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U.S. Department of Health and Human Services

Science & Research

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Volume III - 1.5 Environmental Health & Safety Audit

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Other Laboratory Operations

Food and Drug Administration

DOCUMENT NO.:

III-03

VERSION NO.:1.4

Section 1 - Environmental Health & Safety

EFFECTIVE DATE:
04-19-04
REVISED: 01-29-13

Laboratories in ORA are inspected under the Administrative Quality Assurance Plan program (AQAP). Items that are inspected and evaluated during this inspection include:

  • Environmental (e.g. temperature, lighting, noise, tripping hazards, stable shelving, and odors); 
  • Housekeeping (e.g. neat storage areas, clear aisles, safe storage, trash disposal); 
  • Fire safety (e.g. emergency evacuation plan, emergency lights, clearance of combustibles from open flames and hot equipment);
  • Electrical (e.g. switch cover plates used, no power cord frays, permanent wiring used, GFCI used in wet areas, circuit breakers identified);
  • General laboratory safety (e.g. no food or drink in the laboratory, proper storage of chemicals, proper facility for solvent storage, no excess chemicals, certified hoods and Biosafety Cabinets, proper use of hoods, labels on chemicals and refrigerators,  hazard signage on laboratory doors, proper management of carcinogens, peroxide labels used, no mercury contamination, pipetting devices used, equipment is grounded, equipment operated under pressure inspected, glass under pressure taped) ;
  • Compressed Gas Safety (e.g. gas cylinders are labeled, secured, properly transported, and properly stored, correct regulators used);
  • Protective Equipment (e.g. laboratory coats, safety glasses, goggles, face shields, gloves, closed toe shoes, respirators, flushed eyewashes and safety showers, maintained first aid kits)
  • Radiation Safety (e.g. radiation safety plan and radiation safety officer, proper signage, spill kits, film badges used); and 
  • Waste management, including infectious, hazardous, select agent, radioactive, recycled, and universal wastes(e.g. regulated wastes properly managed, labeled, proper disposition and documentation)