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MINISTRY OF
HEALTH
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THE
SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
32/2023/TT-BYT
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Hanoi,
December 31, 2023
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CIRCULAR
ON ELABORATION OF THE LAW ON MEDICAL EXAMINATION
AND TREATMENT
Pursuant to the Law on
Medical Examination and Treatment No. 15/2023/QH15 dated January 9, 2023;
Pursuant to Government's
Decree No. 95/2022/ND-CP dated November 15, 2022 on functions, tasks, powers
and organizational structure of the Ministry of Health;
At the request of the
Director of the Department of Medical Examination and Treatment Management and
the Director of the Department of Science, Technology and Training, and the
Director of the Department of Human Resources;
The Minister of Health
promulgates a Circular on elaboration of the Law on Medical Examination and
Treatment.
Chapter
I
GENERAL
PROVISIONS
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This Circular provides for:
1. Medical Continuing
Professional Development for medical examination and treatment (hereinafter referred
to as medical CPD) as prescribed in Clause 14, Article 2 and Clause 4, Article
22 of the Law on Medical Examination and Treatment.
2. Scope of medical
examination and treatment practice (hereinafter referred to as scope of
practice) for professional ranks or titles specified in Clause 3, Article 26 of
the Law on Medical Examination and Treatment.
3. Form of license to
practice medical examination and treatment (hereinafter referred to as medical
license) specified in Clause 5, Article 27 of the Law on Medical Examination
and Treatment.
4. Recognition of quality
standards of medical examination and treatment facilities (hereinafter referred
to as healthcare facilities) promulgated by domestic and foreign organizations
as prescribed in Point d, Clause 1 and Clause 4, Article 57 of the Law on
Medical Examination and Treatment.
5. Medical records and
medical record summaries specified in Clause 1, Article 69 of the Law on
Medical Examination and Treatment.
6. Shift work practice in
healthcare specified in Clause 3, Article 70 of the Law on Medical Examination
and Treatment.
7. Standards and health
check-ups specified in Clause 2, Article 83 of the Law on Medical Examination
and Treatment.
8. Good Clinical Practice
(GCP) as prescribed in Point d, Clause 4, Article 99 of the Law on Medical
Examination and Treatment.
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10. Mobilization and
dispatch of persons participating in medical examination and treatment
activities in response to natural disasters, calamities, group-A infectious
diseases or a state of emergency specified in Clause 4, Article 115 of the Law
on Medical Examination and Treatment.
Article
2. Interpretation of terms
1. “medical CPD provider”
means a healthcare facility or educational institution that provides
training in medical examination and treatment for medical personnel and
social-professional organizations that meets the medical CPD requirements laid
down in this Circular.
2. “credit hour in
medical CPD” means the unit of time for a practitioner to participate in
one of the forms of medical CPD with the conversion formula as prescribed in
Appendix No. I issued together with this Circular.
3. “Clinical trial” means
a research study that investigates the safety and efficacy of new techniques,
new methods, and medical devices in human volunteers; identify and detect
harmful reactions due to their effects; the ease of use of medical devices for
doctors and healthcare workers; assess or validate methods and evaluate the
clinical performance of in vitro diagnostic medical devices.
4. “Good Clinical
Practice (GCP)” means a set of principles and standards for designing,
implementing, supervising, monitoring, checking, recording, analyzing, and
reporting clinical trials of new techniques, new methods, and medical devices
to ensure the creditability and accuracy of research data and reports, and also
protect the rights, safety, and information security of research subjects.
5. “Investigator's
Brochure (IB)” means a document with general information about clinical
data on investigational new techniques, new methods, and medical devices;
pre-clinical document and previous clinical trial documents (if any).
6. “Case Report Form
(CRF)” means a paper or electronic paper which is used in a clinical trial
on new techniques, new methods, and medical devices to collect data from each
participant.
7. “ICD” means
international classification of diseases.
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MEDICAL
CONTINUING PROFESSIONAL DEVELOPMENT FOR MEDICAL PRACTITIONERS
Article
3. CPD hour requirements
1. Medical practitioners are
obliged to undertake at least 120 credit hours of medical CPD for 5 consecutive
years (1 credit hour for a short-term training and refresher course is
equivalent to 1 class period).
2. Medical practitioners who
undertake any of the medical CPD activities outlined in Articles 4, 5, 6, and 7
of this Circular can earn credit hours. These credit hours will be totaled to
calculate the practitioner's overall medical CPD hours.
Article
4. Medical CPD by undertaking short-term training and refresher courses,
conferences, and seminars related to medicine appropriate to the scope of
practice
1. Medical CPD by
undertaking short-term training and refresher courses:
a) Short-term training and
refresher courses in medical examination and treatment are those with training
programs and documents developed, evaluated and issued in accordance with this
Circular;
b) Short-term training and
refresher courses are held in the form of in-person training or combination of
in-person and online training, tailored to the professional content of each
course;
c) Medical CPD provider is a
healthcare facility or educational institution that provides training in
medical examination and treatment for medical personnel and social-professional
organizations;
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dd) The content of the
medical CPD program must align with either the scope of professional activities
authorized for the medical CPD provider or the training level of the designated
educational institution' disciplines and majors in medical examination and
treatment. The medical CPD program must be developed following the guidelines
in Appendix III of this Circular and is regularly reviewed and updated to maintain scientific rigor and address practical needs;
e) Medical CPD documents are
developed on the basis of the promulgated program and according to the
guidelines in Appendix III of this Circular. These documents must be regularly
reviewed and updated to maintain scientific rigor and address practical needs;
g) Medical CPD providers can
use programs and documents issued by another provider, but only with the
written approval of that provider;
h) The head of the medical
CPD provider shall select and arrange enough lecturers to meet the requirements
of the training program;
i) Certificate of
participation in short-term training and refresher courses: Practitioners who
successfully complete short-term training and refresher courses will be awarded
a certificate according to Appendix II of this Circular.
2. Medical CPD by joining
conferences and seminars:
a) Medical conference or
seminar is an event organized by medical CPD providers with content related to
medical examination and treatment;
b) Organizing body: has a
scope of professional activities approved by the competent authority consistent
with the content of the conference and seminar;
c) Topic and content:
suitable for the scope of medical examination and treatment of the organizing
body;
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dd) Form of organization: In
person or online;
e) Certificate of
participation in conference or seminar: Practitioners who join a conference or
seminar will be granted a certificate of completion by the organizing body
according to Appendix II of this Circular.
Article
5. Medical CPD by development of medical textbooks and teaching materials, and
medical documents
1. Development of medical
textbooks, teaching materials, and medical documents involves participation of
specialized boards or groups to draft medical textbooks and teaching materials,
medical documents, and clinical pathways, and these materials are promulgated
by the head of the developing body.
2. Medical practitioners lead
or join specialized boards or groups to draft medical textbooks and teaching
materials, medical documents appropriate to their scope of practice, and these
materials are promulgated by the head of the developing body.
3. Certificate of
participation in developing medical textbooks and teaching materials, and
medical documents: Medical practitioners who lead or join development of
medical textbooks and teaching materials, medical documents, and clinical
pathways will earn credit hours and be granted a certificate by the head of the
developing body according to Appendix II of this Circular.
Article
6. Medical CPD by conducting scientific research and teaching medicine within
the scope of practice
1. Medical CPD by conducting
scientific research within the scope of practice:
a) Practitioners lead or
join science and technology tasks at grassroots, ministerial, provincial and
state levels or technical innovation initiatives, writing scientific articles
on medical examination and treatment, both domestically and internationally, in
accordance with their scope of practice. These scientific and technological
tasks have been accepted, technical innovation initiatives have been
recognized, scientific articles have been published in scientific journals,
newsletters, and special issues at home and abroad;
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2. Medical CPD by teaching
medicine within the scope of practice:
a) Teaching medicine is the
process of transferring knowledge, skills, and attitudes in medical examination
and treatment within the practitioner's scope of practice;
b) Practitioners are
assigned or invited to teach training courses that award health-related
diplomas or certificates in areas related to their expertise;
c) Certificate of participation
in medical teaching: Practitioners engaged in medical teaching within their
scope of practice will receive credit hours for their work. The head of the
teaching body will calculate these credit hours based on evidence of the
practitioner's teaching and grant them a certificate according to Appendix II
of this Circular.
Article
7. Medical CPD by self-directed medical CPD and other forms
1. Self-directed medical CPD
is the process of independently studying, reflecting on, and researching
medical knowledge and skills relevant to their scope of practice.
2. Self-directed medical CPD
and other forms include:
a) Practitioners serve as
thesis or dissertation advisors appropriate to their scope of practice and these
theses and dissertations have been approved by the School-level Thesis and
Dissertation Evaluation Council;
b) Practitioners participate
in thesis and dissertation evaluation councils; councils for acceptance of
science and technology tasks at all levels; the expert panels that evaluate
medical training programs and documents appropriate to the scope of practice,
the assessment councils, and the medical error review councils;
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d) Participate in diploma
training courses at home and abroad (excluding study extensions) appropriate to
their scope of practice;
dd) Participate in training
courses in the following specialties to be granted relevant certificates:
specialties, subspecialties, specialized techniques, and technical transfer
appropriate to their scope of practice;
3. Certificate of
self-directed medical CPD and other forms: Practitioners who complete
self-directed medical CPD and other forms may be granted a relevant certificate
specified in Appendix II of this Circular by the head of the leading body or
the practitioner’s superior body.
Article
8. Conversion to credit hours and certificate of participation in medical CPD
1. Conversion to credit
hours of given medical CPD forms is carried out according to Appendix I of this
Circular.
2. For medical CPD provided
by foreign CPD providers: The head of the practitioner’s superior body shall
convert the CPD participation hours to credit hours and issue a relevant
certificate to the practitioner according to Appendix II of this Circular.
Article
9. Responsibilities of the medical CPD provider
1. Enable practitioners to
undertake medical CPD; monitor and manage; confirm and calculate credit hours
for practitioners who undertake medical CPD they provide.
2. Assign staff to be in
charge and manage the provider's CPD activities.
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4. Manage and keep records,
programs, and documents of short-term training courses, conferences and
seminars of the medical CPD provider; manage the certification for
practitioners who have completed medical CPD in accordance with this Circular.
5. For medical CPD providers
that provide short-term training and refresher courses: Before providing a
training or refresher course, the medical CPD provider under the management of
the Ministry of Health shall send a relevant notice specified in Appendix No.
IV of this Circular to the Administration of Science Technology and Training
affiliated to the Ministry of Health and the medical CPD provider under the
management of the Department of Health shall send relevant notices to both
Ministry of Health and Department of Health.
Chapter
III
SCOPE OF
PRACTICE OF PRACTITIONERS AND FORM OF PRACTICING LICENSES
Article
10. Principles for determining scope of practice of practitioners
1. A practitioner's scope of
practice should align with the medical qualifications (diplomas and
certificates) they are granted or recognized in Vietnam and be commensurate
with their demonstrated abilities in medical examination and treatment. This includes
professional methods and techniques specific to their registered specialty.
2. The practitioner's scope
of practice includes medical examination and treatment, prescribing subclinical
methods, applying medical examination and treatment methods, providing
healthcare expertise, prescribing medications, setting care and nutritional
regimes, evaluating examination and treatment outcomes, offering consultations
and health education to patients according to professional titles and
regulations of the Minister of Health specified in Article 11 This Circular
corresponding to each professional title or rank.
3. Ensuring the quality of
medical examination and treatment services and patient safety.
4. Suitable for practical
conditions, especially in units with specific characteristics and diverse
levels of healthcare expertise, in disadvantaged and severely disadvantaged
socio-economic areas.
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Article
11. Scope of practice of practitioners
1. Medical doctors: Their
scope of practice is specified in Appendix V of this Circular.
2. Traditional medicine
doctors: Their scope of practice is specified in Appendix VI of this Circular.
3. Preventive medicine
doctors: Their scope of practice is specified in Appendix VII of this Circular.
4. Odonto-Stomatology
doctors: Their scope of practice is specified in Appendix VIII of this
Circular.
5. Specialists:
a) Intensive care
specialists: Their scope of practice is specified in Appendix V and Appendix IX
of the Internal Medicine and Intensive Care sections of this Circular;
b) Nutrition specialists:
Their scope of practice is specified in Appendix V and Appendix XV of this
Circular;
c) Other specialists: Their
scope of practice is specified in Appendix V and Appendix IX of this Circular.
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a) General physician
assistants: Their scope of practice is specified in Appendix No. stipulated in
Joint Circular No. 10/2015/TTLT-BYT-BNV dated May 27, 2015 of the Ministry of
Health and the Ministry of Home Affairs on codes and standards for professional
titles of doctors, preventive medicine doctors, physician assistants);
b) Traditional medicine
physician assistants: Their scope of practice is specified in Appendix No. XI
of this Circular.
7. The scope of practice of
practitioners with the professional title of nurse is specified in Appendix XII
of this Circular.
8. The scope of practice of
practitioners with the professional title of midwife is specified in Appendix
XIII of this Circular.
9. The scope of practice of
practitioners with the professional title of medical technician is specified in
Appendix XIV of this Circular.
10. The scope of practice of
practitioners with the professional title of clinical nutritionist is specified
in Appendix No. XV of this Circular.
11. The scope of practice of
practitioners with the professional title of clinical psychologist is specified
in Appendix XVI of this Circular and provision of continuous and comprehensive
care services on cognition, behavior, emotions, and psychosocial aspects for
individuals, groups, and families, including assessment of mental disorders,
prescribing, developing and implementing psychological interventions at
healthcare facilities.
12. The scope of practice of
practitioners with the professional title of (out-of-hospital) paramedic is
specified in Appendix No. XVII of this Circular.
13. The scope of practice of
practitioners with the professional title of herbalist who is allowed to
examine and treat diseases using specialized methods and techniques of
traditional medicine and the list of techniques specified in Appendix No. XVIII
of this Circular.
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a) Holder of a folk remedy
is allowed to examine and use the folk remedy certified by a competent
authority to treat a disease or illness;
b) A folk remedy used for
treatment must have the proper ingredients, dosage form, uses (indications),
dosage, and method of administration;
c) The holder may use many
folk remedies certified by competent authorities to treat different diseases or
illnesses on the same patient;
d) Holder of a folk remedy
and therapy may use them at the same time for the patient;
dd) The holder may not
prescribe and use chemical drugs, herbal drugs, and use professional methods
and techniques of modern medicine for their medical examination and treatment.
15. The scope of practice of
holder of a folk therapy :
a) Holder of a folk therapy
is allowed to examine and use the folk therapy certified by a competent
authority to treat a disease or illness;
b) A folk therapy used to
treat diseases must comply with the proper process, diseases or illnesses
approved by the competent authority;
c) The holder may use many
folk therapies, combined with folk remedies to treat different diseases and
conditions on the same patient;
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Article
12. Form of medical license
The Ministry of Health, the
Department of Health of provinces and cities, the Ministry of National Defense,
and the Ministry of Public Security issue medical licenses using Form specified
in Appendix No. XIX of this Circular.
Chapter
IV
RECOGNITION OF
QUALITY MANAGEMENT STANDARDS FOR HEALTHCARE FACILITIES
Article
13. Recognition of international standards and quality management standards for
healthcare facilities
1. Recognition of
international standards and quality management standards for healthcare
facilities by International Society for Quality in Healthcare – ISQua.
2. The Department of Medical
Examination and Treatment Administration reviews, publishes, and updates these
standards on the Ministry of Health's website, the Department of Medical
Examination and Treatment Administration and the management information system
of medical examination and treatment.
Article
14. Criteria for recognizing quality management standards for healthcare
facilities other than those specified in Article 13 of this Circular
1. General criteria:
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b) Standards stipulate that
quality certification is a voluntary activity of healthcare facilities;
c) Standards ensure
scientific rigor and efficiency to manage the quality of each field of medical
examination and treatment services;
d) Standards ensure the overall
evaluation of quality characteristics: safety, efficiency, timeliness,
fairness, and patient-and healthcare worker-centered care;
dd) The standard includes
criteria and indicators that ensure full assessment of 3 quality elements:
input, process, and performance results.
2. Specific criteria are
provided in Form No. 1, Appendix No. XX of this Circular.
Article
15. Application for recognition of quality management standards for healthcare
facilities
1. Application form for
recognition of quality management standards for healthcare facilities using
Form No. 02, Appendix XX of this Circular.
2. The full version of the
quality management standard proposed for recognition.
3. Certified copy of the
Certificate of assessment and certification of quality of healthcare facilities
of the Quality Certification Organization held by the Quality Certification
Organization as prescribed in Article 76 and Article 77 of Decree No. 96/2023
/ND-CP dated December 30, 2023 of the Government on elaboration of the Law on Medical
Examination and Treatment (hereinafter referred to as Decree No.
96/2023/ND-CP).
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5. Documents proving that
the standard has been applied on a trial basis at healthcare facilities in
Vietnam, including: report on trial application of the standard; opinions of
administrative officers of healthcare facilities and experts in the field of
quality management.
6. The responses meet the
specific criteria for recognition of the quality management standards for the
healthcare facility, using Form No. 1, Appendix No. XX of this Circular.
Article
16. Procedures for recognition of quality management standards for healthcare
facilities
1. The Quality Certification
Organization submits one set of application as prescribed in Article 15 of this
Circular to the Ministry of Health (Department of Medical Examination and
Treatment Management).
2. Establishment of an
Appraisal Council:
a) The Appraisal Council
established by the Minister of Health is composed of:
- The leader of the Ministry
of Health is the President of the Council;
- The leader of the
Department of Medical Examination and Treatment Management is the Standing
Deputy President, the Leader of the Legal Department is the Deputy President of
the Council;
- Leaders of certain
Departments and Institutes of the Ministry of Health, certain quality
management experts, representatives of relevant Ministries, agencies,
organizations, and associations are invited to become members of the Council
corresponding to their expertise in the standard proposed for recognition.
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3. Standard appraisal
process:
a) The Secretariat reviews
and checks the completeness and validity of the application. If the application
is complete and valid, the Secretariat shall compare the quality management
standards with the recognition criteria specified in Article 14 of this
Circular and prepare an appraisal report to submit to the Council;
b) The Council meets to
appraise, reach consensus on conclusions, and approve the minutes of the
meeting.
c) Within 20 days of
receiving a complete and valid application stated in the Acknowledgement Form
using Form No. 03, Appendix XX of this Circular, based on the Council's
conclusions:
- If the Council agrees to
recognize the standards, the Department of Medical Examination and Treatment
Administration shall propose the Minister of Health to issue a decision on
recognition of the standards of the Quality Certification Organization using
Form No. 04 in Appendix XX of this Circular;
- If the Council disagrees
to recognize the standards, within 5 working days from the date of the
Council's conclusion, the Department of Medical Examination and Treatment
Administration shall provide the Quality Certification Organization with
explanation in writing.
d) The decision on
recognition of the standards of the Quality Certification Organization is
published on the website of the Department of Medical Examination and Treatment
Administration within 5 working days from the date of issuance of that
decision.
Chapter
V
GOOD CLINICAL
PRACTICE (GCP)
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Article
17. GCP rules and standards
Promulgate GCP rules and
standards in Appendix XXI of this Circular based on reference to guidance from
ICH and WHO.
Article
18. GCP evaluations and compliance assessment
1. Initial evaluation:
Conducted when the clinical testing body conducts clinical trials of new
techniques, new methods or medical equipment (hereinafter referred to as the
testing body).
2. Scheduled evaluation:
Conducted to maintain compliance with GCP, scheduled assessment is carried out
every 3 years from the date of issuance of GCP compliance certificate
(excluding unscheduled assessments and inspections).
3. Unscheduled evaluation of
GCP compliance is carried out in accordance with Article 27 of this Circular.
4. Assessment of GCP
compliance: The Ministry of Health and Department of Health, based on state
management requirements, shall assess GCP compliance or integrate GCP
compliance assessment into the annual inspection schedule for other
professional activities or during unscheduled assessments of the testing body’s
compliance with GCP.
Article
19. GCP compliance levels
1. Level 1: The testing body
is in full compliance with GCP, with no findings requiring corrective action.
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3. Level 3: The testing body
does not meet GCP in the following cases:
a) There is a matter that
does not comply with GCP standards and may compromise the accuracy and
integrity of research data and/or the health and safety of clinical trial
participants;
b) Commit fraud,
falsification, alteration of figures, data and documents.
Section
2. INITIAL EVALUATION OF GCP COMPLIANCE
Article
20. Application for initial evaluation of GCP compliance
1. Application form for initial
evaluation of GCP compliance is provided in Form No. 01 in Appendix XXII of
this Circular.
2. Declaration of general
information about the testing body; facilities, list of medical devices; list
of personnel who are eligible for GCP compliance assessment; standard operating
procedures (SOPs), the quality control system for clinical trials and documents
to prove and confirm those declarations. Documentation details follow the
instructions in Appendix No. XXII of this Circular.
3. Copy of the operating
license if the testing body is a healthcare facility; copy of the establishment
decision or a copy of the business registration certificate accompanied by a
copy of the certificate of scientific and technological activities if the
testing body is a scientific and technological organization.
Article
21. Procedures for receiving applications for and evaluation of GCP compliance
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2. Within 10 working days of
receiving the application, the Department of Science, Technology and Training
checks the completeness and validity of the application. In case the
application is complete and valid, the Department of Science, Technology and
Training organizes an evaluation team according to Article 28 of this Circular
to undertake an on-site evaluation at the testing body within 15 working days.
In case the application is
not complete and valid, the Department of Science, Technology and Training
shall notify the testing body in writing.
3. The evaluation team
undertakes an on-site evaluation of the testing body’s compliance with the GCP
standards specified in Appendix No. XXI of this Circular.
4. Based on the on-site
evaluation results at the testing body, the evaluation team discusses with the
testing body about the evaluation matters to meet GCP and prepares an
evaluation report Form No. 02, Appendix No. XXIII of this Circular, which
determines the level of GCP compliance of the testing body according to Article
19 of this Circular.
Article
22. Process for evaluating GCP compliance
1. The evaluation team
announces the Decision to establish the evaluation team; purposes, evaluation
matters and plan at the testing body.
2. The testing body presents
a summary of the organization, personnel, activities, application of GCP or
other issues according to the evaluation matters.
3. The evaluation team
undertakes an on-site evaluation of the implementation of GCP application at
the testing body according to each specific evaluation matter.
4. The evaluation team meets
with the testing body to notify the testing body's level of compliance with GCP
according to Article 19 of this Circular, non-compliant issues that need to be
remedied, found during the evaluation process (if any); discuss with the
clinical testing body if they have a different opinion on any non-compliant
matter with the team's evaluation.
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Article
23. Handling of GCP evaluation results
1. In case the GCP
compliance evaluation report concludes that the testing body meets GCP as
prescribed in Clause 1, Article 19 of this Circular, then within 10 working
days of signing the evaluation report, the Minister of Health assigns the
Department of Science, Technology and Training to issue a Certificate of GCP
compliance according to Form No. 03 specified in Appendix No. XXIII of this
Circular.
2. In case the GCP
compliance evaluation report concludes that the testing body needs to address
their non-compliance as prescribed in Clause 2, Article 19 of this Circular:
a) Within 5 working days of
completing the on-site evaluation at the testing body and signing the
evaluation report, the Department of Science Technology and Training sends a
GCP compliance evaluation report with a written notification of non-compliant
issues that need to be remedied to the testing body;
b) After resolving the
mentioned non-compliant issues, the testing body must have a written report
with evidence (documents, photos, videos, certificates) proving that they have
been completed that;
c) Within 20 days of
receiving the remediation report from the testing
body, the Department of Science, Technology and Training shall review that
report and conclude on the GCP compliance status of the testing body:
- In case the remediation is
satisfactory: the Department of Science, Technology and Training shall comply
with Clause 1 of this Article.
- In case the remediation is
unsatisfactory: the Department of Science, Technology and Training shall issue
a written request for further remediation.
d) Within 6 months from the
date the Department of Science, Technology and Training issues a written
request for further remediation, if the testing body fails to submit such a
report as requested, their submitted application will be considered invalid and
the evaluation of GCP compliance must be done again from the beginning.
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4. Within 5 working days of
issuing the certificate of GCP compliance, the Department of Science,
Technology and Training shall publish on the Ministry of Health's website and
the Department of Science, Technology and Training’s website the following
information:
a) Name and address of the
testing body that meets GCP;
b) Full name of the person
in charge, practice certificate number (if the testing body is a healthcare
facility);
c) Number of certificate of
GCP compliance (if any);
d) Expiry date of GCP
compliance evaluation and next periodic evaluation date;
dd) Scope of operation of
the testing body.
Section
3. EVALUATION OF GCP COMPLIANCE MAINTENANCE
Article
24. Scheduled evaluation of GCP compliance maintenance
1. Every December, the
Department of Science, Technology and Training publishes on their website a
list of testing bodies subject to evaluation of GCP compliance maintenance in
the following year.
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3. In case the testing body
fails to submit such an application for scheduled evaluation within the time
limit specified in Clause 2 of this Article, within 15 working days from the
deadline, the Department of Science, Technology and Training shall issue a
document requesting the testing body to submit the application according to
regulations.
4. Within 45 days from the
date the Department of Science, Technology and Training issues a written
request, the testing body must submit a report on their GCP compliance
maintenance together with an explanation for late submission. If the testing
body fails to submit a report after this deadline, the Department of Science,
Technology and Training shall undertake an unscheduled evaluation to check if
the testing body maintains their GCP compliance according to Article 27 of this
Circular.
5. After submitting the
application for scheduled evaluation of GCP compliance maintenance within the prescribed
time, the testing body may continue to conduct their clinical trials of new
techniques, new methods or medical devices according to the scope specified in
the issued certificate of GCP compliance until there are results from the
mentioned scheduled evaluation and must ensure maintenance of meeting GCP
principles and standards.
6. Application for scheduled
evaluation of GCP compliance maintenance includes:
a) Application form for
scheduled evaluation of GCP compliance maintenance laid down in Form No. 04
specified in Appendix XXIII of this Circular;
b) Summary report on
clinical trials of new techniques, new methods or medical devices of the
testing body during the last 3 years from the previous evaluation (excluding
unscheduled evaluations, inspections and examinations by the Ministry of
Health, Department of Health) to the date of application for the scheduled
evaluation;
c) Updated documentation on
the testing body's facilities, technical capabilities, and personnel (if
changed).
7. The process and handling
of results from evaluation of GCP compliance maintenance shall comply with
Article 22 and Article 23 of this Circular.
Article
25. Handling of results from scheduled evaluation of GCP compliance maintenance
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Within 10 working days of
completing the on-site evaluation at the testing body and signing the
evaluation report, the Department of Science, Technology and Training shall
issue a certificate of GCP compliance according to Form No. 03 in Appendix
XXIII of this Circular.
2. In case the GCP
compliance evaluation report concludes that the testing body needs to remedy
the non-compliance as prescribed in Clause 2, Article 19 of this Circular:
a) Within 5 working days of
completing the on-site evaluation at the testing body and signing the
evaluation report, the Department of Science, Technology and Training shall
send a written request to the testing body to remedy the non-compliance, send a
remediation report to the Department of Science, Technology and Training;
b) Within 45 days from the
date the Department of Science, Technology and Training issues a written
request, the testing body must complete the remediation and submit a written
report with evidence (documents, images, videos, certificates) to prove they
have completed the remediation of existing issues stated in the evaluation
report;
c) Within 20 days of
receiving the remediation report accompanied by evidence (documents, photos,
videos, certificates), the Department of Science, Technology and Training to
evaluate the results from remediation by the testing body and conclude on the
testing body’s GCP compliance status as follows:
- If the remediation is
satisfactory: The Department of Science, Technology and Training shall issue a
certificate of GCP compliance according to Form No. 03 in Appendix XXIII of
this Circular.
- If the remediation is
unsatisfactory: the Department of Science, Technology and Training shall issue
a written request for further remediation of remaining non-compliant issues.
The extension period for remediation and report is 45 days from the date of the
written request.
d) Within 90 days of
completing the on-site evaluation, if the testing body fails to submit a
remediation report or the remediation done as prescribed in Point c of this
Clause is still unsatisfactory, the Department of Science, Technology and
Training shall issue a notice of GCP non-compliance, and the Department of
Science, Technology and Training shall then, depending on the nature and extent
of the violation, take one or more measures according to Points a and b, Clause
3 of this Article.
3. In case the GCP
compliance evaluation report concludes that the testing body does not meet GCP
as prescribed in Clause 3, Article 19 of this Circular: Within 5 working days
of completing the on-site evaluation at the testing body and signing an
evaluation report, based on the evaluation of the detected existing risks to
the quality of research, health and safety of participants of new techniques,
new methods, and medical devices , the Department of Science, Technology and
Training shall issue a notice of GCP non-compliance, and the Department of
Science, Technology and Training shall then, depending on the nature and extent
of the violation, take one or more of the following measures:
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b) Revoke the certificate of
GCP compliance issued to the testing body.
4. Within 5 working days
from the date of conclusion that a testing body is evaluated as GCP compliant or
from the date of issuance of the decision on revocation of the certificate of
GCP compliance, the Department of Science, Technology and Training shall update
corresponding information on their website as prescribed in Clause 4, Article
23 of this Circular.
Article
26. Change control
1. At intervals between
scheduled evaluations, the testing body must apply for evaluation of GCP
compliance or report changes using Form No. 05 specified in Appendix No. XXIII
issued herewith if they falls under one of the following cases:
a) Change the scope of the
certificate of GCP compliance;
b) Change the location of
clinical trials of new techniques, new methods or medical devices; change the
location of one of the technical rooms serving clinical trials of new techniques,
new methods or medical devices (examination rooms, treatment rooms, emergency
rooms, laboratories) at a new location;
c) Change or add one of the
technical rooms to serve clinical trials of new techniques, new methods or
medical devices (examination rooms, treatment rooms, emergency rooms,
laboratories) at the same location of clinical trials;
d) Change information about
the name and address of the testing body, update information related to the
testing body, change the names of departments and divisions of the testing body
related to the clinical trials of new techniques, new methods or medical
devices.
2. If a testing body makes
any changes as prescribed in Points a and b, Clause 1 of this Article, they
must send an application for evaluation of GCP compliance as prescribed in
Article 20 of this Circular. The procedures of evaluating GCP compliance,
classifying results and handling results from evaluating GCP compliance are
carried out according to Articles 22 and 23 of this Circular.
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Article
27. Unscheduled evaluation of GCP compliance
1. Unscheduled evaluation of
GCP compliance at the testing body is undertaken in one of the following cases:
a) The testing body fails to
submit a report on evaluation of GCP compliance maintenance as prescribed in
Article 24 of this Circular;
b) The testing body has made
changes or additions as prescribed in Point c, Clause 1, Article 26 of this
Circular, and those changes and additions pose a risk of affecting the accuracy
and integrity of research data on clinical trials or affect the safety and
rights of clinical trial participants;
c) The testing body has been
found in serious violation of GCP principles and standards, based on inspection
findings of competent authorities;
d) The testing body has been
reported to seriously violate GCP principles and standards.
2. Documentation of and
procedures for unscheduled evaluation at the testing body are set out in
Clauses 6 and 7, Article 24 of this Circular.
Section
4. EVALUATION TEAM OF GCP COMPLIANCE
Article
28. Composition and qualifications of evaluation team members
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a) Representative of the
Leadership of the Department of Science, Technology and Training as the team
leader;
b) Representative of the
Leadership of the Legal Department as the deputy team leader;
c) Representative of the
Leadership of the Department of Infrastructure and Medical Devices as the
deputy team leader (evaluation of GCP compliance by a testing body of medical
device);
d) Representatives from
units affiliated to the Ministry of Health as members, including: Department of
Science, Technology and Training; Department of Medical Examination and
Treatment Management; Legal Department; Department of Infrastructure and
Medical Devices; Department of Traditional Medicine and Pharmacy
Administration;
dd) Representative of the
Department of Health of province where the testing body is headquartered as
member;
e) Experts in the field of
expertise related to the scope of evaluation as members. Members of relevant
agencies and units where necessary;
g) Expert from the
Department of Science, Technology and Training as the team secretary.
2. Standing evaluation team
of GCP compliance specified in Clause 1 of this Article is located at the
Department of Science, Technology and Training affiliated to Ministry of
Health. The evaluation team leader invites appropriate members for each
specific evaluation case.
3. Evaluation team members
who are experts in specialized fields related to the scope of evaluation must
have the following qualifications:
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b) Have been trained on GCP
and GCP evaluation;
c) Be honest, objective ,and
strictly comply with regulations and legal regulations during the evaluation
process, have no conflicts of interest with the testing body being evaluated
according to Clause 4 of this Article.
4. Principles for assessing
conflicts of interest: Members of the evaluation team are considered to have
conflicts of interest with the testing body being evaluated if they fall into
one of the following cases:
a) Have worked within the
last 5 years for the evaluated testing body;
b) Have engaged in
consulting services within the last 5 years for the evaluated testing body;
c) Have a financial interest
in the evaluated testing body;
d) Have a spouse, child,
parent, sibling, parent's sibling, or spouse, or child working for the
evaluated testing body.
Article
29. Responsibilities and powers of the evaluation team and responsibilities of
the testing body
1. Responsibilities of the
evaluation team:
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b) Keep all relevant
information about the evaluation and testing body confidential; except in cases
with the consent of the testing body or at the request of a competent authority
to serve inspection and investigation.
2. Powers of the evaluation
team:
a) Inspect the entire area
related to clinical trials of new techniques, new methods or medical devices of
the testing body;
b) Request to provide
documents related to clinical trials of new techniques, new methods or medical
devices of the testing body;
c) Collect documents and
evidence (copy documents, take photos, record videos) to prove the
non-compliant issues found during the evaluation process;
d) Make a report and request
the testing body to suspend clinical trials of new techniques, new methods or
medical devices if during the evaluation process the team has found that the
testing body has violated the regulations that seriously affect the accuracy
and integrity of research data and/or the safety and health of participants in
clinical trials, and then report it to competent persons as per regulations.
3. Responsibilities of the
testing body:
a) Implement this Circular
in line with the circumstances of the testing body;
b) Maintain compliance with
GCP principles and standards throughout the testing body’s operation;
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d) Comply with regulations
on deadlines, applications, and procedures for evaluating GCP compliance in accordance
with this Circular;
dd) Submit to unscheduled
inspection and evaluation of GCP compliance maintenance conducted by competent
authorities as per the law.
Chapter
VI
STANDARDS AND
HEALTH CHECK-UPS
Section
1. GENERAL PROVISIONS ON STANDARDS AND HEALTH CHECK-UPS
Article
30. People who need to have a health check-up
1. People who need to have a
health check-up:
a) Health check-ups for
Vietnamese citizens and foreigners living and working in Vietnam: periodic health
check-ups; health assessment of fitness for school or work; health check-ups
for students;
b) Health check-ups upon
request;
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2. The health check-ups in
this Chapter does not apply to the following cases:
a) Outpatient and inpatient
medical examination in healthcare facilities;
b) Medical examination,
forensic examination, forensic mental examination;
c) Examination to issue
injury certificate;
d) Occupational disease
examination;
dd) Health check-ups for
people under the management of the Ministry of National Defense and the
Ministry of Public Security;
e) Health check-ups for
specific industries and professions.
Article
31. Principles of performing health check-ups
1. Health check-ups are
performed at healthcare facilities that have been licensed to operate medical
examination and treatment according to the Law on Medical Examination and
Treatment.
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3. For people with a health
check-up certificate issued by a competent healthcare facility of a foreign
country, that health check-up certificate is used in cases where Vietnam and
that country have an agreement or mutual recognition agreement and the validity
period of that health check-up certificate is not more than 6 months from the
date of issue. The health check-up certificate must be translated into
Vietnamese and have a certified translation.
Article
32. Use of health standards to classify health
1. The health classification
of people undergoing health check-ups (hereinafter referred to as examinees) is
carried out in accordance with the regulations of the Ministry of Health on
health classification standards for recruitment and periodic examination of
workers.
2. For cases of health
check-ups according to health standards of a field issued or recognized by
competent authorities of Vietnam, health classification is based on the health
standards in that field.
3. For cases of health
check-ups upon request, if the healthcare facility does not fully examine all
specialties as prescribed in the health check-ups form issued in this Circular,
the health check-up facility will only examine and make conclusions for with
each specialty as required and without health classification.
Article
33. Health check-up costs
1. Corporate and individual
applicants for a health check-up must pay the health check-ups costs to the
health check-up facility, according to the prices approved by a competent
authority or based on an agreement made between the applicant and the facility,
except for cases of exemption or reduction as prescribed by law.
2. In case the examinee requests
two or more health check-up certificates, that examinee must pay an additional
fee for issuing extra certificates according to the regulations of that
healthcare facility.
3. Collection, payment,
management and use of fees from health check-ups are carried out in accordance
with law.
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Article
34. Health check-up applications
1. Health check-up
application of people aged 18 (eighteen) years or older is a health check-up
application form No. 01, Appendix No. XXIV of this Circular, with a portrait
photo 4cm x 6cm, taken on a white background within no more than 6 (six) months
prior to the date of application submission.
2. Health check-up
application of people under 18 (eighteen) years old is a health check-up
application form No. 02, Appendix No. XXIV of this Circular, with a portrait
photo 4cm x 6cm, taken on a white background within no more than 6 (six) months
prior to the date of application submission.
3. An application for health
check-up for a legally incapacitated person or person with limited active legal
capacity but not subject to a periodic medical examination shall include:
a) An application form for health
check-up as prescribed in Clause 1 or Clause 2 of this Article;
b) Written consent of the
patient's relative specified in Clause 11, Article 2 of the Law on Medical
Examination and Treatment.
4. As for periodic
examinees, their application shall include:
a) Periodic health check-up
book according to Form No. 03, Appendix No. XXIV of this Circular;
b) Referral letter from
their employer in case of a single periodic health check-up or being on the
list of periodic health checkups issued by their employer to perform periodic
health check-ups under a contract.
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1. An examinee will submit
an application according to the prescribed form of the health check-up
facility.
2. After receiving the
health check-up application, the health check-up facility shall carry out the
following:
a) Verify the identity of
the examinee by comparing them with the photo on the application;
b) Affix the fan stamp on
the photo after verification according to Point a of this Clause for the cases
specified in Clauses 1, 2 and 3, Article 37 of this Circular;
c) Check and compare valid
identification documents of the patient for the cases specified in Clause 3,
Article 37 of this Circular;
d) Instruct on the health
check-up process for the examinee or their guardian (if any);
dd) The health check-up
facility shall develop, promulgate, and implement their health check-up
procedures;
e) Return results and keep
medical examination records.
Article
36. Health check items
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2. For health check-ups for
people under 18 (eighteen) years old but not subject to periodic health
check-ups: Examine health check items in the application form for health
check-up No. 02, Appendix No. XXIV of this Circular.
3. For periodic health
check-ups: Examine health check items in the periodic health check-up book Form
No. 03, Appendix No. XXIV of this Circular.
4. For female employees,
their periodic health check-up will include the obstetrics check items
mentioned in the list specified in Appendix No. XXV of this Circular.
5. Every health check items
of each specialty must be examined. In difficult cases, it is necessary to
consult or order a subclinical test to determine the diagnosis and the degree
of illness and disease as a basis for health classification.
6. In the case of health
check-up upon request, only examination and conclusions are made for each
specialty upon request and health classification is not required.
Article
37. Health classification
1. Health classification
standards of people undergoing health check-ups comply with regulations of the
Minister of Health.
2. The examiner shall
document relevant diseases and disabilities from the specialized examination
and classify the patient's health based on their specialty.
3. Based on all specialty
examination results, the practitioner that is designated to determine the final
health classification and sign both the health check-up certificate and
periodic health check-up book (hereinafter referred to as health classification
determiner) shall determine the final health category as follows:
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b) In case the examinee has
a disease or disability, the health classification determiner will recommend
treatment and rehabilitation options or refer them for further examination and
treatment.
4. After classifying the
health, the health classification determiner must sign, clearly state their
full name, and stamp the health check-up facility’s seal on the health check-up
certificate or periodic health check-up book. The use of seals in official
transactions by health check-up facilities is regulated by laws on seal
management and use.
5. For cases of health check-ups
according to health standards of a field issued or recognized by competent
authorities of Vietnam, health classification is based on the health standards
in that field.
6. For cases of health
check-ups upon request, if the healthcare facility does not fully examine all
specialties as prescribed in the health check-ups form issued in this Circular,
the health check-up facility will only examine and make conclusions for with
each specialty as requested by the person being examined and without health
classification.
Article
38. Issuance and archive of health check-up certificate
1. The health check-up
certificate is issued 1 (one) copy to the examinee and 1 copy is kept at the
health check-up facility. The archive duration of health check-up documentation
is as prescribed in section 20, group 01 Documentation on medical examination,
treatment, and rehabilitation issued with Circular No. 53/2017/TT-BYT dated
December 29, 2017 of the Minister of Health on archive duration of specialized
records and documentation in the health sector. Periodic health check-up
applications are preserved and archived by examinees’ superior bodies.
2. In case the examinee
requests multiple health check-up certificates, the health check-up facility
shall issue multiple copies of the health check-up certificate. Issuance of
multiple copies is carried out in accordance with Decree No. 30/2020/ND-CP
dated March 5, 2020 of the Government on clerical work (hereinafter referred to
as Decree No. 30/2020/ND-CP).
3. Time limit for returning
health check-up certificates and periodic health check-up books:
a) For individual health
check-ups: the health check-up facility returns the health check-up certificate
and periodic health check-up book to the examinee within 24 (twenty-four) hours
from the end of the examination, except in cases where additional examination
or testing is required at the request of the health examiner;
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4. Validity period of health
check-up certificate and periodic health check-up results:
a) The health check-up
certificate is valid for 12 (twelve) months from the date of signing;
b) Results of periodic
health check-up are valid according to law.
Chapter
VII
MOBILIZATION
AND DISPATCH OF PERSONS PARTICIPATING IN MEDICAL EXAMINATION AND TREATMENT
ACTIVITIES IN RESPONSE TO NATURAL DISASTERS, CALAMITIES, GROUP-A INFECTIOUS
DISEASES OR A STATE OF EMERGENCY
Article
39. Mobilization and dispatch of persons participating in medical examination
and treatment activities in response to natural disasters, calamities, group-A
infectious diseases or a state of emergency
1. In case the unit or
locality's human resources do not meet the requirements for medical examination
and treatment in the event of a natural disaster, calamity, group A infectious
disease, or state emergency, in addition to the mobilization and dispatch of
professionals in line with the circumstance as per the law, competent
authorities and persons may mobilize and dispatch the following persons to
participate in medical examination and treatment, including testing, sample
collection, vaccination, first aid, and emergency care:
a) Medical practitioners in
Vietnam (including foreigners) are allowed to perform testing, vaccination,
medical examination, and treatment, first aid, and emergency care outside the
permitted scope of practices in their medical licenses;
b) Foreigners and overseas
Vietnamese who have been licensed by foreign competent authorities to practice
medical examination and treatment are allowed to perform testing, vaccination,
first aid, emergency care and other activities at healthcare facilities
established to perform or assign the performance of receiving patients,
providing first aid, providing health care, and treating people infected with
group A infectious diseases or patients in accidents, patients who need first
aid, emergency care, and treatment in natural disasters, calamities, or state
of emergency without a medical license issued by a competent agency of Vietnam;
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Article
40. Grounds and authority for mobilization and dispatch of persons
participating in medical examination and treatment activities in response to
natural disasters, calamities, group-A infectious diseases or a state of
emergency
1. Grounds for mobilization
and dispatch of persons participating in medical examination and treatment
activities in response to natural disasters, calamities, group-A infectious
diseases or a state of emergency:
a) At the request of Presidents
of the People's Committees of provinces and centrally affiliated cities,
Directors of Departments of Health, Presidents of the People's Committees of
urban districts, suburban districts, provincial cities, centrally affiliated
cities who seek human resources to participate in testing, vaccination, medical
examination and treatment in the event of a natural disaster, calamity, group A
infectious disease epidemic or state of emergency, using Form specified in
Appendix No. XXVII of this Circular;
b) At the request of heads
of healthcare facilities, facilities that admit and treat patients with group A
infectious disease, and preventive health facilities that seek human resources
to participate in preventing and controlling group A infectious diseases, or emergency
care and treatment of patients in natural disasters, calamities, or state of
emergency;
c) According to the Minister
of Health’s mobilization of additional human resources to support local
governments, healthcare facilities, and preventive health facilities to further
prevent and control group A infectious diseases, emergency care and treatment
of patients in natural disasters, calamities, or state of emergency.
2. Authority for
mobilization and dispatch of persons participating in testing, vaccination,
medical examination and treatment in response to natural disasters, calamities,
group-A infectious diseases or a state of emergency:
a) The Minister of Health
may mobilize and dispatch forces to participate in the prevention and control
of group A infectious diseases, first aid, and treatment of patients in natural
disasters, calamities, or state of emergency nationwide, except for forces
managed by the Ministry of National Defense and the Ministry of Public
Security;
b) Presidents of People's
Committees of provinces or agencies authorized by People's Committees of
provinces may mobilize and dispatch forces to participate in prevention and
control of group A infectious diseases, first aid and treatment of patients in
natural disasters, calamities, or state of emergency in the provinces;
c) Heads of healthcare
facilities, facilities that admit and treat patients with group A infectious
diseases, preventive facilities, and health-sector training institutions may
mobilize and dispatch forces to participate in prevention and control of group
A infectious diseases, first aid and treatment of patients in natural
disasters, calamities, or state of emergency within their scope of management.
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1. Directors of Departments
of Health shall receive and assign forces mobilized by competent agencies to
each facility to perform vaccination, testing, medical examination and
treatment, care of patients with group A infectious diseases, perform first aid
and treatment of patients in natural disasters, calamities, or state of
emergency.
2. Heads of healthcare
facilities, facilities that admit and treat patients, preventive medicine
facilities, and health-sector training institutions shall receive and assign
detailed tasks to each position and person suitable to the professional
requirements to participate in prevention and control of group A infectious
diseases or perform emergency care and treatment of patients in natural
disasters, calamities, or state of emergency.
Chapter
VIII
ON-CALL PRACTICE
IN HEALTHCARE
Article
42. Healthcare entities that provide on-call practice
On-call practice, for the
purpose of this Chapter, applies to health facilities with inpatient beds;
healthcare facilities with beds for monitoring and treatment of patients ;
out-of-hospital emergency care facilities (hereinafter referred to as
healthcare facilities).
Article
43. Rules for on-call practice
1. On-call practice outside
of office hours and on holidays, and days off must be organized by healthcare
facilities to ensure continuous medical examination and treatment 24 hours a
day.
2. On-call shifts must be
strictly organized, with adequate human resources, means of transportation,
medical devices, and drugs for emergency care.
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4. On-call staff must be
present before the on-call time to receive the handover from the previous
on-call shift, and then hand over to the next on-duty shift when the time ends,
must not leave the duty position and must comply with the on-duty orders of the
superior.
5. On-call schedule is made
monthly and announced at least one week before the on-call time, approved by
the hospital leader, and specified on the board for each on-call position.
Officers, public employees, and employees who have been assigned in an on-call
schedule can only change their own on-call schedule with those who are at their
same level, together with the approval from the leader.
Article
44. Duties of on-call positions in the hospital
1. On-call leaders:
a) On-call leaders:
Director, deputy director, dean of department, head of department who are
designated by the director to participate in leadership on-call and this type
of on-call practice must be authorized in writing.
b) Duties of on-call
leaders:
- Check and supervise
on-call shifts in the hospital.
- Direct the resolution of
difficult problems and situations that are beyond the professional capabilities
of on-call subordinate staff.
- Direct the handling of
unusual security and order incidents occurring in the hospital.
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2. On-call clinical staff:
a) Organization of on-call
clinical practice:
- The head of on-call shift
is a practitioner holding the position of dean, deputy dean, or doctor with a
postgraduate degree.
- On-call clinical doctor is
a qualified practitioner who independently solves tasks and is responsible for
their task solution.
- Nurses, midwives, and
medical technicians who are practitioners assigned to on-call clinical practice
by the hospital director.
b) Duties of the head of
on-call clinical shift:
- Manage human resources
during the on-call shift.
- Examine and order treatment
for emergency cases, newly arrived patients and seriously ill patients
undergoing treatment with unusual developments when the on-call clinical doctor
of the department cannot resolve the issue.
- Report and seek advice
from direct leadership in cases beyond their professional capacity to handle
and special cases such as suicide, epidemics, catastrophes, and mass
emergencies.
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- Check and urge on-call
positions to fulfil their duties.
c) Duties of on-call
doctors:
- Receive patients coming to
the emergency room.
- Monitor and handle
transferred patients.
- Guide and urge on-call
staff to fully implement instructions.
- Assign responsibilities to
each on-call member to closely monitor and promptly respond to any adverse
changes in level-1 seriously-ill patients.
- Examine patients and
document medical records after each visit.
d) Duties of on-call nurses,
midwives, and medical technicians:
- On-call nurses are nurses
of each department who can organize inter-department nursing duties as decided
by the hospital director.
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- Urge patients to follow
hospital regulations.
- Preserve records, medicine
cabinets, and assets of the department.
- Detect a patient with
unusual developments, at risk of death, report to the on-call doctor, and
record all developments in the monitoring sheet.
3. On-call subclinical staff:
a) Organize separate on-call
practice for each department, depending on the workload in each department to
arrange the appropriate number of on-call staff;
b) Duties of on-call
subclinical staff: perform tasks for diagnosis and treatment according to clinical
instructions.
4. On-call logistics and
administration staff:
a) On-call pharmacy and
medical device staff shall ensure adequate supply of medicine and operation of
medical devices to serve the on-call team;
b) The on-call finance and
accounting staff shall ensure the collection of hospital fees from outpatients
and inpatients outside of business hours;
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d) On-call electricity and
water staff shall ensure operation of generators when there is an unexpected
power outage; repair abnormal electricity and water damage;
dd) On-call administration
staff must ensure communication by phones and other forms of information
(according to regulations of the healthcare facility);
e) On-call security guards
shall ensure security and order in the hospital;
g) On-call drivers shall
ensure that ambulances are ready to perform duty when ordered.
5. Out-of-hospital on-call
permanent staff:
a) In addition to the people
assigned to be on call as mentioned above at the 4 permanent levels, depending
on the actual circumstances of each hospital, hospital leaders can arrange
on-call permanent staff outside the hospital to be ready to provide
professional and administrative support when needed;
c) On-call permanent staff
must keep in constant contact during their on-call time and be present at the
hospital when mobilized.
Article
45. Required items in an on-call shift report
1. After an on-call shift,
the on-call sub-teams shall document developments of all required report items
in the on-call book; faculties and departments must hold briefings to hear the
on-call shift reports from the following on-call sub-teams: clinical,
subclinical, logistics, and administration sub-teams.
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a) Death: Clearly state the
patient's progress, treatment, cause, time of death, and specific actions after
the patient's death;
b) Emergency: Clearly state
the name, age, address, diagnosis, and solution for each patient coming to the
emergency room;
c) Serious developments of
inpatients: Clearly state the developments of illness and treatment for each
patient;
d) Medicines: release
statistics and reports on the number of medicines used during the on-call
shift.
3. On-call subclinical
staff: Report emergency tests and paraclinical techniques performed during the
on-call shift.
4. On-call logistics and
administration staff: Report the items as prescribed in Clause 4, Article 44 of
this Circular.
5. On-call leaders: Give
general comments on the progress of on-call shift at the hospital-wide
briefing.
Article
46. On-call practice at a healthcare facility that is not a hospital but has
inpatient beds or beds for monitoring and treatment of patients
1. A healthcare facility
that is not a hospital but has inpatient beds or beds for monitoring and
treatment of patients (except for the case specified in Clause 2 of this
Article) must arrange human resources for an on-call shift as follows: There is
at least 1 practitioner with the title of doctor or physician assistant and 1
practitioner with one of the following titles: nurse, midwife, or medical
technician.
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Article
47. Out-of-hospital on-call emergency
1. Out-of-hospital emergency
facilities (including patient transport facilities established under the Law on
Medical Examination and Treatment No. 40/2009/QH12) shall organize 24-hour
emergency operations (including holidays and days off) according to Decision
No. 01/2008/QD-BYT dated January 21, 2008 of the Minister of Health on
emergency and intensive care and anti-toxic care.
2. Healthcare faculties with
out-of-hospital emergency operations must arrange:
a) 24-hour human resources
on call;
b) the minimum number of
people for one on-call shift as follows:
- 1 practitioner with the
title of doctor or physician.
- 1 practitioner with one of
the following titles: nurse, midwife, or medical technician.
- 1 ambulance driver.
c) Staff in the on-call
emergency shift specified in Point b of this Clause must be distinct from
personnel assigned to other concurrent on-call shifts and can be arranged in
the form of permanent duty.
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ORGANIZATION
AND OPERATION OF THE EXPERT PANEL AND DISPUTE RESOLUTION PROCEDURES UPON
OCCURRENCE OF MEDICAL ACCIDENTS
Article
48. Organization of the Expert Panel
1. The organizational
structure and number of members of the Expert Panel include:
a) President: 1 person;
b) Deputy President: 1-2
people;
c) Members: At least 3
people;
d) Secretary: At least 1
person.
2. Principles for
establishing the Expert Panel:
a) Ensure independence,
objectivity, and no conflicts of interest;
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c) The number of members of
the Panel (including the President) must be an odd number.
Article
49. Operation of the Expert Panel
1. Conditions for holding an
Expert Panel meeting: at least 2/3 of the Panel members must be present.
2. Meeting sessions:
a) The Panel may meet in one
or more sessions;
b) Each member of the Panel
uses relevant medical records to make an evaluation of the medical accident;
c) The Panel has a
collective discussion and concludes by majority vote based on the opinions of
its members and take legal responsibility for its conclusions;
d) The content discussed at
the Panel session must be recorded in minutes, with all signatures of the Panel
members attending the session.
3. The conclusion of the
Expert Panel must determine the cause of the medical accident:
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b) In case a medical
accident occurs due to healthcare professional errors during medical
examination and treatment, the following must be specifically concluded:
- Whether the practitioner
commits a violation in one of the cases specified in Clause 1, Article 100 of
the Law on Medical Examination and Treatment.
- Levels of healthcare
professional errors and actions to be taken against the practitioner(s) (if
any).
4. The written conclusion
signed by the President of the Panel must have content consistent with the
conclusion in the Panel meeting minutes and be made into 2 copies, 1 copy is
kept at the agency that established the Panel, 1 copy is sent to the agency
that requests to establish the Panel unless the establishing agency is a
healthcare facility where the medical accident occurs. The signature of the
President of the Panel must be authenticated by the agency that established the
Panel.
5. During the Panel meeting,
if necessary, the President of the Panel may request their establishing agency
to invite more experts to participate in the meeting without having to
supplement the decision on establishment of the Panel.
Article
50. Dispute resolution procedures upon occurrence of medical accidents
1. Dispute resolution
procedures for hospitals under the management of the Department of Health (including
hospitals of ministries and agencies, except hospitals under the Ministry of
National Defense and the Ministry of Public Security):
a) When a medical accident
occurs and there is a dispute that needs to be resolved, at the request of the
patient, the patient's representative, the practitioner(s), the investigation
body, or the court, the hospital must establish an Expert Panel as prescribed
in Clause 1, Article 101 of the Law on Medical Examination and Treatment
(hereinafter referred to as the grassroots Expert Panel);
b) In case the parties to
dispute do not agree with the conclusion of the Expert Panel specified in Point
a of this Clause, they may send a written request to the Department of Health to
establish another Expert Panel to resolve it together with documentation
related to the dispute;
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d) In case the parties to
dispute do not agree with the conclusion of the Expert Panel established by the
Ministry of Health, the parties shall file a lawsuit to court.
2. Dispute resolution
procedures for healthcare facilities under the management of the Department of
Health other than hospitals (including healthcare facilities other than
hospitals of ministries and agencies, except facilities under the Ministry of
National Defense and the Ministry of Public Security):
a) When a medical accident
occurs and there is a dispute that needs to be resolved, at the request of the
patient, the patient's representative, the practitioner(s), the investigation
body, or the court, the healthcare facility shall send a request to the
Department of Health in writing to establish an Expert Panel together with documents
related to the dispute;
b) In case the parties to
dispute do not agree with the conclusion of the Expert Panel specified in Point
a of this Clause, they may send a written request to the Ministry of Health to
establish another Expert Panel to resolve it together with documentation
related to the dispute. The conclusion of the Expert Panel of the Ministry of
Health is final and conclusive;
c) In case the parties to
dispute do not agree with the conclusion of the Expert Panel established by the
Ministry of Health, the parties shall file a lawsuit to court.
3. Dispute resolution
procedures for hospitals and infirmaries under the management of the Ministry
of National Defense and the Ministry of Public Security:
a) When a medical accident
occurs and there is a dispute that needs to be resolved, at the request of the
patient, the patient's representative, the practitioner(s), the investigation
body, or the court, the hospital/infirmary must establish an Expert Panel as
prescribed in Clause 1, Article 101 of the Law on Medical Examination and
Treatment (hereinafter referred to as the grassroots Expert Panel);
b) In case the parties to
dispute do not agree with the conclusion of the Expert Panel specified in Point
a of this Clause, they may send a written request to the Department of Military
Medicine affiliated to Ministry of National Defense, Department of Health
affiliated to Ministry of Public Security to establish another Expert Panel to
resolve it together with documentation related to the dispute;
c) In case the parties have
a dispute and do not agree with the conclusion of the Expert Panel specified in
Point b of this Clause, they may send a written request to the Ministry of
Health to establish another Expert Panel to resolve it together with documentation
related to the dispute. The conclusion of the Expert Panel of the Ministry of
Health is final and conclusive;
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4. Dispute resolution
procedures for healthcare facilities under the management of the Ministry of
National Defense and the Ministry of Public Security other than hospitals or
infirmaries, or being infirmaries but not eligible for establishing an Expert
Panel:
a) When a medical accident
occurs and there is a dispute that needs to be resolved, at the request of the
patient, the patient's representative, the practitioner(s), the investigation
body, or the court, the healthcare facility shall send a request to the
Department of Military Medicine affiliated to Ministry of National Defense,
Department of Health affiliated to Ministry of Public Security in writing to
establish a Expert Panel together with documents related to the dispute;
b) In case the parties to
dispute do not agree with the conclusion of the Expert Panel specified in Point
a of this Clause, they may send a written request to the Ministry of Health to
establish another Expert Panel to resolve it together with documentation
related to the dispute; The conclusion of the Expert Panel of the Ministry of
Health is final and conclusive;
c) In case the parties to
dispute do not agree with the conclusion of the Expert Panel established by the
Ministry of Health, the parties shall file a lawsuit to court.
5. Dispute resolution
procedures for hospitals under the management of the Ministry of Health:
a) When a medical accident
occurs and there is a dispute that needs to be resolved, at the request of the
patient, the patient's representative, the practitioner(s), the investigation
body, or the court, the hospital must establish an Expert Panel as prescribed
in Clause 1, Article 101 of the Law on Medical Examination and Treatment
(hereinafter referred to as the grassroots Expert Panel);
b) In case the parties to
dispute do not agree with the conclusion of the Expert Panel specified in Point
a of this Clause, they may send a written request to the Ministry of Health to
establish another Expert Panel to resolve it together with documentation
related to the dispute; The conclusion of the Expert Panel of the Ministry of
Health is final and conclusive;
c) In case the parties to
dispute do not agree with the conclusion of the Expert Panel established by the
Ministry of Health, the parties shall file a lawsuit to court.
6. Dispute resolution
procedures for healthcare facilities under the management of the Ministry of
Health but other than hospitals:
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b) In case the parties to
dispute do not agree with the conclusion of the Expert Panel established by the
Ministry of Health, the parties shall file a lawsuit to court.
Chapter
X
MEDICAL
RECORDS
Article
51. Medical records, medical forms used in medical records
1. 82 medical records and
medical forms issued together with this Circular include:
a) Medical records in
Appendix XXVIII of this Circular;
b) Medical forms in Appendix
XXIX of this Circular;
Article
52. Regulations on use of medical records and documentation of medical records
1. Regulations on use of
medical records:
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b) Healthcare facilities
that use electronic medical records must ensure that all information fields of
the medical records are complete.
2. Regulations on
documentation of medical records:
a) Accurately, truthfully,
and completely document all information in medical records, medical examination
results, subclinical tests, functional tests, diagnosis, treatment, care, and
other information related to the patient's treatment process at a healthcare
facility;
b) The documentation must
comply with the contents and professional instructions that have been issued;
c) Use clear and scientific
words, present easily to understand and read. Do not use abbreviations in
documents provided for patients, including: summaries of medical records,
documents handed over to other healthcare facilities, referral letters for
medical examination and treatment, health insurance-covered medical documents,
follow-up appointment letters. For abbreviations, they must follow the list of
symbols and abbreviations used in medical records that have been developed and
issued for uniform use at the healthcare facility;
d) Information in the
medical records should clearly show the time and person who documented it.
Chapter
XI
IMPLEMENTATION
Article
53. Entry into force
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2. The following documents
cease to be effective from the effective date of this Circular:
a) Circular No.
35/2019/TT-BYT dated December 30, 2019 of the Minister of Health;
b) Circular No.
55/2015/TT-BYT dated December 29, 2015 of the Minister of Health;
c) Circular No.
14/2013/TT-BYT dated May 6, 202013 of the Minister of Health;
d) Circular No.
09/2023/TT-BYT dated May 5, 2023 of the Minister of Health;
dd) Standing regulations in
Clause 1, Part IV of Decision No. 1895/1997/QD-BYT dated September 19, 1997;
e) Decision No.
4069/2001/QD-BYT dated September 28, 2001 of the Minister of Health;
g) Medical record summary
form (CV-01) replaces "Medical record summary form" in Appendix 4
issued with Circular No. 18/2022/TT-BYT dated December 31, 2020. 2022 of the
Minister of Health;
h) Decision No. 1941/QD-BYT
dated May 22, 2019 of the Minister of Health;
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k) Circular No.
41/2011/TT-BYT dated November 14, 2011 of the Minister of Health;
l) Circular No.
41/2015/TT-BYT dated November 16, 2015 of the Minister of Health;
m) Regulations on medical
CPD in Circular No. 22/2013/TT-BYT dated August 9, 2013 of the Minister of
Health.
Article
54. Terms of reference
In case the documents
referenced in this Circular are superseded or amended , the new documents shall
prevail.
Article
55. Transitional provisions
1. In case a practitioner
has been granted a medical certificate (hereinafter referred to as a medical
license) according to the Law on Medical Examination and Treatment No.
40/2009/QH12, their scope of practice is applied according to regulations of
this Circular.
2. For testing bodies that
have been granted a Certificate of GCP compliance with the scope of clinical
drug trials (pharmaceutical drugs, herbal drugs, traditional drugs, biological
products, therapeutic biological products), the testing bodies shall review and
prepare conditions to meet GCP principles and standards as prescribed in this
Circular and send documents as prescribed in Article 20 of this Circular to the
Department of Science, Technology and Training.
3. The Department of
Science, Technology and Training shall check and evaluate if they comply with
GCP based on the documentation of the testing bodies. In case the application
of a testing body is complete and meets the requirements specified in this
Circular, the Ministry of Health shall assign the Department of Science,
Technology and Training to issue a certificate of GCP compliance with the trial
scope of corresponding new techniques, new methods and/or medical devices
within 20 working days of receiving the complete and valid application.
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a) The testing body requests
a certificate of compliance with good clinical practice for medical device
trial;
b) Documents proving the
eligibility of the testing body do not meet the requirements in this Circular;
c) Documents show signs of
erasures or modifications;
d) The testing body has been
sanctioned by a competent authority for administrative violations related to
clinical trials.
5. In case of on-site
evaluation at the testing body, the handling of evaluation results is carried
out in Article 23 of this Circular.
Article
56. Implementation
1. Chief of the Ministry
Office, Director of the Department of Medical Examination and Treatment
Management, Director of the Department of Science, Technology and Training,
Director of the Department of Traditional Medicine and Pharmacy, Directors of
Departments, Directors of Departments under the Ministry Health, heads of
agencies and units under the Ministry, Directors of Health Departments of
provinces, heads of health agencies of Ministries, branches and relevant
organizations shall implement this Circular.
Difficulties that arise
during the implementation of this Circular should be reported to Department of
Medical Examination and Treatment Management or Department of Science,
Technology and Training affiliated to the Ministry of Health for
consideration./.
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PP. MINISTER
DEPUTY MINISTER
Tran Van Thuan