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[Systematization of clinical laboratory--some problems caused from specimen transport through laboratory reports].

Through error and trials we have designed an ideal system for the clinical laboratory. Truly, it has been a very difficult task requiring our long-term experience working in the clinical laboratory. For example, if we purchase new examination equipment without any consideration or if we decide what type of equipment to introduce according to the common advice of the purchase committee of the hospital or the medical school, then we cannot design an ideal system of laboratory examinations and are forced to invest a large sum of money in vain. Moreover, the use of innumerable examination containers or test tubes which are disposable, can become a financial burden to the hospital. We have been trying to design a system of laboratory automation for more than ten years and have been successful in designing not only a specimen transport system using conveyer-belts but also various kinds of examination robotic systems. This report describes our own examples of designing a system of laboratory automation.

Automation↗

Experience of an academic reference laboratory using automation for analysis of cystic fibrosis mutations.

OBJECTIVE: To examine the use of partial automation for molecular analysis of cystic fibrosis and to evaluate the diagnostic experience gained. DESIGN: Twenty-four cystic fibrosis mutations, with cumulative mutation detection of 89% in North American whites and of 97% in the Ashkenazim, were tested by multiplex amplification and allele-specific oligonucleotide hybridization. SETTING: A university-based DNA diagnostic laboratory. SUBJECTS: More than 700 serial specimens were analyzed for cystic fibrosis mutations over a 5-month period. The study included 377 individuals tested for carrier status, of which 288 had no family history for cystic fibrosis; prenatal diagnosis for 17 fetuses at a one in four risk and eight pregnancies at lower risk; fetal or parental samples for 33 pregnancies with fetal ultrasound abnormalities; 40 individuals diagnosed with cystic fibrosis; and 87 individuals with a possible diagnosis of the disease. RESULTS: Automation has permitted increasing numbers of mutations while decreasing personnel time and cost. Mutation testing identified 10 carriers with no family history for cystic fibrosis, four couples at a one in four risk, and five affected fetuses, one ascertained by abnormal fetal ultrasound. Mutation analysis also identified two mutant copies of the gene in 26 of 40 individuals with a clinical diagnosis of cystic fibrosis, and in two of 87 patients with possible cystic fibrosis. CONCLUSION: This partially automated, direct mutation analysis provides DNA diagnostic laboratories with the capacity to process a larger number of samples at lower cost with greater sensitivity for mutation detection. As pilot screening programs are reported, it is appropriate to reevaluate recommendations regarding population-based carrier screening for cystic fibrosis.

Automation↗

Influence of the needle bore size used for collecting venous blood samples on routine clinical chemistry testing.

BACKGROUND: Despite remarkable advances in technology and laboratory automation, results of laboratory testing still suffer from a high degree of preanalytical variability. Although there is no definitive evidence, the use of small-gauge needles for venipuncture is usually discouraged to reduce the chance of producing unsuitable specimens. METHODS: The purpose of this investigation was to assess the influence of the needle size used to collect venous blood on the measurement of 14 common analytes, including free hemoglobin, the most representative enzymes, protein-bound substances and electrolytes. Results for venous blood samples collected from 20 fasting voluntary physicians using either a 23- (0.60 mmx19 mm) or 25-gauge-needle (0.50 mmx19 mm) butterfly devices with polyvinyl chloride tubing (1.40 mmx300 mm) were compared with reference specimens collected using a 21-gauge-needle (0.80 mmx19 mm) butterfly device with polyvinyl chloride tubing (1.40 mmx300 mm). RESULTS: All means for paired samples collected using the smaller needles did not differ significantly from the reference specimen by paired Student's t-test analysis. Passing-Bablok regression analysis and Pearson's or Spearman (creatine kinase, aspartate aminotransferase, alanine aminotransferase and chloride) correlation were acceptable for most of the analyses, although a lower correlation coefficient was observed for electrolytes. In addition, when expressed as a percentage of the mean for paired samples, the s(y,x) value exceeded the desirable bias for free hemoglobin, glucose, lactate dehydrogenase, aspartate aminotransferase, sodium, chloride, calcium and magnesium (in samples collected using both 23 G and 25 G needles) and potassium (in samples collected using a 25 G needle). Although Bland-Altman plot analysis and +/-1.96 SD agreement intervals for the set of differences between values was acceptable overall, the bias was rather broad for free hemoglobin and several critical electrolytes (calcium, chloride, potassium, sodium), exceeding the respective limits for desirable bias. CONCLUSIONS: The results of our investigation indicate that 23 G needles, if handled correctly, will not introduce any statistically or clinically significant error to the measurement results compared to a 21 G needle. For the 25 G needle, we observed increased variability for potassium compared to a 23 G needle. Small-bore needles of 25 G or less cannot be universally recommended when collecting venous blood for clinical chemistry testing and should be reserved for selected circumstances, such as in patients with problematical venous accesses and newborns. In such cases, however, the bias introduced by the use of smaller needles should always be taken into consideration when interpreting test results.

Adult↗

[Hardware].

For effective management of clinical laboratory in spite of a shortage of medical technologists, we modified conventional analytical instruments on the market, and developed the automatic transport mechanism and the robotic analytical instruments to suit the operational needs of our laboratory. Consequently, we succeeded in designing a system in which the results for 89% of all the tests ordered were reported within 60 minutes after the time when the specimens were received at the laboratory. As a result of this laboratory automation system, medical technologists were spared from their routine work, and their expertise was now diverted to the other duties like examination for microbes in hospital facilities, evaluation for sterilization of surgical instruments, and maintenance of measuring apparatuses in the operating rooms. In addition, the technologists also became involved in preventive health activities for university personnel such as: periodical healthy check, and screening programs for adult diseases, and the like. Some became engaged in the health management programs for radiological department workers. Thus, the introduction of this laboratory automation system, enabled the medical technologists to cooperate in hospital operation activities and to contribute to the prevention of iatrogenic disorders.

Automation↗

National survey on the pre-analytical variability in a representative cohort of Italian laboratories.

BACKGROUND: Owing to remarkable advances in automation, laboratory technology and informatics, the pre-analytical phase has become the major source of variability in laboratory testing. The present survey investigated the development of several pre-analytical processes within a representative cohort of Italian clinical laboratories. METHODS: A seven-point questionnaire was designed to investigate the following issues: 1a) the mean outpatient waiting time before check-in and 1b) the mean time from check-in to sample collection; 2) the mean time from sample collection to analysis; 3) the type of specimen collected for clinical chemistry testing; 4) the degree of pre-analytical automation; 5a) the number of samples shipped to other laboratories and 5b) the availability of standardised protocols for transportation; 6) the conditions for specimen storage; and 7) the availability and type of guidelines for management of unsuitable specimens. The questionnaire was administered to 150 laboratory specialists attending the SIMEL (Italian Society of Laboratory Medicine) National Meeting in June 2006. RESULTS: 107 questionnaires (71.3%) were returned. Data analysis revealed a high degree of variability among laboratories for the time required for check-in, outpatient sampling, sample transportation to the referral laboratory and analysis upon the arrival. Only 31% of laboratories have automated some pre-analytical steps. Of the 87% of laboratories that ship specimens to other facilities without sample preparation, 19% have no standardised protocol for transportation. For conventional clinical chemistry testing, 74% of the laboratories use serum evacuated tubes (59% with and 15% without serum separator), whereas the remaining 26% use lithium-heparin evacuated tubes (11% with and 15% without plasma separator). The storage period and conditions for rerun/retest vary widely. Only 63% of laboratories have a codified procedure for the management of unsuitable specimens, which are recognised by visual inspection (69%) or automatic detection (29%). Only 56% of the laboratories have standardised procedures for the management of unsuitable specimens, which vary widely on a local basis. CONCLUSIONS: The survey highlights broad heterogeneity in several pre-analytical processes among Italian laboratories. The lack of reliable guidelines encompassing evidence-based practice is a major problem for the standardisation of this crucial part of the testing process and represents a major challenge for laboratory medicine in the 2000s.

Automation↗

Validation of a laboratory-constructed automated gas chromatograph for the measurement of ozone precursors through comparison with a commercial analogy.

An automated gas chromatographic (auto-GC) system aiming at performing unattended hourly measurement of ozone precursors was developed in the laboratory. To encompass volatile organic compounds (VOCs) of a wide range of volatility within each analysis, the system uses dual-traps and dual-columns to simultaneously analyze both low and high-boiling compounds with each injection. Since sorbents with sufficient retention of C2 compounds at room temperature, namely ethane, ethene, and ethyne are not yet available, cooling with a thermoelectrical device was built around the low-boiling trap to facilitate quantitative enrichment of C2 compounds. The effectiveness of using micro-trap with low dead volume plumbing was manifested in reducing peak width and increasing peak height for particularly the lower-boiling compounds. The increase in sensitivity allowed sufficient detector response with a small amount of air sample, e.g. 200 ml in our routine operation, which in term eliminate the need for remove water prior to sampling trapping. The performance and applicability of this laboratory-built auto-GC system was validated by comparison with a commercial analog, i.e. the ATD-400 system made by Perkin-Elmer, in the field sharing a common air intake. During more than 3 weeks of synchronized monitoring of ambient volatile organic compounds both systems showed highly consistent results on almost every monitored compound, clearly demonstrating the robustness of this self-built system.

Automation↗

Blood sample volumes: emerging trends in clinical practice and laboratory medicine.

Blood loss because of phlebotomy for diagnostic laboratory tests is a well-recognized risk to neonates, particularly low-birthweight infants. In contrast, the risk of anemia from blood drawing in adults is relatively poorly studied. A few clinical studies have demonstrated the magnitude of this issue for critical care patients; most adult patients can easily tolerate the loss of blood volumes typically used for laboratory tests. Recommendations for promoting blood conservation in adults who frequently are phlebotomized include using smaller collection tubes, but more importantly organizing blood draws to eliminate duplicate and other unnecessary test requests and consolidating multiple collections into as few as possible by scheduling them. Emerging trends in medicine that will bear on the practice of blood conservation are "bloodless surgery," standardization of collection tubes for laboratory automation systems, and smart laboratory information systems that provide instant feedback to ordering physicians.

Adult↗

Robotics, automation, and the new role of process control.

The natural progression of automation in the clinical laboratory next will lead to robotic devices to perform many of the manual tasks still remaining. To date, most efforts of laboratory automation have been directed at the analytic phase. New targets for automation will be at the preanalytic and postanalytic phases where many of the bottlenecks in specimen flow now occur in highly repetitive manual tasks. Laboratory professionals will have a unique opportunity to incorporate new concepts of robotics in their facilities to improve error rates and to use massive laboratory databases to improve medical and public health services.

Autoanalysis↗

[Trial digitalization of analog-data obtained from the AutoAnalyzer].

The AutoAnalzer(Basic Model) manufactured on Technicon corporation was a very useful instrument for clinical laboratory automation, but it was necessary to convert the data obtained from the instrument to digital values used the chart reader. This was very troublesome and there was apprehension that there would be errors in A-D conversion. We tried converting data obtained from the AutoAnalzer to a digital value by on-line connection of the instruments with minicomputers(LINC-8 and FACOM-R). The output of the recorder was converted to voltage(0 to 100 V) using a potentiometer, quantitated(0 to 1.000) by the A-D converter attached to LINC-8, and processed by the minicomputer. The control-box was an experimental device mainly designed for the convenience of users. The functions of the control-box were designated analytical items, No. of A-D converters, start and stop of the AutoAnalzer operation to the minicomputer. Employing the control-box, a technician operated this system freely, without direct computer operation. We established a generally satisfactory system for clinical laboratory automation using the minicomputer.

Analog-Digital Conversion↗

Timeliness of automated routine laboratory tests: a College of American Pathologists Q-Probes study of 653 institutions.

Benchmarks for timeliness of early morning routine clinical laboratory tests were developed from over 17,000 urea nitrogen and 16,000 white blood cell count measurements made for inpatients in 653 institutions participating in the College of American Pathologists Q-Probes program. Urea nitrogen and white blood cell counts were considered surrogates for routine chemistry and hematology tests. Laboratories at the 50th percentile reported median urea nitrogen and white blood cell counts by 09.04 and 08.51 h, respectively, whereas those at the 10th percentile reported these median measurements by 11.30 and 11.18 h, respectively. Results were available sooner in non-teaching than teaching institutions, and in smaller rather than larger institutions, with the degree of computerization affecting test availability. Timeliness also was affected by instrument type and mode of operation, but was unaffected by the percentage of stat testing. Based on modeling by regression analysis, there was little evidence that longer routine test turnaround times affect patient length of stay.

Blood Urea Nitrogen↗

A Pascal program for the semi-automation of laboratory cell counting procedures.

A program that allows a microcomputer to function as a semi-automatic multi-keyed laboratory cell counter is presented. Using a microcomputer as a cell counter allows laboratory personnel to work faster, more efficiently and more accurately than the traditional multi-keyed laboratory counter. Automatic data storage, automatic calculation of results and error trapping are also available. The program is presented in the Pascal programming language.

Cell Count↗