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1 Patient Safety, Quality, and Evidence-Based Medicine

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1 Patient Safety, Quality, and Evidence-Based Medicine 1 Patient Safety, Quality, and Evidence-Based Medicine Vijayalakshmi Padmanabhan, Gautham K. Suresh Health care is viewed as a system, a network of interdependent facilities, equipment, services, and manpower available for components working together to accomplish a specific aim, care; the qualifications, skills, and experience of the healthcare which is to meet the needs of patients, families, and communi- professionals; and other characteristics of the hospital or sys- ties while constantly improving its performance. The quality of tem providing care. Examples of structural measures for a neo- health care is defined as “the degree to which health services for natal unit include space per patient, the layout of the unit, the individuals and populations increase the likelihood of desired nurse–patient ratio, the availability of imaging facilities around health outcomes and are consistent with current professional the clock, the types of respiratory equipment used, and the level knowledge.”1,2 A medical error is the failure of a planned action of training and skills of the health professionals working in the to be completed as intended, or the use of a wrong plan to unit and subspecialists available for consultation. achieve an aim, and an adverse event is defined as an injury The process consists of the activities and steps involved and resulting from a medical intervention. Unfortunately, as noted the sequence of these steps when patients receive health care. in numerous research studies and in the Institute of Medicine It refers to the content of care, i.e., how the patient was moved (IOM) reports in 2000 and 2001,2,3 the US healthcare delivery into, through, and out of the healthcare system and the services system does not consistently provide high-quality care to all that were provided during the care episode. In a neonatal unit, patients and populations, deficiencies in the quality of health the process of each aspect of care received by each infant can care are highly prevalent,4,5 and numerous patients suffer from be analyzed and improved. For example, the processes of deliv- preventable harm due to medical errors. ery room stabilization, neonatal transport, admission to the neonatal unit, performance of an invasive procedure, clinical EDITORIAL COMMENT: The Institute of Medicine report rounds, and discharge home can all be studied and improved. concluded that up to 98,000 people die each year as a result Process measures of quality can be developed and monitored, of preventable medical errors. The report was discussed not such as the percentage of personnel performing hand hygiene only in medical journals but also in lay journals and news me- prior to patient contact, percentage of eligible infants stabilized dia. One especially vivid analogy came from safety researcher on continuous positive airway pressure (CPAP) at birth, the Dr. Lucian Leape, who stated that this was the equivalent of percentage of infants in whom the examination for retinopa- three jumbo jet crashes every 2 days. thy of prematurity (ROP) is performed on time, the efficiency with which a neonate is transported from a referring hospital, Ideally, units caring for neonates should monitor the and the time taken to administer the first dose of antibiotic to care they provide and continuously improve the quality and infants with suspected sepsis. safety of the care provided, both to improve clinical outcomes Outcomes are consequences to the health and welfare of and to avoid medical errors and preventable adverse events. individuals and society, or, alternatively, the measured health Examples of errors and adverse events noted in neonatal status of the individual or community. Outcomes of care have intensive care are shown in Box 1.1. To ensure high-quality also been defined as “the results of care…(which) can encom- and safe care with the best possible outcomes, each neonatal pass biologic changes in disease, comfort, ability for self-care, unit should have a framework to assess, monitor, and improve physical function and mobility, emotional and intellectual per- the quality of care provided, both generally and for neonates formance, patient satisfaction, and self-perception of health, with specific conditions. Such a framework can be developed health knowledge and compliance with medical care, and using Donabedian’s triad and the IOM’s six domains of quality. functioning within family, job, and social role.” For Newborn Intensive Care Unit (NICU) patients and their parents, exam- DONABEDIAN’S TRIAD AND THE INSTITUTE ples of outcome measures are mortality rate, the frequency of OF MEDICINE’S SIX DOMAINS OF QUALITY chronic lung disease (CLD), percentage of very-low-birth- weight (VLBW) infants developing ROP, the number of nos- In the 1960s, Donabedian proposed that the domains of qual- ocomial blood stream infections per 1000 patient days, the ity of care are structure, process, and outcomes.6–8 Structure percentage of NICU survivors that are developmentally nor- includes the environment in which care is provided; the mal, and parental satisfaction with the care of their baby. 1 2 CHAPTER 1 Patient Safety, Quality, and Evidence-Based Medicine BOX 1.1 Errors and Adverse Events in CLINICAL MICROSYSTEMS AND HOW TO Neonatal Care15 ASSESS AND MONITOR THE QUALITY OF • Intra tracheal administration of enteral feeds CARE PROVIDED • Intravenous lipid given through orogastric/nasogastric tube A clinical microsystem can be defined as the combination • Hundred-fold overdose of insulin of a small group of people who work together on a regular • Administration of fosphenytoin instead of hepatitis B vac- cine basis to provide care and the subpopulation of patients who 9 • Subtherapeutic dose of penicillin for Group B Streptococcal receive that care. Each neonatal unit is a functioning clinical infection given for 3 days before discovery microsystem with the patient at the center and the physicians, • Infusion of total daily intravenous fluids over 1–2 hours nurses, respiratory therapists, and other professionals work- • Intravenous administration of lidocaine instead of saline ing with the patient and the family. It is the place where qual- flush ity, safety, outcomes, satisfaction, and staff morale are created. • “Stat” blood transfusion took 2.5 hours Multiple microsystems are nested within a mesosystem • Antibiotic given 4 hours after ordering (departments such as the pediatric department, or service • Delay of greater than an hour in obtaining intravenous dex- lines such as women and children’s services), and multiple trose to treat hypoglycemia mesosystems are in turn components of a larger entity—the • Medications given to the wrong patient macrosystem or the larger organization. This macrosystem is • Infant fed breastmilk of wrong mother • Medications with adverse side effects: embedded in the environment—the community, healthcare • Benzyl alcohol (gasping, intraventricular hemorrhage, market, health policy, and the regulatory milieu. Assessment and death) and monitoring of the quality of care provided in a neonatal • Chloramphenicol (gray baby syndrome) unit will ultimately be shaped by the organizational culture • Tetracyclines (yellow-stained teeth) and the environment. • Intravenous vitamin E (liver failure and death) Each neonatal unit should establish a set of indicators that measure the quality of neonatal care provided. The exact indi- Other Errors cators to measure can be determined using the frameworks of • Consent for a blood transfusion obtained from wrong the Donabedian triad and the IOM’s quality domains. Local infant’s parent • Infant falls from weighing scale, incubator, and swing priorities, local patterns of practice, ease of access to data, • Failure of supply of compressed air throughout neonatal and resources required to collect, analyze, and display data, intensive care unit etc., will also play a role in determining the measures that are • Incubator drawn toward magnetic resonance imaging established to indicate the quality of neonatal care. The qual- machine requiring four security guards to pull it away ity indicators collected can be used for (1) comparison, and (2) improvement. Six domains of quality were described by the IOM in 2001 Quality Indicators for Comparative Performance in the report “Crossing the Quality Chasm.”2 These domains Measures of care include safety, timeliness, effectiveness, efficiency, Comparator indicators can used to compare a unit’s clinical equity, and patient-centeredness (these can be remembered performance (and not process measures) against the quality by the acronym STEEEP). A neonatal unit should try to indicators of other similar units, national benchmarks, or provide care optimally in all these domains. Safety of care targets. To make the comparisons valid, these data should be provided is a high-priority domain that deserves separate risk adjusted using statistical methods to differentiate intrin- emphasis and is defined as freedom from accidental injury sic heterogeneity among patients (e.g., comorbid conditions, (avoiding harm to patients from the care that is intended to severity of underlying disease) and institutions (e.g., available help them). Timeliness is providing care within an optimal hospital personnel and resources). With risk adjustment, an range of time, without delays and unnecessary waits, and also outcome can be better ascribed to the quality of clinical care without undue haste for patients, their families, and health provided by health professionals and system, and help
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