Consolidated Document number 07/VBHN-BYT stipulates on the organization and operation of tissue banks and the National Center for Organ Transplantation.

DECREE

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

Decree No. 56/2008/ND-CP dated April 29, 2008 of the Government stipulates the organization and operation of tissue banks and the National Organ Procurement and Transplantation Center, which took effect from May 26, 2008, amended and supplemented by:

1. Decree No. 118/2016/ND-CP dated July 22, 2016 of the Government amending and supplementing certain articles of Decree No. 56/2008/ND-CP dated April 29, 2008 stipulating the organization and operation of tissue banks and the National Organ Procurement and Transplantation Center (hereinafter referred to as Decree No. 118/2016/ND-CP), which took effect from September 15, 2016.

2. Decree No. 155/2018/ND-CP dated November 12, 2018 of the Government amending and supplementing certain provisions related to business conditions within the scope of management of the Ministry of Health in Decree No. 188/2016/ND-CP dated July 22, 2016 of the Government amending and supplementing certain articles of Decree No. 56/2008/ND-CP dated April 29, 2008 of the Government stipulating the organization and operation of tissue banks and the National Organ Procurement and Transplantation Center.

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,1

Chapter I. TISSUE BANKS

PART I. ESTABLISHMENT OF TISSUE 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 banks2

Tissue banks are medical facilities organized in two types as follows:

1. Tissue banks within the organizational structure of medical facilities, medical universities, and medical colleges of the state or private sector; of the National Organ Procurement and Transplantation Center (hereinafter referred to as tissue banks within medical facilities).

2. Independent tissue banks with a separate organizational structure of the state or private sector (hereinafter referred to as independent tissue banks).

Article 2a. Scope of professional activities of tissue banks3

1. Receiving, preserving, storing, and transporting tissues.

2. Supplying tissues to medical facilities, research institutions, and medical training centers.

3. Supplying and exchanging tissues with other tissue banks.

4. Cooperating with foreign agencies, organizations, and individuals in tissue exchange for diagnostic, treatment, training, and medical research purposes.

5. Tissue banks meeting the conditions prescribed in Clause 3 of Article 3a of this Decree are permitted to extract corneas from deceased donors.

Article 3. Establishment of tissue banks4

1. Agencies, organizations, and individuals have the right to establish tissue banks when they meet the required conditions as stipulated.

2. Conditions, authority, and procedures for establishing state tissue banks are implemented according to the provisions of Decree No. 55/2012/ND-CP dated June 28, 2012 of the Government on the establishment, restructuring, and dissolution of public health units.

3. Conditions, authority, and procedures for establishing private tissue banks are implemented according to the provisions of the Enterprise Law and related detailed implementing regulations of the Enterprise Law.

Article 3a. Conditions for operation and issuance of a Banking Tissue Operation Permit.5

1. Conditions for operation of a tissue bank: A tissue bank may only operate after obtaining a Tissue Banking Operation Permit issued by the Ministry of Health.

2. Conditions for issuing a Tissue Banking Operation Permit:

a) There must be a Decision on establishment of the tissue bank or the tissue bank must be listed in the document of the competent authority stipulating the organizational structure of medical facilities for state-owned tissue banks or a Business Registration Certificate for private tissue banks.

b) Suitable physical infrastructure, including the following components:

- A technical room for receiving, processing, storing, and supplying tissues;

- A laboratory. For tissue banks within medical facilities, laboratory testing can be shared with the facility's laboratory department;

- An administrative area for managing records and providing consultation.

c) Minimum human resources:

- The professional manager of the tissue bank must meet the conditions specified in Clause 4, Article 35 of the Law on Organ, Tissue Transplantation and Donation and Cadaver Donation.

- One general practitioner with a practice certificate in laboratory medicine (Biochemistry, Hematology, or Microbiology) or one bachelor’s degree holder in laboratory science with a practice certificate in laboratory examination;

- One technician or nurse with a diploma or higher in a relevant medical field, holding a practice certificate in medical examination and treatment.

For tissue banks within medical facilities, personnel can hold concurrent positions, except that technicians or nurses must work exclusively in their roles.

d) Equipment: Must have all equipment as prescribed in the List attached to this Decree. For tissue banks within medical facilities, shared equipment with the facility is permissible. Appendix I - If the tissue bank engages in cornea activities, it must meet the conditions set out in Clause 3 of this Article.

- Administrative management procedures

- Technical procedures for collection, storage, and distribution of each type of tissue registered by the bank.

3. Conditions for issuing a permit to operate a cornea bank (tissue bank operating solely in corneas):

a) Physical infrastructure: Must meet the conditions stipulated in Point b, Clause 2 of this Article.

b) Equipment: Must have all equipment as prescribed in

c) Human resources: Appendix I issued together with this Decree.

- Must meet the human resource requirements stipulated in Point c, Clause 2 of this Article;

- Personnel collecting corneas must have a high school education and training in cornea collection and preservation, transportation.

Article 4. Documents and Procedures for Requesting a Tissue Banking Operation Permit

1. Documents for requesting a Tissue Banking Operation Permit include:6

a) A request form for a Tissue Banking Operation Permit according to the prescribed model at

b) A copy of the decision establishing the tissue bank or a photocopied original for comparison, or a Business Registration Certificate for private tissue banks; Seal Registration Certificate to this Decree;

c) A declaration of physical infrastructure and medical equipment to prove compliance with the conditions stipulated in

Article 3a of this Decree d) For independent tissue banks: A declaration of human resources of the tissue bank to prove compliance with the conditions stipulated in;

. For the professional manager, a certified copy of academic credentials and certificates is also required; d) For independent tissue banks: A declaration of human resources of the tissue bank to prove compliance with the conditions stipulated inFor tissue banks within medical facilities, only a practice certificate is necessary.

2. Procedures for issuing a Tissue Banking Operation Permit:

a) Organizations, individuals submit one set of application documents as prescribed in Clause 1 of this Article to the Ministry of Health through administrative channels or direct submission;

b) Upon receipt, within five working days, the Ministry of Health is responsible for examining the validity of the documents. In cases where the documents are incomplete, the Ministry will issue a notification guiding the organization, entity, or individual to complete the documents;

c) Within five working days from the date of receiving valid documents, the Minister of Health issues a Decision to establish an Evaluation Board for issuing a Tissue Banking Operation Permit. The Evaluation Board must consist of at least five members representing relevant units of the Ministry of Health, medical experts, and legal experts;

d) Within twenty working days from the date of the Decision, the Board conducts an evaluation at the tissue bank, prepares an evaluation report, and reports the results to the Minister of Health. Based on the Board's evaluation results, the Minister of Health issues a Tissue Banking Operation Permit according to the prescribed model attached to

this Decree; Appendix III Processing time: From the date the Ministry of Health receives valid application documents from the requesting entity until the issuance of the permit is thirty days.

Time for resolution: From the date of receipt of the valid dossier submitted by the entity requesting the Ministry of Health to issue the License for Human Tissue Banking Operations to the date the Ministry of Health issues the license is thirty days.

PART 2. ACTIVITIES OF THE TISSUE 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 collection 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 shall be carried out at the tissue collection room of healthcare facilities that have the necessary conditions and functions for tissue and human body part collection and 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. Tissues must be packaged immediately after collection; they must be placed in sterile containers, preserved with chemicals or solutions, stored at appropriate temperatures, and not opened until delivered to the tissue bank.

2. Containers holding tissues must be labeled with the type of tissue; donor identification code; 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) Documentation transferred by the healthcare facility that collected the tissues, including information about the donor's name; date, time, and location of the collection; name of the person directly collecting the tissues; type of tissue and relevant medical information about the donor and collected tissues;

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 specify the coding numbers 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 processes of extraction, reception, storage, supply, and transplantation of tissues reported by medical 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 on professional activities of tissue banks as specified in Articles 9, 10, 11, and Article 12 of this Decree. Article 16. Principles for Determining Operating Costs of Tissue Banks.

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. Article 17. Organization of the National Organ Transplant Coordination Center

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.

2. The functions and tasks of the National Organ Transplant Coordination Center are carried out according to the provisions of Article 12, Article 18, and Clause 2 of Article 36 of the Law on Donation, Extraction, and Transplantation of Tissues and Organs and Cadaveric Donation, as well as other specific tasks as follows:

a) Receiving and compiling lists of individuals registering 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;

b) Managing health information and other relevant information about donors and recipients designated for tissue and organ transplantation;

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) Notify the name, age, address, and related medical indices concerning the health status of patients with a prescription for human organ transplantation to the National Coordinating Center for Human Organ Transplantation.

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 PROVISIONS7

Article 20. Effective Date

This Decree takes effect 15 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./.

ANNEX 1

LIST OF EQUIPMENT FOR TISSUE BANKS
(Attached to Decree No. 118/2016/NĐ-CP dated July 22, 2016 of the Government)

ANNEX II

SAMPLE APPLICATION FOR LICENSE TO OPERATE A TISSUE BANK
(Attached to Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government)

SOCIALIST REPUBLIC OF VIET NAM
Independence - Freedom - Happiness
---------------

....8… day ... month... year 20...

PETITION FOR APPLICATION

to issue a license to operate a tissue bank

Respectfully submitted to: Ministry of Health (Department of Medical Examination and Treatment)

Name of the tissue bank requesting the license to operate... 9 ……………………..

Type of tissue bank (independent or affiliated with a healthcare facility): ...

Name of healthcare facility (if the tissue bank is affiliated with a healthcare facility)10………………………………………

Location: ...

Phone:... Email (if any): ...

Please submit along with this application a dossier including the following documents:

We respectfully request the Ministry of Health to consider and issue the license to operate.

ANNEX III

LICENSE TO OPERATE A TISSUE BANK
(Attached to Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government)

LICENSE TO OPERATE A TISSUE BANK
THE MINISTER OF HEALTH

- Based on the Law on Donating, Removing, and Transplanting Tissue and Organs from the Human Body and Donating and Removing Corpses;

- Based on Decree No. 155/2018/NĐ-CP Amending and Supplementing Certain Provisions Related to Business Conditions within the Scope of Management of the Ministry of Health under Decree No. 188/2016/NĐ-CP dated July 22, 2016 of the Government amending and supplementing certain provisions of Decree No. 56/2008/NĐ-CP dated April 29, 2008 of the Government on the Organization and Operation of Tissue Banks and the National Coordinating Center for Human Organ Transplantation;

- Considering the proposal of…,

ISSUE LICENSE TO OPERATE A TISSUE BANK

Name of tissue bank: …

Name of professional manager: …

Type of tissue bank:…1 …

Place of operation:…2 …

Scope of professional operations:…3 …

…day…month……. year 20...

THE MINISTER OF HEALTH
(Signature, stamp)

____________________

¹ Indicate whether it is an independent tissue bank or a tissue bank affiliated with a healthcare facility;

² Address of the tissue bank;

³ Specify the scope of professional operations of the tissue bank based on Clause 2a of Decree No. 155/2018/NĐ-CP dated November 12, 2018 of the Government.

1 Decree No. 118/2016/NĐ-CP amending and supplementing certain provisions of Decree No. 56/2008/NĐ-CP dated April 29, 2008 on the organization and operation of tissue banks and the National Coordinating Center for Human Organ Transplantation, is promulgated based on the following grounds:

"Based on the Law on the Organization of the Government No. 76/2015/QH13 dated June 19, 2015;

Based on the Law on Donating, Removing, and Transplanting Tissue and Organs from the Human Body and Donating and Removing Corpses No. 75/2006/QH11 dated November 29, 2006;

Pursuant to the Investment Law number 67/2014/QH13 dated November 26, 2014;

At the proposal of the Minister of Health,

The Government promulgates the Decree amending and supplementing certain provisions of Decree No. 56/2008/NĐ-CP dated April 29, 2008 on the organization and operation of tissue banks and the National Coordinating Center for Human Organ Transplantation."

Decree No. 155/2018/NĐ-CP amending and supplementing certain provisions related to investment and business conditions within the scope of management of the Ministry of Health, is promulgated based on the following grounds:

"Based on the Government Organization Law dated June 19, 2015;

Considering the proposal of the Minister of Health;

The Government promulgates the Decree amending and supplementing certain provisions related to investment and business conditions within the scope of management of the Ministry of Health."

2 This provision is amended and supplemented pursuant to Clause 1, Article 1 of Decree No. 118/2016/ND-CP, and shall take effect from September 15, 2016.

3 This provision is added pursuant to Clause 2, Article 1 of Decree No. 118/2016/ND-CP, and shall take effect from September 15, 2016.

4 This provision is amended and supplemented pursuant to Clause 3, Article 1 of Decree No. 118/2016/ND-CP, and shall take effect from September 15, 2016.

5 This provision is added pursuant to Clause 4, Article 1 of Decree No. 118/2016/ND-CP, and shall take effect from September 15, 2016, and amended pursuant to Article 7 of Decree No. 155/2018/ND-CP, and shall take effect from November 12, 2018.

6 This provision is added pursuant to Clause 5, Article 1 of Decree No. 118/2016/ND-CP, and shall take effect from September 15, 2016, and amended pursuant to Clause 2, Article 7 of Decree No. 155/2018/ND-CP, and shall take effect from November 12, 2018.

7 Articles 2, 3, and 4 of Decree No. 118/2016/ND-CP, which shall take effect from September 15, 2016, are stipulated as follows:

"Article 2. Transitional Provisions

A tissue bank that has been granted permission to operate in accordance with the provisions of Decree No. 56/2008/ND-CP dated April 29, 2008, issued by the Government on the organization and operation of tissue banks and the National Transplantation Center, shall continue to operate until June 30, 2017. From July 1, 2017, a tissue bank must be granted an Operating Permit in accordance with the conditions and procedures prescribed in this Decree.

Article 3. Effectiveness

This Decree shall take effect from July 1, 2016.

Article 4. Responsibilities for Implementation

The Ministers, Heads of ministerial-level agencies, Heads of government-attached agencies, Chairpersons of provincial People's Committees under central cities are responsible for implementing this Decree./."

Articles 20 and 22 of Decree No. 155/2018/ND-CP, which shall take effect from November 12, 2018, are stipulated as follows:

Article 20. Effective Date

This Decree shall take effect from the date of issuance.

Article 22. Responsibility for enforcement

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

8 Place name.

9 Name of tissue bank applying for operation.

10 Record the name of healthcare facility, medical examination and treatment facility. In case of a tissue bank established by a Medical University or a University of Medicine and Pharmacy, record the name of the university when it is a tissue bank affiliated with a healthcare facility.