▪ ANALYSIS OF STRUCTURE, PROCESS, AND OUTCOME
Throughout the 1970s, as the JCAHO explored ways to measure and affect quality, the tools for quality improvement slowly matured under the influence of W. Edwards Deming in industry
16 and Donabedian in medicine.
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17 In the 1960s, Donabedian established a model for the objective assessment of the quality of care. The concepts were derived from, but different than, industrial quality control, in which the elimination of variation in production through standardization provides the basis for quality improvement.
18 Donabedian’s approach to quality evaluation and improvement introduced three enduring interdependent elements that continue to form the core of quality assessment systems today: Structure, process, and outcome.
Each of these elements applies to the quality management activities of administrators, nurses, and physicians
in healthcare organizations. Individual elements specific to each group will tend to receive more emphasis by that group, although all require the collection of verifiable data on the basis of predefined criteria. The goal is to define the causes of adverse outcomes and provide a basis for assessing improvements that translate into reduced risk. Historically, the elements have come into common use in the order listed.
Structural Review
This review validates the presence of adequate structural elements, that is, physical facilities, equipment, and personnel, management algorithms (clinical and logistical), safety measures, and expected performance limits. The definition of what constitutes adequate structure is essential for structural review to be useful. For example, expectations need to be identified for staffing levels and expected capacity to move patients along the surgical care pathway, from the operating room (OR) to the nursing unit. If the suitability of equipment is to be validated, the expected purpose, performance standards, and limits of that equipment should be specified.
Often, obvious structural deficiencies go unrecognized as such, even in extensive, well planned studies. Half of the deaths and neurological injuries in a classic study of 198,103 patients in 460 French institutions were caused by hypoventilation during the postoperative period.
19 The study concluded that this was a result of the popularity of narcotic anesthesia in France. Similar results were obtained in a retrospective study of over two million anesthetics in North Carolina.
20 Although narcotic usage may have been the precipitating factor, the lack of recognition of hypoventilation (an issue of process) may have been the more correctable root cause not addressed in either study.
Even when the objective of the study is to relate structural failure to the process of anesthetic administration, the definition of structure may be drawn too narrowly. Cooper, using critical incident techniques, described a 4% occurrence of critical incidents attributable to equipment failure in 1089 patients.
21 Drug administration errors, IV apparatus problems, gas flow errors, anesthesia circuit disconnects, and other factors were defined primarily as errors in the process rather than the structure of providing anesthesia. However, these elements have significant structural significance, the appreciation of which is reflected in the subsequent improvements to anesthesia machines. The study did conclude that many of these incidents could be reduced by changes in monitoring techniques or the adoption of different management algorithms, that is, structure-related changes.
The key to maximizing the use of structure analysis, therefore, is to include within its sphere the identification of errors in the decision-making process that can be modified by structural change, for example, intelligent alarm systems, redundant syringe labeling, or the automatic detection of potentially hazardous combinations of drugs. Elements of process, which can be reduced to algorithms or policies, for example, generally accepted, reproducible standards for monitoring, techniques, or procedures should also be included.
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Process Review
Elements that comprise process review include the proper use of techniques, management strategies and judgments, drugs, blood products, medical records, and surgical procedures according to accepted practice guidelines and standards to produce an acceptable outcome. Differences between process and structure may be reduced when the scientific basis of an action is so well understood and developed that it has defined indications and methods of execution. If medication orders are written with errors in dosage and spelling, a review of the process or structure might both show that those errors could be eliminated through use of a computer-based order writing system.
A more complex example is the selection of patients for elective tracheal intubation. Assume that reliable evidence shows rapid sequence inductions fail in an unacceptable number of patients with a body mass exceeding a certain index. A policy for performing awake intubations in the entire cohort of these patients might be adopted, thereby converting a problematic decisionmaking process, by virtue of standardization, into one of structure. As with all standards, such a policy does not restrict the right of the individual anesthesiologist to decide a matter of process to reduce a known risk based on evidence in a cohort when one cannot determine in advance which member of the cohort is at risk.
For the process of assessment to be successful, the following issues should be defined: (i) Adverse events to be reduced, (ii) ideal outcome, and (iii) highly specific and verifiable changes in management. When these changes are adopted, they should lead to the desired outcome through a reduction in adverse events. Ultimately, it is not necessary to make an absolute distinction between errors in management (process), technical errors (process or structure), and purely equipment problems (structure), as long as the quality assessment process detects the problem and can correct it with the appropriate improvement in outcome.
Outcome Review
These types of evaluations involve endpoints of care, including morbidity and mortality, length of hospital stay, escalation of care including unexpected outpatient admission, and overuse or underuse of blood products, drugs or monitoring techniques. The purpose of the outcome review is to determine when a problem exists that requires corrective action. Because the multiple antecedents of outcome often reinforce or cancel each other, good care and bad care do not always result in proportionally good and bad outcome. Therefore, although outcome is the result of its antecedent causes, inferring these antecedent causes from outcome is not straightforward in medicine.
Episodic outcome assessment has a long tradition in anesthesiology in the form of mortality and morbidity
conferences; they often served before the 1980s as the only form of quality review. This practice was an integral part of surgery, from which anesthesia emerged as a discipline.
23 Our use of outcome analysis to point to specific problems of structure and process is more recent and still evolving. Not until 1999 was a structured peer review (SPR) model in anesthesiology introduced that looked at system errors as critically as human errors.
24 The measurement of defined indicators of outcome along the care pathway became a central piece in the JCAHO’s Agenda for Change paradigm in the early 1980s and had a major influence on outcome measurement. However, measurable outcome rarely points to the root cause of a problem, only its existence.
Outcome may be positive or negative, although the terminology most commonly refers to adverse outcomes. Adverse patient-related occurrence (APO) is a relatively old term, but is as useful as any number of other terms—complication, adverse event, untoward outcome, or variance—that refer to negative outcomes related to care. While the occurrence of negative outcomes tends to be most frequently measured, positive outcomes, when expectations are met, are also important. An APO in this chapter designates a negative outcome related to patient care.
Sometimes outcome causes are obscure or multivariate. The usefulness of outcome studies in altering clinical practice depends on our ability to ferret out sometimes complex cause-and-effect relationships. Good outcome does not prove the absence of management errors. Conversely, the absence of patient management errors does not preclude a bad outcome because the mechanisms can be subtle and previously unknown.
23 For example, the injudicious use of muscle relaxants may be reflected by the number of patients who require unexpected postoperative ventilation or reintubation in the acute recovery period. Many coexisting variables interact to cause the specific incidence of this problem: (i) The frequency with which relaxants are used determines the population of patients at risk and is inflated by the frequency with which relaxants are used in excess of that needed; (ii) the methods of reversal and testing of adequate reversal of relaxants may be the proximate cause of residual postoperative relaxation; and (iii) the monitoring capabilities and size of the staff available in the postanesthesia recovery area can amplify or reduce the frequency of the problem and may determine its early detection and intervention.
Multiple process and structure variables present the potential for changing the outcome if any one of the variables changes. If there is a high institutional use of muscle relaxants, but the intraoperative and postoperative monitoring and control of these agents is excellent, then the excess use is unlikely to be detected. However, if a shortage of twitch monitors, oximeters, capnographs, or postanesthesia recovery room nurses were to develop, a major increase in respiratory arrests might occur in the postoperative period.
In summary, outcome measurement is useful in evaluating the gross confirmation of successes and failures and results of changes in processes and structures. Its usefulness in evaluating individual performance or pointing to specific processes that need improvement is limited by uncontrollable variables and the difficulty of distinguishing provider-caused events from those caused by process. The same outcome may result from the combination of a competent provider using a flawed process and an incompetent provider using a well designed process. In addition, delayed outcome blurs its relation to the behavior of the provider and the quality of the process.