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Immediate steps toward patient safety.

Patient safety should be a fundamental element in any hospital's philosophy, mission, and vision. Use of barcode point-of-care technology (BPOC) to reduce medication errors is a patient-safety approach that hospitals can implement within a short time frame and obtain immediate benefits. Advantages of BPOC are that it is intuitive, cost-effective, and conducive to improved patient satisfaction.

California↗

[Research and development of a clinical laboratory information system].

A clinical laboratory information system consists of two parts--the information system and the management system. Its development is based on scientific and rational lab-workflow, consulting the international standard HL7 Protocol, and combined with barcode technique and instrument communication. The information system mainly manages the data which come from the whole lab testing process while the management system is dominating the lab office work and management decisions.

Clinical Laboratory Information Systems↗

From single cell gene-based diagnostics to diagnostic genomics: current applications and future perspectives.

Molecular diagnostics is a branch of clinical diagnostics that uses primarily DNA or RNA as a biomarker for clinical testing. It combines various gene-based amplification technologies with highly sophisticated detection methods for the clinical diagnosis of a vast variety of diseases including infectious diseases, cancer, and inherited diseases. The principal application of gene-based amplification technology is to identify pathogen or gene-specific nucleic acid sequences that are used as surrogate markers for the identification of either infectious pathogens or alteration of disease-related genes. There are generally three classes of gene-based amplification technologies: target-based, e.g., PCR; probe-based, e.g., LCR; and signal-based, e.g., bDNA. Real-time detection of PCR allows us to quantify amplified amplicons with a broad dynamic range and it offers a unique way to detect genetic mutations. Other technologies such as immuno-PCR and bio-barcode assay (BCA) combine different amplification tactics offering extreme detection sensitivity ranging from femtogram (10(-15)) to zeptogram (10(-21)). Even though quantum dots technology is in its infant stage, its potential to further increase diagnostic sensitivity and specificity is likely beyond our current imagination. Future diagnostic technologies include the use of genomic and proteomic approaches especially in pure cell types or even in the single-cell level, which open up endless new possibilities for gene-based diagnostics at entirely different levels. In this article, principles of various current gene-based amplification and detection technologies along with their clinical applications are discussed. New technologies that could potentially be used in future gene-based diagnosis are introduced.

Genetics, Medical↗

[Guidelines for electronic-data-processing-controlled serial diagnosis of donor blood samples].

UNLABELLED: Increasing performance figures and the necessity to save expenses oblige transfusion services to automatize their donors' laboratory examination. Sufficient hard- and software for sample distribution and processing is now available. Following aspects should be regarded when switching to automatic serial screening: SAFETY: The identity of blood-donor, donation and laboratory result will be achieved by machine readable labeling and on-line communication between working-stations and central administration. Flexibility: Easy automatic selective laboratory screening will be possible using special barcodes including sample identification and working orders. A modular hardware concept with easily accessible programming control allows it to implement new devices or methods. Ergonomy: Automatic sample processing including selective screening and simultaneous operating robotic sample processors increase working quality, sample output and time benefits. Economy: Improved working conditions will result in saving reagents and compensating staff limitations.

Blood Banks↗

The merits of a robot: a Dutch experience.

PURPOSE: To determine the merits of a robot at the community pharmacy in a quasi-experiment. METHOD: The applied methods for data-collection were barcode-time measurements, direct observations, time-interval studies, and tally at a Dutch community pharmacy. The topics consisted of workload, waiting times, congestion, slack, general work, counter work, and work at the consultation room. The topics were studied in pre-test and post-test stages, each stage during six weeks. By using these topics and some additional data from the pharmacy, the economics of the robot were also assessed. RESULTS: The workload decreased with 15 prescriptions per person per day. The waiting times decreased with one minute and 18 seconds per dispensing process, reducing the wait until counter contact. The day congestion decreased with one hour 27 minutes and 36 seconds, and the day slack increased with 28 minutes. The analysis of the general work showed no appreciable difference in the bulk of the care-related activities and the other activities. However, some work was re-shuffled: 7% increase at counter work and 7% decrease at logistics. Moreover, statistically significant increases were observed at counter work (5%) and robot work (4%), and significant decreases at telephone (3%) and filling work in presence of the patient (4%). The counter tally study showed a rise in care-related activities with 8%. Moreover, it also illuminated a statistically significant decrease at no information (11%) and an increase at only social (2%). The consultation room was never used during the study. The pharmacy economics of the robot showed that the robot had high estimated costs for purchase, depreciation, and maintenance: EUR 187,024 in the first year. Moreover, the robot had positive impact on waiting times, congestion, staffing, logistics, and care-related work, which was estimated on EUR 91,198 in the first year. The estimated payback time of the robot was three years. CONCLUSIONS: An introduction of the robot may indeed have the often supposed positive effects on pharmaceutical care. Even though the costs are high and the technical problems are present, the robot seems to be financial beneficial after three years. The robot can create space for pharmaceutical care, but it has a substantial cost.

Community Pharmacy Services↗

Automated blood-sample handling in the clinical laboratory.

The only significant advances in blood-taking in 25 years have been the disposable needle and evacuated blood-drawing tube. With the exception of a few isolated barcode experiments, most sample-tracking is performed through handwritten or computer-printed labels. Attempts to reduce the hazards of centrifugation have resulted in air-tight lids or chambers, the use of which is time-consuming and cumbersome. Most commonly used clinical analyzers require serum or plasma, distributed into specialized containers, unique to that analyzer. Aliquots for different tests are prepared by handpouring or pipetting. Moderate to large clinical laboratories perform so many different tests that even multi-analyzers performing multiple analyses on a single sample may account for only a portion of all tests ordered for a patient. Thus several aliquots of each specimen are usually required. We have developed a proprietary serial centrifuge and blood-collection tube suitable for incorporation into an automated or robotic sample-handling system. The system we propose is (a) safe--avoids or prevents biological danger to the many "handlers" of blood; (b) small--minimizes the amount of sample taken and space required to adapt to the needs of satellite and mobile testing, and direct interfacing with analyzers; (c) serial--permits each sample to be treated according to its own "merits," optimizes throughput, and facilitates flexible automation; and (d) smart--ensures quality results through monitoring and intelligent control of patient identification, sample characteristics, and separation process.

Blood Specimen Collection↗

Accuracy and time requirements of a bar-code inventory system for controlled substances.

The effect of a bar-code system on personnel time requirements and data-entry accuracy in an existing automated controlled substances inventory system was determined. In the previous system, technicians used a keyboard and alphanumeric codes to enter into the computer data about the physical transfer of controlled substances among hospital areas. A system for barcode data entry was adapted for use with the existing procedure. After learning to use the bar-code system, four experienced technicians entered data by the keyboard method for eight days and the bar-code method for eight days during a 32-day study period. The amount of time required to enter all transactions and the accuracy of data entry were measured. Mean data-entry times for the keyboard and bar-code methods were not significantly different, most likely because of the greater number of manipulations needed for bar-code data entry. The mean percentage error associated with the bar-code method (0.79%) was significantly less than the error associated with the keyboard method (1.53%). For this particular computer system in which bar-code data entry was adapted to existing procedures, use of bar codes to enter controlled substances inventory data was not substantially faster but was more accurate than a traditional key-board data-entry method.

Drug and Narcotic Control↗

Enzyme immunoassay system for panel testing.

An immunoassay system based on enzyme immunoassay technology has been developed for quantitative panel testing. The system includes test card disposables, reagents, and an instrument. Patients' samples are processed semiautomatically in the instrument with minimum user intervention. The test card has multiple test areas at individual locations on a membrane solid phase so that simultaneous determinations from a single specimen are possible. Each panel also includes positive and negative reagent procedural controls. Factory-determined calibration curves for each analyte are provided in barcode form with each test kit. The reagents include a specimen dilution buffer, enzyme conjugate, and precipitogenic substrate. Up to 10 test cards at a time can be processed in random-access and continuous-access modes, with automated agitation of sample and reagents over the solid phase, temperature-controlled incubation, and membrane washing and reading, data reduction, and printout of results. The optical reader measures diffuse reflectance and features source intensity and wavelength compensation.

Chemistry, Clinical↗

Development of a computerized system for inventory of controlled drug substances.

An automated drug inventory system was developed to facilitate record keeping requirements for controlled drug substances. A hand-held barcode scanner and a computer-accessible top-loading electronic balance are used to identify and weigh samples each time they are removed from or returned to the safe. A computer compares the initial sample weight to its last recorded weight to assure that no discrepancies occurred prior to sample use. Upon return, the computer compares the difference in initial and return tare weights to the stated amount of drug used to assure accuracy of the written inventory record. Unreconciled errors are immediately brought to the attention of the safe custodian. During its first year of operation, 2791 sample out/sample return transactions on 381 drug samples were tracked by the system. The most common errors detected by the system include sample loss of moisture (9), sample absorption of moisture (4), wrong sample used (4), incorrect weight recorded (4), and sample used without log entry (4). Importantly, all errors were immediately identified and reconciled. At the end of each working day, a printout of all daily transactions shows sample use, possible errors, and whether all samples have been returned to the safe. A printout of the total drug inventory is immediately available when called for. This system provides enhanced vigilance and security, and has been readily accepted by all investigators using controlled drug substances in our laboratory.

Autoanalysis↗

[Batch documentation of blood products].

BACKGROUND: In former years transmission of infectious diseases by blood products was repeatedly observed. To trace these incriminated batches of blood products proved to be nearly impossible. METHODS: This publication describes the documentation of different batches of blood products. In the simpliest case the batch numbers of blood products can be stored in files using forms. Besides this documentation of batches can be aided by EDP using databases and barcodes. A test for the correct and complete input of data is given. RESULTS: The registration of batches of commercially available blood products as well as blood preserves is possible. Incriminated batches can be traced back. CONCLUSIONS: Besides donor selection, control of the manufacturing process and the use of inactivation procedures for viruses the documentation of batches substantially contributes to the safety of plasma derivatives. With the applied techniques documentation is easily achieved.

Blood Component Transfusion↗

[Experiences with the ES-600 equipment].

We report on the adaptation of a 'Walkaway' instrument (ES 600, Boehringer Mannheim) to be used in a blood transfusion service for donor screening of HBsAG and anti-HIV 1 + 2. Anti-CMV is obtainable, and anti-HCV will be available in the near future. Sample processing is done by a Tecan 8051 ID from barcoded primary tubes into ES 600 carousels. The capacity of this instrument is limited to 150 specimens and 600 tests per run. After mounting of reagents and control specimens, the tests are performed fully automatically without a technician. Regarding our experiences, the instrument is unanimously suited for use of blood donor testing in transfusion services with less than 145 samples to be tested daily.

Antibodies, Viral↗

Medical data capture and display: the importance of clinicians' workstation design.

The Department of Veterans Affairs is developing, testing and evaluating the benefits of physicians' workstations as an aid to medical data capture in an outpatient clinic setting. The physician's workstation uses a graphical user interface to aid the clinician in recording encounter data. Various input devices including keyboard, mouse, pen, voice, barcode reader, and tablet are available on the workstations, and user preferences will be examined. Access to general services such as electronic mail and reference databases is also available. The workstation provides a wide variety of patient specific data from the hospital information system, including image data. The single data collection process by the clinician will also provide data for the cost recovery process.

Computer Peripherals↗

[In vitro studies of modification of mucociliary clearance by guinea pig tracheas by exposure to air pollutants of sulfur or nitrogen dioxide].

We studied the effect of sulfur dioxide (SO2) and nitrogen dioxide (NO2) on mucociliary activity (MCA) and ciliary beat frequency (CBF) in 63 guinea pig tracheas. The tracheas were placed in a gas cylinder and exposed for 30 minutes to SO2 concentrations ranging from 2.5 to 12.5 ppm or to NO2 concentrations ranging from 3.0 to 15.0 ppm. Control experiments were performed with exposure of the tracheas to synthetic air. MCA was measured by recording the light reflected from ciliated mucous membranes using an infrared barcode reader and CBF using video-interference microscopy. The exposure to 2.5 ppm SO2 caused a reduction in mean MCA of 63% and no significant changes in CBF. Higher SO2 concentrations caused a further impairment of MCA as well as a dose-dependent decrease in CBF. 10.0 or 12.5 ppm SO2 induced a decrease from baseline values to approximately 20% in MCA and to roughly 30% in mean CBF. The exposure to NO2 at concentrations ranging from 3.0 to 15.0 ppm did not induce any changes in MCA or CBF of the guinea pig tracheas. Our results show that exposure to SO2 for 30 minutes is able to depress the mucociliary clearance of guinea pig tracheas, whereas the exposure to equivalent NO2 concentrations for the same time do not alter the mucociliary transport.

Air Pollutants↗

[Application of DNA fingerprinting to obstetrics and gynecology].

Restriction fragment length polymorphisms (RFLP) are variations in the size of restriction fragments of genomic DNA that hybridize to specific probes. They are the consequence of changes in primary DNA sequences, most of which result from small-scale changes in DNA. Recently minisatellite DNA probes that detect many regions of great variability within the human genome have been described. Minisatellite probes consist of multiple repeated copies of a common 10-15 base pair core sequence. On hybridization to restriction enzyme digests of human DNA, they simultaneously detect many highly polymorphic minisatellites at different loci in the genome, and produce band patterns that are individual specific. The band patterns are called "DNA fingerprints" or "DNA barcode" which can be used for individual identification on forensic and legal medicine. In addition to forensic and legal medicine, DNA fingerprinting can be used in both basic research and clinical examination of obstetrics and gynecology. The RFLP bands in DNA fingerprinting are inherited as single Mendelian co-dominants and we can use such minisatellite DNA probe for the determination of zygosity in multiple pregnancy. This probe can be used for the determination of androgenesis as a cause of complete hydatidiform mole. Each polymorphic band in molar tissues could be identified as being of paternal but not maternal origin. Some polymorphic bands of paternal origin were not observed in molar tissues, indicating that endoreduplication of a normal haploid sperm or fertilization by dispermy to an anuclear oocyte with no effective genome could be the cause of complete hydatidiform mole (androgenesis).(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗

Automated HPLC screening of newborns for sickle cell anemia and other hemoglobinopathies.

Automated HPLC is used to test dried blood-spot specimens from newborns for hemoglobins (Hb) F, A, S, C, E, and D. We present the method and report on its performance determined during >4 years of testing 2.5 x 10(6) newborns. The method features automated derivation of presumptive phenotypes; quantitative quality control and proficiency testing; throughput of one specimen per minute; small sample volume; hemoglobin concentrations quantified with an interlaboratory CV of 14-18%; retention times with interlaboratory CV of <2% and matching, within +/- 0.03 min, of laboratories and reagent lots; control of peak resolution; 0.5% detection limit for Hb S and C, and 1.0% for Hb F, A, E, and D; few interferences; and negligible background and carryover. Shortcomings of the method are the absence of microplate barcode identification and the need for manually pipetting the sample eluate into the microplate.

Anemia, Sickle Cell↗

DNA fiber fluorescence in situ hybridization analysis of immunoglobulin class switching in B-cell neoplasia: aberrant CH gene rearrangements in follicle center-cell lymphoma.

Immunoglobulin class switching usually involves deletion of part of the immunoglobulin CH region. By DNA fiber fluorescence in situ hybridization (FISH) with a barcode of probes covering the DH, JH, and CH genes, the configuration of the entire CH region can be visualized on single DNA molecules. Using this technique, we have studied class switching in three types of B-cell neoplasia, mantle-cell lymphoma (MCL), follicular lymphoma (FL) and hairy cell leukemia (HCL), representing B cells in, respectively, pregerminal center, germinal center, and postgerminal center stages of development. In MCL and FL, simultaneous detection of the t(11;14) and t(14;18) breakpoint with probes for the BCL-1 and BCL-2 loci, respectively, allowed differentiation between productive and nonproductive alleles. In none of 10 MCL cases was class switching detected. In 21 HCL, all nonimmunoglobulin M (IgM) cases had class-switch deletion consistent with the expressed isotype on at least one allele. In FL, however, a peculiar pattern of CH rearrangement was observed. In IgM expressing FL, the translocated alleles had switched in 11 of 13 cases, and the nontranslocated allele showed complex rearrangements downstream from the Cmu-Cdelta genes in 9 of 13 cases. These downstream rearrangements may reflect tumor-specific deregulation of the class-switch machinery. All seven immunoglobulin G (IgG) expressing FL showed class switching on both alleles. Fiber FISH analysis also showed several polymorphisms. The most frequent one, present on 38% of all analyzed alleles, consisted of an extra Cgamma gene or pseudogene in the 3' cluster.

B-Lymphocyte Subsets↗

Recurrent and niche-specific functional bacteriome of maize hybrid revealed by integrated metabarcoding and culturomics.

The plant microbiome plays a pivotal role in plant survival in natural habitats by facilitating nutrient acquisition, stress adaptation, and disease suppression, while also offering opportunities to enhance crop productivity and climate resilience. However, the distribution of persistent and culturable bacteriome across maize-associated niches and their functional potential remain poorly resolved. This study integrated metagenomic next-generation sequencing (mNGS-based metabarcoding) and culturomics to characterise the maize-associated bacteriome of bulk soil, rhizoplane, phylloplane, and cob of the maize hybrid PHM-1 under contrasting cropping and tillage systems, and to identify recurrent and agriculturally promising bacteriome components. The bacteriome exhibited pronounced niche-specific structuring, whereas overall bacterial community composition did not differ significantly across cropping and tillage treatments (ANOSIM, R&#x2009;=&#x2009;0.038, p&#x2009;=&#x2009;0.306). Proteobacteria predominated in the culturable bacteriome (69-84%; mean, 76.2%) but accounted for only 1% of the total bacteriome, whereas Patescibacteria and Firmicutes were relatively enriched. Niche-specific dominance was evident, with Pantoea accounting for 40.79% of the total and 56.27% of the culturable phylloplane bacteriome under cereal monocropping, while Serratia represented 31.59% and 59.40% of the total and culturable cob bacteriomes, respectively. Across niches, mNGS captured substantially greater bacteriome diversity, particularly uncultured and unidentified taxa in soil-associated compartments, whereas culturomics recovered a narrower but functionally accessible fraction. Culturomics yielded 99 isolates representing 32 species across 12 genera, including six genera shared with the mNGS-derived recurrent bacteriome: Bacillus, Enterobacter, Pantoea, Pseudomonas, Serratia, and Stenotrophomonas. Functional screening identified strong biocontrol and plant-beneficial traits among core-associated isolates. Pseudomonas oryzihabitans ZM-DL-PA10 inhibited Rhizoctonia solani, Macrophomina phaseolina, and Bipolaris maydis by up to 40.6%, 43.9%, and 45.2%, respectively, through secreted and volatile metabolites; exhibited P, K, and Zn solubilisation; and produced IAA and siderophores. It also recorded the lowest B. maydis disease index (ADI) of 1.00. Pantoea ananatis ZM-BH-EA4 showed 52.4% and 68.5% inhibition of R. solani and B. maydis, respectively, through volatile metabolites. Collectively, the integration of mNGS and culturomics revealed a strongly compartmentalised maize bacteriome and identified recurrent, culturable, and functionally promising bacterial taxa, providing a targeted resource for microbiome-based crop protection and climate-resilient maize production.

Zea mays↗