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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↗
PubMed1982

Recruitment from medical referrals and clinical laboratories.

Medical referrals represent a recruitment source with a relatively low volume of initial contacts and entries and a high ratio of entries to initial contacts, while referrals from clinical laboratories comprise a relatively moderate volume of initial contacts, a low volume of entries and a moderate ratio of entries to initial contacts. Both sources require a relatively low effort level for the recruitment team. In the CPPT, all centers used these strategies, to provide, overall, 3% of initial contacts, 8% of first protocol visits and 10% of entries. Unwillingness to participate at the first protocol visit excluded less than one-half as many medical referrals as was observed for all sources, while referrals from clinical laboratories were excluded due to unwillingness to participate much more frequently than the all-source mean. Low yields preclude reliance on these sources for any but the smallest clinical trial.

Adult↗
PubMedDate not supplied

Appraising the performance of medical technologists in a clinical laboratory.

Medical technologists and their coworkers serve as a critical link in the delivery of health care, yet their performance typically is appraised in a traditional way, causing stress for both managers and workers. Drawing on Total Quality Management concepts, this article proposes a framework for appraising performance in a clinical laboratory context and shows how it can be used to address the problems that managers face in providing constructive appraisals to laboratory personnel.

Clinical Laboratory Techniques↗
PubMed1982

Emergency biochemistry services--are they abused?

An out-of-hours emergency biochemistry service, which allows access by all medical practitioners of varying experience within a hospital, can lead to overuse or even abuse of limited and costly facilities. When the workload increases, problems of staffing a voluntary (but paid) working rota may emerge. An industrial dispute involving medical laboratory scientific officers (MLSOs) caused the role of the emergency service to be examined and alternative regulating mechanisms to be tested. Experience at Glasgow Royal Infirmary between 1974 and 1981 has been reviewed. From 1977 to 1979, when clinicians (usually junior) arranged analyses directly with the MLSOs, test numbers increased by about 26% per annum. This was not associated with any concomitant increase in the range of analyses offered. During a five-week period in 1980, consultant clinicians had to contact a consultant clinical biochemist to arrange all emergency analyses, and test numbers were reduced to 13% of the previous levels. Subsequently, all requests for emergency analyses were made by clinicians to laboratory medical staff, and test numbers fell to approximately 60% of 1979 levels. This requesting system is now firmly established. Continued vigilance is required to maintain the reduced level of requesting, but too great a limitation on emergency requests may cause less efficient patient management. Senior clinical staff should be encouraged to take greater responsibility for the use of emergency laboratory services.

Chemistry, Clinical↗
PubMed1994

Survey of office laboratory tests in general practice.

OBJECTIVE: To describe the types of laboratory test done in general practice, and to investigate whether practice characteristics were associated with the implementation of certain tests or instruments. SETTING: A questionnaire was mailed to an 8% random sample of Norwegian GPs. RESULTS: 85% responded; and we obtained data from 175 office laboratories. Medical secretaries did most of the analytical work. The "basic" repertoire consisted of haemoglobin, ESR, glucose; urine test strips, microscopy, culture, and HCG; and faecal occult blood. Group practices had a larger repertoire than had solo practices. Overall, 34% of the practices had urine strips with fields for leucocytes and nitrite, 26% had a cell counter, and 17% did clinical chemistry. A large number of different test methods and instruments were in use, but in most cases one or two brands had a market share of more than 50%. Logistic regression showed that employing a medical laboratory technician was associated with a large analytical repertoire, and the use of cell counters and clinical chemistry analyzers. The GP's form of payment (fixed or fee-for-service) did not influence the repertoire. CONCLUSIONS: The diversity of test methods and instruments makes quality assurance difficult, and recommendations are overdue.

Clinical Laboratory Techniques↗
PubMed1996

Trace elements in body fluids: external quality assessment scheme in The Netherlands.

External quality assessment schemes (EQAS) for trace elements in body fluids are organized in The Netherlands by the SKZL (Foundation for Quality Assessment in Clinical Laboratories). Medical laboratories participate on a voluntary base. The EQAS is designed to evaluate laboratory performance in terms of accuracy, precision and linearity. Laboratory-made frozen samples of whole blood, serum and urine, enriched with the elements of interest, i.e. Tl, Cd, Co, Hg, Se, Pb, Mg, Li, Al, Cu, Zn and As, are used. The present state of art shows an acceptable mean recovery, intra-laboratory variation and linearity. Interlaboratory variation, comparability of reference ranges and criteria of interpretation used in different laboratories are less satisfying and require improvement.

Humans↗
PubMed1988

Comparison of media used for the primary isolation of Mycobacterium bovis by veterinary and medical diagnostic laboratories.

Veterinary and medical laboratories engaged in the cultural diagnosis of bovine or human tuberculosis were requested to supply samples of the media that they routinely use for the primary isolation of M. bovis. Fourteen laboratories supplied 7 basic media types; these were Lowenstein-Jensen, Stonebrink's, modified Middlebrook 7H11 agar, tuberculosis bovine blood agar, egg yolk agar, Gerloff's egg and Herrold's egg yolk. Two strains of M. bovis were used to test the media, strain AN5, a glycerol-tolerant laboratory strain and M86/90 a glycerol-sensitive wildtype strain. AN5 grew well on all media with the exception of Herrold's and strain M86/90 did not grow on media containing glycerol and grew poorly on Herrold's medium. It is recommended that Lowenstein-Jensen with pyruvate (but without glycerol), Stonebrink's, modified Middlebrook 7H11 and tuberculosis bovine blood agar should be considered the media of choice for the primary isolation of M. bovis. Egg yolk agar also proved adequate for this purpose in the trial. This medium may be suitable for routine use but to date experience with its use is limited.

Culture Media↗
PubMedDate not supplied

Good clinical laboratory practice (GCLP): the need for a hybrid of good laboratory practice and good clinical practice guidelines/standards for medical testing laboratories conducting clinical trials in developing countries.

There has been a significant increase in the number of clinical drug trials (particularly phase III) being conducted in developing countries for infectious diseases such as HIV, malaria, and tuberculosis. Laboratory results provided by medical testing laboratories in the region are critical to ensuring the safety of patients and the generation of good quality data. A number of well accepted Good Clinical Practice (GCP) and Good Laboratory Practice (GLP) guidelines govern the conduct of clinical trials internationally. Good Clinical Practice guidelines remain too vague with respect to sample analysis to ensure practical implementation in these laboratories. In their strictest sense, Good Laboratory Practice guidelines refer to the analysis of samples from non-clinical studies. A specific set of minimum standards or requirements for practical implementation of clinical trial requirements in medical testing laboratories in the developing world is urgently required.

Benchmarking↗
PubMed1991

[The use of laboratory data].

Medical laboratory data are gained by scientific methods. The method-inherent uncertainties always produce an "inexactitude" of varying degree. The physician who uses these data as a support for his decisions should therefore be able to estimate the reliability of the laboratory data; this can be assessed by statistical methods. The most fundamental characteristics of all analytical methods are analytical inaccuracy and analytical imprecision. The limit of detection and the limits of the measuring interval are functions of these figures. A number of illustrations demonstrate the interdependence of analytical performance and of medical significance of laboratory data. Laboratory data, on the other hand, are--to put it simply--used to distinguish diseased from NON-diseased individuals. The "diagnostic validity" of a certain test for a certain medical problem is determined by comparing appropriate collectives. The selection of these collectives and the choice of the cut-off value determine diagnostic sensitivity and specificity respectively. From these figures and prevalence (or "pre-test probability"), the predictive values of a positive (or negative) result can be calculated. The significance of the position of the cut-off value and of prevalence is demonstrated by a number of examples. If the results are not given in a binary form (positive/negative) but in different grades (slightly, moderately, strongly elevated/depressed), and if the results of several tests must be judged in a multivariate manner, the number of theoretically possible patterns can become extremely large. Various approaches designed to overcome these problems are discussed.

Clinical Laboratory Techniques↗
PubMed2001

[Quality control survey implemented by Japan Medical Association and standardization of external quality assessment in Japan].

International Final Draft on quality management of medical laboratory by International Organization for Standardization (ISO) will be published soon. According to this draft, the accreditation of the laboratories should be given by the third party on the basis of objective matter, and the external quality control survey results is thought to be the most important indices for the accreditation. Although variety of external quality control surveys are now implementing in Japan, most of those surveys are done only once a year. Therefore, we could not evaluate the laboratories performance by any of those survey results. If those quality control surveys are done with the standardized system, summative results from different survey could give us fair evaluation on each participating laboratories. Japan Medical Association (JMA) is now making final draft on standardized method for quality assessment system with the consensus between the JMA, Japanese Society of Laboratory Medicine (JSLM, former Japan Society of Clinical Pathology), Japanese Association of Laboratory Medical Technologists (JALMT) and Japan Registered Clinical Laboratories Association (JRCLA). When this quality assessment system actually starts, Japanese people may receive great benefit from the laboratory tests.

Clinical Laboratory Techniques↗