Eman

The British Society for Haematology (BSH) have just issued an updated version of their "Guidelines on the use of irradiated blood components" (actually on 9th October 2020).

The recommendations for patients who have received allogeneic haematopoietic stem cell transplantation (HSCT) is as follows.
"All recipients (adult and paediatric) of allogeneic HSCT should receive irradiated blood components from the time of initiation of conditioning chemo/radiotherapy.  The recommendation applies for all conditions where HSCT is indicated regardless of the underlying diagnosis.
Irradiated components should be continued until all of the following criteria are met:
1.  >6 months have elapsed since the transplant date.
2. The lymphocyte count is .1.0 x109/L.
3. The patient is free of active chronic GvHD.
4. The patient is off all immunosuppression.
If chronic GvHD is present or continued immunosuppression treatment is required, irradiated blood components should be given indefinitely.
Treatment with irradiated blood components should continue indefinitely if this is required based on transplant conditioning, underlying disease or previous treatment, e.g. previous diagnosis of Hodgkin's Lymphoma (HL) or previous purine analogue treatment.
As far as patients who have undergone an autologous stem cell transplantation (ASCT) are concerned, all patients undergoing ASCT irrespective of underlying diagnosis or indication for this treatment should receive irradiated cellular blood components from initiation of conditioning chemo/radiotherapy until 3 months post-transplant (6 months if total body irradiation was used in conditioning) unless conditioning, disease or previous treatment determine indefinite duration, for example previous diagnosis of HL, or previous purine analogue treatment."
The Guideline is actually quite lengthy (and, of course, is for use in the UK, and not the USA), but can be found (for free) on the BSH website.
I hope this helps.

I think we would refer to this statement in our "Organization" Quality Program document: 
The Quality Unit responsibilities are defined and include: active and prospective participation in quality planning; oversight of all activities relating to quality; ensuring that policies and procedures are properly maintained and executed; ensuring that the quality of products, tests, and services provided conform to regulatory/accreditation, customer, and company standards; and maintenance of the facility quality manual
 

I think we would refer to this statement in our "Organization" Quality Program document: 
The Quality Unit responsibilities are defined and include: active and prospective participation in quality planning; oversight of all activities relating to quality; ensuring that policies and procedures are properly maintained and executed; ensuring that the quality of products, tests, and services provided conform to regulatory/accreditation, customer, and company standards; and maintenance of the facility quality manual
 

With attention to blood utilization, the overall red blood cell usage has gone down.  Consequently blood suppliers have had to pair down the number of overall units they collect in order to avoid out dating products.  Since we are drawing a population, the proportion of desired units in that population (All Rh negs and all group Os) has not changed, but the absolute number of the desired we can acquire units has dropped.  Transfusion practices are still demanding nearly the same number of desired units as before blood utilization practices were implemented.  About half of the Rh neg units distributed go to a non-Rh negative recipient, often because hospitals do not want to "waste" them.  Perhaps if before making that decision to transfuse the blood bank contacted the blood center and asked if there was an immediate need to transfuse an Rh negative unit to an Rh negative recipient, we could better utilize the resources we have.
Also I believe the merging of blood centers has contributed to the problem.  Where the community blood center was usually able to manage the blood needs of the local hospitals, many are selling blood by contract to facilities miles away.  This has decreased the amount of ad hoc blood available for export.
The "low-titer group O" craze is also taking a toll because of the demand for repeat donors to fulfill the need to have Whole blood units with a 21-35 day out date, available for emergencies.
Most blood centers are trying to recruit blood donors by blood group now in order to avoid out-dating Apos and Bpos units. This means that Rh negative and group O donors are approached to give 2-3 times more often than donors of other blood groups.  The desired donors are complaining that they are being approached to give red blood cells too frequently and are starting to ignore our requests.
All of these issues (and perhaps others) are contributing to the nation wide blood shortage of the most desired units. Importing products is also difficult. If they are available at all, did you know that in order to import four group O negative units a blood center might have to also purchase 50- 100 group A Pos units?
Platelet utilization seems to be increasing.  Where do platelet donors come from? Usually whole blood donors. Sometimes the blood center needs to decide whether to take a group O product or obtain a platelet product based on the needs of the day. 
Thank you to those who are excellent stewards of the products you receive!  Blood centers are not shorting you because they are incompetent.  Frequently it is extremely difficult to obtain the most desired products any where at any price.  You can help your blood center serve you by being honest with your inventory.
 
 
 

This is where having a transfusion service director who knows something about clinical medicine and hematology comes in very handy.  It shouldn't be the medical technologists' job to triage requests.  Many transfusions do more harm than good, so it's not that difficult to figure out which patients urgently need transfusion and which can wait, but this requires a knowledgeable and tenacious physician to handle the individual requests and screen them.  As a field, pathology has paid little attention to the need for those who can do such tasks, as compared with surgical pathology skills, cytopathology, etc.  You may need to involve your institution's hematologist(s), intensivist(s), surgeons and anesthesiologists to help make these decisions if your lab physician(s) aren't up to the task.

I am retired but volunteered several years as an AABB assessor. Both CAP and AABB send the deficiencies from the previous assessment to the assigned assessor with the submitted plan of action to correct the previous deficiency. Most plan of actions have a time frame documented to correct the issue.  We were supposed to make checking completion of the plan of action a priority. My first question would be if this individual had completed any work before his training records were completed. Then, I would ask for his competencies that were completed during the allowed time frames.  If I performed a tracer on your FDA reportable, could you provide completed training and competency records for all the employees who worked on that patient?   Your pathologist may be young, but he does not want repeat deficiencies.   Document everything!  

Are your techs generalists or dedicated blood bankers?  If they are generalists, chances are they are not going 2nd guess BB Mgr.  If they are dedicated blood bank techs they should know better.  Unfortunately I have known SBBs who would give inappropriate plasmas (gr O to gr A) just because they were thawed.  Laziness.  Do you have a BBIS?  It should have required an override to give the O plasma.  Having been an inspector/assessor for AABB and still a CAP team leader I would think these issues should have been flagged in your quality plan and subsequently made their way to lab management and hospital quality folks.  Don't be derelict in your duty to your performance program AND your patients.  I'm certain your Medical Director should be in the know as he/she is ultimately responsible.   I would not bring up this individual's past history (though how you discovered this would be an interesting aside).  Don't let your lab's quality suffer because of an individual's poor performance, both the manager and the tech involved.  The transfusion of inappropriate plasma should have resulted in a Biological Product Deviation to the FDA.  Is this in your purview?  I would recommend jumping immediately on errors of this type as soon as they are found.  I also would recommend going directly to the Medical Director as it seems your manager has some serious BB judgement issues.  In the past I have commented to a Medical Director that one would not want to practice Laboratory Medicine in jail.  The Feds can take you out in handcuffs if they think you are culpable (rare but they do have an enforcement arm).  I'm being kind of verbose here but the bottom line is as the quality person for your BB, don't hesitate to call a spade a spade.  Inform lab upper management with your concerns, especially your Medical Director.

Just to state the obvious, if you are using pathogen reduced platelets, no testing is needed.  That has been our choice due to (1) it's a superior method for preventing viral, bacterial, parasite transmission and (2) the logistics of testing 20-30 platelets per day are formidable and not without significant expense for materials, labor, QC, proficiency and competency.  If your supplier provides the option of pathogen reduced, I would go that direction despite the increased expense.

If you put a drop of blood on something like a filter paper, and then add a drop of 1M NaOH, if it is adult blood, after a couple of minutes it will turn a sort of yellow/brown colour, as the Hb is denatured by the alkaline, whereas, if it is blood derived from the baby (including cord blood), the red cells will stay red, as HbF is not denatured by the alkaline for much longer.
It is rather like doing a Kleihauer, but by "bucket chemistry", as it is known!  

This is something that only works when there is expert physician to physician communication. Your medical director needs to undertake this project. There are substantial data from randomized trials and observational cohort studies that leukoreduction abrogates CMV seroconversion.  These are the studies we used twenty plus years ago to convince our practitioners that leukoreduction was not only good enough, but almost certainly superior in overall clinical outcomes to CMV seronegative non-leukoreduced transfusions.  Of course no patient should be receiving non-leukoreduced transfusions at this late date, but in the USA not all transfusion medicine physicians are convinced of this, in my opinion,  strongly justified clinical practice.

Similar, but we go a little higher, I believe 1:200.

The Circular of Information (9/22/16) states "no medications or solutions may be added to or infused through the same tubing simultaneously with blood or blood components with the exception of 0.9% sodium chloride."  When you transfusion whole blood or reconstituted whole blood for exchange you are creating a new product or medication.  Since blood and blood products are considered biologic medication our hospital only transfuses one unit at time.  However, if the patient has multiple lines which our traumas usually do then you can infuse multiple products just not through the same line.  The other problem is if the patient has a reaction how are you going to tell which product is being transfused at the time of the reaction?  Of course this is the same problem we see when patient's are placed on ECMO and both the RBC and FFP are placed in the circuit together. 

The nursing references I have seen specify only normal saline for infusing blood.  If we were releasing a FFP and a RBC at the same time (or two RBCs for that matter), we would ask if they have two lines running.
Scott

We started using the "current edition" designation quite some time ago and never had any problems.  It made life much easier.  

I am enormously honoured to announce that I am going to be awarded the Gold Medal of the British Blood Transfusion Society at their Annual Scientific Meeting in Brighton this year.  It is awarded to an individual for their exceptional and long standing services to the Society and to the practice of blood transfusion in the UK.  Sorry if this sounds egocentric, but I am very excited.

Your product would have a life of 4 hrs upon thawing.  The extreme cold is not bacteriocidal.

For most species,  freezing (even in liquid phase liquid nitrogen (-196C) will not kill the bacteria.  There is a lot of literature concerning this subject for cell processing for BMT and I have personal experience with Staph species and Strep species being alive and perfectly happy in a thawed stem cell product.  Even after lengthy storage at <-150C.

Excellent information!  We do try to use the product as soon as possible, but outdate at 24 hours.  You bring up an interesting point, when we combine a 'double bag' into one... the expiration has to be changed to 24 hours.  Although we don't routinely do that ahead of time, we wait until the nurse is here to pick it up. 

When we were bringing up a platelet collection system I asked the manufacturer some questions about the bag volume limits (100-400mL) and time spent where the volume was greater than 400mL. This scenario occurs for example when a 500mL intended-double is collected, but stored in one bag until counting/processing begins after the collection. That manufacturer said you could go up to 24 hours "out of range" before you compromised the product. Similar concerns about the storage concentration, the manufacturer has validated an acceptable platelet concentration range, odds are your volume reduction process results in a concentration greater than their validated upper limit.
With your closed system scenario I'd be uncomfortable giving the volume reduced product more than 24 hours without having validation data showing viability past that point. Due to container, volume and [PLT] concerns.

At a previous employer we volume reduced platelets and they were pretty ugly products, my current employer no longer volume reduces platelets, we give multiple divided aliquots instead.
[sorry for reiterating some of the points made earlier. they're good points ]

In my experience, if the platelet product is removed from the original container, the expiration period may be affected by the new storage container's ability to maintain optimal storage conditions. Apheresis platelets are collected in bags that are gas-permeable - if product is transferred to another type of bag (not validated for platelet storage),  this should be considered when assigning the expiration date/time even if you volume-depleted using a sterile connecting device. 
I also consider this when removing the supernatant from CPDA or AS red blood cells (as in intrauterine or exchange transfusions) - you can do everything in a functionally closed system but when you remove the "food", the red cells do not exist in the same environment and cannot be expected to maintain the same functionality.
The reason that the Technical Manual is not going to specify is that everything depends on the validation of functional survival of the stored platelet and there isn't data available to make a valid claim.

If I remember correctly AABB has a book on the validation of pneumatic tube systems for the transport of blood products.  It was very thorough and in MY opinion overly and unnecessarily complex.  We validated ours before it was available by simply timing the transport and checking the temp on arrival.  If I remember correctly we may have even let the units used settle out to see if there was any excessive hemolysis visible but I'm not sure on that since is was 16 years and 3 jobs ago.    Since we were transporting to every nursing unit in the facility we were most concerned with those farthest from the blood bank.  We were fortunate to be able to do this prior to moving into the new facility which made life much simpler.    

FDA and AABB had gone back and forth over the years on storage vs transport.  In the past few "Ask the FDA" sessions I've been at during the AABB Annual meetings both FDA and AABB have said coolers are transport.  People even brought up newer cooler technology reminding them that coolers can be out of the blood bank for an extended time.
We validate our coolers to hold temp at 1 - 6.  We do not take temps every 4 hours.

I gave a talk at a seminar on this once many years ago.  I KNEW many of my peers were not reporting things that I was reporting (things that clearly were supposed to be reported).  They would try to make it sound like they didn't think it fell into that category, but I knew they knew better than that.....it was a choice. My comment to them was that "we all know that there are a lot of types of errors we could make, and the FDA would never know unless we reported it (for example, let's say you sent out a non-irradiated unit and it was caught by nursing......even so, when it is returned, it is FDA Reportable because the Blood Bank did not catch it.....but how would the FDA ever know that occurred unless perhaps Nursing wrote an occurrence against the lab)?  It is a system largely based on honesty and integrity.  So one time, I asked an FDA Inspector, are you more concerned about places that report a lot of BPDRs, or those who report none?  Of course a LOT cannot mean a LOT.....but they were more concerned about those that never reported in that as we all know, EVERYONE makes mistakes.
Brenda Hutson, MT (ASCP)SBB

Filtering is to remove white blood cells.  They are not useful in transfusion and often cause transfusion reactions.  Irradiating "inactivates" the white cells by destroying the DNA within the cells and preventing them from engrafting in the recipient.  Washing removes plasma proteins, these can also cause transfusion reactions.
http://www.aabb.org/resources/marketplace/Documents/Primer.pdf
I'm not sure, possibly, but unlikely.

We store our reagents in a blood bank refrigerator and I keep the range 2-6°C so it meets the needs for both blood products and reagents. It's been handy when one of the refrigerators has an issue-there's no questioning if items were stored at the appropriate range.
When we have needed a back up refrigertor, not all of our reagents and products fit in one fridge and we move some of the reagents to heme and take temps every 4 hours.