DIAG207-1011: Quality Management for the Veterinary Clinical Pathology Laboratory, Part II

INSTRUCTOR(S):
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., Board eligible Clinical Pathologist (ECVCP), Hannover, Germany
COURSE OPEN: October 28, 2011 - February 22, 2012
REAL TIME SESSIONS: Sundays, November 6, 20, December 3 and 18, 2011, January 8, 22, February 5 and 12, 2012; 3:00pm-4:30pm ET (USA)

Course RTS Times in Your Area: World Clock Converter

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 RTS. Times and dates will be listed in your course confirmation email. Expect to spend up to 1 hour at one of the 2-4 practice sessions held prior to the first RTS.

Level and Prerequisites: Part I is a prerequisite for Part II.

The instructors require that participants of this course have a specific type of training and experience, due to the advanced level of the course material.

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
- 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 open to veterinarians and veterinary technicians.

Course Description:
The course, "Quality Management for the Veterinary Clinical Pathology Laboratory," 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 60%.

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; library materials supplementing the chapters in the required text; interactive message board discussions; and weekly assignments designed to enhance course effectiveness and material retention.

Upon completion of this course, the participant should be able to:

• know how to apply quality standards for an audit in the Veterinary Clinical Pathology Laboratory and show how to do this by writing an SOP for an audit, and designing an Audit Form for a process or task and conducting an audit for an item within his/her laboratory.
• know how to do health and safety risk assessments for the Veterinary Clinical Pathology Laboratory and show how to do this by designing a Risk Assessment Form and performing a Risk Assessment for an item within his/her laboratory.
• know how to evaluate performance of the laboratory in external Quality Assurance (QA) and show how to do this by evaluating external QA for an instrument within his/her laboratory choice and making recommendations based on the findings.
• know about continuous quality improvement in the laboratory and show how to promote this by developing an Improvement Opportunity Form.
• understand the purpose of Method Validation and Instrument Verification in the laboratory and understand terminology and studies needed to undertake these tasks.
• show how to do this by drafting standard operating procedures for the various aspects of Method Validation and Instrument Verification for an instrument within their laboratory and complete a practical exercise comparing two methods.
• know how to apply concepts for quality planning in order to promote ongoing quality improvement with the veterinary clinical pathology laboratory and show how to apply concepts for quality planning by drafting a Quality Plan for his/her laboratory.
• 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
• successfully pass an examination with multiple choice, short answer and/or essay questions regarding the above topics by achieving a score of > or = 60%

Course Materials: Course materials will be available in the course library prior to each Real Time Session.
Required textbook:

• None

Recommended textbook:

• Westgard, JO. Basic Method Validation, 3rd edition. Available from: http://www.westgard.com/books-and-reference-manuals.htm

About the Instructor(s): Dr. 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, based in Wetherby, West Yorkshire.

She is past Chair of the ASVCP QA Committee and the ECVCP Laboratory Standards Committee and is currently a member of both committees, as well as the ECVCP Examination Committee.

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!

It is that course that provided the inspiration for her to develop THIS course for Quality Management in the Veterinary Laboratory.

Dr. 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.
She is an experienced speaker in various themes of veterinary clinical pathology and could already lecture at several national as well as international conferences.
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 webmaster and chair of the website editorial board in 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.

Course Outline:
Week 1: (Real Time Session November 6): Audits in the Veterinary Laboratory
Instructor(s):
Content:

• Types of audits and reasons for audits in the veterinary laboratory

Week 2: (No Real Time Session): Audits in the Veterinary Laboratory, continued.
Content:

• Draft a SOP for an audit, an audit form and conduct an audit within your laboratory

Week 3: (Real Time Session November 20): Health and Safety Risk Assessment
Instructor(s):
Content:

• Introduction to health and safety risk assessment, draft of a Risk Assessment form and conduct a risk assessment in your laboratory

Week 4: (No Real Time Session): Reference Intervals
Content:

• Introduction to reference interval determination within the veterinary laboratory
• Determine the basis for reference intervals used in your laboratory

Week 5: (Real Time Session December 3): Improvement Opportunities
Instructor(s):
Content:

• The role of improvement opportunities as the basis for ongoing quality improvement in the veterinary laboratory
• Draft an Improvement Opportunity Form and provide an example of how it could be used in your laboratory

Week 6: (No Real Time Session): External QA Performance Evaluation
Instructor(s):
Content:

• Introduction to external quality assurance performance evaluations
• Evaluate external QA performance for an instrument in your laboratory and make recommendations based on your findings

Week 7: (Real Time Session December 18): Method Validation/Instrument Verification
Instructor(s):
Content:

• Introduction to Method Validation/Instrument Verification
  • Purpose, Planning, Types of information, bases for decision-making
  • Definitions and Terminology
• Familiarization Period
  • Reportable Range determination
  • Calibration Verification
  • Detection Limit determination

Week 8: (No Real Time Session): Method Validation /Instrument Verification, continued.

Christmas Break

Week 9: (Real Time Session January 8): Method Validation /Instrument Verification, continued.
Instructor(s):
Content:

• Within run Precision study
• Interference study
• Recovery study
• Initial judgments about method
• Between Run Precision (Replication) Study

Week 10: (No Real Time Session): Introduction to Method Validation/Instrument Verification, continued.

Week 11: (Real Time Session January 22): Audits in the Veterinary Laboratory
Instructor(s):
Content:

• Comparison of Methods Study
• Verification studies and how they differ from Method/Instrument Validation

Week 12: (No Real Time Session): Quality Plan
Content:

• Draft a quality plan for your laboratory covering the core areas of environment, facilities, instrumentation, personnel and quality working practices

Week 13: (Real Time Session February 5): Revision, sharing and additional questions
Instructor(s):

Week 14: (Real Time Session February 12): Examination
Instructor(s):

CE CREDITS: 12

Tuition: $700

**For more on how online CE works see the VSPN Participant's 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 1-800-700-INFO (4636) or email (VIN CE) CEonVIN@vin.com or (VSPN CE) VSPNCE@vspn.org). Please include the course title, your full name, and contact information in your correspondence.

Note: "This course has been approved for 12 continuing education credits in jurisdictions which recognize AAVSB RACE approval; however participants should be aware that some boards have limitations on the number of hours accepted in certain categories and/or restrictions on certain methods of delivery of continuing education." Call VSPN/VIN CE at 1-800-700-4636 for further information. (Attendees are encouraged to check with their licensing jurisdiction(s) for information regarding recognition by their board).

Course withdrawal and refund policy: Withdrawal prior to the listed start date of a course entitles the registrant to a complete refund or a credit toward a future VIN CE course, whichever is preferred. Withdrawal within 1 week after the listed start date (i.e. including no more than one real-time session) entitles the registrant to a credit toward any future VIN CE course. (This policy does not apply to courses with only one real-time session.) After the first real-time session, a registrant may withdraw due to special circumstances and receive prorated credit towards a future VIN course. These requests will be handled on an individual basis. The amount of the prorated credit will be determined based on 65% of the time remaining in the course at the time of withdrawal. It is not possible to withdraw retroactively.
Note: To ensure rapid handling of your request for withdrawal, we recommend that you call the VIN/VSPN office at 1-800-700-INFO (4636).

*For More Information on VSPN's Upcoming CE Courses check the Course Catalog at http://www.vspn.org/CE/VSPN_M02231.htm

Katherine James, DVM, PhD, DACVIM (SAIM)
VIN Education Coordinator

VIN CE Services: CEonVIN@vin.com
1-800-846-0028 or 1-530-756-4881 or direct line to VIN/VSPN from the United Kingdom: 01452226154
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