CLIA Survey

[Kathyang]

   We just got an email about a CLIA Survey and weaknesses in labs. The one that I am questioning is about running an auto control with every antibody screen performed. I was wondering if anyone does it or just done an when completing an antibody ID. It stated that the "Product Insert" states that an auto control may be run with an antibody screen.

   Has anyone ever seen this or been "cited" for not running auto controls with every antibody screen.?

  

     Thank you for any information.

 

        Kathy Angel

 

[SMILLER]

Using Ortho reagents for gel and tube, there is no requirement in the inserts for an autocontrol ("may be used" is mentioned in the gel insert, but only as a negative control).

I am pretty sure that neither CLIA, JCAHO or the FDA require one to be run with every screen. We used to run one when we used tube as our only screen method, but since we switched to gel (several inspections ago) we have not had any comments one way or the other.

If you come up with a specific standard I would be interested in seeing it.

Thanks, Scott

[Deny Morlino]

Agree with Scott.  We have been using gel for more than 10 years and have not used an auto control.  When we use tube method, yes.

[tbostock]

We only do an auto control with our panels, not our screens.

[BBCLS]

We only do auto control in our panel Immucor and Ortho manual method. 

[Malcolm Needs ☆]

I can see no reason to run an auto with a screen.

 

If the screen is negative and so is the auto, so what.

 

If the screen is positive and the auto is positive, then you will need to perform a panel.

 

If the screen is positive and the auto is negative, then you will need to to perform a panel.

 

If the screen is negative and the auto is positive, so what.

 

Only about 2% of screens will be positive in most situations.

 

I can see every reason to run an auto with the identification panel.

[MAGNUM]

I agree whole heartedly. We only do an auto if we do a manual screen in tubes, otherwise we do not perform autos on the echo.

 

scott

[AMcCord]

I agree whole heartedly. We only do an auto if we do a manual screen in tubes, otherwise we do not perform autos on the echo.

 

scott

Same here.

[Eagle Eye]

_{auto only with panels..}

[Dansket]

Haven't run an autocontrol with every antibody screen since CAP dropped it as a requirement 20-30 years ago.  There was a large study (800+ eluates from patients with a positive autocontrol) done by John Judd out of University of Michigan that scientifically refuted the value of the routine autocontrol.