Istat validation forms and acceptable limits

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We are reviewing our iSTAT validation process and were curious on what validation forms others use and how you determined the acceptable limits.  If you could send me one of your forms I would love to see them.

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Adam, total allowable errors can be found on data summaries of your proficiencies.  If you can’t find everything there, google total allowable error and you can find the table showing what you need.  Hope you and Kayla are doing well!

Hello, I am out of office and shall return 7/22/2024. If you require immediate assistance, please contact the main lab at 5872 for Southlake and 4247 for Northlake. Thank you.

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Southlake Campus

(219) 757-7340

Northlake Campus

(219) 881-5183

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Hi Adam,
Since AMR verification acceptability is at the discretion of the LD, we use a combination of TAE and set percentages, depending on the analyte, the range, and the available verification material.  We have spreadsheets built to calculate the acceptability.  I'd be happy to send you a template if you are interested.  What is your email?

So what our situation is, is that we are using forms that were created before us and dont quite understand all of its components.  Like all of the things to the right on this form.

Attachment.
image.png

Do you have a separate policy defining acceptable performance of your precision, accuracy, etc?  That should explain all of the statistics on the right.  It looks like it is evaluating the variability of the repeats and comparing the actual SD vs the expected SD within acceptable confidence limits.  I haven't used Chi-Square and statistics is not my strong suit though.  Hopefully someone better at statistics than me can help you with that.

We use the allowable error table on data innovations website for the majority of our calculations.  The ones that aren't on this site we get from the CAP evaluation booklet.   https://www.datainnovations.com/allowable-total-error-table?field_category_type_tid=44&title=Hemoglobin

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adam ponton
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