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Daily Quality Control


KKidd

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Our transfusion service has one tech scheduled for day shift.  I have been informed that our daily QC must be performed at the same time (+/- 30 minutes every day). This works fine if you are not met with STAT work.  I would love to know how other small labs are scheduling their QC and how the time is documented.  Don't you just love inspections!

 

:confused:

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I'm staffed the same way. We do tube QC with patient work first thing in the AM, but no rigid specific time. Instrument QC and maintenance is at the mercy of the instrument - 24 hours from the time it was last done or you don't run patients...period. We try to do that at 1 PM to fit well into weekend and holiday schedules.

 

Just curious. Who's saying that everything has to be on a rigid schedule?

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I think it is coming from the Joint Commission standards.  Our Chem and Heme depts have been struggling with that one since we changed to Joint accreditation.  Blood Bank has not been roped into the standard yet that I know of (perhaps a surprise awaits!).  Currently I am struggling with trying to share the daily QC with all shifts.  Blood Bank and Micro have always done QC once daily on dayshift, now all techs on all shifts are required to  participate at lease once or twice a year - go figure. 

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I think it is coming from the Joint Commission standards.  Our Chem and Heme depts have been struggling with that one since we changed to Joint accreditation.  Blood Bank has not been roped into the standard yet that I know of (perhaps a surprise awaits!).  Currently I am struggling with trying to share the daily QC with all shifts.  Blood Bank and Micro have always done QC once daily on dayshift, now all techs on all shifts are required to  participate at lease once or twice a year - go figure. 

Yes, we just had our Joint Commision inspection last month and the regs do not specify departments.  My manager asked and she was told that daily QC should be done at the same time every day.  We use gel technology for our antibody screen/ID and AHG crossmatches.  Everything else is tube.  In order to get 2nd/3rd shifts to perform QC, it is a part of their annual competency test.

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I'd like to see the standard that says QC needs to be done at the same time every day, esp for BB and Micro.  I can see in Hem/Coag and Chem a "reasonable" about the same time.  Sounds like an individualized interp of a standard.  Folks need to not take inspectors at verbatim . . . ask to see the documentation. 

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We had a rigorous JC inspection this past summer and the timing of QC was not questioned. They did however, state that every bottle of reagent, used for tube, gel or automated testing needs QC run at least once daily. We have 2 sets of reagents for our Provue that are changed at approximately 7 AM and 7 PM. they are always the same lot #. Prior to our inspection, we were only running QC on the AM set. The inspector told us we needed to run QC on the PM set daily also, But she did not remark on a timeframe. I have studied the JC standards, CLIA and AABB standards quite thoroughly, and I do not recall any standard that states that QC needs to run +/- 30 min. of the same time each day.

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I am seeing more of these types of citations when inspectors who worked in Chem and Hemo want to apply all of these regs to BB and Micro. Some of them should be, and some just don't make sense. As David stated above, we're not looking for BB QC results to fit into a narrow range of values, but do they work as expected or not. And they always do.

Just like the correlation of methods: if you have 2 CBC anaylyzers, you need to correlate that the results from either analyzer are very close...makes perfect sense. Comparing tube testing with solid phase or gel is like apples and oranges; they don't always correlate so you're just proving what we already know...that if you have an Anti-K reacting 1+ in gel or solid phase, it will most likely be negative in tube testing.

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Same Time????? Where did that come from?? We have ISO15189:2012 and Joint Commission Int to adhere to and I have never been challenged on that. I would ask to see the regulation! We generally do it first up in the shift - repeated if new reagent opened - but not if in the middle of urgent XMs. Crazy stuff!

 

Cheers,

 

Wayne

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Not sure that never seeing a reagent work as expected, or not worrying about QC because you are not measuring a exact value, are good reasons to not worry so much about QC regs. 

 

A QC result that is neg or pos, like a screen cell result, better be right every time, unlike a chem result that may be off by a SD of 2.1, which may be acceptable depending on your westguard rule prorocol.

 

Scott

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Not sure that never seeing a reagent work as expected, or not worrying about QC because you are not measuring a exact value, are good reasons to not worry so much about QC regs. 

 

 

I don't think this is the issue - which seems to be that qc needs to be performed at the same time each day and/or by all techs at some point in time/JCAHO guidances.  We all do daily qc of our BB reagents - sometimes prior to work, sometimes concomittant with specimens.  My (our) concern is that the regs which may be justified for hem/chem do not seem appropriate for immunohematology.  My day shift does the main qc of the reagents used on a daily basis.  For the rare reagents, Fetal bleed screens, KBs - the techs perform qc along with the testing as per our policies. 

Edited by David Saikin
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I am no longer surprised when I hear about inspectors being so precise when writing up for deficiencies that we know are not going to affect patient results. 

 

Years ago, we go dinged in Coag because at one of our sites QC runs were not close enough to "every eight hours".  A few were 6, others 10, he wanted them ALL within 1/2 hour of "every 8".  But what can you do?

 

We have not had trouble with our "once a day" QC in BB, however, either from JCAHO or the FDA.  We run usually between 0600 and 0800.  Our BB system is set to outdate a QC run 30 hours after its entered.

 

Scott

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I agree with the other posters.  Our manual tube and Gel QC is once per day, usually early on the a.m. shift.  We can't be expected to drop everything in the middle of a massive transfusion protocol or other urgent situation just to run QC at a specified time.  Our automated QC (ProVue) is run on the night shift, usually around 4 a.m.  We have the instrument set to require QC after 28 hours to give us some leeway if it is crazy at the usual QC time.

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We occasionally get failed QC on the Echo which we were told is due to older  QC samples themselves. Immucor suggested we store our QC samples differently from what we were doing so hopefully that will help. We will also get failed QC of course if we forget to add the stir ball to a new reagent with red cells. ..... I don't recall ever seeing failed QC using the old tube method.

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Had the same arguement with an assessor once and I won!

She thought I should do the QC at the same time andd I pointed out to her that the standard read that it must be done DAILY. Thus our ProVue is set to require it's QC be run every 28 hrs max. instead of the 24 she was asking for.

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