Tympanista

Thank you for the reference! I'm saving this in case any future inspectors "interpret" the requirement differently.

I was told by a past inspector that the annual assessment can be done any time in the following calendar year. The 6-month assessment must be done no later than 7 months after the initial training, but there is no specific timeline for the annual assessment.

Thanks everyone for your feedback! Going forward, I will perform the same competency assessment as the rest of my staff each year, and have one of my techs sign off on it. I was already performing CAP surveys, instrument maintenance, and everything else that is required as part of a competency assessment. I just didn't have it officially documented and signed off by another staff member, which is what CAP was looking for. Maybe sometime in the future I'll be lucky enough to have an assistant manager or lead tech who can perform my assessment.

My facility is part of a larger health system, but the hospitals within the system do not all have the same policies/procedures. We've actually asked several times for assistance from the larger hospital that is considered the "mother ship" for the system, due to not having a Heme or Chem supervisor in our lab for almost 2 years, but they always say they're too busy. Even if they were available to assist, though, I don't feel like someone from outside our facility would be competent to perform our assessments, because they wouldn't be familiar with our facility-specific policies/procedures. I think the ultimate goal for the health system is to have everything be consistent from one hospital to the next, but that dream is still several years away.

Unfortunately, I don't have another supervisor, asst manager, or even a lead tech who can perform my competency. And the only 2 techs who have bachelor's degrees work mainly in Micro, so they're not strong blood bankers. But, according to CLIA, they're qualified to perform competency assessments in blood bank. I think a lot of times these regulations look good on paper, but they don't always carry over to real world situations. That's how people end up in supervisory positions when they have no idea how to actually do the job themselves. There just aren't enough people who meet all of the regulatory requirements and have the knowledge and experience to do the job effectively.

Our director completes an assessment for the supervisors each year, which states that we are competent to perform our supervisory duties, one of which is assessing the competency of our staff. That was not sufficient for CAP, though, to show that I am competent to work the bench. I understand their argument, because I have worked with managers in the past who were not capable of working the bench. But, then those managers were not qualified to assess the competency of their staff, in my opinion. In response to the CAP deficiency, I had one of my techs sign me off using the same competency form I use for the rest of the techs. The issue I have now, though, is that only 2 of the techs trained in our blood bank have bachelor's degrees, and they are not my strongest techs. The best techs I have in my department only have associate's degrees, so they're not qualified per CLIA regulations to perform competency assessments, even though they have over 20 years of experience. But, that's a whole different topic of discussion.

During a recent CAP inspection, my facility was cited for not having an annual competency assessment performed for the Blood Bank supervisor (me). Our lab director completes an assessment each year stating that each supervisor is competent to oversee their respective department(s) and listing specific supervisory tasks that are assessed. Shouldn't this supervisor assessment also be sufficient to verify that I am competent to perform testing in the Blood Bank? It seems a bit silly to me that I am deemed competent to assess the competency of the rest of my staff, but I'm not competent to perform the same tasks myself. I must have one of my staff observe me performing critical tasks, only to turn around and complete that person's direct observation myself. I'm also the one who writes and grades the competency exams each year, but am I also expected to take the test myself? Please let me know your thoughts on the subject. Thanks.

Thank you so much, Carolyn! This will be a tremendous timesaver for me! The form didn't show up in the link, but I shouldn't have too much trouble creating one based on your validation procedure. Thanks again!

I've read a lot of the threads talking about storage vs. transport, so I will definitely be validating them for storage (1-6C). I don't think I'll have any issues meeting that requirement with the Credo bags, so I would rather cover all bases to avoid any arguments during future inspections. Thank you for the advice!

My hospital has a new cancer center opening in a few weeks that is located across the street from the main hospital building. We've chosen the Credo ProMed bags for transporting blood products from the blood bank to the cancer center. Can anyone share a validation plan or procedure that they used when validating new transport containers? I'm going to have less than a week from the time the bags arrive until our cancer center opens (thanks to some poor planning by our purchasing department ), so I would greatly appreciate any help I can get. Thanks so much!

She used to work in document control, so I think she sometimes goes overboard. She said her previous employer recalibrated after changing the batteries, but I know for a fact that my previous employer did not.

Hi everyone, We have several timers in our lab for which the calibrations aren't due until October 2021, per the calibration certificates that came with them from the manufacturer. However, the batteries have all died prematurely. My lab director is under the impression that we would have to recalibrate the timers if we replace the batteries, but we did not do this where I worked previously. It seems like such a waste to buy all new timers every time the batteries die, when the calibrations are still good for over a year. I'm just curious what is being done at other facilities, and if anyone knows of a regulation that states the timers must be recalibrated when the batteries are replaced. I would appreciate any feedback you all have to offer. Thanks.

The Red Cross has specific product codes for thawed convalescent plasma. I believe you should use the corresponding "thawed" code for your convalescent plasma once it is thawed, not the same code you use for regular thawed plasma.

Do you report a titer for the thermal amplitude or just the temperature of reactivity?

The technical manual says to prepare the serial dilutions up to 1:4096. Does anyone take their dilutions out further? Our LIS is currently set up to report up to > 8192, but is there really any clinical significance to reporting a value greater than 4096?