News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel

News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

Hosted by Robert Michel
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Why Whole Human Genome Sequencing Is Poised to Transform Patient Care Is Key Theme at 21st Annual Executive War College on Clinical Laboratory Management

World’s largest medical laboratory management conference will take place on April 26-27 and showcase how innovative labs are delivering more value with lab testing services

By now, most pathologists and clinical laboratory professionals recognize that healthcare is prepared to accept the use of whole human genome sequencing for diagnostic and therapeutic purposes. It is no longer a question of “will it happen?” Rather, the questions are now: “how fast will this happen and what must my lab do to be ready to support physicians in how they use the knowledge derived from whole human genome sequencing?”

Both of these questions will be answered by two globally-respected experts in the rapidly-advancing field of genetic medicine on April 26-27, 2016, at the 21st annual Executive War College on Laboratory and Pathology Management. (more…)

National Health Service Reports that Most UK Hospitals Operating in Deficit Situations

The National Health Service of England (NHS) ended 2014 with a budget overrun of £800 million, placing financial stress on the entire UK health system

According to a recently released report, nearly all hospitals in the United Kingdom are currently in financial stress. The report indicates that only seven of the 138 hospital trusts are profitable, with the remaining ones operating in a deficit situation.

Here in the United States, the UK’s National Health Service is often touted as an example of a successful single-payer health system. Thus, the extraordinary financial problems within the NHS offer pathologists and clinical laboratory managers in this country some insight into the serious challenges confronting the NHS, including increased demand for services, which puts additional stress on existing hospital budgets. (more…)

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…)

Pathologist/Researcher Offers Two Suggestions to Reduce Inappropriate Testing and Improve Patient Safety

Whether either or both of these suggestions can be put into practice is the challenge most clinical laboratories face

For Pathologist Ramy A. Arnaout, MD, DPhil, one of the biggest issues all pathologists face today is how to overcome the breakdown in cooperation between pathologists and referring physicians that can cause patient harm.

An Associate Director of the Clinical Microbiology Laboratories at Beth Israel Deaconess Medical Center (BIDMC), Arnaout was a panel member during a webinar in December sponsored by STAT News and T.H. Chan Harvard School of Public Health. During the webinar, “Medical Tests: Inaccuracies, Risks and the Public’s Health,” Arnaout explained that when errors occur in a lab, they usually happen during test selection and result interpretation, sometimes called the “pre-pre-analytical” and “post-post-analytical” phases. In these two phases of the lab-testing process, pathologists and ordering physicians need to collaborate more closely to help avoid errors and reduce the level of patient harm, he explained. (more…)

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