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Coagulation Testing Quality

Coagulation Testing Quality


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Conference and Workshop

3rd Conference
April 14-17, 2009
(Tuesday-Friday) [ends at Noon Friday]

1st Workshop
April 15-16, 2009
(Wednesday & Thursday Afternoons)

Minneapolis Marriott City Center Hotel
Minneapolis, Minnesota

Presented by:

  • Mayo Clinic Divisions of Hematology and Hematopathology
  • Mayo Medical Laboratories
  • North American Specialized Coagulation Laboratory Association (NASCOLA)

Conference Description

This conference provides a unique international forum for communication and discussion of current issues in quality and standardization of coagulation diagnostic laboratory testing. Continued conference features include abstract presentations (oral and poster) and Breakfast-with-the-Experts sessions. There will also be presentations by expert faculty on a wide range of topics, along with panel discussions and question and answer sessions.

Conference Learning Objectives

Upon completion of the conference, participants should be able to:

  • Describe general aspects of planning and management of coagulation laboratory testing
  • Provide examples of processes and goals of quality assessment and improvement processes
  • Discuss the complexities of testing for disorders of platelets and platelet function
  • Summarize testing quality issues for diagnosis and treatment of von Willebrand disease
  • Review the diagnostic and quality challenges associated with testing for factor VIII inhibitors

Workshop Description

New this year - Two workshop sessions will be conducted Wednesday and Thursday afternoons. The first will be focused on testing for platelet functional disorders, and the second will focus on testing for selected plasmatic coagulation disorders. Each workshop session will begin with participating companies presenting information on specific laboratory instrument and/or reagent testing. Interactive case studies by conference faculty on thematic topics will conclude each workshop session.

Workshop Learning Objectives

Upon completion of the workshop, participants should be able to:

  • Comprehend the role of the coagulation diagnostics industry in achieving high-quality testing
  • Provide specific examples of platelet hypofunctional disorders and testing procedures for them
  • Recount examples of specific complex coagulation disorders and quality of diagnostic testing

Disclaimer

Attendance at this Mayo conference does not indicate nor guarantee competence or proficiency in the performance of any procedures that may be discussed or taught in this course.

Intended Audience

This conference is designed for laboratorians, hematologists, pathologists, scientists, laboratory technologists, and clinicians whose practices and interests include laboratory and clinical aspects of bleeding and prothrombotic disorders.

Date and Location

The Coagulation Testing Quality conference will be held April 14-17, 2009 and the workshop on the afternoons of April 15-16, 2009. The conference will be located in the Minneapolis Marriott City Center Hotel (4th floor) in downtown Minneapolis, Minnesota.

Credit

Conference
The College of Medicine, Mayo Clinic is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians, and designates this educational activity for a maximum of 18 hours of AMA PRA Category 1 CreditTM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Mayo Medical Laboratories is approved as a provider of continuing education programs in the Clinical Laboratory Sciences by the ASCLS P.A.C.E.® program. This program has been approved for 18 P.A.C.E. contact hours. Level of instruction for this program is intermediate.

Mayo Medical Laboratories is approved as a Continuing Education Accrediting Agency for Clinical Laboratory Science for State of California and State of Florida credit. The level of instruction for this program is intermediate. This program has been approved for 18 contact hours.

Workshop
**Due to the nature of the Wednesday and Thursday afternoon workshops and the interactions from industry, Category 1 credit will only be provided for the case studies. The College of Medicine, Mayo Clinic is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians, and designates this educational activity for a maximum of 3 hours of AMA PRA Category 1 CreditTM. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Mayo Medical Laboratories is approved as a provider of continuing education programs in the Clinical Laboratory Sciences by the ASCLS P.A.C.E.® program. This program has been approved for 2.5 P.A.C.E. contact hours. Level of instruction for this program is intermediate.

Mayo Medical Laboratories is approved as a Continuing Education Accrediting Agency for Clinical Laboratory Science for State of California and State of Florida credit. The level of instruction for this program is intermediate. This program has been approved for 2.5 contact hours.

Educational Grants

This course is supported, in part, by educational grants from coagulation-related diagnostics and therapeutics corporations, in accordance with ACCME Standards.

At the time of this publication, a complete listing of commercial supporters was not available. Appropriate acknowledgement will be given to all supporters during the meeting.

Abstracts

As part of the Coagulation Testing Quality conference, participants are invited to submit abstracts for oral or poster presentation, demonstrating new information related to laboratory diagnostic aspects of hemostatic disorders (bleeding and thrombosis). Goals of the abstract presentations are to educate and inform about research innovations, share ideas and interests, and network with other participants. Conference scholarships (reduced registration fee) will be offered to the top 5 accepted abstracts from technologist presentors (submitted abstracts will be reviewed and ranked by a committee).

Questions regarding abstract submission can be directed to Sharon Preuss at 507-284-8742.  Abstracts must be received by Monday, February 23, 2009 for consideration by the review committee, and decisions will be communicated by Monday, March 9, 2009.

  • Call for Abstracts
  • Abstract submission guidelines
  • Abstract submission Form

Faculty

Course Director

William L. Nichols, MD
Consultant, Laboratory Medicine and Hematology/Internal Medicine
Mayo Special Coagulation Laboratory and Coagulation Clinical Centers
Co-Director, Coagulation Education Programs
Director, Mayo International Hemophilia Training Center (WFH)
Associate Professor, Medicine and Laboratory Medicine*

Course Co-Directors

Rajiv K. Pruthi, MBBS
Consultant, Hematology/Internal Medicine and Laboratory Medicine
Mayo Special Coagulation Laboratory and Coagulation Clinical Centers
Co-Director, Mayo Special Coagulation DNA Diagnostic Laboratory
Co-Director, Coagulation Clinical and Laboratory Practice
Director, Mayo Comprehensive Hemophilia Center
Assistant Professor, Medicine*

Catherine P.M. Hayward, MD, PhD
President, North American Specialized Coagulation Laboratory Association
Head, Coagulation Laboratories
Hamilton Regional Laboratory Medicine Program
Professor, Pathology & Molecular Medicine, and Medicine
McMaster University Medical Centre
Hamilton, Ontario, Canada

Mayo Clinic Faculty

Layna K. Cardel, BS, MT(ASCP)
Education Specialist
Mayo Special Coagulation Laboratory
Department of Laboratory Medicine and Pathology
Instructor, Laboratory Medicine*

Dong Chen, MD, PhD
Consultant, Mayo Hematopathology and Special Coagulation Laboratories
Department of Laboratory Medicine and Pathology
Assistant Professor, Laboratory Medicine and Pathology*

*College of Medicine, Mayo Clinic

Guest Faculty

Dorothy M. (Adcock) Funk, MD
Medical and Laboratory Director
Esoterix Coagulation
Aurora, Colorado

Wayne L. Chandler, MD
Director, Clinical Coagulation Laboratory
Professor and Vice-Chair
Department of Laboratory Medicine
University of Washington
Harborview Medical Center
Seattle, Washington

Marilyn A. Johnston, MLT, ART
Director
Hemostasis Reference Laboratory
Hamilton, Ontario, Canada

Steve Kitchen, PhD
Clinical Scientist
Sheffield Haemophilia and Thrombosis Center
Royal Hallamshire Hospital
Sheffield, England

Marlies R. Ledford-Kraemer, MBA, BS, MT(ASCP) SH
President, CLOT-ED, Inc.
130 North Rolling Hill Road
Islamorada, Florida

Richard A. Marlar, PhD
Director, Coagulation Laboratory
Chief, Clinical Pathology
Department of Pathology and Laboratory Medicine
Oklahoma Veterans Affairs Medical Center
Professor of Pathology
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma

Piet Meijer, PhD
Executive Director, ECAT Foundation
Leiden, Netherlands

Karen A. Moffat. MLT, ART, FCSMLS(D)
Technical Specialist, Coagulation
Hamilton Regional Laboratory Medicine Program
Lecturer, Department of Medicine
McMaster University
Hamilton, Ontario, Canada

John D. Olson, MD, PhD
Director of Clinical Laboratories
Professor of Pathology and Vice Chair for Clinical Affairs
Department of Pathology
University of Texas Health Science Center
San Antonio, Texas

Ellinore I. Peerschke, PhD
Professor of Pathology
Associate Director for Clinical Laboratories
Chief, Division of Translational Research
Director, Coagulation and Microscopy Laboratories
Mount Sinai School of Medicine
New York, New York

Elizabeth A. Plumhoff, MT(ASCP), CLS(NCA)
Executive Secretary, North American Specialized Coagulation Association
Scientific Director, Editorial Publications
Mayo Collaborative Services, Inc.
Rochester, Minnesota

F. Eric Preston, MD
Director, WHO/WFH EQA Scheme for Blood Coagulation
Professor, Medicine
Department of Haematology
University of Sheffield
Sheffield, England

Anne Raby, MLT, ART
Hematology Consultant Technologist
External Quality Assessment
Quality Management Program - Laboratory Services
Toronto, Ontario, Canada

Georges E.  Rivard, MD
Clinical Professor
Pediatrics and Hematology
Director
Hemophilia Clinic and Clinical Coagulation Laboratory
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada

Elizabeth M. Van Cott, MD
Director, Coagulation Laboratory
Massachusetts General Hospital
Associate Professor of Pathology
Harvard Medical School
Boston, Massachusetts

Bert Verbruggen, PhD
Haemostasis Laboratory
Central Haematology Laboratory
Radboud University, Nijmegen Medical Center
Nijmegen, Netherlands

James G. White, MD
Regents Professor, Pediatrics, Laboratory Medicine and Pathology
University of Minnesota, School of Medicine
Minneapolis, Minnesota

James L. Zehnder, MD
Director, Coagulation and Molecular Genetic Pathology Laboratories
Professor, Pathology & Medicine (Hematology)
Stanford University School of Medicine
Stanford, California

Faculty Disclosure

As a provider accredited by ACCME, College of Medicine, Mayo Clinic (Mayo School of CME) must ensure balance, independence, objectivity and scientific rigor in its educational activities. Course director(s), planning committee, faculty, and all others who are in a position to control the content of this educational activity are required to disclose all relevant financial relationships with any commercial interest related to the subject matter of the educational activity. Safeguards against commercial bias have been put in place. Faculty also will disclose any off-label and/or investigational use of pharmaceuticals or instruments discussed in their presentation. Disclosure of this information will be published in course materials so that participants in the activity may formulate their own judgments regarding the presentation.

Conference Agenda

Tuesday, April 14, 2009

7:00-8:00 AM Registration and Breakfast
Marriott Minneapolis City Center Hotel, 4th Floor Lobby
Session I: Quality in Laboratory Hemostasis and Thrombosis
Moderator: John D. Olson, MD, PhD
7:55-8:00 AM Welcome and Introduction - Ballroom 1
William L. Nichols, MD
8:00-8:30 AM General Quality Planning in the Hemostasis Laboratory
John D. Olson, MD, PhD
8:30-9:00 AM Hemostasis Test Validation, Performance and Reference Intervals
Richard A. Marlar, PhD
9:00-9:30 AM Sample Integrity and Preanalytical Variables
Dorothy M. (Adcock) Funk, MD
9:30-10:00 AM Internal Quality Control in the Hemostasis Laboratory
Steve Kitchen, PhD
10:00-10:30 AM Break (Exhibits Open)
10:30-11:00 AM External Quality Assessment in Hemostasis: Its Importance and Significance
F. Eric Preston, MD
11:00-11:30 AM Initial Evaluation of Hemostasis: Reagent and Method Selection
Wayne L. Chandler, MD
11:30-12:15 PM Questions and Panel Discussion
Faculty
12:15-1:45 PM Luncheon
Marriott Ballroom 2

Session II: Laboratory Quality Organizations: Updates About New Initiatives and Programs
Moderator: Piet Meijer, PhD

1:45-2:05 PM EQATH: Passing and Failing PT/EQA – Results of an EQATH Survey
John D. Olson, MD, PhD
2:05-2:25 PM QMP-LS: A Canadian Regional EQA Program – How Labs Get In and Out of Trouble in Ontario
Anne Raby, MLT, ART
2:25-2:45 PM ECAT: New EQA Initiatives – Factor XIII, Fibrinolysis, Heparin
Piet Meijer, PhD
2:45-3:05 PM UK-NEQAS: What’s New? - EQA for Heparin-Induced Thrombocytopenia (HIT) Testing and LMWH (Low Molecular Weight Heparin) Assays
Steve Kitchen, PhD
3:05-3:35 PM Break (Exhibits Open)
3:35-3:55 PM NASCOLA’s New Studies and Initiatives – Burning Questions, and Networking to Find Answers
Catherine P.M. Hayward, MD, PhD
3:55-4:15 PM

CLSI: Highlights of New Guidelines for Hemostasis Testing
Dorothy M. (Adcock) Funk, MD

4:15-4:35 PM CAP: Results from New EQA Initiatives – HIT, Heparin, Thrombophilia
Elizabeth M. Van Cott, MD
4:35-5:15 PM Panel Discussion and Questions
5:15 PM Adjourn
6:00-8:00 PM Conference Reception with Hemostasis Product Display and Poster Viewing
Marriott Fourth Floor Lobby

Wednesday, April 15, 2009

7:00-8:30 AM Breakfast
Marriott Fourth Floor Lobby
7:30-8:30 AM

Breakfast-with-the-Experts (Simultaneous sessions, repeated on Thursday; pre-registration required)

Session 1: Pediatric Hemostatic Disorders and Testing: A Case-Based Discussion - Crystal Lake Room
Georges E. Rivard, MD

Session 2: Heparin-Induced Thrombocytopenia (HIT) and Laboratory Testing - Ballroom 1
James L. Zehnder, MD

Session 3: Optimizing Testing for Platelet Disorders – The Nitty Gritty of What We Do - Deer Lake Room
Karen A. Moffat, MLT, ART, FCSMLS(D) and Marilyn A. Johnston, MLT, ART

Session 4: Validating New or Revised Diagnostic Tests - Elk Lake Room
Elizabeth A. Plumhoff, MT(ASCP), CLS(NCA) and Marlies R. Ledford-Kraemer, MBA, BS, MT(ASCP) SH

8:40 AM Announcements and Updates - Ballroom 1

Session III: Platelet Functional Disorders and Testing
Moderator: James L. Zehnder, MD

8:45-9:30 AM Platelet Electron Microscopy for Diagnosis of Platelet Disorders
James G. White, MD
9:30-10:00 AM NASCOLA / ECAT Platelet Aggregometry Interpretive Survey and Proficiency Exercise for Dense Granule Deficiency Evaluation
Catherine P.M. Hayward, MD, PhD
10:00-10:30 AM Flow Cytometry for Evaluation of Platelet Disorders
Dong Chen, MD, PhD
10:30-11:00 AM Break (Exhibits and Posters Open)
11:00-11:30 AM Heparin-Induced Thrombocytopenia (HIT) Laboratory Testing: Results of a New ECAT EQA Initiative
Piet Meijer, PhD
11:30-12:00 PM Panel Discussion and Questions
12:00-1:30 PM

Luncheon
Conference Luncheon - Ballroom 2
or optional attendance at NASCOLA Members’ Luncheon and Business Meeting - Ballroom 3 (pre-registration required)


Session IV: Coagulation Workshop 1: Platelet Functional Disorders and Testing

SPRING TRAINING: Instrument & Reagent Presentations (Pre-registration Required)
Moderator: William L. Nichols, MD

Presentations by Platelet-related Diagnostics/Instruments/Reagents Companies (Companies to provide speaker)

1:30 PM Workshop Opening Comments
William L. Nichols, MD
1:35-2:00 PM

Whole Blood Platelet Aggregation in Clinical Practice
Ravindra Sarode, MD
Director, Transfusion Medicine and Hemostasis Reference Laboratory
Professor of Pathology
UT Southwestern Medical Center
Dallas, Texas
Sponsored by Chrono-Log Corp.

2:00-2:25 PM PFA-100 Testing: Clinical Indications
Donna D. Castellone, MS, MT(ASCP)SH
Clinical Project Manager Hemostasis/Hematology
Siemens Healthcare Diagnostics
Tarrytown, New York
Sponsored by Siemens Healthcare Diagnostics
2:25:2:40 PM The Technique of Platelet Whole Mount Electron Microscopy for Dense Granule Enumeration: A Video Demonstration
James G. White, MD
2:40-2:50 PM Panel Discussion and Questions
2:50-3:30 PM Break (Exhibits and Posters Open)

Workshop: Case-based testing & clinical presentations
Moderator: William L. Nichols, MD
(Faculty Presentations)

3:30-4:00 PM Case A
Catherine P.M. Hayward, MD, PhD
4:00-4:30 PM Case B
William L. Nichols, MD
4:30-5:00 PM Case C
Dong Chen, MD, PhD
5:00 PM Adjourn  (No pre-scheduled evening conference activities)

Thursday, April 16, 2009

7:00-8:30 AM Breakfast
Marriott Fourth Floor Lobby
7:30-8:30 AM

Breakfast-with-the-Experts (Simultaneous sessions, repeated from Wednesday; pre-registration required)

Session 1: Pediatric Hemostatic Disorders and Testing: A Case-Based Discussion - Crystal Lake Room
Georges E. Rivard, MD

Session 2: Heparin-Induced Thrombocytopenia (HIT) and Laboratory Testing - Ballroom 1
James L. Zehnder, MD

Session 3: Optimizing Testing for Platelet Disorders – The Nitty Gritty of What We Do - Deer Lake Room
Karen A. Moffat, MLT, ART, FCSMLS(D) and Marilyn A. Johnston, MLT, ART

Session 4: Validating New or Revised Diagnostic Tests - Elk Lake Room
Elizabeth A. Plumhoff, MT(ASCP), CLS(NCA) and Marlies R. Ledford-Kraemer, MBA, BS, MT(ASCP) SH

8:40 AM Announcements and Updates - Ballroom 1

Session V: Von Willebrand Factor/Disease (VWF/VWD) and Factor VIII Inhibitors
Moderator: Ellinor I.B. Peerschke, PhD

8:45-9:10 AM Laboratory Diagnosis of VWD: The 2008 NHLBI Guidelines
William L. Nichols, MD
9:10-9:30 AM VWF/VWD Testing Practices: NASCOLA Survey Results
Wayne L. Chandler, MD
9:30-10:00 AM Clinical and Laboratory Aspects of Factor VIII Inhibitors: An Overview
Georges E. Rivard, MD
10:00–10:30 AM Break (Exhibits and Posters Open)
10:30–11:00 AM Factor VIII Inhibitor Testing: Nijmegen Modifications, Experience and Recommendations
Bert Verbruggen, PhD
11:00-11:20 AM Factor VIII Inhibitor Evaluation: Mayo Clinic Approach & New Information
Rajiv K. Pruthi, MBBS
11:20-11:35 AM NASCOLA Proficiency Testing Results for Factor VIII Inhibitors
Ellinor I.B. Peerschke, PhD
11:35-12:10 PM Panel Discussion and Questions
12:10-1:30 PM Luncheon
Marriott Ballroom 2

Session VI: Coagulation Workshop 2: Coagulation Disorders and Testing

Spring Training: Instrument & reagent presentations (Pre-registration Required)
Moderator: Rajiv K. Pruthi, MBBS

Presentations by Coagulation-related Diagnostics/Instruments/Reagents Companies (Companies to provide speaker)

1:30 PM Workshop Opening Comments
Rajiv K. Pruthi, MBBS
1:35-2:00 PM Innovations in Monitoring Anticoagulant Therapies
Jim F. DeMase
Marketing Manager - Hemostasis
Beckman Coulter, Inc.
Brea, California
Sponsored by Beckman Coulter / Instrumentation Laboratory
2:00-2:25 PM New Technologies in Coagulation from GTI Diagnostics: VWF & Propeptide Assay & FVIII Antibody Screen
Dave Boyer
Product Manager - New Technology Assessment
GTI Diagnostics
Waukesha, Wisconsin
Sponsored by GTI Diagnostics
2:25-2:50 PM Procoagulant Phospholipid
Gwyn A. Cutsforth, MT(ASCP), PhD
Clinical & Scientific Research Manager
Diagnostica Stago, Inc.
Parsippany, New Jersey
Sponsored by Diagnostica Stago, Inc.
2:50-3:00 PM Panel Discussion and Questions
3:00-3:30 PM Break (Exhibits and Posters Open)

Workshop: Case-based testing & clinical presentations
Moderator: Rajiv K. Pruthi, MBBS (Faculty Presentations)

3:30-4:00 PM Case A
Rajiv K. Pruthi, MBBS
4:00-4:30 PM Case B
Layna K. Cardel, BS, MT(ASCP)
4:30-5:00 PM Case C
Elizabeth M.Van Cott, MD
5:00 PM Adjourn
(No pre-scheduled evening conference activities)

Friday, April 17, 2009

6:45-7:55AM Breakfast (Marriot 4th Floor)

Session VII: Coagulation Testing Potpourri
Moderator: Dong Chen, MD, PhD

7:55 AM Announcements - Ballroom 1
8:00-8:30 AM External Quality Assessment of Point-of-Care Testing (POCT) Devices in Hemostasis Including ACT, ROTEM and TEG
Steve Kitchen, PhD
8:30-8:45 AM Abstract #1: Evaluation of the Haemonetics TEG® 5000 Platelet Mapping™ Method
Suzanne M. Hoffman, MT(ASCP)
Special Coagulation Laboratory
University of Wisconsin Hospital and Clinics
Madison, Wisconsin
8:45-9:15 AM EQA Assessment Incorporating Biological Variation
Piet Meijer, PhD
9:15-9:30 AM Abstract #2: A Regional Quality Assurance Program for Core Coagulation Laboratories
Karen A. Moffat, MLT, ART, FCSMLS(D)
9:30-10:00 AM D-Dimer Assay Issues and Standardization: QMP-LS Studies
Anne Raby, MLT, ART
10:00-10:30 AM Break
10:30-11:00 AM Laboratory Monitoring of Heparin Anticoagulation: Current Issues and Recommendations
Marilyn A. Johnston, MLT, ART
11:00-11:15 AM Abstract #3: Evaluation of an Alternate Activating Reagent for the Performance of Coagulation Factor Assays in the Presence of Lupus Anticoagulants
John Barranco, MT(ASCP)
Florida Hospital Center for Thrombosis Research
Orlando, Florida
11:15-11:30 AM Abstract #4: Laboratory Evaluation of an Automated Latex von Willebrand Factor Activity Assay
Julie I. Tange, BS
Special Coagulation Laboratory
Mayo Clinic
Rochester, Minnesota
11:30-12:00 PM Panel Discussion and Questions
12:00 PM Adjourn
(Box lunches available)