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MINISTRY OF
HEALTH OF VIETNAM
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SOCIALIST
REPUBLIC OF VIETNAM
Independence – Freedom – Happiness
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No. 43/2018/TT-BYT
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Hanoi, December
26, 2018
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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
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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.
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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:
a) Voluntary reporting for adverse events under
Section 1 through Section 6 of Appendix I.
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2. Reporting methods:
a) Voluntary reporting shall be produced in writing
or electronically. If irregular report is required, report can be submitted in
person or via telephone but later must be recorded in writing.
b) Mandatory reporting
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
a) Reporting of adverse events
- 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.
b) Recording of adverse events:
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- 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:
a) Consolidate adverse event reports and send to
supervisory authorities once every 6 months.
b) Details of reports to be consolidated include:
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- Frequency of each type of
adverse event
- Analysis results of root
cause
- Preventive solutions and
recommendations proposed and implemented
2. At Departments of Health:
a) Departments of Professional Affairs and
Departments of Health that consolidate adverse event reports of affiliated
medical establishments shall produce list of adverse events based on level of
severity and frequency in order to determiner tendency of adverse events, issue
general recommendations on preventing adverse events for affiliated entities.
b) On a quarterly basis, consolidate
recommendations and reports and send to Ministry of Health (Department of
Medical Service Administration).
3. At Ministry of Health:
a) Department of Medical Service Administration
shall consolidate periodic reports and irregular reports of medical
establishments affiliated to Ministry of Health and consolidated reports of
Departments of Health.
b) On a quarterly basis, analyze national
statistical reports on adverse events, issue general recommendations for
preventing adverse events for nationwide medical establishments.
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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:
a) Classify adverse events based on level of injury
for patients under Appendix I.
b) Classify adverse events based on incidents under
Section II of Appendix IV attached hereto.
c) Classify adverse events based on cause of the
events under Section IV of Appendix IV.
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
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b) Heads of medical establishments are responsible
for forming groups of experts under command of heads of the medical
establishments which will analyze root causes and factors causing adverse
event, issue preventive measures on the basis of list of adverse events
proposed by adverse event overseeing departments. Clarify whether factors
causing adverse events are systematic or individual in nature. Regarding
adverse events that are systematic in nature and can occur in other similar
medical establishments, immediately report to supervisory authorities of the
medical establishments in order to provide general preventive recommendations.
c) Within 60 days from the date on which report and
analysis of adverse events are received from adverse event reception and
overseeing departments, groups of adverse event analyst experts must propose
preventive solutions and recommendations.
2. Analysis at Departments of
Health
a) Review and recommend adverse events to be
reported to Directors of Departments of Health in order to establish groups of
experts affiliated to Departments of Health in order to find the root causes,
preventive measures with respect to adverse events that have not been
sufficiently or clearly reported or causes, solutions proposed by medical
establishments are not appropriate.
b) Direct medical establishments where serious
adverse events under Point b Clause 1 Article 5 occur to inspect, verify, and
analyze the adverse events using Form of adverse event analysis under Appendix
IV within 60 days.
3. Analysis at Ministry of
Health
a) Review and propose adverse events to be reported
to Deputy Minister of Health in charge of medical examination and treatment
sector to establish groups of experts affiliated to Ministry of Health to
review, find root causes, and preventive measures with respect to adverse
events that have not been sufficiently or clearly reported or causes, solutions
proposed by medical establishments are not appropriate.
b) Direct medical establishments affiliated to
Ministry of Health where serious adverse events under Point b Clause 1 Article
5 occur to inspect, verify, and analyze the adverse events using Form of
adverse event analysis under Appendix IV within 60 days.
Article 9. Handling and feedback of adverse
event handling and response
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a) Health workers working in medical establishments
upon discovering adverse events must immediately take actions to ensure safety
for patients prior to reporting to adverse event reception and overseeing
departments.
b) Departments of Health shall command affiliated
medical establishments to adopt safety measures, carry out inspection and
report to Ministry of Health within 24 hours from the point in which the
adverse events occur in case of adverse events under Point b Clause 1 Article
5.
c) Ministry of Health shall command affiliated
medical establishments to adopt safety measures, carry out inspection and
produce reports within 24 hours from the point in which the adverse events
occur in case of adverse events under Point b Clause 1 Article 5.
2. Feedback on adverse event
reports and handling
a) Adverse event reception and overseeing
departments of medical establishments shall provide feedback for individuals
and organizations reporting adverse events at departmental meetings of the
medical establishments.
b) Contact points of Ministry of Health and
Departments of Health shall provide feedback for individuals and organizations
reporting adverse events in writing.
Chapter IV
RECOMMENDATIONS AND RECTIFICATIONS TO PREVENT ADVERSE
EVENTS
Article 10. Recommendations for preventing
adverse events
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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
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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.
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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.
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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
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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)
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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
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Have not occurred
(NC0)
2
Adverse event has occurred without directly
affecting patients
B
Mild injury[1] (NC1)
3
Adverse event has directly affected patients
without causing harm
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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[2]
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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[3]
(NC3)
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8
Adverse event has caused harm and requires
intensive care
H
Mandatory
reporting
9
Adverse event leads to or causes death
I
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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:
A. Change surgery site during the surgery
B. This change is approved
2.
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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:
A. Change procedures during the surgery.
B. This change is approved
4.
Retained surgical instrument following a surgical
operation or other invasive procedures:
Exception:
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B. Such medical items are present before the
surgery and retained on purpose.
C. Such medical items are not present before the
surgery but are retained on purpose due to potential harm caused by removing
the items. For example: very small needles or screw fragments.
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.
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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.
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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).
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A. Pulmonary embolism or amniotic fluid embolism
B. Acute fatty liver of pregnancy
C. Cardiomyopathy.
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.
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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.
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A. Wrong gas. Or
B. Gas containing toxic substances
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
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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
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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:
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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.)
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Date of adverse event:
Time:
Brief description of the adverse event
Proposed initial solutions
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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
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Initial adverse event classification
□ Not occur
□ Occurred
Initial assessment regarding adverse event
impact
□ Severe
□ Moderate
□ Mild
Information of reporter
Full name:
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Email:
□ Nurse (title):
□ Patient
□ Relatives/visitors
□ Physician (title):
□ Other (specify):
Witness 1:
Witness 2:
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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: ……………
A. For personnel in charge
I. Detailed description of adverse event
(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)
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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
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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
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□ 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
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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
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□ 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
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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
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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
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□ 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
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□ 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
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□ Natural environment
□ Products, technology, and
infrastructure
□ Procedures, service system
6. Other
□ Other factors not
mentioned under Sections 1 through 5
V. Rectification measures
VI. Preventive recommendations
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Proposed preventive recommendations
B. For managerial individuals
I. Assessment of heads of expert groups
Description of observed results (without
repeating adverse event description)
Have discussed and provide
recommendations/resolution for persons making the report
□ Yes □ No □ Not recorded
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□ Yes □ No □ Not recorded
II. Assess level of injury
To patient
To organization
1. Have not occurred (NC0)
□ A
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□ Property damage
2. Mild injury (NC1)
□ B
□ Increased resources
serving patients
□ C
□ Media attention
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□ Complaints of patients
3. Moderate injury (NC2)
□ E
□ Reputational damage
□ F
□ Law intervention
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□ G
□ Other
□ H
□ I
Name:
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Title:
Date: Time:
[1] A mild injury means an injury that can
be healed naturally or without intervention and treatment.
[2] A moderate injury means an injury that
requires intervention and treatment, prolongs hospitalization period, and
affects functions in the long run.
[3] A severe injury means an injury that
warrants emergency medical response or major intervention and treatment, causes
permanent loss of functions or even death.