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

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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.

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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

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AABB US Donor Hemovigilance Working Group Members

• Anne Eder, MD, PhD

– ARC National Headquarters

• Madhav Erraguntla, PhD

– KBSI

• Mindy Goldman, MD

– Canadian Blood Services

• Michelle Greenland

– LifeShare Community Blood Services

• Linda Gruber

– BloodCenter of Wisconsin

• Mary Gustafson

– PPTA

• Barbara Hallenburg

– LifeShare Community Blood Services

• Hany Kamel, MD

– BSI

• Kevin Land, MD

– BSI, (Bonfils)

• Bruce Newman, MD

– ARC, subject matter expert

• Kadi Schroeder, RN

– Bonfils Blood Center

• James Stubbs, MD

– Mayo Clinic

• Peter Tomasulo, MD

– BSI (past chair)

• Mary Townsend, MD

– BSI, (Coffee Memorial Hospital)

• Barbee Whitaker, PhD

– AABB

• Johanna Wiersum-Osselton, PhD

– TRIP, The Netherlands

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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

†Deceased November 18, 2012

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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).

Adapted from Alan Williams

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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

Adapted from Alan Williams

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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

Adapted from Alan Williams

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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

Slide from Alan Williams

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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

Slide from Alan Williams

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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

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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

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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

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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 related to needle Nerve Irritation Hematoma/Bruise Arterial Puncture Apheresis Citrate Hemolysis Air Embolus Allergic Local Systemic Anaphylaxis Other Other

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Summary of Pilot data study How much data is required?

Total Elements Minimum required Allows null Min Elements

Donor Data 7 4 3

Organization name, Donor ID, DOB, gender

Donation Data 36 5

(2 + 3)

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Organization name, Donor ID, Collection Center, Donation ID, Donation Date

Reaction Data 25 7

(2+2 + 3)

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Organization name, Donor ID, Collection Center, Donation ID, Reaction Type, Reaction Category, update-flag

Courtesy Pilot Facility Bonfils Blood Center, Denver Co

+ 80 elements in Denominator Data

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Summary of Pilot feasibility and time study

How much data can be readily imported (eg readily accessible)?

Total Unique Elements (% avail) Inform. System* (BECS) Primary Forms Not Collected Not Relevant Initially Reported to DHV (%) Donor 7 (100%) 7 7 (100%) Donation 34 (46%) 12 7 12

(height/ manufact/kit)

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(total protein/ Hgb)

12 (35%) Reaction 21 (83%) 21 +1 update flag 10 (48%) Total 62 (64%) 31% 44% 19% 6% 29 (47%)

Courtesy Pilot Facility Bonfils Blood Center, Denver Co

Primary Forms: Included on DN Incident Form, Donation Record, or Apheresis Run Sheet Not Relevant: Not intended for our business (eg total protein)

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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

Courtesy Pilot Facility Bonfils Blood Center, Denver Co

+

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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

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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

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How many different attributes were reported? Who is reporting them?

Table X: Attribute Reporting Donor Variable Percent reporting Age 100% Donation History 100% Donation Type 100% Gender 100% Procedure Type 100% Ethnicity 80% Collection Site 80% Pulse 60% Sponsor Group Type 60% Weight 60% Blood Pressure 40% Race 40% Device Manufacturer 20% Device Model 20% Height 20% Device Software 0% Container Manufacturer 0% Container Kit Type 0%

2012-2103 (~22 facilities in the cue)

• 5 facilities reported 2012 data
• 2 other facilities with partial data
• 8 in contract talks
• 7+ adopting CDS

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Donor Demographics (n=1,171,906 individual donations)

*Aph PLT 14.2%, dRBC 14.2%, PLT & RBC 1.2%, PLT & Plasma 1.6 %, other multi-comp 1.7% 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

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16 - 18 years 11% 19 - 22 years 7% 23 - 29 years 9% 30 - 39 years 12% 40 - 49 years 17% 50 - 59 years 23% 60 - 69 years 15% 70 - 79 years 5% ≥80 years 1%

Donations by Donor Age

>40yo = 61% >60yo = 21% High School = 11%

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Reactions By Type and Donor Age

5 10 15 20 25 30 16 - 18 19 - 22 23 - 29 30 - 39 40 - 49 50 - 59 60 - 69 70 - 79 >= 80 Reactions per Thousand Donations Age in Years

Reactions by Type and Donor Age

Vasovagal Reactions Hematoma/Bruise Reactions

28.7% First time donor rate

Age Reaction rate for all reactions types per 1,000 Donations (all p<0.001)* 16 - 18 years 29.7 (2.28)* 19 - 22 years 22.2 (1.69) 23 - 29 years 17.2 (1.3) 30 - 39 years 12.0 (0.91) 40 - 49 years 9.3 (0.7) 50 - 59 years 8.7 (0.65) 60 - 69 years 9.3 (0.7) 70 - 79 years 9.0 (0.67) ≥80 years 12.3 (0.93)

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Surveillance Type Reaction Rate Summary Table per 1,000 donations

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Seasonal Donation Patterns Among Donors

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Reaction Rate by Collection Site Potential limitations of univariant analysis

5 10 15 20 25 30 Fixed Site Mobile donor coach Mobile inside-set-up Reactions per Thousand Donations

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Reactions by Location

Bed 55% Canteen 24% Off site 13%

Other location

• n site

4% Registration 0%

Screening 2% Transit to canteen 2%

• 2% Pre-donation
• 55% While on bed
• 43% Post-donation

6% walking onsite 4% in bathroom 13% offsite

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Collection Facilities are Discovering Additional and Innovative Uses for DHV Data

• Medical Affairs (Assessing post implementation effectiveness of risk

reduction strategies)

– Implementation of pre-hydration stations and salt replacement initiatives – Restrictions on maximum proportion of donor blood volume which can be donated – Impact of staff tension training on donor adverse events

• Quality Assurance (As part of a quality essentials program)

– Comparison of facility reaction rates to national aggregate results – Denominator data helps identify statistical sampling size needed for auditors

• Operations

– Impact on donor adverse events as a result of pure operational changes

– Changes in bag size and manufacturer (450ml – 500ml) – New mobile double red cell collection program – New staff monitoring for high risk donor groups (eg high school blood drives)

– Descriptive denominator data being used for marketing and recruitment

• Business Review Made Easy (Standard DonorHART™ reports are used)

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Current and Future Directions of AABB Donor HV

• Continued alignment with international DHV definitions

(New Charge)

– Help develop thoughts around both Minimum Data Set (MDS) and larger Common Definition Set (CDS)

• Formally define DonorHART™ Lite
• Implement bi-variant and multi-variant denominator data

capabilities

• Begin DHV research projects, such as…

– impact of Iron and Calcium depletion in donors

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International Efforts Summary

• Presentations on DonorHART progress made at several ISBT/IHN meetings
• Several countries have expressed interest potential to use DonorHART
• ISBT/IHN in 2013 set up working group to update Donor HV definitions

– Members of AABB DHV working group were asked to participate

• Updated draft ISBT Donor HV definitions have been made

– ISBT has agreed to adopt many of the US definitions and agrees to allow signs and symptoms (primarily from US system) to be collected optionally – Only 9 issues separate current US HV definitions and draft ISBT definitions – US DHV working group has agreed to 9/9 changes necessary

• 1/9 (related to how nerve injury should be classified) is still under some discussion
• ISBT definitions anticipated to be approved in Seoul during annual meeting,

thus leading to an international unified Donor HV definition set.

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International Donor Vigilance Efforts: Evolving how collection centers view their data

Stage Description Benefits I Internal data collection

Local data gathering and research

II Internal adoption of external standard vocabulary

Ability to compare your data to others based on internationally accepted vocabularies

III Surveillance data (aka minimal data set)

• Minimal common surveillance data that can be

shared and compared internationally

• Surveillance detail summarized in AABB annual

report

• Signs and symptoms are not reported

IVa Basic Benchmarking (aka DonorHART lite)

• Data incorporated into AABB donor

hemovigilance annual report

• Donor hemovigilance dashboard

IVb Enhanced Benchmarking with extended data mining capability (use of common definition set)

• Shared process improvement expertise to

improve donor outcomes

• Increased BECS data liquidity (donor

demographics, business analytics, etc)

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Parting thoughts

Thank you! kland@bloodsystems.org

• US Donor Hemovigilance Pilot Program was a success.

– 2012 Report released. – 2013 Report to begin after June with more centers. – Program likely will need bridge funding for 1-3 years.

• AABB and US Donor Centers are deriving value from DonorHART.

– US Donor Centers are adopting US definitions. – There is some international interest in the system as well.

• Most US donor centers, though, are waiting for new definitions and

answers to questions about what access FDA/HSS wants and what will the future financing look like before jumping onboard.