Sivakumar Murugesan

Consultant Healthcare Projects and Quality Accreditation, Medpoint Healthcare

Patient safety events can cause serious harm or death. They affect anyone. To address and prevent these threats, health care organizations must dig deep to unearth the root cause(s) and develop solutions that address the problems from a systems perspective

Indeed, the very presence of patient safety events indicates a continuing paradox in contemporary health care. Despite remarkable advances in almost every field of health care, the occurrence of errors, or failure the term used increasingly instead of errors persists. When such failures harm patients, the results can be heartbreaking. Most failures and sentinel events—that is, a patient safety event (not primarily related to the natural course of the patient’s illness or underlying condition) that reaches a patient and results in death, permanent harm, or severe temporary harm—are the result of system and process flaws. These flaws are often not immediately apparent and require investigation

The prevalence of patient safety events had been thrust into the limelight with the watershed report To Err Is Human: Building a Safer Health System, published in 2000 by the Institute of Medicine (IOM). The IOM report, however, was just the tip of the iceberg. More reports followed, illustrating the need to improve the quality of care being delivered in the United States. For example, researchers at Johns Hopkins Children’s Center and the US Agency for Healthcare Research and Quality reviewed 5.7 million records of patients younger than 19 years of age from 27 states who were hospitalized in 2000. Of the 52,000 children identified by the researchers as being harmed by unsafe medical care during their hospital stays, 4,483 suffered a fatal injury.

Quality-of-care issues such as these are a problem for hospitals around the world. According to a 2007 report, hospital chart reviews in various countries indicate that adverse events in acute care hospital admissions range from 2.9% in the United States to 5.0%–10.0% in the United Kingdom, 7.5% in Canada, 12.9% in New Zealand, and 16.6% in Australia.

Although these reports and chart reviews illuminate the problem, it is virtually impossible to know how many patients suffer as a result of health care system failures; however, any single patient safety event is a cause for concern. These events can result in tragedy for individuals served and their families, add costs to an already overburdened health care system, adversely affect the public’s perception of an organization, and lead to litigation. They can also deeply affect health care professionals who are dedicated to the well-being of their patients.

Health care organizations, then, have no choice but to answer one key question: Why do these errors or failures continue to occur?

To answer this, a comprehensive systematic analysis must be done. The most commonly used form of comprehensive systematic analysis among quality accredited organizations is root cause analysis—a process for identifying the basic or causal factor(s) underlying variation in performance, including the occurrence or possible occurrence of a sentinel event—and all of its related tools. Root cause analysis can be used to uncover the factors that lead to patient safety events and move organizations to deliver safer care.

Although health care organizations often use root cause analysis to help improve quality en route to accreditation, such analysis has many broader applications around the world. High-quality care is high- quality care, whether it is delivered in New York City or Dubai or Singapore. Organizations worldwide should consider how root cause analysis can be used to help improve quality.

The Current Health Care Environment Health care continues to experience dramatic change. Health care organizations are evolving constantly because of changes in reimbursement, new technology, regulatory requirements, and staffing levels. These modifications cause policies and procedures to change often and, in most cases, quickly. As health care organizations become more complex, their systems and processes are increasingly interdependent.

This interdependence increases the risk of failures and can make the recovery from failure more difficult. Clinical and support staff workloads are growing heavier, resulting in greater stress and fatigue for many health care professionals. Caregivers are working in new settings and performing new functions, sometimes with minimal training. Consequently, maintaining consistency in processes and systems is challenging, leading to variation. Often, this variation results in increased risk to patients.

Media reports about patient safety events are occurring with increasing regularity, including the following examples:

•           In September 2013, researchers estimated that the number of premature deaths associated with preventable harm to patients in US hospitals was more than 400,000 per year. This makes patient safety events the third leading cause of death in the United States. Incidents resulting in serious patient harm were estimated to be 10 to 20 times more common than lethal harm.

•           In November 2014, the journal Pediatrics reported that an annual average of 63,358 medication errors occur in children younger than age 6 in the United States in nonhospital settings and that 25% of those errors are in infants, younger than 12 months old. This means that a medication error affecting a child in the United States occurs every eight minutes.

•           In February 2015, the state of Minnesota reported that 98 patients in that state were seriously injured, and another 13 patients died, as a result of patient safety events during 2014.

•           In May 2015, the Jordanian Ministry of Health began investigating an alleged medical error that resulted in a Saudi patient becoming comatose.

•           In May 2015, the State of California fined a hospital

$100,000 after the unintended retention of a foreign object in a patient’s body following an invasive procedure—in this case a plastic surgical clip that was left inside a patient’s skull.

•           In May 2015, the United Kingdom’s National Health Service paid £15,000 in damages to the mother of an infant who died in utero due to a medical error.

The above examples are only a few of the serious patient safety events that have attracted media attention in recent years. These events cast a shadow on the public’s trust of health care. Stakeholders, including patients, justifiably ask, “What’s going on?” Failure detection, reduction, and prevention strategies are receiving new impetus as the health care community recognize the value of a proactive approach to reducing risk.

Root cause analysis is one such approach. Historically used to investigate sentinel events, root cause analysis shows great promise as a proactive tool. Increasingly, health care organizations are using this methodology to investigate close calls (or near misses), no-harm patient safety events, and other signals of risk. Health care organizations no longer have to wait until after a sentinel event occurs to perform a root cause analysis.

When an adverse outcome, a sentinel event, or a cluster of less serious incidents or near misses occurs, organizations must develop an understanding of the contributing factors and the interrelationship of those factors. Next, the organization must implement an action plan to fortify its systems against vulnerabilities with the potential to impact patients. Resilience is the degree to which a system continuously prevents, detects, mitigates, or ameliorates hazards or incidents.

Important of RCA

Root Cause Analysis in Health Care: Tools and Techniques is intended to help health care organizations prevent systems failures by using root cause analysis to do the following:

•           Identify causes and contributing factors of a sentinel event or a cluster of incidents

•           Identify system vulnerabilities that could lead to patient harm

•           Implement risk reduction strategies that decrease the likelihood of a recurrence of the event or incidents

•           Determine effective and efficient ways of measuring and improving performance

Root cause analysis is an effective technique most commonly used after an error has occurred to identify underlying causes. Failure mode and effects analysis (FMEA) is a proactive technique used to prevent process and product problems before they occur. Health care organizations should learn both techniques to reduce the likelihood of adverse events.

Healthcare organizations do the following:

•           Identify the processes that could benefit from root cause analysis

•           Conduct a thorough and credible root cause analysis

•           Interpret analysis results

•           Develop and implement an action plan for improvement

•           Assess the effectiveness of risk reduction efforts

•           Integrate root cause analysis with other programs

Even without the occurrence of an adverse event, health care organizations should embrace the use of root cause analysis to minimize the possibility of patient safety events and thereby to improve the care, treatment, and services provided at their facilities.