Hello, I recently started working at a Hospital Blood Bank & need to clarify about CAP QC requirement. The QC at the new place is very extensive. We run a positive & negative control for all the reagents daily including the A2 cells. At my old work place, we only ran Positive control for ABORH reagents except for Anti-D. Yet, they got never cited by CAP nor AABB. Is it necessary to run negative controls for ABO antisera & A1 & B cells ? I feel like lots of precious reagent is wasted each day & want to revise our QC policy .Appreciate your inputs. Thank you.

CAP states that a positive and negative test should be run for all reagents, each day of use. However, there is always the bit about following manufacturers recommendations that's involved in meeting CAP requirements. If the manufacturer of the reagents your facility uses recommends running only positive controls daily and your SOP cites that, it's OK to do so. However, even if the package insert states that, your lab's policies may require more extensive QC for reasons specific to your department, facility or the supervisor's preferences. Can't hurt to ask your blood bank supervisor to explain the CAP requirements as they apply to the QC done. 

 

I always preferred running positive and negative controls.  FDA only requires that for anti-D (and gel). 

I also dislike the attitude of doing the minimum.  We QC our gel and tube reagents w pos and neg controls.

28 minutes ago, AMcCord said:

CAP states that a positive and negative test should be run for all reagents, each day of use. However, there is always the bit about following manufacturers recommendations that's involved in meeting CAP requirements. If the manufacturer of the reagents your facility uses recommends running only positive controls daily and your SOP cites that, it's OK to do so. However, even if the package insert states that, your lab's policies may require more extensive QC for reasons specific to your department, facility or the supervisor's preferences. Can't hurt to ask your blood bank supervisor to explain the CAP requirements as they apply to the QC done. 

 

I don't think that is correct about dumbing down to manufacturer's recommendations.  I believe the regs read that at a minimum, manufacturer's requirements for things like QC be followed.  CLIA/JCAHO/CAP regulations are often much more strict than what a particular manufacturer may suggest for their product. 

If you choose to not run a pos and neg control, you better have a better reason than, "the manufacturer said it was OK."

Scott

12 hours ago, Jane12 said:

Hello, I recently started working at a Hospital Blood Bank & need to clarify about CAP QC requirement.  I feel like lots of precious reagent is wasted each day & want to revise our QC policy .Appreciate your inputs. Thank you.

I probably shouldn't go here but I'm curious.  You said that you recently started working at a hospital blood bank, how long is recently?  You also state that you want to revise the QC policy, are you the supervisor or medical director at this facility?  

18 hours ago, Jane12 said:

Hello, I recently started working at a Hospital Blood Bank & need to clarify about CAP QC requirement. The QC at the new place is very extensive. We run a positive & negative control for all the reagents daily including the A2 cells. At my old work place, we only ran Positive control for ABORH reagents except for Anti-D. Yet, they got never cited by CAP nor AABB. Is it necessary to run negative controls for ABO antisera & A1 & B cells ? I feel like lots of precious reagent is wasted each day & want to revise our QC policy .Appreciate your inputs. Thank you.

How many reagent racks do you QC daily?  I wouldn't QC A2 cells daily unless I used them routinely for ABO grouping? There may be other reagents that you QC daily that aren't used daily.

I have been CAP and AABB for 30 years, and I only run pos QC,except both pos and neg for anti D.  Never had a problem.

3 hours ago, ANORRIS said:

I have been CAP and AABB for 30 years, and I only run pos QC,except both pos and neg for anti D.  Never had a problem.

Exactly!

That said, I do currently choose to run positive and negative controls every day of use, though it's not required. Just anal that way I guess. Before that however, for quite a few years I had a statement in my SOP that said I was following manufacturer's recommendations for QC, did the pos and neg for anti-D, and I also never had a problem with inspections. The FDA and CAP had no issues with our QC.

 

On 5/2/2019 at 8:26 AM, SMILLER said:

I don't think that is correct about dumbing down to manufacturer's recommendations.  I believe the regs read that at a minimum, manufacturer's requirements for things like QC be followed.  CLIA/JCAHO/CAP regulations are often much more strict than what a particular manufacturer may suggest for their product. 

If you choose to not run a pos and neg control, you better have a better reason than, "the manufacturer said it was OK."

Scott

The FDA didn't have a problem with it when they were inspecting us.

2 hours ago, AMcCord said:

The FDA didn't have a problem with it when they were inspecting us.

that's right - in the CFR.  The feds can take you to jail if they don't like what you are doing.  Everyone else - you can amend your SOP if you need to.

23 hours ago, AMcCord said:

The FDA didn't have a problem with it when they were inspecting us.

The FDA is one thing. But in the US, you have to also follow the CLIA regs.  Your inspection agency must, at a minimum, satisfy those in their standards.   See the CFR for QC, and review your inspection agency's' standards.  You will see what I mean.

Scott

We use ortho confidence system for qc, there are even quality control record sheets in the box you could use as a template, it is SO easy to do pos/neg controls for anti-A, anti-B, anti-AB, anti-D and rh control, does not take any more time or use much reagent, so in my opinion just do it

We very rarely resort to running manual gel so I gave up doing the controls on it daily a few years ago. We run them if the Vision is down, but of those rare times we have to run manual stuff the reagents have been QCd on the Vision already that day. It makes me wonder if you took the reagents off of the machine to use manually in that case, could you then just do some abbreviated QC. All you'd really be checking is the pipette, incubator, and centrifuge (which work as expected 99.9999% of the time). So I wonder if just running a positive and negative DAT would suffice.

Automated Gel and Manual Gel are two different methods each method requiring Daily/Day of Use QC.  For these reasons, running a positive and negative DAT would suffice only for DAT testing that day, but not for any other test run by Manual Gel.

On 5/4/2019 at 9:39 AM, SMILLER said:

The FDA is one thing. But in the US, you have to also follow the CLIA regs.  Your inspection agency must, at a minimum, satisfy those in their standards.   See the CFR for QC, and review your inspection agency's' standards.  You will see what I mean.

Scott

We've passed several CLIA inspections within the past 10 years.

2 hours ago, AMcCord said:

We've passed several CLIA inspections within the past 10 years.

Yay!  But see CFR 493.1256 (d) (3) (ii) and get back to me on what you think that means.

Scott

Thank you much for all the valuable advice. I am new lead at the current blood bank & wanted to revise our QC policy.  

On ‎05‎/‎10‎/‎2019 at 11:42 AM, Darren said:

We very rarely resort to running manual gel so I gave up doing the controls on it daily a few years ago. We run them if the Vision is down, but of those rare times we have to run manual stuff the reagents have been QCd on the Vision already that day. It makes me wonder if you took the reagents off of the machine to use manually in that case, could you then just do some abbreviated QC. All you'd really be checking is the pipette, incubator, and centrifuge (which work as expected 99.9999% of the time). So I wonder if just running a positive and negative DAT would suffice.

Those are 2 distinct systems.  They each need to be qc's day of use.

On 5/13/2019 at 9:45 AM, SMILLER said:

Yay!  But see CFR 493.1256 (d) (3) (ii) and get back to me on what you think that means.

Scott

That could include appropriate and expected patient test results fgr specific antisera that are non-reactive, if your SOP states that this is how you do your negative controls. Specifically anti-A, anti-B and Anti-A,B. It doesn't say what your negative control materials have to be.

Our hospital only did the minimum for years and was never sited. However, a few years ago it seems like the CAP standard changed to read that all reagents must be tested with positives and negatives. Or maybe I REALLY read the wording closely. So I redesigned my QC with pos and neg for all reagents. And we do check the A2 cells everyday. I know if I left that off, my people would forget to do QC on the rare occasion they actually needed to use the cells. I try to stay ahead of the issue.

I will say, I was inspecting a hospital about 2 years ago and I asked the person in charge of the BB about the negatives he wasn't doing. He pushed back really hard so I called CAP to get a ruling. CAP said doing only positives was OK and she sounded exasperated that I would ask such a question. I got the feeling she thought I was reading it too closely.

I didn't change my QC after that call and I still feel better about proving over and above what is the minimum necessary to prove the reagents work. No one can ding me for not doing enough. The reagent use is minimal and I don't feel I am wasting reagents.

I think you could define the"test" as an ABO/Rh (or even just ABO).  In which case the test's negative QC would include that done for the forward typing.  So that CFR 493.1256 (d) (3) (ii)  would be satisfied.

Scott

4 hours ago, SMILLER said:

I think you could define the"test" as an ABO/Rh (or even just ABO).  In which case the test's negative QC would include that done for the forward typing.  So that CFR 493.1256 (d) (3) (ii)  would be satisfied.

Scott

Are you saying that because the ABO Determination test is self-validating, that those test results can also be interpreted as ‘negative’ QC for the reagent red blood cells and the reagent antisera?  Extending that logic, then why can’t those same test results also be interpreted as Positive QC for both sets of reagents!

Please help me to understand.  Is there any precedent in laboratory medicine for a test to be considered self-qc'ing (I know this isn't a valid word) and therefore not requiring separate positive and negative controls?

On ‎5‎/‎22‎/‎2019 at 6:21 PM, Dansket said:

Are you saying that because the ABO Determination test is self-validating, that those test results can also be interpreted as ‘negative’ QC for the reagent red blood cells and the reagent antisera?  Extending that logic, then why can’t those same test results also be interpreted as Positive QC for both sets of reagents!

 

Please help me to understand.  Is there any precedent in laboratory medicine for a test to be considered self-qc'ing (I know this isn't a valid word) and therefore not requiring separate positive and negative controls?

No.  I was being the devil's advocate for other posters in that post.  We have been using pos and neg control material for all of our ABO reagents for many years.

Scott

Our QC was minimal several years ago based on the fact that the first ABO back type would confirm the antisera. The standard says the Anti-IgG reactivity is checked during crossmatching. I think our QC only had about 6 tubes and 1 gel card.  Very minimal! But I started thinking that we didn't actually have proof the AHG worked on a particular day. (If it isn't documented you didn't do it) I thought proof needed to be added or some tech working that day would need to remember to mark the form hours later. I knew this would get missed multiple times in a year so I added these to the QC form. I even had them add the lot numbers of items that aren't QC'd like the saline cube or the AntiC3b,-C3b. If asked, I have a record of the lot numbers in use on that day if we should need cough up the lot number.

Later I read that all reagents must have a check against known positives and negatives so I expanded the QC. It now has about 13 or 14 tubes and 2 gel cards. It is overkill but like I said they can't ding me for not doing enough. I would rather do too much than not enough.

Could anyone ever be so kind and send me an example of their tube (manual) daily QC procedure so I can take a glance? I am amending our current QC policy to reflect the "neg" tube qc  that are needed to meet regulations.   Could use a hand. Thank you