News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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News, Analysis, Trends, Management Innovations for
Clinical Laboratories and Pathology Groups

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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

Survey Shows Most Wired Hospitals Have Better Outcomes, Lower Mortality Rates

Hospitals that invest in health information technology (HIT) have better outcomes, better risk-adjusted mortality rates, and higher patient satisfaction scores than other hospitals that do not make such investments, according to a recent survey.

Interestingly, the researchers did not establish a direct causal relationship between technology and outcomes. Instead, investment in information technology accompanies other hospital efforts to improve processes and patient care, explained Lydon Neumann, senior executive at Accenture LLC , a consulting firm that assisted in the survey, the Most Wired Survey and Benchmarking Study.

“Most wired hospitals excel in many ways but a strong investment in and commitment to information technology are characteristic of leaders who are looking at all of the elements needed to be a high-performing organization,” Neumann explained.

Hospitals & Health Networks magazine , the journal of the American Hospital Association, in Chicago, has done the survey annually for 10 years. HHN uses the results to name the 100 most wired hospitals and health systems. This year, 556 hospitals and health systems completed the survey, representing 1,327 hospitals.

HHN conducted the survey in cooperation with Accenture, McKesson Corp., and the College of Healthcare Information Management Executives. For the survey, hospitals report on how they use information technology to address five key areas:

1. Safety and quality

2. Customer service

3. Business processes

4. Workforce, and

5. Public health and safety.

“Quality and satisfaction are often tied to key initiatives and goals that hospitals are striving toward through the use of technology and process improvement,” explained Merrie Wallace, R.N., vice president and solution line manager for McKesson Provider Technologies. “The most successful hospitals use technology as part of an overall strategy and achieve significant results. Those that just deploy technology for technology’s sake don’t see these types of results.”

Only six institutions have earned the designation “most wired” every year for the 10 years that the magazine has done the survey. They are:

1. Avera Health, Sioux Falls, S.D.

2. Hackensack (N.J.) University Medical Center

3. MeritCare Health System, Fargo, N.D.

4. Partners HealthCare, Boston

5. Sharp HealthCare, San Diego

6. University of Pittsburgh Medical Center

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Researchers Put Lab Tests on Paper, Send Results by Cell Phone

Watch out! Coming soon may be tests done on low-cost, paper-based “lab-on-a-chips.” Researchers at Harvard University are working to put assays on paper to improve diagnostics in developing countries. The paper-based test strips are similar to those used in at-home pregnancy tests, but may soon be able to offer inexpensive tests for liver, kidney, and metabolic diseases. The researchers aim to develop tests that are easy-to-use, cheap, portable, and disposable.

Although the goal is to make this testing and mass screening device affordable in developing countries, the technology easily could work its way into developed healthcare systems if it delivers high levels of sensitivity, specificity, and reliability.

The university’s Whitesides Research Group is working with Diagnostics-For-All (DFA), a non-profit venture in Cambridge, Massachusetts, to develop the low-cost, paper-based “lab-on-a-chip,” as DFA calls it. These simple diagnostic tests could be used in resource-poor areas of the globe. The technology was developed in the laboratory of George M. Whitesides, Ph.D., the Woodford L. and Ann A. Flowers University Professor, Department of Chemistry and Chemical Biology at Harvard University and a co-founder of DFA.

Here’s how it works. A paper-based microfluidic chip the size of a fingernail is pre-treated with reagents for color-based (or colorimetric) assays to test bodily fluids (such as blood, urine, or sweat) for proteins and other molecules that indicate the presence of disease. The paper is patterned with hydrophobic polymers, forming a series of channels that guide a fluid sample to pre-treated regions of the chip. The resulting color changes can then be read and translated into a diagnosis using a key based on the test being conducted.

The technology offers four distinct advantages over current diagnostic systems. First, the use of paper means the chips could be significantly cheaper-potentially as low as 1 cent per chip-than other microfluidic designs, which use on silicon, plastic, or glass.

Second, the technology is highly portable. No specialized equipment is required to process and read samples, and because it uses the inherent capillary action of paper, the device does not require pumps or power sources.

Third, the device is user-friendly allowing healthcare providers to read the color-based results in minutes with minimal training. DFA could train individual providers to conduct the tests using the chips, and then use cell phones to call doctors who would advise on diagnosis and treatment.

And, fourth, it can be disposed of easily and safety through incineration, which is significant in the developing countries that may lack the resources for biological waste disposal.

“What we have with this technology is the means to help address significant diagnostic disparities between the United States and the developing world,” Whitesides said. “For instance, over time about 5% of patients in the developing world receiving treatment for tuberculosis or AIDS-equivalent to approximately 1 million people-will succumb to drug-related liver complications because of a lack of proper health monitoring. In the United States, tests for these complications are conducted every two weeks, with results returned within hours. In the developing world, when these tests are done, which is rarely, it can take laboratories weeks to send back the findings.

“By developing a low-cost and broadly applicable test system designed to be deployed in regions with no or little access to complex laboratory diagnostic equipment, we hope to make a real impact on public health,” Whitesides added.

Related Articles:
Harvard University and Not-for-Profit, Diagnostics-For-All, Partner to Introduce Innovative, Low-Cost Diagnostic Technology in the Developing World

Leaders Call on Anatomic Pathologists to Develop New Skills

Pathology is changing so quickly that anatomic pathologists need to add new skills to be successful in a clinical and business environment that is now more intensely competitive, particularly in two ways. First, regional and national pathology firms are raising the bar on clinical services in many subspecialties of anatomic pathology. Second, anatomic pathologists must have a better understanding of the business and financial skills required to succeed in today’s laboratory medicine marketplace.

One group on the forefront of these developments is the American Pathology Foundation (APF). “It’s no longer sufficient for a pathologist to come in every day and simply look at slides and make accurate diagnoses of biologic processes,” explained Luke Perkocha, M.D., Assistant Clinical Professor at the University of California San Francisco and chair of the APF’s conference program committee. “Demands for higher quality clinical services, declining reimbursement, and more intense competition for specimen referrals now require every pathology group practice to have skilled leaders. These pathologist business leaders need to understand the fundamentals of business and management. Just as medicine needs physicians who take the whole patient into account, pathology practices need leaders who take the whole business into account and think on a strategic leadership level.”

To give pathologists and lab directors an opportunity to learn the skills necessary to compete effectively today, the APF is conducting the Pathology Leadership Conference on Wednesday, September 17, 2008 at the Marriott Crystal Gateway Hotel in Arlington, Virginia. Perkocha noted that the day is organized around four specific areas of emphasis, with sessions led by experienced leaders of pathology groups from different areas of the country:

  1. Marketing. In this session, George Miaoulis, Jr., Ph.D., Professor of Marketing, at the University of Maine, will speak on, “Advanced Concepts in Marketing Pathology Professional Services: It’s Not Just a ‘Lab Test’ Anymore.”
  2. Finance. Two speakers from large pathology practices will address pathology billing issues. Del Berryman, Executive Director of Brown & Associates, in Houston, Texas, will discuss, “Evaluating and Selecting an Outside Billing Company-What Matters Most.” In the same session, Bob De la Torre, Practice Administrator at Pathology Services of Arizona, in Tempe, will discuss “Insider Expertise on Billing-Do it Yourself-Benchmark your Results.”
  3. Leadership. Pathology groups need an effective plan for succession, recruiting, and retaining skilled pathologists. Eric A. Hanson, Ph.D., Executive Consultant of Development Dimensions International, in Pittsburgh, Pennsylvania, will speak about, “Leadership Succession: Are you ready? What you should be thinking about now.” He will be followed by, Tedd Taskey, Associate Vice President, Pathology, at Slone Partners, in Denver, Colorado, discussing “Recruiting and Retaining Your Next Pathologist: Avoiding Expensive Mistakes.”
  4. Strategic business planning. Pathology practice mergers, consolidations, and integration of regional services will be discussed by Jeffery B. Drummond, an attorney with the law firm of Jackson Walker LLP, in Dallas, Texas, in his session on “Pathology Practice Mergers: New Imperatives and New Models.” Caitlin Cameron, CEO, of CellNetix Pathology & Laboratories, in Seattle, Washington, will address, “Pathology Practice Mergers: Smart Thinking in the Trenches and the Development of ‘Best Practices’.”

Founded in 1959, the American Pathology Foundation was probably the nation’s first pathology organization with a specific focus on business, management, and financial resources that would allow pathologists to succeed and prosper. Thus, it often has early and valid perspectives on unfolding trends within the anatomic pathology profession.

Perkocha’s message about the need for anatomic pathologists to support leadership skills within the pathology group practice setting is consistent with Dark Daily’s observations about unfolding changes in the anatomic pathology marketplace. With genetic medicine on the horizon, Wall Street and the national lab companies believe anatomic pathology will be hugely profitable because of new molecular assays. Community hospital-based pathology groups must respond to these strategic threats if they are to remain both clinically and financially viable. One way to acquire the necessary leadership and business skills is for pathology groups to send their business-minded partners to conferences such as the APF’s Pathology Leadership Conference.

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Lab Industry Entrepreneur Launches New Lab to Offer Molecular Tests to Dentists

For the third time in the past ten years, laboratory industry entrepreneur Brian Carr is heading up a new laboratory company he helped found. Earlier this week, OralDNALabs, Inc. of Brentwood, Tennessee, announced it was open for business. Carr will be its President and Chief Executive Officer.

OralDNALabs has a unique strategy. It plans to offer genetic tests to dentists. It is starting with two proprietary molecular assays. One test, MyPerioPath, uses DNA to identify both the presence and bacterial load of pathogens associated with periodontal disease. The second test, My PerioID PST, uses technology licensed from Interleukin Genetics Inc. (AMEX:ILI) of Waltham, Massachusetts. This test is predictive of the patient’s susceptibility to periodontal disease by analyzing the Interleukin 1 genes. With these first two assays, OralDNALabs says that it will provide dentists with a more precise method for diagnosing and treating gingivitis and periodontitus.

Brian Carr was involved in starting two other laboratory companies. In 1998, he was one of the original founders of Pathology Consultants of America, Inc., (PCA) based in Brentwood, Tennessee, where he served as CEO (see The Dark Report, April 13, 1998). PCA was acquired by AmeriPath, Inc. in December 2000. Then, in April 2004, Carr formed American Esoteric Laboratories, Inc. (AEL), also headquartered in Brentwood, Tennessee (see The Dark Report, April 26, 2004). Carr was Chairman and CEO of AEL up until its acquisition by Sonic Healthcare Ltd in December 2006.

Now, with the launch of his third laboratory company in the past ten years, Carr will attempt to bring molecular diagnostics to the dental profession. As careful readers of Dark Daily will recall, we have written in recent months about research studies that are using saliva specimens to diagnose a variety of diseases, including cancer (see Advances in Salivary Diagnostics Point to New Ways to Detect Cancer and Other Diseases). Experts predict that many of these emerging diagnostic technologies will find ready application in oral health. Newly-formed OralDNALabs may be the first laboratory company organized specifically to serve dentists and other oral health professionals. As they do, they must answer a fundamental question: are dentists ready to order laboratory tests as a regular part of their daily routine?

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Dental and Laboratory Veterans Form Specialty Diagnostics Laboratory Focusing on Dental Related Disease

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