Model User Application System for Clinical Data Processing That Tracks and Monitors a Simulated Out-Patient Medical Practice Using Data Base Management Software

The following work builds upon the subject matter disclosed in an earlier filed U.S. application, Ser. No. 07/542,752, currently pending, which is incorporated herein by reference. That earlier and more comprehensive work was based upon a scheme of hierarchical diagnostic classification for patient ranking and data processing. It generally dealt with a computer-based tracking and monitoring system for the retrospective analysis of patient care results, physician performance and clinical resource management in a primary care out-patient environment. In this earlier work, specific programs were designed to mimic common aspects of out-patient clinical medicine, and specifically allowed for the detection and compilation of unjustified (overuse) office visits, both scheduled and unscheduled, according to a set of computer program specified criterion, the tracking the nature of patient care during protracted episodes of out-patient illnesses at varying levels of clinical severity, the identifying of unnecessary lab work during unremarkable office visits, the monitoring of impending or actual medication induced toxicity, the medication and physical data on cardiac patients during serious symptoms, etc.

In the prior work, the bulk of the pool of clinical data which was used in processing originated from the primary care out-patient visit, both scheduled and unscheduled. Such data included treatment modalities (medication), physical data observation (signs and symptoms), diagnostic tests, etc. All of these were encoded and stored logically in different, related files. Each patient's files were linked by common data fields. These records were created and loaded through prototype data entry routines.

The earlier work, however, did not address some common problems which occur in this environment. First, there is frequently disparity in time (days) between the running of two different types of tests which originate from the same lab test request, such as blood work and EKG/CXR tests. Second, lab tests are sometimes ordered in the absence of or aside from a formal encounter (or "source") office visit. The most frequent example is over the telephone from a spontaneous call by a patient (which is termed a "non-source" request). When this happens there is naturally no link between a source invoice that would normally link various lab tests together. Both problems are not mutually exclusive and are met by the present invention. Further, this invention includes a revision of the specialist record for storing more comprehensive data.

The present invention consists of a new data entry routine for loading EKG and CXR test results into separate EKG/CXR records as distinct logical entities. The labor record structure has been revised to allow for linking of separate EKG/CXR data from the same lab request. The lab entry process is now restricted to the entry of blood work only. The specialty record has been improved to contain separate fields for holding data that identifies both the specific type of specialist (cardiologist, neurologist, etc.) and the general recommendation made from a set common to all specialists. A first report generation program combines salient clinical data from office visits with the EKG/CXR tests results ordered during those visits. A second report generation program combines salient clinical data from office visits with the results from the specialist (consultant) visits referred by those (primary care) office visits.

To be more specific, the patient electrocardiographic (EKG) and chest x-ray (CXR) data, loaded through the same program, are now distinct logical entities stored separately and related to other patient data. Consisting of a full complement of standard specialty diagnoses, the EKG/CXR data, as additional medical attributes, adds critical data elements to the system's knowledge base and enhances the ability to clinically profile each patient. For example, a patient's cardiac symptom (or sign) can now be viewed together with EKG results or a pulmonary symptom can be viewed with CXR data from the same office visit. For the purpose of population analysis, information can be obtained regarding the frequency of EKG abnormalities in patients with certain diagnosis and/or taking certain medication within a certain age range amongst pre-selected doctors.

The lab record data routine is now limited to blood work only (such as bun, Hct, wbc, etc.). However, each time the EKG/CXR data entry routine is run, historical parameter data from the EKG/CXR results are passed to a "companion" lab record along with other data linking both record types. If a labor record isn't already present storing blood work results from the same lab test request, a lab record will be created using the EKG/CXR data entry routine. Similarly, if a lab test request contains orders for both EKG or CXR and blood work, and the EKG or CXR (or both) tests were done first and therefore entered first, a lab record will already be present when the lab data entry routine is run at a latter time. Upon completion of the lab data (blood work) entry routine, the request date will hold the value common to both types of tests (EKG and blood work), the date done field will indicate when the blood work was done and the invoice field of both EKG/CXR and lab record indicating origin will be identical. Such cross-file processing from EKG/CXR to the lab record ensures that the lab record will, in the case of both test types from the same lab test request, hold all the results of lab work taken at that time for that patient. If on the other hand, only EKG/CXR tests were done, a lab record will still be created from the EKG/CXR parameter data. As such, one single composite record may be accessed to review all the lab test results for any patient taken at any time for many general purposes, while at the same time, more explicit and definitive information of a current and fuller nature regarding the EKG/CXR data from the same lab test request is held separately in linked files.

Within the above design for both EKG/CXR and lab data entry, a provision has been made for including and identifying lab test results (EKG/CXR, blood work) ordered in the absence of a formal patient-physician encounter (called a "non-source" encounter). These non-source encounters include tests ordered over the phone or in some other informal way. Those records will be properly identified and matched in cases where both types of tests (CXR and EKG) have been ordered by a blank invoice field and a specific request date. Since that type of practice occurs frequently enough, any information management system that fails to take it into account can lack significant patient data.

The specialty record improvements consist of the addition of separate fields for holding data that identifies both the specific type of specialist (cardiologist, neurologist, etc,) and the general recommendations made from a set common to all. Also, a field has been added to include a request data which is especially important for tracking successive visits to the same specialist stemming from a single original office visit (primary care) referral.

One print program consists of printing out EKG and CXR test results in association with other clinical data documented during the same office visit in which those tests were ordered. Another print program prints out specialty data, such as type of specialist and recommendations, in association with other clinical data documented during those office visits in which the specialty referrals were made.

FIG. 1 illustrates the principal steps in the main calling program (mainmenu.prg). The main calling program contains both the initial and final segments of the EKG/CXR data entry routine.

FIG. 2 illustrates the principal steps in the program (menu.prg) that generates a list of diagnostic choices for display.

FIG. 3 illustrates the principal steps of the program (menu.prg) which allows the operator to confirm the test result entries and then either pass control back to FIG. 1 or the next sequential segment of the routine illustrated by FIG. 4.

FIG. 4 illustrates the principal steps in the program (creatrec.prg) for ascertaining the source of the test request, for accessing appropriate record identifying data and for locating or creating the companion (master) lab record.

FIG. 5 continues from FIG. 4. This segment illustrates the program for enabling the operator to select the kind of historical data to accompany the current EKG/CXR test results. This segment also involves the actual creation and loading of the new EKG/CXR records.

FIG. 6 illustrates the principal steps in a subroutine (find1.prg) for determining and displaying to the operator two (of four possible) types of any prior results of that patient's EKG/CXR test, which are then used to compile the parameter data into encoded form.

FIG. 7 illustrates the principal steps in a subroutine (find2.prg) for determining and displaying to the operator two other types of any prior results of that patient's EKG/CXR test.

FIG. 8 illustrates a prototype source document prepared by the medical department for used in the data entry routine for either EKG or CXR test results.

FIG. 9 illustrates the principal steps in the main calling program (labfirst.prg) for ascertaining the source of the text request, and creating, if necessary, the new lab record and for loading the lab record with identifying data prior to actual entry of the test results.

FIG. 10 illustrates the principal steps of a program (labentry.prg) for obtaining prior results of blood work tests, and for the actual entry of current data to the lab record.

FIG. 11 illustrates the principal steps of a program (findout1.prg) for determining and displaying to the operator two types of (of four possible) of prior results pertaining to the particular blood work test results to be entered.

FIG. 12 illustrates the principal steps of a program (findout2.prg) for determining and displaying to the operator the two other types of prior results pertaining to the particular blood work test results to be entered.

FIG. 13 illustrates a prototype source document prepared by the medical department for the lab record (blood work) data entry routine.

FIG. 14 illustrates the principal steps of a report generation program (print6.prg) that combines salient clinical data from office visits with the EKG/CXR test results ordered during those visits.

FIG. 15 illustrates the principal steps of a report generation program (print7.prg) for combining salient clinical data from office visits with the results from the specialist (consultant) visits referred by those (primary care) office visits.

FIGS. 16-22 show reports generated by the program print6.prg in which salient clinical data from pre-selected office visits are combined with the EKG or CXR (or both) test results ordered during those visits. Note the possible disparity in time between the two types of tests in cases where both were ordered from the same visit.

FIGS. 23-30 show reports generated by the program print7.prg in which salient clinical data from pre-selected office visits are combined with the specialty results from referrals made during those office visits. Note that in some cases (FIGS. 23, 26 and 30) more than one specialty referral was made from the same office visit. Also note that the type of specialist in each case is made explicit and the recommendations are generic in nature for common use with all specialists.

1. EKG (electrocardiographic) and/or CXR (chest x-ray) record creation and data entry routine.

FIG. 1 illustrates the principal steps in the main program (mainmenu.prg) for creating both EKG and CXR records. This program is entered separately for each record creation, EKG or CXR, even if both records are for the same patient. It begins in step (111) by allowing the operator to choose between EKG or CXR for any patient. Then, depending upon the choice, the program will generate a corresponding screen display listing fourteen standard, commonly used technical abnormalities (including just "normal") in step (117). The operator chooses the abnormality which matches that given on the operator's source document previously prepared by the medical department for use in transcription by the data entry department (a prototype of that source document is shown in FIG. 8).

The actual selections are made by allowing the operator to move up and down through the list of fourteen diagnostic options until the appropriate matches are found between the screen display and that present on the source document, up to a maximum of four selections. In order to enter a diagnosis the return key must be pressed while the cursor is positioned to that selection. Immediately and automatically after the diagnostic selections are made, the program will echo back only those diagnoses selected for cross-checking and confirmation in step (120). If a mistake has been made or an error in the number of selections has been made, the program returns to the entry screen for re-entry of data. Instructions are present on both EKG and CXR screen for assisting the operator in the proper method and steps for selecting each diagnosis. The diagnoses are handled as subscripts corresponding to individual table entries, as discussed later. FIGS. 2 and 3 to give a more detailed description of the procedure for entering diagnoses.

When the operator is satisfied that the appropriate selections have been made, the program (mainmenu.prg) then "carries" those EKG or CXR diagnoses into the segment (creatrec. prg) in the form of subscripts. FIGS. 4 and 5 illustrate the principal steps in the creatrec.prg. In step (411) basic identifying data, such as patient I.D., date of request, data test completed, is solicited. In step (414) the operator is then asked to indicate the nature of the encounter existent at the time the "lab test request" was made --either "source" (which includes office visit, emergency room (E.R.) or specialist) or "non-source" (which includes hallway or telephone). A complete "lab test request" consists of both EKG/CXR and a battery of fourteen blood tests which for the purpose of this application will include at least EKG or CXR with or without associated blood work. In the case "source" encounter is specified, the operator is requested to select either office visit, E.R. or specialist, depending on the nature of the encounter in steps (415), (416) and (417). This information is used to access the record's invoice number which is to be also used in cross-linking the three records which will then be related a a result of this segment (creatrec.prg): the source record already present, the EKG or CXR record to be created, and the related lab record which may or may not already exist depending upon the co-existence of other tests also ordered and already done, originating from the same encounter (source or non-source). If a non-source (hallway or telephone) is indicated in step (414), then the creatrec.prg segment just searches the laboratory file to determine if a record already exists holding other test results ordered at the same time. In both cases, source or non-source, where a "companion" lab record is not already present, one will be created prior to the EKG or CXR record creation and data entry step and loaded with identifying data for eventual cross-linkage (such as request date and, if source, invoice number).

Upon finding or creating the related lab record (in both source and non-source encounter) the appropriate parameter data is then obtained by the operator through called subprograms, which are activated by menu selections. The subprograms (find1.prg and find2.prg) access and display a variety of previous EKG (or CXR) data for that patient, such as date of first abnormality, most recent results, etc. The principal steps in these subprograms are illustrated in FIGS. 6 and 7. A customized data entry screen is then generated (format file) for the operator to directly enter three parameter codes (based upon information previously obtained). The entry screen also displays the original identifying data, including patient I.D., request data and date test done, for operator confirmation. Then a blank record is created and appended to either the EKG or CXR file (depending upon which test result is being loaded) and all of the above data (present in the custom data entry screen) is written to that blank record including the subscripts collected earlier representing the diagnoses. In cases where the EKG or CXR test was normal the record will contain only two characters of data, one indicating "normality" and the other for indicating most recent result (if present). The parameter data is then written to the cross-linked "companion" lab record (which may also contain other test results). Thus, an EKG and/or CXR record is created and cross-linked to other related system files for that patient: lab record and in the vast majority of cases, the "source" record.

2. Laboratory (blood work) data entry routine (labfirst.prg, labentry.prg, findout1.prg and findout2.prg).

The current routine has been revised over that disclosed in Ser. no. 07/542,752 in order to adjust for the system's addition of EKG/CXR test result data as complete an separate clinical entities now being stored in their own logically related files. The current routine now takes into account the possibility that the lab record for holding the blood work results to be entered may already exist due to the prior entry of EKG and/or CXR parameter data from test results originating from the same encounter (both source and non-source) and passed to the lab record created (for holding EKG/CXR parameter data) during that separate EKG/CXR data entry routine run at an earlier time (as illustrated previously). In effect, due to this "cross-file" processing present in the EKG/CXR data entry routine for passing partial parameter test results to a "companion" related lab record, the present routine must now take into account the possibility that the blood test results presently being entered may have been ordered, and originated from, the same encounter (source or non-source) in which an EKG and/or CXR test was also ordered. Also, there is the lesser likelihood that the lab record is already existent due to only some of the original blood work ordered being completed earlier, and the routine is now being run to enter the remaining blood test results for that patient which were ordered from the same lab test request as the test results already on file. This latter possibility, although uncommon, may arise whenever a lab test is ordered for up to fourteen separate elements which conceivably may not be run as a complete unit or battery on the same day.

Pursuant to the above, upon entering the labfirst.prg routine, the specific nature of the encounter, whether source or non-source and then which of the three specific sources, is solicited and then collected in step (912) of FIG. 9. In the case of a source encounter, selecting office visit, E.R. or specialty allows the routine to obtain the appropriate invoice for use in searching throught the lab file to determine if a lab record holding lab test results (including EKG/CXR or earlier done blood work) ordered from same encounter is already present. In the case non-source is specified, the lab file is searched directly by using the request date and patient I.D. as the search indices to determine if a lab record holding other lab tests results is already present. If the routine determines that a prior lab record holding test results (created probably in the EKG/CXR data entry routine) is not present, then one will be created in step (921). The created record will be loaded with data identifying the patient, date of request, date tests completed, lab record invoice, and if from a source encounter then the invoice from that office, E.R. or specialty visit.

After completion of the above, the segment for actual lab record creation, or as the case may be, for simply editing the current blood work tests from an already existent lab record, is entered. FIG. 10 illustrates this routine. Prior to this, however, the operator can access a variety of previous test result data for each lab test to be entered through subroutines findout1.prg and findout2.prg, which are selected through menu options. These subroutines are used for obtaining data from different clinical aspects such as first abnormal data, most abnormal value, most recent result, etc. These two subroutines are illustrated in FIGS. 11 and 12.

Once sufficient prior information for each current test result to be entered is obtained, a customized data entry screen is generated (step 1018) with instructions for operator assistance. This screen allows direct entry of both numeric results and parameter data into each of the indivudial lab test fields to be edited. As in the case of EKG-CXR entry, if a lab test result is normal only two characters are entered: a normal indicator and the most recent result, if present. An example of a source document for entry of lab record (blood work) is given in FIG. 13. Note that unlike the EKG/CXR data entry routine where partial parameter EKG/CXR data is passed to the "companion" lab record, there is no such cross-file processing in the opposite direction. In fact, and as can be seen from the format file used here, the EKG and CXR fields common to both lab and EKG/CXR entry records are "hidden" from view. The only way in which parameter data may be entered into these fields is through the EKG/CXR data entry routine.

Thus, blood work form a "lab test request" is loaded onto an existent lab record previously created, most probably during an EKG/CXR data entry routine for loading results from the same "lab test request". Or the blood work is loaded onto a newly created lab record as the only or first results obtained from a "lab test request" (source or non-source). In either caswe and as in the EKG/CXR entry routine, the lab record is also linked for crossreferencing to any possilble co-existent related EKG/CXR records from the same lab test request. In the case of a source encounter, the lab reocrds are also linked to any of three possible settings (office, E.R., specialist) from which the "lab test request" (blood work and/or CXR/EKG) was made.

3. Print program (print6.prg) for reporting office visit based EKG and/or CXR test results in conjunction with other concurrent clinical data present during the primary care visit in which the tests were ordered.

The purpose of this application is to combine logically distinct but related medical data stored in separate files linked throught common fields. Specifically, this routine links office visit (primary care) records with EKG/CXR records in a "parent to child" relationship. It integrates different and separately stored aspects of clinical data commonly derived in time and place, all centered around the office visit, for a broad composite view of medical care and resource usage. FIG. 14 illustrates the major steps of this program.

Consistent with the underlying thrust of the invention, the clinical data viewed in this report has been generated under a uniform standard set of conditions applied to a population of medical database out-patients in order to establish some reference to facilitate its analysis. This has been accomplished by selecting from a primary file, which stores the compiled results of office visits, only those patient records that meet certain clinical criteria (step 1411). These criteria include characteristics such as a chronic cardiac-based diagnosis as the primary problem during that office visit, presence of any of eight possible single character codes for indicating that at least lab work (in general, a "lab test request") was done, the occurrence of the office visit at least two weeks prior to a controld date, and evidence by code that the patient was symptomatic (or more symptomatic than ususal). Those records selected are then written to a secondary file that will serve as the program's basic unit of information processing.

Each patient's records are processed as a group wherein each page of the generated report represents data from the total number of relevant office visit records on file at that time for that patient. Separate categories of information (such as information from office visits and EKG/CXR) for each patient is delimited by broken lines on the report. The appendix computer listing illustrates example reports generated by this program.

The programs advances though each patient's records and prints general indentifying data once per page. For each office visit the routine prints out data uniquely identifying it (such as by invoice or date) along with patient clinical data. In step (1421) it is determined if EKG and/or CXR tests were ordered during each office visit by searching common data items though both EKG and CXR files. If found the stored subscripts corresponding to the various diagnosis are accessed and used to reference the full descriptive texts from the EKG/CXR table entries stored in memory files. The EKG and/or CXR diagnosis in descriptive text in combination with other data uniquely identifying the EKG/CXR records are formatted along with pertinent clinical data from the "parent" office visit record for detail line printing. In the case where either EXG or CXR tests have been performed, but not both, there is no explicit message in place of any would-be data. But in cases where neither has been done, there is a message. FIGS. 16-22 show reports generated by the program print6.prg.

4. Print program (print7.prg) for reporting out specialist (consultant) recommendations in conjunction with related clinical data from primary care office visits from which the referrals were made.

As in the previous reporting routine, the purpose here is to combine, for the purpose of analysis, logically distinct but related medical information stored in separate files linked by common fields. Namely, this routine integrates primary patient-care data (office visit) with subsequent consultant data in a respectively "parent record" to "child record" relationship. FIG. 15 illustrates the principal steps in this routine.

The list of system specialists include eight conventional types, for instance cardiologist, hematologist, rheumatologist, etc. The recommendations used by the system specialists consists of nine general adivsements of courses of action non-detailed in nature. Each of the nine advisements are to be used as universal standards for all specialists. The advisement include "continue present treatment", "change existing meds", "more lab tests", etc.

As in the previous embodiment (print6.prg), this routine begins by selecting out from a primary file containing compiled office visit data only those patient records that meet a predefined set of clinical criteria in step (1511). These criteria include a chronic cardiac-based condition as the primary problem during the office visit, whether the visit occurred at least 2 weeks prior to a control date, presence of a field code (single character) indicating that a specialty referral was made during that primary care office visit, and whether the patient was symptomatic. These records are then written to a secondary file in which all the records present now serve as the program's basis unit of information processing.

With the file indexed by patient name, the program processes each patient's record as a group. Each page of the report represents one patient and each unit of data delimited by broken lines contains the combined office visit and linked specialty data. There may be more than one specialist visit derived from any previous primary care office visit due either to a follow-up visit or the fact that more than one type of specialist referral was made from any primary care office visit. For each office visit a search is conducted in the specialist file based upon patient and request data. If found, three different specialist data are accessed from that related child record: the type of specialist, the individual specialist recommendations and the specialist's own diagnosis. The type of specialist is accessed by a subscript and expanded to text via a tables of entries containing the descriptive names arranged as an array. The individual specialist recommendations are also stored as subscripts and used to reference their corresponding text descriptive courses of action from a table of entries arranged as an array. The specialist's own diagnoses is referenced by it's six digit code from either the short-term or long term (chronic) diagnostic table depending on that specialist's impression. This information is then formatted with pertinent data from the parent office visit record for printing a composite clinical practice containing both primary care and its related specialty data. FIGS. 23-30 show reports generated by the program print7.prg.

The appendix contains the computer code corresponding to the above described programs. ##SPC1##