Nghị định 96/2011/ND-CP

DECREE

ON PRESCRIBING THE SANCTIONS AGAINST ADMINISTRATIVE VIOLATIONS OF MEDICAL EXAMINATION AND TREATMENT

THE GOVERNMENT

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

Pursuant to the Law on Medical examination and treatment of November 23, 2009;

Pursuant to the Law on the donation, removal, transplantation of human tissue and organ and the donation and recovery of cadavers of November 29, 2006;

Pursuant to the Ordinance on Handling administrative violations of July 02, 2002; the Ordinance on amending and supplementing a number of articles of the Ordinance on Handling administrative violations of April 02, 2008;

Pursuant to the Government's Decree No. 128/2008/ND-CP of December 16, 2008 detailing the implementation of a number of articles of the Ordinance on Handling administrative violations of July 02, 2002; the Ordinance on amending and supplementing a number of articles of the Ordinance on Handling administrative violations of April 02, 2008

At the proposal of The Minister of Health

DECREE:

Chapter 1.

GENERAL PROVISIONS

Article 1. Scope of regulation

1. This decree prescribes the acts of violations, forms sanctions, fine rates and authority to sanction against administrative violations of medical examination and treatment.

2. Administrative violations of medical examination and treatment prescribed in this Decree include:

a) Violations of provisions on practicing and using the practice certificates of practitioners in medical examination and treatment;

b) Violations of provisions on conditions for the operation and the use of the operation certificates of medical examination and treatment facilities;

c) Violations of provisions on professional and technical operation;

d) Violations of provisions on using medicines in medical examination and treatment facilities providing inpatient treatment;

dd) Violations of provisions on the conditions for massage services;

e) Violations of provisions on childbirth by scientific methods;

g) Violations of provisions on the donation, removal, transplantation of human tissue and organ and the donation and recovery of cadavers;

h) Violations of provisions on sex reassignment;

i) Violations of other provisions on medical examination and treatment.

3. For acts of administrative violations of medical examination and treatment not being prescribed in this Decree, the provisions in other Decrees on sanctions against administrative violations of relevant State management domains shall apply.

Article 2. Subjects of application

1. This Decree is applicable to individuals, agencies and organizations relating to sanctions against administrative violations of medical examination and treatment.

2. Individuals being officers and officials on duty committing the acts prescribed in this Decree shall not be administratively sanctioned but shall be handled and disciplined as prescribed by law provisions on officers and officials.

Article 3. Forms of sanctions against administrative violations and remedial measures

1. For each of the acts of administrative violations of medical examination and treatment prescribed in this Decree, violating organizations and individuals shall be imposed one of the following forms of sanctions:

a) Warning;

b) Fines of up to 40,000,000 VND.

2. Depending on the nature and the extent of violations, administrative violating organizations and individuals may also be liable to one of the following additional forms of sanctions:

a) Indefinitely or temporarily withdrawing the operation certificate and practice certificate;

b) Confiscating the exhibits and means of administrative violations.

3. Apart from the above forms of sanctions, depending on the nature and the extent of violations, administrative violating organizations and individuals might be compelled to take one of the remedial measures as prescribed by law provisions on handling administrative violations and one or a number of remedial measures as follows:

a) Refunding or returning the illegal money or exhibits for expropriation;

b) Admitting patients eligible for compulsory medical treatment;

c) Offering apologies to the practitioner upon damaging their honor and dignity;

d) Defraying the cost of health care for the practitioner upon damaging their health;

dd) Defraying the cost of medical examination and treatment as prescribed by law provisions on prices for medical examination and treatment services upon using such services;

e) Resolving the unreliability of the conditions for implementing reproduction assistance techniques

Article 4. Applying law provisions on sanctions against administrative violations

1. Principle of sanctions; the handling minors committing administrative violations; the mitigating or aggravating circumstances; the prescription and time limits for sanctions; the time limits considered not sanctioned; the methods of time limit and prescription calculation; the application of forms of sanctions against administrative violations and remedial measures; the determination of administrative sanction authority; the making of written records on administrative violations; the issue of decisions on sanctions against administrative violations; the procedures for fines, fine collection; the procedures for confiscating and handling exhibits and means of administrative violations; the implementation of the decisions on sanctions against administrative violations, deferred implementation of Decisions on fines, on the enforcing the implementation of Decisions on sanctions against administrative violations and the transfer of Decisions on sanctions against administrative violations of medical examination and treatment are implemented as prescribed by law provisions on handling administrative violations..

2. The forms of Records and Decision used in sanctions against administrative violations of medical examination and treatment are provided for in the Annex promulgated together with this Decree.

Chapter 2.

ACTS OF ADMINISTRATIVE VIOLATIONS OF MEDICAL EXAMINATION AND TREATMENT, FORMS OF SANCTIONS AND FINE RATES

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

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

a) Failing to report to competent persons upon detecting the practitioners committing fraud acts against patients, colleagues or committing other violations of the law on medical examination and treatment;

b) Failing to participate in supervising the professional capacity and occupational ethics of other practitioners when requested by competent persons;

c) Failing to participate in local activities of public health protection and education when requested;

d) Using alcohol or smoking while practicing medical examination and treatment.

2. Fines of from 2,000,000 VND to 5,000,000 VND for one of the following acts of violations:

a) Erasing and modifying medical records in order to falsify the information of medical examination and treatment;

b) Using superstitious forms of medical examination and treatment;

c) Disregard the patients’ rights prescribed in Articles 7, 8, 9, 10, 11, 12 and 13 of the Law on medical examination and treatment;

d) Misusing the position for sexual harassment;

dd) Using Vietnamese language not being qualified as fluent Vietnamese or using other languages rather than Vietnamese that have not been registered;

e) Prescribing treatments and medicines in other languages rather than Vietnamese that have not been registered, or the translator is not qualified to translate into Vietnamese.

3. Fines of from 5,000,000 VND to 10,000,000 VND for one of the following acts of violations:

a) Preventing patients eligible for compulsory treatment from entering medical examination and treatment facilities;

b) Prescribing medical examination and treatment services or suggesting patients to go to another medical examination and treatment facilities for personal interests

c) Violating the provisions of professional and technical operation in medical examination and treatment.

4. Fines of from 10,000,000 VND to 15,000,000 VND for one of the following acts of violations:

a) Praticing without practice certificate or while being suspended from practice;

b) Practicing beyond the profession scope specified in the practice certificate, except for cases of emergency

c) Renting, borrowing practice certificates to practice;

d) Leasing, lending the practice certificate;

dd) Failing to provide prompt first-aids or emergency aids; refusing to provide medical examination and treatment except for the case of being entitled to refuse medical examination and treatment as prescribed in Article 32 of the Law on Medical examination and treatment.

5. Fines of from 15,000,000 VND to 20,000,000 VND for one of the following acts of violations:

a) Paying, taking bribes, brokering bribery in medical examination and treatment but not being liable to criminal prosecution;

b) Selling medicines, except for practitioners of medical examination and treatment using traditional medicines;

c) Violating the provisions on professional and technical operation in medical examination and treatment that cause medical accidents to patients.

6. Additional forms of sanctions: withdrawing the practice certificate from 6 to 12 months regarding acts of violations prescribed in point b, c, d clause 4 and clause 5 this Article.

7. Remedial measures: returning the money or exhibits for expropriation regarding acts of violations prescribed in point a clause 5 this Article.

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

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

a) Operating inconsistently with the address in the operation certificate;

b) Operating without signboard or the signboard does not show the correct information compared to that in the operation certificate;

c) Failing to publicize the working hours or posting the service prices;

d) Failing to notify the certificate issue agencies when replacing the person in charge of professional and technical operation of medical examination and treatment facilities or the practitioners being foreigners as prescribed.

2. Fines of from 3,000,000 VND to 8,000,000 VND for one of the following acts of violations:

a) Advertising false prices or beyond the profession scope specified in the operation certificate;

b) Collecting medical examination and treatment charges not being posted or collecting higher charges than the posted prices;

c) Failing to admit patients eligible for compulsory treatment, or deliberately organize compulsory treatments for individuals not eligible for compulsory treatment.

3. Fines of from 10,000,000 VND to 15,000,000 VND for one of the following acts of violations:

a) Failing to ensure necessary conditions for medical examination and treatment within the allowed profession scope;

b) Renting, borrowing operation certificates;

c) Leasing, lending operation certificates.

4. Fines of from 15,000,000 VND to 20,000,000 VND for one of the following acts of violations:

a) Providing medical examination and treatment services without operation certificate or while being suspended from operation;

c) Providing medical examination and treatment services beyond the profession scope specified in the operation certificate, except for cases of emergency;

c) Applying new techniques and methods for medical examination and treatment not being approved by the Service of Health or The Ministry of Health;

c) Using medicines not being allowed to circulate in medical examination and treatment.

5. Additional forms of sanctions:

a) Withdrawing the operation certificate from 6 to 12 months regarding acts of violations prescribed in clause 3, point b, c clause 4 this Article;

c) Withdrawing violating the medicines prescribed in point d clause 4 this Article.

Article 7. Violations of provisions on professional and technical operation

1. Warning or fines of from 300,000 VND to 700,000 VND for one of the following acts of violations:

a) Failing to make or to complete the medical records of patients;

b) Failing to make medical logbook for monitoring outpatients;

c) Failing to retain medical records as prescribed by law provisions on archiving medical records;

d) Failing to settle abandoned patients as prescribed by law provisions on settling abandoned patients;

dd) Failing to settle dead patients as prescribed by law provisions on settling dead patients;

e) Failing to provide medical examination and treatment in accordance with law provisions on medical examination and treatment;

g) Failing to hold consultations when the disease beyond the professional capacity of the practitioners or the medical examination and treatment facilities shows no progress or starts to regress;

h) Failing to take measures for bacterial contamination control in medical examination and treatment facilities as prescribed by law provisions on bacterial contamination control in medical examination and treatment facilities.

2. Fines of from 5,000,000 VND to 10,000,000 VND for one of the following acts of violations:

a) Failing to make books and records to monitor and retain addictive, psychotropic medicines and pre-substances for making medicines as prescribed by law provisions on the use of medicines in medical examination and treatment facilities;

b) Failing to transfer the patients to appropriate medical examination and treatment facilities when their conditions exceed the professional capacity of the facilities.

3. Fines of from 10,000,000 VND to 15,000,000 VND for one of the following acts of violations:

a) Performing surgeries and surgical interventions without the approval of the patients or the patients’ representatives except for the case prescribed in clause 3 Article 61 of the Law on Medical examination and treatment;

b) Failing to ensure the adequate quantity and quality of means of emergency aids, medical equipment, instrument and the emergency aid medicine quantity.

Article 8. Violations of provisions on the use of medicines in medical examination and treatment facilities providing inpatient treatment

1. Fines of from 1,000,000 VND to 2,000,000 VND for one of the following acts of violations:

a) Giving prescriptions with unclear or incorrect medicine names, quantity, contents, dosage, usage and duration;

b) Failing to check the prescriptions, medicine receipts, names, content, dosage, usage and quality of medicines or not comparing the prescriptions with information of the concentration, content, receiving quantity and expiry date on the medicine receipts, medicine labels when dispensing medicines to patients and individuals in charge of medicine dispensing;

c) Failing to check the patient’s full name, medicine names, form, content, dosage, usage and duration before treating patients;

d) Failing to fully record the time of dispensing medicine to patients;

dd) Failing to monitor and record the patients’ post-medication clinical status to the medical records;

e) Failing to promptly detect the post-medication accidents and notifying the direct practitioners.

2. Fines of from 4,000,000 VND to 8,000,000 VND for one of the following acts of violations:

a) Giving prescriptions incorrectly;

b) Failing to monitor the effects and promptly handle the medication accidents of the patients under the direct treatment and prescription.

3. Fines of 10,000,000 VND to 20,000,000 VND for giving prescriptions for expensive and unnecessary proprietary medicines in order to collect commissions from medicine business establishments.

Article 9. Violations of provisions on the conditions for massage services

1. Fines of from 500,000 VND to 1,000,000 VND for one of the following acts of violations:

a) Failing to have signboards;

b) Having improper signboard contents;

c) Failing to put up or improperly putting up posters of technical process of massage in massage rooms;

d) Failing to wear proper clothing and badges when practicing;

dd) Practicing without professional certificates issued by competent agencies.

2. Fines of from 2,000,000 VND to 5,000,000 VND for one of the following acts of violations:

a) The massage beds fail to satisfy the prescribed norms;

b) Failing to set up alarm bells in massage rooms;

c) Failing to satisfy the prescribed conditions for lighting and hygiene;

d) Failing to satisfy the prescribed conditions for the practicing room area;

dd) Failing to have first-aid cabinets, or failing to have sufficient medicines under the prescribed List, or having expired medicines.

3. Fines of from 5,000,000 VND to 7,000,000 VND for one of the following acts of violations:

a) The doors of massage rooms, acupuncture rooms are inconsistent to the law provisions on massage services;

b) Giving massages inconsistently with the technical process;

c) Misusing the vocation for prostitutions.

Article 10. Violations of provisions on childbirth by scientific methods

1. Fines of 1,000,000 VND to 2,000,000 VND for revealing the information of names, ages, address and images of the sperm, embryo donors and receivers.

2. Fines of 5,000,000 VND to 10,000,000 VND for one of the following acts of violations:

a) Illegally donating, receiving sperms, ova and embryos;

b) Failing to satisfy the prescribed conditions for childbirth assistance techniques as prescribed by law provisions on childbirth by scientific methods.

3. Fines of 30,000,000 VND to 40,000,000 VND for one of the following acts of violations:

a) Surrogacy;

b) Human cloning;

c) Implanting sperms, ova and embryos among consanguineous persons or between persons of opposite sexes being three-generation relatives.

4. Remedial measures: resolving the unreliability of the conditions for childbirth assistance techniques as prescribed by law provisions on childbirth by scientific methods regarding acts of violations prescribed in point b clause 2 this Article.

Article 11. Violations of provisions on the donation, removal, transplantation of human tissue and organ and the donation and recovery of cadavers

1. Fines of from 5,000,000 VND to 10,000,000 VND for one of the following acts of violations:

a) Advertising, brokering human organ sale;

b) Revealing the information and secrets of the donors and the receivers except for the case of agreement between the parties, or otherwise prescribed by law.

c) Removing non-regenerable from living donors before obtaining the written approval from The Counseling Council on Human organ removal and transplantation.

2. Fines of from 20,000,000 VND to 30,000,000 VND for one of the following acts of violations:

a) Removing, transplanting, using, storing human tissue and organs for commercial purposes;

b) Removing, transplanting, using, storing human organs before being accredited by The Minister of Health as qualified for human organs and tissue removal and transplantation

3. Fines of from 30,000,000 VND to 40,000,000 VND for one of the following acts of violations:

a) Compelling others to donate their tissue or organs, or removing tissue, organs from involuntary donors.

b) Removing tissue and organs from persons under eighteen;

c) Transplanting tissue and organs from persons suffering from the diseases in the list prescribed by The Minister of Health.

4. Additional forms of sanctions: indefinitely withdrawing the operation certificate regarding acts of violations prescribed in clause 2 and clause 3 this Article.

Article 12. Violations of provisions on sex reassignment

1. Fines of from 1,000,000 VND to 2,000,000 VND for one of the following acts of violations:

a) Revealing the information of other’s sex reassignment

b) Discriminating against sex-reassigned persons.

2. Fines of from 10,000,000 VND to 20,000,000 VND for one of the following acts of violations:

a) Performing sex-reassignment for persons with unexceptionable genders;

b) Performing sex-reassignment for persons before obtaining the approval from The Ministry of Health or Services of Health of central-affiliated cities and provinces as prescribed in Article 8 of the Decree No. 88/2008/ND-CP of August 05, 2008 on sex reassignment

3. Remedial measures: offering apologies to the discriminated persons regarding acts of violations prescribed in point b, clause 1 this Article.

Article 13. Violations of other provisions on medical examination and treatment

1. Warning or fines of from 200,000 VND to 500,000 VND for one of the following acts of violations:

a) Providing untruthful information of the personal health or failing to fully cooperate with the practitioners and the medical examination and treatment facilities in medical examination and treatment;

b) Failing to follow the diagnoses and treatment indication from the practitioners, except for the case of being entitled to refuses prescribed in Article 12 of the Law on Medical examination and treatment;

c) Failing to comply with the regulations of the medical examination and treatment facilities.

2. Fines of from 500,000 VND to 2,000,000 VND for one of the following acts of violations:

a) Damaging honor and dignity of the practitioners during the medical examination and treatment;

b) Failing to observe the decisions on mobilizing from competent State agencies upon occurrence of natural disaster, catastrophes and dangerous epidemics.

3. Fines of from 2,000,000 VND to 5,000,000 VND for one of the following acts of violations:

a) Failing to pay the cost of medical examination and treatment when using medical examination and treatment services except from cases of exemption and reduction as prescribed by law;

b) Failing to establish professional councils as prescribed by law to determine whether or not have the professional and technical mistakes occurred when being requested to settle dispute over medical examination and treatment upon occurrence of medical accidents,

4. Fines of from 5,000,000 VND to 10,000,000 VND for one of the following acts of violations:

a) Advertising the medical examination and treatment services inconsistently with the procedures prescribed by law provisions on advertising in medicine;

b) Damaging health and life of the practitioners during medical examinations and treatments.

5. Remedial measures:

a) Offering apologies to the practitioners regarding acts of violations prescribed in point a clause 2 this Article;

b) Paying the heath care cost regarding acts of violations prescribed in point b clause 4 this Article;

c) Paying the cost of medical examination and treatment as prescribed by law provisions on medical examination and treatment service prices regarding acts of violations prescribed in point a clause 3 this Article.

Chapter 3.

AUTHORITY TO SANCTIONS AGAINST ADMINISTRATIVE VIOLATIONS OF MEDICAL EXAMINATION AND TREATMENT

Article 14. Authority to sanctions against administrative violations of Presidents of the People’s Committees at all levels

1. Presidents of the People’s Committees of communes, wards and towns are entitled to:

a) Issue warnings;

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

c) Impose additional forms of sanctions: confiscating exhibits and means of administrative violations with the level up to 2,000,000 VND;

d) Impose remedial measures prescribed in point a, b and d clause 3 Article 12 of the Ordinance on Handling administrative violations.

2. Presidents of the People’s Committees of districts, provincial cities are entitled to:

a) Issue warnings;

b) Impose fines of up to 30,000,000 VND;

c) Withdraw practice certificates, operation certificates within the authority;

d) Confiscate exhibits and means of administrative violations;

dd) Impose remedial measures prescribed in point a, b and d clause 3 Article 12 of the Ordinance on Handling administrative violations.

3. President of the People’s Committee of central-affiliated cities and provinces are entitled to:

a) Issue warnings;

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

c) Withdraw practice certificates, operation certificates within the authority;

d) Confiscate exhibits and means of administrative violations;

dd) Impose remedial measures prescribed in point 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. Authority to sanction of Health inspectors

1. Health inspector on duty are entitled to:

a) Issue warnings;

b) Impose fines of up to 500,000 VND;

c) Impose additional forms of sanctions: confiscating exhibits and means of administrative violations with the level up to 2,000,000 VND;

d) Impose remedial measures prescribed in point a, b and d clause 3 Article 12 of the Ordinance on Handling administrative violations.

a) Issue warnings;

b) Impose fines of up to 30,000,000 VND;

c) Impose additional forms of sanctions: withdrawing practice certificates, operation certificates, confiscating exhibits and means of administrative violations;

d) Impose remedial measures prescribed in point a, b, and d clause 3 Article 12 of the Ordinance on Handling administrative violations and clause 3 Article 3 of this Decree.

3. Chief inspectors of The Ministry of Health are entitled to:

a) Issue warnings;

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

c) Impose additional forms of sanctions: withdrawing practice certificates, operation certificates, confiscating exhibits and means of administrative violations;

d) Impose remedial measures prescribed in point 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 conduct line inspections, individuals assigned to conduct line inspections are authorized to sanction against administrative violations as prescribed by law provisions on handling administrative violations and relevant law.

Article 16. Authority to sanction of other agencies

Apart from individuals prescribed in Article 14 and Article 15 of this Decree, other individuals under the provisions of Ordinance on Handling administrative violations, within their assigned functions and tasks, upon detecting the acts of administrative violations prescribed in this Decree within the domains or area under their management are entitled to sanctions as prescribed by law provisions on handling administrative violations.

Chapter 4.

IMPLEMENTATION PROVISIONS

Article 17. Effect

This Decree takes effect from December 15, 2011.

Abolishing the Article 25, 26, 27, 28, 29, 30 and 31 of the Government's Decree No. 45/2005/ND-CP of April 06, 2005 prescribing the sanctions against administrative violations in the health sector.

Article 18. Responsibilities and implementation guidance

1. The Minister of Health is responsible to guide, organize and inspect the implementation of this Decree.

2. Ministers, Heads of ministerial-level agencies, Heads of governmental agencies, Presidents of the People’s Committees at all levels and relevant agencies, organizations and individuals are responsible to implement this Decree./.