1

Healthcare Environmental Compliance Pitfalls

December 6, 2007

2

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

3

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

4

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

5

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

6

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

7

Healthcare CAA Violations – All R2

Breakout of CAA Violations from Hospital Disclosures

SIP (including MACT, NESHAPS,

& Title V) 40%

CFCs 51%

Asbestos 9%

8

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

9

Healthcare CWA Violations – All R2

Breakout of CWA Violations from Hospital Disclosures

SPCC/OIL Spill95%

NPDES 5%

10

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

11

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) – Newsome.Dedriel@EPA.gov

13

Goals of Enforcement

Environmental Protection Correction of Violations - Return to

compliance Deterrence Fairness - level playing field

14

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

17

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)

18

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)

19

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!!!

20

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)

21

Common Violations Storage Container Management

What we find… Unmarked/unlabeled storage containers Undated storage containers Open storage containers Incompatibles stored without proper separation

22

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

25

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)

26

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)

27

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

28

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

29

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

32

What Can My FacilityDo Prior to the

RCRA Inspection?

33

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

34

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 dolph.becky@epa.gov

35

Questions