How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
Lab Compliance Advisor
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FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
Outreach Survey Focuses on Clinical Laboratory Industry Trends Amidst Greatest Disruption in Three Decades
By Jeff Myers bio
Accumen Inc. is pleased to announce the launch of the 17th Annual National Hospital and Health System Laboratory and Outreach Survey. The survey is designed to capture intelligence on…
Tool: Model Pandemic Influenza Policy
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Compliance Perspectives: Avoid Privacy Pitfalls in Pandemic Planning & Response
From - G2 Compliance Advisor
Although not officially a pandemic, the 2018 flu season has been the worst in nearly a decade. So why not use it as an opportunity to review your lab's pandemic preparations…
CAP Files Amicus Brief in Support of ACLA Motion for Summary Judgement in PAMA Lawsuit
From - G2 Compliance Advisor
The College of American Pathologists (CAP) filed an amicus curiae brief in support of a motion by the American Clinical Laboratory Association (ACLA) for summary judgement to…
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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Case of the Month: Judge Who Said Labs Must Independently Verify Medical Necessity Takes It Back
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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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