compendium clinic projects 2011

ifa systems AG ifa united i-tech Inc. ifa systems iberia S.L. Augustinusstr. 11 b 1850 SE 17th St. Ste. 107 Cami de Can Manuel 24 50226 Frechen, Germany Ft. Lauderdale, FL 33316, USA 07120 Son Espanyol - Espana phone: +800-43222557 phone: +1-888-4432367 phone: +34-971-438555 www.ifasystems.de www.ifa4emr.com www.ifasystems.es

Compendium

Introducing the

Computerized Patient Record

Published by the Project Management Dept. of

ifa systems AG, Frechen/Cologne


Table of Contents

1. Technical Realization 2

1.1. Local Area Networks (LANs) 2

1.2. Interfaces to Clinic Systems 2

1.3. Interfaces to Diagnostic Instruments 3

2. Requirements in the Clinic Environment 5

2.1. Coordination of Documentation Terminology 5

2.2. Organizational Preparation 6

2.3. Preparation List for Introducing Computers into the Eye Clinic 7

2.3.1. Internal Workgroups with Areas of Responsibility 7

2.3.2. Project and Time Plan with a Computer Partner 7

2.3.3. Collection of all Internal Documents and Forms 7

2.3.4. Installation of a Preparation System (one workstation) and Training from

Computer Partner 7

2.3.5. Discussion and Coordination of the 1st Version of Medical Terminology and

Examples of Patient Histories 7

2.3.6. Preparation of an Organization Handbook 7

2.3.7. Compilation of Instrument Interfaces with Documentation 7

2.3.8. Installation of Software and testing of Functions 8

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 8

2.3.11. Work Meeting with System Partners to Discuss Adaptations and Training Steps 8

2.3.12. Review of Legal Requirements 8

2.3.13. Go live with Real System! 8

2.4. Legal Aspects 8

2.4.1. Data Protection for the Patient 9

2.4.1.1. Access Rights for the Entire System with Code Word 9

2.4.1.2. Access Protection for Single Program Areas 9

2.4.1.3. User Login for Medical Documentation 10

2.4.1.4. Screen Blackout at the Workstation Monitor 10

2.4.2. Quality and Security of Documentation 10

2.4.3. Contracts with Employees and Partners 11

2.5. Time Schedule and Checklists 11

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

Systems Partner (Technical) 24


2.5.2. Area of Responsibility 2 (Workgroups): Establish Organizational Routines and

Project Goals 25

2.5.3. Area of Responsibility 3 (Workgroups): Coordinate Medical Terminology and

Presettings 26

2.5.4. Area of Responsibility 4 (Workgroups): Compile Training Plan 27

2.5.5. Area of Responsibility 5 (Workgroups): Define Access Rights and Authorization

Hierarchy 28

2.5.6. Area of Responsibility 6 (Workgroups): Data Protection and Data Backups 29

3. Special Potential for Digitizing the Eye Clinic 30

3.1. Digital Photo Documentation 30

3.1.1. Links to Fundus Cameras 31

3.1.2. Integration of Image Systems 31

3.1.3. Slide Scanners 32

3.1.4. Video Slit Lamps 32

3.1.5. Link to Other Video Sources 32

3.2. Telematics and Tele-medicine in Ophthalmology 33

3.2.1. Electronic Doctors’ Letters and OP Reports 33

3.2.2. Generated Doctors’ Letters and OP Reports 33

3.2.3. Tele-consultation 34

3.2.4. Screening Projects 34

4. Financial Planning and Legal Basis 35

4.1. Hardware Investments 35

4.2. Recommendations for Hardware 35

4.3. Software Investments 37

4.4. Maintenance, Support and Development 37

4.5. Contract Design 37

5. Summary 39

5.1. Guarantee for further Development from System Partner 39

5.2. User Motivation and Discipline 39

2


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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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

4


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.).

5


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

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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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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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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

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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

10


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.

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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).

12


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.

13


Workgroup Overview

Form No: Project Plan Eye Clinic

Date:

From:

Employee/User 01

Technic IT-Coord

02 Orga-Plan

03 Schedule

04 Training

05 Author. Docum.

06 Data Backup

and Protection

07 08

01

02

03

04

05

06

07

08

09

10

11

12

13

14

14


Example

Workgroup Overview

Form No.: 001 Project Plan Eye Clinic

Date: 10.12.08

From: G. Müller

Employee/User

01

Technic IT-

Coord

02

Orga-Plan

03

Schedule

04

Training

05

Authoris.

Docum.

06

Data Backup 07 08

01 Dr. Baldwin X X X

02 Dr. Smithfield X X X

03 Dr. Meysel

04 Dr. Miller X X

05 R. Longwell X X

06

07

08

09

10

11

12

15


Project Plan Form No: Project Plan Eye Clinic

Date:

From:

Project Requirements Respon.

WG’s 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18

16


Example

Project Plan

Form Nr: 002 Project Plan Eye Clinic

Date: 10.12.07

From: Dr. M. Meyer

Project Requirements Respon.

WG’s 01 02 03 04 05 06 07 08 09 10 11 12 13 14 15 16 17 18

Compile Workgroups X

Coordinating Time plan with IT-

/System-Partner WG

X X

Collecting Internal Documents X X

Installation Preparation system X

1. Coordination X

Work out Terminology X X X

Workout ORGA Handbook X X X

Compile Instrument Interfaces X X

Installation and Function Tests X

Training Employees X X

Experience Protocol X X X X

2nd

Update X

Work out Terminology X X X

17


Training Plan

Form Nr.: Project Plan Eye Clinic

Date:

From:

Employee/User Pre-existing Experience Training Plan

Basic Win Word ifa Basic

01 02 03

WIN

01 02 03

Word

01 02 03

ifa

01 02 03

01

02

03

04

05

06

07

08

09

10

11

12

13

14

15

18


Example

Training Plan


Date: 10.12.08

From: G. Müller

Employee/User Pre-existing Experience Training Plan

Basis Win Word ifa Basis

01 02 03

WIN

01 02 03

Word

01 02 03

ifa

01 02 03

01 X X X X X X X

02 X X X X X X X X X X

03 X X X X X X X X X X X X

04 X X X X X X X X X

05 X X X X X

06

07

08

09

10

11

19


Training Contents

Form Nr.: Project Plan Eye Clinic

Date:

From:

Training Blocks - Place No. Partic. Training Contents

- Date Respon.

- Trainer

20


Example

Training Contents

Form Nr.: 004 Project Plan Eye Clinic

Date: 10.12.08

From: G. Müller

Training Blocks - Place Nr. Partic Training Contents

- Date Respon.

- Trainer

ifa 01 ifa 4 Basic Data Entry

Passwords

Preset System /Abbreviations

19.2.09 MUE

ifa

ifa 02 ifa 6 Entry of Findings

Document Locking

Word Processing

2.3.09 MUE

ifa

21


Workstation Description Form Nr: Project Plan Eye Clinic

Date:

From:

WS-Nr. Location

Peripheral HW

(printer, scanner, card

reader, etc.)

Instruments (AR, LM,

PHOR, NCT etc.) Program areas ifa External Programs

22


EXAMPLE

Workstation Description


Date: 10.12.08

From: G. Müller

WS Nr. Location

Peripheral HW

(Printer, Scanner,

Card reader etc.)

Instruments (AR,

LM, PHOR, NCT etc.) 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

23


Authorization Documentation

Form Nr: Project Plan Eye Clinic

Date:

From:

Employee/User Function Auth.

Level

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

24


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 maintenance,

replacement of spare parts in cycles

2.5.1.11 Coordination of internal interfaces between administration systems and clinic

department systems (functions/responsibilities/time schedule)

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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.

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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

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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

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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

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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)

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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.

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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

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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.

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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

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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).

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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

4 „Why computerize your medical record“ in Ophthalmology Management by James Bolling, Mayo Clinic

Jacksonville

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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

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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 sub-

licenses 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).

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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”).

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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.