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May 2024 Challenge

jeanne.wall

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Posts posted by jeanne.wall

    Blood Bank Testing Day of Surgery Fatalities

    in Transfusion Services

    Posted

    Thanks for your replies. We have had several instances this week where the physician has written an order to do the type and screen day of surgery. This just seems like we are asking for a disaster, but the OR director thinks lab is over reacting so I wanted to give her some data on the importance of having the type and screen done before the patient goes to surgery.

    jerriemc -

    It has been a while since I was running an active transfusion service but we offered physicians the 'oportunity' to order a pre-op antibody screen with the patient's other PAT work. Our approach was that if the antibody screen was negative we'd have some appropriate blood for the patient and the physician could have more confidence accepting 'uncrossmatche' blood if it was necessary. If the antibody screen was positive, we had the opportunity to work through what was going on and discuss issues with the physician. We didn't convert all the physicians but if someone did get 'caught' it didn't happen again. :hooray:

    Jeanne

    Can anyone explain these 2 FDA reportable scenarios?

    in Accrediting Agencies

    Posted

    i am not knowledgeable about FDA reportable but i have this happened to me:

    1/ i have a patient with a negative antibody screen; the DAT was accidentally performed that day and was positive.When i asked the referral lab wether to send the sample for an elution, they told me ,'there's no need, why did you do the DAT"?.i am confused but i did what they told me ..

    2/ for Ag type unit: if we use the 0.8% cell suspension for doing qc (pos and neg) instead of the 3% cell susp (the unit has been dispensed), is it an FDA reportable? (Next day, the qc has been redone with the 3% and it was the same) . There was no any harm /effect or change on the unit.

    Any explanation would be appreciated.

    thanks

    I’ll try to help phan,binh. You can check out the actual CFR reference yourself, 21 CFR 606.171, but in brief, you report any deviation from cGMP, regulations, standards, established specification or unexpected event that may affect the safety, purity or potency of the product, and involves a distributed product, when the deviation has occurred in your facility or under your facility’s control.

    1/ This one is dependent on what your procedures say, if you violated your standard operating procedures and you issued product to the patient then it would be reportable. In general, whether the test was ordered or not, once you know the result, it is considered known and should be managed, so I’d have worked it up. The discussion with your reference laboratory has no impact on whether the situation is FDA reportable or not.

    2/ Since QC was not performed correctly (incorrect cell suspension used) it could be reportable if the antigen type was done as part of pre-transfusion testing (manufacturing according to the FDA definitions) and the product was issued to the patient.

    Can anyone explain these 2 FDA reportable scenarios?

    in Accrediting Agencies

    Posted

    If you violate your own internal policies when it relates to "manufacturing" (i.e. testing/etc) and the product is distributed, it becomes reportable. At my institution both of these would be reportable events. Our internal policies say that if someone leaves and comes back the next day we need a new sample with only few exceptions. We also don't require doctors to specifically order an elution. If a DAT is positive, an elution is automatically performed prior to the release of any blood products.

    I agree - it becomes reportable as soon as you violate the procedure, it doesn't matter if patient safety was actually at risk or not.

    Just For Fun

    in All other topics

    Posted

    I worked in a hospital where the Blood Bank was actually part of the entire clinical lab so we got to intereact with Hematology. They would always come in and give us a heads up if there was a very low Hgb in a patient. On this day one of the techs came in holding a sample in her hand explaining the CBC results on this patient isn't accurate. She then went on to explain that she stuck a stick in his pee hole. I asked "What? You stuck a stick in his pee hole???" She says yes! We went back and forth a couple more times as my eyes continued to widen more and more. Finally it became clear when she said "Yes, I stuck a stick in the sample for patient Espijo and there's a clot in it!".

    Someone has to say it so it might as well be me - whose on first????? :rolleyes:

    Anyone else at AABB?

    in Education / Quality

    Posted

    ...Would people be interested? If yes, I'll start a new post where people can let me know if they are coming and we can vote on different types of food. I'd need to collect the money ahead of time and make a reservation.

    I'd say yes Cliff - sounds great!

    Anyone else at AABB?

    in Education / Quality

    Posted

    I'll be there - looking forward to seeing you all. It is nice to have the meeting in my own back yard, or maybe it is really my front yard. I'll have to think about that. I enjoyed our gathering last year, even though it was small. Jeanne

    competency test

    in Education / Quality

    Posted

    Nova

    As a matter of fact, we just had a Lab JCAHO inspection and found that regulations for competency documentation is way beyond what we would consider adequate. See this link for some details: ......

    Scott

    Scott - it looks like the CLIA requirements "spruced up" into Joint Commission talk. Jeanne

    ALBA Blood Bank Reagents

    in Transfusion Services

    Posted

    We are considering purchasing the partial D and competency kits as well. Our local hospitals do not seem to like their ABO/Rh kits.

    Reactions come off "sticky". Also, we are using buffered saline and their antisera requires unbuffered saline. How are you guys handling that, if you currently are using buffered saline cubes?

    lacs -

    You might want to check the package inserts. In the past, the only Quotient/ Alba product that requires unbuffered saline is their monoclonal Anti-M, which is very pH specific. The other antisera just requires saline (buffered or unbuffered), I doubt that requirements has chanced since I was "in the know". I know that confusion has caught more than one person.

    Jeanne

    Malcolm letting off steam!

    in All other topics

    Posted

    PLEASE don't call me the "great one", or anything else like it.

    Oh Malcolm, I'm afraid my "tongue in cheek" humor didn't come across well. I hate to say it but we've both been around long enough to know that "there, but for the grace of God, go I". I've certainly had my share of moments when half way through a question or comment I realize I'm sawing off the limb I'm sitting on! ;) Jeanne

    Malcolm letting off steam!

    in All other topics

    Posted

    Ah, sorry to disappoint you bbanker2, but I can, actually see from where they were coming.

    Anti-Jka is notorious for "disappearing", both in vitro and in vivo, but coming back to bite you on the b*m, causing severe delayed haemolytic transfusion reactions due to an anamnestic response.

    Malcolm -

    Maybe your rant colored your perspective! I feel a little foolish correcting the "great one" but I think bbanker2 was shaking his head about someone thinking that performing a compatibility test with a sample that wasn't demonstrating the antibody, actually had any importance in selecting the units for transfusion. He knew you needed to select antigen negative units for the reason you stated, and using the patient's current sample wasn't going to help anyone select appropriate units. They sent him the "two units" to confirm they had selected the right ones and he was left not only having to find units for them to transfusion, he needed to explain to the facility that they had gone down the wrong path - of course, without offending! I never liked telling someone they were so far off the mark when it was so obvious that they had missed the point completely.

    Just my thought - :salute: Jeanne

    QC Data Sheet/ Immucor vs Immucor Gamma CorQC

    in Education / Quality

    Posted

    I went from SL to writing daily also. I thought it would solve the problem but I have found too many instances of copying from previous days. Not sure this can be fixed. Ideas?

    As painful as it is - a one day use daily worksheet. No one likes it, most of all me but if you are using paper the easiest way to avoid copying is making it easier to write the lot number and expiration date off the bottle, rather than having to get up and find yesterday's form. I switched to computerized reporting ASAP and had the information recorded there.

    I hate to say people are lazy but they often look for the easy way - maybe it was just that I added a reminder. I solved a problem of staff opening a new lot without finishing the in-use lot by putting a rubber band around the new lot. Magic, solved that one.

    Dry Labs!

    in Transfusion Services

    Posted

    Q Juli

    I share your belief that this is wrong and that you need to step up and speak out. If your facility is AABB accredited you have the option of anonymously communicating concerns about quality or safety (the standard is listed below). The contact information is +1.301.215.6492 or accreditation@aabb.org. CAP has a similar program, and while I don’t know about other laboratory accrediting groups I’d expect that you will find a similar program. Good luck!

    1.5 Communication of Concerns

    The blood bank or transfusion service shall have a process for personnel to anonymously communicate concerns about quality or safety. Personnel shall be given the option to communicate such concerns either to their facility’s executive management, AABB or both. AABB’s contact information shall be readily available to all personnel. Standards 6.1.5 Standard 9.1 apply.

    Red Ink

    in Accrediting Agencies

    Posted

    We use blue or black for records. Review is always documented in red (easy to identify that it has been done!). I usually will sign things in blue because you can distinguish a photocopy from an original that way.

    But with more and more color copiers it won't be long until that doesn't matter either! Time moves on and we keep having to find new ways to "win" :whew:

    Red Ink

    in Accrediting Agencies

    Posted

    There is no requirement about ink color, but many folks have a record completion or documentation procedure that limits the ink color that can be used. The requirement to use blue or black ink goes back to the ability of other color ink to be copied or filmed. When documents used to be filmed for microfilm or microfiche colors like red just didn’t film well and so it was a big problem – heck I’m old enough to remember when photo copiers didn’t do a good job unless you used black and some dark blues! Now that we have moved to digital scanning the issue is less important. There is an AABB Standard (6.2.1.1) that requires if you are creating copies that you do need to verified your copy is completely represents the original, other than that, as long as you don’t violate your facilities requirements on ink color you can use whatever color is allowed.

    Jeanne

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