WHAT IS A NEVER EVENT?
A “never event” is an informal term for a serious reportable event (SRE) that could cause patient harm or death as defined by the National Quality Forum (NQF). The NQF is an organization working toward safety in healthcare among other things (1). NQF is known for its 2006, 2009 and 2011 reports on SREs. SRE is the term created for 28 “preventable, serious, and unambiguous” events that should never occur in a healthcare setting. As a perfusionist, I take exception to the use of the word “unambiguous”, which means that these events are not open to more than one interpretation.
Are there “never events” that could apply specifically to perfusion practice? A never event is an adverse outcome that is either always avoidable, preventable or caused by obvious negligence. An example of an adverse event that is not a never event would be an oxygenator failure requiring a change out. Since oxygenator failures are totally unpredictable, this would not be something that a perfusionist could avoid by any preventative action. But a circuit disruption due to failure to ty band connections or a gross air embolus would be examples of perfusion never events since both can conceivably be prevented. Or can they? There are 28 SREs listed of which some could easily be associated with perfusion practices (2).
In the category of “Product or Device Events” there are three possible never events that could pertain to perfusion practice. The first one is the harm from contaminated drugs or contaminated devices. I agree that contamination from multi-dose vials or reused syringes and needles should never occur. But what if the contamination comes from the heater/cooler despite following recommendations from the FDA and manufacturer about removing microbes from these systems? If the patient gets a nontuberculous mycobacteria infection from this contaminated device, is that a never event? A second never event could be caused by the use of a device where it is used or functions other than as intended. Suppose a blood pump or some other ancillary equipment fails even after following all maintenance recommendations, or a pump or oxygenator is used for more than six hours and then fails. Is that a never event? A third never event deals with injury from an intravascular air embolism. A gross embolism that occurs due to emptying of the venous reservoir during bypass is certainly a never event. But what about micro-emboli that are not detectable except with specialized equipment? Does their presence in the patient’s brain constitute a never event?
In terms of a product or device SRE, I think it is naive of the NQF to suggest that their failure is a never event. No matter how thoroughly maintenance is performed on equipment or how selective the choice of a disposable product, in the practice of perfusion these things can never be 100% reliable. NQF acknowledges this to some degree: “Some SREs are universally preventable and should never occur. Others are largely preventable and may be reduced to zero as knowledge and improved prevention strategies evolve”(1). EVERY TIME I ran a pump I expected and planned for some type of equipment or disposable product failure. Fortunately, that was a very rare occurrence for me as it is for most perfusionists, at least in this day and age. (Back in the stone age of perfusion in the 1950s, 60s and 70s, that wasn’t so true.) Unfortunately, it is the perfusionist who does not plan ahead of time for every conceivable failure who causes the greatest harm when it could have been avoided. Take for example the poor schmuck who couldn’t find a hand crank when he needed it and his even more unfortunate patient (3).
But how does one plan for every conceivable failure? A good place to start is the AmSECT Safety page. Here you will find a wealth of material in the form of failure modes and effects analyses (FMEAs) against which you can test your program’s readiness for dealing with emergencies that could be considered never events. You can also learn how to rank your program as to risk and learn ways to reduce the risks in your program. So take a look at the AmSECT Safety page and prepare yourself for the next “never event”.