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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Patient Safety Guru Lucian Leape, MD, Discusses How Medical Laboratories and Pathology Groups Can Do More to Improve Patient Safety

Panel of webinar speakers included several physicians, a pathologist, and a director from the Food and Drug Administration (FDA)

Patient safety continues to be a major factor in the ongoing transformation of healthcare in the United States. As it does, more scrutiny is being given to how medical laboratories and anatomic pathology groups can contribute to improving patient safety.

One example of the heightened scrutiny of patient safety as it relates to clinical laboratory testing services was a recent webinar at the Harvard T.H. Chan School of Public Health and the online healthcare site, Stat. Titled “Medical Tests: Inaccuracies, Risks and the Public’s Health,” this webinar featured nationally-known healthcare experts and policy makers.

Issues of patient safety associated with medical laboratories was a major topic during this webinar, including discussion about concerns associated with the clinical use of laboratory-developed tests. (more…)

‘10 Disruptive Forces in Healthcare’ Provide Challenges for Clinical Laboratories and Pathology Groups Forced to Respond to a Changing Marketplace

Transition to value-based reimbursement tops Insigniam’s list of factors altering healthcare landscape

Management consulting firm Insigniam recently identified “10 Disruptive Forces in Healthcare”. Several of these development create significant implications for clinical laboratories and anatomic pathology groups that are navigating today’s rapidly-changing healthcare landscape.

ACA and Aging Population Reshaping Healthcare

“I have been doing healthcare for 33 years at this point. And there has been more change in the last three [years] than at any time, and it’s by a long shot,” declared Donald Casey, Jr., Chief Executive Officer of the Medical Segment of Cardinal Health in Ohio. He was quoted by Insigniam Quarterly.

donald casey

Donald Casey, Jr., Chief Executive Officer of the Medical Segment of Ohio-based Cardinal Health, has firsthand experience responding to the fundamental changes taking place in healthcare today. Casey points to the Affordable Care Act (ACA) and an aging population as the two drivers behind what is a fundamental reshaping of American healthcare. (Photo copyright: Cardinal Health.)

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New Tool to Identify Tumor Heterogeneity Could Help Pave Way for Personalized Cancer Therapies and Help Pathologists Add Value for Oncologists

Ohio State University study shows correlation between genetic variability among cancer cells within tumors and the survival of patients with head-and-neck cancers

Anatomic pathologists and clinical laboratories  may gain a tool to identify tumor heterogeneity. This would enable them to ultimately guide personalized cancer therapies if a new method for measuring genetic variability within a tumor and predicting outcomes is confirmed in future studies.

Scientists Seek Cause of Resistance to Cancer Treatment

The new tool was dubbed “MATH” by researchers at The Ohio State University Comprehensive Cancer Center–Arthur G. James Cancer Hospital and Richard J. Solove Research Institute  (OSUCCC–James). MATH is the scoring method they developed and stands for  mutant-allele tumor heterogeneity. MATH was used to measure the genetic variability among cancer cells within tumors from 305 patients with head and neck squamous cell carcinoma  (HNSCC), treated at multiple institutions, from The Cancer Genome Atlas.

In announcing the study results, OSUCCC-James stated  that cancers that showed high genetic variability— called “intra-tumor heterogeneity”—correlated with lower patient survival.

James Rocco, MD, PhD, Professor in the Department of Otolaryngology-Head and Neck Surgery at The Ohio State University Wexner Medical Center, and his colleagues, used MATH values “to document a relation between intra-tumor heterogeneity and overall survival in any type of cancer.” (more…)

Results of Undercover Assessment Suggest Clinical Laboratory Companies Need to Raise the Bar on Quality Control of Non-Invasive Prenatal Tests

Three out of five NIPT laboratories returned normal or negative test results for samples taken from non-pregnant women in undercover test performance assessment

Clinical laboratory companies that offer genetic tests may want to be on the alert. Secret shoppers are submitting specimens for the purpose of assessing the quality, the accuracy, and the clinical relevance of the proprietary medical laboratory tests they perform.

One such report was published in GenomeWeb under the title “Undercover Assessment of Five Commercial NIPT Labs Points to Need for Better Quality Control.” The goal of the report was to emphasize the need for standards to ensure quality and accuracy of molecular assays and genetic tests.

This report discussed results from an undercover performance assessment of five commercial laboratories, each of which offers Non-Invasive Prenatal Tests (NIPTs). GenomeWeb reported that three test results reported normal or negative test results for a female fetus, despite the fact that the samples submitted had been taken from non-pregnant women. (more…)

Study at Boston’s Beth Israel Deaconess Medical Center Determines that 30% of All Clinical Laboratory Tests Are Overused or Medically Unnecessary

BIDMC researchers show that, on average, 30% of all lab tests may be unnecessary and that an equal percentage of tests should not be ordered at all

Every pathologist and clinical laboratory professional knows how often physicians order a medical laboratory test that is inappropriate or unnecessary. That is a problem because, each time a clinician orders an inappropriate test, patient harm is possible. Yet this issue gets little attention from the medical profession at large.

Thus, it is significant that researchers at Beth Israel Deaconess Medical Center (BIDMC), published a study last fall showing that 30% of all medical laboratory tests throughout medicine are overused! A different 30% of medical laboratory tests are underused, as well. (more…)

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