Regulations on the Management of Medical Records in Medical Institutions (2013 Edition) Article 1 These regulations are formulated in order to strengthen the management of medical records in medical institutions, ensure the quality and safety of medical care, and safeguard the legitimate rights and interests of both doctors and patients.
Article 2 Medical records refer to the sum of texts, symbols, charts, images, slices and other data generated by medical personnel during the course of medical activities, including outpatient (emergency) medical records and inpatient medical records. After medical records are filed, a medical record is formed.
Article 3 These regulations apply to the management of medical records by all types of medical institutions at all levels.
Article 4 According to the different recording forms, medical records can be divided into paper medical records and electronic medical records. Electronic medical records have the same validity as paper medical records.
Article 5 Medical institutions shall establish and improve a medical record management system, set up a medical record management department or assign full-time (part-time) personnel to be responsible for medical records and medical record management.
Medical institutions should establish a regular inspection, evaluation and feedback system for the quality of medical records. The medical department of a medical institution is responsible for the quality management of medical records.
Article 6 Medical institutions and their medical staff should strictly protect patient privacy and are prohibited from disclosing patients' medical records for non-medical, teaching, and research purposes. Article 7 Medical institutions should establish a numbering system for outpatient (emergency) medical records and inpatient medical records, and establish a unique identification number for the same patient. Medical institutions that have established electronic medical records should associate the medical record identification number with the patient's identification number. Medical records can be retrieved using both the identification number and the identification number.
Outpatient (emergency) medical records and inpatient medical records should be marked with page numbers or electronic page numbers.
Article 8 Medical personnel should follow the requirements of the "Basic Standards for Writing Medical Records", "Basic Standards for Writing Medical Records of Traditional Chinese Medicine", "Basic Standards for Electronic Medical Records (Trial)" and "Basic Standards for Electronic Medical Records of Traditional Chinese Medicine (Trial)" Write medical records.
Article 9 Inpatient medical records should be sorted in the following order: temperature sheet, medical order sheet, admission record, disease course record, preoperative discussion record, surgical consent form, anesthesia consent form, anesthesia preoperative visit record, Surgical safety verification records, surgical inventory records, anesthesia records, surgical records, post-anesthesia visit records, post-operative course records, seriously ill (critically ill) patient care records, discharge records, death records, informed consent for blood transfusion treatment, special inspections (Special treatment) consent form, consultation records, critical (serious) illness notice, pathological data, auxiliary examination report form, medical imaging examination data.
Medical records should be bound and saved in the following order: inpatient medical record home page, admission record, disease course record, preoperative discussion record, surgical consent form, anesthesia consent form, anesthesia preoperative visit record, surgical safety verification record, Operation inventory records, anesthesia records, operation records, post-anesthesia visit records, post-operative course records, discharge records, death records, death case discussion records, informed consent for blood transfusion treatment, consent for special examination (special treatment), consultation records , notice of critical illness (serious illness), pathological data, auxiliary examination report form, medical imaging examination data, body temperature sheet, doctor's order, and nursing records of seriously ill (critical illness) patients. Article 10 In principle, patients are responsible for keeping outpatient (emergency) medical records. If a medical institution has established an outpatient (emergency) medical record archive or has established an outpatient (emergency) electronic medical record, with the consent of the patient or his legal representative, the outpatient (emergency) medical records may be kept by the medical institution.
Inpatient medical records are kept by the medical institution.
Article 11 If outpatient (emergency) medical records are kept by the patient, the medical institution shall promptly hand over the examination results to the patient for safekeeping.
Article 12 If outpatient (emergency) clinic medical records are kept by a medical institution, the medical institution shall classify or enter the examination and test results into the outpatient (emergency) clinic within 24 hours after receiving them. Medical records, and file outpatient (emergency) medical records within the first working day after each diagnosis and treatment activity.
Article 13 During the patient’s hospitalization, the hospitalization medical records shall be kept uniformly by the ward. When hospitalization medical records need to be taken out of the ward due to medical activities or work needs, specialized personnel designated by the ward should be responsible for carrying and keeping them.
Medical institutions shall classify or enter the inpatient medical records within 24 hours after receiving the examination results and relevant materials of inpatients.
After the patient is discharged from the hospital, the hospitalization medical records will be uniformly saved and managed by the medical record management department or full-time (part-time) personnel.
Article 14 Medical institutions should strictly manage medical records. No one is allowed to alter medical records at will. It is strictly prohibited to forge, conceal, destroy, rob or steal medical records. Article 15 Except for medical personnel who provide diagnosis and treatment services to patients, as well as departments or personnel authorized by the health and family planning administrative department, the traditional Chinese medicine management department or medical institutions to be responsible for medical record management and medical management, no other institution or individual may access it without authorization. Patient medical records.
Article 16 If other medical institutions and medical personnel need to consult or borrow medical records for scientific research or teaching, they shall submit an application to the medical institution where the patient visited them. They can only consult or borrow medical records after obtaining approval and completing corresponding procedures. They should be returned immediately after review, and borrowed medical records should be returned within 3 working days. The medical records reviewed may not be taken away from the patient's medical institution.
Article 17 Medical institutions shall accept applications from the following persons and institutions to copy or review medical records, and provide medical record copying or review services in accordance with regulations:
(1) The patient himself or herself or The authorized agent;
(2) The legal heir of the deceased patient or his agent.
Article 18 Medical institutions shall designate departments or full-time (part-time) personnel to be responsible for accepting applications for copying medical record materials. When accepting an application, the applicant shall be required to provide relevant supporting materials and the form of the application materials shall be reviewed.
(1) If the applicant is the patient himself, he shall provide his valid identity certificate;
(2) If the applicant is the patient’s agent, he shall provide the valid identities of the patient and his agent. Proof of the agency relationship between the agent and the patient, as well as legal certification materials and a power of attorney;
(3) If the applicant is the legal heir of the deceased patient, he should provide the patient’s death certificate and the valid identity certificate of the deceased patient’s legal heir. , statutory certification materials for the relationship between the deceased patient and the legal heir;
(4) If the applicant is the agent of the deceased patient’s legal heir, he should provide the patient’s death certificate and the valid identity certificates of the deceased patient’s legal heir and his agent. , statutory certification materials for the relationship between the deceased patient and the legal heir, legal certification materials for the agency relationship between the agent and the legal heir, and a power of attorney.
Article 19 Medical institutions may copy the temperature sheets, medical orders, hospitalization records (admission records), surgical consent forms, anesthesia consent forms, Anesthesia records, surgical records, seriously ill (critically ill) patient care records, discharge records, informed consent for blood transfusion treatment, consent for special examination (special treatment), pathology reports, inspection reports and other auxiliary examination reports, medical imaging examination data and other medical records material.
Article 20: The public security, judicial, human resources and social security, insurance, and departments responsible for technical appraisal of medical accidents shall be responsible for handling cases, conducting professional technical appraisal in accordance with the law, medical insurance review or arbitration, commercial insurance review, etc. If necessary, if a request is made to review, review or copy medical records, the medical institution may provide part or all of the patient's medical records as needed after the handling personnel provides the following certification materials:
(1) The administrative agency or judicial agency , insurance or the legal certificate for retrieval of medical records issued by the department responsible for technical appraisal of medical accidents;
(2) Valid identity certificate of the person in charge;
(3) Person in charge. Valid work certificate (must be consistent with the administrative agency, judicial agency, insurance or department responsible for technical appraisal of medical accidents).
If an insurance institution makes a request to review, review or copy medical records due to commercial insurance review and other needs, it shall also provide a copy of the insurance contract and statutory certification materials agreed by the patient or his agent; if the patient dies, , a copy of the insurance contract and legal certification materials consented by the deceased patient’s legal heir or his agent should be provided. Unless otherwise provided by contract or law.
Article 21 In accordance with the requirements of the "Basic Standards for Writing Medical Records" and "Basic Standards for Writing Medical Records of Traditional Chinese Medicine", if the medical record has not been completed and the applicant requests to copy the medical record, the completed medical record can be copied first. After personnel complete the medical record in accordance with regulations, they will then copy the newly completed portion.
Article 22: After a medical institution accepts an application for copying medical record materials, the designated department or full-time (part-time) personnel shall notify the medical record management department or full-time (part-time) personnel to make the necessary copies within the specified time. The medical record information shall be sent to the designated location and copied in the presence of the applicant; the copied medical record information shall be stamped with the certification stamp of the medical institution after both the applicant and the medical institution confirm that it is correct.
Article 23 Medical institutions that copy medical records may charge production fees in accordance with regulations. Article 24 When it is necessary to seal medical records in accordance with the law, the medical record agreement must be confirmed and the copy of the medical record signed and sealed in the presence of the medical institution or its authorized agent, the patient or his agent.
When a medical institution applies to seal medical records, the medical institution shall notify the patient or his agent to agree to seal the medical records; however, if the patient or his agent refuses or gives up the sealing of medical records, the medical institution may notify the patient or his agent of the intention to seal the medical records. In the case of institutional notarization, the medical record will be confirmed and the copy of the medical record will be signed and sealed by the notary agency.
Article 25 Medical institutions are responsible for the safekeeping of sealed copies of medical records.
Article 26 After sealing, the original medical records can continue to be recorded and used.
According to the requirements of the "Basic Standards for Writing Medical Records" and "Basic Standards for Writing Medical Records of Traditional Chinese Medicine", if the medical records are not yet completed and need to be sealed, the completed medical records can be sealed first. After the doctor completes the medical records in accordance with the regulations, the medical records can be sealed. Archive the newly completed part.
Article 27 The opening of sealed medical records shall be carried out in the presence of all parties signing and sealing. Article 28 Medical institutions may use microform technology that meets the requirements for file management to process and preserve paper medical records.
Article 29: Outpatient (emergency) medical records shall be kept by medical institutions for no less than 15 years from the date of the patient’s last visit; inpatient medical records shall be kept for no less than 15 years from the patient’s last hospitalization and discharge. Not less than 30 years from the date of purchase.
Article 30 When a medical institution changes its name, the medical records kept shall continue to be kept by the medical institution after the change.
After the medical institution is cancelled, the medical records kept can be properly kept by the provincial health and family planning administrative department, the traditional Chinese medicine management department or the institution designated by the provincial health and family planning administrative department or the traditional Chinese medicine management department in accordance with regulations. Article 31 The National Health and Family Planning Commission is responsible for the interpretation of these regulations.
Article 32 These regulations will come into effect on January 1, 2014. The "Regulations on Medical Records Management of Medical Institutions" (Weiyifa [2002] No. 193) promulgated by the former Ministry of Health and the State Administration of Traditional Chinese Medicine in 2002 were abolished at the same time.