CHAPTER 21

Principles of Quality Improvement: Improving Health Care for Pediatric Patients

Bonnie R. Rachman, MD

History

The origin of medical quality improvement (QI) lies not in medicine but in industry and dates to the 1920s. Walter A. Shewhart, PhD, was an American physicist, engineer, and statistician. In 1924, Shewhart presented a memo in which he showed a schematic control chart. The diagram and text set forth all the essential principles and considerations involved in quality control. Shewhart pointed out the importance of reducing variation in a manufacturing process and noted that continual process adjustment in reaction to nonconformance actually increased variation and degraded quality. He went on to develop data presentation rules that remain important today: Data have no meaning apart from their context, and data contain signal and noise. To be able to extract information, it is imperative to separate the signal from the noise within the data.

In the 1950s, Shewhart’s colleague, W. Edwards Deming, PhD, while working in Japan, taught top management how to improve design and, subsequently, service, product quality, testing, and sales. Deming, applying Shewhart’s concepts, described the Plan-Do-Study-Act (PDSA) method as an approach to QI. He opined, “The key is to practice continual improvement and think of manufacturing as a system, not as bits and pieces.”

In the 1970s, physician Avedis Donabedian, MD, MPH, proposed a model for assessing health care quality by describing 7 pillars of quality (Box 21.1). He posited that structure is the environment in which health care is provided, process is the method by which health care is provided, and outcome is the result of the care provided. He emphasized the importance of measurement and evaluation of health care quality, ensuring completeness and accuracy of medical records, observer bias, patient satisfaction, and cultural preferences for health care.

In 1991, Paul B. Batalden, MD, and Donald M. Berwick, MD, MPP, FRCP, helped found the Institute for Healthcare Improvement (IHI), which has resulted in the application of QI science to health care both in the United States and internationally. The IHI promotes the adoption of measurement and feedback to improve the quality of health care. The IHI is an easily accessible resource for education and information related to QI in health care.

Historically, QI efforts were focused on “quality assurance.” The goal was to minimize “defects” as measured by audits. Currently, the emphasis is on QI, which focuses on moving the entire performance curve toward a higher level of performance by identifying and adopting best practices rather than simply focusing on low performers. Ongoing measurement is vital to sustaining any improvement. The process of QI requires careful planning, thorough documentation, consistent analysis, and open-mindedness to results. In health care, QI consists of systematic and continuous actions that result in a measurable improvement in health care services and the health status of the targeted patient group.

Quality Improvement in Pediatrics

Quality improvement works to strengthen systems and processes and, in medicine, focuses on patients and the use of data to drive improvement in patient safety and health care. To achieve a different level of performance and improve quality, an organization must be willing to change.

The specialty of pediatrics emphasizes health maintenance and disease prevention. Studies have shown that recommended targets are not being consistently realized, however. Mangione-Smith et al reported that children received only 46.5% of recommended care for preventive services, acute illness management, and ongoing care of chronic conditions. In 2017, as reported by the Centers for Disease Control and Prevention, this number had not changed. Shaughnessy and Nickel reported that 21% of outpatient prescriptions in a family medicine practice contained at least 1 error. Other investigators found that medication samples were dispensed with inadequate documentation. In a pediatric emergency department in Canada, 100 prescribing errors and 39 medication administration errors occurred per 1,000 patients. In a sample of new prescriptions for 22 common medications in outpatient pediatric clinics, approximately 15% were dispensed with potential dosing errors. Even with the use of electronic medical records and e-prescribing technology, prescribing errors continue to occur as the result of auto-populate errors and/or choosing the wrong medications and/or wrong formulations from the drop-down menus. Multiple medication alerts during the prescribing task distract the clinician, resulting in errors. In addition, these frequent and often irrelevant alerts may cause “alert fatigue.” Outdated or incorrect information, such as weight entered as pounds rather than kilograms into the electronic medical records also may result in dosing errors.

The Learning from Errors in Ambulatory Pediatrics study aimed to learn the scope of, range of, potential causes of, and possible solutions to medical errors in pediatric ambulatory care. The study found that among 14 pediatric practice sites, 147 medical errors were reported during the 4-month study period. The largest group of errors was related to medical treatment (37%). Of the medical treatment errors, 85% were medication errors. Errors also were associated with patient identification (22%); preventive care, including immunizations (15%); diagnostic testing (13%); and patient communication (8%). According to the Medical Professional Liability Association (formerly the Physician Insurers Association of America), from 2003 through 2012 diagnostic errors accounted for 828 closed pediatric cases, with an average indemnity of $414,455, and medication errors accounted for 113 closed cases, with an average indemnity of $207,916. According to a systematic review, as many as 10% of all pediatric medication orders result in a medication error.

Many examples exist of errors in inpatient care as well. A study of inpatient medication errors found that among 1,000 children in 12 independent children’s hospitals, 1 in 15 children was exposed to wrong medications, side effects, or drug interactions. Takata and Currier reported a rate of 11.1 adverse events per 100 pediatric inpatients; 22% of these errors were deemed preventable. In a 2014 report from The Joint Commission, the root causes of more than 80% of almost 2,400 sentinel events were human factors (eg, staff supervision issues), leadership (eg, organizational planning), communication (eg, with patients or administrators) and assessment, including timing and/or scope.

Kurtin and Stucky describe 5 barriers or challenges to high-quality care in the pediatric and adult health arenas, the first of which is widespread unnecessary variation in care (Table 21.1). To prevent medical error, it is necessary to understand how, when, and where it occurs; evaluate the system that allowed the error to happen; and keep the system open and blame-free (Box 21.2).

Factors associated with risk of error are not the individuals who work in the system but rather the system in which the individuals work. To reduce the risk of error, the language of patient safety must be understood by all health professionals, and a deeper understanding of the principles of systems analysis work models and other solutions must be developed.

Definitions

Understanding QI and improving patient safety requires familiarity with the terminology. The National Patient Safety Foundation defines patient safety as the avoidance, prevention, and amelioration of adverse outcomes or injuries stemming from the processes of health care. The Health and Medicine Division of the National Academies (formerly the Institute of Medicine [IOM]) defines patient safety as freedom from accidental injury.

An adverse event is injury caused by medical management rather than by an underlying condition. Some adverse events are not preventable. One example of a non-preventable adverse event is the patient who receives the appropriate antibiotic at the appropriate time in an appropriate dose and who has an allergic reaction to the medication because of the existence of an allergy that was unknown to both the patient and the staff. This differs from medical error, which is the failure of a planned action to be completed as intended (ie, error in execution) or the use of a wrong plan to achieve an aim (ie, error of planning). Outcomes summarize the effectiveness of care, including adverse events.

James Reason, who did extensive work on organization models of accidents, further delineates the terminology. A slip is an error in execution, that is, the observable action deviates from what was planned. A lapse is an error in execution resulting from a memory failure. A mistake is a knowledge-based failure, that is, the plan was performed correctly, but the planned action was wrong for the situation. An active error (ie, sharp-end error) typically occurs in a patient care area by a frontline practitioner; the effects may be felt immediately. A latent error (ie, blunt error) is the result of a systems-based problem and may relate to poor design, incorrect installation, look-alike packaging, soundalike names, faulty maintenance, or bad management decisions. Latent errors are more difficult to identify and hard to recognize. Health care workers frequently develop workarounds to bypass the problem, which often leads to the belief that the work-around is normal.

A system is a set of interdependent human and nonhuman elements that interact to achieve a common aim. In a hospital, a system may be a unit or a department. Processes are the means by which care is delivered. Questions related to process include the following: Are policies routinely followed? Are evidence-based medicine guidelines implemented? Does the transfer of patients occur in an organized manner? Work models provide a conceptual framework for investigating events and processes to ensure the evaluation of all contributing factors. The PDSA method is an example of a conceptual framework. The premise of all work models is that an organized, systematic approach to event investigation results in reliable data that may be used to develop a new system.

Continuous QI (CQI) is the continued process of reviewing and improving processes and procedures associated with providing goods or services. A CQI approach may involve evaluating structure, process, or outcome either individually or—because of the considerable overlap that exists between the components and quality of care—as a whole.

When evaluating the quality of health by comparing outcomes, it is important to understand the concept of risk adjustment, which allows statistical adjustment of patient differences (eg, severity of illness) to make comparisons of outcomes clinically meaningful. Use of risk adjustment enables the translation of statistically significant tests into clinically meaningful results.

Errors and How They Occur

The pervasiveness of the medical error problem is enormous. In 1999, the IOM published To Err Is Human: Building a Safer Health System, in which it was reported that medical error accounted for approximately 44,000 to 98,000 deaths annually in US hospitals. This is more deaths than from AIDS, motor vehicle crashes, or breast cancer. The types of errors included adverse drug events, improper transfusions, surgical injuries, wrong-site surgeries, mistaken patient identity, and failure to prevent patient suicides. Most errors occurred in intensive care units, operating rooms, and emergency departments. The annual total cost of these errors was estimated to be between $17 billion and $29 billion. The cost of additional care was $8 billion. This figure does not account for lost income and productivity. A 2004 report of inpatient deaths estimated that 575,000 deaths were caused by medical error between 2000 and 2002, approximately 195,000 deaths per year. In 2008, the US Department of Health and Human Services Office of Inspector General reported 180,000 deaths per year resulting from medical error among Medicare beneficiaries alone.

The IOM made many recommendations in their report, including a balanced approach between regulatory and market-based initiatives as well as the establishment of a national focus to create leadership, research, tools, and protocols to enhance the knowledge base about safety. It recommended raising performance standards and expectations for improvements in safety through the actions of oversight organizations, professional groups, and group purchasers of health care. An additional recommendation was to implement safety systems in health care organizations to ensure safe practices at the delivery level.

In 2001, the IOM published a follow-up report, Crossing the Quality Chasm: A New Health System for the 21st Century. Safety was deemed the key dimension of quality. The report also indicated that only a systems approach would work to improve quality in health care; trying harder is an inadequate approach. Per the report, a stepwise correction of problems in the system is the key to success. Additionally, it indicated a need to overcome the culture of blame, because human error is to be expected. Table 21.2 defines types of errors in health care.

Typically, medical errors are neither isolated events, nor are they made by a single person. Normally, numerous safe points and double checks are built into the process; however, each layer of safety has gaps or holes. When these gaps align, the error reaches the patient. Standardized approaches can reduce variability and improve system efficiency. The goal is to make the gaps as small as possible or even eradicate them. Many factors are associated with medical error, including human factors triggered by interruptions, fatigue, time pressures, anger, anxiety, fear, and boredom. Mistakes can result from a wrong plan of action. Mistakes may involve misinterpretation of a problem, lack of knowledge, and habitual patterns of thought. A violation is a purposeful rule violation, whether reasoned or reckless. The factors associated with risk are not the individuals who work in the system but rather the system in which the individuals work.

Harm Versus Error

The ultimate goal of QI is to reduce patient harm. Early QI efforts targeted the elimination of error in the belief that reducing error would decrease harm. This is not true, however; most medical errors never harm patients and may be clinically insignificant (eg, 1-hour delay in administration of acetaminophen). So why does one differentiate? Focusing on harm puts the microscope on the system, not the individual.

Quality Improvement and Organizational Culture

“This is the way we do things around here.”

Patients expect to receive quality health care without experiencing preventable harm. The IOM defined quality in health care as “the degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge.” One factor that influences quality in health care is organizational culture.

Many pediatricians are never taught about organizational culture. It is the invisible, powerful dictator of how things are done in an organization. Organizational culture is a latent and often unconscious set of forces that determines individual and collective behavior, ways of perceiving, thought patterns, and values. Hospitals have their own cultures. Subcultures exist among physicians and nurses as well as within departments (eg, critical care). It may be challenging to understand all the different subcultures within a hospital.

Activities or processes within a health care organization contain 2 major components: what is done (ie, what care is provided) and how it is done (ie, when, where, and by whom). Quality improvement can be achieved by addressing either component, but addressing both simultaneously has the greatest effect on QI. The goal of QI is to enable an organization to achieve the ideal critical pathway, which is one that allows proactive and efficient interaction between the care team and patient to achieve optimal health outcomes.

Promoting change is rarely easy. Some people may adapt and change appropriately, while others resist and become dysfunctional. Making changes requires an environment in which teamwork can grow. Groupthink must be avoided. The term groupthink was coined by Yale psychologist Irving Janis, PhD; it is “a way of thinking that people may adopt when they are members of a cohesive or homogeneous group; in particular, a group whose members seek unanimity of thought to the point that they cannot consider alternative ideas.” It can prevent critical thinking and debate. Without disagreement, creativity can be lost. Negative effects of groupthink include an illusion of invulnerability, insulated leaders who may be protected from contradictory evidence, and members who accept confirming data and reject data that fail to fit their views. Alternatives are not considered, and individuals with conflicting views are discounted or demonized. Talented leaders welcome diversity of thought and ideas. Leaders must empower team members to have open discussions and offer ideas.

Communication is a key component of organizational culture. Communication involves 2 parts: message and meaning. The message is stated; meaning is interpreted and may be interpreted differently by different people. Strategies to improve communication are legion, including methods for remaining calm in high-workload, high-stress situations. Other strategies include increased verbalization, verbalizations that relate to problem-solving, speaking in the first-person plural, readback, and coordinating tasks to the right person’s experience level. Good communication encourages input from team members. Offering positive feedback builds confidence, reduces stress, and clarifies ambiguities. Team evaluations provide input on how well team members are communicating with each other and the progression toward achieving team goals. Benchmarking against a similar team may provide valuable information. An outside consultant may be hired to observe the team and provide feedback. Internally, the use of informal, regular meetings to discuss the team’s progress and provide debriefing sessions to discuss the team process may be constructive in moving the team toward its goals and ensuring effective communication. All teams experience team conflict at some point. Conflict occurs when people come together to resolve a problem, dialogue about care improvement, or discuss changing processes to improve care. Team conflict must be managed effectively so that issues can be resolved while still providing the highest-quality patient care.

Teamwork has been defined by numerous organizations. In 2003, the IOM defined teamwork by stating, “All health professionals should be educated to deliver patient-centered care as members of an interdisciplinary team, emphasizing evidence-based practice, QI approaches, and informatics.” The IOM defined a multidisciplinary team as one in which members cooperate, communicate, and integrate care to ensure that patient care is continuous and reliable.

Measuring Quality

Data are the cornerstone of QI. Ideally, measurements should evolve from the Health and Medicine Division of the National Academies quality aims (Box 21.3). Improvement measures may not be sufficiently valid and reliable for public dissemination yet may still be useful for benchmarking, for identifying best practices, or as part of QI initiatives.

Adult measures may not be appropriate for pediatrics. Pediatrics is unique because of the heterogeneity of patients, including age, size, diagnoses, and treatment modalities, including medication dosing.

Measures must be reliable. Reliability is the capacity of the measure to perform similarly under stated conditions over time. In health care, reliability and precision are often used interchangeably. Precision is the capacity of a measurement process to reproduce its own outcome. To achieve precision, a reliable system requires clear and concise definitions of the data fields to be collected. An effective approach is to train data collectors. A robust method for data coding and entry is also required. Reliability must be intermittently assessed within and between observers over time to ensure consistency.

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