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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]
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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
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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
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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
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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.
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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.
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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
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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.
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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.
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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
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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
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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).
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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)’.
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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
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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
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