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PubMedDate not supplied

Move from patient-focused care model to point-of-care testing: transitioning of laboratory services.

During the past several years, the Clinical Laboratories of the Lee Memorial Health System (LMHS) have been involved extensively in adjusting the delivery systems for the provision of clinical laboratory services as the industry, competitive market, and health system moved through periods of rapid transition. This environment has allowed the opportunities for laboratory services to be provided through a variety of delivery models: central laboratory, point-of-service testing, and point-of-care testing. The Orthopedic Center at Lee Memorial Hospital was designed as a patient-focused care center and operated as a "mini hospital," housing most of the services required to care for the System's orthopedic patients, including a point-of-service (decentralized) laboratory. LMHS decided to conduct a trial of hand-held chemistry analyzers in the Orthopedic Center. The analyzer's test cost and ease of operation were as expected; however, it was found that the analyzers were not appropriate for continued use in the Orthopedic Center. Responsibility for testing for the Orthopedic Center was returned to the Central Laboratory. With the exception of certain traditional point-of-care procedures, the Central Laboratories now provide laboratory services for all of the facilities' patient care areas.

Florida↗
PubMedDate not supplied

Tracing our roots: the first clinical laboratory scientist.

OBJECTIVE: To trace the roots of clinical laboratory science by discussing the development of the role of the "laboratory technician", and describing selected early training programs for clinical laboratory personnel. DESIGN: A survey of literature on the history of clinical laboratory science was conducted. References consulted include various books and professional journals. CONCLUSION: The first clinical laboratory scientists began working in clinical laboratories shortly before World War I. During the war, and in the years that followed, a critical shortage of trained laboratory personnel developed. To alleviate this shortage, pathologists began to hire young women, training them on the job to perform simple laboratory tests. However, there were no established training standards, and few institutions offered a systematic method for instruction. During this same period, three educational programs were established that did offer high quality training that provided systematic instruction to their students.

History, 20th Century↗
PubMed1998

Carotid duplex ultrasonography: importance of standardisation. Asymptomatic Carotid Surgery Trial Collaborators and Vascular Laboratories.

BACKGROUND: Carotid duplex ultrasonography (CDUS) is an established non-invasive tool for assessing patients with suspected carotid bifurcation disease. Current trends show an increased dependence on CDUS in recommending patients for stroke prevention surgery. The aim of the study was to evaluate routine practice in vascular laboratories across 26 countries participating in The Asymptomatic Carotid Surgery Trial (ACST), and to determine the areas which are in need of future standardisation if CDUS is to be the primary tool in recommending patients for CEA. METHODS: Retrospective. Information was gathered from questionnaires, and 22 on-site visits of vascular laboratories between August 1996 to September 1997. SETTING: Clinical vascular laboratory practice. PARTICIPANTS: Eligible participants were vascular laboratories of ACST collaborators. MEASURES: Laboratories were compared in 7 categories: ultrasound equipment, operators, experience, protocols, stenosis evaluation, interpretation criteria, and reporting. RESULTS: Information on 117 respondents showed that (i) experience: at least one operator in each laboratory had more than 3 years experience; (ii) equipment: 88% (103/117) had colour duplex capability; (iii) operators: 54% of laboratories had exams performed by technologists, 33% vascular surgeons, 28% radiologists, and 35% other. The most significant findings were in (iv) stenosis evaluation: only 29% (33/117) were using a standardised Doppler angle (this single factor may greatly alter exam results); and (v) interpretation criteria; with >41 different criteria reported. These specific laboratory variations can affect those patients considered appropriate for CEA. CONCLUSIONS: This study highlights the most significant areas for future standardisation to be Doppler angle and interpretation criteria, if CDUS is to be a primary tool in recommending patients for CEA, when indicated by clinical trial results.

Carotid Stenosis↗
PubMed1999

[Genetic examination in clinical laboratory].

Genetic technology is finding active application today in the field of clinical laboratory medicine. Genetic examinations are divided into following three main classes: 1) examination for infectious disease according to the detection of the gene derived from bacteria or viruses, 2) examination for inherited disease according to molecular analysis of the genetic variation, 3) examination for oncogene according to molecular analysis of genetic abnormalities. At present, the main genetic examination in a large number of laboratories is for infectious disease because of its relatively simplified technique and high demand. The division of genetics is not a new independent section of clinical laboratory, but rather an ultramodern and powerful tool for existing divisions, such as biochemistry, serology, hematology, microbiology, and pathology. Genetic technology quickly provides results with high sensitivity and reliability, and plays a role at the core of the clinical laboratory. We should remember that the genetic technology is a great present given to clinical laboratories, however, it will eventually change into only one of the routine examinations according to the method of used. Examinations utilized in the clinical laboratory must be well established and standardized. Genetic examinations are no exception to that rule. These tests require a remarkably high precision since the results have an extraordinarily important meaning. There are more than 8,000 inherited diseases for instance. It is difficult to cover all examinations for those 8,000 in one laboratory. We need a network of laboratories that possess a genetic division, so that the examinations for as many inherited disease as possible can be comprehensively offered.

Clinical Laboratory Techniques↗
PubMedDate not supplied

Assessing the quality of clinical procedures and technical standards of dental laboratories in fixed partial denture therapy.

PURPOSE: This study was conducted to assess the quality of impressions and tooth preparations sent to dental laboratories in Jordan and to determine the technical capabilities of these laboratories to construct fixed partial dentures. MATERIALS AND METHODS: A sample of 136 impressions and stone casts were examined for clinical errors in 35 laboratories that construct fixed partial dentures. They were sorted into unusable, unsatisfactory, acceptable, or satisfactory categories. The type of impression material and tray, opposing arch impressions, and occlusal records were noted. Instructions to technicians were assessed for completeness and clarity. Information regarding laboratory staff and equipment were collected. RESULTS: Half of the specimens inspected were categorized as unusable or unsatisfactory; these were found in commercial laboratories. They showed at least one clinical error such as drags or indefinite finishing lines in impressions and inadequate reduction, undercuts, or obvious taper on stone casts. Alginate impression material was used for 65% of the cases. Only 27% of specimens were accompanied with instructions; of these 22% were graded poor. No occlusal records were available with 54% of the specimens and no articulators were used except in dental school laboratories. The dental schools and some commercial laboratories had the best staff and equipment and were more capable of fabricating fixed partial dentures than those of the Ministry of Health and the Royal Med cal Services. CONCLUSION: The quality of abutment preparation and impressions were unsatisfactory or unusable in 50% of cases. Of the 37 available instructions 8 were not clear. The dental schools and some commercial laboratories were technically capable of producing good quality fixed partial dentures.

Dental Abutments↗
PubMed2001

[Controversies regarding distribution, instrumentation, and competence of hemodynamics laboratories].

In the last few years we have witnessed a substantial growth in the number of catheterization laboratories, especially in the northern regions of Italy, a phenomenon which has met some controversy and has been discussed in a Symposium at the ANMCO National Conference (Florence, May 20-23, 2000). The controversy is essentially between those who believe in the implementation of catheterization laboratories in all cardiology units equipped with a cardiological intensive care unit (and the creation of a functional network with the tutorial centers) and those who refer to the existing guidelines, standards and VRQ which envisage a geographical distribution of laboratories on the basis of a balance between needs of the population and the minimum quantity of procedures performed by each center in order to guarantee the best quality and cost-effectiveness. The aim of the Symposium was to clarify whether the two "innovations" of these last few years, namely the introduction of new portable radiological equipment on the one hand and the effectiveness of primary angioplasty in the treatment of acute myocardial infarction on the other, may influence the redefinition of criteria regarding the distribution of laboratories, taking into account as well the expansion of indications for coronary angioplasty and coronary angiography. After a lively discussion, the proceedings can be summed up as follows: no agreement was reached regarding the role of portable radiological equipment in the decisional process regarding the setting up of a new catheterization laboratory; primary angioplasty should be carried out in centers with an adequate volume of activity and a functioning inter-hospital organizational structure for this demanding activity; otherwise it does not offer any advantages over fibrinolytic therapy; the proposal of a new organizational model is based on the creation of transverse inter-hospital cardiology departments, the size of which is based on the overall size of the user population, with interventional laboratories distributed in the reference hospitals and diagnostic laboratories in hospitals equipped with a cardiologic intensive care unit (where there is a sufficiently large user population to guarantee at least the minimum number of procedures envisaged by the standards); both parts should work in close cooperation. On this last point there was a contrasting opinion and it was not possible to reach a consensus. The Scientific Societies should formally express their views on this controversial topic, so that guidelines, standards and VRQ can be updated rapidly. The latter should constitute the reference for the procedures of accreditation to which all laboratories and cardiology departments are subjected to, and it is likely that this will be the best way to overcome the present controversy.

Angioplasty↗
PubMed2001

IgG antibodies typical for extrinsic allergic alveolitis--an inter-laboratory quality assessment.

BACKGROUND: Determination of specific IgG antibodies is important for the diagnosis of extrinsic allergic alveolitis (EAA). Various evaluations have however shown, that current methodology lacks sufficient standardization in that the employment of different sources of extracts and techniques makes a comparison of data from one laboratory to another almost impossible. OBJECTIVE: The aim of this study is to establish an external quality control system and to analyse, what the explanations for the different outcomes from various laboratories might be. METHODS: In the past 4 years 5 sera from patients suffering from EAA or healthy controls were sent every 6 months to 11 different allergy laboratories in Austria. The determination of specific IgG antibodies against antigens that are typical for this disease were requested. Results were gained with the method routinely used in the respective laboratory, and then sent back to the reference center for statistical evaluation. Precipitating techniques were used in 8 laboratories during the first mailings, but were gradually exchanged by automated ELISA systems being employed in 8 laboratories in the last mailing. RESULTS: 1127 values were determined in 105 expectedly positive sera and 1003 in 94 negative samples. Of the 562 values obtained with precipitation techniques in positive sera, only 52.0% were reported to be positive, and the results varied considerably among laboratories and antigens. In contrast, 93.3% were positive with commercially available ELISA techniques, with 92.3% for the EnzyDex System and even 95.5% for the UniCAP System. Regarding the specificity however, 93.0% of the expected negative results were correct negative using precipitation methods, whereas merely 75.2% were negative with the EnzyDex System and only 22.5% using the UniCAP System. Moreover 35.8% of the results using this latter method were false-positive. CONCLUSIONS: The traditional precipitation techniques proved not only technically difficult to perform, but also unreliable, difficult to reproduce, insensitive and impractical in daily laboratory work. They suffer from that many draw backs, that their use in daily routine cannot be recommended any more. Automated ELISA systems seem to fulfill the criteria for a routine technique concerning handling, automation, and quality criteria like sensitivity quite well, but not for specificity. Both techniques urgently need external standardization in order to make the results comparable among the different systems and methods; the danger of potentially false-positive results, pretending sensitizations that might be clinically irrelevant in several cases, is high.

Alveolitis, Extrinsic Allergic↗
PubMed2001

[Clinical laboratory's trends in the 21st century].

The new century presents numerous challenges and opportunities for the clinical laboratory scientists. Japan's economic recession has affected health care system directly. Clinical laboratories in particular have been hard hit financially. Laboratory people have striven for financial efficiency and balance within their own fields but now must broaden their view beyond this familiar field to the wider sphere of economics and medicine as whole. As laboratory professionals, we must be able to anticipate and respond to the current changes in disease frequencies, the fewer number of children in the nation, the health needs of the aging society, and the resulting economic implications. We, Japanese scientists, bring into the 21st century two major achievements. One is establishment of a fully automated laboratory system equipped with a transfer module. The second is reduced variation in inter-laboratory test results. Greater uniformity in the test results has been provided for by the supply of certified and calibrated reference materials as well as the dissemination of standard procedure for the measurement of catalytic amounts of enzymes published by the Japan Society of Clinical Chemistry(JSCC). Advances in the fields of diagnostic imaging were marvelous and received widespread attention. No less important were advances in high sensitivity immunoassay systems molecular biology-based diagnostic systems, and miniaturization of laboratory systems. The immediate future of laboratory medicine will be built upon these advanced technologies.

Blood Glucose↗
PubMed1975

State and territorial public health laboratories: the collective experience.

Directors of State and Territorial Public-Health Laboratories have realized for many years that they needed to join together to compare and appraise their operations, identify common problems, and take steps leading to improvement of services provided. Before these objectives could be accomplished, a data base, built from contributions by all the laboratories, was necessary. This article is intended to give a general historical overview of the efforts at data collection and the establishment of a solid data base covering workload and activities of the laboratories which form the Association of State and Territorial Public Health Laboratories. The Consolidated Annual Report (CAR) on State and Territorial Public Health Laboratories--Fiscal Year 1973 is the 10th consecutive report of data concerning these laboratories. The annual issues of the CAR have served as a foundation from which additional documents covering position classification and pay, guide class job specifications, laboratory training activities, and relative values assigned to laboratory tests in measuring costs and workload have evolved over the past decade. Collectively, these documents provide the solid data base available today.

Humans↗
PubMed2002

HIV-1 antiretroviral resistance testing laboratories.

OBJECTIVE: To identify and to describe the genotyping and the phenotyping testing practices of U.S. laboratories performing patient HIV-1 antiretroviral resistance testing. DESIGN: A self-report 44-item mailed questionnaire. PARTICIPANTS: Laboratories potentially performing HIV-1 antiretroviral resistance testing. MAIN OUTCOME MEASURE: Descriptive study. RESULTS: Of 236 laboratories surveyed, 165 (69.9%) returned completed surveys, but only 23 performed HIV-1 antiretroviral resistance testing. Most were university hospitals (47.8%) or independent laboratories (26.1%). All 23 laboratories used genotypic methods, while nine (39.1%) used both genotyping and phenotyping. Most testing was used for clinical trials or laboratory research. The amount of patient information collected by laboratories varied, as did their type of quality assurance measures. Variation was found with regard to: testing volume, testing experience, testing reasons, testing methods availability, testing controls, specimen treatment, and storage stability. CONCLUSIONS: Due to variation in practices in this area of patient testing, it may be advantageous for laboratory professionals to reach a consensus on what is the most acceptable.

Anti-HIV Agents↗
PubMed2003

[Quality improvement of medical diagnostic laboratories].

Service quality in medical laboratories is influenced by a number of variables. Medical laboratories have long recognized the need for total quality management that incorporates the continuous improvement of all stages, such as the pre-analytical, analytical and post-analytical phases, of the diagnostic process, in addition to the traditional internal and external quality control of analytical procedures. Based on national and international experience, continuous improvement of quality and its external assessment are of high priority in order to guarantee a reliable, effective and cost-effective diagnostic service. Certification of health care services, according to ISO 9001 standards in Hungarian hospitals, is not sufficient to prove professional competence of medical laboratories, which called for a system of laboratory accreditation. Accreditation is an external professional audit by which an independent accreditation body gives formal recognition that the medical laboratory is competent to provide high quality services that are compliant with rigorous professional standards of best practice. The primary aim of accreditation is the improvement of the quality of diagnostic services by voluntary participation, professional peer review, continuous training and education and compliance with professional standards. In vitro medical laboratories have pioneered quality control and quality assurance in health care. Based on these strengths and traditions, the introduction of the accreditation program of medical laboratories in Hungary is one of the key professional and ethical responsibilities of diagnostic professions, in order to improve the quality, efficiency and effectiveness of laboratory services during the course of Hungary's accession to the European Union.

Accreditation↗
PubMed2003

Lipid and lipoprotein testing in resource-limited laboratories.

The role of total cholesterol (TC) and lipoproteins in the assessment of coronary heart disease (CHD) is firmly established from population and intervention studies. Total and low-density lipoprotein cholesterol (LDLC) levels are positively associated with CHD, and high-density lipoprotein cholesterol (HDLC) levels are negatively associated with CHD. Efforts to identify and treat people at increased risk based on cholesterol and lipoprotein levels have led to more lipid testing and the need for very reliable test results. Thus, quality laboratory services are an essential component of healthcare delivery and play a vital role in any strategy to reduce morbidity and mortality from CHD. In laboratories with limited resources, establishing laboratory capability to measure CHD risk markers may be a considerable challenge. Laboratories face problems in selecting proper techniques, difficulties in equipment availability and maintenance, and shortage of supplies, staffing, and supervision. The Centers for Disease Control and Prevention (CDC) has been providing technical assistance for more than 30 years to laboratories that measure lipids and lipoproteins and is willing to provide technical assistance as needed for other laboratories to develop this capability. CDC can provide technical assistance to establish lipid and lipoprotein testing capability to support a CHD public health program in areas with limited laboratory resources. This assistance includes: selecting a suitable testing instrument; providing training for laboratory technicians; establishing a simple quality control plan; and instructing staff on how to prepare frozen serum control materials suitable for assessing accuracy of lipid and lipoprotein testing.

Autoanalysis↗
PubMed2004

Improving access to diagnostics: an evaluation of a satellite laboratory service in the emergency department.

OBJECTIVES: To measure the impact of a satellite laboratory upon laboratory result turnaround times and clinical decision making times. DESIGN: A prospective cohort study, the intervention group had blood tests sent Monday to Friday 12 noon to 8 pm and the control group had blood tests sent outside these hours. The data were collected over a six week period before the laboratory was opened, and a subsequent six week period. SETTING: An urban teaching hospital emergency department. PARTICIPANTS: 1065 patients requiring blood tests. MAIN OUTCOME MEASURE: Time from the blood sample being sent to the laboratory to the results being available on the clinician's computer. RESULTS: The time to haematology (blood count) results in the intervention group decreased by 47.2 minutes (95% CI 38.3 to 56.1, p<0.001) after the laboratory was opened. The corresponding control group times were unchanged (0.6 minutes; -13.8 to 15.0, p = 0.94). Similar sized differences were also seen for haemostasis (d-dimer) testing 66.1 (41.8 to 90.4) minutes compared with -14.2 (-47.1 to 18.7) and chemistry 41.3 (30.3 to 52.2) compared with -4.2 (-17.4 to 8.9) testing. Decisions to discharge patients were significantly faster (28.2 minutes, 13.5 to 42.8, p<0.0001) in the intervention group after the laboratory was opened (controls; -2.6 minutes -27.0 to 21.7). No change was seen with decisions to admit patients. There was a trend for earlier laboratory results modifying intravenous drug or fluids orders, or both (p = 0.06) CONCLUSION: A comprehensive satellite laboratory service is an important adjunct to improve the timeliness of care in the emergency department.

Decision Making↗
PubMed2005

[The external quality assessment for Mycobacterium tuberculosis drug susceptibility testing by proficiency testing panel to the commercial laboratories].

OBJECTIVE: The Committee for Mycobacterial Examinations has programmed and implemented the external quality assessment for Mycobacterium tuberculosis drug susceptibility testing by proficiency testing panel to the commercial laboratories that perform drug susceptibility testing more than 20 cases monthly. METHOD: It utilized 20 strains, exactly pairs of 10 strains, of Mycobacterium tuberculosis that were evaluated for the resistance pattern in the WHO/IUATLD supra-national laboratory network (SRLN), and the concordant results within SRLN were employed as the gold standard of the test. Each laboratory performed the drug susceptibility testing with routine method including the preparation of bacterial suspension. RESULTS: As a result, the sensitivity for isoniazid (INH) was 95% on an average, ranging from 29% to 100%. The specificity and efficiency for INH were 100% and 97% (50-100), respectively. Additionally, the reproducibility for INH was 99% (90-100). Similarly, the sensitivity, specificity, efficiency and reproducibility for rifampicin (RFP) were 95% (63-100), 99% (67-100), 97% (70-100) and 98% (90-100), respectively. The sensitivity, specificity, efficiency and reproducibility for streptomycin (SM) were 66% (33-100), 94% (64-100), 86% (65-100) and 96% (80-100), respectively. For EB, the sensitivity, specificity, efficiency and reproducibility were 96% (33-100), 74% (57-86), 81% (60-90) and 96% (80-100), respectively. DISCUSSION: The required standard for satisfactory results of sensitivity, specificity and reproducibility is 95%, and the results for INH and RFP were excellent on an average. However, several laboratories showed unsatisfactory results, especially in sensitivity. Almost all the discordant results for INH and RFP were false-susceptible comparing to the gold standard. For INH, one pair of tested strain showed discordant results in many evaluated laboratories and seemed to reflect the relatively low concordance even in SRLN. On the other hand, the reason for false-susceptible results for RFP was unclear. Several laboratories showed discordant results in one strain pair so that it might be a technical mistake. The sensitivity of SM was remarkably low and it was due to many false-susceptible results, which was twice the number of false-resistance. It was due to the character of tested strain partially considering relatively low concordance in SRLN. However, there was no persuasive explanation for the inconsistency in other strains that showed highly concordant results in SRLN. The difference of critical drug concentration in Lowenstein-Jensen and 1% Ogawa medium might contribute to the discrepancies. The specificity of EB was low and it was due to many false-resistant results. About a specific pair of tested strain, almost 100% of laboratories showed concordant false-resistant results whereas SRLN showed perfectly concordant susceptible result. If this strain was considered as resistant and another strain that showed less than 70% concordance in the tested laboratories was excluded, the sensitivity, specificity and efficiency would improve to 96%, 97% and 97%, respectively. The proficiency testing is a part of external quality assessment system and requires following corrective actions. A permanent quality improvement and maintenance will be expected through the spiral circulation of quality assurance activities.

Antitubercular Agents↗
PubMed2005

IQLM and CLMA take a snapshot of America's hospital laboratory quality management.

CLMA volunteered to conduct an online pilot survey of its membership to help the Institute for Quality in Laboratory Medicine (IQLM) determine quality management activities in laboratories. Among the hospital-based members who were surveyed, approximately 25 percent responded. The data they volunteered provide a snapshot of the current state of laboratory quality management. The pilot survey is part of a larger IQLM plan to develop networks of laboratories to monitor and evaluate laboratory practices and services to enhance laboratory medicine. This pilot survey will be used by IQLM as a model to establish quality and patient safety networks, applicable to laboratories of all sizes and types. Performance comparisons and best practices may then be shared to reduce laboratory errors and improve patient safety.

Data Collection↗
PubMed1992

The impact of new regulations on laboratory testing in physicians' offices.

The reaction of the clinician to the specter of regulation of any part of his or her practice mirrors the reaction of the laboratorian to the implementation of Medicare and Clinical Laboratory Improvement Amendments legislation in 1965 and 1967, respectively. Whether the regulatory burdens that will be visited upon these laboratories are justified or necessary is arguable; the fact of the upcoming regulation is not. The volume and breadth of testing in physicians' office laboratories (POLs) has increased exponentially since passage of the Diagnosis Related Group legislation by Congress in 1983, an increase made possible by remarkable developments in technology. State regulatory initiatives and private accrediting agencies have been perceived as being inadequate to prevent the proliferation of poorly controlled testing in the nontraditional laboratory environment. The testing menu of a given POL varies according to the scope of clinical services offered; the size of the practice group; the funding available for equipment and personnel acquisition; and the general availability of hospital, reference, and consultative laboratory services. Physicians who offer laboratory services as part of their practices must now prepare their laboratories to meet whatever requirements are mandated by regulation. This will include acquisition of trained personnel, improvement of instrumentation and methodologies, participation in proficiency testing, establishment of comprehensive quality-assurance programs, and adequate documentation of laboratory services. Organized medicine should devote its energies to assisting with needed educational processes to assure the survival of POLs.

Chemistry, Clinical↗
PubMed2005

[Activity of clinical laboratory physicians in national health insurance].

As places of activity of clinical laboratory physicians in national health insurance, there are committees of the Japan Medical Association and the Social Insurance Union of Societies Related to Internal Medicine. In 1996, additional management fee was approved due to the efforts of the then President Kinya Kono, and subsequently, fees were increased after every revision, markedly contributing to the income at the department of clinical laboratory in hospitals. Another activity of clinical laboratory physicians is work in the Social Insurance Union of Societies Related to Internal Medicine and that Related to Surgery toward the 2006 revision of medical insurance fees. The former union presented a request paper in cooperation with each scientific society for the revision of medical insurance fees, and clinical laboratory physicians played the central role in summarizing requests associated with laboratory tests. We describe the contents of the request paper for the 2006 revision of medical insurance fees presented by this union. In the previous revisions (2004), after the Ministry of Health, Labour, and Welfare counseled with the Japan Medical Association, the Central Social Insurance Medical Council made the final decisions. In the future, the power of the Ministry of Health Labour, and Welfare may increase. In activities of clinical laboratory physicians in medical insurance fees, clinical laboratory tests and physiological function tests should be evaluated according to each items, and the income/expenditure balance should be improved. In the 2006 revision of medical insurance fees, a marked reduction in medical costs for the increase in medical insurance for the elderly is expected. For this reduction, laboratory tests for which a reduction is easy may become targets. The government reported the principle that reimbursement in 2006 will be reduced by 2-5% to put the brakes on the rise in national medical costs due to the aging of society. The prospective payment system mainly by the diagnosis procedure combination (DPC) is performed mainly at university hospitals at present, and attention is paid to its future progress.

Japan↗
PubMed2006

Toward evidence-based assessment for coverage and reimbursement of laboratory-based diagnostic and genetic tests.

Despite the pervasiveness of laboratory tests and their importance to medicine, evidence for their appropriate use often is very limited. In this article, we argue for a fundamental restructuring of the process by which laboratory tests are evaluated and reimbursed. We present an approach that would promote more evidence- based appraisals for laboratory tests. In addition, we urge that coverage and reimbursement for laboratory tests move toward an evidence- and value-based approach, using the tools that largely have been adopted for pharmaceuticals by many US healthcare payers. To address this information gap for laboratory tests, we note several potential strategies to encourage manufacturers, laboratory service providers, and payers to collect outcome and cost data that will better support effective use of new laboratory tests. Integral to increasing appropriate use and reimbursement will be the development of a common language and format for dialogue--facilitating the development, review, and delivery of evidence-based tests by manufacturers, clinical laboratories, and healthcare payers.

Clinical Laboratory Techniques↗