Best Practice Pathology Collection in Australia

Abstract

Objectives: The specific objectives of the study were to (a) identify current best practice in pathology specimen collection and assess the extent to which Australian pathology services currently satisfy best practice standards; and (b) identify training and other strategies that would mitigate any gaps between current and best practice.

Methods: A total of 22 case studies were undertaken with pathology collector employers from public, not for profit and private pathology organisations andacross urban and rural locations and eight focus groups with pathology collection services consumers were conducted in December 2012 in four different cities.

Results: The preferred minimum qualification of the majority of case study employers for pathology collectors is the nationally recognised Certificate III in Pathology. This qualification maps well to an accepted international best practice guideline for pathology collection competency standards but has some noted deficiencies identified which need to be rectified. These particularly include competencies related to communicating with consumers. The preferred way of training for this qualification is largely through structured and supervised on the job learning experiences supported by theoretical classroom instruction delivered in-house or in off the job settings. The study found a need to ensure a greater proportion of the pathology collection workforce is appropriately qualified.

Conclusion: The most effective pathway to best practice pathology collection requires strong policies that define how pathology samples are to be collected, stored and transported and a pathology collection workforce that is competent and presents to consumers with a credible qualification and in a professional manner.

Abbreviations: CHF – Consumer Health Forum of Australia; KIMMS – Key Incident Monitoring and Management Systems; NAACLS – National Accrediting Agency for Clinical Laboratory Sciences; NACCHO – National Aboriginal Community Controlled Health Organisation; NPAAC – National Pathology Accreditation Advisory Council; RCPA – Royal College of Pathology Australasia; RTO – Registered Training Organisation.

Full text

Best Practice Pathology Collection in
Australia
V Pilbeam, L Ridoutt and T Badrick
RESEARCH
ARTICLE
Victoria Pilbeam
Human Capital Alliance (International) Pty Ltd
Potts Point, New South Wales, Australia.
Lee Ridoutt
Sydney, New South Wales, Australia.
Tony Badrick
Faculty of Health Science and Medicine
Bond University
Gold Coast, Queensland, Australia.
Correspondence:
victoria.pilbeam@humancapitalalliance.com.au
experiences supported by theoretical classroom
instruction delivered in-house or in o the job settings.
The study found a need to ensure a greater proportion
of the pathology collection workforce is appropriately
qualied.
Conclusion: The most eective pathway to best practice
pathology collection requires strong policies that dene
how pathology samples are to be collected, stored and
transported and a pathology collection workforce that
is competent and presents to consumers with a credible
qualication and in a professional manner.
Abbreviations: CHF – Consumer Health Forum of
Australia; KIMMS – Key Incident Monitoring and
Management Systems; NAACLS – National Accrediting
Agency for Clinical Laboratory Sciences;
NACCHO – National Aboriginal Community Controlled
Health Organisation; NPAAC – National Pathology
Accreditation Advisory Council; RCPA – Royal College
of Pathology Australasia; RTO – Registered Training
Organisation.
Key words: pathology collection; phlebotomy; best
practice; training; competency.
Abstract
Objectives: The specic objectives of the study were to
(a) identify current best practice in pathology specimen
collection and assess the extent to which Australian
pathology services currently satisfy best practice
standards; and (b) identify training and other strategies
that would mitigate any gaps between current and best
practice.
Methods: A total of 22 case studies were undertaken
with pathology collector employers from public, not
for prot and private pathology organisations and
across urban and rural locations and eight focus groups
with pathology collection services consumers were
conducted in December 2012 in four dierent cities.
Results: The preferred minimum qualication of
the majority of case study employers for pathology
collectors is the nationally recognised Certicate III in
Pathology. This qualication maps well to an accepted
international best practice guideline for pathology
collection competency standards but has some noted
deciencies identied which need to be rectied.
These particularly include competencies related to
communicating with consumers. The preferred way
of training for this qualication is largely through
structured and supervised on the job learning
Introduction
Pathology tests are an essential part of the healthcare
system, used to aid medical practitioners in the diagnosis of
disease, assist in preventive health, acute care, management
of chronic conditions and more recently genetic research. [1]
In the nancial year 2012/2013 there were over 83 million
pathology tests conducted in Australia initiating a Medicare
benet. This required over 36 million separate pathology
specimen collections – ‘specimens’ including samples
of blood, tissue or body uid taken from patients – that
attracted a Medicare benet. [2] Additionally, signicant
pathology testing is undertaken in hospitals in the public
health sector.
50 Asia Pacic Journal of Health Management 2016; 11: 1

Best Practice Pathology Collection in Australia
Accuracy of pathology test results is paramount, and several
studies have found that in well-developed health systems
error rates are generally low (e.g. Dale and Novis [3] found an
average error rate of less than 0.5% across a sample of tests
analysed from the United States, Canada, Australia and South
Korea). In Australia, analysis of Key Incident Monitoring and
Management Systems (KIMMS) data from the Royal College
of Pathology Australasia (RCPA) for 2012 [RCPA, personal
communication] identies pathology errors for each quarter
from a large sample of pathology laboratories ranged from
only 1.38% to 1.56% of all pathology service episodes.
Notwithstanding the low error rate, in Australia this could
imply problems potentially with over one million tests.
Accordingly both industry and consumers continually press
for reduced rates of error.
There is a large amount of evidence from the literature
identifying the pre-analytical stage (where specimens are
collected and transported) as the area that contributes most
to errors that occur within pathology testing. [4,5,6] Plebani
[1] for instance states:
Most errors are due to pre-analytical factors (46–68.2% of
total errors), while a high error rate (18.5–47% of total errors)
has also been found in the post-analytical phase.
The majority of pre-analytical errors are attributed to
problems with pathology collectors’ skill and adherence
to procedures. [6] Some researchers [1,5] have argued that
skill deciencies are less prevalent in collection workers
supervised by the pathology laboratory when compared
with non-laboratory managed personnel (such as nurses
and doctors collecting specimens in inpatient and primary
care settings). This argument is supported by KIMMS data.
The need for possession of minimum competencies
for pathology specimen collection and handling, and
maintenance of those competencies to ensure ongoing
quality of service, has been identied by the National
Pathology Accreditation Advisory Council (NPAAC), [7]
and the Consumers Health Forum of Australia (CHF) [8] as
a high priority issue and an area where greater attention
to promoting best practice could lead to better patient
outcomes. This study aimed to better understand what
constituted best practice in pathology collection and how it
might be achieved in Australia.
Methods
The key source of data for this study was two sets of
qualitative data collection processes undertaken with
employers of pathology collectors (essentially pathology
laboratories) and with consumers of pathology collection
services.
A total of 22 case studies were undertaken with pathology
collectors’ employers across public, not for prot and
private pathology organisations and across urban and rural
locations. The case study sample population slightly over-
represented the public sector (50%) and the not for prot
sector (18%) and under-represented the private sector (32%)
since one of the major private sector corporate entities
determined not to engage with the study. The employer
case studies collected data according to an agreed common
protocol detailed elsewhere. [9]
Each case study involved interviews with senior managers
(Pathology Collections Manager or Training Manager,
etc). The interviews were structured to discuss what
work pathology collectors were undertaking within
their organisations and to collect the following types of
documentation for further analysis:
• Positiondescriptionstoanalysetheroles,andrequired
skills and attributes of employed collectors;
• Proceduraldocumentationtogainanunderstanding
of current operating procedures and quality control
processes; and
• Trainingmanuals,trainingmatrixesandinduction
procedures to provide an understanding of in-house
training programs and ongoing assessment of
competency and continuing professional development
practices.
In some case study organisations certain documents were
not made available or not able to be removed from the
premises for further analysis as they were considered the
intellectual property of the employer organisations.
In addition to the employer case studies, eight focus
groups with pathology collection services consumers
were conducted in December 2012 in four dierent cities.
These groups were organised in conjunction with the CHF,
the Health Care Consumers Association (Australian Capital
Territory), Health Consumers (New South Wales), Health
Issues Centre (Victoria), Health Consumers (Queensland)
and the National Aboriginal Community Controlled Health
Organisation (NACCHO). Group participant numbers ranged
from two to 13. The aim of the focus group discussions
wasto collectdetailsontheexperiencesandexpectations
of consumers of pathology collection services in order
to identify the required competencies of collectors from
the consumer perspective. Focus group discussions were
guided by a schedule detailed elsewhere. [9]
Asia Pacic Journal of Health Management 2016; 11: 1 51

Best Practice Pathology Collection in Australia
Results
Dened collection procedures
All of the case study employers studied had well developed
procedures manuals that carefully prescribed the
operations, in sequence, which needed to be completed
for a successful specimen collection. Analysis of collected
procedures manuals from case study employers found that
practice guidelines in Australian pathology laboratories
correlated well with international recommendations [10]
and prevailing practice in a range of comparable countries
including the United Kingdom, [11] [12] and the United
States. [13]
Pathology collector qualications
There is no mandatory requirement for pathology collectors
to have a particular qualication in Australia however the
laboratories that employ collectors are subject to guidelines
for laboratory accreditation by NPAAC. In practice this tends
to translate into a mixed workforce of formally qualied
and unqualied workers, the latter having been generally
developed to acceptable levels of competence through on-
the-job training.
The most widely recognised ‘entry level’ qualication by
employers was the nationally recognised Certicate III in
Pathology (course code HLT32612). All case study employers
interviewed accepted this qualication and accordingly
had been for some years attempting to gradually replace
registered nurses and any unqualied collection sta with
those holding the Certicate III qualication. Nevertheless,
most employers still had a signicant proportion of their
sta who did not hold a Certicate qualication III (ranging
from 20% to 50%) and most still had a small proportion of
registered nurses as pathology collection workers. Analysis
of 2006 ABS Population Census data similarly found that just
over one third of non-professional laboratory workers were
unqualied. [14]
In Victoria and South Australia the preferred entry level
qualication was the Certicate IV, although the Certicate
IV as it is currently structured diers little from the Certicate
III in technical competencies.
Current training for pathology collector qualications
There were four reasonably distinct approaches to training
pathology collectors identied through the employer case
studies. These approaches can be described as follows:
A. Completely ‘in-house’ – A pathology laboratory employer
becomes a registered training organisation (RTO) and
is delivering the Certicate III in Pathology entirely in-
house with employed trainers providing classroom based
instructionandstructuredonthejobexperiences.
B. Mostly ‘in-house’ – Similar to above, the pathology service
employer has taken control of most of the parameters
of training but not attempted to become a RTO and
hence needs to ‘partner’ with an appropriate RTO to have
trainees assessed and conferred their recognised (national)
qualication.
C. External training and on-the-job – In this arrangement
the bulk of the training occurs in classroom or simulated
workplace settings within an RTO’s facilities. This is followed
by a period of structured on the job clinical practice
experience. The amount of time spent in clinical practice
variesbutmostcommonlywas fourweeks (approximately
140 hours). This training arrangement was most prevalent
in Victoria.
D. External only – All of the training is completed o the
job in the education institute’s training facilities, through
a combination of classroom-based theory and simulated
practicalexperience.Thistypeof approachwasseemingly
limitedexclusivelytoa smallnumber ofprivateRTOswith
accreditation to deliver the Certicate III.
A specic variation on approach ‘A’ is in West Australia where
the public sector provider Pathwest conducts a completely
in-house training program but this is not supported by an
RTO and does therefore not result in the conferring of a
recognised qualication (at least not nationally nor formally
recognised).
In the interviews conducted with employers it was found
that there was generally a preference for type A and B
approaches above, with the majority of interviewees
identifying that the skill of pathology collectors was mainly
developed through their experience in the role.The more
practicalexperienceobtained,generallythehigherlevelof
skill achieved. Anecdotally, employers reported diculties
in employing individuals who had undertaken the Certicate
III through type D approaches as the course was delivered
over too brief a time period and with little to no practical
experienceand‘graduates’ofsuchprogramscouldstruggle
to gain employment.
Technical competence of individual pathology collectors
Despite general support for the Certicate III qualication
case study employers and consumers through the focus
group discussions identied a number of areas that were
not adequately covered through the current Certicate III
course including:
• Basiccomputerskills/useofoceequipment;
• Transportationofbloodspecimens;
52 Asia Pacic Journal of Health Management 2016; 11: 1

• Understandingandcommunicatingtoconsumersthe
legal requirements of request and consent forms (and
gathering patient history in relation to organisational
policy to support this);
• Customerservice–explainingprocedureandidentifying
special needs of patient, especially language and literacy
needs, i.e. nding best way of communicating with
patient;
• Teamwork/workingwithotherswithinaprofessional
health care team;
• Troubleshooting;and
• Abilitytoevaluateownscopeofpractice(limitations
of own skills) and act within that scope.
Regular consumers of pathology collection (especially
blood collection) services reported a perception that some
collectors possess better skills than others. Essentially,
consumers identied that technical competency concerns
were centred on the ability of pathology collectors to nd
and access a vein within three attempts and that consumers
were not bruised as a consequence of the procedure. It was
acknowledged that some medical conditions can make
accessing a vein dicult for collectors and only collectors
withsucient experience(regardlessoftheirqualication)
should be undertaking these types of collections. Similarly,
experiences from consumers regarding collections from
infants and children identied the need for experienced
and competent collectors in order to reduce the trauma of
the experience and the chance of consumers developing
phobias.
Customer service competence of pathology collectors
Consumersdiscusseda rangeofexpectationsofpathology
collection services, especially around ‘customer service’
competencies of individual collectors. Regularly, consumers
reported they attended pathology collection services with
limited communication with the pathology collector about
what was occurring. One consumer summarised this well:
Most consumers want to be walked through a process, even
when they are likely to know what it is all about. I went three
times in one week to have blood drawn and was only ever asked
my name and date of birth. I was not given any information
about what was happening to me. Consumers feel collection
sta should treat them each time as if it is their rst visit and
explain the procedures. Too often no explanation is provided
and questions are never invited.
In addition, consumers often required information about
how the results would be processed and communicated
back to them and felt that this should form part of the
explanation of process along with an explanation of
billing and payment issues, particularly any out-of-pocket
expenses.
Consumers noted in the consultations that patients might
lodge a complaint with a collection service if they are
dissatised with the way in which they were treated or
becauseofpoorprocedure,forexampleexcessivebruisingor
nerve damage from a blood collection procedure. However,
processes for lodging complaints were considered onerous
and likely to minimise the amount of actual complaints
lodged.
The major themes from the focus group discussions are
similar to those elicited from consumers in the United States,
[15] where a large survey to measure patient satisfaction at
540 pathology collection organisations found three main
areas of quality and safety consumer concern:
• Characteristicsoftheorganisationoeringtheservice,
such as the facilities, ease of access, technology in use,
 exibilityandscopeofservicesavailable;
• Individualcharacteristicsoftheemployeesproviding
the service, such as their attitude, skill, responsiveness,
and ability to make decisions; and,
• Uniquecharacteristicsofeachpatient,suchastheir
 previousexperiencesorexpectations,personalitytraits
and level of health.
Discussion
A distinction emerged from this study between an
industry perspective (that is from pathology laboratories
themselves and associated industry bodies and professional
associations) and a consumer perspective (patients who are
having samples collected for testing) of pathology testing
services. The fundamental dierence between the industry
and consumer perspectives is manifest in their primary
focus in respect to quality and safety concerns.
In terms of industry’s quality and safety concern focus,
industryisprimarily (thoughnotexclusively)concentrated
on the quality of the pathology specimen to be tested.
Problems occurring during pathology collection processes
are identied in a number of ways. Most commonly a
specimen is rejected at the laboratory’s specimen reception
as it has been incorrectly labelled, contaminated, collected
into an inappropriate anti-coagulant, or the sample quality
is compromised, for example, haemolysed or clotted
samples. Consumers on the other hand primarily focus on
the safety and comfort of the patient, although they also
have an interest in the quality of the sample. This tends to
Best Practice Pathology Collection in Australia
Asia Pacic Journal of Health Management 2016; 11: 1 53

translate into a stronger emphasis on the competence of
the pathology collector. While both industry and consumers
consider the process, for consumers this is more about the
degree of condence and safety in the way the collector
relates to the patient than the quality of the sample obtained.
The dierences in perspective between employers and
consumers mean the dierent competencies of pathology
collectorsarenotequallyvalued.Asanexample,acollector
with excellent communication skills and a high customer
focus made not be as technically competent, but be seen
by the patient as a ‘better’ collector. Blood collection can
be stressful for patients and so the importance of good
customer and communication skills to reassure the patient
cannot be over-emphasised and is a core requirement in a
training program. Possessing a qualication is not always
well correlated with actual performance, however it can
be a way to reassure consumers that pathology collectors
are suciently competent. The CHF [8] and consumer focus
group discussions identied that consumers were concerned
that credentialing of pathology collectors is not mandatory.
Case study employers seemed as a whole to be responding
to market preferences and were focused on all pathology
collection sta possessing a qualication. This is reected
in trends in enrolment and completions statistics of the
Certicate III and IV Pathology courses obtained from the
National Centre for Vocational Education Research [personal
communication]. The growth in Certicate III enrolments
and course completions over the ve-year period 2008-2012
has been a signicant 6% per annum.
Parts of the Australian pathology collection workforce
can be considered highly competent by world standards.
The preferred qualication of industry, the Certicate III in
Pathology, maps reasonably well against the competency
guidelines of National Accrediting Agency for Clinical
Laboratory Sciences (NAACLS), a United States-based
organisation which a literature search for this study revealed
to be world best practice. [16] The Certicate III in Pathology
is most similar to the NAACLS set of competencies than any
other set of comparable competency standards, covering
nearly all the main areas of competence in the NAACLS
standards at least to some degree. The areas of NAACLS
competence that the Certicate III arguably covers less
well are the theory elements relating to the anatomy and
physiology of body systems and pathologic conditions
associated with the body systems. Some of the non-technical
areas of competence identied in the benchmark NAACLS
standards, such as communication skills, condentiality,
professional behaviour and customer service skills generally,
are aorded more limited attention in the Certicate III
competencies. Case study employers and consumers in the
results of this study also identify these deciencies.
A signicant proportion of the workforce (estimated to be
between a third and a half) remains unqualied. Regulatory
reforms in relation to existing accreditation processes
(NPAAC Guidelines for Approved Pathology Collection
Centres (Third Edition 2013)) that take into account the
distribution of the pathology collection workforce in
regard to relevant possession of qualications need to be
considered.
Of even potentially greater concern is that a signicant
proportion of collections are undertaken by non-specialist
pathology collectors – general practitioners, practice
nurses, Aboriginal health workers, medical scientists, interns
and nurses in specic hospital wards and emergency
departments. Australian Institute of Health Innovation/
KIMMS data indicates this part of the collection workforce
contributes up to three times the haemolysis rates of
laboratory phlebotomists. (17) Management to reduce error
in pathology results from this source would need to consider
establishing minimum competence requirements for any
collection work (for instance competence in at least a single
unit of the Certicate III in Pathology qualication such
as ‘HLTPAT306C Perform blood collection’). Alternatively,
‘specialist’ pathology collection workers (who remain a
relatively low cost source of labour) could be more widely
deployed to ensure coverage especially in hospitals of
currently poorly covered services.
Conclusion
It is the conclusion of this study that the most eective
pathway to best practice pathology collection requires:
• Strongpoliciesandproceduresthatdenehow
pathology samples are to be collected, stored and
transported;
• Recognitionofthepatientasacustomerandinclusion
of customer service competencies in the core training
and ongoing assessment of collectors; and
• Apathologycollectionworkforcethatiscompetentand
presents to consumers with a credible qualication and
in a professional manner.
Many of the employers interviewed in the course of this
study concluded that increasingly improved training
was key to progressing towards best practice pathology
collection. They advocated universal adoption of the
Certicate III in Pathology as the minimum level of training
that is required as preparation for safe pathology collection
Best Practice Pathology Collection in Australia
54 Asia Pacic Journal of Health Management 2016; 11: 1

practice. A majority of pathology laboratories, both public
and private, were attempting to set this benchmark
unilaterally as the minimum for recruitment in their own
organisations, although there remain many unqualied
pathology collectors in pathology services.
In addition to the training of (specialist) pathology collectors,
other individuals who collect pathology specimens (nurses,
general practitioners, Aboriginal Health Workers, etc.) in lieu
of pathology collectors need to have received minimum
levels of training. A single unit of the Certicate III in Pathology
qualication — ‘HLTPAT306C Perform blood collection’ — is
considered sucient and there is no compelling reason why
training for this unit needed to be anything other than an
on-the-job, in-house training process.
Competing Interests
The authors declares that they have no competing interests.
References
1. Plebani M. Errors in clinical laboratories or errors in laboratory
medicine? Clin Chem Lab Med. 2006;44(6):750–759.
2. Department of Human Services. ‘Medicare Group Reports’ website.
Commonwealth Government of Australia. Available from: https://
www.medicareaustralia.gov.au/statistics/mbs_group.shtml
3. Dale JC, Novis DA. Outpatient phlebotomy success and reasons for
specimen rejection. Arch Pathol Lab Med. 2002;126:416–419.
4. Bonini P, Plebani M, Ceriotti F, Rubboli F. Errors in laboratory
medicine. Clinical Chemistry. 2002;48:5691–698.
5. Lippi G, Guidi GC, Mattiuzzi C, Plebani M. Pre-analytical variability:
the dark side of the moon in laboratory testing. Clin Chem Lab
Med. 2006;44(4):358–365.
6. Bayley K. Pre-analytical errors: make a dierence. WA: Path West
Laboratory Medicine; 2011. Available from: http://www.rcpaqap.
com.au/kimms/gendocs/uploadedles/Pre-analytical%20Errors%
20-%20Make%20a%20dierence%202011.pdf
7. National Pathology Accreditation Advisory Council (NPAAC)
Guidelines for approved pathology collection centres (Requirements
for Medical Pathology Specimen Collection). 2nd Edition. NPAAC;
2012. Available from: www.health.gov.au/internet/main/publishing.
nsf/Content/health-npaac-publication.htm
8. Consumers Health Forum of Australia (CHF). Quality Use of
Pathology Consumer Consultation Project. CHF; 2010.
9. Pilbeam V, Badrick T, Ridoutt L. Best practice pathology collection.
Canberra: Department of Health; 2013.
10. World Health Organization (WHO). WHO guidelines on drawing
blood: best practices in phlebotomy. Geneva: WHO; 2010.
11. Lavery I, Ingram P. Venepuncture: best practice. Nursing Standard.
2005;19(49):55-65.
12. MaxwellH.Updatedphlebotomypractices:proceduresforthe
collection of diagnostic blood specimens by venipuncture.
Available from: http://96.36.117.186/NewsLetter.pdf
13. Ridoutt L, Pilbeam V, Bagnulo J, Graham D. Career structures and
pathways for the scientic workforce in medical pathology
laboratories – nal project report for the Quality Use of Pathology
Program. Canberra: Department of Health and Ageing; 2011.
14. Australian Bureau of Statistics. Population Census Data (2006).
Available from: http://www.abs.gov.au/census
15. Dale JC, Howanitz PJ. Patient satisfaction with phlebotomy
service data analysis and critique. College of American
Pathologists. 1995.
16. National Accrediting Agency for Clinical Laboratory Science
(NAACLS) The Standards of Approved Educational Programs for
the Phlebotomist. US: NAACLS; 2001. Available from: http://www.
naacls.org/PDFviewer.asp?mainUrl=/docs/standards_phleb.pdf
17. Australian Institute of Health Innovation. A benchmark study of
the frequency and variability of haemolysis reporting across
pathology laboratories. Sydney: Macquarie University; 2015.
ISBN: 978-1-74138-432-1.
Best Practice Pathology Collection in Australia
Asia Pacic Journal of Health Management 2016; 11: 1 55