Recently, the Zhangye Municipal Health Commission of Gansu Province plans to carry out a pilot project of preoperative talks and third-party witnessing at the Zhangye People's Hospital affiliated to Hexi University.
The author | Xu Yucai
Source| Medical Community (ID: vistamed)
Recently, the Zhangye Municipal Health Commission of Gansu Province plans to carry out a pilot project of preoperative talks and third-party witnessing at the Zhangye People's Hospital affiliated to Hexi University.
What is a preoperative conversation third party witness?
Informed consent is a fundamental right of the patient, which means that the patient is clear and approved of his or her condition and the diagnosis and treatment plan made by the doctor accordingly. It requires that the doctor must provide the patient with the basis for making a diagnosis and treatment plan, and describe the benefits, adverse effects, dangers and other unexpected circumstances that may occur with such a treatment plan, so that the patient can make an autonomous decision to accept or not to accept such treatment, also known as an informed promise or commitment.
The Regulations on the Administration of Medical Institutions, which will be implemented on May 1, require medical staff to explain their condition and medical measures to patients during diagnosis and treatment activities. Where surgery, special examinations, or special treatment needs to be carried out, the medical personnel shall promptly explain to the patient specifically the medical risks, alternative medical plans, and other circumstances, and obtain their explicit consent; where it is not possible or inappropriate to explain to the patient, it shall be explained to the patient's close relatives and their explicit consent shall be obtained. Where the opinions of patients or their close relatives cannot be obtained due to emergency situations such as rescuing patients whose lives are in danger, corresponding medical measures may be implemented immediately upon approval by the responsible person of the medical institution or the authorized responsible person.
As a risky "surgery", the doctor must perform the obligation to inform and explain in accordance with the law in the form of "preoperative conversation" before it is carried out. This provision is clearly required in the Law of the People's Republic of China on Physicians, the Regulations on the Prevention and Handling of Medical Disputes and other laws and regulations, and doctors must bear responsibility for not doing or not obtaining the explicit consent of patients or relevant personnel.
However, in the actual implementation of preoperative conversation, due to the influence of various subjective and objective factors, some of them intentionally or unintentionally "did not understand", even if they "signed and drew a pledge", once there is a medical dispute that is not satisfied with the medical results or medical process, it is usually based on the fact that the preoperative conversation is not understood or "signed and drawn" is not their true intention. Therefore, some places explore the pilot of third-party witnessing of preoperative conversations, which is also an attempt to avoid similar disputes as much as possible.
The purpose and operation of the Zhangye pilot
According to the Notice of the Zhangye Municipal Health Commission on Carrying Out the Pilot Work of Third-Party Witness of Preoperative Conversations (hereinafter referred to as the "Notice"), the purpose of the pilot is to avoid unnecessary postoperative disputes, reasonably protect the patient's right to informed consent, fully perform the obligation of notification and explanation, and transform medical disputes from post-mediation to pre-event prevention.
The pilot requires Zhangye People's Hospital affiliated to Hexi University to select 1-2 clinical departments to carry out a pilot project of preoperative conversation and third-party witness. Specifically, before the operation, the medical department of the hospital organizes the quality control department and the legal counsel to discuss the condition of major surgical patients in the clinical department, and takes the initiative to ask the Zhangye workstation and the Zhangye Municipal Medical Investigation Commission as a third party to witness the doctor-patient communication and sign the informed consent form on the spot.
In order to ensure the communication effect, the "Notice" requires doctors to be easy to understand, vivid metaphors, and explain the condition, diagnosis and treatment plan, surgical plan (alternative plan), surgical risks, surgical complications, etc. as clearly as possible, and at the same time answer the patient's proposed timing of surgery, the probability of successful surgery, medical expenses, medical insurance reimbursement, etc.
The "Notice" also requires that, after full communication, signed and confirmed in the presence of a third party, the whole process of conversation and communication shall be recorded and recorded.
In order to ensure the norms of the work of third-party witnessing of preoperative conversations, the Notice also formulates the "Workflow of Third-Party Witnessing of Preoperative Conversations".
Basis of the Zhangye pilot
The Notice clarifies that the pilot work is aimed at implementing the Regulations on the Prevention and Handling of Medical Disputes (hereinafter referred to as the Regulations). So what kind of provisions does the Regulations have for preoperative conversations?
The Regulations on the Prevention and Handling of Medical Disputes were adopted at the 13th Executive Meeting of the State Council on June 20, 2018, and approved by Premier Li Keqiang on July 31, 2018, and came into force on October 1, 2018.
The Regulations require that medical institutions should strengthen medical risk management, improve the identification, assessment and prevention and control measures of medical risks, regularly check the implementation of measures, and eliminate hidden dangers in a timely manner.
The Regulations require that medical personnel should explain their condition and medical measures to patients during diagnosis and treatment activities. Where surgery needs to be performed, or clinical trials, or special examinations or special treatments that are dangerous and may have adverse consequences, the medical staff shall promptly explain to the patient the medical risks, alternative medical plans, etc., and obtain their written consent; in situations such as when the patient is in a coma, where the decision cannot be made on their own, or the condition is not suitable for the patient to explain, etc., it shall be explained to the patient's close relatives and their written consent shall be obtained.
Where the opinions of patients or their close relatives cannot be obtained in an emergency, corresponding medical measures may be implemented immediately upon approval of the responsible person of the medical institution or the authorized responsible person.
To carry out diagnosis and treatment activities with high medical risks, such as surgery, special examinations, and special treatments, medical institutions shall prepare response plans in advance and take the initiative to prevent sudden risks.
The Regulations require that medical institutions shall establish and improve a doctor-patient communication mechanism, patiently explain, explain, and handle the consultations, opinions and suggestions made by patients in the process of diagnosis and treatment, and handle them in accordance with regulations; questions raised by patients on diagnosis and treatment behaviors shall be promptly verified and self-examined, and relevant personnel shall be designated to communicate with patients or their close relatives to truthfully explain the situation.
Where medical institutions and their medical personnel fail to inform patients of their condition, medical measures, medical risks, alternative medical plans, etc. in accordance with regulations; or carry out diagnostic and treatment activities with relatively high medical risks, and fail to prepare a response plan in advance to prevent sudden risks, the competent department of health of the people's government at the county level or above shall order corrections, give a warning, and impose a fine of between 10,000 and 50,000 yuan; Relevant medical personnel may be ordered to suspend their professional activities for 1 month to 6 months; where a crime is constituted, criminal responsibility shall be pursued in accordance with law.
Preoperative conversation Third party witness can be tried, but push with caution
As a high-risk medical operation, the operation must be carefully operated, and the preoperative conversation is both a legal requirement and a must for the patient to understand the disease and understand the surgical accident, so it is very important and necessary to explain clearly and understand clearly. In order to make the preoperative conversation process open and transparent, the pilot of preoperative conversation third-party witness can not only reduce or avoid unnecessary postoperative disputes after some major surgeries, but also further standardize the preoperative communication behavior of medical staff, improve the level of communication, and let medical staff better respect the patient's right to informed consent in the process of medical service. However, if the understanding of this pilot is biased, and it is intended as an attempt to reduce the liability for medical fault, it will not be worth the loss, and may go in the opposite direction, because, no matter how standardized the notification is and how many people witness it, it only shows that the "preoperative conversation" is done well, and it does not reduce the responsibility for the damage caused to the patient due to medical negligence (technical error, carelessness, etc.), because the Civil Code of the People's Republic of China stipulates that the patient is damaged in the diagnosis and treatment activities, and the medical institution or its medical staff is at fault. The medical institution shall bear the liability for compensation.
Based on this, for the third-party testimony of preoperative conversations, my view is that it is possible to try, but to push with caution. (This article is published by "Seeing the Medical Community", reprinted with permission, and the author and source are indicated at the beginning of the article.) ）
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