ENFORCEMENT

CMS, OIG Reps Address Attendees at ACLA Annual Meeting

At the American Clinical Laboratory Association annual meeting in Washington, D.C. March 23, representatives of the Centers for Medicare & Medicaid Services (CMS) and the Office of Inspector … [Read more...]

ENFORCEMENT

OSHA Fines Address Bloodborne Pathogen and Violence Hazards

Case: OSHA fined a Pennsylvania mental health hospital $32,158 for a trio of safety violations, including failing to protect nurses, medical technicians and other employees against workplace violence … [Read more...]

HIPAA

TOOL: Model HIPAA Breach Notification Letter to Patient

Data security breaches involving patient records can occur despite your best efforts to prevent them. If prevention fails, your lab needs to switch to incident response mode and take measures to … [Read more...]

COMPLIANCE CORNER

Managing Kickback Risks in Lab Sales & Marketing Arrangements

As with any other business, labs need sales and marketing expertise to survive and grow in the competitive diagnostics market. But to the extent you serve patients in Medicare, Medicaid and other … [Read more...]

ENFORCEMENT

Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry

Family MD Faces Jail for Taking Blood Test Referral Bribes. Case: It took the jury just four hours to find a 79-year-old New Jersey family physician guilty of all 10 counts of accepting bribes from … [Read more...]

ENFORCEMENT

Dealing with the FDA: 12 Best Practices for Responding to a Form 483

Laboratory diagnostic tests and affiliation with drug and device manufacturers have made labs a popular target for U.S. Food and Drug Administration (FDA) quality system inspection. Going through an … [Read more...]

IMMIGRATION

Brief Your CEO: 8 Changes in Trump Travel Ban

Although it applies to all industries, the Trump travel ban will have a disproportionate impact on labs and other health care providers. We recently outlined the major effects and the steps you can … [Read more...]

COMPLIANCE CORNER

Spot the Compliance Mistake(s): Customized Test Panels & Medical Necessity

SITUATION As a convenience to clients, Nonexistent Laboratories (NL) offers medical groups the option of designing their own customized test panels. NL requires the medical director of the group to … [Read more...]

MEDICAL NECESSITY

What Not to Do: Customized Test Panels

We invite you to test your compliance expertise with a new feature in G2 Compliance Advisor. See if you can identify what the laboratory did wrong in the following scenario that puts it at risk of … [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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