AMcCord

We are currently still all on paper in blood bank, so blood is signed out on a paper log. We also have an 8 1/2 x 11 worksheet specifically for emergency release/mass transfusion events that has a spot for signatures when we release blood. We get a signature from someone on the other end when we deliver blood to the patient location. If a runner picks it up (nursing staff), that person signs when they pick up the units or cooler. Our HIS is Epic. We will be coming up on SafeTrace Tx after the first of the year and are planning to use the emergency release option through Tx. If someone picks up blood products from us, we'll go for the badge swipe. If we deliver, we'll probably still have to use a paper form for a signature.

I can relate to that! I can log in to my work desktop from home, so sometimes I ask them to fax a copy of what they are doing to my work email (secure!) and I can see what they've documented. Once we're up with our new blood bank system, I'll be able to access that as well. That can be an enormous help sometimes with the ones who don't communicate well.

OK, I"ll admit it. I'm stubborn. I won't give up on this sort of problem. Even though I really don't have time for it. So here's how I've persisted over a lot of years, with some success. You really need to report all deficiencies you find, through whatever incident reporting system your facility utilizes, hopefully to quality, so that risk management comes into play. A lot of work for you, but it's the only way to get their attention sometimes or to get the attention of someone higher up who can make changes. Do your research - check out their references, which will be nursing manuals, articles, etc. and see if they are compliant with those. Nursing standards of care and practice are everything to nursing management. They aren't much impressed w/ lab references unless there are regulatory teeth behind them. If you can throw specific regulatory references, do so. I tell them that if I'm cited during a CAP inspection, we're going to have an issue with TJC (truthfully) and that gets action here. Sometimes I have to use a back door approach. If there isn't a specific checklist item directly pointed at the problem, can you find something else that will help. Don't forget CLIA regs. As David says, sometimes compromise is helpful. Are the expectations greater than the nursing standard of practice? If they are, that's not necessarily a bad thing, but you might get better compliance if you uncomplicate things a bit. Nurses do have heavy workloads. If you can give a little, they may meet you part way. Education can be helpful - can you get the cooperation of your nursing education staff? CAP requires annual education for transfusion and recognition of reactions (which means I can say that we've got to do it to pass TJC). I ask them to stress that attention to vitals is a very important way to catch reactions and that adverse events have to be documented. And if you don't document, you can't prove one way or the other whether or not a reaction occurred. Whoever your inspectors are, check out the requirements for documentation and education. My experience is that it will take a lengthy period of time for improvement and that 'continuous quality improvement' is going to be the mantra. Staff comes and goes so there are always new people to be educated and good habits will slip over time. It took me years to get buy in that we had a problem. Our first electronic flowsheet for transfusion documentation didn't have mandatory entry fields - I pushed for that and didn't get it because nursing management thought that it would 'set staff up for failure'. I found that puzzling, but had to work with what I got. I looked at patterns of deficiencies and looked for failures to follow policy and reported multiple examples. I directly emailed nurses for followup - 'Hi "name", I noticed that the "whatever was missing" was not documented on the flowsheet for your patient. Please be sure to document "whatever was missing" because it is important for regulatory compliance or patient safety or whatever reason sounded impressive. I cc'd their managers on these emails. Sometimes I cc'd an education staff member I work closely with and she makes sure that common problems are addressed as part of new nurse orientation. We now utilize a flowsheet (Epic) that does have mandatory entry fields (Yippee!). Once they've had time to settle in with the new Epic version and I've got our new blood bank system up, I'll start looking at data again and reporting problems. Can you ask someone in the lab to help you with the chart reviews or delegate some of the reviews? There are some young techs in my lab who are eager for extra responsibility - perfect project for them.

We also keep the original signed document and scan a copy into the patient's EMR. Once we go live with our new blood bank system, we'll also scan a copy directly into the patient's blood bank record. We don't hold the product hostage for the signature. If the provider is available to sign the form, we ask them to do so. If they are too busy that moment, we track them down after things calm down a little. If the ER provider goes off duty, I rely on our trauma coordinator to assist in getting the signature (ED providers are all hospital employees). If it's a surgeon or OB, I send the form and ask them to complete as soon as possible so that I can complete required documentation. Our medical director can give them a little nudge if necessary. Usually not a major issue. My biggest problem is with nursing staff getting their hands on the signed form before I do and sending it to Health Information with other chart material. . . even though there are bold red letters on the form that says 'Return to Blood Bank'.

I was at a session at AABB a few years back when someone from the FDA stated that it was transport if the product was being carried to another facility. It not, it was storage.

And don't forget that you will have to maintain competencies. You will probably have to send out some split samples to your reference lab or find some other means of proving that your methodology and process are good for regulatory purposes. I stopped doing even autoadsorptions because it just got too complicated and spendy to deal with those kinds of issues. Not saying don't do it, just keep an eye on the details.

I had an FDA inspector hit us with the same thing. I asked what her expectation would be for the night shift with one tech on duty. Her response was...well you don't transfuse anyone at night, so that would solve the problem. I guess she thought that a 180 bed hospital in rural American didn't practice medicine or something. I told her that we certainly do transfuse patients at night. Her response was that we should decline to transfuse patients at night. I asked her what we were supposed to do about the trauma patient in the ER or the OB who goes bad or the active GI bleeder admitted with the 5 Hgb. Well, we would have to review the unit prior to distribution. I asked...so you are saying that we have to call someone in to perform that task? Response...isn't there someone that could do that? I asked her (with sarcasm in mind, but not in voice) what she though about a phlebotomist or an RN doing that. She said she didn't think that they would be qualified. I asked her again if she was expecting us to call someone in every time a transfusion was needed on the night shift, possibly multiple times per night. At this point she called someone back at the office and nothing more was said. We now have two techs on the night shift and no FDA registration, so this whole thing no longer applies. Your inspector may have been a little overly zealous or misinterpreting something. Many of the inspectors I saw had no medical background and did not understand the distinction between transfusion service and blood center (though technically that doesn't really matter as far as the regs are concerned). My advice would be to contact the FDA directly - email or phone - and discuss the situation with them. I have found them to be helpful. They may have a useful suggestion. My strongest piece of advice would be to drop your registration - if you are not irradiating product and doing nothing fancier than thawing plasma or pooling cryo, you don't need it. No registration, no inspection. Meet CLIA regs and whatever standards are required for whoever else inspects your facility and you should be fine.

Our trauma coordinator has started experimenting with a module in Epic that is specifically for Mass Transfusion/Emergency Release. It is basically sort of blank with boxes suggesting what should/could be entered. She has successfully scanned in donors and added quick notes to document the transfusion process. She is going to continue working with this as it looks promising and seems quick and easy to use (relatively speaking).

You definitely want to check compliance with manufacturer's requirements whether you are using tube testing, gel, solid phase and/or automation. That said, validation is a must, though it doesn't haven't to be a huge project. Run split samples centrifuged using your current method, then using the new method. Tests should be representative - blood types, antibody screens as surrogate for indirect antiglobulin testing, direct antiglobulin testing, etc. - but don't have to be exhaustive.

Our inpatient consents are also good for the entire admission. I believe that outpatient consents are good for 6 months or the length of a care plan, whichever comes first.

I also think that the J series should cover it. I spread the C, c, E, and e antigen typing out among the techs performing the survey testing, plus they do antigen testing as needed for whatever antibodies they might ID. That gives us a broad spread of testing personnel performing antigen typing. That said, we do also subscribe to the RCBCAT series so that more techs gets a crack at antigens other than Rh. I use their performance on surveys as part of their competencies, so I think it's worth doing financially, as well as work wise.

Thanks for sharing Malcolm ( and Cliff for facilitating).

Ah...but you have to carefully calibrate the use of that finger or fingers. And bare fingers worked better than gloved fingers. Of course, that was before we really had gloves.

Wrong patient drawn for the crossmatch, armband placed when the specimen was drawn (WBIT). Crossmatch performed using specimen. Nurse gets ready to transfuse correct patient, can't unlock FinalCheck lock with code from correct patient's armband. The lock won't open because the specimen used for the crossmatch came from a different patient. The code that will unlock the FinalCheck lock is on the wrong patient's wrist. Electronic ID is used for blood administration, but that isn't going to stop this scenario. We do use electronic patient ID for specimen collection, but it is still possible to get WBIT if the phleb doesn't play by the rules when collecting the specimen. One thing we have seen on rare occasion, usually with an inexperienced phleb, is when the phleb pre-prints the labels after scanning the patient's ID band (they aren't supposed to, but it has happened), fails to obtain the specimen, does not discard the labels and goes to the next patient. Those pre-printed labels get used to label the next patient. This has never happened with a Blood Bank specimen that we know of, but it could.

We are wrestling with that one right now for the CAP checklist. We've got things pretty well locked down for everything else, but the ED and surgical patients remain problematic.

I'm using the Hettich with the brake set for soft braking. We just live with the increased time. I miss those old centrifuges, too. Flip the lid open, apply pipette bulb, eraser or fingers for brake.... OSHA would have a fit today!

Hi Malcolm, I think there is an earlier article as well, but this is a good one. Thanks. And ...regarding your reply to Cliff about giving RhIg...you said to give the lady with Partial D or weak D (other than type 1, 2, or 3) a double dose of anti-D. That's new to me. Can you provide me with a reference for that? I want to discuss that idea with my medical director.

The way Epic is set up here, if the patient is discharged without an order being placed for the blood, we have no way to scan the unit into Epic after discharge. We place an order on the lab side, result the crossmatch and release the unit as transfused. It's in the patient record on our side that way. We then scan downtime paperwork for the unit into the lab results tab of the patient EMR. I don't know how they deal with transfusion documentation on the nursing side in a case like that - I do know that they have a downtime paper flowsheet that could be used and scanned into the EMR. That's probably what should happen. If the patient is not discharged, nursing does have a way to put the unit and transfusion information into the Epic flowsheet after the fact. It is done by nursing IT staff.

Dr John Judd - an expert on gel and many, many other blood bank topics - recommended calling patients Rh positive if they reacted 3-4+ and any patient reacting 2+ or less Rh negative. He had stats from many, many patient samples and if I recall correctly, he was involved with beta testing for gel. I believe this Rh study was published in Transfusion (late 90's?). Maybe someone here can put their finger on that reference. There are newer articles out there that also support this. Your Ortho tech rep should be able to provide you with references.

The provider who requests the Emergency release of the 2 units is who is asked to sign/take responsibility for the uncrossmatched blood, not the provider (usually surgeon or anesthesia) who gives the Transfuse order. However, we would make sure that the surgeon (or anesthesia) was aware that the unit being transfused was uncrossmatched - he/she could then determine whether or not they wanted to continue with the transfusion or wait for the crossmatch to be completed. We are a level III trauma center and this has not been an issue with TJC, CAP or the trauma surveyors from the state up to this point. You should probably check for regulations in your state, as a start.

We use a form (paper) that covers all kinds of things - emergency release uncrossmatched; warm auto w/ incompatible crossmatch; type A plasma emergency release; Rh positive blood released for Rh negative patient; etc. We fill out most of the form and the provider only has to put the reason for the request (like MVA, or whatever applies) and sign his/her name and date it. If it's something they are reluctant to sign for, our medical director will sign it if need be. The signature is not required prior to product issue for emergency release or other urgent situations. We do not require a signature for mass transfusion protocol as such, only if product is released uncrossmatched.

Thanks for the heads up on this. We have a JC inspection coming up next year. Gives us time to get this problem fixed.

We went through all the various committees for approval - Trauma, Med Exec, Therapeutics, and 1 more I've forgotten the name of. The info was presented at a General Staff meeting by our medical director. Use of A plasma is written into our SOPs for traumas and emergency release - basically, until we can type the patient and get type specific thawed, type A liquid plasma will be issued.

We do pretty much what Scott does. Once we go live with SafeTrace TX, we will scan the patient's antibody ID paperwork into their STTX record and shred the paper.