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Medical expenses have been increasing annually, and reducing expenses while maintaining effective medical care is desirable. In the late 1990s, Japanese government introduced policies expected to improve the medical security system. In the clinical laboratory field, some revisions such as packaging of certain tests(blanket test), separation between performance and interpretation fees for laboratory test, proper use of tumor markers, and additional fees for sample management. Japanese government also wants the clinical laboratory to return accurate laboratory test result to patients and physicians. Laboratory physicians have to make a great effort to manage clinical laboratories according to the guideline for GIOs of laboratory physicians from the Japanese Society of Clinical Pathology. The laboratory physician is the key person for good laboratory management.
In 1994 the Alberta government acted to reduce to a decade-long deficit in the provincial budget with draconian reductions in the health, education and welfare expenditures. As a result, funding to Alberta clinical laboratories was to be reduced by approximately 40%. In response, the private and public laboratories in metropolitan Edmonton formed a unique alliance to provide laboratory testing in a more coordinated and efficient manner. Of the five metropolitan hospitals, only University of Alberta Hospital preserved its full service laboratory and its specialty reference testing. The other hospital laboratories were converted to rapid response laboratories with a merged private reference laboratory providing routine testing and support to the four hospitals, and far fewer outpatient collection facilities. This paper describes the steps in the laboratory restructuring from inception to execution.
The introduction of integrated laboratory systems has proceeded rapidly in Japan in these 15 years, but they require large initial investment for installation and do not always succeed in reducing laboratory cost. We also experienced three major events that taught us that total laboratory systems are not always effective: these were an earthquake, a nerve gas attack, and an outbreak of food poisoning. Political changes in the national health care system in Japan have forced the cutting of expenses for laboratory testing. In this context, cost-effective laboratory testing has been considered, and many hospitals have replaced total laboratory systems with small laboratory systems. Our University Hospital introduced a mini-lab system consisting of compact instruments to increase laboratory efficiency, and we have begun point-of-care testing education for medical students. This combination enables rapid and convenient testing, and is responsive to the political changes in the Japanese health care system.
Remarkable changes are affecting the discipline of Clinical Pathology/Laboratory Medicine in Japan. Laboratories are changing from revenue centers to cost centers that have many serious problems(ex. closure of the clinical laboratories in the hospitals and outsourcing of laboratory tests due to restructuring in response to economic aspect, limited numbers of certified laboratory physicians, and other factors). And many clinicians in university hospitals do not know what they should expect correctly from the microbiology laboratory. Therefore, we, laboratory physicians and medical technologists must modify our behavior effectively and establish a good collaborative partnership with physicians, nurses and other health care professionals. The microbiology laboratory should provide information that will affect clinical management guidelines for obtaining specimens, microbial identification, antimicrobial susceptibilities, reporting of data and educational updating. Leadership and management skills must be increasingly critical to the success of laboratory physicians in and outside of academic centers.
A review of the origin of GLP (Good Laboratory Practice) and ISO (International Standard Organisation) directives is followed by a number of definitions of concepts such as quality, guarantees of quality, quality systems, etc. by laboratories (NEN 2653). These requirements are discussed in the paper. Certification is one of the guarantees of quality assessment by laboratories. Certification of laboratories is carried out by STERLAB (Laboratory Accreditation Board of The Netherlands) or the CCKL (National Coordination Committee for Quality Assurance for Health Care Laboratories in The Netherlands). In addition to certification, laboratories in the Netherlands are extremely active as regards external quality control (QC). QC is carried out by the various occupational groups. The paper finally closes with a discussion of future developments regarding quality control and certification in medical and veterinary diagnostic laboratories.
A proposal of essential laboratory tests, made by the Japan Society of Clinical Pathology in 1989, was applied to the education of medical students in Tokushima University. The effects of this proposal on lecture and practice of laboratory medicine were evaluated by obtaining information through a questionnaire from students and clinicians. Our curriculum of laboratory medicine generally received good assessment from students and my opinion and practical training on essential laboratory tests were understood by them. The mean coefficient of variation of intra-assay precision was 3.7% and mean recovery was 70.3 at the measurement for serum protein concentration, which is one of the items in the essential laboratory tests. However, the quality of this experiment was not in accordance with the scholarly attainments or the results of the state examination for physicians. The clinicians in service at the medical school have more selected items than items of essential laboratory tests both at the initial outpatient examination and at hospital admission. Therefore, essential laboratory tests in daily primary medical care may be considered from a different standpoint, when used in the education of laboratory medicine.
The appropriate use of laboratory tests requires that valid, reliable, and reproducible data be obtained and that the clinician know both how to interpret the information provided by diagnostic tests and how to apply it to individual clinical situations. Appropriate interpretation and clinical use of diagnostic tests requires that clinicians understand the principles of laboratory testing, the information provided and not provided by laboratory tests, and how to evaluate the clinical efficacy of laboratory tests. As laboratory testing moves from regional and hospital laboratories into office laboratories, clinicians need to become more knowledgeable regarding the technical and quality control factors that affect diagnostic test accuracy. This will require the establishment of stronger, more effective links between clinicians and laboratory pathologists.
A proficiency testing project was conducted among 48 microbiology laboratories participating in Project ICARE (Intensive Care Antimicrobial Resistance Epidemiology). All laboratories correctly identified the Staphylococcus aureus challenge strain as oxacillin- resistant and an Enterococcus faecium strain as vancomycin-resistant. Thirty-one (97%) of 32 laboratories correctly reported the Streptococcus pneumoniae strain as erythromycin-resistant. All laboratories testing the Pseudomonas aeruginosa strain against ciprofloxacin or ofloxacin correctly reported the organism as resistant. Of 40 laboratories, 30 (75%) correctly reported resistant MICs or zone sizes for the imipenem- and meropenem-resistant Serratia marcescens. For the extended-spectrum beta-lactamase (ESBL)-producing strain of Klebsiella pneumoniae, 18 (42%) of 43 laboratories testing ceftazidime correctly reported ceftazidime MICs in the resistant range. These results suggest that current testing generally produces accurate results, although some laboratories have difficulty detecting resistance to carbapenems and extended-spectrum cephalosporins. This highlights the need for monitoring how well susceptibility test systems in clinical laboratories detect emerging resistance.
In November 2004, the Association of Public Health Laboratories (APHL) conducted a Comprehensive Laboratory Services Survey of State Public Health Laboratories (SPHLs) in order to establish the baseline data necessary for Healthy People 2010 Objective 23-13. This objective aims to measure the increase in the proportion of health agencies that provide or assure access to comprehensive laboratory services to support essential public health services. This assessment addressed only SPHLs and served as a baseline to periodically evaluate the level of improvement in the provision of laboratory services over the decade ending 2010. The 2004 survey used selected questions that were identified as key indicators of provision of comprehensive laboratory services. The survey was developed in consultation with the Centers for Disease Control and Prevention National Center for Health Statistics, based on newly developed data sources. Forty-seven states and one territory responded to the survey. The survey was based on the 11 core functions of SPHLs as previously defined by APHL. The range of performance among individual laboratories for the 11 core functions (subobjectives) reflects the challenging issues that have confronted SPHLs in the first half of this decade. APHL is now working on a coordinated effort with other stakeholders to create seamless state and national systems for the provision of laboratory services in support of public health programs. These services are necessary to help face the threats raised by the specter of terrorism, emerging infections, and natural disasters.
Many changes have recently taken place in the world of laboratory accreditation. These changes include the increased use of voluntary standards in lieu of regulations, a move towards harmonization (equivalent results using voluntary standards) over standardization (using the same procedures or regulations), and an increased focus on competence, which includes the competence of laboratories to conduct testing, the competence of accreditation bodies to operate accreditation programs, the competence of bodies such as the National Cooperation for Laboratory Accreditation (NACLA) to recognize accreditation bodies as meeting the requirements of relevant standards, and the competence of organizations providing services to the accreditation process, such as the operation of proficiency testing programs. To describe these changes, a brief and general description of the International Laboratory Accreditation Cooperation accreditation scheme is provided, including an update on relevant decisions and activities in the United States and a description of the organization and activities of the newly formed NACLA. Following this discussion, with emphasis on veterinary testing, is an overview of several national and international organizations, including accreditation bodies, that promote harmonization, standardization, and analytical excellence. Also outlined are relevant activities of these organizations, an overview of some of the standards and guidelines they produce, and a description of how such organizations interact with each other and with laboratories seeking recognition for competence. Next is a brief discussion of recent developments and trends in laboratory accreditation, the impact of these developments, and the costs and benefits of accreditation to laboratories. Suggestions to veterinary laboratories for formulating strategy for keeping current with developments in accreditation and for determining quality goals are included.
The aim of the present study was to find the cause of inter-laboratory differences in laboratory test data and to examine whether control assessment helps to reduce inter-laboratory differences. Blood and serum samples of one healthy subject and one subject with liver cirrhosis were analyzed by 11 laboratories in the Okayama City area. No differences were found in the assay units of 26 tests surveyed. However, considerable differences were observed in test data, reference interval, and clinical level (CL), though most laboratories pointed out that the test data for the normal subject was within the reference intervals and those for the patient with liver cirrhosis showed abnormalities in tests for liver function. The difference in reference intervals was serious in the tests of direct bilirubin (D-Bil), thymol turbidity test (TTT), alkaline phosphatase (ALP), gamma-glutamyltranspeptidase (GGTP) and choline sterase. Marked differences in CLs were found in the tests of D-Bil, TTT, ALP, GGTP, creatine phosphokinase, amylase, heavy density lipoprotein cholesterol and white blood cell count. However, three hepatologists independently suggested that such inter-laboratory differences would not seriously affect a clinical decision on the disease status of the cirrhotic patient. Most tests that showed a trend error in a recent quality control survey appeared to have the same trend in the present study. These results indicate that inter-laboratory differences occur at various levels and control assessment are helpful in establishing, and therefore reducing, the level of inter-laboratory differences.
The Department of Health and Human Services notifies Federal agencies of the laboratories currently certified to meet standards of Subpart C of Mandatory Guidelines for Federal Workplace Drug Testing Programs (59 FR 29916, 29925). A similar notice listing all currently certified laboratories will be published during the first week of each month, and updated to include laboratories which subsequently apply for and complete the certification process. If any listed laboratory's certification is totally suspended or revoked, the laboratory will be omitted from updated lists until such time as it is restored to full certification under the Guidelines. If any laboratory has withdrawn from the National Laboratory Certification Program during the past month, it will be identified as such at the end of the current list of certified laboratories, and will be omitted from the monthly listing thereafter. This Notice is now available on the internet at the following website: http://www.health.org.
In recent years, concern has increased regarding use of biologic materials as agents of terrorism, but these same agents are often necessary tools in clinical and research microbiology laboratories. Traditional biosafety guidelines for laboratories have emphasized use of optimal work practices, appropriate containment equipment, well-designed facilities, and administrative controls to minimize risk of worker injury and to ensure safeguards against laboratory contamination. The guidelines discussed in this report were first published in 1999 (U.S. Department of Health and Human Services/CDC and National Institutes of Health. Biosafety in microbiological and biomedical laboratories [BMBL]. Richmond JY, McKinney RW, eds. 4th ed. Washington, DC: US Department of Health and Human Services, 1999 [Appendix F]). In that report, physical security concerns were addressed, and efforts were focused on preventing unauthorized entry to laboratory areas and preventing unauthorized removal of dangerous biologic agents from the laboratory. Appendix F of BMBL is now being revised to include additional information regarding personnel risk assessments, and inventory controls. The guidelines contained in this report are intended for laboratories working with select agents under biosafety-level 2, 3, or 4 conditions as described in Sections II and III of BMBL. These recommendations include conducting facility risk assessments and developing comprehensive security plans to minimize the probability of misuse of select agents. Risk assessments should include systematic, site-specific reviews of 1) physical security; 2) security of data and electronic technology systems; 3) employee security; 4) access controls to laboratory and animal areas; 5) procedures for agent inventory and accountability; 6) shipping/transfer and receiving of select agents; 7) unintentional incident and injury policies; 8) emergency response plans; and 9) policies that address breaches in security. The security plan should be an integral part of daily operations. All employees should be well-trained and equipped, and the plan should be reviewed annually, at least.
Integration and standardization of laboratories throughout a medical system can increase the efficiency and effectiveness of laboratory operations. This task is challenging in most health-care systems, as no central governance exists to compel laboratories to standardize and integrate. We describe the initial collaborative efforts to integrate and standardize the laboratories of the Mayo Foundation, which includes more than 60 laboratories of different sizes in diverse locations. The goals and objectives of the group formed to develop this initiative--the Centralized Laboratory Purchasing Group--its origin, and lessons learned are described. Similar initiatives by other academic medical centers and community health-care systems to integrate and standardize their laboratories are discussed. Successful standardization and integration increases the value of the laboratory to the larger health-care system by demonstrating accountability, efficiency, and effectiveness, and can result in considerable cost savings to the entire health-care system.
Previous researchers have identified significant differences between laboratory and road cycling performances. To establish the ecological validity of laboratory time-trial cycling performances, the causes of such differences should be understood. Hence, the purpose of the present study was to quantify differences between laboratory- and road-based time-trial cycling and to establish to what extent body size [mass (m) and height (h)] may help to explain such differences. Twenty-three male competitive, but non-elite, cyclists completed two 25 mile time-trials, one in the laboratory using an air-braked ergometer (Kingcycle) and the other outdoors on a local road course over relatively flat terrain. Although laboratory speed was a reasonably strong predictor of road speed (R2 = 69.3%), a significant 4% difference (P < 0.001) in cycling speed was identified (laboratory vs. road speed: 40.4 +/- 3.02 vs. 38.7 +/- 3.55 km x h(-1); mean +/- s). When linear regression was used to predict these differences (Diff) in cycling speeds, the following equation was obtained: Diff (km x h(-1)) = 24.9 - 0.0969 x m - 10.7 x h, R2 = 52.1% and the standard deviation of residuals about the fitted regression line = 1.428 (km . h-1). The difference between road and laboratory cycling speeds (km x h(-1)) was found to be minimal for small individuals (mass = 65 kg and height = 1.738 m) but larger riders would appear to benefit from the fixed resistance in the laboratory compared with the progressively increasing drag due to increased body size that would be experienced in the field. This difference was found to be proportional to the cyclists' body surface area that we speculate might be associated with the cyclists' frontal surface area.