Jump to content
KKidd

Daily Quality Control

Recommended Posts

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:

Share this post


Link to post
Share on other sites


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?

Share this post


Link to post
Share on other sites

It does not state in the CAP standards that QC must be done within +/- 30 minutes of each day. They just state that QC must be performed each day. Our QC form only has the date and no one has ever questioned the time. That must be the rule where the inspector works so therefore it must be the LAW!

Share this post


Link to post
Share on other sites

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. 

Share this post


Link to post
Share on other sites

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.

Share this post


Link to post
Share on other sites

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. 

Share this post


Link to post
Share on other sites

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.

Share this post


Link to post
Share on other sites

Kirkaw - I kind of like that every regent in use is tested - just the opposite of CAP which says only one bottle of a lot in use needs to be qc'd each day.  You can have racks out all day and night and never qc those reagents if you follow the CAP guidelines.

Share this post


Link to post
Share on other sites

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.

Share this post


Link to post
Share on other sites

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

Share this post


Link to post
Share on other sites

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

Share this post


Link to post
Share on other sites

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

Share this post


Link to post
Share on other sites

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

Share this post


Link to post
Share on other sites

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.

Share this post


Link to post
Share on other sites

I agree with all of the above posters. The regs specify "daily". We try to get it done first thing on first shift, but real work comes first.

Share this post


Link to post
Share on other sites

Has anyone ever had a routine BB reagent (antisera, screen cells, reverse grouping cells) not work? A CAP inspector asked me that question. My answer was no.

Share this post


Link to post
Share on other sites

The only thing I can think of is the occasional weak false positives we get on gel card/screen cells as they age.

 

Scott

Share this post


Link to post
Share on other sites

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.

Share this post


Link to post
Share on other sites

We like to tease our inspectors and tell them that we have done 30 years of validation and decided we don't need to do QC because it always works!  It warms them up and we usually have a pretty good day after that! :D

Share this post


Link to post
Share on other sites

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.

Share this post


Link to post
Share on other sites

Create an account or sign in to comment

You need to be a member in order to leave a comment

Create an account

Sign up for a new account in our community. It's easy!

Register a new account

Sign in

Already have an account? Sign in here.

Sign In Now

  • Advertisement

×

Important Information

We have placed cookies on your device to help make this website better. You can adjust your cookie settings, otherwise we'll assume you're okay to continue.