[Influence of automation of clinical tests on laboratory management].
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Health system costs in clinical laboratories are incurred daily due to human error. Indeed, a major impetus for automating clinical laboratories has always been the opportunity it presents to simultaneously reduce cost and improve quality of operations by decreasing human error. But merely automating these processes is not enough. To the extent that introduction of these systems results in operators having less practice in dealing with unexpected events or becoming deskilled in problemsolving, however new kinds of error will likely appear. Clinical laboratories could potentially benefit by integrating findings on human error from modern behavioral science into their operations. Fully understanding human error requires a deep understanding of human information processing and cognition. Predicting and preventing negative consequences requires application of this understanding to laboratory operations. Although the occurrence of a particular error at a particular instant cannot be absolutely prevented, human error rates can be reduced. The following principles are key: an understanding of the process of learning in relation to error; understanding the origin of errors since this knowledge can be used to reduce their occurrence; optimal systems should be forgiving to the operator by absorbing errors, at least for a time; although much is known by industrial psychologists about how to write operating procedures and instructions in ways that reduce the probability of error, this expertise is hardly ever put to use in the laboratory; and a feedback mechanism must be designed into the system that enables the operator to recognize in real time that an error has occurred.
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Capillary zone electrophoresis (CZE) of serum proteins is increasingly gaining impact in clinical laboratories. Two automated multichannel instruments dedicated to the separation of serum proteins have become available over the last 6 years, the Paragon CZE 2000 (Beckman Coulter, CA, USA) and, more recently, the Capillarys (Sebia, France). This review focuses on the performance of these commercial instruments to separate serum proteins in a clinical laboratory setting. The utility of CZE to recognize various dysproteinemias and to detect and identify monoclonal proteins will be described and systematically reviewed. The reader will be provided with a summation and an understanding of CZE-specific interference.
Operation of automated hematology testing, on-line to a laboratory-dedicated computer, is described. The computer stores, retrieves and monitors the results of two Model S Sr. Coulter Counters, three Technicon platelet counters, one Electra 600-D, and six leukocyte differential consoles, which are interphased to the computer. All other hematology tests are batch-entered via the keyboard of cathode-ray tubes. The computer generates specimen labels, worksheets, and lists of incomplete tests, monitors all on-line instruments, and performs all the calculations used in the procedures of quality control. Results are available instantaneously on cathod-ray tubes strategically located in patient-related areas throughout the institution. These can be obtained as all of the results for a given day or as cumulative summaries or histogram-type plots of results for a given day.
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OBJECTIVES: To evaluate whether routine laboratory data can improve the ability to compare risk-adjusted outcomes of different medical wards, and to detect 'outlier' wards with significantly better or worse outcome. METHODS: Patient data were taken from the Combined Patient Database Systematic Management and Research Tool, a database created by merging different computerized sources at a tertiary care hospital. All patients admitted to internal wards with the diagnosis of pneumonia during the years 1991-1995 were included (n = 2734). The outcome variable was mortality 30 days post-admission. We used three comorbidity measures based on ICD-9-CM codes as possible predictors of mortality: secondary diagnoses; the Health Care Financing Administration severity index; and the Charlson comorbidity index. Models were created using logistic regression. To each model, laboratory data gathered in the first 48 hours after admission were added. To identify 'outlier' services we determined whether the patients' ward was an independent predictor of mortality. The area under the receiver operator curve (ROC) of the models was used for comparisons. RESULTS: The area under the ROC was 0.65-0.72 for the models based on age and comorbid diagnoses. The addition of laboratory data improved markedly the discriminatory ability of each of the models, as reflected by an increase in the area under the ROC to 0.83-0.84. An 'outlier' ward with a higher risk-adjusted mortality rate was identified only by the models that included laboratory data. CONCLUSION: Basic, automated, routinely gathered laboratory data added significantly to the discriminatory power of risk models based on administrative data with abstracted diagnoses. Addition of laboratory data improved the ability to identify providers with possible exceptional quality of care.
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Clinical biochemistry and laboratory diagnostics develops dynamically namely due to the advance of modern analytical techniques, information technologies and with new findings in the molecular biology. According to data from the USA, 70 to 80% of medical decisions in the hospitals depend on comparatively not expensive laboratory tests which represent only 3 to 5% of the health care costs. There are three essential approach models for the automation and consolidation of laboratories in the world. Japan, USA and countries of EU stand for prototype of those directions. Japan has a high level of total laboratory automation starting with the preanalytical phase, over the analytical phase to the postanalytical phase with the partial consolidation of the discipline. In the US the high degree of laboratory consolidation is preferred with so-called modular automation. EU countries prefer high degree of modular automation, including the preanalytical processing of samples. International trends in the laboratory diagnostics manifest in the Czech Republic by modular systems in several laboratories. They can increase the effectiveness of laboratories and subsequently erase differences between the routine and statim examination and develop of molecular-biological techniques. Development of laboratory diagnostic technologies and their economical accessibility are the compulsory condition of acceleration of the diagnostics and treatment, leading to high quality, focussed and finally effectivuess of health care.
Contemporary clinical isolates and challenge strains of Pseudomonas aeruginosa were tested by four automated susceptibility testing systems (BD Phoenix, MicroScan WalkAway, Vitek, and Vitek 2; two laboratories with each) against six broad-spectrum beta-lactams, and the results were compared to reference broth microdilution (BMD) and to consensus results from three validated methods (BMD, Etest [AB Biodisk, Solna, Sweden], and disk diffusion). Unacceptable levels of error (minor, major, and very major) were detected, some with systematic biases toward false susceptibility (piperacillin-tazobactam and imipenem) and others toward false resistance (aztreonam, cefepime, and ceftazidime). We encourage corrective action by the system manufacturers to address test biases, and we suggest that clinical laboratories using automated systems should consider accurate alternative methods for routine use.
In July 1995, we asked 101 experts to anticipate future areas for research in clinical laboratory medicine using a modified Delphi survey approach. The panel included academicians, clinical laboratory professionals, laboratory managers, practicing physicians public health officials, hospital administrators, and representatives of manufacturing industries, managed care organizations, commercial laboratories, and government health agencies. The participants predicted fewer laboratories, more automation, and fewer skilled staff needed in the future. The consensus was that laboratory quality assurance will focus on patient outcomes and be benchmarked against peer groups. They agreed that quality assurance routinely will be integrated into testing kits. Measures derived from medical informatics, such as outcomes analysis and utilization statistics, will become a standard feature of health care. A major area of concern was the effect that reorganizing health care and striving for cost containment will have on laboratory services. These views were consistent with those expressed by participants at a CDC conference on the frontiers of laboratory medicine research held shortly after the study was completed. These topics by now are familiar to most laboratory professionals, and we urge them to explore the many research issues raised with their colleagues in their clinical laboratories, health-care organizations, and industry.
BACKGROUND: Manual validation of laboratory test results is time-consuming, creating a demand for expert systems to automate this process. We have started to set up the program "LabRespond", which covers five validation levels: administrative, technical, sample, patient, and clinical validation. We present the evaluation of a prototype of an automated patient validation system based on statistical methods, in contrast to the commercially available program "VALAB", a rule-based automated validation system. METHODS: In the present study, 163 willfully altered, erroneous test results out of 5421 were submitted for validation to LabRespond, VALAB, and to a group of clinical chemists (n = 9) who validated these test results manually. The test results rejected by three or more clinical chemists (n = 281) served as a secondary reference standard. RESULTS: The error recovery rates of clinical chemists ranged from 23.9% to 71.2%. The recovery rates of LabRespond and VALAB were 77.9% and 71.8%, respectively (difference not significant). The false-positive rates were 82.7% for LabRespond, 83.6% for VALAB, and 27.8-86.7% for clinical chemists. Using the consensus of three or more clinical chemists as the secondary reference standard, we found error recovery rates of 64.8% for LabRespond and 72.2% for VALAB (P = 0.06). Compared with VALAB, LabRespond detected more (P = 0.003) erroneous test results of the type that were changed from abnormal to normal. CONCLUSIONS: The statistical plausibility check used by LabRespond offers a promising automated validation method with a higher error recovery rate than the clinical chemists participating in this study, and a performance comparable to VALAB.
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The outfit of an automated workplace of the biochemical practitioner at the clinical diagnosis laboratory of an emergency hospital is described in the paper. The advantages and disadvantages are analyzed and potentialities of improving the basic outfit are defined.
Four cases showing different means to detect cryoglobulins are reported: effects on blood cell counts performed on 2 technologically different automated hematology instruments and microscopic features in fresh blood samples and on May-Grünwald-Giemsa-stained bloodfilms. These cases were chosen for their instructive value in depicting all artifacts associated with cryoglobulins. Laboratory recognition of the cryoglobulins is important to correct factitious results with automated blood cell counters, mainly pseudoleukocytosis and pseudothrombocytosis. Moreover cryoglobulin-induced laboratory artifacts may be the first factor prompting the assessment for cryoglobulinemia and the diagnosis of the underlying cause.
OBJECTIVE: To determine whether hepatitis B vaccination of newborns increases the incidence of fever and/or suspected sepsis. METHODS: A prospective clinical study was undertaken at the Kaiser Permanente San Francisco Medical Center involving normal full term newborns born between November 1, 1991, and April 30, 1994. During this time 3302 infants were vaccinated within 21 days of birth with hepatitis B vaccine, and 2353 were not. Clinical and demographic data were collected from Kaiser Permanente's existing clinical information systems, and laboratory data for blood and cerebrospinal fluid (CSF) cultures were obtained from the comprehensive automated regional laboratory reporting system. RESULTS: There were no significant differences between vaccinated and unvaccinated newborns in the proportion of infants who received care for fever (0.8% vaccinated and 1.1% unvaccinated, P = 0.28), allergic reactions, seizures or other neurologic events in the first 21 days of life. Vaccinated newborns were significantly less likely to undergo microbiologic evaluation for possible sepsis. Among vaccinated newborns 4.0% had blood cultures and 1.6% had CSF cultures. Among infants who were not vaccinated 8.3% had blood cultures and 1.6% had CSF cultures (P <0.001 for both tests). CONCLUSION: This study found no evidence that newborn hepatitis B vaccination is associated with an increase in the number of febrile episodes, sepsis evaluations or allergic or neurologic events. In addition our data did not support any increase in medical procedures attributed to receipt of hepatitis B vaccine.
The potential microbial hazards to laboratory personnel from operating three pieces of automated laboratory equipment have been tested using challenges of bacteria in serum or water. Aerosols did not seem to be a hazard, and the recommended disinfection procedures seemed quite adequate, although 2% aqueous activated glutaraldehyde is to be preferred to hypochlorite. The use of plastic gloves for protecting hands when changing rinse cups and pH electrodes is recommended.
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