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.