Electronic Clinical
Transfusion Management System
The Chief Medical Officer’sNational Blood Transfusion Committee
right patient
right blood
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National Patient Safety Agency November 2006 ©
Electronic Clinical Transfusion Management System Contents
Contents
1 Introduction
3
1.1 Format
4
1.2 Purpose
5
1.3 Scope and objectives
5
1.4 Intended audience
6
1.5 Background
6
1.6 Further work
6
1.7 Abbreviations, acronyms and references
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1.8 Useful documents
7
2 Description
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2.1 System overview
10
2.2 Features
11
2.3 User types and characteristics
12
2.4 Design and implementation constraints
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3 External interface requirements
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3.1 Software interfaces
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4 Specific requirements
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4.1 System requirements
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4.2 Blood transfusion process
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4.3 Access rights
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4.4 Blood transfusion process Use Cases
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4.5 Use Cases
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4.5.1 Use Cases 1+2
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4.5.2 Use Case 2
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4.5.3 Use Case 3
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4.5.4 Use Case 4
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4.5.5 Use Case 4a
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4.5.6 Use Case 4b
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4.5.7 Use Case 5
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4.5.8 Use Case 6
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4.5.9 Use Case 7
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4.5.10 Use Case 8
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4.5.11 Use Case 9
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4.5.12 Use Case 10
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4.5.13 Use Case 11
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4.5.14 Use Case 11a
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4.5.15 Use Case 11b
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4.5.16 Use Case 12
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4.5.17 Use Case 12a
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4.5.18 Use Case 12b
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Electronic Clinical Transfusion Management System Contents
4.5.20 Use Case 14
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4.5.21 Use Case 15
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4.5.22 Use Case 15a
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4.5.23 Use Case 15b
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4.5.24 Use Case 15c
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4.5.25 Use Case 16
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4.5.26 Use Case 17
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4.5.27 Use Case 17a
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4.5.28 Use Case 17b
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4.5.29 Use Case 18
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4.5.30 Use Case 18a
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4.5.31 Use Case 18b
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4.5.32 Use Case 19
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4.6 Additional requirements
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5 Other non-functional requirements
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5.1 Capacity, scalability and availability
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5.2 Security
96
5.3 Maintainability
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5.4 Applicable standards
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5.5 Reports
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5.6 Business rules
98
5.7 Future requirements
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Appendix A – Glossary
99
Appendix B – The 'Do Once and Share' End to End
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
Process map for emergency issue of blood
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Figure 5
Process map for returned and unused blood
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National Patient Safety Agency November 2006 ©
1 Introduction
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. The NPSA has set a target of reducing the number of ABO incompatible blood transfusion incidents by 50 per cent over three to five years, as measured by the SHOT 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 of bar code technology to help prevent final identity checks carried out at the patient'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, client devices and remote terminals. In this respect the project can be seen as one of systems engineering rather than software engineeringper se. However, for the purposes of this initial specification, the Wiegers SRS template is more than adequate. The specification gives an overall context of the development, gives a user’s
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based largely on the Unified Modelling Language (UML), and specifies functional and non-functional requirements.
1.2 Purpose
The purposes of this specification for an ECTMS are to: • specify the steps in the blood transfusion pathway;
• address the patient safety risks identified in the blood transfusion pathway; • inform Hospital Blood Transfusion Committees and IT managers of the
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.
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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: • the outcomes of the CfH ‘Do Once and Share’ blood transfusion project
(www.transfusionguidelines.org.uk);
• the NPSA’s blood safety IT tracking user group held in September 2005; • 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.
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1.8 Useful documents
Ref Title Issued by Source/location
1 Safer practice notice: Right patient, right blood
NPSA www.npsa.nhs.uk/ health/alerts 2 Safer practice notice:
Right patient – right care
NPSA www.npsa.nhs.uk/ health/alerts 3 Safer practice notice:
Wristbands for hospital inpatients improves safety
NPSA www.npsa.nhs.uk/ health/alerts
4 Briefing Sheet:Wristband specification: developing a standardised specification for wristband design in the NHS in England and Wales
NPSA www.npsa.nhs.uk
5 'Barcode technology: its role in increasing the safety of blood transfusion'
Turner CL et al Transfusion2003; 43: 1200-1209
6 Issues/requirements derived from the user group workshop held on 16/09/05
NPSA IT steering group for blood safety project
www.npsa.nhs.uk
7 'End-to-end electronic control of the hospital transfusion process to increase the safety of blood transfusion: strengths and weaknesses'
Davies A et al Transfusion 2006; 46: 352-364
8 SHOT Annual Reports SHOT www.shotuk.org 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
www.bcshguidelines. com
11 Software Requirements Karl Wiegers, Microsoft Press
www.processimpact. com
