Decision No. 44/2005/QĐ-BYT on the issuance of "Regulations on Handling Complaints in the Health Sector"

DECISION OF THE MINISTER OF HEALTH

Regarding the issuance of "Regulations on Handling Complaints in the Health Sector"

THE MINISTER OF HEALTH

Pursuant to the Law on Complaints and Petitions 1998 and the Law Amending and Supplementing Certain Provisions of the Law on Complaints and Petitions 2004;

Pursuant to Decree No. 53/2005/ND-CP dated April 19, 2005 of the Government detailing and guiding the implementation of the Law on Complaints and Petitions and the Law Amending and Supplementing Certain Provisions of the Law on Complaints and Petitions;

Pursuant to Decree No. 49/2003/NĐ-CP dated May 15, 2003 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Considering the proposal of the Inspector General of the Ministry of Health and the Director of the Legal Department of the Ministry of Health,

DECISION:

Article 1. Issuing together with this Decision "Regulations on Handling Complaints in the Health Sector".

Article 2. The Standard Measurement Quality Control Department shall be responsible for organizing and guiding the implementation of the Regulations adopted herein.

Article 3. The Heads of the Office, Inspectorate, Legal Department, Departments, Bureaus, heads of units under the Ministry of Health, Directors of Provincial Health Services directly under the Central Government shall be responsible for implementing this decision.

REGULATIONS

On handling complaints in the health sector

(Issued together with Decision No. 44/2005/QD-BYT

dated December 20, 2005 of the Minister of Health)

PART I

GENERAL PROVISIONS

Article 1. Scope of Application

These regulations provide for the handling of complaints related to the health sector, applicable to agencies, units, organizations, and individuals involved in complaints and the resolution of complaints within the scope of state management in the health sector.

Article 2. Interpretation of Terms

In these provisions, the following terms are understood as follows:

1. "Complaint" means the act of citizens, agencies, organizations, or civil servants, according to procedures stipulated by the Law on Complaints and Petitions, requesting competent agencies, organizations, or individuals to review administrative decisions, administrative acts, or disciplinary decisions regarding civil servants when there is evidence that such decisions or acts are contrary to the law and infringe upon their legitimate rights and interests.

2. "Complainant" is a citizen, agency, organization, or civil servant exercising the right to complain.

3. "Agency or organization with the right to complain" includes state agencies, political organizations, political-social organizations, social organizations, economic organizations, and people's armed forces units.

4. "Respondent" is an agency, organization, or individual with an administrative decision, administrative act, or disciplinary decision being complained about.

5. "Administrative decision" is a written decision applied once to one or more specific subjects concerning a specific issue in the administrative management activities of state administrative agencies or persons authorized in state administrative agencies.

6. "Administrative act" is the act of state administrative agencies or persons authorized in state administrative agencies when performing tasks and duties as prescribed by law.

7. "Disciplinary decision" is a written decision by the head of an agency or organization to apply one of the following disciplinary measures: warning, reprimand, reduction in salary grade, demotion, removal from office, or dismissal of civil servants under their management according to the law on civil servants.

8. "Handling complaints" is the process of investigating, concluding, and issuing a decision to resolve complaints by the complaint handler.

9. "Complaint handler" is an agency, organization, or individual with the authority to handle complaints.

10. "Final complaint resolution decision" is a decision with binding effect and the complainant has no right to file further complaints.

11. "Legally binding complaint resolution decision" includes: final complaint resolution decision; initial complaint resolution decision which becomes legally binding if the complainant does not file further complaints or initiate administrative litigation at court within the time limit prescribed by law; subsequent complaint resolution decision which becomes legally binding if the complainant does not file further complaints within the time limit prescribed by law.

Chapter II

COMPETENCE TO HANDLE COMPLAINTS

Article 3. General Competence to Handle Complaints

The general competence to handle complaints is stipulated in Section 2, Chapter 2 of the Law on Complaints and Petitions 1998 and the Law Amending and Supplementing Certain Provisions of the Law on Complaints and Petitions 2004.

Article 4. Competence to Resolve Health Sector Complaints

1. Heads of agencies and units under the Department of Health have the authority to resolve complaints against their own administrative decisions and administrative acts, as well as those of directly managed civil servants and officials.

2. The Director of the Department of Health has the authority:

a) To resolve complaints against his own administrative decisions and administrative acts, as well as those of directly managed civil servants and officials;

b) To resolve complaints that have been resolved by heads of departments under the Department and equivalent levels but still have objections.

c) The Inspector General of the Department of Health, heads of functional departments of the Department are responsible for verifying, concluding, and recommending the resolution of complaints within the Director's resolution authority.

d) The Inspectorate of the Department of Health has the duty to assist the Director of the Department of Health in state management regarding the resolution of health sector complaints within its authority.

3. Heads of agencies and units directly under the Ministry of Health have the authority to resolve complaints against their own administrative decisions and administrative acts, as well as those of directly managed civil servants and officials.

4. The Minister of Health has the authority:

a) To resolve complaints against his own administrative decisions and administrative acts, as well as those of directly managed civil servants and officials;

b) To resolve complaints that have been resolved by persons specified in Clause 3, Article 4 of this regulation but still have objections.

c) To resolve complaints with content within the Ministry of Health's state management authority that have been initially resolved by the Chairman of the People's Committee at the provincial level, complaints that have been resolved by the Director of the Department of Health but still have objections.

d) The Minister of Health shall chair or participate in resolving complaints related to multiple localities and multiple areas of state management according to the Prime Minister's directive; review the final decision on complaint resolution that violates the law causing damage to the interests of the State, the legitimate rights and interests of citizens, agencies, and organizations according to the recommendation of the Chief Inspector. The decision on complaint resolution of the Minister of Health stipulated in points b and point c Clause 4 Article 4 is the final decision on complaint resolution.

đ) The Chief Inspector, the Chief of the Office, the Heads of Departments, and the Directors of Bureaus of the Ministry of Health are responsible for verifying, concluding, and recommending the resolution of complaints within the Minister of Health's resolution authority.

e) The Inspectorate of the Ministry of Health has the function of assisting the Minister of Health in state management regarding complaint resolution within the health sector.

Chapter III

PROCEDURES FOR HANDLING COMPLAINTS

Article 5. Receiving Complaint Letters

The Ministry of Health, the Department of Health, and other agencies, organizations, and individuals in the health sector within their functions, tasks, and authorities must be responsible for receiving people who come to complain; promptly receiving and resolving citizens' complaints in accordance with the law.

1. In cases where the complainant comes directly to the Ministry of Health, the Department of Health, or the reception offices of agencies and units in the health sector to present and submit a complaint letter, the heads of these agencies and units or reception officers must comply with the law on receiving citizens.

2. In cases where complaints are made through a letter, the head of the agency or unit or the health inspection agency upon receipt of the letter must record it in the complaint book for tracking before classification and processing.

The complaint book must clearly record the following contents:

a) Date of filing the complaint;

b) The name and address of the agency, organization, or individual being complained about;

c) The content, reason for the complaint, and the complainant's request;

d) The complaint letter must be signed by the complainant.

3. In cases where complaints are made through a representative, the representative must have legal documentation (personal identification papers, power of attorney from the complainant confirmed by the locality or notary).

Article 6. Classification of Complaints

1. The classification of complaints must clarify the following contents:

a) Determining jurisdiction for resolution: complaints within jurisdiction, complaints not within jurisdiction, complaints referred to subordinate units. In the following cases of complaints, they shall not be accepted for resolution:

- Administrative decisions or administrative acts complained about are not directly related to the legitimate rights and interests of the complainant;

- The complainant does not have full capacity to act and has no lawful representative, except where otherwise provided by law;

- An unlawful representative;

- The complaint has already been resolved with a final decision on the complaint;

- The complaint has been accepted by the court for resolution or there is a judgment or decision of the Court.

b) Determining the number of times the complaint was submitted: first-time complaint; subsequent complaint;

c) Determining the time limit for resolution: complaint still within the time limit for resolution; complaint has exceeded the time limit for resolution;

d) Determining the field of complaint:

- Complaints regarding administrative decisions or administrative acts of state administrative agencies;

- Complaints regarding fields under the health sector: medical examination and treatment (including traditional medicine and traditional Chinese medicine), pharmaceuticals, cosmetics directly affecting human health, medical equipment, preventive healthcare, HIV/AIDS prevention and control, food safety and hygiene;

đ) Determining the department or unit responsible for or participating in resolving the complaint according to its content.

Article 7. Handling of Complaints

1. For complaints within jurisdiction and meeting all conditions stipulated by law, the head of the agency or unit receiving the complaint must accept and resolve it; in cases where the complaint bears signatures of multiple people, the head must guide the complainants to write separate complaints to proceed with the complaint.

2. For complaints within jurisdiction but not meeting the conditions for acceptance as stipulated by law, a written response must be issued to inform the complainant of the reasons for non-acceptance.

3. For complaints containing both complaint and accusation content, the agency receiving the complaint is responsible for handling the complaint content according to Chapter IV of this Regulation, while the accusation content is handled according to the laws on handling accusations.

4. For complaints within the jurisdiction of subordinate levels but unresolved beyond the prescribed time limit, the head of the higher-level state agency shall require the subordinate level to resolve it, and simultaneously bear the responsibility to direct, inspect, and urge the subordinate level's resolution process, and apply measures within their authority to handle those who are negligent or intentionally delaying the resolution of the complaint. If measures exceeding their authority are required, they shall propose to the relevant state agency or person with authority for handling.

5. For complaints not within jurisdiction, or complaints that have already received a final decision on resolution, the agency receiving the complaint has no obligation to accept them but must provide guidance and respond to the complainant. The guidance and response shall only be carried out once for each complaint case; if the complainant submits original documents or materials related to the complaint case, these documents and materials must be returned to the complainant.

Article 8. Acceptance and Resolution of Complaints within Jurisdiction

1. Verification

Verification is conducted to determine whether the content of the complaint is correct (partially correct or fully correct), and to identify the responsibilities of the complainant and the respondent in resolving the complaint.

a) Content of verification: verify the content of the complaint and the reasons for the complaint.

b) Methods of verification:

- Reviewing the files provided by the complainant and the respondent.

- The initial complaint resolver must meet and have direct dialogue with the complainant, the respondent, and those with related rights and interests to clarify the content of the complaint, the demands of the complainant, and the resolution of the complaint; meetings and dialogues must be conducted openly and democratically; if necessary, representatives from political and social organizations may be invited to participate.

- The complaint resolver must notify in writing the complainant, the respondent, those with related rights and interests, and representatives from political and social organizations about the time, place, and content of the meeting and dialogue; those notified must attend at the specified time and place as stated in the notification.

- During meetings and dialogues, the complaint resolver must clearly state the topics for discussion and the results of verifying the complaint's content; participants have the right to express their opinions and present relevant evidence concerning the complaint and their demands.

- Meetings and dialogues must be recorded in minutes; the minutes must detail the opinions of the participants, summarize the outcomes of the discussions, and include signatures of the participants; if a participant does not sign, the reason must be noted; these minutes will be included in the complaint case file.

- Request the respondent and the agency being complained against to submit reports in writing.

- Meet with and hear the opinions of related individuals and those who know about the matter (request them to write detailed accounts).

- Conduct on-site verification to collect documents and evidence if the issues under verification remain unclear.

- Request expert appraisal or take other measures as prescribed by law.

2. Conclusion

a) Based on verification, conclusions must be drawn regarding whether the content of the complaint is correct (partially correct or fully correct, partially incorrect or fully incorrect).

b) Legal basis for determining correctness or incorrectness must be based on legal provisions, state policies, professional regulations of the health sector, and internal rules of agencies and units.

3. Recommendations:

Based on the verified results and conclusions, recommendations should be made to the authority responsible for resolving complaints:

a) For cases where the complaint content is correct: recommend revoking administrative decisions, disciplinary decisions, rectifying consequences, and compensating damages (if applicable) according to the law.

b) For cases where the complaint content is incorrect: recommend rejecting the complaint.

4. Issuing a Decision to Resolve Complaints:

The complaint resolver must issue a decision to resolve complaints in writing. The decision to resolve complaints must include the following contents:

a) Date of issuance of the decision;

b) Name and address of the complainant and the respondent;

c) Whether the content of the complaint is correct, partially correct, or entirely incorrect;

d) Legal basis for resolving the complaint;

đ) Conclusion: Maintain, amend, or revoke part or all of the administrative decision, terminate the complained administrative act, or resolve specific issues in the complaint;

e) Compensation for the person suffering losses (if applicable);

g) In the first and subsequent decisions to resolve complaints, it must be clearly stated that if dissatisfied with this decision, the complainant has the right to appeal to a higher authority (Director of the Health Department, Chairman of the Provincial People's Committee, Minister of Health) or initiate an administrative lawsuit at the court.

h) Subsequent decisions to resolve complaints must be sent to the complainant, the previous complaint resolver, those with related rights and interests, and the person who forwarded the complaint within the latest period of 7 days from the date of the decision to resolve the complaint;

Subsequent complaint resolvers, when necessary, shall publicly announce the decision to resolve the complaint to the complainant and the respondent;

i) The final decision to resolve the complaint must also clearly state that this is the final decision to resolve the complaint.

Article 9. Conclusion and Archiving of Files

1. The handling of complaints must be recorded in a file.

The complaint resolution file shall include:

a) The complaint letter or record of the complaint;

b) The response document from the person complained against;

c) Minutes of investigation, verification, conclusions, and inspection results.

d) The complaint resolution decision;

đ) Other related documents.

2. The complaint resolution file must be paginated in the order of documents and stored according to regulations.

3. In cases where the complainant continues to lodge a complaint or files an administrative lawsuit with the Court, such file must be transferred to the competent court authority upon request as prescribed by law.

Chapter IV

COMPLAINT RESOLUTION FOR SOME SPECIALIZED AREAS

IN THE HEALTH SECTOR

Article 10. Resolution of Complaints Regarding Drug Quality

1. Verification

1.1. For the complainant:

- Verify the content of the complaint;

- Request to provide evidence: drug purchase invoices, drug samples; name and address of the drug-selling establishment.

1.2. Verify at relevant units and individuals:

1.2.1. Inspect at retail drug establishments:

- Legal basis;

- Personnel;

- Drug purchase and sale invoices;

- Physical conditions of the retail establishment;

- Implementation of drug quality management regulations;

- Collect drug samples for testing (if necessary).

1.2.2. Inspect at distributors:

- Legal basis;

- Personnel;

- Drug purchase and sale invoices;

- Batch drug test reports;

- Implementation of drug quality management regulations;

- Drug storage warehouses;

- Collect drug samples for testing (if necessary).

1.2.3. Inspect at manufacturers:

- Legal basis;

- Personnel;

- Drug registration files;

- Production batch files;

- Inspect at the manufacturing facility;

- Implementation of drug quality management regulations;

- Quality of retained drug samples;

- Collect drug samples for testing (if necessary).

1.2.4. Inspect at importers:

- Legal basis;

- Personnel;

- Import registration files;

- Foreign contracts;

- Drug test reports;

- Implementation of drug quality management regulations;

- Collect drug samples for testing (if necessary).

1.3. Request drug quality testing (if necessary):

- At local level, the agencies requested for testing are provincial and central city drug and cosmetic testing centers.

- At central level, the agencies requested for testing are the Institute of Testing and the Ho Chi Minh City Branch of the Institute of Testing. Among them, the conclusion of the Institute of Testing is the final conclusion.

- Sampling for testing must be conducted according to the correct procedures and must be carried out by authorized agencies.

1.4. Testing fees shall be implemented according to current regulations.

2. Conclusion

Based on the verification results, drug quality testing results, and relevant legal provisions, conclude:

- The drug meets quality standards;

- The drug does not meet quality standards, if the non-conformity criteria and reference standards are clear.

- The responsibility of related agencies, organizations, and individuals regarding drugs that do not meet quality standards.

3. Recommendations

Based on the verified results and conclusions of the matter, recommend to the competent authority to resolve the complaint:

- If the complaint content is correct (the drug is substandard), recommend handling the violating agencies, organizations, and individuals according to Decree No. 45/CP dated June 4, 2004 of the Government on administrative penalties in the field of health and other relevant legal provisions; recommend handling the evidence according to the regulations. In case of violation indicating criminal offense, the file must be transferred to the investigative agency as prescribed.

- If the complaint content is incorrect (the drug meets quality standards as stipulated), recommend rejecting the complaint.

4. The competent authority issues a decision to resolve the complaint.

Article 11. Handling complaints regarding food safety and hygiene

1. Verify the complaint

1.1. For the complainant:

- Verify the content of the complaint;

- Request to provide evidence: Purchase invoices, contracts of responsibility between the seller and buyer, food samples; name and address of the selling establishment.

1.2. Inspect and verify at relevant units and individuals:

1.2.1. Inspect and verify at distributors:

- Legal basis;

- Purchase and sale invoices for food;

- Copies of acceptance certificates for food safety and hygiene standards of each product;

- Business conditions and food storage conditions;

- Inspect actual batches of similar food products subject to complaint;

- Implementation of labeling regulations for food;

- Implementation of advertising regulations for food;

- Take food samples for testing (if necessary).

1.2.2. Inspect and verify at production facilities:

- Legal basis;

- Announcement of food safety and hygiene standards;

- Requirements for production facility conditions;

- Requirements for managers and direct producers and sellers of food;

- Requirements for ensuring food safety and hygiene;

- Requirements for packaging, labeling, and advertising of food;

- Implementation of regulations on food poisoning and recalled food;

- Take food samples for testing (if necessary).

1.2.3. Inspect importers:

- Legal basis;

- Announcement of food safety and hygiene standards for each product;

- Implementation of state inspection of imported goods' quality for each batch of food that requires state inspection;

- Food storage conditions;

- Food labeling.

1.3. Request laboratory testing of food samples:

- Local food laboratories:

+ Provincial and municipal Preventive Health Centers;

+ District Standardization, Measurement, and Quality Control Agencies under Science and Technology Departments;

+ Drug and Cosmetic Testing Centers (for certain functional food test criteria);

- Central food laboratories:

+ Regional Institutes within the Preventive Health System of the Ministry of Health. Among them, the conclusion of the Institute of Nutrition is the final conclusion;

+ Inspection Institutes and their Branches (for certain functional food test criteria). Among them, the conclusion of the Inspection Institute is the final conclusion;

+ Standardization, Measurement, and Quality Control Centers under the General Bureau of Standardization, Measurement, and Quality Control - Ministry of Science and Technology;

+ Other agencies assigned by Ministries and sectors with the capability to conduct food safety and hygiene testing.

- Sampling must be conducted according to the prescribed procedures and must be carried out by authorized agencies.

1.4. Testing fees shall be implemented according to current regulations.

2. Conclusion

Based on the verification results, food safety and hygiene quality inspection results, and relevant legal provisions, conclude:

- Whether the complaint content is correct or incorrect (partially correct or fully correct, partially incorrect or fully incorrect);

- Whether the food meets the food safety and hygiene quality standards;

- Whether the food does not meet the standards, specifying the non-compliant criteria and reference standards;

- The responsibility of related agencies, organizations, and individuals.

3. Recommendations

Based on the verification results and conclusions, recommend to the competent authority to handle the complaint:

- If the complaint content is correct, recommend handling the violators according to the Government Decree No. 45/CP dated June 4, 2004 on administrative penalties in the health sector and other relevant laws; recommend handling the evidence according to the regulations. In cases where there are signs of criminal offenses, transfer the case file to the investigation agency as required.

- If the complaint content is incorrect, recommend rejecting the complaint.

4. The competent authority issues a decision to resolve the complaint.

Article 12. Handling complaints regarding medical examination and treatment

1. Verify the complaint.

1.1. For the complainant:

a) Verify the complaint content:

- Complaints about lack of responsibility in medical examination and treatment:

+ Regarding compliance with Medical Ethics Regulations;

+ Regarding compliance with Hospital Internal Rules, Departmental Internal Rules;

+ Performance of assigned functions and tasks;

- Complaints about implementation of professional regulations in hospitals:

+ Regarding compliance with Hospital Regulations;

+ Regarding hierarchical classification of public hospitals;

+ Scope of practice for private healthcare establishments;

+ Implementation of professional procedures and techniques.

- Other contents.

b) Request to provide evidence: Discharge papers, prescriptions, other evidence.

1.2. Inspect and verify at relevant units and individuals:

1.2.1. At the treatment facility (the complained facility):

- Review and examine patient records and related documents: Referral letters, transfer papers, admission and discharge logs, ward handover books, consultation minutes, shift change logs...;

- Test results, X-rays, ultrasounds, inspections, cultures...;

- Specimens, slides, photographs... related to the incident;

- Evidence items: needles, syringes, medicine bottles, oxygen tanks, infusions, testing chemicals, specialized equipment related to the incident;

1.2.2. Verify at related organizations and individuals, based on:

- Statements and explanations from individuals and groups involved in the incident;

- Minutes of meetings to review and resolve the incident by departments, wards, hospitals;

- Minutes of Patient Council meetings, feedback letters from patients and their families related to the incident;

- Opinions of leading experts; relevant functional agencies involved in the incident;

- Request expert appraisal: based on the conclusions of Scientific and Technical Committees (Professional Committees) at various levels. Among them, the conclusion of the Scientific and Technical Committee of the Ministry of Health is the final conclusion on the quality of professional procedures and techniques in medical examination and treatment.

2. Conclude.

2.1. Conclusion on the content of the complaint:

2.1.1. The complaint is false (no violation);

2.1.2. The complaint is true (there is a violation):

- Fully correct complaint;

- Partially correct complaint, specify the violated area (administrative violation; signs of criminal offense).

2.2. On the cause of the violation:

2.2.1. Due to violation of medical ethics regulations;

2.2.2. Due to poor professional competence;

2.2.3. Due to unexpected, unforeseeable circumstances or other reasons.

3. Recommend.

3.1. For false complaints (no violation), recommend rejecting the complaint;

3.2. For valid complaints (where there is a violation), depending on the nature and extent of the violation, it is recommended to handle according to the provisions of the law (administrative penalty or transferring the file to the investigation agency (if there are signs of criminal offense) and other administrative measures, as well as measures to rectify the consequences).

4. The competent authority shall issue a decision to resolve the complaint in accordance with the provisions of the law./.