jayinsat

We had an over zealous infection control team (made up of 100% nurses) come to our lab last year making the same demand. We told them, in essence, we will not comply because the risk of injury from handling those containers were greater than the risk they were trying to alleviate. Furthermore, the risk of accidently confusing saline with formalin, whose containers look exactly alike, was to high when removing from the cardboard containers. In addition to that, we told them the man hours required to keep up with that would require additional FTE's, which would not be approved. 
They conceded and we continued on, business as usual. TJC does not really inspect labs that are CAP, AABB, or CLIA certified. Those organizations understand the logistics of the cubes and do not have a problem with it. Most infection control officers are nurses and think from the nursing perspective only.

My guess is the reason your process is "a little over the top" is because, like us, we were cited for non-compliance with COM.30450 New Reagent Lot and Shipment Confirmation of Acceptability - Nonwaived Tests Phase II New reagent lots and shipments are checked against previous reagent lots or with suitable reference material before or concurrently with being placed in service CAP checklist item. According to this checklist you must do one of the following:
Examples of suitable reference materials for qualitative tests include:
Positive and negative patient specimens tested on a previous lot;  Previously tested proficiency testing materials;  External QC materials tested on the previous lot (eg, antigen testing kit controls, immunohematology antisera and reagent red cells)  Control strains of organisms or previously identified organisms for microbiology reagents used to detect or evaluate cultured microorganisms;  If none of the above options is available, control material provided by the assay manufacturer with the new test kit. For our regular antisera (anti-A, B, D), reagent red cells (A1 cells, B cells), we can prove that the new lot is tested using pos/neg controls used on previous lot in accordance with the first option. This is easily verifiable on both the analyzers and our manual recording of daily reagent rack QC.
For Fetal Screen kits, we started testing the new lot against the controls from the old lot upon receipt of the new kit. This is in accordance with the first option, or using a previously tested specimen in accordance with the 2nd option. This is documented on a manual log. It seems to me that, primarily, the fetal screen test kit is where inspectors have caught us on this checklist item.
Hope this helps

We had an over zealous infection control team (made up of 100% nurses) come to our lab last year making the same demand. We told them, in essence, we will not comply because the risk of injury from handling those containers were greater than the risk they were trying to alleviate. Furthermore, the risk of accidently confusing saline with formalin, whose containers look exactly alike, was to high when removing from the cardboard containers. In addition to that, we told them the man hours required to keep up with that would require additional FTE's, which would not be approved. 
They conceded and we continued on, business as usual. TJC does not really inspect labs that are CAP, AABB, or CLIA certified. Those organizations understand the logistics of the cubes and do not have a problem with it. Most infection control officers are nurses and think from the nursing perspective only.

We had an over zealous infection control team (made up of 100% nurses) come to our lab last year making the same demand. We told them, in essence, we will not comply because the risk of injury from handling those containers were greater than the risk they were trying to alleviate. Furthermore, the risk of accidently confusing saline with formalin, whose containers look exactly alike, was to high when removing from the cardboard containers. In addition to that, we told them the man hours required to keep up with that would require additional FTE's, which would not be approved. 
They conceded and we continued on, business as usual. TJC does not really inspect labs that are CAP, AABB, or CLIA certified. Those organizations understand the logistics of the cubes and do not have a problem with it. Most infection control officers are nurses and think from the nursing perspective only.

We had an over zealous infection control team (made up of 100% nurses) come to our lab last year making the same demand. We told them, in essence, we will not comply because the risk of injury from handling those containers were greater than the risk they were trying to alleviate. Furthermore, the risk of accidently confusing saline with formalin, whose containers look exactly alike, was to high when removing from the cardboard containers. In addition to that, we told them the man hours required to keep up with that would require additional FTE's, which would not be approved. 
They conceded and we continued on, business as usual. TJC does not really inspect labs that are CAP, AABB, or CLIA certified. Those organizations understand the logistics of the cubes and do not have a problem with it. Most infection control officers are nurses and think from the nursing perspective only.

We had an over zealous infection control team (made up of 100% nurses) come to our lab last year making the same demand. We told them, in essence, we will not comply because the risk of injury from handling those containers were greater than the risk they were trying to alleviate. Furthermore, the risk of accidently confusing saline with formalin, whose containers look exactly alike, was to high when removing from the cardboard containers. In addition to that, we told them the man hours required to keep up with that would require additional FTE's, which would not be approved. 
They conceded and we continued on, business as usual. TJC does not really inspect labs that are CAP, AABB, or CLIA certified. Those organizations understand the logistics of the cubes and do not have a problem with it. Most infection control officers are nurses and think from the nursing perspective only.

Request new safety committee to audit the trail the saline boxes take from the manufacturer to the blood bank to ascertain where this "dirt" is coming from. Or to put it another way show the manufacturer for this product is required to maintain a level of cleanliness to prevent roaches etc., the couriers the same. As mentioned above this is ridiculous   

I QC reagents before I put them into use; usually not upon receipt.

Does the patient have ITP? Is it possible that she is receiving WinRHO (same as RHIG) for ITP? Does she have a low platelet count. I haven't seen this situation in several years but there was a time when patients with ITP who were rh pos would be treated with WinRHO (as long as they had their spleen). It would present as this very scenario you are describing.
Another possibility is anti-Lw?

Does the patient have ITP? Is it possible that she is receiving WinRHO (same as RHIG) for ITP? Does she have a low platelet count. I haven't seen this situation in several years but there was a time when patients with ITP who were rh pos would be treated with WinRHO (as long as they had their spleen). It would present as this very scenario you are describing.
Another possibility is anti-Lw?

Thanks, everyone. I wanted to validate it especially for 2nd/ 3rd shift staff when there is only 1 tech staffed in the blood bank. They could put on the segment, sample then do other things.

We only use Hematrax just in the event that our LIS is down and unavailable. You have no LIS for your lab? So your lab results are handwritten? I can give you instructions on how to use it but I would need time to dig them up. I will if you still need help. Good luck. 

I have never utilized such a document on the laboratory side of things due to liability issues.  Nursing or physicians have always been responsible for developing their own documentation and the lab reviews it for accuracy.  It's great to see that the lab is being included in this process though, it could really smooth the way for better patient care!

We did this 3 years ago. We did a minimal validation. The reagents were all the same so you're only really validating the mechanical components of the new analyzer. Therefore, we did just enough to show that the new machines got the same results as the old in regards to blood types, antibody screens (no identifications), DAT, and crossmatches. I think we did 10 specimens of each representing each blood type.

We did this 3 years ago. We did a minimal validation. The reagents were all the same so you're only really validating the mechanical components of the new analyzer. Therefore, we did just enough to show that the new machines got the same results as the old in regards to blood types, antibody screens (no identifications), DAT, and crossmatches. I think we did 10 specimens of each representing each blood type.

I would report the crossmatch as compatible and recommend use of a blood warmer for transfusion. No further workup necessary.

I would report the crossmatch as compatible and recommend use of a blood warmer for transfusion. No further workup necessary.

Cold-stored platelets are being used in limited situations in the US. To my knowledge, they can only be used for active bleeding, which FDA has loosely defined. Most hospitals are not yet using them because of this loose definition of "active bleeding" and reimbursement. Here are some articles:
https://www.fda.gov/media/132379/download
https://mrdc.amedd.army.mil/index.cfm/media/articles/2015/FDA_approves_cold-stored_platelets_for_resuscitation#:~:text=The agreement by the FDA,33.8 to 42.8 degrees Fahrenheit.
 

I agree with jayinsat, exlimey and John C. Staley (is this a record????????!!!!!!!!!!!!!!!!!!!!).

Sorry for my ignorance, I have never used the vision. Would you need two different cards, one for IgG and one for IS? If the cards exist why could you not validate their use? As jayinsat said automation helps the generalists especially when short staffed or they are inexperienced. 

We use Immucor ECHO Lumena and, as of right now, it does not do the IS XM. If it did, I would absolutely validate and run them on the automated platform. The reason I say that is because of the staffing and competency issues we are currently experiencing and is forecasted to only get worse. I cannot keep consistent blood bank techs in the blood bank and the generalists, who are often new and weak, do not remember to do the IS portion. I am constantly having to remind them and perform the retroactively. Sure, I can write them up each time but then I would have no one to work the blood bank. Having that on automation eliminates the problem. I did the same with antigen typing, cord bloods, unit retypes, and anything else I could move to automation, simply to make it easier for the generalists. It also provides peace of mind and a level of safety, where I can go back and clearly see what was done. No more wondering whether they added plasma to the tube or not. 
Just my two cents.

I would report the crossmatch as compatible and recommend use of a blood warmer for transfusion. No further workup necessary.

I would report the crossmatch as compatible and recommend use of a blood warmer for transfusion. No further workup necessary.

I would report the crossmatch as compatible and recommend use of a blood warmer for transfusion. No further workup necessary.

We use Immucor ECHO Lumena and, as of right now, it does not do the IS XM. If it did, I would absolutely validate and run them on the automated platform. The reason I say that is because of the staffing and competency issues we are currently experiencing and is forecasted to only get worse. I cannot keep consistent blood bank techs in the blood bank and the generalists, who are often new and weak, do not remember to do the IS portion. I am constantly having to remind them and perform the retroactively. Sure, I can write them up each time but then I would have no one to work the blood bank. Having that on automation eliminates the problem. I did the same with antigen typing, cord bloods, unit retypes, and anything else I could move to automation, simply to make it easier for the generalists. It also provides peace of mind and a level of safety, where I can go back and clearly see what was done. No more wondering whether they added plasma to the tube or not. 
Just my two cents.