Pre-analytical products, automated systems, and Lean Six Sigma combined to improve outcomes
In today’s era of automation and Lean Six Sigma processes in laboratory medicine, the manual urinalysis test may be ready for a major makeover. Such a development would be welcome because, in the typical American hospital, the clinical laboratory performs an average of 120 urinalyses per day.
Some clinical laboratory managers consider it counterintuitive that—during a period of automation and implementation of Lean Six Sigma processes—a diagnostic tool as important and ubiquitous as urinalysis would not be perfectly methodized. But that is frequently the case. In many clinical laboratories, the processes utilized for this line of lab tests are often outmoded, inefficient, and can even lead to erroneous results.
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,