Pharmaceutical Waste Management: Compliance for Hospitals, Pharmacies, and Other Healthcare Facilities

Transcription

1 Presenting a live 90-minute webinar with interactive Q&A Pharmaceutical Waste Management: Compliance for Hospitals, Pharmacies, and Other Healthcare Facilities Leveraging Recent Environmental Enforcement Actions and Understanding Policy Shifts to Ensure Regulatory Compliance THURSDAY, JULY 30, pm Eastern 12pm Central 11am Mountain 10am Pacific Today s faculty features: Gregory W. Blount, Partner, Troutman Sanders, Atlanta Charlotte A. Smith, Senior Regulatory Advisor, WMSS PharmEcology Services, Houston Darrell J. Oman, Program Manager Consulting Services, Stericycle Environmental Solutions, Blaine, Minn. The audio portion of the conference may be accessed via the telephone or by using your computer's speakers. Please refer to the instructions ed to registrants for additional information. If you have any questions, please contact Customer Service at ext. 10.

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5 Pharmaceutical Waste Management: Compliance for Hospitals, Pharmacies, and Other Healthcare Facilities Gregory W. Blount, Esq., Troutman Sanders LLP Charlotte A. Smith, R. Ph., M.S., WM Sustainability Services, PharmEcology Services Darrell J. Oman, Stericycle Environmental Solutions July 30, 2015

6 Pharmaceutical Waste Management Gregory W. Blount Troutman Sanders LLP 6

7 Roadmap Resource Conservation and Recovery Act (RCRA) Basics What is pharmaceutical waste? Why are regulators concerned? How do RCRA and state programs cover this waste? Recent Enforcement Federal and state reform efforts 7

8 RCRA Basics Congress Enacted in 1976 Governs disposal of solid waste and hazardous waste; encourages waste minimization Drafted for industrial facilities, but applicable to medical facilities and retail pharmacies. Two types of Hazardous Waste: Characteristic exhibit one of four traits Toxicity, Ignitability, Reactivity, Corrosivity Listed Wastes: P List (acute) and U List (toxic) Regulated from Point of Generation through point of ultimate disposal. 8

9 What is Pharmaceutical Waste? May include dropped pills, compounding chemicals, Warfarin containers, expired Tylenol, nicotine replacement therapy, IV bags, vials, spill cleanup materials, medicated shampoo and cough drops Regulated by U.S. EPA and U.S. DEA Small amount are RCRA Hazardous Waste States may consider additional pharmaceuticals as hazardous waste (e.g., MN Lethality) CA Medical Waste Management Act Medical waste includes OTCs 9

10 Why Are Regulators Concerned with Pharmaceutical Waste? Why Now? New focus on drugs in the water supply (E.g., 2008 Associated Press Study; USGS Studies) Nicotine replacement therapy waste triggers LQG registration and heightened scrutiny Significant enforcement precedent in California and Connecticut U.S. EPA foot-dragging on RCRA reform and drug risk assessment per Inspector General RCRA ill-suited for retail and many health care providers ( Square peg in a round hole ) 10

11 EPA Regulation of Hazardous Waste Pharmaceuticals Managed under RCRA or more stringent state program 2008: U.S. EPA proposed to add hazardous waste pharmaceuticals to the Universal Waste rule Universal Waste : a subset of Hazardous Waste that have streamlined management standards. 2012: U.S. EPA rescinded the 2008 proposal Lack of tracking for shipments of hazardous waste pharmaceuticals Lack of notification by most handlers managing hazardous waste pharmaceuticals May 2012: Office of Inspector General recommended EPA establish a process for reviewing whether pharmaceuticals are hazardous waste. Expected Summer 2015: New U.S. EPA proposed rule related to hazardous waste pharmaceuticals 11

12 Patchwork of State Requirements States are not always consistent with U.S. EPA Some have adopted U.S. EPA guidance and exemptions; others have not E.g., empty containers do not count toward generator status Reverse Distribution Policies E.g., NM and MN State-specific requirements E.g., Waste Determinations E.g., CA-only Toxics; CA Medical Waste Management Act State Universal Pharmaceutical Waste Rules Florida and Michigan 12

13 Point of Generation Issues Waste Determination: If a pharmaceutical is a waste, the generator must determine whether it is hazardous. When does a pharmaceutical become a waste? At the retailer? At the Reverse Distribution facility? Confusion and risk for Retailers using Reverse Distribution for prescription pharmaceuticals If Nondispensed Pharmaceuticals Qualify for Reverse Distribution Procedures: Not subject to hazardous waste regulations If Pharmaceuticals do not Qualify for Reverse Distribution: Pharmaceutical waste must be managed as hazardous waste (storage, transportation, disposal, etc.) 13

14 Point of Generation Issues U.S. EPA s position Not binding Pharmaceutical products returned through reverse distribution do not become wastes until a determination is made to discard them. States are Inconsistent Most appear to embrace U.S. EPA s position Some are more stringent E.g., Minnesota; New Mexico; Colorado 14

15 Point of Generation Inconsistent Policies 15

16 Point of Generation Inconsistent Policies 16

17 Point of Generation Inconsistent Policies 17

18 RCRA Enforcement Common Misconception 18

19 RCRA Enforcement: Who is Liable? Hospitals; Retail Pharmacies; Retail Groceries; Manufacturers; Wholesalers; Reverse Distributors; Clinics; Surgery Centers; Veterinary Practices; Long term care facilities Federal and State liability Criminal and Civil liability U.S. EPA fines: Up to $37,500 violation/day. Potential Debarment or Suspension 19

20 Wal-Mart Plea Agreement U.S. DOJ in California and Missouri announced on May 28, 2013 Totaled $81 million Investigation began in approx Investigation focused primarily on retail and pharmaceutical hazardous waste mismanagement Retail Industry Leaders Association (RILA) Outreach 20

21 Retail Enforcement Cases 21

22 Retail Enforcement Cases 22

23 DATE OF SETTLEMENT Recent CA Hazardous Waste Enforcement Activity at Retail Facilities COMPANY NUMBER OF LOCATIONS PENALTY 4/3/2013 Save Mart Supermarkets 256 $2,550,000 ($9,961 per facility) 6/5/2013 Winco Foods 38 $375,000 ($9,868 per facility) 9/24/2013 Rite-Aid 590 $12,324,000 ($20,888 per facility) 6/4/2014 Albertsons 188 $3,387,000 ($18,016 per facility) 8/15/2014 Raley s 145 $1,599,000 ($11,028 per facility) 12/30/ Cents Only Stores 251 $2,362,500 ($9,412 per facility) 1/02/2015 Safeway 575 $9,870,000 ($17,165 per facility) 4/24/2015 Dollar Tree 512 $2,720,000 ($5,313 per facility) 23

24 Recent Hazardous Waste Enforcement Activity at Healthcare Facilities Concord Hospital, Concord, NH fined $205,000 by NH Department of Environmental Services in December Aurora Health Care, Milwaukee, WI settled hazardous waste case for $340,000 in May SUNY Downstate Medical Center, Brooklyn, NY fined $156,710 by U.S. EPA in August Danbury Hospital, Danbury, CT fined $41,855 by CT Department of Energy and Environmental Protection in September Sentara Norfolk General Hospital, VA settled with U.S. EPA for $19,920 in May

25 Current Reform Efforts Retailers and Healthcare are hopeful RCRA reform will provide clarity. Current reform efforts include: Generator rule change Pharmaceutical waste reform Retail waste reform California Medical Waste Management Act 25

26 Important Issues Noted by U.S. EPA as Expected for EPA s Proposed Rule Regulatory status of creditable pharmaceuticals Point of generation LQG status due to P-listed hazardous waste Better fix for containers with P-listed pharmaceutical residues Intersection of U.S. EPA and U.S. DEA regulations 26

27 Operationalizing the DEA and EPA Compliance Challenges Charlotte A Smith, R. Ph., M.S. WM Sustainability Services, PharmEcology Services Pharmaceutical Waste Management: Compliance for Hospitals, Pharmacies, and Other Healthcare Facilities July 30 th, 2015

28 Legal Disclaimer This course is solely for educational purposes and provides only a general description of various regulatory requirements. For a complete description, please consult the relevant federal and state regulatory statutes. Nothing in this presentation constitutes legal advice and you should not legally rely on any information provided in this presentation. We make no warranty, express or implied, with respect to such information and disclaim all liability resulting from any use or reliance of this information WM National Services, Inc. 28

29 Drug Enforcement Administration Stocking, dispensing, and disposing of controlled substances involves a high level of risk and regulation, as defined under the Controlled Substances Act (CSA) Healthcare facilities and pharmacies are registered with the DEA as registrants and must meet a variety of security and documentation requirements During the medication administration process in a hospital, ambulatory surgery center (ASC), or other medical clinic, it is common for wastage of controlled substances to occur Such wastage is usually documented in an automated dispensing cabinet at hospitals and may be documented manually in the ASC or clinic environment Retail pharmacies usually do not generate controlled substance waste but may have outdated controlled substances that must be managed through reverse distribution 2015 WM National Services, Inc. 29

30 The CSA Regulates Drugs of Abuse into Five Schedules Schedule I: Illegal substances not recognized for medical use, e.g. heroin, LSD, psilocybin, mescaline Schedule II: medically available under strict controls, high potential for abuse leading to severe psychological or physical dependence e.g. oxycodone, fentanyl, morphine, codeine, amphetamine. Designated as CII on label. Schedule III: medically available under somewhat less strick controls, moderate or low physical dependence, high psychological dependence e.g. codeine combination products, thiopental, anabolic steroids. Designated as CIII. Schedule IV: medically available, low potential for abuse, e.g. Xanax, Tranzene, Valium, Versed, Halcion Designated as CIV. Schedule V: Low potential for abuse and limited concentrations of narcotics e.g. codeine cough syrups. Designated as CV WM National Services, Inc. 30

31 The New DEA Disposal Regulation Published September 9 th, 2014; took effect October 9 th, 2014 Requirements to govern the secure disposal of controlled substances by both DEA registrants and ultimate users Regulations implement the Secure and Responsible Drug Disposal Act of 2010 Expands options for take-back events Creates mail-back programs and collection receptacle locations Reorganizes and consolidates regulations on disposal and role of reverse distributors 2015 WM National Services, Inc. 31

32 Healthcare Sectors Impacted by DEA Rule Changes Registrant Disposal Hospitals, clinics, physicians, veterinarians, dentists Retail Pharmacies including LTCF Provider Pharmacies Reverse Distributors Non-Registrant Disposal Ultimate User collection programs, including law enforcement Mail-back Receptacles (kiosks) Single day events Ultimate User long term care facilities (LTCFs) Receptacles provided and managed by retail pharmacies 2015 WM National Services, Inc. 32

33 Definition of Terms Disposal and dispose: to refer generally to the wide range of activities that result in CS being unavailable for further use or one entity ridding themselves of such substances (e.g., returns). (FR53547 col 2) A controlled substance can be disposed of by destruction, return, recall, sale, or through the manufacturing process. The new rule eliminates the authority of the Special Agent in Charge (SACs) to individually authorize disposal methods for non-practitioners, and retains this option for practitioners ( ) 2015 WM National Services, Inc. 33

34 Definition of Terms Methods of Destruction (FR col1): Intention to allow public and private entities to develop a variety of destruction methods that are secure, convenient, and responsible. Must also meet all other applicable Federal, State, tribal and local laws and regulations. Once nonretrievable, no longer subject to DEA regulations. Supersedes all existing MOAs and MOUs. Retains ability for practitioners to request assistance from the local special Agent in Charge (SAC). ( (a)(5)) WM National Services, Inc. 34

35 Definition of Terms Non-retrievable: the condition or state to which a controlled substance shall be rendered following a process that permanently alters that controlled substance s physical or chemical condition or state through irreversible means and thereby renders the controlled substance unavailable and unusable for all practical purposes. Cannot be transformed to a physical or chemical condition or state as a controlled substance or controlled substance analogue WM National Services, Inc. 35

36 Definition of Terms Destruction ( ): Must be rendered non-retrievable. Incineration is the ONLY method currently accepted by DEA. Sewering and landfill disposal (mixing with kitty litter, etc.) do not meet non-retrievable standard. (FR53547 col 3) The healthcare industry expressed serious concerns about how to meet this definition. DEA issued a clarification letter exempting administered medications from the new rule WM National Services, Inc. 36

37 Registrant Disposal Concerns Expressed to DEA Ability to render a drug non-retrievable in an institutional setting Ability to transfer drug wastage to a reverse distributor from an institutional setting Requirement to double witness the destruction of the CS until it is rendered non-retrievable 2015 WM National Services, Inc. 37

38 DEA Clarification Letter: October 17, 2014 once a controlled substance has been dispensed to a patient by an institutional practitioner on the basis of an order for immediate administration to a patient at the registrant's registered location, the substance is no longer in the practitioner's inventory. For example, after a pre-filled syringe or a single-dose vial or syringe is administered to a patient, any remaining substance in the syringe or vial is not required to be destroyed in accordance with new Part Such wastage cannot be disposed in a receptacle for ultimate user collection Controlled substances from the pharmacy s inventory cannot be disposed in a receptacle for ultimate user collection. All destruction must be in accordance with Federal, State, tribal, and local laws and regulations 2015 WM National Services, Inc. 38

39 DEA Clarification Letter: October 17, 2014 Although Part 1317 does not apply to pharmaceutical wastage, the DEA strongly encourages all practitioners to continue to adhere to security controls and procedures that ensure pharmaceutical wastage is not diverted. For example, most institutional practitioners have implemented policies that require two persons to witness and record destruction of pharmaceutical wastage. _practitioner_pharm_waste_ pdf 2015 WM National Services, Inc. 39

40 Disposal Options for Controlled Substance Waste VERY few controlled substances are EPA hazardous waste Chloral hydrate U034 Alcoholic formulations: diazepam injection, undiluted Consider using a method for discouraging diversion Cactus Smart Sink Activated carbon options DO NOT dispose in regular trash Pharmaceutical waste usually non-hazardous Drain dispose if permitted by state and local publicly owned treatment works DO NOT place into sharps or other waste container as is 2015 WM National Services, Inc. 40

41 Operationalizing the EPA Compliance Challenges Federal Regulations (c) WM National Services, Inc. 41

42 Defining Hazardous Within the Organization EPA Hazardous Waste: meets one of the definitions of hazardous waste federally or at the state level; must be a waste OSHA Hazardous Drug: a risk to employees due to occupational exposure; may be a product or a waste DOT Hazardous Material: a risk to health and safety while in transit; may be a product or a waste Biohazardous: meets the definition of an infectious risk at the state level; may be a product or a waste Regulated medical waste 2015 WM National Services, Inc. 42

43 Identifying Hazardous Pharmaceutical Waste Under RCRA P-listed pharmaceuticals (acutely hazardous) Sole active ingredient; unused; empty containers LD50 (oral) 50mg/kg Examples: nicotine, warfarin U-listed pharmaceuticals (toxic) Sole active ingredient; unused Examples: cyclophosphamide, mitomycin, lindane, selenium sulfide Pharmaceuticals that exhibit a characteristic of hazardous waste (D codes) Ignitability D001 Toxicity D004 D043 Corrosivity D002 Reactivity D WM National Services, Inc. 43

44 Examples of P-Listed Pharmaceutical Waste Arsenic trioxide (chemo) Epinephrine base* Nicotine Nitroglycerin** (weak) Phentermine (CIV)*** Physostigmine Physostigmine Salicylate Warfarin >0.3% P012 P042 P075 P081 P046 P204 P188 P001 * Salts excluded federally as of Oct. 15 th, 2007; most states have accepted this position ** Excluded from the P list federally and in most states ***Salts excluded federally, first communicated October, Most states have accepted this position 2015 WM National Services, Inc. 44

45 Examples of U-Listed Pharmaceutical Waste Chloral Hydrate(CIV) U034 Chlorambucil U035 Cyclophosphamide U058 Daunomycin U059 Lindane U129 Melphalan U150 Mitomycin C U010 Streptozotocin U206 Selenium Sulfide U205 *Italicized items are chemotherapy agents WM National Services, Inc. 45

46 Characteristic of Toxicity 40 chemicals which must be below specific leaching concentrations Fail the Toxicity Characteristic Leaching Procedure (TCLP) Must evaluate IVs, such as total parenteral nutrition (TPN) May come out of regulation due to dilution (chromium, selenium) Examples of potentially toxic pharmaceutical ingredients: Chromium D007 m-cresol D024 Mercury (Thimerosal) D009 Selenium D010 Silver D WM National Services, Inc. 46

47 Examples of Pharmaceuticals Exhibiting the Characteristic of Toxicity Multi-dose Flu Vaccine with thimerosal Fluzone Trivalent Multi-dose vial Human Insulin with m-cresol Humalog, Novolin Selenium and Chromium injectables Multi-vitamin/mineral preparation Centrum Silver (OTC) Silver Sulfadiazine Cream SSD Cream 2015 WM National Services, Inc. 47

48 Characteristic of Ignitability Aqueous solution containing 24% alcohol or more by volume and flash point < 140 F Non-aqueous solutions with flash points < 140 F Oxidizers Flammable aerosols e.g. Proventil Inhaler Hazardous waste code D001 Rubbing alcohol Topical preparations: Clindamycin Some injections: Paclitaxel 2015 WM National Services, Inc. 48

49 Definition of Empty To be RCRA empty, P-listed containers must be triple rinsed & rinsate discarded as hazardous waste; only used syringes excluded EPA regulation (in practice, no triple rinsing) The EPA requires P-listed wrappers & packaging to be managed as RCRA hazardous waste because of the residue remaining in them U-listed and D codes: empty if all contents removed that can be removed by normal means and no more than 3%, by weight, remaining Aerosols never considered empty 2015 WM National Services, Inc. 49

50 Pharmaceutical Waste Management Programs: Insuring Compliance Identifying relevant stakeholders COO, CNO (Chief Nursing Officer or comparable) Risk Management/Legal Director of Pharmacy Nurse Educators Infection Control Officer Environmental Health & Safety Officer Environmental Services Manager Obtaining buy-in from the C Suite down Appointing a Champion Developing a Core Team with a mandate 2015 WM National Services, Inc. 50

51 Determining Which Drugs Become a Hazardous Waste Utilize the services of a specialized consulting firm Initial Inventory Analysis followed by method for maintaining the waste categorization for new drugs entering the system 51

52 Small Percentage of Pharmacy Inventories Designate as Hazardous Waste Federally 2015 WM National Services, Inc. 52

53 Label the Shelves in Pharmacy Pharmacy Implementation Identify Choose Label Launch Hazardous Container Sizes Pharmacy Disposal in Waste and Locations Shelves Pharmacy 2015 WM National Services, Inc. 53

54 Role of Nursing in the Disposal of Pharmaceuticals Define prompts that will help nursing readily recognize hazardous pharmaceutical waste. Messages on automated dispensing cabinets dispensing screens Labeling bins / containers Messages on the electronic medication administration records (emars) and Bar Code Medication Administration (BCMA) dispensing screens Messages on medication labels Select size, type, and location of containers that will be used to dispose of pharmaceutical waste 2015 WM National Services, Inc. 54

55 Commonly Used Color Codes Hazardous Pharmaceutical Waste Non-Hazardous Pharmaceutical Waste Trace Chemotherapy Waste Regulated Medical Waste 2015 WM National Services, Inc. 55

56 Summary of Pharmaceutical Waste Streams: Acute Care Hospital Compatible Hazardous Waste* Aerosols Trace Chemo (Sharps) Trace Chemo (Soft) Non - Hazardous Drugs Red Sharps Municipal Solid Waste Sewer System * Dual waste for sharps P-listed (inc. containers) U-listed D-listed t toxic, Ignitable Bulk chemo Haz/Chemo spill clean up Ignitable aerosols Pressurized aerosols Empty vials and ampules Empty syringes and needles Empty IVs Gowns Gloves Tubing Wipes Packaging All non-hazardous pharmaceutical waste No biohazardous drugs No sharps Empty syringes, needles, ampules (except chemo) Bio-hazardous drugs Most packaging Most empty bottles and vials Most empty IVs Paper Plastic No drugs No P-waste containers IVs o Dextrose o Saline o Sterile Water o Lactated Ringer s o K salts o Ca salts o Mg salts Controlled substances? No other drugs Federally Permitted Hazardous Waste Incinerator Medical Waste Incinerator Municipal Incinerator Permitted for Special Waste (inc. drugs) Autoclave/ Microwave Publicly Owned Treatment Works ( POTW) Ash Ash Ash Shredded (Most states) Lined Hazardous Waste Landfill Lined Non-Hazardous Waste Landfill 2015 WM National Services, Inc. Water Supply

57 Next Steps Determination of Generator Status Recordkeeping and reporting requirements Training and emergency response requirements Planning for RCRA inspections/enforcement actions Lessons learned and best practices observed 2015 WM National Services, Inc. 57

58 Next Steps for Program Management, Planning for Inspections and Best Practices Pharmaceutical Waste Management: Compliance for Hospitals, Pharmacies, and Other Healthcare Facilities July 30, 2015 Darrell J. Oman; Program Manager Consulting Services Stericycle Environmental Solutions

59 Next Steps to Program Compliance 1. Identify and Evaluate All Waste Streams and determination of generator status 2. Collect and Store Hazardous Waste Properly 3. Train Employees 4. Prepare and Save Documentation 5. Know Emergency and Spill Response Procedures IMPORTANT REMINDER Your generator status determines compliance requirements Large Quantity Generator (LQG) Small Quantity Generator (SQG) Conditionally Exempt Small Quantity Generator (CESQG) 59

60 Next Steps Once you ve identified all waste streams and made determinations on which are hazardous waste streams then generator status is determined. Next file (with the state usually) a Notification of Regulated Waste Activity form and receive a site specific USEPA generator I.D. #. NOTE: generator status may change at any time due to: New waste stream(s) identified and generated Changes in monthly generation rate of wastes Therefore compliance requirements may change accordingly and immediately 60

61 RCRA Generator Status Under the Federal rules there are three classes of generators (NOTE: State/Local regulations may be more stringent). 1. Conditionally Exempt Small Quantity Generator (CESQG) Generate no more than 100 kg of hazardous waste, 1 kg of acutely hazardous waste, or 100 kg of contaminated waste from an acutely hazardous waste spill in a month. Accumulate no more than 1,000 kg of hazardous waste at any time. 2. Small Quantity Generator (SQG) Generate between 100 and 1,000 kg of hazardous waste and no more than 1 kg of acutely hazardous waste in one month. Accumulate no more than 6,000 kg of hazardous waste for up to 180 days (270 days if waste is to be transported over 200 miles). 3. Large Quantity Generator (LQG) Generate greater than 1,000 kg of hazardous waste or greater than 1 kg of acutely hazardous waste in one month. Accumulate greater than 6,000 kg of hazardous waste for up to 90 days. 61

62 Next Steps Collect and Store Waste Properly Satellite Accumulation Areas (know rules) Hazardous Waste Storage Area (know rules) Train Employees According to Job Responsibilities Within 6 Months of Hire or Job Change Annual Training Required for Some Generators (LQGs) Prepare and Save Documentation Inspections and Training Records Uniform Hazardous Waste Manifests 62

63 Waste Collection and Storage Hazardous Waste Containers Hazardous Waste Containers can be placed throughout a facility. Hazardous Waste Containers must be: under the control of the staff, near the point of waste generation AND closed unless being used. Containers in the Satellite Accumulation Areas (SAA) must be moved to the Hazardous Waste Storage Area within 3 days of becoming full. SAA Volume limits for P-List (1 quart ) and regular hazardous waste (55 gallons) Containers are then considered a Hazardous Waste Storage Container and must be shipped off-site within 90 days if a LQG and 180 days if a SQG. 63

64 Employee Training Personnel must be trained Employees whose responsibilities include hazardous waste management, storage, transport or recordkeeping must be trained within 6 months of starting or a job change The type and degree of training required depends on each employee s responsibilities associated with his/her job function Generator status establishes training requirements: LQGs most stringent annual training SQGs and CESQGs less stringent 64

65 Inspections and Reporting Hazardous Waste Storage Area Must be inspected weekly (inspection records maintained) Meet all storage area requirements as described in 40 CFR and & 174 including but not limited to: Adequate aisle space Impermeable floor surface Secondary containment Prepare Uniform Hazardous Waste Manifest (EPA Form ) for each hazardous waste shipment 65

66 Uniform Hazardous Waste Manifest (UHWM) Permitted Hazardous Waste vendors pick-up your wastes and provide a shipping manifest The UHWM is multi-copy shipping paper required for shipments of hazardous waste Why is Manifesting Important? A record to ensure that waste is managed properly - Cradle to Grave record The generator (each location) is ultimately responsible for the information contained on the manifest Land Disposal Restriction Notification Form (LDR) also required 66

67 Next Step Know Emergency and Spill Response Procedures LQGs need a Haz Waste Contingency Plan SQGs need elements of a Plan Hazardous Waste Contingency Plan - a written document describing: Emergency response procedures including the following: Emergency coordinator(s) Emergency telephone numbers Hazardous wastes generated Arrangements with local emergency response services Measures to prevent the release of hazardous waste Emergency equipment Evacuation plan 67

68 Hazardous Waste - Inspections, Best Practices and Lessons Learned Inspections and Enforcement USEPA/State Inspections Recent cases How to handle an inspection Examples of common violations Hazardous Waste Program Management Best Practices and Lessons Learned Program management champion Executive leadership and risk management perspective Departments and department leadership perspective 68

69 Federal/State Hazardous Waste Program Inspections Can be brief or comprehensive and unannounced USEPA (Federal) inspections can take 2-3 days Can focus on certain hazardous waste streams or be building-wide or campus-wide inspections No facility employees or leadership are exempt from being questioned or interviewed Examples of typical areas of inspection: Waste determinations documentation Recordkeeping/training/emergency response Storage areas and containers 69

70 RCRA Inspection Recommendations When an inspector or inspection team arrives: Understand that the inspection is an opportunity to learn and to find areas of program improvement Gather and make available the best team of management and subject matter expertise to accompany the inspector(s) Answer questions to the best of your knowledge - if an answer is not known then say so Expect a closing summary meeting where preliminary findings (including alleged violations) are identified and discussed 70

71 Inspection and Enforcement Efforts Examples of Violations Hazardous wastes are not identified Open, unlabeled or mislabeled storage containers Storage area is not adequate Satellite accumulation issues Training records/manifest records Exceeding storage time limit Storage area inspection records Outdated Contingency Plan 71

72 Lessons Learned Program Management Facility/Corporate Executive Team and Risk Management Perspective Regulatory compliance with RCRA is not generally on the radar screen unless there has been an incident or inspection In Healthcare the TJC (The Joint Commission) has trained over 500 accreditation surveyors on the proper management of hazardous and pharmaceutical wastes Operations structure, outsourcing and staff turnover can have a large impact on the compliance performance of the hazardous and Rx waste management program at any facility Many hospitals, hospital systems, retail pharmacies and retailers don t have RCRA environmental compliance expertise onsite or in-house. 72

73 Lessons Learned Program Management (cont.) Store Operations, Facilities, Safety, Laboratory, Pharmacy, Clinical and Housekeeping Management and Staff Perspective Hazardous waste management impacts nearly every department and professional discipline in a Healthcare facility and nearly all Retail operations (stores, distribution centers, etc.) Generally the more centralized the management of the hazardous waste program is the more compliant the program Recommend naming a Program Champion for the entire facility or company Recommend centralizing all waste determinations documentation, inspection reports, waste generation reports and training documentation with the Program Champion Recommend local onsite Program Coordinator and local access to required program documentation 73

74 Questions? Gregory W. Blount Troutman Sanders LLP Charlotte A. Smith, R. Ph., M.S. Senior Regulatory Advisor PharmEcology Services WM Sustainability Services Darrell J. Oman Program Manager Consulting Services Compliance & Regulatory Affairs Stericycle Environmental Solutions

75 15 Most Common Hazardous Waste Violations and Problems Found at Hospitals Improper or lack of hazardous waste (HW) labeling (go to HW labeling). No or infrequent weekly inspections of HW storage/satellite areas (go to for inspections requirements). Open containers of HW (go to container sealing requirement). Improper disposal of chemotherapy drugs (go to hazardous waste determinations and see information for U-list waste). Failure to perform or improper hazardous waste determinations (go to hazardous waste determinations). No or inadequate HW manifests (go to hazardous waste manifest). Throwing HW down the drain. Improper management of mercury-containing wastes, including but not limited to, fluorescent light bulbs, mercury vapor lights, thermometers, sphygmomanometer, gastric tubes, thermostats, etc. (go to mercury in healthcare facilities) Improper management of expired pharmaceuticals, paints, etc. (go to pharmaceuticals in healthcare facilities) Lack of a contingency plan (go to emergency planning). Lack of or inadequate training of employees in HW management (go to personnel training). Failure to ensure that HW meets Land Disposal Restrictions (go to shipping wastes off-site). Failure to upgrade/close underground storage tanks (USTs) by 12/22/98 (go to UST inspection protocol). Malfunctioning leak detection systems. Improper consolidation of wastes from nearby facilities. Source: EPA Region 2. 75

76 References and Resources Healthcare Sector Environmental Laws and Regulations RCRA/Hazardous Waste Resource Locator Profile of the Healthcare Industry USEPA Document otebooks/health.pdf Managing Pharmaceutical Waste A Discussion Guide for Health- System Pharmacists Table of Common Wastes in Health Care (Wisconsin version) Self-audit Checklists for LQGs and SQGs (Wisconsin examples)

77 Resources Environmental Leader Environmental Law & Policy Monitor EPA Management of Hazardous Waste Pharmaceuticals Hazardous Waste Pharmaceuticals Wiki 77

78 References Managing Pharmaceutical Waste: A 10-Step Blueprint for Healthcare Facilities in the United States Management of Hazardous Waste Pharmaceuticals: WM Healthcare Solutions, Inc. 78

79 Retail Inspection Tracker Created through Troutman Sanders subsidiary, emerge Secure, easy to use inspection tracking application Track each inspection finding in detail Beneficial tracking options including: Calendar of upcoming corrective action and response due dates State-by-state inspection trends Analysis of common findings to assist with program improvement Monthly/yearly comparison of inspection activity Comparison of inspections with and without findings Customizable for each retailer s specific issues and preferences Receive automatic, customized alerts for desired metrics E.g., hot states, high-priority inspection findings 79