amym1586

So fun story, one of our supervisors thought the Quality systems stuff for AABB was BS.  So she made a BS manual and every procedure in there is  named BS...

You're welcome!  I'm here all week.

You're welcome!  I'm here all week.

So fun story, one of our supervisors thought the Quality systems stuff for AABB was BS.  So she made a BS manual and every procedure in there is  named BS...

Thank you for slightly improving a miserable Monday morning. Bahahahahahahahaha.

So fun story, one of our supervisors thought the Quality systems stuff for AABB was BS.  So she made a BS manual and every procedure in there is  named BS...

Those silly Orthoniacs!
When we enter in reagents, we have a field for the insert date. (I would think most systems do).  Our procedure for checking in reagents states that when one checks for a newer insert, that the coordinator is notified so proper changes are made (if any) to our procedures.  The entry of that insert date documents that this has been done.
So we do have a book of insert copies, but only check them against Ortho's internet listing when we check in a new batch of reagents.  There is no written logsheet.
Scott
 
Scott
 

It could be a maternal warm auto-antibody, as these rarely cause clinically significant haemolytic disease of the foetus and newborn, but equally, it could also be the result of an allo-antibody the mother has produced against a low prevalence antigen expressed on the baby's red cells, the gene for which was inherited from the father.  I know that you said that the baby's bilirubin is normal (which mitigates against it being HDFN), but not all such antibodies are clinically significant, and certainly not all lead to clinically significant HDFN.
It's a pity you couldn't get a sample of dad's red cells to test against the baby's eluate, but that is so often the case!

Our Lab Director wanted each department to copy and paste one CAP standard on a page, write our response below and provide a copy of evidence (policy, form, QC, ect) behind the standard. We highlight the parts of the evidence to make it easy to find. We have to turn in 1/12 of our standards each month to the Medical Director who looks them over (Yeah, right), signs them and then give them to the Lab director for approval. I really hated this at first because it was so much work and he was so picky but after having gone through it a few years, we each know where we don't quite meet the standard. We also have a book that we can use when an inspector asks a question and our mind goes completely blank. At some point, when the inspectors arrive we will just hand them our evidence book so they can look at how we have satisfied the standard.
I download the Word form of standards from CAP to my computer. I type in my response in the square below the standard. Then I just copy and paste all of that to a blank page to put in my evidence book. When we get new standards, I copy and paste my answers to the new Word Standards. It is a pain but easier than writing everything again. I highlight the new or revised standards to look at them closer since they need more attention. Yes, this is all a pain but I have very good confidence that we meet the standards when an inspector arrives. I also have a book that my people could use if I was out sick.
I love the idea that Webersl uses and I think I will incorporate that into my future volume of work. It never ends!

Borderline?????????????????????????
 
Give some of these inspectors a peaked cap and a neurone and they'd be dangerous.

Borderline insanity!

OOOOOH.  I see that now.   She wrote 1 Non conformance for Standard 1.3 and then wrote 4 procedures that applied to it.  I was thinking I needed to fill out a corrective action for each one she listed but since they all fall back on that one standard... I see that light now.     

LOL!  SOPs to define how you update SOPS!  Don't you just love regulations!
 
Scott

OOOOOH.  I see that now.   She wrote 1 Non conformance for Standard 1.3 and then wrote 4 procedures that applied to it.  I was thinking I needed to fill out a corrective action for each one she listed but since they all fall back on that one standard... I see that light now.     

We also use MediaLab and also have a paper manual in the BB.

We use flowcharts if the electronic P/P is not available.

We are not AABB accredited; we are inspected by CAP, but the concept is the same. Like Cliff, it took a few years, but I went through all my SOP's and all the regulations. I did it in several steps.

I read through every SOP and used the "footnote" tool in MS Word. [insert-->Reference-->Footnote] to tag each statement (or heading, or title) in an SOP that was directly related to a specific regulation with the reference number of the regulation. For example: "The sample must be labeled at minumum with the name, medical record number, date and time of collection, and the collector's employee ID1". Once you add the footnote in Word, it adds the little number and it takes you to the end of the document, or the bottom of the page, where I typed the specific reference "AABB SBBTS 5.11.2, CAP TRM.40230".
I put all of my Word Document SOP's in the same folder. Then, I went through the regulations one at a time and I used the "find" feature in windows (like how you search for a file) to search for each regulation number. If I found it, I marked it off. If I didn't find it, then I knew that this regulation had not been specifically addressed.
For all the ones that had not been specifically addressed, I had to create policy or modify existing policy to make sure each had been fully addressed. (This took a LONG time.)
Now, when the new edition comes out, I use the crosswalk of changes and the "find" feature to quickly find the location of that particular regulation in my SOP's so that I can make adjustments as necessary - or update the reference numbers.

This has worked wonderfully for me! It is also excellent at inspection time when you get nervous and can't think - just use the find feature and your own policies will tell you (and the inpsector) how you meet that standard and where to look for documentation. It's also a great help to your staff if an inspector should come when you are out of town. They don't have to know every little thing - they can just look it up if they don't know.
Good luck!

That should have been provided by the assessor.  They cite a standard, then list the objective evidence they found.
Are you using their form to submit your response?  The first time I responded (100 years ago) I didn't realize they expected me to use this form.  It's found here.  I also attached it.
corractplan.doc

I would question why your system let you issue blood on a patient with an antibody that was not cross matched through AHG phase. Our system (HCLL) sees anti-D as a level three antibody and would have never let us tagged the unit unless it was emergency issued.

Last year we had pizza one day and no one even said anything about lab week.  I think we've been depressed for a year! My staff got me a card thanking me for putting Lab Week together this year.  It was pretty amazing 

I have done many AABB/CAP coordinated inspections sooooooo - I guess using both is actually ok in this instance.  It does keep you from getting inspected twice.

Last year we had pizza one day and no one even said anything about lab week.  I think we've been depressed for a year! My staff got me a card thanking me for putting Lab Week together this year.  It was pretty amazing 

All the best to the hardworking laboratory professionals who do their utmost every day to ensure the quality of results and safety of the patients we help to treat.  We in the lab may be "invisible" to most patients, but there is not a diagnostic or treatment decision made without the support of the lab!    
And Malcolm is absolutely right--there can NEVER be too much dessert! 

I am attaching a copy of our reagent quality assessment. We separate our products specifically and have a binder with all the package inserts and then document lot, receipt, in use, expiration date and inspection. This form goes behind the package insert, so we can see it.
BB REAGENT LOT.xls
BB RM Quality Assessment of Received Reagents.doc

Yum!    I'm drawing a blank as to what to have Thursday and Friday.  We've had pie and cake every day so a dessert seems like too much!