Keeping Patients Safe: How Has the Patient Safety Movement Evolved in the U.S.?

Patient safety culture is a cornerstone of healthcare quality. Fostering patient safety culture requires an understanding of an organization's values, beliefs, and norms.

This article was originally published June 23, 2020 on PSQH by Soumya Upadhyay, PhD, MHA

According to the Agency for Healthcare Research and Quality’s (AHRQ) Patient Safety Network, patient safety is defined as “freedom from accidental or preventable injuries produced by medical care” (Agency for Healthcare Research and Quality [AHRQ], n.d.a). The Institute of Medicine has indicated that patient safety is not different from quality healthcare, emphasizing it as an essential domain of the overarching healthcare quality (Erickson et al., 2003). There have been reports and studies on the large amount of deaths that happen each year due to medical errors (Donaldson et al., 2000; James, 2013; Makary & Daniel, 2016). Even though these estimates and the methodology behind calculating these deaths may be questionable, it is undeniable that adverse events are a concern that needs to be addressed (Shojania & Dixon-Woods, 2016). The issue of patient safety poses a risk to the public, thus providing motivation to providers, policymakers, and researchers to pay attention to this issue.

Definition of patient safety culture

AHRQ uses the British Health and Safety Commission’s definition of patient safety culture as “the product of individual and group values, attitudes, perceptions, competencies, and patterns of behavior that determine the commitment to, and the style and proficiency of an organization’s health and safety management. Organizations with a positive safety culture are characterized by communications founded on mutual trust, by shared perceptions of the importance of safety, and by confidence in the efficacy of preventive measures” (AHRQ, 2009).

Patient safety culture is an important component of an organizational culture. Organizational culture is referred to as a core set of values surrounded by layers including shared beliefs; attitudes; values; norms and rituals; and employee stories and behavioral characteristics (Morello et al., 2013). To establish an organization in which excellence in healthcare quality can flourish, a change in culture needs to be brought about alongside structural reorganization and system reform (Davies, Nutley, & Mannion, 2000).

Patient safety culture is a cornerstone of healthcare quality. Fostering patient safety culture requires an understanding of an organization’s values, beliefs, and norms. Furthermore, it requires an understanding of the appropriate attitudes and behaviors related to patient safety (AHRQ, 2009). To understand the phenomenon of patient safety culture, healthcare systems and hospitals ask staff opinions and perceptions on patient safety. Prior research has also found that patient safety culture perceptions are associated with patient safety outcomes. For example, high perceptions of safety culture are related to lower readmission rates, lower mortalities, and decreased lengths of stay (Hansen et al., 2011). Results from these studies have allowed hospitals and healthcare systems to develop measures and interventions to improve patient safety outcomes (Sammer et al., 2010).

Background

This section of the paper will provide an evolutionary overview of the patient safety movement in the United States. We discuss the macro-environmental changes and legislative efforts and policies that helped shape the nation’s current patient safety environment.

The Institute of Medicine (IOM) report era

The IOM’s 1999 report To Err Is Human was one of the first to herald the culture of safety in the U.S. healthcare system. However, the creation of the IOM report was spurred by changes that happened during President Bill Clinton’s administration. Clinton commissioned an Advisory Commission on Consumer Protection and Quality in the Health Care Industry in March 1998. The aim of this commission was to advise the president on changes in the healthcare system and suggest measures that would be important to improve the quality of healthcare. As a result of the advisory commission, a Quality Interagency Coordination Task Force was formed that focused on improving quality measures, improving information systems, enhancing workforce infrastructure, and keeping patients informed (AHRQ, n.d.c). The advisory commission also led to the formation of the National Quality Forum, which aims at making patients safer and achieving better health outcomes. Its mission is to lead national collaboration to improve healthcare outcomes through measurement (National Quality Forum, 2016).

The aforementioned changes exerted pressure on healthcare professionals to modify their practices, thus leading to the generation of To Err Is Human, which caught the attention of the healthcare community, media, and policymakers. This report estimated that approximately 98,000 people die each year due to medical errors (Donaldson et al., 2000). It exposed an underlying truth: High levels of adverse medical errors are unacceptable and can be prevented.

There was a significant reaction to the IOM report on Capitol Hill. Hearings were held even when Congress was in recess during December 1999. The purpose of these hearings was to evaluate the pros and cons of voluntary and mandatory reporting systems on adverse events and patient safety data. Proposals regarding establishment of a National Center for Patient Safety within the Department of Health and Human Services were considered (AHRQ, 2005). Eventually, the National Center for Patient Safety was developed as part of the Veterans Affairs (VA) department, the largest integrated system in the country. The focus of this center is to lead VA patient safety efforts and develop and nurture a culture of safety throughout the VA health system (U.S. Department of Veterans Affairs, n.d.).

The IOM report and subsequent hearings initiated the introduction of several bills in Congress that focused on disclosing nurse staffing levels and outcomes data; and the establishment of voluntary and confidential reporting systems; these included the Medical Error Reduction Act of 2000 (2000), the Stop All Frequent Errors (SAFE) in Medicare and Medicaid Act of 2000 (2000), and the Patient Safety and Errors Reduction Act (2000). Besides reporting systems, there were efforts to foster research into the causes of errors and promotion of patient safety. In the 106th Congressional session, there was an increased momentum to advance the development of research to reduce medical errors as well as to create a national patient safety database that would allow aggregation of data at the federal and local levels (The Patient Safety and Errors Reduction Act, 2000).

The Patient Safety and Quality Improvement Act of 2005 was signed into law on July 29, 2005 by President George W. Bush (AHRQ, n.d.b). The objective of this law, also known as the Patient Safety Act, was to encourage reporting of adverse medical events. Patient Safety Organizations were created to improve safety; collect and analyze data; maintain a patient safety network database; develop and disseminate recommendations regarding best practices; and utilize a qualified staff (American Medical Association, 2009).

Emergence of high reliability organizations

In recent years, healthcare organizations have become aware of the need to be highly reliable (Hansen et al., 2011). The concept of high reliability organizations originated in the aviation and nuclear power industries and recently became popular in the healthcare industry. Studies have explored ways of achieving high reliability in hospitals (DuPree, 2015; Leykum et al., 2015; Wilson, 2014), alluding to the fact that high reliability can potentially become an antecedent of achieving safety culture in hospitals. The most important attribute of high reliability in hospitals is making the culture safe by directing the organization’s knowledge, beliefs, and attitudes toward reducing preventable harm (Zohar, 1980).

Based on the aviation reporting system, a patient safety reporting system (PSRS) was a confidential and non-punitive program administered for hospitals by the National Aeronautics and Space Administration (Patient Safety Reporting System, 2016). The goal for PSRS is to serve as a main system responsible for encapsulating close calls, adverse events, and concerns regarding patient safety issues (Patient Safety Reporting System, 2016). The concept of high reliability has been welcomed and accepted by leading organizations such as The Joint Commission, IOM, and the Centers for Medicare & Medicaid Services (CMS). The Joint Commission indicated that leadership involvement, organizationwide culture of safety, and effective process improvement tools are necessary components to achieving high reliability in organizations (Chassin & Loeb, 2011).

Over the years, patient safety improvement has happened, but examples are few and isolated. Moreover, their impact is far less than the severity of errors that still occur. Hospital-acquired infections, mortalities due to errors, medication errors, and readmissions due to complications continue to take place (Chassin & Loeb, 2011). In an effort to reduce these events, the hospital community attempts to emulate characteristics of high reliability organizations to work toward a culture of safety (Chassin & Loeb, 2011). High reliability emphasizes developing a mindset to develop a safety culture, with the following characteristics: (1) sensitivity to operations (i.e., quickly identifying system problems to avoid potential mistakes); (2) reluctance to simplify (i.e., understanding that challenges within a complex system are complicated); (3) preoccupation with failure (i.e., proactively eliminating potential accidents); (4) deference to expertise (i.e., de-emphasizing hierarchy and deferring to those most knowledgeable of the issue); and (5) resilience (i.e., retaining well-trained staff to respond to system failures) (Weick et al., 2008).

The Affordable Care Act

President Barack Obama signed the Patient Protection and Affordable Care Act (ACA) into law in 2010. Through this act and the efforts of the AHRQ, the ultimate aim regarding patient safety was to reduce preventable hospital-acquired conditions as well as prevent readmissions by keeping patients safe (Patient Protection and Affordable Care Act, 2010). Under the ACA, there is a focus on improving systems and procedures to improve patient safety. Additionally, the goal is to enhance open communication between patients and providers, reduce the rates of preventable medical errors, and reduce the cost of medical liability insurance (Clinton & Obama, 2006). The ACA aims to achieve safety in overall quality of care through clinically integrated practices. These practices may achieve coordination of care across all conditions, providers, and care settings over a period of time (Belmont et al., 2011).

Under the ACA, there is a focus on restricting federal payments for “never events.” On June 6, 2011, CMS published a rule, Implementing Provider Preventable Conditions, which was authorized by section 2702 of the ACA. Under the provisions of this rule, federal payments to states were restricted if hospitals in those states spend money on conditions that were due to hospital errors or were acquired in the hospital (McHugh et al., 2011). Furthermore, in 2012, as part of the ACA, CMS’ Hospital Compare website added data on the readmission reduction program and measures that were voluntarily submitted by hospitals. Hospitals are required to report their quality measures, including readmission rates for each diagnosis, hospitalwide readmission rates, and hospital-acquired infections, on Hospital Compare (Centers for Medicare & Medicaid Services, n.d.). This allows greater transparency of clinical data regarding patient safety and holds hospitals accountable if they have high medical errors.

In 2013, there were legislative efforts regarding nurse staffing standards. A bill was introduced in Congress to impose minimum nurse staffing ratios to have adequate nurses on the staff to assist in improving quality of care and patient safety (Nurse Staffing Standards for Patient Safety and Quality Care Act of 2013, 2013). The bill suggests that hiring registered nurses, reducing turnover, including stipends for loan repayment, and implementing mentorship projects would help guarantee patient safety. The bill also authorizes a nurse to raise objections against situations where minimum ratios are violated. With this bill, nurses may refuse to take part in those tasks or duties that may present patient safety issues due to lack of training and education (Nurse Staffing Standards for Patient Safety and Quality Care Act of 2013, 2013). Overall, there was a focus on staffing standards against the background of the ACA.

Future trends

In the future, the patient safety movement is expected to see greater involvement from patients as well as patient safety teaching in higher education. Research indicates that patients need to play a more active role in patient safety, but before that, their role should be recognized and encouraged by our healthcare system. Patients need to be well informed about the benefits, harms, and side effects of their treatment (Vincent & Coulter, 2002). Educating healthcare professionals from multidisciplinary teams improves shared learning by students of different professions, thus enhancing their capacity for teamwork across units/departments (Leotsakos et al., 2014). To this effect, the World Health Organization (WHO) has developed the Multi-Professional Patient Safety Curriculum Guide to ensure that patient safety learning is delivered in a coordinated and an integrated way (World Health Organization, 2017).

In summary, patient safety has been on the national radar for the last decade or so. There have been several nationwide efforts to reduce adverse events related to patient safety. The above paragraphs discuss legislative efforts that have shaped the macro-environmental scenario for patient safety movement in the United States. In addition, there have been efforts from both federal and private organizations. For example, the AHRQ has spent $532 million for patient safety research from 2001 to 2011 (AHRQ PSNet Patient Safety Network, 2017). In July 2002, the Joint Commission established the National Patient Safety Goals (Chassin & Loeb, 2011), and the Institute for Healthcare Improvement launched the 100,000 Lives Campaign in 2004 and the 5 Million Lives Campaign in 2006 (Institute for Healthcare Improvement, n.d.). Most recently, in 2014, the National Patient Safety Foundation has established that patient safety will not be elective (Meyer & Wachter, 2017). Patient safety will continue to be an important issue in decades to come, and leading organizations in patient safety will maintain their efforts in this area.

Soumya Upadhyay is an assistant professor in the Department of Healthcare Administration and Policy, School of Public Health, at the University of Nevada at Las Vegas.