Hospital Safety (Adverse) Incident Reporting System
First, the purpose
Standardize the active reporting of hospital safety (adverse) events, enhance risk prevention awareness, discover medical adverse events and potential safety hazards in a timely manner, analyze and feed back the obtained medical safety information, and conduct targeted investigations from the hospital management system, operating mechanism, and rules and regulations continuous improvement.
2. Scope of application
It is applicable to the active reporting of hospital safety (adverse) events and hidden defects in the hospital; however, adverse drug reactions/events, medical device adverse events, and nosocomial infection case reports must be reported according to specific report forms and procedures.
3. Definition and scope of hospital safety (adverse) events
Hospital safety (adverse) events refer to any factors in clinical diagnosis and treatment activities that may affect the patient's diagnosis and treatment results, increase the patient's pain and burden, and may cause medical disputes or medical accidents, as well as affect the normal operation of medical work and the personal safety of medical staff and events. include:
(1) Events that may damage the patient's health or prolong the patient's hospital stay;
(2) Events that may cause disability or death of the patient;
(3) Operations that do not conform to clinical diagnosis and treatment norms;
(4) Events that may cause additional economic losses to patients;
(5) Events that may cause personal injury or economic loss to medical personnel;
(6) Various events that may cause medical disputes;
(7) Other events or hidden dangers that may lead to adverse consequences.
4. Classification of hospital safety (adverse) events
Hospital safety (adverse) events are divided into 4 grades according to the severity of the event:
Grade I Event (Warning Event) - Unexpected death or permanent loss of function not due to natural progression of the disease.
Grade II event (adverse event) - the damage to the patient's body and function caused by the diagnosis and treatment activities rather than the disease itself during the medical treatment of the disease.
Grade III events (events without consequences)—although erroneous facts occurred, they did not cause any damage to the patient's body and function, or had minor consequences and could fully recover without any treatment.
Level IV event (hidden event) - due to timely detection of errors, no facts have been formed.
V. Principles of Hospital Safety (Adverse) Event Reporting
(1) Level I and level II incidents belong to the scope of mandatory reporting, and the reporting principles should follow the State Council's "Regulations on the Handling of Medical Accidents" (Guofa [2002] No. Guanfa [2011] No. 4), the Ministry of Health's "Regulations on Major Medical Negligence and Medical Accident Reporting System" (Wei Yifa [2002] No. 206) to implement.
(2) Level III and IV incidents are encouraged to be reported in accordance with the principles of voluntariness, confidentiality, and non-punishment.
6. Reporting process
(1) Report Form
1. Written report
Within 48 hours after the occurrence of a safety (adverse) event, the parties or other discoverers shall fill in the written "Hospital Safety (Adverse) Event Report Form" (see attached table) as required and report it to the Medical Education Department.
2. Deliver to the mailbox set up by the Medical Education Office.
3. Online report to the mailbox of the Medical Education Department.
4. Emergency call report
It is limited to use in emergency situations where hospital safety (adverse) events may quickly lead to serious consequences, and then perform written supplementary reports. Report to the general staff on duty at the hospital at night and on holidays.
(2) When a hospital safety (adverse) event occurs or is discovered that has caused or may lead to a medical accident, in addition to taking effective measures immediately to prevent the damage from expanding, the on-duty personnel should immediately report to the person in charge of the department where they belong, and the person in charge of the department should report to the department in a timely manner. Relevant functional departments report, and at the same time take appropriate forms to report to the Department of Medical Education. .
(3) The Medical Education Office shall investigate and verify the reported adverse events in a timely manner, and report to the leader of the hospital in charge if necessary.
7. Voluntary, confidential, non-punitive and open nature of hospital safety (adverse) event reporting
(1) Voluntary: All departments and individuals in the hospital have the right to voluntarily participate (or quit), and providing information reports is a voluntary act of the reporter (department).
(2) Confidentiality: The reporter can report by name or anonymously in various forms, and the relevant functional departments will keep it strictly confidential.
(3) Non-punitive: The content of the report shall not be used as the basis for punishment of the reporter or others for violating regulations, nor shall it be used as the basis for punishment of the personnel and departments involved.
(4) Openness: The functional departments will disclose and publicize the hospital safety information and its analysis results in the hospital through appropriate forms, so as to continuously improve the quality of the hospital and departments. The disclosed content is limited to the information of the case itself, and does not involve the personal information of the departments, reporters and defendants.
8. Education and training
The education and training of the adverse event reporting system will be concentrated on the staff of the hospital every six months. The awareness rate of the adverse event reporting system among all hospital staff is 100%.
9. Responsibilities and Supervision
Responsibilities:
(1) Medical staff and related departments
1. Identify and report various hospital safety (adverse) incidents, report and deal with them in a timely manner, and put forward preliminary quality improvement suggestions.
2. Relevant departments are responsible for the implementation of continuous quality improvement measures for hospital safety (adverse) incidents.
(2) Functional departments
1. Functional departments such as the Medical Education Department, Nursing Department, Pharmacy Department, Infection Control Office, Device Department, General Affairs Department, Doctor-Patient Relations Coordination Office, Security Department and other functional departments assign special personnel to collect and verify the "Medical Safety (Adverse) Event Report Form" related to diagnosis and treatment 》, and summarize, count and analyze the events.
2. For the reported medical safety (adverse) incidents, analyze the problems with the relevant departments, put forward suggestions for improvement, and feedback to the relevant departments within 7 working days, and track and evaluate the improvement results.
3. Responsible for training relevant personnel on hospital safety (adverse) event reporting knowledge.
4. Every quarter, the Medical Education Department will summarize the hospital safety (adverse) incidents, propose rewards and punishments, and report to the hospital for resolution.
(3) Department of Medicine and Education
The Department of Medical Education collects and verifies hospital safety (adverse) incidents in a unified manner. Responsible for reporting hospital safety (adverse) incidents to relevant agencies.
1. Report hospital safety (adverse) incidents to relevant agencies in a timely manner.
2. Discuss the medical safety (adverse) events submitted by various functional departments every quarter, and formulate continuous quality improvement measures or suggestions for related events.
3. According to the nature of the incident, whether it is actively reported, the order of reporting, and whether the incident has been continuously improved, give certain rewards and punishments to the reporting individual or department.
(4) Information Section
Gradually establish a network hospital safety (adverse) event direct reporting system and database. Continuously improve the sensitivity of the safety (adverse) incident reporting system to effectively reduce the false negative rate. Use the Ministry of Health's "Medical Safety (Adverse) Event Reporting System" report. The hospital's medical safety (adverse) event direct reporting system has established a network connection with the Ministry of Health's "Medical Safety (Adverse) Event Reporting System".
Supervision:
(1) Reporting management of medical safety (adverse) events implements a management system involving the hospital's medical quality and safety management committee, medical education department, clinical departments and wards.
(2) There are more than 20 reports per 100 beds in the hospital every year, and all departments should actively report hospital safety (adverse) events, especially grade III and IV events. Departments of hospital safety (adverse) incidents should summarize in a timely manner, and the quality management teams of each department carry out at least 2 or more general department tracking activities every year on the implementation of the system of active reporting and hidden defects, and keep records, and propose quality and safety improvement measures for departments.
(3) The Medical Education Office shall investigate and verify hospital safety (adverse) incidents reported by departments in a timely manner, give handling opinions, fill in the "Safety (Adverse) Incident Handling Feedback Form" to feed back to departments, and supervise departments to rectify and implement them to eliminate hidden dangers. The Medical Education Department and the Nursing Department carry out at least 2 or more hospital-wide follow-up activities each year on the implementation of the system of active reporting and hidden danger defects, and keep records. They must analyze the root causes of major adverse safety incidents and propose improvement measures. (Adverse) events are summarized, evaluated, and submitted to the hospital's medical quality and safety management committee every month to take preventive measures. Combine the safety information with the actual situation of the hospital, and carry out targeted continuous improvement from the hospital management system, operating mechanism and rules and regulations.
(4) Use information resources to strengthen management and implement specific and effective improvement measures. Evaluate the implementation of improvement measures. Apply safety information analysis and improvement results to continuously improve and optimize hospital patient safety management programs or system specifications.
10. Rewards and punishments
(1) The hospital encourages employees to take the initiative to report hospital safety (adverse) incidents. Individuals who voluntarily report hospital safety (adverse) incidents will be rewarded with RMB 10 to 500 yuan according to the degree of hospital safety (adverse) incidents. Adverse) events reached more than 10 cases, and the reported hospital safety (adverse) events were significantly helpful to process improvement, and departments that achieved more than 3 process improvements were rewarded accordingly. Prior to January 15 each year, the report persons and departments of the previous year will be rewarded and commended intensively.
(2) The party concerned or the department fails to report the safety (adverse) incident in the hospital in time, which leads to the further development of the incident. Although no personal injury is caused to the patient, it causes some pain to the patient, prolongs the treatment time or increases unnecessary economic costs. Burden, according to the severity of the incident, the party and the department will be punished accordingly, and the performance will be deducted from 0.5 to 5 points.
(3) Hospital safety (adverse) incidents that have constituted hospital accidents and errors shall be implemented in accordance with our hospital’s Regulations on Prevention, Early Warning and Handling of Medical Disputes (Accidents).
(4) For medical deficiencies that actively report hospital safety (adverse) events, the hospital will reduce or exempt punishment according to the circumstances.