Thông tư 37/2017/TT-BYT quy định về thực hành bảo đảm an toàn sinh học trong phòng xét nghiệm do Bộ trưởng Bộ Y tế ban hành

CIRCULAR

ON BIOSAFETY IN LABORATORIES

MINISTER OF HEALTH

Pursuant to the Decree No. 103/2016/ND-CP dated July 01, 2016 of the Government on bio-safety in laboratories.

Pursuant to the Decree No. 75/2017/ND-CP dated June 20, 2017 of the Government defining functions, tasks, powers, and organizational structure of the Ministry of Health.

At the request of Director General of the Department of Preventive Medicine

Minister of Health promulgates the Circular on bio-safety in laboratories.

Article 1. Scope and regulated entities.

This Circular stipulates the provisions on bio-safety in the laboratories where the staff work with microorganisms which are at risk of causing infectious diseases to human and with pathology specimens that carries microorganism with the same risk as mentioned above (hereinafter referred to as “laboratory”)

Article 2. Definitions

The following terms are construed as follow:

1. Decontamination means the process of cleansing an object or substance to remove microorganisms; and remove or neutralize hazardous materials and radioactive substances.

2. Cleansing means the process of removing dust and organic substances in the laboratory by vacuuming and cleaning with water, detergents, and other cleansing chemicals.

3. Disinfection means the process using physical and/or chemical methods to remove most microorganisms but not necessarily remove spores.

4. Sterilization means the process of removing all microorganisms including spores.

Article 3: Regulations on biosafety level I practice.

1. Entry and exit:

Only authorized personnel may enter and exit the laboratory but other people must receive permission and guidance from the authorized personnel to do so.

2. Personal protective equipment and health supervision:

a. Use protective clothes with long sleeves while working in the laboratory

b. Store protective clothes in the laboratory in a separate area.

c. Do not wear protective clothes outside the laboratory

d. Wear proper gloves while working with microorganisms which are at risk of causing infectious diseases to human and with pathology specimens that carries microorganism with the same risk as mentioned above; the gloves and sleeves shall overlap.

dd. Replace dirty or torn medical gloves as required; remove the gloves after working with equipment materials and before leaving the laboratory; do not reuse the medical gloves; do not open and/or close the door with hands wearing medical gloves.

e. Wear shoes and sandals that cover the toes; do not wear high heels in the testing laboratory.

g. The laboratory has the responsibility to provide health supervision for the laboratory staff in accordance with the Labor Code No. 10/2012/QH13 and the Decree No. 45/2013/ND-CP dated October 5, 2013 of the Government.

3. Working area and equipment use:

a. The light in the laboratory shall be used in accordance with the national technical regulation on lighting – the acceptable level of light at workplace.

b. There shall be clean water provided for the laboratory in accordance with Circular No. 05/2009/TT-BYT dated June 17, 2009 of the Minister of Health on national technical regulation on domestic water quality.

c. The equipment using at the laboratory shall have adequate information and shall be labeled, managed, used, tested, and calibrated in accordance with Decree No. 36/2016/ND-CP dated May 15, 2016 of the Government on managing healthcare equipment.

d. During the placement and operation process, the equipment shall meet the requirements and technical specifications of the producer.

dd. Do not use the laboratory equipment for other purposes.

4. Regulations on working in the laboratory:

a. Wash hands thoroughly or use antiseptics before and after performing the test, after removing the gloves and before leaving the laboratory.

b. Establish and follow the testing procedures to ensure that the test is carried out properly to limit the splashing of droplets or aerosol.

c. Pack the specimens to transport them out of the laboratory in accordance with Circular No. 43/2011/TT-BYT dated December 05, 2011 of the Minister of Health on stipulating the management of infectious specimens.

d. Do not replace pipets with syringes or use them in other purposes aside from injecting or expelling liquid or gases in and out of the laboratory animals' bodies.

dd. Do not eat, drink, smoke, shave and/or make up in the laboratory; Do not bring personal belongings and/or foods into the laboratory; Do not insert or remove contact-lenses and do not use mobile phones while performing the tests.

5. Regulations on decontamination, waste disposal and on prevention, handling and remediation of bio-safety problems.

a. Establish and follow the procedures for decontamination and waste disposal.

b. Classify, collect, store, transport and dispose wastes in accordance with the Joint Circular No. 58/2015/TTLT-BYTBTNMT dated December 31, 2015 of the Ministry of Health and Ministry of Natural Resources and Environment on management of medical wastes.

c. Disinfect the surfaces of the workplace after finishing the test or after dropping the infectious specimens.

d. All equipment shall be cleaned and disinfected properly before being maintained, fixed or transported out of the laboratory.

dd. Establish and follow the procedures for evaluating bio-risk and for handling accidents. The procedures shall also include the need to summarize and report all information regarding the accidents in the laboratory.

e. Retain the documents on laboratory accidents and responses for at least 3 years.

Article 4: Regulations on biosafety level II practice

1. Entry and exit:

The bio-safety laboratory level II shall meet all the requirements stipulated in Clause 1, Article 3 in this Circular and shall also have security methods.

2. Personal protective equipment and health supervision:

The bio-safety laboratory level II shall meet all the requirements stipulated in Clause 2, Article 3 hereof and the following provisions:

a. Use eye and face protection equipment (safety masks, goggles/glasses) while performing actions at risk of splashing droplets and/or arousal but without using bio-safety cabinet, and actions at risk of spilling chemicals or actions that cause exposure to ultraviolet light.

b. The laboratory employee shall get vaccinated or take medicines that are prescribed for the diseases related to the infectious specimens used in the laboratory except the diseases that have no vaccines yet.

c. Any laboratory employee who is pregnant, diagnosed with a disease or who has immune deficiency, and/or who has accidents that affect his/her abilities to move arms, legs or who has open worm shall notify the head of the laboratory to be assigned appropriate task.

3. Working area and equipment use:

The bio-safety laboratory level II shall meet all the requirements stipulated in Clause 3, Article 3 hereof and the following provisions:

a. The door shall always be closed during the test.

b. Use steam sterilizer equipment and inspect this equipment in accordance with Circular No. 07/2014/TT-BLDTBXH dated March 06, 2014 of the Minister of Labor, Invalids and Social Affairs on promulgating 27 procedures for safety inspection of equipment and machinery with strict requirements for occupational safety.

4. Regulations on working in the laboratory:

The bio-safety laboratory level II shall meet all the requirements stipulated in Clause 4, Article 3 hereof and the following provisions:

Any practices that cause splashing of droplets and aerosol shall be performed in the bio-safety cabinet except in some cases where the staff use specialty laboratory equipment or other protective methods stipulated in Circular No. 41/2016/TT-BYT dated November 14, 2016 of the Ministry of Health on promulgating a list of microorganisms that cause infectious diseases and are classified into high-risk groups and bio-safety levels.

5. Regulations on decontamination, waste disposal and on prevention, handling and remediation of bio-safety problems.

The bio-safety laboratory level II shall meet all the requirements stipulated in Clause 5, Article 3 hereof and shall also disinfect or sterilize any wastes used during the test before taking them to the waste collection system or temporary waste storage.

Article 5: Regulations on biosafety level III practice

1. Entry and exit:

The bio-safety laboratory level III shall meet all the requirements stipulated in Clause 1, Article 4 hereof and shall also keep track of the people coming in and out of the laboratory including the following details: the person's name, time coming in and out of the laboratory.

2. Personal protective equipment and health supervision:

The bio-safety laboratory level III shall meet all requirements on personal protective equipment and health supervision which are stipulated in Clause 2, Article 4 hereof and the following provisions:

a. Use protective clothes that cover the front of the body, hats, enclosed shoes or use protective clothes that cover the entire body.

b. Wear double gloves while performing the test:

c. Any used protective clothes shall be disinfected before re-using them. Protective clothes shall be disinfected before wash.

3. Working area and equipment use:

The bio-safety laboratory level III shall meet all the requirements stipulated in Clause 3, Article 4 hereof and the following provisions:

a. Establish and follow the time tracking procedures for coming in and out of the laboratory.

b. The infrastructure and equipment of the laboratory shall be checked and maintained at least once a year.

4. Regulations on working in the laboratory:

The bio-safety laboratory level III shall meet all the requirements stipulated in Clause 4, Article 4 hereof, and the laboratory practices shall be performed in the bio-safety cabinet except in some cases where the staff use specialty laboratory equipment or other protective methods stipulated in Circular No. 41/2016/TT-BYT dated November 14, 2016 of the Minister of Health on promulgating a list of microorganisms that cause infectious diseases and are classified into high-risk groups and bio-safety levels.

5. Regulations on decontamination, waste disposal and on prevention, handling and remediation of bio-safety problems.

The bio-safety laboratory level III shall meet all the requirements stipulated in Clause 5, Article 4 hereof and the following provisions:

a. Infectious substance shall be sterilized in the laboratory.

b. The entire laboratory shall be disinfected at least once a year or when necessary.

c. Establish and follow the procedures for handling accidents or emergency situations in the laboratory.

d. Practice the procedures for handling accidents at least once a year.

Article 6: Regulations on biosafety level IV practice.

1. Entry and exit:

The bio-safety laboratory level IV shall meet all the requirements stipulated in Clause 1, Article 5 hereof:

2. Personal protective equipment and health supervision:

The bio-safety laboratory level IV shall meet all the requirements stipulated in Clause 2, Article 5 hereof and the following provisions:

a. When entering the laboratory, the employee shall change his/her clothes entirely into protective clothes at the changing room; before exiting the laboratory, the employee shall take a shower and take off protective clothes at the changing room.

b. Do not bring any personal belongings except glasses or contact-lenses when entering the laboratory

3. Working area and equipment use:

The bio-safety laboratory level IV shall meet all the requirements stipulated in Clause 3, Article 5 in this Circular:

4. Regulations on working in the laboratory:

The bio-safety laboratory level IV shall meet all the requirements stipulated in Clause 4, Article 5 hereof and the following provisions:

a. If there is an employee working in the laboratory, there shall be another employee standing outside to supervise and support him/her during emergency situations.

b. All the laboratory practices which are related to the infectious diseases shall be carried out in the bio-safety cabinet level III.

c. The employee working in the laboratory and the one supporting outside shall follow the contact procedures properly.

5. Regulations on decontamination, waste disposal and on prevention, handling and remediation of bio-safety problems

The bio-safety laboratory level IV shall meet all the requirements stipulated in Clause 5, Article 5 hereof and the following provisions:

a. Materials and equipment shall be transported inside and outside the laboratory using transportation containers which are disinfected with chemicals or sterilized with steam sterilizer equipment.

b. The infectious substance transported out of the laboratory shall be packed with two covers of uneasily broken materials which are decontaminated and approved as bio-safety materials by the responsible person.

c. Establish and follow the procedures for sterilization of equipment that cannot be sterilized by using steam sterilizer.

Article 7. Terms of reference.

In cases where the reference documents used in this Circular are replaced or amended, the replacing or amending document shall apply.

Article 8. Effect

1. This circular comes into force from December 15, 2017.

2. The Circular No. 25/2012/TT-BYT dated November 29, 2012 of the Minister of Health on promulgating national technical regulation on bio-safety in laboratories shall no longer be valid from the day this Circular comes into force.

Article 9. Implementation responsibilities

1. The Department of Preventive Medicine shall take charge and cooperate with the relevant Departments or units in:

a. Provide instructions on, inspecting and evaluating biosafety in laboratories nationwide.

b. Develop manuals of standard procedures for the laboratories.

2. The Departments of Health of provinces shall provide instructions on, inspect and evaluate bio-safety of laboratories in their provinces.

3. The laboratories shall:

a. Develop and approve professional procedures which are related to bio-safety in the laboratories.

b. Provide training and re-training programs for employees in accordance with the current regulations.

c. Comply with the provisions hereof and take full responsibility before the law for the unit's activities.

Any issue that arises during the implementation of this Circular should be reported to the Ministry of Health for consideration.

---------------

This document is handled by Luật Dương Gia. Document reference purposes only. Any comments, please send to email: dichvu@luatduonggia.vn