On May 11, 2023, the FDA’s Center for Biologics Evaluation and Research (CBER) issued guidance updating the blood donor history questionnaire (DHQ). Also known as the DHQ v4.0. The hope was that creating a gender-neutral questionnaire would increase the number of people eligible to donate, improving the nation’s blood supply.
After 3 months, has it made a difference?
The DHQ v4.0 is a series of questions asking potential donors about their lifestyle activities and travel to assess whether they are eligible to donate blood. The questionnaire is a risk-based model and is a critical step in ensuring the safety and potency of the nation’s blood supply.
As knowledge and understanding about disease increases along with the ongoing need to maintain an adequate blood supply, the FDA, in conjunction with the Association for the Advancement of Blood and Biotherapies (AABB), reviewed the restrictions or limitations on groups or individuals who may be allowed to donate with the goal of increasing the pool of eligible donors.
The DHQ v3.0 contains gender-specific questions impacting the eligibility of LGBTQ members. The new DHQ v4.0 was developed to be gender-neutral. There was concern that the new questions (especially the follow-up if any were answered yes) would be uncomfortable, but they were necessary to assess every potential donor the same.
“Some of the follow-up questions can seem to be a bit personal,” states Marvin Opulencia, Donor Operation Trainer at Inova Blood Donor Services (IBDS).
But Marvin thinks the change was a good thing because the questionnaire is no longer gender-specific and makes the process easier. “Some of my friends are members of the LGBTQ community, and now they are able to donate. I’m happy about that.”
Recognizing the difficulty and sensitivity inherent in the impacted topics, the FDA did not issue a deadline for implementation but has allowed blood donation centers to integrate the new guidance at their own pace. However, there were some blood donor centers that were ready to move forward with the recommendations. Their experience tells us that it is still too early to evaluate the effect of the change.
Nicholas Lilly, Interim Director of IBDS in Northern Virginia, believes we still don’t know the overall impact of the DHQ v4.0. “Inova Health System welcomes and supports initiatives improving the diversity, inclusiveness, and equity of our services. That’s why we were one of the first to implement the DHQ v4.0 in June. We serve the DMV area (D.C., Maryland, and Virginia), which is a highly diverse community, and so we saw the new guidance as a continuation of our vision and goals.”
With three months of data to evaluate, Director Lilly still doesn’t know what impact the change has on the blood supply. “Though we have received no negative feedback from our clients, we still haven’t seen a net increase in the number of donors. We have seen more non-binary people donate, but overall, there has not been a noticeable increase in donations. But it’s still early.”
It was expected that changing the Individual Donor Assessment to a more gender-neutral questionnaire would generate a bit of consternation and questions regarding whether it was in the nation’s best interest. However, so far, it was just one more step toward allowing everyone to make a difference.
Stated simply, Blood Saves Lives and is desperately needed. Now everyone has the opportunity to donate. Limitations or restrictions should be determined by science-backed non-judgmental research. That’s what the DHQ v4.0 is… that’s the difference it makes.
–Darryl Elzie is a Quality Consultant for Inova Blood Donor Services. He has been an ASCP Medical Technologist for over 25 years, performing CAP inspections for 15+ years. He has held the roles of laboratory generalist and chemistry senior technologist. He has a Master’s in Healthcare Administration from Ashford University, a Doctorate of Psychology from The University of the Rockies, and is a Certified Quality Auditor (ASQ). Inova Blood Donor Services is the largest hospital-based blood center in the nation. Dr. Elzie is also a Counselor and Life Coach at issueslifecoaching.com.
Good morning!
We’re entering the holiday season, and it’s an exciting time for all. I love
seeing the ethnic and cultural diversity as we all celebrate our favorite
holidays with family and friends. I myself look forward to the holiday season.
It’s a festive time and a season of giving and sharing. It’s a favorite time of
year to share traditions and create new ones. However, at a time when stores
have Christmas candy on the shelves, holiday lights up and holiday music playing
on the day after Halloween, I feel a bit rushed and want to slow down and find
better ways to celebrate and enjoy the season. Over the past few years I have
been making a special effort to become more environmentally conscious;
remembering my reusable bags at stores, purchasing more reusable products, and
reusing, recycling, and upcycling whenever I can. I belong to a community ‘buy
nothing’ group and am warmed by the generosity of strangers to others in the
community. It’s wonderful to give from our abundance and to receive wish list
items from neighbors without having to exchange money. And it’s great for the
environment, too. Used items are being put to use by others, and not into
landfills. People in the community have asked for or gifted furniture,
clothing, tools, toys and many other goods and services. I have gifted no
longer needed clothing, household items, excess fabric from my fabric stash,
and donated my time to participate in a career fair at a local high school. I
have been given a car set for my grandchildren when they visit, toys, and
someone even loaned me a bike trailer so we could take my granddaughter out for
a bike ride. The generosity makes it feel like the holiday season all year
round.
So, you may be
asking, “where is this blog going?” I saw a memo from Red Cross this week that
there is a critical need for blood and platelets and thought that giving to our
community with the gift of blood would be a wonderful way to make this holiday
season even better! It’s one of the most generous gifts we can give, and costs
nothing. Every 2 seconds in the US, someone needs a blood product. That’s about
36,000 units of red blood cells, 7,000 units of platelets and 10,000 units of
plasma needed every day. 21 million blood products are transfused every year.1
That’s a lot of blood. And, these blood
products cannot be manufactured, so must come from volunteer donors.
In
the US, we need to collect about 13,000 units a day to meet demand. Approximately
14 million units of whole blood are collected each year from roughly
7 million donors.1 The blood is processed into components and
used in the treatment of surgical, obstetric, oncology, and other patients. One
unit of whole blood can be made into up to 3 components and used to help up to
3 patients. Yet, even with all these donations we still cannot keep up with
demand. Weather, holidays, illness and travel can all affect blood donations. Shortages
are not just apparent during the winter holiday season. This past summer, the
Red Cross announced a critical blood shortage around the July 4th
holiday. Compared to other weeks, there were 17,000 fewer blood donations
during the week of July 4th. As of July 9, the Red Cross had less than a
three-day supply of most blood types and less than a two-day supply of Type O
blood. 2 During the summer, and particularly during the holiday
week, people are busy with other activities or traveling. In the winter, busy
schedules, holiday travel, winter weather and seasonal illnesses contribute to
fewer blood and platelet donations. Severe weather can also cause the
cancellation of blood drives which greatly impact the blood supply.
Some people donate blood because they see this critical need
and hear the calls for blood. Others donate because a classmate or friend asked
them to. Some people feel it’s their civic duty. For some, it just makes them
feel good to help another person. And, others donate for the cookies and tee
shirt. Yet, for all donors, it is a form of volunteerism and giving to the
community. But, did you know that, other than the benefits from helping others,
there are benefits to the donor, as well? Helping others can improve our
emotional and physical health. It can help reduce stress, improve emotional well-being
and help people feel a sense of belonging. A study conducted in Sweden
concluded that regular blood donors enjoy better than average health.Blood
donors had an overall mortality 30% lower and a cancer incidence 4% lower than
the control population.3 Donating blood may help reduce high iron
stores, a risk factor for heart attack. In addition, there have been several
studies over the past few years, exploring the hypothesis that regular blood
donations may help in the management of hypertension and high cholesterol.
Another
interesting benefit of blood donation is being able to contribute to science
and research. For example, there is currently a study being conducted on donor
blood to test an investigational nucleic acid test for Babesia microti. Babesia
microti is responsible for most transfusion-transmitted babesiosis cases in the
United States, but there is no licensed test for screening for B. microti in
donated blood. Participation in this study can help obtain FDA approval for a
screening test. By giving
your consent to use your blood sample, there is no additional blood taken and
no further time commitment, but you can help protect the public health by
supporting the development of a new blood safety test.
How
can we, as individuals, help? About 38% of the population is eligible to donate
blood, but less than 10% of the population actually donates. To be eligible to
donate, you should be in good general health and feeling well. You
must be at least 17 years old in most states
(16 years old with parental
consent in some states) but there is no age limit to donation. Adult doors must
weigh 110 lbs, but there are additional height and weight requirements for
donors 18 years old and
younger. There have also been some recent changes to blood donor requirements. I
will not be able list all of them here, but some of them don’t change a
deferral, only the reasoning behind the deferral. One of the most prominent
changes is, as of 2016, the indefinite deferral for men who have had sex with
men, has been changed to a 12 month deferral since the last sexual contact with
another man . Also changed is the minimum hemoglobin for male donors. This has been
raised from 12.5g/dl to 13.0 g/dl. Until this time, the cutoff was the same for
both males and females. Males with a Hgb below 13.0 g/dl are considered anemic
and are no longer eligible to donate blood. On the other hand, the criteria for
females to be mildly anemic is a Hgb below 12.0 g/dl, so females between 12.0
g/dl and 12.5 g/dl, though not considered anemic, are still not eligible to
donate. The minimum hemoglobin for females has not changed and remains 12.5
g/dl. To review other eligibility requirements, visit https://www.redcrossblood.org/donate-blood/how-to-donate/common-concerns/first-time-donors.html
So, in this busy season, we often find ourselves with little time to get our own “to do” lists done, yet alone volunteer our time for others. But most of us would welcome an hour to reduce stress and improve our emotional well-being. Please consider a gift of self this season. It takes about an hour of your time, you get to sit and relax with your feet up, to feel good about yourself, and you’ll even get a snack!
Edgre, G et al. Improving health profile of blood donors as a
consequence of transfusion safety efforts. Transfusion. 2007 Nov;47(11):2017-24.
Kamhieh-Milz
S, et al.Regular blood donation may help in the
management of hypertension: an observational study on 292 blood donors. Transfusion. 2016 Mar;56(3):637-44. doi: 10.1111/trf.13428.
Epub 2015 Dec 8.
-Becky Socha, MS, MLS(ASCP)CM BB CM graduated
from Merrimack College in N. Andover, Massachusetts with a BS in
Medical Technology and completed her MS in Clinical Laboratory Sciences
at the University of Massachusetts, Lowell. She has worked as a Medical
Technologist for over 30 years. She’s worked in all areas of the
clinical laboratory, but has a special interest in Hematology and Blood
Banking. When she’s not busy being a mad scientist, she can be found
outside riding her bicycle.
Lablogatory 