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PubMedDate not supplied

The Häma-COM laboratory data management system (LDS): tailor-made computerization of the individual working procedures arising in a hematology laboratory with a high throughput of pathologic samples.

A laboratory data management system (Häma-COM) is presented that is individually adaptable to the different working procedures arising in a hematology laboratory. The Häma-COM can be easily integrated into a hospital and/or another laboratory computer system, providing the facilities of total electronic data transfer between the referring institutions and the laboratory. The system is based on a network of personal computers running Novell Network software and coordinates two hematology analyzers (NE-8000, R-1000) and several microscopic work stations. The entire information provided by the hematology analyzers including scatterplots and histograms is captured by the system, whereby automated results are validated and worklists for further sample workup are created. Corrections of and/or additions to automated analysis results might be directly entered into the system from the respective microscopic working places. The Häma-COM system minimizes the administrative workload without interfering with the individual laboratory organization.

Blood Cell Count↗
PubMed1986

Infection of laboratory workers with hantavirus acquired from immunocytomas propagated in laboratory rats.

Hantavirus has been isolated in cell culture from rat immunocytomas used and stored at a research laboratory in the U.K. where there was evidence of a laboratory-acquired infection leading to haemorrhagic fever with renal syndrome. Both transplantation into LOU/M/Wsl rats and storage of passaged immunocytomas at -70 degrees C over a period of 8-10 years had not eliminated the virus. The isolates were identified as Hantavirus by means of serum obtained from patients with hantavirus infection as well as polyclonal serum derived from laboratory animals. This paper identifies a potential source of hantavirus infection in laboratories. The importing of rats, rat immunocytomas and anti-immunocytoma serum in relation to the potential risks of laboratory-acquired hantavirus infection is discussed.

Animals↗
PubMed1999

Mortality and cancer incidence among laboratory technicians in medical research and routine laboratories (Sweden).

OBJECTIVES: To investigate cancer incidence and mortality among laboratory employees. METHODS: Mortality and cancer incidence were investigated among 2553 female and male laboratory workers employed at the Karolinska Institute and Karolinska Hospital in Stockholm between 1950 and 1989. Mortality was followed from 1952-1993 and cancer incidence from 1958-1992. Expected numbers were based on the general population in Stockholm, standardizing for age, gender, and calendar period. RESULTS: The overall mortality and cancer incidence in the cohort was lower than expected. There were in all 10 cases of hemato-lymphatic malignancies (three acute myeloid leukemias, four non-Hodgkin lymphomas, two Hodgkin's lymphomas, and one multiple myeloma) in the cohort. The standardized incidence ratio (SIR) for hematolymphatic tumors was increased among workers who had ever been employed in laboratories with a high probability for chemical exposure, SIR 224 (95% CI 108-412). The risk of breast cancer among women was increased after more than 10 years of work in high-exposure laboratories, SIR 225 (128-365). The number of malignant melanomas exceeded those expected. CONCLUSIONS: The findings support earlier observations of an increased risk of hematolymphatic cancer among laboratory workers. The routine for handling chemicals and functionality of ventilatory equipment must be under continuous supervision.

Adult↗
PubMed1997

The Pittsburgh Reference Laboratory Alliance: a model for laboratory medicine in the 21st century.

The Pittsburgh Reference Library Alliance (RLA) represents a successful response by hospital laboratories to the new realities of medical economics and practice. By using informatics technology to integrate the laboratory resources of community hospitals and academic medical centers across western Pennsylvania, the RLA has created a large virtual laboratory that can compete for price with large national referral laboratories. More significantly, the combination of medical expertise, the ties to academic and community centers, and the regional medical database of the RLAs allows laboratory medicine to be practiced in a new proactive way. This should provide better and more cost-effective patient care. The success of the RLA is a model for regional cooperation in pathology and potentially in other medical specialties and demonstrates the importance of informatics in the future of medical practice.

Academic Medical Centers↗
PubMed1999

Use of bar code readers and programmable keypads to improve the speed and accuracy of manual data entry in the clinical microbiology laboratory: experience of two laboratories.

AIM: To assess the effect of the use of bar code readers and programmable keypads for entry of specimen details and results in two microbiology laboratories. METHODS: The solutions selected in each laboratory are described. The benefits resulting from the implementation were measured in two ways. The speed of data entry and error reduction were measured by observation. A questionnaire was completed by users of bar codes. RESULTS: There were savings in time and in reduced data entry errors. Average time to enter a report by keyboard was 21.1 s v 14.1 s for bar coded results entry. There were no observed errors with the bar code readers but 55 errors with keystroke entries. The laboratory staff of all grades found the system fast, easy to use, and less stressful than conventional keyboard entry. CONCLUSIONS: Indirect time savings should accrue from the observed reduction in incorrectly entered data. Any microbiology laboratory seeking to improve the accuracy and efficiency of data entry into their laboratory information systems should consider the adoption of this technology which can be readily interfaced to existing terminals.

Consumer Behavior↗
PubMed2004

Methodology in diagnostic laboratory test research in clinical chemistry and clinical chemistry and laboratory medicine.

BACKGROUND: The application of epidemiologic principles to clinical diagnosis has been less developed than in other clinical areas. Knowledge of the main flaws affecting diagnostic laboratory test research is the first step for improving its quality. We assessed the methodologic aspects of articles on laboratory tests. METHODS: We included articles that estimated indexes of diagnostic accuracy (sensitivity and specificity) and were published in Clinical Chemistry or Clinical Chemistry and Laboratory Medicine in 1996, 2001, and 2002. Clinical Chemistry has paid special attention to this field of research since 1996 by publishing recommendations, checklists, and reviews. Articles were identified through electronic searches in Medline. The strategy combined the Mesh term "sensitivity and specificity" (exploded) with the text words "specificity", "false negative", and "accuracy". We examined adherence to seven methodologic criteria used in the study by Reid et al. (JAMA1995;274:645-51) of papers published in general medical journals. Three observers evaluated each article independently. RESULTS: Seventy-nine articles fulfilled the inclusion criteria. The percentage of studies that satisfied each criterion improved from 1996 to 2002. Substantial improvement was observed in reporting of the statistical uncertainty of indices of diagnostic accuracy, in criteria based on clinical information from the study population (spectrum composition), and in avoidance of workup bias. Analytical reproducibility was reported frequently (68%), whereas information about indeterminate results was rarely provided. The mean number of methodologic criteria satisfied showed a statistically significant increase over the 3 years in Clinical Chemistry but not in Clinical Chemistry and Laboratory Medicine. CONCLUSIONS: The methodologic quality of the articles on diagnostic test research published in Clinical Chemistry and Clinical Chemistry and Laboratory Medicine is comparable to the quality observed in the best general medical journals. The methodologic aspects that most need improvement are those linked to the clinical information of the populations studied. Editorial actions aimed to increase the quality of reporting of diagnostic studies could have a relevant positive effect, as shown by the improvement observed in Clinical Chemistry.

Chemistry, Clinical↗
PubMed1992

Clinical Laboratories Improvement Act program; granting and withdrawal of deeming authority to private nonprofit accreditation organizations and of CLIA exemption under state laboratory programs--HCFA. Final rule.

This rule permits HCFA to approve or disapprove accreditation organizations and State laboratory programs and thereby determine that laboratories accredited by a HCFA-approved private, nonprofit accreditation organization are deemed to meet the requirements set forth in 42 CFR part 493 of the regulations, which implement section 353 of the Public Health Service Act (PHSA) or, in the case of State laboratory programs, are exempt from the requirements. Section 353 of the PHSA was enacted by the Clinical Laboratories Improvement Act of 1967 (CLIA '67) and was amended by the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

Accreditation↗
PubMed2000

A national laboratory network for bioterrorism: evolution from a prototype network of laboratories performing routine surveillance.

The need for an enhanced network of laboratories to respond to a bioterrorism attack has been realized. Therefore, the Association of Public Health Laboratories and the Centers for Disease Control are developing a system involving civilian public health and private laboratories that builds on the existing network for routine disease surveillance. It is anticipated that most bioterrorist attacks will not be immediately recognized, so increased laboratory capabilities and communications are necessary. The laboratory network has four categories with different biosafety levels assigned to clearly delineate the correct referral route. Improving communications through World Wide Web-based systems will allow test results, surge capacity, and training and identification algorithms to be shared instantly. There are plans to expand the network to include standard public health surveillance and emerging infectious diseases.

Biological Warfare↗
PubMed2001

[Informed consent for the use of the remaining portion of laboratory specimens for education, research, and quality control of laboratory tests].

The remaining portion of a laboratory specimen is usually used for education, research, and quality control of laboratory tests in hospitals, but informed consent has not been obtained because of the high volume of patients who undergo laboratory tests. However, patients must be informed in some manner. Therefore, we decided to inform patients that any remaining specimen would be used for various purposes by placing such a notice on walls in the central clinical laboratory and hospital lobby. We then obtained a signature on a dissent document, instead of a consent document, from any patient who dissented from such use. This indirect process for obtaining informed consent was approved by the ethics committee of Osaka University Medical School. The number of dissent documents sent in to the director was 54 of about 400,000 patients who underwent laboratory tests over the last 3 years, and there was no complaint against this "informed consent process".

Clinical Laboratory Techniques↗
PubMed2005

Good laboratory practices for waived testing sites: survey findings from testing sites holding a certificate of waiver under the clinical laboratory improvement amendments of 1988 and recommendations for promoting quality testing.

Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), simple, low-risk tests can be waived and performed with no routine regulatory oversight in physicians' offices and various other locations. Since CLIA was implemented, waived testing has steadily increased in the United States. Surveys conducted during 1999-2004 by the Centers for Medicare & Medicaid Services and studies funded by CDC during 1999-2003 evaluated testing practices in sites holding a CLIA Certificate of Waiver (CW). Although study findings indicate CW sites generally take measures to perform testing correctly, they raise quality concerns about practices that could lead to errors in testing and poor patient outcomes. These issues are probably caused, in part, by high personnel turnover rates, lack of understanding about good laboratory practices, and inadequate training. This report summarizes study findings and provides recommendations developed by the Clinical Laboratory Improvement Advisory Committee for conducting quality waived testing. These recommendations include considerations before introducing waived testing, such as management responsibility for testing, regulatory requirements, safety, physical and environmental requirements, benefits and costs, staffing, and documentation. They also cover good laboratory practices for the three phases of testing: 1) before testing (test ordering and specimen collection), 2) during testing (control testing, test performance, and result interpretation and recording), and 3) after testing (result reporting, documentation, confirmatory testing, and biohazard waste disposal). They are intended to be used by those who would benefit from improving their knowledge of good laboratory practices. Continued monitoring of waived testing, with a focus on personnel education and training, is needed to improve practices and enhance patient safety as waived testing continues to increase.

Certification↗
PubMed1988

[Allergies to laboratory animals. An epidemiological, allergological study in persons exposed to laboratory animals].

The nature, frequency and symptoms of laboratory animal allergies (LAA) were explored in 110 persons having contacts with laboratory animals and working in research laboratories at Zürich University Hospital and institutes. 20.9% of these persons were actually suffering from a laboratory animal allergy, a percentage corresponding to international reports in the literature (12-27%). 82.6% of persons with LAA were atopic subjects. In a group without LAA we found an atopic disposition only in 25.3%. The commonest signs of LAA were a combination of rhinoconjunctivitis with bronchial asthma and with contact urticaria in 43.5% over-all. Rats and mice were the laboratory animals most contacted and they represented the largest number of sensitizations. The interval between the beginning of exposure and onset of the symptoms of LAA ranged between a few months and many years. In general, the time space is much shorter in atopic subjects than in non-atopic persons. Skin tests gave better and more precise results in the detection of a LAA than in vitro examinations. This means that investigations with RAST (PHARMACIA) were less sensitive than the prick multitest (STALLERGENES). The last-mentioned can be recommended as very good for serial allergological examinations. The new Phadiatop-test (PHARMACIA)--in the study we obtained positive results in 38.5%--is a sound and most specific examination for discrimination between atopic and non-atopic disposition. Determination of total IgE was of less value.

Adult↗
PubMed1979

Voluntary dental laboratory certification program. Council on Prosthetic Services and Dental Laboratory Relations.

Laboratory certification does not offer concrete guarantees of consistent high quality of products or services. It does, however, identify, for the dental profession, a competency and acceptability factor on which to base a predication of performance by the laboratory. Also, laboratory certification establishes a framework within which the dental laboratory industry can work to continue upgrading its facilities and personnel, demonstrates the concern of certified laboratories for continuing competence, and indicates to government and third-party payers a willingness to develop standards endorsed by the industry.

Certification↗
PubMed1994

Harmonization of good laboratory practice requirements and laboratory accreditation programs.

Efforts to harmonize Good Laboratory Practice (GLP) requirements have been underway through the Organization for Economic Cooperation and Development (OECD) since 1981. In 1985, a GLP panel was established to facilitate the practical implementation of the OECD/GLP program. Through the OECD/GLP program, Memoranda of Understanding (MOU) agreements which foster requirements for reciprocal data and study acceptance and unified GLP standards have been developed among member countries. Three OECD Consensus Workshops and three inspectors training workshops have been held. In concert with these efforts, several OECD countries have developed GLP accreditation programs, managed by local health and environmental ministries. In addition, Canada and the United States are investigating Laboratory Accreditation programs for environmental monitoring assessment and GLP-regulated studies. In the European Community (EC), the need for quality standards specifying requirements for production and international trade has promoted International Standards Organization (ISO) certification for certain products. ISO-9000 standards identify requirements for certification of quality systems. These certification programs may affect the trade and market of laboratories conducting GLP studies. Two goals identified by these efforts are common to both programs: first, harmonization and recognition of requirements, and second, confidence in the rigor of program components used to assess the integrity of data produced and study activities. This confidence can be promoted, in part, through laboratory inspection and screening processes. However, the question remains, will data produced by sanctioned laboratories be mutually accepted on an international basis?(ABSTRACT TRUNCATED AT 250 WORDS)

Accreditation↗
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↗