An excellent teleconference on what to expect during an EPA hospital audit was presented by Hospitals for a Healthy Environment on January 14, 2005. The information was focused on USEPA Region 2 (New York, New Jersey, the Virgin Islands, and Puerto Rico) but has applicability across the country. John Gorman, Chief, Compliance Assistance, USEPA Region 2, noted that of the 480 hospitals in the region, 44 have been inspected to date, resulting in 22 enforcement actions. Nine formal enforcement actions resulted in proposed fines of $911,018 and six settlements were reached for a total of $404,000 in fines.

Thirty-seven hospitals signed audit agreements in which they agree to self-disclose and correct violations through a self-audit process, thereby mitigating potential fines. These have resulted in 81 voluntary disclosures to date. Potential fines of $8,956,016 have been avoided in 49 cases which have been resolved to date. 1100 violations have been corrected. The audits are “multi-media,” meaning they include an inspection by two or more environmental programs, such as air, water, and hazardous waste, at the same time. In the RCRA hazardous waste program alone, which is of most concern regarding pharmaceutical waste, more than 3,960 lb/year of hazardous waste is now being managed properly because of self-disclosure and correct management.

Typical hazardous waste questions include the following:

• Did the facility identify all their hazardous waste? (Pharmaceutical waste is an important part of this question.)
  
  
• How much hazardous waste does the facility generate on a monthly basis?
  
  
• Is the facility properly managing and disposing of its hazardous waste?
  
  
• Is the facility storing hazardous materials safely?
  
  
• Are hospital staff adequately trained in hazardous waste management?
  
  
• Is the hospital prepared for emergencies? (Related to hazardous spills, etc.)
  
  
• Does the hospital have required records?
  
  

The teleconference also included common hazardous waste issues found at hospitals and provided numerous resources to help hospitals address these issues.

To address these concerns, hospitals often contract with an environmental consulting firm to do a complete review of all media in all departments. The piece of the puzzle that is often not well understood is pharmaceutical waste. That’s where PharmEcology Associates, LLC can provide invaluable guidance and specific drug product information to assure identification, segregation, and proper management of all pharmaceutical waste.

For more information, contact us at info@pharmecology.com or at 262-814-2635. For complete information on the EPA presentation including the PowerPoint presentations and additional resources, visit the Hospitals for a Healthy Environment teleconference RCRA for Hospitals - What to expect when an EPA Inspector comes to your door