compendium clinic projects 2011

Compendium Introducing the Computerized Patient Record

Published by the Project Management Dept. of ifa systems AG, Frechen/Cologne

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

Table of Contents 1. Technical Realization 1.1. Local Area Networks (LANs) 1.2. Interfaces to Clinic Systems 1.3. Interfaces to Diagnostic Instruments

2 2 2 3

2. Requirements in the Clinic Environment 2.1. Coordination of Documentation Terminology 2.2. Organizational Preparation 2.3. Preparation List for Introducing Computers into the Eye Clinic 2.3.1. Internal Workgroups with Areas of Responsibility 2.3.2. Project and Time Plan with a Computer Partner 2.3.3. Collection of all Internal Documents and Forms 2.3.4. Installation of a Preparation System (one workstation) and Training from Computer Partner 2.3.5. Discussion and Coordination of the 1st Version of Medical Terminology and Examples of Patient Histories 2.3.6. Preparation of an Organization Handbook 2.3.7. Compilation of Instrument Interfaces with Documentation 2.3.8. Installation of Software and testing of Functions 2.3.9. Employees’ Training Based on Training Schedule and Launch of Test Project 2.3.10. Draft of Experience Protocols and Collection of Suggestions for Presetting the System 2.3.11. Work Meeting with System Partners to Discuss Adaptations and Training Steps 2.3.12. Review of Legal Requirements 2.3.13. Go live with Real System!

2.4. Legal Aspects 2.4.1. Data Protection for the Patient 2.4.1.1. Access Rights for the Entire System with Code Word 2.4.1.2. Access Protection for Single Program Areas 2.4.1.3. User Login for Medical Documentation 2.4.1.4. Screen Blackout at the Workstation Monitor 2.4.2. Quality and Security of Documentation 2.4.3. Contracts with Employees and Partners 2.5. Time Schedule and Checklists 2.5.1. Area of Responsibility 1 (Workgroups): Coordination with the IT Dept. and Systems Partner (Technical)

5 5 6 7 7 7 7

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

7 7 7 7 8

8 8 8 8 8 9 9 9 10 10 10 11 11 24

2.5.2. Area of Responsibility 2 (Workgroups): Establish Organizational Routines and Project Goals 2.5.3. Area of Responsibility 3 (Workgroups): Coordinate Medical Terminology and Presettings 2.5.4. Area of Responsibility 4 (Workgroups): Compile Training Plan 2.5.5. Area of Responsibility 5 (Workgroups): Define Access Rights and Authorization Hierarchy 2.5.6. Area of Responsibility 6 (Workgroups): Data Protection and Data Backups

25 26 27 28 29

3. Special Potential for Digitizing the Eye Clinic 3.1. Digital Photo Documentation 3.1.1. Links to Fundus Cameras 3.1.2. Integration of Image Systems 3.1.3. Slide Scanners 3.1.4. Video Slit Lamps 3.1.5. Link to Other Video Sources 3.2. Telematics and Tele-medicine in Ophthalmology 3.2.1. Electronic Doctors’ Letters and OP Reports 3.2.2. Generated Doctors’ Letters and OP Reports 3.2.3. Tele-consultation 3.2.4. Screening Projects

30 30 31 31 32 32 32 33 33 33 34 34

4. Financial Planning and Legal Basis 4.1. Hardware Investments 4.2. Recommendations for Hardware 4.3. Software Investments 4.4. Maintenance, Support and Development 4.5. Contract Design

35 35 35 37 37 37

5. Summary 5.1. Guarantee for further Development from System Partner 5.2. User Motivation and Discipline

39 39 39

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

1.

Technical Realization

Most clinics already have a computer system for their administration. This system contains patient data for internal administration and billing systems. It can be linked to a local network in the eye department with a communication computer to send data from the patient data which has already been entered into the computerized record. Of course, any PCs and instruments that already exist (provided they have digital ports) can be integrated into the network.

1.1. Local Area Networks (LANs) Nowadays Local Area Networks (LANs) are the standard platform for department-based computerized patient records. The networks are made up of one or many servers and as many intelligent workstations as desired. The topology of the networks is individually based on the requirements of the clinic and the IT department’s concepts.

The number of workstations is based on the number of employees. A number of 10 to 250 workstations is usually available for the computerized patient record application in the final expansion phases, depending on the size of the department. Computerization is often carried out in steps so that the completion can sometimes take up to six to twelve months.

Assorted peripheral instruments can work within the local networks, e.g. scanner, printer, sound systems for dictation and cameras for video conferencing.

1.2. Interfaces to Clinic Systems In most cases, data exchange between the local network (patient record) and the administration system takes place in the second phase. The data exchange can be either unidirectional or bidirectional.

Unidirectional exchange sends patient basic data (and if applicable, insurance data) from the administration program to the computerized patient record. Bi-directional exchange also sends new data from the network in the eye department back to the original system. This new data might include services rendered (billing codes), diagnoses and/or findings. The computerized patient record in the ifa system is linked with a “Mapping Database�. This allows linking an internal documentation language with terminology standards e.g. ICD9/ICD10 and ICPM. This mapping database is ready for use with the SNOMED codes and DICOM reports.

In the ifa system there are different interface programs for data exchange. In most cases, a unique data protocol between the IT department and the ifa project group is worked out. The transfer of data can also be realized with the HL7 protocol (HL7 = health level 7).

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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

In the attachments, you will find an overview of the interfaces and clinical administration systems that are linked with ifa.

1.3. Interfaces to Diagnostic Instruments A lot of the examination results and data in the field of ophthalmology are attained with the help from digital systems. These have either a serial interface port (RS232) or a software application.

Ophthalmic examination systems with interfaces are: 

Autorefractor



Lensmeter



Computer phoropter



Perimeter (visual fields)



Computer perimeter (visual fields)



Non-contact tonometer (NCT)



Keratometer (possibly combined with an autorefractor)



Biometer (A-Scan/B-Scan)



ERG-/VRP systems



Orthoptics examination instruments



Ophthalmometer



Corneal topography systems

A large number of different systems is available worldwide from the above listed instruments. Since no uniform data protocol exists for all of these instruments, new interfaces have to be developed for each instrument. More than 400 interfaces have been developed within the ifa system for the most important instruments used in international ophthalmology. Every year another 15-20 new interface programs are developed. In order to keep this up, the development department keeps close contact with all the leading manufacturers of ophthalmic examination instruments worldwide.

For an up-to-date list of the existing interfaces, please visit the ifa systems website at www.ifasystems.com.

In addition to the serial software interfaces, applications exist from the leading manufacturers of perimeter instruments, image systems etc. Each integration component is described in detail within 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

the EU project OPHTEL (OPHTEL = Telematics in Ophthalmology, Workpackage 11: concepts and realization for the integration).

For a paperless practice in an eye clinic it is important to include image systems of all types especially for the following instruments: 

Slit lamp cameras



Fundus cameras with video output



Fundus cameras with digital cameras



Scanning laser ophthalmoscope



Laser diagnosis systems (HRT, GDX etc.)



Ultrasound systems with video output



Biometer with video output



Video documentation cameras (e.g. for strabismus)

There are analog and digital interfaces for these image systems. The technical realization depends on the existing camera systems and the possibilities to upgrade these systems.

Slide scanners can of course also be linked to the integrated image storage systems for scanning pre-existing slides from the photo department into the computerized patient record.

The technical possibilities are more precisely described in the OPHTEL Deliverable 11. Technical concepts for specific fundus cameras can be supplied in cooperation with the camera manufacturers (e.g. Zeiss, Topcon, etc.).

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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

2.

Requirements in the Clinic Environment

The success of the introduction of a computerized patient record strongly depends on how well the clinic is prepared. Changing from an unstructured paper file to a computerized terminology-based patient record requires the involvement of all employees of the clinic. For this reason, it is recommended to make separate project plans and build a workgroup which is responsible for introducing the changes and coordinating the project.

The preparation can be divided into the following areas: 

Coordination of documentation terminology



Establishment of organization routines



Realization of legal requirements



Technical coordination and follow-through

If more than 25 workstations are planned, support from the IT department is just as important as support from an internal department supervisor (or LAN administrator). The supervisor has the job to support the technical details with the IT Dept., to guarantee first line helpdesk support to all employees with software questions, control data protection and security and coordinate new projects (new investments, expansion, upgrades and updates, etc.).

2.1. Coordination of Documentation Terminology Establishing a thorough documentation concept and internal terminology is the basic requirement for a functioning digital patient record. ifa supplies several terminology databases that are used in eye clinics both on a national and international level.

In the long run it is everyone's desire to have "terminology dictionaries“, which can be used by ophthalmologists worldwide. Since it is essential to have everybody’s agreement for the final development of this dictionary it may take quite some time to develop it.

With the ifa system it is possible to use structured terminology for all documentation areas of the medical record. Code databases exist for the following areas: 

History



Findings (up to 30 findings categories)



Diagnoses



Medications and therapy 5

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



Services parameter



General medical data (patient context)

Depending on the version, the standard terminology covers 6,000 to 12,000 codes. These codes can easily be changed or expanded although any changes or additions should be made by one authorized workgroup and in agreement with the team: Consistent terminology codes are of utmost importance for the quality of the ophthalmic documentation.

2.2. Organizational Preparation The introduction of computer organization can only be as good as its preparation. For this reason, an organizational compendium should be worked out by the clinic team far in advance. The following topics should be taken into consideration: 

Coordination with IT Dept. and systems partner (technical orientation)



Establishment of an organization routine and project goals



Coordination and comparison of medical terminology and presetting the system



Compilation of the training schedule



Definition of access rights and authorization hierarchy



Data protection and backup measures

One employee and a co-representative should be responsible for the entire preparation and organization. The above mentioned task areas can be carried out by the two project leaders or can be delegated to other team members. The preparation phase should include regular meetings and at least one or two meetings with the systems partner (to include a protocol for all employees).

The introduction of computerized documentation and organization can substantially change the workplace and work procedures. These changes have to be carried out by all employees. The more cooperation there is the faster and more efficient the realization of the data processing will be.

The following checklist contains the most important areas for preparation and for the organization plan. Further checklists for the work within separate areas of responsibility can be found in the chapter “Time schedule and Checklists”.

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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

2.3. Preparation List for Introducing Computers into the Eye Clinic 2.3.1 Internal Workgroups with Areas of Responsibility      

Coordination with IT Dept. and system partner (technical) Establishment of an organization plan and project goals Coordination and comparison of medical terminology and system presettings Preparation of schooling and training schedules Definition of access rights and authority hierarchy Steps for data protection and safety

2.3.2 Project and Time Plan with a Computer Partner 2.3.3 Collection of all Internal Documents and Forms     

Examples of doctors’ letters and OP reports External forms (medical/glasses prescription) Internal forms (exam form, etc.)

List of referral doctors (for presetting the system) Stickers and internal patient info fliers

2.3.4. Installation of a Preparation System (one workstation) and Training from Computer Partner 2.3.5. Discussion and Coordination of the 1st Version of Medical Terminology and Examples of Patient Histories 2.3.6. Preparation of an Organization Handbook with the following Chapters:       

Access rights for all employees (who may enter which data?)

Authentication rights from doctors (who authenticates which data?)

Maintenance of code words and passwords Data security and back up (coordination with IT-Dept.)

Data protection measures Documentation guidelines/examination guidelines Quality assurance

2.3.7. Compilation of Instrument Interfaces with Documentation (have the interfaces been tested?)

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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

2.3.8. Installation of Software and Testing of Functions 2.3.9. Employees’ Training based on Training Schedule and Launch of Test Project 2.3.10. Draft of Experience Protocols and Collection of Suggestions for Presetting the System for the following Areas:   

Medical abbreviations (documentation) Print forms Word processing and generating reports

2.3.11. Work Meeting with System Partners to Discuss Adaptations and Training Steps (if applicable) 2.3.12. Review of Legal Requirements for:   

Access controls Documentation authorization Data back-ups/security (technical aspect and archiving)



Data protection

2.3.13. Go live with real System!

2.4. Legal Aspects The use of digital data as such and especially in the field of data transmission in wide area networks sets new requirements for the legal framework. Although the field of "Computer and Law" is relatively new legal opinions already exist. On the one hand, they are oriented towards the technical and practical possibilities and on the other hand towards traditional law. Indeed modern law seems to be a friend of innovation and it seems to support a dynamic development by offering reasonable basic rules. The "legal aspects" are certainly different for each state but a trend towards harmonization is already detectable in the EU. Generally three areas of the eye clinic are affected by the introduction of the computerized patient record: 

Data protection (medical confidentiality) for the patient 8

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



Quality documentation security of medical data



Contracts with employees and system partners

During all phases of the introduction of the computerized patient record all legal aspects should be considered. (see chapter on “Organizational Preparation” and “Checklists”).

2.4.1. Data Protection for the Patient Patient medical data is generally a sensitive topic and deserves a special protection of privacy (medical confidentiality). The users of digital data processing are therefore obliged to take all possible technical and economical measures to ensure that the data is secure and remains secure.

The following technical measures are standard: 

Access control to the entire system with code words



Access control to specific program areas (e.g. medical findings)



User login with user-ID when entering medical documentation



Screen blackout after specified time intervals

The technical requirements are included in ifa program modules. The user (eye clinic) is responsible for activating the function. The system can be activated together with authorized employees from the systems partner. Passwords may never be given to employees from external companies or be changed by these employees unless this is first authorized in writing by the eye clinic.

2.4.1.1. Access Rights for the Entire System with Code Word The system requires a 5 digit code in order to start the entire program. The program menus cannot be called up without this “key code”. This ensures that no outside source can look into the program and/or patient database.

It is recommended to change this code regularly. When it is suspected that data has been tampered with, the code should be changed irregularly so that no system can be detected.

2.4.1.2. Access Protection for Single Program Areas Each area of the program (menu area) can also be protected from unwanted access with a password.

This gives you an additional level of protection of medical data. Here it is also recommended to change the passwords as needed.

Training for “Password Protection” should be carried out with the systems partner. A password to the section on giving passwords must also be given. This password is only to be known by the authorized supervisor. If the password is not documented or falsely documented, the systems 9

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

partner can only open the program with a written authorization and consent. During contract negotiations it has to be decided who is authorized to unblock the password protection area.

2.4.1.3. User Login for Medical Documentation The most important step in measures for data protection in medical documentation is that authorized persons have to register with a user ID. The system holds a complex database with access rights in all areas. Access rights are defined by read (view and print) or read & write (edit) rights.

Rights can only be given by a supervisor. It is recommended to name two different supervisors who can substitute each other. Documentation of passwords and access rights should be kept in a safe place somewhere within the clinic.

2.4.1.4. Screen Blackout at the Workstation Screen The screen can be activated to black out after a specified length of time so that patients and unauthorized persons cannot glance at data on the screen. The system is set so that the monitor will black out automatically after a specified amount of time when keys have not been pressed on the keyboard. The time limits can be set up differently for each workstation. The screen may then only be activated by entering a code.

2.4.2.

Quality and Security of Documentation

In terms of legal aspects, the quality and security of documentation in a computerized patient record is much higher than in paper records. If measures for backing up data are carried out consistently, then no data can get "lost" in the electronic record as opposed to a paper record.

Especially a computerized patient record has to be protected from manipulation of data. Changes made in a manual paper record are easier to detect than changes in a digital record. For this reason, two sets of law are required.

On the one hand, all software which stores sensitive data should have a "document locking" function. Here the data can either be locked by an authorized person or automatic authorization can be set after a specified length of time. Changes can then only be made with a "cross entry" so that the changes made are visible. The original entry remains documented with changes so that the record remains transparent for legal reasons.

In addition to the "document locking" function it is also recommended to do regular data back-ups to archive patient data. Data can be backed up on tapes on a quarterly basis and stored in a secure and neutral place. The tapes can be used as evidence in liability cases. The additional data back-up for legal reasons is normally organized by the IT Dept. It is recommended to back up the entire program environment. Within the ifa system the program can be backed up level by level. This is then documented with the user ID. 10

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

Documents that require a patient’s consent and thus have to be signed can be scanned into the record. Generally, it is easier just to store an abbreviation indicating that a paper archive exists. This archive can be filed by patient number instead of an alphabetical order.

This archive can also store any external documents that are not worth storing on the computer.

Then, for example, suspect diagnoses and peripheral findings can be entered into the CPR from referral reports together with an abbreviation to indicate that a paper document exists in the archives.

When storing images (e.g. fundus photography) it is important to always store the original photograph. If tools have been used on the images this represents that the data has been edited.

This has to be documented in the header and be visible immediately. When documentation standards such as DICOM (Digital Imaging and Communication in Medicine) are introduced, all editing parameters will be automatically stored and thus allow a real interpretation of image data findings.

2.4.3. Contracts with Employees and Partners After the introduction of the computerized patient record the employees’ job descriptions can alter which can also change the requirements for the work contract. In addition, new contracts concerning data protection have to be drawn up with external partners.

Employees working with the computerized patient record have to be made aware of the fact that they are responsible for respecting the medical confidentiality of patient data. This information should be given to employees in written form and it should also be part of their contract of employment.

Generally, the IT Dept. works together with the Personnel Director or representatives thereof to set such regulations although follow through is the responsibility of the doctors/team of doctors.

Contractual agreements should be drawn up for cases when external partners need to have access to patient data in emergency cases e.g. power outage etc. Employees from external partners work within medical confidentiality frameworks. Clinics have to have such contractual agreements with all internal and external persons involved.

2.5. Time Schedule and Checklists Project management for introducing the computerized patient record can be supported by precise time schedules and checklists. Software tools can of course also be helpful (e.g. MS Project).

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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

Attached you will find an example of a time schedule that is based on many years of experience in introducing computers into clinics. The differences mainly lie in the amount of time each clinic has available. The external partners (e.g. ifa systems team) can only support the internal decision making and preparation work but cannot do it independently.

The clinic team will be supported by the system partner via the ifa systems helpdesk hotline. This communication can take place by telephone (between 8:00 a.m. and 6:30 p.m.) or of course also direct by email. A list of all ifa employees (national and international) with their corresponding email addresses and telephone numbers will be given to the clinic during the preparation phases.

The following checklist refers to the areas already mentioned in the chapter on “Organizational Preparation�: Area of Responsibility

Task

Area of Responsibility 1

Coordination with IT Dept. and system partner (technical area)

Area of Responsibility 2

Establishment of the organizational routine and project goals

Area of Responsibility 3

Coordination of medical terminology and presettings

Area of Responsibility 4

Compilation of a training plan

Area of Responsibility 5

Definition of access rights and authorization hierarchy

Area of Responsibility 6

Data protection and back up measures

At ifa systems all clinic projects are supported with an internal computerized support system (ABIS).

All relevant data about the users is entered into the ABIS system so that the responsible support team (national and international) always has access (data transmission) to information about the specific configuration, the responsible partner etc. Any exchange of information will be documented in this program for future reference.

It is recommended that any written protocols or notes on the computerized patient record written by the clinic team during the preparation phase are to be made available for the system partner. This ensures that both teams have the same information. These notes can be sent as an email and longer texts can be sent as Word attachments to the email. The documents can then be stored by both sides involved.

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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

Form No: Date: From:

Workgroup Overview

Employee/User

01 Technic ITCoord

02 Orga-Plan

Project Plan Eye Clinic

03 Schedule

04 Training

05 Author.

Docum.

06 Data Backup and Protection

07

01 02 03 04 05 06 07 08 09 10 11 12 13 14

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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

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Form No.: 001 Date: 10.12.08 From: G. M端ller

Example Workgroup Overview

Employee/User 01 02 03 04 05 06 07 08 09 10 11 12

Dr. Baldwin Dr. Smithfield Dr. Meysel Dr. Miller R. Longwell

01 Technic ITCoord

02 Orga-Plan

Project Plan Eye Clinic

03 Schedule

04 Training

X

05 Authoris.

Docum.

X

X

X X X

06 Data Backup

07

X X

X X

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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

08

Form No: Date: From:

Project Plan

Project Requirements

Respon.

WG’s

01

02

03

Project Plan Eye Clinic

04

05

06

07

08

09

10

11

12

13

14

15

16

17

15

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

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Form Nr: 002 Date: 10.12.07 From: Dr. M. Meyer

Example Project Plan Project Requirements

Respon.

WG’s

01

Compile Workgroups

X

Coordinating Time plan with IT/System-Partner WG

X

Collecting Internal Documents Installation Preparation system

02

03

04

05

Project Plan Eye Clinic

06

X

10

11

12

13

14

15

16

17

X

Work out Terminology

X

X

X

X

X

X

X

X

Installation and Function Tests

X

Training Employees

X

X

Experience Protocol

X

X

nd

2 Update Work out Terminology

09

X

X

Compile Instrument Interfaces

08

X

1. Coordination

Workout ORGA Handbook

07

X

X X

X

X

X

16

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18

Form Nr.: Date: From:

Training Plan

Employee/User Basic

Project Plan Eye Clinic

Pre-existing Experience Win Word

ifa

Basic 01 02 03

Training Plan WIN Word 01 02 03 01 02 03

ifa 01 02

01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 17

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

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03

Example Training Plan Employee/User Basis 01 02 03 04 05 06 07 08 09 10 11

X X

Form Nr: 003 Date: 10.12.08 From: G. M端ller Pre-existing Experience Win Word ifa X

Project Plan Eye Clinic

Basis 01 02 03

X X

X X

X X

X

X

X

Training Plan WIN Word 01 02 03 01 02 03 X X X X X X X X X X X X X X X X X X X

ifa 01 02 X X X X X X X X

18

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

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03 X X X X

- Place

Form Nr.: Date: From: No. Partic.

Training Contents

- Date

Respon.

Training Contents

Training Blocks

Project Plan Eye Clinic

- Trainer

19

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

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Example Training Contents

Form Nr.: 004 Date: 10.12.08 From: G. M端ller

Training Blocks

- Place

Nr. Partic

- Date

Respon.

Project Plan Eye Clinic

Training Contents

- Trainer ifa 01

ifa 02

ifa 19.2.09 ifa ifa 2.3.09 ifa

4 MUE 6 MUE

Basic Data Entry Passwords Preset System /Abbreviations Entry of Findings Document Locking Word Processing

20

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

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Workstation Description

WS-Nr.

Location

Form Nr: Date: From: Peripheral HW (printer, scanner, card reader, etc.)

Project Plan Eye Clinic

Instruments (AR, LM, PHOR, NCT etc.)

Program areas ifa

External Programs

21

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

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EXAMPLE Workstation Description

Form Nr: 004 Date: 10.12.08 From: G. Müller Peripheral HW Instruments (AR, (Printer, Scanner, LM, PHOR, NCT etc.)

Card reader etc.)

Location

WS Nr.

Project Plan Eye Clinic

Program areas ifa

External Programs

01

Login, Enter Patient

- Card Reader - OKI-Printer

-

Basic Data, Print Forms

02

Pretesting 1

-

- AR - Topcon - LM – Humphrey

Refra Data Findings, etc.

-

03

Perimeter room

- Perimeter

- HFA 660

Perimeter

-

04

Office 1

- Laser Printer - Scanner

-

Word Processing

MS Office

22

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

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Authorization Documentation

Employee/User

Function

Form Nr: Date: From: Auth.

Level

Project Plan Eye Clinic

Access to Entry Areas

Login ID valid thru

valid thru

valid thru

01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 23

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2.5.1. Area of Responsibility 1 (Workgroups): Coordination with the IT Dept. and Systems Partner (Technical) 2.5.1.1

Compilation of lists of technical requirements per workstation  High quality monitors (e.g. for image systems)  Chip card reader/ touch mouse etc.  Printer and scanner

2.5.1.2

List of instrument interfaces checking links

2.5.1.3

Configuration plan to include room sketch and workstation function description

2.5.1.4

Coordination of data transmission communication (remote diagnosis through systems partner/email/helpdesk/IDT installation)

2.5.1.5

Plans for ergonomic workstation design (incl. chairs and tables)

2.5.1.6

Organization of technical workgroups in order to include employees from the medical field, IT Dept. and consultants from the systems partner (list of names with phone/fax/email)

2.5.1.7

Time schedule for purchasing hardware, installation and going live

2.5.1.8

Coordination with third parties for the integration of new instruments and camera systems

2.5.1.9

Definition of a routine for emergency cases (emergency measures in case of system failure/1st and 2nd line support/access rights for updates, etc.)

2.5.1.10 Investment and budget planning for hardware repairs, hardware replacement of spare parts in cycles

maintenance,

2.5.1.11 Coordination of internal interfaces between administration systems and clinic department systems (functions/responsibilities/time schedule)

24

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2.5.2. Area of Responsibility 2 (Workgroups): Establishment of Organizational Routines and Project Goals 2.5.2.1 Classification of program area, e.g. based on  Demographic data administration  Billing, private patients and insurance companies  Word processing and forms  Computerized findings documentation  Image storage and processing  Telemedicine applications  Data analysis and statistical analysis  Optimization of the internal organization (Appointment Scheduler/ To-do List) and setting priorities

2.5.2.2 Creation of project goals and plans for the following areas  Quality assurance and control  Efficiency and savings  Clinic marketing with continual improvement in competence  Telemedicine applications 2.5.2.3 Coordination of data flow charts based on patient cases and areas  Inpatient and outpatient  OP area  Long term patients  Specialized departments (e.g. orthoptics, etc.)

2.5.2.4 Compilation of all documents, e.g.  Medications prescriptions and glasses prescriptions  Patient exam form, internal protocols, etc.  Form letters to referral doctors, OP reports  Patient letters (explanations about therapy and diseases)  Statistics and service evaluation  Private billing incl. reminders, etc.

2.5.2.5 Update and coordination between responsibility areas, phases and time schedules.

25

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2.5.3. Area of Responsibility 3 (Workgroups): Coordination of Medical Terminology and Presettings 2.5.3.1 Collection of existing documentation keys  Internal abbreviation lists/coding systems  Standards i.e. ICD, ICPM  Findings key  Examination guidelines (possibly based on reasons for visit) 2.5.3.2 View different terminology keys from system partner (national and international) 2.5.3.3 Build small workgroups for creating documentation concepts e.g. for the following areas:  Cornea  Retina  Glaucoma  Strabism/Orthoptics, etc.  Rework terminology database based on  Type of visit  Medical risks  Histories  Findings (up to 30 findings classifications)  Diagnoses  Medications  General medical terminology 2.5.3.4 Test terminology codes based on systematic approach and completeness  Patient history and overviews  Patient reports (telemedicine, doctors’ letters, etc.)

2.5.3.5 Adoption of terminology, data protection with passwords, establish changing routines (e.g. quarterly workgroup meetings) 2.5.3.6 Exchange experience with national and international user groups

26

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

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2.5.4. Area of Responsibility 4 (Workgroups): Compilation of a Training Plan 2.5.4.1 Creation of job descriptions for all employees working directly or indirectly with the departmental system 2.5.4.2 Note employees’ existing knowledge with computer systems (e.g. Word for Windows) 2.5.4.3 Coordination of training plans by employee, group, department, area  General Windows functions  Use of departmental system  WinWord  Hardware and maintenance (e.g. printer) 2.5.4.4 Decision on training sessions with system partner and if applicable with the IT Dept.

2.5.4.5 Creation of internal documentation for using the system 2.5.4.6 Creation of an archive for technical handbooks (instruments and ophthalmic instruments), peripheral systems (printers, scanners, etc.) and software manuals 2.5.4.7 Modification of the help texts within the departmental system and from Windows applications 2.5.4.8 Establishment of training measures and an internal information system for program updates 2.5.4.9 Determination of a system for user questions and queries (internal and external helpdesks); compilation of the most frequently asked questions and an open access database

27

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

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2.5.5. Area of Responsibility 5 (Workgroups): Definition of Access Rights and Authorization Hierarchy 2.5.5.1 Creation of a list of all employees and their tasks in data entry, e.g. based on the following:  Basic patient data (relevant to billing, etc.)  Test data (refractions, NCT, acuity etc.)  History/medical risks  General findings  Ophthalmic findings  Diagnoses  Prescriptions and orders 2.5.5.2 Creation of a concept for access rights with defined read & write rights 2.5.5.3 Link employee list to a password administration and ID code 2.5.5.4 Integration of the concept within the program (with support from the system partner) 2.5.5.5 Coordination of the authorization hierarchy within departments (who confirms entries from non-MD’s) 2.5.5.6 Integration of the authorization hierarchy within the program (with support from the system partner) 2.5.5.7 Guarantee the access rights are archived in the personnel files (for legal reasons) 2.5.5.8 Determination of the documentation standards based on chief complaints or reason for visit (1st or follow up examinations) 2.5.5.9

Coordination of the guidelines for “document locking” of medical patient data

2.5.5.10 Regular check of use of access rights an authorization hierarchy with protocol (every 3 months) 2.5.5.11 Rewrite employees’ contracts to include their responsibility in this context

28

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

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2.5.6.

Area of Responsibility 6 (Workgroups): Data Protection and Data Backups

2.5.6.1 Compilation of all data protection measures for the introduction of the computerized patient record  Access rights to the entire system with code words  Access protection for each program area (changing abbreviations, billing programs, etc.)  User login in medical record documentation (admin user ID’s)  Screen blackout  Access protection on a network level (WIN 2000/2003) 2.5.6.2 Development of a clear system for the administration of the password for data protection and medical confidentiality 2.5.6.3 Training of all employees in data protection measures; protocol of the session in employee records 2.5.6.4 Coordination of a data backup concept  Technical assurance of IT Dept. or LAN supervisor  Additional paper backups via daily protocols of end of day  Organization of storage of backup externally (legal reasons)  Concept for data backup for local data (e.g. statistics) 2.5.6.5 Employee obligation to use measures to protect data and protocol any relevant information in personnel records 2.5.6.6 Creation of a routine for “document locking” (authorization and validity time period)

29

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

3. Special Potential for Digitizing the Eye Clinic Introduction of a computerized patient record in eye clinics can be spread over two areas. These special areas are:  

Digitizing photographs (fundus, fluorescein angiography etc.)

Telematics and telemedicine

Both of these areas are major topics in different research projects, e.g. in the EU project OPHTEL (Telematics in Ophthalmology). Detailed information about interfaces and integration platforms can be found in the attachments to this compendium.

3.1. Digital Photo Documentation Photo documentation plays an increasingly important role. The trend is going towards the direction of storing more images and less text files. In the future there will be a “structured report” (SR) within the DICOM standardization. The field of ophthalmology offers a large area for use for digital imaging – more than any other field of medicine.

Image sources (analog or digital) available: 

Fundus camera with video camera



Digital imaging system



Slide scanner



Video slit lamp



Other image systems with video source

In most clinics several image sources are available. For this reason it is possible to set up separate “digital folders” for storing different information within the patient record. Folders can be set up for e.g. fluorescein angiography, fundus color photos, corneal photos, slit lamp images etc.

The system offers a compatibility and standard platform for the entire field of digital imaging in eye clinics. On the one hand this presents performance advantages and on the other hand a quicker overview of the real findings data. The images are stored as so-called thumb nails overview buttons.

30

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3.1.1. Links to Fundus Cameras There are three possibilities for the digitization of photographs taken by a fundus camera:   

Combination with a special video camera Pictures from another system e.g. Topcon Image Net, Zeiss Visupac Combination with a digital photo camera (e.g. Nikon)

The decision for one or the other concept depends on the budget since the investment varies from EUR 40,000 to 80,000 (US$ 50,000 to $100,000). The decision also depends on the specialization of the clinic (e.g. fundus photography, fluorescein angiography, etc.)

More detailed information on manufacturers of fundus cameras and imaging systems is available on request. Since ifa’s software engineering works directly with all large manufacturers. A fundus camera can be selected independently of the digital integration system.

Technically, the easiest solution is the combination of a fundus camera with a high quality 3 chip video camera. The camera can be used for all applications. The shutter speed is so fast that even fluorescein angiography sequences can be stored.

For the 3 chip video camera, a synchronization adapter and the corresponding cable are also needed.

This results in a video signal that can be digitized with a high quality framegrabber board (e.g.

Matrox). The quality of the photos depends on the quality of the hardware used (framegrabber and video camera). The image system can store all formats even with different compression rates.

Demand on quality depends on the area of use. Results on digital formats, compression factors and quality were worked on in the OPHTEL project (see documentation to OPHTEL image processing/Diabetes Demonstrator).

Basically the 3 Chip video camera can be used for all fundus cameras on the market (e.g. Canon, Kowa, Nidek, Topcon, Zeiss). It is also possible to upgrade the existing cameras. A list of vendors of the adapters is available through ifa’s international team.

3.1.2. Integration of Image Systems Complete digital imaging systems (usually closed systems) such as Topcon Image Net and Zeiss Visupac are very common today. These systems are based on a traditional fundus camera that is combined with special PC applications and an image storage and processing software package.

Integrating these systems is done on different levels. Depending on the specific requirements, images are stored in the outgoing system, and then the patient record is called up within the external

31

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system. With this solution the functionality of the image system is available and it saves time because patient data only has to be entered once.

Another solution is possible where the image system pictures are imported into the computerized patient record. This increases the performance and the images are always available in an overview in the computerized record. With this solution it is also possible to switch over to the expansive database of the image system.

3.1.3. Slide Scanner Old and existing photos from regular patients can be scanned into the new computerized patient record. Slide scanners are relatively inexpensive and can be linked directly to the computerized record. These images can then be stored within the digital “folders”.

3.1.4. Video Slit lamp A combination slit lamp with a video camera can be used for corneal photography and fundus photography differentiating between integrated video cameras in compact form (e.g. Zeiss and Rodenstock) and video cameras mounted onto a slit lamp. Selecting the appropriate slit lamp camera depends on the procedures and budget available. Both solutions are equivalent in terms of digital integration.

The video signal is captured in a framegrabber (see links to fundus cameras). The quality of the photos depends on the video camera (1 Chip or 3 Chip) and the framegrabber used (Miro, Matrox, etc.).

3.1.5. Link to Other Video Sources In ophthalmology other diagnoses systems with video sources are used:    

Scanner laser ophthalmoscope Laser Systems with video output (HRT/LDT) Biometer (B-Scan) Ultrasound diagnoses system

In general, it is possible to link more than one video source to one framegrabber at one workstation.

32

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

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3.2. Telematics and TeleMedicine in Ophthalmology The importance of telematics and telemedicine is impressively confirmed in the Roland Berger Study (see excerpts from Roland Berger study). The tasks and the experience for the OPTHEL EU project have also proven the importance of telematics and telemedicine in the field of ophthalmology nowadays and in the future.

A prerequisite for qualified telemedicine in the future is the computerized patient record and in addition a standardized terminology such as SNOMED/DICOM. With the introduction of a computerized patient record the requirements for sending doctors letters and OP reports electronically are already fulfilled. In Germany, more than 75% of all ophthalmologists have computer systems and 40% (30% of all ophthalmologists) have internet access.

3.2.1. Electronic Doctors’ Letters and OP Reports The first level of use in telemedicine generates electronic doctor’s letters and OP reports and sends them via data transmission – Internet. Meanwhile there are many communication clients on the market just for the field of health. IDT (=Internet Data Transfer) in the health field is used within the ifa program. The IDT program is given to all users free of charge. IDT was originally developed for the pharmaceutical industry and is also appropriate for the physician’s platform.

3.2.2. Generated Doctors Letters and OP Reports can be in the following digital formats:  

MS Format DOC (for Word for Windows) HTML Format

A Word for Windows document can be created from the computerized record with the integrated Word for Windows application. It is also possible to generate documents in HTML format in Word for windows.

The technical process is to send a short email to the email address with the document as an attachment (using e.g. IDT). Incoming and outgoing emails are organized in the communication client (e.g. IDT). An encrypting mechanism is included in IDT. This is necessary for the transmission of original patient data. Once doctor’s letters are secured as faxes, it is also convenient to send doctor’s reports by email if the data is not confidential.

The electronic doctor’s letters and OP reports are becoming more important in terms of competition.

The referral doctor who works electronically increases his/her competence and it is likely that he/she will search for partners who work on the same technical level. The advantage of this level of 33

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integration is obvious – transmitted relevant patient data is already in the clinic before the patient arrives.

3.2.3. Tele-consultation For tele-consultation two modes of communication are possible. In synchronous communication colleagues are included in treatment plans via video conferencing. In asynchronous tele-consultation data, reports and replies are transmitted as electronic doctor’s letters.

The results of the OPTHEL study in BY-OPTHEL proved that synchronous tele-consultation is almost unusable in practice. It is technically and organizationally relatively difficult to have all parties involved available at one time. Legally it presents difficulties because all telemedical transactions have to be documented for legal reasons. This means that any conferences would have to be recorded either on tape or paper.

In practice, the use of asynchronous tele-consultation will be accepted. It works in the same way as communicating with doctor’s letters and OP reports in digital form.

Other legal requirements also have to be considered in tele-consultation. In a lawsuit the sender as well as the recipient has to prove that the documentation has not been altered. This requires that the “document locking” function has been activated. Tele-consultation functions should therefore include comparable locking functions (see chapter on “Legal Aspects”) The second opinion document can be stored directly in the patient’s record. New findings and external medical information can be separated and stored in different places.

3.2.4. Screening Projects The field of ophthalmology is ideal because the screening projects within the field cross over into other medical fields. Examples can be seen in the work done by ophthalmologists in collaboration with diabetologists. In OPHTEL there are many screening projects in Germany as well as in the UK (see diabetes project in OPTHEL/Shared Care).

34

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4.

Financial Planning and Legal Basis

The Arthur D. Little Study comments on the expenses of IT as part of the clinic budget: „Health care represents roughly 13% of the country’s gross national product but only 1% to 2% of the budget is spent on information technology. For comparison purposes: Banks spend 10% and US industry spends 4%“.3 Although the introduction of a computerized patient record has a large impact on complete computerization, the investment in mid to long term is relatively lower than in large administration systems. This is because high performance PCs can be used at relatively low prices. The profitability is stated in reports by different users in the clinic environment (see article by Dr. Bolling, Mayo Clinic Jacksonville, FL “Why computerize your medical records”).

4.1. Hardware Investments Hardware is generally organized by the IT Dept. Standard high performance PCs are needed for department networks. The exact parameters of the PCs and monitors can be decided upon individually based on the program requirements for each clinic. The hardware requirements for the PCs and monitors are of course higher at the workstations where photographs will be processed.

Hardware recommendations and requirements can be found on the following page. Because of the dynamics of the PC world these requirements will be constantly updated.

4.2. Recommendations for Hardware LAN  Windows 2008 Server, Windows 2003 Server, Windows 2000 Server with the necessary patches and service packs Netware protocol  TCP/IP required  Installed DHCP server (can be the ifa-server)

3

Arthur D. Little Study „Why computerize your medical record“ in Ophthalmology Management by James Bolling, Mayo Clinic Jacksonville 4

35

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

Windows 2008/Windows 2003/Windows 2000 Fileserver (example)  Minimum: Pentium IV 3.4 GHz, 250 GB HDD, 2048 MB RAM  Recommended: Intel Core2Duo E6300 (2 x 1.86 GHz), 300 GB HDD (RAID 1), 4 GB RAM Workstations  Minimum: Intel Pentium IV 3.0 GHz, 100 GB hard disk, 1024 MB RAM  VGA resolution min. 1024 X 768 with high color mode  Recommended: Intel Core2Duo E8200 (2x 2.66 GHz), 300 GB hard disk, 2048 MB RAM  VGA resolution 1280 X 1024 with high color mode  Operating system minimum Windows 2000 or better: XP Professional, Windows Vista  If you want to use Word for ifa, a license for Microsoft Word is necessary (Word 2003 or later versions recommended)  At least one COM port to connect an instrument (better 2 or more COM ports) Backup System  IOMEGA REV drive 35/90 GB or 70/140 GB  Tandberg SLR 4, capacity of 2.6 GB to 50 GB  DLT or AIT tape drives (Quantum DLT-V4 Tape Drive)  Backup software desktop clients: MS-Backup, Veritas Backup, Seagate Backup, Orlogix Backup My PC  Backup software Server: Seagate/Veritas Backup Exec for Windows  Backup possibility to another server Printer  Laser Printer Samsung ML2850D (USB)/ML2851 DN (USB & LAN)  Color Laser Printer: OKI 5650 N (USB & LAN)  For printing forms we recommend: Canon Pixma IP90V/Canon Pixma IP4500 (inkjet printer)  Please ask us which laser printer can print on smaller paper formats (e.g. prescription forms) Monitor  Minimum 17” TFT or higher, resolution 1024 X 768  Recommended: 19” TFT or higher, resolution 1280 X 1024 Security System e.g. paperless practice  Mirrored hard drives in removable media carrier duplexing the server  RAID arrays in server

36

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

4.3. Software Investments The ifa program for eye clinics is sold as a complete system with all of its functions (see software descriptions). The basis license runs at approximately Euro 2,250.00 to EURO 2,950.00 per workstation. The basic licenses are based on the number of workstations. Instrument and data interfaces are calculated separately.

4.4. Maintenance, Support and Development Included in the license contract besides the basic license is an agreement on runtime licenses, maintenance and support fees.

Runtime licenses are the basis of contracts for the entire duration of use of the software applications. The clinic receives an unlimited, transferable (when agreed upon), use of the basic license based on payments made and monthly invoiced runtime licenses. This then covers all sublicenses for the use of additional program tools and for example integrated object oriented databases.

The program maintenance fee is for the constant development and updates of the eye clinic’s applications. The software package will continually be updated in order to keep up with market requirements. This covers systems and network platforms, and in addition new instruments and data interfaces and adaptation for ever changing legal requirements.

The support covers helpdesk support by telephone, fax and email. Several helpdesk centers exist worldwide for clinic applications (e.g. in Cologne and Berlin, Germany).

Included in the maintenance and support agreements are regular user information fliers and user group meetings. This ensures that the users are in constant contact with the development team and can thus give their qualified suggestions for future development.

The monthly service fee (for runtime licenses, software maintenance and support) is 1.5% of the software investment per month. The complete program generation updates are included (e.g. deletion of an outdated operating program).

4.5. Contract Design Contracts are generally unlimited license agreements. The systems partner guarantees continual further program application development to ensure existing investments. Qualified helpdesk support is available at normal business hours in Europe and the USA (German and English).

37

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

The user (eye clinic) has a mutual obligation to ensure the availability of quality software. This includes software error documentation (printout from the system) and if applicable documentation about the context of the error.

Liability exists only for obvious negligent errors in the program. The user is responsible for the user defined presettings (in medical and organizational areas). Measures should be taken in personnel to delegate responsibility for reporting errors and defining presettings. (See also chapter on “Legal Aspects�).

38

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 use of computerized patient records in eye clinics will become standard in the next years. Two factors are essential for a successful product: up-to-date development and professional integration service with system partners.

The system requirements for use of a CPR are extremely complex. ifa software is a program with approx. 18,000 single functions in approx. 45 program areas/modules. Approximately 400 interfaces for the data transmission of digital instruments and other software applications have been developed.

5.1. Guarantee for further Development from System Partner The investments made in the current program package run over more than 120 man years or approx.

EUR 18m or US$ 22m.

The development and consulting team communicate on a close level with international users in order to fulfill the requirements with local interfaces, applications and telemedicine applications. The current versions already contain functions that can use the standards DICOM and SNOMED. 5.2. User Motivation and Discipline The eye clinic users’ willingness to cooperate is an equally important factor for the successful introduction of the computerized patient record. Success can only be attained if the specific requirements of the eye clinic are qualified by the ability of the software to fulfill them. Excellent preparation and creative concepts are essential steps in the process.

The ifa systems team reinforces the preparation and support of the system by supplying information material, checklists and organization forms. User forums and user meetings are organized with a professional infrastructure in the newsgroups on the Internet.

39

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