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Scientific
Feature Performance Evaluation of a Third Party Enzymatic Total
Bile Acid Assay for use on the Roche Integra 800 Analyzer
Development of a Risk Assessment Program of Potential Serious
Laboratory Non-Conforming Events (NCEs)
Official publication of:
PM #40063021
Winter
Fall 2017
2014
| Vol
| Vol
79,
76,
No.
No.
34
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contents
in focus scientific society news
4
Message from the
17 31
Chief Executive Officer Performance Celebrating 80 years
Evaluation of a Third
5
Message from the President
Party Enzymatic Total
Bile Acid Assay for
7 use on the Roche
The most important piece of Integra 800 Analyzer
the learning puzzle: You. by Jianing Chen, Hilary Smith,
by Michele Perry Heather Tarr, Yu Chen
32
23 Board of Directors Election Results
perspectives Development of a
2017 AGM Minutes
9
Risk Assessment
Starting to Find Light: Program of Potential 33
A Reflection of Knowledge Serious Laboratory Welcoming Maria Klement:
2018 CSMLS Vice-President
Gathering Efforts on Non-Conforming
Indigenous People in Our
Profession Events (NCEs) 34
by Andrea Park IFBLS and You
A Healthcare Perspective
by Laura Zychla 35
Newly Certified Graduate
Employment Survey
36
Position Statements
37
CSMLS Announces:
Shorter MLT Exams
12 Mentorship Program
Talent Management 101
A Career Perspective Canadian Pathologists’ Assistants (PA)
by Ashley Rego certification process
13 38
Three Ways New Graduates New Strategic Plan
Can Contribute in the 39
Medical Laboratory CSMLS – The National Voice of Canada’s
Profession Medical Laboratory Profession
A New Graduate Perspective
by Maria Roussakis
14
Breaking the Chain of
Infection in the Laboratory
A Safety Perspective
by Eoin O’Grady English Edition | fall 2017
csmls.org 3
MESSAGE FROM THE CHIEF EXECUTIVE OFFICER
Progress or
Pandora’s Box
T
he Works and Days is an ancient ability to correctly interpret their results in
Greek poem. If you haven’t read it, isolation of patient history and other health
I don’t blame you. It’s 800 lines long. factors. On the other hand, patients taking a
Written around 700 BCE by Hesiod, the proactive role in managing their own health
poem is probably most famous for its telling sounds like a positive step. If arming patients
of the myth of Pandora. According to the with more data leads them to make healthier
Christine Nielsen myth, before Pandora – the first woman on lifestyle choices, what's the harm? It is their
Chief Executive Officer Earth – man lived a life free of illness, evil data after all.
and toil. (No misogynistic undertones here!) A while back, a member of the CSMLS
Later, Pandora opens a jar, or box depending staff volunteered to be a guinea pig and take
on your translation, which releases all the part in a 23andMe test. The idea was to see
evils of the world. This is where the phrase how a member of the lay-public would feel
“Opening Pandora’s Box” comes from, having sudden access to a vast amount of
signifying a small or innocent action that genetic data. Would they be ill-prepared to
turns out to have severe and broad negative respond to the results? We chronicled that
consequences. The phrase has been used story in an earlier issue of the CJMLS (see
when describing the potential effects of Winter 2015). It’s definitely worthy of a read
genetic testing and patients taking a more if you missed it. (He still hasn’t unlocked his
direct role in the ordering of diagnostic tests. results for Parkinson’s disease.)
Genetic testing is proliferating at a The debate over whether consumer access
tremendous rate. 69,000+ genetic testing to genetic testing is good or bad is irrelevant.
products are on the market and it is estimated The testing is here. Innovative companies
that 10 new tests are developed every day. will continue to find ways to make more and
Whether through their health care provider more testing available directly to patients.
or through direct-to-consumer products like This will be the reality we all will have to
like 23andMe and Ancestry.ca, patients now accept; some of us begrudgingly.
have access to a ton of data about themselves The benefits of genetic testing and the
The debate over whether and their health. Technology has enabled this implications for personalized medicine
consumer access to genetic and has opened Pandora’s proverbial box. are incredible. Revolutions in disease
Much like Pandora, you can’t simply put the management and patient care are coming
testing is good or bad is evils back in the box once opened. They’re and the lab has a front row seat for the show.
irrelevant. out there. Now, should patients have access There will be ethical concerns and dilemmas
to this potentially volatile information? that we will have to confront for sure. But we
The testing is here. You can argue both sides of this debate. should embrace this future with open minds
There are valid concerns about a patient’s as well as open eyes.
4 CJMLS Fall 2017
MESSAGE FROM THE PRESIDENT
Building a Solid
Foundation for a
Successful Future
T
here is a time in everyone’s life where new Strategic Plan and the four strategies
they have to rely on the help of that will be put into place beginning in 2018.
others. I was reminded of this when We recognize that the CSMLS faces an
early this year the CSMLS Board of Directors environment where many elements are
headed into Strategic Planning. This was by uncertain and ambiguous. Some are just
no means a solo endeavour for anyone. We plain challenging. Nobody has a crystal
relied heavily not just on each other, but on ball. However, by working together on the
Mary Costantino many other people. same path we can look to the future with
2017 CSMLS President We leaned on the expertise within the confidence.
CSMLS office. Their guidance and advice as CSMLS is recognized as a leader with
we prepared to map the future of the Society many strengths and assets already in place.
was incredibly important. So was the voice This strategic plan will help us continue as
and opinions of the stakeholders within the that leader, and support future success; not
medical laboratory community. We listened just for the Society, but for everyone in the
to everyone; regulators, provincial societies, medical lab community, including you.
educators, students, current members and
retired members.
Once we had all this information
gathered, it was under the facilitation of our
consultant, Meredith Low, that we were able
to start sorting and sifting through it all. I For those of you who have
was so impressed by her ability to help us
not just see the forest, but the trees, leaves participated in strategic
and roots too. Although, at the onset, all that planning processes, the outcome
information was overwhelming, common
themes began to emerge and we used them is more than a mere set of bullet
to guide us in setting the strategies for the points on a page. We aimed to
future of the Society.
For those of you who have participated create an integrated framework,
in strategic planning processes, the outcome where the vision, mission,
is more than a mere set of bullet points on
a page. We aimed to create an integrated strategies, tactics and activities,
framework, where the vision, mission, all flowed from and support
strategies, tactics and activities, all flowed
from and support one another. Take a look one another.
on Page 38 for the full explanation of the
csmls.org 5
IN FOCUS
The Inbox
The Inbox is meant to provide a public forum for us to address questions, concerns editorial and business office
or issues that are raised by members. CSMLS receives feedback through written 33 Wellington Street North
Hamilton, ON L8R 1M7
correspondence, email and through our various social media portals. If you have a Phone: 905-528-8642 Fax: 905-528-4968
question or comment you would like to have addressed in an upcoming issue, talk to Email: cjmls@csmls.org
us on Facebook, Twitter (@csmls) or through email at editor@csmls.org. Editorial Team Cathy Bouwers
Michael Grant
Christine Nielsen
“I found it very difficult to choose work in is the dollars that can be made while Scientific Editor Maurice Goulet
between all of the sessions at LABCON taking call, but with budget cuts in health
Contributors Jianing Chen
this year. There were so many I wanted care, and having more Point of Care (POC) Yu Chen
to attend that were happening at the equipment in emergency, the dollars to be Eoin O’Grady
Andrea Park
same time. I’m not sure if it’s possible made do not match what it costs to live here. Michele Perry
but isn’t there a better alternative The hospital also pays the X-ray techs $5 Ashley Rego
to how the sessions are organized?” an hour more. We could never figure out Maria Roussakis
Hilary Smith
There is a lot of preparation and consideration why. With the lab accreditation requirements Heather Tarr
when it comes to planning the sessions now, the tasks and paperwork have increased Laura Zychla
for LABCON. Our aim in having multiple to ridiculous proportion.
concurrent sessions is to provide a variety of The personal conflict in the lab was Published by:
topics for our members and to ensure that momentous, a controlling power-hungry
there is something for everyone. Sessions are supervisor who barked orders, insulted
divided based on their topics. Those topics people and made offhand snide comments.
are then captured in specific categories and Swift and hard condescension for not doing
Dovetail Communications Inc.
each time block of concurrent sessions offers 12 things at once and zero support for the 30 East Beaver Creek Road, Suite 202,
a session from each category. harassment of a co-worker. Richmond Hill, ON Canada L4B 1J2
We also realize that not everyone can I will never work in another lab as long as Phone: 905-886-6640
www.dvtail.com
attend all of the sessions at LABCON, or even I live. I am so done with politics and egos and
attend LABCON at all. However, we continue ridiculous workloads. Executive Editor Theresa Rogers
to find ways to bring learning opportunities to I am now working at my second career Art Director Katrina Teimourabadi
our members. Beginning at LABCON2016, that I had on hold for a while and even Associate Publisher Chris Forbes
CSMLS now records select sessions to offer though I feared it would take too long to Director, Sales Operations Beth Kukkonen
as webinars for those who were interested but build a clientele, I would rather starve than V.P. Production Services Roberta Dick
weren’t able to attend. There are new webinars spend another day in that lab. Production Coordinator Stephanie Bellows
available from LABCON2017. View our full Thanks. – Anonymous Dovetail Communications
list of webinars at webinars.csmls.org. Susan A. Browne, President
Keep an eye out for our other upcoming On behalf of CSMLS, we are saddened to hear publisher’s statement and policy
in-person learning events such as Dinner & stories such as this. However, we are aware that
The editorial team determines and edits content for the
they exist. We are committed to creating and
Dialogue and save the date for LABCON2018 implementing resources to help our members.
Canadian Journal of Medical Laboratory Science. Contributors
include staff, partners and CSMLS members. Although
in Windsor, Ont. from May 25 - 27, 2018. Most recently, CSMLS launched the Mental CSMLS encourages the sharing of various opinions and
Health Toolkit – an online resource to provide perspectives in an effort to promote thoughtful discourse,
members and organizations with the means contributors’ views do not necessarily reflect the views of
Letter to the CEO to identify, monitor and implement change the Society. We reserve the right to edit all submissions for
for the betterment of the medical laboratory length and clarity. Contents may be reproduced only with
Dear Christine, profession. You and your organization do not
permission.
I can’t begin to tell you how much I stand alone in trying to work through mental Scientific papers are accepted by the Canadian Journal of
Medical Laboratory Science on the understanding that they
appreciated your message in the Spring 2017 health issues in the workplace. The CSMLS
have not been published elsewhere.
journal. Mental Health Toolkit can be a starting point
in obtaining information, support services The Journal is a quarterly publication and is owned and
I recently officially retired. I too had published by the Canadian Society for Medical Laboratory
and treatment for mental health issues for
reached the point of no return. There was individuals, employers and organizations.
Science (CSMLS). Canada Post Publications Mail Agreement
#40063021.
nothing left of me to defend myself or to care
For subscription information contact memserv@csmls.org.
that I was being beaten down daily. -Christine Nielsen, CSMLS CEO
The main draw to the remote community I Learn more at mentalhealth.csmls.org. Advertising inquiries can be sent to editor@csmls.org.
Return Postage Guaranteed
ISSN 1207-5833
6 CJMLS Fall 2017 Printed in Canada
The most important piece
of the learning puzzle: You.
L
earning seems like it should be a fairly simple thing. We’ve been doing it all of our lives traction over the last decade. Treat your
from the moment we were born, we’ve been learning. We learned to eat, walk, talk body well and your mind will function
and play with our friends but then, things got formal. School started and the learning better too. Strengthen your learning
continued, even if we didn’t really want to participate. Now we’re adults and the learning is goals by eating nutritious foods, sleeping
still continuing. Spoiler alert: It never ends. So we better get used to it, right? enough and exercising. There are foods
A learning provider does many things when putting together a course, seminar or that claim to improve memory and
presentation; they research, write learning objectives and hopefully use sound learning cognition such as foods rich in omega
techniques to make sure you get everything you should out of your learning experience. 3 fatty acids (found in fish, flax seeds
Despite all this, you can still walk away never having learned a thing, or at least not as much and nuts) and flavonoids (found in dark
as you should have or expected to. It turns out meaningful learning requires effort.1 This chocolate, green tea and wine). Sleep
means that you can’t just show up. You need to be engaged, motivated and disciplined.2 Think helps to move new information into your
back to your best learning experience. Did you just show up and all the knowledge landed in long-term memory. Exercise can boost
your head or did you have to put some effort into it? the oxygen flow to the brain and in turn
So how can you become a better and, more importantly, an engaged, motivated and boost cognitive function. So go for a walk,
disciplined learner?3 enjoy a glass of wine, eat your chocolate
1. Adopt an attitude of learning. This is especially important if you’re learning something covered almonds and go to bed early all in
that has been mandated and it’s not your subject of choice or if the subject will be quite the name of being a better learner!
challenging for you. Embrace a positive attitude and an open mind or even adopt a “fake
it until you make it” attitude and remind yourself of it every time you open the course Five simple concepts to becoming a better
material. learner. I’m excited to give these a try the
2. Take notes. There has been research conducted on note- next time I dive into a new subject. We
taking and it reveals that your notes should be organized, will also do our best to remind you of
these before you start your next course
Keywords
reviewed many times, re-stated in your own language,
reflected on and connected to your existing knowledge. Detailed or webinar. Do you have tips to be a
One simple approach to note-taking is the Cornell Notes better learner? I would love to hear them.
method. Simply divide your page into three sections: Send me a quick message via email at
• The area on the right is to take detailed notes. michelep@csmls.org or on Twitter
• The narrow area on the left is to note keywords and @micheleaperry.
phrases as you review your notes. Summary
• The bottom area is to write a brief summary of the
subject.
3. Ask questions. If you don’t understand a concept, ask. Chances are you aren’t the only one ReferenceS
wondering. As my father always says, “The only stupid question is the one you don’t ask.” 1 http://www.leadinglearning.com/podcast-
It’s a phrase I’ve repeated many times during my career, especially while training someone. episode-53-learner-responsibility/
2 http://www.leadinglearning.com/podcast-
If you’re too afraid to ask a facilitator in person, you can always do a little research to try to episode-53-learner-responsibility/
understand the concept and ask later. 3 10 Ways To Be a Better Learner, Jeff Cobb,
4. Practice. Perhaps you’ve heard of Malcolm Gladwell’s “10,000 Hour Rule”. The notion is 2012
that to achieve greatness you need 10,000 hours of practice. While this may seem like an
extraordinary amount to practice for a simple professional development course, it drives
home the idea that you can’t just sit and learn about a concept and expect to be able to
execute it immediately. Remember how nervous you were the first time you collected Michele Perry
blood? Think of how much you improved once you had 50 “pokes” under your belt? You Manager, Learning Services
can apply the same principle to learning just about anything. CSMLS
5. Take care of yourself. This isn’t a new concept but certainly one that has gained some
csmls.org 7
PERSPECTIVES The Perspectives section of the Canadian Journal of Medical Laboratory Science (CJMLS) seeks to provide thoughts, insights, and opinions from individuals with different points of views. We hope that as this section evolves, it allows us to present a broader array of topics that reflect the varied careers and experiences of our members. If you are interested in contributing to the Perspectives section, email us at editor@csmls.org.
A health care Perspective
Starting to Find Light:
A Reflection of Knowledge Gathering Efforts on
Indigenous People in Our Profession
I
have to admit, I didn’t realize how much I didn’t know.
Please be kind as I stumble to find the right words and if
I approach sensitive subjects in an awkward way. Think
of me as reaching my hand out to you for support. It is only
through your experience and knowledge that I will truly
comprehend the intricacies of our nation’s indigenous story –
past and present.
This is my story of the first steps taken to understand the
landscape and I hope it helps others who are standing in the
shadows. I am far from knowing it all, but am are willing to
learn and support the Canadian government’s call to help
others grasp the situation with greater conviction.1
I had heard news broadcasters talk about the struggles of
indigenous communities over the years and recognized the
diagnostic and testing connection to our profession – greater
health disparities, lower socioeconomic status, lack of health
care professionals to support reserves and remote areas, impact
of climate change on health, etc. “Medical laboratory assistants
are on the front line taking samples from patients and it is
important that they be equipped to manage themselves with
all cultures, respecting individuality and personal customs,”
noted Brenda Lee Senecal MLT, Diagnostic Services Manitoba.
Colleges and Institutes Canada2 had previously distributed a
series of environmental scans (2005, 2010) that highlighted
the significant reliance of indigenous people on Canada’s
publicly-funded colleges, institutes, polytechnics, cégeps and
universities with a college mandate to obtain education as well
as the barriers for their recruitment and retention, the main
environment in which our medical laboratory professionals are
taught.3
With the change in government, Christine Nielsen, CSMLS
CEO, and I knew it was the right time to shine light on the lack
of information our organization and profession seems to have
on the topic. One of our first steps was to attend the “Working
With Aboriginal People: Recruiting and Retaining” education
session in April 2017, held by Winston McLean, President
of Iron Wolf Consulting and Lionel Laroche, President of
Multicultural Business Solutions. I also wanted to reach out
Top and middle: Audience participates in “Working with Aboriginal People:
to our members as well and hear their stories so a call for Recruiting and Retaining” education session. Photo: W. McLean
information was made in the CSMLS eNews. Christine was
able to attend the Research Canada’s Health Research Caucus Bottom: Winston McLean hosts “Working with Aboriginal People:
Reception at Parliament Hill on Indigenous Health Research Recruiting and Retaining” education session. Photo: W. McLean
csmls.org 9
PERSPECTIVES
in Canada (June 2017), a knowledge and advocacy event featuring scientists, researchers, programs, including increased social
members of parliament and senators. and technical support for high school
I started asking in-depth, potentially intrusive and even cliché questions about indigenous graduation rates that include mathematical
people because I needed somewhere to start. I stripped away the years of muffled broadcaster and science requirements, cultural supports
words which had downplayed the truth and minimized the gravity of the situation. It’s hard for indigenous students from remote areas
to ask tough questions about a vulnerable population, especially as an outsider. I also know who attend post-secondary programs
it’s hard for people to tell their stories – it’s a sensitive and potentially politically charged in large cities and cultural awareness
conversation but an important one to have. courses for students on the expectations
My heart broke as I heard some of the realities of indigenous students in medical laboratory of the professional workplace. Senecal also
programs, the lack of support for those who come to our labs and the lasting effects of the suggested encouragement for using cultural
Indian Residential Schools. However, I also had conversations that were uplifting and languages in the clinical settings to support
intriguing – stories about strength, willpower and cultural unity in the face of political and communication with indigenous elders.
societal turmoil, a fact that shouldn’t be forgotten. I believe it is important that government
McLean described a historical event that hit everyone in attendance. There wasn’t a dry eye funding is streamlined and available to assist
to be seen. But this isn’t about how we felt, it’s about what happened. McLean taught us about indigenous students.
the approximately, 150,000 indigenous children who were removed from their families and In addition, we have to recognize the needs
communities and forced to attend residential schools. of instructors and administrators who may
By the mid-1970s the majority of the 139 Indian Residential Schools had been closed, the not be familiar with the indigenous culture
last closing in the mid-1990s. It wasn’t until 2007 that the implementation of the Residential or the requirements to foster retention of
School Settlement Agreement began with the aim of bringing a fair and lasting resolution.4 indigenous students. Noelle Cater, MLT,
CAE, Instructor for Red River College,
“This morning our elders held a condolence ceremony for those who never heard an described this concept, “Indigenous students
apology, never received compensation, yet courageously fought assimilation so that we tend to have many issues to overcome just
could witness this day. … Never again will this House consider us the Indian problem to make it into a structured program. From
just for being who we are.” my experience teaching them, they also tend
~ Chief Phil Fontaine, National Chief of the Assembly of First Nations5 to have daily struggles that influence their
ability to succeed. In this respect, I think
Coincidentally, a few weeks later I was reintroduced to the concept of intergenerational that instructors need more training to assist
trauma, when serious trauma affects the children and grandchildren of those who had the them in mentoring and counselling when
first-hand experience. This time, the world had started to unfold the biological science behind needed, such as cultural training and crisis
the concept. My thoughts flashed back to the Indian Residential Schools. management.”
Researchers at Mount Sinai hospital in New York, studied the genetics of Jewish people Where does the information gathering
who had experienced the horrors of the Nazi regime and compared their family genetics to go from here? I am going to talk more with
those who had not been in Europe at the time. “To our knowledge, this [study] provides the members about the needs of the indigenous
first demonstration of transmission of pre-conception stress effects resulting in epigenetic patient population and write a follow-up
changes in both the exposed parents and their offspring in humans,” Rachel Yehuda, team article. In the meantime, each of you can
lead, was quoted.6 According to the American Indian and Alaska Native Genetics Research contribute to the conversation and if you
Guide created by the National Congress of American Indians (NCAI), studies have shown that haven’t already, begin thinking about how
various behaviour and health conditions are due to inherited epigenetic changes.7 you can advocate too.
As a health care profession, we can support indigenous communities as our nation rectifies
the past and looks toward improving the future. For example, I learned about the importance • Share your story – reach out to
of medical laboratory academic programs incorporating indigenous cultural training and the research@csmls.org
creation of programs focused on the needs of indigenous students. It was recognized that a • Learn more about the history of indigenous
more flexible and personalized approach to education would be needed. According to Tricia communities to develop a foundation of
VanDenakker, BSc, ART, MLT, Deputy Registrar at CMLTM and former Manager for Training understanding for the culture.
and Staff Development, Diagnostic Services Manitoba, “I believe it is rare to have a program - Attend a cultural training session
available specifically for indigenous students, but such programs can help provide jobs on - Follow governmental news stories
reserves and improve the access to and quality of health care on reserves. I feel it is important • Contribute to data collection efforts that
for existing programs to reserve spots specifically for indigenous applicants. This is key to help clarify health disparities and target
ensuring equity for the indigenous populations in the existing education systems.” support
VanDenakker highlighted some of the critical components to achieving high-quality • Examine your academic program’s cultural
10 CJMLS Fall 2017content and discuss gaps with ReferenceS
2017 from https://www.aadnc-aandc.gc.ca/
administrators 1 Indigenous and Northern Affairs Canada
eng/1100100015697/1100100015700
(2017). Truth and Reconciliation Commis-
I couldn’t conclude this article 6 Church D. (2015). Genetic tags can pass
sion of Canada. Last retrieved Jun 19 2017
better than with these words by trauma from one generation to the next.
from https://www.aadnc-aandc.gc.ca/
Cater: “With politics focusing more HuffPost. Last retrieved un 19 2017
eng/1450124405592/1450124456123
from http://www.huffingtonpost.com/
on the social determinants of health 2 Previous known as the Association of Cana-
dawson-church/genetic-tags-can-pass-
and programs favouring equity and dian Community Colleges
tra_1_b_8068046.html
justice, maintaining medical laboratory 3 Association of Canadian Community Colleges
7 Pember MA. (2015). Trauma may be woven
(2010). Colleges Serving Aboriginal Learners
programs that include the indigenous into DNA of Native Americans. Indian Coun-
and Communities 2010 Environmental Scan.
peoples are tantamount, whether they try Today. Last retrieved Jun 19 2017 from
Last retrieved Jun 28 2017 from http://www.
https://indiancountrymedianetwork.com/
be centered on our students or on our afn.ca/uploads/files/accc-communities.pdf
news/native-news/trauma-may-be-woven-
patients. There is a very significant need 4 Indigenous and Northern Affairs
into-dna-of-native-americans/
in the Canadian population today to Canada (2017). Indian Residential
incorporate more programs that give Schools. Last retrieved Jun 19 2017
from https://www.aadnc-aandc.gc.ca/
indigenous peoples the opportunity to
eng/1100100015576/1100100015577
fully participate in society. I believe that 5 Indigenous and Northern Affairs Canada Laura Zychla
this would serve our profession well (2010). Indian Residential Schools Statement Researcher, CSMLS
and make us a stronger, healthier, more of Apology - Phil Fontaine, National Chief, As-
cohesive country.” sembly of First Nations. Last retrieved Jun 19
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csmls.org 11PERSPECTIVES
A career Perspective
Talent Management 101
A
s a leader or manager in your lab, your initial game plan when it comes to recruiting
employees is to hire the best talent in the industry. But hiring the best of the best isn’t
all there is to it. It’s about hiring, training and retaining top performing employees and
building a solid team for your lab. This is called talent management.
“Talent management is about engaging the appropriate workforce,” says Kris Bailey,
Chief Executive Officer at In-Common Laboratories in Toronto, ON. During her session at
LABCON2017, Bailey spoke on the subject of talent management and explained that it is more
than just recruiting the best people for the job. “It’s about challenging and engaging people and
it’s about how you work as a manager or leader in the organization,” she explains. “When you
link all of those pieces together, it’s talent management.”
During her session, Bailey touched on Maslow’s Hierarchy of Needs, which is a motivational
theory in psychology comprised of a five tier model of human needs1. Maslow stated that When you’re looking for staff, you’ll want
people are motivated to achieve certain needs and that some needs take precedence over others. to make sure you have all of these in play.
The Hierarchy of Needs was used in the presentation to define the types of employees you will You can’t have a functioning team that is too
encounter and how their needs differ from one another. According to Bailey, to make up the heavy in each tier than the other. “You want
best team, you’re going to want a mix of people from each tier of the model. a few ‘A’ players,” says Bailey. “Some that like
to be thanked for the work, the cheerleaders,
Physiological Needs and then you’ll want the ones that come
A human being’s most basic need is for physical survival. Food, water, shelter and clothing all in and do a great job but that’s all they can
land within the need to simply live. These are the types of employees who go to work because give…for now.”
they simply need the paycheque Talent management is more than just
hiring a good team of individuals. You need
Safety Needs to be able to retain them. “So many people I
In the absence of economic safety, due to economic crisis or lack of work opportunities, safety hear have problems related to the retention
and security needs include job, personal and financial security which consist of benefits, of staff,” Bailey explains. “I often hear, ‘I can
pensions, safe work environments and fair work practice. These are the employees who go to recruit them but I can’t retain them’.”
work because they simply feel a sense of security where they are. It also takes asking yourself, “What can
I do as a leader to keep my staff motivated
Social Belonging Needs and engaged?” Bailey’s suggestion is to
Humans have a need to maintain emotionally significant relationships and to feel a sense of bring excitement to the table and be able
belonging, whether it be with large or small groups. For example, some large social groups to communicate effectively. Identify what
include relationships with co-workers or professional associations. Small social groups include is important to them as a team and as
relationships with mentors, colleagues and confidants. It is important for employees to feel individual members of each tier and make
socially accepted with their co-workers. They simply appreciate going to work because they sure to recognize them when they’ve gone
enjoy the people they work with and the relationships they’ve made. above and beyond. With all these factors of
talent management in play, you, your team
Esteem Needs and your lab are sure to achieve success.
All humans have a need to have self-esteem and feel respected. They want to be desired, accepted
and valued by others. People often engage in a specific profession to gain recognition whether ReferenceS
it is through a job title or prestigious job assignments. Typically these employees go to work 1 http://www.encyclopedia.com/medicine/
because they like the work, they’re good at it and they like to be recognized or thanked for it. encyclopedias-almanacs-transcripts-and-
maps/maslows-hierarchy-needs-0
Self-Actualization Needs
This level of need is described as a person’s desire to accomplish everything that they can and Ashley Rego
reach their full potential. These are the types of employees who not only need to achieve their Marketing and Communications
goals, but also master their responsibilities. They are the type to take on challenges, to be the Associate
subject matter experts, to join every committee, to better themselves and ultimately want more CSMLS
in life.
12 CJMLS Fall 2017A new graduate Perspective
Three Ways
I
t seems wild to think that only a year ago,
New Graduates Can Contribute in
I graduated from the Medical Laboratory
Sciences program at the University of
Ontario Institute of Technology (UOIT).
Since graduating and successfully completing
the CSMLS exam, I have been utilizing my
the Medical Laboratory Profession
laboratory skills and knowledge by working in
the core laboratory of a community hospital,
as well as a larger hospital corporation. I to become a better laboratory professional.
have greatly enjoyed rotating between the Many hospitals have Continuing education need not be expensive
disciplines of chemistry, hematology and opportunities for either, as there are many opportunities
transfusion medicine, as this has allowed available for free professional development.
me to gain further knowledge and keep my employees to complete Many professional societies offer free courses
varied skills up to date. At the start of anyone’s and webinars to their members, such as
career, gaining as much clinical experience research within their CSMLS, CAP, etc. In addition, many hospitals
as possible is crucial, in order to actively
work in the profession to serve patients and
field or to participate in host Grand Rounds in which staff members
can attend. I had the pleasure of attending
community members. It is very easy to get validation studies. a Transfusion Medicine Grand Rounds
too caught up in the daily bench work to during my clinical practicum that was very
think of anything else. However, there are educational and broadened the scope of my
other ways new graduates can contribute to eligible to retire and many jurisdictions knowledge on the subject. Finally, for those
the profession. in Canada are already facing shortages. with irregular schedules or where location
For this reason, promoting the laboratory is an issue, several websites offer online
Participating in projects and research: profession to potential students is crucial webinars and virtual conferences that you
While it may seem like a big responsibility and it involves being active within the can attend free of charge. An example of
to take part in projects or clinical research, wider community outside the lab. The such a website is LabRoots.com, which offers
new graduates should take advantage of CSMLS has an Ambassador program where webinars and trending articles on innovative
these opportunities. Many hospitals have volunteers give presentations to schools research in the laboratory. The medical
opportunities for employees to complete and community groups about the medical laboratory profession is constantly changing
research within their field or to participate laboratory profession. Another way that due to various advances in technology and
in validation studies. Performing research laboratory professionals can promote their diagnostics leaving a great deal of opportunity
or special projects within the laboratory profession is during the annual National for new graduates to learn and grow.
is beneficial to one’s career, since valuable Medical Laboratory Week in which they can As you begin your journey in your new
knowledge and experience is gained that can increase the public’s understanding of their career, you should always think about what
help you stand out when applying for more work. These can be through initiatives at the you can do next to advance yourself both
senior positions. Once these studies have been organizational level, such as informational personally and professionally. Make your
completed, opportunities for publication are booths about the laboratory’s role in health mark and find a place for yourself as you enter
available in several Canadian and American care, or as social media initiatives, such as into the field. Show that you are eager to be a
clinical laboratory journals, such as the taking pictures or sharing information online part of the medical laboratory community.
Canadian Journal of Medical Laboratory about the laboratory. This past April, I had Being a keen professional is beneficial to your
Science by CSMLS, Laboratory Medicine by the opportunity to take part in organizing the professional growth and there is a great deal of
the American Society for Clinical Pathology Lab Week festivities at my organization and opportunity just waiting to be discovered.
(ASCP), or the Clinical Laboratory Science it was a very rewarding and fun experience.
Journal by the American Society for Clinical
Laboratory Science (ASCLS), to name a few. Always keep learning: Even though it is a Maria Roussakis
professional practice requirement of many Medical Laboratory
Promote the profession: It’s been said that regulatory colleges to maintain continuing Technologist,
within the next 10 years, half of the medical education, it should not merely be looked at William Osler Health System
laboratory profession in Canada will be as an obligation, but rather an opportunity
csmls.org 13PERSPECTIVES
A safety Perspective
Breaking the Chain of
Infection in the Laboratory
I
n 2016, the Public Health Agency of Canada received forty-seven necessarily physical contact. Indirect transmission requires a vector,
notifications of exposures or laboratory-acquired infections.1 such as an animal or insect.
Receipt of these notifications occurred as part of the federal
reporting system under the Human Pathogens and Toxins Regulations.2 Portal of Entry. Entry of the infectious agent can take place in one of
Laboratory-acquired infections (LAIs) are measured as all infections three ways: penetration, inhalation, or ingestion. The level and severity
that arise through laboratory or laboratory-related activities, of an infection may depend on the depth of penetration.
regardless of whether they are symptomatic or asymptomatic in
nature. As we know, you and your colleagues handle various biological Susceptible Host and all laboratory workers are included in this
hazards on a daily basis in the laboratory. It’s important to understand link. Once in the new host, various factors influence the severity of
the mechanisms by which biological hazards can be transmitted infection, including the status of the immune system. Immune status
from patients to workers, as well as between laboratory personnel. is influenced by conditions such as pregnancy, a pre-existing medical
Understanding the concepts and employing simple techniques condition or medications.
will contribute to a safer and healthier working environment for all Fully understanding the chain of transmission is important so that
laboratory staff. you are ready to break a link in the chain. Each link has a unique role
The transmission of biological hazards and subsequent infection in the chain, and each link can be broken through various means.
within a laboratory setting may be represented by a “chain” with each Breaking the chain requires specific action against any of the links in
“link” in the chain representing a factor related to the spread of these the chain (Figure 1). You are in control of some of the most effective
biological hazards. The chain of transmission is a stepwise process ways to break the chain of transmission. Protecting yourself involves
where all six of the “links” are required for transmission to occur referring to a written hazard assessment and using effective controls,
(Figure 1). such as Routine Practices. The idea for Routine Practices comes from
The links are Infectious Agent, Reservoir, Portal of Exit, Mode of the view that all laboratory samples are potentially infectious, even
Transmission, Portal of Entry and Susceptible Host. when they come from asymptomatic patients. A simple method to
care for yourself is to ensure you use proper handwashing techniques.
Infectious Agent. This is the disease-causing organism or pathogen. Handwashing must be performed after handling biological hazards,
For many illnesses and diseases, the pathogen is a virus or a bacterium. removing gloves, and before leaving the laboratory. These small
steps are part of a hand hygiene program that removes infectious
Reservoir. The infectious agent requires this natural
environment for survival. Reservoirs can be a person, an
animal, or an environmental component, such as soil or
water.
Portal of Exit. This infectious agent depends on this link
to escape the reservoir. If the reservoir is a human, then
the portal of exit may be any one of the samples found in a
clinical laboratory. These samples include blood, as well as
secretions and excretions such as saliva, feces, and nose or
throat discharges.
Mode of Transmission. Transmission of the infectious
agent occurs either directly or indirectly. Direct transmission
requires close association with the infected host, but not
14 CJMLS Fall 2017Figure 1. The Chain of Transmission. This image was adapted with the permission of Public Health Ontario. Public Health Ontario assumes no
responsibility for the content of any publication resulting from adaptation of PHO documents by third parties3.
ReferenceS
agents. Handwashing is so effective because it can break three links in
1 Public Health Agency of Canada. Laboratory Biosafety and Bios-
the chain of infection. Other ways to interrupt transmission include ecurity [Internet]. 2017 [cited 21 June 2017]. Available from: http://
effective immunization programs, safety-engineered sharps, training, www.phac-aspc.gc.ca/lab-bio/index-eng.php
disinfection practices and personal protective equipment. It’s also worth 2 Public Health Agency of Canada. Notifications [Internet]. 2017
mentioning the need to cover any broken skin, securing long hair, and [cited 21 June 2017]. Available from: http://www.phac-aspc.gc.ca/
the importance of never touching your face or mucous membranes with lab-bio/notifications-declarations/index-eng.php
3 Routine Practices and Additional Precautions In All Health Care
potentially contaminated materials.4 Settings, 3rd ed. Toronto: Public Health Ontario; 2017.
Preventing transmission of infectious agents to laboratory staff is 4 Canadian Biosafety Standard. 2nd ed. Ottawa: Public Health
an occupational health and safety issue. Both the employer and the Agency of Canada; 2015.
employee have responsibilities under workplace health and safety
legislation. Understanding the chain of transmission helps identify Dr. Eoin O’Grady, PhD, CRSP
where biological hazards come from; controlling those biological Manager of Occupational Health
hazards requires a conscious effort to break the chain of transmission to and Safety, University Biosafety Officer
protect oneself and others. University of Calgary
csmls.org 15SCIENTIFIC SECTION Performance Evaluation of a Third Party Enzymatic Total Bile Acid Assay for use on the Roche Integra 800 Analyzer pg.17-21 Development of a Risk Assessment Program of Potential Serious Laboratory Non-Conforming Events (NCEs) pg.23-28
Performance Evaluation of a Third Party
Enzymatic Total Bile Acid Assay for use
on the Roche Integra 800 Analyzer
Jianing Chen, MD candidate1,2, Hilary Smith, MLT1, Heather Tarr, MLT1, Yu Chen, MD, PhD1,3
Department of Laboratory Medicine, Dr. Everett Chalmers Regional Hospital, Horizon Health Network, Fredericton, NB, Canada
1
2
School of Medicine, University College Cork, Cork, Ireland
3
Department of Pathology, Dalhousie University, Halifax, NS, Canada
ABSTRACT Introduction
Objectives: Serum total bile acid (TBA) is the most sensitive and The intrahepatic cholestasis of pregnancy (ICP) is the most common
specific biomarker for diagnosis of intrahepatic cholestasis of pregnancy-specific liver disease that typically presents in the third
pregnancy, the most common pregnancy-specific liver disease. trimester. With a reported incidence between 0.2–2%, it is most
There is an increasing clinical demand for a significant reduction prevalent in Northern European and South American countries1,2.
of testing turn-around time to support the care of pregnant women. As a reversible condition in later pregnancy, its severity varies1,2.
The aim of this study was to evaluate the analytical performance of Several pedigree studies have demonstrated the familial clustering
a third party enzymatic TBA assay (Diazyme Laboratories) for use of ICP3. ICP appears to have an autosomal dominant, sex-limited
on the Roche Integra 800 analyzer so that it could be performed in inheritance pattern which is linked with the ATP binding cassette
house. subfamily B member 4 (ABCB4) gene for up to 14% of cases in
the UK who have a positive family history1-7. Nonetheless, other
Methods: The Diazyme total bile acid assay was evaluated using genes, ABCB11 and ATPase phospholipid transporting 8B1
the Clinical and Laboratory Standards Institute (CLSI) evaluation (ATP8B1), also show some linkages to ICP7-9. Sex hormones are
protocols. Split patient samples were compared with the Bio Quant also thought to be related with ICP. Estradiol-17β-D-glucuronide,
total bile acid kit (supplied by Diazyme Laboratories) on Integra a type of estrogen metabolite found to be cholestatic in animals,
400 (n=48), and the LC-MS/MS assay (n=30). is suggestive as a contributing factor10. In addition, sulphated and
glucuronidated progesterone metabolites are increased in ICP
Results: Within-run and total imprecision were 1.0% and 2.5% at patients, which may play a role in its pathogenesis10.
10.8 µmol/L, 0.5% and 1.0% at 30.7 µmol/L, and 0.5% and 1.1%
at 111.4 µmol/L respectively. There was no sample carry-over. Pruritus especially on palms and soles commonly appears
Compared to the Bio Quant total bile acid kit, the Diazyme total bile in the third trimester but it can also develop in the first or
acid assay demonstrated an R2 value of 0.9908, with an average bias second trimester1,10. Steatorrhea, increased aminotransferase,
of 2.4%. Compared to LC-MS/MS, the Diazyme total bile acid assay malabsorption of fat-soluble vitamins, and weight loss are other
demonstrated an R2 value of 0.9904, with an average bias of -8.3%. symptoms of ICP. Clinical features such as pruritus, abnormal
liver function, and raised serum total bile acid (TBA) usually
Conclusions: The Diazyme enzymatic total bile acid assay for use resolve rapidly after delivery. Although ICP is considered a benign
on the Roche Integra 800 analyzer is an acceptable routine method condition for the mother, poor fetal outcomes such as premature
for clinical laboratories. birth, fetal distress and intrauterine fetal death can occur. The
common management of ICP is to treat with ursodeoxycholic
Key Words: Intrahepatic cholestasis of pregnancy, total bile acid, acid (UDCA), which is effective in significantly decreasing
enzymatic assay, LC-MS/MS, method evaluation; comparison study TBA, aspartate aminotransferase, alanine aminotransferase,
csmls.org 17SCIENTIFIC SECTION
and bilirubin levels, and moreover reducing the symptom of known concentrations. They are categorized in levels of low, medium,
pruritus11-13. Although it is indicated that UDCA may reduce the and high. Each sample pool was run in replicates of 10 on a single day.
risk of adverse fetal outcomes such as preterm labor, respiratory The total CVs were determined using the same three sample pools run
distress, and neonatal hospitalization, there is no large scale study in singleton for 10 days.
to establish the beneficial effect of UDCA on poor fetal outcomes
and its mechanism of action is yet to be defined11. A recent study Sample carry-over
suggests UDCA with rifampicin may be more effective on patients It was assessed by assaying 3 replicates of a high concentration
who do not respond to UDCA alone14. sample (sample a), and immediately followed by 3 replicates of a
low concentration sample (sample b). Two different sets of samples
The diagnosis of ICP can be confirmed by the abnormal liver were evaluated. Through the calculation by using the equation,
function tests and elevated TBA. It is proven that the risk of k = (b1 - b3) / (a3 – b3), the carry-over k was determined as we described
fetal complications is linked with maternal serum TBA level, previously26,27.
and greater risk is associated with mothers having more severe
cholestasis15-19. TBA is the most sensitive and specific marker for Method comparisons
diagnosis1. Some clinicians may conduct elective early delivery at Remnant anonymous patient samples stored as frozen aliquots and
37 weeks of gestation in pregnancies complicated by ICP when previously tested and collected at Mount Sinai Hospital Laboratory
TBA reaches a certain threshold, e.g. 40 µmol/L2. Some studies (Toronto, Ontario, Canada) and Mayo Medical Laboratory (Rochester,
indicate that fetal complications may happen above that cut-off2,18. Minnesota, USA) were used. The method comparison study included
the Bio Quant total bile acid kit (supplied by Diazyme Laboratories)
Currently, the TBA testing is sent out of the province of New on Integra 400 (n=48), and the LC-MS/MS assay (n=30). The Bio
Brunswick with a long turn-around time of 2-3 weeks. There is Quant total bile acid kit was run by Mount Sinai Hospital Laboratory,
an increasing clinical demand for a significant improvement to whereas the LC-MS/MS assay was run at Mayo Medical Laboratory.
support the care of pregnant women. The aim of this study was The samples were run in singleton in a single run with the Diazyme
to evaluate the analytical performance of a third party enzymatic total bile acid assay on the Integra 800. All types of assays were run
TBA assay for use on the Roche Integra 800 analyzer so that it according to the manufacturer’s instructions.
could be performed in house.
Assay accuracy
Materials and Methods Nine College of American Pathologists proficiency testing samples
The Diazyme total bile acid assay (Poway, California, USA) was (TBLA 2015-2016) samples were used and run in singleton to
set up on the Roche Integra 800 analyzer (Indianapolis, Indiana, evaluate the Diazyme total bile acid assay accuracy.
USA), and evaluated using the CLSI evaluation protocols for
testing precision (EP5)20, accuracy (EP15)21, bias (EP9)22, and Statistical methods
estimating total analytical error (EP21)23. The method comparison Statistical analysis was carried out using Microsoft Excel. Regression
study included the the Bio Quant total bile acid kit (San Diego, analysis was used to evaluate method correlations, and Bland–
California, USA) and LC-MS/MS (reference method) assays. Altman plots were constructed to assess systematic bias between
In addition, nine College of American Pathologists’ proficiency methods.
testing samples were used to evaluate assay accuracy.
Results
Diazyme total bile acid assay Assay imprecision study
The Diazyme total bile acid assay uses an enzymatic principle: in The Diazyme total bile acid assay on the Integra 800 demonstrated
the presence of Thio-NAD and excess NADH, 3-α-hydroxysteroid clinically acceptable precision for all concentrations. Within-run
dehydrogenase converts bile acid to 3-keto steroids and Thio-NADH. and total CVs were 1.0% and 2.5% at 10.8 µmol/L, 0.5% and 1.0% at
The rate of formation of Thio-NADH is measured at 405 nm. The 30.7 µmol/L, and 0.5% and 1.1% at 111.4 µmol/L respectively (Table 1).
measuring range is 0 to 180 µmol/L.
Table 1: Imprecision study of the Diazyme total bile acid assay on
Integra 800.
Bio Quant total bile acid kit
In the Bio Quant total bile acid kit which is supplied by Diazyme CV (%) Within-run (n=10) Total (n=10)
Laboratories, the reagent composition of R1, R2, and calibrator, are the Levels
same as the Diazyme total bile acid assay24,25. 10.8 µmol/L 1.0 2.5
30.7 µmol/L 0.5 1.0
Assay imprecision
111.4 µmol/L 0.5 1.1
The within-run CVs were determined using three sample pools of
18 CJMLS Fall 2017Sample carry-over study
The sample carry-over equation presumes that any differential
between each of the three high samples and each of the three low
samples should be attributable only to within-run variability if
there is no carry-over. In this carry-over study, the first trial gave
the value of k to be -0.0001439 and the second trial showed k=0,
which indicates that the sample carry-over is negligible (Table 2).
Table 2: Carry-over study of the Diazyme total bile acid assay on
Integra 800.
High value, a Low value, b
k=(b1-b3)/(a3-b3)
(µmol/L) (µmol/L)
141, 139.5, 141.4 2.3, 2.5, 2.5 -0.0001439
149.3, 151.9, 149.6 2.4, 2.2, 2.4 0
Assay accuracy study
The Diazyme total bile acid assay on the Integra 800 differed from
the assigned College of American Pathologists’ proficiency testing
samples (peer group means from 15-19 participating laboratories
on TBLA 2015-2016 survey, n=9) by -2.2% to -9.5%, with an average
bias of -6.4% (Table 3).
Table 3: Accuracy study of the Diazyme total bile acid assay on
Integra 800. CAP, College of American Pathologists. Fig. 1: Comparison of the Diazyme total bile acid on Integra 800 with
the Bio Quant total bile kit (supplied by Diazyme Laboratories) on
CAP group Measured Integra 400 (n=28).
CAP survey Bias
mean values value % Bias
specimen # (µmol/L)
(µmol/L) (µmol/L)
2015 TBLA-01 147.6 136.9 -10.7 -7.2 Discussion
2015 TBLA-02 7.3 6.9 -0.4 -5.3 In this study, the Diazyme total bile acid assay demonstrated to be an
2015 TBLA-03 39.0 37.6 -1.4 -3.6 agreeable routine assay to be used in clinical laboratories. This assay
2015 TBLA-04 40.3 37.6 -2.7 -6.7
manifested acceptable precision and negligible sample carry-over.
It also correlated well with LC-MS/MS assay with the correlation
2015 TBLA-05 7.6 6.9 -0.7 -8.9
coefficient R close to 1. This assay demonstrated small biases in the
2015 TBLA-06 143.0 134.2 -8.8 -6.1 accuracy and comparison studies (Table 3 and Fig. 1 and 2). The
2016 TBLA-01 33.1 30.3 -2.8 -8.3 acceptable analytical performances (total allowable errors, TEa)
2016 TBLA-02 96.5 94.4 -2.1 -2.2 for TBA is not specified by the Clinical Laboratory Improvement
2016 TBLA-03 18.3 16.6 -1.7 -9.5 Amendments requirement or the College of American Pathologists.
TEa is recommended as 23% for veterinary (cats) diagnosis 28 and as
30% in a recent study on human and mice 29.
Method Comparison ICP, a reversible cholestasis condition, is one of the hepatic diseases
Compared to Bio Quant total bile acid kit, the Diazyme total bile specific to pregnant women that could appear in subsequent
acid assay demonstrated an R2 value 0.9908, with an average bias of pregnancies. It may increase the risk of having other hepatobiliary
2.4% (Fig. 1). diseases for example gallstones and cholecystitis1,30,31. The majority
of patients (up to 80%) present with the disease after 30 weeks of
In comparison to LC-MS/MS, the Diazyme total bile acid assay gestation1,10,32. Although this is a benign condition for the mother,
demonstrated an R2 value 0.9904, with an average bias of -8.3% (Fig. which resolves after delivery, poor fetal outcomes including
2). Interestingly, the Diazyme total bile acid assay correlated well premature birth (up to 60%), fetal distress (61%), and stillbirth
with LC-MS/MS on samples significantly containing UDCA (≥ 1 (1.6%) can occur2. In addition to pruritus, clinical presentations also
µmol/L) with an R2 value 0.9894 and an elevated average bias of include the rising of maternal serum TBA, alanine aminotransferase,
-17% (Fig. 2). aspartate aminotransferase, and bilirubin, etc.
csmls.org 19You can also read
