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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Articles and Reports
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
Laboratory Safety: A Universal Right
Approaching laboratory safety from a diversity, equity, inclusion, and accessibility perspective.
FDA Watch: Agency Opens New Pathway for STI At-Home Sample Collection Kits
With US STI cases continuing to climb to numbers not seen in decades, a recent FDA approval comes at an opportune moment.
Special Report: The OSHA Inspection Process and How to Survive It
The basics of how the OSHA inspection process works and how laboratories can successfully navigate it.
December 2023 Labs in Court
A settlement for kickback allegations, prison time for lab owners convicted of COVID-19 fraud, and 10x Genomics gets OK for lawsuit.
Procedural Coding Changes to Note for 2024
Key 2024 coding changes for laboratories and tips for ensuring proper implementation into chargemasters and fee schedules.
Who Needs to Follow the OSHA BBP Standard in the Lab?
Which staff members lab professionals should consider when developing their exposure control plans to ensure OSHA compliance.
Solving Lab Safety Challenges, Both New and Old
Dan J. Scungio, MLS (ASCP), SLS, CQA (ASQ), discusses recent developments in lab safety and how to address key challenges.
How ‘Voluntary’ Safety Standards Impact OSHA Compliance
Lab leaders need to be aware that in some cases, following additional standards such as ANSI may not be voluntary at all.
12 Steps to Manage BYOD Risks to Lab Data
How lab leaders can manage the data security risks of staff using personal devices for work-related purposes.
Compliance Tool: Model Bring Your Own Device (BYOD) Policy
This BYOD policy template illustrates the basic issues lab leaders may want to address to ensure cybersecurity in their facilities.
