Tu3 28 PDF
Tu3 28 PDF
• Dan Waxman, MD
Nothing to disclose
• Susan Rossmann, MD, PhD
Nothing to disclose
• Gay Wehrli, MD, MBA, MSEd
The Foundation for America’s Blood Centers’ grants supported the donor
education materials studies
Nothing further to disclose
www.aabb.org 2
Objectives
1. Describe a challenging donor situation and assess how
best to resolve the situation
2. Cite key points that need to be incorporated in a
universal donor education document
3. Discuss the donor knowledge outcomes after
implementing a universal donor education document
www.aabb.org 3
In memory…
Celso Bianco, MD
August 16, 2018
ABC President and CMO
ISBT President
BPAC member
ACBTSA member
Colleague
Mentor
Friend
Husband, father and grandfather
www.aabb.org 4
Donor Challenges
Susan N. Rossmann MD PhD
www.aabb.org 5
What is a “challenging” donor?
• Challenging the rules
• Challenging our assumptions
• Challenging the staff
• Challenging our knowledge
www.aabb.org 6
What is a “challenging” donor?
• Challenging the rules
• Challenging our assumptions
• Challenging the staff
• Challenging our knowledge
www.aabb.org 7
Donor with tattoo
• 23 year old man with large Halloween tattoo
• Now undergoing removal of tattoo
• What are considerations for donor acceptability?
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Accepting donors with tattoos
• FDA Guidance on Reducing the risk of HIV transmission
by blood
– December 2015
• One year deferral UNLESS
• Tattoo was administered in a state-licensed facility with
– Sterile conditions
– Single-use inks
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Undergoing tattoo removal
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Undergoing tattoo removal
• Laser treatment
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Undergoing tattoo removal
• Laser treatment
• 3 treatments so far
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Undergoing tattoo removal
• Laser treatment
Various wavelengths for different colors
• 3 treatments so far, 10 weeks apart
• Small fragments of dye can be pushed into skin
• Is deferral necessary?
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Before and after laser removal
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Tattoo removal and blood donation
• Wait until skin healed
• No need to defer after
• If original tattoo were infectious risk,
– Donor would have detectable infection by now
(seroconversion or NAT)
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Challenging our assumptions
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Case report- called by hospital
• 45-year old Hispanic woman was hospitalized for
renal issues and had 2 RBC transfusions
• In the next week, patient grew more febrile and
obtunded
• Laboratory technologist noticed ring forms on
peripheral smear
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Diagnosis of malaria
• Patient had been to areas of Mexico where malaria
is present
– (P. vivax only species in Mexico)
• Also investigated 2 donors
– 1 45 year old man, from Houston, no travel
– 2 16 year old high school student, now from Houston
• Had emigrated from Nigeria 2 years previously
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P. falciparum
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Case circumstances
• Diagnosis of P. falciparum based on morphology and level of
parasitemia
• Tested both donors
• Older man completely negative
• Young man from Nigeria had negative smears and negative PCR at
CDC, but positive serology for P. falciparum.
• He denied history of malaria, but Mom said he had had malaria,
treated when 5
• Completely asymptomatic for years
• Repeat PCR was positive
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Numerous assumptions
• We assume donors know their history
• We assume they will understand the question and
tell us the right answer
• We assume our staff can follow the protocol
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Challenging our staff
• 56 year old man on testosterone therapy for
hypogonadism has received prescription from his
urologist for therapeutic phlebotomy
• He comes to a Neighborhood Donor Center and
expects to be drawn
• Staff cannot find order, refuses to draw him
• He leaves angry
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Process for therapeutic phlebotomy
• Our process (approved variance from FDA) involves
– Ordering physician faxes order to TBC, with dx, desired
minimum hematocrit, and desired interval of donation
– Staff enter orders into SafeTrace
– Donor can present to any Neighborhood Donor Center after
prescription is entered (72 hours, we say)
• Although it is FDA approved, many of long-time staff
have strict interpretation of “voluntary” donor standard,
which leads to caution
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What can go wrong?
• Doctor did not fax order
• Doctor did order incorrectly
• Donor’s hematocrit is not high enough to meet rx
• Donor’s donation interval is too short
• Donor can be frustrated, get angry
• Staff can be frustrated
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Testosterone therapy
• Growing exponentially in US
– Men in 40’s are fastest growing group
• Topical and IM forms available and new ones keep being approved
• Has risk of cardiac complications
• Causes erythropoiesis, which can lead to high hemoglobin, relieved
by phlebotomy
• Can also be managed by reducing testosterone dose
• Unclear (to me) relation between hemoglobin and cardiac issues
• Remains a challenging issue that is growing
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Why so much therapeutic testosterone?
• Testosterone helps
– Build muscle
– Reduce body fat
– Improve sex drive
• Of recent prescriptions
– Half had hypogonadism
– 40% had sexual or erectile dysfunction
– One-third had a diagnosis of fatigue
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Challenging our knowledge
• What is the appropriate level of donor
comprehension
– Of educational materials?
– Of screening questions?
• When can donor give consent?
www.aabb.org 32
When is a donor acceptable?
• Accept donors with Down syndrome, early dementia,
schizophrenia and other disorders as long as they are
able to understand the questionnaire and consent and
fully participate in the process
• Only defer if these conditions get to the point where the
independence is lost.
• We do this on a case-by-case basis, using judgment of
most experienced staff
www.aabb.org 33
Donors with early Alzheimer’s
• Or similar, cognitive decline
• Memantine now used for migraines
www.aabb.org 34
When should we turn away donor?
• Donor can sign a waiver of confidentiality so that a legal
guardian can be in the screening, however the legal
guardian is not allowed to function as an interpreter.
• We must be sure the donor knows what is expected of
him
• Please know we’re thankful for people like your son who
want to help save lives, but we need to be sure he is
safe and understands the process of blood donation.
www.aabb.org 35
Father’s response to refusal
I feel he is being treated differently and I will be taking this up
with OCR, a federal government agency that protects the
disabled from discrimination
• Office of Civil Rights, part of HHS
www.aabb.org 36
Is there a right to donate blood??
Probably not But justice is a consideration
• Safety for patients is prime • We rely on public to freely
• Blood collector makes rules for donate, at some risk to
patient safety and own themselves
operational considerations • Want to be FAIR and
• Only impose restrictions that
are reasonable
• MSM discussion
www.aabb.org 37
Decisional capacity for healthcare
• Understanding, including risks and benefits,
alternatives
• Appreciation of information as applied to self
• Reasoning process, ability to manipulate information
• Expression of a choice, consistently
www.aabb.org 38
Aspects of understanding in blood donors
Consent Donor history screening
• Based on autonomy rights • Protection of recipient
• Right to bodily integrity • Protection of donor
• Understand risks and purpose
of activity
www.aabb.org 39
Obtaining valid consent is an ethical
requirement
• Meeting this requirement involves disclosing a lot of
information [about the study] to potential participants
in a manner that gives them a fair opportunity to
understand it, but it does NOT require that all that
information is also understood
www.aabb.org 40
Response from father of son refused
donation
• My son is disabled according to the Federal
Government.
• He would not understand the questions as the
questioner would/is unable to phrase the questions
so he can understand them
• He is not an IDIOT, as you implied, just has issues
understanding the info given
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We need
• A sensitive, consistent method of evaluating these
donors
– For example, some Down syndrome donors can answer
questionnaire independently
• A method that is operationally feasible
www.aabb.org 42
A communication is adequate if
• It contains the information that is material to
effective decision making
• Consumers can access that information
• Consumers can understand that information
• Which facts matter to decision makers
[donors]??
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Can we test understanding?
• Is there a short form we could put in automated
questionnaire
– “Attention” question
• I am male (or female)
• Breaking pattern of responses
• Seems far away from our current comprehension
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We also need
• The best donor materials we can have, to help
donors understand what we are saying
• They will not understand all risk factors we ask
about, but
• We need their confidence we are asking reasonable
questions
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Blood collector responsibility
• A donor may not understand the questions because
the questioner is unable to phrase the questions so
he can understand them
• The responsibility for understanding then is on us as
much or more than on the donor
www.aabb.org 46
Donor Education
Gay Wehrli. MD MBA MSEd
www.aabb.org 47
Background: Educating Donors
• Donors need time and information for a truly informed
consent decision to donate blood
• Donor education materials (DEM) are key to this process
Address topics required by regulatory agencies
• FDA Blood Product Advisory Committee (BPAC)
• AABB
Accessible
Understandable (7-8th grade)
www.aabb.org 48
ABC Working Group
Background
Celso Bianco
Louis M. Katz
• 1976: 8th Edition AABB Standards introduces donor consent
Susan Rossmann
• 2007: Proposed rule on Human Blood & Blood Components for J. Sazama
Kathleen
Transfusion & Further Manufacturing Use Dan Waxman
Written Statement of Understanding (WSU) Gay Wehrli
• 2011: FDA BPAC re-visits WSU
ABC Working Group for Donor Education & Communication
www.aabb.org 49
Background
• 2011: FDA BPAC re-visits WSU
7 Elements (5 focus on TTI and ID)
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Risk Communication
• Share Information
Make the lawyers happy
• Change Belief
Provide risk & benefit info
• Change Behavior
We know what is best
Change belief back-up
www.aabb.org Communicating Risks & Benefits: An Evidence-Based User’s Guide. Published by FDA, US DHHS, August 2011. 52
http://www.fda.gov/ScienceResearch/SpecialTopics/RiskCommunication/ default.htm
Risk Communication: Adequacy test
www.aabb.org Communicating Risks & Benefits: An Evidence-Based User’s Guide. Published by FDA, US DHHS, 53
August 2011. http://www.fda.gov/ScienceResearch/SpecialTopics/RiskCommunication/ default.htm
Risk Communication: What words make sense to people?
• NIH: All of Us Research Program
Office for Human Research Protections, Meeting New Challenges in Informed Consent in Clinical Research, 9/7/2018:
https://www.hhs.gov/ohrp/education-and-outreach/exploratory-workshop/2018-workshop/index.html
www.aabb.org Participant-Centered Design for Informed Consent. Megan Doerr, Sage Bionetworks. 54
The All of Us Research Program: https://allofus.nih.gov/
Kutner, M., Greenberg, E., Jin, Y., and Paulsen, C. (2006). The Health Literacy of America’s Adults: Results From the 2003 National Assessment of
Adult Literacy (NCES 2006–483). U.S. Department of Education. Washington, DC: National Center for Education Statistics.
https://nces.ed.gov/pubs2006/2006483.pdf
Kutner, M., Greenberg, E., Baer, J. (2006). A First Look at the Literacy of America’s Adults in the 21st Century (NCES 2006 2006-470). U.S.
www.aabb.org
Department of Education. Washington, DC: National Center for Education Statistics. https://nces.ed.gov/NAAL/PDF/2006470.PDF
55
Risk Communication: What words make sense to people?
• NIH: All of Us Research Program
Office for Human Research Protections, Meeting New Challenges in Informed Consent in Clinical Research, 9/7/2018:
https://www.hhs.gov/ohrp/education-and-outreach/exploratory-workshop/2018-workshop/index.html
Participant-Centered Design for Informed Consent. (Manuscript in progress.) Megan Doerr, Sage Bionetworks.
www.aabb.org
The All of Us Research Program: https://allofus.nih.gov/
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Early Work: Developing Donor Education Materials (DEM)
www.aabb.org 58
Wehrli G, Rossmann S, Katz LM, Waxman DA. Developing blood donor education materials. Transfusion 2017; 57(S3):106A(CP101).
DEM Overview: Key Points
a. We want you to know more about donating blood. Plan ahead & be
prepared by reading this and asking questions about anything that is not
clear.
b. To give blood you must be healthy & meet minimum age & weight
requirements.
c. You will need a photo ID.
d. In privacy, you will be asked to answer questions about your health,
medicines, travel & very personal things including sex & using needles to
take drugs.
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DEM Overview: Key Points
e. We work to keep donor safe, but a few donors faint & some develop a low
iron level.
f. Do not donate blood to be tested for HIV or hepatitis. Go to your
healthcare provider or public clinic.
g. You will not be paid to donate.
h. Contact us at any time if you think your blood donation might not be
safe for patients.
i. If you have a medical problem after donating, contact us immediately. If
serious, first seek immediate medical attention and then call us.
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DEM Overview: Topics
www.aabb.org 61
DEM Overview: Topics
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2018 Pilot Study
Purpose Specific Aims
We know donor knowledge is less To better understand baseline
than desirable and we believe one knowledge between 4 donor groups
reason is that education materials
(EM) are suboptimal To determine if new EM could
improve knowledge compared to
Therefore, we designed a study to current EM
compare new EM versus current EM
in the blood donor population Identify specific areas of strength and
weakness in donor knowledge
We hypothesized donors would
acquire greater knowledge from the
new versus current EM
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Pilot Study: Methods Overview All Donors
10 Question Post-quiz
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Results: Demographics
Group 1 Group 2 Group 3 Group 4
Totals
ND + NEM ND + CEM RD + NEM RD + CEM
Total (N) 34 41 45 45 165
Male % 35.3% 41.5% 46.7% 44.4% 42.7%
Male/Female 12/22 17/24 21/24 20/24* 70/94
Mean Age ± SD 35.8 ± 15.2 34.2 ± 13.6 45.9± 19.8** 42.3 ± 17.9 39.6
Range 18-66 18-68 18-83 18-73 18-83
Education† 4.4 ± 1.5 4.3 ± 1.3 4.4 ± 1.6 4.3 ± 1.7 4.36 ± 1.5
Range 2-8 3-7 2-8 3-8 2-8
Race: White % 70.6 75.6 89.9 91.1 82.4
Black %‡ 5.9 14.6 6.7 2.2 7.3
Others %‡ 23.5 9.8 3.4 6.7 10.3
*1 did not respond † 4 = 2 year college degree/A.A./A.S. New/Current Education Materials = N/CEM
www.aabb.org **Difference between Group 2 & 3; p<0.05 ‡ Difference between white; p<0.05 New/Returning Donor = N/RD 65
Results: Quiz Scores for each Group
Mean Score Group 1 Group 2 Group 3 Group 4
All Groups
(10 questions) ND + NEM ND + CEM RD + NEM RD + CEM
Pre-Quiz Correct ± SD 5.91 ± 1.99* 6.37 ± 1.93* 7.91 ± 1.20 7.96 ± 1.73 7.13 ± 1.96
(Range) (2-9) (2-10) (4-10) (0-10) (0-10)
Post-Quiz Correct ± SD 8.76 ± 1.44 7.61 ± 1.66 9.36 ± 0.83 8.27 ± 1.50 8.50 ± 1.52
(Range) (4-10) (4-10) (7-10) (1-10) (1-10)
Change Score ± SD 2.85 ± 1.67† 1.24 ± 1.39† 1.44 ± 1.34† 0.31 ± 1.06† 1.38 ± 1.60
(Range) (0-7) (-1.0-4) (-1.0-5) -2.0-3.0 (-2.0-7.0)
1.5
1
*
0.5
0
Groups 1 & 2 Groups 3 & 4
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*Statistically significant difference, p < 0.05 67
Results:
New EM versus Current EM Post-Quiz Scores
10.00 *
9.00
8.00
Post-Quiz Score
7.00
6.00
5.00
4.00
3.00
2.00
1.00
0.00
Groups 1 & 3 Groups 2 & 4
New Educational Current Educational
Materials Materials
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*Statistically significant difference, p < 0.001 68
Results: Quiz Change Scores by Group
3.5
Change in Correct Answers
*
3
2.5
2
1.5
1
0.5 †
0
1 2 3 4
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Results: Pre-Quiz Percent Correct
New Donors Returning Donors
Groups 1 & 2 Groups 3 & 4
120 • 2 weeks
Q1. After successfully
PERCENT CORRECT
40
Q3. At which • Before donating blood.
20 • While donating blood.
point during the
donation process • Immediately after donating
0
might you be blood.
1 2 3 4 5 6 7 8 9 10
asked not to • All of the above are true.
QUIZ QUESTION donate blood? • I don’t know
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Results: Pre-Quiz Percent Correct
New Donors Returning Donors
Groups 1 & 2 Groups 3 & 4
120 Q7. You stayed home • Go donate whole blood
from work one day
PERCENT CORRECT
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Results: New Donors versus Returning Donors
Groups 1 & 2 Pre-Quiz Groups 3 & 4 Pre-Quiz
New Donors Post-Quiz Returning Donors Post-Quiz
100 * * * *
Percent Correct 80 * *
60
40
20
0
1 2 3 4 5 6 7 8 9 10
Pre-Quiz 6.7 74.7 20 84 48 46.7 88 76 94.7 77.3
Post-Quiz 54.7 86.7 48 97.3 80 76 93.3 90.7 97.3 89.3
Pre-Quiz 64.4 96.7 31.1 94.4 61.1 67.8 94.4 88.9 96.7 97.8
Post-Quiz 81.1 97.8 52.2 95.6 83.3 86.7 96.7 91.1 98.9 97.8
Quiz Question Number
www.aabb.org *Change Score Significantly Different between Groups 1&2 versus Groups 3&4; p < 0.05 73
Results: New Donors Group 1 Pre-Quiz Group 2 Pre-Quiz
New EM Post-Quiz Current EM Post-Quiz
100 *
*
Percent Correct
80
*
60
40
20
0
1 2 3 4 5 6 7 8 9 10
Pre-Quiz 2.9 79.4 17.6 73.5 38.2 47.1 85.3 79.4 97.1 70.6
Post-Quiz 79.4 97.1 58.8 100 94.1 76.5 91.2 91.2 100 88.2
Pre-Quiz 9.8 70.7 22 92.7 56.1 46.3 90.2 73.2 92.7 82.9
Post-Quiz 34.1 78 39 95.1 68.3 75.6 95.1 90.2 95.1 90.2
Quiz Question Number
*Post-quiz, significantly more people correct in Group 1 vs. 2; p < 0.05
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Results: Returning Donors Group 3 Pre-Quiz Group 4 Pre-Quiz
New EM Post-Quiz Current EM Post-Quiz
* * *
100
80 *
Percent Correct
60
40
20
0
1 2 3 4 5 6 7 8 9 10
Pre-Quiz 60 95.6 20 95.6 64.4 68.9 100 88.9 100 97.8
Post-Quiz 88.9 97.8 68.9 100 95.6 95.6 97.8 93.3 100 97.8
Pre-Quiz 68.9 97.8 42.2 93.3 57.8 66.7 88.9 88.9 93.3 97.8
Post-Quiz 73.3 97.8 35.6 91.1 71.1 77.8 95.6 88.9 97.8 97.8
Quiz Question Number
*Post-quiz, significantly more people correct in Group 3 vs. 4; p < 0.05
www.aabb.org 75
Summary
• Returning donors have greater baseline knowledge compared to new
donors, but new donors improved more versus returning donors
• Donors utilizing new educational material showed statistically significant
greater improvement in knowledge compared to donors utilizing current
educational material allowing them to have the highest post scores
• With this sample size the results suggest that the findings are
independent of demographic characteristics
• Challenges remain in conveying to donors:
when they may be asked not to donate
the 8 week deferral period between each whole blood donation
www.aabb.org 76
What we have learned
• Keep it short and sweet
• Comprehension level is critical and challenging
• Test your materials for knowledge acquisition
www.aabb.org 77
Next Steps
• Refine new EM
Key points: When you may be asked not to donate
Key points: 8 week deferral after successful whole blood donation
Format
• BPAC presentation
• Manuscript
• Broader study at more sites with more participants
Look at other variables: education, race/ethnicity and age
www.aabb.org 78
Thank you!
Gulf Coast Regional Blood Center &
Ryan Nobles, MLS(ASCP)CMSBB
Director, Neighborhood Donor Centers
www.aabb.org 79
Questions?
“While collecting a safe and sufficient blood supply,
we must encourage, protect and retain our donors.”
www.aabb.org
Wehrli G, Sazama K. Universal donor education and consent. Transfusion 2010;50:2499-2502. 80
Updates from the Blood Collection
Center Frontline: Donor Challenges
and Donor Education
10/16/2018
Faculty Disclosures
The following faculty have no The following faculty have a
relevant financial relationships to relevant financial relationship:
disclose:
– Susan Rossmann MD, PhD
– Dan Waxman MD Roche Molecular:
– Gay Wehrli MD, MBA, MSEd Grant/Research Support
www.aabb.org 2
Learning Objectives
• Describe a challenging donor situation and assess
how best to resolve the situation
• Cite key points that need to be incorporated in a
universal donor education document
• Discuss the donor knowledge outcomes after
implementing a universal donor education document
www.aabb.org 3