Coming from a reference lab perspective, we couldn't do our job if we didn't use some expired reagents.  We have 2 LN2 tanks that hold our library of rare cells.  It has taken our lab over 40 years to accumulate these resources.  In some cases, our cells are from the propositus the antibody/antigen was named after and the donor is no longer alive.  You can't get most of these cells commercially.

In some instances, it appears that regulating groups try to control something just for the sake of control.  Control of a service/technique doesn't necessarily make it better quality, it just makes it more expensive or prohibitive to provide.  Immunohematology isn't like chemistry, hematology, urinalysis, etc.  It's not as easy to put this part of the lab in a box.  At least, that's my opinion.

And there is no such thing as a "mere generalist".  There is much to keep track of when you are working in several different departments; that's no "mere" feat.

1 hour ago, SMILLER said:

It seems odd that we expect less oversight for an area within the lab where the potential outcome of even one mis-interpretation of a test outcome could mean life or death for our patients.

Surely though, any error or oversight in a Transfusion Laboratory  could result in an outcome that could result in either life (if you are lucky) or death (if you aren't), whether you are using time expired panel cells, or in date panel cells?

Just sayin'............

Malcolm

2 hours ago, SMILLER said:

I just have to observe here (being a mere generalist) that when an inspector finds us using ANY expired  reagent or control anywhere else in the Lab, we would certianly be cited---regardless of any evidence of a "rash of patient morbidity/mortality due" to its use.

It seems odd that we expect less oversight for an area within the lab where the potential outcome of even one mis-interpretation of a test outcome could mean life or death for our patients.

 

Just sayin'...

 

Scott

I see your point SMILLER/Scott. It's a fair argument. I'm not advocating "less oversight", but merely acknowledgement that an immunohematology work-up often has a lot more "grey/gray" than the other pathology disciplines. As we all know, "antibodies don't read books" and sometimes it takes all of your resources and experience to resolve a serological problem, including the prudent use of expired materials (or frozen inventory).

One could argue that absolute prohibition of using expired reagents in such cases could potentially put a patient at more risk by leaving an issue unresolved. Using all of your tools, in-date or otherwise, to get a good answer might outweigh the regulatory implications.

As I alluded to earlier......I don't recommend front-line techs use expired reagents willy-nilly - they should be used surgically and by those skillful enough to recognize the limitations.

On 12/14/2016 at 11:48 AM, exlimey said:

"Sometimes I think that the "regulators" feel obliged to fix problems that don't exist."

This is totally true 

43 minutes ago, applejw1 said:

but I know when they report that an anti-Ge3 or anti-Vel was identified in the patient's sample that rare frozen-thawed cells must have been used at some point in the investigation, right?

Not always, but I must admit, mostly!

3 hours ago, applejw1 said:

- but I know when they report that an anti-Ge3 or anti-Vel was identified in the patient's sample that rare frozen-thawed cells must have been used at some point in the investigation, right?

And in the examples you suggested - probably with the strategic application of some chemical and/or exotic enzyme treatments. Totally out of control. Scandalous!

Just now, exlimey said:

And in the examples you suggested - probably with the strategic application of some chemical and/or exotic enzyme treatments. Totally out of control. Scandalous!

Possibly!

I think that a lot of this "fixing problems that don't exist" stems from the change with CMS/CLIA when they combined all the subsections.  Immunohematology used to be separate, but now we are lumped in with Chemistry and Heme, and CMS can't quite get that blood bank is different.  Just my opinion.