Tympanista

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?

My goal is to convince the physician that the thermal amplitude is the appropriate test for these patients, but some physicians are resistant to change, even when presented with definitive evidence to the contrary.

Thank you for the references. I'm always curious to know what is being done in other labs. We don't currently perform thermal amplitude testing here, so that may end up being a sendout test. I've been tracking all of the cold agglutinin titer orders we've gotten over the past few months and they all seem to be coming from one physician who is ordering them as part of an autoimmune panel for patients with Raynaud's. I will have my Medical Director speak with him after reviewing the reference you provided and we may be able to convince the physician to request thermal amplitude testing along with, or instead of the cold agglutinin titers.

My facility purchased a Helmer UltraCW II cellwasher last summer (prior to my employment here) and I have been told they had a very difficult time during the validation process when trying to produce a clearly delineated cell button during the spin phase. They supposedly contacted Helmer and were told that this particular model does not produce a "good" cell button. I have been trying, unsuccessfully, to perform the annual calibration and no matter how long I spin the tubes I cannot produce a clearly delineated cell button in the negative tubes. Has anyone else had this issue?

I will check to see if that is causing the problem. Thank you for the suggestion.

SMILLER: Thanks for your response. I only spun the tubes for 2 minutes to see if the cell button in the negative tubes would be more clearly delineated than it was at 20 and 25 seconds. Our spin times are set at 20 and 25 seconds, depending on which centrifuge we're using. We have 2 cellwashers and a regular centrifuge that we use in our Blood Bank, and none of them are giving us a good cell button with the negative tubes. I'll have to follow up with our Clinical Engineering staff to find out how often they check the RPMs.

I am revising a 30 year old procedure for centrifuge calibration based on the procedure in the Technical Manual. When you check the tubes to see if "the cell button is clearly delineated and the periphery is sharply defined, not fuzzy" is this for the positive tubes only? I have tried the immediate spin procedure taking the centrifuge time all the way up to 2 minutes and the cell button is still not clearly delineated for the negative tubes. I reviewed the calibration records from the past few years and they have been choosing a centrifuge time of 20 seconds based on the fact that the cell button was not clearly delineated in the negative tubes at 10 and 15 seconds, but it supposedly was at 20 seconds. I really don't believe it has ever been clearly delineated at 20 seconds. That was just the suggested time from the manufacturer, so I think they have been "making it work" each time a calibration was done. Should the cell button be clearly delineated for the negative tubes or should we only be looking for a defined cell button in the positive tubes? My centrifuges meet all of the other criteria in the Technical Manual (clear supernatant, cell button easily re-suspended, etc.) using only a 10 second spin, so I was just curious about how other facilities interpret the procedure.

I agree, Malcolm, I believe the titer is not clinically significant, but I haven't yet convinced the ordering physicians of this. I will save the reference you cited in case I have an opportunity to plead my case. We don't currently perform thermal amplitude testing at my facility, so we would have to send the specimens to a reference lab if we decide to do them. Thank you for your input.

Would anyone be willing to share their cold agglutinin titer procedure with me? I am a relatively new Blood Bank supervisor and, though I have many years of Blood Bank experience, I have no reference lab experience. The procedure at my new facility hasn't been revised since 1999 and has several glaring issues. For example, it says to incubate the tubes "overnight." Is that for 8 hours, 24 hours? I reviewed the procedure in the Technical Manual and it makes much more sense to me, but I was hoping I could get some examples of what is being done at other facilities. I would appreciate any information you all are willing to share. Thanks.

Both patients have afibrinogenemia. I am also curious as to why they are still receiving cryo, as opposed to a fibrinogen concentrate, but my pathologist is not very experienced when it comes to transfusion practices.

We spike a bag of saline to add to the pooling bag. I would love to switch to pre-pooled cryo, but our supplier only offers 5-pools, and the physician caring for our regular cryo patients insists on 6, 12, or 36 units, depending on the patient. : (

Is it standard procedure to add a small volume of saline when pooling cryo in order to aid with resuspension of the precipitate? At my previous job we did not add saline, but I just began working at a different hospital and their procedure calls for the addition of approx. 30mL of saline to the first bag. I'm not against the addition of the saline, but we have several patients who receive routine transfusions of cryo (up to 36 units at a time). Adding saline to the first bag and then using the contents of each subsequent bag to resuspend the next bag is very time consuming. The procedure at my previous employer was to just spike into each bag and drain as much of the contents into the transfer bag as possible. This was much less time consuming. Is the recovery of the precipitate significantly increased by the addition of saline and subsequent resuspension of each bag with the previous bag's contents (i.e. enough to justify the added time involved)? I'm just curious to hear what other facilities are doing.