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Healthcare Environmental Compliance Pitfalls
December 6, 2007
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Healthcare Compliance?
In the business to promote health Hospitals already fall under several regulatory
standards Environmental compliance refers to:
Hazardous waste or RCRA Air quality or air permits requirements Waste water discharges
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Healthcare compliance
Regional assistance programs try to educate and help facilities identify compliance gaps and pollution prevention opportunities.
East coast EPA compliance initiative in 2006 Compliance pitfalls identified on east coast, probably
mirror the compliance gaps we have in Midwest
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Healthcare compliance
Our region, Region 7, has begun inspecting hospitals
State tables in vendor area
2006 Region 2 (east coast) audit finding
Adapted from Region 2 August 2006
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Results EPA Region II:Compliance Monitoring & Incentives Programs
Hospitals
Universe480
Inspections49
Enforcement Actions 36
Formal Enforcement Actions 11 ($1,523,613)
Settlements 9 ($642,612)
Audit Agreements 41
Voluntary Disclosures156 covering 581 facilities ($29,947,688 for 143
resolved)
Violations Corrected 3223
Adapted from Region 2 August 2006 presentation
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Healthcare Violations – All R2
Breakout of Violations from Hospital Disclosures
Safe Drinking Water Act -SDWA
Violations0%
Emergency & Planning
Community Right to Know -EPCRA
Violations7%
-Clean Air Act CAA Violations
18%
- Clean Water Act CWA Violations
4%
Toxic Substance Control Act-TSCA
Violations1%
-Hazardous Waste RCRA Violations
70%
Adapted from Region 2 August 2006 presentation
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Healthcare CAA Violations – All R2
Breakout of CAA Violations from Hospital Disclosures
SIP (including MACT, NESHAPS,
& Title V) 40%
CFCs 51%
Asbestos 9%
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Air Compliance Issues
Failure to use properly trained and accredited asbestos personnel.
Failure to notify EPA of asbestos removal projects and keep required documentation/recordkeeping.
Failure to properly dispose of asbestos debris. Failure to close lids on parts washers when not in use. Failure to properly handle CFCs and records. Failure to include ETO sterilizer, spray paint booth, and
parts degreaser in air permit.
Adapted from Region 2 August 2006 presentation
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Healthcare CWA Violations – All R2
Breakout of CWA Violations from Hospital Disclosures
SPCC/OIL Spill95%
NPDES 5%
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Water Compliance Issues
No permit for wastewater discharges Not complying with permit conditions No/inadequate secondary containment of
storage tanks/containers No SPCC plan Floor drains
Adapted from Region 2 August 2006 presentation
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Healthcare RCRA Violations – All R2
Breakout of RCRA Violations from Hospital Disclosures
Accumulation Time1%
Manifest 5%
ID of HW 26%
Universal Waste20%
General Facility Standards10%
Container Management30%
UST 3% Generator
Requirements5%
What to Expect When EPA Shows UP
Routine RCRA Inspections, Common Violations, and Enforcement Follow-up
Dedriel Newsome - RCRA InspectorEnvironmental Field Compliance Branch, USEPA
WK # (913) 551-7049 or (e-mail) – [email protected]
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Goals of Enforcement
Environmental Protection Correction of Violations - Return to
compliance Deterrence Fairness - level playing field
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Purpose of RCRA Inspection
Determine generator status Determine if the facility is in compliance with
the applicable RCRA regulations based on their generator status
RCRA Inspection
Conduct desktop file review Conduct drive-by surveillance of facility Initial facility entry Conduct initial interview (general facility
information)
RCRA Inspection Collect facility process information Collect facility waste stream information Conduct visual inspection – hazardous
waste storage areas and satellite accumulation areas
Conduct records review Conduct exit briefing
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Typical Hospital Wastes / Areas Visually Inspected
Clinical Labs (spent solvents - distillation)
Research Labs (spent solvents, corrosives, off-spec chemicals, unwanted chemicals)
Facilities - Maintenance, Painting, Grounds, etc. (spent solvents, waste paints, used oil, parts washer solvents, rags, waste pesticides, batteries, mercury wastes, fluorescent lamps, aerosols)
Pharmacies (off-spec drugs, investigatives) Operating Room (breathing machine spent media)
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Typical Hospital Wastes / Areas Visually Inspected
Housekeeping (Autoclave indicator tape) Printing (spent solvents, waste inks) Biomedical (batteries, soldering wastes) IT (batteries, soldering wastes, solvent rags) Radiology (lead aprons, film developing
wastes) Chemical Storage Areas (Off-spec and
unwanted chemicals)
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Common Violations Hazardous Waste Determinations
What we find… Mischaracterized or uncharacterized wastes; or Materials that are unused and pending disposal
not characterized Changes in processes!!!
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Common Violations Satellite Accumulation Container
Management
What we find… Unlabeled satellite containers (In MO, also
undated satellite containers and >1yr in area; in KS not having the words “Hazardous Waste”)
Open satellite containers Containers not at or near the point of generation
and under the control of the operator Containers not moved in 3 days of filling
(In KS and MO, one container per waste stream)
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Common Violations Storage Container Management
What we find… Unmarked/unlabeled storage containers Undated storage containers Open storage containers Incompatibles stored without proper separation
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Common Violations Illegal Treatment, Storage, and Disposal
Offering Hazardous Waste Without a Permit
What we find… Evaporation of hazardous wastes Disposal of hazardous waste with non-hazardous
waste (i.e. general trash or biomedical waste)
Following the RCRA Inspection
Following RCRA Inspection, what should the facility do? Achieve compliance with RCRA ASAP!!!!!!! Provide a response to EPA for the Notice of
Violation (NOV) Response is required even if compliance not achieved! Follow-up response should be provided when
compliance is achieved
Following the RCRA Inspection (cont.)
EPA RCRA Inspection Report Provided to a compliance officer for review to
determine enforcement response Typically provided to the facility after it is
completed
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Estimated Hospital RCRA Inspections and Completed Enforcement Actions
in the Past 5 Years
EPA conducted about 30 inspections States conducted about 26 inspections
EPA Informal Orders – 28 completed EPA Formal Orders – 4 completed
State Informal Orders – 11 completed State Formal Orders – 1 completed
(These numbers do not include pending orders)
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Informal Enforcement
Notice of Violation (NOV) Issued by inspector following inspection or Sent via letter
Letter of Warning Sent via letter and/or May include information request (Section 3007)
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Formal Civil Enforcement
RCRA Section 3008(a) Order Includes penalty May include compliance measures May include sampling
RCRA Section 3008(h) RCRA Corrective Action Order Usually includes sampling and monitoring Does not include penalty
RCRA Section 3013 Order Hazardous waste may present a “substantial” hazard to human health
or the environment Includes monitoring, analysis, and testing Does not include penalty
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Formal Civil Enforcement (cont.)
RCRA Section 7003 Order Solid waste and/or hazardous waste may present a “imminent
and substantial” hazard to human health or the environment Usually “fast track” response Does not include penalty
Referral to Department of Justice (DOJ) Referred if negotiations have stalled Referred if facility not complying with Order May be referred if multiple facilities are included in the
enforcement proceedings
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Criminal Enforcement
Inspection information may be turned over to criminal investigation team if violations appear to be “intentional”
Criminal and Civil Enforcement may proceed at the same time
Violator may go to prison
COMPLIANCE ASSISTANCESTATE WEB PAGES
Kansas Department of Health and Environment (KDHE) http://www.kdhe.state.ks.us/environment/index.html
Missouri Department of Natural Resources (MDNR) http://www.dnr.mo.gov/
Nebraska Department of Environmental Quality (NDEQ) http://www.deq.state.ne.us
Iowa Department of Natural Resources (IDNR) http://www.iowadnr.com/
COMPLIANCE ASSISTANCEEPA WEB PAGES
EPA HQ Web Page
www.epa.gov EPA Region 7 Web Page
www.epa.gov/region07/ EPA Region 7 RCRA Web Page
www.epa.gov/region7/waste/index.htm
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What Can My FacilityDo Prior to the
RCRA Inspection?
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What Can My Facility Do Prior to the RCRA Inspection?
Obtain the federal and state regulations and become familiar with them
Keep your facility in compliance – Characterize all waste streams!!!!
Schedule and maintain employee training
Contact EPA or State with questions Access and use various “tools” from
State and EPA websites
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What Can My Facility Do Prior to the RCRA Inspection?
Conduct a self-audit and disclose the violations found to the EPA EPA’s Self-Audit Policy (a.k.a. Self-
Disclosure) See:
http://www.epa.gov/compliance/incentives/auditing/auditpolicy.html
Contact Becky Dolph, EPA R7 CNSL at 913-551-7281 or at [email protected]
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Questions