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Quality control regulations?


masterchef
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I am a year into the lab tech career and am being given the task of taking over the hematology dept. Quite honestly it is a little messy right now. I am needing information on what the regulations are for running qc. We are in the process of getting a new analyzer, an Cell-dyne Ruby. It has two modes, can anyone tell me what the requirements are for commercial qc and patient qc. Thanks

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I would suggest that you get hold of a copy of the CAP or JCAHO (or whatever agency your Lab uses for accreditation) Inspection Checklist and start at the beginning......

You have a great learning opportunity with this assignment!!!

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I am a year into the lab tech career and am being given the task of taking over the hematology dept. Quite honestly it is a little messy right now. I am needing information on what the regulations are for running qc. We are in the process of getting a new analyzer, an Cell-dyne Ruby. It has two modes, can anyone tell me what the requirements are for commercial qc and patient qc. Thanks

I think you will find that in the US Hematology QC requires at least two levels run every day with at least one level run every "shift" (8 hours).

Scott

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  • 3 weeks later...

I have worked as a Med Tech for 25 years and have run a Heme department for just three years.. So I know the huge undertaking you were just handed....good luck to you! We run three levels of commercial QC every 24 hours. You do not have to run a patient control at all. One instrument is qc'ed on day shift, the other on midnight shift. You do not need to run QC on every shift. As far as the two modes go, as long as you run correlations at least once or twice a year (i cannot remember the exact CAP recommendation since we do this monthly for peace of mind!) you will be ok. We are going to be purchasing new heme instuments in the next 9 months. The Ruby is out of the question because of having to mix your own retics...but the technology is great. Love the optical platelet...we had Cell Dynes years ago...hope that helps!

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"We run three levels of commercial QC every 24 hours. You do not have to run a patient control at all. One instrument is qc'ed on day shift, the other on midnight shift. You do not need to run QC on every shift. As far as the two modes go, as long as you run correlations at least once or twice a year (i cannot remember the exact CAP recommendation since we do this monthly for peace of mind!) you will be ok."

That's odd-- much less strict than what I thought they were. Do you have a reference?

Two inspections ago we were surprised to be cited by JCAHO for not having QC on both modes. Likewise, they wanted to be sure we ran at least one level of QC per "shift". Rather than using up twice as much QC material, we have been using a patient control to correlate the two modes once/shift.

We are running two levels of QC for coag tests/shift as well. Maybe we are overdoing it.

I imagine that, if anything, CAP regs would be even more strict.

There is a more practical issue as well. If you only run QC once every twenty four hours, what happens when you find you are out of control? If it can't be resolved, you have 24 hours worth of results that you will need to somehow validate.

For the same reason, I believe you are required to run QC after a reagent change.

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SMILLER, Thanks for the input...you know anyone can say anything on these forums so it is good to get references. If it makes you feel any better, my department had no deficiences at our last CAP inspection for what it is worth.

CAP standard HEM.35850 says Two different levels of stabilized controls are analyzed and results recorded during each 24 hours of analyzer use. We also use XB and XM to ensure our instruments are running well. We have never had our QC go out. Once in a while a vial will go bad, but our QC is always right on. My husbands lab is JCAHO inspected and they are required to run QC every 8 hours. Funny that they are more strict!

We do not run QC after a reagent change (see HEM.24575). When new reagents are put on, you have to do something...you can run QC if you wish (expensive), or you can run a patient you previously ran on the old lot. Again, the med director sets tolerance limits. For inert materials like diluent, you just have to run a background on the reagent lot number. We do this when the diluent comes in...check one background on one box to say the entire lot/delivery is QC OK. The med director sets tolerance limits for this as well.

HEM.30070 states that if you have more than one sampling mode that you must annually compare results between the modes. Our Medical Director has set tolerance limits for this comparison. We do it monthly though it is only required annually.

But, you are correct, you must run Coag QC every 8 hours! HEM.37300

Good Luck!

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Thanks Lah66

I am indeed surprised that JCAHO is more strict on this than CAP! They both kowtow to CLIA, and I always think of JCAHO as regulating to the minimum. Its possible they are over interpreting the requirements.

With a recent inspection we now have a 6-point competency check-off that is way out there. Hours and hours of work for managers and supervisors that we did not do before. There is always something new, but I wonder if someone at JCAHO has been drinking too much coffee...

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  • 8 months later...

JCAHO is not only more strict with the "each mode, every 8 hours", but they also want that QC to be done within a 30 minute time window. We set our QC to be done at 8am, 4pm, and midnight. That means that the days shift has to run their QC between 0745 and 0815. Sounds easy enough, but throw patient stats and phone calls into the mix and it gets to be a hassle on all shifts, expecially when the second and third shifts have fewer people!

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  • 2 weeks later...

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