Audit Disclosure

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					Lessons Learned Region II Audit
        Disclosure Data
        Janet Bowen, EPA Region I

      617-918-1795, Bowen.Janet@epa.gov
        www.epa.gov/region1/healthcare
               January 25, 2007



             Adapted from Region 2 August
                  2006 presentation         1
Region I Approach
• Mercury Challenge Program (1999-2001)
  Rolled 47 Regional partners into H2E

• Regional Hospital email group

• Regional Partners
  * Pledged to reduce mercury and solid waste
  * 164 partners in New England


                                                2
Region 1 Approach (Cont.)

Increased Compliance Assistance

 - Compliance workshop 2001
 - SPCC Conference 2002
 - Compliance workshop: May 20, 2004



                                       3
Region 1 Approach (Cont.)
Increase Enforcement Presence
in Healthcare
• EPA sent letter to hospital CEOs (April 2004)
    - Increase enforcement presence
    - Information about EPA Audit policy
     - Information about Region II
          enforcement cases



                                                  4
Follow-Up Training
- RCRA half day trainings
  * One in each state
  * June 2004- December 2004

- EPCRA Workshops
  *   ME Hospital Association (3/05)
  *   NH Hospital Association (6/05)
  *   MA Hospital Association (1/07)
  *   General EPCRA trainings being offered in every state



                                                             5
EPA’s Audit Policy

National Audit policy
www.epa.gov/compliance/incentives/auditing/au
 ditpolicy.html


Regional Contact
Joel Blumstein
617-918-1771
Blumstein.Joel@epa.gov
                                                6
Audit Disclosure Update
New England
• Six signed hospital agreements
Yale-New Haven Hospital
St. Francis Hospital and Medical Center
Central Connecticut Health Alliance
Bridgeport Hospital
Caritas Christi Health System
Dana-Faber
Audit Disclosures Update
New England
• 29 Audit disclosures received to date

• Three additional disclosures expected May
 2007 pursuant to MOU
EPA Audit Policy
Press Releases – New England
September 23, 2005 Dana-Fabar
http://www.epa.gov/region1/pr/2005/sep/dd050908.html

May 25, 2005 Caritas Christi Health Care
http://www.epa.gov/region1/pr/2005/may/sraw050501.html

April 6, 2005 Saint Francis Hospital and Medical Center
http://www.epa.gov/ne/pr/2005/apr/sr050401.html

February 14, 2005 Portsmouth Regional Hospital
http://www.epa.gov/region1/pr/2005/feb/sr050203.html




                                                          9
 Region I Enforcement
• Veterans Administration Hospital
  - Located in White River Junction, VT
  - Proposed fine of $372,254

Press release: August 5, 2005
http://www.epa.gov/region1/pr/2005/aug/dd050806.html

Press Release – January 2007
VA Developing Comprehensive Waste Tracking System



                                                       10
Recent Region 1 Enforcement
(Cont.)
• Violations
 Failure to conduct waste determination
 Failure to have fire suppression equipment
 Failure to label
 Failure to close containers
 Failure to date containers
 Unauthorized treatment and disposal
 Failure to minimize potential for release
 Universal Waste dating
 Failure to separate incompatibles
                     From October 14, 2005 Lisa
                        Papetti presentation      11
Region I Enforcement
Cont.
• Two New England Hospitals (NH, ME)
  - Sign Expedited Agreement
  - Pay $3,000
  - For Oil Spill Prevention Laws

• Press Release: October 28, 2005
http://www.epa.gov/region1/pr/2005/oct/dd051003.html

                  Adapted from Region 2 May 2005
                            presentation               12
Approach – EPA Region II
• Region 2 combined the following strategies to address
  compliance issues in these sectors:
   – Compliance assistance
   – Compliance incentives (voluntary audit/disclosure)
   – Compliance monitoring
   – Enforcement
   – Pollution prevention
   – Environmental management systems (EMS)




                    Adapted from Region 2 May 2005
                              presentation                13
      Results EPA Region II:
      Compliance Monitoring & Incentives Programs
                                                         Hospitals
        Universe
                                                            480

       Inspections
                                                            49

   Enforcement Actions                                      36

Formal Enforcement Actions                         11 ($1,523,613)

       Settlements                                   9 ($642,612)

    Audit Agreements                                        41

                                     156 covering 581 facilities ($29,947,688 for
  Voluntary Disclosures
                                                   143 resolved)
   Violations Corrected                                    3223

                          Adapted from Region 2 August
                                      2006                                          14
Healthcare Violations – All R2
               Breakout of Violations from Hospital Disclosures
     Emergency                                                     -Clean Air Act
     & Planning                                                   CAA Violations
 Community Right                                                       18%
  to Know - EPCRA
   Violations 7%                                                    - Clean Water Act
                                                                     CWA Violations
                                                                           4%


                                                                     Toxic Substance
                                                                    Control Act -TSCA
                                                                      Violations 1%

                                                       Safe Drinking
                                                      Water Act - SDWA
            -Hazardous Waste                           Violations 0%
             RCRA Violations
                  70%



                               Adapted from Region 2 August
                                    2006 presentation                                   15
             Top 10 Violations
     (From 146 Voluntary Disclosures)
Rank Violation                    Statute                     Frequency
 1    ID of Hazardous             RCRA –          Hazardous   592
      Waste                       waste

 2    Universal Waste             RCRA–       Hazardous       446
                                  waste

 3    Container                   RCRA–       Hazardous       331
      Management                  waste

 4    Labeling                    RCRA–       Hazardous       304
                                  waste

 5    CFC Leak Detection          CAA –     Clean Air Act     264
      Records
                   Adapted from Region 2 August
                        2006 presentation                           16
          Top 10 Violations –Cont.
Rank Violation                         Statute                   Frequency

 6    SIP Requirements                 CAA –     Clean Air Act   230
      (State Implementation Plan)

 7    Chemical Inventory               EPCRA –      Emergency    128
                                       Planning & Community
                                       Right to Know Act

 8    SPCC                             CWA –      Clean Water    120
      Spill Prevention Control &       Act
      Countermeasure

  9   Manifests                        RCRA                      115
 10   Personnel Training               RCRA                      97



                          Adapted from Region 2 August
                               2006 presentation                         17
 Maximum Number Of Violations
(From 156 Voluntary Disclosures)
     Statute                                  Average Number of
                                                  Violations
     RCRA                                            10
      CAA                                             2
     EPCRA                                            1
      CWA                                            1
     SDWA                                           <1
     TSCA                                           <1

               Adapted from Region 2 August
                    2006 presentation                        18
Number Of Facilities With Violations
From 156 Voluntary Disclosures
    Statute          Number of               Percent of Facilities
                      Facilities
    RCRA               145                          93%
     CAA               115                          74%
    EPCRA              101                          65%
     CWA                87                          56%
     TSCA               27                          17%
    SDWA                  15                        10%


              Adapted from Region 2 August
                   2006 presentation                          19
Root Causes Of Noncompliance
Systemic violations appear to stem from:
• Inadequate resources for people,
  equipment and training to carry out
  environmental activities;
• Limited or no environmental compliance
  accountability for individual departments,
  laboratories, and staff;
• Limited authority vested in environmental
  compliance officials;
               Adapted from Region 2 January
                     2006 presentation         20
Root Causes Of Noncompliance
• No clear environmental compliance chain-
  of-command;
• Scattered, incomplete, and missing
  environmental compliance documentation;
• Incomplete institutional knowledge
  regarding environmental regulatory
  requirements; and
• Broad use of hazardous materials when
  effective substitutes exist
              Adapted from Region 2 January
                    2006 presentation         21
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Healthcare RCRA Violations – All R2

            Breakout of RCRA Violations from Hospital Disclosures


                                                   Generator
                             UST 3%             Requirements 5%


       Container
    Management 30%                                                ID of HW 26%




       General Facility
       Standards 10%                                     Universal Waste
                                  Manifest 5%                 20%
             Accumulation Time
                   1%



                          Adapted from Region 2 August
                               2006 presentation                                 51
Hazardous Waste (HW) Issues

• Lack of HW management training of
  employees
• Treating HW without a permit
• Lack of RCRA contingency plan
• Spill control equipment not readily
  accessible
• Failure to make HW determinations
              Adapted from Region 2 May 2005
                        presentation           52
Hazardous Waste (HW) Issues

• Failure to ensure that HW meets Land
  Disposal Restrictions
• Failure to upgrade/close underground
  storage tanks (USTs) by 12/22/98
• Malfunctioning leak detection systems on
  USTs


              Adapted from Region 2 May 2005
                        presentation           53
Common Hazardous Waste Violations

•   Laboratories                    •   Laundry
•   Dental clinics                  •   Morgue
•   X-rays units                    •   Operating rooms
•   Nuclear medicine areas          •   Nursing units
•   Pharmacy                        •   Hazardous waste storage
•   Maintenance areas                   areas
•   Physical therapy                •   Medical technology unit
•   Underground storage             •   Construction areas
    tanks                           •   Satellite accumulation
                                        points

                    Adapted from Region 2 May 2005
                              presentation                    54
Hazardous Waste Environmental
Compliance Audit Protocols
•   Hazardous Waste Generators
•   Used Oil and Universal Waste Generators
•   Underground Storage Tanks
•   Hazardous Waste Treatment, Storage, and
    Disposal Facilities
•   Facilities Regulated under Subtitle D of RCRA

www.epa.gov/compliance/incentives/auditing/protocol.html

                  Adapted from Region 2 May 2005
                            presentation              55
Hazardous Waste Environmental
Assistance Resources
• Hazardous Waste General Resources
  http://www.hercenter.org/hazmat/hazardouswaste.cfm

• Hazardous Waste Generator Regulations, User Friendly
  Guide (web-based)
   http://www.epa.gov/epaoswer/osw/gen_trans/tool.pd

• State Hazardous Waste Resource Locator
  http://www.hercenter.org/hz.cfm

• EPA’s Office of Underground Storage Tanks
  http://www.epa.gov/swerust1/index.htm


                                                         56
Hazardous Waste Environmental
Assistance Resources (Cont.)
• Hazardous Identification
http://www.hercenter.org/hazmat/hazdeterm.cfm

http://www.fedcenter.gov/resources/facilitytour/hazardous/whatis/flow
   chart/

• Universal Waste General Resources
http://www.epa.gov/epaoswer/hazwaste/id/univwast/index.htm

http://www.hercenter.org/hazmat/druniversal.cfm



                       Adapted from Region 2 May 2005
                                 presentation                      57
Healthcare CAA Violations – All R2
        Breakout of CAA Violations from Hospital Disclosures



                   Asbestos 9%


                                                      SIP (including
                                                     MACT, NESHAPS,
                                                      & Title V) 40%



        CFCs 51%




                    Adapted from Region 2 August
                         2006 presentation                             58
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 May 2005
                             presentation             59
Air (40 CFR 50-99)
• Clean Air Act General Resources
    http://www.hercenter.org/regsandstandards/caa.cfm
• Air Conditioning/Refrigeration
    http://www.epa.gov/ozone/title6/608/
• Asbestos
    http://www.epa.gov/asbestos
•   Boilers/Emergency Generators
•   Medical Waste Incinerators
    http://www.epa.gov/ttn/atw/129/hmiwi/rihmiwi.html
• Other (e.g., degreasers, ETO sterilizers, spray booths)
                       Adapted from Region 2 May 2005
                                 presentation               60
Healthcare CWA Violations – All R2

       Breakout of CWA Violations from Hospital Disclosures




                                  NPDES 5%




                     SPCC/OIL Spill
                         95%




                  Adapted from Region 2 August
                       2006 presentation                      61
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 May 2005
                        presentation           62
Water Regulations                    (40 CFR Parts 100-136, 403, 460)


  • Clean Water Act general resources
     http://www.hercenter.org/regsandstandards/cwa.cfm

  • Wastewater Discharges
     NPDES: http://www.epa.gov/npdes
     Pretreatment: http://cfpub.epa.gov/npdes/home.cfm?program_id=3
     UIC: http://www.epa.gov/ogwdw/uic.html

  • Stormwater Discharges
     http://cfpub.epa.gov/npdes/home.cfm?program_id=6

  • Oil above ground and underground tanks - (new inspector guide online)
     http://www.epa.gov/oilspill/index.htm

  • Other (e.g. filtration plants)


                              Adapted from Region 2 May 2005
                                        presentation                        63
Healthcare EPCRA Violations – All R2

        Breakout of EPCRA Violations from Hospital Disclosures




       MSDS 33%




                                                          Chemical
                                                       Inventory 67%




                    Adapted from Region 2 August
                         2006 presentation                             64
EPCRA – General Resources
• HERC site
http://www.hercenter.org/regsandstandards/epcra.cfm


• Overview – EPA site
http://yosemite.epa.gov/oswer/CeppoWeb.nsf/content/epcraOverview.htm


• Tier II Submit
http://dintra02.rtp.epa.gov/host/oswer/CeppoAdmin.nsf/content/tier2.htm


• Compliance Audit Protocol - EPCRA
http://www.epa.gov/compliance/resources/policies/incentives/auditing/apcol-epcra.pdf


                             Adapted from Region 2 May 2005
                                       presentation                                    65
Healthcare TSCA Violations – All R2

       Breakout of TSCA Violations from Hospital Disclosures




                    PCBs 4%




                               Lead Paint 96%




                   Adapted from Region 2 August
                        2006 presentation                      66
Other Requirements
• Pesticides (40 CFR 150-189)
  http://www.epa.gov/pesticides/

• PCBs (40 CFR Part 761)
  http://www.epa.gov/opptintr/pcb/

www.epa.gov/compliance/incentives/auditing/protocol.html

• Lead Paint Region I fact sheet for Colleges
http://www.epa.gov/region1/assistance/univ/pdfs/lead-
  based-paint7-03.pdf


                   Adapted from Region 2 May 2005
                             presentation               67
 National Tools
Profile of the Healthcare Industry (2/05)
  Document Number: 310R05002
 - plain language environmental profile

http://www.epa.gov/compliance/resources/publications/ass
   istance/sectors/notebooks/health.html


Compliance Assistance Center – Healthcare
 - on-line compliance assistance
 - Website www.hercenter.org

                                                           68
National Tools – Cont.
• Managing Pharmaceutical Waste: A 10-Step
  Blueprint for Health Care Facilities in the United
  States, April 2006

http://www.h2e-
   online.org/docs/h2epharmablueprint41506.pdf

• Environmental Compliance and Improvement
  Guide – To improve compliance with JCAHO
  Environmental of Care Standard

http://www.h2e-
   online.org/regsandstandards/jcahointro.html

                                                       69
National Tools – Cont.
Healthcare Guide to Pollution Prevention
  Implementation through Environmental
  Management Systems, second edition
Revised draft second edition: May 2005

Available:
Kentucky Pollution Prevention Center
URL: www.kppc.org, under “Publications”, “Print
  Materials”, “Healthcare Guide”


                                                  70
  Resources – H2E 10 Step Guides
• Integrated Pest Management Program
  http://www.h2e-online.org/docs/h2e10stepipm.pdf

• Green Cleaning
  http://www.h2e-online.org/docs/h2e10stepgreenclean-r5.pdf

• Reducing Mercury
  http://www.h2e-online.org/hazmat/mercguide.html

• Fluorescent Light Bulb Recycling
   http://www.h2e-online.org/docs/h2e10stepfluorescent121802.pdf

• Electronics
   http://www.h2e-online.org/docs/h2eelectronics40504.pdf

• Environmentally Preferable Purchasing
   http://www.h2e-online.org/wastereduction/epp/10steps.html




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