Good Day-

interested in what people are doing in regard to LIS upgrades and validation testing, specifically are you testing every possible product, ie LPC CP2D AS3, AS1, AS5 etc... with every possible compatible and incompatible type in documenting built in flagging systems where applicable or are you only testing a subset of products/blood types. In your response could you indicate if you are currently AABB accredited.

Thanks....

VH

We use the Meditech sytem and have built product groups for RBC, RBC Irr, PHP, PHP irr, FFP, etc. You can assign each product to a group. I validate at least one product from each group. We went live in June 2006 and have had 2 assessments since with no problems.

:boogie::boogie:

Do you test compatibility for each blood type?

Yes, I test each type against the others to make sure that the table I have set up is correct. In fact, I have just checked it again for an upgrade.

Yes we test compatibility table for each product.

I even tested emergency release making sure only O red blood cells can be given as uncrossmatched or to a patient whose blood type is not available.

Same way we make sure that we give only AB FFP to patient who doesn't have blood type available.

Usually when there is an upgrade the vendor provides validation scenarios to validate the processes which were upgraded. Utilizing those scenarios which are appropriate to your operation should suffice. My facility is not AABB but I am an active assessor.

If you have an upgrade of any part, I would advise full recheck, particularly any critical risk areas. We were caught many years ago by just checking the upgraded area, but the upgrade had affected another rule based response and luckily we had an experienced worker on who used her knowledge and over-ruled the warning that had flashed up. Can't remember the details of the scenario now, but remember that when we contacted the IT company, they told us it couldn't happen as they had not touched that part of the program - very apologetic when they came on site and we demonstrated the wrong warning coming up. It is a pain in the butt, BUT if you have inexperienced workers on-call they could be caught out, so well worth going the extra mile.

Cheers

Eoin

Our computer vendor provides validation scripts as David mentioned previously, and I find these very thorough and organized.

If you have an upgrade of any part, I would advise full recheck, particularly any critical risk areas. We were caught many years ago by just checking the upgraded area, but the upgrade had affected another rule based response and luckily we had an experienced worker on who used her knowledge and over-ruled the warning that had flashed up. Can't remember the details of the scenario now, but remember that when we contacted the IT company, they told us it couldn't happen as they had not touched that part of the program - very apologetic when they came on site and we demonstrated the wrong warning coming up. It is a pain in the butt, BUT if you have inexperienced workers on-call they could be caught out, so well worth going the extra mile.

Cheers

Eoin

I agree whole heartedly. Yesterday I was working in the test system of my current version of software and the blood type calculations did not work. Suppposedlly this happened when the test system for my upgrade was loaded. I test every operation even if there has been no change. The validation plans are provided by computer people and they don't think like we do.

Of course, who does!!!!!

:pcproblem:pcproblem:pcproblem:juggle::wave:

I go through all of the scenarios given by our IT vendor ( we have meditech) and then go back and make sure that all day to day operations are covered. I do crossmatches for every type, and make sure incompatibility comes up when it should. I also do antibody checks and try to fool the system in to letting me do something I shouldn't. As far as what was mentioned, the different additives/anticoagulants, we don't deal with that much, no one should unless they are a blood center. I am lucky ( not) in that I wrote/built most of my rules and calcs and know what is supposed to work and what is not. We are CAP, not AABB, probably could but we are non profit and the membership is a bit on the expensive side for institution. Hope that this helps.

KKidd, when I was working at a Meditech hospital as lab manager, I insisted that my old live ring be copied to the new test ring before I started any validations. By doing so, all known items in current live are copied to new test and takes away your situation. It also ensures that if any changes were made in live only, these are not lost. But who would ever make a change in live without working in test first?

I'm with LauraT23 and Eoin. Yes, testing is time consuming (and boring sometimes!) but you really can't test too much. At some point in the testing you will become comfortable that the system is doing what it is supposed to.

I've been involved with an upgrade that was thoroughly tested and when it was moved to Production a couple of things not related to the upgrade "broke". I've always gone back to the SOP's prior to an upgrade and tested the upgrade to make sure there weren't any major workflow changes.