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Evidence-based medicine: its application to laboratory medicine.

The current health care environment of cost-cutting highlights the need to reinforce the contribution of laboratory medicine to improvement in health care. This must be a patient-focused activity using continuous quality improvement, a familiar concept in laboratory practice. Involvement in the creation of clinical practice guidelines, care maps, and outcome measures will place laboratory medicine in the circle of continuous quality improvement. The laboratory must provide strong evidence that tests contribute to better overall resource utilization. Laboratory Information Systems can be used to better integrate laboratory data with clinical, diagnostic, pharmaceutic, statistical, and financial information. Improving laboratory utilization requires clear demonstrations of appropriate versus inappropriate laboratory use, and instructions on implementing appropriate use. The education of laboratory professionals should include search strategies, understanding the diagnostic accuracy of medical tests, and the application of systematic reviews and meta-analysis. With the rapid increase in the data base supporting evidence-based laboratory medicine, there is a significant challenge in translating the existing knowledge into practice. There is also a need for a cooperative strategy between the diagnostics industry and the laboratory medicine profession to provide evidence of the added value of laboratory testing. There is a significant role in developing the academic basis of the unique aspects of evidence-based laboratory medicine.

Clinical Laboratory Techniques↗

Physician satisfaction and emergency department laboratory test turnaround time.

OBJECTIVES: To determine the length of time for the components of the emergency department (ED) turnaround time (TAT) study in 1998 and to ascertain physician satisfaction concerning laboratory services to the ED. METHODS: Using forms supplied by the College of American Pathologists Q-Probes program, participants conducted a self-directed study of ED TAT over a 4-week period. Data requested included various times of day associated with the ordering, specimen collection, laboratory receipt, and result-reporting stages of stat ED TATs for potassium and hemoglobin. Additionally, practice-related questions associated with the laboratory were asked. Participating laboratories also provided a physician satisfaction survey for up to 4 physicians who were users of ED services. Results of both the TAT study and the physician satisfaction survey were returned by mail. Participants were drawn from the 952 hospital laboratories enrolled in the 1998 College of American Pathologists Q-Probes study on ED TAT. The main outcome measures included the components of the ED TAT process, factors associated with decreases in ED TAT, and the results of the physician satisfaction survey. RESULTS: Six hundred ninety hospital laboratories (72.4% response rate) returned data on up to 18 230 hemoglobin and 18 259 potassium specimens. Half of these laboratories responded that 90% of potassium tests were ordered and reported in 69 minutes or less, whereas the TAT for 90% of hemoglobin results was 55 minutes or less. Comparison of the components of TAT for both potassium and hemoglobin with similar studies done in 1990 and 1993 showed no change. Factors found to statistically contribute to faster TATs for both tests were laboratory control of specimen handling and rapid transport time. When whole blood specimens were used for potassium determination, TAT improved. Emergency department physicians chose the study-defined lower satisfaction categories of Often, Sometimes, Rarely, and Never for the questions concerning the laboratory being sensitive to stat testing needs (39.1%) and meeting physician needs (47.6%). Many of the physicians surveyed believed that laboratory TAT caused delayed ED treatment more than 50% of the time (42.9%) and increased ED length of stay more than 50% of the time (61.4%) when compared with other specialty users of the ED. CONCLUSIONS: Laboratory ED TATs have remained unchanged for almost a decade. Emergency department physicians are not satisfied with laboratory services. Although it appears that one issue may relate to the other, the interaction between the laboratory and the ED is quite complex and has been evolving for at least 30 years. Improvement in interoperability between the departments is essential for operational efficiency and patient care. Effective communication channels need to be established to achieve these goals.

Attitude of Health Personnel↗

Hospital nursing satisfaction with clinical laboratory services: a College of American Pathologists Q-Probes study of 162 institutions.

CONTEXT: Monitoring customer satisfaction is an important and useful quality improvement tool and is required of most clinical laboratories in the United States. OBJECTIVE: To survey the level of nursing satisfaction with hospital clinical laboratory services. DESIGN: Participating laboratories provided information regarding laboratory demographics and practices. These laboratories then surveyed hospital nursing personnel regarding their level of satisfaction with defined aspects of laboratory service. SETTING: College of American Pathologists Q-Probes laboratory quality improvement study in 162 hospital laboratories. MAIN OUTCOME MEASURES: Nursing overall satisfaction score (ranging from 1, not satisfied, to 5, very satisfied) and satisfaction scores for 13 specific aspects of clinical laboratory services. RESULTS: One hundred sixty-two institutions submitted data from a total of 7033 nursing surveys. The overall satisfaction score for all institutions ranged from 2.5 to 4.6. The median overall score for all participants was 3.9 (10th percentile, 3.2; 90th percentile, 4.2). Nursing personnel were most satisfied with the accuracy of test results, phlebotomy courtesy toward patients and nursing staff, and notification of abnormal results. They were least satisfied with stat test turnaround time, laboratory management responsiveness and accessibility, phlebotomy responsiveness to service requests, and routine test turnaround time. The most important aspect of laboratory service reported by nursing personnel was stat test turnaround time. CONCLUSIONS: Most nursing personnel are satisfied with the clinical laboratory services that are provided to the patients in their care. Although test result accuracy is very highly regarded, there is room for improvement in several aspects of service, particularly in test turnaround time and laboratory management accessibility and responsiveness.

Clinical Laboratory Techniques↗

[Communication of useful information from laboratory physicians to clinical physicians].

In recent years increasing importance has been placed on the role of hospital clinical research, such as the promotion of intra-laboratory human, material and informational resources, previously restricted to the laboratory, to the whole hospital system, and the appropriate usage of laboratory findings via common consultation systems, or specialized informational consultants in the clinical laboratory department. The volume of clinical laboratory information, which plays an important role in the decision-making process of routine clinical practices, is enormous for each individual hospital, and appropriate use of this information has a major influence on institutional clinical practice efficiency. In response to the need for the communication of useful laboratory information to clinical physicians, departments of laboratory research consultants have been organized in individual hospitals as a way forward. In the near future, laboratory physicians will play a leading role in the communication of research information from the viewpoint of EBLM (evidence-based laboratory medicine). From the work of these laboratory research consultants, it becomes possible to obtain relevant EBLM-related information, such as frequently asked questions and opinions, from their users. By replying to these questions and opinions appropriately, laboratory research consultants can provide information that is both advantageous and useful, and which meets the needs of the clinical physician side. Effective communication of useful laboratory research information should not be restricted to either the laboratory physicians or the technicians; it is a job that needs the cooperation and teamwork of both sets of people. Also, they should always keep in mind that communication by itself is not sufficient; they should not assume the useful evaluation of information by the users, but rather ensure that they are presented with information that precisely meets their needs.

Clinical Laboratory Information Systems↗

Introduction to ISO 15189: a blueprint for quality systems in veterinary laboratories.

BACKGROUND: A trend in human and veterinary medical laboratory management is to achieve accreditation based on international standards. The International Organization for Standardization (ISO) 15189 standard is the first developed especially for accreditation of medical laboratories, and emphasizes the laboratory-client interface. European veterinary laboratories seeking to train candidates for the certification examination of the European College of Veterinary Clinical Pathology (ECVCP) require approval by the ECVCP Laboratory Standards Committee, which bases its evaluation in part on adherence to quality systems described in the ISO 15189 standards. OBJECTIVE: The purpose of this article was to introduce the latest ISO quality standard and describe its application to veterinary laboratories in Europe, specifically as pertains to accreditation of laboratories involved in training veterinary clinical pathologists. METHODS: Between 2003 and 2006, the Laboratory Standards Committee reviewed 12 applications from laboratories (3 commercial and 9 university) involved in training veterinary clinical pathologists. Applicants were asked to provide a description of the facilities for training and testing, current methodology and technology, health and safety policy, quality assurance policy (including internal quality control and participation in an external quality assurance program), written standard operating procedures (SOPs) and policies, a description of the laboratory information system, and personnel and training. Also during this time period multiple informal and formal discussions among ECVCP diplomates took place as to current practices and perceived areas of concern with regard to laboratory accreditation requirements. RESULTS: Areas in which improvement most often was needed in veterinary laboratories applying for ECVCP accreditation were the written quality plan, defined quality requirements for the tests performed, written SOPs and policies, training records, ongoing audits and competency assessments, and processes for identifying and addressing opportunities for improvement. Recommendations were developed for a stepwise approach towards achieving ISO 15189 standards, including 3 levels of quality components. CONCLUSION: The ISO 15189 standard provides a sound framework for veterinary laboratories aspiring to meet international quality standards.

Accreditation↗

The World Health Organization's External Quality Assurance System Proficiency Testing Program has improved the accuracy of antimicrobial susceptibility testing and reporting among participating laboratories using NCCLS methods.

A total of 150 laboratories in 33 countries that followed the NCCLS testing procedures participated in the World Health Organization's External Quality Assurance System for Antimicrobial Susceptibility Testing (EQAS-AST) from January 1998 through March 2001. Laboratories tested seven bacterial isolates for antimicrobial resistance and reported the results to the Centers for Disease Control and Prevention (CDC) in Atlanta, Ga. The results were compared to the results generated at the CDC with the NCCLS broth microdilution and disk diffusion reference methods. Although there were few testing errors with Salmonella enterica subsp. enterica serovar Enteritidis, drugs that are not appropriate for therapy of Salmonella infections were tested and reported by 136 (91%) of 150 laboratories. In addition, 29 (20%) of 150 laboratories used the Staphylococcus aureus breakpoints to report oxacillin results for Staphylococcus saprophyticus. For a vanB-containing Enterococcus faecalis strain, 124 (83%) of 150 laboratories correctly reported vancomycin results that were +/-1 doubling dilution from the reference MIC or +/-3 mm from the reference disk diffusion result. Of the laboratories that tested Streptococcus agalactiae by disk diffusion, 17% reported nonsusceptible results for penicillin in error. While 110 laboratories (73%) tested the S. pneumoniae challenge isolate against a fluoroquinolone, 83% tested it against ciprofloxacin, for which there are no NCCLS interpretive criteria. Ten of 12 laboratories testing levofloxacin and 4 of 4 laboratories testing ofloxacin by an MIC method correctly reported resistant results for the isolate. Feedback letters sent to participating laboratories highlighted areas of susceptibility testing in individual laboratories that needed improvement. The positive impact of the feedback letters and the overall effectiveness of the EQAS program were documented in repeat testing challenges with pneumococci and staphylococci. The 31 and 19% increases in the numbers of laboratories using appropriate testing methods for pneumococci and staphylococci, respectively, in 2000 versus 1998 indicate that laboratory performance is improving.

Anti-Bacterial Agents↗

Laboratory services for mycobacterial diseases.

The philosophy of the recently proposed "Levels of Laboratory Service" program, which will be so vital to the conduct of a successful outpatient tuberculosis treatment and control program, is presented. The hallmark of this program is the decentralization of the diagnostic/monitoring services as they involve laboratory participation. In the long run this could mean more efficient operation, more reliable reporting, and probably less work for the participating laboratories. The greater emphasis on smear examination (Level I) as a monitoring tool will mean fewer cultures, thereby lessening the load for those laboratories that once went through countless clinically requested exercises of repetitively proving by culture the existence of M. tuberculosis in a given patient. Doubtless, the bulk of the work will be conducted in Level II laboratories; but here, too, identification of the most easily defined pathogen, M. tuberculosis, will minimize the over-all workload for these investigators while decreasing their concern about mycobacteria other than tubercle bacilli. Expertise gained in frequent repetitions of a limited number of tests (niacin, nitrate reduction, and pH 7/68 degrees C catalase) will ensure reliable speciation of the clinically most important Mycobacterium. The work of Level III laboratories should eventually be reduced primarily to organisms other than M. tuberculosis, thereby ensuring that a number of highly competent reference institutions will not only attain proficiency in taxonomic aspects of mycobacteria, but will also reflect the regional picture of the changing patterns in mycobacterial pathogens of man. Participation of laboratories in proficiency testing programs will encourage top-level performance in all areas. Additionally, such testing programs will serve a teaching role; a laboratory need not feel "locked in" at a given service level, but may increase its proficiency and move up a step in terms of the service it provides. In contrast, no laboratory need feel compelled to increase its activities; if daily workloads limit the extent of their involvement with mycobacteria, these laboratories can be confident that other institutions are providing needed services. The success of the entire "Levels of Laboratory Service" program depends on the recognition by individual laboratories of their own workload limitation, the directed motivation of personnel, and the maintenance of a free and open pipeline of communication to laboratories at the next higher level of service.

Bacteriological Techniques↗

Survey of antimicrobial susceptibility testing practices of veterinary diagnostic laboratories in the United States.

OBJECTIVE: To describe antimicrobial susceptibility testing practices of veterinary diagnostic laboratories in the United States and evaluate the feasibility of collating this information for the purpose of monitoring antimicrobial resistance in bacterial isolates from animals. DESIGN: Cross-sectional study. PROCEDURES: A questionnaire was mailed to veterinary diagnostic laboratories throughout the United States to identify those laboratories that conduct susceptibility testing. Nonrespondent laboratories were followed up through telephone contact and additional mailings. Data were gathered regarding methods of susceptibility testing, standardization of methods, data management, and types of isolates tested. RESULTS: Eighty-six of 113 (76%) laboratories responded to the survey, and 64 of the 86 (74%) routinely performed susceptibility testing on bacterial isolates from animals. Thirty-four of the 36 (94%) laboratories accredited by the American Association of Veterinary Laboratory Diagnosticians responded to the survey. Laboratories reported testing > 160,000 bacterial isolates/y. Fifty-one (88%) laboratories reported using the Kirby-Bauer disk diffusion test to evaluate antimicrobial susceptibility; this accounted for 65% of the isolates tested. Most (87%) laboratories used the NCCLS (National Committee for Clinical Laboratory Standards) documents for test interpretation. Seventy-five percent of the laboratories performed susceptibility testing on bacterial isolates only when they were potential pathogens. CONCLUSIONS: The veterinary diagnostic laboratories represent a comprehensive source of data that is not easily accessible in the United States. Variability in testing methods and data storage would present challenges for data aggregation, summary, and interpretation.

Animals↗

Allergy to laboratory animals among animal handlers.

OBJECTIVE: To determine the prevalence among laboratory animal handlers of allergy to laboratory animals and of asthma and the factors associated with their development. DESIGN: A cross-sectional survey. SETTING: Teaching and research institutions in Sydney, between January 1989 and December 1992. PARTICIPANTS: Laboratory animal handlers (teaching and research staff, animal house workers and animal husbandry students and teachers). MAIN OUTCOME MEASURES: Duration of exposure to laboratory animals, allergic symptoms on contact, skin reactivity to laboratory and domestic animal allergens and evidence of current asthma. RESULTS: 228 subjects were surveyed. Allergy symptoms occurred in 73 (56%) of the subjects exposed to laboratory animals for three months or more. This group also had significantly higher prevalences of skin reactivity to laboratory animal allergens (62%) and bronchial hyperresponsiveness (21%) than those with shorter exposure (14% and 8%, respectively). Atopic subjects exposed to laboratory animals (particularly those sensitised to domestic animals) and animal attendants (with a high intensity of exposure to laboratory animals) had significantly higher frequencies of skin reactivity to laboratory animals and asthma than other subjects (77% and 30%, respectively, among exposed atopic subjects and 84% and 33%, respectively, among animal attendants). CONCLUSIONS: Allergy to laboratory animals is an occupational hazard among laboratory animal handlers, especially for those who are atopic and sensitised to domestic animals, and may lead to the development of asthma. Screening for atopy and skin reactivity to laboratory animals before and during employment would enable those at risk to take precautions.

Adult↗

Effects of restructuring on the performance of microbiology laboratories in Alberta.

OBJECTIVE: To evaluate the error rates of organism identification and antibiotic susceptibility proficiency testing challenges before, during, and after microbiology laboratory restructuring in Alberta. METHODS: Alberta Health substantially reduced and redistributed laboratory funds to the regional health authorities in 1995, forcing a dramatic restructure of services. Many rural hospitals expanded their microbiology test menus, and urban centers consolidated microbiology testing into a centralized high-volume laboratory. The Laboratory Proficiency Testing Program of the College of Physicians and Surgeons of Alberta mailed regular test profile surveys to microbiology laboratories during the restructure period to determine the type and extent of changes in services. Based on the types of tests and the extent of analysis being done, most rural B-level and some C-level laboratories were reclassified to the A level. The Laboratory Proficiency Testing Program reviewed the error rates of proficiency challenges based on the performance of different levels of laboratories before and after the period of restructure. RESULTS: Overall performance has improved according to the number of errors documented on identification and susceptibility challenges for laboratories that remained at the same classification (ie, A or C). The number of major identification errors for laboratories that were reclassified increased, but the rate of major susceptibility errors decreased. More reclassified laboratories do not have dedicated registered technologist(s) who perform microbiology testing and are not supervised by an on-site pathologist and/or medical microbiologist compared with laboratories that remained at the same classification. CONCLUSIONS: Microbiology laboratory restructuring will have adverse effects on the quality of complex testing if experienced technologists are not retained and services are not medically supervised.

Alberta↗

The effects of a fixed-fee reimbursement system introduced by the Federal Government on laboratory testing in the United States.

Rapid growth of health care expenditures during the 1970s in the United States led to implementation of a prospective payment system (PPS) based on diagnosis-related groups (DRG) for Medicare inpatient reimbursement in 1983. With the introduction of DRG/PPS, hospitals encouraged earlier discharges and discouraged admission of patients who may require expensive services. Patient care has moved into more outpatient and non-hospital settings which have been less regulated and paid on a cost-reimbursement basis. The change of reimbursement system has converted hospital laboratories from "profit center" under the fee-for-service reimbursement practice to possible "cost center" at least for inpatient laboratory services with the advent of DRG/PPS. Hospitals have reduced laboratory operating expenses by constraining laboratory growth and development. Laboratory testing in non-hospital settings such as physicians' office laboratories, which were exempt from license and quality control by governmental regulations, has increased exponentially since implementation of DRG/PPS. To improve the quality of laboratory testing in such unregulated laboratories, the federal government has promulgated the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88), requiring on-site survey and license under CLIA '88 for all laboratories in the United States regardless of the size, complexity, or location of laboratory. Implementation of DRG/PPS resulted in a temporary success in reducing Medicare Part A budget growth, but had only a small impact to slow the actual growth of total national health care expenditures or laboratory-related expenditures. Nevertheless, the change of reimbursement practice has created a large incentive to reduce unnecessary resource utilization, and cost-effective laboratory testing has become an essential concept during the DRG/PPS era.

Clinical Laboratory Techniques↗

Using patient outcomes to screen for clinical laboratory errors.

How to measure the quality of laboratory testing has long been a challenging problem for laboratory managers and accrediting agencies. Traditionally, laboratory quality has been assessed by direct inspection, proficiency testing, and the credentials of staff. None of these methods is entirely satisfactory at answering a fundamental question: does the laboratory give technically accurate and clinically meaningful information for each patient that it tests? This paper discusses how information on patient outcomes can be used to screen for laboratories that may be making frequent random or systematic errors. This approach is called downstream event monitoring (DEM). The basic idea is to look at what happens to a laboratory's patients in a critical window of time after they have been tested. The approach carries out a basic adage of quality management: follow up with your customers to see if your product has met their needs. The main idea of DEM is that if a laboratory has not conveyed accurate information, the clinician may take actions that fail to help, or maybe even harm, the patient. If a laboratory's patients have an unusually high rate of adverse events that happen within a window of time when the laboratory test would have played a critical role, the laboratory should be further examined to see if it is the cause of the problem. Right now, DEM is a technique under development. It needs a clinical logic to relate a patient's outcomes back to a laboratory test, and it needs good data to compare laboratories. This paper discusses how the prothrombin time test and the serum digoxin test have been examined for Medicare patients to see if certain laboratory characteristics are associated with unusually high occurrences of adverse events after testing. The need for future validation studies is also discussed.

Clinical Laboratory Techniques↗

[Accreditation of medical laboratories].

In Hungary, the National Accreditation Body was established by government in 1995 as an independent, non-profit organization, and has exclusive rights to accredit, amongst others, medical laboratories. The National Accreditation Body has two Specialist Advisory Committees in the health care sector. One is the Health Care Specialist Advisory Committee that accredits certifying bodies, which deal with certification of hospitals. The other Specialist Advisory Committee for Medical Laboratories is directly involved in accrediting medical laboratory services of health care institutions. The Specialist Advisory Committee for Medical Laboratories is a multidisciplinary peer review group of experts from all disciplines of in vitro diagnostics, i.e. laboratory medicine, microbiology, histopathology and blood banking. At present, the only published International Standard applicable to laboratories is ISO/IEC 17025:1999. Work has been in progress on the official approval of the new ISO 15189 standard, specific to medical laboratories. Until the official approval of the International Standard ISO 15189, as accreditation standard, the Hungarian National Accreditation Body has decided to progress with accreditation by formulating explanatory notes to the ISO/IEC 17025:1999 document, using ISO/FDIS 15189:2000, the European EC4 criteria and CPA (UK) Ltd accreditation standards as guidelines. This harmonized guideline provides 'explanations' that facilitate the application of ISO/IEC 17025:1999 to medical laboratories, and can be used as a checklist for the verification of compliance during the onsite assessment of the laboratory. The harmonized guideline adapted the process model of ISO 9001:2000 to rearrange the main clauses of ISO/IEC 17025:1999. This rearrangement does not only make the guideline compliant with ISO 9001:2000 but also improves understanding for those working in medical laboratories, and facilitates the training and education of laboratory staff. With the official acceptance of ISO 15189 the clauses of this harmonized guideline fulfill the requirements of the new international standard as well. Accreditation of medical laboratories in Hungary may not only facilitate quality improvement of laboratory services, but also the development of a quality-based purchasing and reimbursement policy of the health insurance fund.

Accreditation↗

[Emergency tests in the central laboratory of a hospital (author's transl)].

In 1975 an emergency laboratory, which is quite independent of the routine laboratory, was established within the central laboratory. The emergency laboratory carries out urgent chemical and hematological analyses and coagulation tests around the clock. As accelerated and late tests as well as not urgent tests on Saturdays and Sundays are done in the routine laboratory it was possible to restrict the demands on the emergency laboratory largely to tests of clinical emergency cases. One medical technician is permanently present in the emergency laboratory, one clinical chemist is on call. The emergency laboratory is subject to a severe quality control to ensure precise and correct results which correspond with the results of the routine laboratory. In 1980 56,392 emergency tests were carried out. These are 5.7% of all tests done in the central laboratory. On the average it takes 21.6 minutes for analytical work from the arrival of the sample until transmitting the result. The costs of the emergency tests amount to 3 to 4 times the costs of the mechanized routine tests. In some foreign hospitals the integration of "actualized" routine tests into the emergency laboratory has led to a share of 25% of the total amount of tests and to the full mechanisation with an own EDV system. These tests should not be carried out in the emergency laboratory. They should be carried out in the "actualized"routine laboratory with the help of a new generation of analyzers and a new concept for electronic data processing.

Austria↗

Impact of managed care on the economics of laboratory operation in an academic medical center.

BACKGROUND: Throughout the 1980s, the number of laboratory tests performed in the United States grew at an annual rate of over 10%, and laboratory costs accounted for approximately 10% of overall health care expenditures. Recently, the influence of capitation, emphasis on cost-effectiveness, and changing roles among specialists and primary care physicians have begun to affect the growth of laboratory testing. We examined the impact of managed care on the economics of the clinical chemistry laboratory at Vanderbilt University Medical Center, Nashville, Tenn, to define the relative position of the clinical laboratory in the managed care environment of an academic medical center. METHODS: The following data were prospectively collected between fiscal years 1984/1985 and 1995/1996: number of inpatients and outpatients, average length of stay, number of laboratory tests, total laboratory revenue, direct costs (consisting of salary and consumable costs), and number of full-time-equivalent (FTE) personnel. Using these data, we derived the following parameters: revenue and direct cost per patient, and revenue and productivity per FTE. RESULTS: Between 1984/1985 and 1995/1996 the number of inpatients and outpatients increased 33% and 155%, respectively. Laboratory utilization, expressed as tests per patient, increased from 17 to 22 for inpatients between 1984/1985 and 1991/1992, and then sharply declined to 14.5 tests by 1995/1996, a 34% decrease compared with the 1991/1992 level. Laboratory utilization for outpatients increased from 0.23 in 1984/1985 to 0.45 tests in 1991/1992, decreased to 0.38 in 1993/1994, but then rose again to 0.43 in 1995/1996. Total revenue more than doubled between 1984/1985 and 1991/1992, mostly owing to increased inpatient revenue. Since 1992/1993, inpatient revenue has steadily declined, leading to a decrease in total revenue, which was partially offset by a continuous increase in outpatient revenue. In 1995/1996, outpatient revenue accounted for 32.1% of total revenue, compared with 7.7% in 1984/1985. Direct test cost per patient increased approximately 20% between 1984/1985 and 1991/1992, followed by a decline below the 1984/1985 level. The number of FTEs increased in parallel to the rising test volume through 1991/1992 and subsequently was reduced in response to the decrease in test volume and productivity. In 1995/1996, a 22.7% reduction in staff was imposed despite an upward trend in test volume, resulting in a sharp increase in revenue and productivity per FTE. The staff reduction did not decrease direct laboratory costs, which have remained constant since 1992/1993. CONCLUSIONS: After three decades of continued growth, managed care has caused a sharp reversal in the upward trend in the number of laboratory tests, the number of tests per inpatient, test costs per patient, laboratory revenue, and productivity. A recent staff reduction significantly increased revenue and productivity per FTE, but showed no effect on direct laboratory costs.

Academic Medical Centers↗

[Consultation services at the commercial laboratories].

Only few customers consult with their using commercial laboratories about how to interpret the laboratory examination results, or how to proceed the laboratory diagnosis. But there are many questions about the test item, methodology, time course, and how to collect a specimen, and also there are many complaints about the test results, methods, reference values and reporting styles. Therefore, most of the commercial laboratories set up the information desk instead of the consultation desk. In our laboratory, Japan clinical laboratories, Inc., information services are done by not only the information telephone desk, but also the persons who go to the customers office(clinics or hospitals) for sales of the tests or collection and delivery of the samples. In this report, our information services were analyzed with the questionnaire and hearing to the sales and laboratory division, and with the records of the transaction of complaints(past 3 years) and the information service daily reports(past 2 months). From the results of the above analyses, it was observed that the commercial laboratory customers, e.g. clinicians, nurses, hospital clerks and medical technologists, have many various questions and complaints to the tests and the laboratories. And it was revealed that the education of the both staff of sales and laboratory division in the commercial laboratory is one of the most important subjects. For more effective use of the laboratory tests, clinical pathologists and medical technologists have to guide and supervise the commercial laboratories more adequately.

Consumer Behavior↗

Central or national veterinary diagnostic laboratories.

Information on laboratory organisational structure and roles was gathered from twenty-four national veterinary diagnostic laboratories around the world. This information was used to develop an overview of the organisation and roles of the national veterinary diagnostic laboratory. In addition, the national diagnostic laboratory for the United States of America (the National Veterinary Services Laboratories) was used as an example to provide more information on the activities of such a laboratory. The survey revealed great variation in organisation and structure among the twenty-four laboratories. A few have only one facility, others function at multiple locations, and all have different supervisory reporting systems. However, these laboratories all form a significant part of the national veterinary infrastructure. All of the laboratories contacted in the survey report to (or are at least partially under the direction of) the Chief Veterinary Officer or another senior animal health official, and most report to the Ministry of Agriculture. The national veterinary diagnostic laboratories have similar roles, and are all responsible for foreign animal disease diagnosis and for providing support to national disease eradication or control programmes. Most also play an active role in import and export testing, either performing the tests themselves or developing a quality assurance programme for other laboratories that perform the testing. In addition, the national veterinary diagnostic laboratories usually undertake research and provide training, consultation, disease surveillance information and, in some cases, vaccine evaluation.

Animal Diseases↗

Specific laboratory methodologies achieve higher model for endstage liver disease (MELD) scores for patients listed for liver transplantation.

Priority for liver transplantation is currently based on the Model for Endstage Liver Disease (MELD) score, a mathematical function which includes the following objective variables: bilirubin, creatinine (Cr), and international normalized ratio (INR). We have noted that specific laboratory methodologies may yield consistently higher values of bilirubin, Cr, and INR. Therefore, we performed a study to determine if higher MELD scores could be obtained by utilizing laboratory methodologies selected to return higher laboratory values than standard methodologies used in our hospital's clinical laboratory. Phlebotomy was performed for routine clinical indications in 29 consecutive patients listed for liver transplantation. MELD scores were calculated using bilirubin, Cr, and INR from laboratory methods in our hospital's clinical laboratory (designated Lab #1) and from 2 other clinical laboratories (designated Lab #2 and Lab #3). The mean MELD score in our hospital's clinical laboratory (Lab #1) (13.6) was not significantly different than in Lab #2 (14.7), but in Lab #3, it was significantly higher by 20% (17.1), P <.03. Virtually all of the difference in MELD score between our hospital's clinical laboratory (Lab #1) and Lab #3 could be attributed to the INR, which was significantly higher by 26% in Lab #3 (1.9) vs. Lab #1 (1.4), P <.00002. Using MELD scores calculated from our hospital's clinical laboratory, the average change in priority for liver transplantation was from the 58th percentile to the 77th percentile (compared to Lab #3), P =.01. In conclusion, patients listed for liver transplantation at our center achieved significantly higher MELD scores and therefore a higher priority for liver transplantation by using laboratory methodologies that yield higher INR values than our hospital laboratory. The selection of laboratory methodologies may have a significant impact on MELD score.

Bilirubin↗