Donor Deferral

[spavlis]

I am currently setting up a computer deferral database and I was wondering who should go into the database. We currently have it set up for all are volunteer donors, the question is whether to consider other donor populations:

1) Patients with cancer who come to donate autos for surgery?

2) Research volunteers with Hepatitis C who donate whole blood for research purposes only?

3) What about allogeneic Stem Cell donors?

4) Therapeutic Phlebotomy patients with Hemachromototis?

At first I thought it was a good idea to enter all these populations into our deferral database, on the chance that they might want to be a volunteer donor someday. I am now thinking is this over-kill. Can we " baby proof" are entire donor population on the chances that someday they might want to be a volunteer donor. Or are we suppose to put more faith into our screening tools (DHQ), on being able to capture this information.

Any thoughts????:star_full

[Cliff]

What do you mean by "I am currently setting up a computer deferral database"? Is this part of a system, or a stand alone tool you are making on your own?

We are implementing a new system now and we are merging two database of donors. We have WB, Platelet, Auto, Stem cell and other donors. They will all have the same rules applied to them. If you qualify for the type of donation you are donating, then all is fine. Your eligibility status is determined at each donation. So if in the past you said you had disease X and an auto donation is acceptable, but an allo isn't, well that's what you are eligible to donate.

So the short answer, we are entering all of the deferrals, about 7500 permanent and many temporary from about 150,000 pooled donors.

With the speed and power of databases these days (excluding Microsoft Access) unless you are going to have many billions of records, there isn't a good reason not to add them all.

[ncehall]

We have the same type of center- we do mostly autos and therapeutics but also allogeneic. We are required by regulatory agencies to enter deferrals for all the reasons you mentioned. It is rare for one of these patients to come back as a donor, but you have to have a system in place to prevent those that should be deferred. We were cited many years ago (FDA, I think) for not deferring auto donors in our computer system from being allogeneic.

[spavlis]

Thanks for the input.

Does deferring a donor ( auto, therapeutic, or research) for having a disease xx, violate any ethical/legal/HIPPAA regulations. Are we allowed to put private information into a database that is used for donors who want to donate allogeneic blood?

Another twist to the problem!

stephanie

[Cliff]

Hi Stephanie,

I think this is the right thing to do, it's safest for the donors' and potential recipients'.

HIPAA is a funny subject, technically it doesn't apply to volunteer blood donors, but as you mentioned, these are patients / volunteers. In our organization we do not distinguish between patients and donors, anyone who receives care / treatment / services is treated as a patient and their information is protected.

Storing data collected in the course of treating the patient is clearly allowed. You would not be able to function unless you did. It's the sharing of that information with others that gets you into the HIPAA pool. I suspect you do not share any of this information with anyone, so it's likely you are doing the right thing.

[rcurrie]

I studied HIPAA in law school, and it does apply to blood donors, including volunteer, paid, and autologous. HIPAA protects a person's individually identifiable health information, no matter what the source. That said, it is not a violation of HIPAA to maintain a database with autologous donor information. You only get into trouble when that information is inappropriately shared with someone outside the institution who does not have a right or need to know that information, or when someone within the institution without a need to know accesses the information. Three principles underpin the privacy rules: (1) patients have a right to access and track use of their personal health information; (2) private health information may not be viewed without authorization; and (3) any use of that information is limited by the concept of "minimum necessary." Who has a right or need to know autologous donor testing information? Obviously, the patient's physician. However, governmental agencies such as the public health department have a right to know if the autologous donor has an infectious disease. In fact, it is required by law that donor centers report this info.

BC