# Presentation: 867524

## 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

**Notes:**
Thank you for inviting me to speak on Blood Systems continued success with the abbreviated questionnaire process.
Blood Systems is the parent company for United Blood Systems, which operates 18 blood centers situated in 12 states west of the Mississippi, collecting 1.1 million units of red blood cells and about 120,000 apheresis platelet concentrates.  We are the nation’s second largest non-profit blood component distributor.  We operate two centralized donor testing labs and 1 transfusion medicine research institute in San Francisco, California.

We believe that the use of the abbreviated questionnaire is important and has benefited our donors and our organization.

We began implementation of the abbreviated donor screening process in August 2003. The experience I am about to share with you includes the results of 16 months of data collection.

## 2003 Presentation to BPAC included...

**Why Blood Systems implemented ADHQ**
**Policy/Criteria**
**Comparison of ADHQ and FDHQ**
**Monitoring Introduction of ADHQ**
**Donor Survey Results**

**Notes:**
In 2003 my presentation to you I included:
Why Blood Systems implemented an abbreviated process—I told you that the reasons were to improve customer satisfaction, increase donor retention, increase donation frequency and increase blood availability.  These remain the reasons today.
I reported on Blood Systems policy for a repeat frequent donor which is 3 previous allogeneic donations and the last donation must be within 6 months.
I provided 3 months of data related to medical history deferrals, temporary deferrals, viral marker rates,post donation information and errors related to the use of the wrong form. Today I will update that information to include our experience for the last 16 months
And lastly I presented the results of an important donor survey.  Today I have new results to share with you from a donor survey just completed.

## Today’s Presentation

**Donor Survey Results**
**Comparison of ADHQ and FDHQ**
**New Data**

**Notes:**
These are the areas I will cover with new data today

Donor Satisfaction
Comparison of results with abbreviated and full questionnaire
New data post donation information and on apheresis platelet donors

## Donor Satisfaction Survey

**Notes:**

This slide shows the results of a general donor satisfaction survey conducted during 4th quarter 2004.  This research was conducted with 1800 donors as part of a larger study examining the donation process.  750 (or 42%) of those interviewed responded to the question “If you could change one thing about your donation process what would it be?’  
This chart illustrates the answer to that question.  In general, it illustrates the desire of donors for a more efficient, less time-consuming process.
Among those who offered any type of suggestion, 82% asked for some type of time-savings—55% said shorten the interview and 27% said speed up the process.  And two-thirds of those specifically named the interview as an area needing improvement.
These data really confirm the need for blood centers to find a safe way to streamline the donation process to continue to ensure an adequate blood supply for patients.

## 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.**

**Notes:**
To confirm that ADHQ addresses this problem cited by donors, we recently completed a new survey with a control group in March 2005.  This survey was specifically conducted for the abbreviated donor history questionnaire process.
Apheresis platelet donors were not included in any of the three groups, The  most recent donation of interviewed donors was a red cell donation.

## Survey Results

**Notes:**
Donors from both groups were asked to rate the person who greeted them, the interviewer and the phlebotomist as well as the entire process in 4 different questions. A rating of 5 was considered excellent and this chart focuses only on excellent responses.  As you can see, donors receiving the ADHQ gave excellent responses more often than similar donors who received the full questionnaire.
This is a remarkable result because the interview length is the only part of the donation process which was truly shorter with the ADHQ.  When these donors were called about their recent donation they thought everything was better if they used the ADHQ.  You might recall we had a similar result last time, but in that survey we relied on historical controls.

This chart shows results between Groups 1 (FDHQ) and 2 (ADHQ), which received the exact same interview.
All differences shown are statistically significant at the 95% confidence level.
This mirrors our historical Donor Satisfaction results, which show a clear increase in satisfaction levels for those donors who feel the process is taking less of their time.  

## 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).**

**Notes:**
We asked all donors in these two groups about their commitment for future blood donations.  As you can imagine almost all these experienced donors indicated that they would donate again.  There was, however, a significant difference.

5% of the donors receiving the full questionnaire were not sure that they would donate within the coming 12 months and only 1% of the donors using the ADHQ were unsure they would donate.

## ADHQ Implementation

|  | Oct 6-25,
 2003 | Apr 11-30,
2004 | Nov 1-20,
2004 |
| --- | --- | --- | --- |
| Number of donors Presented | 53312 | 55169 | 57305 |
| Donor Eligible for ADHQ | 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% |

**Notes:**
Now I would like to turn to the new data we have concerning the use of the abbreviated donor history.
We analyzed data from 3, 20 day time periods, the first one beginning on 6 October 2003 and the last one ending on November 20, 2004.  In each period we analyzed the records of about 55,000 donors.  
The percent of donors eligible for ADHQ was about the same (32-33%) in each time period.
The percent of eligible donors who received the ADHQ did increase substantially over these 13 months going from 48% to nearly 76%.

## Eligible vs. Non-eligible Donors

|  | ELIGIBLE 
For ADHQ |  | NOT ELIGIBLE 
For ADHQ |  |  |  | Total |  |
| --- | --- | --- | --- | --- | --- | --- | --- | --- |
|  | ADHQ & FQ |  | FQ Only |  |  |  |  |  |
|  |  |  | Repeat Donors |  | First Time Donors |  |  |  |
|  | N | % | N | % | N | % | N | % |
|  | 53996 | 32.57 | 69146 | 41.71 | 42644 | 25.72 | 165786 | 100.00 |
| Medical History Deferrals | 271 | 0.50* | 1518 | 2.20 | 2403 | 5.64 | 4192 | 2.53 |
| Temporary Deferral | 3919 | 7.26* | 9312 | 13.47 | 5986 | 14.0 | 19217 | 11.59 |
| Confirmed Positive Test | 11 | 0.02* | 93 | 0.13 | 391 | 0.92 | 495 | 0.30 |
| Post Donation Information (PDI)  | 79 | 0.15 | 128 | 0.19 | 65 | 0.15 | 272 | 0.16 |

*** P<0.001**

**Notes:**
This table is a summary of some data from all three time periods.  
To orient you, on the far right, 165,786 is the total number of donor records we reviewed.  Moving a little to the left, 42,644 of these donors were first time donors.  Moving again to the left, 69146 of these donors were repeat donors who were not eligible for the ADHQ.  53996 donors (33% of total) were eligible for ADHQ.
We can trace the % of medical history deferrals in these three groups again moving from right to left.  FTD = 5.64%, RD = 2.2% and ADHQ eligible donors 0.5% not a surprising trend.
The next line down on this table is the % of temporary deferrals.  These are deferrals for BP, P, T, hct, and really should not be influenced by the use of the ADHQ, but continue to reflect that the group eligible for ADHQ has been frequently screened and only has a few donors who are not healthy enough to donate. FTD have a temp deferral rate of 14%, whereas ADHQ donors have a temp deferral rate of 7.3%.
The same trend is visible when we look at the rate of confirmed positive test results.  The rate in FTD is 0.9% and the rate in ADHQ eligible donors is 0.02% over 40 times lower in the ADHQ eligible donors.
The final row on this table indicates the rate at which we received post donation information from each group of our donors.  As you can see there is almost no variation from group to group.  We analyzed the post donation information in more detail from the final period of our study and I will share that analysis with you shortly.

Let me begin by saying that we need to remember that we are talking about the safest group of donors
During the three 20-days study periods, 165786 donors were interviewed
32.57% were eligible for the ADHQ
The medical history deferral, temporary deferral and confirmed positive rates were significantly lower in this group when compared to the ineligible repeat or first time donors.
The difference in PDI rates was not significant. 

## Results for ADHQ Eligible Donors

|  | ELIGIBLE for ADHQ |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- |
|  | ADHQ |  | FQ |  | TOTAL |  |
|  | N | % | N | % | N | % |
|  | 32496 | 60.18 | 21500 | 39.82 | 53996 | 100.00 |
| Medical History Deferrals  | 145 | 0.45 | 126 | 0.59* | 271 | 0.50 |
| Temporary Deferral | 2170 | 6.68 | 1749 | 8.13† | 3919 | 7.26 |
| Confirmed Positive Test | 5 | 0.02 | 6 | 0.03 | 11 | 0.02 |
| PDI (Post Donation Information) | 43 | 0.13 | 36 | 0.17 | 79 | 0.15 |

*** p=0.024**
**† ****p=<0.001**

**Notes:**
We are looking at the ADHQ eligible subset of donors I showed you on the previous slide.
Of the 53,996 ADHQ eligible donors in our study periods:
60% received the ADHQ and
40% received the full questionnaire.
Again, moving from right to left on the table, one can see that the rates of medical and temporary deferral in donors receiving the full questionnaire were slightly higher than in donors receiving the ADHQ but the numbers are very close and very low.
There were no differences in the rate of positive tests and PDI 
In our previous discussion on ADHQ the question was raised about the potential of frequent donors for example. platelet apheresis donors, to influence the rates observed in each of these categories.  We looked at this and I will show you some data on the next slide.

The only real markers of sensitivity are the rate of confirmed positives in the blood donated and in the qualitative analysis of the PDI. There are no differences in the rates of confirmed positives. Without knowing what information the donors had before the interview process, we can’t know from the rate of medical history deferrals whether we discovered 100% of it.

## Donors whose last donation was < 8 weeks from current donation

|  | ELIGIBLE for ADHQ |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- |
|  | Last Donation < 8 wks |  |  |  |  |  |
|  | ADHQ |  | FQ |  | TOTAL |  |
|  | N | % | N | % | N | % |
|  | 3710 |  87 | 564 | 13 | 4274 |  100 |
| Medical History Deferrals | 8 | 0.22 | 5 | 0.89* | 13 | 0.30 |
| Temporary Deferral  | 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 |

*** p=0.02**

**Notes:**
Of the 53,996 donors eligible for the ADHQ, 4,274 (only 8%) had their last donation within 8 weeks. The platelet donors are such a small proportion of our data set (8%) and their deferral rates are so similar that the impact of these donors on overall rates is minimal.  
Again the rates of medical history and temporary deferrals are very low. The difference in the medical history deferral rate between those receiving the ADHQ and the Full questionnaire is significant.  
The rate of confirmed positivity in blood tests and the rate of post donation information is not different. 

  Of the platelet donors, 13% received the FQ (564) and 87% received the ADHQ.  This is different from the donors whose last donation was > 8 weeks.  In this group, 58% received the ADHQ and 42% receive the full questionnaire.  

## Post Donation InformationNovember 1-20, 2004

| Source of Information | Was Information Known
At time of donation |  |  | Total |
| --- | --- | --- | --- | --- |
|  | NO | YES | Not Sure |  |
| Donor Call Back | 53 | 5 | 2 | 60 |
| Donor Deferral | 8 | 29 | 4 | 41 |
| Tele- recruitment | 11 | 2 | 0 | 13 |
| Third Party | 5 | 1 | 0 | 6 |
| Total | 77 | 37 | 6 | 120 |

**Notes:**
Now let’s turn to another new analysis performed at BSI.  
We studied the PDI events related to the donations from the November 1-20, 2004.
There were a total of 120 events.
50% of the PDIs (60 of 120) were generated when the donors called the center providing “additional” information.
34% were generaated (41 of 120) when they were deferred based on information given at a subsequent blood donation.
11% of the PDIs were generated during telerecruitment phone calls and 5% were generated from conversations with third parties.
Then we looked to see if the donor COULD have provided the deferring information.  In only 37 cases (31%) did the donor know the information and withhold it during the medical history screening.

## Post Donation Information Known at time of donation (N = 37)

|  | vCJD risk | Malaria risk | Medicine | Medical condition | CJD risk | Cancer | High risk | HIV-1 group O risk | Tissue graft | Tattoo | Total |
| --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- |
| Donor Call Back |  | 1 | 2 | 1 |  |  | 1 |  |  |  | 5 |
| Donor Deferral | 15 | 6 | 2 | 1 | 1 | 1 |  | 1 | 1 | 1 | 29 |
| Tele-recruitment |  | 2 |  |  |  |  |  |  |  |  | 2 |
| Third Party |  |  |  | 1 |  |  |  |  |  |  | 1 |
| Total | 15 | 9 | 4 | 3 | 1 | 1 | 1 | 1 | 1 | 1 | 37 |

**Notes:**
The majority of the cases (24/37) relate to travel or residence risk either for malaria or vCJD. Four cases were related to medications the donor received and 3 cases were related to medical conditions the donor did not reveal.

Remember, these are all the cases of PDI we received during the November 2004 time period.  Some of these were from FTD and some were from repeat donors.  Some received ADHQ and some received FQ.

## 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

**Notes:**
In further analyzing these PDI cases we asked the question, how many times might a donor withhold deferring information and is either the ADHQ or the full questionnaire clearly better at discovering deferring information?
Our analysis of these cases shows that 24 donors withheld deferring information on one occasion. Twenty-one of the donors were screened with the FQ and 3 were screened with the ADHQ.
Four donors withheld deferring information on 2 occasions.  Three of these were interviewed twice with the FQ and 1 was interviewed once with the ADHQ and once with the FQ.
Four donors withheld deferring information on 3 occasions.  Three of these were interviewed 3 times with the FQ and one was interviewed twice with the FQ and once with the ADHQ.

Since most of these events were reported by donors ineligible for the ADHQ (26/37 donors), these information were not revealed more often when the full questionnaire was being used.

## 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

**Notes:**
On this slide you can see that a few donors withheld deferring information on 5 or 6 occasions. The FQ failed 13 times and the ADHQ failed 3 times.

This doesn’t tell us definitively which questionnaire is better at discovering deferring information but it does confirm what we all knew and that is that the FQ is not 100% effective at pulling out deferring information.  We are contemplating further studies to try to compare the questionnaires on the basis of PDI..

## 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% |

**Notes:**
This is a follow-up analysis.  You may remember that we were having a little difficulty ensuring that the two questionnaires would be applied to the right donors.  We have created a software application to help select the donors and as you can see errors have been reduced dramatically.

## Experience to Date...

**Donors want a shorter process and like ADHQ.**
**1/3 of donors are eligible for ADHQ.**
- 3⁄4 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

|  | ADHQ | FDHQ |
| --- | --- | --- |
| Current Events (<8 wks) | 10 | 12 |
| Travel | 2 | 3 |
| Medical Conditions/Health Problems | 1 | 10 |
| Deferring Medications/Treatments | 1 | 8 |
| Hepatitis/CJD Risk | 6 | 6 |
| HIV/HIV Risk | 13 | 12 |
| Miscellaneous | 2 | 3 |
| TOTAL | 35* | 54 |

- *23 questions linked to period since donor’s last donation

**Notes:**
General statement;  When it comes to risk factors and behaviors the questions are the same.  The things we worry about are the same. 
Current events- 2 deleted questions are:
Do you understand if you have aids you can infect others?  This information is included in the educational materials given to the donors.
Have you ever donated using another name.  These are frequent donors so will be detected by donor ID, SSN , etc.
Travel:  Capture question is “Have you been outside the United States?”  Depending on the answer eligibility is evaluated for Malaria, SARs, CJD and HIV1 group O.
Medical conditions: Capture Question:  Have you had any new medical conditions or health problems?
Deferring Medications:   Capture question is asked-”  Have you taken any medications on the medication deferral list?”  This deferral list consists of all the deferring  medications and is presented to the donor.
Hepatitis: no changes
HIV:  Number is more because we have added a capture question as part of a study to determine if we can reduce the number of HIV related questions. “Have you or your sex partner participated in any activity that  puts you at risk of catching or spreading the AIDS virus?”
Miscellaneous:  Deleted “Have you read and understood all the donor information presented to you?’
Closing:  We have reduced the number of questions form 54 to 35.  For 23 of the 35 questions the time frame is linked to the donors last donation.

## Donors whose last donation was > 8 weeks from current donation

|  | ELIGIBLE for ADHQ |  |  |  |  |  |
| --- | --- | --- | --- | --- | --- | --- |
|  | Last Donation > 8 wks |  |  |  |  |  |
|  | ADHQ |  | FQ |  | TOTAL |  |
|  | N | % | N | % | N | % |
|  | 28786 | 58 | 20936 | 42 | 49722 |  100 |
| Medical History Deferrals | 137 | 0.48 | 121 | 0.58 | 258 | 0.52 |
| Temporary Deferral  | 1977 | 6.87 | 1716 | 8.20* | 3693 | 7.43 |
| Confirmed Positive Test | 4 | 0.01 | 6 | 0.03 | 10 | 0.02 |
| PDI (PD illness/event)  | 40 | 0.14 | 35 | 0.17 | 75 | 0.15 |
|  |  |  |  |  |  |  |

*** p=0.02**

**Notes:**
Of the 53,996 donors eligible for the ADHQ, 4,274 (only 8%) had their last donation within 8 weeks. The platelet donors are such a small proportion of our data set (8%) and their deferral rates are so similar that the impact of these donors on overall rates is minimal.  
Again the rates of medical history and temporary deferrals are very low. The difference in the medical history deferral rate between those receiving the ADHQ and the Full questionnaire is significant.  
The rate of confirmed positivity in blood tests and the rate of post donation information is not different. 

  Of the platelet donors, 13% received the FQ (564) and 87% received the ADHQ.  This is different from the donors whose last donation was > 8 weeks.  In this group, 58% received the ADHQ and 42% receive the full questionnaire.  

## Comparison of Donation Outcomes:ADHQ versus Full HQ Time Period: August 4 – October 15, 2003     N=182,383

- * Percentage excludes unsuccessful collections

**Notes:**
I thnk this table is not legible at present.  The numbers have to be bigger.  Suggest reducing the number of letters in the far left hand column so that other columns can be wider and then font can get bigger.  Audience won’t be able to read this sldie