LDT Oversight Remains Under CLIA, for Now
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
Keeps You Up-to-Date on Federal & State Laws, Regulations, New Legislation, and Court Cases that Affect Your Diagnostic Lab or Pathology Practice
Judge rules that the FDA has ‘no authority’ to issue its rule governing laboratory-developed tests
How the 2024 proposal will fare on Capitol Hill in 2025 remains to be seen, though
Changes ‘have had a significant impact on the recruitment process for laboratory directors and technical supervisors,’ recruiter says
The free online tool can set a foundation for renewed reimbursement strategies and contract negotiations with insurance carriers
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
The CDC’s OneLab training initiative offers free courses, events, resources, and networking opportunities for clinical lab professionals
For clinical labs, the proposed law could bring more consistency to test ordering
Know where labs may fall foul of compliance requirements—and discover the actions your lab can take to mitigate the risk of noncompliance
Labs, patients, and technology must all work together to deliver forward-thinking patient-centered care.
How lab leaders can manage the data security risks of staff using personal devices for work-related purposes.
This BYOD policy template illustrates the basic issues lab leaders may want to address to ensure cybersecurity in their facilities.