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PubMed1997

Development and coordination of the Polio Laboratory Network in the Western Pacific Region of the World Health Organization.

A multitiered network of polio laboratories, consisting of specialized reference laboratories, regional reference laboratories, national laboratories and, in the case of China, provincial laboratories, was established in the Western Pacific Region of the World Health Organization (WHO) in 1992. The network currently consists of 43 laboratories within the Region and is coordinated through the WHO Regional Office in Manila. As the levels and extent of supplementary immunization and acute flaccid paralysis surveillance activities have increased, so has the work load of network laboratories. The total number of stool specimens collected and processed in Polio Laboratory Network laboratories in this WHO region in 1995 exceeded 15,000. With the Region now establishing the criteria necessary for certification of polio-free status, it is essential for the Polio Laboratory Network to establish international confidence in its ability to carry out its role in the eradication of polio.

Asia, Southeastern↗
PubMed2004

Polysomnography performed in the unattended home versus the attended laboratory setting--Sleep Heart Health Study methodology.

STUDY OBJECTIVE: To compare polysomnographic recordings obtained in the home and laboratory setting. DESIGN AND SETTING: Multicenter study comparing unsupervised polysomnography performed in the participant's home with polysomnography supervised at an academic sleep disorders center, using a randomized sequence of study setting. Sleep Heart Health Study (SHHS) standardized polysomnographic recording and scoring techniques were used for both settings. PARTICIPANTS: 64 of 76 non-SHHS participants recruited from 7 SHHS field sites who had both a laboratory and home polysomnogram meeting acceptable quality criteria. MEASUREMENTS AND RESULTS: Median sleep duration was greater in the home than in the laboratory (375 vs 318 minutes, respectively, P < .0001) as was sleep efficiency (86% vs 82%, respectively, P < .0024). Very small, but significant increases in percentage of rapid eye movement sleep and decreases in stage 1 sleep were noted in the laboratory. Employing multiple definitions of respiratory disturbance index (RDI), median RDI was similar in both settings (for example, RDI with 3% desaturation: home 12.4, range 0.6-67; laboratory 9.5, range 0.1-93.4, P = .41). Quartile analysis of laboratory RDI showed moderate agreement with home RDI measurements. Based on the mean of laboratory and home RDI and using a cutpoint of 20, there was a biphasic distribution, with the RDI 3% above 20 being more common in the recordings performed in the laboratory than in the home and below 20 being more common in the recordings performed in the home than in the laboratory. These differences could not be attributed to quality of recording, age, sex, or body mass index. CONCLUSIONS: Using SHHS methodology, median RDI was similar in the unattended home and attended laboratory setting with differences of small magnitude in some sleep parameters. Differences in RDI between settings resulted in a rate of disease misclassification that is similar to repeated studies in the same setting.

Adult↗
PubMed2005

Changing needs, opportunities and constraints for the 21st century microbiology laboratory.

Clinical microbiologists and microbiology laboratories are experiencing changes due to evolving views on 'healthcare delivery' as an economic activity, due to changes in the medical environment and the demographics of the workforce, and technical evolution. Cost-effectiveness of laboratory procedures has been achieved through consolidation and integration of laboratories. Consolidation offers economy of scale and reduction in numbers of on-site staff, but also leads to separation of microbiologists from their clinical colleagues. Integration puts different laboratory disciplines under a single management, and leads to reorganisation of laboratories along common work-lines. Cost-savings combined with on-site availability of laboratories are achieved at the expense of a reduction in the influence of microbiologists in the daily running of the laboratory. Medically, there is growing emphasis on evidence-based diagnostics. Because of time-delays inherent in culturing, microbiology through rapid testing is mandatory. There is an increasing shortage in Europe and the USA of trained microbiology laboratory technicians and microbiologists. This reinforces the trend towards more automation and integration. Technological advances, particularly in molecular diagnostics, offer the possibility of rapid reporting and improvement of the impact of clinical microbiology on patient management. Molecular tests, however, fit perfectly the concept of an integrated laboratory and may further loosen the link between microbiologist and microbiology tests. The challenge for clinical microbiology will be to use new techniques to improve its cost-effectiveness and impact on infectious disease management. The future organisation of microbiology laboratories must support this but is itself of secondary importance. The training of future microbiologist must prepare them for this changing environment.

Communicable Disease Control↗
PubMed2004

[Present status of Tsutsugamushi disease detection at regional public health laboratories--a comparison between the results from a questionnaire survey and the National Notifiable Diseases Surveillance System].

Tsutsugamushi disease has been a notifiable disease in Japan since the implementation of the Infectious Diseases Control Law in April 1999. In order to assess the role of public health laboratories in detecting Tsutsugamushi disease, a questionnaire regarding routine testing of suspected cases of Tsutsugamushi disease was sent to 73 regional public health laboratories (47 prefectural laboratories and 26 municipal laboratories) in July 2001. The response rate was 92% (67/73 laboratories). It was found that most prefectural laboratories are well prepared to routinely receive and test specimens of suspected Tsutsugamushi disease cases. Additionally, we found that some regional public health laboratories are using two or more detection methods to improve the accuracy of their routine tests. In southern Japan. Kawasaki and Kuroki strains, strains endemic to the region, are widely used in addition to Kato, Karp, and Gilliam strains, the standard strains used for serum antibody tests in Japan. For the years 2000 and 2001, we found that for some prefectures, the annual number of cases confirmed by regional public health laboratories was nearly equal to the annual number of cases the prefecture reported to the National Notifiable Diseases Surveillance System. In these prefectures, it appears that an effective communication network has been established between physicians, public health laboratories, and local health centers, ensuring laboratory confirmation and proper notification.

Cities↗
PubMed2003

Surge capacity for response to bioterrorism in hospital clinical microbiology laboratories.

Surge capacity is the ability to rapidly mobilize to meet an increased demand. While large amounts of federal funding have been allocated to public health laboratories, little federal funding has been allocated to hospital microbiology laboratories. There are concerns that hospital laboratories may have inadequate surge capacities to deal with a significant bioterrorism incident. A workflow analysis of a clinical microbiology laboratory that serves an urban medical center was performed to identify barriers to surge capacity in the setting of a bioterrorism event and to identify solutions to these problems. Barriers include a national shortage of trained medical technologists, the inability of clinical laboratories to deal with a dramatic increase in the number of blood cultures, a delay while manufacturers increase production of critical products and then transport and deliver these products to clinical laboratories, and a shortage of class II biological safety cabinets. Federal funding could remedy staffing shortages by making the salaries of medical technologists comparable to those of similarly educated health care professionals and by providing financial incentives for students to enroll in clinical laboratory science programs. Blood culture bottles, and possibly continuous-monitoring blood culture instruments, should be added to the national antibiotic stockpile. Federal support must ensure that companies that manufacture essential laboratory supplies are capable of rapidly scaling up production. Hospitals must provide increased numbers of biological safety cabinets and amounts of space dedicated to clinical microbiology laboratories. Laboratories should undertake limited cross-training of technologists, ensure that adequate packaging supplies are available, and be able to move to a 4-day blood culture protocol.

Anti-Bacterial Agents↗
PubMed1993

Cost of gentamicin assays carried out by microbiology laboratories.

AIMS: To assess the current range of prices charged for gentamicin assays in United Kingdom laboratories; and to examine the laboratories' likely response to increases or decreases in the demand for the service. METHODS: A postal survey of the 420 members of the Association of Medical Microbiologists was used to establish the range of prices charged for aminoglycoside assays. Additionally, eight private institutions were contacted to determine what the private sector was charging for aminoglycoside assays. Reagent costs in the NHS laboratories were calculated by dividing the total cost of all aminoglycoside assay kits by the number of samples analysed. RESULTS: The NHS and the private institutions both showed a wide price variation. Prices charged to an in-hospital requester for a peak and trough assay ranged from 5.00 pounds to 68.20 pounds (n = 44), and to an external private hospital, under a bulk service contract, from 5.00 pounds to 96.00 pounds (n = 47). Prices charged by private laboratories ranged from 49.00 pounds to 84.00 pounds (n = 8). There was a log linear correlation in the NHS laboratories between the reagent costs per assay and the number of assays performed per year, and most laboratories thought that their price per assay would be sensitive to increases or decreases in demand. Laboratories which had purchased their assay machines had lower reagent costs per assay but higher repair and maintenance costs. Overall, number of assays performed and method of payment for assay machinery only accounted for 44.8% of the observed variation in assay kit costs. CONCLUSIONS: The price range for gentamicin assays in the United Kingdom is wide and is only partially explained by the number of assays performed. Most laboratories believe that they would experience a reduction in unit cost as output increases. The currently offered range of prices is, in part, due to variation in the laboratories' approach to costing the service provided and some laboratories charge prices which do not even cover the cost of assay kits. Overall, we believe that prices charged should be as close as possible to the marginal cost of the tests performed.

Clinical Laboratory Techniques↗
PubMed2006

Laboratory diagnosis of Neisseria gonorrhoeae in St Petersburg, Russia: inventory, performance characteristics and recommended optimisations.

OBJECTIVES: To perform a comprehensive inventory of the number of samples, performance characteristics, and quality assurance of the laboratory diagnosis of Neisseria gonorrhoeae at five laboratories in St Petersburg and Leningradskaya Oblast, Russia, in 2004, and to recommend optimisations for an increased adherence to international evidence based recommendations of diagnostics. METHODS: Surveillance data were obtained with questionnaire and site visits. For evaluation of the culture media utilised at the laboratories, N gonorrhoeae reference strains (n = 29) were used. RESULTS: During 2004 the total numbers of N gonorrhoeae samples analysed at the five laboratories using microscopy of stained smears and culturing were 330 879 (407 positive) and 38 020 (420 positive), respectively. Four laboratories used a Russian non-selective culture medium-that is, Complegon, and one laboratory utilised Biocult-GC. Both media seemed suboptimal. Only two of the laboratories used any species confirmative assay. Antibiotic susceptibility testing of N gonorrhoeae was performed at only two of the laboratories and each year only occasional isolates were analysed. None of the laboratories comprised a complete laboratory quality assurance system. CONCLUSIONS: According to international recommendations, the diagnosis of N gonorrhoeae in St Petersburg and Leningradskaya Oblast, Russia, is suboptimal. More samples need to be analysed by culturing on a highly nutritious and selective medium and, furthermore, species confirmation and antibiotic susceptibility testing should be more frequently performed. In addition, the utilised methods for culturing and antibiotic susceptibility testing, including medium and interpretative criteria used, ought to be optimised, standardised, and quality assured using systematic internal and external quality controls.

Clinical Laboratory Techniques↗
PubMed2003

[Quality control of the serological diagnosis of dengue in laboratories throughout the Americas, 1996-2001].

OBJECTIVE: To report the results from participating laboratories for four external quality control proficiency tests of dengue serological diagnosis that were carried out in the Region of the Americas in the period of 1996-2001. METHODS: External quality control proficiency tests of dengue serological diagnosis were carried out in 1996-1997, 1998-1999, 1999-2000, and 2000-2001. Panels made up of 20 serum samples (12 of them positive for dengue IgM antibodies) were sent to participating laboratories in the Region. The sera were negative for HIV antibodies, hepatitis C virus antibodies, and hepatitis B surface antigen. The sera were stored at -20 degrees C until they were sent in refrigerated shipments to the participating laboratories. The presence of IgM antibodies was determined through IgM-capture enzyme-linked immunosorbent assay (ELISA), while the IgG antibody titer was determined by hemagglutination inhibition or by IgG ELISA. The results of the IgM antibody testing that differed from those of the reference center were considered discordant. The IgG antibody titer was considered discordant when the results differed by two dilutions or more with respect to the reference center's results. RESULTS: A total of 27 laboratories received a total of 59 serum panels over the 1996-2001 period, and the results from testing 54 of those panels (91.5%) were sent back in. Of the total of 1 080 sera samples from those 54 panels, the results from 95.6% of the IgM antibody tests were concordant with the results from the reference center. With 47 of the 54 panels (87.0%) the participating laboratories' agreement with the reference center's results for the IgM antibody testing was 90.0% or higher. The laboratories sent back results from a total of 27 IgG antibody titer tests, and 22 of them (81.5%) coincided with those from the reference center. Considering the IgM antibody testing results from the four periods, the findings from 22 of the participating laboratories coincided with those from the reference center for at least 90% of the samples, and 13 of the laboratories were in complete concordance with the reference center. CONCLUSIONS: The majority of the participating laboratories showed an excellent level of performance in detecting dengue IgG and IgM antibodies. However, the deficiencies found in some instances confirm the need for continuing to improve laboratory diagnosis of dengue in the Region of the Americas.

Americas↗
PubMed1982

Laboratory evaluation and assistance efforts: mailed, on-site and blind proficiency testing surveys conducted by the Centers for Disease Control.

During the last three years, the Centers for Disease Control (CDC) has conducted: 1) on-site surveys in which trained personnel visited laboratories that had experienced performance problems in the quarterly mailed proficiency testing (PT) program, reviewing the laboratories' analytical procedures by using carefully referenced samples to determine sources of errors and providing assistance in correcting them; 2) special assistance surveys in which carefully referenced samples were mailed to laboratories that had performed unsatisfactorily in routine mailed PT surveys and then telephone consultations were conducted to correct the problems; and 3) blind surveys in which carefully referenced samples were sent through normal patient sample acquisition routes to assess the actual day-to-day performance capability of the laboratories. Results suggest that on-site surveys by trained laboratory surveyors and special mailed assistance surveys can be very effective in identifying the source of analytical errors in laboratories previously found, through mailed PT surveys, to have performance problems. Blind-survey results indicate that good performance in mailed PT does not necessarily imply good laboratory performance with routine patient specimens. Although difficult to conduct, blind surveys should be conducted whenever the logistics can be worked out by contractors for laboratory services, clinicians using laboratory services, and the laboratories themselves to assure the continuation of quality service.

Blood Chemical Analysis↗
PubMed1995

Reliability of blood alcohol determinations at clinical chemistry laboratories in Sweden.

Known concentrations of ethanol, methanol, isopropanol and its metabolite acetone were added to plasma or whole blood and aliquots of each specimen were sent to clinical chemistry laboratories in Sweden as a declared collaborative study. All participants used gas-liquid chromatography (GC) for quantitative determination of ethanol and other low molecular weight volatiles. The mean within laboratory precision for analysis of ethanol, expressed as coefficient of variation (CV), was 4.7% (range 0-15%). The corresponding between-laboratory CV spanned from 8.0 to 19.4% for 23 control specimens analysed between 1987 and 1992. The mean concentration of ethanol reported was not significantly different from the target value assigned. Between 0 and 3 laboratories reported deviant results (Z-score > 1.96) for each of the control specimens. One laboratory reported the presence of methanol instead of ethanol and three laboratories saw traces of acetone instead of the actual concentration present. One laboratory failed to report that methanol was present and another failed to report the presence of isopropanol. The between-laboratory CV ranged between 9.4 and 30.3% for analysis of methanol in 8 control specimens. The larger variability between laboratories compared with within laboratories probably reflects the different calibration procedures used, such as the preparation and source of the alcohol standards.

1-Propanol↗
PubMed1990

Regionalization of laboratory care: a viable option for the 21st century.

The conversion of the hospital laboratory to a cost center under pressure of prospective payment and fixed reimbursement is increasingly forcing hospitals to consider alternative modes for delivery of laboratory care. Changes in the health care environment, amended statutes and regulations, and, particularly, dramatic developments in laboratory equipment, methodologies, and data processing technology make it advisable and feasible to contemplate the creation of regional laboratory consortia. A fundamental step in this direction is the "commercialization" of the hospital laboratory through a change in focus from being an in-house support program to becoming a regional resource. By the same token, the hospital laboratory can become an effective competitor of independent laboratories and be reconverted to a profit center. Creation of hospital laboratory consortia in a splintered, competitive environment requires a committed entrepreneurial effort and convincing evidence of potential benefits. The sequence of steps needed to achieve regional laboratory integration include concerting the goals and objectives of the interested parties, creating an appropriate committee structure, conducting a feasibility assessment, identifying alternative organizational and operational options, selecting a favorite option viewed by all parties as a win/win proposition, developing a business plan, and determining an implementation action plan. The major disadvantages of regionalization of laboratories are employee displacement, potential leveling of quality standards, and reduced hospital control. The major advantages include elimination of duplicate capital, personnel, and service costs, improved efficiency through test batching, reduced unit costs, increased technical capability through staff, instrument, and systems sharing, disengagement from hospital-imposed limitations, strengthened ability to penetrate the marketplace, freeing of hospital space for more direct patient care activities, and achieving a means for bonding physicians to the institutions.

Commerce↗
PubMed1984

An introduction to the clinical laboratory for pharmacists.

The intent of this article is to provide pharmacists with an introduction to the clinical laboratory. As clinical pharmacy services expand, interactions between pharmacists and the laboratory will increase. Laboratory results are an essential tool for pharmacists involved in monitoring drug therapy and adjusting dosing regimens. Laboratory medicine, however, is a complex and rapidly changing field with new analytical techniques and instruments continually being developed. Thus, methodologies vary greatly from one laboratory to another and even within the same laboratory from time to time. Quality control procedures are necessary to ensure accurate and reliable results. The medical technologists who staff clinical laboratories are highly trained professionals. Pharmacists should utilize the medical technologist as a consultant on the interpretation and limitations of laboratory tests. Likewise, there are many areas, such as therapeutic drug monitoring, in which the pharmacist can serve as a consultant to the laboratory. Pharmacists involved in patient care will benefit from a greater understanding of the clinical laboratory, and may also find new opportunities for clinical pharmacy practice and interaction with other health care professionals.

Humans↗
PubMedDate not supplied

Tracing our roots: the broadening horizons of clinical laboratory practice (1945-62).

OBJECTIVE: To describe how the field of clinical laboratory science responded to the shortage of qualified laboratory personnel in the 1950s, and to review educators' responses to the changes in clinical laboratory practice. DESIGN: A survey of literature on the history of clinical laboratory science was conducted. References consulted include various books and professional journals. CONCLUSION: Between 1945 and 1962, the demand for certified medical technologists grew as a result of public demand for more health services, including laboratory testing. The shortage of qualified laboratory personnel, coupled with the introduction of new, more complex methods of analysis and the addition of different types of tests gave rise to specialization in each of the clinical laboratory disciplines. These developments also stimulated a renewed interest in creating another class of laboratory worker, the laboratory assistant, who could be assigned to perform simple procedures under the supervision of a certified medical technologist. The broadening horizons of clinical laboratory practice created new opportunities and new challenges for medical technologist educators.

Chemistry, Clinical↗
PubMed1999

Comparison of serum and plasma methylmalonic acid measurements in 13 laboratories: An international study.

BACKGROUND: Detection of cobalamin deficiency is increasingly important, and methylmalonic acid (MMA) appears to be a useful marker. Information on interlaboratory variation and on methodological differences for MMA in serum and plasma is limited. METHODS: Using gas chromatography/mass spectrometry, 13 laboratories participated in a 2-day analysis of 8 serum and 11 EDTA-plasma specimens. Results were analyzed for imprecision, recovery, and differences among laboratories and methods. RESULTS: The mean among-laboratory imprecision (CV) was 19% and 21% for serum and plasma samples, respectively, and 9.3% and 7.8% for serum and plasma samples with added MMA, respectively. The mean within-laboratory (among-run) CV was 13% for both serum and plasma samples and 5.2% and 4.9% for serum and plasma samples with added MMA. Within-method imprecision was the same or higher than among-method imprecision. The mean among-laboratory recovery of MMA was 105% and 95% in serum and plasma, respectively. Most laboratories showed a proportional bias relative to the consensus mean of up to 15%. Two laboratories reported results that on average were almost 30% higher than the consensus mean. CONCLUSIONS: No method differences were found, but significant among-laboratory imprecision was found in the present study. Improvements are needed to reduce the analytical imprecision of most laboratories, and attention must be focused on calibration issues. Differences among laboratories can be improved by introducing high-quality reference materials and by instituting external quality assessment programs.

Calibration↗
PubMed2000

Quality assurance in clinical laboratories in Taiwan.

BACKGROUND AND PURPOSE: In 1994, the Taiwan National Health Administration assigned the execution of a quality assurance (QA) survey program to the Association of Laboratory Medicine. The purpose of this program was to investigate the quality of clinical laboratory assessments and to promote QA in the fields of clinical microscopy, hematology, chemistry, microbiology, serology, and blood banking. We report the findings of QA surveys conducted in 1998 and the effect of voluntary training on improvement of clinical laboratory testing. METHODS: A total of 1,008 clinical laboratories were included in the program in 1998. Proficiency testing (PT) was performed to evaluate various laboratory tests. Continuing education programs were conducted and experts visited laboratories that sought guidance before the PT was conducted. The full mark was set at a score of 100 for each PT scheme. The criterion for acceptability of PT results was set at a score of 80 or more. RESULTS: The rates of acceptable results were 82.4% (607/736) for hematology, 57.4% (267/465) for blood banking, 69.3% (561/810) for chemistry, and 80.1% (321/401) for microbiology. The rates of acceptable microscopy results were 90.9% (509/560) for urine chemical tests and 84.6% (610/721) for others. The rates of acceptable serology tests were 73.3% (384/524) for hepatitis and 85.6% (441/515) for syphilis. The rates of acceptable performance differed significantly among clinical laboratories with different rankings: clinical laboratories at institutions classified below the level of district hospital showed comparatively poor performance. Laboratories that received guidance showed significant improvement in performance from 1997 to 1998. CONCLUSIONS: A QA program is urgently needed in Taiwan to improve laboratory performance.

Humans↗
PubMed2002

[Common diagnostic tests under the Clinical Laboratory Improvement Amendments of 1988 (CLIA '88) in the United States].

The lower quality of laboratory testing in unlicensed physicians' office laboratories(POLs) had led to legislation of the Clinical Laboratory Improvement Amendments of 1988(CLIA '88) in the United States. This legislation extended laboratory regulations for quality control and assurance, personnel qualification, record-keeping, and proficiency testing to all laboratories regardless of size, complexity, or location, including POLs and ancillary testing sites in a hospital. According to the implementation of the CLIA '88 in 1992, all testing sites in this country must have inspections and a certificate issued by the federal government. The CLIA '88 has improved the quality of testing in POLs, forcing office physicians to deal with the problem of laboratory quality management, thereby increasing laboratory costs. Thus, compliance with the CLIA '88 standards is expensive. On-site testing in POLs has been reduced, discontinued, or changed as a result of the CLIA '88 legislation. A number of POLs have closed, and physicians have restricted test menus to those with simpler methodology(waived tests) because waiver laboratories do not require inspections by the government. Large portion of laboratory tests, which were formerly done in POLs, flow into the reference laboratory market as outreach tests. Currently, 77% of POLs are performing only waived tests or tests in the provider-performed microscopy procedures category, while only 23% have a certificate for moderate or high complexity methodology status. Thus, common diagnostic tests performed in POLs are predominantly based on the waived tests, which are largely different from those performed in Japan, with respect to test item and methodology.

Clinical Laboratory Techniques↗
PubMedDate not supplied

A systematic review of the quality of research on hands-on and distance healing: clinical and laboratory studies.

PURPOSE: To systematically review the quality of published experimental clinical and laboratory research involving hands-on healing and distance healing between 1955 and 2001. DATA SOURCES: Studies were identified through comprehensive literature searches on spiritual healing in MEDLINE, PSYCH LIT, EMBASE, CISCOM, and the Cochrane Library from their inceptions to December 2001. STUDY SELECTION: We selected published randomized, controlled trials of spiritual healing (hands-on healing and distance healing) done in clinical and laboratory settings, all of which had been peer reviewed. DATA EXTRACTION: Independent quality assessment of internal validity was conducted on all identified studies using the comprehensive Likelihood of Validity Evaluation scale. Clinical and laboratory studies were analyzed separately and then subdivided into hands-on healing or distance healing interventions. RESULTS: A total of 45 laboratory and 45 clinical studies published between 1956 and 2001 met the inclusion criteria. Of the clinical studies, 31 (70.5%) reported positive outcomes as did 28 (62%) of the laboratory studies; 4 (9%) of the clinical studies reported negative outcomes as did 15 (33%) of the laboratory studies. The mean percent overall internal validity for clinical studies was 69% (65% for hands-on healing and 75% for distance healing) and for laboratory studies 82% (82% for hands-on healing and 81% for distance healing). Major methodological problems of these studies included adequacy of blinding, dropped data in laboratory studies, reliability of outcome measures, rare use of power estimations and confidence intervals, and lack of independent replication. CONCLUSIONS: When laboratory studies were compared to clinical studies in the areas of hands-on healing and distance healing across the quality criteria for internal validity, distance healing studies scored better than hands-on healing studies, and laboratory studies fared better than clinical studies. Many studies of healing contained major problems that must be addressed in any future research.

Clinical Trials as Topic↗
PubMed2003

[Evidence-based laboratory medicine].

Patients and society expect physicians to base their approach to any type of clinical problem on informed diagnostic reasoning. Informed diagnostics means that clinicians understand and readily apply the principles of diagnostic decision making, which include an estimate of the pre-test probability (prevalence) of diseases and information about the characteristics and discriminatory power of the applied investigations. Despite the crucial importance of the appropriate use of diagnostic tools in clinical decision-making, many diagnostic tests have not been subjected to rigorous evaluation to establish the diagnostic accuracy and clinical utility of laboratory investigations using modern standards of clinical epidemiology. The lack of good quality research in the field not only contributes to inappropriate utilization of laboratory services but also to wasting significant resources. Evidence-based laboratory medicine tries to combat this problem by combining methods from epidemiology, biostatistics, clinical and social sciences with basic sciences to evaluate the role of investigations in clinical decision making and outcomes for patients. Evidence-based laboratory medicine aims to advance clinical diagnosis and management of diseases through systematic researching and disseminating generalisable new knowledge which meets the standards of critical review on clinically effective practice of laboratory investigations. The main phases of practicing evidence-based laboratory medicine are 1. question formulation, 2. systematic literature search, 3. critical appraisal of literature, 4. implementation of evidence into practice, and 5. evaluation of impact in a clinical audit cycle. The use of evidence in laboratory medicine requires systematically compiled databases of standardised and critically appraised information on the test characteristics and diagnostic accuracy of laboratory investigations. Such an approach is the Bayes Library that provides information on the global and specific measures of test performance in different patient groups and settings, in addition to prevalence data of common diseases. The Bayes Library will support informed diagnostic decisions and improve patient outcome by integrating evidence-based medicine into the diagnostic service, education and training of laboratories. The process of constant questioning and reviewing the evidence for rational diagnosis of diseases provides a practical tool to identify gaps in our knowledge and thus it generates new research ideas in laboratory medicine.

Clinical Laboratory Techniques↗