Cliff

I rarely post about me, or my family.
I was raised by a single mom from 2 until I was about 10. That was probably really hard for her in the 60s. Whenever I ask her, she just says it wasn't so hard.
We had a lot of roommates to help with the cost of apartments, one was Georganne (Giorgi Baino Sr.). She seemed to be around the longest. I really liked her, she was like an aunt to me.
Maybe 10 or more years ago, we got back in touch - Sadly, just on Facebook. I am going to try to have a video chat with her to catch up.
Anyhow, it seems my mom wrote a poem about me when I was a kid, and Georganne has always played guitar. The song was about me riding bikes, I never heard it until yesterday. For those that know me, you know I've been a cyclist (avid at times) for the last 15 years.
She put the poem to music and sent it to me yesterday. I cried.
Here it is if you're interested.
I cried.

That's really awesome and thank you for sharing! 😊
I also used to be an avid cyclist / endurance racer and have great memories of those times.
Races such as the Vail 100, Brian Head 100 and 24-hour races were my "jam" during those years.

I rarely post about me, or my family.
I was raised by a single mom from 2 until I was about 10. That was probably really hard for her in the 60s. Whenever I ask her, she just says it wasn't so hard.
We had a lot of roommates to help with the cost of apartments, one was Georganne (Giorgi Baino Sr.). She seemed to be around the longest. I really liked her, she was like an aunt to me.
Maybe 10 or more years ago, we got back in touch - Sadly, just on Facebook. I am going to try to have a video chat with her to catch up.
Anyhow, it seems my mom wrote a poem about me when I was a kid, and Georganne has always played guitar. The song was about me riding bikes, I never heard it until yesterday. For those that know me, you know I've been a cyclist (avid at times) for the last 15 years.
She put the poem to music and sent it to me yesterday. I cried.
Here it is if you're interested.
I cried.

I rarely post about me, or my family.
I was raised by a single mom from 2 until I was about 10. That was probably really hard for her in the 60s. Whenever I ask her, she just says it wasn't so hard.
We had a lot of roommates to help with the cost of apartments, one was Georganne (Giorgi Baino Sr.). She seemed to be around the longest. I really liked her, she was like an aunt to me.
Maybe 10 or more years ago, we got back in touch - Sadly, just on Facebook. I am going to try to have a video chat with her to catch up.
Anyhow, it seems my mom wrote a poem about me when I was a kid, and Georganne has always played guitar. The song was about me riding bikes, I never heard it until yesterday. For those that know me, you know I've been a cyclist (avid at times) for the last 15 years.
She put the poem to music and sent it to me yesterday. I cried.
Here it is if you're interested.
I cried.

Like @Bet'naSBB said, there's really no easy answer.
My first response is ALWAYS, check with the manufacturer to see if they have documents or guidance.
Then, read the package inserts, they may have info.
Then, barring anything definitive from above, you and your medical director need to review your patient population and determine how many of each type of patient you want to test. Do you have a lot of antibody patients? Do you treat cancer patients?

Happy Birthday! 🎂

Happy Birthday to all, including our fearless leader Cliff🎂🎆

Definitely!

I actually didn't have to google the answer for this one! I knew that Landsteiner discovered ABO typing at the beginning of the 20th century :)

Today is Biomedical Scientist Day 2025 UK. I would like to wish best wishes to all laboratory staff throughout the world.

I leave that for the physicians to respond to, but I suspect that since there will be lingering lymphocytes, no, they would not be protected.
I, too, was part of a large level 1 trauma center.  Our inventory was typically 700 - 1,000 RBCs.  We were 100% irradiated.  Once they were received, they went right into the irradiator room (we had a double door fridge in there.  We usually had someone in irradiating most of the first and second shift, we had two old cesium irradiators.  It was very hard to keep up.  We looked into getting two x-ray irradiators, but it was cost-prohibitive, even with the government program where they would take the cesium ones away and pay for half the cost of the new ones.

I think there are a lot of variables that you, and your medical director, need to consider.
The biggest is your patient population. 
Do you have a lot of cancer patients taking monoclonal antibody drugs? Do you have a lot of maternity patients? Do you have a lot of antibody positive patients? The only correct answer is to test 100% of the samples to be 100% sure.  That is not practical, and no one would ever suggest that.
Scan the FDA guidance documents to see if you find any relevant ones.
Here are a couple of unrelated ones:
https://www.fda.gov/files/drugs/published/Process-Validation--General-Principles-and-Practices.pdf
https://www.fda.gov/files/drugs/published/Bioanalytical-Method-Validation-Guidance-for-Industry.pdf
For a NEW process that we were unfamiliar with, I always went with 385, regardless of the population size.  We migrated a patient database with millions of records from our homegrown system to a commercial system, we tested different scenarios 385 times.
As time went on, and we grew more confident with that particular software system, and continuously found no errors, we reduced it, slowly, over each validation.
The key point is that you and your medical director need to have a sound, and justified plan.  Your primary goal is to protect your patients.  Your secondary goal is not to get closed down.
Should you test every sample, no.
Should you test 20 samples for a process you have never performed before, no.
I suggest looking at some statistics sites and determining what works best for you.
Here's just one, there are MANY: https://www.calculator.net/sample-size-calculator.html?type=1&cl=95&ci=5&pp=50&ps=&x=Calculate
 

Yes, we needed to reduce the expiration to 28 days from the date of collection.
We issued about 100 units of RBCs a day, we didn't outdate a lot.
We had a huge cancer population, we just felt it was safer to irradiate everything.  We also adopted 100% leukoreduction much earlier than most facilities.

Thank you so much!  I've been perusing the site for a few years and thought, hey, why don't I sign up!  LOL
I'm the BB Lead at a smaller hospital in AZ and have 30 years experience.
Looking forward to learning more here and, hopefully, even providing a few answers along the way. 
 

You can also contact the FDA and ask, I have always found them to be very helpful.
Worst case, report it (again, I don't think it's reportable) and they will reject it and let you know why.  That is safer than not reporting it.
I understand a lot of facilities are reluctant to report, but I came from a large facility and we reported about 50 - 75 events a year and never got in "trouble" from the FDA.

I just answered this question.

My Score PASS  

I just answered this question.

My Score PASS  

I have the guide from the vendor, but they said it up to us how many and what type of scenarios to test with the reader. I was just curious if someone had done it before and had some insight.

You can also contact the FDA and ask, I have always found them to be very helpful.
Worst case, report it (again, I don't think it's reportable) and they will reject it and let you know why.  That is safer than not reporting it.
I understand a lot of facilities are reluctant to report, but I came from a large facility and we reported about 50 - 75 events a year and never got in "trouble" from the FDA.

It's been a while for me, but my initial instinct would be to say no.  The safety, purity, and potency of the product were not compromised due to an error (intentional or not) on your part.
Is it your policy to always check to ensure that every patient has not been previously transfused at any hospital and does not have an antibody?  I'm not being facetious, but if it is, then yes, you did not follow your policy.
You can try to find a code for it here, but I don't think you will.  https://www.fda.gov/media/161919/download?attachment

Hi,
I realize you are not un the US; however, AABB has a lot of terrific resources available, for free.
https://www.aabb.org/news-resources/resources/donor-history-questionnaires/blood-donor-history-questionnaires
There is a questionnaire that you can administer, which will uncover the conditions you are looking at, and they also have guidelines on how to proceed should you receive an unexpected answer.
These should be reviewed with your medical director to ensure the suggestions are what they would like implemented.
In the last blood center where I worked, we pretty much followed them exactly.  Why reinvent the wheel 

Hi,
I realize you are not un the US; however, AABB has a lot of terrific resources available, for free.
https://www.aabb.org/news-resources/resources/donor-history-questionnaires/blood-donor-history-questionnaires
There is a questionnaire that you can administer, which will uncover the conditions you are looking at, and they also have guidelines on how to proceed should you receive an unexpected answer.
These should be reviewed with your medical director to ensure the suggestions are what they would like implemented.
In the last blood center where I worked, we pretty much followed them exactly.  Why reinvent the wheel 

This may be a little outdated, it's from a prior facility.  We did a tremendous amount of transplant infusion, and this evolved over the decades I was there.
Management of Hematopoietic Progenitor Cell Transplant Recipients.docx

My first recommendation is to ask the vendor.  They will often provide the skeleton of a validation plan, that you can then adapt to what you have outlined in your SOPs.

THANKS Cliff.