Tag Archives: Shorts on Standards

January 2023—The fourth edition of the International Organization for Standardization’s ISO 15189, Medical Laboratories—Requirements for Quality and Competence, was published at the end of 2022. This international standard, adopted as an accreditation standard by many countries around the world, applies principles of quality management to the clinical laboratory and has general requirements for competent performance of testing. In the United States, ISO 15189 has been implemented voluntarily by close to 100 laboratories as an adjunct to CLIA ’88 regulations or CAP accreditation.

May 2020—Hazard. Harm. Risk. Benefit. Performing any activity poses risks. The laboratory deals with hazards known and understood, or unknown and unanticipated, that can lead to harm. Laboratorians attempt to minimize these risks to the point where benefit exceeds residual risk that cannot be further minimized. We understand these concepts and terms and deal with them in everything we do. For optimal patient care and for the safety of our employees, a formal approach to risk assessment is desirable to identify pertinent risks, assess those risks, determine if and when the risk has been sufficiently minimized or if mitigation measures are worth the benefit we expect to see, and document each step.

October 2018—The newly developed National Institute on Aging and Alzheimer’s Association (NIA-AA) research framework uses a biological definition of Alzheimer’s disease.¹ This framework has increased focus on biofluid biomarkers, especially because the measurement of cerebrospinal fluid amyloid beta peptide 42 (Aβ42) (or Aβ 42/40 ratio), phosphorylated tau protein (p-tau), and total tau proteins (T-tau) are included in the definition.¹ The field of AD biofluid biomarkers is rapidly evolving. For example, CSF neurofilament light (NfL) is associated with AD neurodegeneration and may be a better CSF marker compared with T-tau.

November 2016—The Laboratory Working Group of the National Kidney Disease Education Program and the IFCC Working Group for Standardization of Albumin in Urine are collaborating with IVD manufacturers to improve standardization of commercial measurement procedures. Urine albumin is an important biomarker for kidney damage.

July 2016—Next-generation sequencing has continued to deliver on its promises and potential in the diagnostic arena. However, as with any emerging and evolving technology, the medical and scientific community faces the challenge of assessing the implications and demonstrating definitive clinical uses of its expanding capabilities, especially in the context of medical efficacy, clinical utility, and cost efficiency.

January 2016—The CAP has 30 official liaisons to various organizations who attend scientific meetings or designate others to do so. They report to the Standards Committee, which reports to the Council on Scientific Affairs. We periodically publish bits of what the CAP’s outbound liaisons hear and see in their liaison roles.

January 2015—As new technology is incorporated into practice and health care reimbursement models evolve, the field of pathology continues to transform. For example, in gynecologic cytopathology, Papanicolaou testing is declining as molecular testing for human papillomavirus is incorporated into cervical cancer screening. This has an adverse impact on daily cytotechnology workload. Simultaneously, decreased reimbursement is affecting pathology practices, and questions have been raised about potential shortfalls in the future pathologist workforce.

November 2013—There’s nothing flashy about specimen tubes, which may look like the most mass-produced, commonplace items in the laboratory, but appearances can be deceptive. All tubes are not created equal. “We know that preanalytical errors account for the majority of errors in the laboratory, and many of those errors derive from the tube type in which you collect your sample,” says Leslie J. Donato, PhD, co-director of the hospital clinical laboratory and point of care at the Mayo Clinic in Rochester, Minn.