Medical Laboratory Requirements

Source:

Article 28 Decree 109/2016/ND-CP⁠

⁠

Article 28. Requirements for issuance of operation licenses to laboratories

1. Facilities:

a. Satisfying the requirements specified in points a, dd and e clause 1 Article 26 of this Decree

a) Satisfying the requirements specified in point a clause 2 Article 25 of this Decree.

a clause 2 Article 25: Having location fixed and separate from areas for daily-life activities, having sufficient light, dustproof ceiling and wall and floor made of materials which can be cleansed easily.

dd) Satisfying the conditions of radiation safety, hospital waste management and fire and explosion prevention according to law; ensuring the aseptic operation.

e) Ensuring the sufficiency of electricity and water supply and other conditions for patient care.

and the following requirements according to the registered practice scope:

For tests of one of the four aspects: hematology, biochemistry, genetics and immunity, the laboratory shall have an area of at least 10 m2;

For tests of two or three of the four aspects: hematology, biochemistry, genetics and immunity, the laboratory shall have an area of at least 15 m2;

For tests of four aspects: hematology, biochemistry, genetics and immunity, the laboratory shall have an area of at least 20 m2;

For pathoanatomic or cytological tests, the laboratory shall have an area of at least 20 m2 and be separated from the laboratories for tests of hematology, biochemistry, genetics and other laboratories;

For tests of microorganism, the laboratory shall have an area of at least 20 m2 and be separated from the laboratories for tests of hematology, biochemistry, genetics and other laboratories;

Walls of laboratories shall have waterproof surface;

Floors of laboratories shall have waterproof and flat surface which can prevent water standing;

Testing tables shall be made of watertight and anti-corrosive materials and associated with wash-basins and fresh-water tap;

There shall be places for taking medical waste, places for keeping medical waste and place for cleansing medical instruments;

Any laboratory conducting tests of microorganisms likely to transmit infectious diseases to human must satisfy the requirements prescribed by

law on laboratory’s biosafety⁠

;

HIV testing laboratories shall comply with law on HIV/AIDS prevention and fighting.

b. Satisfying the conditions of hospital waste management and fire and explosion prevention according to law.

c. Ensuring the sufficiency of electricity and water supply and other conditions for patient care.

2. Medical equipment:

Having sufficient testing equipment and medical instruments for the registered practice scope, including at least sufficient equipment for conducting a test of one of the six types: microorganism, biochemistry, hematology, immunity, pathoanatomy and cytology and medical genetics.

3. Personnel:

a. Any person working at a healthcare facility who wishes to provide healthcare shall have a practice certificate and be assigned according to the practice scope stated in his/her practice certificate.

b. Any chief physician of a laboratory shall satisfy the following conditions:

Being a doctor or a physician having a university degree and a practice certificate specialized in testing; or a bachelor’s degree in chemistry, biology or pharmacy of university higher level, applicable to persons employed to conduct medical test before the effective date of this Decree and issued with a certificate of practice in testing with a title of physician.

Having worked for a suitable laboratory department for at least 54 months (4.5 years) or having worked as a testing practitioner for at least 36 months (3years), including the period of post-graduation study in testing, from the day on which his/her testing job starts (determined from the time on which the labor contract is signed or the recruitment decision is issued) to the day on which he/she is assigned or appointed to be the chief physician of the laboratory.

Working on a full-time basis at the laboratory.

Article 28. Requirements for issuance of operation licenses to laboratories

1. Facilities:

2. Medical equipment:

3. Personnel:

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