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Patient Safety in Office-Based Care Settings
The Institute of Medicine’s 2000 publication To Err Is Human summarized research on the impact of medical error in hospitals, and it is credited with energizing the patient safety movement.1,2 Possibly because the report focused on the acute-care setting of hospitals, much of the early momentum in patient safety research and application focused on hospitals. Many more people, up to 23 times more, receive medical care in office-based or outpatient settings rather than in hospitals.3 Office-based settings appear to be safer than hospital settings, but patient safety incidents do occur, and given the volume of patients receiving care in office-based settings, even rare incidents may impact many people.4 High-quality office-based care, such as primary care, is essential to improve health outcomes, to decrease mortality from chronic disease, and to promote prevention. Also, many office-based settings, such as ambulatory surgical centers, have taken on care which had previously been provisioned primarily in hospitals. But challenges in office-based care settings, such as falls, diagnostic issues, and complications related to ambulatory surgery, can reduce patient safety.
Common Safety Events in Routine Medical Office Settings
With so much care provided in office-based settings, and comparably little attention paid to understanding patient safety in this setting, the ECRI Institute published an analysis of more than 4,000 patient safety events in ambulatory care centers, community health centers, and primary care provider offices over the course of a year. That analysis attempted to make an overall account of the kinds of safety issues that arise in office-based settings. The ECRI Institute found that safety events in ambulatory care fall into four main categories: diagnostic testing errors, medication events, falls, and security or safety incidents, such as workplace violence or violence from patients or trespassers.
Some of these risks overlap with those in acute settings, and may be approached in similar ways in both acute and office-based settings, for example patient falls can occur in any patient setting. AHRQ published a primer on fall prevention summarizing evidence on fall reduction in a variety of healthcare settings. The mitigation strategy of incorporating individualized fall risk screening to identify patients most at risk for falling appears effective in either acute settings or ambulatory settings.
Diagnostic testing errors and delayed or missed diagnoses also lead to patient safety events in office-based settings. For example, communication breakdowns in primary care can lead to failure to discuss abnormal test results with patients, leading to delayed or inadequate treatment. Better patient engagement and reminders can improve diagnostic safety. A delayed or missed diagnosis is more complicated, but it is prevalent in office-based settings. A study of 4,830 cases of diagnostic error in a nationwide cohort in Sweden found that cancers were often misdiagnosed in primary care settings, especially colorectal and skin cancers. But these apparent cases of misdiagnoses may be related to challenges inherent to primary care, as a review of diagnostic safety has noted. Symptom presentation is often poorly defined with non-specific presentations in the office-based setting, and diagnosis may require a longer process than diagnosis in the acute care setting. However, building awareness of frequently misdiagnosed conditions in primary care and developing tools to improve recognition of cognitive biases that may erroneously dismiss rare diagnoses may improve diagnostic safety in office-based settings.
Compared to hospital-based settings, medication prescribing in office-based settings may be associated with greater patient safety hazards because patients may be prescribed medications from many different providers, and these providers may have separate, incompatible electronic health record systems.5 A systematic review found that in office-based care, prescribing errors are the most common type of medication error, although there is variability in the data.6 Despite their frequency, medication errors in office-based settings tended to be of “mild-to-moderate” severity, although with some potential for lethality.6 In assessing factors contributing to medication errors, knowledge lapses regarding special populations or updated treatment guidelines appear to increase error, which may indicate that there is a system-level need for more education and resources.6 Medication error has been a focus of patient safety, and interventions such as software support during prescribing and pharmacist review of medications, both with patients and prescribers, have evidence of reducing harm.5,6
Violence in healthcare settings impacts patient safety, and guidance is emerging that a culture of safety may mitigate the harm of workplace violence in healthcare. Organizational strategies like clear protocols to track violent incidents and address patient violence, including regular monitoring, along with changes to the physical environment and training may help reduce workplace violence. Like other safety improvement measures, such changes could be applied in a variety of settings. In contrast to hospital settings, which typically contain multiple security checkpoints, office-based medical care centers are often designed to be easily accessible to the community, and that access might make them more vulnerable to violence, as the ECRI Institute’s survey of patient safety in office-based settings has noted. Specific office-based medical centers, such as reproductive healthcare facilities, are often targets for violent conduct such as bombings or arsons.7 However, some forms of office-based care, such as primary care, may be positioned to prevent patient violence. Data has suggested that about 85% of violent incidents had warning signs.8 Perhaps the more longitudinal relationship that typically exists in primary care could help identify these warning signs.
Safety Hazards in Ambulatory Surgery Centers
Additional safety hazards exist for surgeries or procedures conducted in outpatient, office-based settings. In the United States, more than 25 million surgeries each year are performed in ambulatory settings, marking an overall shift of a wider range of procedures and more higher-risk patients obtaining care in ambulatory surgery centers. Responding to this shift, AHRQ funded a project to reduce surgical site infections and other complications through rapid-cycle improvement in ambulatory surgery centers. Reporting on this initiative, researchers have found that low rates of complication coupled with high attrition and low data reporting rates made it difficult to collect enough data to achieve statistical significance, which limits their findings. The study authors believe that future programs could improve data collection through more robust data collection strategies. For example, it may be necessary to reduce the data submission burden and mandate data reporting for participating organizations. Additionally, educational materials and tools were developed to address safety in ambulatory care surgeries; these resources could be implemented more widely.
Beyond infections and complications from surgeries, researchers have begun to describe deviations from optimal care in office-based surgeries from both patient and clinician perspectives. They found that such deviations were common, occurring in 70% of reviewed cases. Examples of patient-reported non-routine events in ambulatory surgery include unexpected postoperative pain, vomiting, and feeling rushed out of post-operative recovery. Clinician-reported non-routine events included case delays from machine failures and staffing issues. And while clinicians tended to rate these non-routine events as low in severity, patients reported high distress related to their perceived non-routine events. Notably, better communication between clinicians and patients may reduce patient-reported non-routine events and distress.
Communication and TeamSTEPPS
Care in office-based settings has the potential to reduce healthcare costs and improve outcomes, especially for primary care, which focuses on an individual’s overall health and is often predicated on an ongoing relationship between individual and provider. But the healthcare environment’s complexity makes communication difficult. That difficulty in communication has been found to be the root cause of about 80% of all medical errors. Breakdowns in communication between different medical providers, and across medical providers, patients, and their caregivers, all contribute to lapses in patient safety in office-based care. TeamSTEPPS (Team Strategies and Tools to Enhance Performance and Patient Safety) is a set of evidence-based practices and tools designed to increase the effectiveness of communication to improve patient safety, especially the culture of patient safety. TeamSTEPPS addresses safety in a variety of settings, including office-based settings, with additional resources on care handoffs and team huddles specific to office-based settings. Reporting on implementing TeamSTEPPS in office-based settings, researchers noted improved communication, decreases in clinical error rates, and better patient satisfaction.8,9 Continued implementation of communication strategies in teams, coupled with more interoperative technologies that may improve communication between healthcare teams, is likely to increase safety in office-based settings.
The patient safety movement began with dramatic findings on preventable harm in hospitals. As healthcare evolves, more patients are receiving care in office-based settings. And while some of the patient safety concerns researched in hospital settings are relevant to office-based settings, and some approaches to mitigate those harms, like communication and teamwork, apply across settings, research focused specifically on improving patient safety in office-based settings is needed. To fill this gap, AHRQ has several ongoing funding opportunities focused on Ambulatory care including Understanding and Improving Diagnostic Safety in Ambulatory Care: Incidence and Contributing Factors, Improving Diagnostic Safety in Ambulatory Care: Strategies and Interventions, AHRQ Small Research Projects to Advance the Science of Primary Care, and Making Health Care Safer in Ambulatory Care Settings and Long-term Care Facilities.
Richard Ricciardi, Ph.D., CRNP, FAANP, FAAN
Associate Dean for Clinical Practice & Community Engagement; Exe. Director, Center for Health Policy and Media Engagement
George Washington University, School of Nursing
Ashburn, VA
Merton Lee, PharmD, PhD
Researcher
American Institutes for Research (AIR)
Columbia, MD
Sarah E. Mossburg, RN, PhD
Senior Researcher
American Institutes for Research (AIR)
Arlington, VA
References
- Institute of Medicine (US) Committee on Quality of Health Care in America. To Err Is Human: Building a Safer Health System. (Kohn LT, Corrigan JM, Donaldson MS, eds.). National Academies Press (US); 2000. Accessed August 3, 2023. http://www.ncbi.nlm.nih.gov/books/NBK225182/
- Neuhaus C, Grawe P, Bergström J, St Pierre M. The impact of “To Err Is Human” on patient safety in anesthesiology. A bibliometric analysis of 20 years of research. Front Med (Lausanne). 2022;9:980684. doi:10.3389/fmed.2022.980684
- Lai AY, Yuan CT, Marsteller JA, et al. Patient Safety in Primary Care: Conceptual Meanings to the Health Care Team and Patients. J Am Board Fam Med. 2020;33(5):754-764. doi:10.3122/jabfm.2020.05.200042
- Gaal S, van Laarhoven E, Wolters R, Wetzels R, Verstappen W, Wensing M. Patient safety in primary care has many aspects: an interview study in primary care doctors and nurses. J Eval Clin Pract. 2010;16(3):639-643. doi:10.1111/j.1365-2753.2010.01448.x
- Marshall SE. Practice review: Medication reconciliation in the ambulatory setting. Nurs Manage. 2023;54(11):30-35. doi:10.1097/nmg.0000000000000070
- Naseralallah L, Stewart D, Price M, Paudyal V. Prevalence, contributing factors, and interventions to reduce medication errors in outpatient and ambulatory settings: a systematic review. Int J Clin Pharm. Published online September 8, 2023. doi:10.1007/s11096-023-01626-5
- Recent Cases on Violence Against Reproductive Health Care Providers. Published online May 30, 2023. Accessed January 1, 2024. https://www.justice.gov/crt/recent-cases-violence-against-reproductive-…
- Deep Dive: Safe Ambulatory Care. Published online October 23, 2019. Accessed November 9, 2023. https://www.ecri.org/press/ecri-institute-diagnostic-tests-medication-p…
- Parker AL, Forsythe LL, Kohlmorgen IK. TeamSTEPPS® : An evidence-based approach to reduce clinical errors threatening safety in outpatient settings: An integrative review. J Healthc Risk Manag. 2019;38(4):19-31. doi:10.1002/jhrm.21352
- Mohsen MM, Gab Allah AR, Amer NA, Rashed AB, Shokr EA. Team Strategies and Tools to Enhance Performance and Patient Safety at primary healthcare units: Effect on patients’ outcomes. Nurs Forum. 2021;56(4):849-859. doi:10.1111/nuf.12627
Editor’s note: Richard Ricciardi is the associate dean for clinical practice and community engagement and the executive director of the Center for Health Policy and Media Engagement at the George Washington University. He has served as the director of the Division of Practice Improvement and senior advisor for nursing at AHRQ, and he maintains a part-time clinical practice at Mercy Health Clinic. We spoke to him on patient safety in office-based settings.
Sarah Mossburg: Welcome, Dr. Ricciardi. Please tell us a little bit about yourself and your current role.
Ric Ricciardi: I am currently serving as the associate dean for clinical practice and community engagement at The George Washington University School of Nursing. In that role, I seek ways for the university to build collaborations with health systems and external partners to address the healthcare delivery gaps and to build entrepreneurial opportunities to improve educational, research, clinical, and policy practices. I also serve as the executive director for the Center for Health Policy and Media Engagement, where we are committed to increasing the visibility of nurses and their invaluable expertise and unique perspectives in media, policy, and research. I am passionate about amplifying the voice of nursing. Research has shown that the nurse’s voice is missing in the media. One study found nurses were identified as the source in only 2% of quotes in health news stories and were never sourced in stories on health policy.1 This lack of media engagement hasn’t changed in over 15 to 20 years from the original Woodhull study conducted in 1997. I work with professional organizations, with health systems, and with individuals to develop and operationalize strategies that improve nurses’ voices in the media.
Prior to being an associate dean at GWU, I was at the Agency for Healthcare Research and Quality (AHRQ) for 8 years. I served as the director for the Division of Practice Improvement, where most of our work was exploring methods to improve quality, safety, human factors, workflows, and efficiencies in the implementation of evidence-based practices across ambulatory settings. I had the opportunity to work with many great colleagues at AHRQ, and within Health and Human Services to improve quality and safety nationally in ambulatory settings. We developed a model where quality and safety and practice improvement fall under the larger umbrella of health services research. Addressing the gaps in quality and safety in primary care requires interprofessional quality improvement teams and a team science approach to conduct research.
Sarah Mossburg: You’re currently working as a nurse practitioner as well, right?
Ric Ricciardi: I work on Wednesdays at Mercy Health Clinic, which is a clinic that serves only uninsured individuals. Almost all are migrants from different countries who are here to try to make a better life for themselves, or they’re escaping some very horrific conditions in the country they migrated from. All the patients I see in clinic are uninsured and from underrepresented populations. As you can imagine, safety net clinics that provide care for uninsured populations have a whole gamut of issues that influence quality and safety. These issues are different from the health systems that care for the insured, where they have comparatively larger infrastructure and resource streams.
Sarah Mossburg: Could we step back from there just to touch on context? For a long time, patient safety has been focused on inpatient settings or acute care. And now, office-based settings in general, like medical offices, ambulatory care, clinics like the one that you’re talking about, are getting more focus in the safety literature. Could you talk about why that matters, and what’s the difference between office-based care settings versus acute care that necessitates its own focus and approach to patient safety?
Ric Ricciardi: I agree with you that traditionally, up to maybe 10 years ago, the main focus and investments on quality and safety were on developing strategies and methods to mitigate risks in acute care settings. Errors or unsafe practices in acute care settings were more readily visible and were an immediate concern to health systems, healthcare professionals, and the public.
Thanks to the good work of AHRQ, particularly the Center for Quality Improvement and Patient Safety, we see a shift to expand the focus to include ambulatory areas and to invest in ways to improve quality and safety in ambulatory settings, because the kinds of unsafe conditions that happen in the ambulatory settings were happening much more frequently than in acute care. Over time, these lapses in quality and safety cause significant morbidity, and perhaps even mortality. It was important for AHRQ, and HHS, for that matter, to lead efforts to provide resources to strengthen quality and safety practices in ambulatory care.
Unfortunately, we don’t have a high-functioning integrated healthcare system in the United States. What we do have is a series of primary care and ambulatory practices that are disconnected and underresourced by the current reimbursement structure. Continuity of care and care coordination is a big challenge, and technology has not lived up to its potential. Starting out at the time when the electronic health record thrust was to improve quality and safety, to improve interoperability, that didn’t really happen to the extent that we expected from the meaningful use incentive program. Moving toward an integrated health system like those of Kaiser Permanente, the Mayo Clinic, or the Veterans’ Affairs, with interoperability of information platforms and systems, will greatly benefit primary care. Quality and safety challenges arise due to gaps in continuity of care, transitions in care, and communication between specialty care and primary care.
Another element that makes primary care so challenging is that many individuals within the United States do not have a primary care provider. They don’t have a "go-to” health professional to build a relationship with and who can incorporate the patient’s values and preferences into a whole-person care plan. Follow-up and follow-through on the patient’s health and health issues are key to building trust and relationships that support sustained behavior change and healthy lifestyle behaviors. And that lack leads to risks and quality and safety gaps.
Ultimately, the big reason I think there are lots of challenges in quality and safety in the ambulatory setting is because we don’t have an integrated primary care system, and many people don’t have access to a primary care provider. The way I look at it, and I learned this from a patient, care is really broken into three brackets. Care to me or care delivered in the acute care setting, in which healthcare professionals are primarily responsible for delivering care to someone who is not fully capable, perhaps physically or mentally, to take on the role of caring for themselves.
And then in the ambulatory settings, my patient said, it’s care with me. In these settings, healthcare professionals and primary care teams are partnering with the patient to deliver care, engaging the patient, and incorporating the patient’s values and preferences, to put together a care plan that is tailored for that individual patient. And, as you know, when you see one patient, you only see one patient, because even though we’re more than 99% genetically equal as humans, our determinants of care and our health and lifestyle habits are different. Both of those have a significant impact on health. So how you integrate those determinants of care and the patient’s health habits in a plan is very much individualized for a patient, taking a whole-person approach.
And then the third bucket, it’s care by me. An individual is responsible for their own healthcare, and that’s where you get into the concept of healthy lifestyle habits. Do you smoke or use tobacco products? How much alcohol do you drink? Do you eat healthy? Do you exercise? Do you get sufficient sleep and take time for yourself to relax? Do you take on some responsibility for your own health and well-being, and for your mental health? And are you socializing? Do you have healthy relationships?
These quality and safety risks have very different conceptual areas and approaches in each of those three buckets: care to me, care with me, and care by me. For instance, the patient in the care by me bucket is responsible for leading the effort to mitigate their own quality and safety risks because that involves changes to the activities of everyday living and their unique lifestyle.
Sarah Mossburg: Could you speak to what types of safety issues are likely to arise in the office-based setting through that lens?
Ric Ricciardi: The biggest issues involve communication risks between the patient and the primary healthcare team and communication between teams of teams. Communication is the cornerstone of relationship-based care, and good communication will establish and sustain trust. Do you trust your healthcare provider team? Can you tell them what’s really going on in your life, with your health, and also day-to-day factors that influence health and well-being? All of these determinants of health impact health and well-being greatly. And then, it is critically important to have good communication between teams and within teams. I’ll give you an example, a real-world example. When we built the TeamSTEPPS for ambulatory care, we hosted an annual meeting where we had a large group of healthcare professionals and patient advocates from all disciplines. During the meeting, attendees would talk about the TeamSTEPPS program, the tools and materials, and how they could integrate those in their practice. I was talking to this individual, and he said, “I’m a radiation oncologist.” And I’m thinking, why would a radiation oncologist be coming to this TeamSTEPPS meeting? I said, “Well, what brought you here?” And he replied that he had a patient who had a head and neck tumor, and a cancer that was being treated. The standard treatment protocol required both chemotherapy and radiation therapy, and he was delivering the radiation therapy. And this patient was coming into their clinic for 6 or 7 weeks, and then finally a nurse asked the patient, “How is your chemotherapy going?” And the patient replied, “I’m getting it here.” And the nurse said, “No, I mean the medication you get orally, or IV, besides the radiation.” And the patient said, “I’m not really getting anything else; I’m not going anywhere else. I’m coming here, and I’m getting my radiation.” So this patient was not getting their chemotherapy; they were only getting their radiation, which greatly affected their treatment response and outcome. And the meeting participant said, “I need TeamSTEPPS because we’re not communicating. I need to figure out a better way that we can communicate among providers and teams.”
We sometimes make huge assumptions in primary care, that people are getting what they need when they’re not with us in the other settings. Those assumptions and the lack of real data could lead to quality and safety errors. That is one real-world example.
Sarah Mossburg: That example speaks to the potential for missed care because of challenges and communication. I’m curious about the flip side of that. Unnecessary tests and procedures can sometimes harm patients. Are those problems found in office-based care settings?
Ric Ricciardi: Those problems are important and occur every day in large numbers. They are a focus of the American Board of Internal Medicine Foundation’s Choosing Wisely campaign. It is also an issue for the primary care provider team not to have access to prior diagnostic studies due to lack of access to health information, which causes risks to patients and systemwide inefficiencies.
The lack of continuity in diagnostic testing can lead to additional trauma to patients because there’s a physical trauma of needing to have repeated diagnostic or preventative testing and screening. Many diagnostic procedures are very uncomfortable, but there’s also a psychological trauma of wondering whether you have some significant illness while you are waiting for the results. There’s also risks associated with radiation. If you’re getting a CT scan and you’ve already had one, and you go to an emergency room and they say, “We don’t have time to find the old CT scan, we’ll just give you another one.” Then you’re getting radiation again from a second CT scan.
Sarah Mossburg: Another area that is a potential patient safety issue in office-based settings is related to medication safety events. Could you talk a little bit about medication-related safety events?
Ric Ricciardi: The risk of medication error occurs at many points throughout the system. One point is a prescribing error. Prescribing errors can be mitigated by the pharmacist and electronic health records. For example, I prescribed a medication for a patient and the pharmacist called me and asked, “Did you know this patient was on this other medicine?” I did not know this. It’s important for us to have a relationship with the pharmacy where the patient gets their medicines because they have a record of what this patient is on.
It could also be a dosage error in the prescribing of the medication. This error particularly happens more frequently in pediatrics, where you have weight-based dosing. If you have people who are not familiar with weight-based dosing, you could have a decimal point error that can have serious effects.
And then you have communication errors, where you have teams within teams caring for patients and a lack of interoperability or access between electronic health records. The patient is not clear on what medications they are taking, and then you prescribe a medication that may put the patient at risk for adverse events or be harmful.
Sometimes, patients don’t have the money to purchase the medications, and they don’t have adequate health insurance. I’ve had patients say, “I’m only taking a light dose of that” or “I take it every other day because I can’t afford to take the full dose.” Or they don’t pick up their prescription at all because they don’t have money to. Patients in the ambulatory setting have to make very difficult choices, especially if they’re caring for someone else. Many patients are caring for a loved parent, partner, or child and they often put those individuals’ needs ahead of their own.
If we had an integrated healthcare system where all the patient’s medications are tied into the pharmacy system and tied into the health record, where it’s automated and visible to all healthcare providers and teams, then risks of errors would be reduced. Yes, medications are a big source of potential safety errors. Quality includes access and cost issues where patients are not getting what they need because they can’t afford their medicines or do not have access to healthcare.
Sarah Mossburg: I’m curious about any strategies or tools that providers working in office-based care settings use to improve the safety of care for their patients. You alluded to TeamSTEPPS earlier, and you mentioned interventions to mitigate medication errors. Do you have any other examples?
Ric Ricciardi: Nursing is the largest workforce in healthcare, and nurses are key to improving quality and safety in office-based care settings. Since Florence Nightingale, we have trained and educated nurses to work primarily in acute care settings. I think the role of the registered nurse needs to be expanded dramatically to where the registered nurse is working in office-based settings to do the kinds of follow-up and continuity that would mitigate some of these safety issues we’ve mentioned. Whether it’s going to the patient’s home or calling them, or video conferencing, and really following up on the care and treatment plan. I believe there’s a significant role for the registered nurse, along with care team members such as community health workers and public health nurses as they establish themselves within community-based environments that serve as the liaison across the community, the patient, the family, and the primary care team. The registered nurse could take on multiple practices in primary care. Maybe it’s a small primary care practice that only has one or two providers in it, and they can’t afford to hire a registered nurse all the time. But if we had a virtual registered nurse or if we had registered nurses who were integrated and working with that practice and other practices, then that registered nurse could fill a variety of roles to improve safety and quality. Perhaps they could do follow-up, community assessments, and medication reconciliation after the patient has picked up the medicine. Or the registered nurse could support the patient in trying to change some lifestyle behavior, whether it’s smoking, drinking, or increasing activity, thereby improving their behavior as well as serving as a navigator and advocate for the patient in the healthcare delivery system. Because we know the concept of self-efficacy is critical in primary care and for people to have real, meaningful change, they have to believe that they can do it, and are they are supported. Patients and families should have someone on their medical team whom they trust and count on to help them with the barriers and roadblocks in the healthcare system as well as the treatment plan.
I think one of the biggest possible improvements and mitigators for safety is having registered nurses move front and center into primary care. In my opinion, if nursing doesn’t do it, eventually, I believe the healthcare system is going to find a new provider. But quite honestly, I don’t think we need a new provider. I think that nursing is the perfect provider to improve quality and safety and address communication, health literacy, and system barriers while also integrating the patient’s values and preferences into an implementable plan of care. Also, I think leveraging technology could help improve safety. And probably the biggest potential gain is practicing from a team-based care perspective where, if there are safety issues, you have more eyes on that patient and a better capacity to identify potential safety issues before they happen.
Sarah Mossburg: Well, thank you very much for this conversation. This was really interesting.
1. Mason DJ, Nixon L, Glickstein B, Han S, Westphaln K, Carter L. The Woodhull Study revisited: nurses’ representation in health news media 20 years later. J Nurs Scholarsh. 2018;50(6):695-704. doi:10.1111/jnu.12429
