Introducing MOD-U-LIS. Flexibility - User Modifiability. Designed to Meet Quality Assurance Guidelines. Using Advanced Technologies.

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1 Introducing MOD-U-LIS MODULUS tm LIS provides total solutions to the management of laboratory information, work, and quality. It is complete in its handling of specimen data from patient and order entry to final report. It is comprehensive in scope, providing for all areas of the laboratory, including: Microbiology, Blood Bank, and Anatomical Pathology. Modulus has provided solutions for the hospital environment, it has also provided solutions for large reference laboratories and for specialty areas such as the dialysis laboratory. Using Advanced Technologies Central to the design of MOD-U-LIS is its use of powerful relational data base software. This provides the user with un-compromised access (windowing) to data base information. Windowing eliminates hard copy look-up of physician information, test codes, DRG codes, test mnemonics, etc. MOD-U-LIS is implemented by fourth generation language and augmented with C code. The UNIX TM operating system platform provides software portability, giving the user a high degree of investment protection. Open architecture1 provides the laboratory with the freedom to choose a hardware platform; i.e., the system is not locked to a single vendor s proprietary hardware or operating system. While MOD-U-LIS makes use of the most advanced technologies available for its software, it places similar emphasis in its selection of hardware: providing optical disk technology for archiving, color monitors for uncluttered presentation, laser printers for enhanced readability, RISC computer architecture, and mirrored disks or disk arrays for reliability. Bar code technology is used to reduce patient and specimen identification errors, and auto-faxing provides inexpensive remote reporting capabilities. In a dynamic medical environment where complex decisions must be made quickly, information must be readily available, rapidly accessible, and in a format that facilitates user assessment MODULUS LIS incorporates a number of features to facilitate operation: Data windows. Multiple screen forms facilitate database search. Use of screen forms provides for a near paperless system where reference information is easily conveyed on the screen. Screen aids. The user is constantly provided for a near paperless system where reference information is easily conveyed on the screen. Application selection. The system provides selection through menu screens. For the more advanced user, direct mnemonic calls will facilitate selection and movement about the system. Scalability Modulus systems have been designed for a wide rangeof laboratories serving from 300 to patients. Flexibility - User Modifiability Flexibility is of paramount importance in countering system obsolescence. With this in mind, MODULUS LIS provides the user with modifiable report, screen and label formatting, and control of the operating environment. A key contributor to system flexibility is the inherent capabilities of the relational data base software. It not only allows for orderly changes of files and schema design, but also provides a query language for user created ad hoc reports. Designed to Meet Quality Assurance Guidelines Designed to meet demanding Quality Assurance requirements, MODULUS incorporates such features as: computer assisted ordering (for completeness of testing), interpretive reporting, graphic charting of results, and color highlighting of abnormal results to assure that the significance of test results is not lost to the clinician, Positive Patient/Specimen identification through use of bar code technology; extensive error checking to minimize data entry errors; ANSI standard SQL query language and report writer to produce ad hoc reports. On line remote reporting to reduce test turn-around-time. System Features The use of relational database technology coupled with 4 th generation language implementation is the basis for designing a system that is powerful, flexible and feature rich. Significant features of this system include: 100% up time; i.e. system always available - even during backup periods. Windowing Context sensitive help Extensive user modifiability Expert systems technology provides: Interpretive reporting Reflexive ordering Checks for results consistency Bar code technology Hand held computer (phlebotomy) Specimen label generation - on-line and batch Near robotic specimen-instrument processing Remote reporting FAX, laser or impact printers Reporting at predefined time(s) or at results verification time Color graphics plotting on screen or color printer Test results QC plots Management reports Ad hoc query language and report writer

2 Lab System Functions The primary function of the laboratory system is to manage information, this is accomplished through one or more of the following Patient Registration Order Entry Specimen Processing Specimen Tracking Worksheet generation Results Entry and Instrument data collection Results Verification Reporting QC Management Reporting Patient Registration The patient registration function maintains patient demographic and medical information to support lab work for patients. A patient record may be created at the LIS or transacted via a Hospital information System(HIS). The patient information and related test results are stored in the system until the patient is discharged. Patient information may include: sex, age, attending physician, location, blood type, patient physical data such as height and weight, (used for calculations of Creatinine Clearance), etc. Menu Selection The system provides application selection through a menu system (see above); A menu tree, however, often requires the user to traverse through multiple levels before attaining final selection. To facilitate selection the more advanced user is provided with the capability to issue a two or three letter Mnemonic; i.e., pa = patient admit, oe = order entry, inq = patient inquiry, etc. The system administrator can customize menus for different classes of users; i.e. doctors, technologists, clerks, phlebotomists, microbiologists, etc. The screen above depicts the windowing into the database feature. In this example the user is prompted for blood type, through a drop down window. Once the desired item is selected the user pastes the selection into the appropriate field by pressing a single key. Order Entry Laboratory test ordering may be performed at the LIS, or alternatively, transacted from the Hospital Information System(HIS). The user has the capability to enter tests by numeric code, mnemonic code, by entering the full test name, or entered as a computer assisted (based upon rules) entry based upon DRG or other criteria.

3 specimen collection is accomplished by reading each specimen label at the receiving station. In the above example, an R character follows the specimen identification. The R denotes a Red top tube. Other identifiers can indicate U =Urine, P for Post Dialysis, L for Lavender top, etc. These identifiers can be used for Specimen collection verification, and for implementing a near robotic specimen handling system, where operation is in concert with the query-host instrument. Worksheets Modifying the order at the LIS is relatively simple in that the modification prompt is responded to by entering minus(-) in front of the test name; viz -GLU will remove a Glucose test from the order. Specimen Processing Specimen handling is a critical link in the order process. MODULUS Specimen label generation includes barcoded labels with identification to the container level. Modulus provides extensive capabilities in handling bar-coded specimens. Label formats are user modifiable and can accommodate barcode protocols intermixed to conform to different lab instrument requirements. requirementments. A unique feature of the Specimen identification is the ability to identify a specimen to the container level. Part of the barcoded label includes a unique identifier juxtaposed with the specimen identification number. Confirmation of Worksheets and trayload lists are produced to organize the work performed at each workstation. The user has the option to include only collected specimens, or all tests ordered, regardless of specimen status. Formats for worklists are user modifiable. Worksheets are not required to collect or enter test results. However, some instruments may require creating a trayload list prior to running tests. It should be noted that the query-host instruments working with barcoded specimens do not require loadlists. Results Entry MODULUS LIS provides several methods for capturing test results, including: Instrument on-line data collection Terminal keyboard entry Keypad entry From a terminal keyboard the user may enter test results by either of two methods: Manual result entry is a batch entry operation where method is prompted by a worklist. STAT result entry circumvents the worklist and verification processes to expedite entry and reporting. For either method, data entry is subjected to rigorous quality checks to prevent entry of erroneous data. Those checks include: Normal range - age/sex adjusted Panic range - user defined Technical range - values outside of instrument linearity Delta check - compares test result to previous value Consistency check Failing any of the above will alert the operator to take remedial action. The result entry screen displays the most previous results together with associated date and time. The system accommodates four types of result data; including: Numeric, Free Text, Mnemonic, and Calculated

4 Central to system design is the quick and efficient han dling of manually entered results. Minimal keystrokes is the design and goal and is implemented in various ways. Form mnemonic results, the user can batch enter similar results; e.g. NEGATIVE, can be batch entered through a few keystrokes. Calculations can be predefined and automatically executed. On-line Instrument Data On-line capture of instrument data is essential to improving productivity as well as reducing transcription errors. Data transfer is performed automatically between the LIS and the analyzer. The role of the LIS is to download a test schedule to the instrument and to accept and store test results uploaded from instrument to LIS. Modulus LIS accommodates many interface protocols, including:few keystrokes. Calculations can be predefined and automatically executed. Query-host Batch download of test schedule Broadcast Download of test schedules Interface to Robotic specimen handler Modulus does not use black boxes to effect the interfacing of instruments, but rather uses software drivers for this purpose. A by-product of the results verification module is the execution of rule-based logic for reflexive test ordering. Through this capability, the user can effect automatic order modification based upon the value or values of verified test results(s). For example: IF PT > 30 THEN add PTT test to the order Reflexive logic is designed to satisfy physician s standing orders. To make the reflexive action more specific to a Doctor, the equation could have included the Dr. code: IF PT > 30 AND (physicians code = NNN) THEN add PTT test to the order Results Reporting Modulus provides several types of patient reports. These include: Interim Daily Cumulative Cumulative trend Inquiry Other Data Entry Methods Modulus provides various proprietary keypads for handling test results. These typically provide buffering, backup, enabling data to be reviewed prior to verification, and providing a means for tagging a specimen or accession number to the result(s). The key pads provide for entering: Differential cell counting/rbc morphology data Urinalysis data Results Verification Data collected from instruments or manually entered into the system are placed in a holding state until reviewed and verified (released) by the technologist. Only after verification can a result become available for reporting. Verification can be performed interactively - one result at a time - or in batches. The batch mode provides for verification of groups of results that meet the five criteria for acceptance. The operation is executed by only a few keystrokes. In the interactive mode, the user is prompted (on the screen) to accept, reject, or modify each test result one item at a time. DAILY CUMULATIVE SUMMARY REPORT

5 The daily cumulative summary report shown above, features interpretive capabilities. The user is provided with the capabilities to modify formats as well as define test order and grouping. The interim report is similar in format, but includes only results verified since the last interim report was generated. The cumulative trend report provides the clinician with the visibility to track changes in test values during a period of time to view, chronologically, the effects of dispensing drugs and other therapies. INQUIRY SCREEN Interpretive result interpretive reporting is provided as shown in the above example for blood gas (note the interpretive comment Moderate Metabolic Acidosis appears as result of mapping the ph, PCO2 and HCO3 values). A plot of result trends can also be viewed on the screen. Microbiology CUMULATIVE TREND REPORT The cumulative trend report combines results for the patient over the course of the patients stay. Formatting, grouping and selection of time span are user definable. Either horizontal or vertical orientation can be selected. Patient Inquiry On-line patient inquiries can be initiated by patient name or ID number. Variations of this screen are provided for ward or doctor inquiries. When using a color terminal, abnormals will be highlighted in color; e.g. green denotes normal, orange is abnormal and red exceeds panic range. The microbiology module provides for the complete management of microbiology information. Its tables are user modifiable, thus providing the custom dictionaries for smears, antibiotics, organisms, sensitivities, body sites, etc. While providing for operation in a paperless environment, this module can also generate work cards. At order acceptance time, unique work card formats are provided based on microbiology tests ordered. Work card formats are user modifiable. Microbiology data entry is simplified through the use of mnemonics. QA capabilities include checks fro data consistency. Unlimited cascading of sensitivities are a feature of the module. Batch result entry comments such as no growth observed n days can be assigned to all negative cultures with just a few keystrokes.

6 QC Reporting The QC module is regarded as all important in the management of the analytic processes. Results accuracy depends upon the validity and adherence to defined QC rules and techniques. The system collects, analyzes and validates control results gathered from QC testing. These results are collected and stored automatically for instrument derived data, or entered at a terminal for manually derived data. In either case, results are validated against user defined criteria, such as conformance to selected Westgard rules. If the result is outside a user defined range or fails a rule, the technologist may enter a comment explaining the circumstance and action taken. Standard management reports provided by the LIS include: Work pending Uncollected specimens Daily work log Abnormal, panic, and fail delta results Test Census and revenues Revenue analysis Turn around time Audit log of errors or changes In the interest of measuring laboratory productivity, the system provides workload measurements base upon tests performed as well as repeats, standards and controls. Workload information can be categorized by workstation and shift. Ad hoc Reporting The power of the relational database software and its ability to window (view information in various ways) into the database is brought to the user s fingertips through the SQL query language. Through this tool, the user can write simple short scripts to extract and report investigative information. System Implementation MODULUS LIS has interfaced to a number of different HIS systems including: HBO s Medpro and Medstar, Baxter ibax, Gerber-Alley, SDS Mednet, SMS, AMI and other systems. Over one hundred different instruments have been interfaced. LEVY-JENNINGS PLOT Quality control results can be reported by the system in several different ways. Graphically, data can be presented in Levy-Jennings format, together with Westgard rule violations as shown above. This plot can be displayed on a color monitor, where the chart is selected interactively. It can also be exported to a laser printer for permanent copy. The number of days (horizontal axis) is user definable. Management Reporting MODULUS LIS produces an extensive list of prepared reports and graphic plots for management use. In addition, the user can augment these reports through the ad hoc reporting capability. Management reports can be used to assess laboratory operation, to measure workflow, and to generally provide information to assist in planning. Modulus Data Systems, Inc. provides support service - 7 days per week, twenty four hours per day. Communications between the support personnel and the customer include a hot-line, diagnostic modem to the laboratories computer, and FAX. Modulus reputation for personal service, quality software, and responsive people is unmatched in the industry. Modulus strives for excellence in supplying and serving its customers. For more Information... Call or Write: George Liviakis, President Modulus Data Systems, Inc Walsh Ave. Santa Clara, CA PHONE: (408) FAX: (408) or To sales@modulusdatasystems.com