VIN DIAG207-1219: Quality Management for the Veterinary Clinical Pathology Laboratory, Part II

The lectures for this course will be presented in an audio format using a webinar platform.

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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
Liesl Julie Van Rooyen, BVSc(Hons), BSc
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: December 8, 2019-March 25, 2020
Real Time Sessions (RTS): Sundays, December 15, 2019, January 5, 19, February 2, 16, March 1, and 15, 2020; 3:00-4:30 pm ET (USA)
Course RTS Times in Your Area: World Clock Converter

Level and Prerequisites: This advanced course will be open to to participants training for or who have 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 has been submitted for RACE approval for veterinarians and veterinary technicians/technologists.

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 were 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.

Week 1 (Real Time Session December 15, 2019): Audits in the Veterinary Laboratory
Presenter: Dr. Kathleen Freeman
Format: Audio
Assignment (prior to December 15, 2019 Real Time Session):
  • Read An approach 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 (continued)
Assignment (prior to December 22, 2019):
  • 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 January 5, 2020): Audit/Health and Safety Risk Assessment
Presenter: Dr. Stefanie Klenner
Format: Audio
Assignment (prior to January 5, 2020 Real Time Session):
  • 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

Week 4 (No Real Time Session): Reference Intervals
Assignment (prior to January 12, 2020):
  • 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 January 19, 2020): Improvement Opportunities
Presenter: Dr. Russell Moore
Format: Audio
Assignment (prior to January 19, 2020 Real Time Session):
  • 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
Assignment (prior to January 26, 2020):
  • 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 February 2, 2020): Method Validation/Instrument Verification
Presenter: Dr. Russell Moore
Format: Audio
Assignment (prior to February 2, 2020 Real Time Session):
  • 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 (continued)
Assignment (prior to February 9, 2020):
  • 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 February 16, 2020): Method Validation/Instrument Verification (continued)
Presenter: Dr. Stefanie Klenner
Format: Audio
Assignment (prior to February 16, 2020 Real Time Session):
  • 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 (continued)
Assignment (prior to February 23, 2020):
  • 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 March 1, 2020): Method Validation/Instrument Verification (continued)
Presenter: Dr. Liesl Van Rooyen
Format: Audio
Assignment (prior to March 1, 2020 Real Time Session):
  • Finish up the week 9-10 assignments.
Objectives: Upon completion of this session, the participant should be able to
  • Understand the difference between method/instrument validation and method/instrument verification.
  • List and explain the special considerations that apply to method validation in hematology.
  • Understand the concept of measurement uncertainty (MU).
  • Understand the concept of a quality plan.

Week 12 (No Real Time Session): Quality Plan
Assignments (prior to March 8, 2020):
  • Read Special Consideration for Method/Instrument Validation for Hematology Analyzers
  • Read Basics of Estimating Measurement Uncertainty
  • Read Validation Guideline 3.6.4 - Measurement
  • Read Measurements for 8 Common Analytes in Native Sera Identify Inadequate Standardization Among 6 Routine Laboratory Assays
  • The Use of Error and Uncertainty Methods in the Medical Laboratory
  • 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 March 15, 2020): Revision, Review, Sharing
Presenter: Dr. Liesl Van Rooyen
Format: Audio
Assignment (prior to March 15, 2020 Real Time Session):
  • 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.
  • Successfully pass an examination with multiple choice, short answer and/or essay questions regarding the above topics by achieving a score of > or = 80%.

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.
Recommended Textbook:
  • Westgard JO (2008).
    Basic Method Validation: Training in Analytical Quality Management for Healthcare Laboratories, 3rd edition.
    ISBN-13: 9781886958258
    Available at: Westgard Book Store

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.

A. Russell 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.

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 where 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.

Liesl Van Rooyen qualified as a veterinarian from University of Pretoria (South Africa) in 2011.She then spent three years working in welfare practice while completing BVSc (Hons) degree in Small Animal Medicine and Veterinary Clinical Pathology. In 2015, she enrolled for the MMedVet (Clinical Laboratory Diagnostics) external residency offered by the University of Pretoria and IDEXX Laboratories South Africa, and obtained her MMedVet (CLD) specialist degree in 2018. Her research project conducted at the University was a continuation of previous work done by the Faculty regarding haemostatic derangements in dogs with Babesia rossi infection. She is currently employed as a Clinical Pathologist at IDEXX Laboratories South Africa. Her professional interests include diagnostic cytology and hematology, and laboratory quality management.

Total CE Credit: 13.5

Tuition: $700
Prices are listed in US dollars.

*To ensure participants are ready and prepared for classes, enrollment will close on December 15, 2019 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:
  1. Enrollment qualifications: VIN CE courses are open to VIN member and non-member veterinarians. Veterinarians enrolling in a VSPN CE course must be a VIN member. Veterinary support staff must be a VSPN member to enroll in a VSPN CE or a VIN CE course open to VSPN member enrollment.
  2. Each enrollee must be able to receive emails from @vspn.org and @vin.com addresses. Email is our major form of communication with participants; personal emails are highly recommended rather than clinic/hospital email addresses.
  3. Each person is individually responsible for his/her own registration. To ensure that all information received is secure and correct, please do not enroll for a course on behalf of another individual.
  4. For further assistance call 800-846-0028 ext. 797 or email . Please include the course title, your full name, and contact information in your correspondence.
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"This program (RACE program number to be determined) has been submitted for approval by AAVSB RACE to offer a total of 13.5 CE Credits, with a maximum of 13.5 CE Credits being available to any individual veterinarian or veterinary technician/technologist. This RACE approval is for the subject matter categories of: Non-Medical, 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."

Course withdrawal and refund policy: A complete refund of the paid course price will be 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:
800-846-0028 or 530-756-4881; ext. 797
or direct line to VIN/VSPN from the United Kingdom: 01 45 222 6154
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