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    Preparing To Take The

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    Hussein MOUSSA

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    Preparing To Take The

    Uploaded by

    Hussein MOUSSA
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    Preparing to Take the

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    4 views27 pages

    Preparing To Take The

    Uploaded by

    Hussein MOUSSA

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    © All Rights Reserved
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    of 27

    Preparing to Take The

    Qualification In Apheresis
    Exam
    Christine M. Fernandez RN, MSN/Ed/ OCN
    Associate Director Apheresis Operations
    Argos Therapeutics
    WAA and The French Society For Apheresis 2016 Congress
    April 27-29, 2016
    Paris, France
    Exam process
    • The examination consists of a 50-question multiple choice timed-test that must be completed in
    90 minutes.
    The successful candidate will receive documentation of his/her qualification which is valid for 3
    years.
    • Requalification may be obtained every 3 years with a $50 application fee and documentation of
    completion of 6 contact-hours of acceptable continuing education / other activities in apheresis.
    • We are happy to announce that there will be a dedicated room in the Westin Mission Hills Golf
    Resort & Spa in Palm Springs where you can take the exam, providing you bring a laptop.
    • Please note that to be eligible to take the QIA exam at the ASFA meeting in early May, you
    should apply online at the beginning of February. Apply through ASCP as early as possible if
    you wish to take the exam at the ASFA Annual Meeting.
    The ASFA Website

    • www.apheresis.org
    How to get information
    How do I begin to Study?

    • Each of these subtests comprises a specific percentage of


    the overall 50-question qualification examination. The
    subtests for the examination are outlined in the slides to
    follow.
    Content Outline

    How the Exam is Structured Topics Covered


    • Basic Science
    • Clinical Applications
    • The Qualification in Apheresis
    examination questions encompass • Donor/Patient Care
    different topics or subtests • Instrumentation
    within the area of Apheresis: • Operational Considerations and Standards
    • Guidelines
    • Regulations (ASFA, AABB, CAP, FDA, FACT,
    HIPAA, TJC, etc.).
    Basic Science (5-10%)
    A. Hematology/Coagulation
    B. Immunohematology/Genetics
    1. Blood component therapy
    2. HLA
    3. ABO
    C. Immunology
    1. Antibodies
    2. Immune complexes
    D. Laboratory Testing
    Clinical Applications (10-20%)
    A. Donor Apheresis B. Therapeutic Apheresis
    1. Platelets 1. Plasma exchange
    2. Red blood cells 2. Red cell exchange
    3. Plasma 3. Cell depletion
    4. White blood cells 4. Selective adsorption/filtration
    procedures
    (e.g., granulocytes)
    Clinical Applications (cont.)
    C. Cellular Therapy D. Diseases Treated with Apheresis
    1. Hematopoietic progenitor cells
    2. Extracorporeal photopheresis (ECP)
    3. Mononuclear cell collections
    (e.g., lymphocytes, monocytes)
    Donor Patient Care (30-40%)
    A. Assessment/Monitoring
    B. Replacement Fluids
    C. Anticoagulation
    D. Medications (e.g., calcium, antihistamine) and Drug Interactions
    E. Venous Access
    F. Fluid Balance
    G. Age-Related Considerations
    H. Adverse Reactions
    Instrumentation (10-20%)
    A. Theories and Techniques of Separation B. General Principles of Automated Instruments*
    1. Centrifugation 1. Anticoagulation of extracorporeal
    circuit
    (e.g., intermittent and continuous flow)
    2. Extracorporeal blood volume
    2. Membrane
    3. Efficiencies of separation
    3. Columns
    and/or collection
    4. Clinical applications (see II.A.-D.)
    Operational Considerations(10-20%)
    • A. Quality Assurance (e.g., cGMP, cGTP, validation)
    • B. Quality Control
    • 1. Product yield
    • 2. Instrument efficiencies
    • C. Equipment Maintenance
    • D. Safety (e.g., OSHA, CDC)
    • E. Infection Control
    Standards, Guidelines, and Regulations (10-20%)

    • Including: ASFA, AABB, CAP, FDA, FACT, HIPAA, TJC, etc.


    A. Informed Consent
    B. Confidentiality
    C. Donor Selection
    D. Facility Licensure and Accreditation
    E. Training and Competency
    Reading list

    • The suggested reading list can be found on the


    ASFA website under the QIA tab.
    • Journals
    • Text
    • Regulations
    Journals

    • Journal of Clinical Apheresis. American Society for


    Apheresis (ASFA), Wiley, British Columbia.
    • Reference for special issue
    Journal of Clinical Apheresis
    TEXTS

    • APHERESIS PRINCIPLES
    • Linz, W. et al. (2014). Principles of Apheresis Technology (5th ed.). Vancouver,
    British Columbia: ASFA. Link to Purchase
    • McLeod, B.C. et al. (Eds.). (2010). Apheresis: Principles and Practice (3rd ed.).
    Bethesda, MD: AABB Press. Link to Purchase
    Principles of Apheresis Technology
    Google Search Text
    REGULATIONS

    • AABB. (2014). Standards for Blood Banks and Transfusion Services (29th ed.). Bethesda, MD: AABB
    Publications. Link to Purchase
    • AABB. (2013). Standards for Cellular Therapy Services (6Link to Purchase th ed.). Bethesda, MD:
    AABB Publications. Link to Purchase **NEW EDITION DUE OUT JULY 2016**
    • Center for Biologics Evaluation Research. (2007). Guidance for Industry and FDA Review Staff:
    Collection of Platelets by Automated Methods: Food and Drug Administration. Available online: Link
    to View
    • The Joint Commission. (2015). 2016 Comprehensive Accreditation Manual for Hospitals (CAMH).
    Oakbrook Terrace, IL: The Joint Commission. Link to Purchase
    More Regulations
    • Food and Drug Administration. (published yearly). Code of Federal Regulations Title 21: Food
    and Drugs. Office of the Federal Register National Archives and Records Administration
    Publication, Parts 210, 211, 600, 601, 606, 607, 610, 640, 1271. WashingtonD.C.: Printing
    Office of the Superintendent of Documents. Link to View
    • Food and Drug Administration. (February 2001). Guidance for Industry: Recommendations for
    Collecting Red Blood Cells by Automated Apheresis Methods (Technical Correction). Rockville,
    MD: FDA. Available online: Link to View
    • Food and Drug Administration. (March 10, 1995). Revision of FDA Memorandum of August
    27, 1982: Requirements for Infrequent Plasmapheresis Donors. Rockville, MD: FDA. Available
    online: Link to View
    Online Resources
    • AABB www.aabb.org
    • American Nephrology Nurses Association www.annanurse.org
    • American Society for Apheresis www.apheresis.org
    • American Society of Hematology www.hematology.org
    • American Society of Nephrology www.asn-online.org
    • Centers for Disease Control and Prevention www.cdc.gov
    • College of American Pathologists www.cap.org
    • Food and Drug Administration www.fda.gov
    • HIPAA www.cms.hhs.gov/hipa
    • Occupational Safety and Health Administration www.osha.gov
    Other Sources of Information
    Additional Resources
    • Joint Task Force For Apheresis Education
    • Contact Information:
    • http://wwwsanquin.nl/en/products-services/consulting-services
    • [email protected]
    Thank You

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