Tag Archives: Laboratory errors

February 2022—It was Isaac Asimov who surmised: “The most exciting phrase to hear in science is not ‘Eureka!’ but ‘That’s funny . . .’” And it was coagulation processing in the clinical laboratory that, in a small way, illustrated Asimov’s axiom for Dorothy Adcock, MD, former chief medical officer, Labcorp Diagnostics.

September 2021—Rare wine? Delectable. Rara avis? Magnificent. Rare blue-top collection tube? Uh oh. For Richard Marlar, PhD, coming across a non-FDA-approved tube was an unhappy discovery. Dr. Marlar, medical director, coagulation laboratory, University of New Mexico Hospital, says his lab was among the first to encounter one of these rogue tubes, available for purchase on the internet and likely taking wing due to pandemic supply shortages. When the tube arrived for testing, it quickly kindled concerns, says Dr. Marlar. “It’s a tube we had never seen before. It looks like it has a CE mark on it, and the Europeans don’t know anything about it. It has a label on it that suggests it’s FDA approved—but the FDA is not aware of it,” he says, adding that his lab has spoken with the agency. It feels like a “CSI”-tinged moment in a venue that labs would prefer to keep drama-free. It also points to the ongoing need to keep a keen eye on what passes through coagulation laboratories. It’s not so much that the devil is in the details; rather, that’s where accurate results lie.

February 2018—Requiring strict adherence to the latest industry standard for venipuncture can go a long way to minimizing the risk of phlebotomy-related lawsuits and multimillion-dollar jury awards. “It revolves right back to education,” says Nancy Erickson, PBT(ASCP), an expert witness in more than 30 phlebotomy-related lawsuits. She says lack of education and failure to follow the standard of care cause the two most common patient complaints that lead to phlebotomy-related litigation: nerve damage and syncope.

November 2015—Blood is thicker than water, the saying goes. And thanks to a recent Q‑Probes, the rates of mislabeled specimens submitted for ABO blood typing and of wrong-blood-in-tube errors are now as clear as water. The mislabeling rate hasn’t changed much since a similar Q‑Probes study was performed in 2007. The 2015 Q‑Probes, “Blood Bank Safety Practices,” reviewed 41,333 specimens and found that 306, or 0.74 percent, were mislabeled. The previous study looked at 112,112 specimens, of which 1,258, or 1.12 percent, were mislabeled.

August 2015—The Institute of Medicine is expected to release in September a consensus study on diagnostic error in health care that will offer recommendations for policymakers, payers, medical institutions, physicians, and patients aimed at preventing harmful mistakes. This will come after nearly two years of studying the U.S. health system and reviewing the perspectives of stakeholders such as the CAP.

July 2015—Secondary review of surgical pathology cases is a common, if not universal, practice in U.S. anatomic pathology departments. The evidence has shown that case reviews detect errors. But until now, one important thing has been missing: consensus on the actual standard of practice for such reviews. Anatomic pathology departments have lacked evidence-based guidelines on how and when to conduct reviews.

February 2015—Cincinnati Children’s Hospital Medical Center has all but eliminated errors in laboratory test reporting thanks to a project performed through the Intermediate Improvement Science Series, a nationally accredited course offered by the medical center’s James M. Anderson Center for Health Systems Excellence to leaders from Cincinnati Children’s and other health care systems.

July 2014—Laboratories now may be saved from draconian penalties, such as loss of a CLIA license and probation periods, for mistakenly sending proficiency test specimens to another facility. Under new rules published by the Centers for Medicare and Medicaid Services, laboratories have the regulatory relief the CAP advocated during the past decade. The CMS will still severely punish those attempting to cheat on proficiency testing, but laboratories that unknowingly or unintentionally refer PT specimens will face alternative sanctions, according to the regulations.

December 2013—Quality systems and quality management plans can be as solid as a laboratory can make them and still lab errors will occur. And as laboratories become more automated and test volumes grow, the potential for large-scale errors grows too.