Abstract
MEDICA MediLab: Satellite Symposium Nr. 251
Design for Multi-discipline Integration
The ADVIA Integrated Modular System offers the central laboratory the opportunity for workstation consolidation, streamlining of testing processes and automation of routine operations. It was developed in direct response to market research data and customer feedback.
The ADVIA IMS design provides a platform that can accomodate both current and future analytical processing engines. The built-in flexibility and adaptability allows it to meet today's needs for Clinical Chemistry and Heterogeneous Immunoassay testing. This has been accomplished by providing a common sample processing module, which can support up to four analytical testing engines. As customers need change, additional modules can be added on site.
The ADVIA IMS is a member of a system family that provides built-in redundancy and custom configurations to meet individual customer requirements. At its launch Bayer will offer the ADVIA IMS system with three modules, which use common components including the base, the clinical chemistry and the immunoassay processing module. The base module is the foundation of the system and the primary point of any operator interaction. It consolidates:
Sample loading and unloading (including rerun, reflex and repeat)
Reagent loading and preparation
QC loading and storage
Automated sample pre-treatment and dilution
Environmental support system (refrigeration, power, interfacing).
The ADVIA® Smart Access™ capability enables simultaneous and individual sample processing in parallel, according to clinical needs. Its user interface is easy to use. ADVIA IMS takes modularity to a new height, raising the standard of efficiency in the laboratory.
L. de Luzuriaga
Bayer Corp., 511 Benedict Ave, Tarrytown, NY 10591, USA
Phone 914–524 2193, Fax 914–524 3308
MEDICA MediLab: Satellite Symposium (Nr. 251)
Standardization of Laboratory Automation Systems
NCCLS has successfully undertaken a major world-wide initiative to develop prospective standards for clinical laboratory Automation. These standards are intended to assure the interconnectivity of instrumentation in a way that enhances innovation and encourages use of Automated systems.
AUTO1-P, which deals with specimen containers and carriers, was distributed in July 1999 for wide public review. Major issues are tube dimensions and tolerances as well as the number of specimens in a specimen carrier (“rack”).
AUTO2-P on bar codes for specimen container identification and AUTO3-P on communication with Automated clinical laboratory systems completed the six-month public review and comment period. The subcommittees are currently preparing the standards for approved-level consensus. Major contents are the support of Code 128 symbology (phasing out all other types of symbolgies by the year 2003), as well as the harmonization of Japanese and Western type communication standards.
AUTO4-P on operational requirements (e.g. status information on specimen processing) and AUTO5-P on electromechanical interfaces (e.g. XYZ coordinates of the “point of reference”), have been distributed for comments as proposed standards.
The Area Committee on Automation is considering strategies that can be effectively used to integrate all five prospective standards during the revision process in the year 2000, to update the standards every two to three years and to assess the opportunities for future applications in pharmaceutical industry analytical laboratories.
Steve Savitz, Member of the NCCLS Area Committee
e-mail
MEDICA MediLab: Symposium III (Nr. 250)
Regulatory Affairs in the European Community — The European In-Vitro Diagnostic Directive
The new European IVD Directive (98/79/EC) has been published in the European Official Journal on December 7th, 1999. The IVD Directive is the third of three directives in the field of medical devices, the former two dealing with Active Implantable Medical Devices — 90/385/EEC, i.e., pace makers and Medical Devices — 93/42/EEC such as syringes, needles, cardiac valves, etc. The IVD-D has an impact on any company which wants to do business in Europe. In addition, companies without a European subsidiary will need to appoint an Authorized Representative in Europe to serve as an interface between the Competent Authorities and the Company. IVD manufacturers will be able to indicate that their products are in compliance with the IVD Directive by applying the CE mark on the product itself, or on its labeling and on its instructions for use.
5 different groups of products can be recognized:
HIV1/2, HTLV I/II
Hepatitis B, C, D
A B O, Rh/C,c,D,E,e, anti-Kell
Irregular anti-erytrocytic antibodies
Rubella, Toxopl., CMV, Chlamidia
Phenylketonuria
HLA, DR, AB
PSA, self-tests for blood glucose anti-Duffy, anti-Kidd estimation of the risk of trisomy 21
Self-test products
“All other IVDs”
IVDs for performance evaluation
From December 7th, 98 to June 7th, 2000 each European Country must transpose the Directive into its own national legislative system. It is a requirement to adopt any directive which has been ratified by the European Parliament and the Council of Ministers. The Directive requires that IVDs for self-testing must be supplied in the national language(s). During a transition period from June 7th, 2000 to December 7th, 2003, manufacturers will be allowed to choose between the “old” regulatory system in each specific European country or the new regulatory system provided by the IVD Directive. As an example: a manufacturer of an HIV assay could register his product in Germany, France and Italy separately or only once according to the IVD-D requirements. From December 7th, 2003 onwards only CE marked IVDs will be allowed to enter the European Union market.
The Directive covers all IVD products, independently of the technology used and even those which are for performance evaluation only. Exceptions are research only and home brewed products.
Dr. Maurizio Suppo, Principal Consultant MTC
Via Audello 68, I-10072 Caselle T.se
Phone: +39–011–997–5811, Fax: +39–011–991–6236
MEDICA MediLab: Symposium II (Nr. 224)
The Impact of Web Technology on Laboratory-Medical Competence
One of the main aims of laboratory-medical competence is the provision and presentation of medical information from result constellations in the best possible way. This implies competent decisions for the whole hospital as far as laboratory-medical questions and tasks are concerned. This support of the flow of medical information can be performed in a conventional manner via reports and phone calls, but the optimal use of the new web technologies will enhance this process in a very efficient way. In this context it is crucial to influence the whole process through personal competence wherever possible, keeping in mind the local conditions and prevalences.
This technological improvement has an impact on patients and colleagues from outside, as well as on physicians inside the hospital and the laboratory staff. The power behind the new ways to present and handle information comes from new standards, which will be discussed in detail.
The main advantage of these standards is based on improvements of the so-called markup languages: they have recently shifted from mere content presentation (text only), to real format presentation (providing visual clues, visual foci with object information in as much as location and history of information). This has been achieved by stringent application of object oriented design, analysis and implementation (SGML, Standard Generalized Markup Language). These powerful languages and standards include XML (eXtended Markup Language), and additional tools like Java and Java Beans.
XML is able to convey and represent much more complex information than HTML due to features like:
the possible inclusion of no-standard processes for collection of data of a variety of sources
taking into account heterogeneous healthcare systems, multiple formats
the increasing use of the Internet for information resources of long term value even with complex relationships between information resources (links)
For these reasons XML will also be used within HL7 (Health Level 7), which is one of the most frequently used standards to convey the content of medical information. Within HL7, parts of the laboratory environment can be represented by LOINC (Logical Observation Identifiers for identifying laboratory and clinical observations, Names and Codes). A further improvement is achieved by the use of knowledge based systems, provided that these systems can be modified for local conditions.
With this powerful new world of standards for information exchange, the medical user can now focus on using or configuring data, formats and actions, rather than worrying about how to do it. This will prevent the loss of additional inherent information beyond the simple figures of the test results, which often occur with current Hospital Information Systems. New technologies can help to provide valuable medical information including current status and explanation of test results, interpretation and links with other medical information, thus reinforcing the medical competence of the laboratorian for patient care whenever and wherever needed.
Prof. Dr. Christian Trendelenburg*, A. Wormek and B. Pohl
*Institut für Laboratoriumsmedizin
Städtische Kliniken Frankfurt am Main-Höchst
Gotenstr. 6–8, 65929 Frankfurt
Phone: +49–69–3106 2836
Fax: +49–69–3106 3030