Enough! Hidden Hazards that Impair Safety

This morning my husband, my son, an exchange student and his host brother are holed up in what my mom would call a "no tell mo-tel" 30 miles south of snowy Nashville where I am waiting to greet them with tickets to tonight's Thrashers-Predators game. The boys gave up trying to complete the drive from Atlanta last evening when my husband, who grew up in Canada, said, "Enough." And not a lot more.

Unpredictable things that derail what we intend to do are annoying, and they can be dangerous. Like icy patches hidden under the snow, they're often hidden. Hazards are on my mind today.

On a larger scale, I've been reflecting about hidden places where safety gets derailed ever since a link to an article in the UK hit my Tweet stream last week. The headline and the original tweet used precious characters to say this: "Nurses who overdosed two Heartlands Hospital cancer patients escape punishment by professional body." The re-tweeted version that came to me included these words: "Sometimes sorry is not enough."

Based on the published account of these errors, the tragic events that resulted in the deaths of two patients did not happen because the nurses and physician intended to harm them. Rather, the processes they used to provide care on a regular basis failed when they were subjected to a drug's hidden hazard: Safe dosing of the drug involved, amphotericin, depends upon whether the specific product on hand is in a conventional or liposomal formulation.

The Institute for Safe Medication Practices defines a series of routine checks and balances that should be in place in clinical settings where amphotericin is used. Differentiating--calling out in a way that is obvious and unmistakable to all clinicians who prescribe, dispense, and administer drugs with liposomal formulations--is one of the strategies necessary to prevent these errors. It's also worth noting that liposomal formulations of drugs are part of a group designated as "High Alert Medications" so-called because they are highly likely to cause grave harm when used in error.

The process the clinicians used the day two people in the UK died failed because it was insufficient to prevent or detect a potentially lethal error that was set in motion. The nurses told the professional board that they were "very sorry," words that seem to have fueled the grief of the families and caused some in the global community to judge them, too.

"I'm sorry," no matter how sincerely felt or expressed, does not restore the dead to the living. That is not the purpose of expressing remorse nor for accepting an apology. The survivors of a terrible tragedy caused by medical error must be supported in how they choose to proceed, dealing with the unwelcome life-altering changes such events hoist upon them. Survivors must be free to accept or not accept expressions of regret (although many find  sincere apologies by individual clinicians and organizational leaders lessen their burdens).

But how we treat the people at the "sharp end" of a tragic system failure is ultimately a measure of safety culture. And it's a place where where good people (including many patient safety experts and healthcare professionals) slip on a hidden hazard. Saying that the nurses involved in this error "escape punishment" suggests they deserve punishment. And "sometimes sorry is not enough" leaves me scratching my head. What would be enough?

• An Ohio pharmacist is prosecuted, convicted, and jailed for criminal conduct following the death of a toddler who received a toxic chemotherapy infusion: Jail Time for a Medication Error – Lessons Learned from a Pharmacy Compounding Error. Is this enough? 
• A midwife in the UK hangs herself, believing she is blamed for the death of an infant that followed a failed hand-off of key clinical data. The details appear in Midwife hanged herself thinking she was to blame for baby's death. Enough?
• A new resident physician commits suicide following a medical error. Expectations of perfection and what happens to people when systems are not strong enough to overcome human error are shared in Words fail, a moving tribute written by her colleague. Enough!

The needs of those intimately involved in errors that cause grave harm have remained unexplored, hidden. Don't miss the opportunity to learn more about this error of omission in TRUST: Five Rights of the Second Victim. (Click this [link] to reach the TMIT Articles homepage where a pdf of "Trust: Five Rights of the Second Victim" can be downloaded.) And on Thursday, 2/4 the Institute for Healthcare Improvement is hosting Adverse Events and their Aftermath: SOS from Clinicians, a conversation facilitated by patient safety leaders from the professional and patient communities.

Postscript: You can access a recording of the IHI webcast  mentioned above by clicking this [Link].

Waiting for Rabbit Redux

Good stories are sometimes told across time, and so may be the case in telling the story of how healthcare gets healed.

I found this interesting interview, Medical Errors, 10 Years Post-Op, with two of the authors of the original IOM report. It's nicely bundled with a short history of the "hospitalist" specialty. (Don't miss the history of events that have informed the evolution of patient safety at the bottom of the piece.)

While we're waiting for Rabbit, here's a link to another snapshot of patient safety-sensitive performance measures: a 2009 report, commissioned by the American College of Healthcare Executives entitled, "Bad Blood: Doctor-Nurse Behavior Problems Impact Patient Care."

Maybe get a chair.

Error Prevention Strategies: It's not "Sophie's Choice" folks

Last week on my Medscape medication safety blog On Your Meds, I wrote a piece about how nurses in greater San Francisco area hospitals improved medication safety. The collaborative is reporting an 88% reduction in the incidence of errors in the administration node of the medication use process over a three year period.

At the outset, it's worth noting that these results are astonishing, placing them in the "almost too good to be true" category. The study employed "observed error" methodology, a more robust method of error detection than "reported errors," (the methodology most programs and data sources rely on). The rigor of the detection methodology used in this study adds credence to the results.

But it's worth looking a little more closely at the study design to find the most important take-away lessons.

The nurses tested how adherence to six distinct performance elements in their medication administration process impacted accuracy: [link]

1. Compare medication to medical record
2. Keep medication labeled until administration
3. Check two forms of patient identification
4. Immediately record medication administration in chart
5. Explain the medication to the patient
6. Minimize distractions and disruptions during the administration process

From an engineering standpoint, these elements can be predicted to produce a robust medication administration system. Comparing medications to the medical record and checking two forms of patient identification, for example, add redundancy at high stakes junctures of the process. And "explaining the medication to the patient" creates a recovery opportunity, an engineering control that allows an error that's been set in motion to be detected and remediated before harm occurs. (The practice is also desirable from a participatory care standpoint and also is "the right thing to do" based on variety of ethical principles.)

"Minimizing distractions and disruptions during the medication use process" is the performance element that drew the most attention in the lay press, and it's what I focused on the first time I took on the issue at Medscape. Minimizing distractions at high stakes junctures of performance is a technique that high reliability industries employ. (It's why aviation personnel in the flight deck close the door and why they're subject to tighter performance expectations at altitudes less than 10,000 feet.)

What the San Francisco nurses really studied is whether adherence to a system designed to elicit a specific outcome yields the desired outcome more often than using a loosely defined, variably employed set of expectations does. Minimizing distractions was an important part of the interventions, but it wasn't the only one. The nurses did not find one "magic bullet," but rather moved from an "intention-based" process to a process that was both engineered and adhered to, something that helps explain the very favorable, highly desirable results obtained.

Understanding how these results were obtained is also important before leaping into the comparative arena, especially when the discussion is built around a "forced choice" construct that does not and should not exist. This is what I think is happening in a blog post entitled, Low Tech solution to Med Admin errors better than BCMA?

Designing the most robust system feasible to accomplish a high stakes task is how system engineers approach their work. (Risks surrounding medication administration are well documented and errors at this point remain common.)

Seminal medication safety data show that a substantial portion of errors originate in the administration phase of the medication use process.



Equally important these data reveal that patient harm is highly likely to occur as a result of errors that originate in the administration node.


It's important to recognize that errors in the administration node are problematic, not because nurses are problematic but because the systems nurses rely on and the downstream position of their work confer risk. Managing that risk has been the focus of medication and patient safety specialists over the past decade. IT solutions, specifically the ability to bar code patients and their medications, and to have key patient, drug, and order information integrated and available at the point of care, represent strategies engineers see as reliable, reproducible, and capable of sustaining change over time.

The San Francisco nurses' study did not rely upon bar code medication administration (BCMA) although it appears BCMA was used in at least some of the study sites. But what must be noted is that key performance measures in the study (namely, "compare medications to the medical record" and "check two forms of patient identification") represent standard medication safety practices that are now part of The Joint Commission's healthcare accreditation standards. While they are important elements in the system design the nurses tested, these elements are not "stand alones." They would have occurred, on some level and likely with unwelcome variability, in these hospitals during the study period irrespective of whether they were part of an intervention study.

More important to debunking ill-conceived notions that medication administration accuracy is an "either/or" proposition (pitting low tech performance measures against tech-mediated ones) is the knowledge that BCMA automates key elements of the performance measures the San Francisco nurses built into the system they tested. These include comparing medication to data in the medical record; immediately recording medication administration in the chart; and checking two forms of patient identification. Additionally, BCMA work flows necessarily foster work processes in which medications remain labeled (often in their original packaging) until the point of medication administration.

If BCMA has failed to reach its full potential in the medication administration arena, as John Poikonen questions in his RxInformatics post, the reason has less to do with the inherent fitness of the technology than how user-friendly it is designed to be; how it is incorporated into nurses' work flow; and how it is supported in the aftermath of the initial investment. Most importantly, disappointing results with BCMA likely reflect system design failures that do not take into consideration the limits of human performance when carrying out high stakes tasks. Nurses should rely on automated solutions to accomplish high stakes work and they should not be expected to multitask while using them.

Your pilots get to close the cockpit door when they perform tasks that, if carried out incompletely or incorrectly, could kill the people who depend upon them. Pilots also rely on high tech instrumentation that automates many key performance elements.

Why would you want your nurses to "pick one"?


Note: Representation of the seminal medication error data discussed here was borrowed from similar formats used by the medication safety professionals at the Institute for Safe Medication Practices. I am indebted to them, both for this depiction and the modeling upon which my knowledge of medication safety is based.

God is great, beer is good, and people are crazy

Insanity is doing the same thing over and over again and expecting different results.
- Albert Einstein

Results from a multi-center nursing "time and motion" study show that nurses in acute care settings spend about 35% of their time documenting care, 17% on responsibilities related to medication administration and monitoring, and 21% coordinating care. I've heard Marilyn Chow, one of this study's lead authors present these data before, and she included them in a presentation given last week in an IOM webinar on the Future of Nursing.

I don't think anyone is particularly happy with these statistics. (Although it remains unclear what patients actually think since high profile evaluations, like this one from US News and World Report, measure nursing care by how mom-like the experience of being cared for is.) Real patients--that is, those who have had the experience of being hospitalized and understand that the circumstances that land them there necessitate far more than a chipper smile and a well-timed fist-bump--might be able to evaluate nursing care using different metrics. But, for now, it appears we're living with "% of patients whose nurses were ALWAYS polite and communicative." Sigh. (Can I just say that when I'm an inpatient, I appreciate polite and communicative behavior on the part of all of my caregivers?)

It's hard to look at Chow's data and not be struck by a significant mismatch between intention and outcome. Surely this is not the best use of valuable, high cost resources.

But what makes Chow's presentation worth studying is that, beyond Slide 4, she gets out of the box, tossing out fresh ideas about how nurses will nurse in the future. And why they should. Plus who will benefit. And how technology will enable it. Review the 11 slides in this presentation for inspiration.

If you think I'm crazy, remember what Einstein said.

A Belief Born of Despair

I've been advocating for solutions to medical error that extend beyond what individuals can do (or can reasonably be held accountable for doing) for a long, long time. In the language of cognitive psychology, this means I ascribe to a system approach for modeling and managing human error.

My belief in system approaches did not arise as a result of study, reflection, or facilitated learning, but came in the aftermath of care my son received in a state-of-the-art children's hospital in 1992. Born with a serious, but fixable digestive problem, my son--and our family--logged more than half of the first year of his life in the hospital.

I've long since forgotten the litany of things that went wrong that year (although equipment malfunction, wound dehiscence, breastmilk mix-ups, tubes that stayed in too long and tubes that came out before their time return to the forefront of my mind after a cursory search of the blessedly faltering "hard drive" where I store these memories). But I have no trouble recalling an evening when I sat in a rocking chair beside my son's crib, meeting with the institution's risk manager who had been called in from home in the aftermath of yet another inexplicable error. "Can you just tell me," I asked in despair, "why the team of seemingly reasonable human beings you represent are so patently unable to render care that does not--in some way, shape, or form--harm my child?"

She could not.

But others have been able to, and over time, I've found solace in some unexpected places. I'm sharing a link to Human error: models and management, a 2000 commentary by James Reason that appeared in the British Medical Journal. This work remains the de facto starting point for anyone interested in the science of reducing human error.

The process of resolving feelings about what happened in the aftermath of my son's difficult start was complex, and I'm sharing just a part of that journey. It's telling that Reason's words--written years after my son's birth--resonated with me, helping to express what I intuitively knew. I hope they will be helpful to you.

I was first able to give up the idea that "bad" (think: careless, stupid, lazy, inconsiderate, incompetent) people were responsible for all that went wrong by considering the problem logically: it was statistically unlikely that our family would have had the bad luck to bump into a disproportionate number of mal-equipped, mal-intended, or simply "off-their-game" individuals with a frequency that could account for the host of significant mishaps that befell us. This analysis may not come to your mind if you seek care once in awhile and have an unsatisfactory encounter or uncover a near-miss. But when you get a data set like the one I had in 1992, you come to realize that some norms, like poor penmanship and ambiguous orders, breed the predictable mishaps that follow.

In my son's case, I ultimately concluded that given the variables of "inpatient days logged" and "complexity of care," he probably experienced the same number of adverse events that anyone else in his situation did. Seeing our misfortunes as a series of unacceptable, but common, outcomes helped me get rid of the feeling that my family was being trailed by some dark cloud of bad juju.

The memory of thoughtful words and genuine acts of kindness also helped dispel the notion that errors in my son's care arose largely because of uncaring or negligent people. In our darkest days, following a leak in my son's newly repaired esophagus, the surgeon shared that he prayed for Luke and for our family, expressing his hope for healing, comfort, and restoration of our family life. The rotating resident brigade, whom I unkindly referred to as the "sneakered sycophants," nevertheless tagged my son with some endearing nicknames, a few that we still use today. One of Luke's home care nurses became a godmother. I share the healing power of these moments, not because I think that intending to do the right thing and actually doing something right are the same. They're not. But these moments helped me see that what was lacking in the care my son received simply couldn't be explained by factors under the control of one individual.

I hope you'll return to this discussion ready to explore more about what turns intention into outcomes, what heals without first hurting. Let me leave you with something that always make me smile: