Kathy

Thanks! My medical director said he considered it a very successful inspection. Deficiencies: 1)Need to have date on manual corrections in addition to the single line and initials that are already in the procedure. 2)The one about the storage coolers and accepting back units up to 10 degrees (see my post in Hot Topics) which AABB told me to challenge 3) Need to adjust my freezer alarm to below -18. Need to record room temperature every 4 hours or store thawed cryo in platelet incubator instead of leaving it on the counter 4) Need to get some stuff out of the hallway that is blocking the eyewash/shower station 5) Medical director needs to sign off on the nursing blood transfusion procedure. These were easily fixed in an hour this morning. WHEW! If this was all they could find, then we are doing pretty darned good.

I called AABB today and was told to refute the deficiency. She told me that this is a hot topic and that they need to educate the inspectors better. She said that we are complaint with the regulation, having validated the coolers at 1-6. She wouldn't expect us to discard a unit that was 7-10 degrees because that could happen during a brief removal to check the unit tags. I would like some clearer direction from the FDA, CAP, and AABB on this issue based on some good research that tells us how long we can keep the products at 7-10 degrees.

I received an AABB deficiency because my coolers that go to the ER (which has no monitored blood bank refrigerator) are listed (by me) as being for temporary storage but we send them out with Safe-T-Vue 10 and will accept units back as long as the temperature has not exceeded 10 degrees. The inspectors said that we need to use the 6 degree rule for them and I have to respond to this deficiency. It would be easy to use the Safe-T-Vue 6 and say we will only accept the units back if they haven't turned red and/or the temp does not exceed 6 degrees. In practice, that doesn't make a whole lot of sense. The coolers are only validated for that temperature range for 5 hours and we make sure they come back before the 5 hours are up. I would have a difficult time throwing away a unit of blood with a temperature of 8 degrees just because it wasn't in motion during the time it was away from the blood bank, but it looks like my inspectors are asking me to do just that. How do you deal with this regulation? Maybe some sort of continuous monitoring device in the cooler?

Passed the inspection! Unfortunately, my concerns about them being picky were warranted. I received zero patient safety related deficiencies, but 6 other deficiencies. None of them are going to result in any new procedures. I will only need to slightly modify a few existing procedures and change a few alarm settings on blood storage devices. I do feel like we received a very thorough inspection, which is a good thing...except that I would prefer to have had fewer deficiencies.

Our lab's CAP inspectors came last week, but still no sign of my inspectors. We are set to move to another location within the hospital in less than two weeks, so I sure hope they don't show up during the move. As for the FDA, if you did well on CAP you should be fine with the FDA. I have seen the FDA be very picky before (found dust on top of the cabinets), but you can never tell what they are going to look for. My FDA inspection this past year was a piece of cake. Pawhittecar, good luck to you!

I have documentation from Ortho that states that MSDS is only required for Resolve Panel C, Fetalscreen II, AlbaA-Chek and the ProVue wash solutions. It specifies that the gel cards are exempt from MSDS requirements. If you need documentation, call Ortho tech support and they will be happy to supply it.

Thanks for more great advice. I have everything you guys mentioned...the spreadsheets, competencies, validations, documentation, etc. and I have a very competent team. My medical director also looked over my spreadsheet and made a few comments which I addressed, so it looks like I am good to go.

My medical director doesn't like the idea either and said the same thing, which I agree with, and that is to give me proof that older platelets are not working for your patients. Only then would I start to investigate further...there are so many factors that play into this issue. Maybe it would be a good thing for the residents to research.

Very useful advice from all of you. I will definitely work on thinking of this in a positive way, increasing my confidence level, and adding more exercise. It looks like we have a few more standards to work into our policies, so I will be working on that as well.

I have been the chief tech at my current employer for 1 1/2 years. Prior to that I was a blood bank tech for 20 years. I know blood banking, but having only been a chief tech for a short time, I know that there is a lot that I don't know as far as regulations and performance improvement. As such, I fully expect that the inspectors (AABB/CAP) are going to find something that I have missed. I did do my self-inspection and I know we are strong in some areas and need clarification in others. It is impossible for me to fully address everything in the short time I have been there and with so many other things going on (new hospital computer system with CPOE, four new pieces of equipment, laboratory move within the inspection window period...). The window period starts Monday and I have been nervous for the past week. I know who my inspectors are, and due to their education level (SBB and master's degree), I am already intimidated. I am very hard on myself when I am criticized, so the virtual certainty that they will find something (no matter how minor), is going to be difficult for me emotionally. I do know that this is a great learning opportunity, so I look forward to that aspect of the inspection. Is there anything that will help make this time easier for me so that I can calm down and stay focused, rather than being on edge? I would much prefer to just get this thing over with, but I doubt they are going to come earlier in the inspection cycle.

Our ICU director says that she notices that actively bleeding patients have minimal post-transfusion platelet count increases with platelets that are nearing their expiration date compared with platelets that are fresher. She would like for us to issue fresher units to actively bleeding patients. Obviously, platelet inventory management is a huge problem and we like to have the best use of our inventory so I would like some proof to support her position before I would institute a policy that might increase our platelet wastage. Do any of you know of any studies that specifically deal with platelet refractoriness as a function of platelet storage time in actively bleeding patients?

Unfortunately, budget cuts mean that automation is definitely not an option for us at this point...with Provues running close to $100,000. It is something we had thought of asking for within the next few years. I don't think we could reduce the number of techs since so much of our work is component preparation, so it would be hard to justify from a financial perspective. I do agree that the techs would like the automation and would be more comfortable with the blood bank...several of them are scared of the department since there is so much to remember. I think it would also be safer. We are doing manual testing, so the only advantage we get with gel for ABO typing is the standardization and clearer mixed field reactions. Other than that, in my opinion, tube wins for sensitivity and speed.

We have had a few of them lately too with the same reagent manufacturer. I'd like to know what you find out.

So how many of you guys actually use dataloggers or temperature indicators for your platelets? I am stuck between a rock and a hard place: ensuring the quality of platelets and cost reduction (I have been ordered to cut $1700 per month in spending for my department). Plus, this fall will be my first inspection as a supervisor. If there is something I know about that I could fix before inspection, I want to do it.

If I use the Q-Tag (Berlinger), which is meant to be disposable, and attach it to a durable tag, I would be able to attach that tag to platelet units and reuse the indicators as long as they come back to me and they have not gone out of range. They don't start recording data until you push the "start" button and you can set them to have a startup delay so they don't start recording until a certain amount of time has passed since you pressed the 'start' button. I think it's worth a shot. I also found ThermoAlert (Sensitech), so it does look like there are manufacturers out there. The trick is keeping this whole operation cost-effective. I was told that they would not be able to manufacture a device like Safe-T-Vue for platelets since the temperature range is so narrow.

Malcolm, how would positive patient identification be affected? We don't have automation. Everything is manual.

If my calculations are correct, I can do tube types for about $1.50 each, but it costs me almost $4 each in gel. I have been ordered to reduce my costs by $1700 per month. We currently use tube typing for donor unit retypes and for retypes of new patients. If I switch manufacturers of tube typing antisera, use only tubes (get rid of the gel for blood types), and stop doing QC on my anti-C3b,d daily (only do on each day of use), I can save close to $1000 per month. Is this a bad idea? I do know from speaking with the gel manufacturer and from experience that the tubes show stronger ABO reactions, so I don't think I would be sacrificing quality. The only thing I don't know is the cost of biohazard disposal...the tubes are more bulky.

Ok, I'll answer my own question. I am going to use a hard-sided cooler meant for specimen transport. With any luck, it will work with a bunch of ambient temperature gel packs. For temperature monitoring, I found some temperature indicators with LCD displays...you can have them programmed to alarm at whatever temps you want (up to different 4 temps) for whatever temperature excursion time you want (I could have them programmed to trigger the 'alarm' after 15 minutes of being above 24 degrees or below 20 degrees, for example). They show a check mark if they haven't gone outside temp or an X if they have gone outside temp. Seem really easy to use. The downside is that they are meant to be disposable and cost $10 each. However, according to the manufacturer, they have a several year battery life and can be reused as long as the 'alarm' hasn't been triggered.

What are you using for platelet storage outside your blood banks? I need something that will hold room temp in a cold (17 degree C) OR. I tried soft-sided lunch box type coolers with a bunch of gel packs, but only got 3 1/2 hours out of them. I would like something that is relatively compact and is not red or blue (ie. they need to look much different from our red cell coolers). I am looking into Greenbox...great solution, if only it had a handle. I was looking for something that is more like a cooler. I would also know how you ensure that the temperature of platelets did not deviate from 20-24 while outside your blood bank. I am looking into LogTag which is basically a temperature datalogger that you can program to flash a red light if it deviates from the temperature you set. You can download the temperature data to a pc. I don't know if this is overkill though...

We require everything to match our specimen (name, DOB, MR#, blood bank#). The doctor attending to the patient must determine that the patient is stable before giving the go-ahead to change the patient's trauma (alias) name to the real name. Once the name is changed, they need to give us a new specimen if more blood is needed. If blood is needed and the name has been changed, we will give the crossmatched blood as long as the patient retains the armband with the trauma identification on it and they bring down a request with the trauma identification on it. We tell them to draw a new specimen ASAP. If the trauma armband has been cut off, we will issue uncrossmatched blood until we get a new specimen. Bottom line: everything has to match.

We recently went up on CPOE (Cerner) and we have two red cell products available to order: RBCs and RBCs Leukoreduced/Irradiated. They can order special requirements (including irradiated) on either one. We recently decided that we should monitor orders that are not ordered as irradiated for patients who require irradiated blood products. Of course, we have alerts set up in our blood bank system for patients who require irradiated prodcuts, but the problem arises if people are not in the habit of ordering irradiated blood correctly and we don't have a record in the blood bank system. Non-irradiated blood could be transfused to a patient who requires it. So far it looks like we have a 77% compliance rate. We are aiming for near 100%, but I don't know how realisitic this is...I am still seeing at least one order per day coming across without the irradiated requirement for patients who require it. The blood bank has caught these and issued irradiated products. Does anyone know of any way, besides education (which appears to be relatively ineffective so far) to get them to order the irradiated product? Any kinds of alerts that can be set up in Cerner?

Apparently someone managed to make a computer program at Virginia Commonwealth University Medical Center for this very purpose. Unfortunately, it belongs to them and is not available for purchase. See Medical Laboratory Observer January 2012 pp. 8-11. I would love to have something like that...it would save so much time on the phone.

We are a pediatric hospital, so the whole unit ordering is only a small portion of orders. Usually they are ordering by small volumes and each order they put in by volume, regardless of the volume, translates in SoftBank to 1 unit of blood. I do think it is interesting how you order the type and screen. If the docs don't order the type and screen, we call them and tell them to order it. It would be easier for us to order everything ourselves based on a written order, but I think that is what everyone is trying to get away from with physician ordering.

I understand the point of physician order entry...so that the orders don't get misinterpreted. We are having a huge problem with our blood bank specimen orders with the type and screen (in SoftBank) getting filled up very quickly and then the system will put any new red cell order on a new order without a type and screen, which is a big problem since we have to keep cancelling the physician's orders and assigning the blood to the type and screen order. I am thinking that maybe it is not such a great idea to have the physician's orders for red cells going directly to SoftBank. It would be much easier the doctors to order the red cells as a dummy test or message that we use to add the products to the correct order (the one with the type and screen). Is this okay to do? I don't see any other way around this mess.

Docs would still be able to order the crossmatch directly from us without ordering the transfusion. One of our required fields for ordering deals with when/why (hold, transfuse, surgery, etc.) they want the product, so orders that are not for transfusion would definitely have that indication printed out on them. Hopefully if we are able to make the system fire off an order for the product when they order the transfusion from nursing, the order for us would indicate that it was for transfusion.