The quality of clinical trials is key to determine the value of a clinical research and whether it can transform achievements. In this paper, the characteristics and direction of the implementation of quality control in clinical trials in China, and the characteristics of quality control in clinical trials of Chinese medicine are discussed, and the development direction of quality control in clinical trials in China is explored in order to improve the overall level of clinical trials in China.
ObjectiveTo improve activities of daily living (referring to Barthel Index) in the older inpatients.MethodsIn January 2016, a quality control circle (QCC) was established. According to 10 steps in activity of QCC, we figured out the causes of low Barthel Index score in older inpatients by using Plato method and Fishbone Diagram which were common methods of QCC. In addition, we designed and implemented a rectification program to improve Barthel Index score.ResultsAfter intervention of QCC, the average Barthel Index score of the older inpatients increased from 72.40±6.42 to 89.30±5.87 with a statistical difference (P<0.01); the satisfaction percent of hospitalized patients increased from 94.5% to 98.7% with a statistical difference (P<0.01). The percentage of registered nurses whose theoretical test score were over 90 increased from 57% to 88% (P<0.01) and the satisfaction percent of nurses increased from 90.5% to 95.6% (P<0.01). Moreover, the member’s ability of learning, discovery, analysis and problem solving, communication, application of QCC skills were improved.ConclusionThe application of QCC activities will increase older inpatients’ Barthel Index score, improve the satisfaction of patients and nursing staff, and enhance the members’ ability of solving problems by using QCC skills.
Quality control refers to the general term of operation technology which activities to meet the quality requirements. Quality control is not only the need of the development of the laboratory itself, but also the important requirement of the laboratory accreditation organization for the development of the laboratory. To carry out quality control, first of all, a complete quality control system should be established. According to the pathological experiment process, which can be divided into pre-analysis, in-analysis and post-analysis quality control. There are some similarities between special staining and hematoxylin-eosin staining, but the details are slightly different. There are many kinds of special dyeing items, and each dyeing step is complicated, so it is difficult to control the quality according to the quality control technology of conventional pathological staining. This article reviews the whole process quality control of special dyeing by summarizing the literature and work experience, so as to contribute to the subsequent improvement of the quality of special dyeing.
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.
ObjectiveTo investigate the baseline of quality control system for intensive care unit (ICU), and to provide a scientific basis for the development of ICU in Anhui province.MethodsA questionnaire was used to investigate the quality control indexes in 108 hospitals in Anhui province from 2013 to 2015. SPSS 20.0 statistical software was used to analyze and statistically describe the survey results.ResultsA total of 110 questionnaires from 108 hospitals were received, including 43 tertiary hospitals and 65 secondary hospitals. In these 110 ICUs, 96.36% were integrated ICU. The total average number of ICU beds was 14.46±7.12, accounting for 1.58%±1.04% of the total hospital beds. The ratios of practicing physicians-beds and registered nurses-beds were 0.57±0.24: 1 and 1.54±0.79: 1, respectively. A total of 29 hospitals (26.36%) met the conditions that the ratio of the total number of beds in the ICU to the hospital was 2% to 8%. Only 5 ICU (4.55%) could meet the conditions that each bed covered an area ≥15 m2. The average incidence of ventilator-associated pneumonia, catheter-related blood stream infection and catheter-related urinary tract infection in ICU patients were (17.30±15.36) ‰, (3.07±3.93) ‰, and (3.49±4.27) ‰, respectively. The incidences in the tertiary hospitals were higher than the secondary hospital. There was no ICU to achieve all 19 key technologies. 42.73% directors of ICU engaged in the professional career more than 10 years. Only 2.73% of the medical institutions in the intensive medical staff performance distribution than the average level of hospital.ConclusionICU in Anhui province has been achieved a rapid development, and has covered all municipal hospitals and more than 80% of the county-level hospitals. But it confronts with a series of problems, such as lack of medical resources, the construction of talent echelon lag, low overall level of discipline, lack of specialist, work intensity, low performance and a series of constraints which restricted the development of disciplines. It strongly suggests that we should further improve the quality control system of critical care medicine, standardize the quality control process, improve and implement the standardized operation standard of critical care medicine, strengthen the construction of disciplines talent echelon. We are expected to enhance the overall level of discipline and to ensure medical quality and safety.
Intravitreal drug injection is a treatment for common chronic fundus diseases such as age-related macular degeneration and diabetic retinopathy. The “14th Five-Year” National Eye Health Plan (2021-2025) recommends focusing on fundus diseases and improve the management mode of patients with chronic eye diseases. Therefore, it is imperative to explore how to further optimize the service process of intravitreal injection under the premise of guaranteeing patients' medical safety, to promote medical service efficiency and standardized management level and improve the medical experience of patients. Based on the quality control standard of vitreous cavity injection for retinopathy in China, Chinese fundus disease and related field experts developed the present expert consensus on the establishment of a one-stop intravitreal injection model and the management of its organization after a serious, comprehensive, and complete discussion, focusing on a standardized operation process, quality control, and safety management, providing more references for establishing a suitable intravitreal injection management model for ophthalmology and promoting the development of diagnostic and treatment models for fundus disease in China.
ObjectiveTo investigate the current situation of orthopedic quality control and management in county-level regional general hospitals in Guangdong, and to provide a scientific basis for further standardizing the procedures of orthopedic quality control and management in county-level regional general hospitals and continuously improving the work of provincial orthopedic quality control center.MethodsFrom June 2019 to July 2020, online and offline questionnaire survey and field survey were used to investigate the quality control and management of orthopedic departments in 22 county-level regional general hospitals in Guangdong.ResultsAmong the overall scores of the surveyed hospitals, the highest score was 96.5, the lowest score was 72.0. There were 6 hospitals with a total score of “excellent” (accounting for 27.3%). The “facilities and equipment” and “medical quality” of the surveyed hospitals were relatively valued. Taking Guangzhou, the capital of Guangdong as the center, the districts and counties were divided into the east, the south, the west and the north regions, and the difference in overall scores of orthopedics among the four regions was statistically significant (F=6.299, P=0.004). The unqualified rates of department setting, key technology development, average hospitalization days of representative diseases, equipment allocation, personnel allocation, department management and building layout were relatively high, which were 77.3%, 63.6%, 45.5%, 40.9%, 40.9%, 36.4% and 36.4%, respectively. Most hospitals had set up special debridement rooms in orthopedic department (95.5%), and the management and monitoring of the use of antibacterial drugs was mostly reasonable (90.9%). In terms of the level of orthopedic medical treatment, only 3 hospitals with sufficient key technologies reached the standard, accounting for 13.6%, and only 7 hospitals reached the standard of scientific research capacity, accounting for 31.8%. In terms of quality control, the numbers of hospitals with qualified medical record sampling (72.7%), perfect management and supervision mechanism (86.4%) and quality management team in departments (77.3%) were the least. In addition, among the investigated hospitals, beds were in short supply in orthopedic departments, with 12 hospitals accounting for 54.5% being deducted; 16 hospitals (72.7%) were deducted for unqualified doctor-patient ratio and 11 hospitals (50.0%) were deducted for unqualified nurse-patient ratio.ConclusionsThe overall level of orthopedics construction and management in the surveyed hospitals is uneven. The medical professional and technical level is insufficient. It is difficult to meet the practical needs, and there is an imbalance in the ratio of medical personnel. In the future, it is necessary to strengthen the quality control of orthopedic medical care, strengthen the medical technology training of county-level regional general hospitals and increase the medical and health resources and capital investment, so as to improve the quality control of county-level regional general hospitals.
ObjectiveTo explore the effect of quality control circle (QCC) on the management of hospital medication. MethodsAccording to the existing problems between December 2013 and January 2014, we put forward a series of continuous improvement plans, strengthened the nurses training, and intensified the supervision methods from February to May 2014. ResultsAfter the implementation of QCC, the incidence of leakage from drugs significantly decreased from 15.8% to 0.0%; the nurse-related drug management knowledge rate increased from 64.1% to 92.3%. Withdrawal process execution rate increased from 71.8% to 100.0%, and the difference was statistically significant (P<0.05) from February to May 2014. ConclusionQCC activity improves the hospital medication management, increases the nurses' sense of responsibility, and ensures the medical security of hospitalized patients.
Objective To investigate the application of quality control circle (QCC) activities in improving weight management ability of patients with renal edema. Methods A QCC activity group was founded, and " improving weight management ability of edema patients with kidney disease” was selected as the theme. Then the status of weight management ability in 51 patients with renal edema who were admitted to the Department of Nephrology from April 1st to 30th 2015 was investigated, the reasons of the low weight management ability were analyzed, and then appropriate countermeasures were carried out. After this activity, the status of weight management ability in 54 patients with renal edema who were admitted to the Department of Nephrology from October 1st to 31th 2015 was investigated, to assess the effect and consolidate the results of activities. Result After the QCC activities, the scores of weight management ability increased from 23.84±6.34 to 28.43±4.08 with statistical significance (P<0.05), and the qualified rate of weight management ability increased from 25.5% to 44.4% with statistical significance (P<0.05). Conclusion QCC activities can improve the weight management ability and the qualified rate of weight management ability of patients with renal edema, at the same time, it can improve the overall quality of nurses.
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.