Brenda K Hutson

See my responses which direct you to the Technical Manual. While the Technical Manual is not a regulatory book per se, it was trying to elaborate on regulations for this. As the reply from the FDA/AABB stated, the FDA wrote their regulation before their were pre-pooled Cryos. so they need to revise theirs. Brenda Hutson, CLS(ASCP)SBB

Well, that is ok as long as what they look for at the next site (because they found the problem with the previous site), is an actual regulation; not just "their thing;" the way they think things should be." Brenda

I do not know what SMW is but yes, SCD is a sterile connecting device (a means of attaching two separate pieces of tubing, without an open system; it has a wafer that does a very fast splice of the 2 segments, then brings them together and heat seals them; nice, but expensive). Brenda

I just wanted to direct interested parties back to the Thread on the expiration of thawed, pre-pooled Cryo. The AABB and FDA have given their official response. The short of it is: For Cryo. that is pre-pooled using a closed system (SCD), the expiration after thawing is 6 hours. This coicides to what the Technical Manual says. The previous FDA guidelines were written prior to pre-pooled cryo. Brenda Hutson, CLS(ASCP)SBB

As per previous e-mails I sent in response to this issue, the AABB Regulatory division consulted with the FDA. Here is the official response (which is, that pre-pooled Cryo, if prepared in closed system using SCD, once thawed, is good for 6 hours; this follows the wording then in the Technical Manual). Brenda Hutson, CLS(ASCP)SBB Brenda, After hearing from FDA I can say that it is their interpretation that the Standards are consistent with the FDA regulation 21CFR606.122(n)(5) although the wording may not be clear. The regulation was written before the days of pre-storage pooled cryo approval. I have reprinted from FDA: · 6 hours - if pooled before frozen storage (this must be done using a SCD) It was determined this met the standard for thawing a single unit that has a 6 hour expiration date because the pre-pooled units were frozen, thawed and administered as a single unit · 6 hours - if thawing and administering a single cryo unit (no spiking or pooling before transfusion) · 4 hours - if spiked for pooling just before transfusion (the 4 hours can be counted from the first spike or after the completion of the pooling; pooling should be done using a SCD) I do not think the Technical Manual needs correction, but perhaps elaboration in the next edition would be helpful, as well as the Standard. Regards, Allene M. Allene Carr-Greer, MT(ASCP)SBB Director, Regulatory Affairs AABB

Have you ever had the pleasure of doing a KB? If so, you might understand why Hematology would appreciate it if Immucor would get this fixed (and/or buffered saline was used). Just kidding with you; giving you a hard time (as someone who has worked in a BB where we did the KB). Brenda Hutson, CLS(ASCP)SBB

Well, being new to this website, I think I just learned something. I had quite a few FDA e-mails in my inbox today. I assumed that they would be on this site so I deleted them without reading and logged onto this website. Hmm...I guess you can send e-mails just to the person vs. the site. So, I would LOVE to read what you all had to say; if you would not mind sending the e-mails to me again. Sorry, and thanks... Brenda Hutson, CLS(ASCP)SBB

Yes, depending on the circumstances. Some possible scenarios that come to mind: 1. For OR (especially if RBCs going in cooler); I have worked places that call it the "cocktail;" platelets, cryo and FFP all at once. 2. Patients actively bleeding such that it is coming out as fast as it is going in 3. Patient has 2 lines going 4. Plasma products; these can be infused quickly so you don't have products just sitting around 5. We won't send 2 RBCs at a time to a Nursing Unit unless the patient has 2 lines (unless the patient is crashing; usually in ICU) Brenda Hutson, CLS(ASCP)SBB

The Medical Director was at the closing meeting, and as I said, I did make him aware of what was going on. I know he believed me, but given that experience, perhaps he was correct in thinking we would be best not to get them more upset by reporting it. The upper Management was aware of what was going on, but again, I think we all of this fear put in us of the FDA because we know they have the power to shut us down; and this woman was just mean enough to do it too! And clearly that is how others react given that the Lab Manager at the other Hospital that was cited for something that was a "thing" to that Inspector, almost left because her boss wrote her up for arguing with the FDA Inspector! The Inspector showed this horrible side at our closing meeting and I am grateful for one thing: The Lab Director (Management, not Medical Director) and the Pathologist over my dept. (not the head that I had gone to), both approached this FDA supervisor after the closing meeting and said, "you know, it would have been nice if you had also taken the time to mention all of the "good" things about the dept." They got that "look." I should have said in my initial thread that I know that not all FDA Inspectors are like that. The one in the region where I live now, though tough at times, is fair and treats people with the respect and dignity that she expects. And when I think about careers of "power," I suspect they attract 2 types of people: those that chose it for the right reasons, and those with control issues who abuse that power. Well, we know which category "that" Inspector falls into. I appreciate your support but in all honesty, with your last comment, I have to admit that I was afraid to even post my experience. Brenda Hutson, CLS(ASCP)SBB

With 26 years and 6 Insitutions (having been the point person for many Inspections), here is the worst Inspection I ever had (AABB, FDA, CAP, JCAHO, Sate Dept. of Health Services). I was in charge of a Blood Bank at another Hospital 8 years ago. We were subjected to FDA Inspections because we had a cellwasher (after this Inspection, we stopped washing blood)! The Inspector that came was a Nurse (as for you). We were her 1st Inspection. At the last minute (before she was ready to end the Inspection), she found something (don't you just hate it when that happens ). This caused her to dig deeper. Because she was inexperienced, she kept calling a nearby collegue. After a week of this, the next Monday, she came back with her "nightmare" supervisor, and they re-started the whole Inspection! This supervisor was by far the rudest, most unprofessional person I have come across in my career! She always talked down to me. When she would bring up an issue, if I tried to discuss it with her from a technical perspective, I would get a "look" that said; I don't want to hear any of your "excuses; " you are just trying to get out of being cited. My "explanations" were valid; I was not trying to get out of anything; just trying to explain some things. Though she was rude in many ways at all times, this is by far the worst episode: our platelet rotator was out at room temp. for a few days at one point because the incubator had to be repaired. We did take manual temps. every 4 hours. It was a challenge to maintain the temperature in that the temperature of our dept. fluctuated at times. We did work with Facilities when that happened. There were some issues around the documentation of the whole event and the Inspectors also spoke with Facilities. Toward the end of the Inspection, I received a call from the Inspectors in my office (they refused to let me stay in the conference room where they were reviewing records). They asked me (actually, ordered me) to tell the Director of Facilities that they wanted him at the closing meeting. So, I called him and relayed the information. He said he could not stay; that he had committment XYZ. I told him that "he" needed to go tell them that, not me. A few minutes later, I recieved a call from one of the Inspectors, asking me to come to the conference room. When I got there, the guy from Facilities was standing there. The rude FDA supervisor shockingly said to me: Ms. Hutson, did you try to talk Facilities into not coming to the closing meeting?! I...was...in...shock!:mad: I said, NO; you told me to ask him to come and I did; he said he couldn't so I told him he needed to relay that! Both he and I just stood there with our mouths hanging open. I immdiately went to my Medical Director and told him what happened; I said "this is no Inspection; this is harrassment!" He agreed but said that if we made a big deal of it, it might be worse next time (so retaliation). I don't care if they are government employees; that does not give them the right to come into our Labs (where we all strive to do the best we can) and harrass us and question our integrity like that. They should have to be accountable; just like we all are. Oh, and one other thing that comes to mind. Some months prior to that Inspection, I had been told by my donor facility that a local reputable Hosptial had been cited for XYZ by the FDA. The Manager there almost quit, because XYZ is not a requirement by any regulatory agency (still isn't). He cited them anyway. Because I was told about this, I made a Log to start documenting XYZ. When this Nurse Inspector came, sure enough, she asked to see my documentation. I did comment to her that the only reason I had started doing it was because I heard that this other Inspector had cited a local Hospital. She replied, "oh yeh, that is "his thing," Since when can FDA Inspectors walk into Hosptials and start making their own rules/regulations on the spot; and on top of that, citing you if you aren't doing it?? If there is an issue that an FDA Inspector feel strongly about (it is "their" thing), then they should bring it before the FDA regulatory committe and decide if they should add it to the CFR. Until then, we are all at risk of being cited for something we aren't doing, because we don't know what our Inspector will have a "thing" for; we cannot possibly be prepared for that. But they do get away with it because they work for the government, and because no one wants to make waives and risk being shutdown. The FDA Inspectors should be held accountable just as others are. I am willing to be Inspected and "take my citations like a grown-up;" I am NOT however, willing to have someone come in and treat me like I am totally incompetent, harrass me and treat me with rudeness. Is there any way to anonymously report an Inspector?? I think I still have post traumatic stress from that Inspection! Brenda Hutson, CLS(ASCP)SBB

Ooops, forgot one more point in my response. The Standard Protocol for transfusion of Sickle Cell Patients is (and this is assuming you have determined the complete phenotype of course): Give Rh and Kell System matched if no Alloantibodies ID. When/if patient makes Alloantibodies, give total phenotypically matched. I think you said the only thing found is an "Auto-e;" correct? Brenda Hutson

Yes, while most warm autoantibodies are not hemolytic, some certainly are. There is also something called hyperhemolysis, where a patient actually hemolyzes the blood and ends up with a lower Hgb than they started with. "Been there seen that" in Sickle Cell Patients (I was a Reference Lab Supervisor in an area with a large population of Sickle Cell patients; they can be very difficult patients from an antibody perspective). Had another situation of a patient with a Warm Auto-e; not uncommon. This guy was hemolyzing big time, so we were giving him R2R2 blood. However, he continued to hemolyze. When he was down to about a 4 Hgb, I called Dr. Garratty. He explained that in patients who have hemolytic Warm Autoantibodies, it is actually better to give steroids than to continue to transfuse. Continuing to transfuse actually stimulates the immune system and makes it worse. Also, though the Auto Antibody had an Anti-e specificity, there can also be a non-specific element to it that you may not pick up serologically (so the R2R2 was not protection enough). Good outcome; once we stopped transfusing him, he got better! Brenda Hutson, CLS(ASCP)SBB

Hmmm.don't quite have this website figured out yet. I wanted to say that I like your last sentence (but somehow it ended up on an e-mail "all alone" at the end... Brenda

I like your last sentence... Brenda

By the way, after reading your responses, I noticed I had not addressed the issue of phlebotomy documentation in my original thread. So yes, in addition to complete First and Last Names, MR# or DOB, and Red Armband (if applicable; we don't use it as intended which is my next battle), and the Date/Time/Initials of person drawing the specimen. Thanks again for all of your input.. Brenda Hutson, CLS(ASCP)SBB D

As I mentioned in one of my previous responses, I contaced the AABB Regulatory Division directly; here is their response (so still uncertain of answer). Brenda Hutson, CLS(ASCP)SBB Dear Ms. Hutson, You have sent the question to the correct department. The FDA is the final arbiter of this question: 21CFR606.122(n)(5) Instructions to store at room temperature after thawing and to begin administration as soon as possible but no more than 4 hours after entering the container or after pooling and within 6 hours after thawing. The Standard is intended to reflect the CFR, and indeed there are FDA liaisons to the standards program unit. However, I do not know if this CFR reference takes into account that some cryo may be pooled prior to freezing. I will ask for an interpretation from the FDA and let you know what I find out. The Technical Manual possibly needs a correction. If that turns out to be correct I will forward that to the correct person. Regards, Allene M. Allene Carr-Greer, MT(ASCP)SBB Director, Regulatory Affairs AABB

Maybe not "that" old.....?? Brenda

Yes...clearly you are not an old-timer like me! Brenda

See the 15th Edition of the Technical Manual; page 198 (Thermometers). "The temperature of the thermometer should be compared periodically with the temperature on the recording chart. If the two do not agree within 2C, both should be checked against a certified thermometer." Brenda Hutson, CLS(ASCP)SBB

In looking at that Standard, you are correct in stating that it only discusses a single unit of Cryo. and Pooled Cryo. However, I guess that I am wondering (in light of the reference I made from the Technical Manual), if the issue of "pre-pooled" Cryo. being thawed, just was not differentiated in the Standards?? I don't know what to so; it just seems to me that the way the Technical Manual reads, it does differentiate between Cryo. that was pooled prior to thawing, and that which was pooled after thawing. I think I will look into that some more; espeically given that this Hospital I used to work at, does receive pre-pooled cryo. and does give it a 6 hour expiration. But, let's find out the truth! I will call the AABB for clarification. Brenda Hutson, CLS(ASCP)SBB

David, I am still thinking differently. Even if a single bag of Cryo. is thawed, it can sit out at Room Temp. for 6 hours. So I don't think the fact that the product is at Room Temp., defines the expiration. However, the Technical Manual States: All pooled CRYO, whether prepared in an open or closed system, must be transfused within 6 hours after thawing, or 4 hours after pooling, whichever comes first. So if you thaw multiple units and then pool them, it is a 4 hour expiration. However, It "sounds" to me like this is saying that if thawing (but not pooling; already pre-pooled), that the expiration is 6 hours. Does anyone else interpret it like this? Also, this just in: I spoke to a large local Medical Center where I previously worked, because I knew they were receiving a minimal amount of pre-pooled Cryo. from their Blood Center; they said it has a 6 hour expiration after thawed. Brenda Hutson, CLS(ASCP)SBB

I miss the good old days where you could have 5 different panels in your refrigerator: Immucor, Ortho, Gamma, Dade and BCA. To have lost that competion (as well as selection) is unfortunate. Brenda Hutson, CLS(ASCP)SBB

Well, I suspect my battle will be more productive if I approach it from the standpoint of the ramifications of improperly/incompletely labeled specimens for the Blood Bank. If I try to include ALL Lab Depts. for a consistent policy (which I do agree with by the way), I suspect I will then lose the battle, as all of the other depts. here are willing to accept "less than perfect" and allow some changes to be made. They will turn it around and use it against me; that if these less than perfect specimens are "good enough for them," then they should be good enough for me. I am not "over" those depts., so that is not my call (and we are talking a faciltiy where most of the staff has been here most of their careers and are very set in their ways). So, onward... Brenda Hutson, CLS(ASCP)SBB

Well, it is true that the expiration for "pooled" Cryo is 4 hours, but I am thinking that means Cryo. that is thawed, then Pooled. When a single unit is thawed, it is 6 hours. So the question then becomes, if the pooling occurred "prior" to thawing, when the intact, closed system Cryo. is thawed, could it not be a 6 hour expriation? The Technical Manual states that: All pooled CRYO, whether prepared in an open or closed system, must be transfused within 6 hours of thawing, or 4 hours of pooling, whichever comes first. Since you are receiving it "pre-pooled," I would think 6 hours. However, I do not yet receive that product from my supplier so those are just my thoughts. Brenda Hutson, CLS(ASCP)SBB

Your comments seem a little strong to me. I am all for competition; it gives us choices and hopefully, more competitive prices. I do not object to a vendor contacting me about their products; I have worked with them for 26 years. It is the "way" they have approached me in this situation which I find to be in poor taste. That is my perception, which I think I should be allowed.... Brenda