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PubMed2005

[External quality assessment with reference to the certification/accreditation of medical laboratories].

Since ISO 15189 (Medical Laboratories-Particular requirements for quality and competence) was published in February 2003, interest in the accreditation of medical laboratories has increased in Japan. Under such conditions, the JCCLS (Japanese Committee for Clinical Laboratory Standards) and the JAB (Japan Accreditation Board for Conformity Assessment) are promoting a project on an accreditation program for medical laboratories in Japan. The JAB is planning to start their pilot inspections from October, 2004. In this paper, an external quality assessment scheme in Japan on proficiency testing for the accreditation of clinical laboratories is described.

Accreditation↗
PubMedDate not supplied

Responding to the medical laboratory staffing shortage: the Canadian perspective.

Shortages of qualified medical laboratory personnel have not been a problem in Canada since the early 1960s, when the profession experienced a growth that far exceeded training capacities. Massive immigration, primarily from the United Kingdom, provided a temporary patch for the urgent human resources (HR) supply. Medical laboratory technologist training program enrollments were increased rapidly, and, by the early 1970s, more than 1,200 new graduates were generated each year. In the late-1980s, a trend evolved in Canada that raised concern about the ability to attract suitable applicants to careers in medical laboratory technology. However, that issue quickly faded as a priority when the health reform of the 1990s struck Canada.

Canada↗
PubMed2001

ISO and CEN documents on quality in medical laboratories.

The forthcoming international standard ISO 15189 "Quality management in the medical laboratory" is a document of great importance for the development of quality systems and accreditation for medical/clinical laboratories. For the first time, there will be an internationally recognized standard designed specifically for the accreditation of medical laboratories. The document takes into account the special requirements imposed by the medical environment and by the essential contribution of the medical laboratory service to patient care. It recognizes that medical laboratories must provide not only testing of patient samples, but also advisory, interpretative and educational services. A further document, still in draft form (ISO/DIS 15190), deals with safety management for medical laboratories. ISO 15189 (and probably 15190 also) are expected be adopted by CEN as a European Standard (EN).

Accreditation↗
PubMed1976

Incidence of tuberculosis, hepatitis, brucellosis, and shigellosis in British medical laboratory workers.

A retrospective postal survey of 21 000 medical laboratory workers in England and Wales showed 18 new cases of pulmonary tuberculosis in 1971, a five-times increased risk of acquiring the disease compared with the general population. Technicians were at greatest risk, especially if they worked in morbid anatomy departments. Of the 35 cases of hepatitis, the technicians were again the occupational group most likely to acquire the disease. Microbiology staff were twice as likely to report shigellosis as those in other pathology divisions but only one case of brucellosis was reported in the whole laboratory population. A similar survey carried out in 1973 of 3000 Scottish medical laboratory workers corroborates the results from England and Wales. Medical laboratory workers continue to experience a considerable risk of developing an occupationally acquired infection. Improvements in staff safety and health care seem to be necessary.

Brucellosis↗
PubMed1978

A nontraditional approach to medical laboratory technology education.

The nontraditional program in medical laboratory technology for adult students was initiated at Corning Community College in 1975. The overall design of the model permits adults who have gained knowledge and skills as a result of their work experience to have opportunities for the assessment of these learnings and for flexible, modular instruction to increase their level of competency in medical technology. The central goal of this model is to increase the educational alternatives available to the adult population, specifically, the working adult in the medical laboratory. This approach enables individuals who are currently employed to attain an Associate in Applied Science (AAS) degree and eligibility for certification as a medical (clinical) laboratory technician.

Adult↗
PubMed2004

[ISO 15189 medical laboratory accreditation].

This International Standard, based upon ISO/IEC 17025 and ISO 9001, provides requirements for competence and quality that are particular to medical laboratories. While this International Standard is intended for use throughout the currently recognized disciplines of medical laboratory services, those working in other services and disciplines will also find it useful and appropriate. In addition, bodies engaged in the recognition of the competence of medical laboratories will be able to use this International Standard as the basis for their activities. The Japan Accreditation Board for Conformity Assessment (AB) and the Japanese Committee for Clinical Laboratory Standards (CCLS) are jointly developing the program of accreditation of medical laboratories. ISO 15189 requirements consist of two parts, one is management requirements and the other is technical requirements. The former includes the requirements of all parts of ISO 9001, moreover it includes the requirement of conformity assessment body, for example, impartiality and independence from any other party. The latter includes the requirements of laboratory competence (e.g. personnel, facility, instrument, and examination methods), moreover it requires that laboratories shall participate proficiency testing(s) and laboratories' examination results shall have traceability of measurements and implement uncertainty of measurement. Implementation of ISO 15189 will result in a significant improvement in medical laboratories management system and their technical competence. The accreditation of medical laboratory will improve medical laboratory service and be useful for patients.

Accreditation↗
PubMedDate not supplied

The quality of medical laboratory practice in Trinidad and Tobago, West Indies.

The introduction of automated chemical analyzers in the laboratory service has the potential of adversely affecting professionalism in laboratory practice. The present study assesses the quality of medical laboratory technicians in Trinidad and Tobago using structured questionnaires. Some of the critical questions included job status, years of experience, training, qualification(s) and knowledge of quality assurance and its application. About 82% of laboratory technicians responded to the study. The majority of technicians (62%) had diploma certificates while only one (1.2%) had a postgraduate degree. Although the majority (91.7%) of technicians knew about quality assurance, 36% learnt on the job and 59% knew they were not professionally trained. The results showed that there is paucity of highly trained laboratory technicians in Trinidad and Tobago and this has significant implications on the technical initiative and quality of medical laboratory practice in this country. We recommend the establishment of appropriate professional institutions for training medical laboratory technologists and regular expert inspection and accreditation of all medical laboratories in the country.

Adult↗