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Including in Vitro Diagnostics Point of Care Testing in Continuity of Care Medical and Administrative Data Management Software

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Including in vitro Diagnostics Point of Care Testing in Continuity of Care medical and administrative Data Management Software

B. Spyropoulos, M. Botsivaly


Care medical and administrative Data Management. Software was developed complying with E2369 (CCR), ISO 13606-1, and prEN 13940 Standards, by adopting all crucial features, and the most innovative functional solutions, according to the requirements of those standards. The developed system consists of a first module that is responsible for the creation of a typical CCR that contains the appropriate demographic and administrative data, as well as the relevant clinical information, while a second module is responsible for the creation of a care plan, comprising of PoCT and other relevant data. Finally, the system includes a prototype ontology based upon the HL7-Clinical Document Architecture (CDA), and an application that converts the referral documents into a CDA-compliant format, and the contents of the CDA-compliant documents into ontology instances.


The employment and the management of in vitro Diagnostics (IVD) Point of Care Testing (PoCT) devices include, first, identifying a clinical need before a decision to introduce PoCT is made, second, clinical governance issues related to PoCT, third, the need for local hospital laboratory involvement in all aspects of such a service, and finally the need for Quality Assessment and training of all staff involved. The concept of PoCT was being revisited several times in the last 20 years. There had been important advances in technology, but the overall in vitro diagnostics sector has had a slow-moving growth. Only Molecular Diagnostics and PoCT are growing strongly, the later accounting for a quarter of the total global IVD market, however, almost entirely due to its use in Diabetes monitoring.

An important issue is that of control between central laboratories and the proposed sites for PoCT. The aim will be to control the quality of the test, to maintain the equipment, and to provide support for the clinician in the interpretation of the results [1]. The major problem for an effective PoCT implementation will be the significant changes to patient pathways that will require health-care professionals to change their work patterns. At the heart of this discussion lie the issues affecting:

* The future interface of clinician and laboratory.

* The redirection of test budgets among departments.

* The improved use of overall healthcare funding.

* And finally the regulatory control of both, products and users, of PoCT diagnostics.

Including the Point of Care in vitro Diagnostics Testing in the Continuity of Care medical and managerial Data Management, could offer an adequate interim solution, regarding the emerging disruptive PoCT technology impact, on its technical-managerial and clinical aspects.



E2369 (CCR) The ASTM (ANSI) E2369-05 Specification for Continuity of Care Record (CCR) is a core data set of the most relevant administrative, demographic, and clinical information and facts about a patient's healthcare, covering one or more healthcare encounters. It provides means for one healthcare practitioner, system, or setting to aggregate all of the pertinent data about a patient and forward it to another practitioner, system, or setting to support the continuity of care. XML coding provides flexibility that allow users to prepare, transmit, and view the CCR in multiple ways, for example, in a browser, as an element in a Health Level 7 (HL7) message or as a CDA compliant document, in a secure e-mail, as a PDF file, as an HTML file, or as a word processing document.

ISO 13606-1 This five-part standard, originally developed by the European Committee for ISO 13606-1:2008, specifies the communication of part or all of the electronic health record (EHR) of a single identified subject of care, between EHR systems, or between EHR systems and a centralized EHR data repository. It may also be used for EHR communication, between an EHR system or repository and clinical applications or middleware components (such as decision support components) that need to access or provide EHR data, or as the representation of EHR data within a distributed (federated) record system.

prEN 13940 The standard is organized in two parts: The first part concerns extended architecture and the second one the domain term list. An additional pre-standard, prEN 14463 ClaML syntax to represent the content of medical classification systems, describes a standard for representing the content of classification systems, especially in a medical context, to enable an XML representation of a classification. The syntax will be limited to mono hierarchical systems. Major part of the work involved will be in determining how detailed the syntax needs to be.


Nevertheless, as we move towards this decentralized model, well argued concerns are raising about fragmentation of patient's relevant information and the discontinuity in the delivered care. Furthermore, especially in transitions from hospital to other health-care facilities, including home-care, crucial questions emerge concerning the way the specific PoCT-IVD data will be medically and administratively supervised.

Therefore, the aim of this paper was to contribute towards the development of an appropriate software application, including in vitro Diagnostics Point of Care Testing Data, in the Continuity of Care management frame, and complying with E2369 (CCR), ISO 13606-1, and prEN 13940 Standards, shortly described in Table I.


PoCT is defined as any analytical test performed for a patient by a healthcare professional outside the conventional laboratory setting. Recent years have seen a rapid growth in the use of PoCT, largely as a result of technological advances, such as, new developments in solid phase chemistry, and the integration of microprocessors, resulting in miniaturization of equipment. Consequently the latest PoCT devices are generally more reliable and less prone



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