DECREE NO. 56/2008/ND-CP ON THE ORGANIZATION AND OPERATIONS OF TISSUE BANKS AND THE NATIONAL ORGAN TRANSPLANT COORDINATION CENTER

 

DECREE

Provisions on the organization and operation of tissue banks and the National Organ Procurement and Transplantation Center

_____________________

THE GOVERNMENT

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

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

Considering the proposal of the Minister of Health,

DECREE:

PART I

TISSUE BANKS

Section I

ESTABLISHMENT OF STEM CELL BANKS

Article 1. Legal status, functions, and tasks of tissue banks

The legal status, functions, and tasks of tissue banks are prescribed in Clauses 1, 2, and 5 of Article 35 of the Law on Tissue and Organ Donation and Transplantation and Cadaver Donation.

Article 2. Types of tissue banks

1. Stem cell banks under the Ministry of Health.

2. Stem cell banks under hospitals, institutes, medical universities, and pharmaceutical universities under the Ministry of Health or under other ministries and ministerial-level agencies.

3. Stem cell banks under provincial health departments.

4. Stem cell banks under hospitals under provincial health departments.

5. Private stem cell banks; stem cell banks under private hospitals, private medical universities, and private pharmaceutical universities.

Article 3. Competence to establish and permit establishment of stem cell banks

1. Competence to establish stem cell banks

a) The Minister of Health issues decisions to establish stem cell banks under the Ministry of Health, stem cell banks under hospitals, institutes, medical universities, and pharmaceutical universities under the Ministry of Health or under other ministries and ministerial-level agencies;

b) The Chairman of the People's Committee of provinces and centrally governed cities issues decisions to establish stem cell banks under provincial health departments, stem cell banks under hospitals under provincial health departments.

2. Competence to permit establishment of stem cell banks

The Chairman of the People's Committee of provinces and centrally governed cities issues decisions to permit establishment of private stem cell banks; stem cell banks under private hospitals, private medical universities, and private pharmaceutical universities within their jurisdiction.

Article 4. Documents and procedures for establishing and permitting establishment of stem cell banks

1. Documents for establishing and permitting establishment of stem cell banks: a) The proposal for establishing a stem cell bank includes the following main contents:

- The necessity and legal basis for establishing a stem cell bank;

- Objectives, functions, and tasks of the stem cell bank;

- The type of stem cell bank to be established;

- Organizational structure of the stem cell bank;

- Necessary factors to ensure the operation of the stem cell bank, including personnel, staffing, operating funds, office premises, specialized equipment, and other necessary means of the stem cell bank;

- Operation roadmap of the stem cell bank;

- Recommendations from agencies, units, organizations, and individuals who have developed the proposal for establishing the stem cell bank.

b) The document requesting the establishment of a stem cell bank includes the following main contents:

- The necessity and legal basis for establishing a stem cell bank;

- Main contents of the proposal for establishing a stem cell bank;

- Issues with differing opinions and issues requiring the opinion of the competent authority deciding on the establishment of the stem cell bank.

2. Procedures for establishing and permitting establishment of stem cell banks

a) For stem cell banks under the Ministry of Health or stem cell banks under hospitals, institutes, medical universities, and pharmaceutical universities under the Ministry of Health or under other ministries and ministerial-level agencies:

The application documents for establishing a stem cell bank are submitted to the Ministry of Health.

Within thirty working days from the date of receipt of complete and valid documents, the Ministry of Health issues a decision to establish the stem cell bank; if it does not issue a decision to establish, it must provide a written response stating the reasons.

b) For stem cell banks under provincial health departments, stem cell banks under hospitals under provincial health departments; private stem cell banks, stem cell banks under private hospitals, private medical universities, and private pharmaceutical universities:

Application documents for establishment or permission to establish are sent to the local provincial health department where the stem cell bank is located.

Within twenty working days from the date of receipt of complete and valid documents, the provincial health department submits the documents to the People's Committee of the province or centrally governed city. Within ten working days from the date of receipt of complete and valid documents, the People's Committee of the province or centrally governed city issues a decision to establish stem cell banks under provincial health departments, stem cell banks under hospitals under provincial health departments, or provides a written permit to establish private stem cell banks, stem cell banks under private hospitals, private medical universities, and private pharmaceutical universities; if it does not issue a decision to establish or does not grant permission to establish, it must provide a written response stating the reasons.

ACTIVITIES OF STEM CELL BANKS

Section 2

ACTIVITIES OF THE MONETARY BANK

Article 5. Sources of tissue

The tissue bank shall accept tissues from the following sources:

1. From healthcare facilities with the function of collecting tissues and human body parts transferred to it.

2. From other tissue banks.

3. Through international cooperation or aid.

Article 6. Location, subjects for tissue donation and other necessary conditions:

1. Collection of tissues from deceased donors:

a) The collection of tissues shall be carried out in the operating room, mortuary, or place where the donor's body is located;

b) Prior to the collection of tissues, equipment and tools used for the collection must be sterilized according to the specialized hygiene procedures of the healthcare facility; collected tissues must ensure sterility.

2. Collection of tissues from living donors:

a) The collection of tissues from living donors must be carried out in the operating room of healthcare facilities that have the appropriate conditions and functions for tissue and human organ transplantation;

b) Before collecting tissues, counseling and testing of the donor’s biological parameters must be conducted in accordance with Clause 4, Article 14 of the Law on Organ, Tissue, and Human Body Part Donation, Collection, and Transplantation, and Cadaver Donation;

c) Equipment and tools used for the collection of tissues must be sterilized; collected tissues must ensure sterility.

Article 7. Packaging, storage, and transportation of tissues after collection to the tissue bank

1. Tissue must be packaged immediately after collection; stored in a sterile container, preserved with chemicals or solutions; kept at an appropriate temperature and not allowed to be opened until it is handed over to the tissue bank.

2. The tissue container must be labeled with the type of tissue; donor's code name; name and address of the tissue collection facility and the tissue bank.

Article 8. Acceptance of tissues

1. The tissue bank may accept tissues from healthcare facilities after checking the following contents:

a) The medical records transferred by the healthcare facility that collected the tissue shall include information on the donor's name; date, time, and location of tissue collection; name of the person directly collecting the tissue; type of tissue and related medical information about the donor and collected tissue;

b) The integrity of the tissue container, comparing the information on the container label with the documentation specified in point a of this clause.

2. Tissues from other tissue banks or through international cooperation activities or obtained from international aid sources can only be accepted after checking the contents stipulated in Clause 1 of this Article.

Article 9. Quality assessment and processing of tissues

1. Tissues must be quality assessed before processing in accordance with the regulations of the Minister of Health.

2. Methods of tissue processing include:

a) Soaking in disinfectant solutions or preservative solutions containing antibiotics;

b) Cold storage;

c) Freezing;

d) Complete dehydration;

đ) Irradiation;

e) Sterilization with Ethylene Oxide;

g) Freeze-drying;

h) Other processing methods.

3. The Minister of Health shall establish and promulgate procedures for tissue processing suitable for each method prescribed in Clause 2 of this Article.

Article 10. Packaging and labeling of processed tissues

1. Processed tissues must be individually packaged and placed in tissue storage containers.

2. Each tissue product, container, or box must be labeled with the following information:

a) Type of tissue;

b) Name and address of the tissue bank;

c) Tissue identification number;

d) Expiry date.

3. Each container or box must have attached documentation, including the following contents:

a) Quantity, weight, or size or other parameters specified in Clause 2 of this Article if necessary;

b) Processing method;

c) Batch number, if applicable;

d) Potential residual substances of chemicals or solutions added during processing and preservation;

đ) Recommended storage conditions;

e) Indications and contraindications for tissue use if necessary;

g) Other related contents.

Article 11. Coding information about tissues

1. All information regarding the origin of tissues must be coded on an anonymous basis; names, ages, and addresses of donors shall not be recorded; each time tissue is taken from a donor, a specific code will be assigned.

2. The Minister of Health shall stipulate the code number for the coding of information for each tissue bank.

Article 12. Storage of tissues

1. The storage of tissues must ensure temperature conditions, in a separate area, completely isolated from unprocessed tissues, and in a clean environment free from microbial contamination.

2. Tissue banks must strictly follow the procedures for storing tissues.

3. The Minister of Health shall specify in detail the conditions and procedures for storing tissues as stipulated in Clause 1 and Clause 2 of this Article.

Article 13. Distribution of tissues

1. Tissues before distribution must ensure traceability of origin between the donor, recipient, and tissue bank.

2. Tissue banks must have specialized means of transportation to ensure technical requirements for tissue quality throughout the transportation process until the tissues are received.

Article 14. Recordkeeping and Reporting System

1. Tissue banks must establish and retain all records related to tissues from the reception, processing, packaging, storage stages to the transportation and distribution stages.

2. Every six months, tissue banks must report to the Ministry of Health on the operational status of the tissue bank.

In case of unexpected incidents or severe adverse reactions occurring during the process of tissue collection, acceptance, storage, supply, and transplantation reported by healthcare facilities with transplantation functions, the tissue bank must immediately report to the competent state authority on health matters.

Article 15. Responsibility for Issuing National Technical Standards on Professional Activities of Tissue Banks

The Minister of Health shall issue national technical standards regarding the specialized activities of tissue banks as prescribed in Articles 9, 10, 11, and Article 12 of this Decree.

Tissue banks are permitted to charge service fees based on the principle of ensuring cost recovery without commercial purposes, including the following costs:

1. Reception, processing, evaluation, preservation, storage, and transportation of tissues;

2. Salaries, wages, and allowances;

3. Depreciation of physical assets, property, and equipment;

4. Other reasonable incidental costs.

NATIONAL ORGAN TRANSPLANT COORDINATION CENTER

Chapter II

NATIONAL ORGAN TRANSPLANTATION COORDINATION CENTER

FOR HUMAN ORGAN TRANSPLANTATION

1. The National Organ Transplant Coordination Center is a public service organization, has a network structure, possesses legal personality, its own seal, account, and office, under the Ministry of Health. Based on practical needs, the Minister of Health decides on the organizational network of the National Organ Transplant Coordination Center.

1. The National Organ Transplantation Coordination Center is a public service organization, has its own network, possesses legal personality, seal, account, and independent office, under the Ministry of Health. Based on practical requirements, the Minister of Health decides on the organizational network of the National Organ Transplantation Coordination Center.

2. The functions and tasks of the National Organ Transplantation Coordination Center are implemented according to the provisions of Article 12, 18, and Clause 2 of Article 36 of the Law on Donation, Collection, and Transplantation of Tissues and Human Organs and Donation and Collection of Corpses, and other specific tasks as follows:

a) Receiving and compiling lists of individuals who have registered to donate tissues and organs from living persons and deceased persons; managing the issuance and compilation of lists of living and deceased donors who have been issued cards;

c) Compiling and managing lists of individuals designated for tissue and organ transplantation;

d) Coordinating the extraction and transplantation of tissues and organs among healthcare facilities.

3. The Prime Minister decides on the establishment of the National Organ Transplant Coordination Center.

The Prime Minister decides to establish the National Center for Human Organ Transplantation Coordination.

Article 18. Coordination Relationship between the National Coordinating Center for Human Organ Transplantation and Medical Facilities

1. Responsibilities of medical facilities:

a) Notify the name, age, address, and related medical indices concerning the health status of individuals willing to donate human organs to the National Coordinating Center for Human Organ Transplantation;

b) Notifying the name, age, address, and relevant medical indices concerning the health condition of patients designated for human organ transplantation to the National Organ Transplantation Coordination Center.

2. Responsibilities of the National Coordinating Center for Human Organ Transplantation:

a) Receive and compile lists of donors and recipients of human organs as stipulated in Clauses 1 and 2 of this Article;

b) Coordinate activities of human organ transplantation nationwide according to the principles set forth in Article 37 of the Law on Donating, Removing, and Transplanting Tissue and Organs from the Human Body and Donating and Removing Corpses.

Article 19. Coordination Relationship between the National Coordinating Center for Human Organ Transplantation and Tissue Banks

1. Tissue banks have the responsibility to regularly report the quantity and types of tissues currently available to the National Coordinating Center for Human Organ Transplantation.

2. The National Coordinating Center for Human Organ Transplantation, based on the quantity and types of tissues from tissue banks across the country, shall be responsible for coordinating activities related to tissue supply.

Chapter III

IMPLEMENTING PROVISIONS

Article 20. Effective Date

This Decree shall take effect fifteen days after its publication in the Official Gazette.

Article 21. Guidance on Implementation

1. The Ministry of Health shall take the lead and coordinate with relevant ministries and sectors to provide guidance on implementing this Decree.

2. Ministers, Heads of ministerial-level agencies, Heads of government-affiliated agencies, Chairpersons of provincial and centrally governed city People's Committees are responsible for implementing this Decree./.