Current Issues and Challenges in Laboratory Diagnosis of Hemophilia and Monitoring Its Treatment Module 2: Laboratory Monitoring of Hemophilia Treatment

The following activity features highlights and faculty commentary from the 2017 International Society for Laboratory Hematology CME Symposium that address issues and challenges related to the laboratory diagnosis of non-severe hemophilia A and B, including discrepant hemophilia and detection of inhibitors.

As each module focuses on a different topic, all faculty from the original symposium may not be featured in each module; however; as they were involved in the development of the content, their information is noted in the CME information below.

Target Audience
This activity has been designed to meet the educational needs of hematologists, HEM/ONCs, clinical pathologists, laboratory technicians, registered nurses, and other HCPs who are interested in current issues – including recent MASAC guidelines − related to assays and monitoring of agents used to treat hemophilia.

Statement of Need/Program Overview
Laboratory assays play an essential role in the clinical management of persons with hemophilia. Precise measurements of the clotting factors FVIII and FIX are essential for accurate diagnosis, assessment of clinical severity, evaluation of risk of inhibitor development, and hemostatic therapy.

The medical literature, clinical experience, and surveys of laboratory tests used in the diagnosis of hemophilia and other congenital bleeding disorders suggests variability in the effectiveness of diagnostic strategies.

Considerable variation in the laboratory methods used for the screening, diagnosis, and monitoring of hemophilia and other congenital bleeding disorders includes variability in the techniques used even in long-standing, standardized assays. Some laboratories continue to rely on a single-factor assay in the diagnosis of non-severe disease, although cases with assay discrepancy may be missed by this strategy.

Educational Objectives
After participating in this activity, the participant should be better able to:

  • Discuss the basis for and clinical significance of discrepant non-severe hemophilia A and B and the implications for laboratory detection of hemophilia
  • Relate how clinical factor activity assays used for post-infusion monitoring can be affected by some modified recombinant FVIII and FIX replacement products in the presence of specific assay reagents

Dorothy M. Adcock
Dorothy M. Adcock, MD
Medical Director, Colorado Coagulation
Laboratory Corporation of America® Holdings
Englewood, Colorado

Faculty Presenters
Stefan Tiefenbacher, PhD
Stefan Tiefenbacher, PhD
Technical Director, Vice President, Colorado Coagulation
Laboratory Corporation of America® Holdings
Englewood, Colorado

Connie H. Miller, PhD
Connie H. Miller, PhD
Karna LLC
Consultant, Division of Blood Disorders
Centers for Disease Control and Prevention
Atlanta, Georgia

Physician Continuing Medical Education
This activity has been planned and implemented in accordance with the accreditation requirements and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of Postgraduate Institute for Medicine, the Cardiovascular & Metabolic Foundation and Educational Concepts in Medicine. The Postgraduate Institute for Medicine is accredited by the ACCME to provide continuing medical education for physicians.

The Postgraduate Institute for Medicine designates this enduring activity for a maximum of 0.50 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Nursing Continuing Education
The Postgraduate Institute for Medicine is accredited with distinction as a provider of continuing nursing education by the American Nurses Credentialing Center's Commission on Accreditation. This educational activity for 0.4 contact hour(s) is provided by the Postgraduate Institute for Medicine.

ASCLS P.A.C.E.® Credits
Accreditation Statement
Postgraduate Institute for Medicine is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This program is approved for up to 0.50 ASCLS P.A.C.E.® contact hour(s).

Instructions to Receive Credit
During the period of August 24, 2017 through August 24, 2018, participants must:

  • Read the learning objectives and faculty disclosures
  • Study the educational activity
  • Complete the posttest by recording the best answer to each question
  • Complete the evaluation form

A statement of credit will be issued automatically upon successfully completing the post-activity survey with a score of 75% or better and submitting the activity evaluation.

Disclosure of Conflicts of Interest
Postgraduate Institute for Medicine (PIM) requires instructors, planners, managers, and other individuals who are in a position to control the content of this activity to disclose any real or apparent conflict of interest (COI) they may have as related to the content of this activity. All identified COI are thoroughly vetted and resolved according to PIM policy. PIM is committed to providing its learners with high-quality CME activities and related materials that promote improvements or quality in healthcare and not a specific proprietary business interest of a commercial interest.

The faculty reported the following financial relationships or relationships they or their spouse/life partner have with commercial interests related to the content of this continuing education activity:

Name of Faculty or Presenter Reported Financial Relationship
Dorothy M. Adcock, MD Consulting Fees: Novo Nordisk, Baxalta and Instrumentation Laboratory
Fees for Non–CME/CE Services Received Directly from a Commercial Interest or their Agents: Instrumentation Laboratory
Stefan Tiefenbacher, PhD Consulting Fees: Novo Nordisk
Connie H. Miller, PhD Has no real or apparent conflicts of interest to report.

The planners and managers reported the following financial relationships or relationships they or their spouse/life partner have with commercial interests related to the content of this continuing education activity:

Name of Planner or Manager Reported Financial Relationship
PIM Clinical Reviewers: Trace Hutchison, PharmD; Samantha Mattiucci, PharmD, CHCP; Judi Smelker-Mitchek, RN, BSN; and Jan Schultz, RN, MSN, CHCP Have no real or apparent conflicts of interest to report.
ECM: Patrick J. Crowley, MBA, Partner/CEO; Jo-Ann Angelucci, Program Director; Larry Rosenberg, PhD, Medical Writer Have no real or apparent conflicts of interest to report.

Disclosure of Unlabeled Use
This educational activity may contain discussion of published and/or investigational uses of agents that are not indicated by the FDA. The planners of this activity do not recommend the use of any agent outside of the labeled indications.

The opinions expressed in the educational activity are those of the faculty and do not necessarily represent the views of the planners. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Participants have an implied responsibility to use the newly acquired information to enhance patient outcomes and their own professional development. The information presented in this activity is not meant to serve as a guideline for patient management. Any procedures, medications, or other courses of diagnosis or treatment discussed or suggested in this activity should not be used by clinicians without evaluation of their patients’ conditions and possible contraindications and/or dangers in use, review of any applicable manufacturer’s product information, and comparison with recommendations of other authorities.

Commercial Support
This activity is supported by an educational grant from Novo Nordisk Inc.