ENFORCEMENT

Case of the Month: $33.2 Million Alere Settlement Sends Warning Shot Across Bow of LDT & DX Device Makers

One of the reasons Abbott Laboratories got cold feet about consummating the $5.3 billion Alere acquisition was concern over the legal proceedings against the target firm. Now one of those cases … [Read more...]

ACCREDITATION

Lab Quality & Safety: JCAHO to Crack Down on Handwashing Shortcuts

You can preach hygiene until the cows come home but it may not be enough to get busy and distracted lab employees to wash their hands properly. In addition to undermining test integrity, effective … [Read more...]

MANAGING STAFF

Compliance Perspectives: Can You Require Lab Workers to Get a Flu Shot?

Bottom Line on Top: Yes, a mandatory flu vaccination policy is legally justifiable as long as: You can show that vaccination is a necessary health and safety measure; The policy doesn't … [Read more...]

LAB SAFETY

CLIA Corner: FDA Moves to Boost CLIA Waiver Transparency

The CLIA standards that a lab must meet are based on the complexity of the in vitro diagnostic tests it performs. The FDA's primary role in the CLIA system is to categorize IVDs. Test … [Read more...]

COMPLIANCE

You Make the Call: Is Replacing Spoiled Products for Free an Anti-Kickback Violation?

The following scenario comes right out of an August 25, 2017 OIG Advisory Opinion. See if you can guess how the OIG ruled. SITUATION A pharmaceutical company manufactures biologics prone to spoilage … [Read more...]

ENFORCEMENT

FDA Sends 14 Warning Letters Regarding Cancer Products

The U.S. Food and Drug Administration (FDA) continues to focus on direct-to-consumer marketing and sale of products and has issued warning letters in an effort to protect vulnerable cancer patients … [Read more...]

PATIENT SAFETY

Do No Harm: Diagnostic Errors and the Lab

By Jennifer (McMahon) Dawson, MHA, DLM (ASCP)  bio "Do no harm" is the mantra that health care providers live by. Doctors, nurses and laboratory professionals alike enter into the business … [Read more...]

ENFORCEMENT

Theranos Announces Settlement Agreements with CMS and Arizona Attorney General

After facing federal and state government scrutiny for more than a year, Theranos has reached agreements with the Centers for Medicare & Medicaid Services (CMS) and the Arizona Attorney General to … [Read more...]

ENFORCEMENT

Theranos Settles with CMS and Arizona Attorney General

After facing federal and state government scrutiny for more than a year, Theranos has reached agreements with the Centers for Medicare & Medicaid Services (CMS) and the Arizona Attorney General to … [Read more...]

PATIENT SAFETY

Alert Emphasizes Leadership Sets Tone for Safety and Quality

"Tone at the top" is a frequent refrain in compliance. It's also the message of a Sentinel Event Alert (Alert) issued March 1 by The Joint Commission. According to the Joint Commission's Sentinel … [Read more...]


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