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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Researchers at the Stanford University School of Medicine Develop Cutting-Edge Test to Identify Whether an Infection is Bacterial or Viral

Early results are promising and this technology could lead to a clinical laboratory test that would give microbiologists and pathologists a new tool for helping diagnose infections

Infectious disease physicians and clinical laboratory scientists will be interested to learn that researchers at the Stanford University School of Medicine recently developed a new blood test that can identify whether the source of an infection is bacterial or viral.

These findings were published in Science Translational Medicine in July. The paper was authored by Stanford staff members Timothy Sweeney, MD, PhD, and Purvesh Khatri, PhD, Assistant Professor (Research) of Medicine (Biomedical Informatics Research-ITI Institute) and of Biomedical Data Science. Hector Wong, MD, of the University of Cincinnati was the third co-author of the study.

These findings are timely because, starting on January 1, 2017, hospitals and health systems will need to implement more rigorous antimicrobial stewardship programs to comply with new requirements of the Centers for Medicare & Medicaid Services (CMS) and The Joint Commission (TJC). A clinical laboratory test that makes it easier to determine whether the cause of an infection is bacterial or viral would be a welcome tool for physicians, pharmacists, pathologists, and microbiologists involved in a hospital’s infection control program. (more…)

Lean-Six Sigma Medical Laboratories Begin to Innovate in Ways That Add Value to Physicians, Payers, and Patients

With record attendance of 300 Lean-Six Sigma experts, this week’s conference was a high-energy event that provided medical lab professionals and pathologists with case studies of how to improve lab operations and contribute to better patient care

DATELINE: NEW ORLEANS—Yesterday was the conclusion of the 10th Annual Lab Quality Confab, which showcased innovators in clinical laboratories and anatomic pathology groups. Attendees traveled here from six different countries.

One new trend that emerged from this year’s presentations is that progressive medical labs are beginning to direct their Lean-Six Sigma, and process improvement efforts toward projects designed to add value to client physicians and hospitals. These projects include added-value features of benefit to patients and health insurers.

How Clinical Laboratories Are Succeeding with Lean Projects

This is a shift from prior years. At earlier Lab Quality Confabs, most speakers were describing how their labs were using Lean and quality management methods to improve workflow within their labs, increase the productivity of automation and staff, reduce errors, and cut costs. This was an “inside-the-lab” mindset.

That was not the case here in New Orleans this week. Yes, there were plenty of sessions where workflow redesign, productivity improvement, and cost reduction were discussed. But, at the same time, a significant number of labs doing presentations were describing projects that took the lab team outside of their laboratory to engage with physicians and nurses specifically to help them use clinical laboratory test data in ways that would improve patient care, reduce length-of-stay for hospital patients, and trigger worthwhile reductions of the cost of care. This is an “outside-the-lab” mindset. (more…)

New 3D Sutures Enable Collection of Biodata In Vivo Using Thread-Based Diagnostic Devices

Engineers have designed a microfluidics and nano-scale diagnostic toolkit suitable for attaching directly to muscle and tissue to monitor biomarkers and stream results wirelessly to care providers and medical laboratories

What would change in medicine if physicians had sutures that could collect and report biomarker data, including the kinds of biomarkers that are used in clinical laboratory tests? Such a product may be feasible, based on newly-published research.

“Smart sutures” are a joint project between Tufts University, Harvard University, and Massachusetts Institute of Technology (MIT) engineers. They announced a thread-based diagnostic device (TDD) system capable of detecting biomarkers and analytes using 3D sutures composed of cotton and synthetic threads.

Processing the cotton and synthetic threads in various ways enhances their natural properties. The toolkit of different sutures developed by the team has exhibited a range of uses—including measuring physical stress at an incision, monitoring pH of tissues and fluids, and measuring glucose. (more…)

Mayo Medical Laboratory’s Mary Bonnerup Combines Heartland Values with Mayo Founders’ Legacy of Putting the Patient First to Win the National Lab Sales Excellence Award for Specialty Testing

Providing physicians with the clinical context and knowledge for the best use of specialty clinical laboratory tests helps this highly successful lab sales professional establish win-win client relationships

In support of the many local clinical laboratories and hospital lab outreach programs across the United States that continue to regularly add new clients and take market share away from their national lab company competitors, The Dark Report organized the 2016 National Lab Sales Excellence Award.

The award winners were announced at this year’s Executive War College in New Orleans on April 26–27. Reporting on the lab industry’s top sales producers serves two worthy goals. First, it brings recognition to the accomplishments of these lab sales professionals. Second, it helps medical laboratory administrators and pathologists at other labs and hospital outreach programs learn more about what it takes to use lab sales reps to win new clients.

What follows is a profile of the 2nd winner of the 2016 National Lab Sales Excellence Award. Dark Daily will publish profiles for each of the five laboratory sales professionals who were recognized with this unique national sales award. (more…)

University of Pennsylvania Researchers Develop $2 Zika Proof-of-Concept Test That Needs Neither Electricity Nor a Clinical Laboratory to Return Accurate Results

Using 3D printing and a chemical heat source, University of Pennsylvania researchers have created a proof-of-concept for an affordable Zika test that returns results in just 40 minutes

There’s a gap in Zika virus testing that researchers at the University of Pennsylvania hope to fill. That gap is a point-of-care test for the Zika virus that can produce a fast and accurate result, whether in developed nations or in developing countries that don’t have many state-of-the art clinical laboratories.

Although numerous Zika virus tests have earned Emergency Use Authorizations from the US Food and Drug Administration (FDA), gold standard detection is still limited to medical laboratories. To date, the FDA’s list of current and terminated Emergency Use Authorizations include no point-of-care options to help medical professionals quickly screen patients for Zika infection.

As noted by the Center for Disease Control and Prevention’s “Interim Guidance for Interpretation of Zika Antibody Test Results,” the antibodies that indicate Zika virus activity also share similarities with other flavivirus viruses. Of particular note is similarities with Dengue virus—a virus prevalent in many of the areas in which Zika is found. (more…)

Noted Clinical Laboratory and Anatomic Pathology Legal Experts Jane Pine Wood and Richard Cooper to Address 2017’s Important Changes in Legal, Compliance, and Managed Care Issues for Lab Industry

Medical labs must comply with PAMA lab test price market reporting in 2017, while pathologists will see big changes in Medicare physician payments because of MIPS

It is now budget-planning season for the medical laboratories of hospital and health systems. This fall, lab administrators report grim news as they try to anticipate all the changes coming to the clinical laboratory industry in 2017—just 11 weeks away.

There is a growing consensus among lab executives and pathologists who are the business leaders of their groups that labs will not see any relief in 2017 to the multi-year decline in lab test prices that actually intensified in the past 24 months.

One factor is their assessment of the coverage and pricing decisions being made by the federal Centers for Medicare & Medicaid Services (CMS) and Medicare Administrative Contractors (MACs) for specialty lab tests. The other factor is their experience with private payers who continue excluding local clinical labs from narrow networks and who insist on price cuts when managed care contracts are renewed. (more…)

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