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PubMed1993

Interpretative reporting and alarming based on laboratory data.

The utilisation of laboratory services for patient diagnosis and management involves many steps with both clinical and laboratory components. The clinical components include the decision to order a test, interpretation of the test results and actions taken on the basis of the results. The laboratory components on the other hand include receipt of the request, specimen collection, preparation and analysis, result entry, test result validation and verification and reporting of the results. In this paper, which is part of the OpenLabs project, we concentrate on the post-analytical applications which include interpretation and reporting of the laboratory results to the users in primary care and in high dependency care units. The final objective of the work described is to develop generic modules which can be integrated both with an Open laboratory information system architecture and existing laboratory information processing environment.

Acid-Base Imbalance↗

PubMed1994

The clinical laboratory is in the information business.

Clinical laboratories have always been in the information business. More than ever, this perspective is essential to deal logically with the many current pressures and anticipated changes in laboratory management. Current pressures for test turn-around and report flexibility are readily explained based on the spatial and temporal factors in the information content of a result. A long term trend is apparent toward easier to manage testing systems more often distributed to the point of care. Combined with the trend toward larger and more integrated delivery systems, this increases the need for information management in the laboratory, both to control production of data at many sites and to collect, route, and archive results for each patient. One potential outcome of this trend appears is dispersion of essentially all central hospital laboratory operations to the bedside, the ward based laboratory, or an outside reference lab. These changes will mesh well with the re-design of nursing and ward care jobs underway in the hospital industry which emphasizes cross training of ward personnel and rapid access to services for patient evaluation and monitoring. More than ever, information management will be synonymous with laboratory management.

History, 20th Century↗

PubMed1987

Estrogen and progesterone receptor assays in human breast cancer: sources of variation between laboratories.

The importance of cytosol preparation as a source of inter-laboratory variation in estrogen (ER) and progesterone (PR) receptor measurements was evaluated together with protein measurements and receptor assays for five laboratories in Sydney, Australia, using pooled, fragmented human breast cancer samples. Protein measurement was only a minor source of variation between the laboratories with a CV of 13%. For ER measurements, sources of variation due to either assay or cytosol preparation methods contributed 40 and 39% CV each. However, the variation due to assay method was reduced to 25% CV when the results from one laboratory with a known effect of a different ER assay protocol were excluded, suggesting that assay standardization could readily reduce this source of variation. In contrast, the source of a large cytosol error (39% CV) could not be identified. Variations in PR results were similar to ER, but the sources could not be accurately estimated. It is concluded that cytosol preparation as well as assay methods were major sources of between laboratory variation and need to be further investigated and standardized. This approach should reduce these sources of variation since it was found that the within laboratory cytosol and assay variations were only 13 and 18% CV, respectively, for the ER measurements.

Breast Neoplasms↗

PubMed1995

An audit of pulmonary function laboratories in the West Midlands.

BACKGROUND: Pulmonary function testing has become an integral part of the assessment and follow-up of patients with pulmonary disease. Many factors can influence the results produced by a laboratory. This audit was performed to examine the extent of variation in the pulmonary function test results amongst all laboratories in the West Midlands. This was followed by an attempt to determine the cause of this variation. METHODS: Phase 1. Three normal healthy subjects each underwent a set of pulmonary function tests in all 22 laboratories in the West Midlands. Information regarding technicians' qualifications, training and seniority, protocol and equipment used were obtained in the form of a questionnaire. Phase 2. All 22 laboratories were asked to calculate the predicted values on the same nine sets of demographic data. These data included both sexes, ethnic minorities and range of ages. In addition technical aspects of each laboratory were investigated including the assessment of volume and gas analysers with standard gases containing known concentrations of helium and carbon monoxide. RESULTS: Phase 1. Significant variations (P < 0.05) were observed in all measured values of pulmonary function tests of the three subjects. Significant variations (P < 0.05) were also observed in all predicted values except total lung capacity. Phase 2. There were significant variations (P < 0.05) amongst laboratories in calculating the predicted values of all components of pulmonary function tests. No significant differences were observed in the measurement of volume or concentration of carbon monoxide or helium.

Adult↗

PubMed1996

An intercomparison of gamma-spectrometry on two samples of biological origin by eight laboratories in four countries.

This report gives details of the first inter-laboratory comparison of gamma-spectrometry to be run within SPERA, the South Pacific Environmental Radioactivity Association since its inauguration in 1991. Laboratories in Australia, Chile, French Polynesia and New Zealand participated in the exercise. Two 'unknown' samples of biological origin were analysed. The first was a sample of milk powder derived from IAEA reference material. This sample provided an assessment of overall accuracy of 134Cs, 137Cs and 40K determinations. The second sample consisted of dried fish flesh including natural 40K and spiked with a mixed nuclide solution containing 210Pb, 109Cd, 54Mn, 60Co and trace 133Ba. Together the samples gave information on analytical precision over a range of energies and activities. When the results were compared with the recommended values and confidence intervals of the IAEA reference material, the overall accuracy of the gamma-spectrometry analytical procedures was found to be good. The average mean values for combined laboratory data fell within the recommended value ranges for each isotope. Ninety percent of the individual laboratory isotope mean values were within two standard errors of the 95% confidence interval of the standard, 75% were within 1 s.e., and 33% of the analyses fell within the confidence interval. Technical precision was also adequate with the overall errors being of the same magnitude as that of the reference material values for each isotope with relative standard deviations of 5-10%. There was a tendency for standard deviations of the combined results to be larger than those reported or derived from individual laboratory results by a factor between 1.2-5.6. This result suggested an under-estimate of systematic errors within individual laboratories. The largest sources of error were derived from reporting and calculation of results which gave a 16% gross error rate.

Animals↗

PubMed2005

Establishment of a national network of validated and qualified laboratories for neutralizing anti-vaccinia antibodies titration.

A Proficiency Testing Study (PTS) was organized in France by the French Health Products Safety Agency (Afssaps) aiming at assessing the performance of laboratories in performing a neutralizing anti-vaccinia antibodies titration method by plaque reduction neutralization test (PRNT). The ultimate goal was to establish a national network of qualified and validated laboratories. Five laboratories were included in the PTS and four submitted their data. Three samples of human sera containing various immunoglobulin concentrations (a "high" serum: s-576, a "medium" serum: Ref-19584 and a "low" serum: s-483) were tested by PRNT as described in a procedure supplied by Afssaps and developed in each laboratory during preliminary assays. Data were sent to Afssaps which performed the statistical analysis. The overall performance of the four participating laboratories was satisfactory. This allowed the four participating laboratories to be validated and then to be qualified by the Ministry of Health. Finally a national network for anti-vaccinia immunoglobulins titration was established.

Antibodies, Viral↗

PubMed2004

Salmonella culture: sampling procedures and laboratory techniques.

In some respects, the multitude of options for isolation of Salmonella and the lack of interlaboratory consistency make Salmonella isolation one of the most variable procedures in veterinary laboratories. Even with the vast number of techniques available, it seems that at least one or two new media become available every year that promise to be more sensitive, more specific,and more rapid. With all the potential media and techniques available, the diagnostic laboratory must choose those that efficiently and accurately give the timely results required clinically and epidemiologically. Many veterinary diagnostic laboratories have invested the time and effort to explore these options and usually have developed standard methods to ensure that their laboratory tests have high sensitivity and specificity. Clients have greater assurance in the accuracy of laboratory results if these standards and the process of deriving them are made available to them. Many laboratories participate in external quality assurance programs to demonstrate their ability to culture microorganisms accurately. These quality control programs are designed to ensure that the client receives the correct answers to questions that are vital for the treatment and health care of their horses. This important information is available only if the initial steps of collecting and shipping the samples have been executed appropriately.

Animals↗

PubMed2006

Technologies for laboratory generation of dust from geological materials.

Dusts generated in the laboratory from soils and sediments are used to evaluate the emission intensities, composition, and environmental and health impacts of mineral aerosols. Laboratory dust generation is also utilized in other disciplines including process control and occupational hygiene in manufacturing, inhalation toxicology, environmental health and epidemiology, and pharmaceutics. Many widely available and/or easily obtainable laboratory or commercial appliances can be used to generate mineral aerosols, and several distinct classes of dust generators (fluidization devices, dustfall chambers, rotating drums/tubes) are used for geological particulate studies. Dozens of different devices designed to create dust from soils and sediments under controlled laboratory conditions are documented and described in this paper. When choosing a specific instrument, investigators must consider some important caveats: different classes of dust generators characterize different properties (complete collection of a small puff of aerosol versus sampling of a representative portion of a large aerosol cloud) and physical processes (resuspension of deposited dust versus in situ production of dust). The quantity "dustiness" has been used in industrial and environmental health research; though it has been quantified in different ways by different investigators, it should also be applicable to studies of geological aerosol production. Using standardized dust-production devices and definitions of dustiness will improve comparisons between laboratories and instruments: lessons learned from other disciplines can be used to improve laboratory research on the generation of atmospheric dusts from geological sources.

Aerosols↗

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↗

PubMed2002

Continuing medical education: a challenge to the Italian Scientific Societies of Laboratory Medicine.

BACKGROUND: In the modern health service, it is no longer acceptable for any clinician or other professional to abstain from continuing education after qualification. This is particularly true in the field of laboratory medicine because of the dramatic changes that have occurred in the organization, number and types of tests, and role of medical laboratories. In Italy, a program for continuing education in medicine (Educazione Continua in Medicina (ECM)) has recently been promoted by the National Government. METHODS: Continuing education (CE) in laboratory medicine should include all educational activities that are pertinent to a person's professional skills, activities, interests, and growth. Continuing education can take many forms. In particular, a variety of programs are available that enable employees to improve their knowledge and skills while reducing their travel and absence from the laboratory. RESULTS: The present paper describes the recent redefinition of the mission, aims and structure of the Scientific Division of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) and the role it plays in making available to all associates a program for continuing education in the field of Laboratory Medicine. CONCLUSIONS: The activation of a national program for continuing education in medicine (ECM) in Italy provides a great opportunity for all professionals of the healthcare sector and for laboratorians, in particular. This educational project offers an unrivalled opportunity for the Italian Scientific Societies of Laboratory Medicine to weave quality improvement into their relationships with associates, thus reappraising their missions and goals.

Accreditation↗

PubMed1998

Certification standards transfer: from committee to laboratory.

The ISO 9000 Standards series were developed to provide the international manufacturing industry with a framework to ensure purchased products meet quality criteria. Section 4 of ISO 9001, Quality System Model for Quality Assurance in Design, Development, Production, Installation and Servicing, contains 20 aspects of a quality system that must be addressed by an organization in order to receive ISO 9001 certification. This concept is extended to the clinical laboratory, where a quality system program establishes for the customer (patient/clinician) that the purchased product (requested information on a submitted specimen-test result) meets established quality norms. In order to satisfy the customer, the providing organization must have policies and procedures in place that ensure a quality product, and be certified. To become certified the organization must, through an inspection process, demonstrate to an independent accrediting agency that it meets defined standards. In the United States, the government through the Clinical Laboratory Improvement Amendment (CLIA) 1988 established quality standards for the clinical laboratory. The College of American Pathologists (CAP), through its Laboratory Accreditation Program (LAP), serves as an independent agency that certifies that laboratories meet standards. To demonstrate the applicability of an established clinical laboratory accreditation program to ISO 9001 certification, the standards and checklists of CLIA 1988 and the CAP LAP will be examined to determine their conformance to ISO 9001, Section 4.

Certification↗

PubMed1986

A different laboratory for the future.

The laboratory of the future will not be exclusively centrally placed in the hospital setting, and Laboratory Medicine will not be hospital-based to the extent it has been in the past. The requirement that Laboratory Medicine support necessary and beneficial clinical care remains. Unless laboratory personnel pay greater attention to all aspects of laboratory performance, including test ordering and reporting, the viability of Laboratory Medicine as a specialty may be jeopardized.

Clinical Laboratory Techniques↗

PubMed1987

Performance of an enzyme immunoassay test and anaerobic culture for detection of group A streptococci in a pediatric practice versus a hospital laboratory.

The ability of pediatricians and hospital laboratory personnel to detect group A streptococci in patients with suspected streptococcal pharyngitis was evaluated using the TestPack Strep A and anaerobic culture. Duplicate throat specimens (for similar processing by both the pediatricians and laboratory technologists) were simultaneously collected on rayon-tipped swabs from patients with symptoms of pharyngitis. Each swab was first inoculated to a 5% sheep blood agar plate, then tested for group A streptococcus antigen using the TestPack Strep A according to the manufacturer's instructions. Cultures were incubated anaerobically at 35 degrees C for 2 nights unless positive after 1 night. Group A streptococci were identified using specific antisera. Pediatric office or laboratory cultures from 112 (31.3%) of the 358 patients contained group A streptococci. Of the patients with positive cultures, 96 (85.7%) and 107 (95.5%) were detected by the pediatricians and laboratory, respectively. Respective findings with the TestPack Strep A by the pediatricians and laboratory were sensitivity 68.8% and 74.8%, specificity 94.3% and 95.6%, predictive value of a positive result 81.5% and 87.9%, and predictive value of a negative result 89.2% and 89.9%. Anaerobic culture was significantly more sensitive than the TestPack Strep A for detection of group A streptococci by both the pediatricians (P less than 0.005) and laboratory personnel (P less than 0.05).

Adolescent↗

PubMed1999

Minimum standards in laboratories for infection control.

Laboratory services should be available to support every infection control programme, whether in a hospital or community setting. The services will depend upon available resources and the expectation of the clinicians using the services. Equally, resources reflect the level of staff expertise, equipment and finances supporting laboratory practice. All information given to the clinical staff should be sensible, accurate, comprehensible and in keeping with the clinical needs of the healthcare setting. Internal and external quality controls should be rigorous. Not all laboratories are expected to provide an all-encompassing service and therefore primary, secondary and tertiary or referral laboratories should be established where necessary. It is essential to have clear protocols on laboratory usage, mutually agreed between the laboratory and clinical staff to be cost effective.

Guidelines as Topic↗

PubMedDate not supplied

Emergency physicians versus laboratory technicians: are the urinalysis and microscopy results comparable? A pilot study.

In the literature to date, there are no studies that directly evaluate microscopic urine examination results obtained by a physician compared to those of a trained laboratory technician. Our purpose in undertaking this study was to determine whether there would be comparable results obtained by these two groups. The study took place in an Emergency Medicine Department with 45,000 visits annually. Each urine sample obtained on patients presenting to the Emergency Department was divided into two lots: one was sent to the laboratory and the other was analyzed by the emergency physician. A comparison of both dipstick and microscopic results by physician and laboratory staff was then made using sensitivity, specificity, and Kappa analysis. Statistical analysis of the data revealed close agreement between the emergency physician and laboratory technician with respect to the following components of urinalysis: red blood cell urinalysis and microscopy, leukocyte esterase, and nitrite testing. Microscopy for white cells and bacteria and testing for proteinuria were not in close agreement. Urinalysis by emergency physicians is comparable to laboratory technicians for a number of the testing components. However, in this limited pilot study, emergency physicians were not able to consistently perform urinalysis for the laboratory standard.

Adolescent↗

PubMed2003

Quality management in the ART laboratory.

Unlike most medical laboratories that play a diagnostic role, laboratories for assisted reproductive technologies, ART laboratories, are involved in the treatment of infertile couples. Handling human gametes and producing human embryos in order to achieve much-sought pregnancies form the key tasks of an ART laboratory. The impact of the activities and the possible risks makes it necessary to ensure the safety and reproducibility of all methods. To achieve and maintain the highest level of patient care and the highest success rates, a quality management system should be implemented. Several guidelines, compiled by professional associations of ART experts, official international standards and quality management models have been developed and issued and can be applied. Irrespective of the choice, establishing a quality management system in an ART laboratory leads to a huge amount of additional work and requires a lot of investment in all kind of areas. However, due to the increased standardization and efficiency of all procedures as well as the improved transparency and traceability of all actions performed, the quality of service provided by the laboratory will improve substantially and the effort will be worthwhile.

Humans↗

PubMed2003

Total quality improvement in the IVF laboratory: choosing indicators of quality.

The purpose of this paper is to describe a programme of total quality improvement (TQI) within the IVF laboratory and to provide specific examples of indicators that could be used in such a TQI programme. Although TQI is sometimes confused with quality control (QC) and quality assurance (QA), there are major differences between the three quality plans: (i) QC is an activity designed to ensure that a specific element within the laboratory is functioning correctly; (ii) QA is a comprehensive programme designed to looks at a laboratory as a whole and to identify problems or errors that exist in an attempt to improve the entire process; (iii) TQI is also a comprehensive monitoring process designed not only to detect and eliminate problems, but also to enhance a laboratory's performance by exploring innovation and developing flexibility and effectiveness in all processes. Indicators used in a TQI plan should be objective, relevant to the laboratory, and measure a broad range of specific events or aspects of treatment that reflect the quality of care. Threshold values for each of the indicators should be based on how the specific protocols used in the laboratory impact the outcomes and the nature of the indicators on quality of care.

Fertilization in Vitro↗

PubMed2001

No effect of a parasite on reproduction in stickleback males: a laboratory artefact?

Experiments are often carried out in the laboratory under artificial conditions. Although this can control for confounding factors, it may eliminate important factors that under natural conditions mediate the interaction under investigation. Here, we show that different results can be gained in the field and in the laboratory regarding host-parasite interaction. In the field, courting three-spined stickleback males, Gasterosteus aculeatus, were less often infected with plerocercoids of a cestode tapeworm, Schistocephalus solidus, than shoaling males. However, when a random sample of males was allowed to nest and court females in individual aquaria in the laboratory, both uninfected and infected males built nests and courted females. Moreover, while the few infected males that courted females in the field expressed less red nuptial coloration than uninfected courting males, there was no difference in redness between infected and uninfected males in the laboratory. We argue that the different results gained in the field and in the laboratory are due to differences in the cost of reproduction, due to differences in the resource pool of the males. The favourable conditions in the laboratory exclude factors such as predation risk, social interactions, and fluctuating environmental conditions that may use up resources in the field and mediate the effect of the parasite.

Animals↗