Circular No. 04/2014/TT-BYT stipulates the conditions for operation and procedures for establishing blood donation centers of the Red Cross Society, including blood donation centers and blood donation points.

CIRCULAR

Regulations on conditions for operation and procedures for establishing blood donation centers under the Red Crossỏ

Pursuant to the Law on Red Cross Activities dated June 3, 2008;

Pursuant to Decree No. 03/2011/NĐ-CP dated January 7, 2011 of the Government detailing and providing implementation measures for the Law on Red Cross Activities;

This Circular prescribes procedures for receiving, providing health care for domestic violence victims and statistical reports on domestic violence victims at medical facilities.

At the proposal of the Director of the Department of Medical Examination and Treatment;

The Minister of Health issues this Circular stipulating the conditions for operation and procedures for establishing blood donation centers under the Red Cross.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the conditions for operation and procedures for establishing blood donation centers under the Red Cross.

Article 2. Forms of organization and functions of blood donation centers under the Red Cross

1. Forms of organization:

a) Blood donation centers under the Vietnam Red Cross Society established by the Central Committee of the Vietnam Red Cross Society or the Provincial/Municipal Red Cross Society (hereinafter referred to as blood donation centers);

b) Blood donation points under the Provincial/Municipal Red Cross Society established by the Provincial/Municipal Red Cross Society (hereinafter referred to as blood donation points), with fixed locations or mobile locations according to specific campaigns.

2. Functions: propaganda, mobilization, organization of blood donation, reception of voluntary blood donors, handover of received blood to blood transfusion centers for screening tests, safe processing before use for patients.

Chapter II

CONDITIONS FOR OPERATIONS AND PROCEDURES FOR ESTABLISHING BLOOD DONATION CENTERS UNDER THE RED CROSS

Article 3. Conditions for operations of blood donation centers

1. Physical conditions:

a) Total minimum area is 200 square meters², including:

- Communication and counseling room for blood donation must have a minimum area of 20 square meters²;

- Selection and blood reception room must have a minimum area of 50 square meters²;

- Blood storage room must have a minimum area of 15 square meters² designed in accordance with the regulations of the Ministry of Health;

b) Ensuring conditions for waste collection, treatment, and environmental hygiene in accordance with the provisions of the law.

2. Propaganda materials, equipment, and medicines:

a) Must have sufficient propaganda materials on blood donation;

b) Must have sufficient medical equipment and tools suitable for the scope of activities of the center in accordance with the regulations of the Ministry of Health;

c) Must have sufficient emergency medicines in accordance with the regulations of the Ministry of Health.

3. Human resources:

a) The person responsible for technical expertise at the center must meet the following conditions:

- Must be a general practitioner and hold a certificate of training in Hematology and Transfusion Medicine issued by a competent training institution; must have at least 18 months of practical experience in this field at a healthcare facility, a Hematology and Transfusion Medicine Center, or a blood donation center established and operating in accordance with this Circular;

- Must work full-time at the blood donation center.

b) Heads of departments at the center must meet the following conditions:

- Head of the communication and counseling department for blood donation must have at least a diploma in health science, and a certificate of training in Hematology and Transfusion Medicine for a minimum of three months issued by a competent training institution;

- Head of the selection and blood reception department must be a general practitioner, holding a certificate of training in Hematology and Transfusion Medicine for a minimum of six months issued by a competent training institution;

- Head of the blood storage department must be at least a general practitioner, holding a certificate of training in Hematology and Transfusion Medicine for a minimum of six months issued by a competent training institution; - Heads of departments at the center must have at least 12 months of practical experience in Hematology and Transfusion Medicine at a healthcare facility, a Hematology and Transfusion Medicine Center, or a blood donation center established and operating in accordance with this Circular;

- Must work full-time at the blood donation center;

c) Staff receiving blood must have a minimum diploma in health science, and at least six months of practical experience in Hematology and Transfusion Medicine at a healthcare facility, a Hematology and Transfusion Medicine Center, or a blood donation center established and operating in accordance with this Circular.

d) Volunteers and other staff working at the blood donation center must have appropriate qualifications for their assigned tasks.

4. Scope of Technical Activities:

a) Propaganda, mobilization of voluntary blood donation; counseling for blood donors before and after donation in accordance with the regulations of the Ministry of Health;

b) Asking about medical history, clinical examination, rapid testing for blood donor selection; organizing blood donation and reception;

c) Storing received blood in accordance with technical regulations of the Ministry of Health and handing it over to blood transfusion centers for screening tests, safe processing before use for patients;

d) Cooperating with blood transfusion centers in the health sector in conducting blood and blood product tests, storage according to technical procedures, participating in providing blood products when meeting the conditions regarding infrastructure, equipment, human resources, and technical expertise as stipulated by the Ministry of Health.

5. Blood donation centers may only operate after submitting registration files meeting the operational conditions specified in Article 6 of this Circular to the Department of Health of the province/city (hereinafter referred to as the Department of Health) and obtaining a registration activity confirmation certificate issued by the Department of Health in accordance with Form 1 attached to this Circular.

Article 4. Conditions for blood donation point operation

1. Physical conditions:

a) The minimum total area is 30m², including:

- The communication, counseling, and donor selection section must have a minimum area of 10m²;

- The blood reception and storage section must have a minimum area of 20m².

b) There must be blood storage equipment as prescribed by the Ministry of Health;

c) Ensure waste management and environmental hygiene conditions as prescribed by law;

2. Propaganda materials, equipment, and medicines:

a) Must have sufficient propaganda materials on blood donation;

b) Must have medical equipment and supplies suitable for the scope of operations of the blood donation point as prescribed by the Ministry of Health.

c) Must have sufficient emergency medicines in accordance with the regulations of the Ministry of Health.

3. Human resources:

a) The person responsible for technical expertise at the blood donation point must meet the conditions stipulated in Point a Clause 3 Article 3 of this Circular.

b) Blood reception staff must meet the conditions stipulated in Point c Clause 3 Article 3 of this Circular.

c) Volunteers and other staff working at the blood donation point must hold appropriate professional qualifications for their assigned tasks.

4. Scope of professional activities: carried out according to the provisions of Points a, b, and c Clause 4 Article 3 of this Circular.

5. A blood donation point may only operate after submitting the registration application dossier as stipulated in Article 6 of this Circular to the Department of Health and obtaining the registration confirmation certificate issued by the Department of Health according to the model specified in Appendix No. 1 promulgated together with this Circular.

Article 5. Procedures for establishing a Red Cross blood donation facility

The procedures for establishing a Red Cross blood donation facility shall be implemented in accordance with the provisions of Article 4 of Circular No. 03/2013/TT-BNV dated April 16, 2013, of the Ministry of Home Affairs detailing the implementation of Decree No. 45/2010/NĐ-CP dated April 21, 2010, of the Government on organization, operation, and management of associations and Decree No. 33/2012/NĐ-CP dated April 13, 2012, of the Government amending and supplementing certain articles of Decree No. 45/2010/NĐ-CP.

Article 6. Registration of Operation of Red Cross Blood Donation Facility

1. Blood centers that meet the conditions stipulated in Article 3 of this Circular and blood donation points that meet the conditions stipulated in Article 4 of this Circular shall submit one set of registration application dossier to the Department of Health, including:

a) Application for registration of operation according to the form specified in Appendix 2 promulgated together with this Circular;

b) Documentation proving that the blood center or blood donation point has sufficient area as prescribed;

c) Inventory of facilities, equipment, communication materials, and medicines of the facility;

d) List of personnel responsible for technical matters and staff of the facility, accompanied by certified copies of certificates and credentials as stipulated in Articles 3 and 4 of this Circular;

đ) Certified copy of the establishment decision of the facility;

e) Scope of registered professional activities;

g) Operating regulations of the facility.

2. Within ten working days from the date of receipt of the complete dossier as prescribed, the Department of Health must issue a registration confirmation certificate for the Red Cross blood donation facility.

Chapter III

IMPLEMENTING PROVISIONS

Article 7. Implementation Organization

1. The Medical Examination and Treatment Management Department of the Ministry of Health is the focal point coordinating with relevant units within its functional, task, and authority scope, responsible for directing, guiding, inspecting, and auditing the implementation of this Circular nationwide.

2. Provincial Departments of Health under centrally governed cities are responsible for directing, guiding, inspecting, and auditing the implementation of this Circular within their respective localities.

3. The Central Institute of Hematology and Transfusion is responsible for providing technical guidance to blood donation facilities; organizing specialized training for blood donation staff and accepting blood transferred from blood donation facilities for patient treatment.

4. Medical examination and treatment facilities:

a) Cooperate with blood donation facilities in organizing blood donation and receiving blood for patient treatment;

b) Provide technical support to blood donation facilities when necessary;

c) Accept and guide hematological and transfusion practices for blood donation facility staff.

5. Central Vietnam Red Cross Society:

a) Direct and guide levels of the Vietnam Red Cross Society to improve organizational structure, personnel, and upgrade infrastructure and medical equipment of operating blood donation facilities before the effective date of this Circular;

b) Guide blood donation facilities managed by the Central Vietnam Red Cross Society in receiving, storing, and transferring received blood to hematology and transfusion facilities as prescribed by the Ministry of Health;

c) Monitor and supervise the implementation of this Circular by blood donation facilities nationwide.

6. Vietnam Red Cross Society of provinces and centrally governed cities:

a) Guide blood donation facilities managed by the Red Cross Society in receiving, storing, and transferring received blood to hematology and transfusion facilities as prescribed by the Ministry of Health;

b) Monitor and supervise the implementation of this Circular within their jurisdiction.

Article 8. Effective Date

This Circular takes effect from April 1, 2014.

Article 9. Transitional Provisions

Blood donation facilities operating before the effective date of this Circular must invest in upgrading infrastructure, medical equipment, and human resources to meet the conditions stipulated in this Circular and obtain the registration confirmation certificate as required by this Circular no later than one year from the effective date of this Circular.

Article 10. Responsibility for Implementation

The Director of the Medical Examination and Treatment Management Department, the Head of the Ministry's Office, the Inspector General, Heads of Departments, Directors of Centers and General Directors of the Ministry of Health, Directors of Provincial Health Departments, Heads of Health Services, and Heads of related agencies, organizations, and individuals are responsible for implementing this Circular. 

During implementation, if there are any difficulties, agencies, organizations, and individuals should promptly report to the Ministry of Health (Medical Examination and Treatment Management Department) for research and resolution./.