Continuous Quality Improvement and Medical Informatics:the Convergent Synergy*

Gerald R. Werth MD MSEEDonald P. Connelly MD PhD

Division of Health Computer SciencesDepartment of Laboratory Medicine and Pathology

Medical SchoolUniversity of Minnesota

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

ABSTRACTContinuous quality improvement (CQI) and medicalinformatics specialists need to converge their efforts tocreate synergyfor improving health care. Health careCQI needs medical informatics' expertise and technologyto build the information systems needed to manage healthcare organizations according to quality improvementprinciples. Medical informatics needs CQI's philosophyand methods to build health care information systems thatcan evolve to meet the changing needs of clinicians andother stakeholders. This paper explores the philosophicalbasisfor convergence ofCQI and medical informaticsefforts, and then examines a clinical computerworkstation development project that is applying acombined approach.

KEY WORD PHRASESContinuous Quality ImprovementMedical InformaticsHealth Care Research and Administration

INTRODUCTIONThe premise of this paper is that specialists in continuousquality improvement (CQI) and medical informatics needto converge their efforts to create synergy for improvinghealth care. This paper will explore the philosophicalbasis for convergence of CQI and medical informatics,and then examine a specific effort to apply the combinedapproach in the context of a clinical computer workstationdevelopment project.

What is CQI?Continuous quality improvement is a philosophy andmethodology of organizing group work. It goes undermany names, most of which are permutations ofContinuous or Total + Quality + Improvement orManagement or Control (CQI, TQM, TQC, TQI, CQM,etc.). Whatever name is used, CQI consists, at aminimum, of three essential elements: 1) efforts to knowthe needs of one's stakeholders ever more deeply and tolink that knowledge ever more closely to the day-to-day

activities of one's organization; 2) efforts to mold theculture of one's organization, largely through deeds ofleaders, to foster pride, joy, collaboration, and scientificthinking; and, finally, 3) efforts to continuously increaseknowledge of and control over variation in the processesof work through widespread use of scientific methods forcollection, analysis, and action upon data. [4]

Key to CQI are the concepts of system, process, andvariation. A system is a group of interacting, interrelated,or interdependent elements forming a complex whole.Whether in the manufacture of a product or the deliveryof a service such as health care, a system converts inputs- including people, methods, machines, materials,measurements, and environment- into outputs by meansof actions. These actions form the process of production.Variation in process outcomes may be due to factorsinternal to the system (common cause) or to externalfactors that disrupt the normal process (special cause).Special causes of variation may be identified by carefulobservation and treated, but common causes of variationmay be remedied only by changing the design of thesystem and its processes. CQI seeks to identify andremedy causes of variation, rather than to assign blamefor negative outcomes. Central to this effort iscommunication across traditional organizationalboundaries, both horizontal and vertical. [1, 3, 5, 13]

CQI in Health CareAlthough originally developed in manufacturingindustries, CQI is applicable to service industries as well.In complex services like health care, the businessconcepts of customers and suppliers may be generalizedto the concept of stakeholders. A stakeholder is anyperson or group having an interest in the system, itsinputs, or its outputs.

What is Medical Informatics?Information management constitutes a major activity inthe processes of health care. Medical informatics is therecently emerging field that concerns itself with thecognitive, infonnation processing, and communication

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tasks of medical practice, education, and research,including the information science and the technology tosupport these tasks. An intrinsically interdisciplinaryfield, medical informatics has a highly appliedorientation. It also addresses fundamental researchproblems, as well as planning and policy issues. [10]

Why CQI Needs Medical InformaticsHealth care organizations that manage themselvesaccording to quality improvement principles willinevitably develop and maintain internal informationsystems to measure and track the health status andfunctioning of their patients as well as the processes ofproviding health care. Medical informatics specialistshave an important role in the design of enhanced medicalinformation systems with which to examine and improvepatient care processes. [2, 5]

Why Medical Informatics Needs CQIMedical informatics must develop clinical informationsystems that are useful to and accepted by clinicians andother stakeholders in health care processes. Theperceived needs of stakeholders are shaped by their goalsand by those of their organizations. Given the dynamicnature of modern health care, perceived needs will changein ways that are not predictable. Further, the clinicalexpertise in modern health care organizations lies withindividual clinicians, rather than with hierarchicalmanagers. [8] Therefore clinical information systemsshould empower the clinician to influence the evolution ofthe system design as perceived needs change. This isconsistent with the philosophy of CQI. The need forevolutionary system design is also consistent with modernsoftware engineering theory, as exemplified by the spiralmodel of software development. [6, 9]

Classical approaches to information system design anddevelopment assume that design specifications can beuniquely identified, and that specifications will notchange over time. This is fallacy! Information systems- especially in fields as complex and dynamic as healthcare- must grow and evolve along with the systems andthe organizations that they support. Applying anevolutionary approach to the development of clinicalinformation systems will free designers from theseductive trap of trying to get the design exactly right thefirst time.

How can one apply an evolutionary approach to thedesign of clinical information systems? One way is byembedding mechanisms for continuous formativeevaluation into the infrastructure of the informationsystem and the human organization that uses it. Anotherway is by using the communications power of theinformation system itself to gather feedback about users'perceived information needs. These ways are consistent

with the communications infrastructure of modemnetworked computing. They are also consistent withCQI's emphasis on communicating across traditionalorganizational boundaries, both horizontal and vertical.

Thus medical informatics and continuous qualityimprovement have a mutual need for each other. Whenthey converge and work together, they create a synergythat provides great leverage toward improving the qualityof the health care process.

The next section of this paper examines a specificeffort to apply the combined approach of continuousevaluation and stakeholder communication to a clinicalcomputer workstation development project.

METHODSThere are two major components to the methods used forthis research. The first component is a feasibility study.This part involves technical issues of how to buildevaluation and communication tools into a clinicalworkstation to facilitate CQI. The second component is ameta-evaluation. This part involves issues of how wellthe embedded tools work and whether they are useful andvaluable.

The motivating interest of this research is the secondcomponent, the meta-evaluation. Without the firstcomponent, however, there would be nothing to evaluate.Therefore, this paper will describe in some detail themethods used in the feasibility study. By its nature, thesecond component cannot be explicitly planned inadvance. The outline of the meta-evaluation can beplanned, but the actual stakeholder concerns and issues,the questions needed to address those concerns and issues,and the instruments needed to answer those questions canonly be determined during the course of the evaluation.Because the full ESPRE workstation will not be availableto clinical users until summer 1992, this paper will notaddress the meta-evaluation methods in detail. We willaddress the second component of this research in a futurepaper.

Implementation of CQI in Medical InformaticsThe evolutionary approach to clinical information systemsis currently being applied to a clinical workstation projectbeing developed at the University of Minnesota Hospital.The ESPRE project is developing a network of NeXTlmmicrocomputer workstations on several inpatient clinicalunits. [7] Initial functions will include completelaboratory result retrieval, and ordering of transfusionblood products. The research presented in this paper isbuilt on top of the ESPRE project, and involvesembedding several evaluation technologies into theapplication software and the organizational systems thatwill interact with the ESPRE clinical workstation.

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The computer network itself is used to facilitatecommunication among its stakeholders. This is possiblebecause the network provides built-in means to sendmessages asynchronously from point to point and personto person. Initially the ESPRE project focuses oncommunication between clinicians and softwaredevelopers, but the technology may be used to facilitatecommunication among all on-line stakeholders.

The application software for the ESPRE project isbeing developed using the NeXTsteprm softwaredevelopment environment, which provides object-oriented programming tools for creating customapplications. Because the NeXT system software is basedon Mach (the Carnegie-Mellon University non-proprietary enhancement ofUNIX 4.3 BSD), standardUNIX utility software and C-language functions areavailable for use within NeXTstep-developedapplications. The NeXT system software provides both aforeground application to enable a user to read and sendelectronic mail (E-mail), and background UNIX/Machsoftware to transport mail messages.

Feedback. To facilitate feedback from clinicians tosoftware developers, a.pre-addressed E-mail "SuggestionBox" function was added to the ESPRE applicationsoftware. This feedback function is available to the userat all times, and amounts to an electronic post card fromuser to developer. User comments obtained fromfeedback are used to help defme stakeholder concems andissues that need further clarification. [11] Feedback isimplemented using standard NeXTstep text fields, andsends the user's free-text comment to a "Feedback" E-mail address using the standard UNIX sendmail utilities.It turns out to be fairly easy to send E-mailprogrammatically from a NeXTstep application.

E-mail. To facilitate communication among developersand clinicians, access is provided to the standard NeXT E-mail application. The asynchronous nature of E-mailallows ongoing discussion among stakeholders withoutthe constraints of conventional face-to-face meetings.There are two major issues involved in providing E-mailaccess to clinicians, one of technology and one of accesssecurity. The technical issue involves being able to havethe main application program launch another application,in this case NeXT Mail, and later terminate the secondaryprogram. This is solved by using a Subprocess objectfrom the NeXTstep developer examples library. Thisobject allows an application to launch another applicationor utility and to communicate with it. Unfortunately, theSubprocess object does not allow one to tell the launchedapplication to terminate normally when desired. Anormal termination can be achieved by using a standardSpeaker object to send the Mail application the standardsystem message that the user is ending a work session.

Access Security and the Information Fountain. Theaccess security issue for E-mail is more complicated. TheESPRE clinical application is designed to runcontinuously. The clinicians using it do not "log in" inthe traditional sense, so the ESPRE application musthandle access issues of identification and authenticationthat are normally handled by system software. The usagemodel is much like that of a drinking fountain: the userwalks up, drinks briefly, and leaves. The clinicalworkstation is thus an informationfountain.

This usage model has three states. Level Zero is thestate where the workstation is idle and no user interactionis present. This level is used to announce the availabilityof new information about patients on the clinical careunit. Level One is the state where a user has identifiedhim or herself, but has not been asked to prove thatidentity. This level is used to display information aboutpatient laboratory results. The physical security of theworkstation's location in the clinical care unit is felt toprovide adequate protection of patient confidentiality.Level Two is the state where the user has beenauthenticated by producing a password or other uniquetoken. Access to E-mail and other privileged functionssuch as order entry is restricted to Level Two, and anyrunning E-mail application is terminated upon leavingthat state.

Access security is implemented using standard UNIXfunctions for setting and retrieving the operating contextof the running program. The ESPRE application changesits ownership between a default user at Level Zero and theidentified user at Level One. When the user selects afunction that requires Level Two status, the NeXTstepnikit library and UNIX functions are used to request apassword and authenticate the user's identity. User dataare kept in the standard NeXT netinfo database, and areaccessed using getuid, getpwuid, getgroups, and relatedUNIX functions. Program run-time context is changedusing 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" permissionsenabled. (Some UNIX functions, such as setenv, are notprovided by NeXT and were obtained from Internetarchives for UNIX 4.3 BSD.) When a subprocess islaunched, it inherits the operating context of the parent.This ensures that each user has access only to his or herown E-mail. Clinical users are not provided access to theNeXT workspace application or to a UNIX/Mach shellwindow. If the user walks away from the workstationwithout formally ending a session, a timed event looppolls the event status driver to detect that theworkstation's built-in "AutoDim" screen blanker hasactivated, and returns the main application to Level Zero.

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Surveys. To facilitate clarification of stakeholderconcerns and issues that arise in feedback and E-mailmessages (and elsewhere), on-line survey tools are addedto E-mail. NeXT E-mail allows files and folders to beattached as icons to any message by using "drag anddrop" techniques. Thus a survey application can beattached to a message that is then sent to all relevant on-line stakeholders. The message serves as the "coverletter" explaining what the survey is about and why therecipient should respond. The cover message alsocontains brief instructions about how to launch the surveyapplication by double clicking on its icon.

The survey application is developed in NeXTstep. Itplaces its main window in front of all others on thescreen. This window uses standard NeXTstep text fieldsand radio buttons to implement the desired questionnaire.When the user clicks on a final button to indicate that allquestions have been answered, the survey applicationmails the window object with all data to a "Survey" E-mail address. This is done by writing the window objectto a data stream file, placing the file in a UNIX archive,using the UNIX compress and uuencode utilities toprepare the archive file for mailing, and then passing theresult to the UNIX sendmail utilities as the message body.In its most complete form, the survey application sendsthe stream file of the window object as a standardattachment to a NeXT mail message. Disk space usagemay be minimized by having the survey application loadthe questionnaire window from a standard file location,rather than sending a copy of the blank survey to eachuser.

Off-line stakeholders may be surveyed by printing thequestionnaire window as a paper form, and manuallyentering the data. Advantages of the on-line surveyinclude direct data entry by the user, and the ability toautomatically send a repeat mailing only to non-responders. When resources permit, the survey tools maybe extended beyond simple questionnaire techniques toalso include consensus instruments, thereby supportingmodified Delphi techniques.

Observations. To facilitate observations about user andsoftware behavior, observation tools are added to theworkstation software. These tools allow objectivemeasurements such as usage patterns and system responsetimes. Observations are recorded as event logs, and theselogs are periodically mailed to an "Observe" E-mailaddress. For example, a log is kept of all changes in useraccess level. This is done using UNIX syslog utilities forwriting to event log files, and the same interface to UNIXsendmail utilities used by the feedback and survey tools.As desired by the developers, other embeddedobservations may be stored and periodically collectedusing E-mail.

Analysis and Reporting. To facilitate examining,summarizing, and reporting the data gathered from theembedded tools, analysis and reporting tools are alsoadded. 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 areautomatically tabulated into a conventional report format.Survey and observation results are automatically tabulatedinto formats suitable for analysis by spreadsheet and moreadvanced statistical and graphical tools. Export links toexisting third-party software are supported whereverpractical.

Scalability. A common advantage of all these embeddedevaluation and stakeholder communication tools is thatthey scale without modification from a system used at asingle institution to a system used at many sites.

Meta-Evaluation of CQI in Medical InformaticsThe second component of the present research is a meta-evaluation of the embedded evaluation tools describedabove. This meta-evaluation involves observation of thevolume of usage of the embedded tools, and assessmentof the gathered information's impact on the evolutionESPRE's design. Techniques for meta-evaluation areadapted with minimal modification from the field ofeducational evaluation. [12] This component of thepresent research is less technical and more social scienceoriented. Because of its ethnographic nature, it is morelike a clinical case report than a hypothesis testingexperiment. Full details of this component are beyond thescope of this paper, and will be published separately.

RESULTSLike the methodology, there are two major components tothe results of this research. The first component, thefeasibility study, has been successfully accomplished. Asdiscussed above, it is technically feasible to embedevaluation and stakeholder communications tools into aclinical computer workstation to facilitate CQI.

The second component, the meta-evaluation, is still inprocess. Detailed preliminary results are expected by thetime of the SCAMC meeting in November 1992. Twosignificant ethnographic observations are available at thetime of writing.

First, like the clinical users, the developers are at riskof initially perceiving a new and innovative technology asan unknown complexity that may disrupt their ability toget their work done. The development team has had todeal with at least two new technologies. One of these,which was expected, was the use of an object-orientedsoftware development environment. The other, whichwas not fully anticipated, was the use of embedded tools

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to provide real-time on-line feedback from users of thesystem. As with all initially unfamiliar technologies, eachof these was a potential source of stress for thedevelopers.

Second, early adopters among clinicians, having seenthe feedback tools in prototyping sessions, spontaneouslyrequested that these tools be included in the first phaserelease of the workstation software.

DISCUSSIONContinuous quality improvement and medical informaticsseem to be made for each other. The application ofmedical informatics to support CQI in health care and theapplication of CQI to clinical information systems offergreat synergy in their convergence. This research is anattempt to test that relationship by embedding evaluationtools into a clinical workstation development project.

Several challenges were met while implementingembedded evaluation on the ESPRE workstation. Anongoing challenge to any group learning CQI is theparadigm shift from traditional negative fault-findingthinking to positive process-oriented thinking. It is oftendifficult to anticipate when CQI communications methodswould be helpful. This led to delays in achieving aconsensus view of the user interaction model for ESPRE,making it difficult to resolve design issues of the userinterface, user identification and verification, and securityof information access.

The clinical users' interaction with the ESPREworkstation is different from that of traditional computerterminals and microcomputers. The interaction model ismore like that of a drinking fountain- the user walks up,drinks briefly, and leaves. Thus the ESPRE workstationis in essence an informationfountain. This differencefrom traditional workstation interaction models raisedtechnical difficulties in designing software hooks into thesystem software for E-mail and security.

Fortunately, an iterative, evolutionary approach hasthus far been able to resolve both organizational andtechnical difficulties.

CONCLUSIONSThe synergistic convergence of CQI and medicalinformatics holds much promise for the improvement ofmodern health care. The challenge now to both fields willbe to refine that promise in the crucible of clinicalpractice.

ACKNOWLEDGMENTSThis work was supported in part by NLM Grant LM-07041 and NIH Grant R01-H4A 1086.

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