We’re always looking for studies on patient safety in the office or ambulatory setting but we’ve always been bothered by the relative paucity of high quality studies in the literature on patient safety issues and interventions in those settings. Now a special committee brought together by the AMA Center for Patient Safety has basically come to the same conclusion: research and initiatives in ambulatory safety have been remarkably limited over the past decade. That committee has summarized all the patient safety research done over the past decade in the ambulatory setting in a 192-page monograph (Lorincz 2011).
The new monograph begins with a good description of how features of care in the ambulatory setting differ significantly from that in the inpatient setting. That includes more diversity of patient population, wider range of conditions and severity of illness, more logistical and information challenges, more temporally and spatially dispersed care, and different infrastructures in the ambulatory setting. But importantly the role of the patient differs considerably. Patients themselves have a much greater role in their own care than they typically do while an inpatient.
They go on to discuss various definitions and taxonomies of errors, adverse events, harm, injury, etc., classifications of severity and potential preventability. They conclude that the taxonomies are not consistent or standardized. In particular, they noted that most studies on errors in ambulatory care do not distinguish between those that cause harm and those that do not. Also, most studies have been done in primary care settings and there is little data on other settings or across settings. And, while they note the potential of electronic medical records to improve safety, they acknowledge that EHR’s may introduce errors of their own and that their net effect on patient safety is not yet known. It notes that current EHR’s often encourage “cutting and pasting” and automatic behavior like filling out checklists and templates that tend to take away from the more thoughtful reasoning process that should be part of the history taking and physical examination. They also discuss clumsy user interfaces and fact that computers sometimes fail to fit into the usual flow of work and may also cause information overload and alert fatigue.
The best-studied area of patient safety in ambulatory care is medication safety. They note that there remains a need for large-scale studies on the incidence and types of ambulatory medication errors, adverse drug events (ADE’s), potential ADE’s, ameliorable ADE’s, and the harms they cause. They cite studies on high-risk medications and patient risk factors for ADE’s and errors (eg. advanced age, impaired renal function, polypharmacy, etc.) and the importance of medication reconciliation. They note that some medication errors are under control of the ambulatory practice but others may be only indirectly under their control (eg. dispensing errors, nonadherence, etc.).
Diagnostic error is the next major category. They discuss the difficulties in even identifying diagnostic errors and note that much of the research has utilized malpractice claims, which certainly underrepresent the scope of the problem. Their section on the risk factors for diagnostic error is excellent and covers most of the factors we discussed in our Patient Safety Tips of the Week for September 28, 2010 “Diagnostic Error” and November 29, 2011 “More on Diagnostic Error” plus our multiple columns on failure to follow up on tests ordered. They note a dearth of research on interventions to prevent diagnostic error and note that approaches taken, including using IT and decision support tools or cognition-focused approaches, have yet to demonstrate significant evidence of effectiveness. Note that another paper just published (Singh 2012) reviewed 6 tested interventions and 37 suggestions for possible interventions to reduce diagnostic error and found that empirical studies, while somewhat positive, lacked rigorous methodology. They also highlighted the need for improved research on interventions to reduce diagnostic error.
A section in the monograph on office-based surgery and anesthesia notes that adverse events tend to occur in elective cosmetic procedures more often than in medically indicated procedures and that a disproportionate number of cases with patient harm involved general anesthesia. Much of the research in this area comes from Florida, which has had more oversight of office-based surgery than other states. Since this publication, there has been another review of complications of office-based surgery reported in Florida and Alabama (Starling 2011). It confirms that cosmetic procedures and those done under general anesthesia tend to be more problematic but that certification by independent accrediting bodies and surgeon board certification did not seem to make a difference.
There is a whole section on the patient’s role in patient safety. This includes patient adherence to advice or directions, follow up with appointments, health literacy, and communication issues.
Just as we see in RCA’s of hospital adverse events, communication errors are involved in a great many adverse events on the ambulatory side. Problems at transitions of care, including issues with discharge summaries and test results pending at the time of discharge, have had a fair amount of research. Highlighted are problems in communication between primary care physicians and specialists and discontinuity that takes place at discharge or other transitions of care. The problem of communication of abnormal tests results is again stressed. Included under communication errors is the phenomenon of “alert fatigue” that we see with EHR’s and decision support systems.
While the overall conclusions of this monograph may seem discouraging, this is a very well-researched document and incredibly well-referenced. It contains a great annotated bibliography of published research on patient safety in the ambulatory setting. It certainly highlights the need for us to focus our energies and resources on patient safety issues in ambulatory care.
The report obviously calls for greater research into the prevalence and nature of errors and patient safety issues in the ambulatory setting and focused research on interventions to mitigate those problems. Note that the NQF’s recently updated list of serious reportable events has begun to include events occurring in the ambulatory setting.
One area not really discussed in the AMA monograph is infection control in the office setting. Fortunately, the CDC recently published a helpful guide to infection prevention for outpatient settings (CDC 2011).
There are a few validated tools out there for assessing patient safety in primary care offices. The best known are the MGMA Physician Practice Patient Safety Assessment® and the European Practice Assessment tool. The latter was shown in a recent article to lead to improvements in complaint management, analysis of critical incidents, and quality development/quality policy in primary care practices (Szecsenyi 2011).
We reviewed our site and were actually pleasantly surprised at how many columns we’ve done focusing on topics pertinent to patient safety in the ambulatory setting.
Some of our prior Patient Safety Tips of the Week on diagnostic error:
· September 28, 2010 “Diagnostic Error”
· May 29, 2008 “If You Do RCA’s or Design Healthcare Processes…Read Gary Klein’s Work”)
· August 12, 2008 “Jerome Groopman’s “How Doctors Think”)
· August 10, 2010 “ ”
· November 29, 2011 Patient Safety Tip of the Week “More on Diagnostic Error”
Some of our prior Patient Safety Tips of the Week on medication safety in ambulatory care:
· April 12, 2011 “Medication Issues in the Ambulatory Setting”
· August 2, 2011 “Hazards of ePrescribing”
Some of our prior columns on communicating significant results:
Some of our prior columns on wrong site procedures in the ambulatory setting:
· June 6, 2011 “Timeouts Outside the OR”
Lorincz CY, Drazen E, Sokol PE, Neerukonda KV, Metzger J, Toepp MC, Maul L, Classen DC, Wynia MK. Research in Ambulatory Patient Safety 2000–2010: A 10-Year Review. American Medical Association, Chicago IL 2011
Singh H, Graber ML, Kissam SM, et al. System-related interventions to reduce diagnostic errors: a narrative review. BMJ Qual Saf 2012; 21: 160-170
Starling J, Thosani MK, Coldiron BM. Determining the safety of office-based surgery: what 10 years of Florida data and 6 years of Alabama data reveal. Dermatol Surg. 2011; Oct 19; [Epub ahead of print].
NQF (National Quality Forum). Serious Reportable Events In Healthcare—2011 Update: A CONSENSUS REPORT. 2011
CDC (Centers for Disease Control and Prevention). Guide to Infection Prevention for Outpatient Settings: Minimum Expectations for Safe Care. May 2011
MGMA. Physician Practice Patient Safety Assessment® (PPPSA), a self-assessment tool.
European Practice Assessment Program.
Szecsenyi J, Campbell S, Broge B, et al. Effectiveness of a quality-improvement program in improving management of primary care practices. CMAJ 2011; 183: E1326-E1333