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PubMed2003

[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↗
PubMed2001

Accreditation of medical laboratories in The Netherlands.

Among the medical laboratory professionals, a growing interest exists in the systematic application of quality assurance to their own practice, and consequently in The Netherlands, there is an increasing request for an official accreditation of the quality management system and the competence of the professionals through Coordinatie Commissie voor Kwaliteitsbewaking in Laboratoria in de gezondheidszorg (CCKLtest), the Dutch Accreditation Board for Medical Laboratories. This article gives an overview of the current situation in The Netherlands; regarding the standards, the rules for accreditation, the training and selection assessors and what meanwhile is achieved. Since 1994, 60 clinical laboratories have been recognized by CCKLtest and another 40 laboratories have requested accreditation and are waiting for the inspection in 2001. Thus, 25% of all clinical laboratories in The Netherlands will be inspected within the current year.

Accreditation↗
PubMed1992

The impact of multiskilled practice on the job satisfaction of medical laboratory personnel.

This study examined practice patterns of medical laboratory personnel and investigated relationships of job-related variables and job satisfaction for single- and multiskilled practitioners. Data were collected from a random sample of American Society of Clinical Pathologist-registered practitioners in a five-state region. Twenty-five percent of the sample was categorized as multiskilled. Regression analysis revealed that work performed had a significant positive contribution to overall job satisfaction for medical laboratory technicians (MLTs) and medical technologists. The strength of the relationship was weakest for multiskilled MLTs. Results support the contention that when jobs are redesigned, enriching them by adding tasks of increased complexity and challenge is possibly more effective than simply enlarging the jobs with lower- or parallel-level tasks.

Adult↗
PubMed1998

Concepts for a model of good medical laboratory services.

Several international standards and corresponding interpretation documents for quality management systems have been published. Although these standards are found useful to some extent, they are considered to be insufficient in several areas important for medical laboratories particularly in the pre- and post-examinational phases. The normative document for accreditation of laboratories (ISO/IEC Guide 25) is presently being revised and a document for medical laboratories (ISO/TC 212, CD 15189) is at draft stage. Both aim to include aspects of total quality management. The concept of total quality management is rather vague. Generally, its goal has been defined as "business excellence". This term, however, needs some explanation if applied to medical laboratories. Therefore, a project group of the European Confederation of Laboratory Medicine (ECLM) has developed a model for total quality management, which is based on a comprehensive management concept issued by the European Foundation for Quality Management. In the case of a medical laboratory, the term "business excellence" should be replaced by "good medical laboratory services". The proposed model could serve as a basis for future developments of total quality management standards in laboratory medicine. The goal of the "journey" should be clarified before it starts. To the best of our knowledge, this is the first attempt to develop a model of a good medical laboratory.

Accreditation↗
PubMed1975

Mortality study of pathologists and medical laboratory technicians.

Membership lists of professional bodies were used to establish study populations of British pathologists (1955-73) and medical laboratory technicians (1963-73). The standardised mortality ratio (SMR) for pathologists was 60 and for medical laboratory technicians 67. Twenty-seven of the 310 deaths were due to suicide. These numbers gave SMRs of 250 for pathologists and 243 for medical laboratory technicians. Suicide was the commonest cause of death in female technicians. Access to lethal chemicals at work is a possible factor explaining the high proportion of suicide by poisoning compared with the general population. Suicide rates for pathologists exceed those of all medical practitioners; similary medical laboratory have higher rates than all laboratory technicians. Excess deaths from lymphatic and haemopoietic neoplasms were noted in English male pathologists (observed 8, expected 3-3; P less than 0-01). This difference is not due to Hodgkin's disease or leukaemia and remains unexplained. No other neoplastic diseases were noted as causing excess mortality in either occupational group but a small, possibly spurious, excess number of deaths was noted for aortic aneurysm in male pathologists (observed 4, expected 1-8).

Female↗
PubMed2000

Development of the antinuclear and anticytoplasmic antibody consensus panel by the Association of Medical Laboratory Immunologists.

The Association of Medical Laboratory Immunologists (AMLI) have developed a panel of antinuclear and anticytoplasmic antibody consensus sera that can be useful for enzyme immunoassay (EIA), Ouchterlony, and immunofluorescence assay methods. It was developed to assist in the evaluation of newly available EIA methods for the detection of autoantibodies. The panel of sera was evaluated in several clinical laboratories and a large number of laboratories owned by manufacturers of clinical autoantibody testing kits. The majority of sera performed well for the EIAs in both the clinical laboratories and the manufacturers' laboratories, but some samples had discrepant results. A major source of discrepancy is the current inability of the EIA results to be directly compared in a quantitative way as no standardization exists. The evaluation demonstrated lower sensitivity of detection by the Ouchterlony method. The limited evaluation of the sera with immunoblotting and Western blotting did not show good agreement with other methods. Further work must be done to standardize blotting methods prior to their use in routine clinical testing. The sera are now available to vendors and clinical laboratories for use in the detection of SS-A, SS-B, Sm, U1-RNP, Scl-70, Jo-1, double-stranded DNA, and centromere antibodies. The availability of the consensus sera will help evaluate and improve the EIA methods currently being used.

Antibodies, Antinuclear↗
PubMed1995

INR reporting in Canadian medical laboratories. Thrombosis Interest Group of Canada.

A written survey of all licensed medical laboratories in Canada performing coagulation testing was performed to investigate the level of knowledge and overall usage of the INR system for reporting prothrombin time results in medical laboratories. There was an overall response rate of 857 of 1,228 laboratories surveyed. Fifty-seven percent of responding laboratories utilized some format of INR reporting. The ISI of the individual thromboplastin utilized was known by 89% of laboratories. The ISI of the thromboplastin utilized was known to be specific for the particular reagent/instrument combination in 44% of cases. Fifty-five percent of client physicians preferred PT results to be reported in seconds while 42% desired an INR format. The situation in Canada is similar to the United States in that further education regarding the INR system for PT reporting is required by both medical laboratories and physicians.

Administration, Oral↗
PubMed1994

Quality system in the medical laboratory: the role of a quality manual.

A quality system for a medical laboratory should be directed on all fundamental aspects of its function. This implies the obligation to join the External Quality Assessment schemes, and to make use of its results. It means the setting-up of a quality system according to a medical translation of the items of the EN 45001 standard. And it means taking into account such professional aspects as registration and post-doctoral education, regular contacts with physicians and paying special attention to the suitability of tests. This whole process can be instituted on the basis of an ISO 9000 approach, which means specific standards for the medical laboratories, and inspection, in which the professionals should play an important role. The use of a quality manual facilitates the whole process. It should eventually lead to an accreditation system for medical laboratories. Cooperation in Europe on these aspects is important. An overview is given on the way the system works in the Netherlands.

Europe↗