Hi,

I have 2 unrelated questions regarding AABB requirements.

1) Regarding standard 6.1.4 annual policy/procedure review. Does there need to be a sign-off page for each procedure or just in the front of the manual. This would be for review only. Procedure revision would be handled with a different signoff sheet.

2) Regarding standard 2.1.3, competency testing. If you utilize CAP surveys but everyone has not pariticipated in one by year's end, do you manufacture your own specimens to demonstrate competence?

Thanks!

Amelia

Hi,I have 2 unrelated questions regarding AABB requirements.1) Regarding standard 6.1.4 annual policy/procedure review. Does there need to be a sign-off page for each procedure or just in the front of the manual. This would be for review only. Procedure revision would be handled with a different signoff sheet.2) Regarding standard 2.1.3, competency testing. If you utilize CAP surveys but everyone has not pariticipated in one by year's end, do you manufacture your own specimens to demonstrate competency

Hi Amelia, 1) At the last laboratory I worked, we had a signoff page for each procedure. In the laboratory I currently work at we simply have a list in the front of the book that gets signed off on every year. Neither have seemed to cause issue.2) Competency- We make sure that every tech gets a blind sample for each testing platform we have. In our case it would be Automated, manual gel and manual tube testing. We also have techs complete a tech check (that we get from Immucor) to cover antibody identification and unit antigen typing. Hope this helps! Shaunna

We have a single page sign off, but it must list each SOP, it can't be just a single signature for the whole book. And we rotate CAP surveys and make up specimens for anyone else that still needs a blind sample.Both CAP and AABB were good with our process during our May inspection this year.

You can use survey specimens for other techs (if there is enough volume) once the results are sent in and the deadline has passed I think. You surely can after the results come back but by then the specimen is pretty old. Some of the new companies offer a kit with quite a selection of antibodies that can be used for competency testing. I can't remember if Quotient does it or Hemobioscience.

I know it seems like overkill but we have a sign off sheet on the first page of every policy and procedure. We did this to satisfy a CAP reg. I agree with DPruden, one sign off sheet listing all procedures is easier.

Re: CAP survery samples, we do like Mabel, pass them around if there is enough sample. For those folks that haven't done a CAP survery, in my prior position I have used a "live example". That is, if they have done an antibody workup on a real patient, I make a copy of it and place it with my competency documents. In my book this qualifies as a "true unknown".

You could also do an unknown, dry case study for antibody competency. Have done that for people who only work occasionally and work off shifts.