Quality Assurance and Performance Improvement: Important Approaches in

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Healthcare Services Delivery in Developing Countries....................................................38 New QA Project Products..........................39 QA Project Editorial Quality Assurance and Performance Improvement: Important Approaches in Improving Health Systems James R. Heiby, MD USAID Project Manager HE term performance improvement (PI) is new to most healthcare professionals. However, those who have long worked to improve the quality of care in developing countries will quickly notice how similar PI is to approaches we have known as quality assurance (QA). At first blush, this may seem to be a distinction without a difference, little more than a proliferation of specialized jargon. A closer look, however, leads to a much more interesting and provocative conclusion. For many years, the training of service providers has been the centerpiece of international assistance in health. The development of new interventions, from oral rehydration therapy to HIV/AIDS counseling, requires health workers to carry out new activities, and training is the logical place to begin. The implicit assumption was that this training, supported by the existing health system, would be enough to realize the potential of new technologies. This assump- tion, however, is increasingly being questioned as we gain new insights into the complexities of delivering healthcare. The most impressive advances over the years have been in understanding the process of care itself, that is, in a better T 2 QA Brief QA Project Editorial continued from page 1 understanding of what providers actually do when they leave the training course and return to the work of taking care of patients. Evidence-based clinical guidelines have rapidly gained acceptance as the standard for evaluating the process of clinical care. The principle is straightforward. In many circum- stances, there is enough scientific and clinical evidence to specify what the provider should do. Translating this evidence into a practical written guideline for clinicians is more challenging, of course, particularly since the guideline must reflect what is actually feasible in a given setting. In developing countries, however, most health issues are well suited to guidelines. Further, only a limited number of such guidelines would be needed to cover most visits. The World Health Organization (WHO) guideline for the Integrated Management of Childhood Illness (IMCI) is a prominent example of such a guideline. We are only now beginning to appreciate the far- reaching implications of this apparently simple concept. The health impact of training providers depends on influencing what they do in the clinic, and the guidelines provide a yardstick to measure the way providers are doing their jobs. Such assessments are still too few, but when they are made, they consis- tently show that actual care falls substantially short of the guidelines. We cannot yet specify what this short- fall means in terms of health impact, but there are Quality Assurance Project Editors Donna Vincent Roa University Research Co., LLC Beth Goodrich Center for Human Services Brief Director David Nicholas, MD, MPH Deputy Director Diana Silimperi, MD Special Assistant to the Director Ellen Coates, MPH Associate QA Project Director, Africa Bruno Bouchet, MD, MPH Associate QA Project Director, Jorge Hermida, MD, MPH Latin America Associate QA Project Director, Russia, Rashad Massoud, MD, MPH NIS, Asia, and the Middle East Associate QA Project Director, Donna Vincent Roa, PhD Director of Communication Associate QA Project Director, Bart Burkhalter, PhD Operations Research Associate QA Project Director, Barbara Smith-Hamer, MA, RN Director of Training Associate Director for Administration Jeanne Oliver Training Manager Jolee Reinke, MSN, CPHQ Deputy Training Manager Thada Bornstein, MEd Deputy Director, Operations Research Paula Tavrow, PhD Regional Development Maina Boukar, MD, MPH Senior QA Advisor Joanne Ashton, MN, RN (Joint Commission Resources) Senior QA Advisor Marina Budeyeva, MD, MPH Senior QA Advisor Wendy Edson, PhD, MPH, RN Senior QA Advisor Lynne Miller Franco, ScD Senior QA Advisor Edward Kelley, PhD Senior QA Advisor Stephane Legros, MD, MPH (Johns Hopkins University) Senior QA Advisor Lynette Malianga, BNS, RN Senior QA Advisor and Filiberto Hernandez, MD, MPA Deputy Director, LAC QA Specialist Hany Abdallah, MA, MHS QA Specialist Karen Askov, MHS QA Specialist Mellina Mchombo, BNS, RN QA Specialist Jennifer Shabahang, MHS QA Coordinator, Bolivia Jenny Romero, MD QA Coordinator, Honduras Norma Aly, MD, MA QA Coordinator, Nicaragua Oscar Nuñez, MD Reproductive Health Specialist, Luis Urbina, MD Nicaragua QA Manager, South Africa Maria Fakude, BN Associate Director, West Africa Sabou Djibrim, MNS, RN Senior Communication and Lani Marquez, MHS Research Advisor Communication & Research Specialist Ya-Shin Lin, MPH Project Coordinator, Operations Jennifer Lahaie Research Project Coordinator, Africa Anna Hickman, MPA Project Coordinator, Latin America Luis Sobalvarro Project Coordinator, Russia/Asia Kim Ethier, MA Training Coordinator Elsa Berhane, MPH Web Communication Coordinator Janis Berman Senior Editor Beth Goodrich Senior Writer Cynthia Young, MA Travel Coordinator Ebie duPont The QA Brief, published twice yearly, shares with the international health community the methodologies, activities, and findings of quality improvement initiatives sponsored by the Quality Assurance Project. Those interested in receiving future issues of the QA Brief or any other Quality Assurance Project publication should contact: Communication Division Quality Assurance Project 7200 Wisconsin Avenue, Suite 600 Bethesda, MD 20814-4811, USA TEL (301) 654-8338 FAX (301) 941-8427 www.qaproject.org QA Brief 3 The most impressive advances over the years have been in understanding the process of care itself, that is, in a better understanding of what providers actually do when they leave the training course and return to the work of taking care of patients. grounds for concern: training alone increasingly looks inadequate as a way to improve the quality of health care. The fields of quality assurance and performance improvement have their origins far from the problems of lesser-developed country health systems. From a QA perspective, compliance with clinical guidelines is a central measure of qual- ity of healthcare, and the field offers a wide range of tools for improving quality. Many of these tools reflect the efforts of thoughtful health professionals, but other approaches have been adapted from industry. The idea of a program of accreditation for facilities that is based on objective criteria, for example, comes from the health sector. Nevertheless, QA programs also make exten- sive use of the structured problem-solving technique of quality management first developed in industry. Like quality management (QM), performance improvement began in industry. However, unlike QM, PI begins with a focus on the limitations of staff train- ing rather than on the role of managers. Nevertheless, in their applications to health systems in developing countries, modern quality assurance and performance improvement reach surprisingly similar conclusions. Provider compliance with guidelines is a central mea- sure of both performance and quality. Experts in both fields agree that what providers do is influenced by the nature of the health system in which they work, as well as by training. The approach of both fields is to understand these other factors and change them in ways that support improved compliance with evidence- based guidelines. The two fields do not have every technique in com- mon, but the similarity of their approaches is striking. Indeed, the very fact that two distinct fields have converged on a similar overall idea of what needs to be done should give us confidence. Considering the magnitude of change in health systems that will be required, we will need that confidence. 4 QA Brief Feature Article T The Importance of Involving Physicians in Quality Improvement David Nicholas, MD, MPH, Director, Quality Assurance Project HERE is documented evidence from countries at all economic levels that medical outcomes, both clinical and preventive, can be improved through the work of quality improvement teams. This is especially true when medical systems and work processes are changed to allow for the effec- tive implementation of evidence-based medical guide- lines. Physicians, both as leaders in their organizations and as practitioners adhering to the guidelines, are crucial to the success of these quality improvement teams. Physicians usually play a leadership role in a medical setting: they often serve as managers and may make or influence the decision as to whether improvement activities will occur. Experience shows that if they are not actively involved as members 4and often as leaders 4of these teams, quality improvement work either will not start or will soon come to a halt. Furthermore, if physicians are not involved, they probably will not cooperate in implementing the changes or adhering to the new guidelines. Yet, the Quality Assurance Project experience is that it is not always easy to involve physicians in such improve- ment work. Why is this so? Physicians who are primarily clini- cally involved may see quality improvement as a management function not related to their own respon- sibilities. They also often hesitate to admit that the clinical processes or standards currently in use are not the best. They may not see that clinical outcomes are tied to the processes being followed or that the results and outcomes could be improved. They may also feel that they do not have the time for such activities. Even those physicians who have management respon- sibilities may not have been trained in management and may not be prone to forming or leading teams to improve organizational processes. Physicians are not usually trained to work in teams and may feel uncom- fortable working as an equal member of a team of health workers with less professional training or credentials. They may see themselves more like a military platoon leader than as a coequal member of a team. The QA Project has found that physicians can be mo- tivated to become active participants and leaders of quality improvement activities. This begins by identi- fying physician leaders who are interested in improv- ing certain medical outcomes. Success is most likely if these physicians can attend an cexecutive seminar d in quality improvement principles. The seminar sets the stage for the physician to provide the necessary leadership in future activities. A physician can then involve colleagues in a review of the medical conditions for which he or she thinks outcomes could be improved. Purely administrative issues for improvement should be avoided at first unless the physician demands these priorities. During the review of medical conditions, the physician can choose one condition or area to tackle for the first improvement effort. The physician can also form a team that includes one or more physicians who are key to the process being improved. Other key health workers are also selected for the team as appropriate (nurses, laboratory technicians, pharmacists, etc.). The team reviews the system of care and the steps in the improvement process. This review covers the diagnostic and clinical decision-making steps, as well as treatment and follow-up. For each step, the team assesses the scientific evidence justifying current practice. If evidence is lacking, the team consults the QA Brief 5 literature and/or nationally or internationally accepted guidelines such as those maintained by the Cochrane Center in the United Kingdom or the U.S. Govern- ment (www.guidelines.gov). Interdepartmental steps and relationships, such as involving laboratory or X-ray departments, are also examined. The team may also need to consider logis- tical essentials, such as transportation for emer- gency cases. Community and patient education are other important compo- nents of both preventive and clinical services and need appropriate attention from the team. Finally, the team describes the new process and guide- lines to be followed in treating the condition and iden- tifies the indicators it will use to measure compliance and outcomes. Process indicators could include essen- tial diagnostic or therapeutic tasks carried out. Some- times ccare maps d (or critical pathways) are developed. Other process steps to be monitored could include completed medical records with all essential information. Such information can be obtained by a medical audit of a sample records. (Information that is automated can be analyzed more easily.) Outcome indicators of particular interest to physicians could be case-fatality rates, mortality rates, postoperative infec- tion rates, complication rates, hospitalization rates, client satisfaction, and cost of care. The team works to implement the changes it has designed and to self-assess the results by assisting in the monitoring and analysis of process data and out- comes. The cstory board d of the team 9s work can be posted on a staff bulletin board to communicate the work done, and the results can be charted on a monthly basis for all to observe. Usually the results achieved are quite significant and provide continued motivation to the team along with encouragement to others to begin similar work. Thus, the physicians on the first team become champions of the approach, and others soon follow. This can lead to a multiplying number of improvements in clinical care. This approach has been used in two Russian states by the Quality Assurance Project where the problems of pregnancy-induced hypertension (PIH), neonatal respiratory distress syndrome (RDS), and adult hypertension were tackled. In 18 months, there were dramatic re- ductions in hospitalization for PIH, deaths from RDS, and complications of adult hypertension. 1 In Nicaragua, a similar project dealing with Essential Obstetric Care (EOC) has resulted in an increased use of partographs from a pre-project level of 3 percent to 90 percent in only 10 months. There are strong indica- tions that maternal mortality is decreasing as well. In Bocay, one of the districts in Nicaragua where the QA Project is working, there were 10 maternal deaths in 1999. In the first 10 months of 2000, there were only two. Such visible changes are very motivating to the physicians involved. They are rewarded with a sense of greater professionalism in their work and with the gratitude of their clients and community. Community and patient education are other important components of both preventive and clinical services and need appropriate attention from the team. 1 Detailed data may be found in the article on page 26: (Re)Designing the System of Care for Neonates Suffering from Respiratory Distress Syndrome in Tver Oblast, Russian Federation. 6 QA Brief Quality Improvement and Performance Improvement: Different Means to the Same End? 1 Thada Bornstein, MEd, Deputy Training Director, Quality Assurance Project ERFORMANCE IMPROVEMENT (PI) is a methodology for improving the quality of institutional and individual performance. PI, a term often used interchangeably with Human Performance Technology (HPT), has attracted much attention lately in the international development community, due largely to the enthusiasm of the USAID Office of Population, which is encouraging Cooperating Agencies (CAs) to adopt PI. The CAs are at varying stages of familiarity with both PI and quality improvement (QI). Because even seasoned practitioners have different perspectives on the rela- tionship between PI and QI, the topic has caused lively and useful discussions in the CA community. This article describes some of the similarities and differences between the two methodologies. It is written and should be read with the understanding that QI and PI are continually evolving and that there is no discrete boundary between them. In both QI and PI, their application in the U.S. and other developed countries is at a later stage of evolu- tion and experience than in developing countries. This paper is limited to the application of QA/QI and PI in international healthcare. (Many of the statements in this article apply equally to QA and QI.) The USAID-sponsored Performance Improvement Consultative Group (PICG) is composed of CA repre- sentatives who have worked with the Office of Popu- lation to develop performance improvement strategies, tools, and approaches. The PICG has developed its own framework based on that of the International Society of Performance Improvement (ISPI). The customized version is suited to the needs and experi- ences of those who work in the developing world. This version emphasizes the step of obtaining stake- holder agreement to the PI process from the very beginning, before any intervention is attempted 4 thus avoiding the problems that can arise when there are multiple clients with different goals. PICG has agreed to use the common framework in the field in order to reduce confusion among clients, although each group will apply the PI process somewhat differently. Origins Although PI and QI arise from different beginnings, both take a systems view. ISPI defines HPT/PI as: cHuman performance technology is a set of methods and procedures, and a strategy for solving problems, for realizing opportunities related to the perfor- mance of people. It can be applied to individuals, processes, and organizations. It is, in reality, a systematic combination of three fundamental processes: performance analysis, cause analysis, and intervention selection. d 2 HPT has deep roots in human resources, instruc- tional design, and training, and draws on many fields, including systems theory, learning psychol- ogy and behaviorism, information technology, feedback systems, organizational development, analytical systems, ergonomics, human factors, and psychometrics. 3 PI grew out of the realization that P 1 In general, the Performance Improvement framework is an evolving concept with new concepts emerging as work continues in this f ield. The concepts presented here reflect the current thinking when this article was prepared. 2 International Society for Performance Improvement. 2001. 3 M. Rosenberg, W. Coscarelli, and C. Hutchison. 1992. cThe Origins and Evolution of the Field d in Stolovitch and Keeps, eds., Handbook of Human Performance Technology. San Francisco: Jossey-Bass Publishers. Feature Article QA Brief 7 poor job performance seldom is due solely to the performer 9s lack of skills and knowledge, but usually to other factors in the system. PI is based on the theoretical framework of HPT, a systematic method based on data, aimed ultimately at improving human performance by addressing the gap between the present state and the desired state. Its foundation is the belief that to improve human performance, one must manage the performance improvement system, which must be the core of an organization 9s human resource efforts. 4 Progressive companies in private industry have practiced both PI and QI since the 970s. Performance improvement is helping to change the widespread notion that all performance problems are best addressed by training. Traditionally, management viewed poor performance as a lack of knowledge or skills, without regard for a variety of internal and external determinants of performance, such as motiva- tion, incentives, environmental factors, resources, feedback, coaching, supervisory support, and others. This mentality leads managers to think that workplace performance problems can be cfixed d by training, so training became a panacea for those problems but rarely solves them. Even when training is required, it alone is often insufficient to improve job performance ( ctraining transfer d). Without certain supports present in the workplace, performance may improve for a short period following training, and then erode. Quality assurance (QA) and its component, QI, origi- nated in engineering and manufacturing where sys- tems theory, statistical process control, and continuous quality improvement were combined with general management methods. Both QA and QI have long since been adopted and adapted by healthcare systems in many developed countries. Theory and Principles Simply stated, QI examines processes in order to improve them. Like the other components of QA, QI relies on the guiding principles of teamwork, systems and processes, client focus, and measurement. The focus on teamwork recognizes that team members bring valuable insights regarding the process to be improved because of their knowledge of and experience in it, and are more likely to implement improvements they helped to develop. The focus on systems and processes recognizes that providers must understand the service system and its key service processes in order to improve them; resolving the problem of unclear, redundant, or incomplete pro- cesses or systems yields better results than placing blame on individuals. Focus on the client emphasizes that services should be designed so as to meet the needs and expectations of clients and community. Focus on measurement means that data are needed to analyze processes, identify problems, and measure performance. This focus promotes taking action based on facts rather than on assumptions. A more complete examination of the fundamental principles of QI are presented in cAdvances in Quality Improvement: Principles and Framework, d on page 13 of this issue. However, it is good to remember that the one of the simplest definitions of quality, cDoing the right thing, right, d illustrates that author 9s two major components of care: content (doing the right thing) and process (doing it right). Methodology PI PI addresses human performance within organizations at the individual, process, and organizational levels. It uses a systematic method that has five stages: (a) getting agreement on the project goal from the 4 International Society for Performance Improvement, 2001. 8 QA Brief clients, stakeholders, and PI practitioner; (b) conduct- ing a performance needs assessment (identifying performance gaps and their root causes); (c) designing the interventions to close the gap; (d) implementing the interventions, and (e) evaluating the change in the performance gap. The PICG has identified the following conditions 5 needed for people to perform well: s Clear job and performance expectations s Clear and immediate feedback on performance s A supportive environment, including adequate and proper tools, supplies, and work space s Motivation to perform to expectations (intrinsic motivation to do the job) s Organized support in terms of strategic direction, leadership and management communication, organizational structure, and well-conceived job roles and responsibilities s Knowledge and skills to do the job (technical competencies that match the requirements of the job) The types of interventions most often recommended by PI address the performance factor deficiencies, including: information systems, job aids, job and work design, leadership, organizational design, performance support, staffing selection, supervision, appraisal systems, career development, coaching/mentoring, culture change, compensation, documentation, environmental engineering, health/wellness, team building, training, and education. As illustrated in Figure 1, PI is a systematic process that considers the institutional context, identifies gaps between actual and desired performance, determines root causes, chooses one or more solutions aimed at closing the gap, and measures the change in perfor- mance. The performance needs assessment identifies current performance or competence, comparing the 5 U.S. industrial models of performance factors differ from these and include categories such as Capacity , which refers to individual capability and aptitude for the job, as well as selection of the right person for the job, and Incentives , which encompasses adequate pay and non-pay incentives made contingent upon performance, clear consequences for performance, and absence of disincentives, such as rewarding poor performance or negatively rewarding good performance. Figure 1 The Performance Improvement Process Define Desired Performance Describe Actual Performance Monitor and Evaluate Performance Get and Maintain Stakeholder Agreement Consider Institutional Context Mission Goals Strategies and Culture Client and Community Perspectives GAP Select Interventions What can be done to fix the cause of the gap? Find Root Cause(s) Why does the gap exist? Implement Interventions QA Brief 9 desired state to the actual state, and seeks the root cause of poor performance. PI practitioners also identify the need for future train- ing when new tasks, equipment, or techniques are introduced, anticipating future performance deficien- cies as the worker 9s job changes. Root-cause analysis ensures that the interventions recommended are based on data and are what is really needed. Often a combi- nation of multiple interventions is implemented as part of a comprehensive solution. While PI 9s focus may range from the micro level (individual perform- ers) to the macro level (the organization), its roots and close alignment to human resources, training, and organizational development may influence its practi- tioners to favor certain types of interventions. QA/QI The Quality Assurance Project illustrates QA activi- ties as three points on a QA triangle (see Figure 2). The points are: defining quality (QD), measuring quality (QM), and improving quality (QI). QD means developing statements regarding the input, process, and outcome standards that the healthcare delivery system must meet in order for its patients to achieve optimum health gains. Such statements are used to define expected quality in all aspects of healthcare. QM consists of quantifying the current level of com- pliance with standards. QI involves using appropriate methodologies to close the gap between the current and expected levels of quality; it uses quality manage- ment tools and principles to understand and address system deficiencies. Approaches to conducting QI activities are numerous and lie along a continuum from simple to complex. Four basic approaches are: (a) individual problem solving, (b) rapid team problem solving, (c) system- atic team problem solving, and (d) process improve- ment. (These four approaches are explained in cAdvances in Quality Improvement: Principles and Framework d on page 13). The PI approach is most similar to the third, systematic team problem solving (see Figure 1). QI activities are conducted using variations on a four- step method: (a) identify (determine what to improve), (b) analyze (understand the problem), (c) develop hypotheses (determine what change[s] will improve the problem), and (d) test and implement, or Plan, Do, Study Act (PDSA). In the fourth step, the solution is tested to see whether it yields an improvement; the results are then used to decide whether to implement, modify, or abandon the proposed solution. If the tested solution does not achieve desired results, the process cycles back to the third step for reiteration. If the results are achieved, the solution is implemented on a larger scale and monitored over time for continu- ous improvement. Figure 2 The Quality Assurance Triangle © Improving Quality Measuring Quality Defining quality means developing statements regarding the inputs, process, and outcomes standards that the healthcare delivery system must meet in order for its population to achieve optimum health gains. Measuring quality consists of quantifying the current level of compliance with expected standards. Improving quality requires engaging in appropriate methodologies to close the gap between current and expected level of quality. It uses quality management tools and principles to understand and address systems deficiencies and improve or re-design efficient and effective healthcare processes. Defining Quality Quality Assurance 10 QA Brief QI does not end with step four; it is an ongoing pro- cess. In fact, QI is generally considered in the context of QA, itself an ongoing process. QI vs. PI Although both QI and PI take a systems view, a noticeable difference between them is that PI places more emphasis upon human performance while QI focuses on processes. Both assert the need for data. The QA Project recommends a flexible stance in deciding how to perform the analysis step, i.e., whether to conduct a root-cause analysis, whereas PI holds firmly that root-cause analysis should be per- formed. When root-cause analysis is conducted in QI, hypotheses are produced using a variety of techniques, such as generating possible causes and organizing them on a fishbone (Ishikawa) diagram, or using the Tree Diagram technique ( cFive Why 9s d), narrowing down the most likely causes, and developing simple data collection tools to verify which one is the actual root cause. Descrip- tions of root-cause analysis in PI often exclude the verification step. The QA Project advocates not performing root-cause analysis when the cause is obvious (this usually applies when the individual ap- proach is used), or when the problem solvers are suffi- ciently knowledgeable about the process to make educated guesses as to the cause (often used by teams using the rapid or process improvement approach). These approaches yield a quicker result, but require a level of QI expertise to know when they should be applied. Rapid approaches employ solutions from a list of known change strategies that have a history of results in reducing errors and rework. Another significant difference between PI and QI is that PI is usually led by a specialized practitioner, while QA and QI have always been intended to be managed by the health program staff itself. This approach supports the institutionalization of quality in many of the countries where the QA Project works and is exemplified in the autonomous and continuous character of QI teams, which are central to the sustainability of QI. QI teams are usually self-directed groups of facility-based health workers. The teams are developed and supported by coaches who provide them with both formal and just-in-time training in QI 4the process, tools, and techniques 4 and on team process matters such as: the functions and roles of team members; communication skills (e.g., active listening, giving and receiving feedback); decision making; planning, conducting, and docu- menting team meetings; and presenting team results to managers. Teams use the QI process to decide what they want to improve, and are thus empowered to improve their work conditions and outcomes, often making systemic transformations to their work environment. This contrasts with PI, which does not emphasize the use of teams. QI team members are selected for their expert knowledge of the process being improved or other special skills. This combination of knowledge and skills gives the team the expertise that enables them to deal with complex systems and processes. Often a QI team is wholly responsible for the process they are improving (process improvement teams). Such teams can con- tinually seek opportunities for improvement, and design, test, and implement solutions without requir- ing higher authority to initiate the effort. On the other hand, PI is often initiated at a client 9s request and directed by a PI practitioner. While teams are formed to design and implement interventions, Rapid approaches employ solutions from a list of known change strategies that have a history of results in reducing errors and rework. QA Brief 11 there is less indication that, after the original perfor- mance problem is improved, self-directed facility- level teams continue to initiate PI activities independently as part of their regular way of doing business. However, many CAs are now conducting PI training to develop the capacity of field staff and host country counterparts to use PI independently of headquarters. Because of its roots in human resources (HR) and training, PI is more inclined than QI to consider HR-related causes and solutions, for example, clear job expectations, performance feedback, motivation, and incentives. And QI is more predis- posed toward looking at processes and systems, a focus that generates a broader array of interven- tions. One example of such complex interventions is an accreditation system that may incorporate both internal and external monitoring and improvement. Another is the systematic monitoring of Health Management Information Systems (HMIS) data to generate opportunities for continuous QI. However, there is increasing evidence of common ground between QI and PI: QA/QI is developing and testing so-called cHR d-type interventions, such as supervisory feedback and health worker motivation, while PI is identifying systemic causes such as lack of systematic monitoring and evaluation. Many system-wide intervention mechanisms (e.g., licensure, accreditation, regulation, and certification) that are tailored to healthcare and employed by QI have not yet been adopted in the current practice of PI. 6 Accreditation can take any of several forms: focused accreditation (focused on a single service) and facilitated accreditation with self-appraisal are two such complex interventions that improve quality in an organized way. Another solution that can arise from QI is Quality Design, which employs a well- developed methodology to create new services or processes. QI is only one methodology in the larger QA system, and as such, it is not the sole entry point for improv- ing the performance of a healthcare system. One can just as easily begin with QD or QM. In fact, there are many entry points by which quality can be intro- duced into a healthcare system. It is a function of QA 9s maturity, and the great needs of healthcare systems in developing countries, that the interven- tions mentioned in this article can be implemented and achieve results without necessarily going through the QI process. Both QA/QI and PI emphasize standards, but the former is more systematic and comprehensive. In QA/QI, standards are classified into two domains: technical (clinical, based on evidence-based medicine) and administrative. In each domain, there exist model standards for inputs (e.g., staff, equipment, supplies), processes (e.g., patient care, admission, housekeep- ing), and outcomes (the results of the inputs and processes: e.g., delivery of a baby, health gain of a patient, mother appropriately following a health provider 9s guidance for the care of her child). QA recognizes that standards must be in place and met for these inputs, processes, and outcomes in order to maximize the potential for desired health outcomes. QA recognizes that standards must be in place and met for these inputs, processes, and outcomes in order to maximize the potential for desired health outcomes. 6 This statement excludes Joint Commission Resources, Inc. (JCR), an internationally focused subsidiary of the US-based Joint Commission on Accreditation of Healthcare Organizations (JCAHO), and JCAHO, who use the term cPerformance Improvement d slightly differently from the PICG. For more information on JCR, see their website at <www.jcrinc.com>. 12 QA Brief In PI, the term cstandards d is most often applied to worker performance expectations, namely job descrip- tions or specifications although, as mentioned above, clinical guidelines are a well recognized performance factor and solution in PI. However, PI uses terminol- ogy for performance factors (e.g., cenvironment d) that include elements QI would call cinput standards. d The different terminology can cause confusion. QI and PI may both recognize the same deficiencies, but while one sees the lack of a standard, the other sees a lack of an environmental support mechanism. In this case, the two perspectives may lead to the same conclusion, but QI/QA 9s more comprehensive and systematic process for developing, communicating, and implementing standards around those or similar factors appears more likely to achieve success, and successes are sustained longer if staff retain, refer to, and follow standards. Summary Both QI and PI use a systems approach and are data- based. They also share some tools and techniques. Because proponents of each approach who work in the international arena may not be well versed in both, they don 9t always recognize how much they have in common. However, each has developed unique approaches, along with deep knowledge in specialty areas that the other, in the spirit of continuous improvement, would do well to embrace. Many thanks to the individuals who graciously agreed to review and give comments on this article: Jim Heiby, Diana Silimperi, Jolee Reinke, Joanne Ashton, Lynne Miller Franco, Rick Sullivan, and Jim Griffin, and especially our editor, Beth Goodrich. I thank you for your useful suggestions; any errors are solely my own. For example, PI practitioners could draw on QI 9s use of faster approaches and expand its use of interven- tions to include already developed methodologies such as QD, etc. QI could benefit from formalizing the stakeholder process and placing a greater impor- tance on human performance support systems such as capacity and selection, individual job descriptions, motivation, and incentives. As CAs better define the commonalities and improve our understanding of these two approaches to achieving improvements, we will be better equipped to draw on the strengths of both. USAID has made a significant contribution by bringing both of these approaches to the table, and the clients are the ultimate beneficiaries. QA Brief 13 Advances in Quality Improvement: Principles and Framework M. Rashad F. Massoud, MD, MPH Associate QA Project Director, Russia, NIS, Asia, and the Middle East XPERIENCE with implementing quality improvement in different settings has led to a better understanding of how the method- ology can be applied to the healthcare field and to further development of the methodology. Advances include the simplification of the methodology, its further application to a wide range of circumstances, and the integration of evidence-based medicine in clinical quality improvement efforts. This article outlines the key principles and framework of quality improvement. They comprise the funda- mental principle of improvement, the four principles of quality management (i.e., Focus on the Client, Understanding Work as Systems and Processes, Teamwork, and Focus on the Use of Data), and the framework for clinical quality improvement. The article also describes the four-step quality improve- ment methodology (i.e., Identify, Analyze, Develop, and Test/Implement). Lastly, it illustrates the applica- tion of this methodology to a spectrum of quality improvement approaches. Four points along this spectrum have been chosen to illustrate a range of approaches (e.g., individual problem solving, rapid team problem solving, systematic team problem solving, and process improvement) that can utilize the quality improvement methodology. Key Principles and Framework The Fundamental Principle of Improvement The central idea underlying modern quality improve- ment is captured in the words of D. M. Berwick: cEvery system is perfectly designed to achieve exactly the results that it achieves. d The level of performance (results) is a characteristic of any given system of E work. A system left unchanged can only be expected to continue to achieve the same results it has been achieving. To achieve a different level of performance, it is essential to change the system in ways that enable it to achieve a different level of performance. QI methodology identifies unnecessary, redundant, or incorrect parts of processes, and then changes processes in ways believed to yield improvements. However, because not every change is necessarily an improvement, a change must be tested and studied to determine whether it has actually resulted in improvement. The Principles of Quality Management There are four main principles of quality improvement. Focus on the client. Services should be designed to meet the needs and expectations of clients and com- munity. An important measure of quality is the extent to which customer needs and expectations are met. Understanding work as systems and processes. Providers need to understand the service system and its key processes in order to improve them. Using tools of process engineering allows simple visual images of these processes and systems. Teamwork. Because work is accomplished through processes and systems in which different people fulfill different functions, it is essential to involve in the improvement representatives of the people who fulfill these functions. This brings their insights to the under- standing of changes that need to be made and to the effective implementation of the appropriate processes, as well as to the development of ownership of the improved processes and systems. 14 QA Brief Focus on the use of data. Data are needed to analyze processes, identify problems, and measure perfor- mance. Changes can then be tested and the resulting data analyzed to verify that the changes have actually led to improvements. The Framework for Improving Clinical Quality Improvement looks at two major components: what is done (content) and how it is done (process of care). Either component could lead to improvement, but the most powerful impact occurs by addressing both simultaneously. A key advancement in the use of this framework has been to develop norms, standards, protocols, and guidelines based on clinical evidence. In so doing, the literature on clinical practices is reviewed and the content developed based on the highest levels of evidence available. Where evidence for practices is weak or inconclusive, this is also acknowledged. This concept 1 is illustrated in Figure 1. Quality Improvement Methodology Quality improvement methodology consists of four key steps, as shown in Table 1. Step One: Identify The goal of the first step, identify, is to determine what to improve. This may involve a problem that needs a solution, an opportunity for improvement that requires definition, or a process or system that needs to be improved. Examples of problems or processes that are commonly identified include unavailability of drugs, lost laboratory reports, and waiting time. This first step involves recognizing an opportunity for improvement and then setting a goal to improve it. Quality improvement starts by asking these questions: s What is the problem? s How do you know that it is a problem? s How frequently does it occur, or how long has it existed? s What are the effects of this problem? s How will we know when it is resolved? Step Two: Analyze Once we have identified areas for quality improve- ment, the second step is to analyze what we need to know or understand about this opportunity for improvement before considering changes. The objec- tives of the analysis stage can be any combination of the following: s Clarifying why the process or system produces the effect that we aim to change s Measuring the performance of the process or system that produces the effect s Formulating research questions, such as the following: s Who is involved or affected? s Where does the problem occur? s When does the problem occur? s What happens when the problem occurs? s Why does the problem occur? 1 Adapted from P.B. Batalden and P.K. Stoltz. 1993. A framework for the continual improvement of healthcare: Building and applyin g professional and improvement knowledge to test changes in daily work. The Joint Commission Journal, 424 352. Table 1 Key Steps of Quality Improvement Identify Determine what to improve. Analyze Understand the problem. Develop Hypothesize what changes will improve the problem. Test/ Test the hypothesized solution to see if it Implement yields improvement. Based on the results, decide whether to abandon, modify, or implement the solution. QA Brief 15 s Learning about internal and external clients through the tools available To reach these objectives, this step requires the use of existing data or data collection. The extent to which data are used depends on the quality improvement approach chosen. A few techniques to analyze problems include: s Clarifying processes through flowcharts or cause-and-effect analyses s Reviewing existing data s Collecting additional data Step Three: Develop The third step, develop , uses the information accumu- lated from the previous steps to explore what changes would yield improvement. Hypotheses, tenative assumptions used to test consequences, are formulated about which changes, interventions, or solutions would reduce the problem and thus improve the qual- ity of care. Hypotheses are based on people 9s knowl- edge and belief about the likely causes and solutions of the problem. It is crucial to remember that at this point the hypothesis remains a theory, as it has not yet been tested. Step Four: Test and Implement This step, test/implement, builds on the first three. A hypothesis is tested to see if the proposed intervention or solution yields the expected improvement. Because interventions that prove to be effective may not yield immediate results, allowing time for change to occur is important in the testing process. The results of this test determine the next step (Table 2). Figure 1 How QI Integrates Content of Care and the Process of Providing Care Output/Outcome: Improved quality of care and health status (e.g., standards developed and applied) Process of Care: How it is done s Quality improvement approaches s Cycle of learning and improvement Content of Care: What is done s Norms s Standards s Protocols s Guidelines Table 2 Test Results Determine Next Step Test ResultNext Step Proposed change didStart the improvement not produce anprocess again or look for flaws improvementin the proposed change Proposed change yieldsModify the proposed change improvement that is notand then re-test the completely satisfactorymodification Proposed change yieldsBegin the implementation of satisfactory improvementthe change or intervention 16 QA Brief Testing a Hypothesis The scientific method generally involves plan- ning a test, conducting the test, and studying the results. Quality management has adapted this method, expanding it by adding cact on what is learned. d Thus, the expanded method includes plan, do, study, and act (PDSA), also referred to as Shewhart 9s Cycle for Learning and Improve- ment. 2 PDSA is a four- step process included in the testing and implementa- tion stage of every QI method. The PDSA cycle is represented in Figure 2. The Spectrum of QI Approaches Many approaches to quality improvement exist; deciding on which one to use depends on the circum- stances. Some problems are simple and can be resolved rapidly, while others involve core processes and require extensive research. The approaches can be visualized along a continuum of complexity of increased time, resource allocation, and group partici- pation. Along this continuum, the QA Project has identified four points that represent four approaches to quality improvement. They are not the only points along the continuum of complexity, but they do illus- trate how quality improvement approaches differ. Individual problem solving occurs when an individual identifies an apparent problem, recognizes his or her ability to fix it, and feels empowered to make 2 W. Shewhart. 1934. The Economic Control of Quality of Manufactured Products. New York: D. Van Nostrand. (Reprinted by the American Society of Quality Control, 1980). Figure 2 The Plan, Do, Study, Act Cycle 4. Act s Modify/abandon plan s Or, implement a successful plan s Develop on-going monitoring and consider implementing the change throughout the system (as opposed to testing the change on a small scale) 3. Study s Verify the effects of the change s Check results 2. Do s Test the change s Document the results of the change s Continue to monitor the data 1. Plan s Make a plan for the change s Collect baseline data s Communicate the test of the change necessary changes. Although teamwork is an essen- tial part of quality improvement, the QA Project has learned from experience that the simpler or more urgent improvement needs do not necessitate lengthy team-based approaches. The hallmark of individual problem solving is its use to address problems that are not interdependent, meaning that one person can make and implement the decisions necessary to address a problem. Individual problem solving tends to require little time or data and is methodologically the least complex of the approaches. It is seen in organizations where each individual recognizes the overall goal of delivering quality care and acts accordingly when needs arise that he or she can personally address. QA Brief 17 Rapid team problem solving is an approach in which a series of small incremental changes are tested in a system for improvements in quality. This approach can be used in any setting, although it generally requires that a team has some experience in problem solving and/or seeks a mentor for help in managing this approach quickly. This approach is less rigorous in terms of time and resources required because it relies largely on existing data and the team 9s under- standing of the cause(s) of the problem and likely solutions. Teams are ad hoc and disband once the desired level of improvement has been achieved. Systematic team problem solving is often used for complex or recurring problems that require detailed analysis. The mainstay of this approach is a detailed study of the causes of problems and then the develop- ment of appropriate solutions. This detailed analysis often involves data collection, and therefore often requires more time and resources. Although system- atic team problem solving can be used in any setting, its in-depth nature makes it most appropriate when the ad hoc team is able to work together over a period of time. Process improvement is the most complex of the four approaches because it involves a permanent team that continually collects, monitors, and analyzes data to improve a key process over time. It is generally used in organizations where permanent resources are allo- cated to quality improvement. This permanent team can use more than one approach, for example, form- ing ad hoc teams to solve specific problems. Process Individual Problem Solving Figure 3 Spectrum of Approaches to Quality Improvement Rapid Team Problem Solving Systematic Team Problem Solving Process Improvement Complexity improvement is often used to assure the quality of important services in a health facility or organization. In sum, experience with quality improvement has rendered it a simpler, more robust methodology, and the application of QI methodology to a wide range of settings has become clearer. The settings include both clinical and nonclinical environments, with the approaches ranging from individual problem solving to core-process improvement by permanent teams. In all of these approaches, the methodology and principles remain unchanged though their different aspects are stressed differently. 18 QA Brief COPE: A Process and Tools for Healthcare Erin Mielke, MPH, Program Manager for Quality Improvement, EngenderHealth Karen Beattie, MA, Senior Director, EngenderHealth OPE is both a process and set of tools designed to help healthcare staff at a service delivery site continuously assess and improve the quality of their services. 1 COPE, which stands for cclient-oriented, provider-efficient services d is built on a framework of client rights and staff needs adapted from Huezo and Diaz. 2 COPE 9s four tools are: (a) self-assessment guides (one for each client rights or staff need), (b) a client interview guide, (c) a client-flow analysis, and (d) an action plan. The self-assessment guides encourage staff to review the way they perform their daily tasks and serve as a cata- lyst for analyzing the problems they identify. The guides contain key questions based on international clinical and service standards. The guide on safety includes a medical record review. The tools also highlight client-provider interactions and other client concerns. The COPE Process When introducing COPE, all site staff (or representa- tives of all departments at large sites) describe the key elements of quality services that they would like to receive if they were a patient at the facility. As part of this exercise, the staff reviews the concept of client rights and provider needs. Clients have a right to: s Information s Access s Informed choice C s Safe services s Privacy and confidentiality s Dignity, comfort, and expression of opinion s Continuity of care Staff need: s Facilitative supervision and management s Information, training, and development s Supplies, equipment, and infrastructure Next, working in teams, the staff uses two main tools for identifying problems: the self-assessment guides and the client interviews. Teams analyze the root causes of the problems, asking cWhy? d multiple times. All staff meet together to develop an action plan to resolve the problems identified. Then the site establishes a quality improvement committee to oversee the implementation of the action plan and organize future COPE exercises. Subsequent exercises generally take place every three to four months. In these exercises, the staff reviews the status of the previous action plan and continues to identify new problems through various COPE tools (client-flow analysis, modules for maternal care, child health services, etc.). Why Use COPE? The health staff members, who are held accountable for the quality of services provided, have few tools to help them gauge their performance or identify factors that affect their ability to provide client-centered 1 AVSC International. 1995. COPE: Client-oriented, provider-efficient services. New York: AVSC International. 2 C. Huezo and S. Diaz. 1993. Quality of care in family planning: Clients 9 rights and providers 9 needs. Advances in Contraception. 9:129 339. QA Brief 19 services. Many find COPE user-friendly. Simple and practical, it creates ownership of the quality improve- ment process by involving all levels of staff. It helps staff to put standards and guidelines into practice, as well as to identify where they are unclear about the standards and guidelines. COPE builds teamwork and provides a forum for staff to interact. It is adaptable and transferable 4it has been used in more than 35 countries and translated into 14 languages. Self-assessment guides have been adapted for family planning, reproductive health, maternity care, child health, and post-abortion care. COPE is cost-effective because it relies on local experts 4the staff itself 4 to identify and resolve problems related to the quality of services. It promotes initiative and innovation, encouraging staff to consider the best possible use of existing resources. It is empowering, providing staff with the tools and opportunity to take concrete action to improve the quality of their work, their compe- tency, and their interactions with clients. In the words of a clinic cleaner, cNo one ever asked me before what I thought about services, and I do have ideas. d 3 Similarly, one hospital supervisor said, cI did not know that I could ask for the suggestions of junior staff. Now we work as a team. d Why Use Self-Assessment? Healthcare staff want to perform their jobs well. COPE is based on the value of self-assessment to help staff do just that. Some argue that, compared to exter- nal assessment, self-assessment lacks objectivity and validity and is not based on standards. COPE is not intended to replace periodic, external, objective assessments. Rather, the process can complement and enhance medical monitoring, supervision, and evalua- tion activities by internal and external supervisors. It is an ongoing process that integrates routine self- evaluation into service delivery. COPE tools guide staff members 9 assessment of their service delivery practices through specific, closed (yes/no) questions that are based on international standards. Staff then interpret the results of their own discussions, as well as the client interviews and client- flow analysis, and apply their understanding of their working environment to propose solutions that make sense given their resources and setting. Staff and supervisors have an incentive to be honest about problems because they generally benefit from the solutions. The staff responds more positively to self- assessment than they do to inspection and feel greater ownership of the QI process. As a result, they are bet- ter prepared to collaborate with internal and external supervisors in a more objective evaluation of their work. Some Results to Date Through COPE, hundreds of sites have solved a variety of problems. Some typical examples follow. s Changes in service hours and staff assignments to better meet client needs s Reductions in client waiting time for services through reorganization of staff time s Improved client-provider interaction and counseling following counseling training and periodic technical updates s Improved infection-prevention practices throughout a facility, including such solutions as providing decontamination supplies to all wards and departments s Digging a well to provide a reliable water supply to a site 3 J. Bradley. 1998. Using COPE to improve quality of care: The experience of the Family Planning Association of Kenya. Quality/Calidad/Qualité, No. 9, New York: Population Council. 20 QA Brief s Repairing more than 200 beds in one hospital using local resources s Improved understanding by site managers and providers of user fees introduced as part of health sector reform In a study of 11 clinics in four African countries, 109 problems were identified: 59 percent were solved. Of the problems that could be solved without outside help, 73 percent were solved. 4 COPE Is Not a Magic Bullet COPE alone cannot sustain the QI process at a site. It is only one of a package of approaches. Facilitative supervision , for example, emphasizes coaching, joint problem solving, and two-way communication between the supervisor and those being supervised. Whole-site training evolved to meet the learning needs of all levels of staff at a site through skills train- ing, updates, and orientations. It emphasizes training at the site level and the link between supervision and training. Inreach increases the integration of services and reduces missed opportunities to serve clients by providing information about the facility 9s services to staff, clients, and potential clients in all departments of the facility; improving linkages and referrals between departments; posting signs about services throughout the facility; and orienting staff from other departments about reproductive health services. Newest COPE Modules The original COPE handbook focuses on standards of care for family planning services. Over time, our partners have requested that we adapt the tools for other health services. As a result EngenderHealth has published a working draft of the reproductive health COPE guides addressing twelve specific reproductive health services/issues 5 and a draft of guides on child health services. 6 Expanding the Reach of COPE EngenderHealth is developing and testing a new process and tools to involve the community in site- level quality improvement. In collaboration with community leaders, staff from a service-delivery site engage the community in a process to assess the qual- ity of services at the site and to determine how the site might better meet client needs. With this information, staffs use the same COPE process to develop an action plan for enhancing areas where they excel and addressing areas where the community has suggested improvement. EngenderHealth, formerly AVSC International, provides technical assistance to reproductive health programs in more than 30 countries. 4 P. Lynam, L. McNeil Rabinovitz, and M. Shobowale. 1993. Using self-assessment to improve the quality of family planning clinic services. Studies in Family Planning 24(4):252 360. 5 AVSC International. 1999. COPE Self-Assessment Guides for Reproductive Health Services, Work in Progress. New York: AVSC International. 6 AVSC International. 1999. COPE for Child Health: A Process and Tools for Improving the Quality of Child Health Services, Draft. New York: AVSC International. QA Brief 21 T Facilitating Accreditation: The South African Experience Stuart Whittaker, Managing Director, The Council for Health Services Accreditation of South Africa HE seven-year-old Council for Health Service Accreditation of Southern Africa (COHSASA) is a not-for-profit company that has been working in more than 230 health facilities (public and private sector hospitals and clinics) on the subconti- nent. It recently developed a facilitated accreditation program to assist hospitals in meeting accreditation standards and thus expedite the introduction of an accreditation system in some provinces. The evolution and development of the facilitated ac- creditation program (FAP) was undertaken as a result of the difficulty that healthcare facilities experienced in attempting to meet the standards set by medical, nursing, and other healthcare professional representa- tive associations. The standards define systems and processes designed to help healthcare services and departments within healthcare facilities provide quality care in a safe, legal, effective, and efficient environment. The first step in assisting hospitals to meet the stan- dards was to devise a process to record, measure, and report on the degree to which a facility meets the stan- dards based on the findings of surveyors. A decision was made to develop an instrument that could provide both qualitative and quantitative information. A com- puterized information system was developed to score the standards based on the degree of compliance, and scores were weighted according to the impact of any improvement on patient care and/or the operation of the facility. In addition to providing a scoring system, the information system also captured and processed the reasons for non-conformance to the standards and criteria. This made it possible to produce reports assessing the degree of compliance of all services (clinical, support, and management services), and to list reasons for non-compliance categorized in terms of the seriousness of non-compliance and how urgently it needed to be addressed. The data and information generated in these processes were found to be of fundamental and far-reaching value not only in the standard assessment process, but also in the management of a facility. The reports, for example, could be used to identify deficiencies and to monitor interventions that addressed problem areas at facility, district, regional, and national levels. COHSASA 9s Facilitated Accreditation Program is based on the premise that healthcare facilities should perform as integrated, multi-system environments in which all services and departments are, to a lesser or greater degree, interlinked and inte

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