July 25, 2016 Intelligence: Late Breaking Lab News

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Throughout the profession of laboratory medicine, concern is surfacing following publication of a proposed rule by the Department of Veterans Affairs (VA) that would expand the authority of Advanced Practice Registered Nurses (APRNs) to supervise and perform laboratory testing. This rule would expand APRNs’ authority, currently limited to ordering and interpreting lab tests. In an alert to its members about the proposed rule, the American Society for Clinical Laboratory Science (ASCLS) stated, that if adopted as written, the proposed rule would allow an APRN to supervise and direct a clinical laboratory. The proposed rule is §17.415(d)(1)(i) and was posted on May 25, 2016.

MORE ON: VA Draft Rule

ASCLS opposes implementation of this draft rule on the grounds that nurses are not educated and trained to work in complex clinical laboratories. ASCLS is encouraging its members to submit comments about the rule. Public comments will be accepted by the VA through July 25, 2016. A little-known fact that is part of this story is how, earlier this spring, according to ASCLS, “the CMS Survey and Certification Group quietly changed the personnel requirement for directing or performing non-waived tests under CLIA. Specifically, CMS said, ‘Bachelor’s and Associate’s degrees in nursing meet the requirement for earning a degree in a biological science for, respectively, high complexity testing personnel and moderate complexity testing personnel.’ ”


In a news story titled, “ECRI wants to bring transparency to molecular diagnostics, an arena plagued by useless tests,” ECRI Institute, the 50-year-old not-for-profit based in Plymouth Meeting, Penna., announced that it was establishing a database service for molecular diagnostic tests to help hospitals and physicians identify clinically useful genetic tests. Diane Robertson, the Director of Health Technology Assessment at ECRI, told Med City News that, of the 60,000 tests available, “less than 5% of molecular diagnostic tests are clinically relevant.”


  • Edgar Braendle, MD, PhD, will become the new CEO of ARUP Laboratories of Salt Lake City on August 16, 2016. Braendle will leave his current position as Senior Vice President and Head of the Companion Diagnostics Unit of Novartis.

dark_daily_logoHave you caught the latest e-briefings from DARK Daily? If so, then you’d know about …

… the evidence in support of using non-fasting specimens for cholesterol testing. Non-fasting blood sampling has been the standard practice since 2009 in Denmark. The European Heart Journal published these findings.

You can get the free DARK Daily e-briefings by signing up at www.darkdaily.com.

That’s all the insider intelligence for this report. Look for the next briefing on Monday, Aug. 15, 2016.

Screenshot 2016-07-29 14.07.15


∗ Cigna Expands Genetic Counseling Requirement for More Types of Cancers, Health Conditions

∗ New Developments in Digital Pathology: Progress with the FDA, Innovative Workflow Products.

 Breakthroughs with Labs Helping Physicians Improve Utilization of Clinical Laboratory Tests

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