Sep 17, 2008 | Laboratory Management and Operations, Laboratory Pathology
In the United States and many countries around the world, primary goals for healthcare reform commonly center on better patient safety, improved health outcomes, and higher quality services. As clinicians in these countries actively work to achieve these goals, the clinical laboratories that serve them must respond to these efforts with appropriate lab tests and services.
Last week, Dark Daily Editor Robert Michel traveled to New Jersey to participate in a lab management meeting specifically organized to look at healthcare globalization and identify how this globalization trend is influencing clinical laboratory services. It was the annual meeting of the Customer Advisory Board (CAB) for the Pre-Analytical Services division of Becton, Dickinson and Company (BD) (NYSE:BDX) of Franklin Lakes, New Jersey. To foster productive discussion about globalization in healthcare and laboratory testing, BD arranged for presentations via teleconference from laboratory experts in India, South Africa, Belgium, and Mexico. Here are noteworthy points from each presentation:
INDIA: Healthcare services in this country are provided through government programs and the private sector. Annual spending on health is about US$37 billion. Government health services are delivered at the state level and India has 22 states. Experts identify the need for 896,000 more hospital beds in this nation and the private sector is responding to meet this goal. Because of the lack of healthcare resources in rural areas, telemedicine services are being pushed because it extends the reach of physicians and greatly increases their productivity. In the laboratory sector, there may be as many as 40,000 independent labs. Consolidation and acquisitions have created at least five major laboratory companies. There is a shortage of laboratory technologists. Phlebotomy is performed by medical technologists, each of who must have a four-year degree. Laboratory accreditation often involves an ISO standard and ISO 15189 is gaining favor.
SOUTH AFRICA: This government provides a minimum health insurance program to individuals who fall below a certain level of income. Above that income, private health insurance is the major source of healthcare. One challenge for the country is that it has at least 13 different races which are genetically unique. As genetic medicine advances, personalized services appropriate to these patients must be developed. HIV is a major factor in South Africa. Up to 90% of government health spending goes to HIV positive patients who undergo treatment for other health conditions. There is a shortage of pathologists in the public hospital sector of South Africa. Phlebotomy is done by trained nurses who attended college. Because it can take two or three days to move a specimen from some areas of the country, there is strong interest in point of care testing. (POCT). ISO 17025 is often used by private sector hospitals and laboratories for accreditation.
BELGIUM: As a developed nation with aging demographics, healthcare in this country faces many of the same challenges as the United States. Hospitals have their own laboratories and independent lab companies serve physician offices. There has been some consolidation of the independent lab sector. There is a shortage of both pathologists and technical laboratory staff in Belgium. Laboratories must be accredited with a quality management system (QMS) and ISO 17025 has been used. However, up to 20% of the nation’s laboratories are using ISO 15189 for their accreditation. Lean and Six Sigma is gaining wide acceptance and integrates well with accreditation under ISO standards.
Phlebotomy must be done only by physicians, nurses, and medical technologists.
MEXICO: Healthcare in this country reflects the extremes of wealth and poverty among the population. The government’s social security system provides minimum health benefits to everyone with a job. However, self pay and private health insurance play significant roles in the Mexican healthcare system. A national health priority is extending health services to remote areas of the country. There are still deaths from diseases such as cholera simply because individuals in these areas have no access to healthcare. Phlebotomy is done by nurses and medical technologists. Physicians do not draw blood in their offices, but refer patients to the collection sites operated by independent laboratories. Laboratory accreditation is mandatory in Mexico and ISO 9000 has been used. ISO 15189 is an option to meet accreditation requirements and growing numbers of laboratories are using ISO 15189.
Not surprisingly, everyone participating at the BD meeting on healthcare globalization was fascinated by the similarities and differences in healthcare and laboratory services in each of these four international presentations. Observation number one: Across these four countries, it was obvious that standards of care are tightening. Accreditation of laboratories is one example. In this regard, the quiet inroads being made by ISO 15189 in all four countries caught the attention of the American lab managers participating at this meeting. They recognized that other countries are moving rather rapidly to bring their laboratory services up to the level seen in developed countries.
Observation number two is that the adage “all healthcare is local” remains true. That was illustrated by the different national objectives. In India, use of telemedicine to support rural needs is different than in Mexico, where there are major efforts to create healthcare infrastructure in regions totally lacking any health services whatsoever. Similarly, In South Africa, meeting the health needs of so many HIV positive patients is the primary objective, whereas Belgium’s healthcare system is preparing to serve the many aging, but reasonably well-off individuals soon to reach their retirement years.
Further, it was pointed out that the demand for reliable and cheap point of care (POC) diagnostic tests by countries such as India, South Africa, and Mexico as a way to support rural care, would make these attractive and sizable markets for the IVD industry. Thus, more innovation in POC testing innovation is likely to occur first in those countries, rather than in the United States or Europe.
Your Dark Daily Editor,
Robert Michel
Sep 11, 2008 | Laboratory Management and Operations, Laboratory Pathology
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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Sep 8, 2008 | Laboratory Management and Operations, Laboratory Pathology
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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Sep 3, 2008 | Laboratory Management and Operations, Laboratory Pathology
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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Aug 25, 2008 | Laboratory Management and Operations, Laboratory Pathology
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:
- 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.”
- 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.”
- 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.”
- 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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