Thông tư hướng dẫn báo cáo sự cố y khoa năm 2024
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BỆNH VIỆN SUỐI KHOÁNG MỸ LÂM Đơn vị chủ quản: Sở Y tế tỉnh Tuyên Quang Chịu trách nhiệm chính: BS. Nguyễn Quế Lâm - Giám đốc Bệnh viện Địa chỉ: Phường Mỹ Lâm, TP. Tuyên Quang, Tỉnh Tuyên Quang Điện thoại: 0207.3875.284 Email: [email protected] Thông tư 43/2018/TT-BYT Hướng dẫn phòng ngừa sự cố y khoa trong các cơ sở khám bệnh, chữa bệnh do Bộ trưởng Bộ Y tế ban hành * Cơ quan ban hành: Bộ Y tế . * Ngày ban hành: 26/12/2018. * Ngày có hiệu lực: 01/03/2019. * Nội dung chính: Thông tư này hướng dẫn việc báo cáo sự cố y kha, phân tích, phản hồi và xử lý sự cố y khoa; khuyến cáo, cảnh báo và khắc phục để phòng ngừa sự cố y khoa và trách nhiệm thực hiện (không áp dụng đối với phòng ngừa sự cố ý khoa trong hoạt động tiêm chủng, tác dụng không mong muốn của thuốc và biến cố bất lợi của các thử nghiệm lâm sàng.) Khi phát hiện sự cố y khoa, nhân viên y tế có trách nhiệm nhận diện và phân biệt sự cố y khoa theo các trường hợp mô tả, diễn biến tình huống, mức độ tổn thương . Báo cáo sự cố y khoa gồm: - Báo cáo tự nguyện đối với các sự cố y khoa: + Tình huống có nguy cơ gây sự cố + Sự cố đã xảy ra, chưa tác động trực tiếp đến người bệnh + Sự cố đã xảy ra tác động trực tiếp đến người bệnh, chưa gây nguy hại + Sự cố đã xảy ra tác động trực tiếp đến người bệnh, cần phải theo dõi hoặc đã can thiệp điều trị kịp thời nên không nguy hại + Sự cố đã xảy ra gây nguy hại tạm thời và cần phải can thiệp điều trị + Sự cố đã xảy ra, gây nguy hại tạm thời, cần phải can thiệp điều trị và kéo dài thời gian nằm viện. Báo cáo bắt buộc đối với các sự cố y khoa: + Sự cố kéo dài gây hại và để lại di chứng + Sự cố đã xẩy ra gây nguy hại và cần phải được hồi sức tích cực + Sự cố đã xảy ra có ảnh hưởng hoặc trực tiếp gây tử vong + Các sự cố y khoa nghiêm trọng gồm : Sự cố y khoa gây tử vong cho 01 người bệnh và nghi ngờ có nguy cơ tiếp tục gây tử vong cho người bệnh tiếp theo hoặc sự cố y khoa gây tử vong cho 02 người bệnh trở lên trong cùng một tình huống, hoàn cảnh và nguyên nhân. - Hình thức báo cáo bằng văn bản hoặc báo cáo điện tử , riêng với sự cố y khoa nghiêm trọng phải báo cáo trước bằng điện thoại trong thời hạn 01 giờ, kể từ khi phát hiện sự cố. Cơ sở khám, chữa bệnh tổng hợp báo cáo sự cố y khoa gửi cơ quan quản lý 6 tháng một lần nội dung gồm: Số lượng báo cáo sự cố y khoa bắt buộc và tự nguyện, tần suất xảy ra đối với từng loại sự cố, kết quả phân tích nguyên nhân gốc, giai pháp và khuyến cáo phòng ngừa đã đề xuất và được triển khai. Sau khi tiếp nhận báo cáo sự cố y khoa xảy ra, bộ phận tiếp nhận và quản lý sự cố y khoa cửa cơ sở khám chữa bệnh phải tiến hành phân loại, phân tích sơ bộ về mức độ nghiêm trọng và tần suất xảy ra ở tất cả các sự cố được ghi nhận và đề xuất danh mục sự cố y khoa và nhóm chuyên gia phân tích sự cố y khoa tương ứng báo cáo người đứng đầu cơ sơ khám chữa bệnh . Trong 60 ngày , kể từ ngày nhận được báo cáo, phân tích sự cố y khoa từ bộ phận tiếp nhận và quản lý sự cố y khoa, nhóm chuyên gia phân tích sự cố y khoa phải đề xuất giải pháp và khuyến cáo phòng ngừa sự cố cho đơn vị mình. Trung tâm Y tế huyện Phong Thổ là tổ chức thuộc Sở y tế, chịu sự quản lý, chỉ đạo và hướng dẫn, thanh tra, kiểm tra của Giám đốc Sở y tế về chuyên môn, nghiệp vụ, kinh phí, nhân lực y tế; chịu sự quản lý, chỉ đạo của Uỷ ban nhân huyện Phong Thổ, trong việc xây dựng kế hoạch phát triển y tế của huyện để trình cơ quan có thẩm quyền và chịu trách nhiệm tổ chức thực hiện kế hoạch đó sau khi được phê duyệt. CỔNG THÔNG TIN ĐIỆN TỬ TRUNG TÂM Y TẾ HUYỆN HÓC MÔN Số điện thoại: - Hotline tư vấn tiêm chủng dịch vụ: 02838914032 (Trong giờ hành chính) - Phòng TC-HC: 02837107204 (Trong giờ hành chính) Email: [email protected] Địa chỉ: 75, đường Bà Triệu, Khu phố 1, thị trấn Hóc Môn, huyện Hóc Môn, Thành Phố Hồ Chí Minh. Nội dung đáng chú ý này được quy định tại Thông tư 43/2018/TT-BYT hướng dẫn phòng ngừa sự cố y khoa trong các cơ sở khám, chữa bệnh. Theo đó, sự cố liên quan đến quản lý người bệnh được xếp vào Danh mục sự cố y khoa nghiêm trọng khi thuộc vào các trường hợp hợp sau: - Giao nhầm trẻ sơ sinh; - Người bệnh trốn viện bị tử vong hoặc bị di chứng nghiêm trọng; - Người bệnh tử vong hoặc di chứng nghiêm trọng do tự tử tại cơ sở khám, chữa bệnh. Ngoài 03 trường hợp nêu trên thì còn có 25 trường hợp khác (quy định tại Phụ lục II ban hành kèm theo Thông tư 43) được xác định là sự cố y khoa nghiêm trọng thuộc các nhóm sự cố như: Sự cố phẫu thuật; sự cố do trang thiết bị; sự cố liên quan đến chăm sóc tại cơ sở khám, chữa bệnh; sự cố do môi trường; sự cố được cho là phạm tội hình sự. Thông tư 43/2018/TT-BYT có hiệu lực thi hành từ ngày 01/3/2019. MINISTRY OF HEALTH OF VIETNAM --- SOCIALIST REPUBLIC OF VIETNAM Independence – Freedom – Happiness ---- No. 43/2018/TT-BYT Hanoi, December 26, 2018 CIRCULAR GUIDING PREVENTION OF ADVERSE EVENTS IN MEDICAL EXAMINATION AND TREATMENT ESTABLISHMENTS Pursuant to Decree No. 75/2017/ND-CP dated June 20, 2017 of Government on functions, tasks, powers, and organizational structure of Ministry of Health; At the request of the Director General of the Vietnam Administration of Medical Services; Minister of Health promulgates Circular guiding prevention of adverse events in medical examination and treatment establishments. Chapter I GENERAL PROVISIONS Article 1. Scope and regulated entities ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. 2. This Circular does not apply to prevention of adverse events in vaccination, adverse drug reactions (ADR), and adverse events of clinical trials. 3. This Circular applies to medical examination and treatment establishments (hereinafter referred to as “medical establishments”) and relevant agencies, organizations, individuals. Article 2. Definition In this Circular, terms below are construed as follows: 1. “an adverse event” refers to an unwanted event that occurs during diagnosis, care, or treatment as a result of objective and/or subjective causes other than the illness or body of the patients and affects health and/or lives of the patients. 2. “a near-miss” refers to an adverse event that has already occurred without causing any consequences or almost caused consequences but was then discovered and promptly prevented and did not affect patients’ health. 3. “root causes” are causes that directly correlate with the occurrence of adverse events, root causes can be remediated to prevent adverse events. Article 3. Rules for preventing adverse events 1. Prevention of adverse events must be implemented on the basis of identification, reporting, analysis in order to find the cause, issue recommendations to prevent, avoid adverse events, improve medical examination and treatment quality and for no other purposes. ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. 3. Dossiers on adverse event prevention are managed in accordance with regulation on information confidentiality. 4. Prevention of adverse events is the responsibility of health workers and leaders in medical establishments. Chapter II REPORTING ON ADVERSE EVENTS Article 4. Identification of adverse events Upon encountering adverse events, health workers are responsible for identifying and classifying the adverse events based on description, development, and level of injury under Appendix I attached hereto. Article 5. Reporting and recording of adverse events 1. Reporting of adverse events includes:
... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. 2. Reporting methods:
Report via urgent documents or electronic documents for adverse events that cause severe injuries (NC3) under Appendix II attached hereto. With respect to serious adverse events under Point b Clause 1 Article 5, those adverse events must be reported in advance via telephone within 1 hour from the point in which the events are discovered. 3. Reporting and recording of adverse events in medical establishments
- Voluntary reporting: Persons who cause or discover the adverse events shall report to adverse event reception and overseeing departments of medical establishments. Minimum reporting contents include: Location, time, description, preliminary assessment regarding the adverse events, conditions of affected persons, and initial response using Form of Adverse event report under Appendix III attached hereto. - Mandatory reporting: Persons who cause or discover the adverse events must report to their heads of departments and adverse event reception and overseeing departments. Heads of departments are responsible for reporting to heads of medical establishments. Heads of medical establishments are responsible for reporting to supervisory authorities of the medical establishments. The reports must contain all information on the Form of Adverse event report under Appendix III attached hereto and name of persons making the reports.
... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. - All reported adverse events must be recorded and kept in documents or on adverse event reporting system. Serious adverse events under Point b Clause 1 Article 5 must have their reports sent to supervisory authorities of the medical establishments and Ministry of Health. 4. Reporting and recording of adverse events at Departments of Health: Departments of Professional Affair and Departments of Health shall act as contact point for receiving reports and classifying adverse events of medical establishments under their management, including state-owned and private medical establishments affiliated to centralized health authorities except for those affiliated to Ministry of National Defense. 5. Reporting and recording of adverse events at Ministry of Health: Department of Medical Service Administration shall act as contact point for receiving reports and classifying adverse events of medical establishments affiliated to Ministry of Health. Article 6. Consolidation of adverse event reports 1. At medical establishments:
... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. - Frequency of each type of adverse event - Analysis results of root cause - Preventive solutions and recommendations proposed and implemented 2. At Departments of Health:
3. At Ministry of Health:
... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. ANALYSIS, RESPONSE, AND HANDLING OF ADVERSE EVENTS Article 7. Classification of adverse events 1. Upon receiving reports on adverse events, adverse event reception and overseeing departments of medical establishments must classify the adverse events based on 3 criteria below:
2. Regarding adverse events that are deemed to warrant serious injuries (NC3), these adverse events must be further classified based on List of serious adverse events under Appendix II. Article 8. Analysis of factors and root causes 1. Analysis at medical establishments ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents.
2. Analysis at Departments of Health
3. Analysis at Ministry of Health
Article 9. Handling and feedback of adverse event handling and response ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents.
2. Feedback on adverse event reports and handling
Chapter IV RECOMMENDATIONS AND RECTIFICATIONS TO PREVENT ADVERSE EVENTS Article 10. Recommendations for preventing adverse events ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. 2. Department of Professional Affairs - Departments of Health shall review all adverse event recommendations of affiliated medical establishments to consolidate, make general recommendations to enable provinces and cities to prevent adverse events with high frequency of occurrence and medical establishments to prevent similar adverse events. 3. Department of Medical Service Administration - Ministry of Health shall review recommendations for preventing adverse events of affiliated medical establishments and Departments of Health in order to make national recommendations for preventing adverse events with high reporting frequency, general recommendations to enable medical establishments to avoid similar adverse events. 4. Disseminate recommendations for preventing adverse events on internal news of medical establishments or on guiding documents of supervisory authorities and on “An toàn người bệnh” (Patient safety) section of online newspaper, magazines, journals, and seminars on mass media. Article 11. Rectification to prevent adverse events 1. Adverse event reception and overseeing shall advise heads of medical establishments to develop and request competent authorities to issue plans, implement activities in order to carry out solutions and recommendations for preventing adverse events. 2. Persons in charge of technical matter of medical establishments shall coordinate relevant departments and supervise implementation of recommendations for preventing adverse events according to plan. 3. Contact points of Ministry of Health and Departments of Health shall coordinate and supervise affiliated medical establishments where adverse events have already occurred carry out preventive activities according to plan. 4. Contact points of Departments of Health and Ministry of Health shall coordinate and supervise medical establishments implement general recommendations and national recommendations for preventing adverse events for adverse events with high reporting frequency and in medical establishments with similar risks of encountering, repeating adverse events. Chapter V ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. Article 12. Responsibilities of health workers and medical establishments 1. Be aware of the necessity of preventing adverse event. 2. Execute specific tasks of medical establishments under this Circular. 3. Maintain confidentiality and privacy of individuals and medical establishments that report adverse events. Assign adverse event reception and overseeing departments to act as contact point entitled to look up and disclose information on adverse event reporting. 4. Develop regulations, procedures, and guidelines, and encourage voluntary reporting of adverse events. 5. Guide, manage adverse event reports, and issue regulations incentivizing voluntary reporting and penalizing unreported adverse events. 6. Consolidate, analyze, and report data regarding adverse event resolution results in medical establishments and make preventive recommendations. Article 13. Responsibilities of Departments of Health of provinces and central-affiliated cities and health authorities affiliated to ministries and departments 1. Exercise specific tasks of Departments of Health under this Circular. ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. 3. Direct, organize implementation, manage, supervise, and assess patient safety operation of medical establishments in provinces and cities. 4. Propose amendment to national regulations and guidelines on patient safety. 5. Organize training for affiliated medical establishments regarding reporting of adverse events. 6. Propose commendations for entities and individuals with valuable reports which help Departments of Health to promulgate solutions and recommendations for preventing adverse events. Article 14. Responsibilities of Department of Medical Service Administration - Ministry of Health 1. Exercise specific tasks of Ministry of Health under this Circular. 2. Maintain confidentiality and privacy of individuals and medical establishments that report adverse events. Assign contact individuals and entitled entities to look up and disclose information on adverse event reporting. 3. Take charge or cooperate in developing and amending legislative documents and professional guidelines on patient safety and present to Minister of Health or competent authorities for approval. 4. Direct, organize, guide, inspect, and supervise compliance with legislative documents and professional guidelines regarding patient safety for nationwide medical establishments. ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. 6. Act as contact point and organize professional councils for resolving professional and technical matters, coordinate, guide scientific research activities and international cooperation in patient safety and prevention of adverse events. 7. Develop national policies and national action programs for patient safety and prevention of adverse events. 8. Monitor, inspect, and supervise implementation of policies and action programs regarding patient safety in provinces and central-affiliated cities. 9. Advise Minister of Health in community matters and communication authorities in adverse events. 10. Discover and issue warnings for new and emerging adverse events. 11. Propose commendations for entities and individuals with valuable reports which help Ministry of Health to promulgate solutions and recommendations for preventing adverse events. Take actions and penalize individuals and entities that fail to adhere to applicable laws. Chapter VI IMPLEMENTATION Article 15. Entry into force ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. Article 16. Organizing implementation Director of Department of Medical Service Administration, Chief of Ministry Office, Chief Inspector of Ministry Inspectorates, directors of departments of Ministry of Health, directors of hospitals, directors of Departments of Health of provinces and central-affiliated cities, heads of health authorities of departments are responsible for implementation of this Circular. Difficulties that arise during the implementation of this Circular should be reported to the Ministry of Health (Department of Medical Service Administration)./. PP. MINISTER DEPUTY MINISTER Nguyen Viet Tien APPENDIX I CLASSIFICATION OF ADVERSE EVENTS BASED ON LEVEL OF INJURY (Attached to Circular No. 43/2018/TT-BYT dated December 26, 2016 of the Minister of Health) ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. Description Classification Report methods Based on situation development Based on level of harm to health, life of patient (Level of injury - NC) 1 A near-miss ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. Have not occurred (NC0) 2 Adverse event has occurred without directly affecting patients B Mild injury (NC1) 3 Adverse event has directly affected patients without causing harm ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. 4 Adverse event has directly affected patients and requires monitoring or has been promptly intervened without causing harm D Voluntary reporting 5 Adverse event has caused temporary harm and requires intervention E Moderate injury ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. 6 Adverse event has caused temporary harm, requires intervention, and prolongs hospitalization duration F 7 Adverse event has caused prolonged harm and leaves sequelae G Severe injury (NC3) ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. 8 Adverse event has caused harm and requires intensive care H Mandatory reporting 9 Adverse event leads to or causes death I ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. APPENDIX II LIST OF SERIOUS ADVERSE EVENTS (NC3) (Attached to Circular No. 43/2018/TT-BYT dated December 26, 2018 of Minister of Health) SURGICAL ADVERSE EVENTS 1. Wrong-site surgery (body parts) Refers to cases where surgical operation is performed on the wrong body parts according to the medical record, except for emergencies such as:
2. ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. Refers to cases where surgical operation is performed on the wrong patient according to patient identification in the medical record. 3. Wrong-procedure surgery causing severe injury: Refers to cases where surgical procedures are inconsistent with the laid out procedures, except for emergencies such as:
4. Retained surgical instrument following a surgical operation or other invasive procedures: Exception: ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents.
5. Death during surgery (pre-anaesthesia, incision, incision healing) or immediately after surgery of ASA 1 patients. ADVERSE EVENTS RESULTING FROM MEDICAL DEVICES 6. Death or severe complications relating to medicine, medical devices, or biologicals 7. Death or severe complications of the patients relating to the use or performance of medical devices in patient care that are different from the original plan. ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. Death or severe complications of the patients relating to embolism during patient care and/or treatment. Exception: Peripheral nervous or cardiovascular procedures deemed to warrant high risks of embolism. ADVERSE EVENTS RELATING TO PATIENT MANAGEMENT 9. Babies switched at birth 10. Death or severe complications of patients escaping from hospitals 11. Death or severe complications of patients due to suicide at medical establishments. ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. 12. Deaths or severe complications of the patients relating to errors in drug use: Including: Potential death or severe complications of the patients caused by a type of drugs which the patients have allergic reactions to which is known by the prescribers Exception: Justifiable differences in determining drugs and dose in clinical management. 13. Death or severe complications of the patients relating to hemolytic anemia caused by transfusing the wrong blood type 14. Death or severe complications of pregnant women relating to the process labor and birth: Including all adverse events that occur during postnatal period (42 days following birth). ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents.
15. Death or severe complications of the patients caused by hypoglycemia during treatment. 16. Death or severe complications (Kernicterus) of infant patients caused by high levels of bilirubin in blood. 17. Grade 3 or grade 4 pressure sore during hospitalization. ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. Death or severe complications of the patients caused by physiotherapy-induced spinal injury 19. Errors in organ transplant. Including sperm and/or egg mix-up in artificial insemination ADVERSE EVENTS CAUSED BY THE ENVIRONMENT 20. Death or severe complications of the patients caused by electricity. Exception: Adverse events that follow electrotherapy (defibrillation or cardioversion selective). 21. ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents.
22. Death or severe complications of the patients caused by burns of any origin while receiving care at medical establishments. 23. Death or severe complications caused by falling while receiving medical care at medical establishments. ADVERSE EVENTS CONSTITUTING CRIMINAL OFFENCES 24. Impersonating health workers to provide treatment for patients ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. Abducting (or luring) patients of all age 26. Sexually assaulting patients in hospitals 27. Inflicting death or serious injuries to patients or health workers in medical establishments 28. Other serious adverse events (NC3 of G, H, I classification) not mentioned under section 1 through 27 APPENDIX III ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. FORM OF ADVERSE EVENT REPORTING: -Voluntary: □ -Mandatory: □ Report number/Adverse event code: Reporting date: Reporting entity: Patient information Victim(s) of adverse event Full name: ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. Medical record number: □ Relatives/visitors Date of birth: □ Health workers Gender: Department/ward □ Amenity/infrastructure Location of adverse event Department/ward/location of adverse event (for example: ICU ward, hospital ground) Specific location (for example: restroom, parking lot, etc.) ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. Date of adverse event: Time: Brief description of the adverse event Proposed initial solutions ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. Inform admitting physician/person in charge Record in medical record/relevant document □ Yes □ No □ Not recorded □ Yes □ No □ Not recorded Inform relative/guardian Inform patient □ Yes □ No □ Not recorded ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. Initial adverse event classification □ Not occur □ Occurred Initial assessment regarding adverse event impact □ Severe □ Moderate □ Mild Information of reporter Full name: ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. Email: □ Nurse (title): □ Patient □ Relatives/visitors □ Physician (title): □ Other (specify): Witness 1: Witness 2: ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. APPENDIX IV SAMPLE ADVERSE EVENT RESEARCH AND ANALYSIS (Attached to Circular No. 43/2018/TT-BYT dated December 26, 2018 of the Minister of Health) Report number/Adverse event code: ……………
(Describe both immediate response and consequences. In case of pressure ulcers, specify positions, sides, radius, and conditions at the time of hospitalization. In case of drug-related adverse events, list all drugs (attach a separate sheet if necessary) ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. 1. Performance of technical procedures, professional procedures □ Fail to obtain consent of the patient/relative (with respect to operations, procedures that require the patient/relative to sign the commitment) □ Fail to execute as indicated □ Execute on the wrong patient □ Execute the wrong procedure/operation/treatment method □ Perform surgery/procedure at the wrong site □ Leave instruments or consumables in patient □ Patient deceases during pregnancy □ Patient deceases while giving birth ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. 2. Hospital-acquired infection □ Septicemia □ Pneumonia □ Other infection types □ Surgical wound infections □ Urinary tract infections 3. Drugs and intravenous fluids □ Incorrect drug and/or intravenous fluids □ Insufficient drugs ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. □ Incorrect time of taking drugs □ Incorrect medical order □ Missing drugs/dose □ Incorrect drugs □ Incorrect patients □ Incorrect route of administration 4. Blood and its preparations □ Adverse effects, complication during blood transfusion □ Transfusion of the wrong blood type or blood preparations ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. 5. Medical devices □ Missing use instructions □ Device malfunction □ Insufficient or inappropriate device 6. Behavior □ Self-harm or suicidal tendency □ Sexually assaulted by staff □ Sexually assaulted by patient/visitor □ Violated by patient/visitor ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. □ Escaped from hospital 7. Accident to patient □ Falling 8. Infrastructure □ Damaged or defective □ Lacking or inappropriate 9. Resource management, organization □ Appropriateness and adequacy of medical examination and treatment services □ Appropriateness and adequacy of resources ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. 10. Document, administrative procedures □ Missing or insufficient document □ Unclear or incomplete document □ Prolonged waiting period □ Slow document provision speed □ Wrong document □ Convoluted administrative procedures 11. Other □ Adverse events not mentioned under Sections 1 through 10 ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. III. Implemented treatment/medical order IV. Classify by causes of adverse events 1. Employee □ Awareness (knowledge, understanding, idea) □ Practice (practice skills are inconsistent with regulations, standard guidelines; fail to adhere to the correct regulations and guidelines) □ Attitude, behavior, emotion ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. □ Physiological psychology, physical attribute, pathology □ Societal factors 2. Patient □ Awareness (knowledge, understanding, idea) □ Practice (practice skills are inconsistent with regulations, standard guidelines; fail to adhere to the correct regulations and guidelines) □ Attitude, behavior, emotion □ Communication □ Physiological psychology, physical attribute, pathology □ Societal factors ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. □ Amenities, infrastructure, equipment □ Extreme distance to working position □ Safety and risk assessment of working environment □ Rules, regulations and technical properties 4. Organization/service □ Policies, procedures, professional guidelines □ Compliance with standard practice procedures □ Organization culture □ Group work ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. □ Natural environment □ Products, technology, and infrastructure □ Procedures, service system 6. Other □ Other factors not mentioned under Sections 1 through 5
VI. Preventive recommendations ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. Proposed preventive recommendations
Description of observed results (without repeating adverse event description) Have discussed and provide recommendations/resolution for persons making the report □ Yes □ No □ Not recorded ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. □ Yes □ No □ Not recorded II. Assess level of injury To patient To organization 1. Have not occurred (NC0) □ A ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. □ Property damage 2. Mild injury (NC1) □ B □ Increased resources serving patients □ C □ Media attention ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. □ Complaints of patients 3. Moderate injury (NC2) □ E □ Reputational damage □ F □ Law intervention ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. □ G □ Other □ H □ I Name: ... ... ... Please sign up or sign in to your TVPL Pro Membership to see English documents. Title: Date: Time: A mild injury means an injury that can be healed naturally or without intervention and treatment. A moderate injury means an injury that requires intervention and treatment, prolongs hospitalization period, and affects functions in the long run. A severe injury means an injury that warrants emergency medical response or major intervention and treatment, causes permanent loss of functions or even death. |
