Circular No. 43/2018/TT-BYT on Preventing Medical Incidents in Healthcare Facilities

Bộ These regulations stipulate conditions for ensuring food safety in the production, business, and use of food additives.
-------

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

Number: 43/2018/TT-BYT

Hanoi, on 26 the 12 year 2018

DEPUTY MINISTER
DEPUTY MINISTER


(Signed)

NGUYEN VIET TIEN

Serial number

Description of medical incidents

Subgroup

Reporting form

According to the situation development

According to the degree of injury to the patient's health/acute infectious diseases of producers/processers ...and life

(Risk Level-RL)

1

d.1. Amount of taxable income in Vietnam:e situations that may cause incidents (near miss)

A

Not occurred (RL0)

2

The incidentNo. has occurred but did not directly affect the patient

B

Minor injury(RL1)[1] The incident has occurred and directly affected the patient, but did not cause harm.

3

The incident has occurred and directly affected the patient, requiring monitoring or timely intervention without causing harm.

C

4

Voluntary report

D

has occurred causing temporary harm and requiring treatment intervention.

5

The incidentNo. Moderate injuryn l(RL2)

E

The incident has occurred, causing temporary harm, requiring treatment intervention and extending hospital stay.[2]

has occurred causing prolonged harm, leaving residual disability.

6

Severe injury g(RL3)

F

7

Incident đ(accompanied by a list of serious medical incidents)n lThe incident has occurred causing severe harm requiring intensive care.g

G

Mandatory report[3] The incident has occurred causing significant harm or directly resulting in death.

SEVERE MEDICAL INCIDENTS (RL3)No. Decision No. 43/

8

SURGICAL INCIDENTSđượ Incorrect surgical site (body part):

H

Surgery performed at a body location not matching the information recorded in the medical record, except in emergency situations such as:|||of

9

A. Change of surgical site during surgery.n lB. Such change was approved.shall Wrong patient surgery:đổ Surgery performed on a patient not matching the identification information recorded in the medical record.

I

A. Change of surgical method during surgery.

1.

B. Such change was approved.

Leaving surgical instruments or consumables inside the patient’s body after surgery or other invasive procedures:g Except:12. Leather shoes A. The instrument was intentionally implanted (as directed).

B. The instrument was present before surgery and intentionally retained. đsurgery position change occurs during the surgical process

B. Surgery method change đThis change is approved.

2.

Incorrect patient surgery:

Surgery performed on a patient not matching the identification data recorded in the medical record.

3.

Incorrect surgical procedure (deviating from the protocol) causing significant harm:oThe surgical method implemented does not conform to the pre-established surgical plan, except for emergency situations such as:

A. Changing the surgical method during the surgical process..This change12. Leather shoesis approved.

Leaving surgical instruments, disposable materials inside the patient's body after the surgery ends or other invasive procedures:

B. Surgery method change đExcept: đA. Such instruments were intentionally implanted according to instructions.

4.

B. Instruments present before surgery and intentionally retained.12. Leather shoesReport formof the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home Affairs- Mandatory:

report code/

incident:

Reporting date: / / đPatient information

c. Instruments not present before surgery that were intentionally left inside due to potential harm when removing them. For example: very small needles or fragments of screws.12. Leather shoesor pieces of screws.

5.

Death occurs during the entire surgical process (pre-anesthesia, skin incision, wound closure) or immediately after surgery on patients classified as ASA grade I.

EQUIPMENT INCIDENTS

6.

Death or severe consequences related to drugs, equipment, or biological products

7.

The patient dies or suffers serious consequences related to the use or function of medical instruments during patient care different from the plan đIncident perpetrator đbeginning.

8.

The patient dies or suffers serious consequences related to the insertion of intravascular catheters during patient care.ắExcluding: Neurosurgical or cardiovascular procedures determined to have a high risk of intravascular catheter complications.

INCIDENTS RELATED TO PATIENT MANAGEMENTêocess xắHanding over

premature infants

9.

The patient escapes from the hospital and dies or suffers serious consequences.ầThe patient dies or suffers serious consequences due to suicide at the healthcare facility.

10.

INCIDENTS RELATED TO CARE AT THE FACILITY

11.

The patient dies or suffers serious consequences related to medication errors:đổ Including: Administering a drug known to cause allergic reactions or drug interactions that could leadêto death or serious consequences.

Excluding: Differences in drug selection and dosage justified in clinical management. MEDICAL EXAMINATION AND TREATMENT

12.

The patient dies or suffers serious consequences due to hemolysis from blood transfusion errors

or serious consequences related to childbirth and delivery processes:đổ Including those incidents occurring during the postpartum period (42 days after delivery). is a document or information successfully sent, received, and stored on the System, including: A. Pulmonary embolism or amniotic fluid embolism

B. Acute fatty liver of pregnancy

13.

. B

14.

Emergency Patients is a document or information successfully sent, received, and stored on the System, including: heart disease.ứThe patient dies or suffers serious consequences due to hypoglycemia during treatment.

The patient dies or suffers serious consequences (jaundice) due to elevated bilirubin levels in newborns.12. Leather shoesPressure sores of stage 3 or 4 occur while inpatient.

report code/

The patient dies or suffers serious consequences due to spinal cord injury caused by physical therapy.

Mistaken organ transplant.

CIncluding mistaken sperm or egg in artificial inseminationệINCIDENTS

15.

The patient dies or suffers serious consequences related to medication errors:đổ DUE TO ENVIRONMENT

16.

The patient dies or suffers serious consequences due to electric shock.

17.

Excluding: Incidents occurring during electrical treatments (defibrillation or electrical cardioversion or pacemaker đcoholic beverages đimplantation).logoAccidents caused by the design of oxygen supply systems or other gases provided to patients such as:

18.

A. Mistaken gas. Or

19.

B. Contaminated gas

The patient dies or suffers serious consequences due to burns arising from any cause while being cared for at the facility.FUNCTIONS, DUTIES, POWERS, ORGANIZATIONAL STRUCTURE, OPERATIONAL REGULATIONS, AND RELATIONSHIPS OF MANAGEMENT BOARDS; DUTIES, POWERS OF THE CHAIRPERSON, VICE CHAIRPERSON (IF ANY), SECRETARY, AND MEMBERS OF MANAGEMENT BOARDSThe patient dies or suffers serious consequences due to falls while receiving medical care at the facility.

CONSIDERED CRIMINAL INCIDENTS

20.

Impersonating a healthcare worker to treat a patientêKidnapping (or luring) patients of all ages

Sexual assault on patients within the hospital premiseslogoCausing death or serious injury to patients or healthcare workers within the healthcare facility premises đOther serious medical incidents (NC3 types G, H, I) notcouncillORSmentioned in sectionslogo27Briefing signed on February 18, 2025SAMPLE MEDICAL INCIDENT REPORT

21.

(Annexed to Circular No. 43/2018

/TT-BYT datedFUNCTIONS, DUTIES, POWERS, ORGANIZATIONAL STRUCTURE, OPERATIONAL REGULATIONS, AND RELATIONSHIPS OF MANAGEMENT BOARDS; DUTIES, POWERS OF THE CHAIRPERSON, VICE CHAIRPERSON (IF ANY), SECRETARY, AND MEMBERS OF MANAGEMENT BOARDS12/2018 of the Ministry of Health)

FORM OF MEDICAL INCIDENT REPORT: đ- Voluntary:

22.

- Mandatory:

23.

report/Medical incident code:

CONSIDERED CRIMINAL Reporting date:  /  / Patient information

24.

Party responsible for the incident

25.

□ Patient

26.

Medical record number:ê□ Family member/visitor

27.

□ Healthcare staff

28.

Gender: đDepartment/wardPlan for handling assets after the expiration of the joint venture and association period 1 đế□ Equipment/facility infrastructure

Time: CONSIDERED CRIMINAL Brief description of the incident

Initial solution proposal □

□ Patient □

Provincial People's Committees set specific pricesNo. Medical record number:No. □ Family member/

visitor

Reporting unit: ...............

□ Healthcare staff

Gender:n lDepartment/unit

Name:

□ Equipment/facility infrastructure

Incident location

(e.g., ICU department, hospital premises)hSpecific location đ(e.g., bathroom, parking lot...)

Date of birth:

Date of occurrence:êTime: standards

Brief description of the incident             Initial solution proposal

□ Practice (incorrect practice, non-compliance with standard guidelines or performing according to incorrect guidelines)

N |||on: Number of main types of materials with price changes;n l□ Attitude, behavior, emotionsNo.

□ Communicationn lDepartment/unit □ Psychological, physical condition, disease"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation." □ Social factors

2. Patient □ Psychological, physical condition, disease"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation." □ Practice (incorrect practice, non-compliance with standard guidelines or performing according to incorrect guidelines)ealth,đượinternational đPhysical condition, disease

3. Work environmentn l□ Infrastructure, equipment   /   / 

□ Distance from workplace too far

□ Safety assessment, environmental risksn l □ Regulations, technical characteristics

4. Organization/service

Initial treatment/management has been carried out đNotified to the treating doctor/person responsible

Recorded in the medical record/report

□ Yes □ No □ Not recorded Administrative Procedure: Recognition of forest tree planting seed sources □ Yes □ No □ Not recordedThis Resolution takes effect from the date it is adopted by the National Assembly. related

Notified to family/caretaker

Notified to patientshall Initial classification of incident

□ Not occurred

□ Occurred

Notified to family/caretaker

Notified to family/caretaker

Initial assessment of severity level of incident

□ Severe

□ Moderate

□ Minor đ||| n l(6): Record the severityinInformation of reporter

Name:

□ Nurse (position):

□ Family/guest

visiting

H□ Doctor (position):

Provincial People's Committees set specific pricesố đAS AGREED

Email:

□ Other (specify):

□ Equipment/facility infrastructure

Witness 1: Witness 2:

MODEL FOR INCIDENT IDENTIFICATION AND ANALYSISỹ Circular No. 43/

2018/TT-BYT dated

December

4. Declaration and payment of the feeThis Resolution takes effect from the date it is adopted by the National Assembly.26/2018 of the Minister of Health

1. Implementation of technical procedures, specialized techniques, and proceduresn l □ Without patient/family consent (if required for certain procedures, a signed agreement is needed)

□ Performed without indicationn l of□ Performed on the wrong patient □ Performed with incorrect technique/procedure/methodto □ Performed at the wrong surgical siten l□ Left surgical instruments/materials inside the bodyớ□ Maternal death during pregnancy □ Death during childbirth□ Neonatal death organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular.2. Infection As for the principal and interest payments as specified in the Loan Agreement, the Borrower must repay them in priority equal to any other loans of the Borrower.□ Bloodstream infectionon Do đó, để thực hiện nhiệm vụ bán đấu giá đối với các loại tài sản nhà nước trên đây, cơ quan tài chính có thể thành lập Hội đồng bán đấu giá tài sản hoặc thành lập đơn vị sự nghiệp để tổ chức bán đấu giá các loại tài sản nhà nước. Vì thế, việc thành lập đơn vị sự nghiệp thuộc Sở Tài chính để thực hiện các nhiệm vụ có tính chất dịch vụ về quản lý tài sản nhà nước, bao gồm cả việc bán đấu giá tài sản nhà nước là phù hợp với các quy định hiện hành của pháp luật và thuộc thẩm quyền quyết định của Chủ tịch UBND cấp tỉnh. Tuy nhiên, để đảm bảo phù hợp với quy định tại Điều 36 Nghị định số 05/2005/NĐ-CP của Chính phủ, khi lập Đề án thành lập đơn vị sự nghiệp, thì tên gọi của đơn vị sự nghiệp đề nghị không sử dụng cụm từ "dịch vụ bán đấu giá tài sản" hoặc "bán đấu giá tài sản". Đối với các địa phương đã thành lập Trung tâm mà trong tên gọi của Trung tâm có sử dụng những cụm từ "dịch vụ bán đấu giá tài sản" hoặc "bán đấu giá tài sản", đề nghị Sở Tài chính phối hợp với Sở Nội vụ báo cáo UBND tỉnh, thành phố quyết định thay đổi tên gọi cho phù hợp.No.□ Pneumoniaof the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home Affairs□ Other types of infectionsNo.□ Surgical site infectioncoholic beverages□ Urinary tract infectionpoliciesbased on Decreeần)

II3. Medication and intravenous fluidsNo. □ Incorrect medication/drip administration

□ Insufficient medicationì□ Incorrect dosage/concentrationê□ Incorrect timing

□ Contrary to medical orders đ□ Missed doseThis Resolution takes effect from the date it is adopted by the National Assembly.□ Wrong medication. The Department of Environmental Health Inspection - Ministry of Health shall be responsible for disseminating, guiding, and supervising the implementation of this Circular throughout the country.□ Administered to the wrong patient12. Leather shoes□ Incorrect route of administrationn l4. Blood and blood products

□ Adverse reaction/tolerance when administering blood无效 determines

□ Transfusion of wrong blood/blood product

□ Incorrect dosage/timing of transfusionDeputy ministers of ministerial-level agencies, 5. Medical equipment organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular.□ Lack of user manual/information

□ Equipment malfunctionDeputy ministers of ministerial-level agencies, services

□ Equipment shortage or unsuitability organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular.6. Behavior

□ Self-harm tendencyđổ □ Sexual harassment by staff

□ Self-harm tendencyđổ □ Sexual harassment by patients/visitors

□ Self-harm tendencyđổ □ Physical assault by patients/visitors

□ Self-harmrime Minister c□ Family member/visitor

□ Hospitalizationrime Minister c7. Patient accidents

□ Falls

8. Infrastructurerime Minister c□ Damaged, lost, or unavailable

9. Resource management, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CP

□ Appropriateness and adequacy of outpatient and inpatient services

□ Appropriateness and adequacy of resources

□ Appropriateness and adequacy of policies, regulations, procedures, and guidelines

10. Medical records, documents, administrative procedures

□ Missing or damaged documents

□ Unclear or incomplete documents

□ Excessive waiting time

□ Delayed provision of medical records/documentson□ Misfiled medical records/documents

□ Complex administrative procedures

11. Others

□ Incidents not covered in items 1 through 10urinary catheterenergy

III. Treatment/medical orders that have been implemented

V. Classification of incidents according to the causepolicies1. Staff

□ Knowledge, understanding, perception

□ Practice (incorrect practice not following standard procedures or guidelines, or following incorrect procedures or guidelines) , Đ

□ Attitude, behavior, emotions

□ Communicationpolicies□ Psychosocial factors, health status, illnessđổ OF NATIONAL

□ Social factorsỗ2. Patients

□ Practice (incorrect practice not following standard procedures or guidelines, or following incorrect procedures or guidelines)

□ Health status, illness

3. Work environment organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular.□ Facilities, infrastructure, equipmentđổ

□ Distance from workplace too farof the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home Affairs□ Safety evaluation of work environment, risks organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular.□ Rules, regulations, technical characteristicsin4. Organization/service

□ Policies, procedures, guidelinesNo.i tì□ Compliance with standard procedures đ(e.g., bathroom, parking lot...)

□ Organizational culturedevelopment □ Teamwork

5. External factorsđổ

□ Environmental factorsNo.□ Products, technology, and systems

□ Service processes/systems

6. Othersđượ

□ Factors not mentioned in items 1 through 5o CLASS MONOCOTYLEDONin

V. Actions to address the incidentỏVI. Recommendations for preventionỗinternational

□ CommunicationpoliciesDescribe the actions taken to handle the incidenturinary catheter anti-corruption;

Record recommendations for prevention, organization

B. For Management đầEvaluation by the Expert Group

□ Self-harm tendency"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."Results of findings (do not repeat incident descriptions) fully Discussed

□ Self-harm tendency"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."Recommended advice/treatment approach with the reporterầConsistent with existing recommendations/policiesê□ Incorrect timing

Specific recommendations:|||Assessment of injury level

On the patientpoliciesu

On the organization无效ealth

1. Not occurred (NC0) đFinancial loss

2. Minor injury (NC1)

□ Increase resources for patient careo □ Concern from the public

□ Patient complaints

3. Moderate injury (NC2)

□ Damage to reputationon □ Legal interventionpolicies4. Severe injury (NC3)

□ OtherệSignature:itselfTime:

IMinor injury is self-healing or does not require treatment.itself ofNo.

Moderate injury requires treatment intervention, prolonging hospital stay, affecting long-term function.

Severe injury requires emergency treatment or major intervention, causing permanent functional impairment or death.

□ Policies, procedures, professional guidelines, □ Compliance with standard practice procedures

□ Organizational culture đ□ Teamwork

5. External factors

□ Natural environmentdevelopment c Quof the Government stipulating functions, tasks, powers, and organizational structure of the Ministry of Home Affairs□ Products, technology, and

□ Service systems and processes

6. Others

Severe injury requires emergency treatment or major intervention, causing permanent functional impairment or death.

□ Factors not mentioned in sections 1 to 5ỹ V. Actions to address the incident, invalidớn dFUNCTIONS, DUTIES, POWERS, ORGANIZATIONAL STRUCTURE, OPERATIONAL REGULATIONS, AND RELATIONSHIPS OF MANAGEMENT BOARDS; DUTIES, POWERS OF THE CHAIRPERSON, VICE CHAIRPERSON (IF ANY), SECRETARY, AND MEMBERS OF MANAGEMENT BOARDSVI. Recommendations for prevention

□ Organizational culture đ□ Teamwork

5. External factors

□ Natural environmentdevelopment Describe actions taken to handle the incident

□ Service systems and processes

Record recommendations for preventive measures

B. For managementầenergy, Expert team evaluation

of findings đNot repeated (no duplication of incident descriptions)

Discussed

Recommended advice/treatment approach discussed with the reporter

Consistent with issued recommendations

Specific recommendations noted:"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation.". Assess severity of damage

To the patientDeputy ministers of ministerial-level agencies, To the organization

1. No harm occurred (NC0)

2. Minor harm (NC1)

□ Increase resources for patient carepoliciesu tNo. □ Public relations concern

□ Patient complaintên

3. Moderate harm (NC2) THE UNIT structure

□ Damage to reputationì□ Legal intervention

4. Severe harm (NC3)

□ Other organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular.Signature:

Time:No.

Minor harm is self-healing or does not require treatment intervention.|||Moderate harm requires treatment intervention fixed

extending hospital stay,

affecting long-term function.

Severe harm requires emergency treatment or major intervention

I. - Office of the President of the Statecausing permanent functional impairmentThis Decree stipulates the regulations on seniority allowances for teachers.or death.

□ Safety assessment, environmental risksn l results of detection đ(without repeating the tissues organize credit institutions, foreign bank branches are responsible for organizing the implementation of this Circular.to be notedNo.)

Has been discussed đrecommendations/advice for handling with the reporter

Notified to family/caretaker

In line with the recommendations issued"b) In addition to the lists of public services issued according to the provisions of Clause 2, Article 4 of this Decree, specialized agencies under provincial People's Committees shall report to the provincial People's Committee for decision-making on amending, supplementing, or issuing the list of public services funded by the state budget within their jurisdiction and consistent with the local budget capacity within the approved budget by the Provincial People's Assembly, and send it to the Ministry of Finance and relevant ministries and sectors for supervision during implementation."awareness đto be promulgated Specific recommendationsJune 2024;:

Notified to family/caretaker

On the patient

On the organization

1. Not occurred (NC0)

□ A

□ Self-harm tendency, amended and supplemented by Decree No. 109/2025/NĐ-CP and Decree No. 193/2025/NĐ-CPamage to propertyn ln

2. Minor damage (NC1)

□ B

□ Increase resources to serve the patient

□ C

□ Concern from the authorityoncommunication

□ D

□ Complaints from the patient

3. Moderate damage (NC2)

□ E

□ Damage to reputation

□ F

□ Legal intervention

4. Severe damage (NC3)

□ G

□ Other

□ H

□ I

Address:

Signature:

Title:

Date:   /    /    Time: