15Jones Leadership(F)-ch 15 1/14/07 3:47 PM Page 243 Managing Quality and Patient Safety PAYERS Employers constitute a large proportion of the payers of health-care services Competition in global markets, combined with escalating health-care costs, is driving Fortune 500 companies to join consumers on the quality bandwagon In fact, 170 of these companies have formed the Leapfrog Group, the largest purchasing group of health care The Leapfrog Group wants a system that keeps employees healthy, gets them back to work earlier, and keeps costs down Some Leapfrog initiatives include support of computerized order entry systems, evidence-based hospital referral, and the use of intensivists in critical care units Employers who are not part of the Leapfrog Group are interested in the same issues Through managed care plans and other forms of health insurance arrangements, employers help to bring focus to inefficiencies of the health-care system For example, after learning about the long-term effects on health of tight blood glucose management, a large employer in Connecticut challenged the three local hospitals that provided the majority of care to their employees and their families to work together to develop an integrated program of diabetes management Moreover, an employers’ group in Indianapolis formed a coalition to put pressure on hospitals and physicians to provide it with outcome data that will be publicly displayed at benefits enrollment fairs They are also discussing ways of structuring their benefits programs to have different co-payments, depending on the provider’s outcomes In this type of a program, employees who choose providers with better outcomes would be responsible for lower co-payments than employees who choose providers with poor outcomes These types of efforts on the part of employers are putting tremendous pressure on providers to improve outcomes 243 Sciences Members of the IOM serve as advisors in health, medicine, and biomedical science Members are volunteers who are recognized experts in their areas (Institute of Medicine, 2005) The IOM has taken a leadership position in raising national awareness of patient safety issues in hospitals and has therefore spurred the quality movement The IOM has published several seminal reports: To Err is Human, in which it reported that annual deaths of hospitalized patients as a result of errors number between 48,000 and 98,000; Crossing the Quality Chasm (Institute of Medicine Committee on Quality of Health Care in America, 2001), in which it recommended health-care reform to improve patient outcomes and reduce error; and the most recent report, Keeping Patients Safe: Transforming the Work Environment of Nurses (Page, 2004), in which it reported patient safety issues and recommendations for change to reduce the negative consequences nurses’ work environments have on their ability to provide safe care In Crossing the Quality Chasm, the Committee on Quality of Health Care in America recommended six aims for improvement: systems should be redesigned to provide care that is safe, timely, efficient, effective, equitable, and patientcentered The IOM has been influential in shaping the national agenda for improving quality and safety outcomes for patients The shocking nature of its report attributing death of hospitalized patients to medical error captured the attention of the media, which provided wide public exposure beyond the health-care community The combination of loud public outcry, personal influence of IOM members, and the movement toward pay for performance has contributed to current demands for greater accountability of providers, hospitals, and other health-care agencies National Quality Forum PROFESSIONAL GROUPS The Institute of Medicine and National Quality Forum consist of representatives across professional disciplines that have had tremendous influence on shaping the national quality agenda Institute of Medicine The Institute of Medicine (IOM) was chartered in 1970 as an arm of the National Academy of The National Quality Forum (NQF), a nonprofit public-private partnership that works to improve the health-care system through development and dissemination of voluntary consensus standards, recently recommended nursing performance standards (National Quality Forum, 2004) Member organizations represent health-care providers, educational institutions, consumers, employers, state and federal agencies, and research Four nursing organizations (American Nurses Association, 15Jones Leadership(F)-ch 15 244 1/14/07 3:47 PM Page 244 Skills for Being an Effective Manager American Academy of Nursing, American Association of Colleges of Nursing, and American Association of Nurse Anesthetists) are represented among NQF member organizations The NQF consists of councils, which provide the opportunity for member organizations to discuss issues with each other, and sets consensus standards on issues of current relevance Examples of these types of consensus standards are Cancer Care, Hospital Standards, Patient Safety Standards, and NurseSensitive Quality Indicators (National Quality Forum, 2000-2004) The nursing standards are the first nationally standardized set of performance measures to assess the effect acute care nurses have on patient health and safety outcomes Measures evaluate eight patient outcomes (failure to rescue; pressure ulcer prevalence; falls prevalence; restraint prevalence; falls with injury; and three infections: urinary tract, central line, and ventilatorassociated pneumonia [VAP]), three process indicators (nurse counseling of smoking cessation for patients with an acute myocardial infarction, congestive heart failure, or pneumonia), and four structural measures (skill mix, nursing hours per patient day, nursing work environment, and voluntary turnover) The 15 indicators are intended to be an initial set The notion behind the consensus standards is that all of the NQF member organizations would incorporate the consensus measures into the quality measures they require By doing so, measurement would become standardized and consistent across organizations and settings, which would allow comparison Additionally, inclusion of the measures in the Medicare and Medicaid programs gives them the power of regulation for those organizations and individual practitioners participating in these programs For example, JCAHO has incorporated the NQF nursing-sensitive indicators into its staffing effectiveness measures Organizations accredited by JCAHO must evaluate nurse staffing effectiveness on at least two of its units by collecting and analyzing two human resource indicators and two clinical service indicators The indicators must be trended and are to be used internally to evaluate performance The 15 NQF indicators are included in the set approved by JCAHO for meeting this standard As a result, use of these indicators has spread quickly across multiple settings and organizations; however, because the standard requires internal monitoring, data are not sent to JCAHO, and no comparison data are available for organizations wishing to use external databases for quality improvement American Nurses Association In the mid-1990s, the American Nurses Association (ANA) published a report containing process, outcome, and structural measures that have been shown through research to be related to acute care nursing (American Nurses Association, 1995) These indicators are a subset of the larger set subsequently published by the National Quality Forum Some of the outcome indicators contained in the report include patient mortality, length of stay, adverse incidents such as medication errors and patient falls, and complications such as nosocomial infections and decubitus ulcers Examples of process measures are pain management, use of restraints, and discharge planning Process measures are phenomena associated with nursing interventions Structural measures involve, for example, nurse staffing, such as skill mix, experience, and hours per patient day The report contains operational definitions for all quality indicators as well as references for all evidence linking the indicator with nursing Quarterly submission of these data to the National Dataset Nursing Quality Indicators is a requirement of Magnet certification In return for data submittal, nurse leaders receive a quarterly report that shows their data broken down by type of unit, with comparisons with the average performance for all like units in the database Having such data allows nurses to understand how the results of their care compares with that of other nurses, helps focus attention on care processes that might be substandard, and highlights areas where performance is stellar By using these types of data to determine where the greatest gaps exist between their performance and that of other like units, leaders can prioritize improvement projects and direct resources to those outcomes where the gaps are greatest In addition to the acute care report card, the ANA has published numerous standards of nursing practice Scope and standards documents have been published for nurse administrators, clinical specialty areas, and nursing informatics The standards not replace state law or regulations of individual nurse practice acts; they serve as consensus standards of nurse experts in the areas of the published 15Jones Leadership(F)-ch 15 1/14/07 3:47 PM Page 245 Managing Quality and Patient Safety standards (American Nurses Association, 2004) The criteria for measurement of excellence in nursing care used by the Magnet Recognition Program are based upon the ANA scope and standards for nurse administrators (American Nurses Credentialing Center, 2004) The standards also serve as the basis for specialty certification examinations (Box 15-2) Models of Quality Quality models serve as frameworks for diagnosing and finding solutions to performance problems Often, organizational leadership sets the choice of a model This section describes models frequently used in health-care settings PLAN, DO, STUDY, ACT CYCLE The Plan, Do, Study, Act (PDSA) cycle is an improvement model that is still practiced widely Dr Deming advocated for this method of continual improvement Each step of the model contains a distinct improvement phase The model is meant to be repeated over multiple improvement cycles Use of the PDSA cycle assumes that a problem has been identified and analyzed for its most likely 245 Box 15-2 Baldrige National Quality Award Accrediting bodies and state and federal regulations set minimum standards of quality Organization leaders who wish to be recognized for providing services of the highest quality measure themselves against more rigorous standards, such as those developed for the Baldrige National Quality Award The Baldrige National Quality Award program, named for Malcolm Baldrige, a former Secretary of Commerce, is administered through the National Institute of Standards and Technology The award is based on meeting rigorous quality standards that show an organization has achieved an integrated approach to performance management The award criteria differ for different sectors of the economy There are specific health-care criteria, which use a systems perspective to identify relationships among seven criteria for performance excellence The seven categories encompass: Leadership Strategic planning Focus on patients, other customers, and markets Measurement, analysis, and knowledge management Focus on staff Process management Results of organizational performance (National Institute of Standards and Technology, 2004) Only one health-care system and four hospitals have achieved this distinction (National Institute of Standards and Technology, 2005) Historical Perspectives Box The ideas of Deming, Juran, and Crosby underlie much of the theory, tools, and techniques we use in quality today Understanding their work provides a historical context of the quality movement and the beginning foundation on which the rest of the information in this chapter will build Dr W Edwards Deming Dr Deming (1950) was one of the pioneers of the quality movement Deming took a systems view of the world As a systems thinker, Deming understood that manufacturing a product or delivering a service like health care consists of multiple processes and decisions that are related to one another When we view our work from a systems perspective, we begin to understand how our actions influence others who follow us in providing care to patients Deming suggested that the style of management being practiced in his day, which consisted of use of fear to control workers, inspection of work to reduce defects in manufacturing, and use of targets and quotas to drive productivity, should undergo a transformation He suggested that his System of Profound Knowledge would provide managers with a theoretical map, a tool that would provide better understanding of their organization Deming’s System of Profound Knowledge contains four interrelated parts: Appreciation for a system: all work consists of multiple interdependent processes Understanding of variation: differences in work outcomes are a result of the system of work, not individual worker performance (Continued on following page) 15Jones Leadership(F)-ch 15 246 1/14/07 3:47 PM Page 246 Skills for Being an Effective Manager Historical Perspectives Box (continued) Theory of knowledge: when making improvements we test new designs that we predict will produce better outcomes Our predictions are based on our understanding of how work processes relate to one another Psychology: understanding what motivates people (Deming, 2000) Dr Deming proposed that variation among workers was caused by their work system Managers need to manage the system of work to reduce variation among workers and improve the consistency of their product His model for improvement was the Plan, Do, Study, Act (PDSA) cycle An explanation of how the PDSA cycle is used in practice is in the section of this chapter on quality models Deming was also known for his 14 Points for Management The 14 points were developed in response to frequent requests he received about his transformation of Japanese manufacturing (Stoecklein, 2005) Deming believed it was management’s responsibility to create an environment where employees could produce high-quality products This philosophy can be seen in his 14 points, which cover such elements as constancy of purpose for management, working with vendors so that incoming materials are defectfree, driving out fear among workers, continuous attention to improvement of quality and elimination of waste, and use of statistical quality control rather than mass inspection His theory was instrumental in improving reliability of Japanese products by guiding leaders to foster an environment where front-line workers had the ability to reduce defects in manufacturing by cooperating with each other JOSEPH JURAN Joseph Juran (1950), who was trained as an engineer, was another of the early pioneers in quality Juran also spent time in the early 1950s consulting with Japanese industrialists He is best known for his quality trilogy: quality planning, quality improvement, and quality control (Juran & Godfrey, 1999) Juran defined two different but interrelated concepts, those aspects of a product that meet customer needs and those aspects of a product that are free from defects (Stoecklein, 2005) Similar to Dr Deming, Juran used statistical thinking to understand process variation He introduced the Pareto principle as a method for understanding the “vital few” contributors to the cause of a problem According to Juran, causes and that changes have been recommended for eliminating the likely causes Once the initial problem analysis is completed, a plan is developed to test one of the improvement changes During the 20% of the causes contributes to 80% of the problem Pareto diagrams are used to identify the “vital few”; a full explanation of their use is in the section on quality tools PHILIP CROSBY Philip Crosby (1960) was another of the early pioneers in quality Crosby defined quality as the extent to which processes are in conformance with requirements, i.e., providing what the customer needs and expects Consistent with the other quality theorists, Crosby believed that leaders were responsible for creating an environment that promoted continuous improvement He is most famous for two phrases, which are often found throughout the quality literature: “do it right the first time” and “zero defects” (Nielsen et al., 2004) In other words, managers must not tolerate flaws or errors Deming, Juran, and Crosby all had a process focus All three theorists believed that improvement must be continuous and that knowledge of customer needs and requirements is essential Whereas Deming, Juran, and Crosby pioneered quality improvement in manufacturing, Donabedian was an early quality advocate in health care AVEDIS DONABEDIAN Dr Donabedian (1960) is best known for the structure, process, and outcome quality paradigm, which underpins much of the health outcomes research performed by nurse researchers and is the framework that underlies the Quality Health Outcomes Model developed by the American Academy of Nursing Expert Panel on Quality Health Care (Mitchell, Ferketich, & Jennings, 1998) A description of the Quality Health Outcomes Model is in the section on quality models Structure consists of organizational characteristics such as staffing, models of care, patient types, and volumes Process consists of tools and techniques involved in providing care Nursing process and interventions are types of process measures Outcomes involve the results achieved They reflect the effectiveness of the structural and process components (Donabedian, 1992; Lee et al., 2005) Outcomes are a product of the structure we have put in place and our care processes Both components need to be in place to achieve optimal outcomes For example, a medical-surgical nursing unit that wants to improve its fall rate may need to make improvements in staffing as well as develop a sound process for identifying and protecting patients at high risk for a fall Do phase, the change is made, and data are collected to evaluate results Study involves analysis of the data collected in the previous step Data are evaluated for evidence that an improvement has been 15Jones Leadership(F)-ch 15 1/14/07 3:47 PM Page 247 Managing Quality and Patient Safety Practice Proof 15-1 Article: Comparison of methods for detecting medication errors in 36 hospitals and skilled-nursing facilities Authors: Flynn, E.A., et al American Journal of HealthSystem Pharmacy 59(5): 436–446 Note: This abstract is available online through PubMed The full-text may be accessed through libraries that have subscriptions to Academic Search Premier ABSTRACT The validity and cost-effectiveness of three methods for detecting medication errors were examined A stratified random sample of 36 hospitals and skillednursing facilities in Colorado and Georgia was selected Medication administration errors were detected by registered nurses (R.N.s), licensed practical nurses (L.P.N.s), and pharmacy technicians from these facilities using three methods: incident report review, chart review, and direct observation Each dose evaluated was compared with the prescriber’s order Deviations were considered errors Efficiency was measured by the time spent evaluating each dose A pharmacist performed an independent determination of errors to assess the accuracy of each data collector Clinical significance was judged by a panel of physicians Observers detected 300 of 457 pharmacist-confirmed errors made on 2556 doses (11.7% error rate) compared with 17 errors detected by chart reviewers (0.7% error rate), and error detected by incident report review (0.04% error rate) All errors detected involved the same 2556 doses All chart reviewers and of 10 observers achieved at least good comparability with the pharmacist’s results The mean cost of error detection per dose was $4.82 for direct observation and $0.63 for chart review The technician was the least expensive observer at $2.87 per dose evaluated R.N.s were the least expensive chart reviewers at $0.50 per dose Of 457 errors, 35 (8%) were deemed potentially clinically significant; 71% of these were detected by direct observation Direct observation was more efficient and accurate than reviewing charts and incident reports in detecting medication errors Pharmacy technicians were more efficient and accurate than R.N.s and L.P.N.s in collecting data about medication errors QUESTIONS Why you think there was such a discrepancy among the three methods of error detection? What were the most two most frequent types of error detected by direct observation? If you were to replicate the three methods of data collection used in this study, would there be a more cost effective way to data collection? 247 made The Act step involves taking actions that will “hardwire” the change so that the gains made by the improvement are sustained over time The PDSA cycle has found widespread use in the health-care setting It is not unusual in such complex environments for multiple extraneous factors to influence results Through repetition of the PDSA cycle, multiple corrective actions may be taken and evaluated (Kondo & Kano, 1999) The following example illustrates how the PDSA cycle may be used in health care A nurse manager notices that the number of patient falls with injury has been climbing steadily over the last few months She calls her staff together to brainstorm reasons for the higher number of falls After considering several reasons, the staff develops a process for earlier identification for patients who may be at risk for a fall (the Plan phase of the PDSA cycle) The staff implements its new risk appraisal process and continues to collect data regarding the number of patients who are injured as the result of a fall (the Do phase) After a few weeks of data collection, the staff reviews the injury data to determine if the new risk appraisal process has resulted in fewer injured patients (the Study phase) Finally, the staff members decide that the new risk appraisal process has resulted in fewer falls, but they believe that they could better if they also added bed alarms to alert them to high-risk patients who are attempting to get out of bed without appropriate assistance This is the Act phase (making the risk appraisal process a routine for all patients) and the beginning of another PDSA cycle (implementation of bed alarms) Once the bed alarms are put in place, the staff will again collect patient fall data, examine the data for improvement, and then decide whether the bed alarms resulted in enough improvement to warrant permanent implementation This example illustrates how the PDSA cycle may be repeated over multiple corrective actions to result in better patient outcomes THE MODEL FOR IMPROVEMENT Another model commonly found in health care is the Model for Improvement (Langley et al., 1996) The model uses a systems framework, which adds three questions to the PDSA cycle The questions are meant to bring clarity to the improvement process The three questions are: ... published numerous standards of nursing practice Scope and standards documents have been published for nurse administrators, clinical specialty areas, and nursing informatics The standards not replace... each other, and sets consensus standards on issues of current relevance Examples of these types of consensus standards are Cancer Care, Hospital Standards, Patient Safety Standards, and NurseSensitive... medication errors and patient falls, and complications such as nosocomial infections and decubitus ulcers Examples of process measures are pain management, use of restraints, and discharge planning