DIAG207-1017: Quality Management for the Veterinary Clinical Pathology Laboratory, Part II
The lectures for this course will be presented in an audio format.
Enrollment is closed.
Presenters:
Kathleen P. Freeman,
DVM, BS, MS, PhD, DipECVCP, MRCPath, MRCVS, Certificate in Laboratory Quality Management
(University of Wisconsin), Senior Veterinary Clinical Pathologist at IDEXX Labs, Ltd,
Wetherby, West Yorkshire, UK
Stefanie Klenner, DVM, Dr.med.vet., Diplomate ECVCP, scil animal care company, Viernheim, Germany
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
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
Course Open: October 15, 2017-January 31, 2018
Real Time Sessions (RTS): Sundays, October 22, November 5, 19, December 3, and 17, 2017;
January 7, 21, and 28, 2018; 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.
*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:
This
advanced course will be open to will be open to participants training for or with
experience working in a clinical pathology laboratory. This course is not open to veterinary students.
VIN CE Course: Open to veterinarians and veterinary technicians/technologists.
This course is approved by RACE for veterinarians, veterinary technicians. (RACE 22-31293)
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.
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 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 instructors 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.
This course consists of eight (8) 90 minute Real Time Sessions, supplemental library materials,
interactive message board discussions, and a mandatory end-of-course test. Successful completion
(scoring 80% or better) on the end-of-course test is required to earn a certificate of completion
for the course.
Week 1 (Real Time Session 1 on October 22, 2017):
Audits in the Veterinary Laboratory
Presenter: Dr. Kathleen Freeman
Format: Audio
Assignments:
- Read An approachh to audit in the medical laboratory
- Read An approach to an audit
Objectives: Upon completion of this session, the participant should be able to
- discuss the types of audits and the reasons for audits in the veterinary laboratory.
- apply quality standards for an audit in the Veterinary Clinical Pathology Laboratory.
- write an SOP for an audit.
Week 2 (No Real Time Session):
Audits in the Veterinary Laboratory (cont.)
Assignments:
- Compose answers to the assigned homework questions.
- Identify a department in your laboratory.
Give examples of 4 audits for the specified laboratory department.
- Write an SOP for conduction of an audit in the specified laboratory department.
- Once the instructor approves your Audit SOP, draft an Audit Form
appropriate for the audit described in your SOP.
Week 3 (Real Time Session 2 on November 5 2017):
Audit/Health and Safety Risk Assessment
Presenter: Dr. Stefanie Klenner
Format: Audio
Assignments:
- Read Risk Assessment in the Infectious Disease Laboratory
- Read How to Conduct a Risk Assessment
- Read What are the risks of risk management?
- Read Risk Management
- Briefly summarize the current status of your laboratory with
regard to risk assessment.
- Draft a Risk Assessment Form.
- Once the instructor approves your Risk Assessment Form,
do a risk assessment for a particular item in your laboratory
using the Risk Assessment Form you have drafted.
Objectives: Upon completion of this session, the participant should be able to
- perform a health and safety risk assessment for the Veterinary Clinical Pathology Laboratory.
- design a Risk Assessment Form.
- perform a Risk Assessment for an item within his/her laboratory.
Week 4 (No Real Time Session):
Reference Intervals
Assignments:
- Read An error management system in a veterinary clinical
laboratory
- Read ECVCP Recommendations on Reference Values
- Read Origin of Reference Intervals: A College of American
Pathologists Q-Probes Study of "Normal Ranges" used in 163
Clinical Laboratories
- Read Reference Values and Reference Intervals - Westgard QC
- Read A review of the clinical chemistry and laboratory medicine:
Special issue on Reference Values
- Read A robust approach to reference interval estimation and evaluation
- Read Biological variation and reference change values
of feline plasma biochemistry analytes
- Read Reference Intervals - Western Pathologist
Quality Assurance Association
- Read Effect of outliers and nonhealthy individuals
on reference interval estimation
- Read Basic Method Validation: Reference Interval Transference
- Summarize how reference intervals were established for the department
and instrument you used in this course.
- Write a paper to discuss how you would improve reference interval
establishment and/or review in your "ideal" laboratory.
Week 5 (Real Time Session 3 on November 19, 2017):
Improvement Opportunities
Presenter: Dr. Kathleen Freeman
Format: Audio
Assignments:
- Review the Improvement Opportunities Slides
- Read Quality Planning Circle
- Review LIMS-based Improvement Opportunities Form
- Review KIMS-integrated error management in an ISO 9001
Certified Diagnostic Lab
- Review Commercial QA Programs
- Review QA and System Control
- Review QA by OPSec Charts
- Briefly summarize the current status in your laboratory
regarding Improvement Opportunity identification, implementation,
and continuous quality improvement.
- Draft an Improvement Opportunity Form.
- Once the instructor has approved your Improvement Opportunity Form,
use it to illustrate an example of an improvement opportunity in
your laboratory and how you would approach it.
Objectives: Upon completion of this session, the participant should be able to
- understand the concept of continuous quality improvement in the laboratory.
- show how to promote continuous quality improvement with the development
and use of Improvement Opportunity Forms.
Week 6 (No Real Time Session):
External QA Performance Evaluation
Assignments:
- Briefly summarize the status of external QA and how it is currently
evaluated in your laboratory. Include the type of program, frequency,
performance evaluation, and any actions taken based on the performance
evaluation.
- Obtain external QA performance records for the last 2 times it has been
conducted in your laboratory.
- Summarize the performance of the instrument/tests that you
used earlier in this course.
- Determine and indicate whether the Tea you have chosen previously
or +/- 2SD is going to be more demanding for performance evaluation.
- Summarize the performance with regard to this standard and any
action that you think should be taken.
Week 7 (Real Time Session 4 on December 3, 2017):
Method Validation/Instrument Verification
Presenter: Dr. Stefanie Klenner
Format: Audio
Assignments:
- Read Introduction to Method/Instrument Validation
or Performance Verification
- Read Quality Goal Index
- Read LIMS-Integrated Error Management in an ISO
9001-Certified Diagnostic Lab INVITRO laboratory GmbH, Vienna
- Read Principles of Method/Instrument Performance Verification
- Read Detection Limit
- Read Familiarization Period
Objectives: Upon completion of this session, the participant should be able to
- understand the purpose of Method Validation and Instrument Verification
in the laboratory.
- understand the terminology and studies needed to undertake these tasks.
Week 8 (No Real Time Session):
Method Validation/Instrument Verification (cont.)
Assignment:
- Draft a "general" SOP for Method Validation/Instrument Verification
for your "ideal" laboratory. This should include the various studies
or "experiments" to be done and specify if some are to be done routinely
and other for certain types of assays.
Week 9 (Real Time Session 5 on December 17, 2017):
Method Validation/Instrument Verification (cont.)
Presenter: Dr. Ernst Leidinger
Format: Audio
Assignments:
- Read Interference and Recovery Experiments - Westgard QC
- Read Interference Study
- Read Method Comparison in the Clinical Laboratory
- Read Recovery as Part of the Validation of an Analytical Technique
- Read Replication Experiments
- Review Method Comparison for ALT Calculation spread-sheet
Objectives: Upon completion of this session, the participant should be able to
- draft standard operating procedures for the various aspects of
Method Validation and Instrument Verification for an instrument
within his/her laboratory.
- complete a practical exercise comparing two methods.
Week 10 (No Real Time Session):
Method Validation/Instrument Verification (cont.)
Assignments:
- Draft an SOP for the comparison of methods study. Include
information about the statistical analyses that should be done
and the type of information about error that is obtained.
Include a Form for Data Collection.
- Briefly summarize your thoughts about Method Validation versus
Instrument Performance Verification and its applicability in
your laboratory.
Week 11 (Real Time Session 6 on January 7, 2018):
Method Validation /Instrument Verification (cont.)
Presenter: Dr. Kathleen Freeman
Format: Audio
Assignment:
- Finish up the Week 9-10 Assignments.
Objectives: Upon completion of this session, the participant should be able to
- understand the comparison of methods study and its purpose.
- understand the difference between method/instrument validation
and method/instrument verification.
Week 12 (No Real Time Session):
Quality Plan
Assignments:
- Read Use of the Method Decision Chart
- Read The Comparison of Methods Experiment
- Read Special Consideration for Method/Instrument Validation
for Haematology Analyzers
- Six Sigma MEDx example
- Quality Plan Example
- Read Basics of Estimating Measurement Uncertainty
- Read Validation Guideline 3.6.4 - Measurement Uncertainty
- Read Measurements for 8 Common Analytes in Native Sera Identify
Inadequate Standardization Among 6 Routine Laboratory Assays
- Summarize the basic components that should be covered in a Quality Plan.
- Create an initial draft of a Quality Plan for your laboratory using
the basic components you have identified in previous homework assignments.
Week 13 (Real Time Session 7 on January 21, 2018):
Revision, Review, Sharing
Presenter: Dr. Ernst Leidinger
Format: Audio
Assignment:
- Work with classmates and instructors to improve the initial draft
of the Quality Plan from week 12.
Objectives: Upon completion of this session, the participant should be able to
- better understand the topics covered in this course based on the approaches
taken by the other participants to similar or different laboratory circumstances.
Week 14 (Real Time Session 8 on January 28, 2018):
Examination
Presenter: Dr. Ernst Leidinger
Format: Audio
Objectives: Upon completion of this session, the participant should be able to
- demonstrate understanding of the course materials by successfully completing
(scoring 80% or better) an examination with multiple choice, short answer
and/or essay questions.
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:
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 Councilor 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.
Total CE Credit: 15
Tuition: $700
Prices are listed in US dollars.
*To ensure participants are ready and prepared for classes,
enrollment will close on October 22, 2017 at 5 pm ET (USA)
or when the maximum number of participants is reached.
*For more information on how online CE works, see the
Participant Resource Center.
To Enroll:
Enrollment is closed.
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"This program (22-31293) is approved by the AAVSB RACE to offer a
total of 15 CE Credits, with a maximum of 15 CE Credits being available to any individual
veterinarian or veterinary technician/technologist.
This RACE approval is for the subject matter categories of:
Non-Scientific-Practice Management/Professional Development
using the delivery method of Interactive-Distance: (Web-based, Teleconference or Audio-Conference).
This approval is valid in jurisdictions which recognize AAVSB RACE; however, participants are
responsible for ascertaining each board's CE requirements."
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issued when your withdrawal request is received prior to the listed start date of the course.
If you wish to withdraw after the start date please contact the VIN office 800-846-0028 ext. 797
to discuss eligibility for a pro-rated refund.
*For more information on VIN's upcoming CE courses, check the
VIN Course Catalog.
Katherine James, DVM, PhD, DACVIM (SAIM)
VIN Education Director
VIN CE Services:
CEonVIN@vin.com
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