Compliance Briefing

How to Comply with the New HHS COVID-19 Test Data Reporting Rules

The U.S. Department of Health and Human Services (HHS) has ordered labs that perform COVID-19 testing to report test data to state and local public health agencies by August 1, 2020. What makes the … [Read more...]

Compliance Perspectives: New Laws & the Top 5 Challenges Lab Compliance Officers Face in 2020

Labs remain at the forefront of the federal government’s suspicious persons list and health care fraud enforcement agenda. But in addition to the customary laws that labs are used to, the government … [Read more...]

PAMA

Explaining the Legal News: Why ACLA Court Win Boosts Chances of PAMA Pricing Relief

By now, you've no doubt heard the news that the American Clinical Laboratory Association (ACLA) "won" its lawsuit against CMS over PAMA lab pricing. Only it's not as simple as that. The favorable US … [Read more...]

COMPLIANCE

Compliance Perspectives: What to Do When Respiratory Safety & Religious Rights Collide

THE SCENARIO A lab requires all employees who work with or near materials emitting toxic vapors to wear respirators with tight-fitting facepieces. Since facial hear interferes with a tight seal, … [Read more...]

Compliance Heads Up: New Kickback Safe Harbors Rule Is Almost Ready

After months of promises, posturing and public consultation, the Department of Health and Human Services is getting ready to unveil a proposed rule to liberate labs and other providers from the … [Read more...]

LAB SAFETY

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 … [Read more...]

COMPLIANCE TIPS

Surviving a Medicare Audit: Warn Lab Staffers Not to Lie to Auditors

As a lab compliance director, you understand the dangers of obstructing a Medicare audit. The problem is your staff may not. So, make it clear to any staffer that may come into contact with an auditor … [Read more...]

LEGISLATION

Compliance Alert: New Private-Pay Opioid Law Puts All Drug Addiction & Rehab Labs at Risk of Federal Prosecution

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 abuse banned by the … [Read more...]

WALL STREET JOURNAL WRITER

Carreyrou Captivates Lab Institute With Inside Look at Theranos Fall

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 a vision and more than $400 million in funding from … [Read more...]

LAB SAFETY

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 … [Read more...]


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