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Development of gemifloxacin in vitro susceptibility test methods for gonococci including quality control guidelines. The Quality Control Study Group.

Gemifloxacin (formerly SB-265805 or LB20304a) is a new fluoronapthyridone with documented activity against Gram-positive and -negative organisms. The activity of gemifloxacin was tested against 150 Neisseria gonorrhoeae strains, using reference agar dilution, standardized disk diffusion, and Etest (AB BIODISK, Solna, Sweden) methods. Gemifloxacin was very potent against ciprofloxacin (CIPRO)-susceptible strains (MIC(90,) 0.008 microg/ml) but was significantly less active against the CIPRO-resistant gonococci (MIC(90,) 0.12 microg/ml). Etest and reference agar dilution MIC results showed excellent correlation (r = 0.96), and 98.7% MICs were within +/- one log(2) dilution. Agar dilution MICs were also compared to zone diameters obtained using gemifloxacin 5-microg disks; and complete intermethod categorical agreement (100%) was achieved applying breakpoints proposed as follows: < or =0.25 microg/ml (zone, > or =25 mm) for susceptible and > or =1 microg/ml (zone, < or =21 mm) for resistant. Gemifloxacin MIC and disk diffusion te quality control (QC) ranges were established for N. gonorrhoeae ATCC 49226. Data were collected from > or = seven laboratories, three GC agar medium lots for both agar MICs and disk methods, and two lots each of the 5- and 10-microg disks. The proposed MIC QC range was 0.002 to 0.016 microg/ml and the calculated mm zone ranges (median +/- 0.5x average mm range) for both disks were similar, but contained only 88.1 to 91.9% of participant results. To achieve the acceptable > or = 95% of all study results within range, a 43 to 54 mm limits (5-microg disks) were necessary. The excellent broad-spectrum activity and a low reported adverse effects profile of gemifloxacin shows a potential for treatment of fluoroquinolone-resistant gonorrhea.

Anti-Infective Agents↗

Quality control and quality assurance of platelet counting.

The accuracy and precision of platelet counting using new automated blood cell analyzers is satisfactory. However, there are several errors in automated platelet counting. Careful review of blood cell histograms and peripheral blood films is necessary to avoid false platelet counts as well as to ensure a good quality control regimen.

Automation↗

[Quality control and quality assurance in therapeutic shoes for the diabetic foot].

More than 90% of diabetic patients with previous neuropathic foot ulcers will experience ulcer relapses within 48 months of follow-up. Custom-made cushioned footwear, according to observations in 217 patients at various centres, can prevent approximately 50% of ulcer relapses. However, the reports quoted lack some precision and clarity as to the etiology of the foot lesions taken into account, the time the footwear had been worn by the patients, the quality of the footwear, as well as the quality of simultaneous foot care, and the total observation period. Future long-term studies on the efficiency of footwear for diabetic patients are warranted, with better standardization. It is suggested that new technical equipment for computerized monitoring of in-shoe foot-pressures during gait should be used for quality control of the footwear of diabetic patients.

Diabetic Foot↗

An implementation plan for autopsy quality control and quality assurance.

The few guidelines that exist for performing autopsy quality assurance are vague. Much has been written about the use of the autopsy to monitor clinical services, but not how to monitor the quality of the autopsy and autopsy reports. We present the comprehensive quality assurance program that has been developed and implemented at Hahnemann University Hospital, Philadelphia, Pa, for the past 2 years; this program has encompassed quality control of our diagnostic work. Key features have included in-depth peer review of completed reports, documentation of review at conferences, and careful monitoring of turnaround time. We have found that integrating quality assurance into departmental conferences is a useful supplement to in-depth peer review of randomly chosen autopsies. Our approach to quality assurance may serve as a model for other pathology departments, particularly those with pathology residency training programs.

Autopsy↗

[From quality control to quality assurance. An ISO-9000 oriented approach for the hospital].

Measures taken to assure medical quality in hospital departments have focused on external quality control. Public health insurance organizations and the society of hospital holders in Germany have now agreed to carry out activities that aims not only at outcome but also at structural and procedural aspects of medical quality. The next step will be the introduction of quality management systems according to ISO 9000.

Delivery of Health Care↗

The role of the darkroom in radiograph quality control.

Quality is key to being able to read radiographs. If it is lacking or poor, it is impossible to make a proper diagnosis. This article describes simple techniques and provides answers to problems encountered in the production of quality radiographs, such as, darkroom management, correct safelights, fresh chemistry and clean equipment. It includes a problem-solving guide to causes and solutions for film marks, density and drying, as well as a simple method for evaluating when to change chemical solutions. Using these techniques should greatly improve quality without a large expenditure of time or money.

Humans↗

Quality control and quality assurance.

The office laboratory's need for quality is no different from that of any other clinical laboratory. If patients are to receive the benefit of physician's office testing, reliable, high-quality laboratory results are essential. To achieve this, the physician's office laboratory must have an adequate quality assurance program. Several fundamental components of such a program have been addressed in this article: procedure manuals, record-keeping, maintenance logs, quality control charts, participation in proficiency testing, and laboratory inspection. If your state's regulations do not yet require these activities in the physician's office laboratory, they soon will! A successful laboratory's quality assurance program will provide the following assurances. (1) Quality practices are established and followed by all personnel involved with the testing in the laboratory. (2) The technologist performing the test will know when systems and instruments are working properly and the patients' results are reliable. (3) High-quality information needed by the physician interpreting or evaluating patient laboratory results will be generated. (4) A set of written records is available demonstrating to the inspector that uniform and acceptable protocols have been established and are practiced in the laboratory. One short article cannot provide all the specifics for a laboratory's quality assurance program. The manufacturers and suppliers of instruments and reagents should be able to provide support in the following areas: calibration, type of controls to be used, development of a control chart, required maintenance procedures, establishment of accuracy and precision, and troubleshooting. If they cannot or will not, your laboratory should, perhaps, consider an alternative vendor to supply instrumentation and/or reagents. Additionally, resources such as the professional organizations, consultants, other clinical laboratories, and the inspectors or certifying agencies should also be considered in developing a comprehensive quality assurance program.

Ambulatory Care↗

[Modern techniques for quality control and quality management in gynecological health care].

Information technologies may contribute in many effective ways to total quality management. Their supporting capacity concerns areas such as clinical documentation and quality control as well as problem analysis, quality assurance and improvement and knowledge management. Here however, a great deficit of the available departmental information systems must be stated.

Documentation↗

Clinically useful limits (CUL) criteria as a basis for quality control including minimal and optimal goals for quality control.

Quality control goals for quantitative clinical chemistry assays are reviewed. Recommendations for clinically useful limits (CUL) criteria as minimally acceptable +/- 2 SD for run-to-run and/or day-to-day technical reliability are presented in terms of biologic variations for different levels and clinical applications. A review of the literature and the questionnaire response of a medical school staff presented in this study reveal striking agreement of acceptable analytic goals based on physicians' opinions, biologic variation, and practical analytic feasibility. The current state-of-the-art in clinical laboratories can approach excellence because actual within-laboratory 2-SD variability estimates are somewhere between acceptable CUL criteria and twice as good. Assessing the reliability of laboratory reports based on accuracy and precision or total analytic error is also discussed.

Blood Chemical Analysis↗

Scintillation camera quality control, Part I: Establishing the quality control program.

This is the first article in a four-part series on scintillation camera quality control. This series of articles will include both theory and practical knowledge on setting up a quality control program, acceptance testing and quality control for planar, SPECT and special imaging procedures. On completion of this article the reader should be able to: (a) discuss the purpose of a quality control program; (b) know how to establish the performance criteria for a scintillation camera; (c) know how to design a quality control program; (d) be able to set up the schedule for the quality control program; (e) understand the economics of quality control; and (f) justify the expenditure of the institution's resources on quality control.

Costs and Cost Analysis↗

Selection of candidate quality control isolates and tentative quality control ranges for in vitro susceptibility testing of yeast isolates by National Committee for Clinical Laboratory Standards proposed standard methods.

The National Committee for Clinical Laboratory Standards has developed a proposed standard method for in vitro antifungal susceptibility testing of yeast isolates (National Committee for Clinical Laboratory Standards, document M27-P, 1992). In order for antifungal testing by the M27-P method to be accepted, reliable quality control (QC) performance criteria must be developed. In the present study, five laboratories tested 10 candidate QC strains 20 times each against three antifungal agents: amphotericin B, fluconazole, and 5-fluorocytosine. All sites conformed to the M27-P standards and used a common lot of tube dilution reagents and RPMI 1640 broth medium. Overall, 98% of MIC results with amphotericin B, 95% with fluconazole, and 92% with 5-fluorocytosine fell within the desired 3-log2 dilution range (mode +/- 1 log2 dilution). Excellent performance with all three antifungal agents was observed for six strains: Candida albicans ATCC 90028, Candida parapsilosis ATCC 90018, C. parapsilosis ATCC 22019, Candida krusei ATCC 6258, Candida tropicalis ATCC 750, and Saccharomyces cerevisiae ATCC 9763. With these strains, 3-log2 dilution ranges encompassing 94 to 100% of MICs for all three drugs were established. Additional studies with multiple lots of RPMI 1640 test medium will be required to establish definitive QC ranges.

Amphotericin B↗