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Articles and Reports
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
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
Use Contact Logging to Ensure Lab Employees Practice Social Distancing
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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: 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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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…