Application for access to new technologies for diagnosis and treatment should be to protect patient safety measures and risk management plan

New technologies, new projects

Measures to protect patient safety and risk disposal plan

New technologies, new projects due to the complexity of the technology, the operation of the difficulty of the reasons, the process of carrying out the situation may be difficult to predict in advance. In order to ensure patient safety, reduce medical errors and accidents, and prevent medical disputes, this plan is formulated.

I. Strict implementation of the "new technology and new project access system"

(1) After the proposal of new technology and new project, in order to ensure its safe and effective application in the clinic, before carrying out the new technology and new project, the physicians concerned should extensively review the relevant works and literature at home and abroad, and collect, organize, and write a written synthesis or report (with relevant information), and formulate contingency plans for various unforeseen circumstances

(2) The chief of the department will preside over the departmental discussion. Participants, including the head (deputy) chief physician, attending physicians, residents, etc., fully express their views, serious discussions, and the content of the discussion should be a detailed written record of the results of the project by the person in charge of a written report, the results of the discussion in writing submitted to the Department of Education.

(3) after the discussion of the whole department agreed, should fill out the "new technology and new project application form", with a report and related information sent to the Department of Science and Education, Science and Education Section of the "new technology and new project application form" for the first review of the qualified, and then reported to the hospital "Medical Technology Management Committee" "Medical Ethics Committee" review, assessment, evaluation, and so on. Ethics Committee" review and evaluation, after the demonstration of agreement, submitted to the President for approval, the President can only be implemented after approval.

Second, the strict implementation of informed consent procedures

In order to be responsible for the safety of patients, respect for the right of informed consent of patients, the implementation of new technologies, new projects to carry out the informed consent system for patients (family members). Before carrying out new technologies and projects, physicians should give a detailed account of the patient's condition to the patient or his/her delegate, focusing on the benefits of new technologies and projects to the patient and possible problems, respecting the views of the patient and his/her delegate, and signing the informed consent form before implementation.

Three, the strict implementation of the analysis and evaluation of the efficacy of the procedure

For new technologies, new projects, once carried out that should improve the evaluation of the efficacy of the analysis, and continue to sum up the experience, correct deficiencies, the period of time more perfect.

(A) carefully recorded case data, follow-up observation of the efficacy.

(ii) Periodically summarize the cases and compare with the routine operation.

(iii) Search the literature, review information, and compare with other hospitals.

(iv) At the end of the year, analyze and summarize new cases performed during the year for reporting.

(v) Write a report or paper based on the cases carried out.

Four, the establishment of new technology and new project risk warning mechanism

The implementation process of medical risk warning can be summarized as risk identification. Risk estimation and risk evaluation of three broad stages. Risk identification of a variety of potential risks for systematic generalization and comprehensive analysis in order to grasp the nature and characteristics, to determine which risks should be considered, while analyzing the main factors that trigger these risks and the severity of the consequences, this stage is the qualitative analysis of the risk of the groundwork; risk estimation is

Through a large amount of information collected through the study of the use of probability and mathematical statistics and other tools to estimate and predict the risk of the risk of the project

This stage is the first step in the process of risk identification. Mathematical statistics and other tools to estimate and predict the probability of occurrence of risk and the magnitude of the loss, this stage of work is the quantitative risk analysis, so that the entire risk management is based on science; risk evaluation is based on expert judgment of the safety indicators to determine whether the risk needs to be dealt with and the degree of treatment.

V. Reporting Procedures and Disposal

Once an emergency accident occurs, the risk damage disposal plan is immediately activated. When it is still difficult to deal with after taking remedial action by the attending physician at the scene, it shall be immediately reported to the supervising physician and the head of the department, and if necessary, to the medical department or the head of the hospital. After receiving instructions, the patient or family should also be informed of the situation, and the consent of the patient or family should be obtained and the informed consent form should be signed. The attending physician should keep a record of the changes in the condition of the patient after the emergence of the emergency and accident, the treatment plan, the opinion of the superior physician and the treatment, and at the same time, he must remain at his post and must not leave the post without authorization until the patient's condition is stabilized.

March 11, 2013