Objective To compare product standards of drug and medical device made from sodium alginate and calcium alginate between domestic and abroad, and to emphases on the process parameters monitoring based on different standards. Methods Sodium alginate and calcium alginate standards of both domestic and foreign were analyzed and summarized, and the differences and commonalities of various product standards among each standard were compared. Results Differences exist in product standards of sodium alginate and calcium alginate between domestic and abroad, whether drug or medical device, but the fundamental control points are concordant. Conclusion Companies should focus on product quality control requirements combined with its own unique manufacturing process characteristics to develop reasonable and controllable quality standards, which can ensure safe and effective clinical use.
Objective To analyze and compare the domestic quality standard and foreign quality standard of sodium hyaluronate (HA), and to expatiate on the critical process monitoring parameters. Methods Different quality standards of HA were compared by translating and sorting, and some experimental data were analyzed as well as the manufacturing practice was elaborated. Results Differences exist in raw materials standard or specifications of products between domestic and foreign, but the basic control points are concordant. Conclusion The company should set up reasonable and controllable quality standard based on quality requirements and related process characteristics so as to assure the safety and effectiveness of the clinical application.
Objective To review the development and quality control of modern tissue banks. Methods The rules, regulations and the management literatures about tissue banks were extensivelyand comprehensively reviewed. Results Tissue banks havea significant progress and are developing to concentration, industrialization and standardization gradually. Quality control is being paid more attention in modern tissue banks. Conclusion Modern tissue banks will have a good future and the quality control must be intensified.
Objective To analyze the quality control results of forced vital capacity ( FVC) test in elderly patients. Methods 534 lung function test reports of the elderly patients ( ≥ 80 years old) from January 2010 to December 2010 were collected from pulmonary function testing laboratory in Shougang Hospital of Peking University. Based on the report results, the selected patients were divided into four groups, ie. a normal group, a restricted group, an obstructed group, and a mixed group. The results of lung function tests that met the criteria of quality control in each group were statistically analyzed. Results A total of 534 reports were collected, of which 36 were not credible and treated as test failure. Of the 498 credible reports, 99.6% ( 496 /498) met the start-of-test criteria for quality control. 95. 8% ( 477/498) met the exhalation process test criteria for quality control with the highest rate of 98.6% ( 217 /220) in the obstructed group and the lowest rate of 85. 9% ( 55 /64) in the restricted group. The difference between two groups was significant (Plt;0.01) . 68.1% ( 339/498) met the end-of-test criteria for quality control with the highest rate of 88.6% ( 195/220) in the obstructed group and the lowest rate of 18.8% ( 12/64) in the restricted group. The difference between two groups was significant (Plt;0.01) . 16.7% (88/498) of the reports could be analyzed for repeatability, and the obstructed group had the highest rate of 22.3% (49/220) while the restricted group had the lowest rate of 6.3% ( 4/64) . The difference between two groups was significant too (Plt;0.01) . Only 14.6% (73/498) of the reports met all of the criteria listed above. Conclusions Elderly patients can also complete FVC test but the result may be not credible. There are still lots to be improved in FVC test for elderly patients.
ObjectiveTo investigate the efficacy of Quality Control Circles (QCC) in reducing the emergency application times of maintenance hemodialysis. MethodsIn December, 2012, the quality circle was formed by eight nurses and a physician, through brainstorming. The group finally selected "Reducing emergency maintenance dialysis times" as the theme. With the help of questionnaire, interview, and comparative study, we analyzed the emergency situation of maintenance hemodialysis patients, and regulate and implement related policies. ResultsBy QCC practices, the times of hemodialysis declined from 11.7 to 5.3 cases per month, which exceeded our expectations largely. As to the circle members, their problem-solving skills, responsibility, communication skills, self-confidence, motivation and QCC techniques were also improved. ConclusionQCC can not only reduce the times of maintenance dialysis, but also improve the team cohesion, harmony and quality management capabilities.
ObjectiveTo reduce patients' adverse events caused by needle indwelling through quality control circle (QCC) activities, in order to ensure the effectiveness and safety of intravenous fluids. MethodsGuided by the QCC theory, we set up QCC, selected the topic related to reduction of patients' adverse events caused by needle indwelling, and worked out the plans from September 2012 to April 2013. Then, we adopted Plan-Do-Check-Act (PDCA) cycle method to set up goals, formulate measures, and inspect and improve the results. ResultsThe incidence of needle-related adverse events reduced from 44.8% to 9.8% by implementation of quality circle activities. There was a significant statistical difference between the two groups (χ2=148.16, P<0.05). ConclusionQCC activity can not only reduce the adverse events incidence of needle indwelling, but also improve the nurses' working enthusiasm and responsibility, problem-solving skills and accomplishment, and promote team cohesion.
ObjectiveTo study the effect of quality control circle (QCC) on the improvement of Intensive Care Unit (ICU) nurses' engagement in working. MethodsModified Gallup's Q12 questionnaire was used to survey ICU nurses of our hospital before and after QCC was carried out, and then we compared the engagement scores. ResultsBefore and after QCC was carried out, ICU nurses' engagement scores were statistically significant (P<0.01). ConclusionQCC in the ICU is an effective way of improving ICU nurses' engagement, which is worth promoting.
ObjectiveTo establish a comprehensive, appropriate quality control system on the Sysmex-XN series automatic blood cell analyzer to improve the reliability of blood cell count results. MethodsRoutine quality control was carried out every day, using high, normal and low levels of fresh whole blood controls offered by Sysmex. The results from the Sysmex online quality control was got timely. We monitored the variation of mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), mean corpuscular hemoglobin concentration (MCHC) with the moving average method real-timely, and quality control was performed for fresh whole blood samples of patients once every two hours. ResultsEverything was under control, and the moving average was within the permitted range. ConclusionThe reliability of laboratory blood cell count results can be effectively improved by using this quality control system effectively and comprehensively on the Sysmex-XN automatic blood cell analyzer.
ObjectiveTo improve health care quality and safety by monitoring the performance of PhilipsPrecedence Dual-head single photon emission computed tomography (SPECT). MethodsWith our own homemade point source and the center of rotation model, in accordance with NEMA standards and manufacturers' design conditions, these three indicators including energy peak position of the instrument, intrinsic uniformity and center of rotation were routinely tested between 2008 and 2012 for the Philips-Precedence Dual-head SPECT in our hospital. In addition, the quality control was performed twice a week, and every year the total number of quality control was basically the same. We calculated the results by the weighted average method. ResultsThe 5-year average energy peaks of detector 1 and 2 were (139.23±0.32) and (138.97±0.45) keV, respectively, and they were both within the range of reference values [(140±3) keV]. In addition, the results of center of rotation were also in the normal range, and kept stable. Based on the analysis of quality-control data, for detector 1, compared with the data of 2008, there was no significant diTherence for central field of vision (CFOV) and useful field of vision (UFOV) in these three years from 2009 to 2011 (P>0.05). The diTherence was only significant between data of 2008 and that of 2012 (P<0.05). For detector 2, compared with the data of 2008, there was no significant diTherence for CFOV and UFOV in 2009 and 2011(P>0.05), while there was significant diTherent in 2010 and 2012 (P<0.05). ConclusionThe uniformity of SPECT will gradually deteriorate with prolonged use. However, regular quality control and maintaining can keep the function stabilization, and enhance the availability rate.
ObjectiveTo discuss the application and effect of PDCA cycle in urgent values management in surgical intensive care unit. MethodsWe analyzed the quality of 141 cases of urgent value reports in surgical intensive care unit from May to July 2013 before the application of PDCA management. The quality of urgent values were totally controlled by PDCA circle. There were 135 cases of urgent value reports after the use of PDCA cycle. The data including qualify rate of specimens, record specification rate, and handover of urgent values were compared between the two groups of urgent values. ResultsAfter the application of PDCA cycle management, the awareness rate of urgent value content and disposal processes among medical staffs increased from 75% to 95%, with significant improvement in the quality rate of samples, recording and processing of urgent values and the quality rate of recording. ConclusionThe application of PDCA circle management can constantly correct the problems and ensure the policy implementation in the urgent values system in clinical departments, which can promote continuous quality improvement.