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Spring 2024 - Safety

Improving Patient Safety in the Primary Care Setting

First, do no harm. Next, create systems that help prevent harm before it happens.

RISK. FOR BETTER or worse, it’s everywhere, always — even in healthcare settings.

It might sound counterintuitive, but for patients seeking medical attention to help them heal, the possibility of hurt, damage or loss is top of mind. They are nervous about what their symptoms might mean, overwhelmed by the pros and cons of a given treatment, and afraid of what comes next. They know medical errors and adverse outcomes can and do happen, and they wonder if they will happen to them. Their fears aren’t unfounded. The human body, though strong and resilient, is also fragile and finite. Best-case scenarios don’t always play out. 

Mitigating the risk and building a practice that emphasizes patient safety is important to patients and providers alike. Healthcare workers, including primary care providers, bear responsibility when patients suffer additional harm while under their care. As William James Mayo, MD, famously said, “The best interest of the patient is the only interest to be considered.”1 If it isn’t in the patient’s best interest, it’s a no-go.

But how well do the processes and procedures of primary care practices support patients’ best interests? After all, medical errors, adverse events and negligence can still happen. In many cases, poorly designed processes and procedures lead to human error, which can lead to patient harm. In fact, most medical errors that jeopardize patient safety are out of clinicians’ control, and can instead be traced back to the breakdown of systems.2

We know this to be true in the hospital setting. Much has been said about improving safety there, but improving patient safety in the primary care setting is equally important for the health and well-being of patients and, by extension, the physician and clinical team. The best way to improve patient safety is to understand what it is and how it is related to medical error, assesses how and why mistakes are made and implement processes and procedures that prevent medical errors from happening in the first place. 

Ancient Idea, Modern Mandate

The simplicity of Hippocrates’ ancient imperative “First, do no harm” still remains at the heart of the solemn pledge healthcare providers make today.3 Physicians still practice medicine with the goal of preventing intentional injury, but despite their best intentions, mistakes still happen, and patients can and do get hurt. 

In 1999, the United States Institute of Medicine (IOM) published a paper titled “To Err is Human: Building a Safer Health System,”  a report that echoed Alexander Pope’s famous observation that making errors is part of human nature. According to the paper, it’s natural that physicians should make mistakes from time to time because physicians are people, and it is human nature for people to make mistakes.4 When mistakes are made in healthcare, patient safety is in jeopardy. Between the two ideas — actively working to keep the patient from harm and recognizing humans are fallible — is where modern patient safety finds its nexus. 

Modern patient safety caught national attention nearly 25 years ago when IOM reported that an estimated 98,000 hospitalized patients die every year because of medical errors.4 More recently, a 2016 study conducted by Johns Hopkins Medicine found that medical error is responsible for 250,000 deaths in the United States annually, making it the third leading cause of death in the nation.5 However, the accuracy of this number remains debated, as it remains unclear whether those deaths were directly due to medical error, or whether medical errors coincided with deaths that would have occurred anyway. 

Defining Patient Safety

According to the Patient Safety Network (PSNet), a division of the Department of Health and Human Services’ Agency for Healthcare Research and Quality, patient safety is the “freedom from accidental or preventable injuries produced by medical care.”6 While helpful, this definition remains broad, and it encompasses safety issues ranging from keeping patients’ personal healthcare information confidential to ensuring the right prescription is dispensed to the right patient at the right time (and so much more). Ensuring patient safety is a big task, and despite their best efforts, even the most conscientious practices will encounter a medical error that could jeopardize patient safety. U.S. family physicians report that the top errors in their practices include errors in prescribing and dispensing medication, completing the right lab test(s) for the right patient at the right time, filing system errors and appropriately responding to abnormal lab tests. Further, studies show that most of the errors that occur in primary care are preventable.7 

Patient safety involves medical errors of both commission (doing something wrong) and omission (failing to do the right thing) that lead to an undesirable outcome or significant potential for such an outcome. Notably, errors of commission are more difficult to recognize, but according to PSNet, they likely represent a larger problem.6 

Adverse events, or harmful, negative outcomes that happen when patients have been provided with medical care, are often due to preventable medical error, but sometimes, they are not, and it’s difficult to tease out whether or not human error caused the event. Determining whether patient harm is due to an error or an adverse event (or some combination of both) is difficult, but proactive processes and protocols that reduce the occurrence of preventable errors and adverse events seem to best provide for patient safety.6

 

What Leads to Patient Harm?

According to the World Health Organization (WHO), most mistakes that hurt patients are a result of system or process failures that lead healthcare workers to make mistakes. A confluence of factors lead to patient harm, and more than one factor is usually involved in a single incident. These factors include:8

• system and organizational factors: the complexity of medical interventions, inadequate processes and procedures; disruptions in workflow and care coordination; resource constraints; inadequate staffing; competency development;

• technological factors: issues related to health information systems such as problems with electronic health records or medication administration systems; misuse of technology;

• human factors and behavior: communication breakdown among healthcare workers, within healthcare teams and with patients and their families; ineffective teamwork; fatigue; burnout; cognitive bias;

• patient-related factors: limited health literacy, lack of engagement; non-adherence to treatment; and

• external factors: absence of policies, inconsistent regulations, economic and financial pressures; challenges related to the natural environment.

From Blame to Shared Responsibility

Standardized policies and processes for identifying and reporting errors help give a framework for improving patient safety, but people still bear the weight of responsibility when errors occur. What motivates people to report errors, particularly if they are the ones who are at fault for the incident? When individuals feel guilty or responsible for the misstep, or when they perceive they are betraying the colleague who was involved, they are less inclined to report errors.2 

True, those who make errors must be held accountable for their mistakes. However, blaming and shaming for medical mistakes does little to improve patient safety and instead has a considerable effect on underreporting mistakes when they inevitably happen. Guilt, shame, fear, anger and the possibility of legal action can cause a slew of psychological problems in the people who caused the mistake, but feelings do not lead to any real or meaningful change. Shifting focus away from who made the mistake and toward what, where and how the mistake was made, and then identifying ways to alter and improve the system that yielded the mistake, is a better way to reduce medical error over time.  

A culture of safety recognizes patient safety challenges and empowers stakeholders to actively participate in addressing them. Identifying systems that don’t work and establishing systems that do work is in the best interest of everyone. And, a system that cares less about the who and more about the what, where and how will help cultivate a culture in which errors are seen as areas of concern to address, not incompetence to punish. As WHO explains, “Understanding the underlying causes of errors in medical care requires shifting from the traditional blaming approach to a more system-based thinking where errors are attributed to poorly designed system structures and processes, and the human nature of all those working in healthcare facilities under a considerable amount of stress in complex and quickly changing environments is recognized.”8 Shifting from a culture of blame to one of shared responsibility can help encourage employees to report errors as “incidents of concern.”2

Patient Safety Systems in Primary Care 

How to best achieve a systems approach to safety in a private practice setting is unclear. While it is well-established that a systems approach improves patient safety in the hospital setting, how efficiently it improves patient safety in primary care has not been extensively studied or well understood. Several roadblocks make implementing and studying a systems approach in primary care difficult, including time, cost and lack of overarching standards for reporting errors. Each facility manages its error reporting system differently, making it more difficult to study. Primary care settings vary in location (urban, suburban, rural), type (academic, private, healthcare system, etc.), resources and patient community, and what works for one practice may not work for another. And, with the advent of artificial intelligence and the growth in telemedicine, remote patient monitoring and hybrid medical teams, patient safety is taking on new dimentions and raising questions about whether machine learning and computers negatively or positively influence patient safety, too. Investing in a systematic method of reporting errors, analyzing them and implementing new processes in primary care is time-consuming and costly, and questions about the benefits versus the risks of reporting errors remain. Developing a system that provides clarity and ease of reporting and that encourages providers to report errors without shame or fear of punishment is a daunting task.

National Patient Safety Goals 

To help point healthcare organizations in the right direction, the Joint Commission established its National Patient Safety Goals (NPSGs) in 2002 to work with practitioners, provider organizations, purchasers, consumer groups and others to establish national safety goals for healthcare. According to the Joint Commission, the goals address specific concerns in patient safety, highlighting areas that are prone to avoidable harm. It encourages healthcare organizations to prioritize these goals as they adopt best practices for reducing patient harm. The first set of goals became effective in January 2003, and they are revisited each year to keep them relevant to the changing healthcare landscape. For 2024, the NPSGs are:9 

1) Identify patients correctly. 

2) Improve staff communication.

3) Use medicines safely. 

4) Use alarms safely. 

5) Prevent infection. 

6) Identify patient safety risks. 

7) Improve healthcare equity. 

8) Prevent mistakes in surgery.

These strategies include appointing leadership that is committed to creating a culture of safety; establishing safe procedures and clinical processes; building competencies of healthcare workers and improving teamwork and communication; engaging patients and families in policy development, research and shared decision-making; creating and implementing systems for patient safety incident reporting; and being committed to learning and continuous improvement. 

Five Key Steps to Improve Patient Safety 

Where does a practice start? According to Stephanie Iorio, vice president of operations of products and services at American Data Network, a company that helps healthcare organizations improve patient care, the five most important steps toward improving patient safety include:9

1) Risk assessment and gap analyses. Regularly review and evaluate your practice’s environment, processes and procedures. Identify potential patient safety issues, and proactively implement changes to address them. 

2) Education and training. Keep your staff up to date with patient safety best practices. Empower them with the knowledge they need to provide the best care possible. 

3) Verification processes. Enforce strict patient verification processes, paying particularly close attention to dispensing and administering medications. Always double check. 

4) Monitoring and reporting. Create a cooperative environment in which clinicians and staff work together to report potential errors, both major and minor, to help track, recognize and address error patterns. 

5) Focus on high-risk areas. Pay particular attention to fall risks, infection risk and other high-risk areas, and implement strategies to improve patient safety.

Look Back to Move Forward 

Risk can’t be eliminated completely. However, it can be mitigated by cultivating a culture in which safety is a priority. When mistakes happen and patients get hurt, it can be embarrassing to admit fault, tedious to look backward, difficult to dissect what went wrong and slow-going to move forward, but the investment in patient safety is worth the effort. Learning from mistakes — what works for a given practice and what doesn’t — takes time and effort, but another piece of Dr. Mayo’s insight can help inspire forward movement: “The glory of medicine is that it is constantly moving forward, that there is always more to learn. The ills of today do not cloud the horizon of tomorrow, but act as a spur to greater effort.”1 The rapidly evolving healthcare landscape inevitably (and incessantly) introduces new challenges and, along with them, opportunities to learn. An attitude of all-hands-on-deck creates a collaborative effort to prioritize effective, efficient systems and processes that will reduce patient harm and thus begin to build a safer tomorrow today.

References

1. Quotations from the Doctors Mayo. Mayo Clinic History and Heritage. Accessed at history.mayoclinic.org/toolkit/quotations/the-doctors-mayo.

2. Rodziewicz, TL, Houseman, B, and Hipskind, JE. Medical Error Reduction and Prevention, Updated 2023 May 2. StatPearls, January 2024. Accessed at www.ncbi.nlm.nih.gov/books/NBK499956.

3. North, M. Ancient Greek Medicine. History of Medicine Division, National Library of Medicine, June 2008. Accessed at www.nlm.nih.gov/hmd/topics/greek-medicine/index.html#case1.

4. Institute of Medicine (US) Committee on Quality of Healthcare in America. To Err Is Human: Building a Safer Health System. Kohn LT, Corrigan JM, Donaldson MS, editors. Washington (DC): National Academies Press (US); 2000. Accessed at pubmed.ncbi.nlm.nih.gov/25077248.

5. Studies Suggest Medical Errors Now Third Leading Cause of Death in the U.S. Johns Hopkins Medicine news release, May 3, 2016. Accessed at www.hopkinsmedicine.org/news/media/releases/study_suggests_medical_errors_now_third_leading_cause_of_death_in_the_us.

6. Patient Safety Network Glossary. Patient Safety. Agency for Healthcare Research and Quality. Accessed at psnet.ahrq.gov/glossary-0?f%5B0%5D=glossary_az_content_title%3AP.

7. Kaprielian, V, Ostby, T, Warburton, S, et al. A System to Describe and Reduce Medical Errors in Primary Care. In: Henriksen K, Battles JB, Keyes MA, et al., editors. Advances in Patient Safety: New Directions and Alternative Approaches (Vol. 1: Assessment). Rockville (MD): Agency for Healthcare Research and Quality; August 2008. Accessed at www.ncbi.nlm.nih.gov/books/NBK43616.

8. World Health Organization. Patient Safety, Sept. 11, 2023. Accessed at www.who.int/news-room/fact-sheets/detail/patient-safety.

9. Iorio, S. 2024 National Patient Safety Goals: Guide to Effective Strategies. American Data Network, Nov. 28, 2023. Accessed at www.americandatanetwork.com/patient-safety/national-patient-safety-goals-guide-to-effective-strategies.

Rachel Maier, MS
Rachel Maier, MS, is the Associate Editor of BioSupply Trends Quarterly magazine.