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PubMed1993

Good laboratory practice and laboratory accreditation.

Principles of good laboratory practice (GLP) and laboratory accreditation programs, particularly as they pertain to the environmental sector, are reviewed. The multitude of programs is proving costly for many laboratories and there is mounting pressure to develop reciprocity agreements between programs and to consolidate nationally and internationally. Inclusion of GLP and laboratory accreditation requirements in government regulations is resulting in a significantly increased number of laboratories participating in these programs.

Accreditation↗

PubMed1997

Medicare, Medicaid, and CLIA programs; clinical laboratory requirements--extension of certain effective dates for clinical laboratory requirements under CLIA--CDC, HCFA. Final rule with comment period.

This final rule extends certain effective dates for clinical laboratory requirements in regulations published on February 28, 1992, and subsequently revised December 6, 1994, that implemented provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA). This rule extends the phase-in date of the quality control requirements applicable to moderate and high complexity tests and extends the date by which an individual with a doctoral degree must possess board certification to qualify as a director of a laboratory that performs high complexity testing. These effective dates are extended to allow the Department additional time to issue revised quality control requirements and to ensure laboratory directors are able to complete certification requirements. These effective date extensions do not reduce the current requirements for quality test performance.

Centers for Disease Control and Prevention, U.S.↗

PubMedDate not supplied

Impact on human resources: Core Laboratory versus laboratory information system versus modular robotics.

Technological advances in laboratory systems have had a great impact on human resources. Surviving the changes requires an in-depth understanding of the technology to implement the appropriate operational model. St. Mary's is a 414-bed, acute care hospital. For 18 months, the laboratories went through the process of moving from a noncomputerized traditional model laboratory (i.e., by discipline) to a fully computerized Core Lab. The Core Lab concept fully integrates biochemistry, hematology, blood bank, and microbiology into two sections (not physically separated): tests processed by automation and tests processed manually. This approach led to a 15% reduction in staff while the volume doubled. The transitions occurred sequentially: from traditional laboratory to Core Lab (noncomputerized), from manual Core Lab to fully computerized Core Lab, and ultimately from a simulation of manual preanalytical phase to automated preanalytical phase (modular robotics). The findings show that Core Lab and computerization have almost the same impact on human resources, 35% and 30% respectively, and modular robotics the least impact with 17%.

Clinical Laboratory Information Systems↗

PubMed1989

Polymorphism of T-cell receptor genes among laboratory and wild mice: diverse origins of laboratory mice.

Southern blots of genomic DNA from 23 strains of laboratory mice and 19 individual wild mice were examined for restriction fragment length polymorphisms in their loci encoding the T-cell receptors (Tcr): the constant regions of the alpha, beta, and gamma chains (C alpha, C beta, and C gamma) and a variable region family of the beta chain (V beta 8). Only a few polymorphisms were observed for each locus in the laboratory mice after using three restriction enzymes, Bam HI, Eco RI, and Hind III. All the laboratory mice examined fall into one of two types for the C alpha, C beta, and V beta 8 loci and one of three types for the C gamma. These types are found in some of the wild mice studied, indicating that they were already present in the founder mice of laboratory mouse strains. In contrast, the Tcr genes are highly polymorphic among wild mice. Analysis of the polymorphisms in these loci suggests that laboratory mice have inherited their genes not only from Mus musculus domesticus, but also from other subspecies, and much more than previously believed from Asian subspecies.

Animals↗

PubMed2002

[Age dependence of laboratory parameters in a health study--attempt at calculating a laboratory index for assessing biological aging].

The laboratory analyses of 404 participants of the health study GUNDULA, 201 men and 203 women between 30 and 80 years old, were performed to evaluate the variables for the determination of biological age. From the more than 70 laboratory variables resulting from clinical-chemical and hematologic tests and from urinalysis, less than 40 are significantly age-dependent. About half of these variables were examined by regression analysis to evaluate whether they are useful for the estimation of biological age by a laboratory index. Considerable sex differences were observed. The laboratory indexes for the participants altogether (resulting from 13 parameters) and separated for women (10 parameters) and men (8 parameters) show more variations than the biological age estimated by non-invasive parameters. In men only, there exists a significant but inverse correlation between laboratory index and relative aging rate, the difference between biological and chronological age. The results of some striking variables (e.g. dehydroepiandrosterone sulfate and others) and the results of an explorative factor analysis with regard to possible interconnections between variables and chronological age will be discussed.

Adult↗

PubMed2004

Physician survey of a laboratory medicine interpretive service and evaluation of the influence of interpretations on laboratory test ordering.

CONTEXT: Complex coagulation test panels ordered by clinicians are typically reported to clinicians without a patient-specific interpretive paragraph. OBJECTIVES: To survey clinicians regarding pathologist-generated interpretations of complex laboratory testing panels and to assess the ability of the interpretations to educate test orderers. DESIGN: Surveys were conducted of physicians ordering complex coagulation laboratory testing that included narrative interpretation. Evaluation of order requisitions was performed to assess the interpretation's influence on ordering practices. SETTING: Physicians ordering coagulation testing at a large academic medical center hospital in Boston, Mass, and physicians from outside hospitals using the academic medical center as a reference laboratory for coagulation testing. OUTCOME MEASURES: Physician surveys and evaluation of laboratory requisition slips. RESULTS: In nearly 80% of responses, the ordering clinicians perceived that the interpretive comments saved them time and improved the diagnostic process. Moreover, the interpretations were perceived by ordering clinicians to help prevent a misdiagnosis or otherwise impact the differential diagnosis in approximately 70% of responses. In addition, interpretations appeared to be able to train the ordering clinicians as to the standard ordering practices. CONCLUSIONS: The results demonstrate physician satisfaction with an innovative information delivery approach that provides laboratory diagnostic interpretation and test-ordering education to clinicians in the context of their daily workflow.

Academic Medical Centers↗

PubMed1986

Delta check system for detection and further management of laboratory errors. Second report. Computer program to identify laboratory errors.

A delta-check system has been introduced for routine work in our laboratory to detect laboratory errors in blood chemistry. All pairs of data that exceed allowable limits were displayed for each item. To easily understand the details, these data were displayed on a graph divided for each analyzer. Looking at this graph the responsible causes were inferred from the number or type of analyzers and from the number of items in which errors were detected. Following this first report, the algorithm involved in the last processes was programmed. When all data derived from analyzers were put into the personal computer, 1) the details of errors were shown separately for each analyzer and item, and 2) presumed causes to be identified finally from the results of confirmative tests were displayed graphically at the same time according to our program. By this system, most of the errors that may happen during the whole course of tests, from the time a laboratory test was ordered until it was interpreted, were detected more rapidly, thoroughly and objectively inside the laboratory before the data were reported to the clinical ward. This system is also regarded as an indispensable base for the development of an accurate interpretation of laboratory data.

Blood Chemical Analysis↗

PubMed1994

DIAG, a laboratory information management system developed for regional animal disease diagnostic laboratories in Indonesia.

The DIAG Laboratory Information Management System is a micro-computerised program designed for the use of regional and national animal disease diagnostic laboratories in Indonesia. It facilitates the day to day management of diagnostic data by monitoring the progress and turn round times of samples sent to laboratory sections and by printing outputs detailing the tests undertaken and results obtained. Notifiable disease reports are generated routinely as part of a national disease surveillance programme. Detailed analyses of specific diagnoses allow investigations of diseases over location and time. The database is easily accessed to allow additional analyses. Data entry is facilitated through the use of entry screens which reduce associated errors. The system is flexible and can readily be adapted to meet the demands of different countries, veterinary services and types of laboratory.

Animal Diseases↗

PubMed1975

Laboratory studies of a lymphocytic choriomeningitis virus outbreak in man and laboratory animals.

Investigation of an outbreak of prolonged febrile illness in medical center personnel at the University of Rochester School of Medicine and Dentistry revealed lymphocytic choriomeningitis (LCM) virus to be the causative agent. Syrian or golden hamsters (Mesocricetus auratus) were found to be the only animals involved in maintaining the virus and were the source of human infections. Isolations of LCM virus were made from autopsy specimens of 13 of 46 (28%) golden hamsters. Virus isolations were made from 22 of 28 (79%) frozen specimens of 11 tumor lines transplanted repeatedly in golden hamster cheek pouches. No virus isolations were made from 86 autopsied laboratory mice, laboratory rats, Chinese hamsters (Cricetulus griseus), or laboratory rabbits or from 10 tumor cell lines transplanted in laboratory mice. Complement-fixation testing of 301 animal sera from the vivarium also revealed involvement primarily of golden hamsters. The probable source of virus introduction into the Rochester facilities was found to be two LCM-contaminated tumor lines sent from a biological supplier to Rochester in 1969.

Animals↗

PubMed1988

Environmental ultrasound in laboratories and animal houses: a possible cause for concern in the welfare and use of laboratory animals.

Many laboratory animals are known to be sensitive to sounds (ultrasounds) beyond the nominal upper limit (20 kHz) of the human hearing range. Sources of sound in laboratories and animal houses were examined to determine the extent of ambient ultrasound. Of 39 sources monitored, 24 were found to emit ultrasonic sounds. Many of these (e.g. cage washers and hoses) also produced sound in the audible range. Running taps, squeaky chairs and rotating glass stoppers created particularly high sound pressure levels and contained frequencies to over 100 kHz. The oscilloscopes and visual display units investigated provided particular cause for concern as they emitted sounds that were entirely ultrasonic and therefore were apparently silent. Ambient ultrasound therefore appears to be common in laboratories and animal houses. It is suggested that its effect on laboratory animals should be investigated and guidelines on acceptable levels be formulated.

Animal Welfare↗

PubMedDate not supplied

[Epidemiology and prevention of tuberculous contamination in bacteriology laboratories. Results of a survey on 23 laboratories].

The authors have carried out a survey of 23 bacteriology laboratories to investigate tuberculous contaminations which took place from 1967 to 1972 in these laboratories. They have reviewed 20 accidents in 74 technicians who performs searches for tuberculous bacilli, and 29 accidents in the total amount of 379 technicians working in these 23 laboratories. A comparison of these results with the previous published investigations shows a rather high number of cases reported in our country. A review of the possible causes of contaminations leads to suspect bacterial aerosols and to put forward the use of laminar flow enclosures as a prevention. The authors have tested several vertical flow instruments built to different patterns. All three convenient enclosures have an architectural characteristic: their blowing ceiling overhangs the working plane. As these instruments have been under examination for three years in a laboratory where contaminations are very likely to happen, they have obtained interesting results.

Adult↗

PubMed2004

[For the improvement of management and assurance in clinical laboratories of education hospitals--from the meeting of clinical laboratory members of public university or college hospitals].

Clinical laboratory members, composed of medical doctors, laboratory technologists and office staff from 8 public university or college hospitals and one medical center, have an annual meeting, in which achievements including tested numbers, income, outsourcing ratio, and so on were reported and various agendas from each institution were discussed. The number of agendas for general discussion and in the technologist division has been increasing, which reflects that variables, including management in clinical laboratories, needing solutions have been increasing. Information obtained through discussion could help in the determination of management and the improvement of education and quality assurance in clinical laboratories.

Clinical Laboratory Techniques↗

PubMed1993

[Perspective for clinical laboratory management and its systematization--effects of the systematization of clinical laboratory management].

There are a large number of ideas concerning the systematization of clinical laboratory management. Therefore many types of laboratory systems have been constructed. As our hospital is not large, we adopted a small scale laboratory system. In introducing it, we expected not only an increase in value-added labor productivity by automating laboratory tests, but also an improvement in technologist's cost awareness. Consequently, new system equipment has itself performed the former in many sections, but not the latter. Improvement in cost awareness was caused by the technologist's routine work in managing reagent and material stocks. We found that this soft-type systematization has been more important than the advanced hard-type system.

Awareness↗

PubMed1997

Guidelines for internal peer review in the cardiac catheterization laboratory. Laboratory Performance Standards Committee, Society for Cardiac Angiography and Interventions.

The Laboratory Performance Standards Committee of the Society for Cardiac Angiography and Interventions has proposed guidelines for establishing an internal peer review program in the cardiac catheterization laboratory. The first step is to establish a committee and a data base. This data base should include quality indicators that reflect: physician qualifications, outcomes of procedures, and processes of care. The outcomes must be risk-adjusted to account for the variable severity of illness. Data should be collected by catheterization laboratory personnel and entered into a laboratory-specific computerized data base. These data must be analyzed and organized into profiles that reflect the quality of care. Based on this information, the Committee would institute the following interventions to improve physician performance: education, clinical practice standardization, feedback and benchmarking, professional interaction, incentives, decision-support systems, and administrative interventions. The legal aspects of peer review are reviewed briefly.

Cardiac Catheterization↗

PubMed2003

Cancer incidence among laboratory workers in biomedical research and routine laboratories in Israel: Part I-the cohort study.

BACKGROUND: Laboratory work is associated with exposure to a mixture of carcinogens. METHODS: The cohort is comprised of 4,300 laboratory workers. Cancer incidence was followed from 1960 to 1997. RESULTS: A total of 230 cases were included in the cohort. The overall cancer standardized incidence ratio (SIR) was 1.04 (0.91-1.18). When a 20-year latency was introduced, SIR was increased significantly: 1.35 (1.13-1.61). Among routine workers and researchers, SIR was elevated significantly for the total population and for women, when a 20-year latency was introduced. SIR was also elevated significantly in research, routine, bacteriology and virology, and isotope laboratories. With respect to specific sites, significantly increased SIR was observed in breast, ovary, and thyroid cancer among women; and prostate cancer, leukemia, and melanoma among men. CONCLUSIONS: We suggest that work in research and biomedical laboratories might involve an increased risk of certain types of cancer. Am. J. Ind. Med. 44:600-610, 2003.

Biomedical Research↗

PubMed1992

Cardiac catheterization laboratory survey: 1990. Society for Cardiac Angiography and Interventions, Laboratory Performance Standards Committee.

A survey of 117 member cardiac catheterization laboratories was undertaken by the Society for Cardiac Angiography and Interventions. The survey included numbers and types of procedures, both diagnostic and interventional, in adult as well as pediatric age groups. Radiation safety, various laboratory policies, frequency of short stay, and outpatient procedures were tabulated. Report generation, training programs, administrative organization, and laboratory equipment were all included. The results were compared with a 1978 survey. Areas of concern in terms of safety of the patient and possible underutilization of laboratories were identified.

Angioplasty, Balloon, Coronary↗

PubMed1989

Cardiovascular responses in the laboratory and in the natural environment: is blood pressure reactivity to laboratory-induced mental stress related to ambulatory blood pressure during everyday life?

Cardiovascular activity recorded at rest and during mental stress in the laboratory was studied in relation to ambulatory recorded cardiovascular activity at work and at home. Fifty-five Type A men (M = 42.4 years) underwent a standardized laboratory mental stress protocol in which systolic blood pressure, diastolic blood pressure, and heart rate were recorded at baseline and during a 15 min mental arithmetic task (MAT). On a subsequent day, ambulatory blood pressure and heart rate were recorded at 20 minute intervals for 12-14 hr during normal activities at home and at work. Subjects completed a behavioral diary concurrently with each cuff inflation. High and Low groups were identified based upon a median split of their cardiovascular response levels at baseline and during the MAT. Subjects with high systolic blood pressure levels during the MAT had high systolic blood pressure at home, at work, during physical activity, and when they reported being 'stressed'. Baseline systolic blood pressure in the laboratory was less consistently related to ambulatory systolic pressure across ambulatory conditions. Diastolic blood pressure at baseline was related to ambulatory diastolic blood pressure at work, at home, and when resting. Diastolic blood pressure during the MAT was associated with higher diastolic pressure at work and at home. Heart rate at baseline and during the MAT was related to heart rate at work and during physical activity. Change scores derived by subtracting mean values during the MAT from baseline resting levels were not associated with ambulatory blood pressures or heart rates under any daily conditions. In the best case, systolic blood pressure measured during the MAT was related to systolic blood pressure during physical activity, to systolic blood pressure and heart rate during mental stress, to systolic and diastolic blood pressure at rest, and to systolic blood pressure and heart rate at work but not at home. We conclude that levels of blood pressure and heart rate measured in the laboratory, but not reactivity (i.e, change scores) during the MAT, are related to blood pressure and heart rate levels recorded in the natural environment, especially in the work setting.

Activities of Daily Living↗

PubMed1988

Information for decision makers at hospital laboratory level: an example of a graphical method of representing costs and effects for a replacement automated technology in a haematology laboratory.

The costs and effects on patient management following the introduction of a fully automated blood count analyser have been evaluated for a hospital haematology laboratory in England, during 1985. In the case of the relatively high throughput observed in the laboratory studied, the automated technology was judged to be cheaper if considering laboratory-centred costs alone. But this was no longer necessarily the case once wider costs, including extra medical workload generated for hospital and community physicians, were included. Effects on patient management were measured for all types of patient, including hospital in-patients, out-patients and general practice patients. A graphical method allowing comparison of the costs and effects of the replacement automated system, termed a Technology MAP (Management Awareness Profile) is presented in the paper. MAPs provide a flexible information display which can be tailored to an individual laboratory's situation producing an overall picture of expected costs and effects on patient management following the introduction of a new technology--a full value-in-use assessment. The authors argue that there is a need for a central source of such value-in-use assessments, especially for new medium-priced diagnostic technologies which are likely to become widely spread in Britain.

Blood Cell Count↗