Circular No. 43/2011/TT-BYT on the management regime for infectious disease specimen samples

✦ 스마트 요약

Circular No. 43/2011/TT-BYT stipulates the management regime for infectious disease specimen samples, including collection, preservation, packaging, transportation, storage, use, research, and destruction. This Circular applies to agencies, organizations, and individuals with functions to carry out activities related to specimen samples containing Category A infectious substances.

적용 범위

Agencies, organizations, and individuals with functions to test, research, preserve, store, use, and destroy specimen samples; the Preventive Medicine Department; the Science and Training Department; the Inspectorate of the Ministry of Health; the Health Departments of provinces and centrally governed cities.

핵심 사항

The entity managing specimen samples containing Category A infectious substances must have the function as prescribed in Article 3 of this Circular and meet the Biosafety Laboratory Level III laboratory standard (Article 14).
Specimen samples after collection must be preserved in the specified environment and temperature, packaged separately, and not mixed with other types of goods (Article 6).
An entity importing or exporting specimen samples must have the function before being permitted to carry out these activities (Article 3).
The laboratory receiving specimen samples must record the date, time of receipt, and quality condition of the sample at the time of receipt (Article 10).
Specimen samples after use or upon expiration of their retention period must be destroyed according to Decision No. 43/2007/QĐ-BYT (Article 11).

🌐 이 문서의 사회적 영향

Positive impact: Ensures safety and prevents infection during the collection, transportation, and storage of specimen samples; Enhances medical waste management.
Negative impact: Increased costs for healthcare facilities due to compliance with packaging, preservation, and transportation regulations for specimen samples.

❓ 자주 묻는 질문

Which entities are permitted to manage specimen samples?

Entities with functions to test, research, preserve, store, use, and destroy specimen samples (Article 3).

How must specimen samples containing Category A infectious substances be packaged?

They must be packaged separately, not mixed with other types of goods, including three layers: tube or container holding the sample; bag, box, or protective wrapping; and outer box or protective case (Article 6).

Is there a limit to the transportation time for specimen samples?

Yes, the transportation time must be as short as possible but not exceed the preservation time specified in Article 5 of this Circular for each type of specimen sample (Article 8).

How should specimen samples be handled after use?

After use, specimen samples must be destroyed according to Decision No. 43/2007/QĐ-BYT (Article 11).

Which entities are responsible for inspecting the management of specimen samples?

The Preventive Medicine Department, the Department of Medical Examination and Treatment, the Science and Training Department, the Inspectorate of the Ministry of Health, and the Health Departments of provinces and centrally governed cities (Article 16).

전문

CIRCULAR

Regulations on the management of infectious disease specimen samples

__________________

Pursuant to Decree No. 188/2007/ND-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health, and Decree No. 22/2010/ND-CP dated March 9, 2010 of the Government amending and supplementing Clause 3 of Article 3 of Decree No. 188/2007/ND-CP dated December 27, 2007 of the Government stipulating the functions, tasks, powers, and organizational structure of the Ministry of Health;

Pursuant to Clause 3, Article 25 of the Law on Prevention of Infectious Diseases;

The Ministry of Health stipulates the management regime for specimen samples related to infectious disease pathogens and the conditions for facilities managing infectious disease specimen samples containing Category A infectious substances:

PART I

GENERAL PROVISIONS

Article 1. Scope of Regulation

This Circular stipulates the following contents:

1. Management of infectious disease specimen samples for purposes of research, diagnosis, treatment, and prevention includes the following activities:

a) Collection;

b) Preservation;

c) Packaging;

d) Transportation;

đ) Storage;

e) Use;

g) Exchange;

h) Disposal.

2. Conditions for facilities permitted to preserve, store, use, study, exchange, and dispose of specimen samples containing Category A infectious substances.

Article 2. Interpretation of Terms

In this Circular, the following terms are understood as follows:

1. Specimen sample includes blood, serum, plasma, urine, feces, body fluids, and other human specimen samples containing infectious substances, pathogenic microorganisms causing diseases in humans (hereinafter referred to collectively as specimen samples).

2. Infectious substance is a substance that contains or has the potential to contain pathogens causing infectious diseases in humans, including Category A and Category B.

3. Specimen sample containing Category A infectious substance (as listed in Appendix 1 attached hereto) is a specimen sample that, upon exposure, may cause life-threatening illnesses, death, or permanent disabilities in humans.

4. Specimen sample containing Category B infectious substance is a specimen sample containing infectious substances not included in the list of Category A infectious substances prescribed in Clause 3 of this Article.

Article 3. Facilities permitted to manage specimen samples

1. Organizations, institutions, and individuals with testing, research, preservation, storage, use, and disposal functions are permitted to collect, preserve, transport, export, import, test, store, and study specimen samples.

2. Organizations, institutions, and individuals importing, exporting, or transporting specimen samples must have the relevant functions to be permitted to carry out these activities.

3. Organizations, institutions, and individuals importing, exporting, transporting, testing, researching, preserving, storing, using, and disposing of specimen samples shall bear full responsibility under the law for the quality and safety of products and their activities.

Chapter II

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

Article 4. Collection of Specimen Samples

1. Persons collecting specimen samples must possess the skills for collecting specimen samples.

2. The collection of specimen samples must ensure safety and prevent infection for the collector, co-workers, laboratory staff, and patients.

3. The syndromes requiring specimen sample collection and the types of specimen samples to be collected are specified in Appendix 2 attached hereto.

4. Techniques for collecting specimen samples are specified in Appendix 3 attached hereto.

Article 5. Preservation of Biological Samples

Biological samples must be preserved in the environment and at the temperature specified in Appendix 4 attached to this Circular before being transported to the testing facility.

Article 6. Packaging of Biological Samples

1. Biological samples containing Category A and Category B infectious substances must be packaged separately from other goods, consisting of three layers:

a) The first layer (tube, bottle, container holding the biological sample) must ensure waterproofing, no leakage, and withstand temperatures ranging from -40°C to 55°C;

b) The second layer (bag, box, package) must ensure durability, waterproofing, no leakage, and withstand temperatures ranging from -40°C to 55°C;

Either the first or second layer must withstand pressure of 95kPa;

c) The outermost layer (box, crate) must ensure rigidity and withstand pressure, with an additional cushioning layer between the second and outermost layers. The minimum external dimension of each side is 10cm.

2. For liquid biological samples, there must be an absorbent material layer placed between the first and second layers to absorb the entire volume of the sample if it spills.

3. When multiple samples (already packaged in the first layer) are placed in the second layer, they must be separated to prevent contact between them.

4. For frozen preservatives, dry ice or other cooling agents should be placed around the second layer.

a) If dry ice is used, the outermost layer must not leak.

b) If dry ice is used, the outermost layer must have vent holes for CO2.

c) If liquid nitrogen is used, the first and second layers must withstand low temperatures.

5. The packaging materials for the first and second layers must withstand the storage temperature of the samples.

6. Dehydrated biological samples can be contained in the first layer using sealed glass tubes or glass bottles with rubber stoppers.

Article 7. Labeling of Packages and Testing Forms

1. Attach labels to each tube containing biological samples, including the following information:

a) Patient's name, age;

b) Code number;

c) Type of biological sample (e.g., blood, serum, cerebrospinal fluid, or other types of biological samples), date of collection;

2. Attach labels to the transport packaging, including the following information:

a) Name and address of the sender;

b) Contact phone number of the responsible person familiar with the shipment;

c) Name and address of the recipient;

d) Appropriate code according to United Nations regulations (UN2814 for Category A infectious substances or UN3373 for Category B infectious substances);

đ) Required storage temperature;

e) If dry ice or liquid nitrogen is used, specify the cooling agent, UN code, and net weight;

g) Attach appropriate transport labels for each type of product as specified in Appendix 5 attached to this Circular.

3. For biological samples containing Category A infectious substances, a list of samples must be placed between the second and outermost layers. If suspected of containing Category A infectious substances, clearly mark "Suspected Category A Infectious Substance" in parentheses.

4. Complete all required information on the testing form specified in Appendix 6 attached to this Circular and send it along with the biological samples.

Article 8. Transport of Biological Samples

1. The sampling unit informs the laboratory of the date of sending the biological samples, mode of transportation, and expected arrival time at the laboratory.

2. The sampling unit selects the mode of transportation, ensuring the shortest possible transit time without exceeding the preservation time specified in Article 5 of this Circular for each type of biological sample.

3. Modes of transportation: air, sea, road, rail

a) Air transport:

- For biological samples containing Category A infectious substances:

+ Each package maximum 50ml or 50g for passenger aircraft;

+ Each package maximum 4 liters (liquid) or 4kg (solid) for cargo aircraft.

- For biological samples containing Category B infectious substances:

+ For liquids: One unit of biological sample not more than 1 liter, packaged biological sample not more than 4 liters;

+ For solids (excluding body parts and internal organs): Packaged biological sample not more than 4kg/package.

b) Road, rail, sea transport: There is no limit on the weight of each package of biological samples.

Article 9. Handling Spills During Transportation

1. The affected area must be cleaned or disinfected, sanitized as soon as possible regardless of the agent involved.

2. When infectious material comes into contact with damaged skin, it must be washed thoroughly with soap and water or with a disinfectant, sanitizer, and immediately seek medical advice and treatment at the nearest healthcare facility.

3. Procedures for handling spills:

a) Isolate the spill area;

b) Wear gloves, protective clothing, masks, or goggles according to the type of pathogen;

c) Cover the entire spill area with absorbent fabric or paper;

d) Apply appropriate disinfectant, sanitizer onto the absorbent fabric or paper (from outside to inside);

đ) Clean up after approximately 30 minutes, collect contaminated materials into leak-proof waste containers (if there are glass or sharp objects, they must be placed in sharps containers for disposal).

4. After disinfection and sanitization, the person responsible must report the incident to the transportation agency's leadership.

Article 10. Receiving, Testing, and Storing Specimen Samples

1. Upon receiving notification from the sample-sending unit, the laboratory must promptly arrange to receive the specimen samples. Upon receipt, record the date, time, name of the receiver, and note the quality condition of the specimen at the time of receipt.

2. Conduct testing according to technical procedures for each type of specimen and testing purpose.

3. Specimen samples, viruses, bacteria stored for research purposes must be preserved according to regulations for each type of pathogen, regularly check temperature and condition of the samples.

Article 11. Disposal of Specimen Samples

Specimen samples after use, study, or expiration of storage period must be disposed of in accordance with Decision No. 43/2007/QĐ-BYT dated November 30, 2007 of the Ministry of Health on the issuance of regulations on medical waste management and related laws.

Chapter III

REGULATIONS ON FILES AND PROCEDURES FOR IMPORTING AND EXPORTING SPECIMEN SAMPLES

Article 12. Files for Importing and Exporting Specimen Samples

1. A letter requesting importation or exportation of specimen samples according to the form prescribed in Appendix 7 issued together with this Circular.

2. Documentation proving the need for importing or exporting specimen samples includes: copies of decisions approving the project or research topic implementation (at the ministry level or provincial level and above) and approved research outlines or agreements between domestic and foreign institutions related to the importation or exportation of specimen samples.

3. Copies of business registration certificates, establishment decisions, or other documents proving the entity's functions of exportation, importation, research, storage, preservation, transportation, and testing of specimens.

4. In cases where an entity authorized under Clause 1, Article 3 of this Circular to conduct research delegates another entity with functions of exportation and importation under Clause 2, Article 3 of this Circular to import or export specimen samples, the file must include a contract signed between both parties.

Article 13. Procedures for Submitting and Processing Applications for Importing and Exporting Specimen Samples

1. Entities requesting importation or exportation of specimen samples submit their files to the Ministry of Health (Preventive Medicine Department).

2. Within ten working days from the date of receipt of complete and valid files, the Preventive Medicine Department will review and respond in writing whether to grant permission for the importation or exportation of specimen samples.

Chapter IV

CONDITIONS FOR FACILITIES MANAGING SAMPLES OF INFECTIOUS AGENTS CATEGORY A

Article 14. Conditions for facilities storing, retaining, using, researching, exchanging, and destroying samples of infectious agents category A

1. Facilities managing samples of infectious agents category A must have the functions specified in Clause 1, Article 3 of this Circular and meet the Biosafety Laboratory Level III standards as prescribed in Decree No. 92/2010/NĐ-CP dated August 30, 2010 of the Government detailing the implementation of the Law on Prevention and Control of Infectious Diseases regarding biosafety in laboratories and related guiding documents.

2. Laboratories meeting Biosafety Level II standards may only temporarily retain samples of infectious agents category A, and must transfer them to laboratories meeting Biosafety Level III standards as soon as possible thereafter.

Chapter V

IMPLEMENTING PROVISIONS

Article 15. Implementation Provisions

This Circular takes effect from January 15, 2012.

Article 16. Responsibility for Organization and Implementation

1. The Preventive Medicine Department is responsible for receiving applications and coordinating with other departments to review and issue export and import permits for samples related to infectious disease agents; regularly and spot-checking the research, storage, transportation, retention, and destruction of samples by organizations and individuals.

2. The Medical Examination and Treatment Management Department and the Science and Training Department coordinate with the Preventive Medicine Department to guide and inspect the research, use, and retention of samples by organizations and individuals.

3. The Inspectorate of the Ministry of Health coordinates with functional departments under the Ministry of Health to conduct inspections and audits nationwide on activities related to the import, export, transport, storage, retention, use, research, exchange, and destruction of samples associated with infectious disease agents.

4. Provincial Departments of Health under centrally governed cities implement inspections and audits locally on activities related to the transport, storage, retention, use, research, exchange, and destruction of samples associated with infectious disease agents.

5. Institutes of Hygiene and Epidemiology/Pasteur, provincial health centers under centrally governed cities, hospitals, agencies, organizations, and individuals with the function and conducting activities related to the storage, retention, use, research, import, export, transport, and destruction of samples associated with infectious disease agents shall comply strictly with legal regulations and bear full responsibility for their own activities./.