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[Establishment of a laboratory information office in response to the expanding need for consultation--actual situation of the laboratory information room, Clinical Laboratory Department, Kitasato University Hospital].

Due to the advancement, segmentation and specialization of the medical care, laboratory examinations covered by the National Health Insurance (NHI) tariff have exceeded several hundred, and it is not possible for medical staff to be familiar with all of these and to utilize them appropriately. There is an urgent need for laboratory information for physicians, nurses, and other health professionals. Accordingly, our Clinical Laboratory Department, Kitasato University Hospital, established a "Laboratory Information (Consultation) Office" in July 1995 to provide consultations on clinical laboratory tests to those engaged in daily clinical practice and in medical research. The office is situated on the second floor of the Laboratory Building of the Kitasato University Hospital. One laboratory technician and one laboratory physician (clinical pathologist) are stationed there. They are available for telephone consultations from 9:00 to 17:00 on weekdays, except for holidays, and from 9:00 to 13:00 on the first, third and fifth Saturdays. In addition, since January 1997, this office also has been open to members of medical associations in various cities in our area. To cope with requests for laboratory information, including whether an examination is covered the NHI tariff, selection of appropriate screening examinations and availability of new laboratory tests, consultations by fax are accepted at any time, even after regular working hours. As a post-graduate education program, the clinical laboratory physicians study specimen handling analytical methods and interpretation of results. At medical staff meeting, personnel from the Laboratory Information Office provide clarification on the types of consultations offered, address complex questions and find resolutions for rarely encountered and difficult laboratory issues. At these meetings, a summary of new laboratory examinations also is presented. This system of an information office where full-time laboratory physicians and laboratory technicians are stationed is the first such attempt in Japan. It may be considered a pilot project to determine if such a system may be applied to other laboratory departments in the future.

Clinical Laboratory Information Systems↗

The total laboratory solution: a new laboratory E-business model based on a vertical laboratory meta-network.

Major forces are now reshaping all businesses on a global basis, including the healthcare and clinical laboratory industries. One of the major forces at work is information technology (IT), which now provides the opportunity to create a new economic and business model for the clinical laboratory industry based on the creation of an integrated vertical meta-network, referred to here as the "total laboratory solution" (TLS). Participants at the most basic level of such a network would include a hospital-based laboratory, a reference laboratory, a laboratory information system/application service provider/laboratory portal vendor, an in vitro diagnostic manufacturer, and a pharmaceutical/biotechnology manufacturer. It is suggested that each of these participants would add value to the network primarily in its area of core competency. Subvariants of such a network have evolved over recent years, but a TLS comprising all or most of these participants does not exist at this time. Although the TLS, enabled by IT and closely akin to the various e-businesses that are now taking shape, offers many advantages from a theoretical perspective over the current laboratory business model, its success will depend largely on (a) market forces, (b) how the collaborative networks are organized and managed, and (c) whether the network can offer healthcare organizations higher quality testing services at lower cost. If the concept is successful, new demands will be placed on hospital-based laboratory professionals to shift the range of professional services that they offer toward clinical consulting, integration of laboratory information from multiple sources, and laboratory information management. These information management and integration tasks can only increase in complexity in the future as new genomic and proteomics testing modalities are developed and come on-line in clinical laboratories.

Chemistry, Clinical↗

Use of a major medical center clinical laboratory as a reference laboratory for a developing country: ordering patterns help set laboratory priorities.

BACKGROUND: The test menus for developed and developing countries may differ, depending on many factors, including the expected volume of testing, disease frequency and therapies available, clinical impact of the test, technical skill and equipment needed, cost, the patient population served, and whether alternative testing sites are available, and some of them may not be exactly known. We assessed test priorities in a developing country by making a broad range of tests available and then assessing which tests were actually used by the physicians in the country for the care of their patients. METHODS: The Barnes-Jewish Hospital laboratory and Washington University Medical Center provided patients in the developing country of Eritrea access to the same tests as patients in St. Louis for all analytes that are stable at 4 degrees C, the lowest temperature that could be used for shipping. RESULTS: The use of the St. Louis laboratories increased steadily from 1998 to 2001. More than one-half of the physicians in Eritrea used the reference laboratories, with requests for thyroid function and female fertility representing 48-71% of the test requests over the 4 years evaluated. The high degree of utilization for these test batteries was not predicted. Testing for thyroid function, female fertility, and lipid panels are now performed, or soon will be performed, in Eritrea based on the experience of the reference laboratory system. The reference laboratory system is continuing so that the test priorities of the country can be evaluated on an ongoing basis and specialized tests can be made available at a low cost. CONCLUSION: The experiences of a reference laboratory for a developing country can help to identify unanticipated priorities for medical testing within the country.

Clinical Laboratory Techniques↗

[Less variation in laboratory results after the introduction of INR. Differences between hospital laboratories and laboratories within primary health care are levelled out].

In 1999 a new and simplified procedure for calibration of the Owren prothrombin time (Owren PT) assay was introduced in Sweden by the national external quality assessment scheme (Equalis). The new protocol allowed local calibration by means of lyophilised national plasma calibrators and expression of results as an international normalised ratio (INR). A two-year follow-up involving analysis of data from all laboratories that have returned results to Equalis is reported. There was a significant reduction in both between-laboratory and within-laboratory variation after the introduction of the new calibration procedure. For the larger hospital laboratories analysing external controls with INR > 2, the mean coefficient of variation (CV) was reduced from 9.1% to 5.6% (P < 0.0001). The corresponding results from smaller laboratories in the primary health care units showed a similar decrease in CV from 8.8% to 6.3% (P < 0.0001). This study shows that the Owren PT assay is well suited for INR calibration employing calibrant plasmas.

Anticoagulants↗

Strategic considerations in clinical laboratory management: a laboratory leadership role in clinical pathways. Establishing the laboratory's direct contribution to the institution's performance.

This clinical laboratory serves a unique, though incompletely recognized, function in medical care as the source, moderator, and conduit of vital information supporting the detection, confirmation, and monitoring of disease states. To carry out that function effectively, the laboratory must actively participate in developing clinical pathways based on medical programs. Clinical pathways define the operational and quality requirements for the services involved in meeting the medical program objectives. Because of the laboratory's unique position in the acquisition and flow of information, its contribution must continue as a planned process--based on accurate assessment of value, cost, and resource inputs--rather than in a discrete, event-driven manner. Two examples of clinical pathway development, partly given by the laboratory, illustrate its application in nutritional screening and monitoring for metabolic support and in emergency department admitting decisions on myocardial damage at Bridgeport Hospital (Bridgeport, CT). The paper suggest two activities, point-of-care testing and screening for fetal lung development, that could benefit considerably from clinical pathway information shared across the experiences of several institutions.

Chest Pain↗

[Results of a questionnaire survey about "standardization" of connection methods in Laboratory Automation System or Laboratory Information System by the National University Hospital Clinical Laboratory Divisions].

"Standardization" is very important in the field of clinical laboratory medicine. Enzyme reference materials(ERM) and standard plasma proteins(CRM470) have already been developed. Reference methods for some clinical chemical tests have also been developed. We are studying "standardization" of electric communication methods between computers and automatic analyzers in Laboratory Automation System(LAS) or Laboratory Information System(LIS). We present the results of a questionnaire survey of 73 LAS or LIS making Companies in this paper. Although "standardization" of electric communications or local area network in LAS or LIS has been done in only 22 companies(34.9%), we are planning more functional standard electric communication methods such as Health Level 7(HL7) or American Society for Testing and Materials(ASTM).

Autoanalysis↗

Integrating laboratory processes into clinical processes, Web-based laboratory reporting, and the emergence of the virtual clinical laboratory.

References to integration occur frequently in the health-care literature. Integration in this context refers to the blending or merging of the separate components of a health-care organization to form a cohesive and seamless interoperating whole. The health-care industry is now in the process of reorganizing and consolidating through hospital mergers and the creation of provider networks. The stimulus for these activities, all integrative, has been the introduction of managed care as a replacement for fee-for-service reimbursement. Managed care was designed to introduce competition into health-care delivery, and it certainly has succeeded in this goal. The quest for integration in health care is thus a consequence of the shift to managed care and has been driven by the belief that integration will lead to greater efficiency and cost savings in the industry. The major vehicles for achieving integration in the clinical laboratories will be Web-based reporting and the emergence of the virtual clinical laboratory.

Clinical Laboratory Information Systems↗

Contrast of survey results between state and a cohort of nonstate mycobacteriology laboratories: changes in laboratory practices.

Based on the recommendations of a 1992 conference on tuberculosis, the Centers for Disease Control and Prevention (CDC) established programs for upgrading mycobacteriology laboratories by providing them with monies and focused training. In 1991, state public health laboratories were surveyed to determine the methods they were using for primary Mycobacterium tuberculosis testing and their turnaround times for reporting testing results. A similar survey of nonstate laboratories participating in the National Laboratory Training Network-sponsored, M. tuberculosis-focused training programs was conducted from May 1992 to June 1993. In 1994, follow-up surveys of both the state- and nonstate-laboratory cohorts were conducted with the questionnaire from the initial survey plus additional questions that asked about interventions and changes occurring in the laboratory since the original survey. Although both cohorts showed increases in the percentages of laboratories meeting the recommended turnaround times for reporting M. tuberculosis testing results and using the recommended rapid methods for testing, generally, the increases made by the state laboratories were greater. By June 1994, all state laboratories were using a rapid method for M. tuberculosis isolate identification compared with 88% of the nonstate laboratories. The percentage of laboratories identifying isolates within the recommended 21 days also increased more in the group of state laboratories than in the group of nonstate laboratories (state laboratories, 22 to 73%; nonstate laboratories, 55 to 59%). Responses from the follow-up survey showed large differences in the percentages of laboratories that received CDC funding (state laboratories, 100%; nonstate laboratories, 6%) and participated in M. tuberculosis training (state laboratories, 98%; nonstate laboratories, 45%). These results indicate that adequate funding and focused training are critical in maintaining state-of-the-art mycobacteriology laboratories.

Bacterial Typing Techniques↗

The transformation of hospital laboratories: why regionalization, consolidation, and reengineering will lead laboratories into the 21st century.

In 1990 we predicted that the growth of prospective payment and fixed reimbursement plans would force hospitals to transform the hospital laboratory into a cost center. The need to create alternative modes of care would further lead hospitals to create regional laboratory consortia. This would include the "commercialization" of the laboratory so that it could become a regional resource and expand outreach activities. This report updates events since 1990. Indeed, the arrival of prospective payment and fixed reimbursement has caused a radical upheaval among health care providers in every part of the country. The transformation was more rapid than we expected, particularly in two areas. First, the commercial laboratory industry devoured itself. By 1995 the consolidation movement ended and three huge national laboratory chains now provide laboratory services throughout the United States. Second, not only did prospective payment arrive in the form of capitated contracts for laboratory services, but it arrived with remarkable speed. It was coupled with the absolute decline for three years in Medicare reimbursement for lab services. Such changes to reimbursement levels have seriously undercut the financial viability of the laboratory industry. Hospital-based laboratories are responding to these pressures with three strategies: reengineering, consolidation, and networking. Six identifiable trends will drive the transformation of laboratories into regional provider consortia between now and the year 2000. We predict that the speed of this transformation will be even faster than that experienced by the consolidation of commercial laboratories. This will occur because hospital labs are already a component within integrated delivery systems. As these systems transform and evolve, the laboratories must transform in concert. Our experience indicates that laboratory consolidation delivers economic benefits that are considerably greater than either networking or reengineering. Consolidation, accompanied by new testing technologies and tighter data links, will lead the transformation of today's hospital laboratory into a "virtual" laboratory. Such laboratories will be self-sufficient, capable of performing all but esoteric tests in-house. It will be a "laboratory without walls," emphasizing testing performed at the point of care, be it bedside, physician's office, clinic, nursing home, ambulance, workplace, or patients' homes. A combination of economic and organizational pressures will cause hospital-based laboratories to adopt some form of regionalization within the next two to three years.

Capitation Fee↗

Core functions and capabilities of state public health laboratories: a report of the Association of Public Health Laboratories.

Emerging natural and man-made threats to the health of the nations population require development of a seamless laboratory network to address preventable health risks; this can be achieved only by defining the role of public health laboratories in public and private laboratory service delivery. Establishing defined core functions and capabilities for state public health laboratories will provide a basis for assessing and improving quality laboratory activities. Defining public health laboratory functions in support of public health programs is the beginning of the process of developing performance standards for laboratories, against which state public health laboratories, and eventually local public health and clinical laboratories, will establish and implement best laboratory practices. Public health is changing, and as apart of that change, public health laboratories must advocate for and implement improvements for public health testing and surveillance. These changes are outlined also in the Association of Public Health Laboratories consensus report (Association of Public Health Laboratories. Core functions and capabilities of state public health laboratories: a white paper for use in understanding the role and value of public health laboratories in protecting our nation's health. Washington, DC: Association of Public Health Laboratories, 2000).

Laboratories↗

[Postgraduates' training as laboratory physicians/clinical pathologists in Japan--board certification of JSLM as a mandatory requirement for chairpersons of laboratory medicine].

The educational committee of the Japanese Society of Laboratory Medicine(JSLM) proposed a revised laboratory medicine residency curriculum in 1999 and again in 2001. The committee believes that present undergraduate clinical training is insufficient and that Japanese medical graduates need clinical training for two years after graduation. This two years training should be a precondition for further postgraduate training in laboratory medicine and should include fundamental clinical skills(communication skills, physical examination and common laboratory procedures such as Gram's stain, Wright-Giemsa stain and urinalysis). After the two years training, the minimal training period of laboratory medicine should be three years, and should include: 1) Principles, instrumentation and techniques of each discipline including clinical chemistry, clinical hematology, clinical microbiology, clinical immunology, blood banking and other specific areas. 2) The use of laboratory information in a medical setting. 3) Interaction of the laboratory physician with laboratory staff, physicians and patients. With good on-the-job training and 24 hours on-call duties, laboratory physicians are expected to perform their tasks, including laboratory management, effectively. They should have appropriate educational background and should be well motivated. The background and duties of the laboratory physicians often reflect the institutional needs and personal philosophy of the chairperson of their department. At the moment, few senior physicians in Japan have qualifications in laboratory medicine and are unable, therefore, to provide the necessary guidance to help the laboratory physicians in their work. I therefore believe that the board certification of JSLM should be regarded as mandatory for chairpersons of laboratory medicine. Our on-call service system can enhance the training in laboratory medicine, and improve not only laboratory quality assurance but patients' care as well.

Certification↗