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Physician Signature for Emergency Released Blood

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We are a level 1 Trauma center that routinely gives Emergency Released blood products with approximately 15 MTP activations per month.  We have difficulty obtaining MD signature on our Emergency Release forms after the patient moves to OR or if the bleed initiates in the OR.

Does anyone utilize an electronic order and use the electronic signature for emergency release/MTP activation?  Have you been CAP/AABB/FDA inspected using electronic signatures? If so, were there any problems with the inspection?

I am in discussions with Trauma service about obtaining a physical signature and they are begging us to make it "easier" hoping to obtain better compliance with transfusion documentation in Epic.  I know that transfusion documentation and physician signature are separate issues but they have presented questions linking the two topics. :)

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57 minutes ago, applejw said:

I know that transfusion documentation and physician signature are separate issues but they have presented questions linking the two topics. :)

I can't help you with the basis of your concerns but I do have to say that in Emergency Release situations I certainly consider the physician's signature as an integral part of the transfusion documentation and not a separate issue.  Now, how to consistently get that signature has been an issue since the dawn of time or at least since the dawn of transfusions.  

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1 hour ago, applejw said:

 

Does anyone utilize an electronic order and use the electronic signature for emergency release/MTP activation?  Have you been CAP/AABB/FDA inspected using electronic signatures? If so, were there any problems with the inspection?

 

This is pretty much exactly what we do and neither the FDA or JCAHO inspectors have a problem with it.

Scott

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We built an uncrossmatched blood order in Epic that includes the statement from the AABB standards almost verbatim.  The MD orders it and has to click yes to the statement to finish the order.  We just went live and expect TJC next week and AABB in the next 6 weeks so we will see what they think.

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Very interested in this concept.  What exactly does the electronic order state, other than the standard?  Does it specify a quantity or a duration for the order?  And how do you handle the requirement for the Blood Bank Director's review?  I recently had a physician return a form 3.5 months after I first sent it to him with a signature but no date.  This is the latest one by far, but they usually take a few days to come back.

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We have three "uncrossmatched" orders:  uncrossed RBCs (which would include an indication of quantity), an "initial reforestation cooler" (of 2 unxm'd RBCs and 2 AB plasmas), and an order that initiates a Massive Transfusion Protocol.  The MTP order stands until it is cancelled--we keep sending sets until then.  Once a clean T&S is done, the MTP sets will be crossmatched product if at all possible.

Scott

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This use of a signature as a bludgeon against ordering physicians is something we should give up.  We all know that in most cases of life-threatening bleeding, even 5-10 minutes delay can be fatal, so why pretend that our testing is the key element in good care? We are partners in providing the appropriate care that the clinical situation calls for.  If a physician says he or she cannot wait for testing (ABO/Rh, or antibody screen, or physical crossmatch) it makes no sense to contest that claim or ask them to document it with a signature putting all the responsibility for outcomes on their shoulders.  Physicians give verbal orders for all sorts of things, and documenting that verbal order for blood transfusion prior to whatever testing is missing should include the verbal order. Signatures are a waste of everyone's time and an attempt to shift responsibility for outcomes for what we have to do onto the ordering provider.  Your mileage may vary, but I thought we were a team.

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We require a signature be in the record because it is a requirement of standards.  We don't require it to be completed before we will issue uncrossmatched blood so there should be no delay in care.  We will issue uncrossmatched on a simple verbal request or the order (it is built into our trauma order set).  Our uncrossmatched order in Epic does not send product orders to the Lab; it is a communication order that gives us permission to create the supporting product orders in the BBIS.   Our process is partly for the above situation and also because they sometimes decide they need uncrossmatched units before the antibody screen is complete even though they have already ordered RBCs.   We do request that either the computer order be placed or a paper be signed so we can have that in the record, but it can be done after the patient is cared for.  It seems like just asking if they need uncrossmatched blood will halt the ones who just think that calling the lab repeatedly will speed up the process but remind those who really need it that it is an option.  I am inclined to agree that getting the order/signature doesn't really accomplish much.  I've never even heard of any litigation arising from a case where a patient was harmed from an emergency issued unit.  I've seen a few antigen positive units issued to patients with antibodies who still didn't show evidence of harm so maybe the lack of litigation is because I've never seen harm.  I have seen harm from not transfusing a patient with a strong anti-D during an O neg shortage where they attempted to avoid giving Rh pos blood by just using blood salvage during his emergency aortic aneurysmectomy and he ended up needing dialysis.

I think this is what ended up being our final wording in Epic:

  1. The question “This patient’s clinical situation is sufficiently urgent to require release of uncrossmatched blood.” – must select YES.

 

Where is the requirement that the medical director review them?  Is that CAP?

Edited by Mabel Adams

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Below are the relevant CAP checklist items for emergency release of blood products. My viewpoint is that the emergency release is a 'deviation from SOP' and that is what the blood bank medical director must review. What I regard as a deviation is: our policies require us to perform compatibility testing for RBCs or perform a blood type for plasma (platelets) prior to providing them for transfusion. If we 'emergency release' blood, it is released uncrossmatched, and plasma (platelets) is/are released w/o a patient blood type. We are thus deviating from this policy.

Our medical director is also looking for evidence that we followed the SOP for our emergency release process. We have an ongoing quality project to monitor documentation, how long it takes to provide product after request, and compliance with SOP. Quality improvement projects/processes are also part of regulatory compliance. For us the reviews are not a major problem because we don't have that many emergency releases. Our problem is maintaining staff competency to make sure that everything goes quickly and smoothly This is where the quality improvement part of the equation comes in and we've made some major improvements there. No inspection problems w/ Joint Commission, CAP or CLIA and we've been doing this way for years. I don't know if it's overkill, but it works, and it's good for our patients.

TRM.40770 Life-Threatening Situations Phase II
Adequate policies and procedures have been established for the investigation and
handling of life-threatening situations (such as the use of uncrossmatched blood or
abbreviation of testing) that include the written authorization of a qualified physician.
NOTE: Written policies and procedures must be available to expedite testing for transfusion in
a life-threatening situation. If an institution's procedure allows abbreviated testing in massive
transfusion situations, records should indicate that the procedure was followed. Records must
include the authorization by a qualified physician. (If approved by the institution and recorded
in the laboratory's procedures, the physician responsible for the transfusion service laboratory
may accept this responsibility.)
If an incompatibility is discovered on completion of an incomplete
crossmatch, the responsible physician must be notified in a timely manner and this notification
recorded.
29 of 85
Transfusion Medicine Checklist 08.21.2017
Red blood cells released before testing has been completed must be conspicuously labeled
as uncrossmatched on the tag or label. Records of completion of compatibility testing for units
released uncrossmatched must be maintained.
Evidence of Compliance:
✓ Records of emergency release authorization by a qualified physician

REFERENCES
1) Food and Drug Administration. Current good manufacturing practice for blood and blood components. Laboratory controls.
Compatibility testing. Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.151]
2) ibid. Records and reports. Records. Washington, DC: US Government Printing Office, 1999(Apr 1):[21CFR606.160]

AND

TRM.30900 Records of Deviation From SOP Phase II
The transfusion service medical director or designee provides written authorization for
deviations from the standard operating procedures.

NOTE: The standard operating procedures constitute the approved procedures of the laboratory
and are to be followed at all times. Any deviations from these procedures must either be
authorized by the responsible transfusion medicine medical director or designee prior to their
performance or, if detected only after the event, must be investigated through the laboratory's
quality assurance process. A wide variety of routine procedures may, from time to time, require
the transfusion service medical director or designee to authorize an alternative approach
because of specific clinical situations. Among these, for example, might be the need to give Rh
positive red cells to an Rh negative recipient because of inventory shortages, or to provide a
unit of platelets that was not HLA-matched (or “crossmatch compatible” or “antigen-negative,”
depending on the laboratory's routine approach) to an alloimmunized patient in an attempt to
control hemorrhage.
REFERENCES
1) Lam H-TC, et al. Are retrospective peer-review transfusion monitoring systems effective in reducing red blood cell utilization? Arch
Pathol Lab Med. 1996;120:810-816
2) Shulman G, et al. Creating useful statistics to audit transfusion services. Lab Med. 1998;29:371-374

 

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TRM.30900 appears to apply to those situations that do not follow standard operating procedures and policies.  However, if the hospital and blood bank HAS policies and procedures that cover release of uncrossed blood (approved by the Lab Medical Director -- just like every other P&P in the Lab), then the need for a "written authorization" would not be needed in those situations, as they are not "deviations from SOPs".

Scott

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2 hours ago, SMILLER said:

TRM.30900 appears to apply to those situations that do not follow standard operating procedures and policies.  However, if the hospital and blood bank HAS policies and procedures that cover release of uncrossed blood (approved by the Lab Medical Director -- just like every other P&P in the Lab), then the need for a "written authorization" would not be needed in those situations, as they are not "deviations from SOPs".

Scott

True, but we look at the request for uncrossmatched blood as an occurrence outside the norm, even though we have SOPs in place in Blood Bank to address that. 

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For us, I will agree with Scott's interpretation that uncrossmatched blood is not a deviation because we have a procedure covering it, but improving the service through a quality project is, of course, commendable. I can see the logic of your interpretation, but we have a different interpretation of the deviation requirement.

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I agree that somewhere the responsible transfusion service physician should have signed the SOP, or if the SOP could not be followed, signed a deviation report.  Where I part company from the conventional way of doing things at some centers is asking that the ordering physician also sign an additional form confirming what is hopefully in the medical record, that this was an urgent situation where standard serologic testing could not be performed.  Adding more bureaucracy in this way is obstructive, time wasting and energy sapping, and serves no clinical purpose in my view.

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There is some value in the need for a provider to stop and ask himself if the need is urgent enough to give uncrossmatched blood.  Placing an order, verbal or otherwise, serves that purpose.  Getting a form signed after the fact is just bureaucratic blame-shifting, I agree.  Someone should propose that all of the regulatory standards be changed to reflect that. 

Has anyone ever seen someone request uncrossmatched blood whose mind would be changed by knowing they needed to sign a form?  I have definitely seen some of them change their minds about transfusing when faced with signing our "increased risk" form for transfusing patients with, say, a warm auto, high retic count and Hgb of 6, but maybe that is because we provide more information about the risk when we complete the form.

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I agree with Neil and Mabel about the bureaucracy, but I agree with pbaker.  The number of times I have had a doctor change his or her mind about uncross-matched blood when I have told them that THEY take full responsibility if there is any nasty reactions, and wait for the fully cross-matched blood, is not huge; it is enormous.

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3 hours ago, Malcolm Needs said:

I agree with Neil and Mabel about the bureaucracy, but I agree with pbaker.  The number of times I have had a doctor change his or her mind about uncross-matched blood when I have told them that THEY take full responsibility if there is any nasty reactions, and wait for the fully cross-matched blood, is not huge; it is enormous.

Been there, done that, thank God since I retired I'll never have to do it again.

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We had a policy and form where we could issue on a RN’s signature with a place for the ordering pysician’s name.  The RN was responsible for obtaining the ohysician’s signature once things got calmer. The Blood Bank did follow up if we didn’t get the signed form in a couple of hours. (Due to ER physician groups covering multiple hospitals, a particular physician might not return for weeks.)

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This thread is very timely as my hospital is a level 3 trauma center in active pursuit of level 1 trauma. (Yes, you read that right, we plan to skip level 2.) I am currently working with our trauma coordinator on an order set for MTP. She asked me just today if the emergency release form could be electronic with an electronic physician signature. We have always included the emergency released unit numbers on the form that the physician signs. Of course, this info is easy to obtain from our patient and unit history. After reading through this thread it seems reasonable that we really could eliminate this piece of paper and go to an electronic physician signature. I apologize for this being so lengthy, but I do have a question or 2– do any of you have order sets in your LIS  for MTP? Also, in the midst of an MTP, how do you keep track of which “cooler” you are on? We give a plateletpheresis with every 6 RBCs and FFPs. Cooler 1 is 3 RBC & 3 FFPs, cooler 2 Is 3rbc, 3ffp, & 1 plateletpheresis (obviously not IN the cooler), cooler 3 is 3rbc & 3 FFPs, cooler 4 will have RBCs, FFPs, and platelet. My trauma coordinator is proposing to have this be electronic too, so that as soon as we verify the first order, it will reflex an order for the next set of products and so on until we get an order to discontinue. Does anyone have anything like this set up?

Thanks for bearing with me. We have Cerner Millennium if you were wondering.

Kathryn

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We have an MTP order set but it doesn't order the blood products, just 99 transfuse orders for each product.  Once MTP is called, we enter the product orders in our BBIS (SafeTrace Tx) or use it for emergency issue.  Thus all units are tracked.  We use a paper log to keep track of what cooler we are on plus some lab values etc.  There are downtimes which are still on paper forms.  Epic doesn't send blood product orders through the LIS.  They come straight from the clinical side into the BBIS.  It would not work for us to be able to verify the first order so we can't do your reflex idea but it sounds good.

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I agree that discussing the risks with the ordering provider is essential.  Most physicians have zero formal training about transfusion risk.  Medical school students today receive at most one lecture on transfusion, the most commonly coded procedure for inpatients in the USA. The medical curriculum is a political muddle where there is almost no relationship between what needs to be learned and what is taught. That said, every uncrossmatched blood order (with no ABO typing, no antibody screen) should be questioned, if possible.  But signing a form isn't the key step :).  A brief, to the point discussion of the risks of the giving ABO non-identical blood components, and in the absence of an antibody screen should be had if time permits.  Clinicians, whether physicians, nurses, NPs, PAs, etc. often have no idea that these emergency transfusions are substantially less safe than waiting 20-30 minutes for ABO type specific, antibody screen vetted red cells.

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Interesting idea to try to get the form electronically.  We have fought for years to try and get the Admissions folks to get the patient into the computer in a timely manner so the whole hospital has access to pt. information and computer ordering.  As we try and transition to a Level 4 trauma center (yes - I know - why bother?  We already stabilize and ship), there have been improvements.  But we just discovered we still - even if the pt. is in the computer - have problems getting the name in the Lab if we are not receiving orders.  We currently have a handwritten Emergency release form - it might help us to have that changed to an electronic form so we get the order, the pt. name and the ordering Dr. - all at the same time.  All Blood Bank orders could be entered there to keep the encounter together.

For our MTP - the Blood Bank is doing all of the ordering, but an electronic order to start it might help us there too.  We are currently counting on a verbal order, followed by the handwritten Emergency release form.  We are currently starting our MTPs with 2 units    O Neg, uncrossmatched RBCs and have had 2 encounters decline additional units after receiving only those 2 units.  (Not complaining  - just noting a trend!)

Given the problems we are having getting the ER Drs to order Blood Bank correctly - I really don't know if adding even more orders for them to think about will help though. 

Thanks for the information.

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