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Daily reagent QC question


suhu

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We use the Galileo instruments for routine testing, and manual methods for backup and problem resolution. I have a question regarding daily QC. Is it required to perform daily QC on the ABO reagents by manual methods if the same reagents (lot #'s) are QC'd daily on the instruments?

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Yes. we perform daily QC on all platform (tube, Gel & ProVue). Reagents are tested on your instrument so they are working OK but when you are testing by manual method/Gel method; you are making sure other equipment/reagents are working OK.

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We use gel method and most of our reagents are QC'd on the ProVue. We do not repeat the reagent QC using manual methods. The "manual" equipment, MTS centrifuge and incubator, are QC'd daily - temp - timer countdown, and displayed RPMs within certain range.

JB

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The purpose of performing QC is to assure that the reagents are working properly in the manner in which you are using them.

So this would mean performing QC on both the instrumentation and manual techniques (at least "on the day of use", in case you do not use tube testing every day.)

Donna

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We do daily QC on the reagents and methods not used on the instruments by our manual backup method daily (IAT, anti a,b, checkcells) which ensures the other equipment and reagents work properly. The ABORH test is done by direct agglutination on the Galileo. Does anyone know of any regulatory requirements that state daily QC must be performed by both methods?

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We use different reagents on Echo than we do for manual testing, so we perform QC both ways daily. If we used the same reagent, I would be inclined to think that the reagents should be QC'd for each platform used, but I can't cite a specific source for that.

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One other attribute of QC I didn't see mentioned. You are also QC'ing the user. Is the staff performing the testing correctly? There is more to the testing than just the reagents being functional. Therefore, I see the need for QC of all methods in use at least once each day of use.

:ohmygod:

I know John you would be thinking same as me...

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One other attribute of QC I didn't see mentioned. You are also QC'ing the user. Is the staff performing the testing correctly? There is more to the testing than just the reagents being functional. Therefore, I see the need for QC of all methods in use at least once each day of use.

:ohmygod:

We are performing direct observation audits routinely so we are "QC'ing the user" to determine if the staff are performing the test correctly. We perform correlation studies 2 x year in which we correlate automated vs manual methods. I have searched the regulations and can't find any requirement addressing the initial post.

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We use manual tube testing as our backup method . Never thought of daily reagent QC as a way of checking technologist technique. We do QC once daily, have 18 some technologists. Our Daily QC is to ensure the correct lot #'s are in use and they work as expected. We dont currently repeat the ABORH test/reagents by tube method, the instrument uses the very same reagents. I'm comfortable with this, just concerned if there are any regulations out there so we are in compliance. I appreciate everyones input :)

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One other attribute of QC I didn't see mentioned. You are also QC'ing the user. Is the staff performing the testing correctly? There is more to the testing than just the reagents being functional. Therefore, I see the need for QC of all methods in use at least once each day of use.

:ohmygod:

We are decidedly not QC'ing the user. We do proficiency and competancy testing of our staff for that purpose. If it were QC'ing the staff then we would have every staff member running some sort of QC for every assay they perform evey day. That is not the standard as it is understood today.

We are, however, QC'ing the method and not simply the reagent. With that understanding we should be testing both our automated method as well as our manual method regardless of whether or not they share the same reagents.

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Hello Webersl,which manual method do you use,tubes?

Tubes for ABORH, gel for antibody screen, a combination (if needed) of gel and tubes for antibody identification - otherwise, if we can, we do the whole identification in gel.

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We also perform daily QC on the ProVue for all Gel Cards and reagents in use. We use the same reagents for manual gel QC. However, as aakupaku stated, the manual gel equipment (centrifuge, pipette) is not QC'd daily. So we perform just an antibody screen using an IgG card by manual gel as additional QC. After reading other's posts maybe this additional QC is not necessary since we QC our equipment regularly by checking centrifuge rpms and timer and pipette accuracy and precision.

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We rotate our staff weekly on each station and all OCs and PMs are divided among each station so bascially we are making sure all techs performs QC by each method atleats once every month. I have inspected hospitals where only one tech knows how to do PM on each equipment as he/she is responsible for doing PM or QC on particular equipment. I do not like that as when you ask question to other techs they have no clue!!!

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We rotate our staff weekly on each station and all OCs and PMs are divided among each station so bascially we are making sure all techs performs QC by each method atleats once every month. I have inspected hospitals where only one tech knows how to do PM on each equipment as he/she is responsible for doing PM or QC on particular equipment. I do not like that as when you ask question to other techs they have no clue!!!

All very good in larger labs. But smaller labs can't necessarily rotate like this. We have 1 person in BB on AM and PM, though they sometimes have to help out in main lab. There is only 1 gy person. But gy only does emergency work so GY is the one who does QC. If we run out of something and a new reagent needs to be brought in then a person on another shift must do the qc. All of this is documented in the procedure manual. PM is AM responsiblity as that is when BB is staffed the best (1 person, more or less dedicated to BB). These procedures are also in the procedure manual if someone new is there. So our 'stations' are not really rotatable in that personel are assigned by lab staffing and not just BB. And often BB is understaffed. We fit the 'tasks' where they work into the workload/staffing best. But yes, this means some people don't get a chance to do everything. Though everything is documented in procedure manual in step by step format should they find themselves having to do something out of their norm.

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  • 4 years later...

Sorry to bring a post back..

But I'm watching that Immucor Webinar Proficiency, Competency and QC: A practical approach to CLIA requirements and AABB, CAP and Joint Commission expectations

 

It just said to Rotate QC through all who perform patient testing.  Is everyone doing that now?   We currently only have day shift doing the daily QC.

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2 hours ago, amym1586 said:

Sorry to bring a post back..

But I'm watching that Immucor Webinar Proficiency, Competency and QC: A practical approach to CLIA requirements and AABB, CAP and Joint Commission expectations

 

It just said to Rotate QC through all who perform patient testing.  Is everyone doing that now?   We currently only have day shift doing the daily QC.

Amy, we recently switched to rotating QC through all shifts this year, after re-interpreting CAP/CMS regulations. I think the staff were || (this close) to a mutiny but it's improved our operations overall because now everyone is more comfortable with performing and documenting QC.

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