A Web-Based System Supporting the Certification of the Outpatient and Emergency Departments and Providing for Post-discharge Continuity of Medical Care Software B. Spyropoulos, E. Oikonomi, A. Danelakis, K. Karaboulas, E. Kotsiliti, E. Maridaki, L. Papageorgiou, E. Papalexis, C. Sakellarios, D. Zogogianni, and M. Botsivaly Technological Education Institute (TEI) of Athens, Medical Instrumentation Technology Department, Athens, Greece Abstract— The aim of this paper is twofold: First, to present a status report of the design and the implementation of a Web-based system, supporting the Certification of the Outpatient and the Emergency Departments. An important step, towards setting-up a Quality System, is the acquaintance of the personnel, with the documentation of processes, equipment, directives etc. in each Department, and, thus, this designed and partially implemented on-line “Certification Consultant” will help the involved hospital personnel to become familiar with the documentation and the optimization of the day to day procedures of the Outpatient and the Emergency Departments. The second aim of this project was to ensure the continuity of medical Care, of the patients discharged from the mentioned Departments, by providing simple software tools, however, complying with the E2369 (CCR), ISO 13606-1, and prEN 13940 major Standards. These tools support the creation of a reasonable Discharge Report and an attached Continuity of Care Record (CCR), which are important clinical quality features for these two Departments that constitute the active interface between the modern hospital and the society. Keywords— Certification, Quality System, Discharge Report, Continuity of Care, CCR, Semantics.
this paper is, to present a status-report of this on-going project, focused presently on the Outpatient and the Emergency Departments. The system under development: •
Offers a “road-map” for the certification of each subunit or cluster of these Departments. • Can be used for uploading of the documentation necessary, during auditing. • Supports installation, maintenance and update of a Quality system. The second aim of this project was to ensure the continuity of medical Care, of the patients discharged from the mentioned Departments, by providing simple software tools, however, complying with the E2369 (CCR), ISO 13606-1, and prEN 13940 major Standards. These tools support the creation of a reasonable discharge report and an attached Continuity of Care Record (CCR), which are important clinical-quality features for these two Departments that constitute the “active interface” between the modern hospital and the society.
II. THE ISO 9000: 2008 CERTIFICATION SUPPORTING SYSTEM I. INTRODUCTION Within the present framework of functional, structural and financial reorganization of the Greek National Health System (ESY), it becomes obvious the urgent need of Certification and/or Accreditation of all Units, Departments and Clinics, of the Hospitals and Health Centers of the System, according to a Quality System, such as the ISO 9000 related ones. The first important step, towards setting-up a Quality System, is the acquaintance of the personnel, with the documentation of processes, equipment, directives etc. in each Department. This is a complex, time-consuming, and costly procedure, and under the present condition of the public finances in Greece, the usual approach of the employment of well-paid external consultants, is rather excluded. Therefore, we have initiated the design and the implementation of a Web-based system, supporting the Certification and the Accreditation of Hospitals, and the purpose of
The support for the Certification of the Outpatient and Emergency Departments is offered over a website, providing for a “scaffold of expertise” for each unit, and comprising of: • Structured scientific knowledge for each specialty. • Subject-related national and international legislation. • Relevant directives and appropriate medical guidelines. These materials are based mainly on literature published by the pertinent Medical Societies. These data shape the structure and the contains of the specific for each sub-unit processes, and it is expected to be enhanced and adapted appropriately, to the real conditions and needs of each individual Outpatient and/or Emergency Department, entering the route of Certification, by the specialized Personnel already employed in this Department. Special software-tools are being developed by our group, supporting each unit before, during and after the Certification or Accreditation phase.
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Table 1 The two Departments are divided in eight clusters based on related medical specialties and procedures
Medical Specialty Cluster Heart: Cardiology and associated in vivo Cardiovascular Diagnostics Head: Neurology, Ophthalmology, ENT, Dentistry/ Maxillary Surgery Surgery: Abdominal / GI, Obstetrics, Angiosurgery, Neurosurgery, Endoscopic Surgery, Orthopedics etc. Liver - Spleen - Immunology
Nr. C1 C2 C3
C4
Pneumonology, Nephrology
C5
Hematology, Incretology, Oncology
C6
Internal Medicine, Neurology, Psychiatry, Pediatrics Surgery – Trauma – Orthopedics – Obstetrics, Interlacing with Medical Imaging, in vitro Diagnostics, Blood- Bank, ICU, CCU, NICU, central OP
C7 C8
Table 2 Formal structure of the basic processes according to ISO 9000:2008 Standard Process Description
Area Outpatient Department Outpatient Department Outpatient Department
Administration Responsibility Jurisdiction and Communication Human resources Management. Continuous Education Clinical and laboratory activities control Quality assurance Equipment Management Disposables Management Purchase of disposables, reagents and equipment
Outpatient Department Outpatient Department Outpatient Department Emergency Department Emergency Department
Table 1 presents the eight clusters we have divided the Outpatient and Emergency Departments, for functional reasons, based on related medical specialties practice and procedures. Due to the dynamic nature of the project, the developed system is web-based (XML), enabling updates concerning legislation and workflow changes, facilitating the improvement of the available information, and encouraging the exchange of experience based new ideas, resulting in a flexible system, appropriate to support the certification of an Outpatient and an Emergency Department, of any size and objectives. The access to the site is password protected, and limited to (free of charge) registered persons, however, employed or somehow active in the field of Ambulant and Emergency Medicine. Five different levels of access rights (read only, discussion group, relevant document uploading, procedure editing, and system administrator) can be awarded to the potential users, depending on their eligibility status. The system provides for an educational module comprising of introductory information about quality systems and ISO-standards, applicable National and European legislation, relevant International regulatory guidelines etc. related to the corresponding sub-units, so that it becomes easy to trace the commitments and the duties, of each of them. Table 2 presents the typical basic processes according to ISO 9000:2008 Standard, which should be explicitly described and properly adapted to the reality of each Department under consideration, and clearly synopsized in the Quality Manual of each Department.
Structure and Management of the Quality System
Process Number P1 P2 P3 P4 P5 P6 P7 P8
P9 P10
Non-compliant materials, samples, and results
P11 Documentation & reporting of adverse-effects on P12 patients Continuous improvement and quality indicators P13 Internal evaluation and periodical inspections P14 Preparation Maintenance and Update of the Quality Manual of the Department
Aiming to support the Preparation, Maintenance, and Update of the Quality Manual of both Departments, the requirements are presented with simple and comprehensible terms, employing real world examples. This module facilitates the persons in charge of a Department “en route to certification” to: •
Comprehend the minimal formal requirements of the relevant standards. • Perceive better the importance of the activities of daily clinical routine. • Figure out how to assign neat and measurable quality indicators to the processes. The feedback expected to be received by the potential users of the system, allows for the gradual updating and improvement of this “functional core” of the developed system, by including continuously detailed advice and guidance, with regard to the various sub-unit processes, so that they can reflect reliably their interconnections, and the method of quantifying their output.
III. THE DEVELOPED DISCHARGE REPORT AND CCR SYSTEM
A significant portion of Care related to various Diseases is provided by a General Practitioner or even at at Home, usually but not exclusively, after the discharge of a patient from the Emergency Department, or after a visit to the Outpatient Department of a Hospital.
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Therefore, we have developed an integrated system, supporting the Continuity of Care that includes: First, a typical Continuity of Care Record (CCR) [1], adapted to support also the creation of a Care-Plan; and second, a Prototype Ontology, based upon the HL7 Clinical Document Architecture (CDA), serving as basis for the development of Semantically Annotated Web-Services that allow for the exchange and retrieval of Care information. The flexible design, and the adaptable data-exchange mechanism of the system, results in a useful, and compliant to the above described three standards, tool for contemporary Care. The developed system consists of two modules: The first module 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 the second module is in charge, for the creation of a care-plan which will be included in the CCR. The system is intended to be used upon the transition of a patient from hospital to ambulant or home-care, although the first module alone could actually be used in any case of transition or referral. The typical–CCR module can either collect the necessary data from an already installed EHR system, or allow for the user to enter the data manually, by filling special forms. In any case, the user decides which parts of the patient’s medical record (electronic or paper), is the most significant ones, or are the necessary ones, for the description of the current health status of the patient, and should be included in the CCR. The second module is responsible for the creation of a care-plan by creating a structured subset of data, containing the diagnostic, monitoring, treatment, and nursing activities that should be employed during the postdischarge care period. The developed model allows for every hospital department or medical/nursing group, to individually assign an appropriate set of care-activities (even at home), to specific diagnosis code(s), according to the International Classification of Diseases Version 9 (ICD-9), and if applicable, according to the Australian Refined Diagnosis Related Groups (AR-DRG) patient-code upon discharge. The DRGs codification system was also used, because it offers an adequate and well structured medical diagnostic classification system, while, at the same time, it allows for, its combination with further codification systems, such as AMA Current Procedural Terminology (CPT) and Medicare Home Health Resource Group (HHRGs), covering all aspects of post-discharge healthcare medical-managerial and financial management, including also home-care. The designed activity sets include first, diagnostic, monitoring and treatment activities that can be actually performed in a General Practitioner office or at home, and second, an appropriate nursing activity treatment plan.
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Table 3 Standards ruling the Continuity of Care medical and administrative Data Management. [2], [3]
Standards
Main Features
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 136061
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.
These profiles of care activities are custom-made and every user, e.g. every physician responsible for discharging a patient from a hospital, is actually allowed, to set up his own profiles. Upon the actual discharge of a patient, the physician can use one of the predefined profiles, create a new one or modify an existing one, in order to adapt his care profiles, to specific instances and to emerging new demands. The scheduled procedures are automatically inserted in the CCR, in the section of the Care Plan. However, the system, apart from producing, electronically or in paper, the CCR, also produces a number of additional forms, including advisory and informational notes for the patient himself or for his relatives, and diagrams of physiologic parameters, the patient should monitor.
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The system also provides for the production of forms that will be filled by the nursing personnel during the care visits, in order to document their activities. The filled forms, both the ones regarding the nursing activities and interventions, and the ones regarding the monitoring of physiological parameters, are returned to the responsible physician who evaluates them and, depending on his evaluation, the careplan of the specific patient can be appropriately modified. The Nursing Interventions taxonomy of the Clinical Care Classification (CCC) system [4] was used for the documentation of nursing activities. The structure and the data of the produced CCR are complying with the ASTM E2369-05 Specification, while XML is used for the representation of the data, according to the W3C XML schema proposed by the ASTM. The CCR that is produced by the system is currently automatically transformed to HTML format, using the Extensive Stylesheet Language (XSL), in order to be viewable and printable.
IV. THE SEMANTICAL ASPECTS OF CONTINUITY OF CARE The ISO 13606-1:2008 standard Electronic health record communication seeks to improve Interoperability of health care information systems, by promoting the employment of computing technologies that are able to comprehend the semantics of the underlying data. The emerging Semantic Web, which will employ semantically annotated Web Services, and in which information will have a well defined machine-interpretable meaning, appears currently to be the most appealing approach towards this direction. At the same time, well established standardization efforts, like the Clinical Vocabularies, and the Healthcare Standards mentioned above should not be ignored. The designed system consists of a prototype ontology, based upon the HL7–Clinical Document Architecture (CDA) [5], and an application that converts the referral documents, into CDA compliant format, and finally, the contents of the CDA compliant documents into ontology instances. The developed system approaches the CDA– documents as domains of knowledge, which describe specific events of a case. The proper representation of the concepts of these documents, in terms of an ontology, provides for the shared understanding of the document, and allows for the creation of appropriately designed semantic Web Services, exceeding the problems of, both, incompatible formats in messages, and that of the use of diverse vocabularies. An appropriate semantically annotated Web service is in charge for the distribution of the documents, over the network, by discovering existing instances of the ontology upon demand.
The referral ontology was designed, incorporating the HL7–CDA healthcare standard. The necessary ontology was built up, by the ontology editor “Protégé” [6]. The ontology-development tool “Protégé” allows for defining concepts in the domain (classes), arranging the concepts in an hierarchy (subclass-superclass hierarchy), defining which attributes and properties (slots) classes can have, which are the constraints on their values, and finally, defining individuals, and filling in slot values. The hierarchy of the ontology was defined using the HL7 Reference Information Model (RIM) entities [7], the HL7 data types and vocabularies and the HL7-CDA R2 Hierarchical Description. These four concepts constitute the topclasses of the ontology, and are further analyzed into a hierarchy of sub-classes, which describe the concepts that belong to these main categories. The developed service is currently a quite simple one, which enables the discovery of existing instances of the ontology upon the query of the appropriate patient Identification Number, however, it complies with the requirements of the three relevant major US, EU and International standards.
V. CONCLUSIONS Linking a Web-based system supporting the Certification of Outpatient and Emergency Departments, with software tools ensuring the Continuity of medical Care, complying with the E2369, ISO 13606-1 and prEN 13940 major Standards, is further unlocked to future interoperability demands, through the employment of Semantics.
REFERENCES 1. ASTM, at: www.astm.org: E2369-05, Standard Specification for Continuity of Care Record. 2. ISO 13606-1:2008. Health informatics - Electronic health record communication - Part 1: Reference model, at: http://www.iso.org/. 3. prEN 14463 ClaML: Syntax to represent the content of medical classification systems. 4. Saba V K, Home Health Care Classification of Nursing Diagnoses and Interventions. Washington, DC: George-town University, 1994. 5. Health Level 7 (HL7), at http://www.hl7.org 6. Protégé, Stanford. University at http://protege.stanford.edu/ 7. HL7 Reference Information Model, J Am Med Inform Assoc.; Vol 13, pp 30-39, 2006. ... Author: Prof.Dr.rer.nat. Basile Spyropoulos Institute: Technological Education Institute (TEI) of Athens, Medical Instrumentation Technology Department, Athens, Greece Street: Agiou Spyridonos & Dimitsanas City: 12210 Egaleo, Athens Country: Greece Email:
[email protected]
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