Since our June 22, 2010 Patient Safety Tip of the Week “Disclosure and Apology: How to Do It”, there have been a couple very relevant papers published on disclosure and apology. We had noted in our previous columns the accumulating evidence that malpractice costs and settlement costs may be lower when a policy of disclosure and apology is adopted. Now we have a new study (Kachalia 2010) that gives us a good estimate of the magnitude of the potential savings that results from a transparent disclosure and apology program. The University of Michigan Health System implemented such a system in 2001. It was established not as a means of saving money but to help establish a culture of patient safety. That system included identification and reporting of medical errors, disclosure of harmful medical errors to patients and offers of compensation to patients affected by such errors. They then did a before/after analysis of claims and settlements and found roughly a 60% reduction in average monthly rate of lawsuits, average monthly costs for liability, patient compensation, and non-compensation-related legal costs. The median time for claim resolution also diminished from 1.36 to 0.95 years. The authors do note that there was a trend in Michigan in the latter part of the study toward fewer malpractice claims so such confounding factors cannot be ruled out as having a role in these results. Nevertheless, the findings are quite impressive and further support the concept that disclosure and apology is not only the right thing to do from an ethical standpoint, but it is also the right thing to do from a fiscal standpoint.
The second publication (Dudzinski 2010) deals with disclosure of adverse or potentially adverse events involving multiple people. We’ve previously discussed such events (see our June 16, 2009 Patient Safety Tip of the Week “Disclosing Errors That Affect Multiple Patients”), focusing on an article appeared in the Canadian Medical Association Journal on “ ” (Chafe et al 2009).The new paper discusses in detail many of the dilemmas faced in the decision to disclose in such cases, noting that the issues are not uniform in all large-scale adverse events. There may be differences in the likelihood of harm, the ability to detect such harm, the presence or absence of potential treatment, etc. They even discuss the fact that in some cases the potential psychological harm caused by disclosure itself may be more serious than the risk of potential physical harm. But in almost every scenario they discuss, the bulk of the arguments favor transparency and disclosure.
Perhaps most importantly, they suggest every health care organization should have some preparation (whether it be a formal policy or not) for how to deal with potential large-scale adverse events. Our July 24, 2007 Patient Safety Tip of the Week “model policy put in place by the Veterans’ Health Administration. That policy includes convening of an advisory board that is multidisciplinary and representative of multiple constituencies to help frame all the relevant questions and guide the disclosure process.” provides an example of the sort of tool you need to have available in your organization to guide the response to serious incidents. But it does not include specifics in dealing with large-scale adverse events. The Dudzinski paper points out that without such guidance the responses of healthcare organizations to such events are typically slow and haphazard. They also cite a good
We’d like to refer you back to the CMAJ paper we highlighted in our June 16, 2009 Patient Safety Tip of the Week “Disclosing Errors That Affect Multiple Patients”. That paper nicely spells out the steps necessary in an investigation into multiple-patient events and outlines the many issues in setting up an effective communication strategy. The authors nicely describe the problems involved in the first step – timely identification of the error – because a representative sample of records to review requires an estimate of the potential number of patients affected. This step requires identifying the time period to review, scope of the review, training teams to do the reviews, and developing reliability checks. Then it needs to be determined whether the error affected clinical decision making. Then the physicians need to follow up with patients who may require changes in management after the review is done.
The decision about who and when to notify is complex. Especially when the number of patients to be notified is large, the decision is even harder. The authors voice their opinion that disclosure on a scale this large should be led by a physician other than the one(s) directly involved in the error. A formal disclosure plan should be developed, complete with dates and plans for specific disclosure to all potential stakeholders, including the public and the media. They point out that sensitivity must be used, particularly since some patients may have died in the interim (regardless of whether that was related to the incident or not). They provide some specific examples where timely disclosure to the public helped mitigate the response to errors and stress the need for continued honest updates to the public.
Their guidelines for public disclosure are well thought out. They stress early disclosure and note that it is best if the public hears about the event from you, not the media or other parties. As such, disclosure even before all the details are known may be appropriate, though initial disclosure should avoid making assumptions or identifying specific individuals involved. Patients need to be contacted individually. But using a website or dedicated phone line for keeping everyone up to date may be useful. The results of the investigation of the event need to be made public along with a description of the steps that were taken to prevent similar occurrences in the future. Overall, this is an excellent guideline to help any organization that must deal with an untoward event affecting or possibly affecting multiple patients.
The Dudzinski and Chafe papers plus the VHA directive should help your organization develop guidelines for what to do if you are ever faced with such circumstances.
Kachalia A, Kaufman SR, Boothman R, et al. Liability Claims and Costs Before and After Implementation of a Medical Error Disclosure Program.
Ann Intern Med 2010; 153: 213-221
Dudzinski DM, Hébert PC, Foglia MB, Gallagher TH.
The Disclosure Dilemma — Large-Scale Adverse Events. NEJM 2010; 363(10): 978-986
Chafe R, Levinson W, Sullivan T. Disclosing errors that affect multiple patients. CMAJ 2009 180: 1125-1127
Veterans Health Administration. Disclosure of adverse events to patients. VHA directive 2008-002. Washington, DC: Department of Veterans Affairs, January 18, 2008. http://www1.va.gov/vhapublications/viewpublication.asp?pub_id=1637