Decree No. 96/2011/NĐ-CP on administrative penalties for violations related to medical examination and treatment

DECREE

Regulations on Administrative Offenses in Medical Examination and Treatment

________________

THE GOVERNMENT

Pursuant to the Law on Organization of the Government dated December 25, 2001;

Pursuant to the Law on Medical Examination and Treatment dated November 23, 2009;

On the basis of the Law on Tissue and Organ Donation and Transplantation and Cadaver Donation dated November 29, 2006;

Based on the Ordinance on Handling Administrative Violations dated July 2, 2002, and the Ordinance amending and supplementing certain articles of the Ordinance on Handling Administrative Violations dated April 2, 2008;

Based on Decree No. 128/2008/NĐ-CP dated December 16, 2008 detailing the implementation of certain articles of the Ordinance on Handling Administrative Violations in 2002 and the Ordinance amending and supplementing certain articles of the Ordinance on Handling Administrative Violations in 2008;

Considering the proposal of the Minister of Health,

DECREE:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

1. This Decree stipulates acts of violation, forms, levels of administrative penalties, and the authority to impose administrative penalties for medical examination and treatment.

2. Administrative violations concerning medical examination and treatment specified in this Decree include:

a) Violating regulations on practicing and using practice certificates of medical examination and treatment practitioners;

b) Violating regulations on operating conditions and using permits to operate of medical examination and treatment facilities;

c) Violating technical regulations;

d) Violating regulations on drug usage in medical examination and treatment facilities that provide inpatient treatment;

đ) Violating regulations on operating conditions for massage services;

e) Violating regulations on scientific childbirth methods;

g) Violating regulations on organ and tissue donation, procurement, transplantation, and body donation;

h) Violating regulations on gender reassignment;

i) Other violations of regulations on medical examination and treatment.

3. For other administrative violations concerning medical examination and treatment not specified in this Decree, provisions in other Government Decrees on administrative penalties in related areas of state management shall be applied.

Article 2. Applicability

1. This Decree applies to individuals, agencies, and organizations involved in imposing administrative penalties for medical examination and treatment violations.

2. Individuals who are civil servants, public officials, or employees committing acts prescribed in this Decree while performing their duties shall not be subject to administrative penalties but shall be subject to disciplinary action according to laws on civil servants, public officials, and employees.

Article 3. Forms of Administrative Penalties and Measures to Mitigate Consequences

1. For each act of administrative violation concerning medical examination and treatment prescribed in this Decree, violators must bear one of the following main forms of administrative penalty:

a) Warning;

b) A fine up to a maximum of 40,000,000 VND.

2. Depending on the nature and degree of violation, violators may also be subject to one or more of the following supplementary forms of administrative penalty:

a) Suspension of the right to use operating permits or practice certificates for a limited or unlimited period.

b) Confiscation of objects and means used to commit administrative violations.

3. In addition to the above penalties, depending on the nature and degree of violation, violators may also be subject to one or more measures to mitigate consequences as provided by laws on handling administrative violations and the following measures:

a) Compelling the return of illegal money or property to the public treasury;

b) Compelling the acceptance of patients under mandatory treatment;

c) Compelling a direct apology to the practitioner when causing damage to the practitioner's reputation or dignity;

d) Compelling payment for health care costs for the practitioner when causing harm to the practitioner's health;

đ) Compelling payment for medical examination and treatment costs according to laws on service fees for medical examination and treatment when using such services;

e) Compelling the rectification of situations where conditions for assisted reproductive technology are not met.

Article 4. Application of legal provisions on administrative offenses

1. Principles of punishment; handling of minors committing administrative offenses; mitigating or aggravating circumstances; statute of limitations and time limit for punishment; period considered as not yet punished; calculation of time limits and statutes of limitation; application of forms of administrative offense penalties and measures to remedy consequences; determination of authority to impose administrative offense penalties; issuance of administrative violation records; issuance of administrative penalty decisions; procedures for fines, collection of fines; procedures for confiscation and handling of evidence and means of administrative violations; enforcement of administrative penalty decisions, suspension of enforcement of fine decisions, compulsory execution of administrative penalty decisions, and transfer of administrative penalty decisions for medical examination and treatment to be carried out according to legal provisions on handling administrative violations.

2. The format of administrative violation records and decisions used in the handling of administrative offenses related to medical examination and treatment shall be implemented in accordance with the Appendix issued together with this Decree.

Chapter II

ADMINISTRATIVE VIOLATIONS IN MEDICAL EXAMINATION AND TREATMENT, FORMS OF PENALTIES AND AMOUNTS

Article 5. Violations of regulations on practicing and using practice certificates of medical examination and treatment practitioners

1. Warning or a fine from 300,000 VND to 500,000 VND for one of the following acts:

a) Not reporting to the competent authority when discovering a practitioner's fraudulent behavior towards patients, colleagues, or other violations of laws on medical examination and treatment;

b) Not participating in monitoring the professional competence and professional ethics of other practitioners when requested by the competent authority;

c) Not participating in health protection and education activities in the community when requested;

d) Using alcohol, beer, or tobacco while practicing medical examination and treatment.

2. A fine from 2,000,000 VND to 5,000,000 VND for one of the following acts:

a) Altering or modifying medical records to distort information about medical examination and treatment;

b) Using superstitious practices in practice;

c) Not respecting the rights of patients as stipulated in Articles 7, 8, 9, 10, 11, 12, and 13 of the Medical Examination and Treatment Law;

d) Misusing the profession to commit sexual harassment against patients;

đ) Directly conducting medical examinations and treatments in Vietnamese without being recognized as proficient in Vietnamese or in another language that has not been registered for use;

e) Prescribing treatment or medication in a language other than Vietnamese where that language has not been registered for use or the interpreter has not been recognized as having sufficient qualifications to translate into Vietnamese.

3. A fine of VND 5,000,000 to VND 10,000,000 shall be imposed on one of the following acts:

a) Obstructing patients who are required to undergo compulsory treatment from entering healthcare facilities;

b) Recommending the use of medical services or suggesting transferring patients to other healthcare facilities for personal gain;

c) Violating technical regulations in medical examination and treatment.

4. A fine of from VND 10,000,000 to VND 15,000,000 for any of the following acts:

a) Practicing without a practice certificate or during a suspension period;

b) Practicing beyond the scope specified in the practice certificate, except in emergency situations;

c) Renting or lending a practice certificate for others to practice;

d) Allowing others to rent or borrow a practice certificate;

đ) Not promptly providing first aid or emergency care to patients; refusing to examine or treat patients unless authorized to refuse under Article 32 of the Medical Examination and Treatment Law.

5. A fine of from VND 15,000,000 to VND 20,000,000 for any of the following acts:

a) Giving, receiving, or brokering bribes in medical examination and treatment but not reaching the level of criminal prosecution;

b) Selling medicine to patients in any form, except for traditional medicine practitioners who prescribe based on pulse diagnosis;

c) Violating technical regulations in medical examination and treatment causing harm to patients.

6. Additional form of punishment: revocation of the right to use the practice certificate for six months to twelve months for violations stipulated in point b, c, d Clause 4 and Clause 5 of this Article.

7. Measures to remedy consequences: ordering the return of money or goods to public funds for violations stipulated in point a Clause 5 of this Article.

Article 6. Violations of provisions on conditions for operation and use of the operating permit of medical examination and treatment facilities

1. Warning or fine from VND 500,000 to VND 1,000,000 for one of the following acts:

a) Operating at an address different from that recorded in the operating permit;

b) Operating without a signboard or with a signboard but the information recorded therein does not match the content in the operating permit;

c) Not publicly displaying working hours or posting service prices;

d) Failing to report to the issuing authority in cases where there is a change in the person responsible for technical and professional matters of the medical examination and treatment facility or foreign practitioners as prescribed;

2. A fine of VND 3,000,000 to VND 8,000,000 shall be imposed for any of the following acts:

a) Advertising beyond or inaccurately reflecting the scope of professional activities recorded in the operating permit;

b) Charging for medical examination and treatment services before posting prices or charging more than the posted price;

c) Refusing to admit patients who are entitled to compulsory medical treatment to the medical examination and treatment facility or intentionally organizing compulsory medical treatment for those who are not entitled to such treatment;

3. A fine of VND 10,000,000 to VND 15,000,000 shall be imposed for any of the following acts:

a) Failing to ensure necessary conditions for practitioners to perform medical examinations and treatments within the permitted scope of professional activities;

b) Renting or borrowing an operating permit;

c) Lending or renting out an operating permit;

4. A fine of VND 15,000,000 to VND 20,000,000 shall be imposed for any of the following acts:

a) Providing medical examination and treatment services without an operating permit or during a suspension period;

b) Providing medical examination and treatment services beyond the scope of professional activities recorded in the operating permit, except in emergency situations;

c) Applying new techniques or methods in medical examinations and treatments without permission from the Department of Health or the Ministry of Health;

d) Using drugs that have not been approved for circulation in medical examinations and treatments;

5. Additional forms of punishment:

a) Revocation of the right to use the operating permit for six months to one year for violations stipulated in Clause 3, Points b and c, Clause 4, Article 4 of this Law;

b) Confiscation of drugs violating the provision at Point d, Clause 4, Article 4 of this Law;

Article 7. Violations of provisions on professional and technical matters

1. Warning or a fine of VND 300,000 to VND 700,000 shall be imposed for any of the following acts:

a) Failing to establish or failing to record fully patient files and medical records;

b) Failing to maintain outpatient treatment follow-up registers for patients;

c) Failing to store medical records in accordance with laws on medical record storage;

d) Failing to handle patients without next-of-kin in accordance with laws on handling patients without next-of-kin;

đ) Failing to handle deceased patients in accordance with laws on handling deceased patients;

e) Failing to conduct medical examination and treatment duty shifts in accordance with laws on medical examination and treatment;

g) Failing to convene consultations when the condition of the patient exceeds the professional capacity of the practitioner or the medical examination and treatment facility or when treatment has been provided but the patient's condition does not improve or worsens;

h) Failing to implement infection control measures in medical examination and treatment facilities in accordance with laws on infection control in medical examination and treatment facilities;

2. A fine of VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts:

a) Failing to establish registers and retain narcotic drug prescriptions, psychotropic drug prescriptions, and precursor substances used as drugs in accordance with laws on drug use in medical examination and treatment facilities;

b) Failing to transfer critically ill patients to appropriate medical examination and treatment facilities when their condition exceeds the professional capacity of the current facility;

3. A fine of VND 10,000,000 to VND 15,000,000 shall be imposed for any of the following acts:

a) Performing surgery or interventional procedures without the consent of the patient or the patient's representative, except as provided for in Clause 3, Article 61 of the Medical Examination and Treatment Law;

b) Failing to ensure sufficient quantity and quality of emergency transport equipment, medical devices, instruments, and emergency drug stock.

Article 8. Violations concerning the use of drugs in medical facilities providing inpatient treatment

1. A fine of VND 1,000,000 to VND 2,000,000 shall be imposed for any of the following acts:

a) Issuing a prescription without fully, clearly, and accurately recording information about the drug name, quantity, concentration, dosage, method of use, and time of use on the prescription;

b) Not checking the prescription, drug requisition form, concentration, dosage, method of use, drug name, and quality of the drug, or not cross-checking the prescription with the information about concentration, quantity, and expiration date recorded on the drug requisition form and label when dispensing drugs to patients or persons assigned to dispense drugs;

c) Not verifying the patient's name, drug name, drug form, concentration, dosage, route of administration, method of use, and time of use before allowing the patient to use the drug;

d) Not fully recording the time of dispensing drugs to patients;

đ) Not monitoring and recording clinical changes after drug use in the patient's medical record;

e) Not promptly detecting adverse reactions after drug use and urgently reporting them to the directly treating practitioner;

2. A fine of VND 4,000,000 to VND 8,000,000 shall be imposed for any of the following acts:

a) Issuing a prescription that does not correspond to the disease;

b) Not monitoring the effects and promptly handling adverse reactions caused by drug use in patients under direct treatment and prescribed by oneself;

3. A fine of VND 10,000,000 to VND 20,000,000 shall be imposed for the act of issuing a prescription for expensive brand-name drugs unnecessarily to obtain commissions from drug trading establishments;

Article 9. Violations concerning the conditions for practicing massage services

1. Warning or fine from VND 500,000 to VND 1,000,000 for one of the following acts:

a) Not having a signboard;

b) The signboard not complying with regulations;

c) The massage room not hanging the technical procedure chart for massage or hanging it but not in compliance with regulations;

d) Not wearing appropriate attire and displaying identification in accordance with regulations while practicing;

đ) Practicing without a professional qualification certificate issued by the competent authority;

2. A fine from 2,000,000 VND to 5,000,000 VND for one of the following acts:

a) The massage bed not meeting the standards set forth in the regulations;

b) Not installing an emergency alarm in the massage room;

c) Not ensuring lighting and hygiene as required by regulations;

d) Not ensuring the practice room area as required by regulations;

đ) Not having an emergency medicine cabinet or having one but not adequately stocked with medicines according to the prescribed list or medicines that have expired;

3. A fine of VND 5,000,000 to VND 7,000,000 shall be imposed for any of the following acts:

a) The entrance system of massage rooms and acupressure rooms not complying with the legal regulations on guiding the practice of massage services;

b) Performing massage not in accordance with the technical procedures;

c) Exploiting the profession to engage in prostitution activities;

Article 10. Violations concerning the scientific methods of childbirth

1. A fine of VND 1,000,000 to VND 2,000,000 shall be imposed for disclosing information about the name, age, address, and image of sperm donors, egg donors, and embryo recipients;

2. A fine of VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts:

a) Conducting egg donation, sperm donation, or embryo donation without permission;

b) Not ensuring the conditions for performing assisted reproductive technology as stipulated by the law on scientific methods of childbirth;

3. A fine of VND 30,000,000 to VND 40,000,000 for any of the following acts:

a) Surrogacy;

b) Cloning;

c) Implanting sperm, eggs, or embryos between individuals who are blood relatives within the direct line and between individuals of opposite sexes who are related within three generations;

4. Measures to remedy consequences: Compel the violator at point b clause 2 of this Article to ensure the conditions for performing assisted reproductive technology as stipulated by the law on scientific methods of childbirth.

Article 11. Violations of provisions on donating, removing, and transplanting human tissues and organs, and on donating and using corpses

1. A fine of VND 5,000,000 to VND 10,000,000 shall be imposed for one of the following acts:

a) Advertising or brokering the buying and selling of human tissues and organs;

b) Disclosing information and secrets about donors and recipients unless there is mutual agreement among the parties or otherwise provided by law;

c) Removing non-renewable body parts from living persons without a written opinion from the Advisory Board for Tissue and Organ Removal and Transplantation.

2. A fine of VND 20,000,000 to VND 30,000,000 shall be imposed for any of the following acts:

a) Using, storing, or trading human tissues and organs for commercial purposes;

b) Conducting tissue and organ removal and transplantation activities without recognition by the Minister of Health as a facility meeting the conditions for such activities.

3. A fine of VND 30,000,000 to VND 40,000,000 for any of the following acts:

a) Forcing others to donate tissues or organs or to remove tissues or organs from those who do not consent voluntarily;

b) Removing tissues or organs from living persons under eighteen years old;

c) Transplanting tissues or organs from individuals infected with diseases listed by the Minister of Health.

4. Additional sanctions: permanently revoking the operating license for violations stipulated in Clause 2 and Clause 3 of this Article.

Article 12. Violations of provisions on gender reassignment

1. A fine of VND 1,000,000 to VND 2,000,000 shall be imposed for any of the following acts:

a) Disclosing information about another person's gender reassignment;

b) Discriminating against individuals who have undergone gender reassignment.

2. A fine of VND 10,000,000 to VND 20,000,000 shall be imposed on any of the following acts:

a) Performing gender reassignment on individuals who have completed their gender development;

b) Conducting gender reassignment without permission from the Ministry of Health or the provincial Department of Health as prescribed in Article 8 of Decree No. 88/2008/NĐ-CP dated August 5, 2008 on Gender Reassignment.

3. Measures to remedy consequences: compelling the violator to apologize directly to the person discriminated against for the violation specified in Point b, Clause 1 of this Article.

Article 13. Other violations concerning medical examination and treatment

1. Warning or imposing a fine of between 200,000 VND and 500,000 VND for any of the following acts:

a) Providing false information related to one’s health status or failing to fully cooperate with healthcare practitioners and medical facilities during medical examination and treatment;

b) Refusing to comply with diagnosis conclusions and treatment instructions given by healthcare practitioners, except in cases where refusal is allowed according to Article 12 of the Law on Medical Examination and Treatment;

c) Failing to comply with internal regulations of medical facilities.

2. Imposing a fine of between 500,000 VND and 2,000,000 VND for any of the following acts:

a) Damaging the reputation or dignity of healthcare practitioners while they are providing medical examination and treatment services;

b) Refusing to comply with mobilization decisions made by competent state authorities during natural disasters, catastrophes, or dangerous epidemics.

3. Imposing a fine of between 2,000,000 VND and 5,000,000 VND for any of the following acts:

a) Failing to pay for medical examination and treatment costs when using medical examination and treatment services, except in cases where exemption or reduction is granted according to the law;

b) Failing to establish a specialized committee as required by law to determine whether there are any technical errors in disputes over medical examination and treatment arising from patient complications.

4. A fine of VND 5,000,000 to VND 10,000,000 shall be imposed for any of the following acts:

a) Advertising medical examination and treatment services in violation of legal procedures for advertising in the healthcare sector;

b) Causing harm to the health or life of healthcare practitioners while they are providing medical examination and treatment services.

5. Measures to remedy consequences:

a) Compelling the violator to apologize directly to the healthcare practitioner for the violation specified in Point a, Clause 2 of this Article;

b) Compelling the violator to pay for healthcare expenses for the violation specified in Point b, Clause 4 of this Article;

c) Compelling the violator to pay for medical examination and treatment costs according to the law on service prices for medical examination and treatment for the violation specified in Point a, Clause 3 of this Article.

Chapter III

COMPETENT AUTHORITY TO IMPOSE ADMINISTRATIVE SANCTIONS FOR VIOLATIONS IN MEDICAL EXAMINATION AND TREATMENT

Article 14. Administrative Penalty Authority of the Chairpersons of People's Committees at all levels

1. The Chairperson of the People's Committee of communes, towns, wards has the authority to:

a) To issue warnings;

b) Impose fines up to VND 2,000,000;

c) Apply additional administrative penalties: confiscation of objects and means used for administrative violations with a value up to VND 2,000,000;

d) Apply measures to remedy consequences as stipulated in points a, b, and d, Clause 3, Article 12 of the Ordinance on Handling Administrative Violations;

2. The Chairperson of the People's Committee of districts, towns, cities under provinces has the authority to:

a) To issue warnings;

b) Impose fines up to thirty million dong;

c) Suspend the right to use professional practice certificates, licenses for operation within their jurisdiction;

d) Confiscate objects and means used to commit administrative violations;

đ) Apply measures to remedy consequences as stipulated in points a, b, and d, Clause 3, Article 12 of the Ordinance on Handling Administrative Violations;

3. The Chairperson of the People's Committee of provinces, centrally governed cities has the authority to:

a) To issue warnings;

b) Impose fines up to the maximum amount of VND 40,000,000;

c) Suspend the right to use professional practice certificates, licenses for operation within their jurisdiction;

d) Confiscate objects and means used to commit administrative violations;

đ) Apply measures to remedy consequences as stipulated in points a, b, c, and d, Clause 3, Article 12 of the Ordinance on Handling Administrative Violations and Clause 3, Article 3 of this Decree;

Article 15. Administrative Penalty Authority of Health Inspectors

1. Health inspectors when performing their duties within their functions have the authority to:

a) To issue warnings;

b) Impose a fine up to 500,000 VND;

c) Apply additional administrative penalties: confiscation of objects and means used for administrative violations with a value up to VND 2,000,000;

d) Apply measures to remedy consequences as stipulated in points a, b, and d, Clause 3, Article 12 of the Ordinance on Handling Administrative Violations;

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

a) To issue warnings;

b) Impose fines up to thirty million dong;

c) Apply additional administrative penalties: suspend the right to use professional practice certificates, licenses for operation; confiscate objects and means used for administrative violations;

d) Apply measures to remedy consequences as stipulated in points a, b, and d, Clause 3, Article 12 of the Ordinance on Handling Administrative Violations and Clause 3, Article 3 of this Decree;

3. The Director of the Ministry of Health's Health Inspection Bureau has the authority to:

a) To issue warnings;

b) Impose fines up to the maximum amount of VND 40,000,000;

c) Apply additional administrative penalties: suspend the right to use professional practice certificates, licenses for operation; confiscate objects and means used for administrative violations;

d) Apply measures to remedy consequences as stipulated in points a, b, and d, Clause 3, Article 12 of the Ordinance on Handling Administrative Violations and Clause 3, Article 3 of this Decree;

4. Heads of agencies assigned to perform specialized inspection functions, persons assigned specialized inspection tasks shall have the authority to impose administrative penalties for violations as prescribed by laws on handling administrative violations and relevant laws.

Article 16. Administrative Penalty Authority of Other Agencies

In addition to those specified in Articles 14 and 15 of this Decree, other individuals as prescribed by the Ordinance on Handling Administrative Violations within their assigned functions and tasks who discover administrative violations as stipulated in this Decree within their areas or jurisdictions shall have the authority to impose penalties according to the laws on handling administrative violations.

Chapter IV

IMPLEMENTING PROVISIONS

Article 17. Effective Date

This Decree takes effect from December 15, 2011.

Repeal Articles 25, 26, 27, 28, 29, 30, and 31 of Government Decree No. 45/2005/NĐ-CP dated April 6, 2005, on administrative penalties in the field of health.

Article 18. Responsibility for Guidance and Implementation

1. The Minister of Health shall be responsible for guiding, organizing, and supervising the implementation of this Decree.

2. Ministers, Heads of ministerial-level agencies, Heads of agencies under the Government, Chairpersons of People's Committees at all levels, and related agencies, organizations, and individuals are responsible for implementing this Decree./.