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PubMed2001

Accreditation of medical laboratories. Some reflections from the Nordic Horizon.

Accreditation has been a successful approach to improved quality management in laboratories and applied to a wide variety of medical laboratories. After the initial enthusiastic phase, in which quality improvement is significant, the endurance is threatened by an increasing bureaucracy of the process. A productive balance between the accreditation bodies and the profession needs to be sought. New standards have been suggested by ISO and the profession needs to take the initiative to assure that a global standard specially adopted to the requirements of medical laboratories becomes recognised and used. The new concept of uncertainty may become an important tool to further improve and describe the performance of laboratories by allowing inclusion of pre- and post-analytical sources of uncertainty as well as bias.

Accreditation↗
PubMed1996

History of computer-assisted data processing in the medical laboratory.

Computer-assisted processing of medical laboratory data started in the sixties. The earliest systems, which arose in English- and German-speaking laboratories, pointed the way for the development of laboratory data processing. The significance and evolution of the fundamental components of a laboratory information system, such as the placing of the request to the laboratory, identification of patients and samples, recording of data, quality control, plausibility control and results, are presented. The subject is given a wider perspective by the inclusion of a comprehensive (chronological) literature index.

Clinical Laboratory Information Systems↗
PubMed2006

Olfactory sensitivity in medical laboratory workers occupationally exposed to organic solvent mixtures.

BACKGROUND: Published epidemiological information relating the effects of occupational exposure to organic solvents (OS) to olfaction is limited. AIMS: The objectives of this pilot study were to measure the chemosensory abilities of medical laboratory employees occupationally exposed to OS mixtures, to compare these with control workers employed within the same occupational setting and to correlate chemosensory performance with OS exposure history and with employees' hedonic (pleasantness) perceptions about workplace OS odors. METHODS: Twenty-four medical laboratory employees (OS-exposed technicians plus control workers minimally exposed to OS) completed a health-related questionnaire, a test of pyridine odor detection threshold, along with a gustatory detection threshold test involving aqueous quinine solutions. Estimates of cumulative hours of OS exposure (CSI) were calculated from self-reports. RESULTS: OS-exposed laboratory technicians detected weaker concentrations of pyridine odor. Positive correlations were detected between CSI estimates to both pyridine detection and the degree that participants reported that OS odors were present in the workplace. However, no association was detected between pyridine detection and how unpleasant workplace OS odors were perceived. The OS-exposed participants were able to detect weaker concentrations of quinine. Compared to controls, OS-exposed workers complained more of experiencing several symptoms while working, including headaches, nasal irritation and mild cognitive impairment. CONCLUSIONS: The results of this cross-sectional pilot study indicated that, compared to controls, medical laboratory technicians exposed to low-level OS mixtures displayed evidence of elevated olfactory sensitivity (hyperosmia) to pyridine odor. The relation of this study's results to chemical intolerance warrants further investigation.

Adult↗
PubMed2002

Clinical pathology accreditation: standards for the medical laboratory.

This article describes a new set of revised standards for the medical laboratory, which have been produced by Clinical Pathology Accreditation (UK) Ltd (CPA). The original standards have been in use since 1992 and it was recognised that extensive revision was required. A standards revision group was established by CPA and this group used several international standards as source references, so that the resulting new standards are compatible with the most recent international reference sources. The aim is to make the assessment of medical laboratories as objective as possible in the future. CPA plans to introduce these standards in the UK in 2003 following extensive consultation with professional bodies, piloting in selected laboratories, and training of assessors.

Accreditation↗
PubMed1999

A survey of factors affecting the recruitment and retention of Medical Laboratory Scientific Officers in Pathology.

OBJECTIVE: To survey the perceptions and attitudes of Medical Laboratory Scientific Officer (MLSO) staff in Pathology to explain difficulties in recruitment and retention and inform attempts to solve the difficulties. DESIGN: Questionnaire to a defined group of MLSOs. SETTING: The Laboratory Medicine Directorate, Aberdeen Royal Infirmary. SUBJECTS: MLSO1 and MLSO2 staff currently or recently working in Pathology (histopathology) in Aberdeen. RESULTS: The survey return rate was 100%. Opportunities for career development in Pathology are poor, this being the worst feature of working in Pathology. Remuneration is poor and is a disincentive to remaining in the speciality. MLSOs feel undervalued in relation to other health care workers. Many have concerns about laboratory organisation, but find a sociable and supportive environment that provides job satisfaction. Staff seek work in other laboratories because of opportunities for promotion, learning new skills and increased pay, although pay in specialities other that Pathology is greater only because of shift working in these disciplines. There is a need to increase public awareness of MLSOs' central role in providing and maintaining excellence in Pathology services. CONCLUSION: MLSO staff have concerns about their career structure and salary scales. The responsibility of MSLOs in Pathology for quality assurance and managing MLAs is not recognised. These factors form a disincentive to working in Pathology laboratories and threaten our ability to staff the service and to maintain the turnover and quality of Pathology services. These issues require to be addressed nationally and rapidly to prevent the continuing decline in MLSO numbers. Matters of local organisation might be addressed by trusts and departments, but recognition of the need to resource changes would require reflection in budgets.

Career Mobility↗
PubMed2001

IVD industry role for quality and accreditation in medical laboratories.

Manufacturers of in vitro diagnostic (IVD) medical devices and laboratory management have become integral partners in building and improving the quality of laboratory services. There is an increasing awareness that quality is inherent in the design of any reagent or analytical system. In vitro diagnostic medical devices should provide patients, users and third parties with a high level of health protection. Therefore, both manufacturers and users must work in partnership for continual improvement. For manufacturers, standards such as ISO 9000 already exist to guide applications of quality practices. In the field of laboratory medicine, the availability of a specific, universal standard (ISO/DIS 15189) for quality management in medical laboratories will represent a great opportunity for harmonising medical laboratories at an international level. In addition, accreditation of medical laboratories according to the proposed ISO 15189 standard can help develop the relationships between laboratories, and the biological follow-up of travelling patients. Manufacturers are able to help laboratory management to reach a high level of quality, not only by providing high value products, but also on the basis of their own experience of ISO 9000 certification.

Accreditation↗
PubMed1976

Career planning of medical laboratory science students.

The purpose of this study was to determine the most influential people in the career choices of medical laboratory science students. Methods of investigation used by these students were also explored. A questionnaire survey indicated that students were influenced more by professionals in the field, and that high-school guidance counselors were unable to furnish current and accurate information for decision making. Results of the study have implications for improvements in all areas of guidance. Based on the findings, the best interests of the students are served when both guidance counselors and professionals in the medical laboratory science field provide students with understanding, encouragement, and factual information.

Adolescent↗
PubMed1991

Injuries among medical laboratory housekeeping staff: incidence and worker perceptions.

Housekeepers' injury experiences in medical laboratories have not been reported previously. Review of injury incident reports for housekeepers assigned to medical research laboratories in a major university revealed an incidence rate of 46 injuries per 100 housekeepers per year from 1985 to 1988. Thirty-seven percent of the injuries were cuts and punctures, with 70% of these attributable to glass, needles, or cutting instruments. In a survey, 65% of housekeepers indicated that they do not always report their injuries, but the injury pattern they described paralleled those recorded in incident reports. Housekeepers identified behavioral and environmental factors that can contribute to laboratory injuries, including: lack of knowledge; failure to use protective equipment; carelessness; and, "sharps" (ie, sharp needles or glass) in the trash.

Accidents, Occupational↗
PubMed2003

The Confederate medical laboratories.

During the Civil War, the scarcity and expense of imported drugs forced the Confederate Army to establish several medical laboratories to manufacture drugs for military use. The laboratories produced medicines from indigenous plants and also made non-plant-based drugs. The Confederate Surgeon General and the Chief Purveyor in Richmond, VA, coordinated activities of most of the laboratories. The laboratories employed talented and resourceful personnel and manufactured a large volume and wide variety of drugs, the most useful of which included ether, chloroform, and opiates. The pharmaceutical quality of the laboratories' output was evidently uneven. Empirical testing in military hospitals helped determine the clinical value of indigenous remedies. The Confederate medical laboratories participated in a coordinated effort to supply the Army with substitutes for drugs whose availability was curtailed or uncertain.

Drug Compounding↗
PubMed1997

Essential criteria for quality systems in medical laboratories.

The introduction of total quality systems in medical and clinical laboratories and accreditation of these laboratories is gaining more and more interest. In several countries laboratories have set up quality systems, and accrediation schemes are also operating. The standards of these schemes have much in common although several differences exist. There exists uncertainty in several countries on the choice of a system. Laboratory specialists are confronted with a new way of thinking concerning the management and daily practice of their laboratories. It is not clear, which standards should be used as a basis, and certainly not how to interpret such standards. Particulary in the European Union, harmonisation of criteria for quality systems is desirable. In the present paper, the document entitled "Essential Criteria for Quality Systems in Medical Laboratories" is presented. The document has been accepted in the general Assembly of the European Communities Confederation of Clinical Chemistry (EC4) and by the working group on Good Laboratory Services of the European Council on Laboratory Medicine (ECLM). The criteria in the document are focussed on the particular situation of medical laboratories, including pre- and post-analytical aspects. Reference is made, where applicable, to EN 45001, ISO 9001 and ISO guide 25 draft 3.

Chemistry, Clinical↗
PubMed1995

Student performance appraisal: an approach to evaluation of attitudes in medical laboratory technology students.

This paper describes the development and implementation of a new evaluation format for assessing professional attitudes in medical laboratory technology students--the performance appraisal. This tool measures attitudes considered desirable in the ¿ideal technologist¿, and links the presence or absence of these attitudes to behaviors which can be observed in the student. The performance appraisal functions not only as an evaluation instrument for instructors, but as a learning tool for students, who can identify behavioral objectives, assess their own progress, and set goals and strategies for development of professional attitudes. Details regarding the administration of the evaluation instrument, such as rating scales, remedial planning, and responsibilities of faculty, clinical coordinators, and students are presented. In addition, controversies regarding the evaluation of professional attitudes are discussed, including: optimizing instructor objectivity; timing and grading of evaluations; forwarding of evaluations from one instructor to another; identification of mandatory and desirable attitudes; and criterion referencing of objectives. Plans for future development of the system are included.

Attitude of Health Personnel↗
PubMed1983

An investigation of the cognitive styles of 76 associate degree medical laboratory technology students.

The preferred learning styles of 76 associate degree medical laboratory technology students in four classes at two community colleges were assessed using the Modified Hill Cognitive Style Model. It was found that these students did not have a preference for finding meaning through spoken words or non-word symbols. They had little need to read body language or to be physically involved in order to learn; they preferred not to act out a role for acceptance, and they would have difficulty in influencing another's behavior. These students were capable of making decisions on their own and should do well studying independently. They preferred "categorical reasoning" as a basis for accepting or rejecting ideas and preferred to use deductive or syllogistic reasoning for inferences. Implications for instruction are discussed.

Cognition↗
PubMed1983

The application of measurement systems in the management of medical laboratories.

The Workload Recording System, initially developed by the Canadian Association of Pathologists, with subsequent and joint active participation with the College of American Pathologists and numerous other medical laboratory specialist societies, is a powerful tool for the management of medical laboratories. This article describes the system and its implementation.

Efficiency↗
PubMed1977

Survey of safety and health care in British medical laboratories.

A retrospective postal survey of 24 000 medical laboratory workers in England, Wales, and Scotland showed highly variable standards of safety and health care. Pre-employment health screening was offered to two-thirds of employees, the physicians being the least likely to be examined (15%). Scottish laboratories provided better safety control than English and Welsh laboratories, while Public Health Service Laboratories had a better record than National Health Service establishments. Mouth pipetting is still practised in 65% of English and Welsh laboratories, and the use of protective clothing is rarely compulsory. The servicing of safety cabinets is often inadequate. Known and suspected carcinogens are still apparently used in a few laboratories (2-10%). In view of the wide variation in standards among laboratories, urgent consideration should be given to establishing regulations for codes of safe practice rather than relying merely on recommendations as at present.

Accident Prevention↗
PubMed1998

Quality management in the medical laboratory: a comparison of draft standards.

Clinical laboratories used to rely almost completely on functional tests to monitor and assess their performance. This is known as internal quality control (IQC). A supporting approach is the interlaboratory comparison. In many countries and other disciplines this is known as proficiency testing, whereas, in Europe, the procedure is better known as external quality assessment taken care of by different schemes (EQAS). Probably all laboratories participate in some kind of EQAS and in some countries it is mandatory. It has gradually become apparent that functional tests are not sufficient to achieve, assure and develop quality in medical laboratories. Therefore other means must be sought. The principles laid down in the ISO 9000 series and the total quality concept has become interesting; in particular, accreditation. Accreditation of laboratories has been available for many years and in fact is routine in some specialities e.g. food, water laboratories and in some countries also for laboratories in the veterinary field. The present paper describes some features of the available and planned ISO standards that deal with accreditation of laboratories and particularly those adopted for the medical laboratories.

Accreditation↗
PubMed2000

Usefulness of EC4 essential criteria for quality systems of medical laboratories as guideline to the ISO 15189 and ISO 17025 documents. European Community Confederation of Clinical Chemistry (EC4) Working Group on Harmonisation of Quality Systems and Accreditation.

Many medical laboratories have made a start with the introduction of quality management systems. However, it is still not clear against which standards such systems should be measured. The existing ISO and CEN standards do not cover essential aspects of medical laboratories. The publication of the EC4 Essential Criteria has stimulated the development of the ISO/Draft International Standard 15189. This standard seems adequate for our type of laboratories. However, it is not easy to read. The EC4 Essential Criteria could well serve as a guide, covering additional aspects, e.g. on total quality management and budget management as required in the EFQM model, that are not (yet) included in the ISO standard. In the present article the EC4 Essential Criteria are cross-referenced with two new international ISO standards, ISO/FDIS 15189 and ISO/FDIS 17025, the latter being the successor of ISO guide 25 and EN 45000. Both new ISO documents are in compliance with the new ISO 9000:2000 standard.

Europe↗
PubMed1991

Examining exclusionary conduct of HMOs and PPOs: a case comment on Northwest Medical Laboratories v. Blue Cross and Blue Shield of Oregon.

As the climate of the health care industry has changed to one of cost-containment and competition through the growth of HMOs and PPOs, health care providers have become the subjects of antitrust litigation. One such case, Northwest Medical Laboratories v. Blue Cross and Blue Shield of Oregon, involved a medical laboratory and a radiology center who claimed that they were victims of an illegal group boycott after defendant's pre-paid health plan denied them preferred provider status. The Oregon Court of Appeals, using the traditional antitrust analysis applied to other industries for decades, failed to consider the intricacies that exist within the health care industry. This result led to an inaccurate market share computation and an inadequate rule of reason analysis. This Comment examines the shortcomings of the Northwest Medical opinion and argues that, in applying the antitrust laws to the health care industry, courts in future cases must recognize and respect the unique features of the business of providing health care.

Blue Cross Blue Shield Insurance Plans↗