1. NEW HARMONISED DEFINITIONS FOR COMPLICATIONS OF BLOOD  DONATION: INTERNATIONAL VALIDATION (5A-S29-02)
Kevin Land MD
Chair, ISBT Haemovigilance Working Party
Member, AABB Hemovigilance Steering Committee
Blood Systems Inc., USA
University of Texas Health Science Center

2. Aim
Validate harmonized donor haemovigilance definitions using potential users and subject matter experts around the world.

3. Background: Globally harmonized definitions…~23 years in the making
~1993: Countries begin aggregating AE data ~1994: Medical event reporting system work begins (MERS) 1998: European Haemovigilance Network formed (now IHN) 2002: EU Blood Directive mandates HV systems 2006: Formal efforts in US begin 2008: ISBT standard for surveillance of complications related to donation: iSTARE database started 2009: AABB publishes terms, built on ISBT terms and recent research. DonorHART database started 2014: ISBT and AABB surveillance terms harmonized and jointly published 2016: Global validation of surveillance terms (NOW)
2009 HHS report on the critical gaps in US Biovigilance

4. Methods: 30 real world cases selected some contained multiple diagnoses
Type of Adverse Event
# of Cases
A 1 Blood outside vessel 6
A 2 Arm pain 7
A 3 Localized infection/ inflammation of vein/soft tissues 2
A 4 Other major vessel injury
B Vasovagal reactions
C Related to apheresis
D Allergic reactions
E Other serious complications
F Other (give diagnosis) 1
Minimally edited
Often lack complete information
Few created from case reports
Reside on HV WP website
Collected from around the world
Sent out to experts around the world with help from ISBT, AABB, and ABC
Are full report will be sent out to all participants
A manuscript will be completed by the end of the year
SUBMIT

5. Methods: Survey went out
Sent to ISBT, AABB, ABC members
Cover letter with examples, definitions, cases, answer sheet
Asked to provide at least one diagnosis and grade for severity and imputability for each
Asked to consider all optional criteria in their answer
Given one month to respond (July 2016)
Results compiled in Excel database

6. Results: 54 Respondees 12 self reported were group responses
17(12)
21(3)
11 (6) 1
2 (2) 1
Thank you all for your time, answers, & comments!
It is because of your dedication to Haemovigilance this project is even possible

7. Results
52/54 respondees provided at least one diagnosis, severity, and imputability result for each case.
Multiple and alternated diagnoses were given
Median # single responses 52 (range 18-54)
Median total responses 57 (range )
18/30 Questions utilized optional responses
~1/2 respondees provided optional information
Duration of nerve injury, length of LOC/presence of complications, presence of injury, on/off site most often left empty or incomplete
Other arm pain (A2.2) not used often (except tendon injury)
~400 total comments
7/respondee (range ), 13/question (range )
# correlates with complexity of case

8. Initial Results Diagnosis - fairly consistent except
Haematoma v Arm pain
Presence of significant potential donor factors
Rare AE or non-standard presentation
Incomplete donor information or followup
Severity - most varability
Optional
Lack of objective criteria
More consistent when using a range (mild-moderate)
Imputability – most consistent
Exceptions likely the same reasons seen with Diagnosis

9. Questions to consider
How should we manage multiple diagnoses? Use one or multiple?
If using one, do you report dx associated with first symptom, worst symptom, or the probable cause of the case?
When would you choose haematoma over arm pain?
Should there be a modifier for haematoma leading to arm pain?
Severity
Is “not working for 3 days” enough to classify a reaction as “moderate”?
Should all cases seeking outside medical care be considered > moderate?
Should some diagnoses (e.g. arterial puncture) always be moderate or severe?
Should “delayed bleeding” remain an optional category?
Should it be a modifier to describe haematoma or arterial puncture?

10. Dubai Working Party Thoughts & Recommendations
Free text important especially in complicated cases
Remember that real utility of the terms is to increase our focus on donor safety
Increases communication and stimulates questions for future research
Keep classification simple to help staff use appropriately
Users should use a single diagnosis as much as possible, but use multiple diagnoses when necessary
Please clarify how blood outside vessel with arm pain should be reported (First? Last? Worst?)
In A4 Other major vessel injury: drop “deep” from A4.1 Deep venous thrombosis
“unresponsivenenss” should be added to LOC definition

11. Dubai Working Party Thoughts & Recommendations
“fall” should be added to VV complications list
Unsure if >60sec or <60sec or w/ or w/o complications is best
In D. Allergic Reactions: drop “anaphylaxis” from D2 term
But make sure there is a way to identify anaphylaxis to indicate severity
F Other category is good, but make sure to supply a diagnosis and clarify when to use it
Continue to explore ways to classify severity more objectively
Clarify how “donor factors” should affect reporting

12. Overall impression when information is relatively complete
Terms provide adequate coverage of donor reactions, including optional terms
Some terms and definitions need clarification
Severity grading is currently optional and the terms mild, moderate, and severe are not well defined
Imputability while optional is fairly consistently interpreted

13. Next Steps Finalize full report Publish on ISBT HV WP Website
Waiting for a few more responses
Send final complete slide deck to all respondees
Publish on ISBT HV WP Website
Provide link to submit more cases
Include cases, answers, and discussion as resources
Organize small group to address working party recommendations
Edit standardized definition document as needed
Publish manuscript

14. Special Thank you! All 54 respondees ISBT & AABB working groups
Judith Chapman
Mindy Goldman
Hany Kamel
Lou Katz
Philippe Renaudier
Mary Townsend
Barbee Whitaker
Jo Wiersum