[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↗
[Standardization of cancer treatment and legal medical standards].
Legal medical standards are usually applied in two ways in Japanese medical malpractice cases. One application is a judgment on the quality of medical treatment, and the other is an evaluation of the validity of informed consent. Legal medical standards are not equivalent in all medical institutions. If physicians in a medical institution are expected to be aware of the most recent medical knowledge, that becomes the medical standard of the institution. For physicians in major metropolitan medical institutions, such knowledge constitutes the medical standard even before it is published in the guidelines of a committee of an established national medicoprofessional society. The standardization of cancer treatment may be used as evidence in medical malpractice suits brought by cancer patients based on both the quality of treatment and valid informed consent. In addition, it is possible that the validity of informed consent may be given more weight by the courts than the following of a course of standardized treatment by individual physicians/medical institutions in cases where patients have done extensive research on and exhibit informed knowledge of new treatment modalities.
Humans↗
[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↗
The Universal Standard Scale: proposed improvements to the American National Standards Institute (ANSI) scale for corneal topography.
PURPOSE: To evaluate the American National Standards Institute (ANSI) corneal topography scale (ANSI Z-80.23-1999) and to develop a Universal Standard Scale (USS) based on scientific principles and clinical usefulness. DESIGN: Retrospective data analysis and computer modeling of frequency of corneal power distributions. METHODS: Four variations of corneal topography color scales were constructed using the ANSI standard description. The scales used 21 contour intervals with step sizes of 0.5, 1.0, or 1.5 diopters (D). In example 1, hue was varied, whereas saturation and brightness were held constant. In example 2, hue was varied systematically, whereas luminance was varied to compensate for spectral sensitivity. In example 3, hue was varied, whereas luminance was adjusted to improve color contrast at the center of the scale. In example 4, the palette was generated by varying the red, green, and blue color intensity levels. In the USS, colors were defined by hue, brightness, and saturation, and appearance was optimized by using contrast. The contour interval was determined from the standard deviation of keratometry for 27 normal corneas. The scale range was based on corneal powers found in 388 topography maps of 12 different corneal conditions. RESULTS: ANSI-derived maps were difficult to interpret because of poor color contrast and the inability to associate contours with specific colors in the scale. The 0.5 D interval slightly improved the appearance of some patterns but reduced the useful clinical range of the scale. ANSI colors did not match the user's expectations; abnormal patterns appeared in shades of green, which is associated with normality. The standard deviation of keratometry readings for the normal population was 1.59 D. Hence, the contour interval for the USS was set to 1.5 D. More than 99.9% of the corneal powers in 388 clinical maps were within the range of 30 to 67.5 D, which was chosen as the range for the USS. CONCLUSIONS: The ANSI scale for corneal topography is a series of scales that lead to clinical misinterpretations. The alternative USS would provide uniform presentation, unambiguous interpretation, and greater ease of comparison among maps produced by different topographers.
Color↗
RFLP band size standards: NIST standard reference material 2390.
The procedural standard for DNA profiling developed by the U.S. advisory board on DNA quality assurance methods mandates annual confirmation of forensic DNA measurement systems against an appropriate reference material supplied by or traceable to the National Institute of Standards and Technology (NIST). NIST Standard Reference Material (SRM) 2390 is a suitable and appropriate standard for HaeIII restriction enzyme-based restriction fragment length polymorphism (RFLP) profiling systems. Originally issued in 1992, an among-laboratory SRM 2390 recertification study was initiated in 1997. Using data provided by the 20 state, local, or commercial forensic laboratory participants, quantitative band sizes values (expected mean values and associated bivariate tolerance intervals) are established for two different-source DNAs (female cell line K562 and healthy male "TAW") for genetic loci D1S7, D2S44, D4S139, D5S110, D1OS28, and D17S79. Methods for validating an RFLP measurement system, validating a control material or other secondary standard, and for tracing a particular set of RFLP measurements to NIST SRM 2390 are described in detail.
DNA Fingerprinting↗
[The Endotoxin 10,000 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 10,000 Reference Standard) (Control 0001)].
To establish the fourth lot (Control 0001) of the Endotoxin 10,000 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 10,000 Reference Standard), a candidate standard (CS) was prepared and then evaluated. The potency of the CS was assayed against USP Endotoxin Reference Standard (Lot G-1) and defined as containing approximately 20,000 endotoxin units (EU) per vial by a collaborative study in which 5 laboratories participated. Based on the results, the CS was authorized to be the fourth lot of the Endotoxin 10,000 Reference Standard containing 20,000 EU per vial.
Endotoxins↗
[The Endotoxin 100 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 100 Reference Standard) (Control 0101)].
To establish the second lot (Control 0101) of the Endotoxin 100 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 100 Reference Standard), a candidate standard (CS) was prepared and then evaluated. The potency of the CS was assayed against USP Endotoxin Reference Standard (Lot G-1) and defined as containing approximately 100 endotoxin units (EU) per vial by a collaborative study in which 5 laboratories participated. Based on the results, the CS was authorized to be the second lot of the Endotoxin 100 Reference Standard containing 100 EU of endotoxin per vial.
Endotoxins↗
[The Endotoxin 10000 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 10000 Reference Standard) (Control 0211)].
To establish the fifth lot (Control 0211) of the Endotoxin 10000 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 10000 Reference Standard), a candidate standard (CS) was prepared and then evaluated. The potency of the CS was assayed against USP Endotoxin Reference Standard (Lot G-1) and defined a s containing approximately 16,000 endotoxin units (EU) per vial by a collaborative study in which 5 laboratories participated. Based on the results, the CS was authorized to be the fifth lot of the Endotoxin 10000 Reference Standard containing 16,000 EU per vial.
Endotoxins↗
[The Endotoxin 100 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 100 Reference Standard) (Control 0201)].
To establish the third lot (Control 0201) of the Endotoxin 100 Reference Standard of the National Institute of Health Sciences (the Japanese Pharmacopoeia Endotoxin 100 Reference Standard), a candidate standard (CS) was prepared and then evaluated. The potency of the CS was assayed against USP Endotoxin Reference Standard (Lot G-1) and defined as containing approximately 130 endotoxin units (EU) per vial by a collaborative study in which 5 laboratories participated. Based on the results, the CS was authorized to be the third lot of the Endotoxin 100 Reference Standard containing 130 EU of endotoxin per vial.
Endotoxins↗
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↗