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
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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
Compliance Tool: Checklist for Avoiding 10 Top CLIA Deficiencies for Labs
Even the best labs can incur CLIA deficiencies when unprepared; this checklist can help your lab avoid some of the most common
How to Comply with the New HHS COVID-19 Test Data Reporting Rules
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Compliance Perspectives: New Laws & the Top 5 Challenges Lab Compliance Officers Face in 2020
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Explaining the Legal News: Why ACLA Court Win Boosts Chances of PAMA Pricing Relief
From - Lab Compliance Advisor
By now, you've no doubt heard the news that the American Clinical Laboratory Association (ACLA) "won" its lawsuit against…
Compliance Perspectives: What to Do When Respiratory Safety & Religious Rights Collide
From - Lab Compliance Advisor
A lab requires all employees who work with or near materials emitting toxic vapors to wear respirators with…
Compliance Heads Up: New Kickback Safe Harbors Rule Is Almost Ready
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Changes in hazardous waste management: the Generator Improvement Rule
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
If you haven't heard by now, you should know that the EPA published its Generator Improvement Rule (GIR) in 2016. It is an update to the…
Surviving a Medicare Audit: Warn Lab Staffers Not to Lie to Auditors
From - Lab Compliance Advisor
As a lab compliance director, you understand the dangers of obstructing a Medicare audit. The problem is…
Compliance Alert: New Private-Pay Opioid Law Puts All Drug Addiction & Rehab Labs at Risk of Federal Prosecution
From - Lab Compliance Advisor
Recent federal legislation addressing the opioid crisis may have unintended consequences on the lab industry. The idea was to allow the feds to prosecute a certain kind of…
Carreyrou Captivates Lab Institute With Inside Look at Theranos Fall
From - G2 Compliance Advisor
The tale could be headed to movie theaters around the nation soon. It is a gripping story of a Steve Jobs–wannabe—a young Stanford dropout with…
The Safety Interpretation
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
When hospitals were placed on OSHA's list of "high-risk" workplaces, no one had to ask why. OSHA adjusts that list based on the number of injuries that occur on the job…
