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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Wal-Mart Developing Telemedicine Clinics in Selected Stores

Having jumped feet first into the in-store rapid clinic/minute clinic concept, Wal-Mart Stores, Inc. (NYSE:WMT) is introducing telemedicine services in selected Wal-Mart stores. This may put the company just steps away from an interest in providing appropriate diagnostic tests to customers coming into its in-store medical clinics.

This summer, Wal-Mart announced a joint operating agreement with two companies for the purpose of running telemedicine clinics in selected stores. This pilot project is taking place in Houston, Texas. Collaborating are My Healthy Access, Inc. (OTC:MYHA) and NuPhysicia, LLC . Both companies are based in Houston, Texas. Since August, the partners have opened telemedicine clinics in several Wal-Mart Supercenter stores. The service is marketed as “Walk-In Telemedicine Health Care.” It connects patients with physicians via a telemedicine arrangement. In response to the physician’s directions, medical professionals with the patient at the clinic site provide the appropriate care.

The first telemedicine location was a Wal-Mart store in Pearland, Texas, which opened with two other telemedicine clinics during August. “Changing to a Telemedicine based health care delivery system allows us to substantially decrease the overhead per patient, while simultaneously increasing the level of care each patient receives,” said Kathleen Delaney, President of My Healthy Access, Inc. This telemedicine arrangement allows one physician to provide care to multiple clinic sites. This addresses one criticism of the rapid clinic/minute clinic concept, which was the limited range of services offered to customers. These clinics, located in retail locations, are generally staffed with a nurse practitioner, who is only allowed to diagnose and treat a limited number of clinical conditions.

Over the past year, Wal-Mart has also been shifting its strategy for developing in-store, rapid clinics. It has decided to partner with regional hospitals, health systems, and physicians. Local hospitals and health systems like this approach, because it gives them access to patients. Dark Daily observes that this type of arrangement shows the rapid acceptance of the medical clinic located in a retail store. Healthcare providers are recognizing that, in order to reach more customers, they will need to offer services in non-traditional settings where today’s customers spend their time (and money).

Dark Daily further predicts that, as Wal-Mart gains more understanding about the opportunities to provide medical services in their retail stores, laboratory testing is likely to come on the radar screen. After all, with the growing number of point of care tests (POCT) and rapid tests, this diagnostic service would increase the customer-friendly and fast service offered by these in-store medical clinics. Should Wal-Mart decide that the telemedicine concept is a clinical and financial winner, then one logical path to expanding the clinical services of the retail store rapid clinic is to offer selected laboratory tests on site.

Related Information:
My Healthy Access Announces Grand Opening of Wal-Mart Based Telemedicine Clinic
My Healthy Access Announces Opening Schedule of Wal-Mart Based Telemedicine Clinics

Is New Cervical Cancer Test Better Than a Pap Smear?

Intense research into cervical cancer detection and treatment has yielded significant progress in the past decade. One common cause of such cancer is the human papillomavirus (HPV). New developments involving HPV have produced thin-layer Pap smears, HPV testing, and HPV vaccines. Now, researchers in Italy are reporting a new twist in HPV screening and detection. In research published in the journal Lancet Oncology, Guglielmo Ronco, a cancer epidemiologist at the Centre for Cancer Prevention in Turin, reported that a new way to test for cervical cancer is more accurate than a pap smear alone and identified more dangerous lesions.

Clinicians can improve the specificity of DNA tests for HPV by testing for the presence of a protein that is over-expressed in cervical cancer cells, the new research shows. The molecular test tends to give more false positives, increasing the number of unneeded referrals for colposcopy, Ronco and colleagues reported online in the journal Lancet Oncology. (Carozzi F, et al “Use of p16-INK4A overexpression to increase the specificity of human papillomavirus testing: a nested substudy of the NTCC randomised controlled trial” Lancet Oncology 2008; DOI: 10.1016/S1470-2045(08)70208-0.)

DNA tests for HPV are more likely to pick up cases of high-grade cervical intraepithelial neoplasia (CIN) than conventional cytology, Ronco and colleagues reported. Since the molecular method gives more false positives, it tends to increase the number of unneeded referrals for colposcopy, Dr. Ronco and colleagues reported. To improve specificity, the researchers considered the cyclin-dependent kinase inhibitor p16-INK4A (p16), which is considered to be a marker of HPV infection, according to a report on the findings at www.medpagetoday.com.

Since only a small percentage of women who have an HPV infection actually develop cancer, the challenge for researchers is to identify those who have the highest risk for developing the disease. By testing for a the presence of P16, the researchers said they had identified a biomarker showing cell changes that indicated whether a woman was likely to have pre-cancerous lesions, Ronco and colleagues reported. “The marker shows there was some sort of disruption by the HPV virus,” Ronco said.

“Our data show that in HPV-positive women, p16-INK4A over-expression is strongly associated with the presence of histologically confirmed CIN2+, suggesting that it actually is a marker of progression,” Dr. Ronco said. “This study supports the application of triage by P16INK4A immunostaining in HPV-positive women,” he added.

Data from the U.S. National Cancer Institute show that an estimated 11,000 women in the United States would be diagnosed with this type of cancer and nearly 4,000 would die from it last year. Cervical cancer strikes nearly half a million women each year worldwide, claiming a quarter of a million lives. Studies show 26% of women aged 14 to 59 will contract HPV.

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Two Labs in Friendly Race to Win First ISO 15189 Accreditation in U.S.

It’s a sprint to the finish line in the friendly race to be first laboratory in the United States to earn accreditation under ISO 15189:2007 Medical Laboratories. The two contestants are Piedmont Medical Laboratory (PML) of Winchester, Virginia, and Avera Health Laboratories of Sioux Falls, South Dakota.

Within the next six to eight weeks, both laboratories expect to complete all steps in the accreditation process. Each will eagerly await word that, based on the final assessment by outside auditors, all requirements have been meet and ISO 15189:2007 accreditation is granted.

This achievement will be a milestone event for the clinical laboratory industry. It marks the arrival of quality management systems (QMS) in laboratory management. This changes the status quo because quality management systems, like ISO:15189:2007 Medical Laboratories, are a comprehensive approach to managing all activities in the laboratory organization.

Until recently, both laboratories have chosen to keep their pursuit of ISO 15189:2007 accreditation out of the public eye. That is why this important story has gone unnoticed by the greater laboratory public and unreported in The Dark Report. But that is no longer the situation.

At the upcoming Lab Quality Confab on September 24-25 in Atlanta, both Piedmont Medical Laboratory and Avera Health Laboratories will be present and will make presentations on their quality journey. This is the first opportunity for lab directors and pathologists to directly the reasons behind this strategic decision and the lessons learned during the ISO 15189:2007 accreditation process.

To further help lab manager and pathologists understand the ramifications of this milestone, this week’s issue of The Dark Report published interviews with the laboratory leaders of Piedmont Medical Laboratory and Avera Health Laboratories. Among major motivations to spend the money and resources to achieve ISO 15189 accreditation was the competitive advantage each lab would realize, both with providers in the community as well as managed care plans.

In their Dark Report interview, both PML’s CEO, Joseph Skrisson, and Benita Haines, PML’s Quality Management, Compliance and Education Coordinator, stressed that ISO 15189 accreditation was triggering ongoing benefits to the laboratory, both internally in operations, quality and productivity, and externally, with regional payers and the community at large.

Leo Serrano, Director of Laboratory Services for Avera Health Laboratories, similarly stressed how ISO 15189 accreditation would help boost the competitive position of his laboratory in its service region. In fact, because of Avera’s commitment to quality, Avera’s senior administrators were immediately supportive when the ISO 15189 strategy was first proposed.

The arrival of quality management systems, including ISO 15189, will be discussed in several important sessions at Lab Quality Confab in Atlanta at the Hilton Hotel on September 24-25. Laboratory managers, pathologists, and others wanting to understand the ramifications of this new development in laboratory medicine should make plans to attend the second annual L ab Quality Confab on Quality Management in Diagnostic Medicine.

More than 50 sessions and topics will be presented, covering the full range of laboratory and pathology operations, ranging from specimen collection and courier logistics to using Lean with automation in the high-volume core laboratory. Poster sessions will take place, and national awards and prizes totaling $6,000 will be awarded. To see topics, speakers, and all the events at Lab Quality Confab, visit http://www.labqualityconfab.com.

To register for Lab Quality Confab, visit http://www.labqualityconfab.com/register.htm.

Finally, Dark Daily observes that it has taken only five years, since 2003, for the laboratory industry go from the first examples of Lean and Six Sigma in hospital laboratory operations to the first examples of ISO 15189:2007 accreditation by a hospital laboratory and an independent laboratory. These developments demonstrate how the art and science of clinical laboratory management continues to be influenced by the principles of quality management.

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Washington Post Gives Phlebotomists New Respect

One of the nation’s most prestigious newspapers recently recognized the importance of phlebotomy. The Washington Post reported that one school in our nation’s capital has phlebotomy students train on live humans rather than practice with oranges.

With the title “They’re So Vein: Tapping a Job Market,” The Washington Post did a feature on career opportunities in phlebotomy and the training provided at Sanz College , in Washington, DC. In the July 14 story, the reporter pointedly noted that many phlebotomy training classes have students practice with oranges-but that’s not the case at Sanz College, which requires each student to perform 42 successful venipunctures on humans before they successfully complete their phlebotomy training course. Each member of the class of 13 adults paid $1,900 for 92 hours of instruction in 12 weeks. In that time, the students are expected to complete the 42 venipunctures, mostly on each other.

Sanz College has only offered the phlebotomy training program since December. It recognized the strong demand for phlebotomists. In the article, Ron Sandler, a Corporate Director at Sanz, said, “We identified a market need for phlebotomists in the greater metropolitan area. As our population in the country as a whole [gets] grayer and older, there’s need for more and more [laboratory] testing as people get ill and need to get diagnosed.” The school offers two-year degree programs in computer and information sciences, English language and literature, medical assisting, and medical office management. It has an enrollment of 525 students, 76% of whom are women.

According to The Washington Post, the individuals participating in the phlebotomy class this summer came from a variety of backgrounds. There was a 60-year-old math teacher who had moved to the D.C. area from India and a 34-year-old medical assistant who had relocated from Eritrea. Also attending were 52-year-old car salesman who left New Orleans after Hurricane Katrina, a 32-year-old bank teller, and a 26-year-old college graduate. Each one wanted to learn a marketable skill in healthcare, an area where jobs are available and demand for phlebotomists will stay strong for years to come.

Demand for phlebotomy training is evidently strong in the Washington, DC area. The story noted that Northern Virginia Community College had already filled all of its 16 phlebotomy places for its fall semester training.

Related Articles:
They’re So Vein: Tapping A Job Market

Big Policy Shift on EMR and E-Health by American College of Physicians

It’s big news when the nation’s largest medical specialty organization shifts its policy on physician use of electronic medical record (EMR) systems and e-health services. The American College of Physicians (ACP), in Philadelphia, Pennsylvania, issued a new position paper.

ACP says that physicians, patients, technology companies, and policymakers must collaborate to foster e-health activities and electronic communication among physicians and patients. ACP further states that e-health activities-including remote monitoring of patients, personal and electronic health records, and patients seeking health information on-line-have the potential to transform health care in the United States!

“E-health activities have great potential to improve the quality of patient care, reduce medical errors, increase efficiency and access to care, and achieve substantial cost savings,” said ACP President David C. Dale, MD, FACP. “Furthermore, e-health is a critical part of the patient-centered medical home model of care, which in coordination with the other components, is the future of the U.S. health care delivery system.”

The new positions adopted by the ACP are useful for those pathologists and laboratory directors tracking acceptance of new technologies by physicians. Laboratories that establish electronic links with their physician clients end to enjoy a more productive relationship with those physicians.

The ACP’s new position paper is significant for two more reasons. First, it is a statement by ACP that its 125,000 physician-members are ready to embrace and adopt these new technologies. That’s a change from past years, when healthcare lagged other industries in its adoption of information systems and new technology. Second, physicians have been criticized for their collective reticence to adopt electronic medical record systems. The ACP’s position paper specifically calls for physicians and other stakeholders to recognize the potential that information technology holds for transforming healthcare.

“A recent report from the Robert Wood Johnson Foundation estimates electronic medical record (EMR) use in the ambulatory (physician) setting at 24% and in the inpatient (hospital) setting at 61%,” stated the ACP in its position paper. “According to a 2006 ACP member survey, adoption also varies by practice size; smaller practices (five or fewer physicians) have an adoption rate of 18%, while larger groups, (20 or more physicians) have an adoption rate of 58%. Those practices that have implemented EMRs may also include such services as online appointment self-scheduling and secure patient-physician messaging. This interaction between patients and their physicians through the use of electronic tools for health-related purposes has been broadly defined as e-health.”

In addition to citing the potential the IT holds for healthcare, the ACP position paper also acknowledges the barriers to more widespread adoption of information systems in healthcare. For physicians, the challenges of implementing e-health systems can be substantial in part because IT is expensive and the return on investment is not always certain. “For physicians, the financial costs of purchasing systems and incorporating e-health offerings can be considerable,” ACP said.

ACP also recommended investment in demonstration projects to assess how e-health activities can support the relatively new concept of the patient-centered medical home. A patient-centered medical home is an approach to providing comprehensive primary care for patients of all ages and medical conditions. Dark Daily has already alerted its clients and subscribers to the growing support behind the medical home concept (See Dark Daily, August 8, 2008, Doctors Promote “Medical Homes” as Way to Take Us Back to the Future ).

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