Preparing for passage of regulatory requirements for laboratory-developed tests: November 2018—The FDA has raised concerns, in recent years, about several high-risk laboratory-developed tests (LDTs), including a concern that patients may undergo unnecessary treatment or delay or forego treatment due to the inaccuracy of such tests. Other agencies have also challenged the validity, accuracy, oversight, and safety of LDTs, a subset of IVDs that are intended for clinical use and designed, manufactured, and used within a single laboratory.Read More »
RT-PCR detection of B. microti parasites using BMN antigens as amplification targets October 2018—Babesia microti infection, which is transmitted through the bite of an infected tick, is a growing health concern and continues to be a threat to the blood supply, with 22 states having reported cases of babesiosis in 2014. While most healthy adults with Babesia infection are asymptomatic or present with mild symptoms, including fever, fatigue, and anemia, babesiosis can be severe or fatal in neonates, the elderly, and immunosuppressed individuals.Read More »
Outcomes of an audit of repeat lab testing at an academic medical center
September 2018—Overutilization of laboratory tests increases health care costs and may lead to false-positive test results and ambiguous findings. Unnecessary testing can result from a single order from a provider, an automated function in an order set, or a combination of the two.
Association of perioperative RBC transfusions with venous thromboembolism
August 2018—Hospital-associated venous thromboembolism is a major cause of morbidity and mortality, resulting in 100,000 to 200,000 deaths annually. Surgery can lead to a proinflammatory state and be a prothrombotic stimulus for venous thromboembolism (VTE). General anesthesia, as well as red blood cells transfused in the perioperative setting, is considered an independent risk factor for VTE.
Trends in perioperative RBC transfusion from index cases in five surgical specialties
July 2018—In recent years, greater attention has been given to patient blood management. While contemporary national guidelines recommend restrictive red blood cell transfusion, it is not known whether such transfusions have decreased in surgical patients. Approximately 11 million RBC transfusions are performed annually, and two-thirds of those are for patients in the perioperative period.
June 2018—Multiple myeloma and precursor disease in firefighters at World Trade Center disaster; Association between time to colonoscopy after a positive fecal test and colorectal cancerRead More »
May 2018—Use of a smartphone app to assess neonatal jaundice: Neonates are screened for hyperbilirubinemia before hospital discharge using a transcutaneous or total serum bilirubin measurement. However, levels peak at approximately 96 hours of life, which is after most healthy infants have left the hospital. Outpatient follow-up is often performed by visual inspection, but this can be highly variable and have poor interobserver agreement.Read More »
April 2018—Potential contributors to error in oxygen saturation calculation using a POC assay: Oxygen saturation is important for measuring respiratory status and calculating cardiac output for patients.Read More »
March 2018—Web platform vs. genetic counselor for releasing carrier results from exome sequencing: Genomics can be used to generate a large amount of data that may have important implications for clinical care and selection of therapeutics. However, a bottleneck exists in clinical genomics due to the large volume of results and the lack of availability of knowledgeable professionals to return them to patients in person.Read More »
February 2018—Restrictive or liberal approach to red blood cell transfusion for cardiac surgery: Among the largest group of recipients of red blood cell transfusions are patients undergoing cardiac surgery. Whether a restrictive approach to intraoperative and postoperative transfusion in cardiac surgery is superior to a more liberal approach with regard to patient outcomes is unclear.Read More »