May 2014 Kevin J Land MD Chair, AABB Donor Hemovigilance Working - PowerPoint PPT Presentation

Public Health Services Blood Organ and Tissue Safety May 2014 Kevin J Land MD Chair, AABB Donor Hemovigilance Working Group Senior MD, Blood Systems

Original Purpose The Donor Hemovigilance Working Group (DHVG) will implement a national monitoring program on donor safety issues as an important element of continuous improvement in the comprehensive biovigilance network. This report is an update on activities that culminated in the publishing of the AABB Donor Hemovigilance Annual Report 2012. 2

US Donor Hemovigilance Working Group: Executive Summary • Developed US DHV common definition set (CDS) based on – Existing models, nationally/internationally. – Objective evidence-based criteria, signs and symptoms • Developed software with contract vendor (KBSI) • Presented and published results • Leading Donor Hemovigilance efforts internationally – VVR (inter)nationally decreased as interventions built on hv data have been implemented – Interventions which grew out of US HV data have been incorporated into a set of recommendations sent to ABO centers (North America, Western Europe, Australia and a little Japan) • Helped develop draft International CDS standard with defined minimal (MDS) & optional data elements • Experiencing growing national and international interest 3

AABB US Donor Hemovigilance Working Group Members • Anne Eder, MD, PhD • Kevin Land, MD – ARC National Headquarters – BSI, (Bonfils) • Madhav Erraguntla, PhD • Bruce Newman, MD – KBSI – ARC, subject matter expert • Mindy Goldman, MD • Kadi Schroeder, RN – Canadian Blood Services – Bonfils Blood Center • Michelle Greenland • James Stubbs, MD – LifeShare Community Blood Services – Mayo Clinic • Linda Gruber • Peter Tomasulo, MD – BloodCenter of Wisconsin – BSI (past chair) • Mary Gustafson • Mary Townsend, MD – PPTA – BSI, (Coffee Memorial Hospital) • Barbara Hallenburg • Barbee Whitaker, PhD – LifeShare Community Blood Services – AABB • Hany Kamel, MD • Johanna Wiersum-Osselton, PhD – BSI – TRIP, The Netherlands 4

Acknowledgements • James Berger, MS, MT (ASCP), SBB, US Department of Health and Human Services • CDR Richard Henry, ML, MPH, US Department of Health and Human Services • LTCOL David Lincoln†, Armed Services Blood Program Office, US Department of Defense • D. Michael Strong, PhD, University of Washington School of Medicine • Alan Williams, PhD, US Food and Drug Administration 5 †Deceased November 18, 2012

Brief History: US Biovigilance Gap Report • Drafted in response to 2006 ACBSA recommendations (and concurrence by Assistant Secretary of Health): – DHHS coordinate Federal actions and programs to support and facilitate biovigilance in partnership with private sector initiatives – DHHS form a task group to perform a gap analysis of current systems and make recommendations for public-private partnerships in biovigilance (blood, cell, tissue, and organ therapies). 6 6 Adapted from Alan Williams

HHS Biovigilance Gap report: Key Deficiencies of Hemovigilance in the United States • Absence of………. – Long-term stability – National scope – Multicenter design – Common definitions – Broad data access and sharing – Real Time Data Availability – Active use to document practice improvement 7 7 Adapted from Alan Williams

Brief History: HHS/AABB Donor Hemovigilance Working Group • Funding – 2007 - 2014: Software - DHHS through SBIR with KBSI – 2007 - to date: DH Working group - AABB – 2007 - 2008: DH WG - various blood centers • Focus on Donor Adverse Reactions • Key Participants – DHHS, AABB, ABC, ARC, DoD, Bonfils Blood Center, BSI, Coffee Memorial , Mayo, PPTA, Canadian Blood Service, KBSI, ISBT/IHN 8 Adapted from Alan Williams

HHS/AABB Donor Hemovigilance • National Standards for Donor Reaction Data Collection – Data Elements and Definitions – Reactions and Reaction Categorization • Systemic, Standard Mechanism to Calculate Donor Reaction Rates – Trends at Facility, Organization, Region and Nation Levels – Comparison With Peers, Region and Nation 9 Slide from Alan Williams

HHS/AABB Donor Hemovigilance • Predictive and Causality Analysis – Analyze Variables (Age, Sex, Weight, BP) Affecting Donor Reaction Rates – Device and Kit Analysis – Analyze Associations between Policies, Procedures of Organizations and Donor Reaction Rates • Intervention Analysis and Management 10 Slide from Alan Williams

Primary Charge of US Hemovigilance Focusing on Blood is to develop a system that will be: • Electronic • Voluntary, confidential, non-punitive reporting service • Focused on improving donor safety • Managed by experts • Able to analyze data and understand implications for donors and those caring for them • Provide immediate data access for participants • Provide periodic access for external analysis • Avoid duplication of existing systems 11

Scope : • Standard Data Element Definitions, Reactions and Reaction Categorization • Each Organization Will Provide Mapping Between Organization Reaction Codes and National Reaction Codes • Analysis Methodology Should be Flexible to Support Incomplete Data 12

Scope: Denominators Offer uni-variant, bi-variant, and multi-variant options • Number of Donations • Number of Donations By Predefined Demographic Categories – Age Ranges, Sex, First Time Vs Repeat,.. – Independent Demographic Categories Vs Stratified • Demographic Data For All Donations – Comprehensive Causality Analysis – Future Ad-hoc Analysis 13

Q: What type of data elements are gathered? A: Reaction Type & Category + optional signs &symptoms Table Reaction Example Reaction Type Reaction Category Vasovagal Prefaint, no LOC (uncomplicated or minor) LOC, any duration (uncomplicated) LOC, any duration (complicated) Injury Local Injury Nerve Irritation related to Hematoma/Bruise needle Arterial Puncture Apheresis Citrate Hemolysis Air Embolus Allergic Local Systemic Anaphylaxis Other Other 14

Summary of Pilot data study How much data is required? Total Minimum Allows null Min Elements Elements required Donor 7 4 3 Organization name, Donor ID, Data DOB, gender Donation 36 5 31 Organization name, Donor ID, Collection Center, Donation ID, Data ( 2 + 3) Donation Date Reaction 25 7 18 Organization name, Donor ID, Collection Center, Donation ID, (2+2 + 3) Data Reaction Type, Reaction Category, update-flag + 80 elements in Denominator Data 15 Courtesy Pilot Facility Bonfils Blood Center, Denver Co

Summary of Pilot feasibility and time study How much data can be readily imported (eg readily accessible)? Total Initially Unique Inform. Primary Not Not Reported Elements System* Forms Collected Relevant to DHV (% avail) (BECS) (%) Donor 7 (100%) 7 0 0 0 7 (100%) Donation 34 (46%) 12 7 12 3 12 (35%) (height/ (total protein/ manufact/kit) Hgb) Reaction 21 (83%) 0 21 0 0 10 (48%) + 1 update flag Total 62 (64%) 31% 44% 19% 6% 29 (47%) Primary Forms : Included on DN Incident Form, Donation Record, or Apheresis Run Sheet Not Relevant : Not intended for our business (eg total protein) 16 Courtesy Pilot Facility Bonfils Blood Center, Denver Co

Summary of Pilot feasibility and time study Monthly time commitment ~ 3 ¾ hrs/mo for 175K RBC center • IT Data download (<1h) – electronic reaction information – denominator data • DHV file manual data entry (2.5h) + – Initially, additional documentation from forms added ~15m per record. – Reduced to <5 min each or ~ 15 reports/hr in <1mo use • Upload to DHV website (<15m) • Initially took 6h/mo longer – Now takes same time as before, with more data for analysis 17 Courtesy Pilot Facility Bonfils Blood Center, Denver Co

Conclusion: Useful data surrounds the donation process but without solutions like DonorHART, the data are not readily available to improve donor experience & outcome Who benefits from data freed from its primary donor suitability and component manufacturing use? The donor, others, but ultimately the Patient 18

AABB First Donor Hemovigilance Annual Report: 2012 data • Adverse reactions from 1,171,906 individual donations • Denominator Data: 100% univariant • 99% Allogenic donations (1% total autologous, directed, and therapeutic) • 148 Potential data + 80 univariant denominator data elements 19

How many different attributes were Table X: Attribute Reporting reported? Donor Variable Percent reporting Age 100% Who is reporting them? Donation History 100% Donation Type 100% Gender 100% Procedure Type 100% Ethnicity 80% 2012-2103 (~22 facilities in the cue) Collection Site 80% Pulse 60% • 5 facilities reported 2012 data Sponsor Group Type 60% Weight 60% • 2 other facilities with partial data Blood Pressure 40% Race 40% Device Manufacturer 20% • 8 in contract talks Device Model 20% Height 20% • 7+ adopting CDS Device Software 0% Container Manufacturer 0% Container Kit Type 0% 20

Donor Demographics (n=1,171,906 individual donations) Attribute Donation % Reaction % Reaction %/ Donation% GENDER Female 47.9 65 1.36 Male 52.1 35 0.67 Donation Status First Time Donor 14.6 31.3 2.14 Repeat Donor 85.4 68.7 0.80 Donation Type Whole Blood 75.5 83.6 1.11 Automated* 24.5 16.4 0.67 *Aph PLT 14.2%, dRBC 14.2%, PLT & RBC 1.2%, PLT & Plasma 1.6 %, other multi-comp 1.7% 21