I Contents I 2010 MXS NV/SA Table of Contents Part I Introduction 3 ................................................................................................................................... 3 1 Open IT architecture .......................................................................................................................................................... 3 Open Source software .......................................................................................................................................................... 3 Disclosed source license .......................................................................................................................................................... 3 Webbased user interface ................................................................................................................................... 4 2 GEHR model .......................................................................................................................................................... 4 Short description of the GEHR architecture ................................................................................................................................... 4 3 Application domains ................................................................................................................................... 5 4 Implementations Part II OpenClinic software 5 ................................................................................................................................... 6 1 General aspects .......................................................................................................................................................... 6 User language .......................................................................................................................................................... 6 Technical requirements ................................................................................................................................... 6 2 Patient administration .......................................................................................................................................................... 6 Patient identification .......................................................................................................................................................... 7 Demographic data ................................................................................................................................... 8 3 Admission, Discharge and Transfer (ADT) .......................................................................................................................................................... 8 In-patients ......................................................................................................................................................... 8 Admission and identif ication ......................................................................................................................................................... 9 Admission ......................................................................................................................................................... 9 Transf er ......................................................................................................................................................... 9 Discharge .......................................................................................................................................................... 9 Out-patients ......................................................................................................................................................... 9 Visit identif ication .......................................................................................................................................................... 9 Patient tracking .......................................................................................................................................................... 10 Electronic agenda ......................................................................................................................................................... 10 Resource planning ................................................................................................................................... 10 4 Financial management .......................................................................................................................................................... 10 Activity data .......................................................................................................................................................... 10 Invoicing and accounting ......................................................................................................................................................... 11 Discharge and end of visit ......................................................................................................................................................... 11 Preliminary invoicing ......................................................................................................................................................... 11 Payment and cash transf ers ................................................................................................................................... 11 5 Medical record .......................................................................................................................................................... 11 Record identification .......................................................................................................................................................... 12 History of health events .......................................................................................................................................................... 12 Generic SOAP structure .......................................................................................................................................................... 12 Domain specific registration forms .......................................................................................................................................................... 13 Medical prescription management ......................................................................................................................................................... 13 Ward stock management .......................................................................................................................................................... 14 ICPC2/ICD10 based thesaurus .......................................................................................................................................................... 14 Technical examinations management ......................................................................................................................................................... 14 Laboratory data management ......................................................................................................................................... 14 Order entry ......................................................................................................................................... 14 Results OpenClinic II 2010 MXS NV/SA ......................................................................................................................................................... 15 Medical imaging data management ......................................................................................................................................... 15 Order entry ......................................................................................................................................... 15 Results ......................................................................................................................................................... 15 Pathology lab ......................................................................................................................................... 15 Order entry ......................................................................................................................................... 15 Results .......................................................................................................................................................... 15 Medical record printing ................................................................................................................................... 16 6 Preventive medicine .......................................................................................................................................................... 16 Immunization management ......................................................................................................................................................... 16 Vaccination schemes ......................................................................................................................................................... 16 Vaccination card ......................................................................................................................................................... 16 Planning & campaigns .......................................................................................................................................................... 16 Risk profiles ................................................................................................................................... 16 7 Warnings ................................................................................................................................... 16 8 Reporting .......................................................................................................................................................... 17 Pathologies per consultation .......................................................................................................................................................... 17 Pathologies per admission .......................................................................................................................................................... 17 Pathologies and co-morbidity .......................................................................................................................................................... 17 Pathology cost .......................................................................................................................................................... 17 Activity reports .......................................................................................................................................................... 17 Admission duration reports .......................................................................................................................................................... 17 Total invoices .......................................................................................................................................................... 17 Money transfers .......................................................................................................................................................... 17 Bed occupancy reports .......................................................................................................................................................... 17 Clinical analyzer .......................................................................................................................................................... 17 Medical monitoring engine ................................................................................................................................... 18 9 Document printing ................................................................................................................................... 18 10 Human resource management ................................................................................................................................... 18 11 Technical functionalities .......................................................................................................................................................... 18 Security ......................................................................................................................................................... 18 Access control ......................................................................................................................................... 18 User identif ication ......................................................................................................................................... 19 User prof iles ......................................................................................................................................... 19 Personal prof iles ......................................................................................................................................................... 19 Access monitoring ......................................................................................................................................... 19 Access monitoring ......................................................................................................................................... 19 Intrusion detection ......................................................................................................................................... 19 User tracking .......................................................................................................................................................... 19 Information archiving .......................................................................................................................................................... 20 Clinical mailer and user feedback Index 0 Introduction 3 2010 MXS NV/SA 1 Introduction MXS is a Belgian Medical Software company that has developed a suite of applications for the managemen of healthcare information. The company is led by a physician who is also a software engineer and has a permanent staff of 1 more physician with high-level IT skills, 4 software engineers and 1 research coordinator. Furthermore, the company has a team of 5 healthcare IT-consultants working on project basis and a local Rwandan team of 1 public health expert, a physician-expert in health statistics, 2 technicians and 2 administrative collaborators. MXS has specialized in tailor-made applications, which are built on basic generic technological platform, called the "OpenIT architecture". In this document an introduction is given to the OpenIT architecture and more specifically the Open Clinic Hospital Information Management System that has been developed on top. MXS has a permanent office in Rwanda at the ININD House in Kigali (Kicukiro). 1.1 Open IT architecture The general OpenIT architecture has been the fruit of many years of experience in medical information management. The systems built on this architecture thereby have evolved from standalone software packages (early nineties) over client-server systems (late nineties) towards nowadays distributed and web-based software suites. Today, the OpenIT philosophy aims to deliver IT-systems that can be managed to a large extend by the customer's IT department. Only widely used and solid technologies are being integrated in OpenIT systems, in order to realize reliable and stable products. 1.1.1 Open Source software For customers who really want to cut their budget dramatically the standard OpenIT-kernel is available with OpenSource and Freeware software backbone only: - Sun's Java Runtime Environment - Tomcat Servlet Engine - PostgreSQL database server (all operating systems) or Sybase Adapative Server Enterprise 11.9.2 for Linux Serveral OpenIT products have been implemented on such an OpenSource backbone, even for very large customers (e.g. Federal Police Medical Service in Belgium) 1.1.2 Disclosed source license Once installed, all sourcecode of every OpenIT module is provided to the client. The client can freely use, modify and evolve the sourcecode whithout permission of MXS. Only reselling of the OpenIT modules is prohibited. The advantages of Disclosed Source code: No need for MXS-support for modules for which the customer has a sufficiently skilled ITdepartment. The customer can call in other software companies at any time to support the OpenIT-modules (independency from MXS as a software provider) Internal IT-staff can freely use and copy code-fragments from the OpenIT-kernel for noncommercial (no reselling permitted) internal purposes. 1.1.3 Webbased user interface Many members of hospital staff have little or no experience with computer hard- and software. Therefore the well-known Web interface, one of the easiest and most widely used interface-types in the world, has been selected to be integrated in the OpenIT architecture. All end-user software manipulation can be done through a standard webbrowser, which many users are familiar with. If a user can surf the web, he can use OpenIT based software like Open Clinic. OpenClinic 4 2010 MXS NV/SA 1.2 GEHR model From the beginning, MXS has specialized in health information management. The company's core business lies without any doubt in the healthcare sector (>90% of revenue). Since the early nineties, our IT-trained physicians and information-engineers have been closely following standardization efforts in Europe and the US in the field of medical information management. Today's OpenIT architecture has been built on one of the most influencing medical standardization-projects in the past 15 years, the "Good European Health Record", renamed later as the "Good Electronic Health Record" (GEHR). The Good European Health Record, was a three year project within the European Health Telematics research programme (Advanced Informatics in Medicine) 1991-1995. It has developed a comprehensive multi- media data architecture for using and sharing electronic healthcare records, meeting clinical, technical, educational and ethico-legal requirements. The GEHR project consortium involved 21 participating organisations in seven European countries, and included clinicians from different professions and disciplines, computer scientists in commercial and academic institutions, and major multi-national companies. The architecture object model, exchange format, term sets and the specifications of access and integration tools have been placed in the public domain. 1.2.1 Short description of the GEHR architecture All information in a given Electronic Health Care Record (EHCR) implicitly relates to the care of one person, the patient. Within each patient record, the GEHR architecture preserves both the original structure of the data and how the entries in the record are grouped. Every effort has been made to propose an architecture which is as generic, flexible and non prescriptive as possible. However, where clinicians have identified the need to be prescriptive (e.g. in situations where medico-legal security must be maintained) the architecture incorporates features which may be utilised for this purpose. Principal GEHR architectural components the EHCR provides the container for all data about a particular patient the Transaction provides most of the features needed for the medico-legal aspects of healthcare data provides the mechanism for the control of amendments represents the smallest amount of data which can safely be transferred between EHCR systems the Health Record Item (HRI) provides for aggregation of HRIs and other HRI Collections provides the means of changing the scope (data subject) of the data the Heading provides annotation for groups of HRIs/Collections Each of these constructs is further elaborated using Attributes that address aspects of identification, content and context. They are consistent with the structures apparent in existing records and fullfil the requirements identified by the project for the EHCR. The GEHR project has developed two formal definitions in support of the architecture: the GEHR Object Model and the GEHR Exchange Format. To support the development of healthcare record systems incorporating the GEHR architecture, the project has produced a term set of 2,000 HRI names available in 9 European languages, and a comprehensive set of 47 anatomical drawings. The architecture, term sets and drawings have all been placed in the public domain. 1.3 Application domains The generic OpenIT architecture provides a technological foundation for several applications in the healthcare domain. In fact, the GEHR project proved that a generic mechanism of structuring medical information could be applied to fundamentally different clinical specialties. Typical application domains are curative medicine (private practice and hospital), preventive medicine, disease management and Introduction 5 2010 MXS NV/SA clinical research. Experience however shows that every specialty has it's own way of using these common structuring concepts. Every specialty has it's own typical needs with regard to specific content and information aggregation. Therefore, most OpenIT-based systems are being highly customized to meet the exact requirements of the end-users. 1.4 Implementations Today, OpenIT based systems have been or are being used for: Curative medicine: - Family physicians record management systems (Belgium, Open Clinic: Datamed, Praktis) - Hospital medical record management systems (Belgium, Open Clinic: Hematology, Pneumology, Cardiology) - Hospital Information System (Rwanda, Open Clinic: CHUK, DH Muhima, DH Kibagabaga, DH Nyamata, DH Rutongo, Polyclinique du Carrefour, Croix du Sud hospital, Biomedical Center, Polyclinique La Mdicale, Polyclinique Bien-Natre - RDC, OpenClinic: DH Dondo, CHU Kinshasa, CHU Lubumbashi, CHU Bukavu, CHU Kisangani - Burundi, OpenClinic: Centre Mdico-Chirurgical de Kinindo) Preventive medecine: Occupational healthcare (Belgium: OpenWork) - Vaccination program management (Zare: Open Clinic) - Industrial hygiene (France, Belgium: OpenWork) Disease management programs - Dementia distributed medical record (Belgium: Open Clinic: DementiaNet) Clinical research programs - Pharmaceutical clinical trials (Belgium, Luxemburg: OpenCRF: Olmer3plus, IPAQ, Dilease, Hyperscreen) Other - OpenControl (Belgium: Sickness absence & return to work management) - OpenRecrute (Belgium: Recrutement examinations) 2 OpenClinic software Open Clinic is an integrated Hospital Information System consisting of a series of modules that have been built on the OpenIT Medical Information Architecture (OpenMIA). The system automates information management for all basic functions of small to medium-sized hospitals (50-1.000 beds). Open Clinic is the result of more than 15 years of experience brought together by computer engineers and physicians with high-level ICT-training at MXS (Belgium). The Open Clinic program was first started in 1990 and has been on the market until 2001. In 2004, the OpenMIA architecture and the OpenClinic modules have been completely redesigned and reprogrammed in the Java programming language, one of the most popular programming languages in the world today. The most important features of the Open Clinic system: Very easy graphical user interface (web-based) thanks to custom-made data-entry screens, which exactly match the user-defined business processes in the Hospital Extremely low cost of ownership thanks to the extensive use of OpenSource server- and development components and the complete absence of recurrent license fees. Unlimited number of users and devices in the system. No additional fees are to be paid when the system has to grow with your institution. Use of high-standard proven technologies and software components, such as: 1. The Java programming language 2. Tomcat web application server (Servlet Engine) OpenClinic 6 2010 MXS NV/SA 3. Compatibility with a choice of high quality database servers: - Microsoft SQL Server - Sybase Adaptive Server Enterprise - Oracle database server - MySQL database server - ProgreSQL database server - Cach database server 4. Fully web-based user interface, optimized for Microsoft Internet Explorer (version 5.5 and above) 5. Wide Operating System compatibility - Microsoft Windows NT/2000/2003 Server/XP/Vista - Linux - Sun Solaris Availability of all sourcecode to the customer. Easily extendable multilingual user-interface support (French, English and Dutch provided in standard version) Very open implementation enhancing the integration of interfaces to other software systems or medical devices. Standard integration of statistical classification instruments as ICPC/2 and ICD-10 Open Clinic is modular, thereby ensuring sustained benefits through changes in technology, protecting and providing optimal returns from the investment. It is modeled on a unique combination of a 'patient-centric and medical staff-centric' paradigm, beneficial to the recipients and the providers of healthcare. Integration of clinical as well as financial and administrative applications. Audit logging of all transactions Easy to manage user security 2.1 General aspects 2.1.1 User language The standard Open Clinic system is available in French, English, Portuguese and Dutch. Nevertheless, all user interface- and report-related labels have been isolated in separate language-tables. This means that is is quite easy to introduce new languages into the system. 2.1.2 Technical requirements The OpenClinic software is compatible with basic hardware specifications: ordinary PC's with 512 Mb of RAM or Thinc Client infrastructure with Windows, UNIX, Linux or Mac platform. 2.2 Patient administration Efficient patient administration is one of the cornerstones of a well designed Hospital Information System. Patients must be uniquely identified, in order to keep track of their complete medical and financial history within the institution. The Open Clinic patient administration module has been designed to enable registration of a complete administrative history. Nevertheless, as special (local) needs for particular data fields seem to arise in most Open Clinic projects, the module is easily extensible. Any number of data fields that would seem to be missing in the standard implementation, can be added to the system by the application manager (a specially trained super-user). 2.2.1 Patient identification As stated earlier, patient identification is crucial when handling sensitive personal information like medical or financial records. OpenClinic software 7 2010 MXS NV/SA The OpenClinic patient identification functions include: Possibility to attribute an unlimited number of person identifiers to a patient record (ID card, National register ID, Passport ID, Fingerprint ID etc...) Automatic attribution of a unique, permanent system wide medical record number by Open Clinic to each patient. This ID is the key that brings together all person-related information that is brought into the system. Every person-related document that is printed by Open Clinic can wear this unique ID. Possibility to print patient identification labels to put on paper documents, wrist bands etc... This printout also comprises barcoded tags, which can reduce patient identification time dramatically. However, clinicians need to be actively involved in the development of policies and procedures related to verifying patient identity. These individuals can best identify issues that contribute to errorprone conditions and develop strategies to reduce their likelihood. Next, they must consistently follow the procedure and be accountable for their practice by adhering strictly to the policy. Furthermore, clinicians must hold each other responsible and continually identify risk states and implement processes and procedures to prevent such errors. Nurses should review existing policies, procedures, and practices related to patient identification. They need to identify gaps and situations that place patients at risk and then develop and implement processes to minimize these risks. In many situations, current practices are not adequate to address the pace of admissions and number of surgical cases. Many times, the clerk in the admission office charged with placing a name band does not understand the risks inherent in incorrect identification. If for some reason a patient ends up with more than one medical record in the institution, the Open Clinic software provides a record merging function, resulting in a fusion of two records into one single record. An automatic retrieval engine for records that are 'suspicious' (possible duplicates), facilitates the maintenance of a 'clean' administrative database. 2.2.2 Demographic data Most common patient-demographic data elements have been integrated in the standard Open Clinic implementation: Personal data 1. Name (firstname, lastname, alternate names) 2. Date of birth 3. Record ID number (other than the automatically attributed Open Clinic ID, e.g. reference to a paper based record) 4. National ID number 5. Language 6. Gender 7. Place of birth (city & country) 8. Nationality 9. AlternateID (e.g. fingerprint or other biometric data) 10. Comments Medico-administrative data 1. Family physician 2. Other private physicians (specialists) 3. Health Insurance company 4. Health Insurance Contract number 5. Health Insurance status (code + description) Official addres 1. Street and number 2. Zipcode 3. City OpenClinic 8 2010 MXS NV/SA 4. Country 5. E-mail 6. Telephone 7. Fax 8. Mobile phone 9. Comments Residence address 1. Street and number 2. Zipcode 3. City 4. Country 5. E-mail 6. Telephone 7. Fax 8. Mobile phone 9. Comments For the Rwandan context, the following fields have already been added to the OpenClinic software: 10. Province 11. District 12. Sector 13. Cell 14. Village Occupational data (work environment) 1. Employer name and address 2. Employee record number 3. Work e-mail 4. Work telephone 5. Work fax 6. Work mobile phone 7. Function 8. Employee category 9. Start date of employment 10. End date of employment Any number of missing data fields can easily be added to the Patient administration module. 2.3 Admission, Discharge and Transfer (ADT) The Open Clinic ADT module enables the detailed follow-up of all patient movements within the healthcare facility. Data collected in this module will also be used to calculate bed occupancy rates or provide reports on the actual numbers of available beds. 2.3.1 In-patients 2.3.1.1 Admission and identification Every contiguous period of time a patient occupies a bed in the hospital, is being identified by a unique Admission number. Every medical act, prescription, payment etc... related to the hospital stay will carry this Admission ID. The Admission number being unique, it can also be used to uniquely identify a patient within the system. OpenClinic software 9 2010 MXS NV/SA 2.3.1.2 Admission At the admission of a patient, a number of admission-related data can be collected and stored in the Open Clinic system. The standard Open Clinic implementation holds the following data (some are optional): Date and time of admission Planned date and time of discharge Ward identification Bed number identification Responsible physician identification Comments 2.3.1.3 Transfer A transfer in Open Clinic means a change in ward or bed identification data within the context of one and the same hospital admission. Transfer registration is essential to keep track of bed occupancy and - availability. At the occasion of a transfer, the following data can be entered (some are optional): Date and time of transfer New ward identification New bed identification New responsible physician identification New planned date and time of discharge Reason for transfer Comments A unique transfer identification number is automatically attributed to every transfer in the hospital. 2.3.1.4 Discharge Discharge means the end of a hospital admission. After discharging a patient from the hospital, the admission number is closed and the occupied bed is automatically flagged 'available' in the Open Clinic system. When discharging a patient, the following data can be entered (some are optional): Effective date and time of discharge Reason for discharging the patient Comments 2.3.2 Out-patients 2.3.2.1 Visit identification For outpatients, every visit to the hospital is identified by a Visit identification number. This number will enable the grouping of all patient data related to one and the same hospital visit. When registering an outpatient's visit, the following data can be entered into the system (some are optional): Date and time of the visit Type of contacts (consultation, examination) to be carried out 1. Contact type 2. Responsible clinician 3. Scheduled contact time 2.3.3 Patient tracking Patient ADT information permits to keep track of the patient movements within the hospital. A separate module is provide in Open Clinic to graphically visualize inpatients' bed allocation history and to identify all medical acts which adhere to a specific moment of the admission period. Open Clinic can also show a map of the hospital site with the exact location of the patient's allocated bed at any moment. OpenClinic 10 2010 MXS NV/SA 2.3.4 Electronic agenda A standard electronic agenda has been integrated into Open Clinic. This user-centered agenda can hold all scheduled appointments for every user, permitting the definition of 'user groups' which are granted access to each others agenda. The medical record of a patient can then easily be opened by clicking on the patient's name in the agenda (quick identification). 2.3.4.1 Resource planning In the Open Clinic agenda, a resource planning facility has been integrated. This module enables users to make reservations for shared resources such as operating rooms, diagnostic devices, meeting rooms etc... 2.4 Financial management Financial management in the standard edition of Open Clinic is based on medical act based billing. This means that invoices for hospital visits (outpatients) and hospital admissions (inpatients) can be printed based on medical and technical acts that have been linked to a specific Visit ID or Admission ID. 2.4.1 Activity data Accountable activity data (medical and technical acts) can be provided to the system in multiple ways: 1. By manually adding acts to the patient record. 2. By automatically generating act codes based on medical record data entry. The Open Clinic software contains a sophisticated module to link specific acts to medical record activity. E.g. the output of a laboratory result or an X-Ray report will automatically generate the corresponding act codes. But also medication prescriptions, vaccinations and intellectual activities can be linked to act-codes. This linking is rule-based and can be maintained by the local application manager. Acts that are automatically generated by the system, still have to be validated by a dedicated user. For every act, the following data can be added to the Open Clinic system : 1. Planned flag to indicate that the act has been planned. 2. Executed flag to indicate that the act has been executed. 3. Validated flag to indicate that the act has been validated by a user. Acts that are manually added to the system will automatically have the 'validated' flag set. The 'executed' flag is set for acts which are automatically generated from medical record data entry. Activity codes can easily be grouped into so called 'activity profiles'. These profiles are being stored into the Open Clinic database and can be used to quickly add groups of act codes to the medical record (e.g. several laboratory analyses grouped together) 2.4.2 Invoicing and accounting The Open Clinic invoice module is patient centered. This means that only invoices related to a patient can be printed by the system. Invoices for a particular patient can be selected on a series of criteria: Admission ID based invoicing Visit ID based invoicing Specific period of time Selection of specific act codes 1. Manual selection 2. By act code 3. By care provider (user responsible for the act) Activity code flags (planned, executed, validated) All criteria can be combined, yet providing a very flexible way of outputting invoice data for specific situations. OpenClinic software 11 2010 MXS NV/SA For every invoice, the following data will be recorded (in supplement of the data retrieved from the medical record): 1. Date and time of the invoice 2. Identification number of the invoice (automatically attributed by the system) 3. User generating the invoice 4. Total amount of accountable acts 5. Total amount of payments already registered 6. Balance 7. Destination of the invoice (patient, employer, insurance company...) 2.4.2.1 Discharge and end of visit At the moment of discharge or when closing a visit, a final invoice for the hospital stay or visit can be printed out. This invoice holds all accountable act data related to the Visit ID or Admission ID and for which the 'validated' flag has been set. Cash transfer history related to the Visit ID or the Admission ID has also been integrated in the invoicing module. This means that the invoicing module will subtract all registered payments from the amount due and it will print out the balance on the invoice. 2.4.2.2 Preliminary invoicing Preliminary invoices related to a Visit ID or an Admission ID can be printed out, holding all accountable activity codes for which the 'planned' flag has been set. 2.4.2.3 Payment and cash transfers Payment and cash transfer registration is part of the standard Open Clinic system. Summarized, the following types of payment and cash transfer have been integrated: 1. Deposits 2. Cash payments 3. Other mony transfers (insurance companies) For every payment or cash transfer, the following data are being recorded (some are optional): 1. Visit ID or Admission ID 2. Date and time of payment 3. Origin of payment 4. Amount 5. Currency 6. Wicket or front office identification 2.5 Medical record The medical record is the core object of the Open Clinic Hospital Information System. In a hospital environment, accurate and persistent storage of clinical information is crucial to patients and care providers. Therefore, special attention has been paid to this extended module, for which MXS can refer to more than 15 years of high level experience. 2.5.1 Record identification Medical record identification is a complex matter. In some hospitals, patients have more than one medical record (e.g. service based or functional multiplication of records). Sometimes medical records can only be identified by admission numbers or visit id's (time based or temporal multiplication of records). In Open Clinic, according to the adopted GEHR architecture, every patient has only 1 electronic healthcare record (EHCR). Information in this unique record can easily be clustered in any form (per service, per ward, time-based etc...) In other words, the EHCR carries the same record OpenClinic 12 2010 MXS NV/SA identifier as the patient itself. 2.5.2 History of health events The standard patient medical history is comprehensively summarized on a tab-based screen and contains: Personal history 1. Medications 2. Alcohol & drugs consumption 3. Tobacco usage 4. Medical antecedents 5. Surgery 6. Accidents Family history 1. Marital status 2. Children & medical antecedents 3. Other family & medical antecedents Occupational history 1. Professional diseases 2. Work accidents 3. History of relevant occupations & occupational risk factors 4. Stress assessment 2.5.3 Generic SOAP structure For the purpose of entering data into the patient medical journal, Open Clinic provides a generic SOAP- based data-entry form. The SOAP format is used in most medical schools and allied health schools. It stands for: Subjective, Objective, Assessment and Plan. Each of these sections require the basic understanding of medical terminology to allow continuity of care. The SOAP format requires medical terminology that is considered appropriate by the facility where one is working. Each facility has a listed set of appropriate medical abbreviations and surgical abbreviations. Such a list can easily be integrated into Open Clinic. The "S" includes the patient's goal, patient's pain complaint, medical history and social history. The "O" includes the clinician data collection of strength, range of motion, skin integrity and organ system function. The "A" includes the clinician's opinion about the presented case, prognosis, diagnosis and goals. The "P" includes the plan to progress to the goals set in the "A" and the interventions that are necessary. 2.5.4 Domain specific registration forms Although generic SOAP notes might be sufficient for the majority of clinical documentation needs within the hospital, Open Clinic permits the development of specific custom-made data entry-screens for special purposes. These data-entry forms are being developed in close collaboration with the responsible clinicians, to make sure that the result exactly fits the specific documentation needs and business processes of the concerning service. Examples of such data-entry screens already developed in the past are: - General Practice - Cardiology - Internal medicine - General surgery - Gynecology - Hematology - Pediatrics - Occupational healthcare - Vital signs record OpenClinic software 13 2010 MXS NV/SA - Nutrition 1. Rehabilitation card 2. Daily follow-up form - Malaria follow-up - Family planning - Tuberculosis follow-up - Birth certificates - Death certificates - Surveillance of severely ill patients - FATE record - Cash withdrawal authorization - Check withdrawal authorization - Medico-legal expertise - Physical fitness certificate ... 2.5.5 Medical prescription management Medication prescription management has been readily built-in into the Open Clinic software. Medication prescriptions typically hold the following data: Name of the prescribed drug Total quantity of prescribed drug units Number of prescribed drug units per dag Begin date and end date of the therapy Medical prescriptions can be printed out on paper or can be exported electronically in any format. 2.5.5.1 Ward stock management Open Clinic provides a simple module to manage local medication and medical supply stocks. Stock modifications can be the result of any of the following actions: Stock inventory: with this module initial stock levels can be fixed. The same module is used for recurring stock-corrections (e.g. yearly inventory assessment) Stock exit: removal of medication and supplies from the stock by ward personnel. Every stock exit has to be attributed to a Visit ID or an Admission ID. Stock exits automatically add accountable act codes to the patient record. Stock entry: entry of medication or supplies into the local stock. This information can be entered manually or can be read electronically from the corresponding SAGE SQL-Tables if available (presuming that stock exits from the central stock are stored in an SQL-Table by the SAGE application). For every stock element, the following data can be stored: OpenClinic Item ID Item name Item type (medication, bandage...) Unit (capsule, tablet...) Package type (box, bottle...) Units per package Cost per unit Invoicing code Minimum level of local stock Maximum level of local stock Furthermore, an additional module has been developed to enable printing of Stock entry request forms, specifying a list of items that are requested from the central hospital stock. Items and their corresponding quantities can manually be added to the Stock entry request or automatically be OpenClinic 14 2010 MXS NV/SA calculated by the software (based on data coming from 'active' medical prescriptions and availability in the central stock). 2.5.6 ICPC2/ICD10 based thesaurus The complete ICD-10 and ICPC-2 classifications have been integrated in the standard edition of Open Clinic. The software makes use of the same thesaurus as the one requested by the CHUK. The Open Clinic coding engine is available at all times in any data-entry screen. In order to make real time coding a feasible procedure, automatic coding will be proposed for selected items in the Domain specific registration forms. In that way, common symptoms, diagnosis, procedures and prescriptions can automatically be coded by the Open Clinic package, thus avoiding misinterpretation of clinical notes in the final coding process. 2.5.7 Technical examinations management Technical examination results and requests are being treated by the Open Clinic system just like any other medical documentation transaction. On the other hand, some extra modules have been added to the system to facilitate the Order entry management. 2.5.7.1 Laboratory data management 2.5.7.1.1 Order entry A complete and comprehensive laboratory prescription module is available in the standard edition of Open Clinic. The most important features of the module are: Usage of a Lab analysis reference table, specifying every available analysis. Possibility to use lab analysis profiles (e.g. sets of analysis that go together for certain pathologies, investigations etc...) Automatic calculation of needed sample types Encoding of requesting clinician Automatic generation of a laboratory request ID. Print-out of already filled-in or blank laboratory prescription forms. The forms carry the laboratory request ID in numbers and in barcode for easy identification by the laboratory personnel. 2.5.7.1.2 Results Lab results can be entered into the system in 3 ways: 1. Automatic integration of electronic data coming from an existing Laboratory Information Management System (LIMS). Open Clinic supports several laboratory information exchange formats. 2. Automatic integration of electronic data coming from Laboratory analyzers. 3. Manual data-entry via the Open Clinic miniLIMS user-interface (accessible to the physician, the ward manager or the laboratory staff). The miniLIMS module enables the retrieval of laboratory requests based on different criteria: Laboratory request ID: one particular request Admission ID or Visit ID: all requests linked to the corresponding ID Patient ID: all requests linked to this Patient ID Requesting clinician: all requests coming from the specified clinician Request status: lists all requests with a specified status (complete, incomplete, received) All of these criteria can be combined, yet providing a very flexible request retrieval interface. When a searched request has been retrieved, the laboratory staff can open the corresponding results record. Results can then manually be entered in the results screen. Filled-in results are immediately available in the patient's medical record. Every filled-in result automatically generates a corresponding medical act-code in the patient record (for invoicing purpose). Laboratory results can be viewed by single result record or with full result history from previous laboratory examinations. Every numeric analysis- result can be viewed as a graph. Finally, results can be printed in order to deliver them at the prescribing OpenClinic software 15 2010 MXS NV/SA physician or the patient. 2.5.7.2 Medical imaging data management 2.5.7.2.1 Order entry A complete and comprehensive medical imaging prescription module is available in the standard edition of Open Clinic. The most important features of the module are: Usage of an Imaging examination reference table, specifying all available imaging examinations. Encoding of requesting clinician Automatic generation of an Imaging request ID. Print-out of already filled-in or blank imaging prescription forms. The forms carry the imaging request ID in numbers and in barcode for easy identification by the Medical Imaging staff. 2.5.7.2.2 Results Medical imaging results can be entered into the system in 2 different ways: 1. Automatic integration of electronic data coming from an existing PACS system. Open Clinic supports several Medical Imaging information exchange formats. 2. Manual data-entry via the Open Clinic miniMIMS user-interface (by the physician, the ward manager or the medical imaging staff). The miniMIMS module enables the retrieval of Medical Imaging requests based on different criteria: Imaging request ID: one particular request Admission ID or Visit ID: all requests linked to the corresponding ID Patient ID: all requests linked to this Patient ID Requesting clinician: all requests coming from the specified clinician Request status: lists all requests with a specified status (complete, incomplete, received) All of these criteria can be combined, yet providing a very flexible request retrieval interface. When a searched request has been retrieved, the medical imaging staff can open the corresponding results record. The result protocol can then manually be entered in the results screen. Filled-in results are immediately available in the patient's medical record. Every filled-in result automatically generates a corresponding medical act-code in the patient record (for invoicing purpose). Medical Imaging protocols can be printed in order to deliver them at the prescribing physician or the patient. 2.5.7.3 Pathology lab 2.5.7.3.1 Order entry The Pathology order entry module is completely similar to the Medical imaging data management system. 2.5.7.3.2 Results Pathology results are managed exactly the same way as Medical Imaging results. The same miniMIMS interface is being used. 2.5.8 Medical record printing Open Clinic provides a complete and sophisticated module for printing of medical record content for a single patient. Selections can be made on any combination of the following criteria: Types of examinations Manually selected examinations Admission ID or Visit ID Period of time OpenClinic 16 2010 MXS NV/SA 2.6 Preventive medicine Preventive medical acts have been separately integrated in the Open Clinic hospital information system. However, they can be consulted at any time from any module in the system. 2.6.1 Immunization management Open Clinic lets the user keep track of every patient's vaccination status. The system integrates automatic calculations of vaccination dates based on configurable vaccination schemes. 2.6.1.1 Vaccination schemes Any vaccination scheme can be programmed in Open Clinic with little or no programming knowledge by configuring a simple XML file. Vaccination schemes can thus easily be adapted to local preferences, yet permitting clinicians at any time to make any modifications to system-generated dates. Today, Open Clinic contains international schemes for the following vaccinations: Tetanos/difteria Hepatitis A Hepatitis B Hepatitis A+B Yellow fever Typhus Menigococ meningitis Polio Tick encephalitis 2.6.1.2 Vaccination card All patient vaccination data are comprehensively summarized on a patient vaccination card, which can be easily printed out. 2.6.1.3 Planning & campaigns A complete planning engine has been integrated in Open Clinic in order to provide an easy to use management tool for those who whish to organize large-scale vaccination programs. 2.6.2 Risk profiles Open Clinic fully supports the definition of medical and occupational health risk profiles. These profiles aim to help clinicians in deciding which actions should be undertaken in particular risk situations. Risk profiles also enhance the implementation of hospital-wide protocols for treating common pathologies (basic implementation of clinical pathways). 2.7 Warnings Important information that should be read by any care provider treating a particular patient (such as allergies, important contagious diseases...) can be stored in a specific Warnings module. Warnings are always shown to the user as soon as he opens the patient medical record. Warnings can also include lifetime data (beginning an end of validity) 2.8 Reporting Several standard reports have been developed in Open Clinic. The most important reports are: Pathology distribution per consultation Pathology distribution per admission User activity reporting OpenClinic software 17 2010 MXS NV/SA Admission duration reporting per pathology Bed occupancy reporting Patient origins Reference center profiles Status of decentralized stocks Patient debit and credit operations Provisional financial status of each admitted patient Department activities reporting 2.8.1 Pathologies per consultation Lists the distribution of all main (top 10 or top 20) pathologies per service or per user based on ICD-10 (and eventually ICPC-2) codes. 2.8.2 Pathologies per admission Lists the distribution of the main pathologies per admission 2.8.3 Pathologies and co-morbidity Lists for all main pathologies mortality and co-morbidity (associated pathologies) data 2.8.4 Pathology cost Lists costs distribution per main pathology. It is presumed that a main pathology will be associated to every admission (and eventually to every outpatient visit). 2.8.5 Activity reports Lists all activities (total numbers) per user and per service. Includes also all activities that are not linked to any financial data. 2.8.6 Admission duration reports Duration of admission (average duration & standard deviation) is reported per pathology, per service and per responsible clinician 2.8.7 Total invoices Total invoice values per day. 2.8.8 Money transfers Total money transfers per day, per wicket or front office. 2.8.9 Bed occupancy reports Lists evolution of bed availability and -occupancy per service. 2.8.10 Clinical analyzer MXS developed in cooperation with PatientWeb NV a sophisticated engine for extracting statistical data from clinical data sources. Open Clinic is fully compatible with the SHAMe Clinical Analyser. 2.8.11 Medical monitoring engine Frequently used reports and statistical extracts can be automatically executed by the integrated Medical Monitoring engine. This engine can be configured to automatically run specific reports on pre scheduled moments (e.g. every Sunday night) and to send the results to one or more e-mail addresses OpenClinic 18 2010 MXS NV/SA within the institution (e.g. the department of statistics staff). 2.9 Document printing Open clinic offers an integrated module for management of external documents. These documents are usually provided by the customer (hospital) in one of these forms: paper prints Microsoft Word-documents PDF-documents. Using Adobe Acrobat Professional, any of these forms will be transformed (possibly after scanning) into a PDF-form that exactly matches the layout provided by the customer. These PDF-forms are stored in the Open Clinic software and can be used by any user of the system. Any zones on the PDF-forms, containing medico-administrative data that is present in Open Clinic, will be automatically filled in. Documents stored in Open Clinic can be assigned to specific data-entry screens. If the document module is being called from within such a screen, the default document list will only display the relevant (linked) documents. 2.10 Human resource management Open Clinic is pre-equipped with a an extended Human Resource Management software package (HRM). The HRM module enables follow up of all kinds of personnel data like: Education and training Skills and certificates Work schedules Work contracts Holidays, paid annual leave Sick leave 2.11 Technical functionalities A series of functions of the Open Clinic software are pure technical features. Therefore they have been brought together in this chapter. 2.11.1 Security An efficient and easy to manage security implementation is crucial for a hospital information management system. Being a web based system, all medical records are accessible to authorized users from any workstation in the hospital, regardless the department where the record has been created. All data is stored in one single database and is managed by one single central application server (however, the use of multiple application servers would be permitted in case this becomes necessary in the future). 2.11.1.1 Access control 2.11.1.1.1 User identif ication Users can be identified and granted access to the Open Clinic application in several ways. The most common procedure to identify and authenticate users is via a userid/password combination. Specific password policies (periodic renewal, use of numbers, capitals etc...) can easily be enforced in Open Clinic through a simple point and click interface. Technically, not the password but only a hash-code of the provided password is being stored in the Open Clinic database. This means that even a system administrator has no access to the user login data. Users are to be held responsible for not distributing their userid/password combination to other users. This usually means that strict password-security policy documents have to be developed and distributed OpenClinic software 19 2010 MXS NV/SA to all users. An even stronger user identification mechanism is the use of biometric data/password combinations. In that case, the userid is being replaced by a biometric (e.g. a fingerprint) ID, which has previously been registered in the users record. Once the user has been identified by his biometric ID, the Open Clinic application will ask for a password before granting access to the system. 2.11.1.1.2 User prof iles Access to administrative and medical data is managed through definition of user profiles. Such user profiles define precise access rights (read, write, delete) in every data-entry screen of the system. Well designed and elaborated user profiles will enhance the systematic application of a strict security policy throughout the institution. Consequently, every user in the system is attributed a user profile (e.g. physician, nurse, administrative clerk...), defining his role in the hospital information management system. 2.11.1.1.3 Personal prof iles In some rare cases, users need to be granted specific access rights above those they have received in their user profile. This can be done through a specific point-and-click interface. Rights that have been attributed in this interface apply only to that single user and have no further influence on other users with the same user profile. 2.11.1.2 Access monitoring 2.11.1.2.1 Access monitoring Open Clinic offers a module that temporarily blocks a login if a user tries to connect a specified number of times with a wrong password. This prevents malicious attempts to login to the Open Clinic system using 'stolen' login data. 2.11.1.2.2 Intrusion detection In case a user tries a predefined number of times to enter the system with a non-existing user id, the ip- address of the workstation where the unsuccessful attempts come from, will temporarily be refused access to the Open Clinic software. This mechanism prevents malicious attacks where a user tries out a list of logins. 2.11.1.2.3 User tracking Every access by any user to any single application web-page is being logged by OpenClinic. This Audit Trail feature enables post-factum analysis of 'who has had access to what' in case of complaints or privacy violations. Furthermore, for every page access that is made, performance data (download time, bandwidth usage,data volume) are stored in the system in order to facilitate performance monitoring by trained IT staff. 2.11.2 Information archiving If production databases become to big, patient record information can be archived based on a number of criteria: Deceased patients Records which have shown no activity since a specific date Manual selection of patient records Archiving a record means removing it from the production database and copying it to another medium (hard disk, CD, DVD). The core administrative patient data always remains in the production database: 1. Name (first name, last name, alternate names) 2. Date of birth 3. Record ID number (other than the automatically attributed Open Clinic ID, e.g. reference to a OpenClinic 20 2010 MXS NV/SA paper based record) 4. National ID number 5. Language 6. Gender 7. Place of birth (city & country) 8. Nationality 9. Alternate ID (e.g. fingerprint or other biometric data) 10. Comments 11. Archive medium ID A previously archived medical record can easily be restored from the archive medium identified by the Archive medium ID in the production database. Usually, medical record archiving will not take place because of disk space shortage. Application performance is more likely to be a trigger for deciding to archive medical records. Today, Open Clinic is running in implementations containing about 500.000 active medical records and more than 2.000.000 stored examinations (CBMT). 2.11.3 Clinical mailer and user feedback The standard edition of Open Clinic offers a simple to use, yet powerful internal mailing system. Users can send messages to each other, send feedback and request to the local IT staff etc... without the need of any Internet connectivity or associated mail server infrastructure. The user mailbox is automatically opened at every login whenever unread messages are present.