Continuous Quality Improvement and Medical Informatics: the Convergent Synergy* Gerald R. Werth MD MSEE Donald P. Connelly MD PhD Division of Health Computer Sciences Department of Laboratory Medicine and Pathology Medical School University of Minnesota *

Supported in part by NLM Grant LM-07041 and NIH Grant RO1-HL41086

ABSTRACT Continuous quality improvement (CQI) and medical informatics specialists need to converge their efforts to create synergyfor improving health care. Health care CQI needs medical informatics' expertise and technology to build the information systems needed to manage health care organizations according to quality improvement principles. Medical informatics needs CQI's philosophy and methods to build health care information systems that can evolve to meet the changing needs of clinicians and other stakeholders. This paper explores the philosophical basis for convergence of CQI and medical informatics efforts, and then examines a clinical computer workstation development project that is applying a combined approach.

activities of one's organization; 2) efforts to mold the culture of one's organization, largely through deeds of leaders, to foster pride, joy, collaboration, and scientific thinking; and, finally, 3) efforts to continuously increase knowledge of and control over variation in the processes of work through widespread use of scientific methods for collection, analysis, and action upon data. [4] Key to CQI are the concepts of system, process, and variation. A system is a group of interacting, interrelated, or interdependent elements forming a complex whole. Whether in the manufacture of a product or the delivery of a service such as health care, a system converts inputs - including people, methods, machines, materials, measurements, and environment - into outputs by means of actions. These actions form the process of production. Variation in process outcomes may be due to factors internal to the system (common cause) or to external factors that disrupt the normal process (special cause). Special causes of variation may be identified by careful observation and treated, but common causes of variation may be remedied only by changing the design of the system and its processes. CQI seeks to identify and remedy causes of variation, rather than to assign blame for negative outcomes. Central to this effort is communication across traditional organizational boundaries, both horizontal and vertical. [1, 3, 5, 13]

KEY WORD PHRASES Continuous Quality Improvement Medical Informatics Health Care Research and Administration

INTRODUCTION The premise of this paper is that specialists in continuous quality improvement (CQI) and medical informatics need to converge their efforts to create synergy for improving health care. This paper will explore the philosophical basis for convergence of CQI and medical informatics, and then examine a specific effort to apply the combined approach in the context of a clinical computer workstation development project. What is CQI? Continuous quality improvement is a philosophy and methodology of organizing group work. It goes under many names, most of which are permutations of Continuous or Total + Quality + Improvement or Management or Control (CQI, TQM, TQC, TQI, CQM, etc.). Whatever name is used, CQI consists, at a minimum, of three essential elements: 1) efforts to know the needs of one's stakeholders ever more deeply and to link that knowledge ever more closely to the day-to-day

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CQI in Health Care Although originally developed in manufacturing industries, CQI is applicable to service industries as well. In complex services like health care, the business concepts of customers and suppliers may be generalized to the concept of stakeholders. A stakeholder is any person or group having an interest in the system, its inputs, or its outputs. What is Medical Informatics? Information management constitutes a major activity in the processes of health care. Medical informatics is the recently emerging field that concerns itself with the cognitive, infonnation processing, and communication

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tasks of medical practice, education, and research, including the information science and the technology to support these tasks. An intrinsically interdisciplinary field, medical informatics has a highly applied orientation. It also addresses fundamental research problems, as well as planning and policy issues. [10] Why CQI Needs Medical Informatics Health care organizations that manage themselves according to quality improvement principles will

inevitably develop and maintain internal information systems to measure and track the health status and functioning of their patients as well as the processes of providing health care. Medical informatics specialists have an important role in the design of enhanced medical information systems with which to examine and improve patient care processes. [2, 5] Why Medical Informatics Needs CQI Medical informatics must develop clinical information systems that are useful to and accepted by clinicians and other stakeholders in health care processes. The perceived needs of stakeholders are shaped by their goals and by those of their organizations. Given the dynamic nature of modern health care, perceived needs will change in ways that are not predictable. Further, the clinical expertise in modern health care organizations lies with individual clinicians, rather than with hierarchical managers. [8] Therefore clinical information systems should empower the clinician to influence the evolution of the system design as perceived needs change. This is consistent with the philosophy of CQI. The need for evolutionary system design is also consistent with modern software engineering theory, as exemplified by the spiral model of software development. [6, 9] Classical approaches to information system design and development assume that design specifications can be uniquely identified, and that specifications will not change over time. This is fallacy! Information systems - especially in fields as complex and dynamic as health care - must grow and evolve along with the systems and the organizations that they support. Applying an evolutionary approach to the development of clinical information systems will free designers from the seductive trap of trying to get the design exactly right the first time. How can one apply an evolutionary approach to the design of clinical information systems? One way is by embedding mechanisms for continuous formative evaluation into the infrastructure of the information system and the human organization that uses it. Another way is by using the communications power of the information system itself to gather feedback about users' perceived information needs. These ways are consistent

with the communications infrastructure of modem networked computing. They are also consistent with CQI's emphasis on communicating across traditional organizational boundaries, both horizontal and vertical. Thus medical informatics and continuous quality improvement have a mutual need for each other. When they converge and work together, they create a synergy that provides great leverage toward improving the quality of the health care process. The next section of this paper examines a specific effort to apply the combined approach of continuous evaluation and stakeholder communication to a clinical computer workstation development project. METHODS There are two major components to the methods used for this research. The first component is a feasibility study. This part involves technical issues of how to build evaluation and communication tools into a clinical workstation to facilitate CQI. The second component is a meta-evaluation. This part involves issues of how well the embedded tools work and whether they are useful and valuable. The motivating interest of this research is the second component, the meta-evaluation. Without the first component, however, there would be nothing to evaluate. Therefore, this paper will describe in some detail the methods used in the feasibility study. By its nature, the second component cannot be explicitly planned in advance. The outline of the meta-evaluation can be planned, but the actual stakeholder concerns and issues, the questions needed to address those concerns and issues, and the instruments needed to answer those questions can only be determined during the course of the evaluation. Because the full ESPRE workstation will not be available to clinical users until summer 1992, this paper will not address the meta-evaluation methods in detail. We will address the second component of this research in a future paper.

Implementation of CQI in Medical Informatics The evolutionary approach to clinical information systems is currently being applied to a clinical workstation project being developed at the University of Minnesota Hospital. The ESPRE project is developing a network of NeXTlm microcomputer workstations on several inpatient clinical units. [7] Initial functions will include complete laboratory result retrieval, and ordering of transfusion blood products. The research presented in this paper is built on top of the ESPRE project, and involves embedding several evaluation technologies into the application software and the organizational systems that will interact with the ESPRE clinical workstation.

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The computer network itself is used to facilitate communication among its stakeholders. This is possible because the network provides built-in means to send messages asynchronously from point to point and person to person. Initially the ESPRE project focuses on communication between clinicians and software developers, but the technology may be used to facilitate communication among all on-line stakeholders. The application software for the ESPRE project is being developed using the NeXTsteprm software development environment, which provides objectoriented programming tools for creating custom applications. Because the NeXT system software is based on Mach (the Carnegie-Mellon University nonproprietary enhancement of UNIX 4.3 BSD), standard UNIX utility software and C-language functions are available for use within NeXTstep-developed applications. The NeXT system software provides both a foreground application to enable a user to read and send electronic mail (E-mail), and background UNIX/Mach software to transport mail messages. Feedback. To facilitate feedback from clinicians to software developers, a.pre-addressed E-mail "Suggestion Box" function was added to the ESPRE application software. This feedback function is available to the user at all times, and amounts to an electronic post card from user to developer. User comments obtained from feedback are used to help defme stakeholder concems and issues that need further clarification. [11] Feedback is implemented using standard NeXTstep text fields, and sends the user's free-text comment to a "Feedback" Email address using the standard UNIX sendmail utilities. It turns out to be fairly easy to send E-mail programmatically from a NeXTstep application. E-mail. To facilitate communication among developers and clinicians, access is provided to the standard NeXT Email application. The asynchronous nature of E-mail allows ongoing discussion among stakeholders without the constraints of conventional face-to-face meetings. There are two major issues involved in providing E-mail access to clinicians, one of technology and one of access security. The technical issue involves being able to have the main application program launch another application, in this case NeXT Mail, and later terminate the secondary program. This is solved by using a Subprocess object from the NeXTstep developer examples library. This object allows an application to launch another application or utility and to communicate with it. Unfortunately, the Subprocess object does not allow one to tell the launched application to terminate normally when desired. A normal termination can be achieved by using a standard Speaker object to send the Mail application the standard system message that the user is ending a work session.

Access Security and the Information Fountain. The access security issue for E-mail is more complicated. The ESPRE clinical application is designed to run continuously. The clinicians using it do not "log in" in the traditional sense, so the ESPRE application must handle access issues of identification and authentication that are normally handled by system software. The usage model is much like that of a drinking fountain: the user walks up, drinks briefly, and leaves. The clinical workstation is thus an information fountain. This usage model has three states. Level Zero is the state where the workstation is idle and no user interaction is present. This level is used to announce the availability of new information about patients on the clinical care unit. Level One is the state where a user has identified him or herself, but has not been asked to prove that identity. This level is used to display information about patient laboratory results. The physical security of the workstation's location in the clinical care unit is felt to provide adequate protection of patient confidentiality. Level Two is the state where the user has been authenticated by producing a password or other unique token. Access to E-mail and other privileged functions such as order entry is restricted to Level Two, and any running E-mail application is terminated upon leaving that state. Access security is implemented using standard UNIX functions for setting and retrieving the operating context of the running program. The ESPRE application changes its ownership between a default user at Level Zero and the identified user at Level One. When the user selects a function that requires Level Two status, the NeXTstep nikit library and UNIX functions are used to request a password and authenticate the user's identity. User data are kept in the standard NeXT netinfo database, and are accessed using getuid, getpwuid, getgroups, and related UNIX functions. Program run-time context is changed using setruid, setrgid, setenv, and related UNIX functions. To do this, the program file must be owned by the system, and must have "set user" and "set group" permissions enabled. (Some UNIX functions, such as setenv, are not provided by NeXT and were obtained from Internet archives for UNIX 4.3 BSD.) When a subprocess is launched, it inherits the operating context of the parent. This ensures that each user has access only to his or her own E-mail. Clinical users are not provided access to the NeXT workspace application or to a UNIX/Mach shell window. If the user walks away from the workstation without formally ending a session, a timed event loop polls the event status driver to detect that the workstation's built-in "AutoDim" screen blanker has activated, and returns the main application to Level Zero.

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Surveys. To facilitate clarification of stakeholder concerns and issues that arise in feedback and E-mail messages (and elsewhere), on-line survey tools are added to E-mail. NeXT E-mail allows files and folders to be attached as icons to any message by using "drag and drop" techniques. Thus a survey application can be attached to a message that is then sent to all relevant online stakeholders. The message serves as the "cover letter" explaining what the survey is about and why the recipient should respond. The cover message also contains brief instructions about how to launch the survey application by double clicking on its icon. The survey application is developed in NeXTstep. It places its main window in front of all others on the screen. This window uses standard NeXTstep text fields and radio buttons to implement the desired questionnaire. When the user clicks on a final button to indicate that all questions have been answered, the survey application mails the window object with all data to a "Survey" Email address. This is done by writing the window object to a data stream file, placing the file in a UNIX archive, using the UNIX compress and uuencode utilities to prepare the archive file for mailing, and then passing the result to the UNIX sendmail utilities as the message body. In its most complete form, the survey application sends the stream file of the window object as a standard attachment to a NeXT mail message. Disk space usage may be minimized by having the survey application load the questionnaire window from a standard file location, rather than sending a copy of the blank survey to each user. Off-line stakeholders may be surveyed by printing the questionnaire window as a paper form, and manually entering the data. Advantages of the on-line survey include direct data entry by the user, and the ability to automatically send a repeat mailing only to nonresponders. When resources permit, the survey tools may be extended beyond simple questionnaire techniques to also include consensus instruments, thereby supporting modified Delphi techniques. Observations. To facilitate observations about user and software behavior, observation tools are added to the workstation software. These tools allow objective measurements such as usage patterns and system response times. Observations are recorded as event logs, and these logs are periodically mailed to an "Observe" E-mail address. For example, a log is kept of all changes in user access level. This is done using UNIX syslog utilities for writing to event log files, and the same interface to UNIX sendmail utilities used by the feedback and survey tools. As desired by the developers, other embedded observations may be stored and periodically collected using E-mail.

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Analysis and Reporting. To facilitate examining, summarizing, and reporting the data gathered from the embedded tools, analysis and reporting tools are also added. Because all data are collected as E-mail messages, these tools are implemented as separate applications, rather than being embedded in the clinical application. For example, free-text feedback comments are automatically tabulated into a conventional report format. Survey and observation results are automatically tabulated into formats suitable for analysis by spreadsheet and more advanced statistical and graphical tools. Export links to existing third-party software are supported wherever practical. Scalability. A common advantage of all these embedded evaluation and stakeholder communication tools is that they scale without modification from a system used at a single institution to a system used at many sites. Meta-Evaluation of CQI in Medical Informatics The second component of the present research is a metaevaluation of the embedded evaluation tools described above. This meta-evaluation involves observation of the volume of usage of the embedded tools, and assessment of the gathered information's impact on the evolution ESPRE's design. Techniques for meta-evaluation are adapted with minimal modification from the field of educational evaluation. [12] This component of the present research is less technical and more social science oriented. Because of its ethnographic nature, it is more like a clinical case report than a hypothesis testing experiment. Full details of this component are beyond the scope of this paper, and will be published separately.

RESULTS Like the methodology, there are two major components to the results of this research. The first component, the feasibility study, has been successfully accomplished. As discussed above, it is technically feasible to embed evaluation and stakeholder communications tools into a clinical computer workstation to facilitate CQI. The second component, the meta-evaluation, is still in process. Detailed preliminary results are expected by the time of the SCAMC meeting in November 1992. Two significant ethnographic observations are available at the time of writing. First, like the clinical users, the developers are at risk of initially perceiving a new and innovative technology as an unknown complexity that may disrupt their ability to get their work done. The development team has had to deal with at least two new technologies. One of these, which was expected, was the use of an object-oriented software development environment. The other, which was not fully anticipated, was the use of embedded tools

to provide real-time on-line feedback from users of the system. As with all initially unfamiliar technologies, each of these was a potential source of stress for the developers. Second, early adopters among clinicians, having seen the feedback tools in prototyping sessions, spontaneously requested that these tools be included in the first phase release of the workstation software.

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DISCUSSION Continuous quality improvement and medical informatics seem to be made for each other. The application of medical informatics to support CQI in health care and the application of CQI to clinical information systems offer great synergy in their convergence. This research is an attempt to test that relationship by embedding evaluation tools into a clinical workstation development project. Several challenges were met while implementing embedded evaluation on the ESPRE workstation. An ongoing challenge to any group learning CQI is the paradigm shift from traditional negative fault-finding thinking to positive process-oriented thinking. It is often difficult to anticipate when CQI communications methods would be helpful. This led to delays in achieving a consensus view of the user interaction model for ESPRE, making it difficult to resolve design issues of the user interface, user identification and verification, and security of information access. The clinical users' interaction with the ESPRE workstation is different from that of traditional computer terminals and microcomputers. The interaction model is more like that of a drinking fountain - the user walks up, drinks briefly, and leaves. Thus the ESPRE workstation is in essence an informationfountain. This difference from traditional workstation interaction models raised technical difficulties in designing software hooks into the system software for E-mail and security. Fortunately, an iterative, evolutionary approach has thus far been able to resolve both organizational and technical difficulties.

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CONCLUSIONS The synergistic convergence of CQI and medical informatics holds much promise for the improvement of modern health care. The challenge now to both fields will be to refine that promise in the crucible of clinical practice.

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ACKNOWLEDGMENTS This work was supported in part by NLM Grant LM07041 and NIH Grant R01-H4A 1086.

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Continuous quality improvement and medical informatics: the convergent synergy.

Continuous quality improvement (CQI) and medical informatics specialists need to converge their efforts to create synergy for improving health care. H...
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