Decree No. 118/2016/ND-CP dated July 22, 2016 amendments Decree 56/2008/ND-CP on organization and operation of tissue banks and National Coordination Center for Human Organ Transplantation

DECREE

AMENDMENTS TO A NUMBER OF ARTICLES OF THE GOVERNMENT’S DECREE NO.56/2008/ND-CP ON ORGANIZATION AND OPERATION OF TISSUE BANKS AND NATIONAL COORDINATION CENTER FOR HUMAN ORGAN TRANSPLANTATION DATED APRIL 29, 2008

Pursuant to the Law on Government organization dated June 19. 2015;

Pursuant to the Law on Donation, removal and transplantation of human tissues and organs, and body donation dated November 29, 2006;

At request of the Minister of Health, the Government hereby issues this Decree on amendments to a number of articles of the Government’s Decree No. 56/2008/ND-CP dated April 19, 2008 on organization and operation of tissue banks and National Coordination Center for Human Organ Transplantation.

Article 1. Amendments to a number of Articles of the Government’s Decree No.56/2008/ND-CP dated April 29, 2008

1. Article 2 is amended as follows:

 “Article 2.Types of tissue banks

Tissue banks are medical facilities that are organized under one of two following forms:

1. 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 (hereinafter referred to as “affiliated tissue bank”)

2. State-owned or private tissue banks that are independent from other organizations (hereinafter referred to as "independent tissue bank")

2. Article 2a below is added after Article 2:

 “Article 2a.Scope of operation of tissue banks

1. Receive, store, preserve and transport tissues.

2. Provide tissues for medical facilities, research institutes and medical education institutions.

3. Provide and exchange tissues with other tissue banks.

4. Cooperate with foreign entities in exchange of tissues for medical treatment, research and education.

5. Tissue banks satisfying requirements in clause 3, Article 3a hereof shall be eligible to take donors’ corneas after death."

3. Article 3 is amended as follows:

 “Article 3. Establishment of tissue banks

1. Every entity satisfying stipulated requirements shall be entitled to establish tissue banks.

2. Requirements, procedures for and the power to establish State-owned tissue banks are prescribed in the Government’s Decree No.55/2012/ND-CP dated June 28, 2012 on establishment, re-organization or dissolution of public medical facilities.

3. Requirements, procedures for and the power to establish private tissue banks are prescribed in the Law on Enterprises and relevant legislative documents detailing the implementation of the Law on Enterprises.”

4. Article 3a below is added after Article 3:

 “Article 3a. Requirements for operation and issue of Licenses for Tissue Bank Operation

1. Requirements for tissue bank operation: Tissue banks shall be entitled to operate only if they obtain the Licenses for Tissue Bank Operation (hereinafter referred to as “Operation License”) issued by the Ministry of Health.

2. The tissue bank shall be granted the License for Tissue Bank Operation only if:

a) 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).

b) It has at least:

- An operating room with the minimum area of 12 m2 to excise, treat and preserve tissues; and

- A laboratory with the minimum area of 12 m2. Medical facilities may share their laboratories with their affiliated tissue banks;

- An administrative office, record-keeping room and consulting room with the minimum area of 12 m2

- Firmly-constructed and well-lit facilities which have dust-proof ceiling and easy-to-clean walls and floor; satisfy requirements for medical waste treatment, bacterial contamination control and fire safety under regulations of laws, and are supplied with sufficient water, electricity and others.

c) It has the following employees in its personnel:

- A tissue bank professional manager who meets all requirements in clause 4, Article 35 of the Law on Donation, removal and transplantation of human tissues and organs, and body donation; and

- 01 doctor or lab scientist having the medicine practice certificate; and

- 02 medical technicians or nurses having at least an associate degree in medicine or medicine practice certificate; and

- 01 office administrator

Employees of an affiliated tissue bank may concurrently hold multiple positions except for medical technicians and nurses.

d) It has all of the equipment on the List prescribed in Annex I hereto. Affiliated tissue banks may share such equipment with their medical facilities.

Tissue banks covering corneas shall meet all requirements in clause 3 of this Article.

3. Requirements for License for eye bank operation (for tissue banks specialized in only corneal transplantation):

Satisfy the facility requirements in clause 2 of this Article.

b) Have all of the equipment on the List prescribed in Annex I hereto.

c) With respect to human resources:

- Have all of the required employees prescribed in clause 2 of this Article; and

- Every employee in charge of taking corneas has at least an associate degree and completed the training course in excision, preservation and transport of corneas."

5. The Article 4 is amended as follows:

 “Article 4. Application and procedures for Operation License

1. “The application for Operation License includes:

a) An application form for Operation License made using the form in Annex II hereto; and

b) A certified true copy or copy enclosed with the original copy for collation of the Establishment Decision or competent authority's documents named the tissue bank in the organizational structure of the medical facilities in case of State-owned tissue banks; or Enterprise Registration Certificate in case of private tissue banks; and

c) A list of facilities and medical equipment as proof of fulfillment of requirements in Article 3a hereof;

d) A List of employees as proof of fulfillment of requirements in Article 3a hereof; For tissue bank professional managers, the certified true copies of disciplinary degrees and certificates, employment verification, health certificate, profile and criminal record are required.

2. The procedure for issue of Operation License is as follows:

a) Any entity wishing to be granted the Operation License shall submit an application for Operation License as stipulated in clause 1 of this Article to the Ministry of Health directly or by post;

b) Within 05 working days after the receipt, the Ministry of Health shall examine the validity of such application. In case the application is found invalid, the Ministry of Health shall instruct the applicant to complete the application;

c) Within 05 working days from the date of receipt of the valid application, the Minister of Health shall issue the Decision on Establishment of Evaluation Board for issue of Operation License. There shall be at least 05 members in the Evaluation Board who are representatives of relevant agencies of the Ministry of Health, legal and medical specialists;

d) Within 20 working days from the date of issue of the Decision on Establishment of Evaluation Board, the Evaluation Board shall carry out a site inspection at the tissue bank, and submit the inspection record and inspection report to the Minister of Health thereafter.

dd) Within 05 working days from the date of receipt of the inspection record, the Minister of Health shall issue the Operation License using the specimen in Annex III attached hereto to the tissue bank In case of rejection, the Ministry of Health shall inform the applicant and provide explanation in writing”.

Article 2. Transitional provisions

Tissue banks granted the Operation License under the Government’s Decree No.56/2008/ND-CP dated April 29, 2008 on the organization and operation of tissue banks and National Coordination Center for Human Organ Transplantation may keep operating until the end of June 30, 2017. From July 01, 2017, they must obtain the Operation License under provisions hereof.

Article 3. Entry into force

This Decree enters into force from September 15, 2016.

Article 4. Implementation organizations

Ministers, heads of ministerial-level agencies, Heads of Governmental agencies and Presidents of People’s Committees of provinces shall be responsible for the implementation of this Decree./.

ANNEX I

LIST OF EQUIPMENT OF TISSUE BANKS
(Enclosed with the Government’s DecreeNo.118/2016/ND-CP dated July 22, 2016)