Further Details to Note about Updated Clinical Lab Director Qualifications
Put into place late last year, the new rules place more emphasis on formal and continuing education requirements
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Articles and Reports
Labs in Court: Alleged Stark Law Violations Lead to $10m Settlement with DOJ
Other recent legal actions include a self-disclosure settlement and punishment for alleged improper diagnostic test add-ons
A Practical Mentoring Checklist for Clinical Labs
Steps that lab leaders, mentors, and mentees can take when establishing mentorships
Keys to a Successful OSHA Annual Review of Your Lab’s Health & Safety Plan
A solid health and safety plan in the lab not only meets regulatory requirements, but also fosters a secure environment for staff
Dx Deals: New Premerger Regulations Could Slow Down Pace of Transactions
The new rules, which were approved by the FTC in October and will go into effect in mid-January, aim to put a damper on consolidation
What to Do in the Event of a Lab Courier Strike
With strikes increasing across industries, what happens if workers involved in the ancillary services labs depend on go on strike?
OSHA Guidance for Labs: 2024 and Beyond
Safety and health guidance for labs—including recent updates, forthcoming changes, and how lab professionals can stay up to date
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
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
Meeting the Needs of Laboratory Learners
The CDC’s OneLab training initiative offers free courses, events, resources, and networking opportunities for clinical lab professionals
Labs in Court: Two EKRA-Related Cases and Some Usual Suspects
Recent enforcement actions involved usual targets such as COVID-19, genetic, and urine drug testing, but EKRA also made an appearance
