Marianne

From the management side;  involve the tech.  Meet with them and have a conversation about how/why the think the error occurred..  Make them feel involved in QA and PI by asking if they have any suggestions that may prevent a recurrence.  Front line staff often have great PI ideas, but won't speak up. 
During the conversation you will also be able to get a good feel for whether the tech knows the procedure and is committed to following processes as written, needs some re-training or whether they purposely deviated because the had "a better way".

From the management side;  involve the tech.  Meet with them and have a conversation about how/why the think the error occurred..  Make them feel involved in QA and PI by asking if they have any suggestions that may prevent a recurrence.  Front line staff often have great PI ideas, but won't speak up. 
During the conversation you will also be able to get a good feel for whether the tech knows the procedure and is committed to following processes as written, needs some re-training or whether they purposely deviated because the had "a better way".

From the management side;  involve the tech.  Meet with them and have a conversation about how/why the think the error occurred..  Make them feel involved in QA and PI by asking if they have any suggestions that may prevent a recurrence.  Front line staff often have great PI ideas, but won't speak up. 
During the conversation you will also be able to get a good feel for whether the tech knows the procedure and is committed to following processes as written, needs some re-training or whether they purposely deviated because the had "a better way".

This is the form developed by our system transfusion managers.  It was based on a sample document shown in a CAP Focus on Compliance webinar a few years back. 
Transfusion competency-final.xlsx

I would suggest considering "issue" as the time the product is out of controlled temperature.
 

The final came out on Sept 20th, no longer a draft.  We have 18mths to implement.
Bacterial-Risk-Control-Strategies-for-Blood-Collection-Establishments_09-2019.pdf

The final came out on Sept 20th, no longer a draft.  We have 18mths to implement.
Bacterial-Risk-Control-Strategies-for-Blood-Collection-Establishments_09-2019.pdf

It is still in draft, and has changed (significantly) a couple of times.  It is rumored to be finalized next month.
This will create significant changes for all of us, I suspect we'll get a year to implement, same as the new Babesia testing requirement.  Our testing vendor isn't ready to offer it to clients yet.

This is the form developed by our system transfusion managers.  It was based on a sample document shown in a CAP Focus on Compliance webinar a few years back. 
Transfusion competency-final.xlsx

This is the form developed by our system transfusion managers.  It was based on a sample document shown in a CAP Focus on Compliance webinar a few years back. 
Transfusion competency-final.xlsx

Actually, if you look back at the responses you will see that the best answer is all three in the proper sequence.  

A - to find out the specifics of the problem - personnel may not talk in front of supervisor, so this needs to be done 1st.
B - to get the other side of the story - if there is one.  Don't spring a meeting on the supervisor with other personnel present without discussing problem 1st. 
3 - to work things out - if possible.

If documentation of proper blood handling for transfusion is not appropriate, I am pretty sure that the inspectors will not care whether it's happening in the Blood Bank in the Lab or in OR.  This is healthcare, after all, and this is my hospital.  
I do think it is worthwhile to try to correct deficiencies.  It make seem like a sisyphean task at times, but one cannot just give up on this stuff just because we "are at the mercy of human beings".  (We should all be used to that by now!) 
I do think that efforts should be concentrated on making things as simple as possible, not only for ourselves, but for those other humans in all the other departments that we work with everyday.  I do think its worth the effort.
Scott

I have read several threads, some maybe 10 years ago regarding this matter but I didn't see anyone really addressing the following. My question is does anyone work at a hospital where anesthesia scans in the blood unit prior to transfusion?? According to AABB 5.28.4 "The transfusionist and one other individual (or an electronic identification system) shall, in the presence of the recipient, positively identify the recipient and match the blood component to the recipient through the use of 2 independent identifiers". There is also a similar statement from CAP TRM.41300. 
We had a near miss several years ago, same situation, different place. One refrigerator being shared in the OR, 2 big cases going on, you get the scenario. To me, it doesn't matter how great the cooler, refrigerator, blood tracking .... there is no fool proof system but can we get close to one? one of the threads addressed the Joint Commissions Sentinel Event Alert regarding blood for multiple OR patients in the same refrigerator among other things (1999). This was 20 years ago!!!! Have we not improved this in 20 years???? Is it that hard to scan in a blood unit? Does it not take more than 5 seconds to do this??? The people making these computer decisions at  our facility just can't see how important this is. Geez and in this day and age of computers all I get is "Our computer system cannot currently check this and that and blah blah blah is all I hear. Calgon take me away! Sorry for the rant but I needed to get that off my chest. 

You might consider offering an alternative to the Typenex bands that would satisfy both sides by offering an electronic system that mimics the rationale for the Typenex system. The current Typenex system is based the use of bar coded blood sample container labels that can only be sourced from the patient identification band.  An electronic mimic of Typenex can be used for identification and labeling of all laboratory specimen containers.

Right now this is a draft guidance, but everything I have read says it will be made a Guidance by this September.  I haven't seen anything yet on what the required implementation timeline they might be.
 

What I quickly realized was that no 2 inspectors/assessors focus on the same thing.  As David noted, they seemed to focus on things they were either cited for or had cited others for recently.  Over the years I had been cited for something that had passed all previous inspections because the inspector simply did not like the way we did it.  When I challenged the citation with the inspecting organization the citation was often over ruled, not always but often enough to make the challenge worth while.  My best advice is to prepare the best you can and consider the inspections a learning experience and hope that David is your next inspector.  On a side note I was a Blood Bank inspector for CAP for 30 years so I had ample experience on both sides.  One last bit of advice, never ever argue with an FDA inspector!  

Irradiation definitely requires FDA registration. You are manufacturing a new product and would need to relabel.

Sorry, but can I just point out that you should be sending out the tests if the patient is a female of child bearing POTENTIAL, rather than child bearing age.  If the female is four (for example), she is not likely to be of child bearing age, but she will be one day, and if she is an individual who has a Partial D type who can produce an anti-D, she deserves as much care as does a female of, for example, 25 years.

We are CAP, AABB, Joint Commission, and FDA inspected.  I feel that AABB prepares you for FDA better than the others.  I'm not talking about only the assessment process, but the total package of AABB membership.  

I take the opposite view as I feel that AABB still adds that higher level of quality and safety needed for Blood Banks and Transfusion Services.  I agree that CAP has changed over the last couple years and is more in alignment with the AABB standards, but the emphasis on Quality and tying that all together is not the same. 
The other points to mention are the training requirement differences and the depth of the inspection.  CAP recommends their on-line training be taken prior to inspecting, but does not mandate or have CE requirements included for inspectors.  AABB does have a monitored assessor program with mandated CE hours in specific categories as well as required training sessions.
The CAP team will be in your facility for just about a half day.  AABB/CAP combined inspection will be mostly likely a day and a half to thoroughly go through all 4 checklists.   Do you view an inspection as a necessary pita, "just something to get through....." and want the inspector in and out as quickly as possible,  or do you really wish to have outside eyes perform a in depth look at your processes to ensure that you are providing the highest level of patient care and service?  My whole career has been in BBTS and I never forget that what we do has the potential to be quickly fatal more so than any other section of the lab and therefore I feel needs that '"extra" review.
 

For our pre-op patients, if they have not been pregnant or transfused in the past 3 months, we'll make the specimen good for 28 days.  We do the type and screen within 3 days of collection.  Once the patient has been transfused, we set the outdate to 3 days.

Follow policies / procedures.
Pay attention to details.
Don't be afraid to ask questions.
Pat yourself on the back when you make it through your first Massive Transfusion Protocol!
Let the adrenaline work for you -- keep calm and work on.
Enjoy Blood Bank -- I've been doing this for 30 years, and I love it!

You know, I hate to be the bearer of bad news but the manufacturer's instructions for gel cards do NOT support recentrifugation of the cards as a valid test method. There may be other reasons that results are not reproducible (e.g. fibrin, weak antibodies, variations in samples collected), but centrifuging the card again is not the way to resolve the problem! I hope no one is using this method to interpret patient test results!
From the insert:
1. False positive or false negative test results can occur from bacterial or chemical contamination of test materials, inadequate incubation time or temperature, improper centrifugation, improper storage of materials, or omission of test samples.



2. Proper centrifuge calibration is particularly important to the performance of the MTS Anti-IgG Card. TheMTS Centrifuge has been exclusively designed to provide the correct time, speed and angle.

and


For best results, it is recommended that following centrifugation, results should be read immediately. If tests are not read immediately, results may be affected by the drying out of the gel; hemolysis of the red cell and slanting of the reaction patterns due to storage in a non upright position.

My thanks too!  I enjoy this fun stress relief each Christmas!