Applying technical requirements of ISO/IEC 17025:2005 in the Zoonotic diseases testing laboratory. Discussion on the challenges M.A Motaung

Introduction Laboratory facilities are designated as basic – Biosafety Level (BSL1& 2), containment (BSL 3) and maximum containment (BSL4). Biological Safety Levels are a series of protections relegated to the activities that take place in particular biological labs. Biosafety level designations are based on the design features, construction, containment facilities, equipment, practices and operational procedures required for working with agents from the various risk groups.

Introduction Laboratory testing for non-infectious agents that pose a minimal potential threat to laboratory workers and the environment are generally considered BSL 1 (Escherichia coli) the lowest biosafety lab level.

Introduction A laboratory testing for potentially (zoonotic disease)deadly infectious agents e.g. Bovine Spongiform Encephalopathy (BSE) disease is designated as BSL3.

E.coli infection & symptoms Escherichia coli (E. coli) is a type of bacteria that normally live in the intestines of people and animals. Some types of E. coli can cause intestinal infection. Symptoms of intestinal infection include diarrhoea, abdominal pain, and fever. More severe cases can lead to bloody diarrhoea, dehydration, or even kidney failure. Contaminated food or water.

E.coli: Treatment Proper food preparation and good hygiene can greatly decrease the chances of developing an intestinal infection. Most cases of intestinal E. coli infection can be treated at home. Symptoms generally resolve within few days to a week.

BSE Disease Bovine Spongiform Encephalopathy. Commonly known as ‘Mad cow disease”. Affects the nervous system of the adult cattle. Has a long incubation period: Signs -four to six years. Zoonotic disease: can infect humans (consumption of milk, brain and spinal cord). Can be detected by post-mortem brain examination.

BSE symptoms and treatment Symptoms of BSE in cattle and humans are: Disorientation, Staring at imaginary objects, Decreased milk production in cattle, Loss of weight despite continued appetite. It is fatal in animals and human: No treatment.

Aim and objectives To highlight the challenges associated with introduction, implementation and maintenance of internationally recognised quality standard (ISO 17025) in laboratories testing for zoonotic diseases.

Study design BSL 3: BSE testing laboratory was compared to BSL 1: E.coli testing laboratory with respect to technical requirements Personnel, Accommodation & environmental monitoring, Sample testing and validation, Equipment.

Personnel (BSL 3)

Personnel BSL3 BSL1 Training and competency declaration procedures lengthy: 1 year. Entering and exiting the lab: red and green lights Showering. Training and competency declaration procedures: 3 months. Entering and exiting the laboratory normally No showering.

Personnel BSL 3 Laboratory BSL1 Laboratory

Personnel BSL3 BSL1 Uncomfortable. Comfortable. Special suits which covers the neck, arms, and legs, goggles & masks. Medical surveillance: vaccination to boost titre (BSE). Comfortable. Normal lab coat and gloves. No routine vaccinations.

Accommodation and environmental monitoring BSL3 BSL1 Negative pressure. Access restricted from untrained personnel/visitors. Vaccination of visitors. Room temperature. Personnel and visitors can access the laboratory. No vaccination of visitors.

Sample testing & validation BSL3 BSL1 Positive samples not easy to obtain for testing (SA free of BSE). Validation as per requirements not possible. Not all validation parameters established. Positive samples easy to obtain. Validation as per requirements. Validation parameters established.

Sample testing & validation BSL3 BSL1 Application import permit (PT/positive samples). Autoclave the samples after testing and incinerate. No application of import permit. Incinerate after testing.

Equipment BSL3 BSL1 Shut down during calibration & repairs. Schedule of calibration aligned with shutdown. Turn around time affected. No shut down during calibration & repairs. Calibration done anytime and as per schedule. Turn around time not affected.

Equipment BSL3 BSL1 Training of technicians calibrating equipment on access and exit of the facility (safety). Vaccination of technicians calibrating equipment. No training provided for technicians calibrating equipment (access and exit of the facility. No vaccination.

Conclusion & Recommendations It is important to know the differences in biosafety levels and their corresponding safety requirements. It has been observed that there are differences between laboratories testing for diseases classified as BSL 1 and BSL 3. Clauses such as 5.2; 5.3; 5.4 and 5.5 of the ISO/IEC 17025 are regarded as strenuous and challenging to implement in BSL 3 due to costs and risks in relation to BSL1.

Conclusion & Recommendations It is feasible to comply with ISO 17025 requirements in BSL1 and BSL3 laboratories. The procedures should be properly followed to avoid infections and to ensure containment of the diseases and regular medical surveillance monitoring to effectively ensure and assure quality of results produced without compromising personnel’s health.

Conclusion & Recommendations It is recommended that personnel working in BSL3 be compensated for discomfort to ease the burden posed by the biosecurity and biosafety requirements.

Acknowledgements DAFF ARC BSE and Microbiology Staff Dr Gcebe and Dr Sabeta

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