Saturday, March 21, 2009

From Silence to Voice*

I am a member of the Institutional Review Board (IRB) at my university. IRBs, also known as independent ethics committees (IECs) or ethical review boards (ERBs) are committees that have been formally designated to approve, monitor, and review biomedical and behavioral research involving humans in order to protect the rights and welfare of the research subjects. While I sometimes gnash my teeth at the IRB when I'm working on my own research, I enjoy being a part of the board and interacting with my colleagues.

The reality is that there is not a lot of nursing presence on the university's IRB. It is mostly physicians, a few others who are involved with the research process, and the requisite community member. Over the two years that I have been on the board, I have contributed...adequately. I do my reviews, I occasionally ask questions or contribute my thoughts to the discussion. But at the last meeting I attended, I felt that I was present as the Voice of Nursing.

Usually, an IRB meeting has the same components -- reviewing and voting on the status of newly submitted studies, continuing reviews for on-going studies, and modification reviews for studies requesting changes. Occasionally, however we have to deal with Protocol Deviations. Protocol Deviations can range, but generally only those that cause harm or have the potential to cause harm are brought to the board. Last week's meeting included a review of a study with two major protocol deviations. The study is situated in the ICU, and utilizes very aggressive diuresising (i.e. giving medications--in this case IV furosemide--that causes one to eliminate fluid). One of the dangers with diuresis is that the process also causes a loss of potassium and can increase the blood sodium levels. Both of these processes are dangerous: potassium makes muscles contract, and either too much or too little can make muscles flaccid. Seeing how the heart is a muscle, this can be very problematic, and lead to icky things like heart arrhythmias. Sodium is involved in the transmission of electrical impulses, and since that's a very important part of brain function, this too can be very dangerous. Low sodium can cause delirium, high sodium, seizures.

This study had very strict protocols for stopping diuresis and beginning electrolyte and/or fluid replacement if the values go out of range. In this case, potassium got low, sodium high, the protocol was stopped....and then the furosemide was, for some inexplicable reason, restarted. By the time the situation was remedied, the subject's potassium was 1.8 (normal is 3.5-4.5) and sodium was 159 (normal is 135-145). When we questioned the study's principal investigator (PI), he said that a resident must have ordered the furosemide restarted, and while he did not speak with the resident, he and his team went back and worked with the ICU nurses, reeducating them regarding the protocol and electrolyte values.

Part of what I was trying to tease out was where was the root of the problem: was it a hospital systems/QA problem or was it an issue with the study? What I wound up addressing in the meeting was what is common knowledge/common practice for nurses.

First of all, electrolyte balance is nursing 101. Keeping track of critical labs like potassium and sodium is as natural to a nurse as breathing. I cannot imagine an ICU nurse not understanding what was going on, and responding accordingly.

But what really got to me, was the implication in the PI's comments that nurses blindly follow orders, whether they make sense or not. ICU nurses in particular work very collaboratively with providers, and are not known for shrinking away from making independent care decisions. Furthermore, any nurse worth her salt will not carry out provider orders that they feel are unsafe--a common response to a physician insisting on something a nurse feels is unsafe is for the nurse to say "fine, if you want them to have X, then you give it to them."

After the PI left, and the board was discussing the case, I felt it was important to raise these points. Not because they had direct bearing on the case in front of us, but because, as the lone nurse in the room, I felt it important that I remind those assembled of the scope of nursing practice, and of our skills and abilities. Even though it painted that specific nurse in a poor light, it felt more important to stand up for nursing as a profession, not as mindless "handmaidens to doctors." I'm not saying that that is how most providers perceive us, but as much as the public doesn't understand what we do, I sometimes get the sense that our colleagues and co-workers don't always get it either.

*Hat Tip to Bernice Buresh and Suzanne Gordon, authors of From Silence to Voice: What Nurses Know and Must Communicate to the Public


Barbara Olson, MS, RN, FISMP said...

I participate in a lot of RCAs and the last person in the chain (often a nurse) usually winds up looking deficient. (I think this is why, earlier in my career, I spent a disproportionate amount of time educating/remediating individuals instead of moving upstream, looking for underlying, and often more correctable factors.) You give a great example of system thinking within an IRB. Keep up the good work!

susan said...

Not for nuthin', but what about educating the frackin' resident? Where's her responsibility in checking labs?

marachne said...

Susan, follow-up with the resident was what was discussed in reference to the protocol violation. My point was that it was a teachable moment for a gathering of mostly physicians that this is under the scope of practice of the nursing staff, and that if a hospital nurse is not dealing with such a basic issue correctly, there is a potential systemic problem in the hospital. While not the focus of the IRB, we do regularly provide feedback to the institution as a whole when something that happens during a research trial reflects on general hospital practice.

Jim deMaine, MD said...

As a retired Pulmonary/Critical Care doc and an ethics committee member, I applaud your "silence to voice". The ICU nurses bailed me out on many occasions with a quick warning call about electrolytes, blood gases, etc. To me it was always a team approach.

I'm also on a non-profit board which oversees a machine shop for disabled workers. We have several manufacturing board members with lots of experience in zero tolerance for errors with their QA and six sigma training.

We still tiptoe around errors in medicine by "calling it to their attention" or "reporting up the chain" or simply going on with the next pressing case. We don't have the expectations of a Toyota or Boeing. We often try but the systems for improvement aren't yet in our DNA.

Keep up the voice!

Jim deMaine, MD