Thông tư 04/2015/TT-BYT

THE MINISTRY OF HEALTH
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SOCIALIST REPUBLIC OF VIETNAM
Independence - Freedom - Happiness
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No. 04/2015/TT-BYT

Hanoi, March 17, 2015

PP. THE MINISTER
THE DEPUTY MINISTER




Nguyen Thi Xuyen

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

· Plans and projects on the development of quality of medical examination and treatment activities.

· 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.

b) There shall be a specific plan and budget for each target set up by the management level (evidences: schedule for implementation; arrangement of human resources throught management activities; measures for managing and handling the problems)

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

· Be being applied

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

· Associating with supervising and assessing

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;

d) Clinical indices according to the scientific evidences;

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.

1.9

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

Standard of the rights of the patients, including:

· 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

Medical examination and treatment facility shall have a system to receive, examine and handle the questions, comments and complaints  of patients equally and promptly.

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:

· The taste and the choice of patients are prioritized

· 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

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

· About the regulations and rules  

· 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

· Target or expected result when receiving treatments/services

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

Medical examination and treatment facilities shall set up plans for receipt/hospitalization, referral, discharge from the hospital and finish of treatmend progress

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:

3.1

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

a) There shall be evaluation process or certificate of healthcare specialist training

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)

3.5

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

b) Measure and periodical report on the progress on reaching the target

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.

Evidence: assessment of the use of human resources, equipment, material and premises.

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.

4.2

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

c) Process of analyzing the original cause

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

e) Provision for occupational risks from sharp items or from treatment process

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.

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:

a) Structure of human resources

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

Guidance shall be provided to assist the medical examination and treatment facility to manage the activities relating to the safety of patients (any measures appropriate to medical examination and treatment facility among the global measures for the safety of patients defined by the WHO)

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

There shall be prompt reactions in case of unexpected effects and when there is problem with the medicine.

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

f) The procedures for security and retention of data shall be specified

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.

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:

· Legal basis

· 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

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

e) Conditions for allocation of insurance budget shall be included.

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

The standards shall be described with clear and understandable words; must not use ambiguous or obscure language

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

Modified standards shall be approved by a standard establishment unit or a competent authority before wide application

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

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

c) Analyze periodically or regularly the the feedback

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.

6.2

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.

6.4

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