What enlightenment do the 4 administrative penalties and 6 public cases give to medical institutions and medical personnel?
In the face of a severe, complex and volatile situation, it seems that the life of medical institutions and medical personnel is becoming more and more difficult. On January 30, the 2024 National Health Finance Work Conference put forward the "four focuses", one of which is to focus on the bottom line of the "three guarantees", lay a good amount in advance, set aside redundancy, and resolutely hold the bottom line. What is the "three guarantees", that is, to ensure the basic livelihood of the people, to ensure wages, and to ensure operation.
As we move into 2024, the challenges may become even more severe. On the one hand, we must face up to the increasingly strict supervision of medical insurance and the unstoppable DRG DIP reform, and on the other hand, we must also attach great importance to the meticulous and frequent supervision from the health administrative department.
The more you are in such a "cold season", the more you can't make mistakes, and "surviving" naturally becomes the top priority. Yesterday (February 18), the official website of the Anhui Provincial Health Commission disclosed 6 penalty announcements, all of which are punishments for "violations" of hospitals and doctors.
Issuing false medical certificates will result in penalties for both the medical institution and the doctor
Among the 4 penalty cases, 1 case involved the issuance of false medical certificates, and 2 penalty announcements were issued.
The cause of the case is that on September 14, 2022, Zhang from the Anhui Provincial Public Health Clinical Center issued a false medical certificate of "Part of Shi's Diagnosis and Treatment During His Hospitalization", the unit violated the provisions of Article 31 of the "Regulations on the Administration of Medical Institutions", and decided to be given an administrative penalty of "warning" in accordance with Article 48 of the "Regulations on the Administration of Medical Institutions", and Zhang violated the provisions of Article 24, Paragraph 2 of the "Physician Law" and was given a warning in accordance with the provisions of Article 56 (2) of the "Physician Law". An administrative penalty of a fine of 10,000 yuan.
Article 31 of the Regulations on the Administration of Medical Institutions stipulates that medical institutions shall not issue disease diagnosis certificates, health certificates or death certificates and other supporting documents without a physician (doctor) personally examining a patient; Medical establishments must not issue birth certificates or stillbirth reports without a doctor (doctor) or midwife personally receiving a birth.
Article 48 Whoever violates the provisions of Article 31 of these Regulations by issuing false certification documents shall be given a warning by the people's health administrative department at or above the county level; where harmful consequences are caused, a fine of between 10,000 and 100,000 RMB may be imposed; The directly responsible personnel shall be given administrative sanctions by the unit to which they belong or by the organ at a higher level.
Article 24 of the Physicians Law stipulates that physicians who carry out medical, preventive and health care measures and sign relevant medical certificates must personally examine and investigate, and fill in medical records and other medical documents in a timely manner in accordance with regulations, and shall not conceal, forge, tamper with or destroy medical records and other medical documents and related materials without authorization.
Physicians shall not issue false medical certificates or medical certificates that are not related to their scope of practice or do not correspond to the type of practice.
Article 56: Where the provisions of this Law are violated by physicians engaging in any of the following conduct in their practice activities, the competent department of people's health at the county level or above shall order corrections, give warnings, confiscate unlawful gains, and impose a fine of between 10,000 and 30,000 RMB; where the circumstances are serious, order a suspension of practice activities of between six months and one year or even revoke the physician's practice certificate
Item (2) is: issuing false medical certificates, or signing certificates of diagnosis, epidemiology or birth and death without personal examination and investigation.
The use of implantable (grade) medical consumables is not included in the preoperative discussion and the informed consent form is not signed with the patient, and the medical staff is punished
Among the 4 punishment cases, the results of the administrative punishment of Li Moumou's use of implantable medical consumables were not included in the preoperative discussion and the informed consent form was not signed.
The case found that in the process of diagnosis and treatment of patient Chen, Li Moumou used implantable medical consumables that were not included in the preoperative discussion, and the use of medical consumables did not sign an informed consent form with the patient.
The use of medical consumables without signing the informed consent form with the patient violates the provisions of Article 25 of the Physician Law, and the relevant departments shall give an administrative penalty of warning in accordance with the provisions of Article 55 (1) of the Physician Law.
The use of implantable medical consumables that are not included in the preoperative discussion violates the provisions of Article 25 of the "Physician Law" and Article 9, Paragraph 1 of the "Regulations on the Prevention and Handling of Medical Disputes", and the relevant departments shall give a warning and a fine of 10,000 yuan in accordance with the provisions of Article 47 (9) of the "Regulations on the Prevention and Handling of Medical Disputes" and Article 55 (1) of the "Physician Law".
Article 25 of the Physicians Law stipulates that a physician shall explain to the patient his or her medical condition, medical measures and other matters that need to be informed in the course of diagnosis and treatment. If it is necessary to perform surgery, special examination, or special treatment, the physician shall promptly explain to the patient the medical risks, alternative medical treatment options, and other circumstances, and obtain their explicit consent; Where it is not possible or appropriate to explain it to the patient, it shall be explained to the patient's close relatives and their explicit consent shall be obtained.
Article 55 of the "Physician Law" stipulates that if a physician violates the provisions of this law and commits any of the following acts in his or her practice activities, the competent health department of the people's ** at or above the county level shall order him to make corrections and give him a warning; where the circumstances are serious, order a suspension of practice activities of between six months and one year or even revoke the doctor's practice certificate, of which item (1) is "failure to perform the obligation to inform or obtain informed consent in accordance with provisions in the provision of medical and health services or medical clinical research".
Paragraph 1 of Article 9 of the Regulations on the Prevention and Handling of Medical Disputes stipulates that medical institutions and their medical personnel shall be patient-centered in their diagnosis and treatment activities, strengthen humanistic care, strictly abide by medical and health laws, regulations, rules and relevant norms and routines for diagnosis and treatment, and abide by professional ethics.
Article 47 of the Regulations on the Prevention and Handling of Medical Disputes stipulates that if a medical institution and its medical personnel have any of the following circumstances, the competent department of people's health at or above the county level shall order corrections, give a warning, and impose a fine of not less than 10,000 yuan but not more than 50,000 yuan; where the circumstances are serious, the directly responsible managers and other directly responsible personnel are to be given or ordered to be given sanctions of demotion or removal, and relevant medical personnel may be ordered to suspend their practice activities for between 1 and 6 months; where a crime is constituted, criminal responsibility is pursued in accordance with law. Item (9) reads "other circumstances of failure to perform obligations under these Regulations".
Failure to fill out the medical records as required was punished by the doctor
Among the four penalty cases, one case of failing to fill in medical records in accordance with the regulations was included.
In accordance with the law, it was found that Shen did not fill in the medical records in accordance with the provisions in the process of diagnosis and treatment of the patient Chen, which violated the provisions of Article 15, Paragraph 1 of the "Regulations on the Prevention and Handling of Medical Disputes", and the relevant departments gave a warning and a fine of 10,000 yuan in accordance with the provisions of Article 47 (4) of the Regulations on the Prevention and Handling of Medical Disputes.
Article 15 of the Regulations on the Prevention and Handling of Medical Disputes stipulates that medical institutions and their medical personnel shall fill in and properly keep medical records in accordance with the provisions of the competent health department. Where medical records cannot be filled out in a timely manner due to emergency rescue, medical personnel shall make up the record within 6 hours of the end of the rescue and make a note of it. No unit or individual may tamper with, forge, conceal, destroy, or steal medical records. The first paragraph is "medical institutions and their medical personnel shall, in accordance with the provisions of the competent health department, fill in and properly keep the medical records".
Article 47 of the Regulations on the Prevention and Handling of Medical Disputes stipulates that if a medical institution and its medical personnel have any of the following 9 circumstances, the competent department of people's health at or above the county level shall order corrections, give a warning, and impose a fine of not less than 10,000 yuan but not more than 50,000 yuan; where the circumstances are serious, the directly responsible managers and other directly responsible personnel are to be given or ordered to be given sanctions of demotion or removal, and relevant medical personnel may be ordered to suspend their practice activities for between 1 and 6 months; where a crime is constituted, criminal responsibility is pursued in accordance with law. Item (4) is "failing to fill in and keep medical records in accordance with regulations, or failing to make up rescue medical records in accordance with regulations".
Hospitals that fail to formulate and implement medical quality and safety management systems and other management irregularities will be punished
In the 6 penalty announcements, although there are few medical institutions involved, there are many problems, and they are large hospitals. This medical institution is an Anhui Provincial Hospital, and the reason for the punishment is that it failed to formulate and implement a medical quality and safety management system, failed to fill in medical records in accordance with regulations, failed to seal completed medical records and make a sealed list in accordance with regulations, and failed to record the necessary information of implantable and interventional medical devices in the medical records or incomplete information records.
The penalty information shows that the above behavior of the unit violates the provisions of Article 10, Paragraph 1, Article 15, Paragraph 1, Article 24, Paragraph 1 of the Regulations on the Prevention and Handling of Medical Disputes and Article 51, Paragraph 2 of the Regulations on the Supervision and Administration of Medical Devices, and shall be punished in accordance with Article 47 (1), (4) and (7) of the Regulations on the Prevention and Handling of Medical Disputes and Article 90 (3) of the Regulations on the Supervision and Administration of Medical Devices. It is hereby decided to give him an administrative penalty of a warning and a fine of 50,000 yuan.
The first paragraph of Article 10 of the Regulations on the Prevention and Handling of Medical Disputes reads: medical institutions shall formulate and implement a medical quality and safety management system, set up a medical service quality control department or allocate full-time (part-time) personnel, strengthen the standardized management of diagnosis, nursing, pharmaceutical affairs, inspection and other work, optimize the service process, and improve the service level.
The first paragraph of Article 15 reads: Medical institutions and their medical personnel shall, in accordance with the provisions of the competent health department, fill in and properly keep the medical records.
The first paragraph of Article 24 reads: In the event of a medical dispute, it is necessary to seal or unseal medical records, and it shall be done in the presence of both the doctor and the patient. The sealed medical records may be originals or copies, and shall be kept by medical institutions. Where medical records have not yet been completed and need to be sealed, the completed medical records shall be sealed first; After the medical records are completed in accordance with the regulations, the subsequent completed parts will be sealed. Medical establishments shall make a sealed list of sealed medical records, which both the doctor and the patient shall sign or affix a seal, and each shall hold a copy.
Article 47 of the Regulations on the Prevention and Handling of Medical Disputes stipulates that if a medical institution and its medical personnel have any of the following circumstances, the competent department of people's health at or above the county level shall order corrections, give a warning, and impose a fine of not less than 10,000 yuan but not more than 50,000 yuan; where the circumstances are serious, the directly responsible managers and other directly responsible personnel are to be given or ordered to be given sanctions of demotion or removal, and relevant medical personnel may be ordered to suspend their practice activities for between 1 and 6 months; where a crime is constituted, criminal responsibility is pursued in accordance with law. Among them, item (1) is the failure to formulate and implement a medical quality and safety management system in accordance with regulations;
Item (4) is failure to fill in and keep medical records in accordance with regulations, or failure to supplement rescue medical records in accordance with regulations; Item (7) Failure to seal, keep, or unseal medical records and on-site physical objects in accordance with regulations.
According to the second paragraph of Article 51 of the Regulations on the Supervision and Administration of Medical Devices, if large-scale medical devices and implantable and interventional medical devices are used, the medical device user shall record the name, key technical parameters and other information of the medical device and the necessary information closely related to the quality and safety of the medical device in the medical records and other relevant records.
Article 90 of the Regulations on the Supervision and Administration of Medical Devices stipulates that in any of the following circumstances, the competent health department of the people's health at or above the county level shall order corrections and give a warning; where corrections are refused, a fine of between 50,000 and 100,000 RMB is to be given; If the circumstances are serious, a fine of not less than 100,000 yuan but not more than 300,000 yuan shall be imposed, and the relevant medical device use activities shall be ordered to be suspended until the original licensing department revokes the practice license, and the relevant responsible personnel shall be ordered to suspend the practice activities for more than 6 months and 1 year in accordance with the law, until the relevant personnel practice certificate shall be revoked by the original licensing department, and the legal representative, main responsible person, directly responsible person in charge and other responsible personnel of the illegal unit shall be confiscated from the income obtained from the unit during the occurrence of the illegal act, and 30% of the income obtained shall be disposed of A fine of less than 3 times shall be punished in accordance with law. Among them, item (3) is that the medical device user fails to record the information of large-scale medical devices and implantable and interventional medical devices in medical records and other relevant records in accordance with regulations.
Although only the 4 and 6 public punishment cases publicized in Anhui this wave have been sorted out, it only involves the issuance of false medical certificates, the use of implantable (grade) medical consumables that were not included in the preoperative discussion and did not sign the informed consent form with the patient, and did not fill in the medical records as required, as well as the failure to formulate and implement the medical quality and safety management system, the failure to fill in the medical records as required, the failure to seal the completed medical records and the sealing list as required, As medical staff and hospital managers, we must pay attention to the study of medical and health management laws and regulations and implement them in the process of medical services, only in this way can we ensure the safety of patients and not be punished by the health administrative department.
* See the medical profession.