Circular No. 09/2011/TT-BYT guiding conditions and scope of expertise for healthcare facilities treating with antiretroviral drugs

CIRCULAR

Guidelines on conditions and scope of expertise for healthcare facilities treating with antiretroviral drugs

for HIV-infected individuals

Pursuant to Decree No. 188/2007/NĐ-CP dated December 27, 2007 of the Government on the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Article 38 of the Law on Prevention and Control of Infection with Viruses Causing Acquired Immunodeficiency Syndrome (HIV/AIDS) dated June 29, 2006;

Upon consideration of the proposal by the Director of the Department of HIV/AIDS Prevention and Control and the Director of the Department of Medical Examination and Treatment,

PART I
GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular guides on the conditions and scope of expertise for healthcare facilities treating with antiretroviral drugs for HIV-infected individuals.

Article 2. Principles of treatment with antiretroviral drugs

1. Treatment with antiretroviral drugs shall only be carried out at healthcare facilities that meet the conditions stipulated in this Circular.

2. Ensuring compliance with and continuity in treatment with antiretroviral drugs for HIV-infected individuals.

3. Treatment with antiretroviral drugs must be conducted concurrently with HIV/AIDS counseling and opportunistic infection treatment for HIV-infected individuals.

4. Treatment with antiretroviral drugs for HIV-infected individuals must comply with the "Guidelines for Diagnosis and Treatment of HIV/AIDS" issued together with Decision No. 3003/QD-BYT dated August 19, 2009 of the Minister of Health and the Antiretroviral Drug Treatment Process (ARV) issued together with Decision No. 2051/QD-BYT dated June 9, 2006 of the Minister of Health.

Article 3. Operating funds

1. Sources of funding for antiretroviral drug treatment include:

a) Annual state budget funds;

b) Assistance funds;

c) Health insurance fund;

d) Fees for medical examination and treatment services;

đ) Other lawful sources of funding.

2. Cases of antiretroviral drug treatment using the sources of funding specified in point a and point b of Clause 1 of this Article must be provided free of charge.

3. Management and utilization of these sources of funding must comply with legal regulations.

Chapter II
CONDITIONS FOR HEALTHCARE FACILITIES TREATING WITH ANTIRETROVIRAL DRUGS

Article 4. Conditions for healthcare facilities implementing antiretroviral drug treatment according to the first-line regimen

1. Human resources conditions:

a) At least one physician or pharmacist authorized to prescribe medication under legal provisions;

b) At least one nursing staff member with a secondary education level or higher;

c) At least one pharmacy technician with a secondary education level or higher;

d) One administrative staff member;

đ) The personnel specified in points a, b, and c of Clause 1 of this Article must have certification of training in HIV/AIDS diagnosis and treatment.

2. Equipment conditions:

a) One set of examination beds;

b) One set of examination tables and chairs;

c) One resuscitation kit, oxygen tank;

d) One otolaryngology examination set;

đ) One blood pressure monitor for adults;

e) One blood pressure monitor for children;

g) One stethoscope;

h) One clinical thermometer;

i) One scale;

k) One height measuring tape;

l) One ultraviolet sterilization lamp;

m) One medicine cabinet;

n) One patient record storage cabinet;

o) Having equipment and means to ensure requirements for infection control as prescribed in Circular No. 18/2009/TT-BYT dated October 14, 2009 of the Minister of Health.

3. Infrastructure conditions:

a) Minimum area of 18 square meters (excluding waiting areas), divided into two rooms for examination and counseling of patients;² b) A waiting area for examinations and seating for patients and their families;

c) A place to store and distribute antiretroviral drugs meeting the conditions stipulated in the Pharmacy Department Regulation within the Hospital Regulation issued together with Decision No. 1895/1997/BYT-QĐ dated September 19, 1997 of the Minister of Health and Circular No. 09/2010/TT-BYT dated April 28, 2010 of the Minister of Health on "Guidelines for Medication Quality Management";

d) A place to store and retain records and files of HIV-infected individuals.

The areas specified in points a, b, and c of Clause 3 of this Article must ensure ventilation and adequate lighting.

4. Possessing the ability to directly provide or having a contract for technical support with healthcare facilities capable of providing follow-up tests for antiretroviral drug treatment according to the first-line regimen as prescribed in the "Guidelines for Diagnosis and Treatment of HIV/AIDS" issued together with Decision No. 3003/QD-BYT dated August 19, 2009 of the Minister of Health.

4. Possess the ability to directly provide or have a contract for specialized support with healthcare facilities capable of providing follow-up drug treatment tests according to the first-line antiretroviral therapy regimen as prescribed in the Guidelines for Diagnosis and Treatment of HIV/AIDS issued together with Decision No. 3003/QD-BYT dated August 19, 2009, of the Minister of Health.

Article 5. Conditions for medical facilities to implement antiretroviral therapy according to second-line regimen

In addition to meeting the conditions stipulated in Article 4 of this Circular, medical facilities implementing antiretroviral therapy according to the second-line regimen must also meet the following additional conditions:

1. The treating physician must have at least 24 months of experience in treating HIV-infected individuals with antiretroviral therapy according to the first-line regimen.

2. Possess the ability to directly provide or have a professional support contract with medical facilities capable of providing tests related to evaluating failure of antiretroviral therapy according to the first-line regimen as prescribed in the Guidelines for Diagnosis and Treatment of HIV/AIDS issued together with Decision No. 3003/QD-BYT dated August 19, 2009 of the Minister of Health.

3. Possess the ability to diagnose and manage severe side effects of antiretroviral drugs.

Chapter III
SCOPE OF SPECIALIZATION OF MEDICAL FACILITIES

ANTIRETROVIRAL TREATMENT

Article 6. Responsibilities of medical facilities implementing antiretroviral therapy according to the first-line regimen

1. Advise on issues related to prevention of HIV transmission, care, support, and treatment of HIV/AIDS.

2. Examine, diagnose, and assess clinical stage and immune status of HIV-infected individuals.

3. Prevent and treat opportunistic infections in HIV-infected individuals.

4. Treat HIV-infected individuals with antiretroviral therapy according to the first-line regimen.

5. Monitor antiretroviral therapy according to the second-line regimen for cases that have been stably transferred from other medical facilities or with the consent of the medical facility implementing antiretroviral therapy according to the second-line regimen after consultation.

6. Provide post-exposure prophylaxis for HIV.

7. Monitor and care for children born to HIV-infected mothers.

8. Refer patients to other necessary healthcare facilities for examination and treatment.

9. Coordinate with units implementing home and community care in supporting patient adherence to treatment, monitoring drug side effects and complications, ensuring quality and effectiveness in long-term management and follow-up of the disease.

Article 7. Responsibilities of medical facilities implementing antiretroviral therapy according to the second-line regimen

In addition to performing the responsibilities of medical facilities implementing antiretroviral therapy according to the first-line regimen as stipulated in Article 6 of this Circular, medical facilities implementing antiretroviral therapy according to the second-line regimen must also perform the following additional tasks:

1. Diagnose and treat severe opportunistic infections.

2. Diagnose and treat severe and complex side effects of antiretroviral drugs.

3. Evaluate failure of antiretroviral therapy.

4. Treat with antiretroviral drugs for severe, complex cases, and cases requiring transfer to antiretroviral therapy according to the second-line regimen.

5. Refer patients to medical facilities implementing antiretroviral therapy according to the first-line regimen where the patient resides or at the request of the patient after stable treatment.

Article 8. Management of medical records and case files

1. Medical records, files, forms, and notebooks on HIV/AIDS treatment: Implemented according to the Procedures for HIV/AIDS Treatment with Antiretroviral Drugs issued together with Decision No. 2051/QD-BYT dated June 9, 2006 of the Minister of Health.

2. Medical records and files shall be established, managed, and stored in accordance with the Regulations on Storage of Medical Records under the Hospital Regulations issued together with Decision No. 1895/1997/BYT-QD dated September 19, 1997 of the Minister of Health. After three years of treatment, they may be copied, summarized, and new medical records opened. Original medical records after copying must be stored in the medical record storage department of the medical facility implementing antiretroviral therapy.

Article 9. Reporting System

1. Types of reports:

a) Reports on patients using antiretroviral drugs, usage situation, and stock levels of antiretroviral drugs;

b) Reports on the situation of care and treatment of HIV/AIDS.

2. Report Format:

b) Ad hoc reports;

b) Ad hoc reports.

3. Content of the Report:

a) Periodic reports:

- Reports on patients using antiretroviral drugs, usage situation, and stock levels of antiretroviral drugs: Implemented according to the Procedures for HIV Treatment with Antiretroviral Drugs (ARV) issued together with Decision No. 2051/QD-BYT dated June 9, 2006 of the Minister of Health;

- Reports on the situation of care and treatment of HIV/AIDS: Implemented according to the Regulations on Reporting and Reporting Forms for HIV/AIDS Prevention and Control Activities issued together with Decision No. 28/2008/QD-BYT dated August 14, 2008 of the Minister of Health.

b) Ad hoc reports: Implemented according to the requirements of the requesting agency. In urgent situations, reports can be sent via fax, telegram, or email but the original must be sent through official correspondence within 72 hours.

4. Reporting process: Implemented according to the Regulations on Reporting and Reporting Forms for HIV/AIDS Prevention and Control Activities issued together with Decision No. 28/2008/QD-BYT dated August 14, 2008 of the Minister of Health.

Chapter IV
IMPLEMENTATION

Article 10. Responsibilities of the Ministry of Health

1. The AIDS Prevention and Control Department shall take the lead and coordinate with the Department of Medical Examination and Treatment to be responsible for managing, coordinating, guiding, inspecting, and supervising antiretroviral therapy for HIV-infected individuals.

2. The AIDS Prevention and Control Department shall be responsible for managing, coordinating antiretroviral drugs and testing reagents for antiretroviral therapy for HIV-infected individuals purchased from state budget sources or funded by domestic and foreign organizations and individuals.

Article 11. Responsibilities of other Ministries and sectors

The heads of health management agencies of Ministries and sectors shall be responsible for inspecting, supervising, and evaluating the treatment activities with antiretroviral drugs for people living with HIV at healthcare facilities under their jurisdiction.

Article 12. Responsibilities of the Department of Health

1. Directing, managing, coordinating, inspecting, and auditing the treatment activities with antiretroviral drugs for people living with HIV at all healthcare facilities within their administrative area.

2. Investing in infrastructure, equipment, and staffing for state-owned healthcare facilities within their administrative area to meet the conditions stipulated in this Circular for implementing antiretroviral drug treatment.

Article 13. Responsibilities of Provincial Centers for HIV/AIDS Prevention and Control

1. Advising the Director of the Department of Health on directing, managing, and coordinating the treatment activities with antiretroviral drugs for people living with HIV at all healthcare facilities within the provincial administrative area.

2. Monitoring the treatment activities with antiretroviral drugs for people living with HIV at all healthcare facilities within the provincial administrative area.

3. Coordinating with relevant units to organize training sessions on HIV/AIDS diagnosis and treatment for medical staff at healthcare facilities.

Article 14. Responsibilities of the Heads of Healthcare Facilities Implementing Antiretroviral Drug Treatment

1. Developing plans, implementing treatment, and reporting on antiretroviral drug treatment activities for people living with HIV at their facility in accordance with the provisions of this Circular.

2. Managing, using, and reporting on the utilization of funding sources for antiretroviral drug treatment activities for people living with HIV at their facility in accordance with the law.

Chapter V
IMPLEMENTING PROVISIONS

Article 15. Reference Provisions

1. In cases where the referenced documents in this Circular are replaced or amended, they shall be applied according to the replacement or amended documents.

2. In addition to complying with the provisions of this Circular, healthcare facilities providing antiretroviral drug treatment must also comply with the provisions of the Medical Examination and Treatment Law effective from January 1, 2011.

Article 16. Effective Date

This Circular takes effect from March 15, 2011.

Article 17. Transitional Provisions

By no later than July 1, 2012, healthcare facilities currently providing antiretroviral drug treatment for people living with HIV before the effective date of this Circular must meet the human resource, equipment, and infrastructure conditions specified in Article 4 of this Circular.

During implementation, if there are any difficulties, please promptly report them to the Ministry of Health (National Center for HIV/AIDS Prevention and Control) for research and resolution.