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Estimation, prevention, and quality control of carbon dioxide loss during aerobic sample processing.

We find that 2 to 6 mmol of carbon dioxide per liter (mean: 4.1 mmol/L) is lost during routine laboratory processing of patients' serum samples after centrifugation. Additional CO2 may be lost if evacuated blood-collection tubes are not filled completely during phlebotomy. More than 2 mmol of CO2 per liter is lost from samples stored in tightly stoppered tubes for 120 min if the tubes are less than half full. In extreme cases, 8 mmol of CO2 per liter may be lost from samples exposed to room air in open cups of automated micro-sample instruments. Clinically significant CO2 loss (greater than 2 mmol/L) before analysis is not detected by many laboratories because the generally accepted quality-control programs monitor only the very last step of the analytical process. A valid CO2 quality-control program should include samples with high as well as the generally used low pCO2 values. Alkalinization of serum and plasma samples with tert-butylamine prevents CO2 loss. Optimum tert-butylamine concentration, pH, and pCO2 were about 14 to 16 mmol/L, 9.0 to 9.3, and 0.4 to 1.5 mmHg (about 50 to 200 Pa).

Autoanalysis↗

Quality control measures in the assay of common urinary steroids as applied to a multi-column chromatographic procedure.

Quality control measures in the assay of common urinary steroids include stringent controls not only with details of the procedure but also, through a steady monitoring of the output, with the use of "blind" duplicates, the application of estimates of duplicate variability, comparison of the sum of individual steroids chromatographically estimated with independent total group assays and the use of internal standards in the procedure.

Chromatography, Liquid↗

Using a computer to manage the radiation safety and quality control activities in diagnostic radiology.

Software has been developed to aid in the management of a radiation safety quality control program in diagnostic radiology. The core of the system is a data base of radiation safety activities. Software design goals were the prioritization, scheduling, and reporting of these activities. Computerization has helped organize the timely performance of surveys necessary for compliance with regulatory and accreditation agencies. Clear, concise program documentation and reporting are also provided.

Georgia↗

Heart failure and protein quality control.

The heart is constantly under mechanical, metabolic, and thermal stress, even at baseline physiological conditions, and cardiac stress may increase as a result of environmental or intrinsic pathological insults. Cardiomyocytes are continuously challenged to efficiently and properly fold nascent polypeptides, traffic them to their appropriate cellular locations, and keep them from denaturing in the face of normal and pathological stimuli. Because deployment of misfolded or unfolded proteins can be disastrous, cells, in general, and cardiomyocytes, in particular, have developed a multilayered protein quality control system for maintaining proper protein conformation and for reorganizing and removing misfolded or aggregated polypeptides. Here, we examine recent data pointing to the importance of protein quality control in cardiac homeostasis and disease.

Animals↗

[Quality control from the viewpoint of clinical obstetrics].

Recommendation of the Society for Perinatal Medicine of the GDR for quality control in clinical obstetrics and early neonatology. A continuous data collection and periodical summary of the recommended most important figures are the supposition for internal and external comparison and the prediction of average efficiency for hospitals with different specialisation in obstetrics and early neonatology.

Female↗

On improved calibrations of unknowns in a system of quality-controlled assays.

Two new estimators for calibrating unknowns from dose-response curves, in a system of quality-controlled assays, are examined. In contrast with the conventional estimator which uses only the results of the one assay in which the response of the unknown dose is measured, the new estimators also utilize the results of all other assays through the replications of the control samples in the system. The first estimator is based on maximizing the likelihood of the given system (with respect to the different dose-response parameters, the levels of the control samples and the levels of the unknowns) when response errors are normally distributed. The second estimator is a regression-like estimator obtained by subtracting from the conventional estimator its estimated regression on the deviation of the calibrated control levels in the given assay from their average values in the system. Evaluations of the reductions in bias and variance attained by the new estimators show when substantial reductions in mean square error can be expected. The new estimators are illustrated with a system of 22 hFSH radioimmunoassays.

Animals↗

[Quality control during mammography I. Standardisation of technique and physical measurements (author's transl)].

The general problems in evaluating the radiographic quality of mammograms are outlined. A new method is described which provides an analysis of the physical conditions on a standardised mammogram and by which results can be obtained from a single film. The method is designed for detecting technical shortcomings of the mammographic imaging system, including the x-ray apparatus, films system, including the x-ray apparatus, film systems and development. As part of a programme for quality control of mammograms, the method represents an addition to spot checks.

Female↗

Organ donation quality control in Abruzzo region (Italy).

Abruzzo is a region in central Italy with a population of 1,262,392. Within this region there are 13 hospitals with intensive care units, four of which have neurosurgical units. The Regional Centre for Transplants in L'Aquila is notified of encephalic deaths in hospitals in Abruzzo and Molise and coordinates organ retrieval and transplantation. Organ donation is a process that involves a whole series of professionals who, operating in a sequential manner in each hospital, make possible the use of a cadaveric organ to give life to a person or improve the quality of life of a patient on a waiting list. Quality control procedures were introduced in 2001 and involve all of the hospitals in the region with intensive care units. The system for quality control was computerized in 2004 and is used in the four hospitals with neurosurgical units (type A hospitals) and in the 13 hospitals without (type B hospitals); the different types of deaths (cause of death, age, etc) are also analyzed with this system. One of the aims of this system is to discover the theoretical donation capacity, taking as benchmark values those resulting from the regional average and those published in international literature, and noting any shortcomings. It has emerged that donor identification is well organized and efficient and this is thanks to a concerted effort that has been made to overcome technical and organizational problems connected to donor detection and donor maintenance during the 6 hours of legal observation. The high percentage of opposition to organ removal, despite the fall registered in the first half of this year (2005), is still above the national average and still remains a critical point in the organ donation process.

Hospital Mortality↗

A non-pathogenic vibrio for the routine quality control of TCBS cholera medium.

A non-pathogenic "indicator" organism to relapse Vibrio cholerae in the routine quality control of TCBS medium was sought among a large collection of freeze-dried vibrios isolated mostly from environmental sources. One strain, which was consistently more sensitive to inhibition of growth on TCBS medium that strains of V. cholerae and V. parahaemolyticus, is recommended for this purpose. It has been deposited with, and is available from, the National Collection of Type Cultures as NCTC 11218.

Culture Media↗

ER-associated degradation in protein quality control and cellular regulation.

The ER-associated degradation (ERAD) pathway directs ubiquitin-mediated degradation of a variety of ER-associated misfolded and normal proteins. Recent studies have delineated the molecular machinery responsible for protein ubiquitination and highlighted mechanistic questions surrounding the recognition, extraction and proteasomal destruction of the diverse array of ERAD substrates. Consideration of separate lines of work on this versatile pathway now indicate that despite its central role as an avenue of cellular quality control, ERAD is also harnessed for feedback regulation of sterol synthesis, and most likely numerous other cellular processes. These studies give ERAD a larger role in cellular function, and imply that cellular quality-control pathways could be widely employed in both natural and pharmaceutical control of individual proteins.

Adenosine Triphosphatases↗

Glycoprotein tertiary and quaternary structures are monitored by the same quality control mechanism.

Folding of glycoproteins entering the secretory pathway is strictly surveyed in the endoplasmic reticulum by a quality control system. Folding intermediates and proteins irreparably misfolded are marked via glucosylation by the UDPglucose:glycoprotein glucosyltransferase, an enzyme that acts as a folding sensor by exclusively labeling glycoproteins not displaying their native structures. Here we show that this sensing mechanism also applies to the oligomerization of protein complexes, as the glucosyltransferase appeared to be able to glucosylate folded complex subunits lacking the full complement of oligomer components.

Glycoproteins↗

The NMR-MOUSE: quality control of elastomers.

New applications of the NMR-MOUSE (mobile universal surface explorer) to non-destructive quality control of elastomers are reported. One example concern the thermal aging of fast clutches which was probed by measurements of 1H transverse relaxation time. Novel methodological developments show that 1H double-quantum filtered NMR signals can be generated in the inhomogeneous fields of the NMR-MOUSE for characterization of residual dipolar couplings. This technique was applied to characterize reference natural rubber samples with different crosslink density and carbon black and silica fillers.

Elastomers↗

Signal probability effects on error detection performance in a quality control task.

This study was designed to examine the influence of signal probability on detection accuracy in a quality control task patterned after the checking of prescriptions in a pharmacy. Signal probability was defined as the ratio of erroneous scripts to correct scripts. 91 participants were either exposed to signal probabilities ranging from 26 to 30% ("low probability") or 34 to 38% ("high probability") while checking two sets of 40 simulated scripts for accuracy. Wrong item, wrong number, and wrong label information errors were possible, and performance was measured in terms of sensitivity (percentage of errors detected) and specificity (percentage of correct orders accepted). Analysis indicated that sensitivity was significantly worse for participants in the high signal probability condition, but specificity was not significantly different between signal probability conditions. Connections to existing theory and future directions for research are discussed.

Adult↗

Quality control criteria for quantitative enzyme-linked immunosorbent assay of porcine immunoglobulins A and M.

Using radioimmunoassay methods, quality control criteria were applied to monoclonal antibodies produced to measure porcine immunoglobulins by quantitative ELISA. Porcine IgM and IgA were purified to homogeneity and were used to produce murine hybridomas that secreted antibodies against IgM, IgA, and immunoglobulin light chains. A competitive ELISA was developed to measure IgM, and a sandwich ELISA was used to quantify IgA in serum and colostrum. Both ELISA were tested for specificity, accuracy, sensitivity, and precision. Monoclonal antibodies were specific for porcine IgM or IgA in serum and colostrum, and competitive and sandwich ELISA fulfilled all validation criteria.

Animals↗

Quality control of lymph node dissection in the Dutch randomized trial of D1 and D2 lymph node dissection for gastric cancer.

BACKGROUND: Variability among surgeons and reduced protocol adherence threaten the conduct and outcome of surgical multicenter trials. We introduced, in the Dutch Gastric Cancer Trial of D1 and D2 (extended) lymph node dissection for gastric cancer, a novel way of managing instruction, quality control, and evaluation of protocol adherence.METHODS: Of 1078 patients entered in the Dutch trial, 711 patients with potentially curative resections were evaluated. Numbers and locations of lymph nodes detected at pathological investigation were compared according to the guidelines of the Japanese Research Society for the Study of Gastric Carcer. Non-compliance indicated inadequate removal of lymph node stations, whereas contamination indicated that lymph nodes were detected outside the intended level of dissection. Protocol adherence during the course of the trial, and the impact on complications, hospital mortality, and survival were evaluated.RESULTS: Major non-compliance was noted in 15.3% of D1 and 25.9% of D2 patients. Contamination was present in 22.9% of D1 and 23.5% of D2 patients, and was limited to one or two lymph node stations only. Intensification of quality control resulted in only a marginal improvement in protocol adherence and in the number of lymph nodes detected. There was no association between protocol adherence and the occurrence of complications or long term survival.CONCLUSIONS: Contamination proved an important parameter to substantiate protocol adherence by the surgeon, whereas non-compliance had a multifactorial cause. Non-adherence to the protocol did not lead to increased hospital morbidity and mortality, but also had no impact on long term survival.

Journal Article↗

[Informed consent for the use of the remaining portion of laboratory specimens for education, research, and quality control of laboratory tests].

The remaining portion of a laboratory specimen is usually used for education, research, and quality control of laboratory tests in hospitals, but informed consent has not been obtained because of the high volume of patients who undergo laboratory tests. However, patients must be informed in some manner. Therefore, we decided to inform patients that any remaining specimen would be used for various purposes by placing such a notice on walls in the central clinical laboratory and hospital lobby. We then obtained a signature on a dissent document, instead of a consent document, from any patient who dissented from such use. This indirect process for obtaining informed consent was approved by the ethics committee of Osaka University Medical School. The number of dissent documents sent in to the director was 54 of about 400,000 patients who underwent laboratory tests over the last 3 years, and there was no complaint against this "informed consent process".

Clinical Laboratory Techniques↗

Calibration, quality control, and stability of a quantitative enzyme immunochromatographic method for therapeutic drug monitoring.

We describe a noninstrumented quantitative method for therapeutic drug monitoring (AccuLevel test) that uses a factory-calibrated unit test format and a novel single-level approach to quality control. The AccuLevel method is based on the principles of immunochromatography, which provides a number of convenient protocol advantages without sacrificing assay performance or quality assurance. Most of the benefits of the immunochromatographic method derive by virtue of the fact that quantification is dependent on enzyme migration rather than enzyme activity. Since migration height is almost solely a function of a highly stable, immobilized, dry antibody reagent, the AccuLevel test is extremely insensitive to environmental factors. The predictable and uniform dependence of quantification on antibody site concentration allows complete reliability with a single-level control. These features of stability, factory calibration, and unitized test components make the AccuLevel immunochromatography method amenable to new quality control schemes.

Antibodies, Monoclonal↗

[Evaluation of the first program of external quality control in hematology of the Spanish Hematology and Hemotherapy Association. Experience of 1 year's activity].

The External Quality Control Programme in Haematology (EQCP-H) comprises a monthly remittance of two whole-blood control samples for evaluating red cell count (RBC), white cell count (WBC), platelet count (PC), haematocrit (HT), haemoglobin rate (HB) and red cell indices (MCV, MHC, MCHC), as well as lyophilized plasma for prothrombin time (PT), partial thromboplastin time (PTT) and fibrinogen (F) determination. The participant laboratories were classified for each determination in accordance with the methods used. The evaluation was made on the basis of 1986 data, the number of participants being 230, from Public Health (54%) and private 46%) laboratories. A mean (means) or target value, along with the standard deviation (SD), was obtained for the results received in the Organising Centre for each parameter. In order to find deviation of individual results with respect to means, a deviation index (DI) was calculated with regard to the whole group and to those laboratories using the same methods. The graphic evaluation of the results was plotted on a Youden diagram. The active participation was 58.3 +/- 5.7%, ranging from 33% (PC) to 74% (RBC, HB, HT and MCV). Upon evaluating the whole programme, stress was laid on the global variation coefficient (VC%) attained for each parameter and those pertaining to the analytical systems employed, grouped in accordance with the methodological principles. Global VC% ranged between 3.6% (HB) and 31.9% (PTT), and the values corresponding to the analytical procedure used were below 4% for RBC, HB, MCV and MCHC in automatic systems and also for HB and MCV in semiautomatic systems. Although the working period of EQPC-H is too short to draw definitive conclusions on the improvement it may induce in the methodological quality, the high VC% values found for WBC, PC and manual determination of HB, along with the unacceptable values for PT, PTT and F, should be stressed.

Hematologic Tests↗