Special Report: Preparing for Stage 1 of the FDA’s LDTs Final Rule
Considerations for addressing compliance with Stage 1 of the FDA’s lab-developed tests final rule
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Articles and Reports
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
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
How to Create a Legally Sound COVID-19 Medical Screening Policy
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A 5-Step Game Plan for Protecting Lab Employees from COVID-19 Infection
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Compliance Perspectives: New Laws & the Top 5 Challenges Lab Compliance Officers Face in 2020
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Compliance Perspectives: 5 Ways to Avoid Kickback Risks When Placing Phlebotomists in Ordering Physician’s Offices
It’s not uncommon for labs to place a phlebotomist in a physician’s office to collect and process samples for testing. While not strictly illegal, this practice raises bright red flags under kickback laws. So, it’s imperative to carefully vet your in-office phlebotomist arrangements to ensure they don’t cross any kickback lines.
Compliance Perspectives: Using Document Management Systems to Avoid HIPAA Pitfalls
By Andreas Rivera bio
Record-keeping can be one of the most stressful aspects of running a healthcare business since privacy compliance is scrutinized in healthcare more than any other industry.
Anyone with experience in the healthcare industry knows that violating HIPAA comes with steep penalties…
Special Report: Long Awaited Kickback Relief Rules Keep Labs in the Cold
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You Make the Call: Does Lab Manager Have a Valid Claim for Age Discrimination?
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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 Perspectives: Complying with HIPAA Isn’t Enough to Manage Data Breach Liability Risks
From - Lab Compliance Advisor
Memo to lab managers and compliance officers: It may be time to rethink your data breach response strategy. This directive is…
