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Integrating Industry Standards and Donor Management in the
Integrating Industry Standards and Donor Management in the 21st Century Roger Brinser Director, Regulatory, BioLife Plasma Services Chair, PPTA Regulatory Policy & Compliance Steering Committee Member, PPTA Medical Policy Committee IPFA/BCA Global Symposium on The Future for Blood and Plasma Donations 23-24 September 2014 Sacramento, CA www.pptaglobal.org Overview • • • • • Industry at a Glance Donor Eligibility—Brief Overview PPTA Standards—IQPP PPTA Standards—QSEAL Continuous Improvements (Standards) Plasmavigilance Cross Donation Management • Continuous Improvements (Donor Safety) PPTA Regulatory Workshops FLIPD Study 2014 IPFA/BCA Global Symposium Slide 2 www.pptaglobal.org Industry At-A-Glance • Source Plasma industry no longer comprised primarily of single collection centers or small organizations Includes international corporations with multiple centers Governed by large organizational systems • In calendar year 2013, ~29.4 million Source Plasma donations were collected from ~1.6 million donors 2014 IPFA/BCA Global Symposium Slide 3 www.pptaglobal.org U.S. Source Plasma Collection Centers* * Map produced by Dr. Adelbert James, Epidemiologist, Emory University School of Medicine, Atlanta, GA, 2013 2014 IPFA/BCA Global Symposium Slide 4 www.pptaglobal.org Number of Centers by State 2014 IPFA/BCA Global Symposium Slide 5 www.pptaglobal.org Number of Centers 1999-2011 2014 IPFA/BCA Global Symposium Slide 6 www.pptaglobal.org Donor Eligibility Brief Overview • Each Source Plasma collection organization has standard operating procedures for determining prospective donor eligibility Based on US FDA and other National requirements (e.g., EC) Donor history questionnaire (e.g. PPTA DHQ*) is administered on date of donation Physical examination / laboratory testing / vital signs Informed consent (including educational information) • Documents provided to donor as part of eligibility process (hard copy or electronic) include: Risk poster (HIV and Hepatitis) Travel poster (vCJD) Medication list (impacting product safety) * FDA has recognized version 1.2 dated September 2012 as acceptable mechanism consistent with donor history guidance 2014 IPFA/BCA Global Symposium Slide 7 www.pptaglobal.org Donor Eligibility Donor History Questionnaire • Center conveys to prospective donor: Importance of donor history questionnaire to: • • Protect donor’s health Protect safety of Source Plasma supply Responsibility to provide accurate information • DHQ administered by: Trained health historian in direct donor questioning Self-administration, e.g. computer-assisted self-interview process (CASI) 2014 IPFA/BCA Global Symposium Slide 8 www.pptaglobal.org Donor Eligibility Continuous Monitoring • • Donor collection records maintained (according to national requirements e.g., 30+ years) Donor Unit Testing performed at each donation • Blood sample drawn at least every 4 months* • Serology—Anti-HIV ½, Anti-HCV, HBsAg NAT—HIV RNA, HCV RNA, HBV DNA NAT—HAV and Parvo B19 (QSEAL) Perform syphilis test, total protein determination, serum protein electrophoresis (SPE) Accumulated laboratory data, including SPE pattern, component values, collection records reviewed within 21 days of draw to determine continued eligibility Annual physical All donors administered full-length DHQ with physical at least annually Abbreviated DHQ available to elicit important information from frequent donors only * 21 CFR 640.65(b)(1)-(2) 2014 IPFA/BCA Global Symposium Slide 9 www.pptaglobal.org PPTA Standards "PPTA's voluntary standards program provides global leadership for the plasma protein industry's goal of continuous improvement with a focus on safety and quality from the donor to the patient. The Standards Program will be transparent, credible, innovative and responsive to stakeholder and industry needs." - Mission Statement, PPTA Voluntary Standards Program International Quality Plasma Program (IQPP)* •IQPP certified centers provide manufacturers with the highest quality source material •IQPP certification focuses on: Donor Management and Donor Health Center Management Quality Standards of Excellence, Assurance & Leadership (QSEAL)** • PPTA established the QSEAL Program to provide independent certification of adherence by fractionators to the voluntary standards * http://www.pptaglobal.org/safety-quality/standards/iqpp ** http://www.pptaglobal.org/safety-quality/standards/qseal 2014 IPFA/BCA Global Symposium Slide 10 www.pptaglobal.org PPTA Standards – IQPP • Donor Management and Donor Health Community-based Donor Standard Cross Donation Management Standard Donor Education Standard National Donor Deferral Registry (NDDR) Standard Qualified Donor Standard Viral Marker Standard 2014 IPFA/BCA Global Symposium Slide 11 www.pptaglobal.org Community-based Donor Standard • This standard only allows donors who permanently reside within the defined Donor Recruitment Area of the plasma center to donate at that center. • The standard helps to maintain a steady and reliable donor population and supply of quality plasma. 2014 IPFA/BCA Global Symposium Slide 12 www.pptaglobal.org Community-based Donor Literature 2014 IPFA/BCA Global Symposium Slide 13 www.pptaglobal.org Community-based Donor Outreach 2014 IPFA/BCA Global Symposium Slide 14 www.pptaglobal.org Community-based Donor Outreach 2014 IPFA/BCA Global Symposium Slide 15 www.pptaglobal.org Community-based Donor Amenities 2014 IPFA/BCA Global Symposium Slide 16 www.pptaglobal.org Community-based Donor Convenience 2014 IPFA/BCA Global Symposium Slide 17 www.pptaglobal.org Community-based Donor Recognition International Plasma Awareness Week (IPAW) Celebrated October 12-18, 2014 Raise awareness about Source Plasma collection Celebrate and recognize the contributions of Source Plasma donors Expand knowledge about plasma protein therapies and rare disease 2014 IPFA/BCA Global Symposium Slide 18 www.pptaglobal.org Donor Education Standard • This standard requires new donors to engage in an educational program and follow-up assessment regarding HIV/AIDS and activities that place them at risk for HIV/AIDS. It is important that donations are collected from a low-risk donor population. Those potential donors, who acknowledge being involved in defined high-risk behaviors, are deferred from donating. • The educational program also encourages donors to lead a healthy lifestyle 2014 IPFA/BCA Global Symposium Slide 19 www.pptaglobal.org Donor Education Promoting a Healthy Lifestyle 2014 IPFA/BCA Global Symposium Slide 20 www.pptaglobal.org Donor Education Nutrition and Health 2014 IPFA/BCA Global Symposium Slide 21 www.pptaglobal.org Donor Education Donor information and Tips 2014 IPFA/BCA Global Symposium Slide 22 www.pptaglobal.org Donor Education Web Applications 2014 IPFA/BCA Global Symposium Slide 23 www.pptaglobal.org Donor Education Connecting to Recipient 2014 IPFA/BCA Global Symposium Slide 24 www.pptaglobal.org Donor Education Recognition 2014 IPFA/BCA Global Symposium Slide 25 www.pptaglobal.org PPTA Standards – IQPP • Center Management Personnel Education and Training Standard Professional Plasma Collection Facility Standard Quality Assurance Standard 2014 IPFA/BCA Global Symposium Slide 26 www.pptaglobal.org Personnel Education and Training Standard • This standard ensures that the facility has knowledgeable and experienced staff that is highly trained in their job responsibilities. • Additionally, this standard requires an in-depth initial training program and an ongoing training program. • This ensures that the center staff is always upto-date on the most recent regulatory requirements and latest and most innovative procedures. 2014 IPFA/BCA Global Symposium Slide 27 www.pptaglobal.org Personnel Education and Training Training Programs 2014 IPFA/BCA Global Symposium Slide 28 www.pptaglobal.org Personnel Education and Training Example of Mission and Vision 2014 IPFA/BCA Global Symposium Slide 29 www.pptaglobal.org Personnel Education and Training Dedicated Facilities 2014 IPFA/BCA Global Symposium Slide 30 www.pptaglobal.org Professional Education and Training Professional Environment 2014 IPFA/BCA Global Symposium Slide 31 www.pptaglobal.org Donor Education and Training Classroom Setting 2014 IPFA/BCA Global Symposium Slide 32 www.pptaglobal.org Donor Education and Training Curriculum Based Training 2014 IPFA/BCA Global Symposium Slide 33 www.pptaglobal.org Donor Education and Training Application Based Training 2014 IPFA/BCA Global Symposium Slide 34 www.pptaglobal.org Professional Plasma Collection Facility Standard • It is imperative that all medical facilities maintain a high level of professionalism and quality regarding their cleanliness, safety and appearance. • This standard ensures that IQPP-certified centers uphold that level of professionalism and quality. 2014 IPFA/BCA Global Symposium Slide 35 www.pptaglobal.org Professional Plasma Collection Facility Facility Exterior 2014 IPFA/BCA Global Symposium Slide 36 www.pptaglobal.org Professional Plasma Collection Facility Facility Exterior 2014 IPFA/BCA Global Symposium Slide 37 www.pptaglobal.org Professional Plasma Collection Facility Entrance 2014 IPFA/BCA Global Symposium Slide 38 www.pptaglobal.org Professional Plasma Collection Center Reception Area 2014 IPFA/BCA Global Symposium Slide 39 www.pptaglobal.org Professional Plasma Collection Facility Donor Phlebotomy Area 2014 IPFA/BCA Global Symposium Slide 40 www.pptaglobal.org Professional Plasma Collection Facility Plasma Processing Area 2014 IPFA/BCA Global Symposium Slide 41 www.pptaglobal.org Professional Plasma Collection Facility Our Donors! 2014 IPFA/BCA Global Symposium Slide 42 www.pptaglobal.org Quality Assurance Standard • IQPP certified plasma centers are based on compliance with current Good Manufacturing Practices (GMP). This Standard is an enhancement to those requirements, focusing on the aspects of Complaint Resolution and Lot Release Procedures. This Standard ensures that a plasma center has put into place systems that consistently guarantee a quality product. IQPP requires that there be a person on staff who is responsible for evaluating customer and/or donor complaints and that those complaints be dealt with and investigated as quickly as possible. Lot Release procedures must adhere to GMP rules. IQPP certified plasma centers must have a system in place to both release shipments of plasma and stop them if necessary. 2014 IPFA/BCA Global Symposium Slide 43 www.pptaglobal.org Quality Assurance Technology Improvements 2014 IPFA/BCA Global Symposium Slide 44 www.pptaglobal.org Quality Assurance Electronic Media 2014 IPFA/BCA Global Symposium Slide 45 www.pptaglobal.org Quality Assurance Standard Questions/Electronic Format 2014 IPFA/BCA Global Symposium Slide 46 www.pptaglobal.org Quality Assurance Donor ID and Medical History 2014 IPFA/BCA Global Symposium Slide 47 www.pptaglobal.org Quality Assurance Continuous Improvement 2014 IPFA/BCA Global Symposium Slide 48 www.pptaglobal.org PPTA Standards – QSEAL • Controls on Incoming Plasma (New in 2013) • Inventory Hold • Nucleic Acid Amplification Technology (NAT) Testing (Revised in 2013) • Intermediates Purchased from an External Supplier (Revised in 2013) • Recovered Plasma Specification (New in 2013) • Qualified Donor • Viral Marker 2014 IPFA/BCA Global Symposium Slide 49 www.pptaglobal.org Continuous Improvement Standards Proposed Revision to IQPP Cross Donation Management Standard • • • • • • FDA regulations were developed to limit donation frequency Individual companies have systems in place to ensure compliance Donor may not fully understand reasons donation frequency and attempt to donate at an alternate site more often than regulations allow Current standard developed to protect donor safety by minimizing the risk of cross donation Automation of standard using 510(k) cleared device to track donation frequency. Minimal information will be shared among collectors. Revised standard with automated system is targeted for implementation by end of 2014 2014 IPFA/BCA Global Symposium Slide 50 www.pptaglobal.org Continuous Improvement Standards New IQPP Standard for Recording Donor Adverse Events (DAE) •Each Source Plasma organization currently has procedures in place to monitor donor health and safety Definitions of DAE between organizations similar but not standardized Standardization necessary for data aggregation and establishment of national benchmarks. PPTA IQPP standard was solution •Hemovigilance for Source Plasma industry = Plasmavigilance Common language to classify DAE within industry Generally acceptable categories applicable to industry Easy to use with objective definitions based on simple and common signs and symptoms Does not dictate medical judgment (e.g., no definition of “hypotension”) •New standard is targeted for approval and implementation by end of Q2 2015 2014 IPFA/BCA Global Symposium Slide 51 www.pptaglobal.org Continuous Improvements Donor Safety • • • PPTA Regulatory Workshop—Industry’s commitment to Safe and Healthy Donors (10 June 2013). Topics included: Plasma donation today Plasma donor eligibility Plasma donor surveillance PPTA Regulatory Workshop—Safety from Donor to Patient (25 June 2014). Topics included: Focus on the donor Focus on the product Focus on the patient Ferritin Levels in Plasma Donors (FLIPD) Study Examine ferritin levels in Source Plasma donors, to determine whether there is association with frequent donation 2014 IPFA/BCA Global Symposium Slide 52 www.pptaglobal.org Continuous Improvements Donor Safety--FLIPD Study • A Source Plasma donation is associated with little red blood cell (RBC) loss; no information on iron status for frequent donors • Despite little RBC loss, questions about accumulated loss over large number of donations was raised during November 2011 FDA Public Workshop on Hemoglobin Standards and Maintaining Adequate Iron Stores in Blood Donors (PPTA/AABB/ABC/ HHS/NHLBI co-sponsors) • Industry decided to conduct large cohort, cross-sectional study of association between frequent donation and ferritin levels 2014 IPFA/BCA Global Symposium Slide 53 www.pptaglobal.org Continuous Improvements Donor Safety--FLIPD Study Results •Frequent donation not associated with: Lower plasma ferritin values Reduced body iron stores Increase in iron deficiency •Iron deficiency no more common among female donors than among age-comparable populations* (NHANES 2003-2006) •Unlike situation with WB and Platelet donation, iron deficiency not a short- or long-term issue associated with Source Plasma donation •Results presented at June 2014 PPTA Regulatory Workshop; paper in development for publication * M. Cogswell et al., Am J Clin Nutr 2009; 89, 1334-42 2014 IPFA/BCA Global Symposium Slide 54 www.pptaglobal.org Summary • Industry is global and as such is regulated by FDA and international Health Authorities (e.g., EMA, CFDA, MFDS, etc.) • PPTA standards reflect industry best practices beyond regulatory requirements • PPTA standards are not static. Continuous improvement of existing standards and new standards added • Coordinated industry efforts to study donors health and safety • Industry standards are integrated in donor management process 2014 IPFA/BCA Global Symposium Slide 55 www.pptaglobal.org Acknowledgments Thank you to all PPTA members* for providing information! * http://www.pptaglobal.org/membership/current-members 2014 IPFA/BCA Global Symposium Slide 56 www.pptaglobal.org
