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

Hosted by Robert Michel
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Shrinking Computer Chips Expand Market for Point-of-Care Handheld Devices

Siemens AG has introduced a PDA-sized portable ultrasound machine dubbed the P10 that allows emergency room doctors to assess patients quickly and easily. Devices like the P10 are possible largely because analog chip makers are racing to develop electronics that allow portability. Like cell phones before them, these portable ultrasound machines will become increasingly smaller, faster, and cheaper over time. They will also consume far less power than their full-sized counterparts.

Technology advances like these will also trigger new, smaller analyzers for in vitro diagnostics. The explosive growth in this market is demonstrated by a simple fact: semiconductor sales associated with medical equipment totaled $3.02 billion in 2007, up 65% from 5 years ago! Sales of portable systems-those weighing less than 11 lbs-climbed 42% to $565 million last year and are forecasted to reach $1.2 billion in 5 years, according to Klein Biomedical Consultants, Inc., General Electric Co’s GE Healthcare, SonoSite Inc., and Zonare Medical Systems, Inc. together accounted for 85% of the market in 2007.

These portable devices are expected to make ultrasound, which has traditionally been limited to radiologists, cardiologists, obstetricians, and gynecologists, available to new classes of specialists, including anesthesiologists and emergency care physicians. The expanded use of ultrasound could help cut healthcare costs through earlier and more accurate diagnoses.

Technology incorporated in the P10 and other portable ultrasound devices does need improvement. For example, the P10 currently does no show color, so doctors won’t see some problems. Its battery life is limited to four hours of normal use. Refinements to improve image quality and reduce power usage in the pipeline and will soon reach clinical use.

The refinement of computing chips for use in portable ultrasound devices is of note to laboratory staff because this technology has easy applications in creating more and better portable laboratory testing devices. That will expand the types of near patient and point-of-care (POC) testing systems available for diagnostic purposes. It will also enable a new generation of patient self test systems to find ready acceptance by patients. In fact, the development of blood glucose monitoring systems for diabetic patients provides one good example of how manufacturers are regularly adding new features and capabilities to these consumer self-test products.

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CMS Approves Norwegian Company for Hospital Accreditation in the U.S.

When it comes to hospital accreditation, the Centers for Medicare and Medicaid Services (CMS)  recently disrupted the status quo in at least three ways. First, last month it approved Norway-based Det Norske Veritas (DNV)  as a hospital accreditation program in the United States. Significantly, this is the first new hospital accreditation organization in the U.S. in 40 years.

Second, by taking this action, CMS is bringing the hospital industry closer to the use of ISO 9001 quality management systems. That’s because Det Norske Veritas, which already accredits hospitals in several countries worldwide, bases its accreditation process on use of ISO 9001. It has also created a program that combines the CMS “Conditions of Participation” with the ISO 9001 quality management system. DNV calls this program the “National Integrated Accreditation for Healthcare Organizations  (NIAHO).” At least 22 hospitals in the United States have already earned accreditation using NIAHO.

Third, by granting deeming status to DNV, CMS has introduced a new competitor for accreditation business into the U.S. marketplace-one that incorporates its accreditation standards on the ISO 9001 quality management system (QMS). Dark Daily predicts that it won’t take long for the Joint Commission to respond to this new competition by introducing an accreditation program that is also based on a quality management system like ISO 9001.

One U.S. hospital that has worked with Det Norske Veritas since 2005 is Newport Hospital in Newport, Rhode Island. During this time, the 120-bed community hospital has been surveyed four times by teams from DNV under its NIAHO program. Early in 2008, Newport Hospital was also surveyed by the Joint Commission and CMS, giving it a unique perspective on the similarities and differences from each of these survey programs. According to Terry McWilliams, Vice President of Medical Affairs at Newport Hospital, “They [Det Norske Veritas] consistently look for system-related issues and overall process improvement.” He further stated that the DNV survey, as conducted in his hospital was “clearly never inferior to our experience with any other agency-and at times superior! They really objectively look at your processes and how you might be able to improve them to get to that next level.”

For regular subscribers and readers of Dark Daily, these new developments are consistent with the healthcare trend of incorporating quality management systems, such as ISO 9001 and ISO 15189 Medical Laboratories, into the operation of healthcare organizations. It was in September that Dark Daily reported that the first two American laboratories were closing in on their ISO 15189:2007 accreditation. Piedmont Medical Laboratory (PML) of Winchester, Virginia, and Avera Health Laboratories of Sioux Falls, South Dakota, are in the process of completing the final steps required to earn accreditation under ISO 15189:2007. Each laboratory is using the College of American Pathologists (CAP) as its ISO 15189 accrediting body. (See “Two Labs in Friendly Race to Win First ISO 15189 Accreditation in U.S.“)

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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.

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They’re So Vein: Tapping A Job Market

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