DERBY HOSPITALS NHS FOUNDATION TRUST. Final Report. Purchasing for safety - Injectable medicines

Transcription

1 DERBY HOSPITALS NHS FOUNDATION TRUST Final Report Purchasing for safety - Injectable medicines Document Control Version Status Date Author and summary of changes 1 Draft 25 Jul 07 Tom Gray Approval/endorsement Title Name Signature Date PASA Project Sponsor Samantha Forrest PASA Project Manager Trust Pilot Sponsor Trust Pilot Manager and Lead Medical Devices Co-ordinator Clinical Risk Manager Consultant Anaesthetist Lara Qatami Kay Fawcett Tom Gray Mark Cannell Gill Ogden Susanne Piggott Distribution Name Title Organisation Samantha Forrest PASA Project Sponsor PASA Lara Qatami PASA Project Manager PASA Tom Gray Pilot Lead Derby Pilot Kay Fawcett Pilot Sponsor Derby Pilot Members Pilot Project Board Derby Pilot Avril Satchwell Pilot Facilitator Atos Consulting Documentation Appendix Title A Pilot Plan Phase Timings B Pilot Risk Register C Governance Chart D Communications Plan E Reference Materials F Executive Summary G Focus Group Outputs NHS PASA Purchasing for Safety Pilot 1 of 67

2 Contents Background Introduction to the Project Pilot Organisation Pilot Acceptance Governance Pilot Team Roles and Responsibilities Objectives Scope Methodology Introduction: Design and process Data collection Cultural Analysis Incident Reports Process Flow Mapping Medical Devices Procurement Focus Groups and selection of Case Studies Structured Interviews Questionnaire Outputs PID and Executive Summary Communications Plan Risk Register Project Plan Areas Selected Focus Groups and Stakeholder Map Output Analysis and Case Study Selection Structured Interviews Case Study A Theatres and Imaging Case Study B Chemotherapy Case Study C Maternity Procurement Focus Group (summary) Questionnaire Recommendations and Benefits Benefits for Patients Benefits for Healthcare Professionals Benefits for the Procurement Community Benefits for the Healthcare Industry Benefits for the Pilot Trust Lessons Learnt Project Experience Project Lessons Summary of issues Procurement Information Storage Preparation Checking Administration Training Prescribing and documentation Conclusions Acknowledgements Proposal for Phase 2 Implementation plan Recommendations for Trust Recommendations for NHS PASA NHS PASA Purchasing for Safety Pilot 2 of 67

3 Appendix A - Pilot Project Plan & Phase Timings Appendix B - Pilot Risk Register Appendix C - Governance Chart Appendix D - Communications Plan Appendix Ei Reference Materials: Example NPSA risk assessment Appendix Eii Reference Materials: NPSA Alert 20 Action Plan Appendix Eiii Reference Materials: Risk assessment of drugs identified for ready to use preparation Appendix F - Executive Summary Appendix G Summary of Feedback from Focus Groups FOCUS GROUP: Maternity FOCUS GROUP: Chemotherapy FOCUS GROUP: Theatres and Imaging Appendix H Staff Electronic Questionnaire Appendix I Equipment Standardisation NHS PASA Purchasing for Safety Pilot 3 of 67

4 Background 1.1 The last few years have seen the issue of patient safety rise up the political agenda. In 2004, a National Patient Safety Agency (NPSA) & Design Council report stated that: international research suggests that ensuring patient safety is becoming one of the most important challenges facing healthcare today, not just in the UK but worldwide. 1 The Government s commitment to reducing medical errors was demonstrated in the 2000 publication: An organisation with a memory. This report and the subsequent implementation plan: Building a safer NHS for patients - led to the establishment of the NPSA, and the principles set out have become pillars of the NHS quality and clinical governance agendas. One of the specific risks targeted for action in the latter document was building safety into purchasing policy within the NHS. 1.2 Human error is often implicated in medical mistakes. But human beings make mistakes because the systems, tasks and processes they work in are poorly designed 2. Consequently, the Department of Health has endorsed a design-led approach to patient safety in delivering safer products, services, processes and environments, and has recognised the interdependency between design and procurement. For safety solutions to be effective, design briefs and procurement decisions must be based on a detailed understanding of how staff and patients use and sometimes misuse these items. 1.3 In 2005, discussions involving Lord Warner, PASA and Baxter Healthcare resulted in a Ministerial submission, which recommended: more effective implementation of existing safety and procurement guidelines, thereby providing Trusts with the ability to take a more systems based approach to purchasing, particularly in high-risk areas, such as drug delivery and specialist therapies recognition of the need for a more formalised process between PASA, NPSA, the Healthcare Commission and the DH, which requires regular interaction relating to patient safety issues implementation and associated funding of pilot sites within the NHS to test Purchasing for Safety benefits. 1.4 Whilst the procurement function has contributed to a number of initiatives designed to reduce medical errors, there has, to date, been no systematic, joinedup approach to purchasing for safety. This project is designed to address that issue by demonstrating that procurement can play a vital role not just in supporting but in delivering a key government policy. To do that, one major area with considerable scope to reduce risk to patient safety has been identified: injectable medicines. 1.5 The Pilot Trust places significant importance and emphasis on maintaining and delivering high standards of patient care. In particular, the Trust has been keen to address and improve patient safety with respect to Injectable Medicines. Analysis and reporting against clinical incidents and near misses has been conducted, which has included a focus on standardisation and centralisation of equipment; pharmacy-led production of ready to administer injectable medicine products and introduction of new pump technology and staff training for safer administration. 1 NPSA. Design for Patient Safety: a design-led approach to tackling patient safety in the NHS Prof Lucien Leape, Harvard School of Public Health, quoted in Design for patient safety, NPSA 2004 NHS PASA Purchasing for Safety Pilot 4 of 67

5 1.6 Having received Chief Executive support, The Pilot Trust has therefore applied to be one of the pilot sites for the project supported by PASA focusing on agreed areas within the Trust around Injectable medicines. 1.7 The timing of this project coincides with the recently published NPSA Alerts on improving medication safety in the NHS, in order to reduce the number of medication errors. Alert 20 promotes the safer use of injectable medicines. 1.8 The Cambridge University Engineering Design Council, Exodus and Atos Consulting were engaged by PASA to support the delivery of this Pilot. 1. Introduction to the Project 2.1 Over a quarter of NHS patients will receive intravenous therapy as part of their treatment, with over 90 per cent of patients passing through an acute hospital receiving IV fluid for re-hydration, to correct a biochemical imbalance or as a carrier for other medication. 3 In 2003/4, the NPSA reported an annual adverse incident rate in the preparation, administration and delivery of IV therapy of more than 700. Of these, 80 cases resulted in the death of a patient In 2004, the NPSA reported on the outcomes of a pilot study to determine the root causes of incidents involving infusion devices, where no fault with the equipment was found. The study identified a lack of competency-based staff training, together with unsystematic purchasing and management of devices as key factors contributing to infusion device incidents. This demonstrates a) that current purchasing practices can be part of the problem, and b) that purchasing cannot be tackled in isolation of the system as a whole. Lack of standardisation and poor usage and storage of equipment all contributed to the creation of latent system risks. Consequently, the NPSA recommended the reduction of incidents through standardisation and centralisation of IV device management. Further work by NPSA looking at injectable medicines has shown that the arrangements for their provision can also increase risks to patients. 2.3 It is recognised that a number of steps have already been taken to purchase for safety. The Pilot Trust has already completed some base-lining and has developed an Intranet based e-version of the Manchester Patient Safety Questionnaire, which is to be incorporated into the early assessment phase of this pilot project. Many other initiatives have also been implemented including pharmacy preparation of many injectable medicines from dedicated near-patient pharmacy facilities. The Trust has a clear approvals process for the purchasing of equipment, and manages the training of its staff around medical devices. The Trust has previously undertaken activities to improve safety with injectable medicines, including development of guidance information on the Trust intranet. An effective formulary limits access to safe, clinical and cost-effective medicines. 2.4 The Pilot Trust has agreed to work in partnership with PASA, and to participate in this project taking a system-wide and holistic view of patient safety in the area of injectable medicines. Working with a wide range of NHS stakeholders, as well as industry, the Trust will, via the project, seek to address the purchasing issues identified in numerous studies and reports. It will do so in the context of the system or environment into which changes are to be made, building on work that has previously been carried out, and recognising that effective design requirements are a prerequisite to improvements in procurement and innovation practice. 5 3 Source: Intravenous, Topical and Irrigation Fluids (report prepared for NPSG, October 2006) 4 National Reporting and Learning System data 5 Design for Patient Safety, NPSA/Design Council, 2004 NHS PASA Purchasing for Safety Pilot 5 of 67

6 2.5 This project supports the ongoing work undertaken by the Trust s Clinical Effectiveness and Medicines Management Committee, and wider Trust objectives. The outcomes and deliverables of the Project will inform not only the Trust and PASA, but shall also provide information for other NHS Trusts as deemed appropriate by PASA. 2. Pilot Organisation 2.1 Pilot Acceptance 1. The Pilot acceptance was secured by: 2. Agreement from the Trust s Chief Executive 3. Agreement by the Pilot Project Board and Pilot Sponsor 4. Agreement by key stakeholders 5. Sign-off by the Trust Project Board 6. Sign-off by PASA (MET) 3.2 Governance A Programme Board was established within PASA to monitor closely the progress of the pilot against their plan. This allowed for the rapid escalation and resolution of issues and risks identified by the Trust Pilot, to enable them to meet the project Gateways. The Trust formed a Pilot Project Board, which met monthly and was co-chaired by the Trust Pilot Lead and the Pilot Facilitator (Appendix C) 3.3 Pilot Team Roles and Responsibilities Pilot Project Sponsor (Kay Fawcett, Director of Nursing) The Project Sponsor had responsibilities for championing and overseeing the project at a high level, reporting progress to the Trust Integrated Governance Committee. They were responsible for high level ownership of the pilot and high level activities, including: Executive level communications, including media communications management and broad stakeholder engagement resolution of Trust issues or queries related to the pilot championing the pilot within the Trust provide and negotiate the necessary Trust resources removal of barriers and resolution of issues that cannot be resolved at steering group level key decisions affecting the pilot high level and corporate risk management attending the Pilot Project Board reporting to Trust Executive Board presenting project outputs/outcomes to stakeholders. Pilot Manager and Lead (Tom Gray, Chief Pharmacist) The Pilot Manager and Lead was responsible for the day-to-day management of the project, reporting to the Project Sponsor. The Trust Pilot Lead was required to act as local change agent and be responsible for mobilising the resources at the Trust. NHS PASA Purchasing for Safety Pilot 6 of 67

7 Duties included: attendance at all Pilot Board meetings chairing regular meetings between the Pilot Facilitators day-to-day management of the pilot risk register managing the Gateway process. achieving the objectives and deliverables specified in the Trust Project Initiation Document co-ordinating the project activities of Trust-based staff organising and maintaining records for project meetings as agreed with the Pilot Facilitator local implementation and embedding of agreed solutions and working practices managing the change associated with new ways of local working. Pilot Facilitator (Avril Satchwell, Management Consultant, Atos Origin) An independent specialist was available to the Trust 1 day per week to drive the programme and to facilitate data collection and implementation. The Pilot Facilitator was responsible to the Pilot Board, in conjunction with the Trust Pilot Lead, for: achieving the objectives and deliverables specified in the local Project Initiation Document managing and driving the project plan reporting progress to the Pilot Board reporting progress to the Programme Board managing and mitigating risks associated with the pilot identifying, monitoring and resolving or escalating project issues co-chairing pilot team meetings with the Trust Pilot Lead Other Pilot Project Team Members Susanna Piggott (Consultant Anaesthetist) Gill Ogden (Clinical Risk Manager) Mark Cannell (Medical Devices Coordinator) Anne Johnson (Assistant Director of Nursing) Leslie Hancock (Professional Development Unit) The pilot project team members were responsible to the Pilot Project Board, through the Pilot Facilitator and Trust Pilot Lead for carrying out tasks related to the project. These included: 1. attendance at Pilot Project Board Meetings and process workshops/focus groups as required. 2. collection and verification of data to support analysis and process mapping activity 3. identifying, recording and evaluating ways of overcoming risks associated with the project 4. supporting management of change associated with the project 5. contributing to the activities of a project work streams as required by the Pilot Facilitator and Trust Pilot Lead. NHS PASA Purchasing for Safety Pilot 7 of 67

8 4. Objectives 4.1 The objectives of the pilot were: i) to demonstrate that strategic purchasing can reduce clinical risk associated with the administration of injectable medicines ii) to learn lessons relating to the case of injectable medicines that will be of benefit to Trusts and Collaborative Procurement Hubs across the country iii) to develop an approach that could serve as a model for addressing wider government policy issues through procurement. 4.2 The pilot objectives are closely aligned to the NPSA recommendations on improving medication safety in the NHS (March 2007). Including, (but not limited to) reduction of patient risk via the following means: a) colour, design and labelling of products b) standardisation of devices, medicines and sets, and supporting training and protocols c) centralisation of devices, medicines and sets d) elimination/reduction of open system medication in favour of pre-prepared products e) elimination of injectables requiring complex calculation and dilution f) double checking systems (e.g. bar-coding, electronic dose limiting software) g) provision of written information by manufacturers for clinical staff. By addressing the above areas, the Pilot Trust aims to: reduce the risk of errors (particularly user error) occurring alert users to possible dangers reduce the effect of use errors that occur. 4.3 Consideration will also be given to reduction of risk to staff, for example from needle stick injuries. 4.4 With this in mind, The Pilot Trust focussed on: A. standardising and centralising infusion devices A.1. review how purchasing and product selection decisions are made A.2. introduce or review process for evaluating the necessity for an infusion device prior to purchase A.3. identify the IV delivery system(s) that will minimise risk to patients and staff and promote procurement of products with inherent safety features A.4. determine the scope for reducing the range of infusion device types in use and, within each type, agree default configurations B. identifying scope for rationalising medicine product ranges (e.g. by dose-banding cytotoxics and antibiotics) and moving towards ready-to-administer or ready-to-use products wherever possible C. developing an evidence-based best practice/best value approach (practice and products) to IV drug delivery to optimise patient outcomes, system efficiency, user satisfaction, safety, cost-effectiveness and product use. This will include consideration of drug preparation in the clinical setting, delivery options, management of the intravenous access and monitoring of infusions throughout administration D. ensuring stakeholder buy-in at local level through pro-active engagement and opportunities for input to decision-making from planning to implementation stage NHS PASA Purchasing for Safety Pilot 8 of 67

9 E. delivering an agreed implementation plan that will support compliance with the recommended changes to products and practice F. developing a process to measure the short, medium and long term outcomes (clinical and financial) of the implemented recommendations. This will include a means by which Trusts can demonstrate to commissioners their approach to patient safety. 5. Scope 5.1 It was not possible, in the scope of this project, to include all departments, wards and clinical areas within The Pilot Trust. Therefore the Trust focussed on the following areas, and their respective processes and systems currently in place: Theatres, Imaging, Maternity Oncology and Procurement Pilot Processes: Acceptable testing undertaking risk assessments, analysis looking at process and selection of equipment and drug products, Chemotherapy dose banding, Safe administration and risk reduction processes Education and training of staff. Device management 5.2 In terms of product, all injectable medicines and the devices and consumables for their administration were in scope initially. Consideration was also shown to the systems and processes that supported the products and services, thus included (but was not limited to), packaging, labelling, use of colour and bar coding. The umbrella of injectable medicines is seen to cover intraosseous, intravenous (push, infusion and combination) subcutaneous, intramuscular, epidural and intrathecal, intraarterial and intraoccular administration. Administrations via the oral route are out of scope. 5.3 In terms of process, the Trust s pilot project encompassed supply and storage, preparation and administration (including monitoring) of injectable medicines. Quality control also played an important role. Prescribing issues were also not in scope. 5.4 In terms of setting, The Pilot Trust, as far as possible, reflected the distribution of IV therapy across the secondary care settings NHS PASA Purchasing for Safety Pilot 9 of 67

10 6 Methodology 6.1. Introduction: Design and process The project methodology design included 5 main stages. These are demonstrated in figure 1 below. Data Collection Implementation NPSA Data Trust incidence Data PASA Pharmex Data Risk Assessment tools Risk Assessment Risks Risks & Issues National Projects Focus Group Focus groups Issues Review Phase 1 Detailed Analysis Selected Case Studies Interviews Questionnaires Case Studies Pilot Projects Figure 1- project methodology The first stage consisted of data collection and review for 4 main sources of reports and assessment tools. These included the: National reporting and learning systems incident data analysis Trust incident reports data Trust Pharmex data NPSA Risk assessment tools These delivered the components of the risk assessment phase in a form of risk and issue register as summarised in section 6.8 As part of issue investigation in the pilot Trust, focus groups were conducted in major areas of specialty which each delivered an issue log (Appendix G). Selected case studies were further analysed in detail via one-to-one interviews with key staff identified in each area (Sections ). A web based staff questionnaire was used to evaluate injectable medicines therapy by a large range of clinical staff of different disciplines and grades (Sections 6.10 and 7.9) As part of the implementation phase, the audit findings were further analysed and reviewed to identify which risks and issues represent national projects versus local initiatives for implementation (Sections 9 and 10). NHS PASA Purchasing for Safety Pilot 10 of 67

11 6.2. Data collection NPSA Risk Assessment Tool for Near-Patient Areas NPSA practice standards and standard operating procedures relating to near-patient areas Manchester Patient Safety Framework (MaPSaF) to assess the safety culture within the Pilot Trusts NPSA/NHS PASA information pack, comprising: Purchasing toolkit NPSA patient leaflet NPSA evaluation report on infusion device pilot project work FAQs. ( s/infusion%20devices 6 ) Task analysis techniques SWIFT (Structured What-If Technique) for hazard identification (relating to infusion devices in use, particularly the human and organisational factors). Root cause analysis tools and techniques Cost-benefit analysis (affordability versus value/quality/safety) Medical Devices Training Criteria (THOTH). Trust policies, processes and guidelines Trust clinical risk data and other relevant data related to the administration of injectable medicines. 6.3 Cultural Analysis Derby Hospitals NHS Foundation Trust has a positive safety culture as demonstrated in the response to the Manchester Patient Safety Framework (Figure 2). Over 4,000 evaluation forms were sent out with 990 returned (22%). Of those that returned forms, 54% of respondents rated the Trust as having a good or excellent safety culture being proactive and integrated into strategy and daily activity - with only 3% of respondents rating this as poor. Some variation was seen across staff groups, and in response to the individual questions, although it is difficult to draw conclusions from these results. Senior clinicians and managers have been trained in the use of Root Cause Analysis techniques and these are routinely used to investigate incidents with future moderate or high risk as well as develop learning from low risk incidents. Medication errors are routinely reviewed by the Trust Medicines Management Committee (reporting to Clinical Effectiveness Committee) and incidents involving medical devices and administration equipment to the Infusion Systems subcommittee. Incidents deemed to have a moderate or high potential future risk are reviewed and quality assured by the Trust Incident Review Group a high level group including the Medical Director, Director of Nursing, Chief Pharmacist, Clinical Risk Manager, Complaints Manager and Trust Solicitor. 6 Login and password may be needed to access on NHS Supply Chain s website NHS PASA Purchasing for Safety Pilot 11 of 67

12 45% 40% 39% 35% 34% 30% Response % 25% 20% 15% 15% 10% 10% 5% 3% 0% Poor Fair Average Good Excellent Statement Figure 2 - MaPSaF Trust Overall Score Derby Hospitals NHS Foundation Trust has a history of proactive medicines management, with the safe, effective and economic use of medicines underpinning pharmacy services. Medicines management encompasses the entire way that medicines are selected, procured, delivered, prescribed, administered and reviewed, to optimise the contribution that medicines make to producing desired outcomes of patient care 7. Medicines Management is led by the Chief Pharmacist and strategy delivered through the Drugs and Therapeutics Committee, Medicines Management and other sub-committees (Appendix C). Safe storage and effective use of medicines requires a team approach and this is reflected in the multi-professional representation of these committees and practice standards defined in the Trust policies and procedures for medicines. The safe use of injectable medicines has been a priority for the Trust for many years and significant work has been done to rationalise and standardise medicine products and equipment (Section 6.6). All injectable medicines are supplied from pharmacy via central stores for ward stock, a central licensed aseptic manufacturing facility and decentralised satellites operating to NHS standards for aseptic dispensing. Conservative issue data from pharmacy stock control systems suggests that 20% of injections are dispensed or manufactured by pharmacy in a ready to administer form, 26% being prepared using a simple, closed reconstitution system at ward level (Baxter Minibag plus ) and 42% being infusion of standard intravenous fluids. Only 12% of injections are prepared near patient (including clinically urgent therapy and emergency care). Risk assessments of injectable medicines have been carried out in response to the recent NPSA Alert on safer use of injectable medicines 8 and an action plan developed (Appendix Ei and Eii). 7 Audit Commission, A spoonful of sugar Medicines Management in NHS Hospitals Alert 20 Promoting the safer use of injectable medicines. NPSA March 2007 NHS PASA Purchasing for Safety Pilot 12 of 67

13 6.4 Incident Reports National incident reporting data from the NPSA National Reporting and Learning System (NRLS) further demonstrates that the Trust has a good reporting culture, typical of other large acute Trusts. Whilst this does not breakdown incidents related to injectable medicines it does demonstrate that most reported errors occur during medicine administration (53.5% and across cluster 57.4%) with 15.6% (18.6% across cluster) related to preparation and dispensing in all locations 9. Further breakdown shows that the most common errors relate to omission of medicines (26%), wrong dose or strength (22.6%) and wrong medicine (15.1%). The % reported errors related to patient allergy and wrong methods of preparation are 1.5% (less than half the average % across the cluster), although a third of allergy incidents lead to patient harm. These results are reflected in a recent report from the NPSA (period Apr 2005 Sep 2006), where administration errors account for greater than 50% of reported incidents. Whilst the majority cause no harm (83%) or only temporary harm (15%), over half the incidents that do lead to severe harm (0.8%) or death (0.2% of total incidents reported) are due to injectable medicines % of administration errors by the wrong route, leading to severe harm or death, are due to injectable medicines (compared with 38% for oral medicines), and of these opiates contribute 13%, anaesthetic agents 5.4%, Chemotherapy 4.3% and infusion fluids 3.3% 10. The low rates of preparation errors (15.6%) seen in Derby may reflect the fact that the majority of injectable medicines are already supplied to the Trust in a safe ready to administer form. Further analysis of local incident reporting data on parenteral medicines (Jan Dec 2006) suggests that error rates due to injectable medicines are fairly low with no reports of severe harm or death. Errors reported with injectable medicines Jan-Dec 2006 (n=576) Error Stage % Administration 55 Prescribing 29 Preparation 13 Other 3 Further analysis of the error stage can be seen in the table below: Error stage (n=576) All stages (% of total) Prescribing (% of total) Preparation (% of total) Administration (% of total) Dose Omission Drug Storage Frequency Preparation Expiry Mismatch Label Route Allergy NRLS Report for Derby Hospitals NHSFT Period Apr-Sep NPSA. 10 Safety in Doses improving the use of medicines in the NHS. NPSA London May 2007 NHS PASA Purchasing for Safety Pilot 13 of 67

14 Dose errors account for the most common medication errors with injectable medicines in Derby Hospitals with over half of these occurring at the prescribing stage. In most cases these will be intercepted before they reach the patient and can therefore be considered clinical near misses. However, a third of these occur at administration and evidence suggests that up to 60% of these will reach the patient. Nearly a fifth of all injectable medicines errors result in omission of the medicine from the patient s prescription, or where prescribed at administration. This is a cause of concern leading to delays in treatment and potential harm through under dosing. The injectable medicines most commonly involved in errors include: Injectable Number Prescribing Preparation Administration Medicine Heparin Morphine Gentamicin Sodium Chloride Furosemide Cefuroxime Dexamethasone Phenylephrine Metoclopramide Amoxicillin Hydrocortisone Oxytocin Ranitidine A risk assessment of the injectable medicines involved in errors, suggests that these are already relatively low risk in terms of preparation and administration (Appendix Eiii). Whilst there might be value in purchasing for convenience as pre-filled ready to administer products, wherever possible, this is unlikely to add significant safety to their use in practice. Local data supports national findings from the NPSA Patient Safety Observatory that the majority of medication errors occurring with injectable medicines do so at the point of administration. Given the therapeutic potency of many injectable medicines, and potential associated harm, interventions should be focussed on trying to reduce this risk. Work has been done by the Medicines Management Committee to focus on the high risk medicine groups to raise awareness, control the availability and present these in an appropriate form, for example: standardisation of heparin preparations providing clinical guidelines and dosing charts for heparin and gentamicin dose banding gentamicin for once daily administration reducing the number of high strength opiates stocked in clinical areas Further work is being conducted in response to the NPSA Alerts and guidance. Nevertheless incident reporting is lower than expected in some areas of the Trust e.g. critical care areas and by some staff groups e.g. medical staff this is surprising given the complex injectable medicines therapy in critical care and number of prescribing errors. Concerns have also been raised about the quality of reporting and suitability of the current incident form for medication errors NHS PASA Purchasing for Safety Pilot 14 of 67

15 6.5 Process Flow Mapping Process flow maps (developed by the United Lincoln Hospitals Pilot Team) were utilised within the Focus Groups sessions to identify issues relating to generic processes for prescribing, supply and administration by relevant staff groups (Figure 2). A separate process flow was used for chemotherapy (Figure 3), reflecting the greater complexity associated with this treatment. Figure 2 Process Flow Injectable Medicines Figure 3 Process Flow Chemotherapy Issues relating to process were identified within the focus groups and are identified within the summary of feedback from the Focus Groups (Section 7.6). This contains proposals for separate case reviews and other internal Trust action. NHS PASA Purchasing for Safety Pilot 15 of 67

16 A further process flow was described for device selection (Figure 4) Figure 4 Process Flow Device selection 6.6 Medical Devices Medical devices are managed in the Trust through the Infusions Systems subcommittee of Drugs and Therapeutics, with procurement decisions from the Medical Devices Committee. Mark Cannell, Medical Devices Coordinator and Pilot Board member, leads this work in association with colleagues from Clinical Engineering and Procurement (Appendix I) In 2004 the use of infusion devices across the Trust was rationalised in response to NPSA guidance on improving infusion device safety 11, reducing these from over 40 different types of device to just five core standard devices (a volumetric infuser, large volume syringe pump, epidural pump, PCA pump and small volume syringe driver (for palliative care). Specifications for these devices (including safety features such as keypad lock out and integral guardian software / drug libraries) were agreed and used to inform purchasing decisions. Centralised equipment libraries were opened (DCGH site 2004 and DRI site 2006) to control and maximise availability of equipment. These have resulted in a significant reduction in incident reports for equipment in clinical use, equipment failure and above all, lack of availability. Other benefits include: Reduced risk from inappropriate use or unsafe equipment Better use and availability of equipment Improved processes for evaluating and procuring equipment Rationalisation and standardisation of equipment Better planned preventative maintenance Simplified and improved training Reduced consumable costs 11 NPSA Safer Practice Notice 1 improving infusion device safety. May 2004 NHS PASA Purchasing for Safety Pilot 16 of 67

17 6.7 Procurement A procurement focus group was undertaken in May, facilitated by staff from the Cambridge Engineering Design Centre, and involved Trust purchasing staff (for devices, pharmaceuticals and consumables, together with representatives from NHS PASA and the Re:Source Procurement Hub. The Focus Group reviewed current processes for product selection, evaluation and decision-making, and discussed opportunities to develop and improve this for injectable medicines and administrative systems. Outputs from the Procurement Focus Group are shown in Section Focus Groups and selection of Case Studies Focus Groups were identified from a combination of Trust intelligence and the published literature. In general, areas which had a reasonably high use of injectable medicines (Theatres, Chemotherapy), complex or high risk therapy (Theatres, Imaging, Chemotherapy and Maternity) or received little pharmacy input to medicines management (Theatres, Imaging and Maternity) were chosen. In addition these areas, with the exception of chemotherapy services, reflected low reporting of medication incidents, which was surprising given the nature and complexity of the injectable medicines employed. Published literature relating to injectable medicines practices were used to support the choice of Focus Groups, for example, recent concerns about unsafe open bowl practices used within Imaging 12. There are numerous publications on the risks associated with handling cytotoxic chemotherapy and national best practice guidance relating to its safe preparation, administration and disposal. Focus Group selection and stakeholders are summarised in section 6.6 Focus Group outputs are documented in Appendix G, providing a rationale and risk assessment for choice of case studies to take forward to structured interviews 6.9 Structured Interviews Structured interviews were conducted with senior clinical staff within each Focus Group area, using a semi-structured interview technique. Pre-prepared questions were used (see section 7.7.1) although interviewers were able to follow leads arising from discussions. The interviews lasted minutes and the output is summarised in sections to of the report Questionnaire A general questionnaire on injectable medicines practice was developed by NHS PASA with input from pilot Trusts, seeking information from a wide range of clinical practitioners of different professions and grades. To maximise feedback the questionnaire was developed as an online survey hosted by Exodus market research. A copy of the questionnaire can be obtained from NHS PASA or accessed on line: Accessed using the password riskmeds. Outputs from the survey are included in section 7.8. A copy of the electronic questionnaire is enclosed in Appendix H. 12 Cousins D.H. Patient safety issues with x-ray contrast media. Hospital Pharmacy Europe. Feb 2007 NHS PASA Purchasing for Safety Pilot 17 of 67

18 7 Outputs 7.1 PID and Executive Summary A project initiation document was provided by NHS PASA to provide context to the purchasing for safety project and supplemented with an Executive Summary. This was sent to Trust Executives and Associate Directors in order to engage their support. A copy of the Trust Charter (Executive Summary) is included within Appendix F. 7.2 Communications Plan A communication plan is included within Appendix D. Summary information was also made available to all Trust staff via a dedicated webpage on the Intranet at: Risk Register A project risk register was maintained in order to escalate issues to the Pilot and Project Boards. Following publication of the pilot sites in the Health Services Journal, local media took a close interest in the project, concerned that Derby Hospitals must have been chosen on account of errors with injectable medicines. Much work was done to manage this and limit any damage to the Trust, resulting in a brief but reasonably positive article being published Derby at the sharp end of an injection error trial. This risk sue was escalated to NHS PASA communications to encourage joint communication in future. Resource issues within the Trust project team remain a concern. A copy of the Risk Register (to July 2007) is included in Appendix B. 7.4 Project Plan A project plan, detailing phase timings and completion of objectives (to July 2007), has been maintained by Atos Consulting and is available in Appendix A 7.5 Areas Selected As detailed under section 6.8, the following clinical areas were chosen for review: Chemotherapy Services Theatres and Imaging Maternity Services Within each clinical area Focus Groups were run to obtain establish issues and risks associated with process, equipment, injectable products, knowledge and incident reporting. Details can be reviewed in section 7.6 and Appendix G. NHS PASA Purchasing for Safety Pilot 18 of 67

19 7.6 Focus Groups and Stakeholder Map NHS PASA Purchasing for Safety Pilot 19 of 67

20 7.7 Output Analysis and Case Study Selection Structured Interviews Focus Group Chemotherapy Case Study Interview Questions Rationale Stakeholders Chemotherapy Dose Banding Bolus administration versus infusion What is current practice with dose banding? Is there any scope for increasing dose banding? If so, how might this be achieved? What barriers to increasing dose banding practice exist in the following: - The patient having effective treatment? - The time resource for pharmacy staff? - The cost of wastage? The benefits of bolus versus infusion? The risks associated with bolus / infusion? The risks with ward preparation of bolus? The constraints to changing practice? How can these be overcome? Establish what exists Understand opportunities to expand practice Understand the limitations of where changes can be realistically achieved Risk : benefit analysis Pragmatic options Opportunities Sister or Staff Nurse Pharmacist Consultant Risk Manager Sister or Staff Nurse Pharmacist Risk Manager Theatres and Imaging Maternity Services Storage, presentation, labelling & selection of injectable medicines Knowledge decay maintaining skills and competency Preparation of injections prior to list - skill mix and checks Standardisation of Syntocinon products Use of extension lines, and multiple connectors Flagging products with essential information Do you have sufficient storage space? How could this be improved? Problems with selection of injections? Which drugs would you like pre-prepared and why? How much time could be saved using preprepared medicines? (using your examples) What extra storage space would be required for pre-prepared injections? What are the issues with maintaining knowledge and training? How do you prevent knowledge decay? Disadvantages of current process? Could a multi-professional approach mitigate these? What are the benefits of second checking? How could this be safely introduced? What products are prepared currently? What consensus with local and national guidelines? What would be ideal product range? Why extension sets, connectors are used? Why? What are risks with this approach? Are safer / alternative methods available? What are current problems with available information for injectable medicines? Where can you obtain information on injections? What information do you consider most important? To explore what the risks are with selection To establish priorities and options for high density Estimation of time and other resource implications Explore barriers for change Understand limitations of training and ways of overcoming this Establish risks Establish role of ODPs Establish understanding Practicalities Establish current practice Any consistency? Standardisation Establish current practice Establish perceived risks Consider options Scope issues Establish what information is held and where Identify priorities ODP Anaesthetist Theatre or Recovery Nurse Pharmacist Pharmacy Technician Risk Manager ODP Anaesthetist Theatre or Recovery Nurse ODP Anaesthetist Theatre or Recovery Nurse Pharmacist Risk Manager Anaesthetist, Obstetrician Midwife, Pharmacist? Risk Manager Anaesthetist, Obstetrician Midwife, Pharmacist? Risk Manager Anaesthetist, Obstetrician Midwife, Pharmacist? Risk Manager NHS PASA Purchasing for Safety Pilot 20 of 67

21 7.7.2 Case Study A Theatres and Imaging - Presentation and storage of injectable medicines - Knowledge decay in training - Second checking of injectable medicines Case Study B Chemotherapy - Dose banding for chemotherapy - Bolus injection versus infusion NHS PASA Purchasing for Safety Pilot 21 of 67

22 7.7.4 Case Study C Maternity - Standardisation of Syntocinon products - Use of Extension lines - Poor labelling and product information 7.8 Procurement Focus Group (summary) See section 5.7 for details of participants and objectives for this Focus Group. Process mapping resulted in a clear distinction between: Purchasing for device Purchasing for delivery system (giving sets, etc) Purchasing for pharmaceuticals (medicines, solutions, etc) It was clear that the pharmaceutical side is well regulated and controlled by national policies, hence facilitating many procedures. Such safety checks could be implemented in procurement processes too. It was noted that procurement roles overlap this was to be explored through further mapping. In terms of developing a maturity model for procurement processes, a number of aspects were considered, including: Ease of use/device selection: Criteria need to be set for selection of devices taking into consideration how they will be used in the clinical context. Standardisation: Certain degree of standardisation needs to be made within the Trust, taking into account previous history of models, ease of use, training requirements, servicing and maintenance, and appropriateness of final use. Procurement Process: Well-defined, regulated procurement procedures in place within the Trust. (No by-passing and formalised involvement of sales representatives) NHS PASA Purchasing for Safety Pilot 22 of 67

23 Life Cycle Costing: As part of the selection criteria, full costs and benefit analyses of new devices. National Information: Readily available information on new devices, history of device problems, other Trusts experience, etc. Communication: Better internal communication between stakeholders involved in decision-making on purchasing. Evaluation: Local evaluation of devices to match national data (and constant feed-back from user experience back to national bodies) Purchasing for safety processes and decisions could be summarised as: Standardisation: Using criteria such as: - Ease of use - User experience - Servicing and maintenance history - Training requirements Procurement Process: Well-defined structure to include: - Life-cycle costing - Internal Communication - Feedback systems within trust wards Evaluation Data: Available both local and nationally available, to include: - National info on evaluations well disseminated to all Trusts - Local evaluation well disseminated within trust - Readily available information on other trusts evaluations and experience Evaluation of MaPSaF framework was not considered appropriate by participants. 7.9 Questionnaire Results from the online questionnaire are shown below: Awaiting feedback from Exodus Research NHS PASA Purchasing for Safety Pilot 23 of 67

24 8 Recommendations and Benefits A number benefits can be identified from the project which are summarised below. 8.1 Benefits for Patients Patient safety is paramount and this project has helped to raise awareness of the risks associated with injectable medicines. The project has highlighted a number of high risk processes which must be modified (e.g. the lack of second checking in some theatre areas and use of open bowl techniques in Imaging), as well as opportunities to enhance safety through use of better products (e.g. more standardisation and ready to administer products). Patient experience is also important and it is clear from feedback that this may be compromised through unsupervised infusion of injectable medicines (e.g. when short infusions are left to infuse over a prolonged period). 8.2 Benefits for Healthcare Professionals Health professionals involved in the focus groups and case studies have benefited from the opportunity to review processes, products, devices and training in detail through brainstorming and structured interviews. A wide range of staff have participated in the online injectable medicines survey, reflecting on safe practice issues. Despite the large number of products that are already provided by pharmacy in a ready to use form, and the widespread use of the Baxter Minibag Plus administration system, the project has identified a number of injectable medicines that could be presented in a safer or more convenient form and staff will benefit from more ready to administer products in the future. Infusion devices have already been rationalised and staff benefit from greater availability of functional equipment through centralised equipment libraries. Whilst this has streamlined information and training in infusion devices and techniques there is opportunity for further work to maintain this and promote best practice in clinical areas. Some work has already been undertaken to rationalise consumable use in the Trust, although there is opportunity for further standardisation. 8.3 Benefits for the Procurement Community Derby Hospitals have a strong reputation for cost-effective procurement of pharmaceuticals through the Trent Purchasing Consortium. Pharmaceutical procurement has always focussed on quality and increasingly on patient safety through, for example, review of packaging design and labelling. Increasingly purchasing has been centralised through national PASA contracting (e.g. the supply chain excellence programme) and regional commercial procurement hubs (e.g. East Midlands Re:Source Procurement Hub). It is essential that patient safety remains central to decisions made by this and other commercial procurement hubs. There are significant opportunities to rationalise procurement both nationally and regionally through these hubs and to standardise products. This will require good communication with healthcare professionals and clear specification for high quality, safe products. Increasingly medical devices and consumables are being targeted by procurement hubs and this is welcomed. The project has identified a number of areas where national / regional procurement makes good economic sense and would bring significant patient safety benefits (e.g. dose banding). NHS PASA Purchasing for Safety Pilot 24 of 67

25 8.4 Benefits for the Healthcare Industry The project offers the healthcare industry opportunity to trial and evaluate new injectable medicine products and devices. Rationalisation and standardisation of the product range will ensure supply continuity to the NHS. Clear product specifications which focus on product safety and quality will encourage greater innovation in product design and business opportunity. The healthcare industry supplying this market will benefit from the opportunity to add value to their product offerings and to differentiate their products based on safety considerations. A focus on simplification through clear labelling, effective product information, design and use of materials which are safe to handle and administer will encourage uptake from the NHS. 8.5 Benefits for the Pilot Trust The pilot Trust has benefited from an increased focus and awareness of safety issues relating to injectable medicines. The project has clarified the extent of use and identified many areas of strength and opportunity as well as examples of poor practice and high risk. Early exposure to the media was a little negative but there is opportunity to develop positive headlines and the Trust will benefit from sharing best practice in many aspects of injectable medicines practice. The Trust has benefited from a closer working relationship with NHS PASA and access to researchers from the Cambridge Engineering Design Institute, as well as gaining experience in project methodology and the use of various analysis tools, from the project facilitators, Atos Consulting. 9 Lessons Learnt 9.1 Project Experience The project experience has generally been positive with pilot board staff engaging in the data collection activities and supporting analysis. Pilot Board meetings have been well attended and supported by Atos Consulting, with relevant up-to-date paperwork. That said the project has on occasions involved unnecessary duplication in paperwork and methodology which has constrained the analysis (e.g. unnecessary explanation in focus groups and too much emphasis on keeping to the project timetable, rather than maximising data collection and analysis). In particular, the questionnaire was rushed resulting in technical issues. Participation by healthcare staff has been reasonable although could have been improved by better forward planning and a clearer brief prior to the project starting. It has been difficult to engage medical staff and this reflects working commitments under the new consultant contract which requires six weeks notice; nevertheless we have enjoyed support and guidance from a Consultant Anaesthetist on the Pilot Board. The lack of time and resource to support the project from within the Trust has been a concern, given competing pressures and priorities, however the Pilot Board have been supportive and proactive in assisting the Project Manager. Assumptions have been made by the PASA Project Board regards available resources and earlier engagement of the Trust Executive and Management Teams prior to the start of the project would have helped to prioritise this and ensure that sufficient resources were available to support the Project Team. NHS PASA Purchasing for Safety Pilot 25 of 67

26 9.2 Project Lessons Earlier engagement of Trust Executive Team and Senior Managers to ensure adequate resource and support were available to support Pilot Team. Clearer brief of project objectives, timescales and resources available to support project team and engage clinicians. Realistic project objectives and timescales that recognise Trust priorities. Proactive management of media interest to ensure appropriate headlines. 9.3 Summary of issues The project identified a wide range of issues with injectable medicines practice and products, as well as risk reduction measures that can be taken forward as Trust-specific or national recommendations. These include issues and opportunities to improve products, processes, devices and training, together with recommendations for purchasing for safety and purchasing for convenience, and are summarised below: Procurement Patient safety issues must be central to all procurement decisions for injectable medicines, medical devices and consumables. These will include evaluation of product material design, labelling and packaging, ease of use and differentiation from other similar products. This evaluation will occur during national and regional contracting. However, due to supply chain issues it is often necessary to make local decisions to buy off contract. Such decisions should recognise the above, with evaluation of the product, where possible, prior to purchase. All medicine products should be quarantined and checked on receipt to ensure that they meet minimum quality and safety standards this is best achieved through use of a scoring system. Where changes in packaging occur, then these should be communicated to the Trust as appropriate to minimise risk. For example, where there is a high risk of selection errors or confusion (e.g. similar packaging or different concentration) staff should be alerted via a new product alert that identifies can be attached to the new product and displayed in clinical areas where medicines are prepared. Products must not be released from quarantine until safety concerns have been addressed (for example, provision of an English language leaflet for imported products or flagging with essential information (see 9.3.2) for high risk products) Information Essential summary information on dose, dose range, preparation, route of administration and administration method should be presented clearly and concisely on product packaging. Ideally this would be adopted by MHRA labelling guidelines for injectable medicines; if not, high risk products should be flagged with this information in-house. More detailed monographs summarising the clinical use, preparation and administration of moderate and high risk injectable medicines may be used as appropriate. High risk medicines that require complex preparation within clinical areas (e.g. for emergency use) should have a simple worksheet to assist staff in the stepwise preparation and documentation of important in-process checks. NHS PASA Purchasing for Safety Pilot 26 of 67

27 More general information, such as the Summary of Product Characteristics, and a future national Injectable Medicines Guide, should be available within clinical areas via the Trust Medicines Intranet Storage Effective storage of injectable medicines is important to ensuring that the correct medicine can quickly and easily be identified and correctly selected when working under pressure. Storage space is often inadequate within clinical areas and can result in cupboards being over-filled and injectable medicines being removed from outer packaging to maximise available space. This is an extremely dangerous and high risk approach medicines should always be kept in their original packaging in line with NPSA best practice guidance and cupboards stocked up on a regular basis, with removal of named patient products and loose ampoules. High density storage solutions should be considered with clear ordering and labelling of cupboards to facilitate selection. Standardisation of medicines storage within clinical areas will assist staff to locate products (e.g. anaesthetic rooms in Theatres). Emergency drugs should be available from specific locations and consideration should be given to having a Theatre / Critical Care Emergency Drug box to include products, consumables and clinical guidelines for use in emergency situations Preparation Where suitable injectable medicines products cannot be procured, then they should be prepared in an appropriate location. Currently only about 12% of all injectable medicines used in the Trust are prepared at ward level. Wherever possible all moderate and high risk products should be prepared in centralised and decentralised pharmacy aseptic facilities. However some high risk medicines are required urgently, and will require preparation at ward level. Preparation areas should be clean, tidy and quiet, allowing undisturbed preparation and checking of injectable medicines. Diluents, such as sodium chloride 0.9% injection and water for injections BP, used in preparation should be kept in original packaging to prevent incorrect selection and either used or discarded, rather than risk being returned to the wrong outer box. Injectable medicines prepared at ward or theatre level should be used as soon as possible (e.g. during operating session) and not stored. All products should be labelled using either the Trust approved critical care labelling or a generic label stating the contents of the syringe (drug, dose), when it was prepared and by whom. Other injectable medicines will be prepared using the Baxter Minibag Plus system wherever possible, or as a bolus injection; injectable medicines should not be added to infusion fluids outside the pharmacy department. Contrast media should be procured or prepared prior to imaging as pre-filled syringes; the use of open bowl techniques to draw up and administer contrast media and flushes is dangerous and should cease immediately within the Trust. All syringes should be labelled (using sterile labels where necessary) and consideration given to including these with sterile kits. Coloured syringes may also be useful for distinguishing route (e.g. epidural) along with clear labelling. Dose banding offers an important means of simplifying prescribing and preparation of complex regimens and should be used where appropriate for cancer chemotherapy and other products, where dose is standardised by weight or body surface area. Dose banding has been successfully applied to Gentamicin in the Derby Hospitals and this could be extended to other injectable medicines NHS PASA Purchasing for Safety Pilot 27 of 67

28 having a wide dose range. National standards should be adopted for dose banding and, together with a clear product specification, used to commercially procure suitable products. Pharmacy could consider dispensing or manufacturing further dose banded products within the constraints of licence, in the interim Checking In-process checking during preparation of injectable medicines, positive patient identification and reconciliation of the product, prescription and patient prior to administration is essential to ensuring patient safety. Wherever possible these checks should be conducted independently by a second practitioner, who is familiar with the process and conversant with the risks associated with injectable medicines. This approach is standard in many areas of the Trust such as in paediatrics and cancer chemotherapy, but there is more variation in theatre areas where the same individual can be responsible for prescribing, preparing and administering injectable medicines with no independent checks. Team working within secondary care facilitates this approach to second checking and it is unusual for practitioners to be working in isolation. For example, an Operating Department Practitioner (ODP) might prepare medicines prior to the operating list, which are second checked by the Anaesthetist. Administration of the medicines by the Anaesthetist might be second checked by a theatre nurse or ODP Administration Administration of injectable medicines is perhaps the highest risk activity, and most likely to lead to a medication error or clinical incident. The risk of error can be reduced if injectable medicines are clearly labelled and available in a ready to administer form. Second checking of administration, including positive patient identification and reconciliation of the product with the prescription are fundamental to safe administration and should be standard practice. The use of needle-free systems can reduce risk to staff handling injectable medicines and to patients receiving these; whilst a needle-free system is routinely used in Cancer Services to administer chemotherapy, this is not the case in other areas where chemotherapy is administered e.g. rheumatology, renal services etc. Phase 2 of the project offers an opportunity to trial needle-free preparation and administration equipment such as the Tevadaptor (Teva) and Chemo-aide (Baxter). Infusion fluids should be spiked at waist level (e.g. on bench in clinical area, or even patient bedside table) using a no touch technique, rather than trying to insert a set at eyelevel which can result in spillage, contamination or damage to the infusion bag. Opportunities exist to use technology such as barcoding and RFID to positively identify a patient and product and reconcile with their prescription, to ensure administration of the correct product at the correct time. This is built into the Derby Hospitals OBS for electronic prescribing and medicines administration, but slow progress by our solution provider, isoft, have resulted in delays introducing these important safety enhancements. RFID can also be used for tracking medical devices and monitoring status of equipment. Software currently available in our Baxter Colleague infusion pump allows a drug library to be set up with preprogrammable drugs, concentrations and dosing rate limits; the software also tracks key presses and error codes. Greater use needs to be made of this Guardian software to simplify device setup and prevent human error. NHS PASA Purchasing for Safety Pilot 28 of 67

29 Extension lines and multiple connectors should only be used in critical care areas where absolutely necessary. Multiple lumens can result in administration by the wrong route and lines should be labelled to clearly distinguish these (e.g. black text on a bright pink background is used for all epidural products). Standardisation of extension sets and connectors will simplify selection, training and reduce costs Training Training is required for all nursing staff involved in injectable medicines therapy and this takes the form of a knowledge based assessment, ward based observation and an IV training study day. No similar training is available for medical staff and work pressures make it difficult to release staff from clinical areas. A web-based e-learning package on drug administration (including calculations) is being developed and will be available in September / October and should be evaluated during phase 2 of this project. An IV trainer should be established within each clinical area to promote best practice and provide refresher training of all staff involved in injectable medicines therapy; a register of suitably trained staff should be maintained. Training resources, such as posters and information depicting processes for preparation and administration on injectable medicines, using no touch technique, should be developed and prominently displayed in clinical areas. An effective chemotherapy training programme is used within Cancer Services, all staff involved in handling, administering and disposing of cytotoxic chemotherapy (whatever the clinical indication) should undertake this programme. Cytotoxic chemotherapy products dispensed to areas outside Cancer Services should be accompanied with a simple brief that reminds staff of safe handing and disposal requirements Prescribing and documentation Although prescribing is out with the scope of this project, a number of important issues have been identified. All injectable medicines are Prescription Only Medicines (POM) and must therefore be prescribed by a registered medical or non-medical prescriber before they can be dispensed or administered to a patient. Concerns were raised with regards to prescribing within Theatre areas, as this is often retrospective and completed when the patient moves to the recovery area. Staff administering medicines peri-operatively should do so against a written prescription or under direct supervision of the prescribing anaesthetist. Administration of all medicines should be documented. Within imaging areas, there is often no actual prescription for the administration of contrast media, as this is integral to the diagnostic test that has been requested. Staff requesting tests should however be aware that in so doing they are authorising the administration of POMs. Software used for the prescribing and tracking of cytotoxic chemotherapy must be properly validated and piloted before roll out to minimise the risk of introducing errors into the process. Patient weight should be checked on each admission / cycle to ensure that body surface area calculations are accurate. Incident reporting should be improved for injectable medicines to ensure that reports are easy to complete, timely and capture all essential information. Feedback should be given and lessons learned regularly disseminated. A web based version of Datix should be implemented within the Trust to facilitate this. NHS PASA Purchasing for Safety Pilot 29 of 67

30 9.4 Conclusions As well as highlighting current best practice in Derby Hospitals NHS Foundation Trust, the project has highlighted a number of weaknesses and issues with medicines management of injectable medicines; there is room for improvement. High standards must be applied to all stages of the medicines use process procurement, storage, prescribing, preparation, administration and disposal of injectable medicines to safeguard patient care. This project has identified weaknesses and opportunities in each stage to improve products and processes. The open methodology approach adopted during phase 1 of this pilot has allowed the Trust to also consider and evaluate its own processes and concerns around injectable medicines whilst still working within the boundaries of the PID and pilot study. This has led to a series of recommendations for both the Trust (section 10.1) and NHS PASA (section 10.2) to take forward into phase Acknowledgements The Project Manager has received invaluable advice and support from members of the Pilot Board and Project Team in developing this pilot and completing phase 1 focus groups, interviews and data analysis. Particular thanks to clinical staff and their managers who have given up valuable time to share their experience, insight and expertise to inform the project findings. NHS PASA Purchasing for Safety Pilot 30 of 67

31 10 Proposal for Phase 2 Implementation plan 10.1 Recommendations for Trust Procurement - Off contract product evaluation and communication / alert process - Standardisation of extensions sets, connectors etc & policy for use Information - Essential information label for high risk injectable medicines packaging - Drug monographs for safe prescribing, preparation and administration of high risk products (with worksheet for complex preparation in clinical areas) - Develop basic Trust injectable medicines guide (with focus on administration), pending publication of NHS Injectable Medicines Guide in future Storage - Review RHS medicines storage and preparation facilities and ensure designated area for medicines preparation conforms to best practice standards - Standardise medicines storage and stock levels within clinical areas, to maximise correct selection through positive identification; utilise supplementary labels on outer packaging to aid correct selection - All medicines to be kept in original packaging in ALL clinical areas - Removal of all expired, over stocked and named-patient supplies regularly - Emergency drugs in separate accessible kit with consumables, diluents etc (i.e. Theatre emergency box) - Limit storage of injectable medicine preparations in clinical areas to session (maximum 6 hours) Preparation - Regular audit of facilities / practices for preparing medicines in clinical areas - Pharmacy preparation to focus on moderate and high risk injectable medicines, then high volume manufacturing and any remaining capacity for other convenience products. - ALL injectable medicine preparations to be clearly labelled with drug preparation details unless directly prepared and administered - NO addition of injectable medicines to infusion fluids outside pharmacy service - NO use of open bowl techniques anywhere in Derby Hospitals NHS FT - Dose banding for chemotherapy and other dispensed medicines where appropriate, and no commercially available product Checking - Second checking standard for preparation AND administration of intravenous medicines in ALL clinical areas. In process checks documented for high risk products (via worksheet) as appropriate Administration - Needle-free systems for ALL chemotherapy preparation and administration - Labelling of all administration and extension sets (apart from standard peripheral IV lines), multiple lumens, using standardised labels - Early development and adoption of barcode reconciliation for medicines - Full implementation of drug library / guardian software limits in infusion pumps - Evaluate Baxter Guardian software NHS PASA Purchasing for Safety Pilot 31 of 67

32 Training - E-Learning training, information resources and IV nurse champions - Injectable medicines training for medical staff - Maintain Trust wide register for induction and to prompt follow up training Prescribing and Documentation - Incident reporting to be improved for reporting medication errors - All medicines must be prescribed in Derby Hospitals NHS FT - Prescribers aware that they are prescribing medicines with diagnostic tests - All prescribing software to be fully validated and piloted before roll out 10.2 Recommendations for NHS PASA Procurement - Commercial availability of dose banding for cytotoxic chemotherapy and other appropriate products against clear product specification - Ready to administer products for Syntocinon, Contrast media, and other injectable medicines as appropriate (stability, volume etc) - Safety issues core to purchasing decisions in commercial Procurement Hubs Information - Influence MHRA to change labelling guidelines to clearly display essential information on packaging (i.e. prioritise over license / licensee information) - Support and input to the new NHS Injectable Medicines Guide regards commercial availability and purchasing for safety recommendations Administration - Medical devices should be designed with safety at forefront; current safety options are all to often buried under layers of menus instead of being offered as default primary choices NHS PASA Purchasing for Safety Pilot 32 of 67

33 Appendix A - Pilot Project Plan & Phase Timings v1.4 12july2007 PfS Derby Pilot Plan Activities Mobilisation 1 Conduct mobilisation meeting 2 Identify Pilot Project Manager & Pilot Sponsor 3 Identify Pilot Project Board & Project Team members 5 Agree high level plan Planning 6 Confirm dates for pilot weekly review meetings 7 Confirm dates for pilot monthly Project Board Meetings 8Draft PID 9 Draft Governance Structure 10 Draft Risk Register 11 Draft Project Charter 12 1st Project Board Meeting 13 Sign off Derby PID 14 Sign off Governance Structure 15 Sign off Project Charter 16 Implement Risk Register - maintained by Trust Pilot Project Manager and Pilot Facilitator 17 Confirm Project Members and Stakeholders 18 Commence planning of focus groups, meetings & interviews 19 Agree dates, times and venues for Focus Groups 20 Confirm stakeholders for attendance at Focus Groups 21 Develop Stakeholder Plan 22 Develop Communications Plan 23 Draft High Level Plan 24 Sign off Stakeholder Plan 25 Sign off High Level Plan 26 Sign off Communications Plan 27 Issue Pharmex data to Pilot for review Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 11 Week 12 Week 13 Week 14 Week 15 Week 16 %achieved Activity Owner 19-Apr 23-Apr 02-May 08-May 18-May 22-May 06-Jun 05-Jul 31-Jul PASA PASA and Trust Project Manager 100 Trust Project Manager PASA and Project Manager Pilot Project Manager and Pilot Facilitator PASA, Pilot Project Manager and Pilot Facilitator Pilot Project Manager and Pilot Facilitator Pilot Project Manager and Pilot Facilitator Pilot Project Manager and Pilot Facilitator Pilot Project Manager and Pilot Facilitator PASA and Pilot Project Board Members PASA, Pilot Project Manager and Pilot Sponsor PASA, Pilot Project Manager and Pilot Sponsor PASA, Pilot Project Manager and Pilot Sponsor PASA, Pilot Project Manager and Pilot Sponsor 100 Pilot Project Manager 100 Pilot Project Manager and Pilot Project Team 100 Pilot Project Manager 100 Pilot Project Manager Pilot Project Manager and Pilot Facilitator Pilot Project Manager and Pilot Facilitator PASA and Pilot Facilitator Pilot Project Manager and Pilot Sponsor PASA and Pilot Project Team and Pilot Project Sponsor Pilot Project Manager and Pilot Sponsor PASA, Pilot Project Manager and Pilot Facilitator NHS PASA Purchasing for Safety Pilot 33 of 67

34 Week 1 Week 2 Week 3 Week 4 Week 5 Week 6 Week 7 Week 8 Week 9 Week 10 Week 11 Week 12 Week 13 Week 14 Week 15 Week 16 Activities %achieved Activity Owner 19-Apr 23-Apr 02-May 08-May 18-May 22-May 06-Jun 05-Jul 31-Jul FOCUS GROUPS 29 Commence process mapping of procurement & clinical processes N/A Pilot Team 30 Collation and Analysis of Data 100 Pilot Team 31 Review written procedures & protocols with regards to injectable medicines 100 Pilot Team 32 Conduct Focus Groups 33 Write up findings and observations captured from Focus Groups 34 Agreed on the main cases and problems 35 Establish specialised & focussed case studies, teams and analysis plans 36 Develop and agree mini questionnaire for use in meetings & specialised interviews Pilot Team Pilot Team, Pilot Facilitator, Exodus and Project Manager Pilot Team, Pilot Facilitator and PASA Pilot Sponsor, Pilot Project Manager, Pilot Pilot Team and Pilot Facilitator 37 Disseminate and complete mini questionnaire 100 Pilot Team and Pilot Facilitator 38 Collect findings, and analyse mini questionnaires 50 Exodus and PASA SPECIALISED INTERVIEWS 39 Plan and arrange specialised interviews 100 Pilot Facilitator, Pilot Project Manager, Exodus, EDC 40 Conduct specialised interviews 100 Pilot Facilitator, Pilot Project Manager, Exodus, EDC 75 Pilot Project Manager, 41 Capture findings and write up results of specialised interviews Exodus MULTI DISCIPLINARY WORKSHOP 42 Plan and arrange Multidisciplinary Workshop 43 Conduct Multidisciplinary Workshop, process mapping & simulation Findings, Recommendations & Case Study N/A N/A Pilot Project Manager, Pilot Facilitator, EDC Pilot Project Manager, Pilot Facilitator, EDC 44 Finalise analysis cases, and identify further analysis toolkits 45 Complete all analysis toolkits 75 Pilot Project Board, Pilot Facilitator, PASA Pilot Project Manager, 50 Pilot Team and Pilot Facilitator 46 Collect data from manufacturers, suggestions for improvement 47 Review of data 48 Produce summary of findings 49 Prepare and complete case study following pilot completion 50 Formalise reports and agree on improvement and implementation plans Pilot Project Manager, Pilot Facilitator Pilot Project Manager, Pilot Team, Project Manager and Pilot Facilitator Pilot Team, Pilot Project Manager, Pilot Facilitator Pilot Project Manager and Pilot Facilitator Pilot Project Board, PASA, Pilot Facilitator NHS PASA Purchasing for Safety Pilot 34 of 67

35 Appendix B - Pilot Risk Register OWNER : Tom Gray, Pilot Lead & Project Manager, Derby ID 1. Raised By Avril Satchwell (Fowler) Date Raised Issue Type Issue Description Impact Actions Curr. RAG Prev. RAG Due Date Status Owner May 07 PEO Lack of pilot team Pilot may deliver 1. Monitor impact and report Green none Review open AS (F) available resources to project plan any issue to the pilot lead weekly to undertake pilot timescales and pilot sponsor activities. 2. Notify PASA and seek further action advice from PASA Avril Satchwell (Fowler) Avril Satchwell (Fowler) Tom Gray May 07 PEO Lack of availability of Trust staff to attend focus groups and 1-1 interviews May 07 PEO The Trust Chief Pharmacist is taking on 2 roles within the pilot May 07 REP Trust are recieving unwanted media interest in pilot and number of injectable incidents at Derby Poor input from Trust staff may have an effect on realistic Trust benchmarking He may not have sufficient time available to deliver activities within the pilot plan 1. Damage to Trust reputation 2. Impact on other pilot Trusts and PASA 3. Loss of public faith in Trust services 1. Monitor and inform pilot lead and pilot sponsor of any serious impact on the pilot 1. Monitor situation and escalate any increase in this risk 1. Escalate as an Issue 2. Notify PASA of issue 3. Collaborative approach to media communications between PASA and the remaining Trust Pilots Green none Review weekly Green none Review Weekly Amber Green Review weekly Closed Open Open AS (F) AS (F) TG 5. Mark Cannell 5th June PEO Pilot Team do not have the time to undertake the interviews in the time required. The Pilot plan is likely to slip slightly 1. Monitor the situation 2. PASA Project Manager and Trust Pilot Lead are confident that the one week slip will not impact on the final completion date of Phase 1. Green Green Weekly Closed TG NHS PASA Purchasing for Safety Pilot 35 of 67

36 Issues - Guidelines An issue is a problem or question affecting the progress programme now. The issue may be resolved or, in cases where the core team is not able to resolve the issue, the core team must maintain visibility and awareness of the issue ID Issue Type Number assigned to issue using the following convention: Owner initials prefix followed by issue number in issue log e.g. JB/013 PEO: People and Skills ORG: Organisational FIN: Financial TEC: Technical (i.e. methodologies, procedures) REP: Reputational OTH: Other Raised by Name of the person raising the issue Date Raised Date first raised Actions Recommended/ proposed actions. Due Date Expected completion date for proposed mitigation actions Status Open - be clear about what action is required from others Closed - keep for 1 week and then shade grey to show completion Deferred - explain why and when to re-examine RAG Red Typically indicates an issue that need to be escalated to the Consulting Management Team for information / action Amber Typically indicates the an issue that need to be escalated to the Delivery Director for action Green Typically indicates the an issue that can be managed within the engagement team Owner Person assigned to monitor and manage actions. NHS PASA Purchasing for Safety Pilot 36 of 67

37 Appendix C - Governance Chart NHS PASA Purchasing for Safety Pilot 37 of 67

38 Appendix D - Communications Plan Document Pilot Project Board Pilot Project Team Pilot Pilot Clinical Nurse Anaes Med Ass. Dir PASA Pilot Clinical Device Principal Procuremt Sponsor Lead & Risk Clinical Obs & Director Of Project Facilitator Facilitator Training Pharmacist Hub Project Mngr Facilitator Gynae Nursing Mngr Coord. (Purchasing) Liaison Mngr Manager Kay Tom Gill Yvonne Ruth Kathy Ann Lara Avril Lesley Mark Peter Ian Lead Nursing Fawcett Gray Ogden Jackson Broadbent McClean Johnson Qatami Fowler Hancock Cannell Fox Pettit Clinician Midwife Stakeholders Pharmacy Clinician Other Trust PID X X X X X X X X X Executive Summary X X X X X X X X X X X X X X X X X X Governance Structure X X X X X X X X X Risk Register X X X X X X X X X Project Action Plan X X X X X X X X X Trust Project Plan X X X X X X X X X Communications Plan X X X X X X X X X Infusion Device Form X X X X X X X X X X Focus Group Briefing X X X X X X X X X X X X X X X X X X Document Trust Pharmex Data X X X X Project Board Agenda X X X X X X X X X Project Board Minutes X X X X X X X X X X X X X X X X Trust Weekly Report X X Clinical Incident Data & Reports X X X X X X X X X MaPSaF Questionnaire X X X X X X X X X NPSA Proforma 1, 2 & 3 X X X X X X X X X X Current Policies and Procedures X X X X X X X X X X X X X X X X X X Flow Charts X X X X X X X X X X X X X X X X X X Summary Information on purchasing for safety pilot published on Trust Intranet site: NHS PASA Purchasing for Safety Pilot 38 of 67

39 Appendix Ei Reference Materials: Example NPSA risk assessment Step 4 Name of near patient area: THEATRES Name of pharmacist Date of risk assessment: Name of clinical practitioner Product Risk Assessment and Risk Reduction Summary Therapeutic risk Use of concentrate Complex calculation Complex preparation Reconstitute vial Part/multiple container Use of infusion pump/driv Non standard infusion se Unlicensed route Unfamiliar process Total Risk Factors Overall Risk Rating Red = 6 and above, Amber= 3-5, Green= 1-2 Risk Reduction Measure(s) Total Risk Factors Overall Risk Rating, Red = 6 and above, Amber= 3-5, Green= 1-2 Adrenaline Y Y N N N Y Y N N N 4 A Pharmacy manufacture bags (60 micrograms per ml) Reduce risk of use of concentrate (1mg) 3 A Alfentanil Y N N N N Y Y N N N 3 A Prepared in Theatre areas 3 A Alteplase Y Y N Y Y Y Y N N N 6 R Aminophylline Y Y N Y N Y Y N N N 5 A Amiodarone Y Y N Y N Y Y N N N 5 A Pharmacy dispense for individual patient in ready to use form No concentrate, preparation, part container Pharmacy dispense for individual patient in ready to use form No concentrate, preparation, part container Pharmacy dispense for individual patient in ready to use form No concentrate, preparation, part container 2 G 2 G 2 G Atracurium Y Y N N N Y Y N N N 4 A Prepared by Anaesthetist 4 A Bupivacaine Y N N N N Y N N N N 2 G Straight draw up 2 G Heavy bupivacaine Y N N N N Y N N N N 2 G Straight draw up 2 G Calcium chloride Y Y N N N Y Y N N N 4 A Digoxin Y Y N N N Y N N N N 3 A Ephedrine Y N N N N N N N N N 1 G Pharmacy dispense for individual patient in ready to use form No concentrate, part container Pharmacy dispense for individual patient in ready to use form No concentrate, part container Straight draw up, but risk of name selection error with Epinephrine (continue to label with BAN 'Adrenaline') 3 A 1 G 1 G Epidural bags Y N N N N N Y Y N N 3 A Pharmacy standardised infusion products already used in Trust. 3 A Fentanyl Y N N Y N Y Y N N N 4 A Pharmacy pre-filled syringes available 2 G Demonstrating the impact of using ready to administer pharmacy prepared injectable medicines on reducing overall risk NHS PASA Purchasing for Safety Pilot 39 of 67

40 Appendix Eii Reference Materials: NPSA Alert 20 Action Plan NHS PASA Purchasing for Safety Pilot 40 of 67

41 NHS PASA Purchasing for Safety Pilot 41 of 67

42 Appendix Eiii Reference Materials: Risk assessment of drugs identified for ready to use preparation Derby Hospitals - PASA 'purchsing for safety' pilot - injectable medicines Name of near patient area: Various clinical areas Date of risk assessment: July 2007 Name of pharmacist: Tom Gray Chief Pharmacist Name of clinical practitioner Product Risk Assessment and Risk Reduction Summary Therapeutic risk Use of concentrate Complex calculation Complex preparation Reconstitute vial Part/multiple container Use of infusion device Non standard infusion se Unlicensed route Unfamiliar process Total Risk Factors Overall Risk Rating Red = 6 and above, Amber= 3-5, Green= 1-2 Alfentanil Y N N N N Y Y N N N 3 A Prepared as needed in Theatre areas 3 A Amoxicillin intermittent infusion Y N N N Y N N N N N 2 G Not routinely used in DHFT. Use minibag plus 2 G Cefuroxime intermittent infusion N N N N Y N N N N N 1 G Use Baxter 'minibag plus' to administer cefuroxime 1 G Dexamethasone bolus N N N N N N N N N N 0 G Straight draw up for IV bolus. For slow bolus 0 G Ephedrine Y Y N N N Y N N N N 3 A Prepared as needed in Theatre areas 3 A Furosemide bolus N N N N N Y N N N N 1 G May use multiple product if large dose. For slow bolus 1 G Gentamicin bolus Y N N N N Y N N N N 2 G Restricted access / quantity for catheterisation 2 G Gentamicin infusion (dose banded) Y N N N N N Y N N N 2 G Available as pre-made infusion. Improve guideline 1 G Granisetron bolus N N N N N N N N N N 0 G Straight draw up for IV bolus. For slow bolus 0 G Heparin 5000 Unit bolus Y N N N N N N N N N 1 G Use standard loading dose of 5000 Units 1 G Heparin variable rate (500 Unit/ml) Y N N N N N Y N N N 2 G Available as ready to use pre-filled syringe 2 G Hepsal bolus flush N N N N N N N N N N 0 G Not used first line routinely apart from CVADs 0 G Hydrocortisone bolus N N N N Y N N N N N 1 G Low risk simple ward preparation 1 G Ketorolac N N N N N N N N N N 0 G Selection error risk and used peri-opertaively (unlicensed) 1 G Lorazepam bolus Y N Y N N Y N N N N 3 A Standarise dosing guidelines 2 G Metaraminol Metoclopramide bolus N N N N N N N N N N 0 G Higher doses prepared by pharmacy for infusion 0 G Morphine variable dose bolus Y N N N Y Y N N N N 3 A Restrict number of strengths. Provide PFS 1 G Omeprazole bolus N N N N Y N N N N N 1 G Bolus prepared on ward. Infusion (unlicensed) in pharmacy 1 G Ondansetron infusion N Y N N N N N N N N 1 G Usually prepared by pharmacy as small volume infusion 0 G Oxytocin Y Y Y N N Y Y N N N 5 A Prepare in advance (limited stability) but different doses used 5 A Phenylephrine bolus Y Y Y Y N Y N N N N 5 A Prepared as needed in Theatre areas 5 A Propofol infusion Y N Y N N Y Y N N N 4 A Prepared in Theatre, Use Pre-filled syringe to limit preparation 3 A Ranitidine bolus N N N N N N N N N N 0 G Dilute before administration by slow IV bolus 1 G Salbutamol bolus Y N N N N N N N N N 0 G Danger of selection of infusion concentrate 1 G Salbutamol infusion Y Y N N N N N N N N 2 G Prepared by pharmacy. Caution selection of infusion 1 G Sodium Chloride 0.9% bolus flush N N N N N N N N N N 0 G Use plastic ampoules - storage to reduce selection errrors 0 G Sodium Chloride infusion N N N N N N Y N N N?1 G IV checklist to monitor infusion, site, device etc 1 G Suxamethonium bolus Y Y N N N Y N N N N 3 A Prepared as needed in Theatre areas 3 A Vitamin K bolus N Y N N N Y N N N N 2 G Risk of administering whole vial (10mg), normal dose 2mg 2 G Preparation and administration of majority of these injections is already low risk; not priority for pharmacy preparation. NHS PASA Purchasing for Safety Pilot 42 of 67 Risk Reduction Measure(s) Total Risk Factors Overall Risk Rating, Red = 6 and above, Amber= 3-5, Green= 1-2

43 Appendix F - Executive Summary NHS PASA Purchasing for Safety Pilot 43 of 67

44 Appendix G Summary of Feedback from Focus Groups FOCUS GROUP: Maternity Issue Priority Risk to Patient Safety to Staff Risk Safety Process Medical Devices & Consumables Injectable Medicines Knowledge comment Recommendations Process 1. It was suggested that labour ward had the highest incidents of injectable medication errors as the pre and post natal ward do not carry out the same level of usage of pumps, or injectable medication. Pumps and consumables 2. Equipment for infusion not always available. Intervention commenced on labour ward and treatment transferred with patient to post natal ward pump required back in labour ward. 3. Syntocinon no pre made available as no stability. 3 different regimes required for different aspects of care, induction, post delivery and during post partum haemorrhage. During emergency situation 2 preparations are required in different quantities. 4. Skills decay. Devices not used frequently including PCA pumps used only once per week on one patient. 2 2 Need to confirm from medication incident data Need to ensure good representation from labour ward in semi-structured interviews Gill Ogden to review and provide breakdown of errors in Maternity areas Avril Satchwell Fowler to include labour ward 2 2 Need to review transfer process to ensure continuity of care; see Trust Transfer policy. Review access to equipment library for pumps Mark Cannell to follow up as appropriate Currently making up different solutions with different concentrations which increase the risk of error or confusion 3 3 This could be one for a case study This could be an action for the Trust to consider the concentration of syntocinon such that the same bag could be run at different speed during stages of labour, delivery and post delivery. This has been looked at in the past, but warrants review. Action taken to separate bolus and infusion strengths, but agree standardisation of concentration. Lisa Robb to address with Maternity services Consider trained staff facilitators in each area to manage infrequent use. Mark Cannell and Leslie Hancock to review IV training needs NHS PASA Purchasing for Safety Pilot 44 of 67

45 5. Same device used for IVs infusions as per epidurals. Alternative pump available, however maternity staff believe this pump to takes too long to set up. Therefore several actions have been taken to ensure the IV pump for epidurals is clearly labelled and identified with different colour giving set to that used for IVs 6. IV access lines have extension line attached. These increase the dead space between the IV and the infusion. When bolus doses are given the dead space fluid is also primed which gives and overdose of the drug. Medicines 7. Drug cupboard not universally stored. 8. drugs often in different boxes change of manufacturer 9. Hydralazine often cannot be found in a hurry 10. Boxes to be clearly labelled detailing routes not to be administered by. 3 2 This has been reviewed extensively by Risk Management. Action taken to minimise risk, and as part of NPSA Alert 21 Safer Use of Epidural Injections and Infusions. Any further action to be undertaken by Action Group This could be part of a consumables design case study This is obviously and issue for the Trust as a whole Use of extension lines, three way taps, ramps etc add to complexity of infusion system and risk of incorrect administration, incompatibility and confusion. Project team to review as case study in Trust Action plan or case study. This is a significant risk for theatre / critical care areas in particular Pilot team to review as case study for Trust 3 4 As mentioned before Action plan or case study. As in item 20 in Theatres / Imaging feedback. Action pharmacy 3 2 As above. Consider separate area / kit for emergency drugs This could be part of a case study Important development flagging essential information (dose, route, prep, admin etc). Pilot team to review as case study for Trust 11. Pre draw syringes at start of shift 2 2 Action plan. As in items 2,16 in Theatre plan 12. Phenephedrine made up to concentration in a bag and then multiple doses are drawn up for one patient as required. 13. Infusion checklists are available for use in the Trust however these were reported as not being used routinely in maternity. One reason for this was thought to be due to not being commenced in theatre or recovery of 1 2 As per Theatre feedback item 23. Currently requires dilution to appropriate concentration prior to administration of dose. Alternatives under review. 2 2 Action plan. The infusion checklist should be used throughout the Trust to document checks and monitor important parameters for safe IV administration. To monitor incidents via IFSC NHS PASA Purchasing for Safety Pilot 45 of 67

46 patient. 14. Maternity was shown to have a higher than average reporting of needle stick injuries this was reported as being due to a number of suturing incidents which occur during emergency caesarean sections when doctors do not remover their hands in time during the procedure. 15 glass ampoule design is leading to multiple cuts to hands 16. Transfers from other hospitals occasionally are admitted with pumps in progress which are not consistent or cause confusion to Derby Trust staff due to differences. 17. There was a reported blanket usage of Clexane for all post C/S patients which increases the risk of PPH etc Knowledge 18. Timeline of training to next use of equipment 19. Maternity has their own clinical incident reporting system separate to the Trust one. This is in part due to the requirements by CNST 20. High risk drugs often given via a number of different routes, therefore single preparation not applicable. 21. Identification of multiple accesses good practice would be to tuck the epidural route which is not used as frequently under a pillow. 1 2 No further action within this project 1 3 Consider availability of ampoule openers or plastic alternatives to use of glass ampoules 1 3 Trust policy is to transfer patient to DHFT approved administration equipment on arrival. May require new infusion to be prepared by pharmacy. 2 2 This is a quick win for the Trust and should be part of an action plan. VTE guidelines currently under review by Trust clinical committees. Audit use against documented assessment and clinical guidelines. Action: Directorate 2 3 Case study As in item 15 theatres feedback decay of knowledge and competency. 1 2 Mandatory requirement. Concern that current standardised incident reporting form is less effective for medication errors and analysis of root causes. Review by Risk Management. 2 3 As in item 10, could be included within essential information flagged to product. Pilot team to review as part of case study 3 2 These need to be clearly labelled / identified. Agree protecting epidural access will reduce risk. Anaesthetists to agree as standard practice across Division. NHS PASA Purchasing for Safety Pilot 46 of 67

47 FOCUS GROUP: Chemotherapy Issue Priority Risk to Patient Safety to Staff Risk Safety Process Medical Devices & Consumables Injectable Medicines Knowledge comment Recommendations Process 1. Chemotherapy Suite has undergone teething problems with their new e- prescribing management system (CCIS) implementation was found to be problematic. Data from the system was also found to be problematic regimes were inaccurate. 2. BSA checks are often either absent or inaccurate clinical staff often rely on these lack of re checking process 3. Within the full clinical process there is a lack of checking for errors in data This one could be considered as one of the case studies as work with the supplier would improve efficiency and reduce errors although this is not a national application as part of the National Programme for IT Poor implementation and a lack of process for validation has resulted in errors, some of which reached the patient. This is an internal concern regards systems and accountability and does not need to be reviewed as part of the project. However, there are aspects that might be appropriate to feedback to Compucore and Connecting for Health for future development. Colin Ward to develop validation process Colin Ward to progress any issues to CfH, CCIS 3 1 Quick Win Trust should consider implementing a policy of checking the recorded BSA within the clinical pathway. BSA is routinely checked and recorded but not always updated regularly resulting in too high (or low) a dose being prescribed. CCIS automatically calculates dose from BSA. Chemotherapy staff to check Ht/Wt each cycle to calculate BSA 3 3 Old MAISY - medical Audit and Information System (predecessor to CCIS) had limited functionality and checks. CCIS is much more advanced with additional checks. NHS PASA Purchasing for Safety Pilot 47 of 67

48 4. Chemotherapy has introduced a hairdresser chair system which has improved their capacity issues. Pumps and consumables 5. The Trust currently has approximately 5% of its chemo drugs dose banded there is the possibility of increasing this to 25% 6. Needle free systems are used throughout the chemotherapy areas however there is some inconsistency on the wards where chemo is only occasionally given. In these areas the risks are greater. 7. The Trust guideline for spiking Fluid bags containing chemo is to spike at waist level to reduce the risk of spillage in the face. Other fluids and areas in the Trust do not undertake this practice therefore the risks remain for non chemo products and elsewhere in the Trust. 8. Elasomeric Device unable to match the delivery pressures of other pumps. 9. The design of some syringes makes it difficult and impractical to use. e.g. 50mls syringes are too big to handle, often the plunger falls off the end. The Trust has a workaround process of only filling syringes to 40ml maximum. 1 2 This has allowed better planning of treatment and control of capacity in pharmacy satellite and chemotherapy suite This could be a good case study dose banding reduces time preparing drugs, contamination issues Is there a case for needle free systems through out the Trust for all cases not just chemo? If so then this could be a case study 1 2 What is the national policy for this is there one? 2 2 Could this be a case study? 1 1 Could this be one case study to look at design of syringes another issue was also clear marking of and consistency of graduations This has already been identified as a project task by the Project Board and at national level after presentation by Colin Ward (Cancer Network Pharmacist). Colin Ward to progress at local & national level together with PASA project team Quick win for the Trust Needle free system to be mandatory for all chemo drugs. Trust to put in process, policy etc to ensure all ward areas adhere to this level of safety. To be applied across all ward areas using chemotherapy (including non-cancer areas) Consider alternative devices e.g. Mito-in, Tevadaptor for some non-cancer areas) Jenny Sidle to progress via Network Delivery Quick Win Trust should consider changing the Trust guidance policy for connection of IV fluids. Good practice recommendation. Stephanie McCarthy & Practice Development Community to take forward in policy and procedure. Approve through IFSC. This is a recognised problem with elastomeric devices; alternatives are being considered. Chemotherapy team to review alternatives Standard practice within chemotherapy areas to only fill 50ml syringe to maximum 40 ml to ensure syringe integrity and safe handling. All syringes are standard graduation in millilitres (one episode where US syringes obtained with dual graduations in fluid ounces alert issued and removed from stock). No further action. NHS PASA Purchasing for Safety Pilot 48 of 67

49 10. Delivering drugs as a bolus has many benefits it reduces the risk of tissue damage, and provides the clinical staff time to talk to the patient which is often neglected, can even save time as pumps can cause tissue damage by the time they alarm, or they are time consuming due to alarms keep activating with no identified cause, vital information from talking to the patient is not recognised. Medicines 11. Pre prepared bolus drugs would be welcomed. 12. Intermittent infusions -?increase risk of iatrogenic infection 13. Bedside medicine cabinets are not correct size to hold all types of medication and quantities. 14. Multi dose preparations increase risk of contamination and error. These include Insulin and heparins This could be a case study into bolus versus pumps and the pros and cons of both. What is the idea solution? Vesicant drugs are routinely administered from pre-filled syringes given by slow manual bolus. There is a case for bolus administration of all IV drugs, although not all are suitable (due to volume, concentration, stability, convenience). It would be interesting to study impact of bolus versus minibag plus intermittent infusion on nursing time, patient satisfaction, phlebitis rate. Bolus administration is considered low risk and preferred route in some literature e.g. Use of IVs in near patient areas (NHS Scotland 2002). Pilot Board to take forward as case study * Staff to identify top 5 drugs they would like pre made ready to administer. 2 1 Need to review evidence for this if closed system (e.g. minibag plus). Stephanie McCarthy to review literature 2 3 Injectable medicines should not routinely be held in bedside lockers (TTA medicines only). Under review as part of RHS development 4 3 This could be a case Multidose vials are not routinely used in Trust study. To look at and have been withdrawn from general areas ways to prevent multi as infection control hazard. Vials of insulin are dose preparations for Named Patient use and are labelled. Pharmacy review supply of multi-dose vials Knowledge 15. Mandatory training for all staff. 1 1 Chemotherapy training well established 16. Training for non-chemo cancer areas (see item 6 and 7) 17. The introduction of higher network level committees has led to perceived loss of local initiatives and innovative approaches to practice This could be a case study as training could be provided by supplier of products to non chemo units Quick Win Trust to consider reviewing training. Most non-cancer areas using cytotoxic chemotherapy e.g. urology and rheumatology have training programmes. Review training in renal services Cancer Network Delivery Group does not address non-cancer areas / concerns. Need to reconsider Trust oversight of these areas. Tom Gray to review oversight of non-cancer areas and framework for development. NHS PASA Purchasing for Safety Pilot 49 of 67

50 FOCUS GROUP: Theatres and Imaging Issue Priority Risk to Patient Safety to Staff Risk Safety Process Medical Devices & Consumables Injectable Medicines Knowledge Comments Recommendations Process 1. Theatre patients many do not have their drugs prescribed before administration. 2. Staff are often distracted in theatres whilst preparing drugs as in many cases this is done before the patient arrives therefore others do not see the potential risk in distracting the preparer. 3. Insufficient information on how to prepare IV drugs with the correct concentrations of diluents. There is some direct pharmacy support to theatres through satellite facility in theatres at DRI site. 4. There is as reported lack of checking such as routine U&Es prior to treatment within imaging this could lead to a risk of renal failure when drugs are administered * 2 2 * * This process might be worth while the Trust evaluating will do as part of observation of practice, and Tom Gray to discuss with the Anaesthetics Division on 17 July * Is this one which could be a case study looking at what drugs are prepared before the patient arrives, how they are labelled and distractions whilst preparing Could the information for use from manufacturer be a case study. Designing easy and quick to read prep details. Distractions are a significant risk and common cause of error, especially where no double checks. Recommend that injectable medicines process is reviewed in theatres to identify who does what and when. Tom Gray / Susanna Piggott / Jenny Cuttell to review typical session. What is prepared pre-op, how and by whom? Does this meet legal / practice standards? What checks are in place for preparation? What is wasted? Recommend extension of monographs used in other Critical Care areas (e.g. ITU) to guide preparation and administration of complex injectable medicines. Consider simple worksheet to document in-process checks for high risk preparations, and for use by other theatre staff e.g. Operating Department Practitioners (ODP) Stuart Parkes / Jenny Cuttell to progress * 4 3 This is a quick win the Trust should consider reviewing the process and knowledge of staff to treat prior to correct tests being performed. Consider as a part of authorised request, along with explicit detail of what drugs may be administered as part of imaging procedure. Tom Gray / Sue Johnson to progress NHS PASA Purchasing for Safety Pilot 50 of 67

51 5. Many drugs in imaging are often prepared and checked by nursing staff and administered by medical staff who were not part of the checking process. 6. It was suggested that many doctors when ordering tests are not informed or aware of the inherent administration of drugs to undertake the investigation some of which may have adverse effects. 7. Coloured syringes are used to identify which drugs are which these are not always labelled also 8. The process of drawing up multi dose solutions of imaging preparations is undertaken using an open bowl technique. Where multiple doses can be drawn up from this solution. Equipment 9. Contrast injectors (pumps) are known to be different on both sites 10. Fluid administration sets in theatre on many occasions blood giving sets are used despite the patient not requiring a blood transfusion 11. Staff highlighted their experience in shortage of volumetric pumps 2 3 Quick Win The Trust should consider the process and staff knowledge of principles in preparing and administering medications. Consider second checking of all intravascular contrast media, by nurse or radiographer. Sue Johnson / Joy Trenchard to progress * 2 4 As in 4 above. Prescriber must be made aware that they are authorising administration of a prescription only medicine as part of a procedure. Administration recorded in CRIS. (Computerised Radiology Information system). Currently not on paper request forms or in electronic requests via CRIS 2 3 All syringes containing drugs must be labelled. Consider use of coloured syringes for other high risk injectable medicine procedures in Trust e.g. intrathecal injections; (note purple oral syringe). IFSS to consider and recommend to MMC Could this be a good case study to identify new processes and order dilatants which are pre-prepared? This is a high risk area, recently reported in the literature along with case report from USA resulting in patient death. Recommend observation of practice and discussion with radiologists and other clinicians re alternative delivery e.g. multiple pre-filled syringes drawn up pre-procedure (as in operating sessions). Tom Gray / Sue Johnson to progress 1 2 Recommend only staff trained and competent in use of specific imaging and injecting equipment should use that equipment. Sue Johnson / Joy Trenchard to maintain list 1 1 Recommend review alternative wide bore set for routine use where blood transfusion unlikely for cost-effectiveness. Mark Cannell to assess alternatives and make recommendations 2 1 Theatres manage their won equipment, which is not generally part of equipment library. Mark Cannell to review availability / further resource NHS PASA Purchasing for Safety Pilot 51 of 67

52 12. The style, size and measure markings on Syringes were commented on not being clear enough or have the manageable graduation marks on them. 13. There was a reported shortage of TCI /TIVA administrator pumps in theatres 14. PCAs are used in imaging on rare occasions with no training 15. Training knowledge decay was reported. Staff in theatre reported that from training to use of equipment knowledge is often lost. They reported the most knowledgeable person around pump usage was sited as the recovery staff. Injectable medicines 16. Staff reported the need for preprepared syringes 17. Central versus peripheral information on usage is often poor. 18. Bupivicaine was reported to be confusing when calculating usage. 2 1 This could be a good case study looking at design of syringes and labelling etc. Standardised syringes in a range of sizes are available and used routinely. Pharmacy products are prepared in BD syringes (stability data). Could be considered along with 7 above. 1 1 Only approved pumps should be used in the Trust. Some products require administration using specific equipment, this should be approved by IFSS. 3 3 No equipment should be used in areas / by staff not trained or conversant in its use. Mark Cannell to follow up / train as appropriate * 2 3 Could this be a good case study looking at training versus the frequency of use of equipment and should someone more familiar with equipment be responsible for setting pumps throughout the Trust. This ties in with the number of pump errors. The Project Board have highlighted training as a key project area. Retention of knowledge and familiarity of equipment is a particular challenge and warrants a full review to look at approaches to maintaining this, and may include: Training updates Regular documented, observed practice Training champion within each area Mark Cannell to undertake review and make recommendations to maintain competency. * 2 2 Staff are to site the Top 5-10 drugs they would like to see pre-prepared. To risk assess this list against NPSA criteria and consider expanding the range of pre-filled syringes from pharmacy or commercial sources, where appropriate. Tom Gray / Directorate Pharmacists to risk assess and advise on alternative availability. 2 2 Consider clearer guidance for administration of medicines via central venous access devices. Jenny Sidle to review and progress guidance 2 2 Review products available and clinical use i.e. dose required, route of administration etc. Stuart Parkes to recommend alternatives. NHS PASA Purchasing for Safety Pilot 52 of 67

53 19. Poor labelling of expiry dates on medications. 20. It was reported that sometimes the manufacturer of products are changed due to national shortages which changes the size, colour and other packaging details which sometimes leads to confusion. And an added risk of giving the wrong medication in an emergency and the ability to store in the usual place in the drug cupboard which is sometimes dictated by size of packaging. 21. It was reported that in theatre each of the theatres store their medication in different places within the drugs cupboards this leads to not being able to locate medication when staff use other theatres. (non standard) 22. Some products look similar and are therefore at risk of being given in error. These were reported to be saline and lignocaine and adrenaline. 1 1 This is yet another example of design issues which could lead to risks this would be a good case study for the Trust Not just expiry dates, but information on vials and ampoules of parenteral products. Currently being reviewed by NPSA and Design College to make recommendations to MHRA / Pharma industry. Consider feeding into NPSA findings. All products should be carefully checked and stored in original packaging to aid identification A number of errors have occurred due to lack of availability of English language product information with imported products. Although not explicitly identified, it is likely that changes in product packaging may have led to product selection / administration errors. Evidence from internal pharmacy error reporting systems, identifies this as a risk in dispensing. Most products purchased on contract and these issues are considered at procurement stage. Need to draw up criteria for information update to Trust on new products, and triggers for Medicines Alert when significant risks identified. Peter Fox to progress via Procurement focus Gp This reflects poor medicines management by theatre and pharmacy staff and risks confusion, wastage and selection errors. Pharmacy to work with theatre staff to optimise theatre stock lists and locations to ensure risks minimised, whilst maximising availability. Peter Fox to review with Catherine Haslam and Theatre team rearrange and audit to standards 1 2 This could be a good one goes back to the design of products and packaging. Significant work has already been done to minimise risk through change in vial sizes, keeping in original packaging and use and lose policy see Medicines Updates. Catherine Haslam to review and enforce in theatre and imaging areas. NHS PASA Purchasing for Safety Pilot 53 of 67

54 23. Some drugs were reported as not being available in sizes which are typically administered. E.g. Phenylephrine - inappropriate concentrations 24. It was reported that Heparin loading doses often cause confusion in the preparation of this drug due to the need to use weight as a measure in the calculations. kg/ concentration conversion causes problems and calculations Knowledge 25. Knowledge decay was sited as an issue when preparing pumps and deciding on medication regimes. 26. Staff reported that medical reps continue to visit the clinical areas in an uncontrolled manner and offer free trial of products. Incidents 27 Staff reported the lack of availability of specialist pumps 1 2 Design and content of available injectable medications. This is again an example of design. This is a common problem and well documented particularly in paediatric medicine, where few appropriate paediatric formulations are available. PASA, along with NPSA need to press manufacturers and MHRA to require appropriate formulations. Peter Fox to see if alternative for Phenylephrine * 3 2 Heparin (and LMWH Enoxaparin) are high risk medicines and in top 10 for drug errors (this is in line with national NRLS data and focus of NPSA alert). Usual standard loading dose for adults is 250 Units per kg, rounded to 5000 Units, and administered from 5000 Unit per ml vial. Jane Lawrie to progress as part of NPSA Alert 18 Action Plan for IV Heparin preparations 2 3 A Quick Win for the Trust would be to evaluate the need and appropriateness of equipment usage guides on the equipment and availability of laminated guidelines for quick reference in the clinical areas. As in 15 above. Mark Cannell to review and progress 1 1 A Quick win for the Trust would be to consider their policy around medical representatives and the trialling of new products. Policy to be reviewed in line with ABPI policy Tom Gray to progress via D&T and MAC 1 2 Regularly reviewed via IFSS, and reports demonstrate significant reduction in issue. NHS PASA Purchasing for Safety Pilot 54 of 67

55 28. Staff reported that feedback from incidents which they reported was poor and could have an impact on future reporting of incidents. 29. Staff reported issues with the style and format of the Trust incident reporting forms. Much of the information is not relevant for all cases. This leads to the forms not being correctly completed and hampering any investigations due to poor information 1 2 This could also be a case study looking at the system and whether the system could incorporate an automatic ing of entry and any incident investigation outcome The Trust could review their process around offering acknowledgement of completed incident forms and any outputs of incidents investigated. A common complaint. Gill Ogden to review via Risk Management * 1 2 Quick Win for the Trust to review its incident reporting forms Consider web-based reporting into Datix to reduce delay and ensure completion of form Gill Ogden to review via Risk Management 30. Staff reported that the incidents of needle-stick injuries continue. This could be seen as ampoule design, inappropriate placement of sharps bins or poor technique in preparing medications. 1 2 This could be a good case study looking at what can be done to reduce the number of needle stick injuries. Consider as part of observation of practice and training in parenteral therapy and infection control. Consider use of needle free systems in other areas using high risk drugs / techniques 31. Spraying from, needles / luer connectors 1 1 As 30 above Mark Cannell and Leslie Hancock to review and make recommendations to minimise risk and business case for use of needle-free systems. NHS PASA Purchasing for Safety Pilot 55 of 67

56 Appendix H Staff Electronic Questionnaire NHS PASA Purchasing for Safety Pilot 56 of 67

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