Patient Safety, Quality, and Evidence-Based Medicine

Health care is viewed as a system, a network of interdependent components working together to accomplish a specific aim, which is to meet the needs of patients, families, and communities while constantly improving its performance. The quality of health care is defined 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.” A medical error is the failure of a planned action to be completed as intended, or the use of a wrong plan to achieve an aim, and an adverse event is defined as an injury resulting from a medical intervention. Unfortunately, as noted in numerous research studies and in the Institute of Medicine (IOM) reports in 2000 and 2001, the US healthcare delivery system does not consistently provide high-quality care to all patients and populations, deficiencies in the quality of health care are highly prevalent, and numerous patients suffer from preventable harm due to medical errors.

Editorial Comment:

The Institute of Medicine report concluded that up to 98,000 people die each year as a result of preventable medical errors. The report was discussed not only in medical journals but also in lay journals and news media. One especially vivid analogy came from safety researcher Dr. Lucian Leape, who stated that this was the equivalent of three jumbo jet crashes every 2 days.

Ideally, units caring for neonates should monitor the care they provide and continuously improve the quality and safety of the care provided, both to improve clinical outcomes and to avoid medical errors and preventable adverse events. Examples of errors and adverse events noted in neonatal intensive care are shown in Box 1.1 . To ensure high-quality and safe care with the best possible outcomes, each neonatal unit should have a framework to assess, monitor, and improve the quality of care provided, both generally and for neonates with specific conditions. Such a framework can be developed using Donabedian’s triad and the IOM’s six domains of quality.

BOX 1.1

Errors and Adverse Events in Neonatal Care

Intra tracheal administration of enteral feeds
Intravenous lipid given through orogastric/nasogastric tube
Hundred-fold overdose of insulin
Administration of fosphenytoin instead of hepatitis B vaccine
Subtherapeutic dose of penicillin for Group B Streptococcal infection given for 3 days before discovery
Infusion of total daily intravenous fluids over 1–2 hours
Intravenous administration of lidocaine instead of saline flush
“Stat” blood transfusion took 2.5 hours
Antibiotic given 4 hours after ordering
Delay of greater than an hour in obtaining intravenous dextrose to treat hypoglycemia
Medications given to the wrong patient
Infant fed breastmilk of wrong mother
Medications with adverse side effects:
- Benzyl alcohol (gasping, intraventricular hemorrhage, and death)
- Chloramphenicol (gray baby syndrome)
- Tetracyclines (yellow-stained teeth)
- Intravenous vitamin E (liver failure and death)

Other Errors

Consent for a blood transfusion obtained from wrong infant’s parent
Infant falls from weighing scale, incubator, and swing
Failure of supply of compressed air throughout neonatal intensive care unit
Incubator drawn toward magnetic resonance imaging machine requiring four security guards to pull it away

Donabedian’s Triad and The Institute of Medicine’s Six Domains of Quality

In the 1960s, Donabedian proposed that the domains of quality of care are structure, process, and outcomes. Structure includes the environment in which care is provided; the facilities, equipment, services, and manpower available for care; the qualifications, skills, and experience of the healthcare professionals; and other characteristics of the hospital or system providing care. Examples of structural measures for a neonatal unit include space per patient, the layout of the unit, the nurse–patient ratio, the availability of imaging facilities around the clock, the types of respiratory equipment used, and the level of training and skills of the health professionals working in the unit and subspecialists available for consultation.

The process consists of the activities and steps involved and the sequence of these steps when patients receive health care. It refers to the content of care, i.e., how the patient was moved into, through, and out of the healthcare system and the services that were provided during the care episode. In a neonatal unit, the process of each aspect of care received by each infant can be analyzed and improved. For example, the processes of delivery room stabilization, neonatal transport, admission to the neonatal unit, performance of an invasive procedure, clinical rounds, and discharge home can all be studied and improved. Process measures of quality can be developed and monitored, such as the percentage of personnel performing hand hygiene prior to patient contact, percentage of eligible infants stabilized on continuous positive airway pressure (CPAP) at birth, the percentage of infants in whom the examination for retinopathy of prematurity (ROP) is performed on time, the efficiency with which a neonate is transported from a referring hospital, and the time taken to administer the first dose of antibiotic to infants with suspected sepsis.

Outcomes are consequences to the health and welfare of individuals and society, or, alternatively, the measured health status of the individual or community. Outcomes of care have also been defined as “the results of care…(which) can encompass biologic changes in disease, comfort, ability for self-care, physical function and mobility, emotional and intellectual performance, patient satisfaction, and self-perception of health, health knowledge and compliance with medical care, and functioning within family, job, and social role.” For Newborn Intensive Care Unit (NICU) patients and their parents, examples of outcome measures are mortality rate, the frequency of chronic lung disease (CLD), percentage of very-low-birth-weight (VLBW) infants developing ROP, the number of nosocomial blood stream infections per 1000 patient days, the percentage of NICU survivors that are developmentally normal, and parental satisfaction with the care of their baby.

Six domains of quality were described by the IOM in 2001 in the report “Crossing the Quality Chasm.” These domains of care include safety, timeliness, effectiveness, efficiency, equity, and patient-centeredness (these can be remembered by the acronym STEEEP). A neonatal unit should try to provide care optimally in all these domains. Safety of care provided is a high-priority domain that deserves separate emphasis and is defined as freedom from accidental injury (avoiding harm to patients from the care that is intended to help them). Timeliness is providing care within an optimal range of time, without delays and unnecessary waits, and also without undue haste for patients, their families, and health professionals. Effectiveness is the provision of healthcare interventions supported by high-quality evidence to all eligible patients. Efficiency is avoiding waste, including avoiding intervention in those in whom it is unlikely to be beneficial, and waste of equipment, supplies, ideas, and energy. Equity is provision of care that does not vary based on a patient’s personal characteristics such as gender, ethnicity, geographic location, and socioeconomic status. Patient-centered care is the provision of care that is respectful of, and responsive to, an individual neonate’s family preferences, needs, and values, and ensuring that the family’s values are incorporated into clinical decisions.

Clinical Microsystems and How to Assess and Monitor The Quality of Care Provided

A clinical microsystem can be defined as the combination of a small group of people who work together on a regular basis to provide care and the subpopulation of patients who receive that care. Each neonatal unit is a functioning clinical microsystem with the patient at the center and the physicians, nurses, respiratory therapists, and other professionals working with the patient and the family. It is the place where quality, safety, outcomes, satisfaction, and staff morale are created. Multiple microsystems are nested within a mesosystem (departments such as the pediatric department, or service lines such as women and children’s services), and multiple mesosystems are in turn components of a larger entity—the macrosystem or the larger organization. This macrosystem is embedded in the environment—the community, healthcare market, health policy, and the regulatory milieu. Assessment and monitoring of the quality of care provided in a neonatal unit will ultimately be shaped by the organizational culture and the environment.

Each neonatal unit should establish a set of indicators that measure the quality of neonatal care provided. The exact indicators to measure can be determined using the frameworks of the Donabedian triad and the IOM’s quality domains. Local priorities, local patterns of practice, ease of access to data, and resources required to collect, analyze, and display data, etc., will also play a role in determining the measures that are established to indicate the quality of neonatal care. The quality indicators collected can be used for (1) comparison, and (2) improvement.

Quality Indicators for Comparative Performance Measures

Comparator indicators can used to compare a unit’s clinical performance (and not process measures) against the quality indicators of other similar units, national benchmarks, or targets. To make the comparisons valid, these data should be risk adjusted using statistical methods to differentiate intrinsic heterogeneity among patients (e.g., comorbid conditions, severity of underlying disease) and institutions (e.g., available hospital personnel and resources). With risk adjustment, an outcome can be better ascribed to the quality of clinical care provided by health professionals and system, and help evaluate interinstitutional variations.

A wide variation in neonatal process measures and neonatal outcomes that persists after risk adjustment is noted in published studies of comparator quality indicators from several neonatal networks. Persistence of the variation after risk adjustment suggests that the observed differences in outcomes are the result of the quality of care provided to the patients and that the units with the poorer clinical outcomes have room to improve their quality of care. When quality indicators are monitored—although there is often a time lag between the events being measured and the analysis, display, and comparison of the data—the discrepancy between an individual unit’s performance and the comparators can be used to motivate change and launch improvement projects around specific topics. Quality indicators may also be used by regulators and payors to rank hospitals and neonatal units (sometimes publicly) according to the quality of care they provide (their performance), withhold payments, and provide incentive payments. They may also be used by families of patients, when choice is feasible (for example, in an antenatally diagnosed fetal anomaly), to choose the neonatal unit where their infant will receive care. Many neonatal networks, such as the Vermont Oxford Network (VON), the Pediatrix neonatal database, and the Canadian Neonatal Network, collect predefined data items from member neonatal units and provide reports to these units that include quality indicators. For example, the VON provides member units each quarter and each year a report that includes, among others, their rates of ventilation, postnatal steroid use, surfactant use, inhaled nitric oxide use, pulmonary air leak, bronchopulmonary dysplasia (BPD), ROP, and mortality.

One of the most important subset of quality indicators is that of patient safety events. A variety of medical errors and adverse events related to neonatal care have been described in the literature. Each neonatal unit should monitor medical errors and adverse events. These patient safety events are most commonly identified through reporting by health professionals involved in or witnessing the event. Although reporting is convenient and requires minimal resources, other methods to identify patient safety events include the use of trigger tools, chart review, random safety audits, mortality and morbidity meetings, autopsies, and review of patient family complaints or medical-legal cases. However, these methods do not yield a true rate of these events and therefore cannot be used to evaluate a unit’s performance against comparators. The ideal method to identify patient safety events is prospective surveillance, as it yields accurate rates and can be used for comparison. However, it is not widely used, as it is laborious and requires many resources.

Quality Indicators for Improvement

These indicators are usually a combination of outcome measures and process measures and are used to monitor the progress of a specific quality improvement (QI) project. They are collected in real time and used by QI teams (see below) to monitor the progress of the project, identify unintended consequences, and draw inferences about the effects of their attempts to make change. Ideally, these data should be disaggregated as much as possible (not lumped together) and displayed over time (with time on the x -axis and the indicator on the y -axis) in the form of either run charts or statistical process control charts, as displayed in Fig. 1.1 .

Fig. 1.1, Example of statistical process control chart.

Why is Quality Improvement Important in Neonatal Care?

Published literature on wide variations in neonatal process measures and neonatal morbidity that persists after risk adjustment suggests that the observed differences in outcomes are the result of the quality of care provided to the patients, that a significant proportion of neonates managed in NICUs suffer from preventable morbidity, and that the units with the poorer clinical outcomes have opportunities to improve their quality of care. A particular concern is the high incidence in VLBW infants of morbidities such as CLD, necrotizing enterocolitis, ROP, periventricular-intraventricular hemorrhage, and other conditions that often result in major long-term medical and neurodevelopmental morbidity, require chronic complex care, and are associated with high healthcare and societal costs. Despite significant advances in neonatal care over time and a decrease in frequency in some neonatal units, these conditions continue to occur in high-risk infants, and demonstrate significant variation in frequency across units despite adjustment for confounding factors (suggesting that a proportion of these conditions is preventable). Neonatal health outcomes are influenced by a variety of endogenous and exogenous factors such as birth weight, gestation, obstetric management during delivery, resuscitation practices, initial respiratory support, nutritional management, and prevention of infections. Application of systematic QI methods has the potential to reduce various forms of preventable neonatal morbidity and mortality through reliable and consistent application of existing high-level evidence, without depending on new medications, technology, or innovations to be developed. Such efforts are described below.

Editorial Comment:

A mantra of quality improvement is to “borrow shamelessly,” and indeed, healthcare quality improvement efforts have looked to other high-reliability industries such as aviation, nuclear power plants, naval aircraft carriers, and other industries that operate in complex, high-risk environments. Crew resource management, for example, which has been used in the aviation industry for years to improve communication, has been incorporated relatively recently in neonatal resuscitation as a way to improve teamwork.

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