In the decade since the Institute of Medicine’s landmark report, "To Err is Human," revealed an epidemic of preventable medical errors and safety problems in the nation’s hospitals, virtually all of the safety efforts in health care have focused on improving inpatient care. According to the authors of a new study in the Journal of the American Medical Association, these efforts have contributed to an overall 23.3% drop in the number of paid malpractice claims involving physicians between 2005 and 2009.
But the study, which uses data from the National Practitioner Data Bank (NPDB), a repository of all malpractice payments paid on behalf of practitioners, found that while the number of suits filed by patients harmed in hospitals decreased by almost 25%, there was a less significant 19% drop in suits filed by those experiencing adverse events in outpatient settings.
In fact, the proportion of successful lawsuits filed by outpatients or their families has now reached 43% of total malpractice suits and is growing: In 2009, more than half of adverse events leading to malpractice suits occurred in outpatient setting, resulting in settlements that added up to $1.3 billion.
Meanwhile, there are now almost “30 times more outpatient visits than hospital discharges annually,” according to the JAMA study, “and invasive and high-technology diagnostic and therapeutic procedures are increasingly being performed in the outpatient setting.” In an accompanying editorial in the same issue, the authors say that these findings should be a “wake-up call” for physicians who practice in outpatient settings, adding that the “absence of risk management programs in ambulatory care settings across the country, is a cause for concern.”
The reason for this concern: “[M]alpractice claims represent the tip of the iceberg for patient safety events. For every claim, there are likely many near-misses or events with less severe outcomes that can be related to process errors similar to those that resulted in the claim,” write the JAMA authors. Doctors and health care administrators need to look at the patterns of malpractice claims and identify high-risk areas where the most serious errors are made. By doing this, they can “accelerate the development of programmatic interventions to improve patient safety and mitigate risk.”
It's clear that In the hospital setting, improved facility-wide safety protocols, checklists and other risk-abatement tools are helping reduce the number of serious accidents and medical errors that result in lawsuits. But these systematic and benchmark-driven safety initiatives have not trickled down to the growing number of independent outpatient settings that include doctors’ offices, community-based clinics and for-profit ambulatory surgery and imaging centers.
The JAMA authors report that in the past five years, “the number of studies funded by the Agency for Healthcare Research and Quality on inpatient safety has been almost 10-fold that of outpatient studies.” Incentive-driven safety initiatives undertaken by payers, such as Medicare’s refusal to pay for “never-events” and other preventable complications in the hospital, have also focused solely on the inpatient setting.
Meanwhile, approaches that are effective in reducing errors in hospitals may need to be modified for outpatient settings. In hospitals, surgical errors are the number one reason patients or their families file malpractice suits (34%), with diagnostic errors (21%) and treatment errors (20%) rounding out the top three. In the outpatient setting, diagnostic errors were implicated in a whopping 46% of the malpractice settlements while treatment decisions comprised 30% of the errors. At 14%, surgical errors were cited far less frequently as the basis for successful lawsuits. In both settings though, more than two thirds of the time these errors led to serious outcomes—for outpatients some 70% of the malpractice claims involved death or a major injury like permanent brain damage.
Why are we seeing an increase in malpractice claims that originate in outpatient settings? One reason is the overall shift to move patient care out of the hospital. “This shift has resulted in complex patients with multiple comorbid illnesses being increasingly cared for in less structured environments, potentially increasing the risk of errors,” according to the JAMA editorial. Another change is that doctors are seeing more patients for shorter periods of time, making it easier to miss symptoms or misdiagnose conditions. Finally, the amount of data related to each patient and the need to coordinate care between several specialists can be overwhelming to doctors. According to the editorial, a typical primary care doctor now processes 900 laboratory results each week. “Identifying and tracking the few significant abnormal test results from the abundance of normal results becomes a daunting task for busy physicians in the outpatient setting,” the authors write.
Another important trend is the growth in the number of stand-alone ambulatory surgery centers. According to the JAMA authors, these centers often do not adhere to the same safety controls employed by hospitals and they don’t receive as stringent oversight from state regulators. A recent article in Bloomberg focusing on problems at spinal surgery centers that market their services on the internet reports, “the number of U.S. Medicare-certified ambulatory surgery centers—those that focus on outpatient procedures—grew to 5,260 in 2009 from 3,512 in 2002. All but 4 percent of them are for-profit entities.”
According to the Ambulatory Surgery Center Association, about 90 percent of these centers include doctors as investors. They offer so-called minimally-invasive—and sometimes experimental—surgery options like laser spine surgery, bariatric (weight loss) surgery and arthroscopic procedures. The Bloomberg piece adds, “Doctor-investors may lower their standards for deciding when to operate, according to researchers from the University of Michigan in a study in the journal Health Affairs last year. Looking at five common procedures at Florida surgery centers, they found that once doctors became investors, the number of surgeries they performed increased by 87 percent.”
In the JAMA report, surgical events only accounted for some 14% of malpractice claims paid on behalf of outpatient practitioners. This figure might be inaccurate as individual doctors are sometimes dropped from suits that target institutions (like hospitals) or private companies. Recent evidence suggests that patient complaints and malpractice suits are increasing as more for-profit ambulatory surgery centers open. But for now, it seems that the most effective approach to curbing outpatient malpractice lawsuits—and preventing medical errors in general—is to concentrate on reducing diagnostic and treatment errors.
The JAMA authors write; “Events related to diagnosis may be particularly important in the outpatient setting, where follow-up is more difficult than in the hospital and where patients often present with symptoms and signs that may be subtle or not adequately noted amid the many short-term, long-term, and preventive care activities often undertaken in a single outpatient visit.” These “activities” have become more important as doctors focus their attention on meeting the demands of pay-for-performance and other public reporting programs that “may divert clinicians’ time and attention from the critical area of diagnosis.”
It’s not hard to see where serious—yet preventable—errors can be made. Missing key test results that indicate a viral illness, for example, can lead to patients being prescribed inappropriate or unnecessary antibiotics, worsening of the disease and even death. Failure to diagnose or properly stage a tumor can similarly lead to delayed or ineffective treatment and, again, hasten death. When patients are discharged from the hospital or visit specialists they may, unbeknownst to their primary care doctor, be taking new medications that interact badly with older drugs or cause debilitating side effects.
Despite the lack of studies on adverse events in outpatient settings, there are some evidence-backed methods that practitioners can already use to help reduce treatment and diagnostic errors. Increased “meaningful” use of health information technology offers one possibility. Electronic medical record systems can help busy doctors manage test results by automatically highlighting those that are questionable or clearly signal trouble. Equally helpful for reducing treatment errors are systems that track information about which medications are prescribed to individual patients and that alert office personnel when dosages are incorrect or dangerous interactions are possible.
For now, these systems are still nascent in many outpatient treatment settings and are often not part of networks involving hospitals. “The bad news is that rigorous, effective ambulatory risk management programs currently do not exist,” according to the JAMA editorial. “There are no defined best practices or benchmarks.”
This may be changing. Yesterday, the National Quality Forum Board announced an effort to define benchmarks that relate to outpatient care. The NQF, an independent nonprofit that partners with a wide range of state-based and national groups on improving health care quality, released an expanded list of 26 “serious reportable events” (SREs) that are now applicable to three new care settings—office-based practices, ambulatory surgery centers, and skilled nursing facilities. The SREs represent largely preventable errors and events, such as wrong-site surgery, patient falls, or serious medication errors. One new “reportable event” that is particularly relevant to outpatient settings: “Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results.”
Although the SREs were originally envisioned as forming the basis for a national state-based reporting program, they are now used voluntarily by a little over half of all states as well as a number of large health care organizations, medical centers, and professional groups to serve as benchmarks for improving care and preventing errors. Getting individual outpatient practices, ambulatory surgery centers and clinics to participate in this reporting program could provide needed insight (difficult to obtain by only reviewing malpractice claims) into identifying and eventually preventing serious events that can lead to poor outcomes.
More federal funding for outpatient safety initiatives will also help drive improvements. The Agency for Healthcare Research and Quality (AHRQ) provided $19.7 million in demonstration grants last year for evidence-based patient safety and medical liability projects. But just one of them—a $3 million grant to a collaboration that includes the Massachusetts Department of Public Health, Brigham and Women’s Hospital and the Institute for Healthcare Improvement—is aimed at reducing malpractice suits that arise in outpatient settings. We need to develop and fund more of these initiatives.
It’s become clear that improving risk-management in outpatient settings is vitally important as more care is delivered outside the hospital. Better oversight of for-profit ambulatory surgical centers should definitely be part of this effort. Investment in information technology that promotes safer prescribing, better follow-up of test results and other quality improvements may help practitioners reduce serious errors. So will adding benchmark measures that reward doctors for accurate diagnosis and follow-up to existing pay-for-performance efforts. The goal is to make care safer for all patients, regardless of where they are treated.