Conditions for issuance of Licenses for Tissue Bank Operation in Vietnam

According to Article 3 of Decree No. 56/2008/NĐ-CP, Clause 4 Article 1 of Decree No. 118/2016/NĐ-CP and Clause 1 Article 7 of Decree No. 155/2018/NĐ-CP of Vietnam’s Government, the tissue bank shall be granted the License for Tissue Bank Operation only if:

Establishment condition: It has the Establishment Decision or be named in the competent authority’s document on organizational structure of medical facilities (for State-owned tissue banks) or Enterprise Certificate (for private tissue banks).

Facilities conditions: It has at least:

- Technical room for receiving, treating, storing and providing tissues.

- Laboratory. If the tissue bank is under the management of the health facility, the testing can be conducted in the testing department of the health facility.

- Administrative area which is used for collecting and managing documents, as well as providing counseling.

Personnel conditions: Minimum quantity of personnel:

- The specialized manager of the tissue bank must satisfy the requirements specified in clause 4, Article 35 of the Law on Donation, Removal, Transplantation of Human Tissues and Organs and Donation and Recovery of Cadavers.

- 01 general doctor who has a laboratory practice certificate (Bio-chemistry or Hematology or Microorganism) or 01 laboratory technician who has a bachelor degree and a medical laboratory practice certificate.

- 01 medical technician or 01 nurse who has a medical intermediate degree and a medical practicing certificate.

If the applicant is a tissue bank under the management of the health facility, its personnel can hold several positions, however, a medical technician or a nurse must perform special tasks.

Equipment conditions: Equipment must be sufficiently provided according to the List specified in Appendix I attached to Decree No. 118/2016/NĐ-CP. If the applicant is a tissue bank under the management of the health facility, it may share the same equipment with such facility.

- If the tissue bank performs tasks related to the cornea, it must satisfy the requirements specified above. Moreover, the technician removing the cornea must have a high school diploma and must be trained in removing, storing and transporting the cornea.

- Administrative management procedures.

- Technical procedures for removing, storing and distributing each type of tissue registered by the bank.

Thus, in order to be granted a tissue bank operating license, 04 conditions for establishment; facilities; personnel and equipment must be simultaneously satisfied. If one of these conditions is missing, of course the License will not be granted.

Note:

- Tissue is a combination of cells of the same type or different types to perform certain functions of human body.

- Tissue bank is an establishment that receives, preserves, stores, transports and supplies tissues that is organized under one of two following forms:

+ Tissue banks that are affiliated to State-owned or private medical facilities, Medical Universities, Universities of Medicine and Pharmacy or National Coordination Center for Human Organ Transplantation;

+ State-owned or private tissue banks that are independent from other organizations.

Nguyen Trinh

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