Consent for Rh Ig

[cthherbal ☆]

I am wondering if/how other hospital Transfusion Services (that distribute Rh Ig) handle consent.

Do you:

consider it a blood product and consent is included with the standard blood consent form?

require a separate Rh Ig consent form (with risks benefits, etc.) be signed?

handle it like a medication, and don't consent separately for it?

I look forward to your responses!

Colleen Hinrichsen, MT(ASCP) SBB

[David Saikin]

It is not a blood product but a derivative . . . handled like medication . . . general consent.

[pbaker]

When we got a new pharmacy director, she about flipped out when she discovered that Rhogam, WinRho and coag factors were still in the BB. She stated that they were a drug and should be maintained, ordered, consented, etc. by the pharmacy.

I'm sure every institution is different, but I was really happy to get them out of the BB.

[carolyn swickard]

We do not yet use a consent form for RhIg. Our Blood/blood products consent is not really applicable for RhIg - different specifics - and RhIg is not mentioned on it. That did not stop our Infusion Therapy unit from starting to use it though for outpts, even though the rest of the services (ER, Surgery and Labor and Delivery) were not using it. Our Risk Management folks are starting to think about it though and may recommend something in a while. Might be interesting to see the Pharmacy consent form - our Pharmacy handles all of the rest of the plasma derivative products, we only have the RhIg left in Blood Bank. Maybe it would be usable if Risk Mgmt says we have to start using one.

[tbostock]

No consent needed here as it is not considered a blood product. To handle the pharmacy issue described by pbaker above, when the nurse/doc orders RhIg, it sends the order to us in the Blood Bank so that we can make sure all of the proper testing is done prior to issue. The computer also sends a "fake" RhIg order to the pharmacy so a pharmacist can review the order (there is a lot of concern about the FDA classifying this as a drug), and so that it goes on the MAR so that the nurse can scan it in when she gets it. It was a bit of work, but it works well.

[marvy1]

No consent needed here as it is not considered a blood product. To handle the pharmacy issue described by pbaker above, when the nurse/doc orders RhIg, it sends the order to us in the Blood Bank so that we can make sure all of the proper testing is done prior to issue. The computer also sends a "fake" RhIg order to the pharmacy so a pharmacist can review the order (there is a lot of concern about the FDA classifying this as a drug), and so that it goes on the MAR so that the nurse can scan it in when she gets it. It was a bit of work, but it works well.

In Canada, Rhogam and WinRho are considered blood products, because they are blood products. They are not blood components however. From Rhogam product insert:

RhoGAM and MICRhoGAM are made from human plasma and may carry a risk oftransmitting infectious agents, e.g., viruses, and theoretically the Creutzfeldt-Jakobdisease (CJD) agent. The risk that such products will transmit an infectious agent hasbeen reduced by screening plasma donors for prior exposure to certain viruses, bytesting plasma for the presence of certain current virus infections and by using pathogenremoval and inactivation techniques during the manufacturing process. All of the abovesteps are designed to increase product safety by reducing the risk of pathogentransmission. Despite these measures, such products can still potentially transmitdisease. There is also the possibility that unknown infectious agents may be present insuch products. All infections thought by a physician possibly to have been transmitted bythese products should be reported by the physician or other healthcare provider in theUnited States to Ortho-Clinical Diagnostics, Inc. at 1-800-421-3311. Outside the UnitedStates, the company distributing these products should be contacted. The physician

should discuss the risks and benefits of these products with the patient.

[LCoronado]

Same here.

No consent needed here as it is not considered a blood product. To handle the pharmacy issue described by pbaker above, when the nurse/doc orders RhIg, it sends the order to us in the Blood Bank so that we can make sure all of the proper testing is done prior to issue. The computer also sends a "fake" RhIg order to the pharmacy so a pharmacist can review the order (there is a lot of concern about the FDA classifying this as a drug), and so that it goes on the MAR so that the nurse can scan it in when she gets it. It was a bit of work, but it works well.

[cthherbal ☆]

Thanks, everyone. We just had a meeting that included Risk Management. OB and OB clinic were using a Rh Ig specific consent form but ED was not. End decision: everyone will follow the same process and consent. Probably overkill but it's a nice consent form, and doesn't hurt anything, so I couldn't argue.

[carolyn swickard]

Thanks, everyone. We just had a meeting that included Risk Management. OB and OB clinic were using a Rh Ig specific consent form but ED was not. End decision: everyone will follow the same process and consent. Probably overkill but it's a nice consent form, and doesn't hurt anything, so I couldn't argue.

Any chance your facility would let you post the RHIg consent form here?

[cthherbal ☆]

Any chance your facility would let you post the RHIg consent form here?

I can probably email a copy. Send me a request to chinrich@rwjuhh.edu. Bear in mind it is a form that's been in use for many years and is up for revision, but you'll get the general idea.

[Malcolm Needs ☆]

As a reknowned pedant, I have to agree with marvy1!

Whole blood is blood.

Any component of that blood, including packed red blood cells, FFP, cryoprecipitate, buffy coat, etc are all blood components, because they are all direct derivatives produced from the blood by centrifugation (or settlement) and then separation, with no further manipulation (other than, perhaps, leukodepletion, irradiation, etc.

Things like anti-D immunoglobulin, human albumin solution, IVIG, anti-tetanus, clotting factors, etc are blood products, because there is much more manipulation involved (such as Cohn's fractionation, etc), and are not a direct component from blood.

[profbaud]

Colleen

Our OB dept treats it like a drug and the doctor writes an order to transfuse RhIg, then the blood bank signs it out.

Good to hear from you, long time no hear

Debbie

Rush [uIC] SBB program

I am wondering if/how other hospital Transfusion Services (that distribute Rh Ig) handle consent.

Do you:

consider it a blood product and consent is included with the standard blood consent form?

require a separate Rh Ig consent form (with risks benefits, etc.) be signed?

handle it like a medication, and don't consent separately for it?

I look forward to your responses!

Colleen Hinrichsen, MT(ASCP) SBB

[tbostock]

As a reknowned pedant, I have to agree with marvy1!

Whole blood is blood.

Any component of that blood, including packed red blood cells, FFP, cryoprecipitate, buffy coat, etc are all blood components, because they are all direct derivatives produced from the blood by centrifugation (or settlement) and then separation, with no further manipulation (other than, perhaps, leukodepletion, irradiation, etc.

Things like anti-D immunoglobulin, human albumin solution, IVIG, anti-tetanus, clotting factors, etc are blood products, because there is much more manipulation involved (such as Cohn's fractionation, etc), and are not a direct component from blood.

Totally agree with you Malcolm, although I said it was not a blood product. I should have said not "considered" a blood product. I always thought it interesting that Jehovah's Witnesses would accept derivatives, but not "blood products"...they all come from the same human.

Uh oh...hope I didn't start another controversial topic.

[cthherbal ☆]

Colleen

Our OB dept treats it like a drug and the doctor writes an order to transfuse RhIg, then the blood bank signs it out.

Good to hear from you, long time no hear

Debbie

Rush [uIC] SBB program

Hi, Debbie!