Health Telematics (AIM) Final Report


	Updated: Feb 1, 97
OPENLABS

Application of advanced informatics and Telematics for Optimisation of clinical laboratory services

Project Code: A2028

Project value: 8284 KECU

EC contribution: 4150 KECU

No of partners: 15

No of countries: 9

Duration: 36 months

Contact:
Mr. Brendan McAllister
Irish Medical Systems
Clara House
Glenageary Park
IRL-Glenageary Co. Dublin, Ireland
Tel.: +353-1-284.05.55
Fax: +353-1-284.08.29

Overview

The project has developed a common architecture and facilities for data exchange among the clinical laboratories throughout Europe.

The application work packages, which address the various functionalities of the laboratory, are connected to an open architecture which will provide the overall integration of services. The communication and telematics aspects of the project focus on standards for data transmission among laboratories and with the clinical/administrative information systems.

Purpose and objectives

Over the past two decades there has been rapid technological progress in Clinical Laboratories. Doctors have become increasingly dependent on an ever widening range of diagnostic services. The latter are often provided through the use of multi-channel and other automated analytical instruments, which generate increasing numbers of test results which are becoming available more and more rapidly. Laboratory workloads have been growing by 5-10% per annum. Physicians receive increasing amounts of data out of which information must be sifted. It has been shown that a considerable proportion (up to 60%) of tests ordered are unnecessary and that only a small proportion (10%) of the test results actually influence medical decisions. Knowledge based systems are being developed in OpenLabs to aid in the selection of tests and to provide feed-back on test requesting behaviour.

Highly specialised tests are available not only in central laboratories but also at the bedside in large hospitals and in small remote laboratories. The interpretation of laboratory test results is becoming increasingly refined; factors such as age, sex, sampling procedure, concurrent drug therapy and so forth need to be taken into account. Thus, the expertise to interpret test results is frequently lacking where required. This is particularly true for general practitioners, as the delivery of health services moves from hospitals to ambulatory and primary care. To answer the need for expertise in the area of test result interpretation, knowledge based decision support systems are being developed in OpenLabs.

A number of surveys have shown that the hospital service which is in greatest demand by remote users (GP's, health centres, smaller hospitals) is the transmission of laboratory test results. This is further evidenced by the proliferation of proprietary test result message formats such as EDIFACT in Europe. The suppliers of GP and Laboratory Information Systems (LIS) do not have the resources to support such a variety of solutions. A standard for EDI of laboratory information is required. The work of the AIM exploratory phase project EUCLIDES continues in OpenLabs. Test codes and the semantics & syntax of messages for the exchange of laboratory information are being developed in co-operation with CEN TC-251.

Most of today's LISs are dedicated laboratory databases which are neither modular nor open. It is difficult to build new interfaces to them for the purposes of telecommunications or the addition of advanced features. An Open Architecture for a LIS incorporating advanced features is being specified within OpenLabs and will be demonstrated in the project.

Results

The Specification of the OpenLabs Architecture for an open Clinical Laboratory Information System (OpenLIS) have been published at the conclusion of the project.

User assisted development, refinement and evaluation of a range of OpenLabs modules which interoperate on the OpenLabs platform architecture. These modules give added functionality which enhance the efficiency and effectiveness of Clinical laboratory services. In addition to the modules which will form part of the OpenLabs demonstrator (see below) modules have been developed for:

Automatic enforcement of locally agreed guidelines of protocols for laboratory investigation/monitoring of patient in High Dependency units. This system has been successfully transferred from its site of origin (UK) and integrated with a LIS/Hospital Information System in Belgium.
Dynamic scheduling of laboratory investigations so that additional tests may be scheduled or deleted based on results available.
Advanced management facilities providing support for management of scheduling both workflow and staff deployment in the laboratory.
A knowledge based system which draws attention to the interference of drug therapy with a patients laboratory results.
Local and remote fault diagnosis and corrective maintenance of equipment (2 modules).
A knowledge-based system for serial interpretation of acid base data.
A prototype system for monitoring biochemical markers in coronary care units.
OpenLabs Neural Network Tool to be integrated with Laboratory Information Systems.
Neural network classification of haematology image data.
A knowledge-based system for interpretation of organ profiles.

Considerable contributions have been made to the work of CEN TC 251 on Telematics Standards. The OpenLabs Coding system Version 2.0 was submitted to and is being utilised by the WG3 PTOO2L and PTOO8. Significant contributions have also been made to WG5 in the areas of Interfaces to laboratory equipment and Vital signs in Intensive Care and WG.6 on Data Protection Security issues.

Implementation and validation of the OpenLabs architecture integrating a number of OpenLabs modules developed throughout Europe.

The following "advanced" OpenLabs functionalities and OpenLabs architecture infrastructure were demonstrated at the end of the project:

Open architecture for a laboratory information system including a demonstration of the heterogeneity concerning the communication layers of the Architecture.
A knowledge-based module to give advice to GP's on appropriateness of laboratory requests concerning disorders of thyroid metabolism.
Remote requesting and reporting of laboratory tests fully integrated with the Health l, G.P. Patient Management System (GEHR Project).
A generic, configurable advanced instrument interface.
Advanced Instrument Workstation providing automatic QC and Instrument Calibration Assessment and technical validation of results.
Knowledge-based patient result validation ensuring "clinical believability" of the results.
Knowledge-based interpretation of results of thyroid function tests.
Knowledge-based module giving interpretation and advice on appropriate management of patients with lipid disorders.
Laboratory test result display and management system for GPs.
Multimedia application to Maintenance procedures for analytical instruments.
Knowledge based generation of alarms and alerts on laboratory data from patients in High Dependency areas such as Intensive Care or Transplant units.

The benefits gained from OpenLabs will be related to the fulfilment of the user requirements as specified by the three groups of users within the OpenLabs project. These are laboratory professionals (physicians, scientists, technologists), General Practitioners and clinical staff working in Intensive Care units. Some of these benefits have been realised already. More will follow as OpenLabs modules are integrated with different LIS's in the future.

Plans for Exploitation

The exploitation plan for the end products of the OpenLabs project depends on two key strategies. Firstly, the setting up of OpenLabs Foundation International (non-profit) which will concentrate on global promotion of OpenLabs standards including dissemination of information and awareness relating to the OpenLabs Architecture specification and modules.

The second major thrust for exploitation will be to transfer know-how and exploitation rights relating to the modules to industrial partners within the project and other industrial collaborators who have indicated their interest in exploiting OpenLabs. Finally, it is the intention of the consortium to apply to R&D funding agencies to enable further work on development and integration of OpenLabs modules into other Laboratory Information systems and also to extend OpenLabs modules into other areas of Laboratory Medicine (Microbiology and Histopathology) which are particularly suitable for multimedia applications.

List of Deliverables

Year 1

Project Handbook (03/R/P)
Applications of Advanced Informatics and Telematics in Laboratory Medicine : Synthesis of State-of-the-art- activities (07/R/P)
Pre-prototype systems for post-analytical functionalities, with chapters on the primary care and high dependency environments (08/P/I)
Preliminary Prototypes for essential methodologies in laboratory medicine (08/R/I)
Pre-prototype modules of advances instrument workstation (08/P/I)
Model solutions on problems inherent in problem oriented data production encompassing dynamic test scheduling. Part a) the organisational perspective; b) the LIS perspective; c) the instrument perspective (08/R/R)
Advanced facilities management: foundations for prototyping/model development (08/R/P)
Pre-prototype clinical decision support systems for the management of demand for laboratory investigations by primary and secondary care physicians (08/P/I)
Second Year Detailed Plan (09/R/I)
Final syntax specification for each additional data message (10/S/P)
Classification layers (11/S/R)
Fundamental activity and data specification for syntax tele-maintenance and version management (11/S/R)
Data interchange models (12/S/R)
Combined Committees and Annual Management Report (12/R/I)

Year 2

Security requirements specifications (01/S/P)
A multilingual system for management of demand, within the European context, through reinforcement of protocols (01/R/I)
Final data set and nomenclature of preferred terms and abbreviations (02/S/P)
Final convergence and transformation requirements from the OpenLabs syntax towards each existing syntax and vice versa (03/S/P)
A database management system optimised for the storage and retrieval of extensive test request and result data to facilitate a) the detailed audit of GP usage of laboratory services; b) the determination of investigation protocols for specified clinical conditions; and c) feedback relating to compliance with agreed local guidelines and protocols (03/R/I)
User Requirements and Functional Specifications (06/R/R)
Final report on current and future trends in LIS in Europe (06/R/I)
Prototype DSS for the secondary care environment together with documentation and user manual (07/P/I)
Assessment of the techniques studied for effecting change in demand for and improving the appropriateness of laboratory investigations and confirmation of techniques to be implemented in PRE-4 (08/R/I)
Telecommunication needs and requirements as regards dynamic test scheduling (08/R/I)
Intermediate prototype systems for post-analytical functionalities, with chapters on the primary care and high dependency environments (08/P/I)
Third Year Detailed Plan (09/R/I)
Revised Prototypes and evaluation report for essential methodologies in laboratory medicine
Advanced facilities management: preliminary prototypes/models (08/P/I)
Prototype modules of advanced instrument workstation (08/P/I)
Final translated data set and nomenclature by target language (11/S/P)

Year 3

Final Prototypes for essential methodologies in laboratory medicine (09/R/I)
Specification of the Architecture for an Open clinical Laboratory Information System Environment (11/R/R)
Assessment of validity, functionality, impact (including transferability) of the model solution
Pilot implementation, evaluation and benefits realisation report for each prototype system
Final Exploitation Report (12/R/I)
Action-plan for implementation of the open architecture framework (12/R/I)
Applications of Advanced Informatics and Telematics in Laboratory Medicine: - evaluation of developments (12/R/P)
Evaluation of the Open Architecture design and implementation (12/R/I)
Combined Committees and Annual Management Report (12/R/I)

List of Participants

Prof. Torgny Groth Univ. Uppsala Biomedical System Analysis PO Box 174 Academic Hospital Entrance 17,5 S-75114 Uppsala , Sweden Tel.: +46-18-18.28.43 Fax: +46-18-53.12.02	Dr. Pietro Toniolo Sogess srl Via de Amicis 53 I-20123 Milano, Italy Tel.: +39-2-89.40.03.07 Fax: +39-2-89.40.15.39
Dr. Peter McNair Hvidovre Hospital Dept. Clinical Chemistry 339 Kettegaards Alle 30 DK-2650 Hvidovre, Denmark Tel.: +45-36-32.36.32 Fax: +45-31-75.09.77	Mr. Peter Scott Selly Oak Hospital Biochemistry Dept. Birmingham B29 6JD, U.K. Tel.: +44-21-472.52.12 Fax: +44-21-414.00.78
Mr. Kim Bisgaard CRI A/S - Computer Resources Intl. Bregneroedvej 144 DK-3460 Birkeroed, Denmark Tel.: +45-45-82.21.00 Fax: +45-45-82.29.83	Prof. Arie Hasman Univ. Limburg Dept. Medical Informatics Annalaan 60 NL-6217 KC Maastricht, The Netherlands Tel.: +31-43-88.83.98 / 88.84.17 Fax: +31-43-43.60.80
Mrs Margaret Peters Wolfson Research Laboratories Queen Elizabeth Medical Centre Dept. Clinical Chemistry Edgbaston Birmingham BT15 2TH, U.K. Tel.: +44-21-472.13.11 ext. 45.46 Fax: +44-21-472.04.99	Dr. Barry Clarke Informed Software 2 the Square Glasgow G12 8QQ, U.K. Tel.: +44-41-339.07.88 Fax: +44-41-357.45.47
Prof. Jos Willems Katholieke Univ. Leuven Medical Informatics Oude Markt 13 B-3000 Leuven, Belgium Tel.: +32-16-21.38.01 Fax: +32-16-21.37.96	Prof. George De Moor Ramit State University Ghent Medical Informatics Dept. De Pintelaan 186 B-9000 Gent, Belgium Tel.: +32-91-40.34.36 Fax: +32-91-40.34.39
Dr. Pirkko Nykanen VTT - Medical Engineering Lab. Kanslerinkatu 8 SF-33101 Tampere, Finland Tel.: +358-31-16.33.60 Fax: +358-31-17.41.02	Dr. Pierre Poncet Bayer Diagnostics - ISEC 49, Chemin de vieux Chêne - BP 115 F-38242 Meylan, France Tel.: +33-76-90.41.72 Fax: +33-76-90.11.52
Mr. Louis Schilders Methode Nouvelle Excelsiorlaan 4a B-1930 Zaventem, Belgium Tel.: +32-2-720.90.60 Fax: +32-2-721.42.85	Dr. Gerald Boran Guys & Levisham Hospitals Trust Chemical Pathology Dept. London DE13 6LH, U.K. Tel.: +44-81-690.43.11 Fax: +44-81-690.98.29
Prof. Rory O'Moore FDVH/St. James Hospital PO Box 795 IRL-Dublin 8, Ireland Tel.: +353-1-53.23.85 Fax: +353-1-53.75.94



	Copyright 1997 © EHTO All rights reserved This server is the only official EHTO WWW knowledge repository. Mail suggestions to: webmaster@ehto.org

OPENLABS