Sunday, October 24, 2010
Quality and the Disclosure Dilemma
There is an interesting article that is getting a lot of discussion around the quality arena. The Disclosure Dilemma – Large Scale Adverse Events by Dudzinski and others was published in the September 2, 2010 edition of the New England Journal of Medicine. (N Engl J Med 363:10. 978-986.). Dr. Dudzinski writes from the perspective of Bioethics and clearly has dovetails with the perspective of Quality.
The article raises the challenge associated with events where a "large" number of patients may have adverse effects and poses the questions of the appropriateness of notification, whether to inform, who to inform, and how to inform. The events that they write about include issues of potential infection exposure in a variety of situations, and also, relevant to this writing, issues that result from laboratory error. Many of the laboratory issues cited we have previously raised, such as the immunohistochemistry problems in Newfoundland and New Brunswick. From the perspective of laboratory quality, perhaps one of the largest large scale adverse events not included in the situations described was the examination problem reported by Quest Diagnostics with regard to Vitamin D testing where thousands of patients were affected.
What the authors conclude is pretty basic. Many of the situations are not that easy to work through. For some the impacts are huge and obvious, and for others they are minimal and the process of call-back and notification may cause more harm than good. That being said, as much as decisions on call-backs and full scale notification are not simple, the process can be made much more straight forward if decisions are based on pre-existent policy and process. Tools such as likelihood – outcome table can be very helpful for establishing an objective base for decision making (see September 25 – Medical Laboratory Quality and Risk).
Many events that will occur will fall into the category of "unknown unknowns" and many details will be, by their nature event specific. But the issues of if, when, who, and how for disclosure need to be principles driven. Rather than waiting for “the bad thing” to happen, having worked through the principles and having a plan in place will make the go-forward much easier.
Right out of the Quality Management and Risk Management playbooks.
Congratulations to the authors and congratulations to the New England Journal of Medicine for profiling an issue so relevant to medical laboratory quality.