Quality and Safety: Terminology and Frameworks
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.” Many publications and expert reports have emphasized that, in addition to widespread deficiencies of quality in health care, preventable harm to hospitalized patients from medical errors is frequent. A medical error is defined as the failure of a planned action to be completed as intended or the use of a wrong plan to achieve an aim. An adverse event is defined as an injury resulting from a medical intervention.
Institutions providing care for neonates with respiratory and pulmonary illness should ideally monitor and continually improve the quality and safety of care provided to ensure that their patients receive the best care possible and that they attain the best clinical outcomes possible. To ensure this, each neonatal intensive care unit should have a framework and approach for assessing, monitoring, and improving the quality of care in general and for neonates with respiratory illness in particular. Two frameworks in particular are useful—Donabedian’s triad and the six domains of quality described by the Institute of Medicine.
Donabedian’s Triad
An important framework for quality of care was proposed in the 1960s by Donabedian, who proposed that the domains of quality are structure, process, and outcomes. Structure denotes the facilities, equipment, services, and labor available for care; the environment in which care is provided; the qualifications, skills, and experience of the health care professionals in that institution; and other characteristics of the hospital or system providing care. Therefore, for a neonatal unit it encompasses aspects of quality such as space per patient, the layout of the unit, the nurse/patient ratio, the availability of radiology facilities around the clock, the types of respiratory equipment used, and the neonatology training and skills of the personnel. Process is defined as a “set of activities that go on between practitioners and patients.” It refers to the content of care, i.e., how the patient was moved into, through, and out of the health care system and the services that were provided during the care episode. Process is what physicians and other health care professionals do to and for patients. For a neonatal unit, process can include aspects of quality such as the percentage of personnel washing their hands prior to patient contact, the duration of time between birth and the first dose of surfactant, the percentage of infants in whom the examination for retinopathy of prematurity is performed on time, the efficiency with which a neonate is transported from a referring hospital, the frequency of medical errors, and so on. Finally, outcomes are the end results of care. They are the 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 viability of family, job and social role functioning.” For neonatal intensive care unit (NICU) patients and their parents, examples of outcome measures are mortality rate, the frequency of chronic lung disease, the number of nosocomial bloodstream infections per 1000 patient days, the percentage of NICU survivors who are developmentally normal, and parental satisfaction with the care of their baby. Table 6-1 demonstrates common quality measures in the field of neonatal respiratory care.
| Endotracheal Intubation |
| Use of wrong size of endotracheal tube |
| Right main stem bronchus intubation |
| Unplanned extubation |
| Obstruction of endotracheal tube due to inadequate suction |
| Airway injury leading to subglottic stenosis |
| Tracheal perforation from endotracheal tube suction catheter |
| Kinking of endotracheal tube |
| Initiation of Mechanical Ventilation |
| Improper setup of ventilator and accessories |
| Failure to add water to humidifier |
| Misconnection of ventilator tubing |
| Omission of safety limits on ventilator settings |
| Omission of alarm settings |
| Use of Mechanical Ventilation |
| Delay in changing ventilator settings in response to blood gas results |
| Inadvertent delivery of high or low ventilator pressures (e.g., auto-positive end-expiratory pressure) |
| Failure to wean inhaled oxygen when oxygen saturation is high |
| Ventilator-associated pneumonia |
| Inadequate drainage of condensate in ventilator tubing leading to inadvertent pulmonary lavage |
| Ventilator failure due to poor maintenance by biomedical engineering |
| Overriding ventilator alarms |
| Ignoring ventilator alarms |
The Institute of Medicine’s Domains of Quality
Six domains of quality were described by the Institute of Medicine in its 2001 report Crossing the Quality Chasm —safety, timeliness, effectiveness, efficiency, equity, and patient-centeredness (these can be remembered by the acronym STEEEP). A neonatal unit should try to provide respiratory care optimally in all these domains. Safety in particular 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 the reduction of delays and unnecessary waits for patients, their families, and health professionals. Effectiveness is the provision of health care interventions supported by high-quality evidence to all eligible patients and avoidance of those that are unlikely to be beneficial. Efficiency is avoiding waste, including waste of equipment, supplies, ideas, and energy. Equity is the 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 guide all clinical decisions.
Assessing and Monitoring the Quality of Care
The quality of respiratory care can be assessed and monitored using a set of quality indicators that measure different domains of quality. Individual units should choose the exact indicators to monitor based on local priorities, previously identified deficiencies of care, local patterns of practice, and ease of access to data and resources required to collect, analyze, and display data. Quality indicators should be collected both for (1) comparison and (2) improvement.
Quality Indicators for Comparative Performance Measures
Such indicators are typically used to compare a unit’s clinical performance (and not process measures) against comparators. Comparators can be the quality indicators of other similar units, national benchmarks, or targets. Ideally these data should be risk adjusted to make the comparisons valid. Risk adjustment applies statistical methods to differentiate intrinsic heterogeneity among patients (e.g., comorbid conditions) 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 institutions. Several models of risk adjustment have been developed for the NICU setting and used to evaluate interinstitutional variation.
When quality indicators are monitored, although there is often a long 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 for such judgment may also be used by regulators and payers to rank 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 (e.g., 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 quarterly and annually with a report that includes their rates of ventilation, use of postnatal steroids, use of surfactant, use of inhaled nitric oxide, pulmonary air leak, bronchopulmonary dysplasia, and mortality.
Published data from several neonatal networks reveal the existence of wide variations in neonatal process measures and neonatal outcomes (including respiratory outcomes) that persist after risk adjustment. This 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.
A particularly important subset of quality indicators is that of patient safety events. Each neonatal unit should monitor medical errors and adverse events (patient safety events) related to respiratory care. These events are most commonly identified through reporting by health professionals involved in or witnessing the event, a method that is convenient and requires few resources. Other methods to identify patient safety events are 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. 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 these events is prospective surveillance. This system yields accurate rates and can be used for comparison but is not widely used because it is laborious and requires many resources. A variety of medical errors and adverse events related to neonatal respiratory care have been described in the literature (see Table 6-1 ). In one study of 10 Dutch neonatal intensive care units, 9% of patient safety incidents were related to mechanical ventilation. Of all recorded incidents, those related to mechanical ventilation and to blood products had the highest risk scores (an indicator of the likelihood of recurrence and likelihood of severe consequences).
Quality Indicators for Improvement
These indicators are used to monitor the progress of a specific quality improvement project. These usually are a combination of outcome measures and process measures. They are collected in real time and used by quality improvement 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 are 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 Figure 6-1 .
Improving the Quality of Care
Since 1995 quality improvement (QI) has emerged as a strong movement in the health care systems of developed countries. It reflects the effort to import into health care principles, tools, and techniques from other industries for improving product quality to meet their customers’ needs and expectations. The basic premise of QI in health care is that improvements in patient care can be achieved by making a focused, conscious effort, using a defined set of scientific methods and by constant reflection on the results of our attempts to improve care. It is based heavily on systems thinking and therefore emphasizes the organization and systems of care. Many approaches to QI have been described (IMPROVE, Model for Improvement, Lean or Lean-Six-Sigma (Define, Measure, Analyse, Improve, Control [DMAIC]) or Toyota Production System, Rapid Cycle Improvement, Four Key Habits (VON), Advanced Training Program of Intermountain Healthcare, Microsystems approach) and all are broadly similar in their approaches. Of these, one simple and effective approach that can be used to improve the quality of care is the Model for Improvement (see Fig. 6-1 ) that was formalized by Langley et al. The use of the Institute for Healthcare Improvement model and the Plan–Do–Study–Act cycles to achieve improvement are discussed below.
The Improvement Team
To successfully carry out QI projects, it is important to have a core team of people in each unit. This is usually a multidisciplinary team composed of physicians, nurses, and others who are directly or indirectly involved in aspects of the topic that is targeted for improvement. The more disciplines represented, the better the QI efforts will be. The members of this team have to become skilled in several techniques, such as how to have productive meetings, how to work together as a team, how to bring about change in a unit, how to deal with barriers to improvement, and how to collect, analyze, and display data. The involvement of the entire NICU team in QI efforts should increase “buy-in” and heighten awareness of a problem, thereby possibly creating a Hawthorne effect, which is beneficial.
Collaboration
Improvement in patient care is impossible without cooperation—working together to produce mutual benefit or attain a common purpose. Collaboration and cooperation have to occur within each unit. Collaboration is a powerful force in motivating people toward improvement and in sustaining the momentum for change in each unit. The improvement team has to get buy-in from other members in their unit and get them to participate in the improvement effort. Collaboration and cooperation among units is also helpful. Different units can work together, share ideas, and help one another to improve care. Clemmer et al. suggest five methods to foster cooperation: (1) develop a shared purpose; (2) create an open, safe environment; (3) include all those who share the common purpose and encourage diverse viewpoints; (4) learn how to negotiate agreement; and (5) insist on fairness and equity in applying rules.
Aim: What Are We Trying to Accomplish?
The first step in any improvement project is to set a clear aim. This can be done in three stages. First, a list of problems faced by the unit or opportunities for change is made. The existence of quality indicators as described above will assist the compilation of such a list. Second, the problems or opportunities for change that are listed are then prioritized using criteria such as the resources available, the probability of achieving change, emotional appeal, the importance to stakeholders (including patients and their families), and practicality. Third, one item is finally selected from this list as the aim for improvement. For those unfamiliar with QI, it is best to choose for the initial project a small and well-focused topic on which data are easy to obtain that will be more likely to generate interest among clinicians and nurses. Very low birth-weight (VLBW) neonates have been the obvious target for QI in many QI initiatives. VLBW neonates contribute significantly to the mortality and morbidity burden in the neonatal units, consume the largest proportion of resources, are easily identified, and develop potentially preventable outcomes like nosocomial infections, intraventricular hemorrhage, bronchopulmonary dysplasia (BPD), and retinopathy of prematurity (ROP). When an aim is selected, it should be specified as a SMART aim—that is, it should be specific, measurable, achievable, realistic, and time-bound.
Measurement: How Will We Know That a Change Is an Improvement?
Measurement is key to QI. Measuring the quality of care serves three purposes: (1) It indicates the current status of the unit or practice. This is called assessing “current reality.” Without objective measurement, clinicians will be left guessing or relying on subjective impressions. Objective measurement of structures, processes, and outcomes provides strong motivation for a unit to embark on an improvement project. (2) Measurement of quality will inform QI teams whether they are actually making an improvement, without having to rely on subjective impressions or opinions, with the attendant risk of being misguided. (3) Measuring quality helps teams learn from attempts to make improvements and also learn from their successes as well as failures. Fig. 6-2 represents a statistical control chart – a common way of displaying measured metrics over time.
What Changes Can We Make That Will Result in an Improvement?
The answers to this question come from many sources. Some of these include:
- 1.
A detailed analysis and mapping of the process by which care is provided (process mapping). For medical errors and adverse events a detailed systems analysis is recommended. Such an analysis (the most extensive form of which is a root cause analysis (RCA), which attempts to identify workplace-related, human-related, and organizational factors that contributed to the occurrence and propagation of the event. Table 6-2 details the steps involved in the RCA process. It is critical for the leader of the RCA process to be well versed in RCA methodology and also be focused on identifying system-related challenges rather than assignment of individual blame.
