How are other hospitals preparing for an EPA audit.

1. How are other hospitals preparing for an EPA audit. Alisa Otteni Senior Project Manager URS Corporation 28 Corporate Drive, Suite 200 Clifton Park, New York 12065 Phone: (518) 688-0015 extension 232 Fax: (518) 688-0022 Email: Alisa_Otteni@URSCorp.com

2. Approaches Taken by Hospitals • Self Audit completed by internal staff • Media specific assessment and correction by internal staff or with help of consultant • Audit by outside consultant

3. Pros No external costs Learning experience for staff involved Usually quicker than hiring a consultant Cons Checklists obtained from most websites are usually too general for most staff Lack of knowledge of issues and of the regulations Not thorough Overlook potential issues If written document, it is unprotected (discoverable) Self Audit by Internal Staff

4. Pros No or lower external costs Staff gets hands-on experience and learn about issues and regulations at a slower pace. If using a consultant to assist, staff has an educated/reliable resource Cons Slow process –may take many months per media depending on staff availability. Although there maybe assistance from consultant, staff still lacks knowledge and may still miss issues. If written document, it is unprotected (discoverable) Media Specific Assessment

5. Pros Multi-media audit would be thorough for local, state, and federal regulations. Auditors are independent of the hospital departments/politics and understand the regulations. The written audit report would list issue, citation, and recommended corrective actions. Auditors would be familiar with healthcare industry and knowledgeable on BMPs. Cons External costs Needs legal counsel to ensure confidentiality Must have an action plan, staff, and financial resource to address and close issues brought up by the audit. Must have a strong Scope of Work in the proposal and an experienced consultant. Beware of junk/fluffy training, educational materials, and courses. Get recommendation from respected healthcare organizations. Audit by outside consultant

6. Repeated downfalls • Personnel typically responsibility for environmental compliance are not dedicated (wear many hats) and in most cases have little environmental experience/training (ie. Risk Managers, Safety Officers, Facilities Engineers) • Lack of financial support to closing out findings- equipment, training • Lack of Standard Operating Procedures (SOPs), or inadequate SOPs

7. Repeated downfalls (Cont.) • General lack of understanding past JCAHO: • facilities believe that JCAHO environmental guidelines are all they need to comply with. • However JCAHO is a framework only, and does not provide a comprehensive environmental review of the regulations that affect your facility.

8. Audits and their liability-are lawyers need for audits? • Pros • Provides liability protection on documents (not discoverable) • Knowledge and experience when negotiating/disclosing with the regulators • Limits employees with access to the actual audit document. • Cons • Can slows process as all correspondence is required to go through the lawyer • Audit is not able to be distributed to all employees that may be affected by it or who would need it to understand and act on closing a finding.

9. Common findings and troubles • Reverse Distribution-Who classifies the material as hazardous or non-hazardous? • Lead –Is it a hazardous waste or a financial appealing recycled material? • Picric acid (D003) - Why so many have it and do not know it? • Formaldehyde (U122) - Why to manage used or unused separately? • Anesthetic Gases – What kind of waste are they?

10. Reverse Distribution The regulatory issue is “Who determines the expired drugs are hazardous or non-hazardous waste.” • The RCRA regulations, in 40 CFR 262.11, require a generator to determine whether an item is a waste and, if so, whether it needs to be classified as a HW or a non-hazardous waste. Based on two EPA guidance letters to the industry (Merck, 1981; BFI Pharmaceutical, 1991), EPA considers an outdated drug to be a product until the decision is made to discard it. This interpretation enables pharmacies to ship outdated drugs as products to a Reverse Distributor if no decision has been made as to the product’s eligibility for return based on the manufacturers’ policies. At this point, the Reverse Distributor is making the determination of the product. • However, the EPA letters are clear that reverse distribution should not be used primarily as a waste management tool. Any items that are 1) inherently "waste-like" at the facility, or 2) for which the decision to discard has already been made by the facility or previously by the Reverse Distributor, cannot be shipped as products and must be managed according to the EPA’s Resource Conservation and Recovery Act (RCRA).

11. Lead • Lead is a characteristic (toxic) hazardous waste under RCRA. • Lead is also a valuable recyclable metal. Currently, the going rate is about $0.10 per pound in the Northeast and $0.14 per pound in the Southwest. • We found many hospital throwing lead shielding, lead lined wall board, bricked lead, small cylinders of lead from nuclear medicine in the solid waste. • During one audit, a hospital pulled the lead out of the construction debris dumpster and made a profit of $375.10 on the recycled lead.

12. Picric Acid (D003) • 15 of 17 hospitals audited have had Picric Acid that was partially or fully crystallized. • Bouin's fixative solution (also known as B-5 fixative) is used in the histology lab for fixing tissue and staining. This solution contains 9-25 % Formaldehyde (U122), 5% Acetic Acid; 5% Methanol (U154); < 1% Picric Acid; and the balance is water. It can either be purchase as a commercially pre-made solution or it can be prepared in the laboratory by mixing the appropriate amounts of the required ingredients. May labs have at one point made Bouin’s solution and have or had Picric Acid. • Picric Acid is shock and friction sensitive when dry. The Picric Acid in the Bouin's solution is considered saturated and is unlikely to form crystals under normal conditions of use and storage. Care should be taken to ensure that crystals are not allowed to form during use of the solution by wiping the threads of the container and cap after pouring. The picric acid and Bouin’s solution should be properly managed and stored and disposed of when it reaches its expiration date. • A complete chemical inventory and a thorough chemical sweep once a year should have identified this material.

13. Formaldehyde (U122) • Formaldehyde and Formalin is found in morgues, pathology labs, maternity, dialysis, and in the hazardous waste accumulation areas. Formalin is a mixture of typically 32-40 percent formaldehyde, water, and usually 10 percent methanol. 10% Formalin (i.e., a 4 percent formaldehyde solution) is often used for tissue fixation, or as a preservative holding solution for fixed tissues or organ specimens. • Most facility audited were managing used and unused formaldehyde and 10% Formalin the same way. • Once the Formaldehyde and Formalin solution has been used for its intended purpose and it is no longer considered a commercial product. It is a spent solution which does not possess the same constituents as the original unused solution; it is changed in nature from having been used and therefore, does not meet the criteria stated in the RCRA regulations at 40 CFR Part 261.33f. This means that the used solution is not a hazardous waste because it is not listed and it is not a characteristic hazardous waste. It does not have the RCRA characteristic of ignitability, corrsitivity, reactivity, or toxicity (40CFR 261.21 - 261.24).

14. Anesthetic Gases Exactly what waste type are anesthetic gases like fluoroethanes, isofluranes, and haloethanes? • They are not P- or U- listed wastes. • Based on a review of many MSDS they do not have the RCRA characteristic of ignitability, corrsitivity, reactivity, or toxicity (40CFR 261.21 - 261.24). • They do have air implications due to the Hazardous Air Pollutants (HAPs). • OSHA strictly manages for worker exposure and safety. • But in the end they usually are US DOT hazardous material Hazardous Class -2.1 Flammable Gases.

15. Achieving Compliance • Get top management commitment and sufficient support (personnel, equipment, training, and funding). • Implement an Environmental Management System (EMS) with Standard Operating Procedures (SOPs). • Conduct regular compliance audits • Get support and team with other healthcare organization like H2E.