Marianne

From the management side; involve the tech. Meet with them and have a conversation about how/why the think the error occurred.. Make them feel involved in QA and PI by asking if they have any suggestions that may prevent a recurrence. Front line staff often have great PI ideas, but won't speak up. During the conversation you will also be able to get a good feel for whether the tech knows the procedure and is committed to following processes as written, needs some re-training or whether they purposely deviated because the had "a better way".

We are looking for comments on the BioRad Tango instruments from any current users on this site. If you are currently using the instrument and can share feedback with your experience (reliability, service response and so forth), it would be greatly appreciated. Thank you-

Transfusion competency-final.xlsx I have attached again and I hope it opens for you this time. The sites often insert a copy of the documentation into the appropriate box. You could also just type in the accn number as well for easy reference.

Our integrated Transfusion Services workgroup is reviewing the requirements for serological centrifuge calibration. After reviewing both AABB (stds 3.2 and 3.5) and CAP regulations (TRM.31900, COM.30600,COM.30625,COM.30550) and manufacturer's inserts, the group still is not in accord about a standard policy. The need to perform calibration upon receipt and after repair is very straight forward. But for years many of the group have performed this task annually. That is not mandated anywhere and the "functionality" testing or "defined intervals" lines in the regs leave this open to interpretation. Therefore we wished to poll this group to see what our peers are doing. We would love to hear what other sites are doing to determine if there might be a national best practice in the US as part of our review before making a final policy determination.

I would suggest considering "issue" as the time the product is out of controlled temperature.

The final came out on Sept 20th, no longer a draft. We have 18mths to implement. Bacterial-Risk-Control-Strategies-for-Blood-Collection-Establishments_09-2019.pdf

If you meet whatever the qualifications are these days, you should do it!

This is the form developed by our system transfusion managers. It was based on a sample document shown in a CAP Focus on Compliance webinar a few years back. Transfusion competency-final.xlsx

Cerner Millenium-3rd day at MN.

Right now this is a draft guidance, but everything I have read says it will be made a Guidance by this September. I haven't seen anything yet on what the required implementation timeline they might be.

I take the opposite view as I feel that AABB still adds that higher level of quality and safety needed for Blood Banks and Transfusion Services. I agree that CAP has changed over the last couple years and is more in alignment with the AABB standards, but the emphasis on Quality and tying that all together is not the same. The other points to mention are the training requirement differences and the depth of the inspection. CAP recommends their on-line training be taken prior to inspecting, but does not mandate or have CE requirements included for inspectors. AABB does have a monitored assessor program with mandated CE hours in specific categories as well as required training sessions. The CAP team will be in your facility for just about a half day. AABB/CAP combined inspection will be mostly likely a day and a half to thoroughly go through all 4 checklists. Do you view an inspection as a necessary pita, "just something to get through....." and want the inspector in and out as quickly as possible, or do you really wish to have outside eyes perform a in depth look at your processes to ensure that you are providing the highest level of patient care and service? My whole career has been in BBTS and I never forget that what we do has the potential to be quickly fatal more so than any other section of the lab and therefore I feel needs that '"extra" review.

CAP does define the time periods. You are not required to do a full 6 element competency for the initial, but you do need to show they are competent to perform independently, so you need to have that defined. The 6 mth competency does need to be the full 6 element competency. Annual does not mean anytime during the calendar year. It is a rolling 12 month period. So if it was done Jan 2018, you need to perform in Jan 2019 (or within a few weeks). I am attaching a CAP presentation document from 2014. Might be helpful. CAP competency webinar.docx

My thanks too! I enjoy this fun stress relief each Christmas!

It is up to your site to define what you are calling this (transport or storage) in an SOP and then follow the correct temps for what you defined. As long as it is defined in a written procedure and you follow that procedure, regulatory agencies are happy.

Hi-does anyone have a Charter for their Transfusion Committee that they are willing to share? We are reworking and I would like to see what some other facilities are using. Thank you-