VALIDATION PROTOCOL PARTICIPANTS: <<Hospital>> <<Hospital Transfusion Laboratory>> <<ANO>> Validation of Traceability / Return Label VALIDATION REF # <<Number>> Prepared by: <<>> The document has been issued to:- Name Position Department Written by G Brown Page 1 of 1 Printed 31/07/05
1. CONTENTS PAGE Title Page Page 1 1 Contents Page Page 2 2 Introduction and Validation Objectives Page 3 3 Approval to Proceed with Validation Study Page 4 4 Responsible Persons and their Roles Page 5 5 Design of the Validation Study Page 6 6 Evaluation Criteria Page 7 7 Acceptance Criteria Page 8 8 Staffing Issues Page 9 9 Data Collection and Analysis Page 10 Appendix 1(a) Completed Tasks Record Page 11 Appendix 2(a) Problem Report Page 12 Appendix 3(a) Staff Register Page 13 Appendix 4(a) Documentation Summary Record Page 14 Appendix 5(a) Training Summary Record Page 15 Appendix 6(a) Bibliography Page 16 Appendix 7(a) Validation Study Completion Record Page 17 Written by G Brown Page 2 of 2 Printed 31/07/05
2. INTRODUCTION AND VALIDATION OBJECTIVES 2.1 2.1.1 2.2 2.2.1 INTRODUCTION A new label, which will satisfy existing guidelines and the traceability requirements of the Blood Safety and Quality Regulations 2005, has been designed by the EUD Blood Pack Label Group. This label will clearly and safely identify the patient to whom a blood component has been transfused. The main difference between the old and the new label is that the new label includes a portion that must be completed by the ward staff who administered the component and returned to the hospital laboratory as an unambiguous statement that a blood component has been transfused to the patient named on the label. VALIDATION OBJECTIVES To demonstrate that this new system complies with the traceability requirements of the Blood Safety and Quality Regulations 2005 i.e. it provides unambiguous evidence of the identity of the person who received each blood component, including the final fate if not transfused. To demonstrate that systems are in place to allow the pilot implementation to proceed to the next level To permit the review any lessons learnt and incorporate these into a revised implementation plan To share the pilot implementation plan and associated documentation with other hospitals to facilitate and speed their implementation process Written by G Brown Page 3 of 3 Printed 31/07/05
3. APPROVAL TO PROCEED WITH VALIDATION STUDY The staff below, as designated Responsible Persons, having read the plan detailed in this Validation Protocol, approve and authorise the Validation Study to proceed: Name Position Signature National Project Director Implementation Project Director Implementation Project Manager Implementation QA Manager Implementation team at <<HTL>> Implementation team <<Hospital>> Implementation team <<Hospital>> Implementation team <<Hospital>> IT Managers Transfusion Practitioner Training Officer Written by G Brown Page 4 of 4 Printed 31/07/05
4. RESPONSIBLE PERSONS AND THEIR ROLES 4.1 This section details those staff with overall responsibility for major areas of the validation study. Other staff will be designated as responsible persons for defined tasks within the process. These staff will be named on appropriate documentation that will be completed as the work progresses 4.2 All of the staff detailed below will be required to approve and sign off this plan prior to any work commencing (see page 3) Name Position Responsibility 4.3 <<name>> National Project Director Lead project nationally 4.4 <<name>> Implementation Project Director Lead pilot project 4.5 <<name>> Implementation Project Manage project Manager 4.6 <<name>> Implementation QA Manager Ensure validation completed 4.7 Implementation team <<HTL>> Ensure implementation in their area and advise on implementation group 4.8 Implementation team <<Hospital>> 4.9 Implementation team at the <<Hospital>> 4.10 Implementation team at <<Hospital>> Ensure implementation at <<hospital>> and advise on implementation group Ensure implementation at <<hospital>> and advise on implementation group Ensure implementation at <<hospital>> and advise on implementation group 4.11 IT Managers Oversee all IT changes and requirements 4.12 Transfusion Practitioner 4.13 Training Officer Written by G Brown Page 5 of 5 Printed 31/07/05
5. DESIGN OF THE IMPLEMENTATION PROJECT 5.1 Workload Workload (i.e. annual number of red cells issued from SNBTS) at the 4 hospitals is as follows: <<Hospital>> <<Number>> RBC <<Hospital>> <<Number>> RBC <<Hospital>> <<Number>> RBC <<Hospital>> <<Number>> RBC The first test batch of <<number>> labels will be divided amongst these hospitals 5.2 Time-scale The traceability system must be in place by 9 th November 2005. The pilot implementation is scheduled to start by <<>>, with a target duration of 4 weeks but earlier information may permit other sites to prepare for their own implementation e.g. order labels. 5.3 Location Pilot Implementation Sites The following laboratories have been chosen to test the new labels and traceability system: i) <<Sites / wards>> ii) <<Sites / wards>> iii) <<Sites / wards>> iv) <<Sites / wards>> These hospitals were chosen as patients and blood are frequently moved between them. The wards were selected as they have a wide range of different serological requirements and have a good personal relationship with their Blood Banks 5.4 Materials/Consumables New traceability and return blood bag labels x <<number>> Tamper proof label ties x <<number>> Wax resin ribbon, (size 83mm x 450mm) x <<number>> 5.5 Equipment 5.5.1 <<number>> x thermal transfer printer 300DPI 5.6 Comparison with Current Practice Within the blood transfusion laboratory, currently there are no systems which keep a record of the name of the member of staff who transfused the blood component and no unambiguous traceability. 5.7 Evaluation of Compliance Each laboratory will record total number of labels issued Each laboratory will record number of label returned Wards will be informed of labels not returned and will be asked retrospectively to confirm transfusion or final fate if not transfused Non-conformances will be recorded using the appended non-conformance report Written by G Brown Page 6 of 6 Printed 31/07/05
6. EVALUATION CRITERIA Demonstrate that the labels are printed in the laboratory as per the label specification (eye readable and barcode readable) Demonstrate that the laboratory computer system can record blood components which have been transfused and that these records can be readily accessed, including from backup media Demonstrate that the laboratory system can record blood components which have been issued but not transfused and that these records can be readily accessed, including from back-up media Demonstrate that the laboratory computer system can record the final fate of all blood components that were not transfused, including the reason and that these records can be readily accessed, including from back-up media. Confirm that the process works with all scenarios e.g. normal issue of blood for transfusion; emergency blood and blood issued to an unknown patient where labels would be completed and added to the computer system retrospectively Confirm that all associated SOPs have been written and issued Confirm that there has been an effective programme of communication with all relevant staff Confirm that all associated staff training has been completed Confirm that the project risk management register has been maintained and that all outstanding risks are under control Confirm that the process successfully maps to the OIG flowchart Written by G Brown Page 7 of 7 Printed 31/07/05
7. ACCEPTANCE CRITERIA the labels are printed in the laboratory as per the label specification (eye readable and barcode readable) the laboratory computer system can record blood components which have been transfused and that these records can be readily accessed, including from back-up media the laboratory system can record blood components which have been issued but not transfused and these records can be readily accessed, including from back-up media the laboratory computer system can record the final fate of all blood components that were not transfused, including the reason and these records can be readily accessed, including from back-up media. the process works with all scenarios e.g. normal issue of blood for transfusion; emergency blood and blood issued to an unknown patient where labels would be completed and added to the computer system retrospectively all associated SOPs have been written and issued there has been an effective programme of communication with all relevant staff all associated staff training has been completed the project risk management register has been maintained and all outstanding risks are under control the process successfully maps to the OIG flowchart > or = 90% of the return labels are completed correctly and sent back to the laboratory any missing return labels being identified and appropriate exception reports generated an audit of the traceability pilot is performed in all <<HTLs>> with a successful outcome If these criteria are met and signed off (see appendix 7) then the new traceability system will be rolled-out to all other wards within the <<hospitals>> and all other hospitals in <<region>> will be given access to the system. Written by G Brown Page 8 of 8 Printed 31/07/05
8. STAFFING ISSUES 8.1 Training The BMS staff in the laboratory will need to be trained in generating the new label and fixing it to the blood pack. The MLA staff will need to be trained in recovering the tear-off portion of the label from the ward. The MLAs will have to be trained in inputting the transfusion-confirmed code into the laboratory computer system. The BMS and MLA staff will have to be trained in generating the TX exception report. The ward staff will have to be trained in the use of the new label and their responsibilities in ensuring its return to the hospital laboratory. This training will be performed by members of the Implementation Team and staff they co-opt e.g. training officers etc. Staff Numbers Extra work resulting from the implementation of this new system will require an increase in staff (BMS or MLA) the requirements will be evaluated during the pilot. Additional support for this system may require a permanent extension to the Transfusion Specialists role 8.2 Standard Operating Procedures and Associated Documentation. Current SOPs, worksheets and forms will be reviewed and changed to reflect the new procedure. New SOPs will be produced. 8.3 Impact on Other Departments Increase in workload and funding for consumables will have effects in other departments. Written by G Brown Page 9 of 9 Printed 31/07/05
9. DATA COLLECTION AND ANALYSIS Data will be gathered from the <<No>> hospitals and a summary will be prepared. If the system is working by the stated criteria and the validation process is approved (see appendix 7), further wards will be added in all the hospitals until all blood and blood components are issued with the new label. The NHSS Implementation Group will assess rollout to further hospitals in <<Region>> early information may permit other sites to prepare for the own implementation e.g. order labels. NHSS Implementation Group will advise accordingly. Written by G Brown Page 10 of 10 Printed 31/07/05
Appendix One (a) COMPLETED TASKS RECORD Validation Protocol No: <<Number>> : dd/mm/yyyy Work Area: Person(s) Responsible Type work area here Type Names here Task Signature Note of Problems Identified Detailed Incident Report Attached YES / NO Checked and approved by the Validation Study Manager and the QA Manager Validation Study Manager Signature QA Manager Signature Written by G Brown Page 11 of 11 Printed 31/07/05
Appendix Two (a) PROBLEM REPORT Validation Protocol No: <<Number>> : dd/mm/yyyy Work Area: Person(s) Reporting Type work area here Type Names here Details of Problem(s) Documentation Attached YES / NO No. of Pages Corrective Actions Performed By : : The problem(s) detailed above has / has not been fully resolved and further corrective action is / is not required. Validation Study Manager Signature QA Manager Signature Written by G Brown Page 12 of 12 Printed 31/07/05
Appendix Three (a) STAFF REGISTER Validation Protocol No: <<Number>> : dd/mm/yyyy Work Area: Type work area here Name Signature Comments The above staff participated fully in this Validation Study Validation Study Manager Signature QA Manager Signature Written by G Brown Page 13 of 13 Printed 31/07/05
Appendix Four (a) DOCUMENTATION SUMMARY RECORD Validation Protocol No: <<Number>> : dd/mm/yyyy The following documentation / outputs must be retained for each relevant Validation Study activity by the person responsible. It must be returned to the QA/Validation Study Managers for checking and record purposes. Record Comment Signature The above records have been retained and checked as appropriate: Validation Study Manager Signature QA Manager Signature Written by G Brown Page 14 of 14 Printed 31/07/05
Appendix Five (a) TRAINING SUMMARY RECORD Validation Protocol No: <<Number>> : dd/mm/yyyy The following staff have received appropriate training in the new procedure(s) and have been assessed as competent to perform the new procedure(s). Name SOP No.(s) Staff Member Sig. Signed off by Sig. Written by G Brown Page 15 of 15 Printed 31/07/05
Appendix Six (a) BIBLIOGRAPHY Validation Protocol No: <<Number>> : dd/mm/yyyy 1. SOPs 1.1 List your first SOP reference and title here 1.2 List your second SOP reference and title here 2. Literature References 2.1 List your first literature reference here 2.2 List your second literature reference here 3. Policy References 3.1 List your first policy reference and title here 3.2 List your second policy reference and title here 4 Other Documents 4.1 List your first document reference and title here Validation Study Manager Signature QA Manager Signature Written by G Brown Page 16 of 16 Printed 31/07/05
Appendix Seven (a) VALIDATION STUDY COMPLETION RECORD Validation Protocol No: <<Number>> : dd/mm/yyyy Comments: 1. Record your summary of Validation performance versus stated objectives in 2.2.1 This Validation Study has been successfully completed and all major issues, concerns and problems have been resolved. If there are any outstanding issues, list them here Validation Study Manager Signature QA Manager Signature Written by G Brown Page 17 of 17 Printed 31/07/05