Systemic Errors at Canadian Forensic Laboratory Motherisk Make National News and Provide another Example of Consumer Interest in Accuracy of Clinical Laboratory Testing

Investigations find hair-strand analysis at hospital-based laboratory was ‘inadequate and unreliable’ for tests performed over a period lasting five years or more

Another case of a medical laboratory that produced inaccurate test results for an extended period of time has been making headlines in Canada. It demonstrates, once again, that both the news media and consumers are keenly interested in stories involving systemic lab test errors that could possibly lead to patient harm.

In this specific instance, the lab testing involved forensic testing for drugs and alcohol that were part of the Canadian legal system and thus were not clinical laboratory tests used by physicians to diagnose and treat patient care. Concerns center on the methodology used by the lab in question to perform forensic toxicology tests over a period of at least five years. Another source of concern is how proficiency testing was conducted at this laboratory.

In covering this case, the Toronto Star published a story pointing out that “flawed” results from Canadian forensic testing laboratory Motherisk may have been used in thousands of child protection cases and numerous criminal proceedings. Because of this fact, the owner of Motherisk, Toronto’s Hospital for Sick Children (SickKids) has been put into an unwelcome spotlight. (more…)

FDA’s New Next-Generation DNA Sequencing Platform Intended to Increase Collaboration among Scientists, Pathologists, and Clinical Laboratory Experts

Federal agency hopes its open-source precisionFDA web portal will aid in development of laboratory-developed tests and inform regulatory decision-making

One recent initiative launched by the Food and Drug Administration (FDA) to foster the greater sharing of genetic information may be of some value to pathologists and clinical laboratory scientists  who are developing laboratory-developed tests (LDTs) that incorporate molecular and genetic technologies.

The FDA unveiled an open-source platform for community sharing of genetic information. It is called precisionFDA, and the FDA describes its new web platform as an “online, cloud-based portal that will allow scientist from industry, academia, government, and other partners to come together to foster innovation and develop the science” of next-generation DNA sequencing processing. (more…)

Diagnostic Errors Get the Attention of the Institute of Medicine, Reinforcing Efforts by Nation’s Clinical Pathology Laboratory Scientists to Improve Patient Safety

Along with its assessment of the rate of errors in diagnosis, the IOM has a plan to improve, but will doctors accept the IOM’s advice, or continue business as usual?

Diagnostic errors in the American healthcare system is a problem that is now on the radar screen of policymakers at the Institute of Medicine (IOM). Pathologists and clinical laboratory professionals will welcome this development, because recommendations from the IOM carry weight with Congress.

Thus, should the IOM develop specific actions items intended to reduce medical errors, not only are these suggestions likely to involve more effective use of medical laboratory tests by physicians, but there is a strong probability that Congress might eventually write these recommendations into future healthcare legislation.

The Institute of Medicine is a division of the National Academies of Sciences, Engineering, and Medicine. The IOM recently convened a committee that released a list of recommendations to address the problem of diagnostic errors in medicine. Those recommendations, however, are running up against ingrained mindsets and overconfidence on the part of physicians who are reluctant to include decision-support technology in the diagnostic process. (more…)

Steady Increase in the Number of Workers with ‘Critical Illness’ Coverage Presents Clinical Laboratories and Pathology Groups with a New Challenge

Medical laboratories will have to rethink billing practices when providing services to consumers receiving lump-sum payouts from their critical illness policy

Employers continue to look for ways to control the cost of health benefits for their employees. One emerging approach that will have financial consequences for clinical laboratories and anatomic pathology groups is a newer type of insurance that provides a lump-sum payout for some critical illnesses.

Policies with this lump-sum payment feature are sometimes referred to as critical illness coverage. Such policies typically pay a lump sum if someone is diagnosed with cancer, suffers a heart attack, stroke, kidney failure, or needs an organ transplant. Some plans also provide benefits for other major medical problems, such as loss of vision, paralysis, and Alzheimer’s disease. (more…)

Virus Attacks Hospital’s Medical Laboratory Department Computers, Crippling Workflow and Spreading to Other Departments

Incident highlights need for anatomic pathology and clinical laboratories to protect computer and LIS systems from hackers and malware

Anatomic pathology labs and clinical laboratories that continue to run Microsoft Windows XP on their computer systems now have a real threat to address. In Australia, the computers in a hospital’s medical laboratory were infected in January with a computer virus that shut down the system. To maintain clinical services, the lab staff was forced to use paper-based methods, among other solutions.

The computer virus crippled the pathology department at the Royal Melbourne Hospital and spread throughout the hospital system by targeting computers running Microsoft Windows XP. This is a 14-year-old operating system that Microsoft no longer supports.

According to a story in iTnews, the Qbot malware first infected computers in Royal Melbourne Hospital’s pathology department in mid-January, handcuffing the pathology department. Staff was forced to develop manual workarounds to process specimens and to record and communicate results. (more…)