Overregulating patient safey

By Bob Wachter

In responding to dysfunctional systems, America instinctively turns to “more regulation” (Exhibit A: today’s Wall Street). But regulation can, and often does, go too far, and – in patient safety – I believe that it now has.

Note that this comes from someone who believes that health care was under-regulated until recently, not a popular viewpoint (just more mavericky behavior, I guess). But you must admit that it was rather odd that until 5 years ago, I was more likely to have my order read back when I called my Chinese takeout restaurant than when I called my hospital ward with a complex medication order. (Parenthetically, the reason for this disconnect is that my takeout restaurant has a more powerful business case to avoid screw-ups – they lose a customer – than does my hospital). So now there is a Joint Commission requirement to perform “read-backs” of important verbal communications. And it's hard to question the need for regulation when a prescription that said, “Inject 10U Insulin,” could be followed without question, despite the fact that such orders have been mistaken for “100 Insulin” thousands of times, leading to scores of patient deaths.

I reviewed the first 5 years of the patient safety field a few years ago. In an article in Health Affairs, I opined that increased regulatory/accreditation pressure had been the most potent force for change in the first years of the safety revolution:

Because physicians remain highly individualistic (which causes them to resist regulatory solutions and standardization), and hospitals continue to lack a robust set of incentives to drive patient safety, regulatory solutions have arguably been the most important early step, particularly when it comes to procedural safety (creating safe systems, standardization, and redundancies) in hospitals.

At the time, I was referring largely to the actions of The Joint Commission (formerly JCAHO). (I understand that TJC is an accreditor, not a regulator, but this is a meaningless difference when a rebuke from “The Joint” can lead to a freezing of Medicare payments.) Part of my positive assessment was based on changes that TJC had enacted over the past decade. Starting in 2003, the Chicago-based organization began to issue a series of commonsensical National Patient Safety Goals, including the abolition of high-risk abbreviations, and requirements for “sign your site” and the surgical “Time Out.”

Moreover, TJC has completely re-tooled its hospital surveys. Previously, hospitals were given several year's notice of an upcoming TJC visit, and the inspection consisted mostly of reviews of policies and procedures, gleaned from flipping through thousands of pages in dusty binders. A few years ago, the Joint Commission changed to unannounced visits (for our last inspection at UCSF, we had a one hour notice, which is as it should be), and the new Tracer Methodology brought the inspectors out to the floor, talking to patients and providers to get a sense of what is really happening on the ground.

Don’t get me wrong. It isn’t that I love Joint Commission visits, or that I don’t recognize that the process can be arbitrary and the inspectors a bit – how shall we say – musty. But I did, and do, believe that the overall pressure from TJC has been an immensely positive force for patient safety.

In the same article in which I praised TJC and the stepped-up regulatory environment, I predicted that problems were on the horizon:

Unfortunately, the history of regulation is beset with examples of overreaching and unintended consequences, both of which can ultimately hamper flexibility and innovation. Moreover, it is hard to regulate the creation of a safety culture and the implementation of information technology.

On this one, I’m afraid I was right, but the problem hasn’t really come from TJC. Sure, TJC has gotten into the weeds requiring complex changes like Medication Reconciliation before anybody really knew how to do it, but overall their requirements have remained measured and sensible. In fact, for every doctor or hospital exec moaning about TJC overreach, there are important stakeholders criticizing the organization for not being aggressive enough. This, of course, was predictable – if TJC was doing its job, how could there still be terrible medical errors? The result: intense pressure on TJC to become even tougher, and the recent endorsement of a private accreditation agency (DNV Healthcare, a U.S. subsidiary of a Norwegian company) to provide some competition.


All of this represented a natural ebb and flow... but then states jumped into the patient safety regulatory pool. Beginning a few years, many states began to increase their safety enforcement profiles, using the Centers for Medicare & Medicaid Services (CMS) playbook – the “Conditions of Participation” – as their touchstone. Armed with immense regulatory powers, including the ability to fine hospitals (potential hospital fines in California were recently bumped from $25,000 to up to $100,000) and suspend their operations, state health inspections throughout the country have become far more aggressive and unforgiving than TJC visits.

So what’s the problem, you might ask. It's not exactly like we're cured the problem of medical errors, right?  Well, there is a problem: because many of the new state processes are so draconian – a single transgression can mean catastrophe for a hospital – this Regulation 2.0 environment is sapping much of the joy and enthusiasm from the safety field, replacing any effort to create a safe, collaborative culture with one that is far more frantic, with much more finger-pointing and nastiness, than the one many of us had been trying to build.

Just as importantly, rather than promoting a holistic approach to safety improvement (with a broad array of investments in training, staffing, simulation, new processes and procedures, IT, and more), a state inspection leads to a laser-like focus on the problem at hand. The environment begins to resemble airport security, where even a single failure is catastrophic. This is fine for the TSA (a failure in airport security can lead to hundreds of deaths) but a little skewed if the transgressions might (repeat: might) result in harm to a single patient.

Let me briefly describe my own hospital’s situation (if he’s still reading, it is at this point that my medical center’s CEO is starting to cringe). Over the past few years, we had a couple of serious medication errors that we dutifully reported to the state, even as we began to aggressively attack their root causes. Fine so far. But the state inspections that followed – accompanied by a series of required changes that were extraordinarily expensive to implement, and often not evidence-based – have consumed a huge proportion of the medical center’s financial, organizational, and psychic bandwidth over the past 18 months.

As one tangible example, inspectors found that some medication orders didn’t precisely hew to the correct form (a typical example: ordering a medicine giving both a dose and a time range, such as Morphine sulfate, 2-4 mg every 4-6 hours prn pain). Under the microscope of a state inspection, such orders, if found too often, could have led to the closure of our hospital. Since our computerized order entry system is still a year or so away, our only viable response was to hire literally scores of new pharmacists and “medication safety nurses” whose main job was to catch these “errors” before meds were dispensed. The cost of these stop-gap and patchwork solutions: tens of millions of dollars.

But did all of these expenditures improve safety? Probably a little. Were they worth the cost in scarce safety money? No way. Could we have spent the same money and created more safety benefits? Easily. Did we have any choice but to do what we did to get out of the doghouse? None whatsoever.

I have spoken to several other hospital leaders in California (and elsewhere), and they all harbor the same concerns. But few raise these concerns publicly because – and here’s another problem with regulation – nobody wants to anger the regulators lest that triggers another visit. This is understandable, but it means that we’re accepting a status quo that may harm patient safety. That seems just plain wrong.

I had the privilege of being the keynote speaker earlier this month at a national meeting of these same state inspectors (the “Association of Health Facility Survey Agencies”), and I told them just what I'm telling you. I found them to be highly respectful and quite open to these critiques. These are good people being asked to do a tough and important job, and they recognize that overly draconian tactics and inflexibility might well cause harm. Kathleen Billingsley, who runs the surveying program for the California Department of Health Services, vowed to try to create more of a “partnership” with providers. I found her and the other surveyors sincere, and I hope they follow through on that promise.

In the meantime, the state activity is having an unanticipated (or maybe it was anticipated, in which case it was very clever) consequence. I often get asked whether there is a business case for investing in safety and quality. Of course, the facile and PC answer is “yes,” because we want it to be so. And most folks think that, even if there isn’t really a business case today, there will be one eventually.

But my own view is that there really hasn't been a business case for safety, at least in terms of short-term payoff. By this, I mean that until recently, a hospital CEO or board was not making a wrongheaded business decision by choosing not to invest in teamwork training, or simulation, or bar coding, or CPOE. A problematic ethical decision, to be sure, but not necessarily a flawed business decision.

However, the fact that state inspectors can swoop in and require you to spend several million dollars in clean up and prevention costs does shift the ROI. I know that my hospital now regrets that it didn’t move more quickly on CPOE – though the decision to implement our Electronic Medical Record (rather than CPOE) first was completely rational several years ago, we hadn’t (and couldn’t have) factored in the cost of compliance in today’s hyper-regulatory environment. Today, we might well have made a different choice. Would that have been a good thing? I'm not sure.

I hope that regulators will read this and consider the possibility that their work and style may need to be modified to further the goals of patient safety. I also hope that the regulated will recognize that the inspectors are good people trying to do a tough job – and that some of the problems they’re identifying do need fixing, and have for years.

With regard to America's financial meltdown, we’ll all soon discover that – while there are problems with under-regulation – over-regulation creates important hazards of its own. Here’s to hoping that our patient safety regulatory framework quickly assumes a thoughtful place between the poles of under- and over-regulation – a place that best protects our patients and promotes the wisest use our scarce safety resources.