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 Healthcare Experts Critical of Direct Access Testing Advise Clinical Laboratories to Take Precautions

Test ordering and results interpretation can confuse the public says Dartmouth Institute, which is why some clinical laboratories limit the types of lab tests that people can request

Giving consumers direct access to medical laboratory testing continues to be a subject of some controversy. One factor in this debate is Theranos, which brought much attention to direct access testing, followed by extensive news coverage in recent months of its problems with reporting accurate clinical laboratory test results.

Concerns about allowing consumers to have direct access to lab testing were the subject of a recent National Public Radio (NPR) Shots Health News story. Several medical experts were interviewed and described why they had concerns about direct access testing (DAT).

One such expert is H. Gilbert Welch, MD, MPH, Professor of Medicine, Community and Family Medicine at The Dartmouth Institute (Dartmouth). According to Welch, DAT could contribute to over-diagnosis and give people an inaccurate impression of what good health actually means. (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…)

When Recruiting and Training Generation Y to Work in Medical Laboratories, U.S.A and U.K. Face Same Challenges

DATELINE—BIRMINGHAM, ENGLAND: Workforce issues in medical laboratories received special attention here at the 10th Annual Frontiers in Laboratory Medicine (FiLM) conference that ended last week. Probably the major concern going forward is how to attract, train, and sustain adequate numbers in the medical laboratory workforce.

Two speakers addressed medical laboratory workforce issues at a strategic level, with an overview about developments in the United Kingdom and the United States. Speaking about the United Kingdom was Professor Sue Hill, OBE, Ph.D., Chief Science Officer for the National Health Service. Speaking about the United States was Elissa Passiment, Ed.M., CLS (NCA), Executive Vice President, American Society of Clinical Laboratory Science (ASCLS). (more…)

Clinical Chemists and Medical Laboratory Professionals Gather at AACC’s Annual Meeting in Atlanta

Lots of products involving molecular diagnostics and genetic testing were on display at the exhibition

DATELINE: Atlanta, Georgia—Yesterday was the close of the 2011 annual meeting of the American Association of Clinical Chemistry (AACC). Organizers played host to what—pre-event—they announced was a record-breaking number of exhibit booths sold to vendors at the exhibition. Despite a rather quiet economy, there was plenty of traffic and much interest in products on display in the clinical laboratory.

Many lab industry vendors believe that there is pent-up demand by medical laboratories because of the long recession in 2008 and 2009, combined with the clamp-down on laboratory spending that resulted as hospitals and health systems slashed budgets during the recession to protect their cash flows. But now, having deferred equipment replacement for up to three full years, a number of clinical pathology laboratories have returned to the marketplace to acquire new medical laboratory testing equipment.

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AACC’s Clinical Pathology Laboratory Exhibition Showcases New Technology and Greater Interest in Lab Testing

Many new in vitro diagnostics companies show their products last week in Anaheim


It’s a troubling fact that most health policymakers in the public and private sectors continue to handle clinical pathology laboratory testing as a commodity. That often translates into health insurance programs paying medical laboratories ever less money for the tests they provide. Under-reimbursement for lab tests is a threat to the integrity of laboratory medicine in this country.

However, two groups in our country think differently than this group of health policymakers. These are patients and Wall Street investors. Individuals in both groups are closely tracking advances in laboratory testing and laboratory medicine that positively affect patient care. They know the clinical and economic benefit of using new clinical lab test technology for the right patient at the right time.

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