Townsend

I just answered this question.

My Score PASS  

I just answered this question.

My Score PASS  

Following - I am so glad you asked this question as I have asked the same thing to both Ortho and AABB with no direct response.
My question was, is there a requirement for an incubator and centrifuge to be an FDA cleared medical device?  We use them throughout the lab and blood bank for specimen centrifugation and for serologic tube testing, and those are not FDA cleared devices.  As long as your equipment is maintained and is meeting the requirements of the circular/instructions for use, aren't you compliant?
 

Following - I am so glad you asked this question as I have asked the same thing to both Ortho and AABB with no direct response.
My question was, is there a requirement for an incubator and centrifuge to be an FDA cleared medical device?  We use them throughout the lab and blood bank for specimen centrifugation and for serologic tube testing, and those are not FDA cleared devices.  As long as your equipment is maintained and is meeting the requirements of the circular/instructions for use, aren't you compliant?
 

Following - I am so glad you asked this question as I have asked the same thing to both Ortho and AABB with no direct response.
My question was, is there a requirement for an incubator and centrifuge to be an FDA cleared medical device?  We use them throughout the lab and blood bank for specimen centrifugation and for serologic tube testing, and those are not FDA cleared devices.  As long as your equipment is maintained and is meeting the requirements of the circular/instructions for use, aren't you compliant?
 

There is a CAP proficiency code "VES" (viscoelastic testing) for TEG and ROTEM testing.

I just answered this question.

My Score PASS  

We are only doing Anti-A and Anti-B titers at this time (pediatric facility, so we aren't doing prenatal titers).  I'm not sure what version of software you all are on, but when we went live with our titers on the Vision Swift and latest software version, there is a glitch in the serial dilution setup.  We have to skip the 1:1 on both IgG and Buffered Card titers (doing that on the bench) and then only setup the 1:2 to 1:1024 on the Vision or we get errors.  The Vision will keep trying to setup the dilution series, getting all the way to the end where it pipettes the 1:1 in the cards, and then abort the entire test.  Then it tries over and over again to set up the dilution, and repeats error/setup until the sample is all used up.  I sure hope this gets fixed soon - if you do titers, reach out to QuidelOrtho before taking the latest software update!!!!!!

We run our Poly and IgG DATs on the Vision.  We make up our own in-house pos/neg DAT samples as recommended by the Ortho rep.  Here is our procedure to prepare those tubes and labels below.  If you don't have an SCD, you might be able to enter a unit that was expiring, but you'd have to establish some sort of expiration for the cells/sample then:
1.   Select an Rh Positive red cell unit with a good outdate from the available inventory.
2.   Complete a label with the lot “DPMMYY” (using MMYY as the month and year of preparation; i.e. “DP0521”).  Add the expiration date equal to the expiration date of the red cell unit as well as the date prepared and your initials.  Place a barcoded P10000 LIS accession label on the vial so it can be scanned onto the Vision.
3.   Complete a label with the lot “DNMMYY” (using MMYY as the month and year of preparation; i.e. “DN0521”).  Add the expiration date equal to the expiration date of the red cell unit as well as the date prepared and your initials.  Place a barcoded N20000 LIS accession label on the vial so it can be scanned onto the Vision.
4.   Connect a syringe set to the red cell using the Sterile Connection Device and remove approx. 10mL of packed cells.  Place the red cells evenly into two plastic 12x75mm test tubes (one labeled P10000 and the other with the N20000 label made above).
5.   Add 2 drops of Anti-D (Ortho Bioclone) to the P10000 packed cells, mix well, and incubate for 30 minutes at 37°C.  Mix again about half-way through incubation.
6.   Test each of the prepared red cells by performing a Poly DAT in gel on the bench.  Ensure that the results are 1-3+ on the P10000 cells and negative on the N20000 cells prior to placing the vial into use.

We do our titers in gel (ABO titers only as we are not a delivering hospital; pediatric only).  Any positive reaction seen in gel should be interpreted as 1+ since there is no w+ interp in the MTS gel interp. guide - there is also no w+ on the Vision.  So, our end-point is the dilution with the last 1+ positive. Our results have correlated well with the CAP samples done in tube when looking at all of the methods reported, but we have only done these for about a year now (only about 3 CAP survey's so far).
We haven't looked at bringing this onto the Vision yet..... all though I am aware that it is now able to do the dilutions for both the buffered card and IgG titer reactions; so maybe with the next software upgrade???  Would love to hear back if you successfully implement the titers on the Vision!
Stephanie

Yes, you should do at least a small parallel study using the old and the new.  Your director will have to decide on how many would be acceptable and define acceptability criteria prior to implementation.  I would summarize and have them sign-off before placing it into use.

Yes, you should do at least a small parallel study using the old and the new.  Your director will have to decide on how many would be acceptable and define acceptability criteria prior to implementation.  I would summarize and have them sign-off before placing it into use.

Yes, you should do at least a small parallel study using the old and the new.  Your director will have to decide on how many would be acceptable and define acceptability criteria prior to implementation.  I would summarize and have them sign-off before placing it into use.

Pediatric hospital - we have been transfusing both PAS and pathogen-reduced platelets to our patients since April of this year, including neonates.  We have only had one minor allergic reaction reported from PAS to date, and it was an older patient (teenager).

Pediatric hospital - we have been transfusing both PAS and pathogen-reduced platelets to our patients since April of this year, including neonates.  We have only had one minor allergic reaction reported from PAS to date, and it was an older patient (teenager).

Pediatric hospital - we have been transfusing both PAS and pathogen-reduced platelets to our patients since April of this year, including neonates.  We have only had one minor allergic reaction reported from PAS to date, and it was an older patient (teenager).

Pediatric hospital - we have been transfusing both PAS and pathogen-reduced platelets to our patients since April of this year, including neonates.  We have only had one minor allergic reaction reported from PAS to date, and it was an older patient (teenager).

With regard to PI with platelets, it is true you do not need to test the PI products but Babesia testing still needs to be done for RBCs collected in the 13 states of interest.
Regarding test strategies, some hospitals,eg Johns Hopkins, has opted to do secondary bacterial testing on day 4 rather than the PGD test.  Attached is a recent study covering the cost effectiveness of the approaches believed to be acceptable by the FDA.  However, as noted the Guidance is not Final. This paper is a good starting point though. 
platelets Cost effectiveness methods bacteria testing Transfusion 0419.pdf

Just to state the obvious, if you are using pathogen reduced platelets, no testing is needed.  That has been our choice due to (1) it's a superior method for preventing viral, bacterial, parasite transmission and (2) the logistics of testing 20-30 platelets per day are formidable and not without significant expense for materials, labor, QC, proficiency and competency.  If your supplier provides the option of pathogen reduced, I would go that direction despite the increased expense.

We must have a current ABO/Rh done on the current visit.

You are correct.  However, in a facility with a very low volume of transfusion <1000 units annually, we elected to standardize the criteria for collection of pretransfusion blood samples, i.e., collecting a blood sample within 3 days of the intended date of transfusion for both red cell and non-red cell transfusions.

Agree - also, what blood type is the mother?  From an operational stand-point you have a couple of options: Call the blood type "indeterminate" or "unable to determine" or call the baby AB.  Either way, we would suggest repeat testing at 4-6 months and include A1 lectin typing if discrepancy still exists.  In the meantime we would give group O red cells and AB plasma/platelets until resolved.

Agree - also, what blood type is the mother?  From an operational stand-point you have a couple of options: Call the blood type "indeterminate" or "unable to determine" or call the baby AB.  Either way, we would suggest repeat testing at 4-6 months and include A1 lectin typing if discrepancy still exists.  In the meantime we would give group O red cells and AB plasma/platelets until resolved.

Agree - also, what blood type is the mother?  From an operational stand-point you have a couple of options: Call the blood type "indeterminate" or "unable to determine" or call the baby AB.  Either way, we would suggest repeat testing at 4-6 months and include A1 lectin typing if discrepancy still exists.  In the meantime we would give group O red cells and AB plasma/platelets until resolved.

Agree - also, what blood type is the mother?  From an operational stand-point you have a couple of options: Call the blood type "indeterminate" or "unable to determine" or call the baby AB.  Either way, we would suggest repeat testing at 4-6 months and include A1 lectin typing if discrepancy still exists.  In the meantime we would give group O red cells and AB plasma/platelets until resolved.