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PubMed1996

[Radiologic practice and radioprotection in Italian hemodynamic laboratories].

Increasing numbers of diagnostic and therapeutic cardiac catheterization procedures are performed in Italy each year. Radiation exposure of the cardiac catheterization laboratory staff is a known hazard, and there is growing public and professional concern over the risks of low-energy medical ionizing radiation for the patients. The aim of this study was to outline the range of current radiological and radiation protection practice in large-volume cardiac catheterization laboratories in Italy. In August 1994 a questionnaire was submitted to the chief invasive cardiologist of the 32 cardiac catheterization laboratories nation-wide having performed at least 1000 procedures in 1993. All laboratories responded. There were variations in both the radiologic technique (cine framing speed, mean film lengths and fluoroscopy times) and the radiation protection practice (use of shields, leaded collars and glasses, and sites where dosimeters are worn). In 22 of 32 laboratories the cardiologists were not aware of radiation exposure data, and only 6 laboratories could quote the exposure provided by their X-ray system or estimates of the dose absorbed by patients during diagnostic or therapeutic procedures. The results of this survey indicate that radiological practice, and techniques for measuring and reducing exposure of the personnel vary widely in cardiac catheterization laboratories in Italy. These data suggest also that reducing patients' radiation exposure is not, in general, considered to be a quality assurance priority by interventional cardiologists.

Cardiac Catheterization↗
PubMed1996

Laboratory work flow analysis and introduction of a multi-functional analyser.

Laboratory work flow analysis was performed in order to define guidelines for improved laboratory organisation and efficiency. All activities were monitored from the moment a laboratory test was requested until the result was reported and received. Detailed information was collected on numbers of samples and tests, work-stations and sample splitting, number of staff and laboratory costs and management. From the data thus obtained requirements for optimal reorganisation could be developed. Reduction of work-stations appeared to be of primary importance. This could be achieved by replacement of seven different work stations by instruments for multi-functional analysis (Cobas Integra) in the department of routine clinical chemistry. Effects of reorganisation were evaluated by repeated work flow analysis. The multifunctionality of the analysers (photometry, turbidimetry, ion selective electrodes and fluorescence polarisation) provides opportunities for efficient work structuring, avoiding the need for sample splitting, distribution of sub-samples and performing analyses at different work stations. Manual and clerical errors could thus be reduced. Laboratory service to clinicians was improved by reduction of turnaround times to such an extent that all test results are reported within 60 minutes (stat service) even during peak hours. Laboratory costs were reduced by decreasing the number of laboratory staff and work-stations. Both clinicians and patients expressed great satisfaction with the effects of this reorganisation, for which work flow analysis appeared to be an indispensable instrument.

Blood Chemical Analysis↗
PubMed1996

Audit in laboratory medicine.

Laboratory medicine is at a crossroads that provides great opportunities to improve the efficacy of the service and its role in healthcare. Many of the new roles for laboratory staff will be outside the boundaries of the traditional laboratory. These roles include increased emphasis on consultative activities, participation in interdisciplinary teams, and efforts to assure appropriate test utilization. Audit in laboratory medicine may be defined as a process of review and assessment of laboratory performance, and its purpose should be to improve patient care by enhancing laboratory performance and making better use of resources. Here we discuss the rationale of audit in laboratory medicine, its goals as well as its topics. The suggested conduct for an audit and the involvement of personnel are also reviewed.

Laboratories↗
PubMed1997

Total clinical laboratory test volume in Connecticut, 1994-1995.

OBJECTIVE: To measure the volume of clinical laboratory testing in Connecticut during a one-year period. To explore the potential value of such data. DESIGN: Summary and analysis of federal and state clinical laboratory registration/licensure/inspection forms. SETTING: 2,333 clinical laboratory test facilities registered in Connecticut. MAIN OUTCOME MEASURES: The total clinical laboratory output for Connecticut by type of facility and category of technology over a 12-month period. RESULTS: During 1995, 2,333 registered clinical laboratory test facilities performed approximately 65,427,103 analyses in Connecticut. This represents approximately 20 tests per person per year. Thirty-five acute care hospitals performed 59.4%, nine large commercial laboratories 33.2%, 30 small commercial laboratories 1.7%, 1,491 physicians' offices 3.9%, and a miscellaneous group 1% of the tests. Test volumes are further segregated into eight major categories of technology: chemistry 59%, hematology 23.3%, microbiology 5.6%, blood banking 2.9%, coagulation 2.8%, waived tests 2.7%, urine analysis 1.8%, cytology 0.9%, and histology 0.8%. CONCLUSION: For the first time mechanisms are in place to measure essentially all clinical testing for a given area. With minor changes the data collection system could be greatly improved. The possible uses for such a data bank are discussed.

Clinical Laboratory Techniques↗
PubMed1997

Mistakes in a stat laboratory: types and frequency.

Application of Total Quality Management concepts to laboratory testing requires that the total process, including preanalytical and postanalytical phases, be managed so as to reduce or, ideally, eliminate all defects within the process itself. Indeed a "mistake" can be defined as any defect during the entire testing process, from ordering tests to reporting results. We evaluated the frequency and types of mistakes found in the "stat" section of the Department of Laboratory Medicine of the University-Hospital of Padova by monitoring four different departments (internal medicine, nephrology, surgery, and intensive care unit) for 3 months. Among a total of 40490 analyses, we identified 189 laboratory mistakes, a relative frequency of 0.47%. The distribution of mistakes was: preanalytical 68.2%, analytical 13.3%, and postanalytical 18.5%. Most of the laboratory mistakes (74%) did not affect patients' outcome. However, in 37 patients (19%), laboratory mistakes were associated with further inappropriate investigations, thus resulting in an unjustifiable increase in costs. Moreover, in 12 patients (6.4%) laboratory mistakes were associated with inappropriate care or inappropriate modification of therapy. The promotion of quality control and continuous improvement of the total testing process, including pre- and postanalytical phases, seems to be a prerequisite for an effective laboratory service.

Chemistry, Clinical↗
PubMed1997

[Codes and names of clinical laboratory tests and shared interlaboratory databases].

Physicians need to combine and compare laboratory data for one patient results from many laboratories and hospital officers and policy makers also need to merge them form the view point of public health. As there are many different codes used by different sources for the same test, it is impossible to transmit results using electronic massage standards. This problem would not exist if all laboratories used the same universal set of test identifiers. Public use sets of codes and names of clinical laboratory tests are available. We have to select and use them properly. We proposed a project to have a systematizing guideline for laboratory systems not for rationalization of laboratory works but for sharing database to assess appropriate laboratory use.

Clinical Laboratory Information Systems↗
PubMed1997

The nature and extent of training activities in clinical pathology required for effective consultation on laboratory test selection and interpretation.

OBJECTIVE: The goal of this study was to identify the activities in clinical pathology training and the length of time required in each to effectively train residents as consultants on laboratory test selection and interpretation. METHODS: The information needed to address these questions was obtained from a study of 20 residents in clinical pathology at our institution between 1990 and 1996. In the survey participants were asked to assess the value of specific training activities in developing their confidence when addressing consultative questions on laboratory test use and interpretation. Participants were also asked to assess the length of time required to gain confidence in performing this role. RESULTS: The results of the study demonstrate that confidence in providing advice on clinical laboratory test selection and interpretation is acquired to a significant but not absolute degree after an intense 8-week experience in a single clinical laboratory subspecialty, during which time no other responsibilities are assigned. The data also indicate that interactions with clinical pathologists and formal lectures provided to the trainees during their rotations are critical components of the consultation service. There was a significant decrease in the length of time required to provide effective information on test selection and interpretation as the residents progressed through their training. CONCLUSIONS: For all of the major subspecialties in clinical pathology, the residents gained significant confidence by 4 weeks of intense training, and by 8 weeks participants were very confident in answering consultation questions. Even after 8 weeks, however, fewer than 10% of the residents felt absolutely confident in their own decisions regarding laboratory test use and interpretation prior to discussion with senior residents and faculty. Thus, acquisition of expertise to effectively provide advice on laboratory test selection and interpretation required up to 8 weeks of focused training in each clinical laboratory subspecialty. Gaining confidence in multiple areas requires a significant commitment of full-time training. This study provides an understanding of the type and extent of training required to attain the skills necessary to effectively provide consultation in clinical pathology.

Clinical Competence↗
PubMed1999

Perspective on the clinical laboratory: new uses for informatics.

Enhanced capabilities of modern information systems will have a major impact on the way that clinical laboratories generate diagnostic information and transmit that information to their physician clients. This article provides a perspective on how some of the most imminent changes in informatics are likely to alter laboratory practices and to create new roles for the clinical laboratory through the ability to manage vast quantities of information. The areas covered include utilization of laboratory services, process control in the laboratory, interpretation of test results, and laboratory economics.

Clinical Laboratory Information Systems↗
PubMed2005

Assessing the risk of laboratory-acquired meningococcal disease.

Neisseria meningitidis is infrequently reported as a laboratory-acquired infection. Prompted by two cases in the United States in 2000, we assessed this risk among laboratorians. We identified cases of meningococcal disease that were possibly acquired or suspected of being acquired in a laboratory by placing an information request on e-mail discussion groups of infectious disease, microbiology, and infection control professional organizations. A probable case of laboratory-acquired meningococcal disease was defined as illness meeting the case definition for meningococcal disease in a laboratorian who had occupational exposure to an N. meningitidis isolate of the same serogroup within 14 days of illness onset. Sixteen cases of probable laboratory-acquired meningococcal disease occurring worldwide between 1985 and 2001 were identified, including six U.S. cases between 1996 and 2000. Nine cases (56%) were serogroup B; seven (44%) were serogroup C. Eight cases (50%) were fatal. All cases occurred among clinical microbiologists. In 15 cases (94%), isolate manipulation was performed without respiratory protection. We estimated that an average of three microbiologists are exposed to the 3,000 meningococcal isolates seen in U.S. laboratories yearly and calculated an attack rate of 13/100,000 microbiologists between 1996 and 2001, compared to 0.2/100,000 among U.S. adults in general. The rate and case/fatality ratio of meningococcal disease among microbiologists are higher than those in the general U.S. population. Specific risk factors for laboratory-acquired infection are likely associated with exposure to droplets or aerosols containing N. meningitidis. Prevention should focus on the implementation of class II biological safety cabinets or additional respiratory protection during manipulation of suspected meningococcal isolates.

Adult↗
PubMed1992

Medicare, Medicaid and CLIA programs; regulations implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA)--HCFA. Final rule with comment period.

This final rule revises regulations applicable to laboratories and implements provisions of the Clinical Laboratory Improvement Amendments of 1988 (CLIA), Public Law 100-578. The regulation applies to laboratories that examine human specimens for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of, human beings. They specify the performance requirements, based on 19 test complexity and risk factors related to erroneous test results, that apply to laboratories that are subject to CLIA. They also list requirements for laboratories performing certain limited testing to be eligible for a certificate of waiver. These laboratories will not be inspected routinely, nor will they be required to meet certain other CLIA requirements.

Accreditation↗
PubMedDate not supplied

Educating laboratory staff for the future.

The escalating shortage of laboratory workers is compounded by fewer graduates of accredited programs and changes in the work environment. Looking ahead, the National Accrediting Agency for Clinical Laboratory Sciences held a national conference and invited a wide spectrum of stakeholders to address what CLS/MT and CLT/MLT skills will be needed in the years 2005 and 2015. The results of the conference were used to revise accrediting standards. Faculties in accredited programs are working to transform the new standards into new curricular configurations. Laboratory administration must contribute to this transformation by actively supporting the clinical components of education and maintaining strong communication links with academic institutions. Administration needs to lead the way in creating a laboratory workplace that is more interesting and inviting to those making career decisions. It will take the combined efforts of laboratory administration and staff, educators, and professional organizations to restructure the workplace for the future and to redesign curriculum for appropriately educating professionals. This will be an important step toward addressing the staffing crisis in the laboratory.

Accreditation↗
PubMed2006

Developing a lean culture in the laboratory.

The Director of Pathology at Jackson Memorial Hospital was interested in improving the operational efficiencies of the department in order to enhance the department's level of service in conjunction with the expansion of the overall health system. The decision was made to implement proven Lean practices in the laboratory under the direction of a major consulting firm. This article details the scope of the initial project as well as the operating principles of Lean manufacturing practices as applied to the clinical laboratory. The goals of the project were to improve turnaround times of laboratory results, reduce inventory and supply costs, improve staff productivity, maximize workflow, and eliminate waste. Extensive data gathering and analysis guided the work process by highlighting the areas of highest opportunity. This systematic approach resulted in recommendations for the workflow and physical layout of the laboratory. It also included the introduction of "standard workflow" and "visual controls" as critical items that streamlined operational efficiencies. The authors provide actual photographs and schematics of the reorganization and improvements to the physical layout of the laboratory. In conclusion, this project resulted in decreased turnaround times and increased productivity, as well as significant savings in the overall laboratory operations.

Clinical Laboratory Techniques↗
PubMed2004

Effects of an alternate dissection schedule on gross anatomy laboratory practical performance.

The current medical curricula reform that is taking place in many medical schools throughout the world has resulted in less time for gross anatomy laboratory instruction. In response, anatomists are using a variety of approaches (e.g., peer teaching, prosections, plastinated anatomical models, etc.) to adapt to these changes. To accommodate recent curricular reform at the University of Health Sciences College of Osteopathic Medicine, an alternating dissection schedule was implemented. The purpose of this study is to examine the effects of the alternating schedule on gross anatomy laboratory practical performance. Using a Mann-Whitney Rank Sum test, back and upper limb (back-upper limb), and lower extremity laboratory practical performance for students who dissected in every laboratory (EL group; n = 227) is compared to students who dissected in every other laboratory (EOL group; n = 254). For the back-upper limb part of the anatomy laboratory practical, the mean percentage scores for the EL and EOL groups were 74.5% and 68.1%, respectively (P < 0.001). The mean percentage scores for the EL and EOL groups on the lower limb portion of the anatomy lab practical were 75.9% and 75.6%, respectively (P = 0.994). These data suggest that the use of an alternating dissection schedule had an equivocal effect on the students' gross anatomy laboratory practical performance for these two sections. The reasons for these conflicting results may have been related to regional complexity or volume of information, and the sequence in which the regions were taught.

Anatomy↗
PubMed2006

Infection control guidelines for the cardiac catheterization laboratory: society guidelines revisited.

In the early years of diagnostic cardiac catheterization, strict sterile precautions were required for cutdown procedures. Thirteen years ago, when the original guidelines were written, the brachial arteriotomy was still frequently utilized, femoral closure devices were uncommon, "implantables," such as intracoronary stents and PFO/ASD closure devices, were in their infancy, and percutaneous valve replacement was not a consideration. In 2005, the cardiac catheterization laboratory is a complex interventional suite with percutaneous access routine and device implantation standard. Despite frequent device implantation, strict sterile precautions are often not observed. Reasons for this include a decline in brachial artery cutdown, limited postprocedure follow-up with few reported infections, limited use of hats and masks in televised cases, and lack of current guidelines. Proper sterile technique has the potential to decrease the patient infection rate. Hand washing remains the most important procedure for preventing infections. Caps, masks, gowns, and gloves help to protect the patient by maintaining a sterile field. Protection of personnel may be accomplished by proper gowning, gloving, and eye wear, disposal of contaminated equipment, and prevention and care of puncture wounds and lacerations. With the potential for acquired disease from blood-borne pathogens, the need for protective measures is as essential in the cardiac catheterization laboratory as is the standard Universal Precautions, which are applied throughout the hospital. All personnel should strongly consider vaccination for hepatitis B. Maintenance of the cardiac catheterization laboratory environment includes appropriate cleaning, limitation of traffic, and adequate ventilation. In an SCAI survey, members recommended an update on guidelines for infection control in the cardiac catheterization laboratory. The following revision of the original 1992 guidelines is written specifically to address the increased utilization of the catheterization laboratory as an interventional suite with device implantation. In this update, infection protection is divided into sections on the patient, the laboratory personnel, and the laboratory environment. Additionally, specific CDC recommendation sections highlight recommendations from other published guidelines.

Antibiotic Prophylaxis↗
PubMed2003

Improved DNA flow cytometric, DNA ploidy, and S-phase reproducibility between 15 laboratories in analysis of breast cancer using generalized guidelines.

BACKGROUND: Lack of generalized guidelines for DNA flow cytometric analysis (FCM) may be the main reason for its limited use in the clinical management of breast cancer. METHODS: After an initial interlaboratory reproducibility study (Round I), we concluded that it was the evaluation of the DNA histograms rather than the technical performance of the analysis that was the main reason for discordant results between laboratories. Guidelines for the interpretation of DNA histograms were therefore drawn up. We present here data from a new reproducibility study (Round II) using these guidelines. RESULTS: For 10 laboratories also participating in Round I, use of the guidelines increased the concordance in DNA ploidy status from 89% to 100% for the 46 samples used in both rounds. The concordance rate for SPF also increased; mean r(s)-value increased from 0.81 to 0.88, and mean kappa value (lower two-thirds versus upper third versus not reported) increased from 0.55 to 0.71. Five new laboratories, participating only in Round II, also agreed with the 10 original laboratories regarding DNA ploidy status. With the inclusion of all 15 laboratories, we obtained a mean r(s)-value of 0.81 and a mean kappa value of 0.72 for SPF. CONCLUSIONS: Generalized guidelines for DNA FCM increase interlaboratory agreement, which is highly important in clinical routines and in multicenter studies. Furthermore, inexperienced FCM laboratories using generalized guidelines can produce and interpret DNA FCM data equally as well as experienced laboratories.

Breast Neoplasms↗
PubMed1985

Development of a standard protocol for in vitro cytogenetic testing with Chinese hamster ovary cells: comparison of results for 22 compounds in two laboratories.

A major problem of cytogenetics testing in mammalian cells is lack of agreement of results among laboratories. Our objective was to develop a sensitive in vitro test protocol that was applicable to large-scale chemical screening and yielded comparable results in two laboratories. We used sister chromatid exchange (SCE) and chromosome aberration (CAb) tests in Chinese hamster ovary (CHO) cells. The initial protocol used standard cell densities, medium, batch of rat liver S9 for metabolic activation; positive, negative, and solvent controls; staining and scoring techniques; and fixation times. Treatment without S9 was for 8-12 hr (CAb) or 26 hr (SCE), and with S9 for 2 hr in serum-free medium. Bromodeoxyuridine (BrdUrd) (10 microM) was added to SCE cultures only, 2 hr after addition of the test chemical. Doses were based on the 50% toxicity level in a preliminary test of cell survival 24 hr after treatment. One hundred cells (CAb) or 50 cells (SCE) were scored from each control and from five dose levels. Five clastogens were tested in the first two-laboratory comparison: mitomycin-C, triethylenemelamine, N-methyl-N'-nitro-N-nitrosoguanidine, cyclophosphamide, and benzo(alpha)pyrene. There was quite good agreement between laboratories. Seventeen compounds were then tested "blind" in the two laboratories. As testing proceeded, some discrepancies occurred between the laboratories, and the protocol was modified in attempts to improve the resolution of marginal responses and make dose selection more consistent. The preliminary test for cell survival was omitted. A 10(5) dose range in a half-log series was tested, and cells were scored at the highest dose at which sufficient mitotic cells were obtained, and at the next two lower doses. By delaying fixation times, SCE and CAb were scored at doses that inhibited cell cycle progression. This protocol gave comparable results in the two laboratories in many cases and by testing up to a maximum dose, limited by solubility and/or toxicity, should detect a high proportion of clastogens and SCE inducers.

Animals↗
PubMed1992

The local lymph node assay: results of a final inter-laboratory validation under field conditions.

The local lymph node assay (LLNA) assesses the sensitizing activity of chemicals by measurement of primary lymphocyte proliferation in lymph nodes draining the site of application. In this final inter-laboratory study the consistency of LLNA results between laboratories and with guinea pig maximization test (GPMT) data was examined under 'field' conditions. Nine chemicals were evaluated independently by each laboratory according to guidelines for test concentration and vehicle selection developed during previous validation studies to ensure assay optimization. Equivalent predictions of sensitization potential were obtained by all laboratories for eight chemicals. Five of seven chemicals identified as sensitizers in the GPMT were correctly identified in the LLNA--four by all laboratories and 1 (4-chloroaniline) by one laboratory only--although in this latter case, two other laboratories obtained clear dose responses, suggestive of sensitization. The LLNA identified correctly those chemicals predicted to be extreme or strong sensitizers in the GPMT. The remaining two chemicals were non-sensitizers in the guinea pig and failed to elicit positive proliferative responses in the LLNA. These data demonstrate that sensitivity and reliability of the LLNA is retained when chemicals are evaluated independently, and that it provides a reliable pre-screen for the identification of chemicals with significant sensitization potential.

Animals↗
PubMed1997

Cu accumulation in Lumbricus rubellus under laboratory conditions compared with accumulation under field conditions.

Experiments were performed to determine Cu accumulation in earthworms under laboratory conditions using soil from a Cu-contaminated site, followed by field experiments in this contaminated site. The aims of the laboratory experiments were (a) to determine Cu accumulation rate, (b) to determine the effect of soil Cu content on the steady-state concentration, and (c) to evaluate the effect of soil moisture on accumulation. The field experiments were performed to evaluate the use of accumulation data obtained from laboratory experiments for prediction of accumulation under field conditions. In the laboratory experiment, earthworms (Lumbricus rubellus) were introduced into four homogeneously mixed Cu-contaminated soils and a reference soil. The total extractable Cu content in the soil (Cu(T)) varied from 10 to 130 mg kg-1, soil pH varied from 4.0 to 5.0, and soil moisture content was set to approximately 25, 35, and 45% of the dry weight for each treatment. The tissue Cu concentration (Cuw) was determined by sampling earthworms after 1, 7, 14, 28, and 56 days. In the field experiment, 500 earthworms were introduced at four different Cu-contaminated locations at a contaminated arable field. After 14, 28, and 70 days, earthworms were sampled to determine Cuw. In both experiments, soil Cu contents significantly affected Cuw. Soil moisture only significantly affected Cu accumulation for the wettest soil. Under laboratory conditions, a steady state did not seem to be achieved after 56 days; the Cu accumulation can be described by the toxicokinetic one-compartment model. The field experiment was considerably affected by variation in soil temperature resulting in significant fluctuations in tissue Cu concentrations. The tissue Cu accumulation was significantly correlated to the CuT, which is in agreement with the results from the laboratory experiments. Variance of Cuw at Day 14 in earthworms from the field experiments was significantly larger than in the worms from the laboratory experiment. At Day 28, the differences were not significant.

Analysis of Variance↗