DIAG206-0117: Quality Management for the Veterinary Clinical Pathology Laboratory Part I
Some of the lectures for this course will be presented in a text format
while others will be presented using audio.
Enrollment is closed.
Presenters:
Kathleen P. Freeman,
DVM, BS, MS, PhD, DipECVCP, MRCPath, MRCVS,
Certificate in Laboratory Quality Management (University of Wisconsin), IDEXX Labs, UK,
Wetherby, West Yorkshire, UK
Ernst Leidinger,
DVM, Dip.ECVCP, Specialist for Clinical Pathologist (national);
Lab director and clinical pathologist at In Vitro laboratory in Vienna, Austria
Stefanie Klenner, DVM, Dr.med.vet., Diplomate ECVCP,
SCIL Animal Care Company, Viernheim, Germany
Emma Hooijberg, BVSc GPCert(SAP) DipECVCP,
Senior Lecturer in Clinical Pathology, Department of Companion Animal Clinical Studies,
Faculty of Veterinary Science, University of Pretoria, South Africa
Unity Jeffery VetMB, PhD, DACVP (clinical pathology), MRCVS. Assistant professor,
Department of Veterinary Pathobiology, Texas A&M University, USA
A. Russell Moore, DVM, MS, DACVP, Assistant Professor,
Department of Microbiology, Immunology, and Pathology, College of Veterinary Medicine,
Colorado State University, Fort Collins, CO 80524, USA
Course Open: January 1-April 19, 2017
Real Time Sessions (RTS): Sundays, January 8, 22, February 5, 26, March 12, 26, and April 9, 2017; 3:00-4:30 pm ET (USA)
Course RTS Times in Your Area:
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Practice Sessions: In order to prepare you for a successful experience
in your CE course, we request you attend a Practice Session prior to the first
Real Time Session. Please arrive promptly at the start time; each Practice Session
is up to 1 hour in length.
For more information, please visit the
CE Practice Area.
*One or more of the presenters for this course will be using audio which will require you to have a headset or speakers to listen.
If you have any concerns regarding your computer's audio capabilities, please be sure to attend
one of the Practice Sessions.
Level and Prerequisites:
Due to the
advanced nature of the course material, the instructors require
that the course participants have a specific type of training and experience.
The majority of candidates will be those in training for a career in clinical pathology
or those who already working in the clinical pathology laboratory.
In some instances there may be a practitioner or veterinary nurse with an intense interest
in clinical pathology that may wish to take this course, but should be advised that
the course is intensive and will require a considerable input of time and effort
when coming from a background without prior experience in a clinical pathology laboratory
typical of a University or reference laboratory.
Desired experience should include:
- Prior experience in a clinical pathology laboratory environment.
- Prior experience in clinical pathology laboratory testing.
- Interest in quality systems for the clinical pathology laboratory>
- Interest in provision of leadership and quality management in the clinical pathology laboratory.
- a desire to gain experience in application of quality management and planning principles
using data from your own laboratory, with guidance from experienced clinical pathologists
who are experts in quality leadership and quality management.
This course is a prerequisite for the Quality Management for the Veterinary Clinical
Pathology Laboratory, Part II course.
VIN CE Course: Open to veterinarians and veterinary technicians/technologists.
This course is approved by RACE for veterinarians and veterinary technicians/technologists.
(RACE 22-16780)
Course Information:
The "Quality Management for the Veterinary Clinical Pathology Laboratory"
course is designed to provide an introduction to and practical application
of quality management in the veterinary clinical pathology laboratory.
It is given in two parts (Part I and Part II). Part I is a prerequisite for Part II.
In Part I, participants will be introduced to theories of management and
concepts vital to quality planning. Examples of ISO-based and GLP standards
are included. Laboratory design, Westgard Rules, QC Validation and
Sigma Metrics are covered.
In Part II, participants will learn about audits in the veterinary clinical
pathology laboratory and determination of reference intervals, as well as
Improvement Opportunities, external Quality Assurance performance and a
Quality Plan for the laboratory. There is an introduction to Method Validation
and Instrument Performance Verification.
There will be real time classroom sessions approximately every 2 weeks.
The majority of the work will be done by e-mail of drafts and revisions to
the instructors, with the final products of some sections shared with the rest
of the participants by posting on the course message boards. The review and
participant questions will also be shared on the course message boards.
In order to demonstrate satisfactory participation in this course, participants
are expected to attend all of the real-time sessions, hand in completed homework
assignments and to work with the instructor(s) in revising assigned items until
both the instructor(s) and participant are satisfied with the results,
as well as pass the examination with a score of at least 80%.
There is some flexibility in the length of time of the course to accommodate
holidays for the instructors and participants. These should be arranged in
advance between the instructor and the participants assigned to him/her.
Week 1 (Real Time Session January 8, 2017):
Introduction to Concepts of Total Quality Management, LEAN management and Six Sigma Management
Presenter: Stefanie Klenner
Format: TBA
Objectives: Upon completion of this session, the participant should be able to
- Understand current concepts of laboratory quality management,
including Total Quality Management, LEAN and Six Sigma Management.
- Demonstrate understanding by explaining the inter-relationships and
use of these concepts in laboratory management.
- Demonstrate knowledge by examination of concepts relating to TQM,
LEAN and Six Sigma Management.
Week 2 (No Real Time Session):
Introduction to Quality Planning and Quality Standards
Week 3 (Real Time Session January 22, 2017):
What Should a Veterinary Clinical Pathology Laboratory Look Like?
Presenter: Emma Hooijberg
Format: TBA
Objectives: Upon completion of this session, the participant should be able to
- Understand the importance of quality planning and the quality standards
provision of high quality laboratory services.
- Demonstrate understanding by critical evaluation of the laboratory standards
and planning processes currently in place in their laboratory and recommendation
for improvements, if any.
- Discuss the ISO-based and GLP-based standards applicable in the veterinary laboratory.
- Understand the relationships of appearance and function of the veterinary
clinical pathology laboratory.
- Demonstrate knowledge by examination of concepts underlying veterinary
clinical pathology laboratory design and what a veterinary clinical
pathology laboratory should look like.
- Demonstrate understanding by critical evaluation of the appearance and function
of their laboratory and recommendations for improvements, if any.
- Demonstrate knowledge of quality planning, quality standards and laboratory
design by examination of concepts relating to these topics.
Week 4 (No Real Time Session):
Westgard Rules
Week 5 (Real Time Session February 5, 2017):
Westgard Rules and Policies and Audits
Presenter: A. Russell Moore
Format: TBA
Objectives: Upon completion of this session, the participant should be able to
- Understand and apply the 'Westgard rules' for quality control.
- Demonstrate understanding by evaluation of the rules currently used
in their laboratory and the bases for their use.
- Demonstrate knowledge of Westgard rules by examination on this topic.
- Understand the use of policies and audits in the veterinary clinical laboratory.
- Demonstrate understanding of policies and audits by drafting SOPs for
a policy and audit and discussion of various audits in the veterinary
clinical laboratory.
- Write Standard Operating Procedures(SOP) and Policies for the veterinary
clinical pathology laboratory and show how to do this by developing a list
of Policies and SOPs for a depart of his/her choice, writing a SOP for am SOP,
a Policy and SOP for a process of his/her choice.
- Demonstrate knowledge by examination on various aspects of quality standards
and processes involved in quality planning.
Week 6 (No Real Time Session):
Westgard Rules + General QC
**** BREAK - February 19, Holiday (President's Day) ****
Week 7 (Real Time Session February 26, 2017):
Westgard Rules, General QC, and Biological Variation
Presenter: Kathleen Freeman
Format: Audio
Objectives: Upon completion of this session, the participant should be able to
- Understand advantages and disadvantages of various QC applications
in the veterinary laboratory and statistical and nonstatisitcal QC
commonly applied in veterinary laboratories.
- Demonstrate understanding by application of Westgard Rules to determine
acceptability of QC data and show how to do this by analyzing data from
an instrument within his/her laboratory and making recommendations for
QC based on his/her findings.
- Demonstrate knowledge by examination of various Westgard rule applications
and QC data.
- Understand the basic design for studies of biologic variation in veterinary
species, as well as its application in various laboratory and clinical applications,
including its place in the Milan hierarchy of quality specifications,
determination of quality specifications, determination of applicability of
population-based reference intervals or reference change value via the index
of individuality, its use in evaluation of serial results, dispersion of results
and application with expert recommendations or cut-off values.
- Demonstrate knowledge by examination on the concepts of biologic variation
noted above.
Week 8 (No Real Time Session):
Sigma Metrics
Week 9 (Real Time Session March 12, 2017):
QC Validation and Sigma Metrics
Presenter: Unity Jeffery
Format: TBA
Objectives: Upon completion of this session, the participant should be able to
- Understand the calculation of and application of sigma metrics in
the veterinary clinical laboratory and their relationship to
statistical QC and choice of rules for statistical QC, as well
as other applications in the laboratory.
- Demonstrate knowledge and understanding by calculation of sigma
metrics for tests for an instrument with the laboratory of
his/her choice.
- Demonstrate knowledge by examination on concepts related to sigma
metrics and their relationship to statistical QC and choice
of control rules.
- Understand the process of QC Validation in providing a scientific
basis for choice of control rules applied in the veterinary laboratory.
- Demonstrate knowledge and understanding by undertaking QC validation
for an instrument within the laboratory of his/her choice and making
recommendations for QC rules to be applied.
- Demonstrate knowledge by examination on concepts related to sigma metrics,
QC validation and the relationships between these.
Week 10 (No Real Time Session):
QC Validation (continued)
Week 11 (Real Time Session March 26, 2017):
Additional Revisions
Presenter: Ernst Leidinger
Format: TBA
Objectives: Upon completion of this session, the participant should be able to
- Understand the process of QC Validation in providing a scientific
basis for choice of control rules applied in the veterinary laboratory.
- Demonstrate knowledge and understanding by undertaking QC validation
for an instrument within the laboratory of his/her choice and making
recommendations for QC rules to be applied.
- Demonstrate knowledge by examination on concepts related to sigma metrics,
QC validation and the relationships between these.
Week 12 (No Real Time Session):
Additional Revision
Week 13 (Real Time Session April 9, 2017):
Review, Discussion, Questions and Sharing
Presenters: Stefanie Klenner, Unity Jeffery, Emma Hooijberg, Kathleen Freeman and Ernst Leidinger
Format: Text/Audio
Objectives: Upon completion of this session, the participant should be able to
- Share their thoughts, experiences, comments and work with others
in the course in order to contribute to better understanding of the topics
and appreciation of the approaches taken by others to similar or different
laboratory circumstances.
Week 14 (No Real Time Session):
Examination
Successful completion (scoring 80% or better) on the end-of-course test is required
to earn a certificate of completion for the course.
To learn more about the requirements for earning a CE certificate, please refer to
Receiving Your CE Credit and Course Completion Certificate.
Course Materials: Course materials will be available
in the course library prior to each Real Time Session.
Required Textbook(s): There is no required textbook for this course.
About the Presenters:
Dr. Kathleen Freeman is a 1981 graduate of Oklahoma State University,
College of Veterinary Medicine and received her MS and PhDs from OSU in 1984 and 1987,
respectively. She was on faculty at OSU and then at Cornell University before taking
a detour and teaching all sorts of Science courses and in the Educational Opportunity
Program at Ithaca College for several years.
During these years she was also doing cytology and laboratory consultations for
commercial laboratories.
She then moved into commercial laboratory medicine and worked as Director or
Senior Clinical Pathologist at several laboratories. She moved to the UK in 1997
to develop a diagnostic laboratory service for the Animal Health Trust and was Head
of Anatomic and Clinical Pathology there. She subsequently moved to Scotland and works
from home for IDEXX Laboratories, Ltd, based in Wetherby, West Yorkshire.
She is past founding Chair of the ASVCP Quality Assurance and Laboratory Standards
Committee and the founding Chair of the ECVCP Laboratory Standards Committee.
She is currently a member of both committees. She has special interests in QA, QC,
customer service, cytology and general clinical pathology.
She obtained a Certificate in Laboratory Quality Management via e-learning from the
University of Wisconsin and had the opportunity to work with James Westgard which she
says was a great experience!
Stefanie Klenner graduated in 2004 from the University of Veterinary
Medicine, Hannover, Germany. Between 2004 and 2006 she wrote her thesis about canine
intestinal permeability tests at the same University, successfully receiving her
Dr. med. vet. After a rotational internship at the Small Animal Clinic at the
Justus-Liebig-University in Giessen, Germany, Dr. Klenner started a residency in
veterinary clinical pathology at the Central Laboratory of Justus-Liebig University.
Currently, she is working as scientific product manager laboratory diagnostic for
scil animal care company.
She is an experienced speaker in various themes of veterinary clinical pathology
and lectures often at national as well as international conferences.
She is the current Chair of the Lab Standards Committee of the ECVCP.
Since 2009 Dr. Klenner is one of the instructors of the VIN Quality Management Course
and provides her skills and knowledge also to other courses of VIN.
She is especially interested in general clinical pathology, quality control
as well as learning strategies.
Ernst Leidinger graduated from the vet-school in Vienna, Austria
in 1986 and worked as assistant professor at the department for medical chemistry
for about 10 years. Since 1995 he is director of a private veterinary diagnostic
lab in Vienna were he established the lab's QM system resulting in an ISO 9001
accreditation about ten years ago. Being one of Dr. Freeman's Students in the
VIN QM course, he has been course instructor for several years now.
He is a Councillor for the Executive Board of the ECVCP.
His special interest in the lab are clinical chemistry, LIMS
(computer bases lab management systems) and all aspects of quality control.
If there's some time left he enjoys SCUBA diving.
Emma Hooijberg graduated from the Faculty of Veterinary
Sciences at the University of Pretoria in South Africa in 2001.
She headed off to Europe and worked in private small animal practice in the
UK until starting a 4-year ECVCP residency program at the In Vitro Laboratory
in Vienna. After completing the residency, she worked part-time at both In Vitro
and the VetMed University in Vienna for 2 years. At the end of 2014, Emma returned
to South Africa to take up a post at the Faculty of Veterinary Sciences,
where she is employed as a senior lecture in clinical pathology.
She first developed an interest in quality assurance during her residency
under the supervision of Ernst Leidinger, and contributed towards maintenance
and improvement of the ISO-certified QM system in place in the lab.
She has used this experience, and the knowledge gained from the VIN QM courses,
to consolidate and improve the QM system in the clin path lab in her present
position in Pretoria. She is currently trying to complete her MSc, where she is
looking at analytical and quality control validation and assessment of field
performance of a point-of-care chemistry analyzer for use in the white rhinoceros.
The project also involves method comparison and reference interval generation
and has been a great chance to put theory into practice.
Emma particularly enjoys the Sherlock Holmes aspect of trouble-shooting QC problems
and how continuous improvement of a QM system results in happy clients, both inside
and outside the lab. She hopes that her practical, day-to-day experience with
quality management will be of benefit to students in the course.
Unity Jeffery graduated from the University of Cambridge in 2008
and completed a residency in veterinary clinical pathology at Iowa State University
in 2013. She continued at Iowa State working on a PhD investigating canine
immune-mediated hemolytic anemia and will be joining the Department of Veterinary
Pathobiology at Texas A&M in November 2016 as a clinical pathologist.
Taking this course in 2012 sparked Unity's interest in quality control, she is a
previous instructor on the course and a member of the ASVCP Quality Assurance and
Laboratory Standards committee. Her other interests in the lab are coagulation
and test development. Outside of work, she enjoys spending time with her sighthounds.
A. Russel Moore received his DVM from Purdue University in 2006,
after which Dr. Moore practiced veterinary medicine in a small animal predominant
clinic for 5 years. He returned to academia for a residency in clinical pathology
and completed a MS at the University of Illinois. In keeping with his interests
included exotic animal pathology and quality control practices, Dr Moore's masters
project developed a method for measuring fibrinogen in turtles, validated that method
for clinical use and produced reference intervals for red-eared slide fibrinogen.
Dr. Moore sat boards and was made a Diplomate of the American College of Veterinary
Pathologists in 2014.
He is currently an assistant professor at Colorado State University in Fort Collins,
Colorado where he enjoys the outdoors, biking and playing with his wife and three children.
Current research interests focus on methods for increasing diagnostic accuracy in
clinical pathology and other clinically relevant projects.
Total CE Credit: 10.5
Tuition: $650
Prices are listed in US dollars.
*To ensure participants are ready and prepared for classes,
enrollment will close on January 8, 2017 at 5 pm ET (USA)
or when the maximum number of participants is reached.
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Participant Resource Center.
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total of 10.5 CE Credits, with a maximum of 10.5 CE Credits being available to any individual
veterinarian or veterinary technician/technologist.
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Katherine James, DVM, PhD, DACVIM (SAIM)
VIN Education Coordinator
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