jayinsat

First, blood given pre-hospital is quite routine these days. Both ambulances and helicopters are carrying Low Titer O Positive whole blood that they transfuse on scene in response to traumas and hemorrhagic shock. In South Texas, the ambulances and helicopters receive their blood directly from our blood supplier. Who will be stocking your helicopter? Will it be your facility? If so, you have a lot of work to do. If your supplier, you have nothing to fear.
Second, when a unit is given pre-hospital, our EMS techs give the empty blood bag and a record of transfusion to the receiving nurse in the Emergency room, who then sends them to the blood bank (theoretically, practically we seldom get them right away). Our emergency room physician orders a type and screen upon arrival. Only if an antibody is detected (or we have a history of a clinically significant antibody) will we perform any crossmatching with the unit. 
I would suggest you google the topic Low Titer Whole Blood. It will help you answer your question.

When you use extended sample expiration, how does this affect electronic crossmatch? The sample collection date would cause our LIS to reject the EXM rule. Do you just perform IS serological crossmatches?

Our LIS is set up to allow an EXM for PAT specimen outdates of 14 days if the patient qualifies for EXM. 

I would consider switching to Immuco ECHO Lumena before going to Grifols. You could also look at Bio-Rad's IH system for gel alternatives. That said, I prefer Ortho for gel and Immucor for solid phase. 

For those interested, this is what we have settled on for now unless it comes out that other locations are tracking something else useful:
-Post-wash total Hbg >15 (Hct>45) to indicate good wash quality
-effluent line clear or not
-Also found post-wash heparin concentration of >0.5IU/mL as indicator of poor wash quality, but not sure if this is feasible to test anti-Xa levels... this one is to be continued.

Transfusion Medicine in our institution includes the Blood Bank/Transfusion Service, Donor Service and Stem Cell Processing Laboratory.  Outside each facility we have the relevant signage.  Some places it includes Therapeutic Apheresis, which in our institution is both physically separate (so is our Donor Room) and located in the Dept. of Medicine (Cancer Center).  As long as the facilities are well defined, I'm not sure the overall name matters much, except on stationery, which no one uses much anyway :).

I suggest reaching out to your director of the O.R. and to your Biomed Director. Start a conversation with them showing them the CAP standard and ask them how they are measuring the safety and efficacy of recovered products. Ask them to provide you a copy of their data to include in your records. Also, since your medical director has to actively participate in the program, they may need to officially report to them as well. Perhaps this could be covered in your transfusion committee, if you have one.

I would add it to the title. For instance, I my blood bank collected donors, provided blood for transfusion, and participated in stem cell collection and infusion, my department would be called, "Transfusion Medicine, Donor Services, and Cell Therapy Laboratory."

I would add it to the title. For instance, I my blood bank collected donors, provided blood for transfusion, and participated in stem cell collection and infusion, my department would be called, "Transfusion Medicine, Donor Services, and Cell Therapy Laboratory."

I suggest reaching out to your director of the O.R. and to your Biomed Director. Start a conversation with them showing them the CAP standard and ask them how they are measuring the safety and efficacy of recovered products. Ask them to provide you a copy of their data to include in your records. Also, since your medical director has to actively participate in the program, they may need to officially report to them as well. Perhaps this could be covered in your transfusion committee, if you have one.

I do not have any remote refrigerators but, is there a way to have an automated comment added to the unit history when a unit is removed from the remote refrigerator that states it was visually inspected? That would give you documentation. Of course, you would need to have clearly stated in your policy that visual inspection is performed when units are retrieved, and nursing training would have to have that documented as well. That's how I would resolve that issue.
That said, I think that the inspector may be improperly applying the checklist item to your situation. The checklist item states:
TRM.40900 Blood/Tissue Sign-Out Phase II The process for signing blood and tissue out of the laboratory provides adequate protection for the potential recipient. NOTE: A person authorized by the transfusion medicine service must perform a clerical and visual inspection of each component immediately before it is issued. Transporters of blood components and tissue must be trained in prompt delivery. Training may consist of instruction at the time the product is dispensed.
There is no blood bank staff that is "issuing" the blood so, technically, there is no "person" signing out the unit. I would argue that the inspection would have to take place when the unit is placed in the remote remote refrigerator. I would challenge the deficiency on those grounds.

I do not have any remote refrigerators but, is there a way to have an automated comment added to the unit history when a unit is removed from the remote refrigerator that states it was visually inspected? That would give you documentation. Of course, you would need to have clearly stated in your policy that visual inspection is performed when units are retrieved, and nursing training would have to have that documented as well. That's how I would resolve that issue.
That said, I think that the inspector may be improperly applying the checklist item to your situation. The checklist item states:
TRM.40900 Blood/Tissue Sign-Out Phase II The process for signing blood and tissue out of the laboratory provides adequate protection for the potential recipient. NOTE: A person authorized by the transfusion medicine service must perform a clerical and visual inspection of each component immediately before it is issued. Transporters of blood components and tissue must be trained in prompt delivery. Training may consist of instruction at the time the product is dispensed.
There is no blood bank staff that is "issuing" the blood so, technically, there is no "person" signing out the unit. I would argue that the inspection would have to take place when the unit is placed in the remote remote refrigerator. I would challenge the deficiency on those grounds.

I do not have any remote refrigerators but, is there a way to have an automated comment added to the unit history when a unit is removed from the remote refrigerator that states it was visually inspected? That would give you documentation. Of course, you would need to have clearly stated in your policy that visual inspection is performed when units are retrieved, and nursing training would have to have that documented as well. That's how I would resolve that issue.
That said, I think that the inspector may be improperly applying the checklist item to your situation. The checklist item states:
TRM.40900 Blood/Tissue Sign-Out Phase II The process for signing blood and tissue out of the laboratory provides adequate protection for the potential recipient. NOTE: A person authorized by the transfusion medicine service must perform a clerical and visual inspection of each component immediately before it is issued. Transporters of blood components and tissue must be trained in prompt delivery. Training may consist of instruction at the time the product is dispensed.
There is no blood bank staff that is "issuing" the blood so, technically, there is no "person" signing out the unit. I would argue that the inspection would have to take place when the unit is placed in the remote remote refrigerator. I would challenge the deficiency on those grounds.

I do not have any remote refrigerators but, is there a way to have an automated comment added to the unit history when a unit is removed from the remote refrigerator that states it was visually inspected? That would give you documentation. Of course, you would need to have clearly stated in your policy that visual inspection is performed when units are retrieved, and nursing training would have to have that documented as well. That's how I would resolve that issue.
That said, I think that the inspector may be improperly applying the checklist item to your situation. The checklist item states:
TRM.40900 Blood/Tissue Sign-Out Phase II The process for signing blood and tissue out of the laboratory provides adequate protection for the potential recipient. NOTE: A person authorized by the transfusion medicine service must perform a clerical and visual inspection of each component immediately before it is issued. Transporters of blood components and tissue must be trained in prompt delivery. Training may consist of instruction at the time the product is dispensed.
There is no blood bank staff that is "issuing" the blood so, technically, there is no "person" signing out the unit. I would argue that the inspection would have to take place when the unit is placed in the remote remote refrigerator. I would challenge the deficiency on those grounds.

I would make the argument that the blood was inspected when it was issued to the remote storage unit.  At that point the transfusion service had completed it's obligation.  I am assuming (and we all know how that goes!) that the remoted storage unit has been exhaustively validated and monitored with documentation to confirm my assumption.  As well as any training required for those accessing the remote storage unit.  I'm always more worried about the blood going to the wrong patient in these situations than I am for the quality of the unit.
  Personally I always enjoyed challenging such citations.   

Apologies in advance for my ignorance on these matters. Are the units/products in the remote storage locations assigned to specific patients, or are they available to random patients ?
If the former is true, arguably they've already been issued.

I do not have any remote refrigerators but, is there a way to have an automated comment added to the unit history when a unit is removed from the remote refrigerator that states it was visually inspected? That would give you documentation. Of course, you would need to have clearly stated in your policy that visual inspection is performed when units are retrieved, and nursing training would have to have that documented as well. That's how I would resolve that issue.
That said, I think that the inspector may be improperly applying the checklist item to your situation. The checklist item states:
TRM.40900 Blood/Tissue Sign-Out Phase II The process for signing blood and tissue out of the laboratory provides adequate protection for the potential recipient. NOTE: A person authorized by the transfusion medicine service must perform a clerical and visual inspection of each component immediately before it is issued. Transporters of blood components and tissue must be trained in prompt delivery. Training may consist of instruction at the time the product is dispensed.
There is no blood bank staff that is "issuing" the blood so, technically, there is no "person" signing out the unit. I would argue that the inspection would have to take place when the unit is placed in the remote remote refrigerator. I would challenge the deficiency on those grounds.

Had a CAP inspector cite for not performing a visual inspection at "issuance" from a Blood Track Emerge remote refrigerator.  For those of you with a Blood Track Emerge or Haemobank, how are you documenting visual inspection at issuance (the removal from the refrigerator)?  She stated that even though the unit is visually inspected at the bedside prior to transfusion, this does not meet the requirement of VI at issuance as the unit can be in the remote refrigerator for several days.  

I would consider switching to Immuco ECHO Lumena before going to Grifols. You could also look at Bio-Rad's IH system for gel alternatives. That said, I prefer Ortho for gel and Immucor for solid phase. 

"The bottom line was, if the treating physician wanted to use up the entire inventory trying to save a life, we could not deny them the blood, even though it places other patients at risk. "
I would call this some combination of cowardice and insanity, speaking purely personally.  Taking responsibility for difficult decisions is why physicians get paid well, and avoiding decision making is irresponsible.

I suggest you challenge that citation. CAP inspectors are not infallible as proven by the response from CAP above.

I suggest you challenge that citation. CAP inspectors are not infallible as proven by the response from CAP above.

I suggest you challenge that citation. CAP inspectors are not infallible as proven by the response from CAP above.

Just underwent AABB and CAP inspection - we were cited for CAP in not including antibody identification, DAT, and compatibility testing for all method platforms. We have been performing comparability testing for ABO/Rh and antibody screen for the last 13 years and multiple inspections without citation.
Anyone else had this experience? 

Meditech provided a validation guide that complied with everything @SbbPerson listed above. This was several years ago however. We kept all the screen shots of each validation step on a network drive in a folder to show inspectors. Still have them to this day. Most CAP inspectors will only ask for records for the period covering your last biennial inspection so no one ever asks to see that anymore (unless there was a significant change of course).