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PubMed1989

Sources of improvement in between laboratory variation in estrogen and progestin receptor measurement using tissue samples during the Australian Quality Assurance Programme.

Tissue and cytosol samples were compared as quality control material for assessment of between and within laboratory error in measurement of estrogen and progestin receptors (ER and PR) in a series of four trials for a total of 17 participating laboratories during the Australasian Quality Assurance Programme. For tissue samples, a substantial reduction in between laboratory CVs for both ER and PR from about 90 to 50% was achieved during the programme. In contrast, for cytosol samples a substantially lower between laboratory CV of about 30% was obtained. Tissue sample heterogeneity could be excluded as a major source of variation between laboratories. The likely source of the observed improvement in CV for tissue samples during the trials was due to a reduction of the initial under-estimation of receptor concentration in tissue samples by some of the participants. Although cytosol preparation from tissue samples was shown to be one major source of error, other sources of error such as the receptor assay itself and the associated protein measurements were identified. It is concluded that fragmented tissue samples are essential for a realistic assessment of between laboratory error in receptor measurements in biopsy material such as obtained from clinical breast cancer samples.

Animals↗
PubMed1991

Efficiency in pathology laboratories: a survey of operations management in NHS bacteriology.

In recent years pathology laboratory services in the U.K. have experienced large increases in demand. But the extent to which U.K. laboratories have introduced controls to limit unnecessary procedures within the laboratory was previously unclear. This paper presents the results of a survey of all 343 NHS bacteriology laboratories which records the extent to which such operations management controls are now in place. The survey shows large differences between laboratories. Quality controls over inputs, the use of screening tests as a culture substitute, the use of direct susceptibility testing, controls over routine antibiotic susceptibility testing, and controls over reporting of results all vary widely. The survey also records the prevalence of hospital antibiotic policies, the extent to which laboratories produce antibiograms for user clinicians, the degree of computerisation in data handling, and the degree of automation in processing specimens. Finally, the survey uncovers a large variation between NHS labs in the percentage of bacteriology samples which prove positive and lead to antibiotic susceptibility tests being carried out.

Bacteriological Techniques↗
PubMed1997

Changes in the American health care system: crisis in the clinical laboratory.

American medicine is undergoing unprecedented changes, and the resulting distortions are affecting the economics, organization and operations of all clinical laboratories. Professionals who work in these laboratories are facing administrative and economic pressures to reduce costs, to increase productivity, and to comply with proliferating new statutes and regulations. The medical 'cottage industry' in which the patient was the focus of the medical professionals' attention and endeavours is being replaced by the corporate management of many health care activities in which financial profits are being given first priority. Medical facilities, including clinical laboratories, are being bought and sold, being consolidated, or simply being closed. The clinical laboratories may be at the vortex of the maelstrom affecting American medicine. Cost pressures are encouraging further automation and retraining of laboratory staffs. If the leaders in laboratory medicine are unable to accomplish the necessary tasks to meet the new challenges, there inevitably is a non-medical, non-scientific financial manager at hand who is willing to define the changes and the desired outcome. Because of the rapidity of the changes taking place, it is not possible to predict with any confidence the modifications that will achieve a permanent status or the degree to which medical professionals will remain masters of their fates. The evolving health care system will become less costly, more technologically advanced, and a more challenging system in which to work.

Autoanalysis↗
PubMed1980

Optimal utilization of the laboratory in making clinical decisions.

The clinical laboratory is an essential component in the medical care system, and laboratory information is necessary in many clinical decisions. There is no inherent conceptual reason why laboratory information should be used any differently in the decision making process from the information collected by the physician himself, but there are logistic and economic factors that prevent this. The laboratory can be considered an information system, and the performance of the entire system depends upon the effectiveness of each of the sequential steps in the information generating process. Optimization of laboratory utilization requires the identification of explicit criteria regarding when laboratory tests should be used and the development of methods to insure that the resulting data are utilized properly.

Autoanalysis↗
PubMed1999

Effect of current and forthcoming European legislation and standardization on the setting of quality specifications by laboratories.

A network of national and international guidelines and directives developed in the last few decades by various bodies will lead to a new concept of total quality for medical laboratory services comprising legislative regulations on national and international levels, standardizations backed up by legislation and recommendations of professional societies. One example is the IVD Directive of the European Community. It will not only stimulate accreditation in the field of laboratory medicine, but also necessitate numerous standardization activities which are presently co-ordinated by the European Committee for Standardization (CEN). Another standardization example is the development of quality management systems, mainly by ISO. The ISO 9000 series has become the most successful family of standards world-wide. Meanwhile, specific standards for the needs of laboratories (ISO 17025), and in particular of medical laboratories (ISO 15189), are being worked out. A new trend to develop quality management systems towards total quality management systems can be observed including additional aspects such as economic and quality interests of society, customers and owners of laboratories. The goal of all activities is to create a network of confidence which provides some guarantee to the clients, i.e. the physicians and their patients, that they will receive a high-quality medical laboratory service.

Clinical Laboratory Techniques↗
PubMed1978

The role of the microbiology laboratory in surveillance and control of nosocomial infections.

The microbiology laboratory's rapid and consistent identification of nosocomial pathogens is a keystone in the surveillance and control of hospital-acquired infections. In addition, the laboratory serves as a source of expert consultation for clinicians and infection control personnel and as an "early warning center" for infection problems. In making its contributions to infection control most effective, the laboratory must recognize its capabilities and limitations, must insure that the materials and methods it uses and the specimens it processes meet high standards, must provide retrievable records, and must have a good working knowledge of microbiologic technics used to evaluate both endemic and epidemic infections. Moreover, because laboratory workers come into contact daily with potentially infectious specimens and isolates, the laboratory's contributions to infection control should also include the prevention and surveillance of laboratory-acquired infections.

Cross Infection↗
PubMed2000

The development of a continuous quality control programme for strict sperm morphology among sub-Saharan African laboratories.

Inter-technician and between-laboratory differences, especially during the evaluation of sperm morphology, have been a major cause of concern. The study aimed to develop an intensive training programme with intervals of continuous quality control assessments for sperm morphology. Twenty andrology laboratories from sub-Saharan Africa were invited to participate in a World Health Organization Special Programme of Research, Development and Research Training in Human Reproduction semenology workshop. Following intensive training in strict sperm morphololgy evaluation, a continuous quality control programme was introduced on a quarterly basis. At baseline, the mean (+/- SD) percentage difference reported between the participants and the reference laboratory reading was 33.50 +/- 11%. After training, the mean percentage difference had decreased to 14.32 +/- 5% at 3 months and to 5.00 +/- 5% at 6 months. Pairwise comparison of the differences at each evaluation time revealed the following: Baseline differences (pre-training) differed significantly from the differences at 3 months (P = 0.0002) as well as at 6 months after training (P = 0.007). The differences at 6 months did not differ significantly from those at 3 months (P = 0.27). Training of andrology technicians as well as continuous proficiency testing can be conducted on a national and international level with the support of a referring laboratory. Global quality control measurements in andrology laboratories should become mandatory, since these results indicate that continuous quality control for laboratory technicians can be highly successful.

Africa, Northern↗
PubMed1997

Eradication of wild poliovirus from the Americas: wild poliovirus surveillance--laboratory issues.

The Pan American Regional Poliomyelitis Laboratory Network, developed to support the program to eradicate indigenous wild poliovirus transmission in the Americas, included 10 laboratories, distributed in eight countries in the Americas, organized according to the diagnostic procedures they regularly performed. All laboratories isolated and typed virus in stool specimens, several did intratypic differentiation by nucleic acid probe hybridization, and 2 sequenced wild poliovirus isolates for molecular epidemiologic studies. High performance of the network was maintained through comprehensive training of virologists, continuous monitoring of laboratory performance, and prompt investigation of problems. Recommended field and laboratory procedures were regularly reviewed and revised to optimize sensitivity, specificity, and diagnostic efficiency. Close integration of field and laboratory surveillance was achieved through frequent meetings between virologists and epidemiologists, effective communication of program priorities, and the distribution of weekly surveillance reports.

Americas↗
PubMed1995

Clinical practice and the use of laboratory tests at the May 15 Hospital in Egypt.

The purpose of this study was to assess physicians' practices in the use of laboratory tests at a public hospital in Egypt. Methods included medical record reviews, interviews with selected physicians, literature review, and cost analysis. Three variables were examined in the medical record: appropriateness of laboratory tests, laboratory tests performed but not used as a basis for clinical treatment, and laboratory tests requested but not performed. Direct and indirect costs for each test were calculated. Results of the study indicated that 31.4% of the tests were inappropriate, 20.1% of test results were not used in treatment decisions, and 16.3% were not performed. Inappropriate and unused tests accounted for 22.6% of the annual total budget deficit for the hospital laboratory. To improve the quality of patient care and to decrease the wasteful use of resources, the hospital formed process improvement terms to develop clinical guidelines for problem-prone tests and to improve processes for requesting and providing laboratory results in a timely manner.

Clinical Laboratory Techniques↗
PubMed1980

Technological change and clinical laboratory utilization.

Many believe that improvement in laboratory automation has been responsible for the considerable growth in the volume of tests that has occurred in recent years. Results are presented from an 8-year national survey of hospital laboratory utilization that show no definitive correlation between technological change and growth in volume of well-established clinical laboratory tests. These results leave room for hypothesizing other major contributory factors to volume increases such as a behavioral change on the part of practitioners who order tests and place increased diagnostic importance on laboratory results in addition to medical histories and physical examinations. If the findings prove correct, successful regulatory strategies for the containment of laboratory costs might be as likely to come from those that directly address practitioners' behavior as from those that limit capacity by requiring prior approval for acquisition of new laboratory equipment.

Autoanalysis↗
PubMed2005

Autonomic nervous system laboratories: a European survey.

We present a questionnaire-based survey on methods adopted in European autonomic nervous system (ANS) laboratories in the year 2002. Seventy-nine laboratories from 16 countries in Western and Eastern Europe provided information on test methods, equipment, staff, educational programme and research activities. The results confirmed the anticipated heterogeneity of techniques used to investigate ANS disorders. However, cardiovascular (84.8%) and sudomotor (43.0%) tests were the most common. There were no standards regarding equipment, but devices used varied widely, in part commercially available, in part self-developed. Some ANS laboratories performed cardiovascular tests using standard EMG devices with implemented routines to measure heart rate variability. Many investigators used published normative data (75.4%). Most of the responders were involved in scientific work, half were active in education of trainees. A wide variation was found in number and profession of staff members. As more than 60% of questionnaires were returned by neurologists our results may be limited to neurological ANS laboratories. Given the wide variation of methods and equipment used in European ANS laboratories, minimal standards for routine ANS testing are desirable. Standards may help to compare results of diagnostic tests, evaluate equipment and test laboratory methods and commercial devices and set-up educational programmes.

Autonomic Nervous System↗
PubMed2005

Sensitisation to mites in laboratory animal workers with rhinitis.

AIMS: To determine the frequency of sensitisation to mites among rhinitic laboratory animal workers and to clarify whether sensitisation could be occupational. METHODS: Skin prick tests (SPT) were performed in 40 subjects who were working with laboratory animals in Kuopio University research units and who had been referred to Kuopio University Hospital for work related rhinitis. The SPT panel consisted of three storage mites, two house dust mites, 11 other common environmental airborne allergens, latex, and 2-4 individually relevant laboratory animals. To determine signs of mites in animal facilities, guanine was determined in 22 dust samples taken from feedstuffs or bedding material used for laboratory animals and from rooms where these materials were stored and handled. RESULTS: Positive SPT results were found in 35 out of 40 workers: in 14 for storage mites, four for house dust mites, 25 for other common aeroallergens, as well as positive reactions to laboratory animals in 19 individuals. The guanine test was positive, indicating the presence of mite derived material in 21 out of 22 dust samples. CONCLUSIONS: This study suggests that subjects who are occupationally exposed to laboratory animals are also exposed to mite derived allergens. Sensitisation to mites is common and may be work related.

Adult↗
PubMed2005

Incidence of allergy and allergy symptoms among workers exposed to laboratory animals.

BACKGROUND AND AIMS: Few studies have described relations between exposure to laboratory animals and the incidence of laboratory animal allergy (LAA). Studies that have found exposure-response relations have been cross sectional in design or have focused on exposure to rats and mice. This study used longitudinal data collected over a 12 year period to describe the relations between indices of exposure to laboratory animals and the development of LAA and LAA symptoms. METHODS: Data were obtained from questionnaires and serological laboratory results from a dynamic cohort of workers exposed to a variety of laboratory animals in a pharmaceutical manufacturing company. Poisson regression was used to model the incidence rate ratios of species specific and general LAA and LAA symptoms at different levels of exposure. RESULTS: The 12 year incidence rates of LAA symptoms and LAA for all workers were 2.26 (95% CI 1.61 to 2.91) and 1.32 (95% CI 0.76 to 1.87) per 100 person-years, respectively. Higher rate ratios were seen with increasing reported hours of exposure to tasks that required working with animal cages or with many animals at one time. The most common symptoms were related to rhinitis rather than to asthma. CONCLUSIONS: This study suggests that the risk of LAA increases with duration of exposure to animals and work in animal related tasks. Incidence might be reduced by limiting hours per week of exposure to laboratory animals.

Adolescent↗
PubMed2006

Standardizing laboratory data by mapping to LOINC.

The authors describe a pilot project to standardize local laboratory data at five Indian Health Service (IHS) medical facilities by mapping laboratory test names to Logical Observation Identifier Names and Codes (LOINC). An automated mapping tool was developed to assign LOINC codes. At these sites, they were able to map from 63% to 76% of the local active laboratory tests to LOINC using the mapping tool. Eleven percent to 27% of the tests were mapped manually. They could not assign LOINC codes to 6% to 19% of the laboratory tests due to incomplete or incorrect information about these tests. The results achieved approximate other similar efforts. Mapping of laboratory test names to LOINC codes will allow IHS to aggregate laboratory data more easily for disease surveillance and clinical and administrative reporting efforts. This project may provide a model for standardization efforts in other health systems.

Clinical Laboratory Techniques↗
PubMed2001

Which surrogate marker can be used to assess the effectiveness of the laboratory and its contribution to clinical outcome?

Assessment of the effectiveness of the clinical laboratory and its contribution to outcomes is gaining increasing emphasis, as part of the overall attempts at making clinical services more transparent and accountable. Tools traditionally used in the assessment of laboratory effectiveness and efficiency have included laboratory accreditation, Q-probes, performance in quality assurance programmes and staffing and cost issues. There is, however, a need to introduce different measures that highlight the laboratory efficiency and contribution to clinical effectiveness and outcomes. Such measures should, ideally, be quantifiable and evidence-based. The use of markers of efficiency and effectiveness could be used as tools to aid this process. Such markers could include incident reporting, the appropriateness of assay repertoire, adding value to reports, the quality of comments made, provision of information on the effect of analytical and biological variation on results, cascading requests to help making diagnoses and unearthing such diagnoses. We suggest that these measures contribute towards the implementation of the clinical governance agenda in relation to the laboratory, and could be used as indicators in laboratory accreditation.

Accreditation↗
PubMed2005

Reducing laboratory turnaround time outliers can reduce emergency department patient length of stay: an 11-hospital study.

Poor core laboratory performance that causes delays in diagnosis and treatment is an impediment to optimal patient care, particularly in high-volume patient care areas such as the emergency department (ED). To evaluate the impact of laboratory performance on patient care outcomes, we obtained data from 11 hospitals related to laboratory test turnaround time (TAT) parameters and ED patient throughput. We observed that the average length of stay (LOS) in the ED correlated significantly with the percentage of total laboratory outliers (R2 = 0.75; P < .01) and to a lesser extent the TAT means (R2 = 0.66; P < .01). Furthermore, improvements in laboratory performance during the study were associated with concurrent decreases in ED LOS. Although in the past, laboratories have focused on TAT means for performance assessment, our observations suggest that a more appropriate method of benchmarking might be to aggressively set clinically driven TAT targets and assess performance as the percentage of results achieving this goal.

Clinical Laboratory Techniques↗
PubMed2003

LOINC, a universal standard for identifying laboratory observations: a 5-year update.

The Logical Observation Identifier Names and Codes (LOINC) database provides a universal code system for reporting laboratory and other clinical observations. Its purpose is to identify observations in electronic messages such as Health Level Seven (HL7) observation messages, so that when hospitals, health maintenance organizations, pharmaceutical manufacturers, researchers, and public health departments receive such messages from multiple sources, they can automatically file the results in the right slots of their medical records, research, and/or public health systems. For each observation, the database includes a code (of which 25 000 are laboratory test observations), a long formal name, a "short" 30-character name, and synonyms. The database comes with a mapping program called Regenstrief LOINC Mapping Assistant (RELMA(TM)) to assist the mapping of local test codes to LOINC codes and to facilitate browsing of the LOINC results. Both LOINC and RELMA are available at no cost from http://www.regenstrief.org/loinc/. The LOINC medical database carries records for >30 000 different observations. LOINC codes are being used by large reference laboratories and federal agencies, e.g., the CDC and the Department of Veterans Affairs, and are part of the Health Insurance Portability and Accountability Act (HIPAA) attachment proposal. Internationally, they have been adopted in Switzerland, Hong Kong, Australia, and Canada, and by the German national standards organization, the Deutsches Instituts für Normung. Laboratories should include LOINC codes in their outbound HL7 messages so that clinical and research clients can easily integrate these results into their clinical and research repositories. Laboratories should also encourage instrument vendors to deliver LOINC codes in their instrument outputs and demand LOINC codes in HL7 messages they get from reference laboratories to avoid the need to lump so many referral tests under the "send out lab" code.

Clinical Laboratory Information Systems↗
PubMed2002

Aspects of the development of clinical chemistry and laboratory medicine in the former East Germany.

Clinical chemistry and laboratory medicine developed rapidly in the industrialised world after the Second World War, as evidenced by the recruitment of physicians and natural scientists, the intensive development of methods and technologies, the founding of societies such as the IFCC, and the organisation of scientific life. In East Germany a working group of clinical pathologists and chemists came together in 1960, out of which grew the Gesellschaft für Klinische Chemie und Laboratoriumsdiagnostik (Society for Clinical Chemistry and Laboratory Diagnostics) in 1968. Within the socialist health care system laboratory services were structured in a pyramid form based on the country's governmental districts. Each local diagnostic laboratory was part of a hierarchy; tests not possible in local laboratories were performed in larger ones. Groups of experts prescribed standardised methods and recommendations of quality control were administered at the district level. However, the funding of this quite acceptable structure was insufficient, resulting in difficulties. Although the development of equipment was carried out in close cooperation with users, it was hindered by shortages extant in the socialist economy. Postgraduate training of physicians, natural scientists, technicians and laboratory assistants was well organised, and clinical chemistry and pathobiochemistry were well established in the medical curriculum.

Chemistry, Clinical↗