Need HELP with extended antigen testing worksheet...

[mcclanmd]

Hello to all of you brilliant Blood Bankers out there! Let me start by saying how valuable this website is to me. The insight I obtain by reading all of the numerous posts is truly invaluable. We had our Joint Commission Lab inspection this week, and overall, things went well. However, the inspector was not impressed with my extended antigen typing worksheet. When I showed him the documentation in MediTech, he said it was not acceptable to document only the reaction, along with the interpretation of POSITIVE or NEGATIVE. For example, if the reaction is to be read following a 10-minute room temp incubation, he wants precise documentation for the reaction, room temperature recording, and some sort of documentation to reflect that the reading was obtained after incubation. It was not acceptable to have all of this info in P&P. He said you had to document everything! Do any of you have any suggestions on how to fix this in MediTech? Would any of you be willing to share your extended antigen typing worksheets with me? I'm mentally drained at this point, and feel hopeless on how to fix this. I appreciate any and all help! Thanks in advance!

[David Saikin]

I am not familiar with how Meditech deals with abid's. Most systems have a page of cells #1-12 (or some such designation). Without the antigram I have always found these useless. We keep the paper antigrams and document above the reaction grids what we are recording (is.37C, ahg/igg . . . etc). I don't think you need to document that you incubated for however long you incubate - that is part of your procedure but it is good practice to be able to see at what phase(s) you are getting reactivity.

[Eagle Eye]

we do record all the phases for donor and patient antigen typing in cerner classic.

For antibody ID we do not document reaction for each cells--this is on antigram and paper document.

[Dr. Pepper]

I've been through many CAP, AABB and Joint Commission inspections and never heard of that much detail required! Too bad your MD inspector wasn't a gynecologist or psychiatrist. Did he insist on documentation that you actually incubated your antibody screens as well before washing or centrifuging?

Getting back to your problem, assuming you don't want to challenge the opinions of this nitpicking SOB, I don't think you can do much more in Meditech short of putting canned result comments in (lab eyes only), which still might be too generic. We use antigen typing worksheets as well, why not include a column or two in the grid to record room temp, incubation time etc.? If you have a platelet rotator that's in ambient air or a temp-controlled cabinet, I assume you have a temeperature recorder - you could do your room temp incubations there and use your recorder temp as documentation.

[ckcheng]

Do not understand what do you mean by extended antigen typing? Do you mean antigen type the patient or donor unit? If yes, then you should test the sample along with positive and negative controls, and document the reactions, then conclude the sample has or does not have that antigen.

Hope that helps.

CK Cheng, MSc, SBB(ASCP), CQA(ASQ)

[starmom]

We set up the usual result codes for antigen typing Reaction Results... the standard 0, 1+, 2+, 3+,.....but added a few specific to antigen typing: 0/0 (negative IS/ negative 15 minRT incubation), 0/* ( negative AHG/ postive Coombs check), etc. We defined the result codes in our procedure manual. We feel we've documented the reactions adequately but really haven't had any inspector question it.

[GilTphoto]

I don't like the antigen typing procedures that require 2 readings (I.S., then incubate negatives for 15 minutes.)

Why can't we just incubate all tubes for 15 minutes, then take only 1 reading?

Are we really in that much of a rush?

We only document the final result and have never been questioned by CAP or AABB. We don't document the incubation time either., That is in the procedure.

[ckcheng]

Can not help but follow the manufacturer's procedure.

Agree that result score in the final step to determine whether the reaction is positive or negative is the most important one.

CK Cheng, MSc, SBB(ASCP), CQA(ASQ)

[mcclanmd]

Thanks so much for all of your replys. I've only been documenting the final result, too. I hadn't been questioned by CAP, COLA, or JC until last week. I showed him the procedure for each anti-sera we use for phenotyping, but all attempts were useless! I am forced to submit a plan for corrective action within 60 days. He wasn't happy with my antigen typing worksheet, and I've been trying to devise a new worksheet. However, I can't seem to come up with a generic worksheet that works for all of the anti-sera I use for phenotyping. He even suggested a separate worksheet for each anti-sera I use, but I'm lucky if my techs use one worksheet, much less ask them to pick and choose the correct worksheet. Anyone have a generic worksheet that you'd be willing to share?

[David Saikin]

That's how I do these - I only incubate for the extended period and report the result. The IS/5 min reading is valid only for + tests . . . so why spin everything twice.

I don't like the antigen typing procedures that require 2 readings (I.S., then incubate negatives for 15 minutes.)

Why can't we just incubate all tubes for 15 minutes, then take only 1 reading?

Are we really in that much of a rush?

We only document the final result and have never been questioned by CAP or AABB. We don't document the incubation time either., That is in the procedure.

[Eagle Eye]

Do not include specific phases on worksheet. have threee columns, 1st one to write donor#, two more for phases...I have it blank and depends on phases(antigen testing procedure), tech can write phases...eg. 1) IS, RT 2) IS, 37 3) AHG, CC etc.

[vilma_mt]

Hello to all of you brilliant Blood Bankers out there! Let me start by saying how valuable this website is to me. The insight I obtain by reading all of the numerous posts is truly invaluable. We had our Joint Commission Lab inspection this week, and overall, things went well. However, the inspector was not impressed with my extended antigen typing worksheet. When I showed him the documentation in MediTech, he said it was not acceptable to document only the reaction, along with the interpretation of POSITIVE or NEGATIVE. For example, if the reaction is to be read following a 10-minute room temp incubation, he wants precise documentation for the reaction, room temperature recording, and some sort of documentation to reflect that the reading was obtained after incubation. It was not acceptable to have all of this info in P&P. He said you had to document everything! Do any of you have any suggestions on how to fix this in MediTech? Would any of you be willing to share your extended antigen typing worksheets with me? I'm mentally drained at this point, and feel hopeless on how to fix this. I appreciate any and all help! Thanks in advance!

I agree with the citation. In Blood Bank "everything" must be documented.

If Meditech does not give you the option, you may have to document results on paper and final result/interpretation in Meditech.

A generic form with:

IS / 37C / AHG or IgG / check cells

Method used example tube vs gel

Incubation time

Controls used

Remember document who did what when etc......

Goodluck

[dal6164]

If you will email me at david.a.lail@tenethealth.com I will share my antigen typing worksheet with you and maybe that will be a start for you.

[adiescast]

[ATTACH]474[/ATTACH]I don't know if it will help you or not, but here is mine.

Antigen Typing Form.xls

[Bill]

Adiecast, your worksheet looks very nice. I am going to update mine to the same. THANKS!

[Brenda K Hutson]

I have never heard of this requirement either. Our SOP clearly states to follow the Manufacturer's Instructions (and we certainly don't enter the method of testing for other reagents such as ABO Antisera, etc.).

In our computer system (HCLL), there is a place to document the strength of reactivity and interpretation, but it does not ask for the phase or time. We do also use a manual Antigen Typing Form which does have a space to document the "method," however, that was not created to meet a regulatory requirement, but rather to organize the work (especially if typing multiple units for multiple antigens), as well as have spaces at the bottom to initial that they entered the results in the computer, on the unit, and that heterozygous cells were used for the Positive control (due to internal issues of our own; I am requiring the Form). I keep the Forms until I audit the results in HCLL (which I do for all testing; to ensure proper controls were used).

Did they give you a specific reference for this requirement?

Brenda Hutson, CLS(ASCP)SBB

[tbostock]

There is no Joint Commission reg that specifically requires this level of detail. This was just the inspector's preference. In your response to the citation, quote the reg that was cited and explain how you believe you are meeting it. It is possible to get these citations overturned.