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Does anyone have online competency forms (word or excel preferably) that went through CAP inspection without deficiencies they would be willing to send me?  I'm specifically looking for something easy to use that's not more than a couple of pages.  Our last CAP we as a lab got hit again, not that are staff aren't competent but because our paperwork was not consistent between departments.  Now we started using a packet that contains 6 different forms:  Competency Summary Form (one for each patient test method), Patient Testing Direct Observation Checklist (one for each test method), Instrument maintenance Direct Observation Checklist (one for each piece of equipment used in patient testing), Problem-Solving Skills form (one for each test method), Authorized Test System Form plus for BB only I have a non-testing competency summary form/checklist to cover non-testing procedures.  This seems excessive and it's really time consuming filling out paperwork especially I have to bench as well.  

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I highly suggest you change the 6 month Competency to "Semi-annual." Our lab got dinged several years ago by a "by the book" inspector. Some of the leads had the 6 month evaluation at 6.5 or 7 month. If you have a OCD inspector with no grace, you could get cited for every competency that is one day over 6 months.

I had an inspector a few years ago that was going to cite me for completing the thermometer checks 10 days later than the year before. She took "annual" literally. To her, 10 days later than the year before was past due. I protested and told her the lab performs all thermometer checks in the month of April, sometimes early and sometimes later in the month. She went to ask her pathologist for clarification before she cited me. Thank goodness he reigned her back to reality and she didn't cite me. 

 

 

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On 4/18/2021 at 3:55 PM, DebbieL said:

I highly suggest you change the 6 month Competency to "Semi-annual." Our lab got dinged several years ago by a "by the book" inspector. Some of the leads had the 6 month evaluation at 6.5 or 7 month. If you have a OCD inspector with no grace, you could get cited for every competency that is one day over 6 months.

I had an inspector a few years ago that was going to cite me for completing the thermometer checks 10 days later than the year before. She took "annual" literally. To her, 10 days later than the year before was past due. I protested and told her the lab performs all thermometer checks in the month of April, sometimes early and sometimes later in the month. She went to ask her pathologist for clarification before she cited me. Thank goodness he reigned her back to reality and she didn't cite me. 

 

 

Sounds like a couple of the FDA inspectors I've experienced.

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CAP competency requirement is labor intensive, regardless of how you document. I have been trying to put more on their competency assessment tool they offer. Setting that up alone is labor intensive. It is the number 1 cited issue of most labs in America. It is not that we are not competent, of course. We have a hard time showing it the way CAP wants it. It really requires a full time QA position just to keep up with the competencies of all the staff in every department.

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6 hours ago, jayinsat said:

CAP competency requirement is labor intensive, regardless of how you document. I have been trying to put more on their competency assessment tool they offer. Setting that up alone is labor intensive. It is the number 1 cited issue of most labs in America. It is not that we are not competent, of course. We have a hard time showing it the way CAP wants it. It really requires a full time QA position just to keep up with the competencies of all the staff in every department.

I liked their competency assessment tool. Definitely labor intensive, but very good documentation. Will be working to replicate it in MediaLab.

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It drives me nuts when I go to a talk and the person speaking says we all make competency too hard.  It is hard, it's really hard.  I don't care if you have 5 staff or 50, it's hard.

That said, we've tried to make it as simple as possible while still trying to make it a value-added process.

  • First, follow the CLIA rules, period. (<-- link and attached)
  • Next, follow the rules of all your inspectors / surveyors...  We are FDA, AABB, and TJC, and DPH for NRC.  For TJC they define annual and 6 months...  Follow their rules.  DPH says AABB is law in my state, follow their rules.
  • When we created our competencies, we added a [1], [2],... after each element so we could show our inspector what element was being met by what.  It was a little extra work one time but saves us during an inspection.
  • If you're fortunate enough to have an electronic system (we recently moved to MediaLab), yay, otherwise, ensure you've reviewed the heck out of your completed forms.  Try to design them so it's easy to see if you have any blanks.  Inspectors have an easy time finding things that should have been signed.

Again, it's far from easy.  We, like many places, are understaffed and overworked, and we have a large Blood Bank, so it's hard.  In a perfect world we'd have at least a 1/2 an FTE to manage this program, but like most other places, we need to absorb it as another task to be completed.

CLIA_CompBrochure_508.pdf

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