Electronic Clinical Transfusion Management System

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1 The Chief Medical Officer s National Blood Transfusion Committee Electronic Clinical Transfusion Management System Supporting the automated tracking of blood products right patient right blood

2 National Patient Safety Agency Electronic Clinical Transfusion Management System Contents 1 Contents Format Purpose Scope and objectives Intended audience Background Further work Abbreviations, acronyms and references Useful documents 7 2 Description System overview Features User types and characteristics Design and implementation constraints 13 3 External interface requirements Software interfaces 16 4 Specific requirements System requirements Blood transfusion process Access rights Blood transfusion process Use Cases Use Cases Use Cases Use Case UseCase Use Case Use Case 4a Use Case 4b Use Case Use Case Use Case Use Case Use Case Use Case Use Case Use Case 11a Use Case 11b Use Case Use Case 12a Use Case 12b Use Case 13 61

4 Design and implementation constraints 13 3 External interface requirements 15 3.1 Software interfaces 16 4 Specific requirements 17 4.1 System requirements 18 4.2 Blood transfusion process 18 4.

3 2 Electronic Clinical Transfusion Management System National Patient Safety Agency Contents UseCase Use Case Use Case 15a UseCase15b Use Case 15c Use Case Use Case Use Case 17a Use Case 17b Use Case Use Case 18a Use Case 18b Use Case Additional requirements 94 5 Other non-functional requirements Capacity, scalability and availability Security Maintainability Applicable standards Reports Business rules Future requirements 98 Appendix A Glossary 99 AppendixB The'DoOnceandShare'EndtoEnd Process Map for Blood Transfusion 105 Appendix C System requirements 131 Figures Figure 1 Overall context diagram 10 Figure 2 Simple blood transfusion process map 19 Figure 3 Blood transfusion process map for special requirements 20 Figure 4 Processmapforemergencyissueofblood 21 Figure 5 Process map for returned and unused blood 22 Figure 6 Use Case diagram for simple blood transfusion process 24

6 Additional requirements 94 5 Other non-functional requirements 95 5.1 Capacity, scalability and availability 96 5.2 Security 96 5.3 Maintainability 96 5.4 Applicable standards 97 5.5 Reports 97 5.

4 National Patient Safety Agency Electronic Clinical Transfusion Management System 3 1

5 4 Electronic Clinical Transfusion Management System National Patient Safety Agency 1 Blood transfusions involve a complex sequence of activities, with a correspondingly high opportunity for error. To ensure the right patient receives the right blood, there must be strict checking procedures in place at each stage. The National Patient Safety Agency (NPSA), the Chief Medical Officer s National Blood Transfusion Committee (NBTC) and Serious Hazards of Transfusion (SHOT) have collaborated to develop and evaluate a series of national initiatives to improve blood safety.thenpsahassetatargetofreducingthenumberofaboincompatibleblood transfusionincidentsby50percentoverthreetofiveyears,asmeasuredbytheshot database. Following a blood safety stakeholder workshop, four initiatives to improve blood safety were selected for further testing and development. One of these initiatives was the use ofbarcodetechnologytohelppreventfinalidentitycheckscarriedoutatthepatient's side (at the bedside) from failing. This national specification, which is part of the NPSA's blood safety initiative, Right patient, right blood, has been developed with the following objectives: to address the patient safety risks in the transfusion process; to identify IT requirements for a blood tracking system; to provide an initial specification for IT suppliers. This specification for an Electronic Clinical Transfusion Management System (ECTMS) focuses on the steps in the transfusion pathway taking place outside the laboratory and is relevant to both bar coding and Radio Frequency Identification (RFID) technology. This document also addresses the requirement of the 2005 Blood Safety and Quality Regulations (Medicines and Healthcare products Regulatory Agency, MHRA) to maintain a complete record for all blood components and products from donor to recipient for 30 years. 1.1 Format This specification for an ECTMS is based on a widely-used Software Requirements Specification (SRS) template (Weigers et al, 2003; see Section 1.8) with some minor modifications by the NPSA. The implementation of an ECTMS will require more than the development of software, as it will need to be integrated with, for example, server hardware,clientdevicesandremoteterminals.inthisrespecttheprojectcanbeseen as one of systems engineering rather than software engineering per se. However, for the purposes of this initial specification, the Wiegers SRS template is more than adequate. Thespecificationgivesanoverallcontextofthedevelopment,givesauser s perspective of the system through the use of use-case driven modelling processes,

The National Patient Safety Agency (NPSA), the Chief Medical Officer s National Blood Transfusion Committee (NBTC) and Serious Hazards of Transfusion (SHOT) have collaborated to develop and evaluate

6 National Patient Safety Agency Electronic Clinical Transfusion Management System 5 based largely on the Unified Modelling Language (UML), and specifies functional and non-functional requirements. 1.2 Purpose ThepurposesofthisspecificationforanECTMSareto: specify the steps in the blood transfusion pathway; address the patient safety risks identified in the blood transfusion pathway; inform Hospital Blood TransfusionCommitteesandITmanagersofthe requirements identified; form the basis of an initial requirements specification for IT suppliers; provide an initial specification that can be extended to cover other clinical tracking applications. This document does not in itself provide sufficient detail for IT suppliers to develop the systems and software required for a complete blood tracking solution. 1.3 Scope and objectives The specification builds on the experience of users of IT technology in blood transfusion that is currently available and informs both Connecting for Health (CfH) and commercial companies producing both hardware and software. The main objective of this specification is to support the automated tracking of blood products from the initial ordering of a blood transfusion for a patient, through to the taking of a blood sample for cross matching, to administration of a blood transfusion and subsequent updates to care records. The scope of the specification includes the following scenarios: routine blood transfusion; transfusion for special requirements (for example, cytomegalovirus (CMV) seronegative blood, irradiated blood or antigen negative blood); emergency issue of blood; management of returned and unused blood units. This specification focuses on the actual requirements for an IT tracking system to work. It does not attempt to define or include any additional business processes or guidelines that may need to be in place, for example, the administration of users on the system, or transferring or transporting data to or from local systems. The requirements described in this document are specifications for the tracking of blood products from arrival at hospital through to administration. In addition, it is anticipated that any system designed to meet the requirements in this document could be extended to cover other clinical tracking applications such as, for example, tracking drugs and pharmaceuticals.

Hospital Blood TransfusionCommitteesandITmanagersofthe requirements identified; form the basis of an initial requirements specification for IT suppliers; provide an initial specification that can be

7 6 Electronic Clinical Transfusion Management System National Patient Safety Agency 1.4 Intended audience This specification is aimed at: IT suppliers; CfH; Informing Healthcare; external stakeholders. 1.5 Background The requirements detailed in this document have been derived from: theoutcomesofthecfh DoOnceandShare bloodtransfusionproject ( thenpsa sbloodsafetyittrackingusergroupheldinseptember2005; discussions with various members of staff at the NPSA and Oxford Radcliffe Hospital. 1.6 Further work Starting in March 2007, CfH (with the support of the NPSA) will carry out a pilot with one or more acute healthcare organisations to build on and improve the requirements of the IT specification that will be delivered to Local Service Providers. The NPSA will also work with Informing Healthcare to facilitate introduction of similar technology in the acute sector in Wales. 1.7 Abbreviations, acronyms and references All abbreviations and acronyms used in this document are consistent with the standards used elsewhere and are defined in the Glossary (Appendix A). For the purposes of traceability of the requirements in the subsequent development phases, the requirements specified in this document have been identified and numbered using the RQ-xx notation.

uk); thenpsa sbloodsafetyittrackingusergroupheldinseptember2005; discussions with various members of staff at the NPSA and Oxford Radcliffe Hospital. 1.

8 National Patient Safety Agency Electronic Clinical Transfusion Management System Useful documents Ref Title Issued by Source/location 1 Safer practice notice: Right patient, right blood 2 Safer practice notice: Right patient right care 3 Safer practice notice: Wristbands for hospital inpatients improves safety 4 Briefing Sheet: Wristband specification: developing a standardised specification for wristband design in the NHS in England and Wales NPSA NPSA NPSA NPSA health/alerts health/alerts health/alerts 5 'Barcode technology: its role in increasing the safety of blood transfusion' Turner CL et al Transfusion 2003; 43: Issues/requirements derived from the user group workshop held on 16/09/05 NPSA IT steering group for blood safety project 7 'End-to-end electronic control of the hospital transfusion processtoincreasethesafety of blood transfusion: strengths and weaknesses' DaviesAetal Transfusion 2006; 46: SHOT Annual Reports SHOT 9 The 'Do Once and Share' End to End Process Map for Blood Transfusion CfH 'Do Once and Share' programme www. transfusionguidelines. org.uk 10 BCSH IT Guidelines British Committee for Standards in Haematology 11 Software Requirements Karl Wiegers, Microsoft Press com com

hospital inpatients improves safety 4 Briefing Sheet: Wristband specification: developing a standardised specification for wristband design in the NHS in England and Wales NPSA NPSA NPSA NPSA www.

Health Service Circular

Health Service Circular Series Number: HSC 2002/009 Issue Date: 04 July 2002 Review Date: 04 July 2005 Category: Public Health Status: Action sets out a specific action on the part of the recipient with