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THE
MINISTRY OF HEALTH
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SOCIALIST
REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No.
04/2015/TT-BYT
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Hanoi,
March 17, 2015
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CIRCULAR
ON RECOGNITION OF QUALITY CONTROL ON EXAMINATION AND TREATMENT
FACILITIES
Pursuant to the Law on Medical
examination and treatment No. 40/2009/QH12 dated November 23, 2009;
Pursuant to the Decree No.
87/2011/NĐ-CP dated September 27, 2011 by the Government detailing a number of
Article of the Law on Medical examination and treatment;
Pursuant to the Decree No.
63/2012/NĐ-CP dated August 31, 2012 by the Government defining the functions,
tasks, powers and organizational structure of the Ministry of Health;
The Minister of Health promulgates
the Circular providing for the recognition of quality control on examination
and treatment facilities
Article 1. Scope
of regulation
1. This Circular provides for:
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b) Criteria, documents and procedures
for recogntion of the standards other than those recognized by the Ministry of
Health in Point a of this Clause.
2. The certification of the
conformity of a body certificating examination and treatment facility quality
shall be in accordance with the legislation on healthcare and the legislation
on National technical regulation and standard and is not within the scope of
regulation of this Circular.
Article 2. The
recognition of international standards and the standards of foreign countries
for quality control on examination and treatment facilities
1. The international standards and
foreign standards of quality control on examination and treatment facilities
are approved by International Society for Quality in Healthcare (ISQua) and
recognized by the Ministry of Health to be applied in Vietnam. The list of such
standars is displayed and updated on electronic information pages of
Administration of Medical Examination and Treatment.
2. Vietnamese standards of quality
control on examination and treatment facilities are recognized by the ISQua and
approved by the Ministry of Health as prescribed in Clause 1 of this Article.
Article 3.
Criteria for recognition of standards of quality control on examination and
treatment facilities other than those specified in Article 2 of this Circular
1. General criteria
a) Standard regulating the time limit
and the assessment of the standards.
b) The standards regulating that the
recognition of quality is the voluntary of the examination and treatment
facility.
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d) The standards regulating that the
general assessment of quality features like safety, effectiveness, promptness,
fairness, focus on patients and health workers shall be ensured.
dd) The standards including the
criteria and indicators ensuring to assess sufficiently 3 quality components: the
entry, process and the results.
2. Specific criteria are provided in
Appendix 01 enclosed herewith.
Article 4.
Application for recognition of quality control on examination and treatment
facilities
1. The form in Appendix 02 enclosed
herewith.
2. The full version of Standards of
quality control
3. A certified true copy of the
License for the conformity of quality certification body according to the
provisions of Clause 4 Article 13 of the Decree No. 87/2011/NĐ-CP dated
September 27, 2011 by the Government detailing a number of Article of the Law
on Medical examination and treatment.
4. A certified true copy of
Establishment Decision, the Certificate of Enterprise registration or the
Investment certificate issued by a quality certification body.
5. Documents proving that the
standards are applied in the examination and treatment facilities in Vietnam,
including: a report on the application of the standards; a collection of
opinions of the administrative officers of the examination and treatment
facilities and the experts in field of quality control.
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Article 5.
Procedures for recognition of quality control on medical examination and
treatment facilities
1. The quality certification body sends
the application specified in Article 4 of this Circular to the Administrative
of Medical Examination and Treatment affiliated to the Ministry of Health.
2. Establishment of Appraisal council
(hereinafter referred to as Council):
a) The Minister of Health is in
charge of approving the Decision on the Establishment of the Council.
Members of the Council:
- A chairman (a leader of the
Ministry of Health);
- A standing vice-chairman (a leader
of the Administration of Medical Examination and Treatment), a vice-chairman (a
leader of the Legal Department).
- Members (leaders of a number of
regulatory bodies affiliated to the Ministry of Health, a number of experts in
quality control, representatives of relevant regulatory bodies).
b) A Secretary team led by the
manager of the quality control division, the Administration of Medical
Examination and Treatment.
3. Process of the appraisal of
standards:
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b) The Coucil shall conduct an
appraisal, make conclusion and approve the minutes.
c) Within 20 days from the day on
which the satisfactory application is received (written on the Form prescribed
in Appendix 04 enclosed herewith):
- If the Council approve the
recognition of the standards, the Administration of Examination and Treatment
shall request the Minister of Health the Decision precribed in Appendix 03
enclosed herewith.
- If the Council reject the
recognition, within 05 working days from the day on which the conclusion of the
Council is received, the Administration of Examination and Treatment shall send
the applicant a writing containing the explanation.
d) The Decision on recognition of
standards of the quality certification body is displayed on electronic
information pages of the Administration of Examination and Treatment within 05
working days from the day on which the Decision is promulgated.
Article 6.
Responsibilities
1. The Administrations of Examination
and Treatment are responsible for:
a) Being the leading unit assisting
the Minister of Health to manage the recognition of quality control on medical
examination and treatment facilities and organize the implementation of this
Circular;
b) Supervise the certification in
Vietnam of the Quality certification body having quality control standards
recognized.
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3. The Quality
certification body is responsible for reporting to the Administration of
Medical examination and Treatment on the result of the quality certification
towards the examination and treatment facilities in Vietnam right after the
certificate of quality is issue and periodical reporting on the result of the
supervision of quality of the examination and treatment facilities within the
effect duration of the certifícate of quality.
Article 7. Effect
This Circular comes into effect from
May 01st, 2015
Difficulties that arise during the
implementation of this Circular should be reported to the Ministry of Health
(via the Administration of Medical Examination and Treatment) for guidance or
consideration and handling./.
PP.
THE MINISTER
THE DEPUTY MINISTER
Nguyen Thi Xuyen
APPENDIX 01
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Item
Requirement
Response from
the certification body with evidences
1
QUALITY IMPROVEMENT
The medical examination and treatment facilities are encouraged to
maintain, innovate and increase the quality, manage effectively and enlarge
the medical examination and treatment service includes:
1.1
Medical examination and treatment facilities
within the scope and function shall determine:
· Quality control targets and tasks
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· Regulation and code of conduct
1.2
General responsibilities and specific
responsibilities in the maintenace and innovation/increase of quality shall
be determined
Responsibilities of administrative officers, doctors,
pharmacists, other health workers and apprentices (if any) shall be specified
1.3
Responsibilities in management and direction of
medical examination and treatment facilities shall be determined
a) Evidences: general oritentation, the formulation
of target and policy on quality control, provision of guidance on the
implementation, methods for monitoring the implementation to reach the
target.
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1.4
Medical examination and treatment facilities shall
publicize the list of services and the quality of such services.
1.5
Policies, plans, procedures for the performance
of all functions and services of the medical examination and treatment
facilities shall:
· Be issued in writing
· Be licensed
· Be in effect
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Evidences: signatures of competent persons on
the writings containing policies, plans, procedures or decisions on
establishment of an organization/division.
1.6
Medical examination and treatment facilities shall
maintain, innovate/increase the quality:
· Systematically
· Continuously
· With a great number of participants
· Involving all functions and services
· Encouraging creative contribution
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1.7
The ouput result of functional activities and
healthcare services shall be measurable with:
· Indices
· Survey/assessment of the pleasure of
patients/service users
· Other measures
a) For instance, measures for assessing the
quality of human resources, infection control, handling problems and managing
services;
b) The use of indices in form of ratio with
determined numerator and denominator is encouraged;
c) Other measures like survey, inspection and
receiving feedback;
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e) Medical examination and treatment
facilities are encourages to increase the indices or register for building up
national quality indices
1.8
Assessment and analysis of measurement database shall
be available serving the modification and increase of the service quality.
Example of database:
a) The indices; results expressing the
pleasure of patients and other measurements
b) Complaints, response;
c) Problems/mistakes and unexected effects.
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The provisions of the applicable legislative
documents, decisions, regulations and policies on healthcare shall be
complied with.
a) For example: standards formulated according
to the regulations of the State and the Ministry of Health on staff
organization, safety, environment protection, waste management, food safety,
practice licencing , healthcare information, medicine management and use,
infectious diseases control
b) Health policies are decisions,
instructions, guidances that are promulgated according to the reseach
findings and are not legislative documents.
2
PATIENT IS THE CENTRALITY
The standard of focus on patient is expressed
with:
2.1
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· Respect for human dignity
· Privacy protection
· Information security
· Safety and security
Evicendes:
a) The documents about rights and
responsibilities of patients;
b) The provision of training for health
workers in rights and responsibilities of patients.
2.2
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a) Patients may decide whether to get
treatment or not; may decide whether to take the measure or not; may choose
doctor and carer.
b) There shall be information about the taste
of the patients in term of the care services, personal items, clothes,
self-care habits, daily food/drinks/meals, activities, sercurity request,
visiting entities.
c) Documents proving the consent to
participate in any:
· Reasearches/processes of pilot treatment
project;
· Surgery, anaesthesia using medium/big dose
of tranquillizer
Processes/services with risk of unexpected
effect.
2.3
Patients shall be provided with care service and
treatment in which:
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· The choice of care and treatment services are
notified to the patients
· The treatment are agreed by the patients before
being applied
2.4
Medical examination and treatment facilities
shall recognize and respect for culture, belief and religion of the patients
Evicendes:
a) Advisory service and other services are provided
satisfying the demand of patients about belief and religion.
b) Training in demand for services of various
culture/religion are provided for health workers
c) Specific instruments and services are
provided for male patients and female patients according to their culture
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2.5
Service accessibility of patients shall be
proved, including:
· Services with supply conformable to the demand
and the range of expertise of medical examination and treatment facilities
· Ability to provide services for the disabled
and other particular demand
· Process of hospitalization and treatment
2.6
There shall be collection of feedback from
patients:
· About all services
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· That the medical examination and treatment
facilities note and promptly handle
For example: feedback from patients about:
a) The demands and risks from each type of
service
b) The matters like medicine, material and
spirit, behaviors, attitudes, emotions and nutrition
2.7
The preparation and record of plan for provision
of treatments/services provided to patients shall be sufficient, including:
· Demands of the patients, record of the results
of relevant test and diagnotic of other medical examination and treatment
facilities (if any)
· Evidences of the receipt of treatments/services
of patients and their family
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2.8
Health workers shall:
· Comply with the plans for provision of
treatment and services
· Observe the conditions of the patients and
predict the ability to reach the target/expected result
· Consider the demand of patients when choosing
treatments
· Adjust the plans for provision of treatments
and services appropriate for the conditions of the patients
2.9
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a) Plans shall be set up immediately when receiving
the patients and updated constantly during the provision of
treatments/services
b) Plans shall include provision for both
patients and their family
c) Plans for cooperation with medical
examination and treatment facilities at all lines and provider of relevant
services
d) If it is inevitable that the patient will
die, plans for preparation of patients and their family shall be set up to
face the possible spasm of pain and syndromes, cooperate with other units in
assisting, advising and responding to the spiritual and cultural demands.
3
ORGANIZATION AND PERFORMANCE
The standards for assessment of proficiency and
effectiveness of medical examination and treatment facilities include:
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Medical examination and treatment facilities
shall set up planning for payroll with detail about qualification for each
position to satisfy the proficiency and service supply of such medical
examination and treatment facilities.
a) Planning for official payroll: the number
of boarder employees and students, requirements for seniority and
qualification conformable to function of medical examination and treatment
facilities
b) Planning shall be provided in writing
3.2
The positions in term of orient, proficiency,
knowledge and experience shall be detailed
3.3
Medical examination and treatment facilities
shall be issued with operation license, health workers shall have practice
certificates indicating the licensed practice
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b) Available certificates and pratice licenses
that are regularly reassessed.
3.4
Health workers at medical examination and
treatment facilities (including apprentices, if any) shall:
a) Have proficiency and efficiency regularly
assessed
b) Receive constantly training programs
c) Be enable to study and develop proficiency
domestically or abroad
Evidence: documents on capacity and efficiency
assessment are retained and publicized to relevant health workers (or
apprendices)
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Health workers shall comply with the applicable
standards, technical processes and technical guidance, clinical practice on
the basis of the evidences
3.6
The establishment of additional plans, development
of services of medical examination and treatment facilities shall be with the
attendance of patients and their family and health workers (and surveys in
residents in administrative division if possible).
Evidence: documents containing the plan establishment
process and the list of participants.
3.7
Medical examination and treatment facilities
shall determine the services subject to supplement and development; expected
result and measurement of progress in the plans
a) Strategies and plans for long-term and
short-term targets
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3.8
Plan on service development shall be in
accordance with the strategic orient and appropriate to the environment and the
financial budget of medical examination and treatment facilities.
3.9
Plans on specialist activities and innovation of
divisions and wards, necessary services shall include the provisions for the
scheme for corperation between the divisions in medical examination and
treatment facilities as well as outside service providers.
3.10
Medical examination and treatment facility shall
compare regularly the plan with the budget estimates to assess the effectiveness
of the use of human resources.
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4
SAFETY
Measures ensuring the increase of safety or
patients, health workers and visitors to the medical examination and
treatment facility:
4.1
The management of risks shall be systematic so as
to determine all possible risks.
A risk management plan shall include: a)
Policy; b) Scope; c) Target and criteria for assessment of risks; d) Responsibilitites
and management of risks; e) Training for health workers; f) A list of
determined risks and stategies, actions, finance and possible difficulties;
g) A Record of the risks and analysis of the cause; h) A plan on handling the
main risks; i) Procedures for dealing with relevant parties.
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Risk management plan shall be supervised; the
result of the management of risk inside the medical examination and treatment
facility shall be publicized
a) Commit to supervise regularly and compare
the completed activities with the requirements in the plan.
b) Inspect regularly and irregularly the
particular contents
c) Use the result of supervision to innovate
the quality.
4.3
The medical examination and treatment facility shall
set up procedures for making report and inspecting unexpected effects that
may happen to the patients, health workers or visitors and procedures for use
of the result for the innovation of service quality.
a) Provide training for health workers
b) Set up document and report on the risks
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d) Procedures for notifying the patients of
the unexpected effects.
4.4
Medical examination and treatment shall take protective
measures for health and safety of the employees
Protective measures for health and safety of
employees shall be in accordance with possible risks in their profession:
a) Personal protective clothes and equipment
b) Working environmental supervision and
observation
c) Supervision of the overload and pressure
from work
d) Provision of vaccination for health workers
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f) Avoidance of risk of occupational diseases.
4.5
Medical examination and treatment facility shall:
· Provide training for health workers in
operating equipment, including medical equipment
· Assign only proficient employees who have
received training to operate the specialized equipment
4.6
Medical examination and treatment facility shall
comply with the legislation and regulation on safety, planning, construction
and use of the space; equip sufficiently safety materials and equipment.
Facilities shall be examined, maintained and replaced systemly, according to
the plan.
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4.7
Medical examination and treatment facility shall
supervise the clinical risks to protect the patients from unpredictable
accident during the treatment.
a) Risks from medicine like allergy,
anti-antibiotics
b) Risks from the equipment like being burnt
or injured because of laser
c) Risks from staying too long in the hospital
4.8
Medical examination and treatment facility shall
run the programs for protection and control of bacterial contamination, including
the program for cleaning hands and hygienic requirements for cleaning
process.
There shall be requirements for specific
divisions and services, including:
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b) Isolation measures and provisional
techniques
c) Supervision of the use of antibiotics
d) Decontamination and terilization
e) Supervision of bacterial contamination
f) Collection, analysis and use of data on
bacterial contamination
g) Report activities
h) Training for health workers
4.9
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The guidance shall include:
a) Safety in management and use of blood and
preparations from blood
b) The accuracy of entity, measure and time
c) The safety in pre-surgery, while-surgery
and post-surgery, safety in anaesthesia and safety in use of medium/big dose
of tranquillizer.
d) Safety in management of medicine in term
of:
· Provision of prescription and medical
instruction
· Transport and maintenance of medicine
· Handling of expired medicine
· Prevention, supervision and record
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4.10
Information in medical records shall be
sufficient, exact, secured and sorted by time so as to assist the safety and constancy
of treatment activities.
Requirements for electronic medical
record/written medical record (according to the particular division):
a) The record shall be readable, updated
promptly and sufficiently with date of update, signature and seal
b) Symbol shall be noticed
c) The progress, symptoms, medical
consultation reports and diagnostic examination reports shall be noted
d) All the important events like the change in
conditions and reactions of the patients to the treatment methods shall be
noted.
e) Any risks or problems shall be noted
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g) Only recognized abbreviation are used
h) Process of retention and cancelation of
medical record shall be specified
5
ESTABLISHMENT OF STANDARDS
The standards are drawn up and assess strictly
and systemly, including:
5.1
The standards may be modified and have order of
priority adjusted according to the opinions of policy formulation
specialists, opinions of groups of patients, groups of service suppliers and
relevant parties about the previous-version standards.
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5.2
The standards shall be conformable to the
applicable legislation, the specialized regulations and standards of other quality
certification bodies
Reference from other sets of standards shall
be taken to avoid the repetition, overlap and contradiction during the
implementation
5.3
There shall be plan for establishment, innovation
or modification of standards to determine the target, human resources and
progress.
5.4
The standards shall be conformable to:
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· Available researches, evidences and experience
· The guidance and proceducres recognized by
foreign countries
· The recommendations from the WHO and the
domestic and foreign occupational associations
· Opinions from technical specialist
The standards may be modified according to the
cultural features and requirements for healthcare services in different
countries/medical examination and treatment facilities.
5.5
The establishment and modification of the
standards shall receive the advices from experts in policy formulation,
service supply, service use and relevant fields
Relevant entities may contribute in the
establishment and modification through the annoucement and suggestion
collection on means of media like internet
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5.6
The standards shall specify:
· Target
· Regulated scope and entities: general or
specialist medical examination and treatment facility; applicable to the
whole hospital or specific divisions/wards/service types in medical
examination and treatment facility
· The reasons and the need for application of the
standard
a) The minimum quality level shall be
determined
b) Conditions for innovation of quality shall
be created
c) The quality shall be recognized and
certified
d) There shall be license for operation
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5.7
The standards shall be clear enough for medical
examination and treatment facility to apply and assess
a) The standards shall be collected to groups
and sorted according to the topic, for instance group sorted by functions or
system
b) Any standards shall have tittle containing
the main content;
c) The standards shall be ordered and numered
systemly so as for easy searching;
d) Methods for applying and assessing the
standards shall be described and explained clearly in the enclosed documents
5.8
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a) Any sentences shall contain specific
subjects (specific request; responsibility for implementing)
b) Terms that have multiple meaning and qualitative
terms shall be explained carefully (for example well, enough)
c) There shall be strict examination to select
understandable words and replace the unclear ones
d) Guidance documents shall be enclosed to
help the users to understand more clearly the standards
5.9
Any standards shall be tested at medical
examination and treatment facilities and assessed by assessors before
approving to ensure that they are correctly understood. Any standard shall be
conformable, feasible and assessable (the matters relating to quality;
medical examination and treatment facility able to apply and reach the
standard shall be assessed exactly)
5.10
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5.11
Determination of the condition that organizations
in charge of assessing the standards shall be independent of organizations in
charge of constructing, approving and promulgating the standard.
The requirement may include:
a) Writing containing procedures for
determining the condition
b) The requirements shall be determined
clearly and agreed by the 2 parties, for example: the standards shall be use for
a certain purpose and the independent assessing organizations shall provide
the response and the result of the assessment of the standards for the
organizations in charge of establishing, approving and promulgating the
standards.
5.12
The staff of medical facilities (the appliers)
and the assessors shall be provided with notification and training so as to
understand and apply effectively the modified standards
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5.13
The content, time of effect and any new
regulations on replacement and modification in the application of the new
standard shall be determined and complied with.
The requirements may include: the late
versions of the set of standards that is publicized and provided for the
appliers and the assessors in a period of time sufficient for them to
understand clearly the requirement before the standard is applied.
5.14
The opinions and reactions of appliers/assessors
and relevant parties to the standard shall be collected, retained and analyzed
to assist the innovation of standards
The procedures may include:
a) Collect the feedback of
organizations/individuals that have carried out the assessment of the
standard
b) Make survey periodically for collecting
suggestions of the relevant parties about the standard
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d) Use the analyzed data as the basis for
modifying the standard
6
ASSESSMENT OF STANDARDS
The assessment shall be consistent, explicit and include
the rank of quality
6.1
There shall be an explicit system for the
assessment of the performance of medical facilities towards each standard,
each criterion or each item of a standard.
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There shall be document providing guidance and
other correlative information so that the appliers carrying out the
independent assessment and the medical facilities carrying out
self-assessment of the application of the standard get similar/unified results.
The documents of guidance shall determine the
important standards/criteria and the methods to rank when applying and
assessing the risks and the issues about safety.
6.3
The consistent method shall be determined to
assess the general result of each group of standards
a) For example, the result assessing methods
may be: compulsory standards are reached; all of the standards are reached or
none of standards is failed.
b) Methods for medical facilities to assess
their own general result
c) The result of general assessment of
standards may be used for considering issuing operation license or quality
certification to medical facilities even when the issuance of such documents
requests a number of supplement criteria not relating to the set of standards.
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Survey on the pleasure of medical facilities and
the assessor staff with the assessment conformable with the standards The
result the survey is used for innovating the standards
The procedures may include:
a) Collect the feedback of independent
assessing organization and the assessor staff about the quality ranking
system after the assessment process, for example the standards that are
useful and easy to apply
b) Analyze regularly the collected feedback
c) Use the analysis results as the basis for innovating the ranking
system
Date:
Competent representative