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

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
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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.
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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.
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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.
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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.
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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.
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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. 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.
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9. 9

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
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