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PubMed2000

Standardization in biological staining. The influence of dye manufacturing.

The purpose of biological staining is to obtain specimens of biological material that can be assessed in the microscope. These specimens are influenced by all processes from removal from the intact organism to mounting on the microscopic slide. To achieve comparable results with various techniques for biological staining, standardization of all procedures and reagents is mandatory. In this paper, I focus particularly on dyes and consider the possibilities for obtaining standardized dyes. In general practice, most biological staining takes place with available commercial dyes. These dyes may or may not have been subjected to quality assessment either internally by the producer or vendor or externally by independent investigators or organizations such as the Biological Stain Commission. Concerted attempts at standardization in Europe are discussed. The latest results of this work, the European standard EN 12376, is presented. This standard is concerned with information supplied by the manufacturer with in vitro diagnostic reagents for biological staining. The standard has been prepared by a Working Group on Staining in Biology under Technical Committee 140, In Vitro Medical Devices, of the European committee for standardization, CEN.

Animals↗
PubMed1990

Standard specimens for stain calibration: application to Romanowsky-Giemsa staining.

Standardized specimens with reproducible staining properties were fabricated from extracts of biological objects (bovine liver, nucleoprotamine and defatted muscle). The standard specimens were stained with two formulations of the Romanowsky-Giemsa stain (RG), using the same azure B and eosin Y. One formulation used methanol and Sorensen's buffer and the other DMSO and Hepes buffer as solvents. The standard specimens were stained either in the composite stain or in the individual dyes dissolved in the same solvents and at the same concentration as the composite stain. Solution spectroscopy demonstrated different spectra for the two formulations with some wavelength regions varying by more than an order of magnitude. The RG spectra were also very different from those of the individual dyes dissolved at the RG concentration in the respective solvents. The stained standard specimens were analyzed by microspectrophotometry and were found to have spectra similar to those of cell smears. Furthermore, the standard specimens were shown to be a repeatable substrate for stain uptake. The transmitted light intensity from random fields of the same standardized specimen varied +/- 5%. When specimens were stained at the same time, the specimen-to-specimen variation depended on preparation conditions and the measurement wavelength, but was as good as +/- 5% for some conditions. The quantitative stain performance of both formulations was studied and compared. The standardized specimens provide a tool for the quantitative study of staining processes and specimen preparation procedures and for stain calibration.

Animals↗
PubMed2004

Ensuring that the competent are truly competent: an overview of common methods and procedures used to set standards on high-stakes examinations.

Determining whether or not an examinee has met an adequate standard of performance constitutes a central task for licensure and certification bodies. Consequently, standard setting is a key activity for all certification and licensing testing programs. The purpose of this article is to provide an overview of methods that have been proposed for set a passing standard on an examination. First, the distinction between norm-referenced and criterion-referenced methods for setting a standard will be outlined. Then, both test-centered and examinee-centered methods for setting a passing standard will be explicated. The importance of factoring in the consequences of adopting a standard will also be illustrated via the Hofstee method. In the concluding section, important issues pertaining to the selection of panelists as well as the validation of the standard will be addressed briefly.

Animals↗
PubMedDate not supplied

Follow up retrospective study of compliance with a standard of care for retinopathy of prematurity in one neonatal intensive care unit.

A retrospective chart review was conducted to determine the impact of recently instituted guidelines on compliance with the standard of care for retinopathy of prematurity (ROP) in the Newborn Intensive Care Unit at the University of Utah Medical Center. In a previous study, it was found that infants eligible for participation in a National Institutes of Health-funded study of ROP were routinely receiving screening eye examinations, whereas infants who qualified for ROP screening according to the standard of care, but not eligible for the study, were seen infrequently. Consequently, a plan to improve the compliance with the standard of care for all infants who fit the standard criteria was implemented. The comparison revealed significant improvement in compliance rates. In one subgrouping of infants, compliance rose from three of 16 (18.75%) infants screened for ROP according to the standard of care, to nine of 11 (82%) infants screened for ROP according to the revised standard. This increase in compliance appears to be due to adherence to guidelines recommended in an earlier study, which included increasing staff awareness of the standard of care, designating a person to schedule and track infants who fit the screening criteria, and including the need for ROP screening on the admission and discharge summary.

Female↗
PubMed1991

Development of outcome standards in critical care.

The forces influencing the development of outcome standards are gaining momentum. These forces are professional nursing issues, accreditation standards, and reimbursement issues. Traditionally, structure and process measures provided the means for evaluating the quality of nursing care. But nurses also play an important role in achieving positive patient outcomes. Outcome standards provide a mechanism for measuring patient outcomes. In 1990 the American Association of Critical-Care Nurses (AACN) published Outcome Standards for Nursing Care of the Critically Ill. The book serves as a model for developing and using outcome standards in critical care units. This chapter describes these outcome standards and recommends ways to use them. The Joint Commission on the Accreditation of Healthcare Organizations' (JCAHO) ten-step model outlines development of unit-specific outcome standards. Methods focus throughout on a quality assurance framework.

Critical Care↗
PubMed1991

Oncology nursing care standards.

Oncology nursing as a specialised nursing discipline has no published nursing care standards for South Africa. The purpose of this study was to formulate oncology nursing standards for a particular research hospital. A specific approach was used and the oncology nursing experts in the research hospital compiled and formulated the standards. Group discussions and critical debating of the standards followed. The standards were ratified by means of verbal consensus between the experts and professional nurses in the oncology unit. These standards could serve as a guide to ensure quality oncology nursing care. National validation of the standards is recommended.

Academies and Institutes↗
PubMed1986

Assessing clinical skills of residents with standardized patients.

Current techniques do not provide a reproducible, reliable, or valid basis for assessing clinical skills. The need for large-scale direct observation and standardized assessment procedures has precluded development of better techniques. A project using standardized patients presenting with common clinical problems evaluated the skills of 336 internal medicine residents at 14 New England residency programs in 1289 standardized patient and resident encounters. Results indicated that reproducible assessment of the clinical skills could be achieved in approximately 1 day of testing time using standardized patients. Resident performance improved with years of training, and senior residents and those from programs with stronger reputations performed better and were more homogeneous in ability. Low correlations between standardized-patient-based measures of clinical skills and other evaluation techniques suggested that standardized patients provided unique information. Reactions of residents and faculty to standardized-patient-based evaluations were favorable.

Clinical Competence↗
PubMed1991

Assessment of clinical skills of residents utilizing standardized patients. A follow-up study and recommendations for application.

OBJECTIVE: To determine the reliability and validity of "standardized patients" to assess clinical performance of internal medicine residents. DESIGN: Each resident spent 2 half-days interacting with 19 standardized patients (nonphysicians taught to portray patients in a reproducible fashion). Each resident was asked to obtain focused histories, perform relevant physical examinations, and provide patient education or counseling. At the end of each 10- to 15-minute encounter, the resident was asked to identify positive findings on physical examination and to prioritize a differential diagnosis. Other, more traditional indicators of clinical skills were also obtained. PARTICIPANTS: Three hundred ten residents from nineteen internal medicine training programs in the New England region of the United States. RESULTS: Reproducible estimates of data gathering and interviewing skills were achieved with 1 day of testing. Validity analyses were difficult to interpret because of the lack of an external "gold standard." However, faculty judgments of performance from reviewing videotapes corresponded with standardized-patient-based scores. Differences in group performance were also demonstrated across years of training and between U.S. or Canadian and foreign medical graduates. CONCLUSIONS: Systematic and effective procedures for developing standardized-patient-based test materials and for training standardized patients have been developed. This technique is best used for measuring data gathering and interviewing skills. Correlations with commonly used evaluation methods were generally low; this may be because standardized patients measure different skills. Local use of this technique by residency programs and the development of regional consortia sharing resources, costs, and expertise are advocated.

Clinical Competence↗
PubMed1995

Management of information: analysis of the Joint Commission's standards for information management.

In the 1994 Accreditation Manual for Hospitals, the Joint Commission on Accreditation of Healthcare Organizations published ten standards relating to the management of information. Using Andrew Abbott's systems theory of professions, the article compares the views of information management that were prevalent in hospitals before the publication of the standards with the view of information management represented by the new standards. Five characteristics of the standards are discussed: conceptual view of information management, tension between the unity and diversity of information management activity, lack of specificity about who performs information management activities, separation of professional qualifications from functions, and privileging of information systems concepts and vocabulary. The unfamiliarity of the standards and their inherent ambiquities will give rise to many attempts to interpret their meaning and intent. Five interpretive themes that may arise from the characteristics of the standards are identified: unified diversity in information management, unity in information management, diversity in information management, monotheistic view of information, and information management czar. The future of information management in hospitals will be affected by the jockeying over the interpretation and implementation of the Joint Commission's standards.

Accreditation↗
PubMed1996

Setting standards.

To ensure that a housekeeping department operates smoothly, various standards must be established and applied. Standards serve as a guide to quality and quantity. The standards will be determined cooperatively by members of top management with input from the housekeeping director and the user department. An appraisal of the facility needs to be made in order to establish proper standards. Once the appraisal has been completed, time standards, frequency standards, and quality standards can be established.

Guidelines as Topic↗
PubMed1985

Medical devices; invitation for offers to submit or to develop a performance standard for cardiac monitor (including cardiotachometer and rate alarm)--FDA. Notice of inquiry.

The Food and Drug Administration (FDA) is issuing this notice to invite interested persons, including any Federal agency, to submit any existing standard as a proposed performance standard for the cardiac monitor (including cardiotachometer and rate alarm) for use in measuring heart rate, or to submit an offer to develop such a proposed standard. If FDA does not receive any response to this notice, or receives a response to but does not accept any existing standard or offer to develop a standard, the agency will proceed to develop a performance standard or take other appropriate action to facilitate the development of a performance standard for the device.

Electrocardiography↗
PubMed1986

Medical devices; invitation for offers to submit or to develop a performance standard for breathing frequency monitor (neonatal apnea monitor)--FDA. Proposed rule.

The Food and Drug Administration (FDA) is issuing this notice to invite interested persons, including any Federal agency, to submit any existing standard as a proposed performance standard for the breathing frequency monitor intended for use on infants (also called the neonatal apnea monitor), or to submit an offer to develop such a proposed standard. If FDA does not receive any response to this notice, or receives a response but does not accept any existing standard or offer to develop a standard, the agency will proceed to develop a performance standard or take other appropriate action to facilitate the development of a performance standard for the device.

Apnea↗
PubMed1998

Proposal of a new Internet standard for DICOM: DICOM-QR URL.

This paper proposes a new Internet standard that is combination of two standards in different domain, Internet and medical informatics. The both standards are described briefly in this paper. We describe how to combine them into a Internet standard. With a new standard, there are several advantages for medical information systems. The standard should be established by the following way of the Internet standards.

Internet↗
PubMed1999

Use of standard radiography to diagnose paranasal sinus disease of asthmatic children in Taiwan: comparison with computed tomography.

Paranasal sinus disease and bronchial asthma are frequently associated. Computed tomography imaging is currently the most reliable method for confirming the diagnosis of sinusitis. Due to the cost and amount of radiation during computed tomography, our aim was to analyze whether standard radiography, under computed tomography-control, had a reasonable degree of confidence in the diagnosis of sinusitis. Fifty-three asthmatic patients (42 males and 11 females) with a mean age of 9 years (range 4-14) were enrolled. We evaluated the maxillary sinuses, ethmoidal sinuses, frontal sinuses, and sphenoidal sinuses using standard radiography (Waters' view, Caldwell view, and lateral view) and compared with computed tomography (coronal views), the latter served as a standard. Computed tomography (CT) showed paranasal sinusitis in 58% (31/53) of the asthmatic children. Compared with the results of computed tomography, standard radiography revealed a sensitivity of 81.1% and a specificity of 72.7% for maxillary sinusitis. The sensitivity and specificity for ethmoidal, frontal, and sphenoidal sinusitis were 51.8%, 84.8%; 47.3%, 87.2%; and 40.8%, 93.3%, respectively. In 21 (40%) of the 53 patients, discrepancies were seen between the interpretations of standard radiography c and those of CT scans. In patients with maxillary sinusitis, the correlation between standard radiography and CT was good. However, ethmoidal, frontal, and sphenoidal sinusitis were poorly demonstrated using radiography. Standard radiography can be recommended as a screening method for maxillary sinusitis, but it is not recommended for the diagnosis of other paranasal sinusitis.

Adolescent↗
PubMed1999

A randomized comparative study of the Bandloop versus the standard loop for transurethral resection of the prostate.

PURPOSE: The Bandloop is a new electroresection loop that is broader than the standard loop and thickens from front to back. We compared the safety and efficacy of the Bandloop to the conventional loop electrode for transurethral prostatectomy. MATERIALS AND METHODS: A randomized prospective study was performed on 53 patients with lower urinary tract symptoms and estimated prostatic volume greater than 30 ml. on transrectal ultrasonography. The Bandloop was used in 25 cases (Bandloop group) and standard loop was used in 28 (standard group). Surgical outcomes, including International Prostate Symptom Score, resected prostatic weight, operative time, uroflowmetry, post-void residual urine, postoperative catheterization period, time to disappearance of macrohematuria, and serial changes of hemoglobin and urinalysis, between the 2 groups were compared. RESULTS: A total of 23 Bandloop and 28 standard loop cases were evaluable. There was no difference in preoperative estimated prostatic volume (mean 44.7 versus 47.8 ml.), resected prostatic weight (36.5 versus 29.4 gm.) or operative time (61 versus 60 minutes) between the 2 groups. The ratio of resected weight-to-estimated prostatic volume was significantly greater in the standard group (81.4% versus 61.9%). There was no difference in postoperative catheterization period (3.3 versus 3.4 days) or time to disappearance of macroscopic hematuria (5.0 versus 5.0 days). Postoperative changes in symptom score (-15.1 versus -15.9), maximum flow rate (11.8 versus 16.3 ml. per second at 12 weeks) and residual volume (-31.6 versus -48.6 ml. at 12 weeks) demonstrated no significant difference between the 2 groups. There was no difference in intraoperative and postoperative bleeding estimated by serial changes in serum hemoglobin and urinalysis after surgery. No patient had major complications or required transfusion. CONCLUSIONS: Transurethral prostatectomy using the Bandloop is as safe and effective in achieving subjective and objective improvements as standard transurethral prostatectomy. However, our randomized study indicates that the Bandloop offers no advantage compared to the standard loop electrode for transurethral prostatectomy.

Aged↗
PubMed2000

[Anatomopathological and biochemical correlation of lesions produced by standard and irrigated 4 mm radiofrequency catheters].

INTRODUCTION AND OBJECTIVES: The influence on the size of radiofrequency lesions by cooling of the tip of the electrode remains unclear. Moreover, the possible effects of two different cooling systems, closed and open, have not been well differentiated. We designed this study to compare both systems of irrigated-tip catheters and the lesions produced with standard 4 mm catheters and also to evaluate the pathological and biochemical marker release correlation (cardiac troponin I) in an experimental model. METHODS: The study was performed in 20 pigs. Applying between 1-8 radiofrequency pulses, at a power of 15, 25 or 50 watts, for 15-60 seconds to each animal. After 7 days, the pigs were sacrificed for anatomopathological study. RESULTS: A total of 54 lesions were produced, 25 with standard catheters and 29 with irrigated catheters. The mean volume of the lesions produced with standard catheters was 146 +/- 110 microl and with irrigated-tip catheters 856 +/- 864 microl (p < 0.001). Peak values of cardiac troponin I were also higher for irrigated catheters (18 +/- 15 ng/ml) than for standard (6.5 +/- 3 ng/ml). The correlation between the size of the lesion and the levels of cardiac troponin I were 0.86 and 0.79 with the standard and irrigated-tip catheters, respectively. The incidence of cratering was higher with standard catheters (60%) than with irrigated (27%). CONCLUSIONS: The lesions produced with an irrigated catheter are greater than those observed with standard catheters. The mean peak value of postablation cardiac troponin demonstrate a good correlation with the real size of the necrosis.

Animals↗
PubMed2002

[Standards, options and recommendations for nutritional support in bone marrow transplant patients].

CONTEXT: The "Standards, Options and Recommendations" (SOR) project, started in 1993, is a collaboration between the Federation of French Cancer Centers (FNCLCC), the 20 French cancer centers and specialists from French public university and general hospitals and private clinics. Its main objective is the development of clinical practice guidelines to improve the quality of health care and outcome for cancer patients. The methodology is based on literature review and critical appraisal by a multidisciplinary group of experts, with feedback from specialists in cancer care delivery. OBJECTIVES: To develop, according to the definitions of the Standards, Options and Recommendations, clinical practice guidelines for nutritional support in bone marrow transplant patients. METHODS: Data were identified by searching Medline , web sites and the personal reference lists of members of the expert groups, then submitted for review to 75 independent reviewers. RESULTS: The main recommendations for nutritional support in bone marrow transplant patients are: 1) Nutritional evaluation and monitoring may be proposed to bone-marrow transplant recipients (options). 2) Nutritional evaluation consists of body weight assessment and percent weight loss evaluation (standard, expert agreement). 3) Nutritional monitoring should include daily weight monitoring, clinical monitoring of hydration and assessment of daily dietary intake (standard, expert agreement). 4) Artificial nutrition is recommended in immuno-suppressed bone marrow transplant patients. This is not systematically indicated in other situation (standard). 5) Artificial nutrition, intravenous hydration and oral nutrition can be proposed to bone-marrow transplant recipients (option). 6) There is no standard modality for artificial nutrition (level of evidence B 1). Exclusive enteral or parenteral nutrition and enteral plus parenteral nutrition may be proposed to bone-marrow transplant patients (options). 7) Lipid intake representing up to 30% of the non-protein caloric intake should be supplied to patients undergoing bone marrow transplantation (standard, level of evidence B1). 8) Oral supplementation with nitrogen substrates or glutamine is not recommended. Parenteral glutamine supplementation may be proposed (option).

Algorithms↗
PubMed2002

PET performance measurements using the NEMA NU 2-2001 standard.

UNLABELLED: The NU 2-1994 standard document for PET performance measurements has recently been updated. The updated document, NU 2-2001, includes revised measurements for spatial resolution, intrinsic scatter fraction, sensitivity, counting rate performance, and accuracy of count loss and randoms corrections. The revised measurements are designed to allow testing of dedicated PET systems in both 2-dimensional and 3-dimensional modes as well as coincidence gamma cameras, conditions not considered in the original NU 2-1994 standard. In addition, the updated measurements strive toward being more representative of clinical studies, in particular, whole-body imaging. METHODS: Performance measurements following the NU 2-1994 and NU 2-2001 standards were performed on several different PET scanners. Differences between the procedures and resulting performance characteristics, as well as the rationale for these changes, were noted. RESULTS: Spatial resolution is measured with a point source in all 3 directions, rather than a line source, as specified previously. For the measurements of intrinsic scatter fraction, sensitivity, and counting rate performance, a 70-cm line source is now specified, instead of a 19-cm-long cylindric phantom. The longer configuration permits measurement of these performance characteristics over the entire axial field of view of all current PET scanners and incorporates the effects of activity outside the scanner. A measurement of image quality has been added in an effort to measure overall image quality under clinically realistic conditions. This measurement replaces the individual measurements of uniformity and of the accuracy of corrections for attenuation and scatter. CONCLUSION: The changes from the NU 2-1994 standard to the NU 2-2001 standard strive toward establishing relevance with clinical studies. The tests in the updated standard also are, in general, simpler and less time-consuming to perform than those in the NU 2-1994 standard.

Gamma Cameras↗