DebbieL

I listened to the same webinar. Basically what I heard is.... if the kit has positive and negative controls, then the new kit will have to be compared to the old kit. If the kit does not have controls, then they will not have to be compared. So according to that, we must compare Fetal kits but do not have to compare Elu-kits (no internal controls.)
I have my people take the old controls and run with the new kit and the new controls to run with the old kit. This is supposed to be done while the old kit is still in-date, in that week of overlap. (We have had a few bumps in the road on that part). I made up a form showing the results for current kit with new controls and new kit with the current controls. Both tests should be about the same. Acceptable or not acceptable. I would attach the form but I think I am blocked here from attaching forms and procedures.

I listened to the same webinar. Basically what I heard is.... if the kit has positive and negative controls, then the new kit will have to be compared to the old kit. If the kit does not have controls, then they will not have to be compared. So according to that, we must compare Fetal kits but do not have to compare Elu-kits (no internal controls.)
I have my people take the old controls and run with the new kit and the new controls to run with the old kit. This is supposed to be done while the old kit is still in-date, in that week of overlap. (We have had a few bumps in the road on that part). I made up a form showing the results for current kit with new controls and new kit with the current controls. Both tests should be about the same. Acceptable or not acceptable. I would attach the form but I think I am blocked here from attaching forms and procedures.

I listened to the same webinar. Basically what I heard is.... if the kit has positive and negative controls, then the new kit will have to be compared to the old kit. If the kit does not have controls, then they will not have to be compared. So according to that, we must compare Fetal kits but do not have to compare Elu-kits (no internal controls.)
I have my people take the old controls and run with the new kit and the new controls to run with the old kit. This is supposed to be done while the old kit is still in-date, in that week of overlap. (We have had a few bumps in the road on that part). I made up a form showing the results for current kit with new controls and new kit with the current controls. Both tests should be about the same. Acceptable or not acceptable. I would attach the form but I think I am blocked here from attaching forms and procedures.

We enter the units we are testing in the computer and we can enter our results. QC for antigen typing is maintained on a paper log so other techs can see that controls have been done for the day on a particular type and lot number of antisera. We don't want to waste those precious drops by having to repeat it. I keep those logs for at least a full 10 years.
On that log I have a column to indicate that the antisera was visually acceptable on the day of use and a column to write the panel lot # used for Ag controls and if the panel cells were visually acceptable. The column for panel lot # was my way of documenting that the panel performs as expected with the antisera used. This shows the panel is QC'd multiple times over the life of panel. (TRM.31234) Probably overkill but I have something documented if they ask if I QC my panel. If something didn't work right, I would hear about it!
 

We have pooled plasma for many years. Our computer was fine as long as we had Coda-bar numbers. ISBT has been a horrible problem. The therapeutic apheresis operators really really want us to pool because it is so much easier on them while they are running the instrument and taking care of the patient. It is a total pain to us and takes a tech almost an hour to pool once the units are thawed. We get the night techs to thaw when we know we have a patient the next morning. We have pooled as much as 7000ml each day for days on end. Ugg! We use 1000 and 2000ml transfer bags.
We have to do it in two steps, 1) thaw but don't print an ISBT label at this point, 2) pool and then print the pool label. Our computer is built to only thaw CPD units but the blood center sends us other Ecodes which throws a monkey wrench in the whole process. We ask them not to send us anything but CPD when we are dealing with pooling but you know how that goes.
We recently got this built in our system and these are the codes we have used:
Pool FPCR TH CPD makes FPCR TH CPD P E5304  (cryo-reduced)

Pool TH PLAS CPD makes TH PLAS CPD P E5275
Good luck

Our Lab Director wanted each department to copy and paste one CAP standard on a page, write our response below and provide a copy of evidence (policy, form, QC, ect) behind the standard. We highlight the parts of the evidence to make it easy to find. We have to turn in 1/12 of our standards each month to the Medical Director who looks them over (Yeah, right), signs them and then give them to the Lab director for approval. I really hated this at first because it was so much work and he was so picky but after having gone through it a few years, we each know where we don't quite meet the standard. We also have a book that we can use when an inspector asks a question and our mind goes completely blank. At some point, when the inspectors arrive we will just hand them our evidence book so they can look at how we have satisfied the standard.
I download the Word form of standards from CAP to my computer. I type in my response in the square below the standard. Then I just copy and paste all of that to a blank page to put in my evidence book. When we get new standards, I copy and paste my answers to the new Word Standards. It is a pain but easier than writing everything again. I highlight the new or revised standards to look at them closer since they need more attention. Yes, this is all a pain but I have very good confidence that we meet the standards when an inspector arrives. I also have a book that my people could use if I was out sick.
I love the idea that Webersl uses and I think I will incorporate that into my future volume of work. It never ends!

Our Lab Director wanted each department to copy and paste one CAP standard on a page, write our response below and provide a copy of evidence (policy, form, QC, ect) behind the standard. We highlight the parts of the evidence to make it easy to find. We have to turn in 1/12 of our standards each month to the Medical Director who looks them over (Yeah, right), signs them and then give them to the Lab director for approval. I really hated this at first because it was so much work and he was so picky but after having gone through it a few years, we each know where we don't quite meet the standard. We also have a book that we can use when an inspector asks a question and our mind goes completely blank. At some point, when the inspectors arrive we will just hand them our evidence book so they can look at how we have satisfied the standard.
I download the Word form of standards from CAP to my computer. I type in my response in the square below the standard. Then I just copy and paste all of that to a blank page to put in my evidence book. When we get new standards, I copy and paste my answers to the new Word Standards. It is a pain but easier than writing everything again. I highlight the new or revised standards to look at them closer since they need more attention. Yes, this is all a pain but I have very good confidence that we meet the standards when an inspector arrives. I also have a book that my people could use if I was out sick.
I love the idea that Webersl uses and I think I will incorporate that into my future volume of work. It never ends!

We are not AABB accredited; we are inspected by CAP, but the concept is the same. Like Cliff, it took a few years, but I went through all my SOP's and all the regulations. I did it in several steps.

I read through every SOP and used the "footnote" tool in MS Word. [insert-->Reference-->Footnote] to tag each statement (or heading, or title) in an SOP that was directly related to a specific regulation with the reference number of the regulation. For example: "The sample must be labeled at minumum with the name, medical record number, date and time of collection, and the collector's employee ID1". Once you add the footnote in Word, it adds the little number and it takes you to the end of the document, or the bottom of the page, where I typed the specific reference "AABB SBBTS 5.11.2, CAP TRM.40230".
I put all of my Word Document SOP's in the same folder. Then, I went through the regulations one at a time and I used the "find" feature in windows (like how you search for a file) to search for each regulation number. If I found it, I marked it off. If I didn't find it, then I knew that this regulation had not been specifically addressed.
For all the ones that had not been specifically addressed, I had to create policy or modify existing policy to make sure each had been fully addressed. (This took a LONG time.)
Now, when the new edition comes out, I use the crosswalk of changes and the "find" feature to quickly find the location of that particular regulation in my SOP's so that I can make adjustments as necessary - or update the reference numbers.

This has worked wonderfully for me! It is also excellent at inspection time when you get nervous and can't think - just use the find feature and your own policies will tell you (and the inpsector) how you meet that standard and where to look for documentation. It's also a great help to your staff if an inspector should come when you are out of town. They don't have to know every little thing - they can just look it up if they don't know.
Good luck!

I also listened to the Immucor webinar. What I got out of it was BB does not have to do lot to lot for our reagents, rare or otherwise. We do daily QC and the reagents must pass before use. We do have to compare current FMH kits to incoming FMH kits. You must make sure the controls on the current kit work on the new kit and vise-versa. This is to make sure the controls on the new kit work as expected and that the shipping conditions did not cause the cells to deteriorate. We had also been comparing Elu-Kits but someone specifically asked if those needed to be compared and they do not. I think I heard that it is because there are not any controls in the kit. I am grateful for small favors so I am getting rid of the Elu-kit comparison portion of my procedure.
When it comes to comparison of panel cells, look carefully at the package insert instructions. Does it say you HAVE to QC? Then you must. Does it say you MAY test, then it is up to the facility if testing is done. I personnally take that as a legal loop-hole and will run with it. Besides how could you ever compare one panel to another since you would be comparing different donors?
I had talked to CAP in the past about this subject. They said you must check all incoming shipments for proper shipping conditions AND must be checked prior to use and these checks must be documented. I made up a form that reagents are listed as they come in (date arrived, #, lot number,etc.) and I added a column for checking the shipping container. Acceptable Yes or No. At the bottom of the page in small writing I listed what was acceptable and what was not so there was not question.  All of this checking must be documented. We all know if it is not written down, it hasn't been done.
Below is the next slide from the Immucor presentation:
TRM.31241 All new lots of reagents and critical materials (e.g. blood collection sets) are inspected and tested, as applicable, before use with records of acceptance.
- If manufacturer’s instructions require testing prior to use (e.g. panel cells, antisera) then lab is expected to test
-If manufacturer’s instructions recommend testing prior to use, it is up to the discretion of the laboratory to test
-Once reagents are put into use, TRM.31400 applies

We also thaw all plasma straight to 5 day thawed plasma. Thankfully my previous boss did this years ago so I didn't have to go thru the process of explaining to the heart doctors the difference between thawed FFP and thawed plasma. Everyone gets thawed plasma except for neonates. Neonates get 24 hour expiration plasma. We have very few neonates that get any type of blood products much less plasma.
 
We have an ISBT printer that prints the correct everything on the label. There was a ton of validation that had to be done for every type of anticoagulant that might show up before the printer went into service.
 
It is cost effective to use thawed plasma because we waste very little. We keep two type A and one type B thawed at all times for possible trauma. Our computer is set so we can give type A to a patient of unknown blood type during a trauma.We rotate the thawed plasma thru surgery and thaw more as needed. Surgery is happy because they can get plasma in a hurry when they need it. They don't have to wait for us to thaw what they need. If a physician changes their mind about giving plasma after we got the order to thaw, we have 5 days to find another patient to give it to. We are happy to not waste.

The only time I have ever done correlations between antisera was when the manufactuer switched from AHG to RT. I had a few select people compare a few samples with the poly and then the mono and write results on a nice little form. Did training and got everyone's signatures. But really this was more of a process change. I do have something to show an inspector which is always a good thing!
The CAP standards state that reagents must be correlated. I somewhat freaked out about this so I called CAP to get the scoop. The lady at CAP said BB reagents were different and correlations were not required. BB reagents must meet FDA potency requirements and we do QC on each day of use. I think Chem and Heme must correlate because QC is not done every day or their results are more of a range. With BB you are either positive or negative, not alot of gray area. She said some reagents were very expensive and it would waste reagents to do correlations. She did say that we must correlate "kits" which would include FMH and Elu-kit and any other kits we use in BB. Bummer, but better than having to do all the rare and not so rare reagents.
I really wish CAP would be a bit more clear on the standards. If BB is exempt I wish that would be stated in the fine print. I want to do what I should for patient safety but I surely do not want to do more than is necessary. It is a waste of tech time and reagents. That is all for my rant!

The only time I have ever done correlations between antisera was when the manufactuer switched from AHG to RT. I had a few select people compare a few samples with the poly and then the mono and write results on a nice little form. Did training and got everyone's signatures. But really this was more of a process change. I do have something to show an inspector which is always a good thing!
The CAP standards state that reagents must be correlated. I somewhat freaked out about this so I called CAP to get the scoop. The lady at CAP said BB reagents were different and correlations were not required. BB reagents must meet FDA potency requirements and we do QC on each day of use. I think Chem and Heme must correlate because QC is not done every day or their results are more of a range. With BB you are either positive or negative, not alot of gray area. She said some reagents were very expensive and it would waste reagents to do correlations. She did say that we must correlate "kits" which would include FMH and Elu-kit and any other kits we use in BB. Bummer, but better than having to do all the rare and not so rare reagents.
I really wish CAP would be a bit more clear on the standards. If BB is exempt I wish that would be stated in the fine print. I want to do what I should for patient safety but I surely do not want to do more than is necessary. It is a waste of tech time and reagents. That is all for my rant!

We also thaw all plasma straight to 5 day thawed plasma. Thankfully my previous boss did this years ago so I didn't have to go thru the process of explaining to the heart doctors the difference between thawed FFP and thawed plasma. Everyone gets thawed plasma except for neonates. Neonates get 24 hour expiration plasma. We have very few neonates that get any type of blood products much less plasma.
 
We have an ISBT printer that prints the correct everything on the label. There was a ton of validation that had to be done for every type of anticoagulant that might show up before the printer went into service.
 
It is cost effective to use thawed plasma because we waste very little. We keep two type A and one type B thawed at all times for possible trauma. Our computer is set so we can give type A to a patient of unknown blood type during a trauma.We rotate the thawed plasma thru surgery and thaw more as needed. Surgery is happy because they can get plasma in a hurry when they need it. They don't have to wait for us to thaw what they need. If a physician changes their mind about giving plasma after we got the order to thaw, we have 5 days to find another patient to give it to. We are happy to not waste.

If we are getting different answers from CAP about the same thing, there is no hope for us all. We are doomed to total confusion if the experts can't agree.
I think if you call and you get a CAP person that is a Chemistry expert they would say you had to compare because that makes perfect sense to them. If you get a person that is a BB expert, they would know more about the nature of our work and reagents. The person I talked to even said that BB was different and our reagents were different. Our reagents are QC'd everyday of use. If it doesn't work, we don't use it. The person I talked to about this said we didn't have to compare reagents or antisera BUT we did have to compare "kits to kits" to show that the new kit gave comparible results as the old kit. I guess kits are different because there are several parts or steps that could fail to work correctly.
I am going to stick with comparing my kits (FMH and Elu-kit) and not comparing my regular and rare antisera until forced.

If we are getting different answers from CAP about the same thing, there is no hope for us all. We are doomed to total confusion if the experts can't agree.
I think if you call and you get a CAP person that is a Chemistry expert they would say you had to compare because that makes perfect sense to them. If you get a person that is a BB expert, they would know more about the nature of our work and reagents. The person I talked to even said that BB was different and our reagents were different. Our reagents are QC'd everyday of use. If it doesn't work, we don't use it. The person I talked to about this said we didn't have to compare reagents or antisera BUT we did have to compare "kits to kits" to show that the new kit gave comparible results as the old kit. I guess kits are different because there are several parts or steps that could fail to work correctly.
I am going to stick with comparing my kits (FMH and Elu-kit) and not comparing my regular and rare antisera until forced.

If we are getting different answers from CAP about the same thing, there is no hope for us all. We are doomed to total confusion if the experts can't agree.
I think if you call and you get a CAP person that is a Chemistry expert they would say you had to compare because that makes perfect sense to them. If you get a person that is a BB expert, they would know more about the nature of our work and reagents. The person I talked to even said that BB was different and our reagents were different. Our reagents are QC'd everyday of use. If it doesn't work, we don't use it. The person I talked to about this said we didn't have to compare reagents or antisera BUT we did have to compare "kits to kits" to show that the new kit gave comparible results as the old kit. I guess kits are different because there are several parts or steps that could fail to work correctly.
I am going to stick with comparing my kits (FMH and Elu-kit) and not comparing my regular and rare antisera until forced.

I called CAP and this is not a requirement for regular BB reagents because we do QC each day of use. Plus think of all the drops of precious rare antisera we would use trying to compare lots.
This comparison requirement is mostly for Chem or Hemo because they are not required to perform QC each day and their tests are more of a "range" test. They have to make sure that the "range" is the same between lot numbers or they could report out erroneous results. With BB you are either positive or negative. You either have it or you don't.
CAP did tell me we must compare "kits" lot to lot. This would be FBS kits and Elu-Kits or any other kits you might use. I was sad we had to do this but happy that we didn't have to compare all other reagents.

I called CAP and this is not a requirement for regular BB reagents because we do QC each day of use. Plus think of all the drops of precious rare antisera we would use trying to compare lots.
This comparison requirement is mostly for Chem or Hemo because they are not required to perform QC each day and their tests are more of a "range" test. They have to make sure that the "range" is the same between lot numbers or they could report out erroneous results. With BB you are either positive or negative. You either have it or you don't.
CAP did tell me we must compare "kits" lot to lot. This would be FBS kits and Elu-Kits or any other kits you might use. I was sad we had to do this but happy that we didn't have to compare all other reagents.

I called CAP and this is not a requirement for regular BB reagents because we do QC each day of use. Plus think of all the drops of precious rare antisera we would use trying to compare lots.
This comparison requirement is mostly for Chem or Hemo because they are not required to perform QC each day and their tests are more of a "range" test. They have to make sure that the "range" is the same between lot numbers or they could report out erroneous results. With BB you are either positive or negative. You either have it or you don't.
CAP did tell me we must compare "kits" lot to lot. This would be FBS kits and Elu-Kits or any other kits you might use. I was sad we had to do this but happy that we didn't have to compare all other reagents.

I called CAP and this is not a requirement for regular BB reagents because we do QC each day of use. Plus think of all the drops of precious rare antisera we would use trying to compare lots.
This comparison requirement is mostly for Chem or Hemo because they are not required to perform QC each day and their tests are more of a "range" test. They have to make sure that the "range" is the same between lot numbers or they could report out erroneous results. With BB you are either positive or negative. You either have it or you don't.
CAP did tell me we must compare "kits" lot to lot. This would be FBS kits and Elu-Kits or any other kits you might use. I was sad we had to do this but happy that we didn't have to compare all other reagents.

We enter the units we are testing in the computer and we can enter our results. QC for antigen typing is maintained on a paper log so other techs can see that controls have been done for the day on a particular type and lot number of antisera. We don't want to waste those precious drops by having to repeat it. I keep those logs for at least a full 10 years.
On that log I have a column to indicate that the antisera was visually acceptable on the day of use and a column to write the panel lot # used for Ag controls and if the panel cells were visually acceptable. The column for panel lot # was my way of documenting that the panel performs as expected with the antisera used. This shows the panel is QC'd multiple times over the life of panel. (TRM.31234) Probably overkill but I have something documented if they ask if I QC my panel. If something didn't work right, I would hear about it!
 

Many years ago, my hospital decided to start a therapeutic apheresis program and gave it to the BB. (!!??!!) We had a few regular out patients with myasthenia gravis that we could schedule according to our workload. The ones that were a problem were the patients that arrived in a bad state due to TTP or ITP and needed their first treatment STAT. They would have to get a port placed and then the treatment would begin. We might have to start the procedure at 11 PM by the time the port was in. Only about 4 of us were competent and we could be called in at any time during the night or weekend for the first treatment. Some physicians would order the procedure when they didn't have anything else to offer the patient. It was the new miracle treatment. The pathologists we had then would allow them to order daily or every other day procedures for weeks at a time. We hated every minute of it. My thoughts were, we were not nurses and we were messing with ports that we shouldn't be messing with. (Think clots close to the heart) We didn't know what we didn't know. If a patient crashed, we would not have been able to deal with it other than push the button and call a nurse or call a code.
Thankfully, dialysis came to us and said they wanted to add it to their procedures. We celebrated when they were out of earshot, we didn't want them to know how happy we were that they took it from us. Think very carefully before you take this on because dialysis will give it all to you and your department because it sounds like they don't want it either. It will take one person out of your department for 4 to 6 hours or someone will have to be called in. The machine has to be set up and then the procedure could take about 2 to 4 hours. Dialysis nurses are the most qualified because it is somewhat similar to dailysis and nurses are better qualified to deal with a crashing patient. I really don't think a med tech is qualified to deal with the same things nurses deal with. I wouldn't want them trying to ID antibodies. Think very carefully and go into it with open eyes. My opinion, I would run as fast as I could in the other direction.
According to CAP standard TRM.42245, there has to be a physician in charge of the program and they also have to meet specific qualifications so check on that too.

We enter the units we are testing in the computer and we can enter our results. QC for antigen typing is maintained on a paper log so other techs can see that controls have been done for the day on a particular type and lot number of antisera. We don't want to waste those precious drops by having to repeat it. I keep those logs for at least a full 10 years.
On that log I have a column to indicate that the antisera was visually acceptable on the day of use and a column to write the panel lot # used for Ag controls and if the panel cells were visually acceptable. The column for panel lot # was my way of documenting that the panel performs as expected with the antisera used. This shows the panel is QC'd multiple times over the life of panel. (TRM.31234) Probably overkill but I have something documented if they ask if I QC my panel. If something didn't work right, I would hear about it!
 

I just went to the CAP site and logged in. I typed in IQCP in the search box and selected IQCP Webinar and found a current Q&A.  I just copied the part that is relevant to BB below.
 
This is basically the answer I got when I called CAP with several questions about QC on panels and expired panels used for rule-out/rule-in. You must follow what the manufacturer insert says is required for QC but also a visual inspection of the panel at receipt and BEFORE use. I added some columns on my antigen typing form for the panel lot # and a visual check prior to use. We have always looked at our red cells before use but have never documented that they were OK.
Hope this helps.
 
 
 Topic: Individualized Quality Control Plan (IQCP) Frequently Asked Questions
Date: May 5, 2015 (last updated October 20, 2015)
 
 
37. Do I need to implement an IQCP for my blood bank antibody identification panels? (NEW 10/20/2015)
No, IQCP is not applicable to antibody panels used in the transfusion service laboratory. An antibody panel is considered a critical material and is subject to TRM.31241 for inspection and testing, as applicable, of new lots before use. This involves visual inspection of new lots and shipments for appropriate physical characteristics (e.g. no hemolysis) and quality control following manufacturer's instructions described in the product insert. If the manufacturer does not provide specific instructions for QC, the laboratory must define its own mechanisms to detect errors and monitor test performance. Because antibody panels are not used alone for identification of an antibody, laboratories typically have a variety of other control processes that are being used as part of the work-up, such as having specific rules for ruling in or ruling out antibodies based on panel reactions, correlating the results of the antibody screen to the antibody panel, and performing antigen typing on the patient to confirm the absence of the corresponding antigen. The control criteria used must be defined in the procedure

I just went to the CAP site and logged in. I typed in IQCP in the search box and selected IQCP Webinar and found a current Q&A.  I just copied the part that is relevant to BB below.
 
This is basically the answer I got when I called CAP with several questions about QC on panels and expired panels used for rule-out/rule-in. You must follow what the manufacturer insert says is required for QC but also a visual inspection of the panel at receipt and BEFORE use. I added some columns on my antigen typing form for the panel lot # and a visual check prior to use. We have always looked at our red cells before use but have never documented that they were OK.
Hope this helps.
 
 
 Topic: Individualized Quality Control Plan (IQCP) Frequently Asked Questions
Date: May 5, 2015 (last updated October 20, 2015)
 
 
37. Do I need to implement an IQCP for my blood bank antibody identification panels? (NEW 10/20/2015)
No, IQCP is not applicable to antibody panels used in the transfusion service laboratory. An antibody panel is considered a critical material and is subject to TRM.31241 for inspection and testing, as applicable, of new lots before use. This involves visual inspection of new lots and shipments for appropriate physical characteristics (e.g. no hemolysis) and quality control following manufacturer's instructions described in the product insert. If the manufacturer does not provide specific instructions for QC, the laboratory must define its own mechanisms to detect errors and monitor test performance. Because antibody panels are not used alone for identification of an antibody, laboratories typically have a variety of other control processes that are being used as part of the work-up, such as having specific rules for ruling in or ruling out antibodies based on panel reactions, correlating the results of the antibody screen to the antibody panel, and performing antigen typing on the patient to confirm the absence of the corresponding antigen. The control criteria used must be defined in the procedure