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
Labs In Court:
A roundup of recent cases and enforcement actions involving the diagnostics industry
From - G2 Compliance Advisor
Quest to Pay $1.15 Million Case:for Self-Disclosed CMP Violations
Quest Diagnostics, Inc., New Jersey has agreed to fork over $1.151 million for a trio of…
8 Tips for Investigating Sexual Harassment
From - G2 Compliance Advisor
President Trump declared April National Sexual Assault Awareness and Prevention Month. Sexual harassment is a related problem that all employers must proactively address and…
False Billing of Nuclear Stress Tests at Center of $50 Million Cardio Fraud Scheme
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OIG and DOJ Offer Tips for Evaluating Compliance Effectiveness
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23andMe Gains FDA Approval for DTC Test
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8 Traps to Avoid When Investigating a Sexual Harassment Complaint
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Watch Out for Resume Fraud
By Lynne Curry, Ph.D bio
You know that new laboratory assistant you just hired—the one with the terrific resume and reference? It turns out she never worked for the employers named on the resume or…
Avoid Liability for Commission-Based Marketing Arrangements
From - G2 Compliance Advisor
Contracts between labs and sales and marketing firms raise red flags under both the Anti-Kickback Statute (AKS) and Stark Law, especially when payment is by commission or based on…
Making Laboratory Safety as Simple as ABC
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
When it comes to safety in the laboratory, there are several rules, regulations, and guidelines to keep track of from multiple organizations. If your responsibilities for lab safety are…
CMS Exercises Enforcement Discretion for PAMA Reporting
From - G2 Compliance Advisor
As we previously reported, the Centers for Medicare & Medicaid Services (CMS) has indicated that laboratories had sought relief from the March 31 deadline for reporting applicable information under the…