Given that this week U.S. Congress is holding hearings into the possible exposure of multiple Veterans’ Administration patients to infectious contamination during endoscopies and other procedures, it is fitting that an article appeared in the Canadian Medical Association Journal on “Disclosing Errors That Affect Multiple Patients” (Chase et al 2009).
Most of you have followed in the news the events in the VA system in which cases of possible contamination were discovered in late 2008 affecting patients from at least 3 different VA sites and going back possibly as far as 203. Cases involved endoscopies, colonoscopies and ENT procedures and involved patients in Murfreesboro TN, Augusta GA, and Miami FL. In February 2009 the VA began sending out notices of possible exposure to 10,000 plus patients who received care at these facilities and testing for possible infectious complications was provided. Of those tested, there have been 34 patients testing positive for hepatitis C, 13 for hepatits B, and 6 for HIV.
Frankly, given that relatively low prevalence of positivity in that large population tested, it may never be known whether any patients were contaminated as a result of exposure in those procedures. Nevertheless, the VA has embarked on an investigation of its infection control practices for such equipment in all its facilities. Non-VA facilities would also be wise to look at their own procedures for decontamination of such equipment.
And though events of this type generate lots of negative press, the VA appears to have handled this in an honest, transparent manner with the best interests of its patients in mind.
We have long been an advocate of disclosure and apology (see our July 24, 2007 Patient Safety Tip of the Week “Serious Incident Response Checklist”). One of the items in our serious incident response checklist, actually developed back in 1991, is identifying who should talk to the patient or family after an incident in which medical error and/or patient harm has taken place. That is usually the attending physician, or in some circumstances, the medical director.
The National Quality Forum’s Safe Practice 7 “Disclosure” states: “Following serious unanticipated outcomes, including those that are clearly caused by systems failures, the patient and, as appropriate, the family should receive timely, transparent, and clear communication concerning what is known about the event.”.
Disclosure of medical errors has been the trend in medicine over the past decade or so (Gallagher et al 2007). However, most such disclosures involve events isolated to a single patient and the disclosures have thus been to that single patient and his/her family, where appropriate. Disclosure of events potentially involving multiple patients is much more complex and the need to balance individual patient confidentiality against the need to make a much larger patient population and the public aware is problematic.
The CMAJ 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.
We can also thank our Canadian colleagues from the Canadian Patient Safety Institute who produced the Canadian Disclosure Guidelines in 2008. These deal more with disclosure to one patient and or family. But they are extremely useful in recommending what to disclose, the setting for disclosure, who should participate, how to disclose, and how to express regret. They include a very practical checklist for the entire disclosure process.
Chafe R, Levinson W, Sullivan T. Disclosing errors that affect multiple patients. CMAJ 2009 180: 1125-1127
Gallagher TH, Studdert D, Levinson W. Disclosing Harmful Medical Errors to Patients.
New Engl J Med 2007; 356: 2713-2719
Safe Practices for Better Healthcare
2009 Update A Consensus Report
Canadian Patient Safety Institute. Canadian Disclosure Guidelines. 2008