the Doctors, Tomorrow the Labs
From - G2 Compliance Advisor
A 67-year-old Michigan M.D. is the most recent doctor taken down in what has become a crucial part of the federal government's opioid drug crusade…
Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Case: Texas-based United Allergy Services (UAS) is suing Quest Diagnostics for conspiring with…
Enforcement Trends: Whistleblowers Get in on the EHR “Meaningful Use” Action
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Compliance Perspectives: Can You Require Lab Workers to Get a Flu Shot?
From - G2 Compliance Advisor
Bottom Line on Top: Yes, a mandatory flu vaccination policy is legally justifiable as long as…
Tools: Model Flu Vaccination Policies—Mandatory & Voluntary
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OIG Work Plan Monthly Review: January 2018
From - G2 Compliance Advisor
Opioid drug-related issues continue to command the lion's share of OIG Work Plan attention, including two of this month's six new items. While none of the new…
Brief Your CEO: After 36 Years, CLIA Comes Under CMS Review
From - G2 Compliance Advisor
Even as your lab makes the transition to the new, supposedly market-based PAMA Medicare Part B fee schedule for tests, big changes may be in store for another rock of…
Emergency Staffing ABCs
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
When I was growing up near Buffalo, New York, experiencing two snow storms in three weeks was no big deal; in fact, it was rather commonplace. When I…
Case of the Month: Feds Turn Up the Heat on False Billing of Nuclear Stress Tests
From - G2 Compliance Advisor
While the feds have made urine drug testing of opioid drug patients their number one target for lab-related False Claims Act (FCA) charges this year, nuclear stress tests …