Ortho Panel Cells -Quality Assurance

[ffriesen]

I am wondering how those of you who use  Ortho's Panel cells comply with the manufacturer's requirement for quality assurance to test periodically with weak antibodies. 

[SMILLER]

We use a dilution of our regular QC sera and run and document Pos and Neg QC results when we receive a new lot number.

Scott

[Laurie Underwood]

Same as SMiller. Was asked to be shown panel QC by our Joint Commission inspector and had it all documented in a folder to hand to him.

[AMcCord]

We dilute anti-K 1:20 with 6% albumin and run a K antigen positive and negative cell for QC every day of use.

[exlimey]

On 3/3/2017 at 9:08 AM, SMILLER said:

We use a dilution of our regular QC sera and run and document Pos and Neg QC results when we receive a new lot number.

Scott

Just to clarify and to play Devil's Advocate: Your facility's interpretation of "periodic(ally)" is once upon arrival ?

And, apparently, according to LaurieU, that met at least one JC inspector's requirements. Sounds too good to be true.

[exlimey]

On 3/7/2017 at 9:07 AM, AMcCord said:

We dilute anti-K 1:20 with 6% albumin and run a K antigen positive and negative cell for QC every day of use.

More Devil's Advocate: That only tests the K antigen - a very stable structure. What about other antigens that are more likely to and are known to deteriorate over time - Le^a, Le^b, Fy^b, to name but a few ?

The only value to testing a K- cell against a diluted antisera is to check the DAT on the chosen panel cell, i.e., it's potential to cause a false-positive. You could simply do a DAT instead.

I'm certainly not suggesting that everyone completely phenotype their Screening Cells and Panel Cells each day (or periodically). I'm all in favor of a minimalist approach to this issue, and it appears that similar testing algorithms are acceptable to inspectors. 

I really just wanted to highlight the flaws in this whole concept, from both the regulatory side and that of the users. And.....don't forget.....the manufacturer's of the red cell reagents have a huge amount of stability data.

[goodchild]

I think I'm with you exlimey. We don't do any QC with our Ortho gel panels, other than review every antibody ID within one business day and monitor for trends.

[KKidd]

We make a 1:20 dilution of Anti-Fya and test the panel cells prior to first use. 

[AMcCord]

1 hour ago, exlimey said:

More Devil's Advocate: That only tests the K antigen - a very stable structure. What about other antigens that are more likely to and are known to deteriorate over time - Le^a, Le^b, Fy^b, to name but a few ?

The only value to testing a K- cell against a diluted antisera is to check the DAT on the chosen panel cell, i.e., it's potential to cause a false-positive. You could simply do a DAT instead.

I'm certainly not suggesting that everyone completely phenotype their Screening Cells and Panel Cells each day (or periodically). I'm all in favor of a minimalist approach to this issue, and it appears that similar testing algorithms are acceptable to inspectors. 

I really just wanted to highlight the flaws in this whole concept, from both the regulatory side and that of the users. And.....don't forget.....the manufacturer's of the red cell reagents have a huge amount of stability data.

There is no 'good' way to run QC on a panel. In my mind, a better way to control a panel is to look at it and see if it makes sense with the results you get from your antibody screen. However, that doesn't seem to tick the box for QC for an inspector as well as a specific test defined in a policy.

Method comparison is another of those things that we do with questionable results. I run an antibody screen (or ID panel if I can find a patient with a nice antibody and enough plasma to spare) using all the methods we use, get different results from those screens and interpret it as differing sensitivity - something I expect to see. What have I proven by doing it? Nothing much. The results I get are not surprising. Works great for chemistry and hemo but does it give blood bankers information we don't already have/know? I'm still going to use the Echo for my primary method with tube/PeG for backup.

 

Edited March 9, 2017 by AMcCord

[SMILLER]

27 minutes ago, AMcCord said:

There is no 'good' way to run QC on a panel. In my mind, a better way to control a panel is to look at it and see if it makes sense with the results you get from your antibody screen. However, that doesn't seem to tick the box for QC for an inspector as well as a specific test defined in a policy.

 

I find it odd that in almost all other aspects of blood banking, from refrigerator temps to centrifuge speeds, there are specific regs on everything--and yet there are so many different ways to satisfy manufacturer's "periodically check" for QC on panels.  If someone knows of another reg in BB that is as inconsistently practiced and enforced, I would like to hear it!

I believe it is just one of those lab methods (there are several found in other clinical laboratory areas) where there is no practical way to ensure in the testing facility that the panel is going to work 100% as advertised by using some method of QC. One of those rare things where inspectors tend to hem and haw if asked specifically for guidance.

Scott

[mollyredone]

What we do is use the current cells for our QC for our antigen typing, using a heterozygous cell as a positive control for whatever antigen we are testing.  That seems periodic to me.

Edited March 9, 2017 by mollyredone
added QC

[goodchild]

My impression is Ortho used the "periodically" term as a CYA. I think it's sufficiently vague to be defensible by Ortho when there are problems with the reagent: "well, did you do your periodic QC?" and also vague enough that people like me can completely disregard it without being out of compliance, technically: "I define periodically as the 7th of never, unless inconsistencies are noted."

[John C. Staley]

This topic keeps popping up periodically and I find it both interesting and frustrating.  My personal view, as stated in previous discussions on the topic, is that what ever you do is little more than smoke and mirrors in an attempt to pacify some regulator.  I'm sure that's also why the manufacturer puts such nonsense in their package inserts. They claim specificity for many antigens yet it is acceptable to confirm the reactivity of a select few!!  I'm sure that can be rationalized but it still makes no sense to me.  

[exlimey]

3 hours ago, mollyredone said:

What we do is use the current cells for our QC for our antigen typing, using a heterozygous cell as a positive control for whatever antigen we are testing.  That seems periodic to me.

Very clever ! I like that idea, but suspect it would be a real pig to collect, collate and hand over said results to an inspector.

[exlimey]

1 hour ago, John C. Staley said:

This topic keeps popping up periodically and I find it both interesting and frustrating.  My personal view, as stated in previous discussions on the topic, is that what ever you do is little more than smoke and mirrors in an attempt to pacify some regulator.  I'm sure that's also why the manufacturer puts such nonsense in their package inserts. They claim specificity for many antigens yet it is acceptable to confirm the reactivity of a select few!!  I'm sure that can be rationalized but it still makes no sense to me.  

Well said. Smells like trying to fix a problem that doesn't exist. Or perhaps an attempt by regulators to align Blood Bank work to other pathology departments which do instrument-performed assays in a assembly-line fashion. Blood Bank doesn't fit.

[Malcolm Needs ☆]

11 minutes ago, exlimey said:

Well said. Smells like trying to fix a problem that doesn't exist. Or perhaps an attempt by regulators to align Blood Bank work to other pathology departments which do instrument-performed assays in a assembly-line fashion. Blood Bank doesn't fit.

Completely agree.  We have something called "the element of uncertainty" (it isn't "element", but it is something similar) that is required by one of our more officious regulators (not that any of them are less than officious), but we struggle with this because, apart from titrations/quantifications and measuring an FMH, I struggle to think of any tests that we perform that are quantitative, rather than qualitative, which means there is no "element of uncertainty" - as long as your controls have worked, but these numpties stil ask for evidence.  You will be surprised to learn that most of the inspectors for this particular regulator have never stepped foot over the threshold of a transfusion laboratory prior to inspection!!!!!!!!!!!!!!!

[exlimey]

59 minutes ago, Malcolm Needs said:

You will be surprised to learn that most of the inspectors for this particular regulator have never stepped foot over the threshold of a transfusion laboratory prior to inspection!!!!!!!!!!!!!!!

Unfortunately, I'm not surprised. I would consider myself lucky to get an inspector who even knows blood groups.

[SMILLER]

Here in Michigan in the US, overall we have had a few inspections where we are not quite comfortable with the way the inspector runs things, but they all seem to be pretty knowledgeable.  Our Lab is inspected by JCAHO and the BB also by the FDA.

Scott

[mollyredone]

21 hours ago, exlimey said:

Very clever ! I like that idea, but suspect it would be a real pig to collect, collate and hand over said results to an inspector.

We could show them our antigen typing worksheets so they could see the different lot numbers.  We keep two years of antigrams, although most of anti-sera testing is IS (3%) now, only Fya and Fyb are AHG, which we validated in gel.

[exlimey]

On 3/10/2017 at 10:10 AM, mollyredone said:

We could show them our antigen typing worksheets so they could see the different lot numbers.  We keep two years of antigrams, although most of anti-sera testing is IS (3%) now, only Fya and Fyb are AHG, which we validated in gel.

Fair enough. I was picturing the results living with each patient record, but if you're antigen screening donors and the results are kept together, that would be easy.

[DebbieL]

I redid my antigen typing sheet and included a column for the lot # of the panel we use for pos and neg controls on the day we perform testing. I end up with multiple examples of controls done on each panel until expiration. Yeah it is not a weak example but it might dazzle an inspector's eyes with quantity and with multiple different types of antigen controls. The controls must work as expected.

We use Immucor and thank goodness it just says we MAY test.

[Joanne P. Scannell]

We do both of the above ...

1. Test the panel against QC antisera upon receipt, as we do for all reagents; It shows the reagent survived shipment.

2. Record the Lot#/Cell# and antigen types (zygocity) of the cells used for Antigen Typing QC (heterozygous except K)  ... that's periodic enough.

[macarton]

We use a patient with an antibody that was tested with the previous lot before placing a new panel in use.  We haven't had any issues with past inspections.

[Malcolm Needs ☆]

3 hours ago, macarton said:

We use a patient with an antibody that was tested with the previous lot before placing a new panel in use.  We haven't had any issues with past inspections.

With all due respect, that means you have either "pulled the wool" over the eyes of an inspector who knows nothing about a blood group serology, or you have been lucky enough to come across an inspector who actually does know something about blood group serology, and realises that this kind of quality assurance of ANY panel (not just the Ortho panel) is nothing more than "smoke and mirrors" - and I am not blaming you for either scenario.

[SMILLER]

I think, in general, not too many inspectors want to go here.

Scott