Apr 13, 2016 | Compliance, Legal, and Malpractice, Instruments & Equipment, Laboratory Management and Operations, Laboratory Pathology
FDA sends letter to the California-based start-up concerning clearance for SureDNA test kit before accepting pre-orders from consumers
Competition to market whole-human genome sequencing to consumers is heating up. Not only is the Food and Drug Administration (FDA) watching these developments, but it is taking action to regulate companies that offer direct-to-consumer whole-human genome sequencing in developments that should be watched by clinical laboratory managers and pathologists.
One example is Sure Genomics. It claims to be breaking barriers by offering a $2,500 at-home whole human genome test to consumers.
The company believed the new test kit, called SureDNA, would escape FDA restrictions on the direct sale of health reports to consumers. However, the FDA’s recent letter to the California-based startup indicates Sure Genomics may face the same regulatory roadblocks that have stymied other direct-to-consumer genetic testing companies. (more…)
Apr 11, 2016 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology
A 1999 case involving California phlebotomist charged with reusing needles resulted in similar widespread testing of thousands of patients
Because of possible exposure to HIV, hepatitis B, and hepatitis C from a healthcare worker, thousands of patients treated in multiple hospitals in different states are being offered free clinical laboratory testing. This situation is attracting national media attention and is a reminder to pathologists and medical laboratory professionals of the increased transparency that is being given to different types of medical errors that expose patients to risk.
A surgical technologist who allegedly stole the drug fentanyl from multiple hospitals provides an example of how the healthcare system can miss systematic misconduct by individual employees that can put thousands of patients at risk. (more…)
Apr 8, 2016 | Digital Pathology, Instruments & Equipment, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Sales and Marketing, Laboratory Testing, Management & Operations
New technology from researchers at the University of Texas Southwestern Medical Center enables the ability to study cancer cells in their native microenvironments
Imaging research is one step closer to giving clinicians a way to do high-resolution scans of malignant cells in order to diagnose cancer and help identify useful therapies. If this technology were to prove successful in clinical studies, it might change how anatomic pathologists and radiologists diagnose and treat cancer.
Researchers at the University of Texas Southwestern Medical Center developed a way to create near-isotropic, high-resolution scans of cells within their microenvironments. The process involves utilizing a combination of two-photon Bessel beams and specialized filtering. (more…)
Apr 1, 2016 | Compliance, Legal, and Malpractice, Laboratory Management and Operations, Laboratory News, Laboratory Operations, Laboratory Pathology, Laboratory Testing, Management & Operations
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…)
Mar 30, 2016 | Compliance, Legal, and Malpractice, Digital Pathology, Laboratory Instruments & Laboratory Equipment, Laboratory Management and Operations, Laboratory Pathology, Laboratory Testing
IBM Health’s data combined with Truven’s patient records will create an enormous big-data collection representing 300 million patient lives
If any pathologist or clinical laboratory manager still doubts the importance of healthcare big data, the multi-billion-dollar acquisition of Truven Health Analytics by IBM should put those doubts to rest.
Last month, IBM Corp. (NYSE:IBM) announced an agreement to acquire Truven Health Analytics, (Truven) for $2.6 billion. Truven is a provider of cloud-based healthcare, analytics, and insights and is based in Ann Arbor, Michigan. (more…)
