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Apheresis information management system (AMIS)
Transfusion and Apheresis Science 36 (2007) 281–283 intl.elsevierhealth.com/journals/tras
Apheresis information management system (AMIS) ¨ nder Arslan *, Mutlu Arat O Ankara University, Faculty of Medicine, Department of Hematology, Blood Bank and Apheresis Unit, Ankara, Turkey Received 10 January 2007; accepted 20 March 2007
Abstract Data collection in the field of medicine is extremely important for patient safety. It is viewed as a quality issue in several countries around the world. In order to achieve this goal, nationwide apheresis registries were planned. In 2003, World Apheresis Association (WAA) decided to establish a world-wide apheresis registry. Although some of the apheresis centers in our country sent data to this registry, we believe that we need our own Turkish Registry. For this purpose, we launched new web based apheresis software for donor and therapeutic apheresis procedures. This paper summarizes the characteristics of this new software. Ó 2007 Elsevier Ltd. All rights reserved.
1. Introduction New apheresis devices are being developed and indications for apheresis may vary. More than 45 different diagnoses treated with apheresis technology have been reported. In order to achieve more reliable information on the effects and side effects, more extensive sampling of data is needed. For this purpose, new software for data collection for nationwide or world-wide registries are needed. Collection of such data is considered a safety and quality issue in several countries. Analyses of such data enable improvement of quality of apheresis. The establishment of national registries and analyses of data on a global level therefore seems important [1]. *
Corresponding author. Address: Ankara University, Faculty of Medicine, Department of Hematology, Faku¨lte Cad. Cebeci Kampu¨su¨, 06520, Dikimevi, Ankara, Turkey. ¨ . Arslan). E-mail address: [email protected] (O
World Apheresis Association (WAA) decided to start a world-wide apheresis registry in 2002. It has been developed to enable registration through internet by centers all around the world. Its main function was to gain insight into the extent of treatment, adverse events, and to facilitate contacts among centers in rare treatment indications and also stem cell and other blood products collections intended for therapeutic applications. This registry was the merged version of the French, Canadian and Swedish registries [2–6]. In order to achieve this goal for our country a new software system was launched in close collaboration with the Ankara University Apheresis Unit and the Hemosoft Software Company. Apheresis information management system (AMIS) is a new software system consisting of the application of apheresis unit procedures. It is also designed in order to train the personnel and increase the service quality, standardization of all the procedures in the apheresis unit and permits access to desired reports.
1473-0502/$ - see front matter Ó 2007 Elsevier Ltd. All rights reserved. doi:10.1016/j.transci.2007.03.009
282
¨ . Arslan, M. Arat / Transfusion and Apheresis Science 36 (2007) 281–283 O
It is a web based system which is also compatible with HemosoftÒ Blood Bank Information Management System [7]. Apheresis devices, laboratory instruments and security pass systems can be integrated into the system. It is compatible with HL7 V.3 standards. By using this system we are willing to collect nationwide apheresis data to establish our Turkish Apheresis Registry.
2. Basic features of the software The basic information required for apheresis procedures such as weight, body-mass index, proposed apheresis volume etc. can be computed by the system. Formulas for those computations are stored in external files, so they can be easily modified which eliminates the need for software update. The computations module is specifically designed for complex aphaeresis procedures such as stem cell apheresis to easily incorporate the latest protocols. The following common steps are carried out for apheresis procedures regardless of the procedure type: Record Patient/Donor demographics and contact information. Scheduling appointments and appointment follow-ups. Informed consent and approval of procedure by a physician. Catheter follow-ups. For both patients and donors, pre- and post-procedure measurements (such as hemogram and bio-chemicals blood tests) are recorded and will be used to evaluate the efficiency of the procedure. Complications observed during the procedure can be recorded. For apheresis donations, validation, labeling, storage and follow-up of units. Follow-up of consumables. Information collected from operators and external systems are written to the database. System has a flexible search engine enabling users to perform queries by any field on any user interface screen. The system contains a security module and defines several access rights for each user group. Access rights are granted or revoked by system administrators. Each and every operation is automatically recorded in action log by storing type of
the operation, staff identifier, date and time of the operation, and can be queried when required. 3. Modules of system Apheresis procedures is composed of three modules; donor apheresis, therapeutic apheresis, and stem cell apheresis. Donor apheresis module is composed of five procedures; platelet, granulocyte, lymphocyte, plasma and multi-component apheresis. Selection of donors is guided by the system in accordance with international standards. All the components produced by apheresis are labeled in accordance with ISBT128 standards. Therapeutic apheresis module is composed of two modules; cytapheresis and exchange. Exchange is composed of plasma and red blood cell exchange procedures. Cytapheresis is composed of leukapheresis, platelet and lymphapheresis procedures. For each apheresis procedure carried out on patients, pre- and post-procedure measurements (such as vital signs, hemogram and biochemistry blood tests) are recorded and will be used to check the status of the patient. Complications are also recorded and reports can be generated when required. For therapeutic treatment protocols, diagnosis information and medical procedures can be recorded. The stem cell apheresis module is composed of allogeneic and autologous stem cell apheresis procedures. Pre-apheresis and post-apheresis tests specific to stem cell collections and cryogenic protocols can be recorded. Complications can be recorded in three categories as; patient related, procedure related and device related complications. Procedure Complication Report can be printed and approved by the expert. The details of the reports consist of apheresis device details, solutions and additives used, phases of the procedure and the team performing the procedure. The details can be used to evaluate apheresis efficiency and as a quality indicator. Printed form templates can be edited and standard computations can be defined dynamically. Printed form templates can be edited by authorized staff. In this way, most of the desired layout changes can be performed without requiring software update. 4. Technical features The system is a web based system that can be accessed from most web browsers. ISBT128 labeling
¨ . Arslan, M. Arat / Transfusion and Apheresis Science 36 (2007) 281–283 O
and printed form generation can be carried out from Microsoft Windows 2000 and higher using AMIS Client Add-On program. Application server is a server system that runs Microsoft Internet information server (IIS 5.0+) and Microsoft.NET framework 1.1. The database server is Microsoft SQL Server 2000. The system has XML Web Service access points in order to expose data to external systems and perform management tasks. 5. Standards The system is developed in accordance with related rules by the Ministry of Health and Directives on Preparation and Usage of Blood and Blood Components of Turkey. Component labeling and workflow is carried out in accordance with ICCBBA (International Council for Commonality in Blood Banking Automation) ISBT-128 (International Standards of Blood and Transfusion) Labeling Standards. ECF, AABB, Commission of The European Community Directives (Directive 89/381/EEC) are followed closely.
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Acknowledgement This study is supported by the Ankara University Research Project No. 2003-00-00-025. References [1] Stegmayer B, Korach JM, Norda R, Rock G, Fadel F, et al. Is there a need for a national or a global apheresis registry? Transfus Apher Sci 2003;29:179–85. [2] Stegmayr BG, Ivanovich P, Korach JM, Rock G, Norda R, Ramlow W. World apheresis association—world apheresis registry. Transfus Apher Sci 2005;32:205–7. [3] Stegmayr B, Klingstedt J, Grahn BE, Vinnervik P. The new WAA apheresis registry. Transfus Apher Sci 2006;34:259–62. [4] Rock G, Clark B, Sutton D. The Canadian apheresis registry. Transfus Apher Sci 2003;29:167–77. [5] Korach JM, Bussel H, Annane D, Gajdos P. 1991 Registry of the French Society of Hemapheresis (SFH): preliminary results for the first year of the on-line computer access file. The Registry Study Group. Transfus Sci 1993;14:281–5. [6] Korach JM, Guillevin L, Petitpas D, Berger P, Chillet P. Apheresis registry in France: indications, techniques, and complications. French Registry Study Group. Ther Apher 2000;4:207–10. [7] Arslan O. Hemosoft: a new software for blood bank and apheresis management. Transfus Apher Sci 2004;30:193–6.
Apheresis information management system (AMIS) ¨ nder Arslan *, Mutlu Arat O Ankara University, Faculty of Medicine, Department of Hematology, Blood Bank and Apheresis Unit, Ankara, Turkey Received 10 January 2007; accepted 20 March 2007
Abstract Data collection in the field of medicine is extremely important for patient safety. It is viewed as a quality issue in several countries around the world. In order to achieve this goal, nationwide apheresis registries were planned. In 2003, World Apheresis Association (WAA) decided to establish a world-wide apheresis registry. Although some of the apheresis centers in our country sent data to this registry, we believe that we need our own Turkish Registry. For this purpose, we launched new web based apheresis software for donor and therapeutic apheresis procedures. This paper summarizes the characteristics of this new software. Ó 2007 Elsevier Ltd. All rights reserved.
1. Introduction New apheresis devices are being developed and indications for apheresis may vary. More than 45 different diagnoses treated with apheresis technology have been reported. In order to achieve more reliable information on the effects and side effects, more extensive sampling of data is needed. For this purpose, new software for data collection for nationwide or world-wide registries are needed. Collection of such data is considered a safety and quality issue in several countries. Analyses of such data enable improvement of quality of apheresis. The establishment of national registries and analyses of data on a global level therefore seems important [1]. *
Corresponding author. Address: Ankara University, Faculty of Medicine, Department of Hematology, Faku¨lte Cad. Cebeci Kampu¨su¨, 06520, Dikimevi, Ankara, Turkey. ¨ . Arslan). E-mail address: [email protected] (O
World Apheresis Association (WAA) decided to start a world-wide apheresis registry in 2002. It has been developed to enable registration through internet by centers all around the world. Its main function was to gain insight into the extent of treatment, adverse events, and to facilitate contacts among centers in rare treatment indications and also stem cell and other blood products collections intended for therapeutic applications. This registry was the merged version of the French, Canadian and Swedish registries [2–6]. In order to achieve this goal for our country a new software system was launched in close collaboration with the Ankara University Apheresis Unit and the Hemosoft Software Company. Apheresis information management system (AMIS) is a new software system consisting of the application of apheresis unit procedures. It is also designed in order to train the personnel and increase the service quality, standardization of all the procedures in the apheresis unit and permits access to desired reports.
1473-0502/$ - see front matter Ó 2007 Elsevier Ltd. All rights reserved. doi:10.1016/j.transci.2007.03.009
282
¨ . Arslan, M. Arat / Transfusion and Apheresis Science 36 (2007) 281–283 O
It is a web based system which is also compatible with HemosoftÒ Blood Bank Information Management System [7]. Apheresis devices, laboratory instruments and security pass systems can be integrated into the system. It is compatible with HL7 V.3 standards. By using this system we are willing to collect nationwide apheresis data to establish our Turkish Apheresis Registry.
2. Basic features of the software The basic information required for apheresis procedures such as weight, body-mass index, proposed apheresis volume etc. can be computed by the system. Formulas for those computations are stored in external files, so they can be easily modified which eliminates the need for software update. The computations module is specifically designed for complex aphaeresis procedures such as stem cell apheresis to easily incorporate the latest protocols. The following common steps are carried out for apheresis procedures regardless of the procedure type: Record Patient/Donor demographics and contact information. Scheduling appointments and appointment follow-ups. Informed consent and approval of procedure by a physician. Catheter follow-ups. For both patients and donors, pre- and post-procedure measurements (such as hemogram and bio-chemicals blood tests) are recorded and will be used to evaluate the efficiency of the procedure. Complications observed during the procedure can be recorded. For apheresis donations, validation, labeling, storage and follow-up of units. Follow-up of consumables. Information collected from operators and external systems are written to the database. System has a flexible search engine enabling users to perform queries by any field on any user interface screen. The system contains a security module and defines several access rights for each user group. Access rights are granted or revoked by system administrators. Each and every operation is automatically recorded in action log by storing type of
the operation, staff identifier, date and time of the operation, and can be queried when required. 3. Modules of system Apheresis procedures is composed of three modules; donor apheresis, therapeutic apheresis, and stem cell apheresis. Donor apheresis module is composed of five procedures; platelet, granulocyte, lymphocyte, plasma and multi-component apheresis. Selection of donors is guided by the system in accordance with international standards. All the components produced by apheresis are labeled in accordance with ISBT128 standards. Therapeutic apheresis module is composed of two modules; cytapheresis and exchange. Exchange is composed of plasma and red blood cell exchange procedures. Cytapheresis is composed of leukapheresis, platelet and lymphapheresis procedures. For each apheresis procedure carried out on patients, pre- and post-procedure measurements (such as vital signs, hemogram and biochemistry blood tests) are recorded and will be used to check the status of the patient. Complications are also recorded and reports can be generated when required. For therapeutic treatment protocols, diagnosis information and medical procedures can be recorded. The stem cell apheresis module is composed of allogeneic and autologous stem cell apheresis procedures. Pre-apheresis and post-apheresis tests specific to stem cell collections and cryogenic protocols can be recorded. Complications can be recorded in three categories as; patient related, procedure related and device related complications. Procedure Complication Report can be printed and approved by the expert. The details of the reports consist of apheresis device details, solutions and additives used, phases of the procedure and the team performing the procedure. The details can be used to evaluate apheresis efficiency and as a quality indicator. Printed form templates can be edited and standard computations can be defined dynamically. Printed form templates can be edited by authorized staff. In this way, most of the desired layout changes can be performed without requiring software update. 4. Technical features The system is a web based system that can be accessed from most web browsers. ISBT128 labeling
¨ . Arslan, M. Arat / Transfusion and Apheresis Science 36 (2007) 281–283 O
and printed form generation can be carried out from Microsoft Windows 2000 and higher using AMIS Client Add-On program. Application server is a server system that runs Microsoft Internet information server (IIS 5.0+) and Microsoft.NET framework 1.1. The database server is Microsoft SQL Server 2000. The system has XML Web Service access points in order to expose data to external systems and perform management tasks. 5. Standards The system is developed in accordance with related rules by the Ministry of Health and Directives on Preparation and Usage of Blood and Blood Components of Turkey. Component labeling and workflow is carried out in accordance with ICCBBA (International Council for Commonality in Blood Banking Automation) ISBT-128 (International Standards of Blood and Transfusion) Labeling Standards. ECF, AABB, Commission of The European Community Directives (Directive 89/381/EEC) are followed closely.
283
Acknowledgement This study is supported by the Ankara University Research Project No. 2003-00-00-025. References [1] Stegmayer B, Korach JM, Norda R, Rock G, Fadel F, et al. Is there a need for a national or a global apheresis registry? Transfus Apher Sci 2003;29:179–85. [2] Stegmayr BG, Ivanovich P, Korach JM, Rock G, Norda R, Ramlow W. World apheresis association—world apheresis registry. Transfus Apher Sci 2005;32:205–7. [3] Stegmayr B, Klingstedt J, Grahn BE, Vinnervik P. The new WAA apheresis registry. Transfus Apher Sci 2006;34:259–62. [4] Rock G, Clark B, Sutton D. The Canadian apheresis registry. Transfus Apher Sci 2003;29:167–77. [5] Korach JM, Bussel H, Annane D, Gajdos P. 1991 Registry of the French Society of Hemapheresis (SFH): preliminary results for the first year of the on-line computer access file. The Registry Study Group. Transfus Sci 1993;14:281–5. [6] Korach JM, Guillevin L, Petitpas D, Berger P, Chillet P. Apheresis registry in France: indications, techniques, and complications. French Registry Study Group. Ther Apher 2000;4:207–10. [7] Arslan O. Hemosoft: a new software for blood bank and apheresis management. Transfus Apher Sci 2004;30:193–6.