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Modular workcells: modern methods for laboratory automation.

Laboratory automation is beginning to become an indispensable survival tool for laboratories facing difficult market competition. However, estimates suggest that only 8% of laboratories will be able to afford total laboratory automation systems. Therefore, automation vendors have developed alternative hardware configurations called 'modular automation', to fit the smaller laboratory. Modular automation consists of consolidated analyzers, integrated analyzers, modular workcells, and pre- and post-analytical automation. These terms will be defined in this paper. Using a modular automation model, the automated core laboratory will become a site where laboratory data is evaluated by trained professionals to provide diagnostic information to practising physicians. Modem software information management and process control tools will complement modular hardware. Proper standardization that will allow vendor-independent modular configurations will assure success of this revolutionary new technology.

Automation↗

Investigation of Laboratory cross-contamination of Mycobacterium tuberculosis cultures.

Many clinicians and laboratory personnel are unaware that a culture positive for Mycobacterium tuberculosis may represent contamination. Laboratory cross-contamination with the M. tuberculosis laboratory control strain (H37Ra) occurs infrequently and therefore demands heightened awareness and recognition. We report 3 occurrences of laboratory cross-contamination from the same laboratory. These occurrences illustrate the importance of interpreting laboratory results in conjunction with the patient's clinical presentation. Failure to recognize laboratory cross-contamination with M. tuberculosis leads to both erroneous administration of unnecessary medications and expenditure of resources required to conduct contact investigations.

Adult↗

Implementation of a quality systems approach for laboratory practice in resource-constrained countries.

Under the direction of the US Global AIDS Coordinator's Office, Department of Health and Human Services, the CDC Global AIDS programme helps resource-constrained countries to address the global HIV/AIDS pandemic. Activities include laboratory capacity and laboratory infrastructure development in 25 resource-constrained countries. Medical practitioners and public health programme leaders in industrialized countries rely on the use of quality laboratory data for evidence-based medical decision-making to determine policy for the implementation of disease control measures, to monitor disease to determine the impact of control programmes, and to support surveillance activities. In these countries, laboratory data to support decision-making processes have a level of quality attributable to laws, regulations and guidelines developed over many years. However, resource-constrained countries have not had similar experiences. Few countries have developed laws, regulations or guidelines, nor is there a data-use culture (e.g. evidence-based medicine) for those in the decision-making environment in resource-constrained countries. The strengthening of laboratory capability and capacity in resource-constrained countries is an important goal to improve accurate and reliable data for the diagnosis, treatment and monitoring of disease.A process for the implementation of a quality systems approach for a laboratory is presented: (i) acknowledgement of the need to improve the laboratory programme in the country at the Ministry of Health and at all decision-making levels within the provinces/states of the country; (ii) assessment of capabilities, capacities, infrastructure, and training needs; (iii) implementation of a national meeting of laboratorians; (iv) designation of a national Quality Assurance Office and leadership within that office; (v) the development and provision of technical training.

Developing Countries↗

Prospective study of laboratory-animal allergy: factors predisposing to sensitization and development of allergic symptoms.

In a prospective study of laboratory technicians, selected indicators of allergy and atopy were studied in an attempt to determine predictors of laboratory-animal allergy (LAA). Laboratory technicians underwent spirometry, methacholine provocation tests, and blood sampling, and responded to a questionnaire during training and after 2 years' work. Among 38 laboratory-animal-exposed subjects, total IgE before exposure gave the best correlation (P < 0.01; Mann-Whitney U-test) to reported symptoms caused by laboratory animals (n = 8) at follow-up. The prevalence of atopy and allergic symptoms had increased in exposed technicians at follow-up, but this was also found among unexposed matched referents (n = 36 pairs). One subject in the exposed group reported asthma before exposure, compared with seven at follow-up (P < 0.05; Fisher's exact test). However, the prevalence of asthma had increased from two to six (not significant) also among unexposed technicians. There were no significant differences between the groups in any measured variable at follow-up. Among 43 subjects who later worked with laboratory animals, 21% had a positive skin prick test for common allergens, as compared with 37% among 112 without animal exposure (P = 0.06; chi2 test), suggesting selection for laboratory animal work.

Adolescent↗

Laboratory technologists' attitudes towards AIDS and AIDS patients.

The purpose of this study was to examine the attitudes of laboratory staff towards AIDS and AIDS patients and related factors. The population consisted of the working-age laboratory technologists living in Finland (n = 5,973). A sample of 249 laboratory technologists was selected from the register of the National Research and Development Centre for Welfare and Health using systematic random selection. The material was collected with a questionnaire. The younger laboratory technologists had more knowledge about AIDS than the older ones, and those who had more knowledge about AIDS had a more positive attitude than those with less knowledge. The attitudes were connected with the way the disease was contracted: the most positive attitudes were expressed towards the patients who had contracted AIDS through blood transfusion and the most negative towards the patients who had contracted AIDS from non-sterile needles. The factor analysis yielded six factors representing attitudes. The fear factor explained most (19%) of the laboratory technologists' attitudes towards AIDS and AIDS patients. The older laboratory technologists were more afraid of work-related infections than the younger ones. The laboratory technologists with adequate knowledge of AIDS were less afraid of contracting the virus than those with little knowledge. They wanted information mainly on the care of AIDS patients, on how to respond to them and on the ways AIDS is transmitted.

Acquired Immunodeficiency Syndrome↗

Survey of safety and health care in British medical laboratories.

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

Accident Prevention↗

Evaluation of vocabularies for electronic laboratory reporting to public health agencies.

Clinical laboratories and clinicians transmit certain laboratory test results to public health agencies as required by state or local law. Most of these surveillance data are currently received by conventional mail or facsimile transmission. The Centers for Disease Control and Prevention (CDC), Council of State and Territorial Epidemiologists, and Association of Public Health Laboratories are preparing to implement surveillance systems that will use existing laboratory information systems to transmit electronic laboratory results to appropriate public health agencies. The authors anticipate that this will improve the reporting efficiency for these laboratories, reduce manual data entry, and greatly increase the timeliness and utility of the data. The vocabulary and messaging standards used should encourage participation in these new electronic reporting systems by minimizing the cost and inconvenience to laboratories while providing for accurate and complete communication of needed data. This article describes public health data requirements and the influence of vocabulary and messaging standards on implementation.

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

A comparison of interactive videodisc instruction with live animal laboratories.

This study compared interactive videodisc-simulated laboratories with two types of traditional labs: a traditional general cardiovascular physiology participation lab and a traditional fibrillation/positive pressure ventilation demonstration lab. The two laboratory sections (a total of 85 first-year veterinary medical students) were divided into 12 lab groups of 3-4 students per lab section. These groups were randomly assigned to either a traditional live animal laboratory or an interactive videodisc-simulated laboratory to compare the effectiveness and efficiency of these methods in teaching physiology. A 22-item, multiple-choice/short answer test was given to all students after the laboratories. In both the participation and the demonstration laboratories, there were no significant differences between group test scores of the interactive videodisc groups and the live animal laboratory groups, but there were differences in time spent by both students and instructors. It was concluded that the interactive videodisc-simulated lab was as effective as the traditional live-animal labs and was more time efficient than the traditional participation lab.

Animals↗

Risk factors for increased airway responsiveness to methacholine challenge among laboratory animal workers.

As a first step in a prospective study of the incidence of asthma to laboratory animals, a group of 364 adults 18 to 48 yr of age who were beginning employment with laboratory animals were evaluated in terms of their past history, health status, allergy, and airway responsiveness to methacholine. At entry to the study, 269 had previous occupational contact with animals, 109 had chest symptoms in the previous year, 168 had a history of allergic symptoms to laboratory animals (any with asthmatic responses were systematically excluded), and 118 had positive immediate skin tests (29 had positive skin tests to laboratory animals). When defined as a PD20FEV1 of 80 breath units or less, 18.4% of these young adults had methacholine hyperresponsiveness (HRA). Significant risk factors for HRA were found to be younger age, female sex, lower educational level, a history of allergic symptoms to laboratory animals, and a history of chest symptoms. Positive skin tests to laboratory animals were present in 8% of workers; this was not a significant risk factor for HRA although positive skin tests to pollen and household allergens were. Previous work experience was a risk factor, especially among those with allergic symptoms, and a trend toward self-selection was suggested in that the rate of HRA was lowest in workers with more than 2 yr of experience or with two or more previous jobs with laboratory animals.

Adolescent↗

Protein S assays: an analysis of North American Specialized Coagulation Laboratory Association proficiency testing.

To assess current laboratory practice and the performance of different reagent-instrument combinations for protein S testing, protein S results from the North American Specialized Coagulation Laboratory Association (NASCOLA) proficiency testing surveys for 2002 and the first half of 2003 were analyzed. A written survey of NASCOLA laboratories also was performed to further assess current laboratory practices for protein S testing. The free protein S antigen assays and the Diagnostica Stago Staclot protein S assay were extremely accurate in detecting a heterozygous type I protein S deficiency. Another functional protein S assay and most total protein S assays were less reliable, depending to some extent on the instrument. All assays used by NASCOLA laboratories appropriately identified normal protein S specimens. NASCOLA laboratories performed at least as well as European Concerted Action on Thrombosis laboratories in the proficiency tests. The results suggest that the diagnosis of heterozygous protein S deficiency may be problematic with some currently available assays. Many total protein S antigen assays do not add to the diagnosis and can be unreliable for protein S deficiency subtyping. Better standardization of functional and antigenic assays is needed.

Biological Assay↗

External Quality Assessment: an effective tool for Clinical Governance in laboratory medicine.

The implementation of Clinical Governance will require a redefinition of duties and accountability as a prerequisite to develop and achieve an overall improvement in clinical care through a culture of assessment and monitoring of quality. External Quality Assessment Schemes (EQAS) are the main tool enabling laboratories to measure the quality of their results; they must carefully assess and monitor all elements contributing to the formulation of laboratory information (results, reference ranges/decisional levels, interpretative comments and diagnostic algorithms). There are different ways to design and manage a Scheme and EQAS coordinators are mainly responsible for its effectiveness. The present paper reports, as an example, some experiences of the Centre of Biomedical Research (CRB), which manages EQAS according to high quality specifications and laboratories' needs, that can reflect the Clinical Governance philosophy. Our findings show that EQAS are able to control all the above aspects and, if organisers are committed to fulfilling the responsibility and accountability principles, they will be of great value in quality assessment and in developing an External Quality Assurance Program (EQAP). This is an inter-laboratory comparison designed and conducted to assure the following: evaluation of participants' performance (by evaluating not only analytical performance, but also test interpretation, and advice for clinicians on laboratory requests and diagnosis); evaluation of method performance; and continuous education, training and help. The main aim of the activities of an EQAP in Laboratory Medicine is to sustain improvements in the quality of services provided by participating laboratories for the benefit of patients.

Clinical Laboratory Techniques↗

Implementation of a point-of-care satellite laboratory in the emergency department of an academic medical center. Impact on test turnaround time and patient emergency department length of stay.

CONTEXT: Emergency department (ED) overcrowding has reached crisis proportions in the United States. Many hospitals are seeking to identify process reengineering efforts to reduce crowding and ED patient length of stay (LOS). OBJECTIVES: To investigate the impact of a point-of-care testing (POCT) satellite laboratory in the ED of a large academic medical center. SETTING: The ED of the Massachusetts General Hospital, Boston, Mass. DESIGN AND OUTCOME MEASURES: Evaluation of physician satisfaction, turnaround time (TAT), and ED LOS before and after implementation of a POCT laboratory. ED LOS was measured by patient chart audits. TAT was assessed by manual and computer audits. Clinician satisfaction surveys measured satisfaction with test TAT and test accuracy. RESULTS: Blood glucose, urine human chorionic gonadotropin, urine dipstick, creatine kinase-MB, and troponin tests were performed in the ED POCT laboratory. Test TAT declined an average of 87% after the institution of POCT. The ED LOS decreased for patients who received pregnancy testing, urine dipstick, and cardiac markers. Although these differences were not significant for individual tests, when the tests were combined, the decreased LOS was, on average, 41.3 minutes (P =.006). Clinician satisfaction surveys documented equivalent satisfaction with test accuracy between the central laboratory and the POCT laboratory. These surveys also documented dissatisfaction with central laboratory TAT and increased satisfaction with TAT of the POCT program (P <.001). CONCLUSIONS: The POCT satellite laboratory decreased test TAT and decreased ED LOS. There was excellent satisfaction with test accuracy and TAT.

Academic Medical Centers↗

A comparison of results from two mycology laboratories for the diagnosis of onychomycosis: a study of 85 cases in a geriatric population.

An investigative study was performed to compare the results from two mycology laboratories for the diagnosis of onychomycosis in a geriatric population and to determine the possible pharmacologic treatments based on the two laboratories' results. In this study, 85 cases of suspected onychomycosis involving men and women 65 years and older from a nursing home setting in South Florida were used. Samples were taken from the hallux toenail and sent to two different mycology laboratories for fluorescent potassium hydroxide preparation and microscopic examination of a fungal culture. Of the 85 cases studied, the two mycology laboratories reported similar potassium hydroxide preparation results for 58.8% of the patients and similar fungal culture results for genus and species identification for 37.6% of the patients. When the potassium hydroxide preparation and fungal culture results were combined, the two mycology laboratories reported similar results for only 27.1% of the patients. As a result of the two mycology laboratories' findings, the possible US Food and Drug Administration-approved pharmacologic treatments may differ for 43.5% of the patients studied. The discrepancy between the two independent laboratories leaves physicians to question the reproducibility of fluorescent potassium hydroxide preparation and fungal culture analysis in a geriatric patient population for the diagnosis of onychomycosis.

Aged↗

Attrition in a clinical laboratory technician associate degree program.

OBJECTIVE: To determine the reasons for attrition in a clinical laboratory technician-associate degree program, a retrospective study was done on classes entering from 1987 to 1992. Suggestions are made to increase retention. SETTING: The medical laboratory department at the Community College of Philadelphia in Pennsylvania. PRACTICE DESCRIPTION: There were 43,987 students enrolled for the 1993 to 1994 academic year; 17,846 full time equivalents at the college. Clinical laboratory technician students averaged 26.2 years and were 26% male and 74% female, which closely paralleled the college. The ethnic make-up of the clinical laboratory technician classes was 54% White, 32% African American, 11% Asian, and 3% Latin American, compared to 48% African American, 36% White, 10% Asian, and 6% Latin American students in the college. PRACTICE INNOVATION: A retrospective study was performed to evaluate attrition rates for the classes entering the clinical laboratory technician program at the Community College of Philadelphia from 1987 to 1992. Reasons for this attrition were tabulated and evaluated. RESULTS: One hundred twenty-nine students entered the program and 75 graduated, producing an attrition rate of 42%. There were 6 categories of reasons given for not completing the program: academic difficulties, dislike of the laboratory science field, family problems, financial problems, substance abuse, and other problems not specified. CONCLUSION: Because 80% of the attrition was due to poor academic performance and a dislike of the field, several changes are being made in the Community College of Philadelphia's retention program. An enhanced orientation will be given to all students, and students will be required to visit a hospital laboratory. Early faculty intervention and peer counseling for students with poor academic performance will be instituted.

Adult↗

Specific list for categorization of laboratory test systems, assays and examinations by complexity--PHS. Notice with comment period.

The Clinical Laboratory Improvement Amendments of 1988, Public Law 100-578, requires that the Secretary provide for the categorization of specific laboratory test systems, assays and examinations by level of complexity. 42 CFR 493.17, published in the Federal Register on February 28, 1992 established criteria for such categorization. It is the Department's intention to complete the categorization of all currently available clinical laboratory test systems, assays and examinations prior to the effective date of 42 CFR 493 (September 1, 1992). This notice announces the second of a series of lists containing specific clinical laboratory test systems, assays and examinations, categorized by complexity. This notice also includes deletions and corrections to the list of test systems, assays and examinations published on February 28, 1992. Additional lists of test systems, assays and examinations as well as deletions and corrections will be published periodically. On or before September 1, 1992, a complete list of all laboratory test systems, assays and examinations, categorized by complexity, will be published in the form of a compilation of these Notices. Any clinical laboratory test system, assay or examination that is not on that final list will be considered high complexity, until categorized otherwise as provided under 42 CFR 493.17. After publication of the compilation, applications will be taken to categorize (or recategorize) other laboratory test systems, assays and examinations following the procedures delineated in 42 CFR 493.17(d). After September 1, 1992, notices will be published periodically in the Federal Register to announce any additional test system, assay or examination that has been categorized (or re-categorized) during the preceding interval.

Autoanalysis↗

Reproductive laboratory technology: an alternative career.

OBJECTIVES: Define the job description for reproductive laboratory technologist (RLT); describe the RLT laboratory setting; identify education level and certification of the respondents; establish level of job satisfaction and job security; determine if certification and position affect performance and job satisfaction; compare RLT job with any previous clinical laboratory position; and document education and training important for the position. SURVEY INSTRUMENT: A questionnaire was developed with questions targeted to answer objectives. SURVEY POPULATION: The questionnaire was mailed to a random sample of 300 non-physician members from the Reproductive Biology Professional Group and the Reproductive Laboratory Technology Group from membership lists provided by the American Society for Reproductive Medicine. STUDY POPULATION: 81 survey respondents. RESULTS: RLTs are mostly college-educated, certified and non-certified laboratory professionals, trained on the job for specialty work in andrology and assisted reproductive technology (ART). Position, but not certification, correlate with job performance and job satisfaction. Respondents describe the position of RLT as stressful, but very interesting, exciting, fulfilling, and secure. Respondents with previous clinical laboratory experience rated level of job satisfaction higher for the reproductive laboratory. The CLS curriculum is an excellent background for RLT. CONCLUSIONS: RLT is an exciting career alternative for CLSs. Newly formed laws and regulations, and the demand for more stringent regulation, will continue to increase the demand for certified CLSs for this position. Formal education and certification requirements are anticipated for RLT. The specialty is being incorporated in CLS training programs.

Career Choice↗

[Is the general practice laboratory medically and economically valuable?].

UNLABELLED: Between 1998 and 2000 we evaluated the office-based laboratory activities of general practitioners. The aim was to clarify whether there is a medical and economic benefit of these activities. METHODS: The study was performed in four parts: I. A cross-sectional study with a random sample of general practitioners of the German and French speaking part of Switzerland. II. A prospective evaluation of the office-based laboratory activities of 56 GP's. III. A cross-sectional study of the preference of 837 patients in 52 of GP's offices. IV. A consensus panel with nine experts using the RAND method. RESULTS: 1999 there were 55.4 Million laboratory tests ordered by GP's (excl. pediaters) of which 78.9% were analysed in the office-based laboratory. The probability of a second visit is reduced by 60%, if all of the tests could be performed in the office-based laboratory. 85% of the patients appreciate the possibility to discuss the test results within the same consulation. In the consensus panel, 43 tests were proposed of which only bicarbonate, chloride and urea were assessed as not useful for the office based laboratory. CONCLUSION: The office-based laboratory is a well embodied institution in Switzerland. It's predominant advantage is the possibility of point of care testing. It allows a quick management of the patient and avoids unnecessary second consultations.

Adult↗

Suspected cutaneous anthrax in a laboratory worker--Texas, 2002.

On March 6, 2002, CDC's National Institute for Occupational Safety and Health (NIOSH) received a request for a health hazard evaluation from the director of Laboratory A to assist in the evaluation of a worker who had been diagnosed with cutaneous anthrax. Laboratory A, a provisionally approved Laboratory Response Network level B laboratory, had been processing environmental samples for Bacillus anthracis in support of CDC investigations of the bioterrorist attacks in the United States during fall 2001. Since March 7, CDC has interviewed the ill laboratory worker and other workers at the laboratory and conducted environmental assessments of the workplace. This report summarizes the epidemiologic and environmental investigation of this case, which indicates that the likely source of exposure was the surface of vials containing B. anthracis isolates that the worker placed in a freezer on March 1. Laboratory workers handling specimens of B. anthracis should follow recommended procedures to minimize the risk of B. anthracis transmission and anthrax.

Anthrax↗