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National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines, August 2010 Submission to the Australian Commission on Safety and Quality in Health Care 9 August 2010 Contact details: Diana Shipp Project Officer NSW Therapeutic Advisory Group (NSW TAG) Email: [email protected] 1 NATIONAL INJECTABLE LABELLING PROJECT National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines (August 2010): FINAL REPORT 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Executive Summary Background Aims, Development and Outcomes 3.1 Project Aim 3.2 Project Development 3.3 Project Outcomes 3.4 Key Findings 3.5 Project Recommendations Project Team and Advisory Committee Membership 4.1 NSW Therapeutic Advisory Group (NSW TAG) Project Team 4.2 Advisory Committee: National Injectable Medicines Labelling Project National Consultation Label Production 6.1 Initial scoping and engagement 6.2 Label proof development 6.3 Sterile label production 6.4 Bag/burette additive label visibility 6.5 Education support Pilot Testing 7.1 Engaging pilot test clinical areas 7.2 Establishing the pilot test 7.3 Current practice survey 7.4 Pilot test site visits 7.5 Pilot test follow up 7.6 Education in pilot test clinical areas Project Extensions 8.1 Extending beyond AS 4940 and pilot testing 8.2 Extension to include the sterile field 8.3 Ethics approval Finance Summary Project Timeline Reference of Electronic Files The National Labelling Project National recommendations for user-applied labelling of injectable medicines, fluids and lines (August 2010) Education support - PowerPoint Presentation - Explanatory Notes - Poster: A3 Label Guide – All Labels - Poster: A4 Label Education Posters Implementation Guide 2 1. Executive Summary Safe use of medicines is fundamental to Quality Use of Medicines which underpins Australia’s National Medicines Policy. Labelling of injectable medicines and fluids, and the devices used to deliver these, is a recognised patient safety issue. In Australia, guidance on appropriate labelling of injectable medicines is inconsistent. To improve practice relating to administration of injectable medicines, the Australian Commission on Safety and Quality in Health Care (ACSQHC) funded national consultation and pilot testing of a draft set of recommendations developed by NSW Therapeutic Advisory Group (NSW TAG) Safer Medicines Group. NSW TAG undertook the project to develop ‘National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines’, with funding and support from ACSQHC. The project, known as the National Injectable Labelling Project, commenced in February 2009 under a formal contract and has concluded within the agreed timeline and budget. The project has resulted in standardised ‘National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines (August 2010)’ for use in all Australian hospitals and facilities where injectable medicines are administered. This final report describes the development process, key outcomes and recommendations. All resources to facilitate implementation of the Labelling Recommendations, including implementation advice and educational materials are provided. The success of the initiative will depend on mandatory implementation and provision of resources for education and label procurement. Following implementation the Labelling Recommendations are expected to result in minimal impact on workflow. Ongoing use will inform quality improvement monitored through change register feedback. Electronic files accompany this report. They are listed on page 14. 2. Background The labelling of injectable medicines and fluids during their preparation and administration, and the labelling of devices used to deliver these, is a major patient safety issue. The incidence of errors in administration of injectable medicines is higher than with other forms of medicine. Multiple manipulations required to prepare the injectable medicine combined with inadequate or absent labelling are major contributors to errors. The potential for errors related to injectable medicines is recognised on a national and international level. International organisations (including the World Health Organization, National Patient Safety Agency in the United Kingdom, the Joint Commission in the United States and the Institute for Safe Medication Practices in the United States and Canada) have made recommendations for safe labelling practices, including the recommendation to standardise labelling of injectable medicines and administration lines. Two Australian Standards apply to labelling of injectable medicines AS 4940 and AS/NZS 4375. However, they have limited scope in relation to detailed guidance for best practice in this area. NSW TAG and NSW TAG Safer Medicines Group developed draft ‘Parenteral Medicines, Fluids and Lines: Labelling Recommendations (August 2008)’ to provide a means of improving patient safety relating to administration of injectable medicines. The draft Labelling Recommendations underwent a wide, multidisciplinary consultative process within NSW. They encompass existing Australian Standards pertaining to labelling, go beyond these standards and represent a significant change to clinical practice. In February 2009, ACSQHC and NSW TAG agreed to collaborate to develop national recommendations for user-applied labelling of injectable medicines, fluids and lines in Australia. These recommendations would be based on the draft “Parenteral Medicines, Fluids and Lines: Labelling Recommendations” developed by the NSW TAG Safer Medicines Group (August 2008). Initially developed for use in NSW; the principles within the recommendations apply across Australia. NSW TAG took the draft 3 recommendations through a series of reviews designed to incorporate expert opinion, gain support from all relevant peak professional bodies and utilise insight from practical application. The final National Labelling Recommendations (August 2010) offer a practical initiative for public and private hospitals to review relevant policies and procedures, and improve patient safety in relation to administration of injectable medicines. 3. Aims, Development and Outcomes 3.1 Project Aim The aim of the project was to develop a national set of recommendations for user-applied labelling of injectable medicines, fluids and lines in Australia based on existing Australian Standard AS 4940: Userapplied identification labels for use on fluid bags, syringes and drug administration lines. The Labelling Recommendations promote safer use of injectable medicines through: Standardised user-applied labelling of injectable medicines; and Minimum requirements for user-applied labelling of injectable medicines. 3.2 Project Development The project development process (outlined in detail in sections 4 – 8) included: Establishment of a multidisciplinary expert advisory committee Consultation with all state and territory health jurisdictions and 13 national peak professional organisations Revision of the draft recommendations Development and production of draft labels together with education tools for their implementation Ethical approval (where relevant) Pilot testing of draft recommendations and labels in 12 different clinical areas at 8 sites across Australia, including testing on the sterile field A survey of labelling practice, pre and post pilot testing Refinement of the draft recommendations based on test feedback. 3.3. Project Outcomes 1. ‘National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines (August 2010)’ 2. Education support Explanatory Notes A3 Label Guide – All Labels A4 Label Education Posters Slide Presentation 3. Implementation Guide The following benefits resulting from these outcomes are proposed: Consistency and standardisation for user-applied labelling across Australian hospitals A reduction in wrong route errors, particularly when multiple medicines administered Improved line identification when multiple lines are in use Improved safety at staff shift changes/clinical handover Improved safety for patients 4 3.4 Key Findings 3.4.1 Overarching Principles The Labelling Recommendations gained ‘buy-in’ by nursing staff in the 12 pilot test clinical areas covering a diverse range of clinical areas and hospitals across the country. The impact on workload is minimal following implementation (i.e. after education, selection and procurement). Labelling to identify lines (administration and invasive monitoring lines) is a change in practice for the majority of clinical areas tested and potentially assists in prevention of tubing misconnection errors. Labelling to identify medicines on the sterile field in operating rooms and other clinical areas administering medicines on the sterile field represented a change in practice. In operating rooms this potentially prevents errors relating to incorrect identification of medicines in jugs, basins and syringes used by scrub/scout nurses. The Labelling Recommendations potentially assist in preventing medicine administration error. This will require ongoing monitoring and assessment. Increased staff acceptance of user-applied labelling in the clinical setting. Minimal impact on daily workflow once Labelling Recommendations were in place. 3.4.2 General Labelling - Colour Colour coding labels according to route assists route recognition. Apply colour to the entire route identification label to maintain visibility. For bag labels visibility is a priority. Test hospitals have provided feedback on the test label vs. a full blue label, ‘IV labelling alternatives 8 June 2010’. Process Blue is prescribed in AS 4940. However, to provide visibility and readability of black text on blue a lighter tone of blue (PMS 2985) is used; 100% on borders and 70% on background. Colour ‘miscellaneous’ route labels pink to ensure whole label is visible, to promote correct label selection and assist differentiation from other labels. White is prescribed in AS 4940. The test did not include labels to identify the line for continuous infusion via a miscellaneous injectable route. The omission is addressed but the label untested. 3.4.3 General Labelling – Size No clear indication of preferred size due to variability in syringe sizes in use. Simplification of the label selection process by providing 2 sizes of container labels for use on either syringes or bags is possible as the information required for syringe and bag labels is nearly identical. 3.4.4 General Labelling – Content Diluent to be retained on bag/bottle and syringe labels. The base fluid can be identified from the fluid bag. However, ensure label is compatible with use on 50mL syringes for infusion by including diluent. Include the amount of medicine, total volume and expression of concentration on bag, syringe and burette labels, with prompts for units. 3.4.5 Items to be Labelled Retain labelling of bags and bottles with additives for infusion Retain labelling of syringes for bolus use and infusion Retain labelling of burettes for intravenous (IV) infusion Retain labelling of containers (e.g. jugs and syringes) on the sterile field Pre-printed labels to be included in recommendations as a more practical alternative for the labelling of syringes containing 0.9% sodium chloride Retain line labelling to identify for route Lines with a continuous infusion to be labelled for medicine content - retain black on white medicine label as tested Keep medicine/route labels separate to provide flexibility Route label includes a prompt for line change. 5 3.4.6 Label Placement Label front of bags. Ensure fluid name, batch number and expiry date remain visible Label syringes parallel to long axis of syringe barrel, flush with graduations. Flag labels for smaller syringes Label lines near the injection port on the patient side. Place label far enough from injection port to a) not interfere with mechanics of bolus administration and b) not introduce infection. Exceptions: Young children and patients that may tamper with label – place label near source. 3.5 Project Recommendations 3.5.1 Key Recommendations Mandating the Labelling Recommendations This is essential to ensure uptake and compliance. The Labelling Recommendations provide a set of minimum standards and represent a change in practice to a greater or lesser extent depending on current practice in each facility. Pilot testing the Labelling Recommendations was relatively straightforward with ‘buy-in’ via expressions of interest including authority to proceed within each facility. With no mandate, feedback from pilot testing indicates a lack of uptake. Adequate resources are required for: o Procurement of printed labels in line with the Labelling Recommendations o Implementation of the Labelling Recommendations through education. Label procurement requires a three-step process by each facility: 1. Establish the exact requirements, i.e. type of labels anticipated to be used at ward level. 2. Central supplies to seek quotes from label production companies to provide the required label types in quantities suitable for use by each ward/facility. 3. Purchase appropriate quantities of necessary labels for distribution to each ward/facility. This approach requires duplication of effort within a hospital and again within an area and State/Territory. A central approach to establishing label requirements across facilities and obtaining quotes from label providers would reduce duplication. In addition, economies of scale would reduce costs of printing larger quantities of labels. Current practice for ordering ward supplies could extend to reordering labels once the Labelling Recommendations are established. Implementation of the draft Labelling Recommendations in pilot test clinical areas was facilitated by provision of printed labels to be tested and an education package. The education in the form of slide presentation and label guide was tailored by each facility to suit local requirements. This was a straightforward process and the pilot test has informed the provision of these materials as described in 3.3 Project Outcomes. Policy and procedure revision to accommodate Labelling Recommendations will be required at every level, e.g. institution, area and State/Territory. Development of a timeline and provision of adequate resources is necessary for this process. 3.5.2 Labelling Recommendations Rollout Hospital-wide implementation from the outset will facilitate staff awareness for the patient ‘journey’ through the hospital. Alternately, a staggered rollout across the hospital could be adopted. In this case, communication between areas is essential to ensure the new labelling is recognised and understood across the health facility not only those areas where the Labelling Recommendations are introduced. This would: Assist staff working across more than one area Ensure smooth transfer of patients between wards Avoid unnecessary reissue of existing infusions. 6 Ongoing audit and feedback of Labelling Recommendations uptake at all levels e.g. institution; area and State/Territory will support implementation 3.5.3 Labelling Recommendations Feedback A change practice register posted on the ACSQHC website should be maintained to capture feedback and log implementation issues from: Clinical staff in hospitals Hospital governance committees State and Territory health jurisdictions and peak professional bodies. This register will inform ongoing review. This is particularly important as the draft Labelling Recommendations tested were modified following pilot testing and labels devised in relation to the revised and issued Labelling Recommendations are untested. Once sufficient facilities are using the Labelling Recommendations and detailed feedback is obtained a ‘Frequently Asked Questions’ section with answers posted on the ACSQHC website would assist facilities with less advanced implementation and reduce the resources required by the ACSQHC clinical support team. 3.5.4 Labelling Recommendations Audit An audit of incident management systems relating to administration of injectable medicines is proposed after a 12-month period with the Labelling Recommendations in place across a whole facility. Comparing these data with a baseline audit of data collected in the preceding 12-month period will give an indication of any difference in the numbers of errors arising due to injectable medicine administration. These data combined with a qualitative analysis to establish how the Labelling Recommendations may or may not have influence these figures could be collated and used with the information obtained by the change practice register to inform any modifications of Labelling Recommendations. 3.5.5 Liaison with key stakeholders with associated with safety of injectable medicines Australian Standards: Report findings on the use of the Australian Standard 4940 in clinical practice (Refer to ‘Australian Standards comparison’) and the evidence based approach of the National Injectable Labelling Project to establish practical recommendations, retaining the principles and key features of AS4940 as far as practicably possible. Baxter Healthcare: Orange additive labels are supplied free of charge by Baxter for all bags and syringes. Continued supply of Baxter labels represents a direct conflict with the Labelling Recommendations and liaison with Baxter over future supplies will be necessary. I-Flow Corporation (PainBuster manufacturers): Liaise regarding supply of labels supplied with accompanying these devices in Australia and compatibility with Labelling Recommendations. Sterile label manufacturers & sterile procedure pack manufacturers: In some facilities labels are provided with administration or monitoring lines in sterile packs. E.g. yellow epidural labels with epidural administration lines and red intra-arterial labels with intra-arterial monitoring lines. The labels are not required to be sterile but are provided for application after line insertion. These labels are not standardised between providers and communication with sterile pack providers will be necessary to ensure the pack contents are consistent with the Labelling Recommendations. Emergency medical services providers: To address local policy around medicine identification in an emergency in relation to the Labelling Recommendations. Waste management system providers: Retaining patient confidentiality when disposing of containers (e.g. syringes and bags) displaying patient identification details is necessary. All clinical waste with patient details will require incineration. Syringes and bags not labelled with patient identification can be discarded in the cheaper to dispose general waste. This has potential to increase costs for waste 7 management. Removing labels prior to disposal (placing the label in clinical waste and syringe in general waste) may reduce costs, but staff safety in areas where safe ‘sharp’ removal is not available must not be compromised. 3.5.6 Special considerations for rural/remote facilities: Implementation through education across rural/remote areas could be managed through: A cascade education process via regional centres, to rural hospitals, to GP clinics, including health centres operated by non-medical staff. A combination of teleconference and DVD with voiceover. An electronic audit of education feedback to monitor uptake. Procurement and supply support for smaller rural hospitals is critical to ensure implementation and continued compliance. Smaller rural hospitals may not use sufficient labels to justify independent supply. 4. Project Team and Advisory Committee Membership 4.1 NSW Therapeutic Advisory Group (NSW TAG) Project Team NSW TAG is an independent, not-for profit association of clinical pharmacologists, pharmacists, nurses and clinicians committed to promoting quality use of medicines (QUM) in NSW public hospitals and the wider community. NSW TAG focuses on providing information, advice and support to decision-makers in NSW public hospitals, the NSW Department of Health and other relevant organisations. The NSW TAG project team: Ms Diana Shipp Dr Jocelyn Lowinger Mr David Maxwell 4.2 Advisory Committee: National Injectable Medicines Labelling Project A multidisciplinary Advisory Committee representing 4 relevant clinical disciplines (anaesthesia, nursing, oncology and pharmacy) provided expert opinion during development of the Labelling Recommendations. The Advisory Committee oversaw all project activities under ‘Advisory Committee Terms of Reference’ to ensure a practical set of final recommendations: Professor Alan Merry (Chair) Professor of Anaesthesiology University of Auckland Dr Kay Price Senior Lecturer, School of Nursing and Midwifery University of South Australia Ms Josie Quin Medication Safety Officer, High Risk Medications and Systems Safe Medication Practice Unit, Queensland Ms Christina Crosbie (from 25 May 2009) Clinical Nurse Manager, Haematology Care Centre Sir Charles Gairdner Hospital Ms Julianne Bryce (from 31 July 2009) Senior Federal Professional Officer Australian Nursing Federation Mr Graham Bedford Policy Team Manager Australian Commission on Safety and Quality in Health Care Ms Diana Shipp Project Officer NSW Therapeutic Advisory Group For full titles and affiliations refer to Appendix 3: Labelling Recommendations. 8 Mrs Susan Hyde, Nurse Practitioner Haematology, Sir Charles Gairdner Hospital participated on the Advisory Committee until the second meeting. Mrs Hyde moved to a new post in Western Australia and resigned from the committee. Ms Christina Crosbie joined the committee at this time. Ms Julianne Bryce joined the Advisory Committee from the 4th meeting. It was concluded after meeting on 31 July 2009 that engagement of nursing staff is pivotal to the project and additional support from a nursing peak professional body would provide an additional constructive perspective. The Advisory Committee operated under Terms of Reference (See ‘Advisory Committee – Terms of Reference’) and met on 6 occasions (via teleconference unless otherwise stated) to review project development. For minutes of these meetings refer to Minutes as dated: 25 March 2009 25 May 2009 (face to face, ACSQHC offices) 31 July 2009 30 September 2009 9 February 2010 16 June 2010 (face to face, Qantas Meeting Rooms, Sydney Airport) The Advisory Committee has reviewed the Labelling Recommendations document and relating label artwork. They have been kept informed of project developments and have responded to requests for assistance during intervening times. 5. National Consultation In the first phase of the project, a detailed review of draft Labelling Recommendations (August 2008) and resulting opinion was sought from: All State and Territory Governments All State and Territory Safer Medicine Groups The Council of Australian Therapeutic Advisory Groups and the following national professional bodies: Australian and New Zealand College of Anaesthetists (ANZCA) Australian and New Zealand Intensive Care Society Australian Nursing Federation APHS (Australian Pharmaceutical Healthcare Systems) The Australian Private Hospitals Association Cancer Council Australia Clinical Oncological Society of Australia Consumers Health Forum Faculty of Intensive Care Medicine, ANZCA Intensive Care Coordination and Monitoring Unit Royal College of Nursing Australia The Society of Hospital Pharmacists of Australia Women’s & Children’s Hospitals Australasia This national consultation program provided valuable feedback (refer to ‘NC - Compiled feedback’) used to inform and revision of the Labelling Recommendations (refer to ‘Application of consultation feedback to Recommendations’). Contacts within the above organisations are provided in ‘Feedback Status working document’. Alongside this consultation process, a detailed literature review was conducted into evidence relating to injectable medicine administration, labelling and related errors (Refer to ‘Labelling literature review September 2009’). This was supplemented by unpublished case reports from incident management databases. 9 6. Label Production 6.1 Initial scoping and engagement Four Australian label production companies were identified as potential suppliers to the project; Defries Industries; Abel Labels; Stirling Fildes and Baypac. Each company was asked to supply examples of existing work and engaged in initial scoping discussions with NSW TAG. Defries Industries were unable to progress as their production systems would not allow for one-off customised printing. The 3 remaining companies were asked to provide initial artwork and quote for development of 25 different label types. Abel Labels chose not to respond. Baypac provided a ballpark quote with no artwork. Stirling Fildes provided a detailed ballpark quote with explanation of costs and artwork. It was clear from discussions that Stirling Fildes were keen to understand the complexities of the project including the relation to the Australian Standard. Despite the higher quote, Stirling Fildes were chosen to provide artwork and labels for the project and this decision has been proved appropriate. Requests have been met in a timely, professional manner, with good understanding of the project through each stage of label production. 6.2 Label proof development A series of mock up labels were devised alongside the Labelling Recommendations development from the period May 2009 to November 2009. It was important to create basic mock-ups for the project team and advisory committee to visualise the final materials. Label production for pilot testing would only commence when the Labelling Recommendations were finalised for testing. For an example of one stage of the development of mock-up labels, see ‘Label mock-ups 16 October 2009’. On sign-off of the Labelling Recommendations by the Advisory Committee the artwork for pilot testing was prepared for production (refer to ‘Labels for Pilot Test 10 December 2009’). Alongside the artwork development, an estimate of label quantities required to print was established with the pilot test sites by requesting how many labels of each type would be required per week in their clinical area (See ‘Label print quantities questionnaire‘). Provision was made for a 6-week trial and total quantities calculated are shown in ‘Label quantities for pilot test December 2009’. 6.3 Sterile label production Five clinical areas requested labels for testing on the sterile field. Their requirements were identified and are shown in ‘Sterile label quantities’. An alternate label for use primarily in operating rooms was developed and produced by Stirling Fildes. An investigation into Australian companies providing a customised service for packaging and sterilisation is reported in ‘Sterile label production October 2009’. On production of the labels for testing a portion of labels were directed to ITL Healthcare who provided packaging of labels and sterilisation for the 5 test clinical areas. 6.4 Bag/burette additive label visibility Pilot testing highlighted the importance of visibility of bag and burette labels to identify the presence of an additive. To ensure a label for IV use was visible whilst retaining the ability to see the writing applied to the label a bag label was devised in association with Stirling Fildes and Go Media (design and graphics agency). This label would be fully coloured to be visible, use the colour blue to denote delivery via the intravenous route whilst using PMS 2985 and 292 (rather than Australian Standard prescribed Process Blue) to allow for visibility of text with the coloured background. These alternatives were considered alongside the pilot tested bag label by the pilot test centres with PMS 2985 selected as an appropriate means of IV bag additive identification (‘IV labelling alternatives 8 June 2010’). Colours cannot be reproduced using electronic print media so these label were printed alongside a label in PMS 292. Refer to ‘Blue alternate IV labels 25 May 2010’ for assessment by the Advisory Committee. Stirling Fildes has produced IV labels as 100% PMS 2985 and 70% PMS 2985 to seek a balance between high visibility and legibility of black writing on a blue background. The project team and Advisory Committee selected the 70% background with a 100% border. 6.5 Education support Following pilot testing of labels produced in accordance with the Labelling Recommendations and agreement on the final label design, a set of final label proofs were created by Stirling Fildes (‘Final labels 10 July 2010’). Four labels were required to be printed for use in photographs displaying label placement in the education support material: IV bag/syringe labels (2 sizes), IV line label and IV burette label. 7. Pilot Testing 7.1 Engaging pilot test clinical areas To establish participants in the pilot testing, expressions of interest were invited from all public and private hospitals in Australia. The objective was to test the draft Labelling Recommendations in 10 different clinical areas where labelling of injectable medicines would apply. (Refer to ‘Expressions of Interest Invitation). Test hospital applicants completed an ‘Expression of Interest submission form’. A good response was received and a provisional allocation compiled from expressions of interest received (‘Hospital Allocations’). Final allocations were made using the ‘Pilot test selection criteria 25 May 2009’ and the clinical areas selected are provided in ‘Pilot test hospitals and contacts’. 7.2 Establishing the pilot test As an introduction to the trial, each hospital received an outline plan (Refer to ‘Pilot test plan and timeline Feb 2010’ based on ‘Pilot test methodology’). Each pilot test clinical area provided a profile on their area and facility. (Refer to ‘Pilot test clinical area profiles’). Pilot test sites provided an estimate of label quantities required to print for each label type to conduct the trial in their clinical area (See ‘Label quantities questionnaire‘). 7.3 Current practice survey Each pilot test clinical area provided details on current practice to form a basis for establishing their potential requirements during the trial and to provide a baseline for testing by completing the ‘Current Practice Surveys, parts A and B’. The results of the survey are presented in ‘Results Current Practice Survey Part A’ and ‘Results Current Practice Survey Part B’. 7.4 Pilot test site visits Pilot testing was introduced in a staggered process from 11 February 2010 to 9 March 2010 (Refer to ‘Schedule of pilot testing –working doco’) following review of the draft Labelling Recommendations to be tested by the Advisory Committee and endorsement at the committee meeting on 9 February 2010. The Advisory Committee requested to establish if ethics approval was required before trial and this issue was addressed as detailed in Section 8.3. At each visit the following materials were provided: ‘Draft Labelling Recommendations for pilot test (November 2009)’ ‘Pilot testing plan and timeline Feb 2010’ ‘Label Guide December 2009’ ‘Guide to collecting feedback’ PowerPoint presentation (‘Pilot test presentation’) Education support explanatory notes (‘Pilot test education – explanatory notes’) Education activity log (‘Pilot test – Education activity log’) Labels for testing. In general, each visit involved a presentation of the project to the clinical area coordinator, nurse unit manager, pharmacy liaison, clinical education facilitator(s) and other groups according to the facility construct. This was followed by a review of education support and provision of materials and labels. A detailed review of current procedures and a discussion of the clinical area requirements usually involved the clinical area coordinator and nurse unit manager. The implementation of the draft Labelling Recommendations (Nov 2009) by the clinical area additionally involved the clinical education facilitator. These visits were well received by the staff immediately involved in the project. 7.5 Pilot test follow up Pilot testing of the Labelling Recommendations concluded in May 2010 and results provided valuable information about use of labels in the sterile field, use of colour to differentiate route of administration, use 11 of medicine-name line labels for continuous infusions and acceptability of a standardised approach to labelling amongst a diverse group of hospitals and clinical areas. 7.5.1 Follow up surveys ‘Follow up survey parts 1, 2 and 3’ were provided as electronic questionnaires with sections to be completed relating to aspects of care tested in each clinical area. These were accompanied by instructions (‘Follow up survey cover sheet’). The pilot test clinical areas completed these surveys and their results were collated in ‘Pilot test results – complete’. 7.5.2 Pilot test debrief Each test clinical area was given an opportunity to discuss their findings with the project manager to highlight any areas of particular interest/concern that were less easy to categorise by questionnaire. ‘Pilot test results – complete’ also contains the feedback from these pilot test debrief sessions conducted according to ‘Follow up schedule 6 May 2010’. In reviewing the test results, the following factors should be considered: The trial was conducted for 4 weeks in each clinical area There was variable level of staff engagement in each clinical area In some cases there was site coordinator or other staff absence during the trial due to inflexibility of start dates Only one example of each clinical area was tested Test areas have made suggestions for improvement and these have been logged. However, incorporating suggestions from test areas into the Labelling Recommendations may involve incorporating untested options. 7.6 Education in pilot test clinical areas Pilot test clinical area coordinators were requested to provide education on the Labelling Recommendations and their implementation to staff within their area. The education activity log ‘Pilot test – Education activity log’ was developed to capture feedback on this process and to guide discussion on escalating the implementation of the Labelling Recommendations beyond one area within a larger facility. The summary of the feedback from the education activity log is presented in ‘Education feedback summary’. Essential findings: The majority (75 – 95%) of staff received education in the 4 week period. Education for medical and pharmacy staff was successfully undertaken in each clinical area by nominated project liaison staff. Education materials based on pilot test rollout require development. Phased rollout of education is required at ward level, from group sessions through to one to one education. Project officers are required at area level to coordinate rollout. Clinical champions are required at ward level to provide ongoing education. Reinforcement is essential during implementation and in review. Designated staff member with the ability to work offline (i.e. with no operating room patient responsibilities) to coordinate project in perioperative area. Finance to support education within appropriate time frames. Estimated education reinforcement over a 4 to 6 month period is necessary to reach full implementation at ward level. Access to a website and a base contact is necessary to support implementation. 7.7 Application of pilot test findings to the Labelling Recommendations The pilot test results and education feedback were reviewed and proposals to accommodate the findings were discussed by the Advisory Committee in their 6th and final meeting on 16 June 2010 (Refer ‘Pilot test feedback application’). Decisions from this meeting (‘Minutes meeting 16 June 2010’) informed the final revision of the Labelling Recommendations (August 2010). 12 8. Project Extensions 8.1. Extending beyond AS 4940 and pilot testing In initial stages of development, it became evident that constraints of the Australian Standards with regard to size and colour coding for route of administration were a barrier to producing a practical set of recommendations without compliance issues. To address this issue the following actions were taken: A revision of the Labelling Recommendations with a review of the literature and reference to evidence and international guidelines to support the revision Establishing evidence from pilot test hospitals, in addition to the current practice survey, to test the move away from AS 4940 (see ‘Survey label size AS 4940’). Alignment of proposed mock up labels with the revised Labelling Recommendations Pilot testing was also extended to involve 12 (rather than 10) clinical areas and 8 (rather than 5) test centres. In addition, each clinical area would receive face-to-face presentation of the draft Labelling Recommendations, the mock up labels and education package with support for implementation. The contracted schedule originally allowed for communication by post and telephone. Refer to ‘Project extension (Standards and pilot testing). 8.2 Extension to include the sterile field During project development it was recognised that the sterile field is exposed to medication error as a result of lack of available guidance and resource. In addition, the application of the Labelling Recommendations to address this issue has become apparent. Recommendations for labelling on the sterile field have been developed by other international bodies, including the Institute for Safe Medication Practices (US & Canada), the Joint Commission and the Association of Perioperative Registered Nurses. Indeed, 5 of the 12 pilot test clinical areas currently administer injectable medicines on the sterile field, including operating rooms where infection control is imperative. Staff at the hospital engaged to pilot test the 3 perioperative areas requested have identified this as a risk area for medication safety and have requested to test on the sterile field in the operating room. The project was extended to source and test sterile labels on the sterile field with subsequent inclusion in the Labelling Recommendations. Refer to ‘Project extension (sterile field)’. 8.3 Ethics approval Each clinical area had an opportunity to consider application for ethics committee approval prior to trial commencement. In NSW, the St Vincents and Mater Health Human Research and Ethics Committee (HREC) formally considered ethics approval. The HREC concluded that the National Injectable Medicines Labelling Recommendations Project was a low risk, quality improvement project and therefore exempt from full HREC review. As a NSW lead HREC, this assessment applies to all NSW public hospitals. Hospitals beyond NSW participating in the project were asked to consider consulting the chairman of their ethics committees to ensure any potential ethical issues were addressed. Only Princess Alexandra Hospital (PAH) required formal consent from an ethics committee to enable commencement of the trial in the 3 perioperative clinical areas. Following application on 17 February 2010, approval was signed on 15 April 2010. The inclusion of the perioperative area in the Labelling Recommendations will provide a change to current clinical practice and the inclusion of this area is important in achieving an optimal project outcome. The timeline for the project extended dependant on receipt of ethics approval for PAH. Refer to ‘Project extension (ethics)’. 13 9. Finance Summary Income and expenditure to 9 September 2010: Total Project $ Income Original grant Project management Other costs Agreed Extensions Recommendations document Additional pilot testing Sterile field testing Ethics approval Estimate to complete $ To 31/7/10 $ 92,000 20,100 112,100 17,150 10,474 8,575 12,864 49,063 Total income 161,163 161,163 161,163 Expenditure Project management team Labelling Recommendations - pilot test Labelling Recommendations - final Label production - pilot testing Label production - PMS 2985 decision Label production - Education Package Education package (design) Travel Conference costs Stationery & copying Postage & phone Reference & technical material Insurance Other 141,851 390 1,300 3,000 745 1,523 4,320 838 2,064 944 630 589 713 1,596 2,400 200 1,200 500 139,451 390 1,300 3,000 745 1,523 4,320 638 864 944 630 589 713 1,096 Total expenditure 160,503 4,300 156,203 660 156,863 4,960 Net income over expenditure to date All figures exclusive of GST 14 10. Project Timeline Refer to ‘Schedule key project activities’ Activity 2009 Feb 2010 Mar Apr May Jun July Aug Sept Oct Nov Dec Jan Feb Mar Apr May Jun July Execution of contracts Advisory Committee meetings National consultation and feedback Mock-label design and production EOI and recruitment of pilot sites Review of draft recs and label design (Extension 1) Additional literature review Current-practice survey of pilot sites and label quantities for pilot testing Sterile labels – processes and production (Extension 2) Development of education package Pilot site visits Ethical review of pilot test methodology (Extension 3) Pilot testing of recs and labels Final revision of recs and education package Submission of recs, education package and final report to ACSQHC 15 Aug 11. Reference of Electronic Files (In order of appearance) 1. Introduction National Recommendations for User-applied Labelling of Injectable Medicines, Fluids and Lines (August 2010) 2. Background Parenteral Medicines, Fluids and Lines: Labelling Recommendations (August 2008) 3. Aims and outcomes Education support - Explanatory Notes Poster A3 Label Guide – All Labels Poster A4 Label Education Posters Education support - Slide presentation Implementation guide IV labelling alternatives 8 June 2010 Australian Standards comparison 4. Project team and Advisory Committee membership Advisory Committee – Terms of Reference Minutes 25 March 2009 Minutes 25 May 2009 Minutes 31 July 2009 Minutes 30 September 2009 Minutes 9 February 2010 Minutes 16 June 2010 5. National consultation NC - Compiled feedback Application of consultation feedback to Recommendations Feedback Status working document Labelling literature review September 2009 6. Label production Label mock-ups 16 October 2009 Labels for pilot test 10 December 2009 Label print quantities questionnaire Label quantities for pilot test December 2009 Sterile label quantities Sterile label production October 2009 Blue alternate IV labels 25 May 2010 Final labels July 2010 7. Pilot testing Expressions of Interest Invitation Expression of Interest submission form Hospital Allocations Pilot test selection criteria 25.5.10 Pilot test hospitals and contacts Pilot test plan and timeline February 2010 Pilot test clinical area profiles Label quantities questionnaire (See 6. Label production) Results Current Practice Survey part A Results Current Practice Survey part B Schedule of pilot testing –working document Draft Labelling Recommendations for pilot test (November 2009) Label Guide December 2009 Guide to collecting feedback Pilot test presentation Pilot test education – explanatory notes Pilot test – Education activity log Follow up survey part 1 Follow up survey part 2 Follow up survey part 3 Follow up survey cover sheet Pilot test results – complete Follow up schedule 6 May 2010 Education feedback summary Survey label size AS 4940 Pilot test feedback application 8. Project Extensions Project extension (Standards and testing) Project extension (sterile field) Project extension (ethics) 9. Finance 10. Project timeline Schedule key project activities 16