Brief facts of the case
The patient, Mr. Zhang (aged 51), was hospitalized in the provincial hospital for 6 days due to bilateral macroleasty, and the admission record recorded that "bilateral macroveoli were found for 9 years", and the situation at the time of admission in the discharge record was recorded: "Bilateral macroveoli were found for 9 years". After one month of discharge, the patient applied for the first time to copy 19 discharge records, pathology reports, etc., 1 second copy of discharge records after 1 year, and 44 discharge records for the third time after 2 years.
After that, the patient was hospitalized in other hospitals for "dizziness for 3 days, aggravation with hearing loss for 1 day", and was discharged from the hospital for diagnosis: 1. Left idiopathic sudden deafness (?) ）2． Bilateral bullae (postoperative) 3. Oblique hernia in the left inguinal groove (postoperative) 4. Bilateral lung shadow 5. Pleural hypertrophy 6. Hepatic cyst of the right lobe of the liver.
The provincial hospital medical record copy application form and the electronic medical record recall application form show that after the second copy of medical record materials, the patient requested that the medical history be revised from 5 years to 10 years due to legal disputes, and the external hospital chest CT report was issued to prove it. After that, the provincial hospital applied for the modification of the electronic medical record, and the revision item was: "The 5-year part of the original medical record history is revised to 9 years according to the CT report on the chest of the outer hospital provided by the patient." The electronic medical record recall application form has the application of the doctor and the consent of the department director, and has been approved by the Medical Department and signed by the corresponding personnel of the case room.
The patient believes that due to the diagnosis and treatment fault of the provincial hospital 2 years ago, it suffered damage, the situation recorded in the two discharge records copied in the provincial hospital archives was not the same, and one of the discharge records was missing from the medical case information provided by the provincial hospital, and there was a fact that the content of the medical records was inconsistent before and after, and it should be determined that the provincial hospital had tampered with the medical record data, and it was presumed that the provincial hospital was at fault for its damage, and the lawsuit went to the court to request the provincial hospital to compensate it for various economic losses totaling more than 60,000 yuan.
Court hearings
The provincial hospital applied to the court for a medical malpractice technical appraisal by the Medical Association. The Medical Association replied that the medical malpractice technical appraisal certificate was no longer applicable as a basis for compensation for civil disputes and was not accepted. Subsequently, the court of first instance entrusted the appraisal six times, and the appraisal institution refused to accept it on the grounds that it exceeded the technical conditions of the institution.
The court of first instance held that because the judicial appraisal could not be conducted in this case, it could not confirm whether the provincial hospital's treatment behavior was at fault. Although the patient claimed that the provincial hospital amended the content of the complaint "5 years for the discovery of bilateral alveoli" to "9 years for the discovery of bilateral alveoli", it was a falsification of medical records and should be presumed that the medical institution was at fault. However, the provincial hospital's revision of the main complaint was made at the request of the patient, as evidenced by the electronic medical record recall application form, the patient's application form for three times to apply for copying the discharge record, and the doctor's course record for modifying the medical record record.
The provincial hospital's revision of the main complaint is not a alteration or alteration of the medical record. Therefore, the patient's claim was not supported, and the patient's claim was rejected.
The patient appealed, and the court of second instance ruled to reject the appeal and uphold the original judgment.
Brief analysis of the law
Whether the medical institution or its medical staff is at fault for the medical act, and whether there is a causal relationship between the fault and the patient's damage, is the key to determining the liability for medical damage. The affected party often needs to complete the burden of proof by applying to the court for medical damage appraisal, and the appraisal institution will conduct an appraisal of the relevant professional issues. However, when a medical institution has statutory circumstances such as loss, falsification, falsification, alteration or illegal destruction of medical record information, the court may also directly presume that the medical institution is at fault.
According to the principle of "who claims, who proves", in cases where the medical damage appraisal cannot be completed, the patient needs to prove that the doctor has a presumption of fault. Because medical records are the most important evidence in medical damage liability dispute cases, in this case, in the case of inadmissibility by many appraisal institutions, the determination of whether the medical records have been tampered with has become the key to the trial of the case.
Electronic medical records include outpatient (emergency) electronic medical records, inpatient electronic medical records and other electronic medical records. The content of the electronic medical record includes all the information of the paper medical record and has the same effect as the paper medical record.
According to the regulations, medical institutions using the electronic medical record system for medical record writing shall follow the principles of objectivity, truthfulness, accuracy, timeliness, completeness and standardization. Medical institutions should strictly abide by the relevant provisions of medical record writing, and shall establish management systems for the establishment, recording, modification, use, storage, transmission, quality control, and security level protection of electronic medical records to ensure that the content of electronic medical records and modified information can be traced. The electronic medical record system shall set the authority and time limit for medical personnel to write, review, and modify.
The medical records recorded by intern medical personnel and probationary medical personnel shall be reviewed, revised and confirmed by the medical personnel at the higher level who have the qualifications to practice in the medical institution. When higher-level medical personnel review, modify, or confirm the content of electronic medical records, the electronic medical record system shall identify them, save traces of previous operations, mark accurate operation time and operator information. Electronic medical records shall be archived, and medical institutions shall, in accordance with the relevant provisions of medical record management, transfer electronic medical records to archived status in a timely manner after the end of the patient's outpatient (emergency) visit or discharge.
In principle, electronic medical records shall not be modified after archiving, and if it is truly necessary to modify them under special circumstances, they shall be modified after approval by the medical department of the medical institution and the traces of modification shall be retained.
In this case, although the two discharge records claimed to be provided by the patient were different, after trial and investigation by the court, it was found that they applied for copying before and after the revision of the medical records, respectively, and the provincial hospital modified the medical history according to the patient's request, filled in the application form and was approved by the Medical Department and signed by the corresponding personnel of the case room, so the court held that the provincial hospital's revision behavior complied with the relevant laws and regulations. This case also reminds the majority of medical staff that when encountering similar incidents, they must strictly modify the contents of medical records in accordance with regulations to avoid legal risks.
In addition, this case also involves the issue of technical appraisal of medical malpractice. Medical malpractice refers to an accident in which medical institutions and their medical personnel violate medical and health management laws, administrative regulations, departmental rules, diagnosis and treatment norms and routines in medical activities, and negligently cause personal injury to patients. For whether it constitutes a medical accident, the medical association shall organize an expert appraisal team to independently conduct a medical malpractice technical appraisal in accordance with medical and health management laws, administrative regulations, departmental rules, and diagnostic and nursing technical operation norms and routines, using medical scientific principles and professional knowledge.
In accordance with the provisions of the Regulations on the Prevention and Handling of Medical Disputes, the administrative investigation and handling of medical malpractice in diagnostic and therapeutic activities shall be carried out in accordance with the relevant provisions of the Regulations on the Handling of Medical Malpractice. This article clarifies that the technical appraisal of medical malpractice is the main basis for the administrative punishment of medical institutions or their medical personnel by the competent health departments, and belongs to the scope of administrative law. Therefore, after a medical dispute, how to apply for an appraisal and whether it is necessary to conduct a technical appraisal of medical malpractice, it is recommended to consult a medical professional lawyer before litigation to protect rights according to law.
(This article is the original of Medical Law Hui, based on real cases, and adopts pseudonyms to protect the privacy of the parties)
Source | Medical Law Exchange
Author | Medical Law Club team
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