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Large-Scale Disclosure Panel Presentation from 2008 Annual Meeting of American Society of Bioethics and Humanities

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I was invited to present on a panel on the disclosure of adverse events at this annual meeting of the American Society for Bioethics and Humanities in Cleveland, and covered the VA policy at that time. I had been involved in the implementation of the policy and the writing of the policy documents, but not the core thinking behind the policy which was developed by a committee convened by the VA Center for Ethics in Health Care a few years earlier. Disclosure of adverse events is an area where VA has been a leader, but it has been challenging, especially in gray areas such as when it is unknown whether any patients were actually harmed by a breach in appropriate practices. The current VA policy is on-line at: http://www.va.gov/vhapublications/ViewPublication.asp?pub_ID=2800 . Also on-line is a 2008 transcript when I participated as a speaker in a national VA call organized by the VA National Center for Ethics in Health Care: http://www.ethics.va.gov/docs/net/NET_Topic_20080226_Disclosure_of_Adverse_Events.doc

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Large-Scale Disclosure Panel Presentation from 2008 Annual Meeting of American Society of Bioethics and Humanities

  1. 1. “Large Scale” Disclosure of Adverse Events in Health Care ASBH Annual Meeting, Cleveland, Ohio Noel Eldridge, MS [noel.eldridge@va.gov] Department of Veterans Affairs National Center for Patient Safety 10/24/08 1
  2. 2. What Merits Disclosure? (1) Adverse events that have had or are expected to have a clinical effect on the patient that is perceptible to either the patient or the health care team. (2) Adverse events that necessitate a change in the patient’s care. (3) Adverse events with a known risk of serious future health consequences, even if the likelihood of that risk is extremely small.* (4) Adverse events that require providing a treatment or procedure without the patient’s consent. 2
  3. 3. History • Disclosing Adverse Events has been required in VHA going back at least to 1995. ▫ Also required by Joint Commission. • VHA National Center for Ethics in Health Care wrote an excellent White Paper on the Topic in 2003. • 2005 VHA Directive on Disclosure of Adverse Events to Patients was issued in to make requirements clear. ▫ But some details were still arguable and a rewrite was assigned in 2006, especially to accommodate “large scale” disclosures. 3
  4. 4. New Directive Issued • New VHA Directive, Disclosure of Adverse Events to Patients, #2008-002, was issued January 2, 2008.  Establishes “Clinical Risk Assessment Advisory Board” (CRAAB) to make recommendations to USH re “Large Scale Disclosures”.  Sets 1 in 10,000 risk of harm as the unofficial threshold for disclosing risk in a case of possible exposure.  Most other aspects unchanged from 2005 Directive. 4
  5. 5. CRAAB • The CRAAB is made up of appropriate representative(s) from: ▫ Office of Public Health and Environmental Hazards (Chair), ▫ Office of the Deputy Under Secretary for Health for Operations and Management, ▫ National Center for Ethics in Health Care, ▫ Office of Nursing Services, ▫ Office of Quality and Performance, ▫ National Center for Patient Safety, ▫ Office of Patient Care Services, ▫ Subject matter experts from VHA or non-VA experts as needed. 5
  6. 6. (3) Adverse events with a known risk of serious future health consequences, even if the likelihood of that risk is extremely small.* In some cases, however, no definite exposure of this type can be determined. Only an increased risk of exposure is known or thought to exist. In such cases, disclosure should be decided on a case by case basis considering the best interests of the patient, weighing the risks and benefits of disclosure relative to the probability of serious future health consequences. 6
  7. 7. Leadership Decision Process (1 of 2) The CRAAB Considers (highly abridged)… • Do we have all the important facts? • Have we involved everyone who should be part of the decision? • Does this decision reflect our values? • Do likely benefits outweigh potential harms? • Will this decision keep the problem from recurring or establish a good precedent? • How will it look from outside the organization?
  8. 8. Leadership Decision Process (2 of 2) • CRAAB Considers Two Yes/No Questions: • If effect would be “Clinically Significant,” i.e., a condition that causes harm or illness and/or that requires testing, monitoring, or short-term or long-term treatment. • If the probability of a Clinically Significant effect would be greater than or less than 1 in 10,000. 8
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  10. 10. Links of Potential Interest • 2008 Directive: http://www1.va.gov/vhapublications/ViewPublication.as p?pub_ID=1637 • 2003 White Paper: http://www.ethics.va.gov/ETHICS/docs/necrpts/NEC_R eport_20030301_Disclosing_Adverse_Events.pdf • 2005 PowerPoint: http://healthit.ahrq.gov/portal/server.pt/gateway/PTAR GS_0_1371_37087_0_0_18/Noel%20Eldridge.ppt 10

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