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Deviation Reporting


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Hello all, 

I have been working in the blood bank of a level one trauma center for almost 7 years and October of 2018 took the job as supervisor. I am learning many things but have a long way to go. Currently I am looking for a better way to report deviations. We have a form called the deviation investigation report (DIR) and I do not like the way it is structured, it is very cumbersome and some parts I feel are redundant. I am looking for a more simplistic way for my staff to report errors but because I have only worked in this blood bank I am not familiar with other options. Would any of you be willing to share the form you use for reporting so I can see what others are doing? Also, I know errors are not supposed to be punitive but due to this some techs are not making an effort to improve their processes. How do you encourage your staff to improve without the option of discipline? Thank you for any advice you may offer. 

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I will preface my reply by saying I am not in a managerial position, just a tech in the lab. My facility has "Occurrence Reports" that record intentional deviations, reported errors, any workflow influence, etc. You can write them anonymously online or by hand. It's helpful at some points, but there's a fine line between people filling them out to report coworkers for silly things, or just filling them out when they feel "inconvenienced." I have a few problems with this process, but the form itself is outlined decently enough. It mainly just records the time a deviation is recorded, what area of the lab, what happened, corrective action, and future flow.

Overall, I would say it comes down the culture of your lab. Who takes responsibility, and who places blame? If it's a workflow adjustment or something that takes less than 5 minutes to explain, or doesn't affect a patient in any way, emphasize communication between techs and talking to individuals directly to fix process kinks. Doing a whole roundabout where you report it and they find out weeks later about it through a form -- it's a little off-putting and not direct enough for cause and effect adjustment. If it's a real punitive-required situation, that's another problem. Complacency, which seems to be your mention, is something that starts to get into warnings, re-training, responsive action. If someone keeps incorrectly doing a test "their" way, force a re-train (people will want to avoid a whole session of teaching them how to do something they already know how to do, so maybe that's incentive).

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Our Deviation from SOP form is pretty simple.:

  • Tracking # (a sequential # which I add when I review the form)
  • Patient ID information
  • Date/time of occurrence
  • Description
  • Reason for Deviation
  • Action Taken - this is most often information completed by the tech who is responsible for the deviation or who discovered/corrected the deviation. Sometimes it is more appropriate for me to complete this part. I may add information to Description/Reason/Action sections. The medical director may add to any of these sections, though usually doesn't.
  • Reported To/By/Date and Time
  • Tech - person completing the report. This is usually the person who reports the occurrence, but not always.
  • Signature lines for Supervisor and Medical Director
  • Comment section - used for additional information or comments regarding the occurrence. This section is not always needed but is completed by myself (supervisor) and/or the Medical Director when necessary. This would be where I note retraining, disciplinary actions, whether or not a hospital occurrence report or safety huddle report was made, BPDR# if filed, calls to providers, etc.  The Medical Director will comment on appropriateness of the deviation or contacts with providers as he sees fit. Example would be if the event was due to something like emergency release of uncrossmatched blood to a patient with an antibody.

This form is one page and most of the events reported don't fill up all the spaces provided for entries. Once reviewed and addressed, I file them. I think if I was at a larger facility I would think about using a form online or at least a from that could be completed on our shared drive and emailed to me and the medical director. One of my goals is to build a spread sheet to track/trend by occurrence type - good quality project for my abundant spare time :clone:.


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When the reason for a deviation is determined we can decide how it needs to be addressed. In some cases, the deviation was an acceptable response to a given situation. No follow up required. If education or training is required, that is provided and documented on the same form. If the deviation is the result of continued 'bad behavior', training/education issues, or egregious disregard for policy, then our next step is an 'Opportunity for Improvement'. This is something we use throughout our lab. The tech and a lead sit down together to discuss the deviations and the problems identified to determine what the tech needs to do to remedy the problem. The tech is also asked what he/she feels is needed to help him/her resolve the problem. Once the lead and the tech have come to an agreement, the resolution to the problem is spelled out, including any education/training the lead will provide and the expectations for the tech's future performance. An end date for the required improvement is also determined. When that date is reached, the lead evaluates the tech's progress. If all is well, that is documented. The End. If there are still issues, the lead can re-evalute the situation. Additional training or education can be provided, with another periord of evaluation. If need be, the problem can be referred to the lab manager for possible disciplinary action.

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  • 3 months later...

We use a system called CAPA(corrective action/preventive action). I don't know if it is something the QA people built or what. Anyone can write one but after that only the leads, supervisors and managers can review and follow up on. Some techs have felt it is punitive but that as seem to have ebbed once the number of CAPAS you received  is no longer brought up in your yearly review . 

It begins with a brief description of what happened, when it happen and the name of the Tech involved (if applicable) then entered in the file for new occurrences. The QA specialist assigns it a tracking number and puts it in the departments "in box".

Once in the "in box# one of the leads investigates starting with the Tech involved.  And the explains what was the immediate action, how did this happen and what was being done to prevent it from happening again.

Then it is moved to either a folder for preventive action. Where it stays to up to 30 days for either further comment from another lead, supervisor , ect. Then it is moved to the closed folder

Or it may be moved to the corrective action folder where you  have to do a RCA and an effectiveness check. This can't be moved until the manager and medical director of the department review it.

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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".

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  • 4 months later...

Hello fellow lab frontliners,

I am a newbie working in Blood Bank , What kind of report to do you file in case OTHER department  are involved, for example in my case admission dept register the patient using old /wrong patient file in which historical blood type does not matched the current blood type result.

These scenario was twice happen this year. I dont know if occurence report would be enough or there is other proper reporting method to properly addressed the issue to other department. i will greatly appreciate all your response .


Thank you.

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