Applying laboratory quality management system ISO 15189 for regulatory purpose may well be applied to laboratories with Biosafety levels, as these relates to the virus threats P1 through P4;

  • Level I (P1): Known-characterized biological agents agents that are known to consistently cause disease in healthy adult humans but with minimal potential of hazard to laboratory personnel and the environment. The control level within the laboratory is safe, and autoclave provides decontamination within laboratory competent personnel.
     
  • Level II (P2): These are viruses that involves biological agents of moderate potential hazard to laboratory personnel and to the environment. These includes bacteria and viruses that cause mild disease to humans and are difficult to contaminate / spread by airborne. The contamination may occur through mucous and fluids exchange. The controls to access the laboratory are restricted to qualified personnel with precautionary measures.
     
  • Level III (P3): Life threatening applicable to medical-clinical, diagnostic, research, academia, pharmaceutical or production working with agents which may cause serious or potentially lethal effects through inhalation for which there is cure. Some of these includes West Nile, Bacillus anthracis, Salmonella typhi, SARS coronavirus, Yellow fever and others. The laboratory controls includes specific air filtration, directional air into the work rooms, restrictions when work in-progress, and rigorous biosafety measures apply.
     
  • Level IV (P4): When working with life threatening bio-agents for which there is no cure or treatment. These poses high risk to individuals byway of airborne or other means causing severe to fatal disease with no vaccines or treatments available. These includes Ebola, Smallpox (with 30-33% mortality), Anthrax, Organic viruses, Crimena-Congo hemorrhagic fever and other hemorrhagic fever agents. Controls are rigorous and sever includes those of P3 plus working in a self-containment suit and all that goes out (air, fluid, waste) needs be totally neutralized before arriving to the macro environment.  

For biosafe laboratories, an entity providing accreditation to specialty laboratories based ISO 15189 may well be an alternative to demonstrate competence with the necessary impartiality to demonstrate to others. Dr. Juan Jose Badiola, Delegate of the GOB operates a P3 laboratory center in Europe.

 

 

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