Documentation of gel testing vs. tube testing

[Prilly]

Can anyone tell me if it is a requirement to document what method the tech uses to perform the testing? (gel vs. tube) We utilize both methods in our laboratory. Currently we document the method in our log book (yes, we are still paper). We are in the process of installing computer software and validating it. I had in my head that it was a requirement, but wasn't positive. The software doesn't have a way to document this that I am aware of, so I am trying to see how creative I am going to have to be to stay compliant.

[AMcCord]

We are still on paper as well. I currently require documentation of the method used. My rationale is that it's going to be easier for me to evaluate what someone else was getting with a problem patient if I know how they were doing it. It would also allow you to track reagent or method sensitivity problems if you knew what was being used in a given time period and with which patients. I don't believe that is specifically a requirement on the CAP checklist to document method by patient, though you do have to document which lot #s of all reagents in use on a given day.

[Deny Morlino]

We are paper as well. My techs document when they go to tube method (primary is gel) in the workbook so it is easy to track. Just thinking about the two methods I would be inclined to set up both testing methods in the software since there are different resulting schemes for each. With tube there is IS, AHG, and Coombs so that would require three results per screen cell anyway vs tube method needing only a single entry per screening cell. Just my 2 cents worth.

[David Saikin]

I find it interesting that your techs can use either methodology . . . is one a primary or can they just decide which one they want to use? My lab is primarily gel - we would not use tube testing for anything routine except a quick ABORh.

[Prilly]

I find it interesting that your techs can use either methodology . . . is one a primary or can they just decide which one they want to use? My lab is primarily gel - we would not use tube testing for anything routine except a quick ABORh.

Gel is our primary, except for our repeat front types that we primary do in tube. Most testing is performed in gel and that is the choice of most techs. It would be rare to perform an Antibody Screen in tube, but not really a rare occurence to see a full type performed in tube. We do stock and QC tube reagents and they are available for use if need be. I just wasn't sure if it was a requirement to document, since I have documented at every other institution I have worked at.

[Likewine99]

I'm not aware of a reg that states that you have to list what methodology you used. I would outline in your SOP's which test is your primary method with your secondary method used as backup.

You could also add a statement somewhere in the procedure that says something similar to: "Gel (or tube) is the primary test methodology. Secondary/backup methods may be employed as an alternate method of testing."

One you switch from paper I bet your system will tie the testing to a QC rack.

[AMcCord]

We use the Echo for our primary, with tube types for confirmation. If we have problem patients that are not clear cut, then we may use tube. We stock and use both PeG and LISS for tube screens and panels, when needed. When I'm reviewing a tube antibody ID panel or repeat screen, I want to know which enhancement method was used - it helps in the interpretation of results. We do have to have documentation for comparability of methods, so every method you use is going to add some paperwork. If you like life simple, stick to one method and send out anything that doesn't play nicely.

The suggestion to state in your SOP which method is primary and which is secondary sounds good to me. I'm going to review my SOPs with that idea in mind.

[tbostock]

We built different tests in our LIS so it is documented. Gel screen, PeG screen, etc.

We also have it in our SOP that the Tango is our primary method, gel is secondary, etc.

[Barbarakym]

The only requirement I know is to follow your policy. The blood bank is legally responsible for the results it turns out regardless of method and doctors do not need to know how you got to your answer. Of course the blood bank does need to know. So in your procedure you should (I believe) have the proper flow chart. What method for what test is primary and when and where you go to next if primary does not work (or reagents are unavailable). This should be defined in your procedure manual. And when you review your work-card or log or whatever you use to follow people's individual work should show all steps done. These steps should correspond to your policy. Then you are compliant (provided your policy is compliant of course).

[SMILLER]

Not sure about AABB or whatever but CLIA surrogates like CAP and JCAHO are going to want to know what you used for ANY test in the Lab. I believe this means that, should an inspector trace a BB test, they are going to want to see documentation about which reagents are used in addition to abunch of other stuff.

Having saud that, look at your software and see if you can set up alternate fields on the same entry window for entering screening results. One set for gel, one set for tube. You'll need to do the same thing for crossmatch entry.

I would contact other users of your system (if you haven't already). These types of problems have probably been figured out by some other lab using ther same software.

[applejw]

We use automated testing on the Galileo as our primary with different test codes in our computer system to designate the 2 cell and 4 cell screen. When we switch to gel (our secondary testing method) we have a different test code to desginate a gel 3 cell screen. If we use tube, we have a 4th test code to designate the tube method (ABSC tube) with a 3 cell screen.

A similar method could be used for paper documentation but any time results are documented it is important to designate the enhancement plus Coombs reagent (polyspecific vs IgG).

[Barbarakym]

Not sure about AABB or whatever but CLIA surrogates like CAP and JCAHO are going to want to know what you used for ANY test in the Lab. I believe this means that, should an inspector trace a BB test, they are going to want to see documentation about which reagents are used in addition to abunch of other stuff."

For those of us on paper systems (like original poster, software niceties don't apply).

For those that have computer systems which record reactions, your policies still take precedence. You define your workflow in your policy. For work that does not follow the primary flow path, some software will allow different fields so internally you can document how you came to that result. Others do not and you have to put in a internal comment. I have worked in several places with several systems not all computer systems are good at individualist entry systems.

Still, all in all, the doctors do not need to know if you came upon your answer viz tube, gel or whatever. They just need the result. If you report out chemistries on your main analayer and now it is down, you do not need a different reporting field for the back up analyzer. Internally in the department you have already validated your instruments and your results on both insturments and yes your CLIA and other accrediation agencies do need to know that, but the doctors do not. They expect the same good results from you regardless of how you obtained them.

[Malcolm Needs ☆]

We always record the reagents used for each and every test, and the method of testing. I think that this is good practice for one thing and, secondly, may be required in court if the worst comes to the worst.

[MAGNUM]

Can anyone tell me if it is a requirement to document what method the tech uses to perform the testing? (gel vs. tube) We utilize both methods in our laboratory. Currently we document the method in our log book (yes, we are still paper). We are in the process of installing computer software and validating it. I had in my head that it was a requirement, but wasn't positive. The software doesn't have a way to document this that I am aware of, so I am trying to see how creative I am going to have to be to stay compliant.

Our primary method is Gel, only on rare occasions such as quick types, retypes, abid's, etc. do we use tubes. On those occasions I have spreadsheets set up in the computer system for both the tubes and for gel testing.

[Barbarakym]

Yes Malcolm. I agree. It needs to be documented. But not needed on the report that ends up on the patient chart.

[Malcolm Needs ☆]

Oh, I entirely agree there.

[donellda]

In our grid, we have to document whether we did our testing by gel or by tube.