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Trying to Manage Outpatient Risks


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Growing incidence of malpractice suits from ambulatory settings prompt affiliated hospitals and liability insurers to explore interventions for outpatient care.


  • Thomas Cunningham, MD; Newton-Wellesley Internists; Newton, MA

  • Tejal Gandhi, MD, MPH; Brigham and Women’s Hospital; Boston, MA

  • Ann Louise Puopolo, BSN, RN; CRICO; Cambridge, MA


As more and more health care is provided in the ambulatory setting, the data from malpractice carriers show that more and more lawsuits get their start in the same setting. By far the most common allegations are related to a failure in diagnosis.

Yet traditional risk management, and even the emerging field of patient safety, have been focused elsewhere. Staffing, education, and protocols for preventing and responding to adverse events are geared toward inpatient care. But for ambulatory sites, those prevention efforts are largely missing.

Nobody’s comfortable with the status quo.

Professional liability carriers worry about rising payments for outpatient lawsuits, ambulatory care providers themselves are keenly aware of what’s at stake; and hospital administrators worry about their institution’s reputation and responsibility for patient outcomes in outpatient sites that have a close affiliation—sometimes even sharing the hospital’s name.

Everyone wants to prevent the next delay in diagnosis, or medication error. But a concerted effort will likely take more than simply grafting an inpatient model of risk management onto an ambulatory practice.

“I think the reasons for this are multiple…”

Dr. Tejal Gandhi is Executive Director of Quality and Safety at Brigham and Women’s Hospital in Boston.

“…one is you have a variety of practices with a variety of infrastructures and sizes and the different terms of who’s really responsible or who owns the practice.  The other thing is, unlike hospitals who tend to have an infrastructure for doing quality work, clinics are not set up to really do that. So the person power needed to actually do a quality improvement initiative or collect data to help improve on a certain project just doesn’t exist in many of these outpatient practices.”

Dr. Gandhi says another challenge in the outpatient setting is that the resources typically marshaled to prevent the kinds of errors seen in ambulatory care are lacking. The tracking of test results and performance of  cancer screening for timely detection of a disease, for example, is optimized with robust electronic medical records and other computerized functions.

But there is no magic bullet for good coordination and hand-offs to other providers in ambulatory care. Dr. Gandhi says another difficulty is standardization—a major patient safety principle.

“I think that the key point is that these are really often very independent entities so it is hard to standardize across all of these independent factions. And they are all very different in a lot of ways in terms of size, in terms of systems, in terms of resources. A two-physician practice is very different from a 10-physician practice. A specialty practice is very different from a primary care practice. So, it may be hard to actually standardize across all those settings, but I think we should have some basic protocols that we’re trying to implement everywhere, such as tracking of critical test results such as electronic prescribing, those kinds of things.”

Malpractice claims data and a growing body of literature are beginning to show where the major threats to patient safety lie. It is clear that office practices and other ambulatory sites—even those that are closely affiliated with a hospital—sometimes have trouble covering the basics. Dr. Gandhi’s own research has shown that the breakdown most likely to result in an outpatient malpractice suit is failure to track abnormal test results.

In the Harvard medical system, between 2002 and 2006, the two most common diagnostic process breakdowns in high-severity claims were failure to order diagnostic tests, and failure to develop a follow-up plan and referral if indicated.

Ann Louise Puopolo is Director of Loss Prevention and Patient Safety at CRICO, the malpractice and patient safety company owned by the Harvard medical institutions.

“In the last two-and-a-half-plus years, outpatient diagnosis claims, high severity, have actually superseded the diagnosis-related claims from the inpatient setting. The data tell us that, particularly as it relates to outpatient care, our friends in general medicine most frequently are involved in the care of these patients. But so are some of the medical subspecialties, most notably gastroenterology. And other services that are frequently involved include radiology and emergency medicine.”

Puopolo says that in order for hospitals to help their affiliated out-patient sites, they may have to start almost from scratch. Care for in-patients is much more likely to be related to treatment, rather than diagnosis, while the opposite is largely true for the outpatient side. That means much of the risk management and patient safety systems designed for  inpatient care will have to be adapted or completely re-conceptualized for the out-patient setting.

“Since the bulk of the case types that we’re seeing in the outpatient setting are centered around failure or delay to diagnose, much of those breakdowns in care stem from cognitive issues that the provider may not be considering in terms of making appropriate decisions while they’re caring for the patient in the office.  So, the kinds of things that the hospital can help the outpatient practices look at often times are related to decision making in real time. So, at CRICO we’re very interested in providing the content that we’ve already developed that could be better implemented within the electronic medical records of the physician at the office setting, to get some decision support, if you will, while they’re caring for patients in the office that present to them either with some complaints or are people that need to be considered at risk for certain kinds of cancer types and should have some more rigorous screening than perhaps they would consider.”

Dr. Thomas Cunningham is President of Newton Wellesley Internists, affiliated with Newton-Wellesley Hospital in Massachusetts. Dr. Cunningham’s practice has seven physicians and a number of advance practice nurses, and they meet at least monthly to do quality improvement work for their practice. Their efforts to track test results and referrals for further evaluation are helped by connection to the hospital’s electronic medical record system.

Still, Dr. Cunningham points out that such a system doesn’t solve every problem, since it relies on patients getting tested within that hospital network. There are other potential holes. Suppose a patient doesn’t follow through on a test or referral to a specialist.

“If we order something and there is not a visit attached to it, if it is something just over the phone, there is a way that we can go into the system and put a tickler in and it will say if such and such isn’t done by a certain date then it will come up on the screen. And the problem with that is that the physician has to actually do something to put that tickler reminder in.  So, we’re trying to work on some methods that might make it a little bit easier.  We’re trying to figure out how maybe a nurse could do it for us, put that tickler in there as things are ordered or just make sure the doctors do it. Because if the doctor doesn’t do it and the patient doesn’t go for the test then there is no way of knowing that the patient didn’t follow up.”

These are not the kind of acute adverse events or medical errors that are quickly reported to risk management departments in a hospital. Focused interventions are much less likely to result, because the trends are harder to spot. And the lawsuits that arise from non-hospital care can seem to come out of the blue years later.

“In the beginning it might seem as though it is no big deal, that things are followed up on rather quickly afterwards, even though it could have been maybe done a little bit sooner. But the long term consequences really aren’t apparent in the beginning. And I think that, the statute of limitations being three years, I think sometimes we hear about things kind of a surprise three years later. All of a sudden somebody is upset that maybe something could have been done a little bit sooner and that now there is a suit in the works, so to speak.”

The data for these results in outpatient settings don’t show up in a typical QI program at the hospital. And on the hospital side, improvement specialists may never learn about the problem.

Dr. Gandhi is not pessimistic, though. Hospital networks are increasingly sharing technology with their outpatient affiliates to help with the follow-up of clinical complaints, as well as coordination among multiple providers and settings. Malpractice data, and even third-party mandates are helping raise awareness about the problems and the need to increase resources to solve them.

“I think the progress is that we know more about what the outpatient safety issues are. That definitely has been progress. The Joint Commission requirements also help us think about where we should be putting our focus. …I think awareness is definitely increasing in the outpatient setting. I think 10 years ago people probably wouldn’t even have really thought patient safety was that relevant in outpatient care and now I think people definitely understand patient safety and know it’s an issue …But I still think we have a long way to go to really get every practice to the point where we’d like them to be.”

November 1, 2007
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