Decree No. 56/2008/ND-CP dated April 29, 2008 of the Government stipulating the organization and operation of tissue banks and the National Coordination Center for Human Organ Transplantation

DECREE

STIPULATING THE ORGANIZATION AND OPERATION OF TISSUE BANKS AND THE NATIONALCOORDINATIONCENTER FOR HUMAN ORGAN TRANSPLANTATION

THE GOVERNMENT

Pursuant to the December 25, 2001 Law on Organization of the Government;
Pursuant to the November 29, 2006 Law on Donation. Removal and Transplantation of Human Tissues and Organs and Donation and Recovery of Cadavers;
At the proposal of the Minister of Health,

DECREES:

Chapter I

TISSUE BANKS

Section 1. ESTABLISHMENT OF TISSUE BANKS

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

Tissue banks have the legal status, functions and tasks stipulated in Clauses 1,2 and 5, Article 35 of the Law on Donation, Removal and Transplantation of Human Tissues and Organs and Donation and Recovery of Cadavers;

Article 2. Types of tissue banks

1. Tissue banks under the Ministry of Health.

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

3. Tissue banks under provincial/municipal Health Services.

4. Tissue banks of hospitals under provincial/ municipal Health Services.

5. Private tissue banks: tissue banks of private hospitals, private medical or pharmaceutical universities.

Article 3. Competence to establish and license the establishment of tissue banks

1. Competence to establish tissue banks

a/ The Minister of Health shall issue decisions on establishment of tissue banks under the Ministry of Health, tissue banks of hospitals, institutes, medical or pharmaceutical universities under the Ministry of Health or other ministries or ministerial-level agencies:

b/ Presidents of provincial/municipal Peoples Committees shall issue decisions on establishment of tissue banks under provincial/municipal Health Services, and tissue banks of hospitals under provincial/municipal Health Services.

2. Competence to license establishment of tissue banks

Presidents of provincial/municipal Peoples Committees shall issue decisions to license the establishment of private tissue banks; tissue banks of private hospitals or private medical or pharmaceutical universities in localities under their management.

Article 4. Documents and procedures for establishing or licensing the establishment of tissue banks

1. Documents for establishing and licensing the establishment of a tissue bank include:

a/ A scheme on the establishment of a tissue bank, which contains the following principal details:

- Necessity and legal grounds of the establishment of the tissue bank;

- Objectives, functions and tasks of the tissue bank;

- Type of the tissue bank to be established;

- Organizational structure of the tissue bank;

- Necessary conditions for ensuring the operation of the tissue bank, including projected personnel, payroll, operating fund, working office, professional equipment and facilities and other necessary equipment of the tissue bank:

- Operation schedule of the tissue bank;

- Proposals of agencies, units, organizations and individuals that elaborate the scheme on the establishment of the tissue bank.

b/ A written request for the establishment of a tissue bank, which contains the following principal details:

- Necessity and legal grounds of the establishment of the tissue bank;

- Principal contents of the scheme on establishment of the tissue bank;

- Issues on which opinions remain divergent and issues on which opinions of agencies competent to decide on establishment of tissue banks are required.

2. Procedures for establishing and licensing the establishment of tissue banks

a/For tissue banks under the Ministry of Health or tissue banks of hospitals, institutes, medical or pharmaceutical universities under the Ministry of Health or other ministries or ministerial-level aaencies:

Dossiers of request for the establishment of tissue banks shall be sent to the Ministry of Health.

Within 30 working days after receiving a complete and valid dossier, the Ministry of Health shall issue a decision on the establishment of a tissue bank. If no establishment decision is issued, there must be a written reply clearly stating the reason.

b/ For tissue banks under provincial/municipal Health Services, tissue banks of hospitals under provincial/municipal Health Services; private tissue banks and tissue banks of private hospitals or private medical or pharmaceutical universities:

Dossiers of request for establishment or application for licenses for establishment shall be sent to provincial/municipal Health Services of localities where tissue banks are projected to be located.

Within 20 working days after receiving complete and valid dossiers, provincial/municipal Health Services shall summit them to provincial/municipal Peoples Committees. Within 10 working days after receiving complete and valid dossiers, provincial/municipal Peoples Committees shall issue establishment decisions for tissue banks under provincial/municipal Health Services, tissue banks of hospitals under provincial/municipal Health Services, or issue establishment licenses for private tissue banks, tissue banks of private hospitals or private medical or pharmaceutical universities. If no establishment decision or license is issued, there must be a written reply clearly stating the reason.

Section 2 OPERATION OF TISSUE BANKS

Article 5. Tissue supply sources

Tissue banks may receive tissues from the following supply sources:

1. Medical establishments with the function of removing human tissues and organs.

2. Other tissue banks.

3. International cooperation or aid programs.

Article 6. Places for tissue removal, persons from whom tissues are removed and other necessary conditions:

1. Removal of tissues from deceased donors:

a/ Removal of tissues from deceased donors shall be carried out in operation rooms, mortuaries or places where bodies of tissue donors are kept;

b/ Before removing tissues, equipment and tools to used for tissue removal must be sterilized according to professional hygiene regulations of medical establishments. Removed tissues must be aseptic.

2. Removal of tissues from living donors:

a/ Removal of tissues from living donors shall be carried out in operation rooms of medical establishments which have sufficient conditions for and the function of removing and transplanting human tissues and organs;

b/ Before tissues are removed, health counseling and examination of biological parameters of donors must be given under Clause 4, Article 14 of the Law on Donation, Removal and Transplantation of Human Tissues and Organs and Donation and Recovery of Cadavers;

c/ Equipment and tools to be used for tissue removal must be sterilized. Removed tissues must be aseptic.

Article 7. Packaging, preservation and transportation of tissues after removal to tissue banks

1. Tissues must be packaged immediately after being removed, put in aseptic boxes, preserved with chemicals or solutions and kept at proper temperatures, and their packages may not be opened before they are delivered to tissue banks.

2. Tissue-containing boxes must be stuck with labels displaying names of tissues, identification numbers and names of donors, names and addresses of tissue-removing establishments and tissue banks.

Article 8. Receipt of tissues

1. Tissue banks may receive tissues transported from medical establishments after checking the following:

a/ Dossiers transferred by. medical establishments that have removed tissues, which contain information on names of tissue donors; date, time and places of tissue removal; names of persons who have manipulated the tissue removal; types of tissue and medical information on removed tissues and their donors;

b/ The intactness of tissue-containing boxes and information shown on labels of tissue-containing boxes compared with that in dossiers specified at Point a of this Clause.

2. Tissues from other tissue banks or obtained through international cooperation or from international aid sources can be received only after the contents specified in Clause 1 of this Article are checked.

Article 9. Assessment of quality and treatment of tissues

1. Before being treated, tissues must go through quality assessment under the Minister of Healths regulations.

2. Methods of tissue treatment include:

a/ Soaking in formalin or preservative solutions with antibiotics;

b/ Chilled preservation;

c/ Freezing;

d/Total dehydration;

e/ Radiation;

f/ Sterilization with ethylene oxide;

g/ Lyophilization (freezing-drying);

h/ Other methods.

3. The Minister of Health shall elaborate and promulgate the process of treating tissues appropriate to each treatment method specified in Clause 2 of this Article.

Article 10. Packaging and labeling of treated tissues

1. Treated tissues must be separately packaged and kept in tissue containers

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

a/ Type of the tissue;

b/ Name and address of the tissue bank:

c/ Identification number of the tissue;

d/ Expiry date.

3. Each tissue container or tissue-containingbox must be accompanied with documents clearly stating the following details:

a/ Quantity, weight or dimensions or parameters specified in Clause 2 when necessary;

b/ Treatment method:

c/ Lot number, if applicable;

d/ Potential residues of chemicals or solutions added in the process of treatment and preservation;

e/ Suggested conditions for storage;

f/ Indications and contraindications for use of tissues, when necessary;

g/ Other relevant contents.

Article 11.Encoding of information on tissues

1. All information on tissue origin must be encoded in compliance with the principle that names, ages and addresses of tissue donors must not be disclosed. Each removal of a tissue from a donor is given a specific code.

2. The Minister of Health shall specify codes for information encoding for each tissue bank.

Article 12. Storage of tissues

1. Tissues must be stored at proper temperatures and separate places, in total segregation from untreated tissues and clean environments free from microorganism contamination.

2. Tissue banks shall strictly comply with the prescribed tissue storage process.

3. The Minister of Health shall specify conditions and the process of tissue storage mentioned in Clauses 1 and 2 of this Article.

Article 13. Distribution of tissues

1. Before the distribution of tissues, convenient search for origins of these tissues from donors to recipients and tissue banks must be ensured.

2. Tissue banks shall have special-use transportation vehicles which satisfy technical requirements for tissue quality throughout the course of transportation to places of receipt.

Article 14. Regulations on archive of documents and reports

1. Tissue banks shall compile documents and archive all documents related to tissues from the stages of receipt, treatment, packaging and storage to the stages of transportation and distribution.

2. Every six months, tissue banks shall report to the Ministry of Health on their operation.

In case an unexpected incident or serious side effect occurs in the course of removal, receipt, storage, supply or transplantation of tissues reported by medical establishments with the function of tissue transplantation, tissue banks shall promptly report it to the competent agency in charge of health.

Article 15. Responsibility to promulgate national technical regulations on professional operations of tissue banks

The Minister of Health shall promulgate national technical regulations on professional operations of tissue banks specified in Article 9, 10, 11 and 12 of this Decree.

Article 16. Principle for determining operation expenses of tissue banks

Tissue banks may collect service charges on the principle of ensuring the revenue-expenditure balance for non-commercial puiposes, covering the following expenses:

1. Receipt, treatment, quality assessment, preservation, storage and transportation of tissues:

2. Payment of wages, remunerations and allowances:

3. Depreciation of physical foundations, assets, equipment and facilities:

4. Other reasonable expenses.

Chapter II

THE NATIONALCOORDINATIONCENTER FOR HUMAN ORGAN TRANSPLANTATION

Article 17. Organizational structure of the NationalCoordinationCenter for Human Organ Transplantation

1. The National Coordination Center for Human Organ Transplantation is a non-business organization that has its own network, legal entity status, own seal, bank account and head office, and is attached to the Ministry of Health. Based on practical requirements, the Minister of Health shall decide on the organization of the network of the NationalCoordinationCenter for Human Organ Transplantation.

2. Functions and tasks of the NationalCoordinationCenter for Human Organ Transplan-tation comply with the provisions of Articles 12 and 18 and Clause 2, Article 36 of the Law on Donation. Removal and Transplantation of Human Tissues and Organs and Donation and Recovery of Cadavers, and other specific tasks as follows:

a/To receive registrations and draw up a list of persons registered for tissue or organ donation as living donors or after their death; to manage the grant of donor cards and draw up a list of living and deceased tissue and organ donors who have been granted donor cards;

b/ To manage information on health and other information related to donors and persons who need human tissue or organ transplantation;

c/ To draw up and manage a list of persons who need human tissue or organ transplantation;

d/Tocoordinate the removal and transplantation of human tissues and organs among medical establishments.

3. The Prime Minister shall decide on the establishment of the NationalCoordinationCenter for Human Organ Transplantation.

Article 18. Coordinative relationship between the NationalCoordinationCenter for Human rgan Transplantation and medical establishments

1. Responsibilities of medical establishments:

a/To notify names, ages, addresses and medical parameters related to the health of voluntary donors of human organs to the NationalCoordinationCenter for Human Organ Transplantation;

b/ To notify names, ages, addresses and medical parameters related to the health of patients who need human organ transplantation to the National Coordination Center for Human Organ Transplantation.

2. Responsibilities of the NationalCoordinationCenter for Human Organ Transplantation:

a/ To receive registrations and draw up a list of human organ donors and persons who need human organ transplantation specified in Clauses 1 and 2 of this Article;

b/ To coordinate human organ-transplanting activities throughout the country on the principles defined in Article 37 of the Law on Donation, Removal and Transplantation of Human Tissues and Organs and Donation and Recovery of Cadavers.

Article 19. Coordinative relationship between the NationalCoordinationCenter for Human Organ Transplantation and tissue banks

1. Tissue banks shall regularly notify the quantity and types of available tissues to the NationalCoordinationCenter for Human Organ Transplantation.

2. The National Coordination Center for Human Organ Transplantation shall base itself on the quantity and types of tissues available at tissue banks nationwide to coordinate the supply of tissues.

Chapter III

IMPLEMENTATION PROVISIONS

Article 20. Implementation effect

This Decree takes effect 15 days after its publication in CONG BAO.

Article 21. Implementation guidance

1. The Ministry of Health shall assume the prime responsibility for, and coordinate with concerned ministries and branches in, guiding the implementation of this Decree.

2. Ministers, heads of ministerial-level agencies and government-attached agencies, and presidents of provincial/municipal Peoples Committees shall implement this Decree.