Circular No. 08/2011/TT-BNNPTNT stipulates the procedures and formalities for evaluating and recognizing aquatic disease diagnostic and testing laboratories.

CIRCULAR

Regulations on the procedures and processes for evaluating and recognizing aquatic disease diagnostic and testing laboratories

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Pursuant to the Veterinary Law dated April 29, 2004;

Pursuant to Decree No. 01/2008/ND-CP dated January 3, 2008, of the Government stipulating the functions, tasks, and organizational structure of the Ministry of Agriculture and Rural Development; Decree No. 75/2009/ND-CP dated September 10, 2009, of the Government amending Article 3 of Decree No. 01/2008/ND-CP dated January 3, 2008;

Pursuant to Decree No. 33/2005/ND-CP dated March 15, 2005, of the Government detailing the implementation of certain provisions of the Animal Health Ordinance; Decree No. 119/2008/ND-CP dated November 28, 2008, of the Government amending and supplementing certain articles of Decree No. 33/2005/ND-CP;

The Ministry of Agriculture and Rural Development issues this Circular stipulating the procedures and processes for evaluating and recognizing aquatic disease diagnostic and testing laboratories as follows:

PART I

GENERAL PROVISIONS

Article 1. Scope and Applicability

1. This Circular stipulates the procedures and processes for evaluating and issuing a Certificate of Recognition of Diagnostic and Testing Capacity for Aquatic Diseases (hereinafter referred to collectively as the Certificate) to laboratories with the function of diagnosing and testing aquatic diseases.

2. The subjects to which this Circular applies are organizations and individuals in Vietnam; foreign organizations and individuals having diagnostic and testing laboratories for aquatic diseases (hereinafter referred to as testing laboratories) on Vietnamese territory that are conducting diagnostic and testing activities for aquatic diseases.

Article 2. Explanation of terms

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

1. Proficient testing: is the performance of testing on the same sample by two or more testing laboratories under predetermined conditions to assess the ability to produce consistent results from such testing.

2. Laboratory evaluation: is the activity of inspecting and reviewing the suitability of the quality management system and analytical capacity for each disease index compared to specific regulations or standards.

3. Polymerase Chain Reaction (PCR) technique: is a molecular biology technique aimed at amplifying (producing multiple copies) a DNA segment in a test tube simulating the DNA synthesis machinery of living cells.

Article 3. Forms of Evaluation

1. Initial evaluation, applicable in the following cases:

a) A laboratory applying for initial evaluation and recognition;

b) The Certificate of a laboratory has expired.

2. Re-evaluation, applicable in the following cases:

a) A laboratory that has been initially evaluated but does not meet the conditions for issuance of the Certificate;

b) A laboratory that has been issued the Certificate but has changed its place of operation;

c) A laboratory whose Certificate has been suspended;

d) A laboratory that has been issued the Certificate but has changed ownership; or has changed the location of the Electrophoresis Room (one of the laboratories within the testing laboratory using PCR technology);

e) A laboratory that has been issued the Certificate but has changed major equipment or analytical methods affecting the test results.

3. Evaluation for extending the validity period of the Certificate: three (3) months before the expiration date of the Certificate, the laboratory must resubmit an application for extension.

4. Expanded evaluation, applicable to laboratories that have been issued the Certificate but have submitted applications requesting additional evaluations for new disease testing criteria or expanding the scope of testing for recognized criteria.

5. Unscheduled evaluation, conducted when there is a recommendation or indication of violation by the laboratory. Unscheduled evaluation is not announced to the laboratory beforehand.

6. Annual periodic evaluation, applicable to laboratories that have been issued the Certificate. Periodic evaluation is carried out according to a plan established and notified in writing by the Department of Animal Health to the laboratory.

Article 4. Evaluation Authority and Issuance of Certificate

1. The Veterinary Bureau shall be the authority to issue certificates recognizing diagnostic and testing capabilities for aquatic animal diseases as stipulated in this Circular. In specific cases, based on actual capacity, the Veterinary Bureau may delegate subordinate units to conduct inspection and evaluation of laboratories.

2. Where a laboratory has a certification confirming compliance with ISO/IEC 17025 standards or equivalent standards (referred to collectively as the Standard Certification) issued by authorized organizations and still valid, it does not need to register for evaluation with the Veterinary Bureau or can be recognized by the Veterinary Bureau according to the criteria already recognized by the aforementioned organizations (if necessary).

Article 5. Rights of Testing Laboratories

1. Testing laboratories that have been issued a certificate have the right:

a) To participate in monitoring programs and recognition of safe disease control laboratories for aquatic animals;

b) To engage in sample testing activities serving disease prevention and control work for aquatic animals;

c) To have their test results considered by competent authorities for exemption or reduction in sampling during aquatic animal quarantine inspections.

2. Specifically, for testing conducted to declare a disease outbreak as prescribed, it must be confirmed by the results of a laboratory under the Central Animal Health Diagnostic Center or Regional Animal Health Office.

Chapter II

TESTING LABORATORY FOR AQUATIC ANIMAL DISEASES

Article 6. Conditions for Testing Laboratories for Aquatic Animal Diseases

1. Testing laboratories must be constructed according to local planning or approved by competent authorities.

2. The minimum equipment of testing laboratories must meet all types of machines and devices specified in Appendix 1 or Appendix 2 attached to this Circular.

3. Regarding human resources:

a) There must be technical staff who have been issued a practice license for diagnosis and testing of diseases by the competent authority;

b) There must be at least two testing staff who are fisheries engineers; biology majors or aquatic animal pathology graduates or veterinarians but have participated and obtained certificates of completion from training courses on aquatic animal diseases organized by the Veterinary Bureau or other authorized training institutions.

4. Testing laboratories must establish regulations on hygiene and safety.

5. Personnel working in testing laboratories must be equipped with labor protection gear; there must be safety measures for those using thermal, electrical, mechanical, and pneumatic equipment.

6. Waste collection and treatment system:

a) The waste and wastewater treatment system must be designed appropriately for the testing laboratory to ensure the collection of waste and wastewater from all sources without causing pollution to the testing area and surrounding areas;

b) Each area within the testing laboratory must have appropriate waste containers that are easy to transport. Wastewater and waste must be treated to meet standards before being discharged into the environment;

c) Test samples or diseased specimens must be collected separately and handled in a manner that ensures no environmental pollution and prevents the spread of pathogens outside the environment.

Chapter III

PROCEDURES AND REQUIREMENTS FOR EVALUATION AND ISSUANCE OF CERTIFICATE FOR TESTING LABORATORIES FOR AQUATIC ANIMAL DISEASES

Article 7. Application Documents for Laboratory Evaluation

Testing laboratories submit one set of application documents to the Veterinary Bureau when:

1. Conducting initial evaluation as prescribed in Clause 1, Article 3 of this Circular, including:

a) An application form according to the model in Appendix 3 attached to this Circular;

b) A report on the operational capacity of the testing laboratory according to Appendix 4 attached to this Circular;

c) Copies of practice licenses and certificates of participation in relevant training courses of technical staff;

d) Diagnostic and testing procedures for diseases to be recognized, suitable for the equipment used;

e) Copies of establishment decisions along with the functions and tasks of the testing laboratory;

g) Copies of results from proficiency testing programs for the testing criteria being evaluated and recognized (if applicable).

(If the documents are in a foreign language, they must be translated into Vietnamese and certified)

2. For re-evaluation as prescribed in Point b, Clause 2, Article 3 of this Circular, the application documents include Points a and b of Clause 1 of this Article and reports on other changes in capacity and procedures (if any).

3. For re-evaluation as prescribed in Points a and c, Clause 2, Article 3 of this Circular, the documents include:

a) An application form according to the model in Appendix 3 attached to this Circular;

b) A report on corrective actions taken by the testing laboratory for non-conformities identified by the evaluation team and recorded in the evaluation record.

4. For re-evaluation as prescribed in Point d, Clause 2, Article 3 of this Circular, the documents include:

a) An application form according to the model in Appendix 3 attached to this Circular;

b) Relevant documents related to legal basis and establishment decisions of the testing laboratory (if ownership has changed);

c) Layout diagrams of the testing laboratory (if location has changed).

5. For re-evaluation as prescribed in Point e, Clause 2, Article 3 of this Circular, the documents include:

a) An application form according to the model in Appendix 3 attached to this Circular;

b) A report on new diagnostic and testing procedures or new equipment.

6. For re-evaluation to renew the Certificate as prescribed in Clause 3, Article 3 of this Circular, the documents include:

a) An application form according to the model in Appendix 3 attached to this Circular;

b) A report on operational activities during the validity period of the Certificate;

c) A report on changes in equipment and personnel compared to the original situation (if any), excluding changes covered by Points d and e, Clause 2, Article 3 of this Circular.

7. For expanded evaluation as prescribed in Clause 4, Article 3 of this Circular, the documents include:

a) Points a and d of Clause 1 of this Article;

b) Copies of certificates of recognized capacity that have been issued;

c) Point b of Clause 1 of this Article (in case the new testing criteria differ from the previously recognized group of criteria).

8. For the case prescribed in Clause 2, Article 4, the documents include:

a) An application form according to the model in Appendix 3 attached to this Circular;

b) Copies of the Standard Certification confirming compliance with ISO/IEC 17025 standards or equivalent standards issued by authorized organizations and still valid;

c) A report on the operational capacity of the testing laboratory according to Appendix 4 attached to this Circular.

9. For regular and ad hoc evaluations as prescribed in Clauses 5 and 6, Article 3 of this Circular: The Veterinary Bureau will proactively implement according to its plan or as assigned by the Bureau's leadership.

Article 8. Acceptance and Processing of Applications

1. Within one working day from the date of receipt of the registration application, the Animal Health Department shall check the validity of the application; if the application is invalid, it shall guide the laboratory to supplement the application in accordance with the regulations.

2. Within ten working days from the date of receipt of a valid application, the Animal Health Department shall review the application and establish an Inspection Team.

3. In cases of surprise inspections or regular inspections, upon the request of the specialized department, the Director of the Animal Health Department shall issue a decision to establish an Evaluation Team.

Article 9. Establishment of the Evaluation Team

1. The decision to establish the Evaluation Team must clearly state the scope, content of the evaluation, and the list and assignment of responsibilities for each member.

2. The composition of the Evaluation Team includes:

 a) Team Leader: A leader of the Animal Health Department or a leader of the specialized department of the Animal Health Department;

 b) Members: At least two people, including specialized officers of the Animal Health Department, specialized management agencies, or other relevant units.

 3. Within five working days from the date the Animal Health Department issues the Decision to establish the Team, the Evaluation Team must conduct the evaluation at the registered laboratory. The Animal Health Department shall notify the laboratory of the evaluation plan at least two days before conducting the evaluation (except in cases of surprise evaluations as stipulated in Clause 5, Article 3 of this Circular).

Article 10. Content of Evaluation

1. In the case stipulated in Clause 1, Point e, Clause 2, Article 3 of this Circular, the Evaluation Team shall inspect:

a) Compliance and suitability of the quality management system of the laboratory with the provisions of Article 6 of this Circular and current regulations on requirements for diagnostic and testing capabilities of aquatic disease laboratories;

b) Suitability of analytical methods/equipment for recognized disease indicators;

c) Diagnostic and testing capabilities meeting the requirements as guided by the Animal Health Department.

2. In the case stipulated in Point b, Clause 2, Article 3 of this Circular, the Evaluation Team shall inspect according to the provisions of Point a, Clause 1 of this Article.

3. In the case stipulated in Points a and c, Clause 2, Article 3 of this Circular: based on the inspection report from the previous inspection, the Evaluation Team shall re-inspect points that were not in compliance with the previous inspection.

4. In the case of extending the validity period of the Certificate as stipulated in Clause 3, Article 3 of this Circular: based on the results of periodic inspections or during the validity period of the Certificate, the Evaluation Team shall propose the content to be inspected (as stipulated in Clause 1 of this Article) for approval by the leadership of the Animal Health Department.

5. In the case stipulated in Clause 4, Article 3 of this Circular, based on the evaluation criteria registered, the Evaluation Team shall inspect according to the provisions of Point b, c or according to the provisions of Point c, Clause 1 of this Article.

6. In the case stipulated in Point d, Clause 2, Article 3 of this Circular: based on the changes in the laboratory, the Team Leader shall propose the content to be inspected for approval by the leadership of the Animal Health Department.

7. In the case stipulated in Clause 5, Article 3 of this Circular: based on the complaint content or questionable points, the Team Leader shall propose the content to be inspected for approval by the leadership of the Animal Health Department.

8. In the case of periodic evaluation as stipulated in Clause 6, Article 3 of this Circular: based on the annual operation results, the Team Leader shall propose the content to be inspected (one of the contents stipulated in Clause 1 of this Article) for approval by the leadership of the Animal Health Department.

9. In the case stipulated in Clause 2, Article 4 of this Circular: the Animal Health Department shall only consider and evaluate the application without needing to establish an Evaluation Team. If the application meets the requirements, the Certificate shall be issued as stipulated in Clause 2, Article 14 of this Circular.

Article 11. Evaluation Method

1. Interviewing directly the manager and technical staff of the laboratory.

2. Reviewing stored records, activity logs of the laboratory, and original certificates of technical staff participating in training courses.

3. Inspecting the actual layout, environmental conditions, equipment status, testing personnel operations, and other conditions of the Laboratory as stipulated in Article 6 of this Circular.

4. Evaluating the skills, methods, and test results of the laboratory personnel.

Article 12. Evaluation Results

1. The evaluation team reports the evaluation minutes at the final meeting (Annex 5). The evaluation minutes include all contents and signatures of representatives from the Laboratory and the Team Leader.

2. In case the Laboratory representative disagrees with the report of the evaluation team, they have the right to record their comments at the end of the minutes before signing and stamping. The evaluation minutes still have legal validity when signed by all present members of the evaluation team even if the Laboratory representative does not sign the minutes.

3. Within 10 (ten) days from the date of receiving samples, the laboratory sends the analysis results according to the model in Annex 6 issued together with this Circular to the evaluation team for result comparison and compilation of a report to the Animal Health Department leadership.

Article 13. Handling of Evaluation Results

Within 05 (five) working days from the date of receiving the complete file (including the evaluation minutes and test results), the Animal Health Department will review the evaluation results and take appropriate measures depending on each specific case as follows:

1. For laboratories that have not been granted a Certificate of Recognition for diagnostic and testing capabilities for aquatic animal diseases:

a) When the evaluation results meet the requirements as specified in Article 10 of this Circular, the Animal Health Department will issue or extend the Certificate of Recognition for the laboratory for the evaluated criteria according to the model in Annex 7 issued together with this Circular;

b) If the results do not meet the requirements, the Animal Health Department will notify the laboratory in writing and request them to rectify the non-compliant items within a specific period based on the specific circumstances;

c) In cases of re-evaluation as stipulated in Point c Clause 2 Article 3: if the re-evaluation results meet the requirements, the laboratory's revoked Certificate of Recognition will be reinstated.

2. For laboratories that have already been granted a Certificate of Recognition, applicable to regular and unscheduled evaluations:

a) If the evaluation results meet the requirements as specified in Article 12 of this Circular, the laboratory will maintain its recognition decision;

b) If the evaluation results do not meet the requirements, depending on the specific circumstances and severity, the evaluation team will report to the Animal Health Department leadership to require the laboratory to rectify or handle according to the provisions of Article 15 of this Circular.

3. For extended evaluation cases: if the evaluation results meet the requirements, the laboratory will be granted additional Certificates of Recognition for diagnostic and testing capabilities for aquatic animal diseases for the registered diseases.

4. For cases of extending the validity period of the Certificate of Recognition: Within 05 (five) working days from the date of receiving the valid extension application file of the laboratory, based on the regular evaluation results, the evaluation team will propose inspection content (not overlapping with the content inspected regularly in the year - if any) as stipulated in Clause 4 Article 10 of this Circular for approval by the Animal Health Department leadership. The inspection results will be handled according to the provisions of Clause 1 of this Article.

Article 14. Validity Period of the Certificate

1. The validity period of the Certificate for recognizing diagnostic and testing capabilities for aquatic diseases is three (3) years.

2. In cases where a laboratory has been issued a standard certificate according to Clause 2, Article 4, if the laboratory requests the Department of Animal Health to issue a recognition certificate, then the criteria, methods of recognition, and the validity period of this certificate shall be consistent with the recognized content and equal to the remaining validity period of the previously issued standard certificate.

Article 15. Suspension or Revocation of the Certificate's Effectiveness

1. Based on the results of periodic or ad hoc assessments or audits, upon the recommendation of the Assessment Team, the Department of Animal Health issues a decision to temporarily suspend the recognition scope for the laboratory until the laboratory completes the rectification of non-conformities.

2. The Certificate's effectiveness is revoked in the following cases:

a) The laboratory is found to have non-conformities that it cannot rectify or exceeds the rectification deadline without rectification;

b) The laboratory is dissolved or ceases operations within its recognized scope;

c) The laboratory is temporarily suspended but does not take corrective actions for non-conformities.

3. Based on the assessment report and the request document from the Assessment Team, the Department of Animal Health leadership issues a decision to revoke the previously announced Certificate's effectiveness.

Article 16. Complaints and Complaint Resolution

1. Complaints related to the assessment and recognition of laboratories are submitted to the Department of Animal Health for examination and resolution within its authority.

2. Complaints related to test results are submitted to the laboratory issuing those results. If dissatisfied with the laboratory's response, the complainant may continue to file a complaint with the Department of Animal Health for examination and resolution.

3. If the complainant disagrees with the resolution of the Department of Animal Health, they have the right to appeal to the Minister of Agriculture and Rural Development.

Chapter IV

FEES AND CHARGES

Article 17. Fees and Charges for Assessment

1. Collection and use of fees and charges for assessment and issuance of certificates for disease laboratories are carried out in accordance with current laws or agreements when there are no regulations.

2. Ad hoc inspections are not charged (except when implementing the provisions stipulated in Point c, Clause 1, Article 10 and the inspection results do not meet requirements).

3. In the case stipulated in Clause 2, Article 4 of this Circular: The Department of Animal Health only collects fees for issuing certificates.

Chapter V

RESPONSIBILITIES OF THE RELATED PARTIES

Article 18. The Animal Health Service Bureau

1. Develop and promulgate forms and guidelines for laboratory assessment and certification.

2. Organize and implement laboratory inspection and assessment activities.

3. Audit, assess, and guide the evaluation procedures for authorized units conducting evaluations and issuing certificates for laboratories.

4. Announce the list of recognized laboratories/cancelled recognition decisions on the Department of Animal Health’s website.

5. Manage and inspect recognized laboratories according to the prescribed periodic and ad hoc assessment frequencies under this Circular.

6. Organize and guide participation in proficiency testing or inter-laboratory programs for recognized laboratories.

7. Maintain confidentiality of information and data related to evaluated laboratories. Retain all relevant inspection and assessment files. Provide complete and accurate explanations of assessment results when requested by the Ministry of Agriculture and Rural Development.

8. Uniformly manage and organize professional training for members of the Assessment Team and laboratory staff. Guide and support laboratories in meeting current regulatory requirements.

Article 19. Members of the Evaluation Team

1. Assess and review the current capability status of the laboratory against existing standards and regulations.

2. Ensure objectivity in the evaluation process.

3. Report to the Animal Health Department's leadership for handling cases exceeding their authority as defined.

4. Maintain confidentiality of information related to the evaluated laboratory's secrets, complying with all current legal provisions.

5. Are permitted to interview, request examination of records, documents, and files related to the laboratory, collect and record necessary information, require performance of specialized tasks, and provide evidence to support the evaluation activities.

Article 20. Laboratory

1. Ensure the reliability and accuracy of test results for registered indicators.

2. Have the right to appeal the Evaluation Team's assessment results.

3. Facilitate conditions for Evaluation Team members during the inspection and evaluation process at the laboratory.

4. Develop plans to submit to competent authorities for approval of funding and participation in inter-laboratory proficiency testing sessions organized by the Animal Health Department or relevant agencies.

5. Report to the Animal Health Department about changes related to recognized content no later than 10 (ten) days from the date of change.

6. Annually, laboratories recognized must report to the Animal Health Department on testing activity status within the recognized scope every six months.

7. Pay fees and charges as prescribed.

Chapter VI

IMPLEMENTING PROVISIONS

Article 21. This Circular takes effect 45 days from the date of signature.

During implementation, if there are difficulties or obstacles, they are requested to reflect them to the Ministry of Agriculture and Rural Development for timely revision and supplementation./.