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Posts posted by mhc
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I was way behind in reading BBT and came upon this thread- so happy to see that you and your family are safe, Malcolm!!
Just to add my 2 cents to the discussion- dont forget to do a thorough process validation and computer validation (if applicable) before you implement your new process. Involve the staff with this- it will help them see that the process will work and is safe in your lab.
Melanie
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Friday is the only night I can do it- not particular on food but Boston can be pricey. Maybe Italian might be most economical?
Melanie
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So nice to see that the NHS got a part in the opening ceremonies! I cant imagine the US healthcare system ever getting a mention at any event- never mind an international one. You have a lot to be proud of!:cool:
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Liz
Terri
Colleen
Julie
Jeanne
Aakupaku
Kate (organising place, date and time)
More...?
I'll be there and would like to join if my schedule permits. I know some of you, and look forward to meeting all! Melanie
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In addition, you have to have a policy for reporting Biologic Product Deviations to CBER. This is required regardless of whether you are FDA registered/licensed or not.
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Collection of blood from healthy subjects for research must be performed under an IRB approved protocol. The PI would be responsible for determining the guidelines for the collections and writing that into the protocol. Sometimes, it's just as simple as saying that the FDA/ AABB requirements for allogeneic donation will be met. Or they may have a special need for other criteria. All that needs to be spelled out. Google 'human research subjects'- you'll get a boatload of information.
Oh, and yes, they can be compensated for their time and trouble...
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"If you perform electronic crossmatches, it IS a CAP standard to perform testing on a second phelebotomy (we still do tube crossmatches)."
Can you tell me which CAP standard you are referring to? I cant find it. Thanks
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I think it depends on the qualifications of the "non-BB" staff. Are they techs, lab aides, clerks? In a previous life we trained BB lab aides to dispense blood products. If you have a good SOP and good training, I think they can be successfully used.
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Malcolm,
ABO compatible units (O+) were xmatched. At the end of the day, I found out there's no consistency among the CLS's when ruling out antibodies. Some techs will perform gel using the PANOCELL 3% selected cells, and the rest prefers LISS method. As outlined in their current SOP, when Panocell 3% is used to exclude antibodies, LISS method is followed and not gel. Cold screen is + at 4 C , 15 mins, DAT=neg, auto neg, all clinically significant antibodies were r/o. He noted CAA to be reported. I'm lost Malcolm. We reported it out as Inconclusive and gel xmatch compatible units were given to the patient.
Sounds like you need to develop an algorithm for working up problems. You should not leave it to the CLS's to do whatever they want.
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I doubt that you will find any requirement that a laboratory be a certain size, regardless of the type of facility that you serve. What is required by the CFR (a.k.a. cGMPs) and AABB standards is that you have adequate space for the activities performed. What your laboratory needs to do is a thorough assessment of your operations, identify and eliminate waste, create a map of your current and proposed value stream and your current and proposed "spaghetti" diagram. Then, find some paper with grids and lay out your new lab to scale. When properly performed, this process should take no less than 2-3 months. We have tackled this in many of our laboratories by contacting our local NIST Manufacturing Extension Partnership and requesting Lean training.
Great answer. Also, using an experienced laboratory architect will help. Obviously, there are codes that need to be met as well such as the aisle width, etc.
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A forward type should suffice. If you have a historical type that also suffices as one of the two.
I think that if a patient has not been previously typed, that 2 forward and reverse groups are required. They can be on the same sample, but FDA recommends against it.
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We use the following ISBT codes: E4643, E4644, E4645, and E4646. We label all of our platelets with the actual yield by using an additional label on the bag.
Do you have a low count threshold for these products where you wouldnt label/distribute them? Also, do you collect data to determine how many of these products you are collecting and the reason(s) why they do not meet the 3.0E+11 threshold?
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Thanks, never mind- it's a refractometer- that's classified as moderate complexity by CLIA. Dont understand why that should be though. They are pretty simple to use.
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Um, I'm a dumb blood banker- what's a TS meter?
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Can anyone recommend a CLIA waived analyzer that will perform blood/serum total protein?
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It appears the rulemakers believe that the IS xm is capable of 100% accuracy in detecting ABO incompatibility. I think the computer software is more reliable considering the number of weak reverse types I have seen compared to the number of ABO matching computer failures I have seen. If we choose to validate gel for ABO incompatibility, we only have to make sure it is as effective as IS xm, not 100% effective.
I agree with you that there is misguided thinking on the part of the rulemakers. But right now, you will be cited by AABB, CMS and CAP if you do not use an IS (or buffered gel card) along with your IgG gel XM. I think that we should begin lobbying these organizations and provide documentation that a validated computer system is more effective and safer than an IS XM for detecting ABO incompatibility. Once they have hard data, I hope that they would change this requirement. I think that's our only recourse now.
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You cant use the electronic crossmatch if the patient doesnt qualify, and for us, the only time we use the gel xm is when the patient doesnt qualify for an IS or electronic. The easiest way to incorporate this into your computer is to rebuild your gel xm to include an IS phase along with the AHG results. It wasnt that difficult for us to do
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This issue has been debated here for several months, and the answer is that IgG Gel cards are not labeled by the manufacturer for the purpose of detecting ABO incompatiblity. Period. You cant in-house validate them for this puspose either, and be in compliance with CMS, FDA, or AABB. I attach an article from the AABB assessor newsletter which explains it nicely, I think. Also, the vendor for our IgG gel cards recently sent out a memo to this effect as well, so there should be no more confusion about the why and the wherefores on this subject!
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Bio-Rad carries DTT, not sure about 2ME
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CLSI has a guideline for validating automated systems for immunohematological testing- you might want to check out their website for more info.
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Actually, I thought that the 3 day rule had to do with sample integrity for the antiglobulin test, specifically for complement dependent antibodies. I just followed the logic that if you have to do an antibody screen within 3 days, that an antiglobuling crossmatch, if needed, should also be done on a less than 3 day old sample.
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From the current edition of the AABB technical manual, p442: : "If histories of transfusion and pregnancy are certain and if no transfusion or pregnancy has occurred in the previous 3 months, no limit exists to the length of time tha a pretransfusion sample is valid for donor red cell selection." I believe this is irregardless of the antibody history. BUT, the type and screen must be performed within 3 days of collection.
According to AABB standards, a patient who has a record of previously detected clinically significant antibodies, even if the antibody screen is now negative, still requires an antiglobulin crossmatch. My interpretation of the AABB standards is that the sample used for an antigloblin screen or crossmatch must be less than 3 days old.
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Our facility interprets the UNOS rule as 2 separate samples drawn at 2 different times . The transplant team insists on a hard copy report as well.
Puzzled by the cord blood testing
in Transfusion Services
Posted
Right- the baby could be D neg, C pos and the mom's anti- G is reacting against the G antigen on the C pos cells.