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In the present experimental study, the A. put in evidence a very important aspect for the management and the organization of the Public Health Service: the definition and the control of the "quality care". After a short introduction, the A. explains the methods and the results of the study: in the discussion the A. emphasizes the lacks and the qualifying aspects of the present study.
BACKGROUND: The increasing interest for quality in hospital care brought the need to evaluate the effect of quality control and quality assurance strategies that are being or could be implemented in spanish hospitals. METHODS: This article describes the results of the pre-assessment phase of a study carried out as a european concerted action in a total of 262 hospitals in 15 european countries. Spain contributed with 88 hospitals divided in two groups of 62 and 16 hospitals. The study herein reported refers to the group of 62 hospitals belonging to the spanish National Health System in which the characteristics of the hospital and the baseline situation in respect to quality assurance structures and activities have been assessed through the answers to the standard questionnaire used the study. RESULTS: Sixty-two hospitals filled out the preassessment questionnaire. Twenty three (37%) have a quality assurance programme and eighteen have personnel assigned to it. Clinical or quality control committees exist in 56 hospitals (90.3%). Fifty six hospitals (88.7%) know their autopsy rate, and 27 (43.5%) know their nosocomial infection rate as well as the adverse reactions due to blood transfusions. Complaints are registered in 56 hospitals (90.3%) and patients surveys are carried out in 54 (87.1%). Only 33 hospitals (53.2%) actually use this data for quality assurance purposes. CONCLUSIONS: Most of the quality activities in hospitals are carried out by physicians or nurses in the different clinical committees considered as quality committees. The patients surveys results and the data from patients complains are not used in those committees as inputs for quality actions. The committement of the top hospital management is needed to achieve an integrated approach to quality activities in hospitals.
Due to a technical rule for dangerous agents (TRGS 410), issued by the Ministry of Labor in the Federal Republic of Germany in 1979, toxicological analyses in biological materials must be carried out under conditions of "statistical quality control". This quality-control scheme provides internal and external control programmes. For internal quality control, the results of many years of experience with five commercially available control specimens and one "home-made" control have been evaluated. The control samples showed good, comparable results over a long period. Except in a few cases, there was good agreement between our results and the assigned values. Since 1982, the German Society of Occupational Medicine has offered eight intercomparison programmes for external quality. In samples from 80-90 laboratories, 6 metals in blood and around 20 inorganic and organic parameters in urine in 2 concentration adjustments have been analysed. Successful participation was certified if both results obtained for one parameter were within the tolerance range (assigned value +/- 3 SD). The average success rate was around 60%.
A comprehensive set of acceptance tests is the basis for an effective quality control program. Acceptance tests indicate whether the scintillation camera meets published specifications but should also include evaluation of certain parameters not specified by the vendor but that can seriously affect image quality. Once a camera is "accepted," initial quality control tests serve as a benchmark for future measurements. Tomographic systems must be subjected to the same basic quality control program as planar cameras. Flood field images must be acquired and evaluated daily; spatial resolution must be tested once each week. Less frequently, parameters such as multiple-window spatial registration, collimator uniformity, system sensitivity, and camera "dead time" should be evaluated. Single photon emission computed tomographic systems require additional tests to ensure optimum performance. Center-of-rotation calibration and verification of detector registration are needed to avoid losses of spatial resolution. Flood corrections based on high-count images eliminate residual detector nonuniformiaties and correct for subtle collimator defects. Pixel size must be calibrated to avoid errors in attenuation correction and distortion when cardiac and brain reorientation software is used. Completed clinical studies must be checked for unacceptable patient movement and incomplete views. A quality control program may be time-consuming, but, from the standpoint of maximum benefit to patients and confidence in clinical interpretations, there is no alternative.
The College of American Pathologists (CAP) Interlaboratory Survey Program in microbiology was reviewed for quality control practices of the Special Bacteriology participants (907 laboratories) using the disk agar diffusion antimicrobial susceptibility test method. Data from a questionnaire was compared to performance results on two well recognized quality control strains, e.g., Pseudomonas aeruginosa ATCC 27853 and Streptococcus faecalis ATCC 29212. The results show no significant difference in survey performance between those participants using daily controls (97.78 and 96.99% acceptable results) and those using weekly controls (97.33 and 96.67% acceptable results). Similarly, the number of tests done per work day had little influence on the reported mean zone diameter and subscriber results were comparable to published means from the reference literature. Recommendations are made to use weekly quality control after test proficiency has been repeatedly demonstrated by daily or batch control results. More frequent testing would be required if any reagent lot were replaced or altered. Comparable data on quality control intervals of greater than 7 days was not evaluated due to small numbers of test results.
Methods for statistical quality control for the clinical laboratory in general, and radioimmunoassay in particular, have been proposed for many years. Unfortunately, only a very small number of laboratories have adapted these procedures. By use of teletypes and other remote terminals, it is possible for all laboratories to access centralized computers where a general purpose quality control program can be stored. This relieves each laboratory of the costly task of developing software, provides some degree of inter-laboratory standardization and facilitates comparison of precision and accuracy between laboratories. A prototype program for this purpose is described. This program evaluates within-assay and between-assay variability, by means of an analysis of variance for a one-way classification random-effects model, and can monitor any assay parameter by use of control chart techniques. In addition, several tests are provided to evaluate the temporal stability of the assay system, and appropriate tests for outliers are included. Also, methods are described for combination of information from several quality control samples. This provides a valid basis for adjustment of assay results or for outright rejection of an assay. For convenience, this program is designed for output on a teletype or similar terminal located in the laboratory. Simplified versions of this program can be readily adapted to desk-top calculators. The original purpose for developing this system was to provide the clinical laboratory with a simple, general, and flexible method for assessing the performance of radioimmunoassays, but its usefulness should extend to virtually all assay methods.
A quality Control Program for Chest Radiography was established in a six room Radiology Department. After a preliminary educational session on the definition of a "good" chest film, and the factors which affect the image quality, a "Chest Team" was established. The technologists were divided into three groups: Standard Chest Group, Consistency Group and Monitoring Group. Each group served as a control for the other, resulting in standardization of all methods, techniques, and acceptance criteria in the department. A random inspection of chest radiographs, both before and after the project, showed significant improvement in the overall quality of chest films in the department over a three month period. Follow-up confirmed that the established standard was maintained with minimal effort.
Quality control is an essential element in clinical laboratory investigations. In the basic programs for quality control used in recent years accuracy control has been carried out through a comparison with method-dependent assigned values. With this system the "accuracy" of results from different laboratories is relative, and comparability is assured only when the laboratories use the same analytical method. Considering the steadily increasing variety of methods and equipment, a meaningful exchange of information in patient care, teaching and research is becoming more and more difficult; but clinical requirements make such an exchange essential. In this paper a new concept for quality control is presented for discussion. In the basic program incorporating the new concept the method-dependent assigned values are replaced by reference method values, which are method-independent. In addition to accuracy control, an ongoing monitoring procedure using a Shewhart control chart is also carried out. The maximum allowable day-to-day imprecision and the maximum allowable deviation from the reference method value are fixed on the basis of clinical requirements. This means that the ratio of biological variation to analytical between-day imprecision should be greater than or equal to 2. If the biological variation is unknown, then the reference interval is used in its place; the quotient, reference interval/analytical between-day imprecision, should then be greater than or equal to 8. The decision limits for the interlaboratory surveys should be fixed in an analogous manner independent of the analytical method. After the introduction of quality control based on the new concept the results from different laboratories would be comparable to the extent dictated by clinical requirements. The main principles underlying the new concept and the effects of using the new approach are presented for discussion, and the reader is invited to submit comments in writing.
Quality control sera for radioimmunoassay (RIA) are supplied commercially, as lyophilized sera will become more common due to the ease of their usage, good reproducibility and the constant supply. This paper demonstrates the improvement in accuracy and precision of analyses proved over the year by the tracking of recovered and recommend proper analysis simplified enough for routine application. The recovery test for quality control is described and can be used to control intra-day variation with R values and to control long-term intra and inter-day variation and suits the purpose that is not supported by commercial control sera well.
We have designed a quality control tool for haemoximetry using the principle that standard p50, calculated from blood gas and haemoximetry measurements using the Siggaard-Andersen algorithm, remains unchanged when a specimen of venous blood is oxygenated progressively to 97% saturation of haemoglobin. If the haemoximeter is inaccurate, progressively larger deviations of standard p50 from the constant value occur above 80% saturation. Deviations too small to be detected by analysis of quality control materials comprised of non-haemoglobin dyes and yet sufficient to cause significant errors in derived extractivity parameters can be detected by this method. The suggested protocol is easy to perform, and is recommended as a quality control tool for blood gas analyser/haemoximeters used to determine arterial extractivity parameters.
AIM: To establish methods and requirements for the quality control of recombinant human neu epitope peptide 12. METHODS: Biological activity of recombinant human neu epitope peptide 12 was evaluated in FVB/N transgenic mice (TgN MMTV neu 202 Mul, Jackson Lab., USA) administered with samples. The percentage of antibody-positive mice detected by ELISA was used in the biological activity evaluation. The peptide map was performed by peptic digestion. The antigen content was determined by SEC-HPLC. RESULTS AND CONCLUSION: The quality control methods, such as biological activity, peptide map, antigen content, and the requirements for the quality control of recombinant human neu epitope peptide 12 were established. The established methods and requirements were already used for the quality control of recombinant human neu epitope peptide 12 products.
One method of quality control which has recently been recommended by professional bodies in the UK is the 'rapid review' method. This involves the microscopic 30 s review of all negative cervical smears with the intention of flagging potential missed abnormalities. Although it has been suggested that rapid review is better than 10% random rescreening of negative smears, the efficiency and efficacy of this method of quality control have not been thoroughly evaluated. We have used the AxioHOME system, which can record the area of a slide covered and the screening time, to investigate slide coverage during rapid review quality control, as performed by 15 cytoscreeners and MLSOs reviewing a test set of 22 slides each. The test set comprised 18 negative slides, three positive slides, and one unsatisfactory slide. We have recorded two distinct methods of rapid review in use amongst cytotechnologists, the step method and the whole slide method. The data show that rapid review takes longer on average than the recommended 30 s, the mean screening times being 76 s and 82 s for the step and whole slide methods, respectively. Abnormal smears were missed on three of 15 occasions by the step method (sensitivity 80%, positive predictive value 85%), and on seven of 30 occasions by the whole slide method (sensitivity 76.6%, positive predictive value 45%). However, the 95% confidence intervals were wide (57.7-90.7% for the step method, and 51.9-95.7% for the whole slide method). Analysis of scanning tracks and screening rates shows significant flaws in the methodology of rapid review. Abnormal cells were not identified, although dyskaryotic cells were included in the scanning track on nine occasions, seven using the whole slide method and two using the step method. On one occasion (using the step method) abnormal cells were not identified because they were not included in the scanning track. Further research is in progress to determine optimal methods of rapid review, and whether the rapid review technique is as effective as automated screening systems for quality assurance in cytology.
Fractures of the acetabulum are severe injuries of the hip joint. Exact preoperative management is necessary to make possible an anatomical reconstruction. Postoperative quality control is done best with computed tomography. Is the higher radiation exposure caused by this routine examination justified?During the 5 years from 1995 to 1999, a total of 154 patients with fractures of the acetabulum were examined postoperatively at our clinic using CT to control reconstruction, implant position and the remaining free fragments in the joint. Thirteen of these patients (8.4%) had to be re-operated after postoperative CT control. The causes of the re-operation were four cases of an intra-articular implant position, three of free fragments remaining in the joint, and in 6 patients showed inadequate reconstruction. The mean radiation exposure was 25 mGy per patient. The low mean age of the patients and the long lasting consequences of a probably unrecognised complication, justify routine, postoperative CT control, even though the radiation exposure is about 10 mGy higher than the conventional radiological diagnosis. The use of CT diagnosis as a routine postoperative measure is an appropriate control procedure that allows an objective assessment of the quality of the result for the patient as well as for the surgeon.
UNLABELLED: A good quality assurance system ensures that a product will be safe and suitable for the intended use. Quality control is an important part of the quality assurance system. Two main topics are discussed in this paper: General aspects including regulations, possibilities, economics and responsibility; and PROCEDURES: Methods for the determination of the physical, chemical, pharmaceutical and biological purity with special regard to new methods, problems and pitfalls, e.g. the measurement of radioactivity using an isotope calibrator; the radionuclide purity of 123I; alpha- and beta-emitting impurities in 99mTc ; High performance liquid chromatography (HPLC); Mini-chromatograms; and the value of animal tests.
It goes without saying that assurance of quality control in a clinical laboratory is the most essential factor which can be easily influenced by how medical support is practiced. In recent years, the appreciation of a narrow sense of quality control in analysis has become the central focus. These days, however, we are seeing that reports of examinations have been submitted to doctor with mistake which come in stages from the patient's materials for examinations to making the report. We have not only cleared up the cause but we have also checked our work on these kinds of faulty reports and thought of measures for mistake in putting them to practical use. Moreover, as we have developed the laboratory system with full-time staff in our institution, we have been able to take advantage of this kind of problem to accomplish our laboratory work. To avoid a mistake, comprehension and collaboration of MD and co-medical staff is required. To ensure this end, it is also required that we usually communicate with an MD and nurse. It is possible that our carelessness cause us to make mistake in our work such as bleeding examination after usual hours. These examinations are based on a basic line of sharing this sort of work with all staff. In future, we aim for laboratory examination to permeate not only in a laboratory but also in the whole hospital.
In our nuclear medicine laboratory the quality control (QC) of radioimmunoassay (RIA) has been performed along the line of WHO program for standardization and quality control of RIA. The QC procedure was automated using a minicomputer in order to avoid tedious and time-consuming hand processing. The program was written with BASIC language. The counts of radioactivity measured in autowell counters are regarded in PTR, through which the data are read into a minicomputer (Scintipac 200). After informations on the concentrations of standards are registered through keyboard of CRT, the data processing is performed including curve fitting, dose calculation and quality control. As the indicators for QC response error relationship (RER), standard curve, precision profile and QC chart are displayed on CRT. On the basis of rejection criteria using these indicators, bad assays are identified to be omitted from reporting. The subroutine installed in the minicomputer system is used for the storage of data on QC samples in each assay, which are used for construction of QC charts. The use of a minicomputer enables implementation of QC of RIA on routine basis with ease and speed.
To obtain a pure ornithine carbamoyltransferase for quality control in clinical chemistry, the authors compared human plasma and bovine liver ornithine carbamoyltransferase. The data show that the KM of both enzymes are similar (respectively 1.03 and 1.33 mmol when ornithine is used as substrate; 1.02 and 1.06 mmol with carbamyl phosphate). The following properties are shown to be equivalent: linearity of the enzymatic reaction, inhibition by higher substrate concentrations, and temperature denaturation. The similarities between the two enzymes indicate that bovine liver ornithine carbamoyltransferase can be used in clinical chemistry quality control.
Quality control is essential for maintenance and improvement of a successful human in vitro fertilization and embryo transfer (IVF/ET)/intracytoplasmic sperm injection(ICSI) program. Quality control of medium, serum and equipments were performed using endotoxin measurement and human sperm survival test. It was proved by high pregnancy rate that the method of quality control at present study was essential for the development of the program.