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Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
Emergency Staffing ABCs
By Dan Scungio, MT (ASCP), SLS, CQA (ASQ) bio
When I was growing up near Buffalo, New York, experiencing two snow storms in three weeks was no big deal; in fact, it was rather commonplace. When I…
CLIA: After 36 Years, CMS Gives Lab Accreditation a Good Hard Look
From - National Intelligence Report
If you've been in the clinical labs business for a while, you probably appreciate the wisdom behind this ancient Chinese curse. 2018 is shaping up to be a very…
FDA Watch: Greenlights for NGS Tumor Panels May Augur New Approach to LDT Approvals—Both Product & Pathway
From - Laboratory Industry Report
A pair of tumor tests highlights the list of new FDA approvals from mid-November through December, including…
Case of the Month: Feds Turn Up the Heat on False Billing of Nuclear Stress Tests
From - G2 Compliance Advisor
While the feds have made urine drug testing of opioid drug patients their number one target for lab-related False Claims Act (FCA) charges this year, nuclear stress tests …
POC Susceptibility Testing No Aid for Antibiotic Prescribing with UTI
From - Diagnostic Testing & Emerging Technologies
Adding point-of-care (POC) susceptibility testing to POC culture does not improve appropriateness of antibiotic prescribing for patients with suspected…