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
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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
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.
Expected Audit Targets for 2024 and How Laboratories Can Ensure Compliance
An overview of likely lab audit targets for the coming year, and how laboratories can ensure they’re prepared.
Lab Marketing & Staffing: 4 Common Kickback Pitfalls to Avoid
How laboratories can avoid compliance issues involving certain marketing and staffing practices.
Laboratory Relocation: 6 Common Pitfalls to Avoid
Missing small details or getting them wrong can be disastrous for a lab move—here’s how to avoid major issues.
Dx Deal Roundup: A Major Proteomics Merger, Ginkgo Makes Pharma Inroads, and More Legal Woes for Illumina
As is usual at this time of year, deals in the diagnostics industry were up, both in terms of volume and value.
FDA Watch: Simplifying and Speeding Up 510(k) Authorization
What lab leaders need to know about the FDA’s three new 510(k) draft guidances.
