Transcript Abbreviated Donor History Questionnaire: Blood Systems Experience FDA Blood Products Advisory Committee

Abbreviated Donor History
Questionnaire:
Blood Systems Experience
FDA Blood Products Advisory Committee
March 18, 2005
Mary Beth Bassett
Vice President of Quality Management & Regulatory Affairs
2003 Presentation to BPAC
included…
• Why Blood Systems implemented
ADHQ
• Policy/Criteria
• Comparison of ADHQ and FDHQ
• Monitoring Introduction of ADHQ
• Donor Survey Results
Today’s Presentation
• Donor Survey Results
• Comparison of ADHQ and FDHQ
• New Data
Donor Satisfaction Survey
Shorten interview, less
questions, simplify
interview
(interview-specific)
55%
6%
27%
Other
12%
Speed up process, ta k e
less time, less time
commitment
(non-interview specific)
'If you could change one thing ab out the donation process, what would it b e?'
(Among those offering a suggestion; n=750)
Source: UBS 4th Quarter 2004 Donor Satisfaction Research
Less pa inful, no finger
stick , better job dra wing
blood (a ctua l
dona tion-rela ted)
March 2005 Survey of
Donors Eligible for ADHQ
• Survey objective was to determine if donors are more
satisfied and more likely to donate in the future if
they receive the abbreviated questionnaire.
• 250 interviews were completed with donors who were
eligible for and received ADHQ, and 250 with donors
who were eligible for ADHQ but received the FDHQ
interview.
• Both groups were administered the same interview.
• Results are statistically significant to the 95%
confidence level.
• Research conducted by WestGroup Research,
Phoenix AZ.
Survey Results
45%
Receptionist/Greeter
61%
46%
Interviewer
59%
45%
Phlebotomist
63%
41%
Overall Experience
57%
0%
20%
40%
60%
80%
FDHQ
(Percent rating each as 'excellent' f or most recent donation)
100%
ADHQ
Commitment to Future Donations
Do you plan to donate blood in the coming
12 months?
• Even though respondents were eligible for ADHQ (and
therefore repeat donors), 5% of those receiving
FDHQ were unsure that they would donate during the
coming 12 months.
• Among ADHQ recipients, only 1% of the sample were
unsure that they would donate during the coming year
(99% stated they would donate).
ADHQ Implementation
Oct 6-25,
2003
Apr 11-30,
2004
Nov 1-20,
2004
53312
55169
57305
17144
(32.16%)
17802
(32.27%)
19050
(33.24%)
Donors received
the ADHQ
8229
9818
14449
ADHQ/Eligible
for ADHQ
48.00%
55.15%
75.85%
Number of
donors
Presented
Donor Eligible
for ADHQ
Eligible vs. Non-eligible Donors
ELIGIBLE
For ADHQ
NOT ELIGIBLE
For ADHQ
FQ Only
ADHQ & FQ
Repeat Donors
N
%
53996
32.57
69146
271
0.50*
3919
Confirmed Positive
Test
Post Donation
Information (PDI)
Medical History
Deferrals
Temporary
Deferral
* P<0.001
N
%
First Time
Donors
Total
N
%
N
%
41.71
42644
25.72
165786
100.00
1518
2.20
2403
5.64
4192
2.53
7.26*
9312
13.47
5986
14.0
19217
11.59
11
0.02*
93
0.13
391
0.92
495
0.30
79
0.15
128
0.19
65
0.15
272
0.16
Results for ADHQ Eligible Donors
ELIGIBLE for ADHQ
ADHQ
N
Medical History
Deferrals
Temporary Deferral
Confirmed Positive Test
PDI (Post Donation
Information)
* p=0.024
† p=<0.001
FQ
%
N
TOTAL
%
N
%
32496
60.18
21500
39.82
53996
100.00
145
0.45
126
0.59*
271
0.50
2170
6.68
1749
8.13†
3919
7.26
5
0.02
6
0.03
11
0.02
43
0.13
36
0.17
79
0.15
Donors whose last donation was
< 8 weeks from current donation
ELIGIBLE for ADHQ
Last Donation < 8 wks
ADHQ
N
3710
FQ
TOTAL
%
N
%
N
%
87
564
13
4274
100
8
0.22
5
0.89*
13
0.30
193
5.20
33
5.85
226
5.29
Confirmed Positive Test
1
0.03
0
0.00
1
0.02
PDI (PD illness/event)
3
0.08
1
0.18
4
0.09
Medical History Deferrals
Temporary Deferral
* p=0.02
Post Donation Information
November 1-20, 2004
Source of
Information
Was Information Known
Total
At time of donation
NO
YES
Not Sure
Donor Call
Back
53
5
2
60
Donor
Deferral
8
29
4
41
Telerecruitment
11
2
0
13
Third Party
5
1
0
6
Total
77
37
6
120
Post Donation Information
Known at time of donation (N = 37)
vCJD
risk
Donor Call
Back
Donor
Deferral
15
Malaria
risk
Medicine
1
2
1
6
2
1
CJD
risk
Cancer
High
risk
HIV-1
group
O risk
Tissue
graft
Tattoo
1
1
1
1
1
1
1
9
29
2
Third Party
15
Total
5
2
Telerecruitment
Total
Medical
condition
4
3
1
1
1
1
1
1
1
37
How many times can a donor
withhold deferring information?
• Information not provided on ONE occasion: 24
donors
– On Full Questionnaire (FQ) = 21
– On Abbreviated Questionnaire (ADHQ) = 3
• Information not provided on TWO occasions: 4
donors
– On 2 FQ = 3
– On 1 FQ & 1 ADHQ = 1
• Information not provided on THREE occasions: 4
donors
– On 3 FQ = 3
– On 2 FQ & 1 ADHQ = 1
How many times can a donor
withhold deferring information?
• Information not provided on FIVE
occasions: 2 donors
– On 5 FQ = 1
– On 3 FQ & 2 ADHQ = 1
• Information not provided on SIX
occasions: 1 donor
– On 5 FQ & 1 ADHQ = 1
Errors from ADHQ Interviews
3rd Quarter 2003 to 4th Quarter 2004
ADHQ
Interviews
Error Rate
2003
1st Quarter
17,254
.23%
2nd Quarter
39,662
.09%
2004
1st Quarter
42,582
.02%
2nd Quarter
43,780
.02%
3rd Quarter
46,346
.02%
4th Quarter
59,590
.008%
Experience to Date…
• Donors want a shorter process and like ADHQ.
• 1/3 of donors are eligible for ADHQ.
– ¾ of those received ADHQ in recent months.
• There are no data indicating ADHQ increases risk.
• Platelet donors are probably not biasing our
analyses.
• Analysis of PDI shows that donors withhold
information during both the FQ and the ADHQ.
• Analysis of root cause and implementation of
corrective action has reduced ADHQ application
errors.
Collaborators
•
•
•
•
•
•
•
Chris Paden
Hany Kamel , MD
Michael Rangel
Brian Custer Ph.D.
Michael Busch, MD, Ph.D
Dennis Harpool
Peter Tomasulo, MD
Comparison of ADHQ and FDHQ
Current Events (<8 wks)
Travel
Medical Conditions/Health Problems
Deferring Medications/Treatments
Hepatitis/CJD Risk
HIV/HIV Risk
Miscellaneous
TOTAL
ADHQ
10
2
1
1
6
13
2
35*
*23 questions linked to period since donor’s last donation
FDHQ
12
3
10
8
6
12
3
54
Donors whose last donation was
> 8 weeks from current donation
ELIGIBLE for ADHQ
Last Donation > 8 wks
ADHQ
N
2878
6
Medical History Deferrals
Temporary Deferral
Confirmed Positive Test
PDI (PD illness/event)
* p=0.02
FQ
%
N
58
209
36
TOTAL
%
N
%
42
4972
2
100
137
0.48
121
0.58
258
0.52
1977
6.87
1716
8.20*
3693
7.43
4
0.01
6
0.03
10
0.02
40
0.14
35
0.17
75
0.15
Comparison of Donation Outcomes:
ADHQ versus Full HQ
Time Period: August 4 – October 15, 2003
Eligible for ADHQ
N=182,383
Ineligible for ADHQ
Received
ADHQ
Received
Full HQ
Repeat
Donors
First Time
Donors
Number Presenting
24,040
44,090
75,010
39,243
Medical History Deferral
0.38%
0.43%
1.42%
3.03%
Temporary Deferral
7.86%
9.02%
14.95%
19.08%
Units Collected*
87.05%
86.07%
78.70%
71.94%
Repeat Reactive
0.35%
0.29%
0.45%
1.23%
Confirmed Positive
0.01%
0.03%
0.25%
1.88%
Post Donation Illness
0.16%
0.18%
0.25%
0.31%
* Percentage excludes unsuccessful collections