With the dissemination and popularization of EBM around the world, the evidence-based laboratory medicine has boomed gradually. However, the substantial researches in tbe field are still inadequale now. Based on the facts of hospital laboratory medicine, this article discussed the feasibility that apply the rationale and methods to orient the laboratory quality control.
In order to guarantee the safety and accuracy of the whole treating process as well as better link up of each section during the treatment, we did research in order to establish a project concerning the process quality control (PQC) of treating liver cancer with CyberKnife. From the safety and accuracy point of view, we divided the whole process of treating liver cancer with CyberKnife into ten links, i.e. the registration of patients' information, the implantation of fiducial markers, fixation of body posture, CT localization, target delineation, design of the treatment plan, quality assurance in physics, implementation of the treatment plan, inspection on the correctness and data archiving. We analyzed the possible mistakes in each link and the consequences brought by them. To smoothly connect all the links, a special part "Attention" was added between every two links. Various wrong operations which may influence the safety and accuracy of treatment were illustrated, and the consequences brought by them were also explained. The "Attention" part among links offers important information for the next step, and gives us reminding and warnings. The project of quality control covers all the important links when treating liver cancer with CyberKnife. It offers regulations, reminding and warning for us so that the safety and accuracy of treatment can be guaranteed, and the work of all staff could be closely connected.
To evaluate the influence of different brands of syringes on performance parameters and application quality of syringe pump, we carried out matching experiment of infusion/syringe pump analyzer Rigel Multi-Flo, made by ALK Co. in Sweden, for 3 different types of syringes to measure the flow rate, occlusion alarm pressure, occlusion time and bolus volume of 26 syringe pumps. Data of quality control were analyzed with statistical method. The results demonstrated that there were significant differences in the flow rate, occlusion alarm pressure, occlusion time and bolus volume (P<0.01) between those of common syringes and original syringes. This study points out that the health care providers should select compatible syringes for syringe pumps, which provides evidence and guidance to assure the reasonable and safe application of syringe pumps in clinical practice.
Objective To monitor surgical quality and analyze learning curve of minimally invasive totally thoracoscopic cardiac surgery. Methods We retrospectively analyzed the clinical data of 150 consecutive patients who underwent minimally invasive totally thoracoscopic cardiac surgery in the Guangdong General Hospital between January 2013 and December 2015. There were 60 males and 90 females at age of 43.1 years. There were 60 patients with atrial or ventricular septal defect repair, 12 patients with cardiac tumor resection, 53 patients with mitral valve replacement and 25 patients with mitral valve repair. According to the surgical sequence, all the patients were divided into 3 groups including a group A, group B, and group C with 50 patients in each group (every 10 patients as a sequence, every 5 sequence as a group). Surgical outcomes were compared among the 3 groups, and surgical quality was analyzed with descriptive statistics. Results Surgical failure rate was 6.7% (10/150). There was no in-hospital mortality. Aortic cross-clamp time, cardiopulmonary bypass time and duration of mechanical ventilation, duration of ICU stay, duration of hospital stays of the group C were significantly shorter than those of the group A and group B. Analysis showed a significant learning curve effect in totally thoracoscopic cardiac surgery. When surgical cases reached about 100 cases, cardiopulmonary bypass and aortic cross-clamp time was shorter than the average value stably. Conclusion Totally thoracoscopic cardiac surgery is safe and reliable. For the beginners, it needs about 100 patients of surgery to master the totally thoracoscopic cardiac surgery.
As a standard of care, lymph node dissection is an indispensible step in lung cancer surgery. The quality of dissection determines completeness of surgery and the accuracy of N staging. Hereby, we suggest labeling all surgically resected nodes according to the new lymph node map in the 8th TNM classification for lung cancer. As systematic lymph node dissection remains the gold standard of lymphadenectomy, at least three mediastinal stations and ten nodes should be removed in an en-bloc fashion, if possible. For patients with stage Ⅰ lung cancer, lymph node dissection via video-assisted thoracoscopic surgery (VATS) or open thoracotomy may has similar oncological outcome. Besides, limited lymph node sampling in selected patients with early staged lung cancer to minimize unnecessary surgical damage still need further investigation.
Quality control of general thoracic surgery contains many links including the qualification and technical conditions of medical institutions, preoperative diagnostic system, surgery, postoperative management, pathological diagnosis and follow-up. Standards of quality control should be based on evidence-based medicine, and general rules with detailed criteria. As one of the core concepts of quality control, fine management is ought to strictly follow clinical practice guideline of thoracic surgery, to be clear with quality standards of each key link in clinical pathway, and to improve the clinical quality control system that combines self-evaluation and supervision and inspection.
It has been absent from an accepted criteria for normalization and quality control of the thoracic surgery until now. The ideal assessing instrument which will be used to evaluate the technical skills and surgical procedures should present a few vital characterizations below: objectivity, speciality in the content, detailed structure, and quantifiability. Objective structured assessment of technical skills (OSATS) has developed as a reliable method of surgical skills measurement. This article focuses on the history of OSATS and its prospect in the thoracic surgery area by reviewing relevant literatures.
Thoracoscopic pulmonary segmentectomy is one of the important treatment methods for early lung cancer. Only the premise of surgical precision can make the radical resection of lesions and maximum reservation of healthy lung tissue be simultaneously guaranteed. As a representative of the precise lung operation, the " cone-shaped lung segmentectomy” focuses on the lesion, and combines the anatomical characteristic of the patient to design individualized operation scheme. The technological core consists of three parts, three dimensional-computed tomography bronchography and angiography (3D-CTBA) surgery path planning, accurate definition of intersegmental demarcation and anatomic dissection of intersegmental borders along the demarcation. This paper aims to explore the technical process and quality control of the key techniques of thoracoscopic precise segmentectomy, so as to standardize the segmentectomy procedure under the principle of radical and minimally invasive therapy.
ObjectiveTo analyze standards of alginate-based medical devices at home and abroad, and to emphasize key issues of quality control that should be concerned about.MethodsBased on investigation of alginate application in medical devices and alginate-related medical standards, alginate-related technical indicators and quality control points were comprehensively analyzed.ResultsWith the rapid development of alginate-based medical materials and medical devices, the relevant standards at home and abroad have been elaborated on the basic technical indicators and detection methods. In addition to Chinese Pharmacopoeia, China has issued one alginate standard for tissue engineering and three alginate related product standards.ConclusionConsidering the special physical and chemical properties of alginate, researchers also need to focus on the sterilization method, expiry date, molecular weight, and ratio of α-L-guluronic acid to β-D-mannuronic acid of alginate, and impurity content.
This article reviewed other literatures in the quality management of clinical trials and summarized author’s experience in quality control of clinical trials which the author conducted as principle investigator over the past years. It provides a reference for fresh investigators before they conduct their own clinical trials.