Does anyone have a Neonatal Exchange Transfusion Policy they could share with me? We have a policy but we haven't performed one in years and I just want to make sure our policy is up to date and detailed enough for the techs. Our hospital is going to become a level 3 NICU so I suspect we will start getting orders for Exchange Transfusions.

 

Thank you!

We had to recently update and revamp our too - same reason.  Hope this helps.  Our procedure is specific for Meditech, but most of it is usable.

61-Newborn Exchange Transfusion - 2.doc

67-Transfusion of the Neonatal Recipient (under 4 months) (2).doc

Exchange Transfusions RBC Unit Worksheet.doc

We have Meditech also. Thanks so much!

I just have aquestion how fresh the RBC should be used for neonatal exchange transfusion? is there any reference standard for this? In our institution we use RBC less than 7 days old. Thanks.

Thank you Carolyn for the downloads. I would like to ask why do you irradiate FFP and cryo for your neonates? Does anyone else do this?

In the UK there is no requirement to irradiate cryo or FFP - didn't realise other countries were

We do not.

How is  the final product labele?  Do you have a reconstituted rbc label for the product?

We  ONLY irradiate the Cellular Components, FFP and Cryoprecipitate are NOT cellular components.

We do not irradiate FFP and Cryo; only cellular products are irradiated.  That being said, according to the ICCBBA requirements (may be USA only???) for ISBT labeling of the reconstituted product, you are not allowed to use the E code for an Irradiated reconstituted RBC product unless everything in the product (including the plasma) is irradiated.  Go figure.  So when we combine E0207 (Leukoreduced Irradiated CPDA1 RBC and Thawed Plasma) we label the reconstituted product with E6453 (RED BLOOD CELLS|CPDA-1/500mL/refg|Open|ResLeu:<5E6|Plasma added) and not E0219 (RED BLOOD CELLS|CPDA-1/500mL/refg|Open|Irradiated|Plasma added).

 

Per ICCBBA ISBT128 Standards and FDA requirements, the system prints the following on the ISBT128 reconstituted red blood cell label: CMV negative, leukocyte reduced, irradiated, or IgA deficient when both the original red cell and the original plasma have the same attribute and Hemoglobin S negative or Washed if the original red cell is Hemoglobin S negative or Washed.

 

Added changes:  Now that I am re-reading this guidance, I think I have picked the wrong E code since E0207 is Leukocytereduced and I can only use that if both the Red Cell and the Plasma are leukoreduced???  This make my head spin.

Edited January 15, 201510 yr by Sandy L

Further researching of ICCBBA document for attributes for reconstituted RBC products (RBC plus plasma added): 

The document says “US Guidance”, so every one else can ignore this post.

 

Leukocyte Reduction: IF both the red cells and the plasma are leukocytes reduced (or the combined product is leukocytes reduced), THEN in the Product quadrant label “LEUKOCYTES REDUCED” in Attribute line.  IF Red cells are leukocytes reduced; Plasma NOT leukocytes reduced, THEN “Leukocytes Reduced” shall NOT appear as Attribute text. It shall appear as additional text. For example “Approx ___ mL Leukocytes Reduced Red Blood Cells from …”

 

Irradiation: IF both the red cells and the plasma are irradiated (or the combined product is), THEN label “IRRADIATED” in Attribute line.   IF Red cells irradiated; Plasma NOT irradiated, THEN “Irradiated” shall NOT appear as Attribute text. It shall appear as additional text. For example “Approx ___ mL Irradiated Red Blood Cells from …

 

So, yes, I am using the wrong E code for Reconstituted RBC's.    

I see the rational for the ISBT labeling as many facility irradiate after reconstituting WB and some facility without irradiator on site end up using irradiated RBC and plasma to it...

SandyL, when making a resuspended red cell at our facility, we use a non-irradiated LR red cell and an FFP unit.

 

Once the resuspended unit is created, the unit is irradiated. A process indicating irradiation was performed is added in the computer system which creates a new ISBT code for an irradiated, leukoreduced resuspended red cell. It is a more streamlined process.

 

Since, as everyone else has pointed out, there is no reason to irradiate FFP or Cryo products, are there ICCBA ISBT codes for such products?

rm thorkelson,

 

Since we do not irradiate, we obtain irradiated RBC's from our supplier and reconstitute with non-irradiated plasma.   As you said "since, "as everyone else has pointed out, there is no reason to irradiate FFP or Cryo."  In scanning through the ICCBBA product database, I see lots ofE codes for frozen and thawed plasma and also cryoprecipitate products, so someone must be irradaiting these products.  Not sure why.

here is what we do..hope this helps.  We also use Meditech

BB10490 Reconstitution of RBCs.doc

BB10450 Exchange Transfusion - Neonatal.doc

reconstitution chart for rbc w plasma.pdf

here is what we do..hope this helps.  We also use Meditech

 

Thank you DIANITA!

Don't forget that you must be registered with the FDA to manufacture blood products.  Making reconstituted whole blood is manufacturing!

We haven't done an exchange in so many years, I can't remember the last time we did one. I called ICN and questioned them about exchanges and they said they may still do them. So I can't get rid of my ancient procedure.

 

I don't want to register with the FDA for a procedure that may never be used. That is a can of worms that I don't want to open. What do other hospitals do for these situations? Do the exchange and claim ignorance of the law?

We haven't done an exchange in so many years, I can't remember the last time we did one. I called ICN and questioned them about exchanges and they said they may still do them. So I can't get rid of my ancient procedure.

 

I don't want to register with the FDA for a procedure that may never be used. That is a can of worms that I don't want to open. What do other hospitals do for these situations? Do the exchange and claim ignorance of the law?

I wouldn't EVER recommend that.  FDA would probably not excuse "ignorance" and it would put you on their radar...not a good place to be.  At my place if someone needed an exchange transfusion they would need to be transferred out.

As a level 3 though you may have to do them often enough where you might have to go with registration.

We just ditched ours.  They havent done one in about 10 years.  Ordered them..but never actually did them.  I would get the Medical Director involved.  You have to be FDA registered and it is difficult to maintain or assess staff competency if you have no volume.  For those reasons and some other reasons we decided that if one was absolutely needed, the patient would be transferred to a bigger institution. 

You may find the following FDA response of interest:

 

2009 AABB Ask the FDA Transcript

 

"Question 14:  At previous Ask the FDA sessions, the FDA has explained that combining Plasma and Red Blood Cells to create a "reconstituted" Whole Blood for neonatal exchange transfusion is considered manufacturing and requires FDA registration. Is there a threshhold frequency before registration is required (for this or other infrequent occurrences), e.g., if a procedure is only performed 1-4 times per year, is the facility required to register with the FDA for these infrequent activities?

               

MS. CIARALDI:   FDA does require registration for this procedure because the reconstitution of red cells and plasma to make a third product, the Whole Blood, meets the general definition of manufacture in 21 CFR 607.3(d). There is no threshold frequency that is described in any of our guidance documents or regulations, but we feel, if you have established procedures for performing this process, you must register regardless of the frequency. 

                I would like to add a comment on top of that because it just came in right before I came to the meeting and it came in from a field investigator.  There was a concern expressed and I do want to share that with you.  If you are having staff members perform a procedure as infrequently as described in the example on the slide, how will you ensure their competency, consistent with our requirements in 21 CFR 606.20 (b ?  For procedures performed infrequently, there may be a GMP issue with making sure that staff are competent and experienced and knowledgeable about doing these procedures.  It is just something to think about."

 

As a separate consideration, how would you feel having staff (at the bedside as well as in the Blood Bank) performing a procedure on your newborn that they had never or only performed once 10 years ago?  Might vs.should performed are very different!

We have our blood supplier manufacture the product for us. 

I spent 24 years working in 2 pediatric hospitals with level 3 NICUs and can count on one hand the number of times I or any of my colleagues did the procedure.  I doubt there is any hospital that does a lot of them.

 

For competency, you can save up expired RBCs and FFP so that you can do a direct observation. Make sure their final product has the target hematocrit. I would also make a thorough written quiz for assessment of problem solving skills.