tcoyle

The storage temp does not need to be updated if you are not changing the product code for a plasma that is used in that 6-24 hour window.  If you are extending a unit of plasma to 'thawed plasma' that is good for five days, you'll need to change the product code and expiration date which will then include the new storage temp.

Per the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 Version 3.0.0 March 2013 published by ICCBBA, for thawed plasma products or Cryo AHF, thawed plasma products that are used with the 6-24 hour expiration can keep their original product code.  The expiration date and time must be changed and that information does not need to be bar coded.  The original expiration date bar code should be lined thru, date and initialed.  You can then write the new expiration date and time below that.

Per the United States Industry Consensus Standard for the Uniform Labeling of Blood and Blood Components Using ISBT 128 Version 3.0.0 March 2013 published by ICCBBA, for thawed plasma products or Cryo AHF, thawed plasma products that are used with the 6-24 hour expiration can keep their original product code.  The expiration date and time must be changed and that information does not need to be bar coded.  The original expiration date bar code should be lined thru, date and initialed.  You can then write the new expiration date and time below that.

All, I am about to blow your mind....
Our plasma freezer is down and so is our backup. The freezer will not get colder than -18 C. I was preparing to move all the products into boxes with dry ice until I had a conversation with my 87 year old dad, a retired blood banker from University of Chicago. He said to me, do not take the plasma out of the freezer and put it in boxes, PUT THE DRY ICE IN THE FREEZER, IT IS THE BEST STORAGE BOX YOU HAVE!!!!
MIND=BLOWN!!!!
I did that. Our freezer is currently reading -25.1C and getting colder. Furthermore, the probes in the freezer continually monitor the temp in the freezer so you don't have to record temps every 4 hours, the chart is doing that for you!!!
Isn't that cool? That perfectly illustrates the difference between wisdom and knowledge there. I wish we could hire my dad.
I just had to share this here.
PS. Freezer is now at -26.4C.
 

Medical directors REVIEW policies every two years to ensure they are current and appropriate then sign, which is evidence of review. Staff read and sign when changes have been made. 

So, why, pray tell, does the alarm even sound at a nursing desk?  This is quite unnecessary and obviously inconvenient for all involved.  If the reason is, as usual, "that's the way be been as long as anyone remembers", it's time for a change.  Hopefully you can get this easily rectified.  Good luck.

If this is the case, I would propose you do not need remote monitoring.

I contacted AABB directly about  the added standard 5.7.2.1.3 because it requires the vendors to provide expiration dates of the transfer bags even if the weld is complete which for us is a huge issue.  I'm glad they are reversing this.  That all being said, as long as the weld is complete we keep the expiration date/time of the product placed in the transfer bag.   We only keep platelets in the mother bag and take aliquots from it for transfusion.  We do change the expiration time to 4 hours when we place them in a syringe.

Hi Mabel,
Best to check the package insert that came with the aliquot bag.  There is a new AABB standard:  
5.7.2.1.3
 
Regardless of the integrity of the weld, if no storage time limit is specified in the package insert or the package insert is not available, the component shall have an expiration time of 4 hours after transfer from original container.

Hi Mabel,
Best to check the package insert that came with the aliquot bag.  There is a new AABB standard:  
5.7.2.1.3
 
Regardless of the integrity of the weld, if no storage time limit is specified in the package insert or the package insert is not available, the component shall have an expiration time of 4 hours after transfer from original container.

Hi, can you cite the standard/regulation that requires biannual validation?

Clarifying question - Is it Friday afternoon or Monday morning?  

We've been converting FFP to TP directly for some time now.  All of our thawed units start with a 5-day outdate.
 
Scott

From the My Two Cents Dept...
I would just point out that it is important that people doing testing understand what and why they are doing what they are doing.  I guess this goes without saying.  I am not a fan of throwing computer AI at problems when staff have trouble understanding what it is they are doing.  I get it that with staff shortages and what not, that generalists have a lot of hats to wear, but a computer algorithm should never be a substitute for appropriate education and regular, effective performance evaluation.
Scott

Blood products that were taken into isolation are never returned to us.    If they are not used, they are discarded in the room.

Blood products that were taken into isolation are never returned to us.    If they are not used, they are discarded in the room.

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!  

If you feel that you are not being heard or appropriate action is not being taken you have the option of reporting to your accrediting agency AABB, CAP, TJC. This can also be done anonymously. The agency will contact the lab for information/investigation.
If patient safety is being put at risk then you need to do everything you can to get these situations addressed which it sounds like you are doing.
The other thing I would highly recommend is that you keep written/hard copy documentation of everything. You may need it sometime in the future to have proof of your diligence in trying to force compliance. Always remember the old adage "If it's not in writing, it never happened"
Good luck

You are not overreacting.  You are being responsible, which is what all healthcare workers need to be.
Other than discussing all of this with your department administrative director (your manager's manager -- maybe you have done this already -- at our hospital, this is at the department director level), I am not sure there is much else you can do within your department.  You mentioned talking to the FDA and your risk management department. 
Your hospital should also have a corporate compliance fallback for things like this (that cannot be resolved through management -- you can report anonymously if you desire)  For corporate compliance issues, the business must respond to your concerns and report back to you within a limited amount of time. 
Good luck.
Scott

As far as my interpretation of this standard and how my facility operates, the training is not the same thing as the competency testing. Each area of the lab has an initial competency testing, then the 6 month, then the corresponding annual along with everyone else. I don't think mere completion of training without an initial competency assessment is sufficient. Training is often just acknowledging the trainee has been taught a task and can perform said test; the competency is a pre-set blind sample that already has a determined result, so you can tell if your trainee is passing/failing the competency.
I would say: sign off training, sign off competency, then you can perform solo testing.
There is a previous thread here, and another here about GEN.55500 that may be helpful?

We use a training/competency sign off initially. Then follow up at 6 months and one year with repeat competency assessments. I think that you need to have documentation that training has been completed satisfactorily, which is best demonstrated  by an acceptable performance on a competency assessment. The individual may not be performing at as a high level of competency as they hopefully will be at 6 months or a year, but they should demonstrate a minimum level of competency, as determined by your facility, before performing patient testing.

I'm with David on this one.  Doing both paper and computer entry just adds one more opportunity for mistakes.  If you can't trust some one to put it in the computer correctly how can you trust them to write it down correctly!  The key is the ability to enter the results as they see them and not have to walk over to a computer station to do it.  Also, if you are entering from an instrument print out I highly suggest you get that instrument interfaced as quickly as possible.  Again, you are entering results from paper and that should be avoided.   

Stop using paper once you have your BBIS validated.  It is just as easy to type 4 as to write 4+.
The system shouldn't let you make interpretation errors.  Trust it.
I know I've been turned down for positions because I told the technical staff that their papers would be history from my day 1.
I also have inspected places that did the paper first.  Went to watch a transfusion and had to return because the patient needed irradiated products - only found in the computer.  It was a good lesson that you don't want repeated when you get inspected.

We went through this a few years ago.  The problem with any kind of written worksheet is that it becomes your primary record -- the computer entry is secondary. -- resulting in both sets of records must be retained.  When results are directly entered into the computer, almost all written testing records are not needed.
Scott

As far as I know, FDA currently has a draft guidance for pathogen reduced platelets.  FDA recently came out with the final regarding bacterial risk and platelets.
You can search for FDA guidance's any time.  Copy this link             https://www.fda.gov/regulatory-information/search-fda-guidance-documents