Project Data Model

Data Model for Ophthalmology Documentation

Published by the Project Management Division at ifa systems AG/ Cologne, Germany

Table of Contents 1.

Concepts on structured medical documentation.................................................................................. 4 1.1 1.2 1.3

2

Computer Science in Ophthalmology............................................................................................ 4 Individualizing and Standardizing .................................................................................................. 4 The 3 levels of medical Service procedures .................................................................................. 6

Data Entry Structure .............................................................................................................................. 6 2.1 Patient Context.............................................................................................................................. 7 2.2 Risk Factors .................................................................................................................................... 7 2.3 Ophthalmic Numerical Findings .................................................................................................... 7 2.4 Refraction data .............................................................................................................................. 7 2.5 Observation Classes....................................................................................................................... 8 2.6.1 Ophthalmic Surgery ................................................................................................................... 9 2.6.2 Orthoptics ................................................................................................................................ 10 2.7 Diagnoses for Refractions............................................................................................................ 10 2.8 Ophthalmic and Global diagnoses............................................................................................... 10 2.9 Treatment Plan ............................................................................................................................ 10 2.10 Service Codes............................................................................................................................... 11 2.11 Medications ................................................................................................................................. 11 2.12 Medical Surgery ........................................................................................................................... 11 2.13 Glasses/CL Prescriptions.............................................................................................................. 11 2.14 SNOMED Mapping Observation Classes ..................................................................................... 12 2.15 SNOMED Diagnosis Mapping ...................................................................................................... 12 2.16 SNOMED Medications (Database)............................................................................................... 12 2.17 Free Text Documentation............................................................................................................ 12

3.

Data OUTPUT Structures ..................................................................................................................... 13 3.1 Complete Patient Record ............................................................................................................ 13 3.2 Filtered Patient Data ................................................................................................................... 13 3.3 Chart with Numerical Findings .................................................................................................... 14 3.4 Graphic Findings .......................................................................................................................... 14 3.5 Structured Reports ...................................................................................................................... 14 3.6 Administration reports, forms and Billing ................................................................................... 15 3.6.1 Administration reports ............................................................................................................ 15 3.6.3 Billing ....................................................................................................................................... 15 3.7 Statistics and Analysis.................................................................................................................. 16

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3.8 Export Interfaces ......................................................................................................................... 16 3.9 SNOMED (Structured Reports) .................................................................................................... 16 4. Organization of Introducing Ophthalmic Documentation .............................................................. 18 4.1 Data Input and Output Areas ...................................................................................................... 18 4.1.1 Data Input Areas ...................................................................................................................... 18 4.1.2 Data Output Areas ................................................................................................................... 20 4.2 Checklist for generating and presetting the system ................................................................... 22 4.3 System Analysis for Data Interfaces ............................................................................................ 24 5.

Summary ............................................................................................................................................. 26

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Data Model for Ophthalmology Documentation (ifa systems AG) 1. Concepts on structured medical documentation By the use of computers, a milestone in history has been reached - to have the ability to document with standardized terminology and structured data. Scientific development and quality can be increased rapidly if valid and digitally processed data is available. The era of text reports in the medical field is over and instead observations are being systemized and made communicable.

1.1 Computer Science in Ophthalmology Ophthalmology was predestined for a complex data model for documenting medical and demographic patient data for the computerized patient record. Within 20 years (from 1987 to 2006) a multidimensional data model for documentation in eye clinics and practices was developed by the ifa systems Group. The system was supported by the official EU project (OPHTEL – Telematics in Ophthalmology) and the international IEE-Project (Integrated Eyecare Environments).

With the data model it is possible to systematically document more than 98% of all patient cases in ophthalmology as well as in global medical observations. For this, there are approximately 40 terminology databases that are linked to one another for individualized as well as standardized terminology. Doctors can link their own individualized vocabulary (coded) with a standardized terminology dictionary (e.g. diagnosis codes (custom) with ICD terms).

Additionally, the data model offers very flexible and variable documentation because descriptive terms as well as classifying terms are available in different databases. This makes the data model compatible with the ICD classifying system and the descriptive SNOMED nomenclature.

1.2 Individualizing and Standardizing A data model is only acceptable when a doctor can keep using the methods he/she has learned for documentation. The digital data structure has to be flexible in a way that it can be adapted to the doctor’s methods and not the other way around.

In ophthalmology, there are different models for examination and treatment procedures as it is the case with medical documentation. Some ophthalmologists work systematically based on the area of the eye (organ oriented e.g. cornea, retina, lens etc.). Others work based on the examination steps and document accordingly (diagnosis, slit lamp, refraction, etc.).

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These examination and treatment procedures are represented by so-called observation classes (observation classes in SNOMED) which can be defined by users within the ifa program. The user can use pre-existing terminology databases and –for a specialized field – can expand upon these and differentiate.

The elements in observation classes are made up of 5 digit codes (abbreviations) each with a long text description. Additionally, the codes can be modified, localized and ranked (SNOMED modifiers). For example, a code for an embedded corneal foreign body might be COFBE. With the additional fields the entry can be further qualified with e.g. OD for right eye, 3O for 3 o’clock localization and FR for rusty iron. Another clinic (or practice) may use different abbreviations for the same observations.

Standardization comes through at a later point of time with the so-called mapping database.

The mapping functions can be understood clearly in an example with diagnosis. Ophthalmologist can map (link) their own abbreviations with corresponding ICD Codes. A further advantage of this data model is the fact that customized abbreviations can be linked to more than one diagnosis standardized term.

For example DR01 can be used for Diabetic Retinopathy, Retinopathy is the basic disease and diabetes is the modifier. In a SNOMED report it is also possible for colleagues from different fields of medicine to interpret the standardized report.

By linking customized terminology with standardized terminology a worldwide communication system is created. This makes it possible for doctors in Italy to document in their own language, the system summarizes the codes into a report and a colleague in the USA receives the report in English.

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1.3 The 3 levels of medical Service procedures The procedures for patient examinations and treatments can be organized into 3 levels. At the beginning level there are assorted observations, tests and patient interviews (findings survey). In the second level, medical evaluation or classification takes place (diagnosis). From here the third level is derived e.g. doctors orders, prescriptions, surgery or other therapy.

Level 1

Observation and Examination Results

- Reason for visit - History - Findings - Test results, etc.

Level 2 Medical Classification - Diagnosis - Suspect diagnosis - Rule out diagnosis Level 3 Doctor’s Treatment - Prescriptions (glasses , medicine, etc.)

- Surgery - Treatment plan - General therapy The data model for ophthalmic documentation (ifa program) makes it possible to link 3 levels. Repeat processes can be transferred to the data model where findings are linked with the diagnosis and these are then linked to suggested doctor’s orders.

In all 30 observation classes up to 5 suggested diagnoses can be linked to one findings code. Diagnoses can then be mapped with service codes (e.g. billing codes) and suggested medications.

Linking different levels of typical service procedures in the clinic can simplify data input on the one hand and can function as a sort of a guideline on the other hand.

Presettings for the data model are made in the ”User“ and ”Abbrev.“ area of the program.

2 Data Entry Structure Ophthalmic documentation in the ifa program offers approx. 200 different types of data (with different field structures) for the fields of conservative ophthalmology as well as ophthalmic surgery and orthoptics/strabismus. Within the OP documentation it is possible to generate additional customized types of data.

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2.1 Patient Context In order to optimize data input, age and sex are automatically generated from the demographic data (date of birth and salutation). Since race can be relevant to certain eye diseases an additional data field within the demographic part of the system is available for that use.

Other social patient factors are stored within the 30 findings classes and not in the demographic area of the program so that these factors are available if needed for reports.

2.2 Risk Factors In order to emphasize the importance of medical risk factors this data can be entered into a separate area. Medical risk factors are defined as allergies, blood pressure, handicaps, etc. This area of the program was designed so that assistants (non-physicians) can enter this data in the pretesting phase of the examination. The 30 findings classes are generally used for differential and more discreet types of risks since this data is entered by doctors.

The medical risk factors in this data category are constantly displayed at the top of the screen of the patient’s medical record. This data can also be exchanged with monitoring programs in order to establish an ”Early Warning System“ (watch dog) in the clinic.

2.3 Ophthalmic Numerical Findings In ophthalmology important findings and results from tests made with instruments can be produced which makes data interfaces available. These data records are compatible with standard output from examining instruments. The following areas are available:  Intraocular Pressure (IOP)  Visual acuity  Keratometer data

-> -> ->

Connection to NCT Connection to phoropter AR/keratometer systems

Other numerical test results e.g. perimetry and biometer data are entered and stored in separate software applications. More and more software modules are becoming available from the instruments manufacturers. These applications are linked to the patient history via interfaces.

2.4 Refraction data Two different types of data records are offered for refraction data:  objective refraction -> Connection to autorefractor  subjective refraction -> Connection to autophoropter Results from refraction data are used to generate suggested prescriptions for glasses and contact lenses.

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2.5 Observation Classes The observation classes are extremely important for structured ophthalmic documentation. 30 different observation classes can be custom defined by the user. An unlimited number of codes (abbreviations) is available for each observation class.

For example, observation classes can be defined for the following areas:  General history  Family history  Medical risks  Corneal findings  Fundus findings etc.

Standard presettings in the 30 observation classes cover from 6,000 to 10,000 abbreviation codes. The basis code consists of a 5 digit abbreviation (that can be digitally stored) and a description that can be 40 characters long. The descriptions are linked with the presetting table to the stored abbreviation.

Example:

GLAOA Glaucoma open angle

Within data entries observation classes (findings abbreviations) can be qualified with further abbreviations called modifiers. These specific modifiers contain data on: whether the observation was made on the left, right or both eyes, the localization of the finding, the severity of the finding. For each finding 3 additional fields exist for entering these modifiers.

When designing the observation codes, two different concepts can be used. The observation code can be entered very generally and the specifications will be entered into the modifier fields. Theoretically it would be sufficient to differentiate between only two different types of glaucoma and any further specifications could be made in the 3 modifier fields. The other option consists of using the findings codes to differentiate distinctively between diseases and then only use the modifier fields for special localization modification (or special cases). The advantage of the last concept is that by differentiating the findings codes distinctively the findings can then be used for specific statistical analysis. The modifiers are included in all data output functions i.e. text reports, letters, etc. but in quantitative statistics only the observation codes (findings) of each class can be evaluated. The suggestions for presettings are usually so distinctive that they can be used by other specialized eye clinics.

Currently, standardized terminology for ophthalmology is being written on an international level. A committee from the AAO (American Academy of Ophthalmology) is currently developing proposed terminology, based on the so-called SNOMED standard (SNOMED = Systemized Nomenclature for Medicine).

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SNOMED is a descriptive documentation language that differentiates between model levels and observation classes. The data model in the ifa program is completely compatible with the SNOMED concept. As soon as the reworked ophthalmic SNOMED nomenclature is finished it will be possible to link custom finding abbreviations (observation codes) with SNOMED codes with the so-called mapping program.

In the data model it is also possible to link certain findings with proposed diagnoses. For example, the finding ”visual field loss“ could be linked with several glaucoma diagnoses. If these links have been set, when entering this finding, the linked diagnosis will be recommended to select from. The user can simply click on the appropriate diagnosis or enter a different or new diagnosis into the medical record. These links on different levels help to simplify data input and more than that help to establish the use of certain documentation guidelines.

The abbreviations and the corresponding descriptions of observation classes are displayed in the computerized patient history, printed out in reports or displayed in interfaces.

2.6 Special-Documentation Ophthalmic documentation can cover all areas of ophthalmology because of the flexibility in the program’s design (see 30 observation classes). Additionally, the CPR software offers special data models for 2 extra areas in ophthalmology:  Ophthalmic surgery  Orthoptics Both of these documentation areas are integrated in a way that they are directly linked with one another. In practice, this means that all general findings and diagnoses are also available for the OP documentation and patient orthoptics records.

2.6.1 Ophthalmic Surgery Additional data records are supplied for documenting surgical cases. Types of OP’s (e.g. phaco) can be preset to include all of the standard steps for that OP. Complete documents i.e. OP reports are linked with these OP types. Changes can be added with customized information to accommodate any deviations in the procedures for that surgery (e.g. complications).

A data record generator (designer) exists in the OP program. This designer can be used to generate customized special data records that are not already included in the program. Data records for lens specifications already exist in the OP program.

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2.6.2 Orthoptics A complete additional data model is available for the area of orthoptics. Included in this model are data records for e.g. binocular vision, stereopsis, motility testing with 9 or 49 positions, etc. This numerical data is supplemented by observation codes from the 30 observation classes. If a special department for orthoptics/strabismus exists in the clinic then it is recommended to define and preset one of the observation classes just for that area.

2.7 Diagnoses for Refractions Based on refraction values that have been entered, refraction diagnoses e.g. myopia will be automatically proposed by the program. The system evaluates the refraction data and can even propose combined diagnoses e.g. myopia and astigmatism. A single refraction diagnosis code can include up to 4 different diagnoses.

Refraction diagnoses are part of general diagnoses. They are made up of a 5 digit abbreviations, a 40 character description and a general classification for normal, permanent and quarterly diagnoses (see below).

2.8 Ophthalmic and Global diagnoses A separate database is available for diagnoses, independent of observation classes. Just like the refraction diagnoses, global diagnoses are also 5 digit abbreviations, 40 character descriptions and classified by normal, permanent and quarterly diagnoses.

A permanent diagnosis is automatically reentered into the patient’s medical record at every visit.

Permanent diagnoses are always visible in the header at the top of the patient’s medical record.

The user classifies which diagnoses are considered normal, permanent, etc. Examples of permanent diagnoses might be pseudophakia, glaucoma, etc. Normal diagnoses are any acute illnesses, injuries, etc.

The descriptions for diagnosis codes may include the corresponding ICD codes. It is also possible to link the ICD’s to the diagnosis with the mapping database.

2.9 Treatment Plan A specific patient treatment plan can be derived and generated from service codes. In the treatment plan, all examinations and measures taken are displayed graphically on a time axis. Call up the treatment plan and get a quick overview of all examinations already carried out and all measures planned for the

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future. These measures can then be linked to the departmental “Appointment Scheduler” in the program.

2.10 Service Codes A database is available for all medical services (e.g. procedures, examinations, tests, etc.). The service code field has 5 digits (for alphanumerical codes). The codes can be linked to a service legend. It is also possible to store descriptive tests for the service code descriptions. This database can be used for insurance codes.

2.11 Medications A separate database just for ophthalmic medications is also available. A code is available for all medications and combinations of medications that are on the market (including different package sizes).

The database stores the name, the package sizes and all other relevant data.

It is also possible to link internal medication databases (typical prescribed meds for that clinic) to an external industry database, often available on CD. The distinct central pharmaceutical number is used as the identification code for mapping with corresponding data records (in Germany).

2.12 Medical Surgery Codes for OP’s can be placed in different databases depending on the specific statistical needs. OP codes are included as part of the general documentation within the 30 observation classes. This way, a special class for OP history with the corresponding OP codes is often dedicated within the history part of the program (e.g. ICPM codes).

Furthermore, codes like ICPM can be used to supplement or replace the service codes. This is practical if statistics for service codes are needed.

The third possibility for ICPM codes is in the specialized OP documentation. The ICPM codes are part of the data exchange for AODT (outpatient operations data transfer from the German insurance companies).

2.13 Glasses/CL Prescriptions Based on data input for refractions the program automatically proposes prescriptions for glasses/contact lenses. For the actual prescription additional data (e.g. type of glasses, etc.) needs to be added. The data in the data record “Glasses Prescriptions” is the basis for printing out prescriptions for glasses or contact lenses.

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2.14 SNOMED Mapping Observation Classes The introduction of the SNOMED codes in international ophthalmology represents a new additional database for terminology. The codes from the 30 observation classes can be combined with SNOMED codes. These links already exist for the area of diagnosis.

2.15 SNOMED Diagnosis Mapping Standardized terminology is often not flexible enough for daily documentation in the computerized patient record. For this reason, the data model provides the ability to link custom terminology with standardized terminology (mapped).

The individualized diagnosis codes can be combined with ICD codes, which are part of the SNOMED nomenclature. ICD 9 and ICD 10 databases are also available. These are classified based on WHO (World Health Organization), in a 5 digit system, and further classified with 6 digits. The 6 digit code is based on the ICD catalog published by the American Academy of Ophthalmology (see also book on ICD coding in ophthalmology, published by Biermann Publishing in cooperation with ifa).

Mapping local diagnosis with standardized codes makes it possible to combine custom abbreviations to several diagnoses. Then, for example, the abbreviation DR for diabetic retinopathy is linked to the ICD code for diabetes as the basic disease, and to the code for diabetic retinopathy for the ophthalmic disease.

The ICD database makes it easy to link both codes. An intelligent search algorithm screens and compares the long descriptions in both databases.

In Germany, a linked database combination of local terminology with the ICD terminology already exists.

2.16 SNOMED Medications (Database) Medications can also be linked with external standards. In Germany links exist between medication abbreviations and the so-called Central pharmaceutical numbers.

2.17 Free Text Documentation In addition to the structured input that has been described up until now, the data model also offers the ability to enter free text into all areas of the program. The free text entries should be kept to a minimum though, in order to allow for a systematic analysis of the digitally stored patient data. The custom terminology should be so distinct, especially in the 30 observation classes, that more than 98% of the observations can be systematically stored. The individualized free text should only be used in special cases.

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The individual free text can be entered into the remarks line to all observation classes where codes are attached (F4 function).

Another free text function exists in the program for entering multiple lines of free text. These too, can be combined with the data model.

A third possibility exists by entering information into the so-called “Infobox”. The “Infobox” should be seen as sort of a reminder note that is only usually used on a temporary basis – e.g. special notes about patients.

The fourth possibility is the creation of text reports. Two different text systems exist:  

ifa Write MS Word for ifa

Documents can be created with both systems that can be included as part of the patient record.

3. Data OUTPUT Structures Complex output structures also exist to the differential input areas within the CPR software. The stored patient data in the CPR can be evaluated and exported in all possible forms e.g. text reports, forms, digital data reports as well as billing and statistics.

3.1 Complete Patient Record The complete patient record is a compilation of all stored data for that patient. This is displayed in the screen and contains all numerical results from all 30 observation classes, diagnoses, medications, free text, etc. This complete patient record can also be printed out.

The complete patient record (as well as all other displays of data) can be custom defined by the user and thus modified (see “User”).

3.2 Filtered Patient Data The program offers a variety of possibilities for filtering patient data for compromised analysis and interpretation.

As an example for this, the so-called “patient record short” can be used. This record can be custom defined by the user. It may be used to include all data only from the last visit.

A so-called “Layout Medical Record Screen” can be created for each working area within the program (e.g. observation classes, diagnosis input, etc.). This “Layout Medical Record Screen” displays any "other"

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data that is relevant for that working area or area of documentation. The user can use the information system for entering data from already existing patients.

For clinical documentation it is also sensible and essential to document the "normal" findings. Since this substantially increases the amount of data entered for each patient, it can overload the “quick overviews”. For this reason, a function has been developed to highlight only the “important” findings.

This makes it easier to quickly evaluate the extracted data. The program can be set up in a way that only “important” findings will be displayed thus producing a quicker overview.

Another method of filtering data exists of course in generating reports. All codes are imported into the reports that are necessary to create an overview.

3.3 Chart with Numerical Findings The data model provides graphic charts for visualizing observations and findings for tonometry and visual acuities.

The tonometry trend chart is especially important. Pressures for the left and right eye are displayed separately on a time axis. Additionally, an average of past IOP values can be displayed as a graph.

Graphic displays can have a positive influence on patient education and are often used in clinics to optimize patient compliance (e.g. glaucoma patients).

3.4 Graphic Findings Regardless of the type of data model, the ifa program makes it possible to display findings as graphics.

Symbols can be inserted or drawn onto templates (e.g. fundus picture, picture of the eye). These symbols are stored in a database together with their corresponding descriptions i.e. findings (e.g. horse shoe tear, cotton wool spots, etc.).

Photo documentation for ophthalmic data is also available (see separate pamphlet on storing images and image documentation).

3.5 Structured Reports Several alternatives within the program are available for text output e.g.:  

MS Word for ifa Report Generator within OP Documentation

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Form letters can be generated to be used for all patients where patient data is replaced from each patient. Graphic charts, findings graphics and patient images can also be inserted into the documents.

Reports generated in “Word for ifa” can be sent automatically as attachments to emails.

With Word a complex word processor such as MS Word was combined with the patient data from the ifa system to "MS Word for ifa". Prerequisite is the corresponding Word license. All of the patient data records can also be inserted into these documents. Form documents can be created for doctor's reports, OP reports or extensive individualized expert's reports.

A report generator within OP documentation is also available for quick text output. It generates the preset OP steps in a form document.

3.6 Administration reports, forms and Billing The system contains extensive possibilities for administration functions (e.g. clinic administration) which differentiates between patient relative and time relative reports.

3.6.1 Administration reports In administration reports there are direct and indirect ways of generating statistics. For the direct way, functions like the so-called Explanation Statistics for Coding (explanation of why codes were used, etc.) are available. The results are overviews of patient data with the corresponding diagnoses. On the one hand these documents the quantity of the services rendered, on the other hand the efficiency of the services (seen from an economic point of view).

For an indirect way of generating statistics, data can be exported into a standard database (e.g. MS Access) and evaluated in that program with the appropriate tools.

3.6.2 Forms All stored patient data can be used to create standard forms with a special “forms generator” – i.e. prescriptions, glasses prescriptions, patient release reports and internal patient oriented documentation.

Additional forms are available within the OP documentation.

Users can generate forms or alter existing forms on their own if they have been trained on the forms generator. (See guide to Forms Generator) 3.6.3 Billing Based on procedures and services codes the system can be used for writing and administering insurance bills and private patient bills.

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In Germany and Austria, the ifa system holds a license from the union of national insurance carriers for writing quarterly insurance bills based on ADT standards (exchange data protocol).

The program can also be used for private billing functions. Single or consolidated bills can be written.

Extensive service statistics are available for the area of patient billing.

3.7 Statistics and Analysis The system also offers direct and indirect evaluation methods for the area of statistics and analysis.

Direct statistics can be calculated straight from the system on documented diagnosis and medications prescriptions. Diagnoses are classified based on patient groups and age and the desired time periods can be selected (month, quarter, year, etc.).

Patient profiles can also be created. Statistics based on new and existing patients and single and combination diagnoses can be made (see also Recall).

If the diagnosis codes are mapped with ICD classifications, a distinct ICD statistic can then be made.

The direct evaluations can be supplemented by indirect evaluations with an external database. An export interface exists that can export patient data, based on time periods, into an external database e.g.

Access. The Access standard tools can be used to produce statistics in lists, charts, etc.

The indirect data evaluation makes it possible to filter data or to extract certain data for research which is not possible with the real data for forensic reasons.

3.8 Export Interfaces Extensive export interfaces are available within the ifa system. Data can be exchanged with local evaluation programs or with external administration systems. Although standard tools exist for export interfaces, each interface has to be programmed individually. For this, the IT Dept. will supply a system analysis with examples of data records. The data protocol can either be individualized or follow the HL7 standard. The ifa systems group is a member of the HL7 Organizational Committee.

The different possibilities for export interfaces are described in detail in the OPHTEL EU project (see “Status Report and Interface description“ WP11/Integration).

3.9 SNOMED (Structured Reports) Currently, efforts are being made to introduce the SNOMED structure (standardized terminology) on an international level. ifa is currently working together with CAT, a workgroup from the American Academy

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

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ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

of Ophthalmology, on a special issue of the existing codes for ophthalmology. Standard reports, called Structured Reports (SR) have been worked out within this cooperation.

3.10 DICOM Documents The DICOM standards were initially developed in the field of radiology and are used as the standard for all other areas of medicine. A DICOM document (DICOM = Digital Imaging and Documentation in Medicine) is made up of 3 areas:  Technical header  Image information  Medical data document (SNOMED) The technical header in a DICOM document depends on the instrument that is used (e.g. camera or diagnostic laser). In addition to the image data stored in a specific format, the document will be linked with information from the CPR software based on the SNOMED standards. The ifa systems Group is a member of the international DICOM committee and responsible (with others) for ophthalmology.

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

ifa united i-tech Inc. 1850 SE 17th St. Ste. 107 Ft. Lauderdale, FL 33316, USA phone: +1-888-4432367 www.ifa4emr.com

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

4.

Organization of Introducing Ophthalmic Documentation The complexity of the data model requires consistency in preparation for the computer documentation.

The data flow within the eye clinic/eye department needs to be analyzed ahead of time. The existing type of manual data input and output will then be changed with the corresponding presettings.

4.1 Data Input and Output Areas 4.1.1 Data Input Areas The data to be entered in ophthalmology comes from very different areas and data sources. Data categories can be classified as follows:        

General patient data Secondary history (not medical) Pretests General examinations Diagnosis statements OP area Specialized areas (orthoptics, strabismus, etc.)

Administration and billing

Data input can generally be separated into the 4 following areas:    

Data export from administration systems (demographic patient data) Data collection from non-physician (secondary history, pretests, etc.)

Data collection from physicians (primary history, findings, etc.)

Data export from digital diagnostic and examination instruments (autorefractor, perimeter, etc.)

An overview of the areas for data collection, the sources and the corresponding areas of responsibility helps to support professional use of the computerized data model (see next page).

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

ifa united i-tech Inc. 1850 SE 17th St. Ste. 107 Ft. Lauderdale, FL 33316, USA phone: +1-888-4432367 www.ifa4emr.com

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

Overview Data Input Eye Clinic/Eye Department Collection of Data

No.

Area of responsibility

Dept.

General patient data - Basic data (address, etc.)

- Admin. Data (internal pat. no. etc.)

- Reason for visit - Referring doctor - Billing code Secondary History - Risk factors - Chief complaints Pretesting - Objective Refraction - Lensmeter - Vision - Subjective Refraction - Perimetry General Examination - History - Chief complaint - General finding - Ophthalmic findings - Special examinations results Diagnosis statements OP area (separate entries) Special area (orthoptics, CL etc.)

Administration and billing data

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

ifa united i-tech Inc. 1850 SE 17th St. Ste. 107 Ft. Lauderdale, FL 33316, USA phone: +1-888-4432367 www.ifa4emr.com

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

4.1.2 Data Output Areas Similar to data input areas, data output areas can also be classified into different areas:      

Monitor screens Form printouts Invoices General reports and doctor’s reports Statistics Data interfaces to external systems

Furthermore it is important to differentiate between different data recipients and their communication forms:    

Administration department (billing and statistics) Colleagues (referrals, other treating physicians, etc.)

Patients (private billing, patient education fliers, etc.)

Team (training, internal studies, etc.)

With data output it is important to note the goals of the project (see Compendium for Introducing the Computerized Patient Record in an Eye Clinic). By using computerized data processing, information is consolidated substantially when compared with traditional hand written records. It is important to establish which additional areas for data output would be desired to attain even more efficiency when introducing the CPR. On the following pages you will find an overview of possible data output areas as checklists.

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

ifa united i-tech Inc. 1850 SE 17th St. Ste. 107 Ft. Lauderdale, FL 33316, USA phone: +1-888-4432367 www.ifa4emr.com

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

Overview of Data Output Areas in Eye Clinic/Eye Department Data Output No. Area of Responsibility Monitor Screens - Patient history (complete) - Patient overview - Layout of Medical Screen Forms - Patient registration overview - Exam form - Prescription for meds - Changes in glasses prescrip.

Billing - Internal services documentation - Insurance billing - Private billing - Billing statistics Reports and Doctor’s Reports - Release reports - OP reports - General doctor’s letters - Standard examinations - Special examination results Statistics - Diagnoses - Services - Patient profile Data Interfaces - Data import - Data export

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

ifa united i-tech Inc. 1850 SE 17th St. Ste. 107 Ft. Lauderdale, FL 33316, USA phone: +1-888-4432367 www.ifa4emr.com

Dept.

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

4.2 Checklist for generating and presetting the system The CPR system enables the user to customize presettings and adapt the program to fit the existing practice routines (data flow chart). Various working areas are available for this e.g. “User” and “System”.

The following are some of the areas that will be preset:     

Screen design Database documentation (abbrevation system) Mapping function (links internal and external) OP Documentation and other specialized areas Graphic surfaces (Smart Screen)

System generation and presettings are carried out in the preparation phase together with the systems partner. Suggested presettings are given to the user to be used as a basis for modifying and customizing their own.

Smart Screen (templates and buttons for quick data input) demands a separate special training session.

Customized templates can only be created after all areas of the system have been preset and the routines for data input are concrete and on paper.

On the following page you will find an additional checklist for support on these topics.

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

ifa united i-tech Inc. 1850 SE 17th St. Ste. 107 Ft. Lauderdale, FL 33316, USA phone: +1-888-4432367 www.ifa4emr.com

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

Additional Checklist for Presetting the System in the Eye Clinic/Department Generated Screen No. Area of Responsibility - Menu per workstation - Routine definition per workstation - Medical Screen Layout per workstation - Patient history - Patient file short - Positive findings/negative findings Database Documentation - Diagnosis codes - Observation classes (30) - Service codes - Medications - Other abbreviations Mapping Functions (Links) - Observations/ Findings – Diagnosis - Diagnosis codes - Diagnosis medications - Diagnosis ICD codes - Functions billing codes OP Documentation - OP classes and types - OP standards steps - OP services (ICPM) - OP reports User Surface SMART SCREEN - Menu templates - Entry templates - Functions templates (see separate description)

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

ifa united i-tech Inc. 1850 SE 17th St. Ste. 107 Ft. Lauderdale, FL 33316, USA phone: +1-888-4432367 www.ifa4emr.com

Dept.

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

4.3 System Analysis for Data Interfaces Establishing data exchange between the CPR system and other systems in the clinic is done in a separate system analysis. Included are the requirements from the IT Dept. The system analysis contains the following areas:      

Description of target system (functions, operating system, etc.)

Technical protocol descriptions (transmission, protocols, etc.)

Data description (data form and type of transmission) Mapping overview (if one category is to be transmitted into another category) Examples of desired data transmission Organizational information (Areas of responsibility, time schedule, etc.)

Different interface and data export programs exist (see OPHTEL deliverable Status of Integration). In any case, it is necessary to program and adapt each system individually, since the systems are heterogeneous. This is calculated based on time needed within the project. The system analysis should be available approx. 4 weeks before the test installation. Further changes will be made on the basis of supplements to the system analysis. On the following page, there is an outline for a proposal for a system analysis.

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

ifa united i-tech Inc. 1850 SE 17th St. Ste. 107 Ft. Lauderdale, FL 33316, USA phone: +1-888-4432367 www.ifa4emr.com

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

System Analysis for Export and Import Interfaces for CPR System (ifa) Table of Contents: 1. Description of target system - Admin. system - General documentation system - System platform 2.

Technical description of transmission

3.

Description of data for transmission

4.

Mapping overview (if data from observation class has been transmitted) Examples of desired data transmissions

5.

6.

Organization information

-

Physical transmission (e.g. file, serial, TCP/IP, FTP) Logical transmission Protocol (e.g. HL7, etc.)

-

ID Diagnosis CPT codes, etc.

-

Standard examples Record with all possible patient data to be transferred Examples as printouts and on data medium

-

Responsibility in the IT Dept.

Time schedule Confirmation for changes and budget

-

Remarks to conditions: The system analysis is a part of the project contract. Any changes in requirements after the system’s analysis are additions to the contract and will be invoiced accordingly. Missing information or false information is carried by the project client.

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

ifa united i-tech Inc. 1850 SE 17th St. Ste. 107 Ft. Lauderdale, FL 33316, USA phone: +1-888-4432367 www.ifa4emr.com

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

5. Summary The data model for ophthalmic documentation in the ifa system has been developed based on modern requirements from medical information sciences. Specialized medical ophthalmic documentation has already been realized for more than 30 million patients.

The system is completely compatible to existing international standards and standards that are currently being developed (i.e. SNOMED and DICOM). Existing classification systems such as ICD and ICPM are already included.

Data export from more than 200 examination and diagnosis instruments into the patient medical record have already been developed for the field of ophthalmology. Approximately 20 new instruments and data interfaces are programmed each year.

The success of introducing a computerized patient record depends on how well the custom adaptation of the data model for that clinic’s or department’s specific requirements have been fulfilled. The systems partner (ifa team) gives support by training and acting as a consultant in organizational queries.

Exchange of experience from existing users and information exchange on a regular basis is sensible and necessary. This exchange is supported by the system partner with user meetings and information exchange and communication via internet).

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

ifa united i-tech Inc. 1850 SE 17th St. Ste. 107 Ft. Lauderdale, FL 33316, USA phone: +1-888-4432367 www.ifa4emr.com

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

Definition of Observation Classes No.

Code 2-digit A1 A2 A3 A4 A5 RF RV GL OR VI CC OM PU LL CJ CO AC IC LE GK AH NH OP PE FA OP US TP

Class Description (up to) 20 digits 01 History– Allergies 02 History – Family 03 Risks– Allergies 04 Risks– Medications 05 Risks– Ophthalmology 06 Risks 07 Reason for visit 08 Glasses 09 Objective Refraction 10 Vision 11 Chief Complaint 12 Orthoptic/Muscle 13 Pupil 14 Lids/Lacrimal 15 Conjunctiva 16 Cornea 17 Anterior Chamber 18 Iris/Ciliary Body 19 Lens 20 Vitreous 21 Choroid 22 Retina 23 Optic Nerve.

24 Perimetry 25 Fluo-Angiography 26 Surgery 27 Ultrasound 28 Treatment Plan 29 N.N. 30 N.N. Definition of Observation Classes

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

Version: Example 1 Responsibility Area

ifa united i-tech Inc. 1850 SE 17th St. Ste. 107 Ft. Lauderdale, FL 33316, USA phone: +1-888-4432367 www.ifa4emr.com

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

No. 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

Code 2-digit RS PH PS PO EM MD AL FH FO SH CC HP PU EE MO LI CJ CO IR AC GO LE VI RE ON VE MA AT

Class Description (up to) 20 digits Review of Systems Past Medical Hx Past Surgical Hx Past Ocular Hx Eye Medications General Medications Allergy Hx Family General Hx Family Ocular Hx Social Hx Chief Complaint Hx of Present Illness Pupils External Exam Motility Lids Conjunctiva Cornea Iris Anterior Chamber Gonioscopy Lens Vitreous Retina Optic Nerve Vessels Macula Additional Tests

Version: Example 2 Internal: Responsible area

Definition of Observation Classes Version: Example 3

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

ifa united i-tech Inc. 1850 SE 17th St. Ste. 107 Ft. Lauderdale, FL 33316, USA phone: +1-888-4432367 www.ifa4emr.com

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

No. 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 No. 30 31

Code 2-digit Y1 Q1 L1 S1 D1 T1 C1 A1 Y2 Q2 L2 S2 D2 T2 PA EC Y3 Q3 L3 S3 D3 T3 C3 A3 SE PO CH EM PR Code 2-digit AL PH

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

Class Description (up to) 20 digits Symptom 1 Quality 1 Location 1 Severity 1 Duration 1 Timing 1 Context 1 Associated 1 Other Symptoms Quality 2 Location 2 Severity 2 Duration 2 Timing 2 Pachometer Endothelium Count Symptom 3 Quality 3 Location 3 Severity 3 Duration 3 Timing 3 Context 3 Associated 3 Specialty Exams Past Ocular Hx Contact Lens Hx Eye Medications Ocular Procedures Class Description (up to) 20 digits Allergies Past Medical Hx

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Internal: Responsible area

Internal: Responsible area

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

32 33 34 35 36 37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 No. 62 63 64

MD FH SH GE CN PS EN HB LR GA MU GN SB NE ED IS BL LV PU DL VF MO AD EL LG LD PN FA CB CP Code 2-digit CO EP EO

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

Systemic Medications Family Medical Hx Social Hx Gen.\ Mental Status Constitutional Psychological Ear, Nose and Throat Cardiovascular Lungs & Respiratory Gastrointestinal Muskuloskeletal Genitourinary Skin and Breast Neurological Endocrine Immunological Hem./Lymphatic Low Vision Pupils Pupils Dilation Visual Fields Motility Adnexae AD/Eyelids AD/Lacrimal Glands AD/Lacrimal Drainage AD/Preauricular Node Facial Conjunctiva Conj./Palpebral Class Description (up to) 20 digits Cornea Cornea/Epithelium Cornea/Endothelium

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Internal: Responsible area

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81 82 83 84 85 86 87 88 89 90 91 92 93 94 95 96 97 98 99

ST CS CR IR AC FC L GO LY LA LC LN LP VI OA CD ON RT MA VE PP TP TM TS TC TL SO RO TT AT TI TF OP RM SG

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

Cornea/Stroma CL Soft CL RGP Iris Anterior Chamber Fulfilment Center Letters Gonioscopy Lens Lens/Ant. Capsule Lens/Cortex Lens/Nucleus Lens/Post. Capsule Vitreous Optic Nerve ON CD Ratio ON Nerve Fiber Layer Retina Macula Vessels Periphery Treatment Plan Treatment Meds Treatment Procedures Treatment CL Treatment LV Soft CL Order RGP Order Test/Labs Ordered Additional Tests Test Interpretation FU/To Do/RTC CPT Codes Relationship Mgmt Sign Off

ifa united i-tech Inc. 1850 SE 17th St. Ste. 107 Ft. Lauderdale, FL 33316, USA phone: +1-888-4432367 www.ifa4emr.com

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

ifa united i-tech Inc. 1850 SE 17th St. Ste. 107 Ft. Lauderdale, FL 33316, USA phone: +1-888-4432367 www.ifa4emr.com

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es

ifa systems AG Augustinusstr. 11 b 50226 Frechen, Germany phone: +800-43222557 www.ifasystems.de

ifa united i-tech Inc. 1850 SE 17th St. Ste. 107 Ft. Lauderdale, FL 33316, USA phone: +1-888-4432367 www.ifa4emr.com

ifa systems iberia S.L. Cami de Can Manuel 24 07120 Son Espanyol - Espana phone: +34-971-438555 www.ifasystems.es