Circular No. 40/2018/TT-BYT on the management of infectious disease specimens

CIRCULAR

REGULATIONS ON THE MANAGEMENT OF SAMPLES OF INFECTIOUS DISEASES

       Pursuant to the Law on Prevention and Control of Infectious Diseases;No.       Pursuant to Decree No. 75/2017/NĐ-CP dated June 20, 2017, regarding the tasks, powers, and organizational structure of the Ministry of Health;

       At the proposal of the Director of the Preventive Medicine Department;17 of the Government on dutiesamend       The Minister of Health hereby promulgates this Circular on the management of samples of infectious diseases.

Article 1. This Circular stipulates the management of samples of infectious diseases for the purposes of prevention, research, diagnosis, and treatment of people, including: collection, preservation, packaging, storage, use, exchange, disposal, and transportation of samples of infectious diseases out of testing facilities.

Article 2. This Circular does not apply to samples that do not contain infectious substances or samples containing neutralized or inactivated infectious substances that cannot cause disease in humans, or blood and blood products used in blood transfusion activities.policies Article 3. This Circular applies to agencies, organizations, and individuals with functions and responsibilities for collecting, preserving, packaging, storing, using, exchanging, disposing of, and transporting samples of infectious diseases out of testing facilities.

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation and Applicability

Clause 1. Samples of infectious diseases include blood, serum, plasma, urine, feces, body fluids, other human samples containing infectious substances, microbial strains, and samples containing microorganisms capable of causing disease in humans.

Clause 2. An infectious substance is a substance that contains or has the potential to contain microorganisms (including viruses, bacteria, parasites, fungi) and prions that can cause infectious diseases in humans, including Category A and Category B.

Clause 3. An infectious substance of Category A is a substance that may cause life-threatening illnesses, death, or permanent disabilities upon exposure during transport, as specified in Appendix I attached hereto.

Article 2. Interpretation of Terms

In this Circular, the following terms shall be understood as follows:

Clause 4. An infectious substance of Category B is an infectious substance not included in the list of Category A infectious substances as specified in Clause 3 of this Article.

Clause 5. UN 2814 is an abbreviation for "United Nations 2814," the United Nations code applied in the transport of Category A infectious substances.

Clause 6. UN 3373 is an abbreviation for "United Nations 3373," the United Nations code applied in the transport of Category B infectious substances.

Clause 7. Class 6.2 is a special classification category for infectious substances according to United Nations guidelines.

Clause 8. A culture sample is a sample obtained from the deliberate multiplication process of the pathogen.

REGULATIONS ON THE COLLECTION, PRESERVATION, PACKAGING, TRANSPORTATION, STORAGE, USE, RESEARCH, EXCHANGE, AND DISPOSAL OF SAMPLES OF INFECTIOUS DISEASES

Article 3. Collection of Samples of Infectious Diseases

Clause 1. The collection of samples of infectious diseases must comply strictly with professional technical procedures and prevent infection to the person collecting the sample, the person from whom the sample is collected, related persons, community, and environment.

Chapter II

Clause 2. When collecting samples of infectious diseases, the collector must complete all information on the Information Form accompanying the sample as prescribed in Appendix II attached hereto and submit the form along with the sample.

Article 3. Collection of disease samples

1. The collection of disease samples must comply with the professional technical procedures and prevent infection to the sample collector, the person from whom the sample is taken, other related individuals, the community, and the environment.

2. When collecting disease samples, the collector must complete all information on the Information Form accompanying the sample in accordance with Appendix II issued together with this Circular and submit the form along with the disease sample.

Article 4. Preservation and Packaging of Biological Samples

1. Biological samples must be preserved according to the provisions set out in Appendix III attached hereto before being transported to the testing facility.

2. The packaging of biological samples containing or suspected to contain Category A or B infectious substances shall comply with the provisions set out in Appendix IV attached hereto.

Article 5. Labeling of Biological Samples

1. Each test tube or container holding a biological sample shall bear labels containing the following information:

a) Name or code number of the person from whom the sample was taken;

b) Type of biological sample (e.g., whole blood, serum, plasma, urine, feces, cerebrospinal fluid, or other types of biological samples);

c) Time of sample collection (including hour, day, month, year).

In cases where coding methods are used, all required information as stipulated herein must be ensured.

2. The outermost label shall include the following information:

a) Name, telephone number, and address of the sender;

b) Telephone number of the responsible person (in case of intermediary delivery);

c) Name, telephone number, and address of the receiving facility (unit);

d) Suitable codes as prescribed by the United Nations for international and domestic transportation;

đ) Required storage temperature;

e) If dry ice or liquid nitrogen is used, the name of the refrigerant, its code as prescribed by the United Nations, and net weight must be stated;

g) Classification labels for the transport of biological samples appropriate to each type of infectious substance as prescribed in Appendix V attached hereto.

Article 6. Transportation of Biological Samples

1. The unit collecting biological samples must notify the laboratory or receiving facility about the type of biological sample; date of dispatch; mode of transportation; and estimated time of arrival at the receiving unit.

2. Biological samples must be preserved according to the provisions set out in Appendix III attached hereto throughout the transportation process to the testing facility.

3. Dimensions, weight, and volume of packaging for biological samples transported by air:

a) For biological samples containing Category A infectious substances: Each package of liquid biological samples on passenger aircraft shall not exceed 50 ml, and on cargo aircraft shall not exceed 04 liters. Each package of solid biological samples on passenger aircraft shall not exceed 50 grams, and on cargo aircraft shall not exceed 04 kilograms;

b) For biological samples containing Category B infectious substances: Each package of liquid biological samples shall not exceed 01 liter, and the total volume of packages after packaging shall not exceed 04 liters. Each package of solid biological samples shall not exceed 04 kilograms per package.

4. Transportation of biological samples by sea, road, or rail: Each external package must have a minimum size of 100 mm x 100 mm on each side, with no maximum size limit.

5. The carrier of biological samples must use available equipment and tools to prevent the spread of infectious agents to people and the environment.

Article 7. Handling Spills of Biological Samples During Transportation

1. Handling of spills must be carried out according to the spill handling procedures set out in Appendix VI attached hereto.

2. The carrier of biological samples must contact the receiving unit or the sending unit or the nearest healthcare facility for guidance on handling measures.

3. In cases of direct exposure to infectious material, the exposed area must be thoroughly washed with soap and water or a disinfectant, and the exposed individual must be immediately taken to the nearest healthcare facility for consultation and treatment.

4. After implementing the handling measures as stipulated in Clause 2 and Clause 3 of this Article, the person carrying out the handling must report the incident to the sending unit. In cases involving Category A infectious substances, immediate notification must also be made to the Health Department in the area where the incident occurred.

Article 8. Receiving, using, and storing specimen samples

1. After receiving the notification from the unit sending the sample, the laboratory must arrange for staff to receive it. When receiving the specimen sample, the person responsible for receiving the sample must comply with the laboratory's regulations on opening the sample container, recording the time of receipt, the name of the receiver, the condition of the sample upon receipt, and comparing the acceptance or rejection criteria set by the receiving facility.

2. The receiving facility shall conduct testing according to specialized technical procedures for each type of specimen and the purpose of using the specimen sample.

3. Specimen samples stored must be preserved to ensure protection against human infection and environmental contamination.

4. The receiving, using, and storing of specimen samples must ensure biosafety in accordance with Circular No. 37/2017/TT-BYT dated September 25, 2017, issued by the Minister of Health regarding biosafety practices in laboratories.

Article 9. Disposal of specimen samples

The disposal of specimen samples must be carried out in accordance with the regulations on handling hazardous medical waste as stipulated in Circular No. 37/2017/TT-BYT dated September 25, 2017, issued by the Minister of Health regarding biosafety practices in laboratories, and Joint Circular No. 58/2015/TTLT-BYT-BTNMT dated December 31, 2015, issued by the Ministry of Health and the Ministry of Natural Resources and Environment regarding the management of medical waste.

Chapter III

IMPLEMENTING PROVISIONS

Article 10. Effective Date

1. This Circular takes effect from January 25, 2019.

2. In cases where the legal normative documents cited in this Circular are amended, supplemented, or replaced, they shall be implemented in accordance with the amended, supplemented, or replaced legal normative documents.

Article 11. Responsibility for Implementation

1. The Preventive Medicine Department shall be responsible for organizing and supervising the implementation of this Circular.

2. The Department of Medical Examination and Treatment; the Department of Science, Technology, and Training shall cooperate with the Preventive Medicine Department to provide guidance and supervision on the research, use, and storage of specimen samples by organizations and individuals.

3. The Inspectorate of the Ministry of Health shall cooperate with relevant Departments and Bureaus under the Ministry of Health to inspect and audit nationwide activities related to the transportation, preservation, storage, use, research, exchange, and disposal of specimen samples associated with infectious disease agents.

4. Provincial Health Services under centrally governed cities shall inspect and audit at the local level activities related to the collection, transportation, preservation, storage, use, research, exchange, and disposal of specimen samples associated with infectious disease agents.

5. Institutes of Hygiene and Epidemiology, Pasteur Institutes under the Ministry of Health, Centers for Preventive Medicine/Disease Control Centers of provinces and centrally governed cities, hospitals, agencies, organizations, and individuals involved shall be responsible for implementing this Circular.

During the process of implementation, if there are difficulties or obstacles, agencies, organizations, and individuals shall report to the Ministry of Health (Preventive Medicine Department) for consideration and resolution./.