Responsible party for blood administration

[kirkaw]

We have a statement on our Emergency blood release form that states, 'The risk of delaying the transfusion outweighs the risk of transfusing the blood without complete testing. I accept responsibility for the administration of this blood.'

 

We had a Joint Commission inspector tell us that the second statement is not true; that 'the FDA says that the transfusion service medical director is responsible for the administration of blood products.'

 

I cannot find that documented anywhere and I have looked in the CFR, AABB Standards and the Technical Manual.

 

Can anyone substantiate that the transfusion service medical director is the 'responsible party' for (all) blood administration and point me to where it is stated?

 

Thanks!

[David Saikin]

My experience with the FDA is that the BB has no responsibility for any component once it leaves the BB UNLESS there is a transfusion related fatality.  They do like to see transfusion reaction workups but otherwise - nothing.  As a case in point, there is no need to file a Biologic Product Deviation for any mishandling of a product once it has been released.  They do not review transfusion protocols.  I tried to use their "authority" to achieve increased compliance with transfusion documentation - to no avail.

[tbostock]

I think the JC is "technically" correct here. Ultimately, the Medical Director is responsible. It's why the Lab gets cited when transfusion administration documentation is incomplete, even though we can't control nursing.

Maybe they just don't like the wording and you just need to modify it. Here's what's on mine:

The clinical situation of this patient is sufficiently urgent to require release of blood before completion of compatibility testing or when compatible blood cannot be provided. In my clinical judgment, delaying transfusion may be detrimental to this patient and the benefits of transfusion outweigh the increased risk associated with transfusion of a unit not completely tested/compatible. Other appropriate transfusion alternatives have been considered, implemented, or are not suitable at this time, and transfusion is necessary.

[mollyredone]

I have a question about filling out transfusion forms. Many times when I audit them, something is missing, whether it is the volume of the unit, the post breath sounds, or BP, even initials for verifying. How do you handle this? If it's on the form, I think it should be filled out. We just got a new QA person who is more interested in this, but I haven't gotten any feedback yet.

Any thoughts?

thanks, Mari

[David Saikin]

I brow beat the Nursing staff, usually on a 4 year cycle.  Now we have docmentation in the HIS.  I review each transfusion document for completion - the BB Medical Director, Lab Admin, and CNOs are all advised on the completeness of these documents.  It did not hurt that we had CAP discuss this issue at our last 2 inspections.  Right now our compliance is a bit over 90%, up from <50% 2 years ago.  This was and still is a battle with some nurses.  To their credit our Nursing Admin is enforcing and educating their staff as non-conformances arise.

 

These are medical documents, you might be able to get your HIM people to insist on completeness.

 

Good luck

[mollyredone]

Thanks for your input David!

[tbostock]

 

I have a question about filling out transfusion forms. Many times when I audit them, something is missing, whether it is the volume of the unit, the post breath sounds, or BP, even initials for verifying. How do you handle this? If it's on the form, I think it should be filled out. We just got a new QA person who is more interested in this, but I haven't gotten any feedback yet.

Any thoughts?

thanks, Mari

We highlight missing items and send them back for completion. We hover around 95% for compliance, which is not bad for handwritten records. When I get cited (which I always do), I show that we monitor them, audit them, report compliance at Transfusion Committee where there is nursing representation, etc. Short of following every single unit and staying for the whole 4 hours, I really don't know what else we can do until we go to electronic administration next year.

Edited July 11, 2014 by tbostock

[SMW]

 

We highlight missing items and send them back for completion. We hover around 95% for compliance, which is not bad for handwritten records. When I get cited (which I always do), I show that we monitor them, audit them, report compliance at Transfusion Committee where there is nursing representation, etc. Short of following every single unit and staying for the whole 4 hours, I really don't know what else we can do until we go to electronic administration next year.

Just curious--what is the source of the information that they are using to retrospectively (non-concurrently) complete the forms? 

[cthherbal ☆]

I agree with David and Terri. Can not wait for electronic transfusions, hopefully by the end of this year!

Terri: Will yours be hospital-wide? I'm thinking OR and outpatients which is manual and ER which uses different software then hospital. Perhaps they will stay on paper...

[LCoronado]

David and Terri,

We have been documenting electronically for four years. The learning curve was much steeper and more extended than anyone expected, due to the fact that our entire HIS had changed and there was much that was new to the nurses. The documentation went down to about a 50% completion rate before it started to correct. Then the method of documentation was changed again (still electronic however) and we went back to square one. We are now seeing about 80% completion; we have a committee dedicated to addressing these issues and do re-educate individuals as needed. The interesting thing though, is that the errors and omissions we are seeing are very similar to those that we found in the paper documentation: missing Stop Time, missing Amount Transfused, missing evaluation for signs and symptoms of transfusion reaction. Less frequently, we miss the Start Time, and all or part of the vital signs at required intervals. New since we went electronic: Scanning of the ISBT unit identification number (we get everything from the product code to the patient's account number scanned into that field). It's an adventure!

[tbostock]

 

Just curious--what is the source of the information that they are using to retrospectively (non-concurrently) complete the forms?

Everything is in the EMR; nurses who took care of the patient, vital signs, etc. They can look everything up...or have a really amazing memory. If we keep getting the same ones back incomplete, it goes to the nurse manager for completion.

[tbostock]

 

I agree with David and Terri. Can not wait for electronic transfusions, hopefully by the end of this year!

Terri: Will yours be hospital-wide? I'm thinking OR and outpatients which is manual and ER which uses different software then hospital. Perhaps they will stay on paper...

 

We will go hospital wide. OR will be the worst; after 3 years with our EMR, they still can't figure out how to order blood and don't think they should have to. So I can hardly wait for the complaints about how hard it is.

[AMcCord]

I actually audited ALL transfusions - a couple thousand units - for a year (not my choice...I am not a crazy person) and I made a nice little spread sheet that showed the common errors. These were addressed by their yearly 'training' for transfusions and recognition of reactions. For the serious omissions, I emailed the guilty party with education (we have in house email for all staff - nice tool). If someone kept making the same serious omissions over and over, I contacted their manager. They are doing much, much better now. We have been using an electronic version of the flow sheet everywhere but ER and OR for 5? years now, but it's not a particularly well designed document. I tried to get them to put some mandatory entry fields in to help with getting the essentials reported but that didn't happen. The big thing we've struggled with is paper towel charting - write everything down on a paper towel and after it's all done THEN chart. Work in progress  but getting pretty good. Helps to have the support of the Quality committee.

[David Saikin]

In  our OR transfusions are documented in the anesthesia data.  In the ED it is still on paper - sometimes very creatively.

[Byfaith]

 

Amazing to see the same issues everywhere!

Our hospital was using Electronic records but noticed the same "after the fact" charting.  This was picked up as part of monitering  completion of 15min vitals.  While we were told that they were always done at 15 minutes, the computer recorded the time that they input the data, resulting in many "fall outs".  After 2+ years of educating and retraining the rate of properly documented transfusion still did not improve.  Believe it or not, the next solution implemented was a return to paper!  Of course, that did not solve the problem either.  With some new IT and Nursing managers on board we hope to iron out some of the problems and return to computer records soon.

[goodchild]

I don't really have an issue with jotting down vital sign documentation on a scrap of paper towel or whatever as long as it makes its way to the electronic system and is appropriate to the timeframe. Our electronic system gives the nurse the opportunity to say what time the vitals were taken while keeping an audit trail of when they were entered.