Followup to nonconformances in AABB assessment

[SRMC BB]

We submitted our corrective action plan to the nonconformances cited during our AABB assessment. The assessor didn't act like they were a big deal and we had our plan drafted before the assessment was even over on how to fix the citation. However, we've received a letter back from AABB requesting further information and to do a root cause analysis. (How I hate these!) Anyway, AABB seems to think that since we revised some policies, that there might be an inadequate process to make sure all standards are being addressed in my policies and wants to know why the process used to develop SOPs is failing to asure we meet all standards and no detect failure to confrom to standards. Our practice is in compliance with the standard and a few instances of documentation were missing and we could not prove compliance.

Any suggestions on how to handle the root cause, we don't want to sound argumentative, but we do follow the standards. In the corrective action plan, I tried to be precise and brief and now think I might have been too brief in my root cause and this is why we are being asked for more information. Also, How do your facilities make sure each and everyone of the standards are covered in your SOPs?

Thanks in advance for any advise!

Natalie

[Cliff]

We too have bumped heads with them, and you're right - it won't pay to be argumentative.

They have a form to use for responses on their site, you might want to use that next time.

The basics for what I feel they are looking for is how did you not know you weren't meeting a Standard (RCA), what you did to fix it in the short term, and what you'll do to prevent this from happening again in the future.

You might want to add something into your quality plan about reviewing new / revised Standards in a formalized manner to make sure you are meeting all of the changes. Many years ago (less than 10) to ensure we were meeting all of the Standards we involved all of our management staff and did a full Gap Analysis on each and every Standard. It took years (and we have a lot of staff) to complete the process. That included the analysis as well as correcting the deficiencies. Then it's a little easier to only review the new and changed Standards.

[David Saikin]

There are non-conformances and then there are NON-CONFORMANCES. I think it depends on what these were - process/procedure/policy. I find that most non-conformances are do to the fact that we are all humans and that there are always going to be some vagaries involved. If, however, you have had repeated occurences then I would also recommend the RCA to determined what is going on and then how to fix it.

[tricore]

"inadequate process to make sure all standards are being addressed in my policies and wants to know why the process used to develop SOPs is failing to asure we meet all standards and no detect failure to confrom to standards."

Does your process for SOPs describe how you review SOPs when a new edition of standards is published to ensure you are meeting new/revised standards? Does your SOP for SOPs describe how you check Standards when you write a new SOP to ensure you are meeting current standards? Then, of course, you have to have documentation that the review is performed when a new edition is published.

[SMW]

I'm curious which standard was referenced in your non-conformance and did your response/corrective actions address that specific standard or just the examples listed as objective evidence supporting the non-conformance?

Just taking a guess here but for example, if the non-conformance cited was to 1.3 Policies, Processes, and Procedures--"Quality and operational policies, processes, and procedures shall be developed and implemented to ensure that the requirements of these BB/TS Standards are satisfied. All such policies, processes....." and the objective evidence included some examples of procedures/policies/processes that did not meet standards, simply modifying the specific procedures listed as examples supporting the non-conformance would not address the non-conformance of having a process to meet the Standards in the first place. If 1.3 was the non-conformance, it's highly unlikely you would have been able to effectively identify the root cause during the course of the assessment, let alone develop a corrective action plan.

As for suggestions to identify the root cause in the above example, perhaps you could start by using the 5 Whys......(the responses may obviously be different and would take you down a different path of follow-up questions so are just examples, but)

Why was standard A not included in procedure X and standard B not addressed in procedure Y?

Because the author/reviewer did not know the Standards had changed.

Why did the author/reviewer not know the Standards had changed?

Because the Medical Director received the new Standards but the individual(s) writing/reviewing the procedure did not receive a copy.

Why do the individuals writing/reviewing procedures not have access to the Standards?

etc., etc.

Once you run out of "whys" you've likely identified the root cause(s) and can start with the corrective actions to "fix" those causes.

[SRMC BB]

We did use the form from AABB to submit our responses. Our assessor did not think they were major, and we had already told her what we were doing to correct them and she seemed fine with our responses and didn't indicate any reason that AABB wouldn't accept our plan. I am planning on doing something similiar to what Cliff suggested, going through each standard and referencing it to my prodecures.

On standard was that the medical director approve any deviations to policies, etc (std 1.3.2) and it dealt with conditional releases. My policy said to consult medical director. We thought we were following policy when something was a deviation, we got his approval. Didn't look at it as the deviation itself was out of the ordinary and had to get his DOCUMENTED approval. I think the main issue was we were lacking supporting documentation and that's were we are headed with the followup to the corrective action plan. The root causes are the hard part---why? why? and why? Because I'm human and I didn't interpret the standard that way???? Don't know if they will like that answer.

We are going to make a form to follow (taken from commendable practices on AABB website) to make sure this doesn't happen again.

[SRMC BB]

Does your process for SOPs describe how you review SOPs when a new edition of standards is published to ensure you are meeting new/revised standards? Does your SOP for SOPs describe how you check Standards when you write a new SOP to ensure you are meeting current standards? Then, of course, you have to have documentation that the review is performed when a new edition is published.

[webersl]

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.

1. 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 ID^1". 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".
   
2. 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.
   
3. 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.)
   
4. 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!

[amym1586]

Sorry to bring this post back from the dead.. I'm doing this for the first time with no help.

It says  List the objective evidence that supports the nonconformances.

What are they looking for here?  Just proving our procedure wasn't up to standards ?

[amym1586]

On ‎5‎/‎4‎/‎2012 at 1:38 PM, SRMC BB said:

Does your process for SOPs describe how you review SOPs when a new edition of standards is published to ensure you are meeting new/revised standards? Does your SOP for SOPs describe how you check Standards when you write a new SOP to ensure you are meeting current standards? Then, of course, you have to have documentation that the review is performed when a new edition is published.

We currently do not have any of this in writing, we have the formatting of SOPs and who writes them , reviews them and how they get put into operation.  But not wording on how we are handling new editions of standards.  Could that be part of my corrective action as to why we didn't have a procedure written for a standard ?

[Cliff]

54 minutes ago, amym1586 said:

It says  List the objective evidence that supports the nonconformances.

What are they looking for here?

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

[amym1586]

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.     

[SMILLER]

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

 

Scott

[amym1586]

4 hours ago, SMILLER said:

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

 

Scott

Borderline insanity!

[Malcolm Needs ☆]

Borderline?????????????????????????

 

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

[DebbieL]

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!

[amym1586]

I think I'll definitely be stealing Wbersl idea as well to keep us in check.

Now, I'm stuck on a time line.  I basically have to write or rewrite 5 policies.  That could take a while considering my current situation.   Is a few months an acceptable timeline for these non conformances ?

[Cliff]

I think a few months is acceptable.  They will be more interested in evaluating your root cause and proposed corrective action than the timeline (I suspect).

[Marianne]

Now let's not be harsh here.  Some of us have been AABB inspectors for many years and have only one head and no fangs :).  It requires a lot of CE,training, time and dedication to being a volunteer inspector.  The majority of people  that perform these assessments try very hard to do a good job for the site they are inspecting against the Standards.  Quality and patient safety are why labs choose to be accredited by AABB and the assement is part of what they pay for-it helps to ensure they are meeting the standards to deliver best care to their patients.

That said I will jump off my soapbox. The form and instructions to submit and the 30 day due date for sending in your corrective action plan is part of what is left at the end of the assessment with your non-conformances.  Records and document control are important and a constant challenge for any of us to stay on top of.  Not having a good plan in place for managing change control can lead to serious holes (like missing new standards) so you will definitely want to make sure you have a good policy/procedure in place to guide you moving forward.  So amym1586 has some work ahead of her (and her team should be part of that work).  This thread has provided some great advise and direction (as always) and it will take some time to get through it all.  Don't get overwhelmed, make a plan, do your research, ask here and on the AABB HUB for copies from others willing to share (never recreate the wheel-who has time for that!) or check out the recommended practices on the AABB website and take it one piece/procedure at a time. 

[Malcolm Needs ☆]

15 minutes ago, Marianne said:

Now let's not be harsh here.  Some of us have been AABB inspectors for many years and have only one head and no fangs :).  It requires a lot of CE,training, time and dedication to being a volunteer inspector.  The majority of people  that perform these assessments try very hard to do a good job for the site they are inspecting against the Standards.  Quality and patient safety are why labs choose to be accredited by AABB and the assement is part of what they pay for-it helps to ensure they are meeting the standards to deliver best care to their patients.

I wholeheartedly agree with what you say here Marianne, and that is how I have found most inspectors in the UK.  Sadly, though, much as I would like to say that is how I have found ALL inspectors in the UK, I have come across a minority (not just one, but certainly a minority) who have gone "well over the top", and the work involved in successfully defending the "non-conformances" "found" by such inspectors is dis to the proportionate to the seriousness of the "offence".

As all inspectors are supposed to be "singing from the same hymn sheet" (i.e. looking at the same standards), I fail to see how the inspectors can vary so wildly in their findings, or how the same inspectors can call the same non-conformances either elsewhere, or at the same establishment at the next inspection; surely, they should be re-trained?

Sorry for the rant, because the vast majority of inspectors are, as you say, well trained, educated in the subject and have, also as you say, the patients' care in their mind.

[Marianne]

Hi Malcolm- no apologies needed (and that was far from a rant, haha).  I know there are the few out there that are perhaps a bit overzealous or misfocused, been on the receiving end of that myself!  I once did call the AABB office prior to summation to contest what was going to be cited and the process worked.  The AABB lead in the office listened to the inspector we had and then to me and told the inspector she was incorrect.  So the process worked.  I probably would not have done that in my younger days of managing, but with age comes wisdom.

[Cliff]

I've been through many inspections / surveys / assessments over the years.  I have found all of them to be biased, it's just a degree of how much they are biased.  Also, pretending that "tracers" are being done well is frustrating.  For us, it turns into "go gather lots and lots of records on patients we are tracing and let's go sit in that room and plow through those records".  So often the inspectors do not talk to staff.  That is a shame.  We are a large, complex organization, I would imagine it would take 5 people a week to review all of the Standards for us, but we got 3 people for 1.5 days the last time.

I think the one that comes the closest to getting it right is FACT.  You must submit a pre-assessment checklist that covers every Standard (and their Standards are free for download and very concisely written).  Then when they come, they review every single Standard - they can do this because you've already submitted your checklist and you're prepared.  There is no bias on picking and choosing what Standards they like or have time to assess.  The one thing I will ding them on is again, not spending time with staff.

Phew, I feel better.  I am not knocking anyone in this thread, I think the system is very flawed and offers no real value to patients or donors.