Compliance Concerns: Laboratory Regulations in 2024 and Beyond
Earle S. Collum, chair of the CAP Council on Accreditation, talks through regulatory changes in 2024 and what to expect from 2025
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Articles and Reports
Out with the Old: The 2024 Clinical Lab Experience
What challenges and opportunities affected the experience of medical lab professionals in 2024—and what might the new year bring?
FDA Watch: How Could the Change in US Government Affect IVDs and Labs?
Experts say new leadership could impact the cost and availability of IVDs as well as patients’ ability to afford lab testing
How to Explain the Current State of EKRA to Your Lab Executives
How to explain the current state of EKRA to your lab executives.
March 2023 Labs in Court: Labcorp Wins One, Settles Another
In this month’s roundup of cases involving labs, Labcorp gets one lawsuit tossed and settles another.
Six Steps for a Bloodborne Pathogens Exposure Determination
The first phase in protecting your staff is to carry out an exposure determination to figure out which of your workers are at risk.
Model Code of Conduct for Laboratory Sales and Marketing
A template for creating a general code of conduct that sets out broad parameters and ground rules for compliance.
Six Lab Sales and Marketing Compliance Problem Areas and How to Address Them
It’s imperative for labs to establish and maintain an active corporate compliance program that augments the actual scientific testing.
FDA: EUAs for COVID-19 Lab Tests Will Continue after PHE Ends
Agency says it will continue to have authority to clear new lab tests and other COVID-19 products on an emergency basis even after the PHE ends.
High Billing by Labs Continues to Be Trigger for Audits
As we move further into 2023, COVID-19, add-on, and genetic tests will likely remain targets for federal regulators.
OIG Green Lights Free Hospital NP Services for Referring Physicians
A new OIG Advisory Opinion sheds some light on how to properly structure these arrangements in a hospital inpatient setting.
Why Mobile Phlebotomy Companies and Labs Should Be on Alert
Recent fraud case involving phlebotomy company shows why labs need to pay special attention to Medicare specimen collection and travel allowance rules.
Normal Kickback and Billing Rules Return When PHE Ends on May 11
A look at the US end-of-emergency game plan and how it will impact lab compliance.
