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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Study Finds FDA Relied on Flawed Data When Approving High-Risk Medical Devices for Obstetrics and Gynecology; Are There Implications for Regulation of LDTs?

Researchers suggest FDA approvals be based on more rigorous clinical studies before and after medical devices get approved to market

Do regulators consistently get it right when reviewing medical devices and clinical laboratory tests as part of the market-approval process? New findings provide credible evidence that government regulators have their own problems when reviewing submissions for market clearance.

One example involves researchers at the Northwestern University Feinberg School of Medicine. They recently determined that the U.S. Food and Drug Administration (FDA) based approvals of certain medical devices on flawed data.

Announced in a May 2016 statement,  the study, which was published in the journal Obstetrics and Gynecology, will be of special interest to clinical laboratory executives and pathologists who understand that the findings of this study might be useful ammunition in the medical lab industry’s efforts to forestall FDA regulation of laboratory developed tests (LDTs).

Essentially, if these researchers can find obvious flaws in how the FDA reviews a relatively limited number of medical devices, as identified by this study, then how would the FDA cope with the need to review thousands of LDTs in a timely, cost-effective, and rigorous manner? (more…)

FDA Looks to Clamp Down on Laboratory-Developed Tests and Put an End to ‘Wild West of Medicine’: Might CLIA Problems at Theranos Support FDA’s Position?

The Wall Street Journal examines the FDA’s position on LDTs and looks at the pros and cons of LDT regulation by the federal agency

National news coverage over the deficiencies uncovered by Clinical Laboratory Improvement Amendments (CLIA) inspections of the clinical laboratory operated by Theranos in Newark, Calif., may have an interesting consequence that affects all medical laboratories and pathology groups.

Over the past 30 months, Theranos has regularly asserted that its laboratory-developed tests (LDTs) were under review by the Food and Drug Administration (FDA). For example, in an interview published in the December 14, 2014, issue of The New Yorker, Theranos Founder and CEO Elizabeth Holmes stated, “We believe that to realize our vision we must operate at the highest levels of excellence… And the FDA’s stamp of approval is seen as an indicator of the quality of a product.”

Thus, it would be ironic if the problems in the quality of clinical laboratory tests uncovered by federal CLIA inspectors at the Theranos lab facility in Newark was used by the FDA to justify their intent to regulate LDTs. The FDA has already released a report to the public that identified instances where laboratories running LDTs were alleged to have reported inaccurate lab test results to patients and their physicians. (more…)

Mayo Medical Laboratories Gathers Pathologists and Other Experts to Share Lessons Learned and Successes in Improving How Physicians Utilize Lab Tests

Utilization management of clinical laboratory testing is a big trend in laboratory medicine at the moment as innovative labs strive to add more value

DATELINE: DENVER, COLORADO—Interest in improving the utilization of clinical laboratory tests is at an all-time high among medical laboratories throughout the United States. Last week a national gathering of pathologists and laboratory professionals gathered in the Mile High City to share success stories and identify the best approaches to helping physicians better utilize lab tests.

This one-day conference on laboratory test utilization was organized by Mayo Medical Laboratories and the Mayo Clinic as part of its 27th Annual Conference on Laboratory Outreach. The keynote speaker was Michael G. Rock, MD, Chief Medical Officer at Mayo Clinic Hospitals/Mayo Foundation and an at-large member of the Board of Trustees of the American Hospital Association (AHA) and its Executive Committee.

Analysis of Key Trends in Healthcare

In recent years, Rock has been involved at the highest levels of healthcare strategy development, both at the Mayo Clinic and with several national hospital associations, including the American Hospital Association. He provided attendees at this conference with a razor-sharp analysis of key trends in healthcare. Rock then identified and explained the essential steps that innovative hospitals and health systems are taking to reshape their organization in order to provide the range of clinical services needed to support integrated healthcare and personalized medicine. (more…)

Adoption of Quality Management Systems Could Mean Competitive Advantage for Clinical Pathology Laboratories

ISO 15189 is a quality management system  specifically designed for the needs of medical laboratories

Use of quality management systems (QMS) by innovative clinical laboratories and pathology groups enables them to drive impressive gains in quality, customer satisfaction, and financial performance. This is a key development at a time when medical laboratory budgets are shrinking and more cuts in lab test prices are expected.

Going the Extra Mile to Improve Quality Could Be Strategic Opportunity

On all fronts of laboratory medicine, requirements are becoming more stringent. Each year, labs find themselves held to higher standards for compliance with both Clinical Laboratory Improvement Act (CLIA) requirements and Medicare accreditation guidelines. This situation will become further complicated as clinical labs face the need to also meet the requirements of accountable care organizations (ACOs) and similar models of integrated clinical care. Early adopters are responding to these marketplace dynamics by making strategic use of a QMS to boost the performance of their clinical laboratory organizations. As they do, they often gain a competitive advantage. (more…)

Mayo Medical Laboratories Enters Pathology Testing Agreement with China’s Kindstar

Mayo Clinic to support one of China’s largest clinical laboratory companies

In a trans-Pacific Ocean collaboration with major implications, two important players in clinical laboratory and anatomic pathology  testing in their respective countries have inked a multi-year pact. On June 27, 2011, Mayo Clinic of Rochester, Minnesota, announced its agreement with Wuhan Kindstar Globalgene Technology, Inc. (Kindstar), of Wuhan, Hubei Province, China.

In the press release it issued about the agreement, Mayo Clinic said that it would support Kindstar by providing “specialized laboratory support based on provision of knowledge from Mayo Clinic’s Department of Laboratory Medicine and Pathology and its reference laboratory, Mayo Medical Laboratories.” Mayo Clinic also said that it will receive equity in Kindstar and had participated in Kindstar’s Series B financing, which raised approximately U.S. $11 million.
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