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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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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MT & CLS Laboratory Certification Agencies Agree to Unite

It’s likely to be a welcome development for Medical Technologists (MTs) and Clinical Laboratory Scientists (CLSs). Two credentialing bodies that certify medical technologists and laboratory scientists have agreed to unite. The American Society for Clinical Pathology Board of Registry (ASCP-BOR) in Chicago, Illinois, and The National Credentialing Agency for Laboratory Personnel (NCA) in Lenexa, Kansas, announced a letter of intent last week to form a unified credentialing agency.

Cynthia S. Johns MSA, MT(ASCP) SHCM, the Chair of the Board of Governors of the ASCP-Board of Registry, explained “the main benefit of the agreement is to create a single major certification organization for new individuals coming into the profession. In other words, this is good news for students, employers, and for the profession at large”. Technologists/technicians or clinical laboratory scientists who are currently certified will not be affected. “No one will need to recertify,” says Johns. As for how soon this will occur, “the precise timeline will be determined by the parties involved; however, our goal is to realize this unification as soon as possible.”

“The goal is simplification,” explained Elissa Passiment, CLS, Executive Vice President for the American Society for Clinical Laboratory Science, in Bethesda, Maryland. “Currently, a laboratorian can hold certification as either a Medical Technologist (MT/CP) or Clinical Laboratory Scientist (CLS/NCA)—and it is possible that he or she could be certified by both agencies. For students and employers, this can sometimes cause confusion as to which credential is ‘best.’ This unification would simplify credentialing and create single path for laboratorians. This move also reflects, in part, the globalization of healthcare.”

In the letter of intent, the ASCP, the American Society for Clinical Laboratory Science (ASCLS) , and the Association of Genetic Technologists (AGT) of Lenaxa, Kansas, said they reached an agreement to form a unified certification organization for credentialing. “The next step is to work on the memorandum of understanding (MOU) so that these organizations can formally unite,” Passiment said. “When that happens, NCA will go away and the certification activities will be consolidated under reorganized governance. This new governance will represent both Medical Technologists (MTs) and Clinical Laboratory Scientists (CLSs).”

The parties are now developing an agreement on: 1) the details of governance; 2) how the proposed single certification agency will handle the credentials of currently certified individuals; and, 3) what processes will be established to accommodate both re-certification and new applicants. In the interim, it will be business as usual for both ASCP-BOR and the NCA.

Unification will benefit educational program directors; student applicants from institutions accredited by the National Accrediting Agency for Clinical Laboratory Sciences (NAACLS) in Chicago and the Commission on Accreditation of Allied Health Education Programs (CAAHEP) in Clearwater, Florida; and other eligible individuals who receive on-the-job laboratory training.

Unification of the MT/CLS certification process is likely to be a welcome development across the laboratory profession. It is also in keeping with the well-established trend of consolidation and integration in healthcare and the laboratory industry. Further, the convergence of laboratory operations across the globe is likely to be a factor in the decision of these certification bodies to streamline and unify the credentialing process in this country. Today there are efforts to align regulatory requirements in North America and Europe for laboratory analyzers, systems, and reagents. Similarly, certification agencies for laboratory professionals are recognizing that there will be both a need and a demand for professional certification programs that can be readily accepted by more than one country.

For More Information:
Major Laboratory Certification Agencies Reach Agreement to Unite

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