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
Practical, “What-to-Do” and “How-to-Do-It” Help to Comply with the Latest State & Federal Laws, Rules & Regulations that Affect Your Diagnostic Lab or Pathology Practice
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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
Boosting Retention and Hiring in Medical Laboratories
Key reasons for continued staffing shortages and tips for addressing these issues to support current staff and attract new talent.
We’ve Lost Our Lab Director, Now What?
Key steps to successfully navigate a CLIA laboratory director transition and select the best possible replacement for your organization.
Tool: Guide for Assessing Lab Director Candidates
Key areas to address when reviewing CLIA lab director applicants and developing interview questions.
March 2024 Labs in Court
Recent cases involve another fraud related to finger prick blood testing, as well as alleged malpractice and discrimination.
How to Ensure Retention of Safety Training, from Onboarding and Beyond
In order for lab safety training to be effective and lasting, it must be engaging and become part of the lab’s culture.
Where Is Everyone?
Tackling recruitment and retention challenges in the clinical laboratory.
New Guidelines for CLIA Laboratory Testing Personnel
What lab leaders should know about the CLIA updates that recently went into effect, and how the changes may impact staffing.
Compliance Tool: 8 Questions to Ask About Digital Pathology Business Arrangements
This checklist can help labs monitor their organization’s business arrangements that concern digital pathology to ensure compliance.
Digital Pathology Business Arrangements Bring Fraud and Kickback Worries
Healthcare attorneys explain three digital pathology models for laboratories to be aware of.
Special Report: How to Avoid Problematic Lab Business Arrangements
When structuring business arrangements, addressing six key risk areas can help laboratories avoid major compliance issues.
