It states : If the laboratory uses more than one instrument/method to test for a given analyte, the

instruments/methods are checked against each other at least twice a year for correlation of

results.

NOTE:This requirement applies to tests performed on the same or different instrument makes/models

or by different methods. This comparison must include all nonwaived instruments/methods. The

laboratory director must establish a protocol for this check.

This would mean that if you use a cellwasher to wash your tubes, you would have to compare each maker or model against the other?

The intent of the CAP question is to compare testing methods between your platforms. If you do Gel testing with tube as a backup, you must test both. But if you are only using tubes there is no comparitive testing to be done. I actually called CAP to inquire that since I use the same QC for both gel and tubes why cant that suffice, but because the QC specimens are "manufactured" you cannot use them, the CAP wants true specimens including CAP survey specimens. I developed a policy that states that every quarter I will retest samples on both methods and the samples include both Rh+ and Rh= for A,B,O, and at least 1 postive Ab screen and 1 negative Ab screen. I got popped on my last inspection on this and this method that I developed satisfied the CAP as a correction.

To think that because you use a cell washer you must wash manually is overzealousness. As I stated before it is your testing platforms that you are comparing.

I interepreted the question as you must compare you testing methods against each other. At my hospital we use Gel and Tube method so I take a CAP specimen or a patient specimen that is has a negative antibody screen and one that has a positive antibody screen and compare the two methods. My inspector was happy with this method.

Well hold on there just a minute. Where do CAP Survey "true" specimens come from? Aren't they manufactured? I bet one of the reagent manufacturers make the CAP samples too. But because you purchase them from the CAP, they are ok to use for method comparisons. The CAP allows you to use QC samples for method comparisons in other areas, such as hematology. And these CAP inspectors, MT's just like us who are trying to interpret the same guidelines. It depends on the technologist doing the inspecting as to whether you are following the intent of the guideline. But I believe the intent is to compare the testing methods and determine their relationship to each other. The CAP says that the methods don't have to agree, you just have to know how they compare.

Edited July 20, 201114 yr by Joseph
Second thoughts

I run CAP specimens in gel and in tube using PeG and LISS - for antibodies. Gel and tubes for ABORh

I use my 3 times yearly Automated Transfusion Survey specimens (5 specimens X 3 times/year), record the results from the Echo on a Yearly Method Correlation form I cobbled together and then test the same specimens on both tubes (all ABORhs) and 2 ABSCs and on manual Capture (3 ABSCs) - our two bench methods - and record on same form. Seems to work OK and is easy to document. :cool:

I use my 3 times yearly Automated Transfusion Survey specimens (5 specimens X 3 times/year), record the results from the Echo on a Yearly Method Correlation form I cobbled together and then test the same specimens on both tubes (all ABORhs) and 2 ABSCs and on manual Capture (3 ABSCs) - our two bench methods - and record on same form. Seems to work OK and is easy to document. :cool:

Would you be willing to share your "Yearly Method Correlation" form? It sounds like you've come up with an easier system than what I am currently using (and we use the same methods as you), so I'm hoping your worksheet would work for us! Thanks! Sheri

My email is: sgoertzen@childrenscentralcal.org

we use this for our competancy training and assign two techs an abid--and request they perform in two methods--gel and tube.

grading reactions is not compared.

Would you be willing to share your "Yearly Method Correlation" form? It sounds like you've come up with an easier system than what I am currently using (and we use the same methods as you), so I'm hoping your worksheet would work for us! Thanks! Sheri

My email is: sgoertzen@childrenscentralcal.org

Yes, I too would love to have a copy of your form if you are so willing

tlorme@meridianhealth.com

Me three

anorris@georgetownhospitalsystem.org

"I use my 3 times yearly Automated Transfusion Survey specimens (5 specimens X 3 times/year), record the results from the Echo on a Yearly Method Correlation form I cobbled together and then test the same specimens on both tubes (all ABORhs) and 2 ABSCs and on manual Capture (3 ABSCs) - our two bench methods - and record on same form. Seems to work OK and is easy to document." :cool:

I would love to see someone's SOP and form as well! I'm newly in charge of blood bank, and we don't have a procedure for this CAP requirement yet, so I'd like to get one in place before we get inspected again! My email is mariliddle@chiwest.com. Thanks!

Here's my version. It's pretty simple, but it passed a CAP inspection last month. [ATTACH]527[/ATTACH]

[ATTACH]528[/ATTACH]

Be careful of using proficiency testing samples for any other purpose, such as correlations, training, or competency. This is one of the things I look for, and frequently cite, when I inspect blood banks.

If you use survey samples in this manner prior to the due date of the survey, then you are creating an opportunity to detect an error in performing the proficiency test.

CLIA requires testing the sample the same way as a patient. Are you running all your patients by two methods? (Correlations)? Are you having multiple techs running patient samples? (Training/Competency Testing).

If you must use the CAP samples for some reason, I woud recommend having a policy not to use them until after the due date of the survey (not the date you submit the results).

Don't violate the CLIA rules! I know of a hospital lab that recently lost its CLIA license due to a proficiency testing violation. Don't end your career for something like this!

I agree with dmpollock

If you must use the CAP samples for some reason, I woud recommend having a policy not to use them until after the due date of the survey (not the date you submit the results).

Good point. My thought process is that 'of course everybody knows that' - but that's not always the case. Others might not think of that at all. The intent of a procedure (or at least the thought processes of the writer) and interpretation by the user are not allows the same, as we all know. I am amending my policy today to include such a statement.

If anyone has Method Comparison SOPs or worksheets they would like to share, it would be greatly appreciated. Thanks!

Email - mebejujubee@gmail.com

Here's my version. It's pretty simple, but it passed a CAP inspection last month. [ATTACH]527[/ATTACH]

[ATTACH]528[/ATTACH]

I cannot open this attachment.

 

I would also appreciate if anyone could share their SOP or worksheet for comparison of methods.

Email- aafrin@gmail.com