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I was the safety officer in my lab for over 10 years, and the thought of having to empty a blood bag gives me the shivers! Just too much opportunity for a splash and exposure, never mind the mess. Also, with tubing and hard plastic connectors attached to the unit, it really should be in a hard sided container. The connectors (we also call them spikes) could easily poke through a plastic bag alone.

Also, were any of the transfused units antigen positive? This is the quickest way to get a negative indirect antiglobulin test ;).

(Slightly paraphrased from the Guidance to the 34th Edition of AABB Standards for Blood Banks and Transfusion Services) AABB Standard 5.14.8 requires that there be 2 determinations of a recipients ABO group..... the first determination must be on a current sample and the second determination may be determined by one of the following methods:
1) comparison with previous records
2) testing a second sample collected at a time different from the first sample
3) retesting the same sample if the patient identification was verified at the time of sample collection using an electronic identification system.
CAP standards (12/2024) Changes to Standards clarifies the requirement even further:
"In the transfusion medicine checklist, TRM.40300 Historical Record Check says ABO, Rh, and antibody screen test results must be compared with results of the same tests recorded previously to detect discrepancies and identify patients requiring specially selected units. “New language was added to this existing requirement to clarify what is acceptable ABO and Rh historical records,” says Matthew Karafin, MD, MS, chair of the CAP Transfusion, Apheresis, and Cellular Therapy Committee and clinical professor of transfusion medicine services at the University of North Carolina at Chapel Hill. The revised requirement now says the acceptable ABO and Rh historical records for transfusion purposes are only those generated or entered by laboratory personnel into the health system’s laboratory information system and performed by an accredited lab or certified by the relevant government agency in its jurisdiction.
“We learned that assessors have encountered facilities that were using blood types from other institutions, such as from Epic Care Everywhere,” Dr. Karafin says. “Moreover, we were made aware that blood typing information from these other institutions was sometimes being added by non-blood bank personnel, so we had concerns about the reliability of this information.” For patient safety, the CAP wants to ensure that the ABO and Rh used for transfusion are the ones that laboratory personnel have entered into an LIS. This “implies that a transfusion service reviewed the information and was responsible for its data entry,” Dr. Karafin says."

We have seen this phenomenon from time to time, albeit rarely. We use R1wR1 red cells with all of our antibody identifications, purely because it is always cell 1 in the panel! We also, however, use two R1R1 panel cells and an r'r panel cell.
I'm not too sure why we get the odd sample that reacts like that, because the C antigen on the R1wR1 panel cell is not that much weaker than the C antigen on the R1R1 panel cells, and certainly no weaker than that on the r'r panel cells.
Remember that the "w" of "Cw" stands for "Willis", and not "weak", as it was named after the donor who caused the immunisation to the antigen in the first example of anti-Cw described (something I forgot a few years back in an article I wrote, much to my embarrassment, if that is any solace to you) and that RH8 (RHCw) is allelic to both RH9 (RHCx) and RH51 (MAR), and not to either RH2 (RHC) or RH4 (RHc). Therefore, any weakening must be due to steric hinderance, or something similar.
:confuse::confuse:

Some of the worst hemolysis I have seen was in clostridium septicemia.  Both cases were fatal.
 

The FDA Guidance on Computer Crossmatching calls out that patients with an ABO typing discrepancy should not be allowed to qualify for computer crossmatches. 
" If ABO typing discrepancies exist, you should not rely on a computer crossmatch. This is particularly important if there is mixed field red cell reactivity, missing serum reactivity, or apparent change in blood type following hematopoietic stem cell transplantation. Under those circumstances, your procedures should provide for compatibility testing using serologic crossmatch techniques." 
I wrote our policy to include any non-straightforward ABO types for any reason will be required to get an IS or IAT crossmatch. 

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.

2 people at sign out or issue is not required.  

As far as I know there is no FDA requirement for two people to issue blood.  Obviously some hospitals have only one person working night shift in the lab, so that isn't happening realistically. There is a traditional requirement for two people to identify the recipient and the transfused product, but this is only if positive patient identification is not used these days. 

If u are performing patient testing, then u need to have your competency assessed.  No way around that requirement.  

most of blood bank testing is high complexity so someone with an associate degree would qualify as an assessor.  

My manager and myself (asst manager) both complete the same competency that the staff do in order to be able to be able to fill in at the bench if the need arises.  "This year's" competency is "good" for next year's observations.  It's hard to get done - but, we both feel it's valuable - and the staff seems to appreciate that we remain "competent" since previous management had no clue what went on at the bench....
Keeps us in the loop.

Can you convert the tube panel cells from 3% to 0.8% and test in gel?  We primarily do that to run selected cells that are not already diluted to 0/8%

This was the clarification I got from AABB...   so looks like at least one high/low check of the monitoring system as a whole would be wise?
 

Can you convert the tube panel cells from 3% to 0.8% and test in gel?  We primarily do that to run selected cells that are not already diluted to 0/8%

Can you convert the tube panel cells from 3% to 0.8% and test in gel?  We primarily do that to run selected cells that are not already diluted to 0/8%

Can you convert the tube panel cells from 3% to 0.8% and test in gel?  We primarily do that to run selected cells that are not already diluted to 0/8%

Can you convert the tube panel cells from 3% to 0.8% and test in gel?  We primarily do that to run selected cells that are not already diluted to 0/8%

Can you convert the tube panel cells from 3% to 0.8% and test in gel?  We primarily do that to run selected cells that are not already diluted to 0/8%

Can you convert the tube panel cells from 3% to 0.8% and test in gel?  We primarily do that to run selected cells that are not already diluted to 0/8%

COM.10300
Knowledge of Policies and Procedures
Phase II
 
The laboratory has a defined process and records indicating that all personnel are knowledgeable about the contents of the policies and procedures (including changes) relevant to the scope of their testing activities.
NOTE: The form of this system is at the discretion of the laboratory director. Annual procedure sign-off by testing personnel is not specifically required.
Evidence of Compliance:
✓     Records indicating that the testing personnel have read the policies and procedures, new and revised, OR records of another written method approved by the laboratory director
 
 
 

At our facility, the Trainee has their own log in.  The Trainer is responsible for assuring that all results are entered correctly.  Should something be wrong, we would hold both responsible.

We operate with the same workflow.  It is up to the tech reviewing testing in Soft to expire the "old" specimen or cancel additional TS orders in Epic to prevent the collection of new specimens.  If the provider orders RBC, it will fall into Soft under the existing TS and you will need to develop a workaround for that as well or will generate exceptions when trying to select products.

We have Epic and Soft and this is how our system functions as well. The orders for specimens are collected in a tube that Soft considers to have a 3 day expiration, so they get a new order number and a new Aux number. The Aux number for us is the instrument ID from Epic. To my knowledge, there is no solution to this, this is how the system is designed. Only one active TYSC order should be allowed. 
When a sample is drawn before midnight on the third day, we have to manually go in and inactivate/expire the existing TYSC sample so that product orders will flow onto the new TYSC. 

The problem with retesting the same sample is that you don't have a second sample drawn with a different venipuncture to confirm the patient's ABO and can potentially issue ABO incompatible blood no matter how the compatibility testing is performed.