[On the National Institute of Hygienic Sciences Standard (the Japanese Pharmacopoeia Standard) "methotrexate Reference Standard" (author's transl)].
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Japan↗
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Results for “Standardization”
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[Medical quality in DIN ISO standards? (German Institute of Standardization International Organization for Standardization)].
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Humans↗
The standard of care is not so standard.
Malpractice lawsuits affect most physicians at some point in their career. Proving that malpractice has been committed is based on substantiation of a variety of elements, including that the patient was rendered care that was "below the standard" of care. While many physicians believe that the "standard" will be judged objectively on the basis of published scientific sources and accepted conventions, the standard is established rather by the testimony of expert witness(es). It is the expert testimony that sets the standard and is proof of the standard. The testimony is open for acceptance or rejection by the judge or jury for a variety of nonscientific reasons. We review what the defendant doctor might expect regarding proof required to establish breach of the standard of care and what the prudent expert should be obliged to demonstrate.
Health Services↗
Validity of simple approach to scoring and standard setting for standardized-patient cases in an examination of clinical competence.
The results are disappointing, providing little support for the validity of the case-passing decisions based on this simple approach to scoring and standard setting. The case-passing decisions predicted what the case author intended for about only 73% or 74% of the students on average and, with agreement expected by chance removed, predicted what the case author intended for about only 25% of the students. Even with the use of the optimal pass/fail cutoffs and the dropping of students with ambiguous borderline global ratings, the case-passing decisions failed to agree with the case authors' global ratings for 15% to 30% of the students. The findings might be dismissed as simply due to low reliabilities of passing decisions and global ratings based on a single case. Although this concern would apply to intercase reliabilities, which would be subject to case specificity, the appropriate reliabilities here would seem to be intracase (i.e., intrarater), which should be fairly high (if they could be computed). Nevertheless, it seems reasonable to expect much better agreement between results of case scoring and of standard setting developed by the case author and the case author's global ratings of performance on that case, given that the case author might recall the checklist, assign a weight to each item, and so forth. Also, case-passing decisions would possibly agree more with global ratings of live or videotaped performances than with ratings of written summaries of performance; however, that question remains a challenge for further research. In conclusion, the study provides only weak evidence, at best, for the validity of the scoring and standard setting commonly used with SP assessment. The results do not undermine claims about the realism of the SP approach, however, nor do they call into question the standardization afforded by this method of assessing clinical competence. The results do raise serious concerns about this simple approach to scoring and standard setting for SP-based assessments and suggest that we should focus more on the observation and evaluation of actual student performance on SP cases in the development of valid scoring and standard setting.
Achievement↗
Nursing standards of patient care and standards of nursing practice--a practical approach.
With the revision of the Joint Commission on Accreditation of Healthcare Organizations (JCAHO) nursing standards in 1991, a new emphasis has been placed on the nursing standards of patient care and the standards of nursing practice (Claflin, 1990). These standards provide the basis for nursing care and the foundation for nursing's contributions to an interdisciplinary quality improvement program. This article will describe how nursing standards of patient care and standards of nursing practice have been developed and integrated into a nursing department's documentation plan and quality improvement program.
Accreditation↗
[Improvement of inter-assay for the standardization of PT and TT--clinical significance of local standardization method].
We performed a nationwide Inter-assay including 112 laboratories for the standardization of prothrombin time (PT) and thrombotest (TT). The data were expressed as seconds, percentile and INR. INR was expressed by 2 methods; Method I (conventional method): INR was expressed using each ISI assigned for reagent or reagent-instrument at the respective laboratories and Method II (local standardization method): INR was expressed using each reference curve created with INR assigned standard plasmas at the respective laboratories. (1) Sample distribution of PT as well as TT was the smallest with the data expressed by Method II followed by Method I and then by percentile. The data expressed by seconds was widely distributed and not useful for the standardization of PT and TT. (2) Even the sample distribution obtained by Method II was dependent on the different ISI of the reagents, as it was found that the larger the ISI of the reagents, the wider the distribution of data. (3) The difference between PT and TT of each test plasma was analysed by t-test. It was found that the difference was insignificant when both data were expressed by Method II, but significant when expressed by Method I, suggesting that PT and TT were interchangeable with the use of Method II. (4) Sample distribution of percentile expression and INR with the use of method II was compared. It was revealed that the sample distribution of INR was smaller than that of percentile. It was concluded that INR expressed by the local standardization method was most useful for the standardization of PT and TT.
Humans↗
Preparation and standardization of U.S. Standard Pertussis Vaccine, Lot No. 11.
The Center for Biologics Evaluation and Research within the U.S. Food and Drug Administration has prepared a new U.S. Standard Pertussis Vaccine. Whole cell pertussis vaccine concentrate was diluted in 5% (w/v) lactose and lyophilized. The preparation was tested for toxicity, sterility, heterogeneity and residual moisture. Based on data from an international collaborative study involving 11 laboratories, the potency was estimated in relation to the U.S. Master Standard Pertussis Vaccine, Lot 4 and the International Standard for Pertussis Vaccine, Lot 2. The potency of the preparation was defined to be 90 units per ampoule. When reconstituted and stored according to instructions, no significant change in potency was observed in the 14 days following reconstitution. This material was shown to be suitable for a pertussis vaccine standard and accordingly it was designated as U.S. Standard Pertussis Vaccine, Lot 11 on March 22, 1994.
Animals↗
Development and standardization of solid phase assays for the detection of anti-neutrophil cytoplasmic antibodies (ANCA). A report on the second phase of an international cooperative study on the standardization of ANCA assays.
Anti-neutrophil cytoplasmic antibodies (ANCA) are diagnostic markers for systemic vasculitis. They are classically detected by an indirect immunofluorescence test using normal donor neutrophils as substrate. This assay lacks antigenic specificity and is not quantitative. The 'EC/BCR Project for ANCA Assay Standardization' is an international collaboration study with the aim to develop and standardize solid phase assays for ANCA detection. In this part of the study the isolation and characterization of proteinase-3 and myeloperoxidase, the two main target molecules for ANCA, and the development and standardization of ELISAs with these antigens are described. Six laboratories successfully isolated purified proteinase-3 preparations that could be used. Three of these preparations, together with one myeloperoxidase preparation, were subsequently used for ANCA testing by ELISA. The ELISA technique was standardized in two rounds of testing in the 14 participating laboratories. The coefficient of variation of these new assays decreased from values of approx. 50% in the first round to approx. 20% in the second round. We conclude that purified proteinase-3 and myeloperoxidase can be used in standardized ELISAs for ANCA detection. Whether such procedures offer advantages over the IIF test will be determined in a prospective clinical study.
Antibodies, Antineutrophil Cytoplasmic↗
Standardizing flow cytometry: construction of a standardized fluorescence calibration plot using matching spectral calibrators.
Calibration of flow cytometers is becoming an increasingly important issue for both quality control of instrument performance and quantitation of antibody binding capacity of cells. Due to the numerous different instruments and analysis software currently available, a standardized method of calibration is necessary if interlaboratory comparison of instrument performance and antibody binding is to be achieved. This report describes a new methodology to obtain a standard calibration plot that can be derived from all instruments and from which specific instrument-independent performance parameters may be calculated that can be used to directly compare the performance and setup of these instruments. The requirements that the calibrated standards must meet are discussed, as well as the acceptable ranges proposed for the instrument-independent performance parameters. In addition, data are presented from standard calibration plots generated by different flow cytometers in numerous laboratories. The corresponding Primary Performance Parameters calculated from these plots are presented and compared. It is expected that the use of this calibration method may help standardize flow cytometric measurements and will provide instrument-independent performance parameters to monitor quality control of instruments and reagents.
Calibration↗
Effects of self-focus, discrepancy between self and standard, and outcome expectancy favorability on the tendency to match self to standard or to withdraw.
Objective self-awareness theory (Duval & Wicklund, 1972) assumes that the intensity of attempts to match self to standard or to withdraw is a function of degree of self-standard discrepancy. Self-regulation theory (Carver & Scheier, 1981) assumes that the decision to match or withdraw is determined by outcome expectancy favorability. Combining these assumptions, it was predicted that increasing self-standard discrepancy would increase efforts to conform self to standard when outcome expectancies are favorable. When unfavorable, increasing discrepancy was predicted to increase efforts to avoid the situation. Results from Experiments 1 and 2 provided partial support for these hypotheses. Results from Experiment 3 suggested that deviations from prediction were due to outcome expectancy favorability being a function of the rate of progress toward discrepancy reduction relative to the magnitude of self-standard discrepancy.
Achievement↗
Process standards of nursing care for patients with COPD: validation of standards and criteria by the Delphi technique.
It is common for professional literature to describe quality of care as based on standards. Yet little attention is given to the steps that precede the establishment of these standards. This study answers the question. "Which nursing care standards and criteria should be developed for chronic obstructive pulmonary disease (COPD) patients discharged from a pulmonary rehabilitation center? "Our approach included the following steps: delineating the scope of care and service, identifying indicators, and formulating standards and identifying criteria. Aspects of care included are: establishment and maintenance of a good care relationship with the patient; delineation of the care needs during the home visit; provision of health education, advice, and instruction; support in psychosocial problems; and coordination and continuity of the service. These standards and criteria were validated by the Delphi technique.
Clinical Protocols↗
Standardization of Factor VIII. II. A British Standard for Factor VIII related antigen.
A collaborative study on factor VIII related antigen (VIII R:Ag) has been carried out, involving 11 laboratories in the U.K. Samples of two different freeze-dried plasmas were assayed against participants' own local standards by the Laurell electroimmunoassay method. There was reasonably good agreement on the relative potencies of the two freeze-dried plasmas, but there were considerable differences in the VIII R:Ag content of the plasma pools used as local standards, with values ranging from 83% to 129% of the mean. All participants agreed on the need for a standard for VIII R:Ag, and that the unit be defined by the mean of the local standards. Accordingly, freeze-dried plasma 66/355 was established as the 1st British Standard for factor VIII related antigen, with an assigned potency of 1.05 units per ampoule.
Antigens↗
Stevens' power law and time perception: effect of filled intervals, duration of the standard, and number of presentations of the standard.
Subjects estimated the duration of five different time intervals, either filled or unfilled, in relation to one or two standard intervals. Half of the subjects were presented with the standard at the beginning of the experiment only, and half were presented with the standard before every interval. The five estimations were then used to calculate, for each subject, the exponent in Stevens' Power Law which describes the form of the power relationship. The resulting over-all exponent of .91, although nearly linear, was significantly different from 1.0. The data were then analyzed by a 2 X 2 X 2 analysis of variance which showed a significant interaction between presenting the standard either once or before each interval with the duration of the standard.
Female↗
[Standardization of the complement fixation test (CFT) in brucellosis. I. The Polish standard of anti-Brucella abortus serum].
The purpose of this paper was to prepare an indigenous standard of anti-Brucella abortus serum for the complement fixation test (CFT) as a homologue of the secon International Standard of anti-Brucella abortus Serum (ISABS-II), which contains 1000 international units of complement-fixing antibodies in 1 cm3. The indigenous Standard of anti-Brucella Abortus Serum (ISABAS) was prepared in 1975. The material used was the serum of a cow infected with Br.abortus, biotype 1, under natural conditions. The cow was beheaded on the 54th day after abortion. The serum obtained was filtered through a Seitz EK filter and appropriately diluted with normal bovine serum. The preparation was lyophilized in 8500 ampules, each of which contained 1 cm3 of serum. They were filled with nitrogen before closing them. It was shown that ISABAS activity in CFT was approximate to that of ISABS-II. The studies in CVL, Weybridge showed that one ampule contained 1115 international units of complement-fixing antibodies. ISABAS titres in the agglutination test (AT) and antiglobulin test (AGT) were 320+ + and 2560+ + + respectively. Reduction with 2-mercaptoethanol and separation on a column with Sephadex G-200 gel showed that anti-Brucella antibodies occurred in ISABAS mainly in IgG class. ISABAS lyophilizate is characterized by stability of CFT titre, good solubility and a low anticomplementary activity. The average weight of the lyophilizate in an ampule is 79.57 mg, standard deviation - 0.36%. ISABS may serve as the basis of antigen standardization and other elements of indigenous CFT technique in brucellosis.
Animals↗
Report on skin test standardization. The Committee on Skin Test Standardization of The Netherlands Society of Allergology.
The decision to set up a Committee on Skin Test Standardization was taken in 1985 at the spring meeting of the Netherlands Society of Allergology. The committee's terms of reference were to make recommendations about: (i) the standardization of skin-test techniques; (ii) ensuring the quality of skin-test techniques; (iii) determining whether tests should be carried out using serial dilutions and, if so, under what conditions; (iv) the adaptation of standard series or the use of minimum numbers of allergen extracts with adults and children. This committee cannot be viewed separately from the previously established Committee on the Standardization of Allergen Extracts. The availability of allergen extracts that are as highly standardized as possible is an essential condition for good skin-test diagnostics.
Adult↗
Standardization of factor VIII: establishment and use of secondary standards.
Two secondary standards for use in routine assays of Factor VIII in therapeutic concentrates and in patients, plasmas, respectively, have been established in a multicenter collaborative study. In order to assess the effect of the adoption of these preparations as common Secondary Standards a comparative assay has been performed: one sample of a Factor VIII concentrate of intermediate purity and one plasma sample have been tested in two laboratories for Factor VIII:C activity using as reference, among others, the common working standard. Analysis of the results shows that with the plasma sample the differences of the estimates obtained with any of the references in our two laboratories were not statistically significant (P greater than 0.3), while with the concentrate sample the differences were always statistically significant (P less than 0.005). The study shows that the adoption of common working standards (besides the uniformity in assay method, reagents and basic equipment) is not sufficient to eliminate interlaboratory variation in the measurement of Factor VIII:C.
Antigens↗
Diagnostic value of standardized assays for anti-neutrophil cytoplasmic antibodies in idiopathic systemic vasculitis. EC/BCR Project for ANCA Assay Standardization.
Anti-neutrophil cytoplasmic antibodies (ANCA) are widely used as diagnostic markers for Wegener's granulomatosis (WG), microscopic polyangiitis (MPA), Churg-Strauss syndrome (CSS) and idiopathic rapidly progressive glomerulonephritis (iRPGN). The objective of this study was to evaluate the diagnostic value of ANCA measurement by the indirect immunofluorescence (IIF) test, and by anti-PR3 and anti-MPO ELISA performed in different locations, in patients with idiopathic small vessel vasculitis. Fourteen centers participated in a standardization study of ANCA assays, and entered a total number of 169 newly diagnosed and 189 historical patients with idiopathic systemic vasculitis or iRPGN. Patients were classified according to a pre-defined diagnostic classification system. Results were compared with those of 184 disease controls and 740 healthy controls. The IIF test was performed according to standard methodology; ELISAs had been standardized among the participants in a previous phase of the study. The sensitivities of assays in patients were as follows. The sensitivity in WG was: cANCA 64%, pANCA 21%, anti-PR3 66%, anti-MPO 24%. In MPA the sensitivity was: cANCA 23%, pANCA 58%, anti-PR3 26%, anti-MPO 58%. Sensitivity in iRPGN was: cANCA 36%, pANCA 45%, anti-PR3 50%, anti-MPO 64%. The specificity of assays (related to disease controls) was: cANCA 95%, pANCA 81%, anti-PR3 87%, anti-MPO 91%. When the results of the IIF test were combined with those of the ELISAs (cANCA/anti-PR3 positive, pANCA/anti-MPO positive), the diagnostic specificity increased to 99%. The sensitivity of the combination of cANCA + anti-PR3 or pANCA + anti-MPO for WG, MPA or iRPGN was 73%, 67% and 82%, respectively. From this study we conclude that the value of the IIF test for ANCA detection can be greatly increased by the addition of a well standardized antigen-specific ELISA. In a significant number of patients with idiopathic small vessel vasculitis, however, the ANCA test results (either in IIF or ELISA) are negative.
Adolescent↗
Rapid inoculum standardization system: a novel device for standardization of inocula in antimicrobial susceptibility testing.
A rapid inoculum standardization system for antimicrobial susceptibility testing without incubation or the conventional turbidity adjustment has been developed. The rapid inoculum standardization system consists of a plastic rod with cross-hatched grooves on one end and a specific nutrient medium in a vial. The crosshatched grooves are designed to pick up and release a known number of viable microorganisms. In use, the end of the rod is touched to five colonies 1 to 2 mm in diameter from a primary agar plate, thus filling the grooves with bacteria. The rod is placed into the vial, and the bacteria are suspended in the medium by agitation with a Vortex Genie Mixer. The resulting suspension contains 5 X 10(7) to 5 X 10(8) CFU/ml for most gram-negative bacilli and gram-positive cocci. Microorganisms such as streptococci that have colonies less than 1 mm in diameter require as many as 10 colonies for an adequate inoculum suspension. Ninety-five commonly encountered bacterial isolates were tested in triplicate by agar plate counts. The resulting overall geometric mean of the agar plate counts was 1.52 X 10(8) CFU/ml for the species tested. We have found that the rapid inoculum standardization system provides a consistent and reproducible method for the standardization of inoculum for antimicrobial susceptibility testing without the incubation period and turbidity adjustment.
Anti-Bacterial Agents↗