Presented by: Yvette Salamon

Perioperative Educator

Calvary Wakefield Hospital

Calvary Wakefield Hospital

Calvary Wakefield Hospital, in Adelaide

South Australia, is an acute private hospital

with 180 beds located in the central

Adelaide metropolitan area.

It has a total of eight operating theatres

within its Perioperative Suite

Specialities areas cover most operative

specialities with a strong focus on

neurosurgery, cardiac services and

orthopaedic surgery.

Implementation

Calvary Wakefield Hospital (CWH)

commenced implementation of the Australian

Commission on Safety and Quality in Health

Care (ACSQHC) National Recommendations

for User-applied Labelling of Injectable

Medicines, Fluids and Lines in July 2011

Delays in the implementation of the Labelling

Recommendations occurred when sourcing

labels to use to identify medicines and fluids

on the sterile field in the perioperative suite

Perioperative Issues

This was due to the inability to source a

sterile “Abbreviated Container Label”

There was also concern that manually

completing this label within the fast pace

of the Perioperative setting would slow

down case setup and lead to non

compliance, hence a simple and user

friendly option was investigated

Developing Pre-printed Labels

CWH in conjunction with StirlingFILDES

developed a pre-printed label sheet to

facilitate the introduction of „Labelling for

Medication Safety‟ to the perioperative

sterile field.

In September 2011CWH presented the

labels being developed in their theatre area

for consideration and feedback from those

in attendance at a Labelling for Safety

Information Session facilitated by South

Australia Health

Trial Proposed

In October 2011, CWH submitted a

proposal to the Australian Commission on

Safety and Quality in Health Care (the

Commission) to support testing the pre-

printed labels in the Perioperative Suite at

CWH.

Acceptance of proposal by the Commission

received and parameters decided and final

Draft of the Label Sheet approved.

Aims and objectives

Aims of the trial were to determine if

The use of pre-printed labels is appropriate for the perioperative area

The printed content on the labels ensured safe medication identification in the perioperative area

The label sizes were appropriate

The font sizes were appropriate

Where colour was used this was appropriate

The label quality in relation to strength and durability is suitable.

Methodology

The draft label sheet was aligned with the current Commission advice.

The Commission provided details of label stock issues in pilot testing at the Princess Alexandrina Hospital

The sample group was to consist of all operating lists to held within the 8 theatres

Specialities included the orthopaedic, neurosurgery, ophthalmic, cardiac, ENT, general, oral-maxillofacial and plastic surgical groups.

Methodology (con’t)

Three label manufacturers were asked

to provide quotes for label production

StirlingFILDES were nominated to

supply labels sheets

Bard was selected to package and

sterilise the label sheets for the trial

Trial period was intended to last six

weeks initially

ACSQHC Parameters

The following parameters were applied to the labels Full drug names; no abbreviations; no brand

names; no medicine class names

Colour coding, stripes and borders according to the ASNZ4375: 1996 and ISO26825:2008

Text size as large as possible

A plain sans serif font

Black on white where no colour is specified in the standards

Lower case letters

Process and Timeframes

Due to issues experienced the expected six week

timeframe extended to allow specific issues to be

resolved.

The trial was eventually divided into three stages and

to ensure the validity of the data collected remained

accurate.

Stage 1 commenced on the 13th February 2012 and

went for 9 days

Stage 2 commenced on the16th April 2012 and also

went for 9 days

Stage 3 commenced on the 23rd May 2012 and went

for 10 days

The trial concluded on the 6th June 2012

Stage 1

During the second week of Stage 1 The trial was suspended and labels withdrawn due to a fault in the label sheet.

Samples of the sheets in question were collected which showed that in some instances the label sheet had been punched all the way through by the label cutting block which resulted in some labels floating free from the sheet or only being attached to the sheet by one flap.

Trial was suspended until this production issue was resolved.

Stage 2 Stage 2 was commenced with the intention of

running it for a period of four weeks

However the trial was again halted due to the

unacceptably high number of the labels that were

becoming detached during a procedure.

The label quality in relation to strength and

durability was also in question as the label surface

was easily disrupted

Both these issues appeared to be as a result of

sustained contact with fluid of any type.

Need to procure labels with an alternative

composition that more suitable for the moist

conditions found in the perioperative area.

Stage 3

Stage 3 utilised the new gloss labels on the sterile label sheet as an alternative to the matt labels that had been utilised during Stages 1 and 2.

The addition of waterproofing the label surface led to a significant increase in the quality of the labels regarding their durability and ability to maintain their surface quality

Label adhesiveness also improved with the labels

The staff were positive about the concept of the pre-populated labels

Acceptability

The pre-printed label sheet provided easy to use, practical set of labels used in the perioperative

These were generally well accepted and did not significantly extend preparation time.

For evaluation of setup time for each case, 78.1% of staff agreed the labelling system did not add to the preparation time for their cases.

Perceived increase was minimal and mainly affected fast lists with many small cases

Label Strength and Durability

The labels manufactured with a high gloss finish used in Stage 3 were found to be fit for purpose in terms of strength and durability.

The labels remained intact and no disintegration was reported.

Label Strength and Durability

With the introduction of the gloss label the adhesiveness of the label increased significantly

When a syringe was immersed in fluid, the label remained intact, and did not lift off the syringe.

Labels were left in normal saline 0.9% overnight were intact after 12 hours in the fluid and could withstand normal handling with no disruption of the label surface.

Label Size

Two label sizes were used; a larger label

(55mm x 20mm) for fluids and smaller label

(40mm x 10mm) for other medicines and fluids.

The size of both labels was evaluated by staff

to be appropriate for their intended purpose.

Font Size

The font size used was proportionate to

the label sizes.

For the larger labels the font is 20 point,

the smaller labels used 12 point and the

small labels with two medicine names

(e.g. Bupivacaine / Adrenaline) used 11

point

The size of font used on all labels was

evaluated to be appropriate for the

intended purpose

Printed Content

The introduction of waterproofing in Stage 3 led to the need to add concentration to the pre-populated labels as writing on label was thought to be no longer possible

Staff who tried to write on the Stage 3 labels reported this was achievable with a surgical marking pen with no run of ink if they become wet

Printed Content (con’t)

The comments made related mainly to

the need to identify preparation solutions

as there was no labels available for this

purpose on the trial sheet

95.1% of staff reported there was

sufficient information to allow for

accurate identification of medicines and

fluid on the sterile field

Colour

In Stage 3, 51.2% of staff stated that

colour of the labels was useful for

identification

46.4% were undecided

There was no feedback to indicate the

colour used was detrimental to

identification

Packaging

Staff commented on the size of the

packaging although this was not part of

the evaluation

They indicated the pack size was too

large in Stage 1 and 3 and that the

Stage 2 packaging was a better size as

it was easier to handle when opening

and presenting the item to be taken onto

the sterile field

Label Adhesive Residue Labels were tested through all stages for their

ability to peel off containers cleanly

Container types including steel, reusable plastic and

disposable plastic were tested

A variety of irrigation solutions were used to moisten

the labels

Labels were left on for periods of 1, 2 and 6 hours

Little to no residue was observed on removal and

any adhesive left was easily removed with alcohol

wipes

Only when the label was immersed was there any

issue with excessive residual being left on the plastic

syringe which was disposable and thus discarded

Conclusion The results of the trial were very positive

The pre-printed label sheet was durable and fit for

purpose with the improvement of the water resistant

layer in Stage 3

The pre-printed labels were easy to use and well

accepted by staff

The label sheet can be changed to accommodate

any fluids or medication required

The ability to remove the sticker with little to no

residual adhesive will be acceptable for Suites who

still have reusable hollowware

An option for stronger adhesive is available if there

is no requirement to remove labels from hollowware

Acknowledgements

Perioperative Nursing Staff and Surgeons

at Calvary Wakefield Hospital

Ian Glasson from StirlingFILDES

Diana Shipp from the Australian

Commission on Safety and Quality in

Health Care ACSQHC

Roy Anlezark from Bard Australia

References

Australian Commission on Safety and

Quality in Health Care 2012, National

Recommendations for User-applied

Labelling of Injectable Medicines, Fluids

and Lines: Issues Register, ACSQHC,

Sydney.

http://www.safetyandquality.gov.au/wpconte

nt/uploads/2012/02/38460ImplementationG

uide.pdf. Accessed 27.06.12