Training program from Virginia Blood Services based on their policy and practices as well as patient demographics for the Central Shenandoah Valley in VA. The emphasis of Data on Harrisonburg, VA and Winchester, VA

1. The Therapeutic Donation Process
*
Instructor:
Christopher Bayonet, NRAEMT
Collections Supervisor - RMBC

2. *
* Therapeutic Donations are those donations where the Donor’s Physician has directed a
patient to donate blood because of a specific medical condition. Most Likely Hereditary
Hemochromatosis or Primary/Secondary Polycythemia. Some of these donations we are
able to “crossover” or use the same as an allogeneic donation.
Their Physician (not our Medical Director) will set the volume to be drawn (250mL or
500mL), their frequency and their minimum hemoglobin value. They will need to
update this once per year. Either their physician or our Medical Director can
discontinue their phlebotomies at any time.
Review
 All Patient Services Donations must be scheduled ahead of time. Walk-In Therapeutics are only to
be performed if it will not impact the donor flow of the day, and you will not exceed 5 Therapeutic
Phlebotomies for that day.
 All Patient Services Donations are to occur between the hours of 9a to 4p Monday to Friday. Any
which the Collections Supervisor/Charge allow to be drawn outside of those hours may need to be
deferred if there are any aberrances beyond those of an allogeneic donation.
 You want to have about 30 to 45 minutes between each Therapeutic Donor to allow for adequate
time to properly address any concerns. This means you will need to check the schedule in
RecruitView prior to scheduling a donor for a day to ensure there is proper spacing of donors.
 No Patient Services Donors should be able to schedule themselves online. If you notice one please
inform the Collections Supervisor/Charge Person so they can notify Julie Miller and Hariet Newman
immediately in order to correct it.

3. *
Before we register a Therapeutic Donor we want to check their chart
for a few items – to ensure completion, accuracy, legibility and
validity.
These are to include:
* The Current Rx is (a) Correctly Dated w/ a Logical Date [not post
dated] (b) Within 1-Year from Issuance and (c) is on the correct Rx
version for the date.
* The Current Consent Form is (a) Appropriate to the Diagnosis and (b)
Within 1-Year from Issuance.
* Donor is donating as per correct frequency (i.e. 1 Month = 1 Month,
not 4 Weeks or 30 Days) and that the frequency is not a “PRN”
* All Therapeutic Prescriptions must either be signed (or noted as
“Verbal Approval” by either Hariet Newman and/or Julie Miller) by Dr.
Sheppard (our Medical Director) prior to phlebotomy being
performed.

4. *
You will proceed to register the donor as per SOP – the only difference will be that you may need to
“override” the donor because of either frequency or other deferral(s).
* A “4310” error is purely a frequency based error and should be printed out on an ALLOGENEIC DHF as we
should be able to “cross them over”
* A “4320” error is any other non-frequency based error and should be printed out on an
AUTOLOGOUS/THERAPEUTIC DHF and we will not be able to “cross them over” for today’s donation.
If you feel that they should be a “crossover” donor but were not; speak with your Collections Supervisor to
assess and then contact Julie Miller and Hariet Newman for possible “Therapeutic Re-Entry.”
When registering a THERAPEUTIC (Non-Crossover) Donor be sure to register them on an
Autologous/Therapeutic DHF (DS-003A); Therapeutics (Crossover) Donors will go on the Allogeneic DHF
(DS-003), as normal.
Never under any circumstances use your Therapeutic Override abilities to register a Non-Patient Services
Donor . This is a major violation if you do. Do not override a Allogeneic Donor “because they will be out of
town when they are due.”

5. *
Before printing the DHF please make sure you check
your BBCS (F5) Comments to ascertain if the following
comment codes have been previously recorded:
* HHEM – Hereditary Hemochromatosis Donors
* TSTV – Secondary Polycythemia: Testosterone Donors
* THER – All other Therapeutic Donors
Why is this important? It lets Central Receiving what
components (if any) can or cannot be made from this
donor’s donation today.

6. *
Therapeutic Vital Signs are done the same as we do an
Allogeneic Donor; the only difference is their Hemoglobin
Cut-Off can be different.
Note: If the donor is below their therapeutic cut-off we will not continue with
the screening process; the donor will be eligible to return in three days.
For example, a Male Donor with an Rx of 11.5, and a finger
stick today of 12.0 can be drawn – just not “crossed over”
even if they meet all the other criteria.
[You would still defer them as a 56ML for three months from Allogeneic
Donations, but can return for a Therapeutic Donation in three days. They will
still be eligible to donate as a “Therapeutic Donor” as per their Prescription.]

7. *
Another main difference is that we can (and often do obtain)
permission to draw Therapeutic Donors that do not meet other
allogeneic criteria.
Such as Hemoglobin where we would defer them from allogeneic
donations (and note it accordingly) unlike Hemoglobin we are
required to call Medical Help Desk to obtain this permission – just
noting that this would be for a “THERAPEUTIC ONLY DONATION” at
the time of the call.
This includes donors with temperatures, taking antibiotic, currently
“sick”, aberrant pulses, etc… Please note that we can ONLY get these
permissions Monday to Friday between 9a and 4p, as Patient
Services and the Donor’s Physician (as well as Dr. Sheppard) might
need to be reached at that time to do such.

8. *
Screening the donor for the Therapeutic donation will be pretty much the same as you
have done for Allogeneic Donors, especially in regards to “Crossover” Donors (HHEM and
TSTV Donors) – they actually answer the allogeneic donor history form (DHF) questions.
For all other Therapeutic donors they will be answering an abridged questionnaire
consisting of only 6 questions. Three of them are pertaining to is it safe for the donor to
donate here, the rest are for is it safe for us to draw them.
After you have obtained responses for them all, refer to the AUTOLOGOUS/THERAPEUTIC
MCM calling Medical Help Desk as necessary to obtain approval.
Note: If something is screaming inside you that the donor may not be safe to donate
today, please inform them as to what you are noticing as well that is making you
think this at today’s donation (especially if this is a NEW donor).

9. *
You have screened the donor, and found him acceptable to donate today … where do
we go from here?
* If the donor meets all the Allogeneic Criteria then you need to do a “910”, as per the
appropriate SOP, in BBCS prior to phlebotomizing the donor.
* If they are Hereditary Hemochromatosis – the code is WBH
* If they are Secondary Polycythemia: Testosterone – the code is TV.
* Proceed to make the appropriate bag and label tubes (if “Crossover”).
* Crossover Donors go in RC2D Bags with a note in the top right corner of the
main bag of either “WBH” or “TV”
* Throwaway Donors go in a Nutricel Bag with a RED “X” (in ink, not pencil)
marked on each labelled bag and a Quarantine Tag attached to the Main
Bag noting “THERAPEUTIC DONOR – DO NOT USE”

10. *
* If you are unable to perform a “910” on a donor, draw as a
THROWAWAY THERAPEUTIC – if you are not certain why you
cannot, asses the donor with your Collections Supervisor as
per “Re-Entry” and submit it to Julie Miller and Hariet
Newman, if eligible.
* If when attempting to perform a “910” you get a “4320”
error, stop and do not cross that donor over… if uncertain as
to why, please see above.
* When performing a “910” please be certain to change the
group code to the appropriate Collections Center. (i.e. AMCB,
RMBC, WIN and/or CHAR)

11. *
* We do not draw “Follow-Up Labs” for any Therapeutic Donor; (a) the
Follow-Up Labs are the responsibility of the Physician and (b) We do not
have the facilities to do such for any donor. Any Prescriptions asking for
such needs to be returned to the Physician for Re-Issuance and/or
Clarification noting that this is not a service we provide.
* Therapeutic Phlebotomies are performed as “Whole Blood Only” we do
not perform Apheresis (i.e. Double Red Cell) Therapeutic Phlebotomies at
this time. This is mainly because we do not have the proper Variances in
place to accommodate such requests. Prescriptions asking for such need
to be returned to the Physician for Re-Issuance and/or Clarification noting
that this is not a service we provide.
* We do not schedule a Therapeutic (or any other Patient Services) Donor
on a Holiday – we cannot (nor should we be) drawing them those days as
Patient Services and most Physician(s) offices are closed on Holidays.

12. *
* Both the Rx and Consent Forms must be within 1-Year of issuance (and
appropriate to the physician’s diagnosis); if not we need a new one of
each before we are able to phlebotomize them.
* The Donors must be able to ambulate on their own, as well as hold
pressure by themselves. If they are unable to do either you need to reach
out to Julie Miller and/or Hariet Newman if the donor has yet to appear.
Or reach out to Dr. Sheppard if that donor is currently in the center.
* These donors may not be suitable for In-Center Therapeutic
Phlebotomies, and may need to referred to the Hospital (or their
Physician’s Office). Our Medical Director makes the decision whether or
not the donor can be phlebotomized by us, or if they need to go to
another site instead.
* If the donor’s prescription will be expired before their next eligible
donation, we cannot (nor should we be) scheduling them before receipt
of a new Rx.
* When Re-Scheduling Therapeutic Donors, use the EXACT verbiage of the
doctor’s prescription. If it says 1 Month, it is 1 Month and not 4 weeks or
28 (or 30) Days.