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Quality Assurance Occupational Health and Safety

LATG Chapters 4 & 5. Quality Assurance Occupational Health and Safety. Chapter 4 – Quality Assurance. ongoing verification system for the various aspects of laboratory operation - provides confidence - ensures reliability. Good Laboratory Practice. FDA regulations

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Quality Assurance Occupational Health and Safety

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  1. LATG Chapters 4 & 5 Quality Assurance Occupational Health and Safety

  2. Chapter 4 – Quality Assurance • ongoing verification system for the various • aspects of laboratory operation • - provides confidence • - ensures reliability

  3. Good Laboratory Practice FDA regulations - must have a quality assurance unit - responsible for monitoring studies - members separate from personnel engaged in study

  4. Good Laboratory Practice • Requirements • Maintain a copy of master schedule indexed by test article • Maintain copies of all protocols • Inspect studies periodically • No deviations from approved protocol or SOP • Review final report for conformity • List available to FDA of methods of recording and indexing

  5. Good Laboratory Practice • Standard Operating Procedures ( SOPs) • Handling of test and control articles • Maintenance and calibration of equipment • Animal care • Animal room preparation • Test system observations

  6. SOPs • Laboratory tests • Handling of dead or moribund animals • Necropsy of animals • Collection and identification of specimens • Histopathology • Data handling, storage, and retrieval • - Transfer, placement, and identification of animals

  7. Good Laboratory Practice • Equipment Design • of appropriate design and capacity; function according to • protocol; located suitably • Maintenance and Calibration • written SOPs to cover equipment maintenance • actions to be taken for malfunction • designate personnel responsible for each operation • written records of maintenance to include dates and any revisions

  8. GLP • Animal Care • SOPs for feeding, handling, housing, and care • facilities for quarantine, health evaluations • ID, separate rooms for species • - analysis of feed and H2O

  9. Good Laboratory Practice • Protocol • each study must have an approved written protocol that indicates study objectives and all methods to be used • - all changes and reasons for changes must be documented and signed by the study director • Nonclinical Study • - all data recorded directly, promptly, in ink • - entries dated & signed; changes not to obscure original

  10. Components of a Good Quality Assurance Program • Procuring Animals • Animal Husbandry • Animal Health • Genetic Monitoring • Equipment Monitoring • Monitoring Climate • Microbial Monitoring of Environments • Monitoring Techniques

  11. Components Procuring Animals - specifications according to needs - suppliers in compliance with regulations Animal Husbandry - Feed (expiration dates; autoclavable; certified) - Water Quality ( automatic devices; RO; contaminant analysis) - Bedding (processed bedding best; lookout for dust; foreign materials, feces) - Disposal Services (timely and thorough; use discretion)

  12. Components Animal Health Microbial monitoring of live animals - 10 – 14 days to develop immune response* - serology - sample size = Loge (1.0 – C) C = confidence level Loge (1.0 – M) M = morbidity Sentinel Animals - should resemble study animals - immunocompetent - indirect association (soiled bedding; airborne transmission) - in place 3 – 6 weeks

  13. Components • Microbial Monitoring of Environments • - agar plates incubated for 24 hours at 37ºC (CFUs) • frequency tailored to need (mouse cage vs. dog run) • Equipment Monitoring • - autoclaves (autoclave tape; chemically treated paper) • - Bacillus stearothermophilus spores • - cage washers (adhesive plastic tape changes from • silver to black at 82 +/- 1ºC at 13 secs) *

  14. Components • - water bottles; filling stations; automatic watering system • - (test for Salmonella; Shigella; Pseudomonas; coliforms) • ventilated racks/hoods • (filter replacement; airflow; hoods certified)

  15. Components Monitoring Climate Ventilation: within microenvironment - elevated temp; humidity; ammonia increases susceptibility to infectious agents Noise: adverse effects > 85 dB - house noisy animals away from rodents and rabbits - hearing protection for humans - reduces fertility; audiogenic seizures - loud equipment away from animal rooms

  16. Components Illumination: > 75 foot-candles = retinal damage to albino animals - 30 foot-candles at one meter above floor adequate - 12/12 light cycle (changes detrimental to breeding)

  17. Components • Genetic Monitoring (inbred strains) • 1. It must be accurate and precise and therefore highly • reproducible • 2. It must be relatively easy to carry out • 3. It must be efficient • 4. It must be economical • done by qualified experienced technicians

  18. Components • Monitoring Techniques • Biochemical Markers – enzymes in animal tissue detected using electrophoresis and histochemical staining • Immune Markers – antigens found on cell surfaces erythrocyte & histocompatibility antigens common • Mandibular Morphometrics – measures size and shape • Breeding Performance – sudden increase in first litter size • Breeding Index • Lane Petters Q Index • Polymerase Chain Reaction ( PCR) – newest method utilizes DNA patterns *

  19. OccupationalHealth and Safety Chapter 5

  20. ILAR 1997 - Occupational Health and Safety in the Care and Use Of Research Animals Considered the standard by which all occupational health programs involving research animals are measured.

  21. Risk Assessment • Knowing what hazards are present, then determining • the level of protection necessary to minimize danger • Physical hazards (equipment, bites, sharps) • Chemical and biological (carcinogens; infectious agents) • Allergens • Zoonoses TRAINING !!

  22. Physical and Chemical Hazards • 1. Animal bites, scratches, kicks, related injuries • - know your species; proper handling • 2. Sharps – improper disposal • 3. Flammable materials • 4. Pressure vessels – cylinders chained; autoclaves • 5. Lighting • 6. Electricity – report defects

  23. Physical and Chemical Hazards • UV Radiation – eye & skin protection • 8. Lasers – protection from beams • 9. Ionizing Radiation - type, dose, half-life • - proper shielding, monitoring exposure, waste handling • 10. Housekeeping – safe work environment • 11. Ergonomic Hazards- lifting; repetitive motion • 12. Machinery – good maintenance

  24. Physical and Chemical Hazards 13. Noise – hearing protection 14. Chemicals – nature & quantity; mode and duration of exposure; MSDS ; fume hoods 15. Infectious Agents and DNA – virulence, pathogenicity, communicability, and route of spread

  25. Allergens Laboratory animal allergy (LAA) - MOST COMMON occupational health problem - dander, saliva & urine proteins Prevention - face mask - gloves/ washing hands - surgical gowns/ lab coats - filtered cage tops *

  26. Allergens - positive pressure air flow - HEPA filtered exhaust systems - frequent air changes - biological safety cabinets

  27. Zoonoses Diseases of animals transmissible to humans TB testing – NHPs Toxoplasmosis – pregnant women Immunizations Tetanus Rabies – random source dogs/cats; bats Vaccinia Hepatitis B – serum, blood, tissues from humans/apes

  28. Personal Protection Protective apparel – lab coats, safety goggles, face shields, gloves Special equipment - biological safety cabinets

  29. Personal Protection Respirators - toxic chemical vapors; gases - BSL 3 & 4 agents - allergies “fit test” for proper mask-to-face seal OSHA specifications

  30. Personal Protection Eye and Skin Protection - Safety glasses - Gloves – primary barrier (latex best)

  31. Personal Protection Biological Safety Cabinets Class I and II - air curtain creates barrier Class II - laminar flow or biosafety hood Class III- physical barrier prevents direct contact HEPA filters – * remove 99.97% of particulates 0.3 microns or larger Fume hood – for gaseous constituents

  32. Waste Disposal Must comply with institutional, local, state and federal regulations General waste – soiled bedding, carcasses from healthy animals Hazardous waste – toxic chemicals, infectious and radioactive materials, contaminated or diseased animal carcasses - separated from other waste - clearly identified (universal symbols) - use protective gloves and clothing

  33. Waste Disposal - packaged in leak resistant paper/cardboard, stainless steel, polymers - rigid , puncture resistant sealable containers for sharps - wet waste double bagged

  34. Waste Disposal Infectious waste – steam autoclaving best for decontaminating prior to removal from biocontainment area Incineration – best for treating large volumes of infectious waste Radioactive waste – separated ; labeled according to isotope and form Mixed waste – use caution for treatment

  35. Emergencies and First Aid Emergency plan to cover both humans and animals - evacuation routes - meeting places - facilities for medical treatment - procedures for reporting emergencies Assist injured Provide first aid Use resources (fire dept; medical help) Plan to evacuate and save animals

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