Macroergonomics in Quality of Care and Patient Safety

Transcription

1 Human Factors in Organizational Design and Management VII 21 H. Luczak and K. J. Zink (Editors) 2003 All rights reserved. Macroergonomics in Quality of Care and Patient Safety Pascale CARAYON Systems Engineering Initiative for Patient Safety (SEIPS) Center for Quality and Productivity Improvement & Department of Industrial Engineering; University of Wisconsin-Madison; Madison, WI USA Abstract. Healthcare institutions can benefit from the models and methods of macroergonomics in order to improve the quality and safety of care provided. Keywords. Macroergonomics, Healthcare, Quality of Care, Patient Safety, Technology, System Design. 1. Introduction Healthcare issues of importance vary from one country to the other, such as access to healthcare, availability of healthcare professionals and healthcare facilities, access to medication, etc All over the world, many countries are faced with issues of healthcare cost, as well as the quality and safety of care provided. Much discussion on the quality and safety of care has occurred in Australia (McNeil & Leeder, 1995) and the UK (UK Department of Health, 2002). The US spends a large amount of its GDP on health care. In 2000, healthcare expenditures represented more than 13% of the GDP (Agency for Healthcare Research and Quality, 2002a). In the US, the 1999 publication of a report by the Institute of Medicine has raised the level of awareness regarding medical errors and patient safety (Kohn, Corrigan, & Donaldson, 1999). Discussion has occurred regarding the number of medical errors in the American healthcare system and elsewhere. However, most agree that changes need to occur to improve the quality and safety of care (Institute of Medicine Committee on Quality of Health Care in America, 2001). This paper argues that healthcare institutions can benefit from the models and methods of macroergonomics in order to improve the quality and safety of care provided. 2. Quality of Care and Patient Safety The extent to which healthcare systems provide high-quality, safe care has been much debated. A 2000 report published by the UK Department of Health provides some data

2 22 on the extent to which the English healthcare system fails to provide high-quality, safe care (UK Department of Health, 2002). About 400 people die or are seriously injured in adverse events involving medical devices. About 10,000 people report having experienced serious adverse reactions to drugs. The UK National Health Service pays around 400 million a year for settlement of clinical negligence claims. Data for the US indicates that Preventable adverse events are a leading cause of death in the United States (Kohn et al., 1999). It has been suggested that at least 44,000 and perhaps as many as 98,000 Americans die in hospitals each year as a result of medical errors. Much debate has occurred around the validity of those numbers (Leape, 2000). However, healthcare experts and practitioners agree as to the necessity to redesign healthcare systems to improve the quality and safety of care. Quality of care has been conceptualized and assessed in a variety of manners. First, the performance of a healthcare practitioner can be evaluated on two dimensions: (1) technical performance that depends on the knowledge and judgment used to arrive at the diagnostic and strategy of care and the skills in implementing the strategy; and (2) interpersonal performance that emphasizes the relationship between the practitioner and the patient (Donabedian, 1988). Second, the quality of care can be assessed at various levels: care provided by a practitioner (e.g., physician, nurse) to an individual patient, care provided by a healthcare institution (e.g., hospital, nursing home), care provided by a health plan, care received by community, etc (Brook, McGlynn, & Cleary, 1996; Donabedian, 1988). Third, quality of care can be evaluated on the basis of structure, process, or outcome (Donabedian, 1988). According to Donabedian (1988), structure relates to the attributes of the settings in which care occurs and includes material resources, human resources and organizational structure. Process is defined as what is actually done in giving and receiving care, and outcome relates to the effects of care on the health status of patients and populations. Debate is on-going as to whether structural, process or outcome measures of quality should be emphasized (Brook et al., 1996; Clancy & Eisenberg, 1998). Fourth, quality of care problems have been categorized into misuse (i.e. occurs when an appropriate service has been selected but a preventable complication occurs and the patient does not receive the full potential benefit of the service ), overuse (i.e. occurs when a health care service is provided under circumstances in which its potential for harm exceeds the potential benefit ), and underuse (i.e. failure to provide a health care service when it would have produced a favorable outcome for a patient ) (Chassin, Galvin, & The National Roundtable on Health Care Quality, 1998). According to the 1999 IOM report (Kohn et al., 1999), issues of overuse and underuse should be addressed by changing healthcare practices and achieving practices consistent with current medical knowledge; and issues of misuse fit the patient safety concerns. However, overuse and underuse can also be related to patient safety, such as too much care provided that put patient safety at risk or too little use of appropriate care that may decrease unnecessary complications (Wakefield, 2001). According to AHRQ the goal of patient safety is to reduce the risk of injury and harm from preventable medical errors, and according to the IOM patient safety is freedom from accidental injury (Institute of Medicine Committee on Quality of Health Care in America, 2001). Patient safety can be considered as one piece of the quality of health care puzzle (Institute of Medicine Committee on Quality of Health Care in America, 2001; Kohn et al., 1999; Wakefield, 2001). The different approaches to quality of care and patient safety emphasize the characteristics of the system (or structure) in which care processes occur and which lead to pa-

3 tient outcomes. Therefore, macroergonomics has an important role to play in helping in the human-centered design of systems and processes in order to achieve both positive individual and organizational outcomes, as well as improved patient outcomes (improved quality and safety of care) (Sainfort, Karsh, Booske, & Smith, 2001) Human Factors in Healthcare Recently, much emphasis has been put on human factors approaches to patient safety (Bogner, 1994; Cook, Woods, & Miller, 1998; Leape, 1994; Wears & Perry, 2002). The healthcare field has embraced the various models and approaches to human error in order to analyze and evaluate risk and safety (Reason, 2000; Vincent, Taylor-Adams, & Stanhope, 1998). There is increasing recognition in the human error literature of the different levels of factors that can contribute to human error and accidents (Rasmussen, 2000). If the various factors are aligned appropriately like slices of Swiss cheese, accidents can occur (Reason, 1990). Table 1 summarizes the different approaches to the levels of factors contributing to human error. It is interesting to make a parallel between the different levels of factors contributing to human error and the levels identified to deal with quality and safety of care (Berwick, 2002; Institute of Medicine Committee on Quality of Health Care in America, 2001). The 2001 IOM report on Crossing the Quality Chasm defines four levels at which interventions are needed in order to improve the quality and safety of care in the United States: Level A-experience of patients and communities, Level B-microsystems of care, i.e. the small units of work that actually give the care that the patient experiences, Level C-health care organizations, and Level D-health care environment. These levels are similar to the hierarchy of levels of factors contributing to human error (see Table 1). Models and methods of macroergonomics can be particularly useful because of their underlying system approach and capacity to integrate variables at various levels (Hendrick, 1991; Luczak, 1997; Zink, 2000). Human error models and approaches provide much information on how to understand, analyze and evaluate near misses and accidents (Shojania, Wald, & Gross, 2002). However, there is another large body of literature in human factors that has been relatively ignored in the discussion on quality of care and patient safety. This body of literature (macroergonomics) provides much information on how to design and improve work systems (Hendrick, 1997; Hendrick & Kleiner, 2001). Hendrick (1997) has defined a number of levels of human factors or ergonomics: human-machine: hardware ergonomics human-environment: environmental ergonomics human-software: cognitive ergonomics human-job: work design ergonomics human-organization: macroergonomics. Research at the first three levels has been performed in the context of quality of care and patient safety. Much still needs to be done at the levels of work design and at the macroergonomic level in order to design healthcare systems that produce high-quality safe patient care.

4 24 Table 1. Levels of Factors Contributing to Human Error. AUTHORS FACTORS CONTRIBUTING TO HUMAN ERROR Rasmussen (2000): levels of a Work complex socio-technical system Staff Management Company Regulators/associations Government Moray (1994): hierarchical systems approach that includes sev- Physical ergonomics Physical device eral layers Individual behavior Team and group behavior Organizational and management behavior Legal and regulatory rules Societal and cultural pressures Johnson (2002): four levels of Level 1 factors that influence the behavior of individual causal factors that can contribute clinicians (e.g., poor equipment design, poor ergonomics, to human error in healthcare technical complexity, multiple competing tasks) Level 2 factors that affect team-based performance (e.g., problems of coordination and communication, acceptance of inappropriate norms, operation of different procedures for the same tasks) Level 3 factors that relate to the management of healthcare applications (e.g., poor safety culture, inadequate resource allocation, inadequate staffing, inadequate risk assessment and clinical audit) Level 4 factors that involve regulatory and government organizations (e.g., lack of national structures to support clinical information exchange and risk management). For comparison, levels of factors contribution to quality and safety of patient care (Berwick, 2002; Institute of Level A experience of patients and communities Medicine Committee on Quality Level B microsystems of care, i.e. the small units of of Health Care in America, 2001) work that actually give the care that the patient experiences Level C health care organizations Level D health care environment 4. Technology in Healthcare In healthcare, technologies are often seen as an important solution to improve quality of care and reduce or eliminate medical errors (Bates & Gawande, 2003; Kohn et al., 1999). These technologies include organizational and work technologies aimed at improving the efficiency and effectiveness of information and communication processes (e.g., computerized order entry provider systems and electronic medical record systems) and patient care technologies that are directly involved in the care processes (e.g., bar code technology for medication administration). For instance, the 1999 IOM report recommended adoption of new technology, like bar code administration technology, to reduce medication errors (Kohn et al., 1999). However, implementation of new technologies in health care has not been without troubles or work-arounds (see, for example, the study of Patterson and colleagues (2002) on the side effects of bar code medication ad-

5 ministration technology). Technologies can change the way work is being performed and because healthcare work and processes are complex, negative consequences of new technologies are possible (Cook, 2002). When looking for solutions to improve patient safety, technology may or may not be the only solution. For instance, a study of the implementation of nursing information computer systems in 17 New Jersey hospitals showed many problems experienced by hospitals, such as delays, and lack of software customization (Hendrickson, Kovner, Knickman, & Finkler, 1995). On the other hand, at least initially, nursing staff reported positive perceptions, in particular with regard to documentation (more readable, complete and timely). However, a more scientific quantitative evaluation of the quality of nursing documentation following the implementation of bedside terminals did not confirm those initial impressions (Marr et al., 1993). This later result was due to the low use of bedside terminals by the nurses. This technology implementation may have ignored the impact of the technology on the tasks performed by the nurses. Nurses may have needed time away from the patient s bedside in order to organize their thoughts and collaborate with colleagues (Marr et al., 1993). This study demonstrates the need for a macroergonomic approach to understand the impact of technology. For instance, instead of using the leftover approach to function and task allocation, a human-centered approach to function and task allocation should be used (Hendrick & Kleiner, 2001). This approach considers the simultaneous design of the technology and the work system in order to achieve a balanced work system. One possible outcome of this allocation approach would be to rely on human and organizational characteristics that can foster safety (e.g., autonomy provided at the source of the variance; human capacity for error recovery), instead of completely trusting the technology to achieve high quality and safety of care. Whenever implementing a technology, one should examine the potential positive AND negative influences of the technology on the other work system elements (Battles & Keyes, 2002; Kovner, Hendrickson, Knickman, & Finkler, 1993; Smith & Carayon- Sainfort, 1989). In a study of the implementation of an Electronic Medical Record (EMR) system in a small family medicine clinic, a number of issues were examined: impact of the EMR technology on work patterns, employee perceptions related to the EMR technology and its potential/actual effect on work, and the EMR implementation process (Carayon & Smith, 2001). Employee questionnaire data showed the following impact of the EMR technology on work. Increased dependence on computers was found, as well as an increase in quantitative workload and a perceived negative influence on performance occurring at least in part from the introduction of the EMR (Hundt, Carayon, Smith, & Kuruchittham, 2002). It is important to examine for what tasks technology can be useful to provide better, safer care (Hahnel, Friesdorf, Schwilk, Marx, & Blessing, 1992). The human factors characteristics of the new technologies design should also be studied carefully (Battles & Keyes, 2002). An experimental study by Lin et al. (2001) showed the application of human factors engineering principles to the design of the interface of an analgesia device. Results showed that the new interface led to the elimination of drug concentration errors, and to the reduction of other errors. A study by Effken et al. (1997) shows the application of a human factors engineering model, i.e. the ecological approach to interface design, to the design of a haemodynamic monitoring device. Whereas micro-ergonomics has been applied to technology design in healthcare, macroergonomics has not been applied yet. Luczak (1995) proposed a method for con- 25

6 26 sidering macroergonomics early in the phase of system design. This method has been applied to manufacturing production systems. The question remains of how macroergonomic anticipatory design can be performed to create safe healthcare systems. The new technology may also bring its own forms of failure (Battles & Keyes, 2002; Cook, 2002; Reason, 1990). For instance, bar coding technology can prevent patient misidentifications, but the possibility exists that an error during patient registration may be disseminated throughout the information system and may be more difficult to detect and correct than with conventional systems (Wald & Shojania, 2001). In addition, the manner in which a new technology is implemented is as critical to its success as its technological capabilities (see for example Eason (1982), and Smith and Carayon (1995)). End user involvement in the design and implementation of a new technology is a good way to help ensure a successful technological investment. Korunka and his colleagues (Korunka & Carayon, 1999; Korunka, Weiss, & Karetta, 1993; Korunka, Zauchner, & Weiss, 1997) have empirically demonstrated the crucial importance of end user involvement in the implementation of technology to the health and well-being of end users. The implementation of technology in an organization has both positive and negative effects on the job characteristics that ultimately affect individual outcomes (quality of working life, such as job satisfaction and stress; and perceived quality of care delivered or self-rated performance) (Carayon and Haims, 2001). Inadequate planning when introducing a new technology designed to decrease medical errors has led to technology falling short of achieving its patient safety goal (Kaushal & Bates, 2001; Patterson et al., 2002). The most common reason for failure of technology implementations is that the implementation process is treated as a technological problem, and the human and organizational issues are ignored or not recognized (Eason, 1988). When a technology is implemented, several human and organizational issues are important to consider (Carayon-Sainfort, 1992; Smith & Carayon, 1995). More macroergonomic knowledge needs to be applied to the implementation of technologies in healthcare. 5. Macroergonomic Design and Redesign in Healthcare A question raised by ergonomists is how to ensure that ergonomic criteria are considered in the early stage of work system design (Clegg, 1988; Luczak, 1995; Slappendel, 1994). Johnson and Wilson (1988) discuss two approaches for taking into account ergonomics in work system development: (1) provision of guidelines, and (2) ergonomics input within collaborative design. In order to define macroergonomic guidelines, we need to better understand the specific work system elements (and their combinations) that affect the outcomes of quality and safety of health care. We have limited information on this. The other strategy proposed by Johnson and Wilson can be more rapidly implemented. This necessitates the close collaboration of macroergonomists and healthcare professionals at various stages of work system design. Three different stages of work system development can be distinguished (Clegg, 1988): 1. design of work system 2. implementation of work system 3. operation of work system.

7 Phase of Work System Design Ergonomic criteria should be considered as early as possible. Unfortunately, very little research has been conducted to examine how ergonomic criteria are considered in the design of new work systems. Wulff and her colleagues (1999a; 1999b) have conducted a study of the implementation of ergonomics requirements in large-scale engineering projects of the design of off-shore installations. Exploratory case studies in two engineering design companies involved in two different design projects were conducted. Considerable resistance to using ergonomic requirements in their design was observed within the engineering teams. A reason for the resistance appeared to be the lack of familiarity with this new set of requirements in combination with high total workload. A solution to this problem may be to include an active ergonomics resource person in the design organization. When an ergonomist with high legitimacy was actively involved in the design process, ergonomics requirements were more likely to be used. In addition, organizational means can be used to ensure the implementation of ergonomic criteria in the design process. Examples of organizational means include: emphasis on ergonomics in general company policy documents, high organizational status for ergonomics, and active support of senior management. How does this research translate to the design of work systems in healthcare in order to achieve high-quality, safe patient care? This raises issues regarding the availability of human factors expertise within healthcare institutions, as well as the need for resources allocated to ensure that ergonomic criteria are considered as the work system design stage. Clegg (1988) argues that organizations have many choices when they design manufacturing systems. Decisions are made regarding the following factors: the type and level of technology. Different elements can impact decisions regarding the type and level of technology: resources available, expected return on investment, technology push. the allocation of functions between humans and machines. In general, the human aspect is considered late in the design of manufacturing systems, therefore leaving the leftover tasks to people. the roles of humans in the system. Once allocation of function decisions have been made, the various tasks need to be organized into job designs for the future operators of the system. the organizational structures to support workers. Companies who are introducing new manufacturing systems could usefully ask themselves what organizational structures are appropriate. the way in which people participate in their design. The type, extent and timing of worker participation in the design of work systems are all important aspects to consider (Smith & Carayon, 1995). Choices made regarding these different issues have important ergonomic and health implications. Similar choices are made by healthcare organizations when designing work systems and structures, patient care processes, as well as other processes. How do we ensure that designers of healthcare work system and technologies take into account ergonomics, in particular macroergonomics? One example of work system design is the construction of a new health care facility. Health care facility construction, whether a new building or an expansion of an existing medical center, can present a number of challenges and a number of opportunities, not the least of which is improving working conditions, quality of care and patient safety.

8 28 However, a far-sighted health care facility in West Bend, Wisconsin is demonstrating that new construction projects actually present an opportunity to improve working conditions and patient safety. In April 2000, St. Joseph s Community Hospital of West Bend, Wisconsin, a member of SynergyHealth Inc., started focusing on how the design of a new facility could affect patient safety. A participatory learning laboratory developed recommendations that St. Joseph s could apply in the design process (Reiling & Chernos, 2004). St. Joseph s facility design process for patient safety is an interesting case study. However, more needs to be learned about how ergonomics knowledge (including macroergonomics) can be integrated at the stage of healthcare system design. 5.2 Phase of Implementation In the phase of work system implementation, the question arises as to the methods and processes to use in order to facilitate the change process, and rapidly achieve the expected outcomes (i.e. improved quality and safety of care). The way change is implemented (i.e. process implementation) is central to the successful adaptation of organizations to changes. A successful work system implementation from the human factors viewpoint is defined by its human and organizational characteristics: reduced/limited negative impact on people (e.g., stress, dissatisfaction, etc.) and on the organization (delays, costs, medication errors, etc.), and increased positive impact on people (e.g., acceptance of change, job control, enhanced individual performance) and on the organization (e.g., efficient implementation process, safe patient care). Success also includes decreasing medical errors and improving quality of care. Several authors have recognized the importance of the process of implementation in achieving a successful organizational change (Tannenbaum et al., 1996; Korunka et al., 1993). Participatory ergonomics is a powerful method for implementing work system changes (Wilson, 1995). Participation has been used as a key method for implementing various types of organizational changes, such as ergonomic programs (Wilson & Haines, 1997), continuous improvement programs (Zink, 1996) and technological change (Carayon & Karsh, 2000; Eason, 1988). Noro and Imada (1991) define participatory ergonomics as a method in which end-users of ergonomics (workers, nurses) take an active role in the identification and analysis of ergonomic risk factors as well as the design and implementation of ergonomic solutions. Evanoff and his colleagues have conducted studies on participatory ergonomics in health care (Bohr, Evanoff, & Wolf, 1997; Evanoff, Bohr, & Wolf, 1999). One study examined the implementation of participatory ergonomics teams in a medical center. Three groups participated in the study: a group of orderlies from the dispatch department, a group of intensive care unit (ICU) nurses, and a group of laboratory workers. Overall, the team members for the dispatch and the laboratory groups were satisfied with the participatory ergonomics process, and these perceptions seem to improve over time. However, the ICU team members expressed more negative perceptions. The problems encountered by the ICU team seem to be related to the lack of time and the time pressures due to the clinical demands. A more in-depth evaluation of the participatory ergonomics program on orderlies showed substantial improvements in health and safety following the implementation of the participatory ergonomics program (Evanoff et al., 1999). The studies by Evanoff and colleagues demonstrate the feasibility of implementing participatory ergonomics in health care, but highlight the difficulty of the approach in a high-stress, high-pressure environment, such as

9 an intensive care unit, where patient needs are critical and patients need immediate or continuous attention. More research is needed in order to develop macroergonomic methods for implementing work system changes that lead to improvements in human and organizational outcomes, as well as improved quality and safety of care. This research should consider the high-pace, high-pressure work environment of healthcare. The implementation of any new work system always engenders problems and concerns. The process by which these problems and concerns are resolved is important from a human factors point of view, but also from a quality of care and patient safety point of view. It is necessary to have the capability and tools to identify potential human factors, and quality and safety of care problems in a timely manner Operational Phase During the operational phase, the new work system is in place. What are the characteristics of a work system that lead to quality of care and patient safety? Much work is needed to specify the structural component of quality of care. For instance, what working conditions are related to quality of care? Much is known about the working conditions that affect stress, job satisfaction and other human outcomes (Kalimo, Lindstrom, & Smith, 1997; Smith, 1987). However, we need to know more about the working conditions that affect quality and safety of care, and more importantly how to improve working conditions in order to improve both human outcomes (e.g., reduced stress, increased job satisfaction and reduced injuries) and patient outcomes. Some of the patient safety research funded by the American Agency for Healthcare Research and Quality (AHRQ) addresses this issue (Agency for Healthcare Research and Quality, 2002b). Workload is one working condition of particular importance in healthcare quality and safety. For instance, Tarnow-Mordi et al. (2000) examined the relationship between mortality rates and the workload of hospital staff in one adult ICU in the United Kingdom. The measures of ICU workload most strongly associated with mortality were: peak occupancy, average nursing requirement per occupied bed per shift, and the ratio of occupied to appropriately staffed beds. This study illustrates the current approach to workload and patient safety: workload is typically measured at the unit level (e.g., an ICU). Such level of analysis does not reveal the system design characteristics that may contribute to workload and patient safety problems. In the previous study, explanations for the association between high workload and mortality highlighted several system characteristics, such as insufficient time for clinical procedures to be done appropriately, inadequate training or supervision, errors, overcrowding and consequently nosocomial infections, limited availability of equipment, and premature discharge from the ICU. Macroergonomic conceptualization and assessment of workload would reveal the sources of workload, and help identify ways of redesigning the work system to reduce workload and improve patient safety. How does one ensure that continuous improvements in work system design and important outcomes (quality of care and patient safety, as well as human and organizational outcomes) are achieved? Various models and approaches to quality improvement and management have been proposed and implemented in healthcare (for example, Shortell et al., 1995). This research would benefit from a macroergonomic point of view in order to simultaneously optimize work system design and improve quality and safety of care. Macroergonomic approaches to quality management and improvement have

10 30 emphasized the importance of job and organizational design and quality of working life (Carayon, Sainfort, & Smith, 1999), the link between ergonomic deficiencies and quality deficiencies (Axelsson, 2000; Eklund, 1995), and the importance of management approaches for improved safety and health (Zink, 2000). All of these macroergonomic approaches have much to offer to designing continuous improvement systems and processes in healthcare. The goal of the improvement systems and processes would be to improve human and organizational outcomes, and as well as quality of care and patient safety. There is much debate around the quality and safety of healthcare, the extent of the problem, and its associated costs. The recent surge in interest in patient safety probably stems from various reasons, including the sheer desire to improve quality and safety of health care, media interest, public opinion, and insurance and litigation costs (Johnson, 2002). Much human factors research has been performed in healthcare. In particular, emphasis has been put on human error and its application to the understanding of patient safety. Macroergonomics is another important piece of the human factors and ergonomics discipline that has much to contribute to patient safety, in particular with regard to system improvement. However, there is still much that needs to be learned, especially regarding macroergonomics knowledge and tools applied to quality of care and patient safety. 6. Acknowledgements Funding for the SEIPS ( Systems Engineering Initiative for Patient Safety ) project is provided by the Agency for Healthcare Research and Quality (Principal Investigator: P. Carayon, Grant # P20 HS ). 7. References 1. Agency for Healthcare Research and Quality. (2002a). Health Care Costs. Fact Sheet (AHRQ Publication No. 02-P033). Rockville, MD.: Agency for Healthcare Research and Quality. 2. Agency for Healthcare Research and Quality. (2002b). Impact of Working Conditions on Patient Safety (AHRQ Publication No. 03-P003). Rockville, MD: Agency for Healthcare Research and Quality. 3. Axelsson, J. R. C. (2000). Quality and Ergonomics - Towards Successful Integration. Unpublished Ph.D. Dissertation, Linkoping University, Linkoping, Sweden. 4. Bates, D. W., & Gawande, A. A. (2003). Improving safety with information technology. The New England Journal of Medicine, 348 (25), Battles, J. B., & Keyes, M. A. (2002). Technology and patient safety: A two-edged sword. Biomedical Instrumentation & Technology, 36 (2), Berwick, D. M. (2002). A user's manual for the IOM's 'Quality Chasm' report. Health Affairs, 21 (3), Bogner, M. S. (Ed.). (1994). Human Error in Medicine. Hillsdale, NJ: Lawrence Erlbaum Associates.

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