Franklyn

We were originally a gel site using the Tecan and Ortho ID MTS system. Our annual transfusion volume (RBCs only) is over 30,000 units a year. The Tecan wasn't a true walk away analyzer and the ProVue was a disappointment. We switched to solid phase when the Galileo was in testing and are now a market site for both the Galileo and Echo. So we have extensive experience with both systems. In all honesty, the systems each have their own strengths and weaknesses and your mileage with vary with your patient population and the type/volume of testing you perform. The solid phase seems to pickup emerging antibodies sooner than gel but the gel is easier to read manually than solid phase. However, there isn't a real need to read solid phase manually so, that difference is a bit mute. The solid phase testings biggest advantage is the analyzers are truly walk-away with predicable testing times. The Echo has the added advantage of being pretty quick, but that will soon be passed on to the Galileo with a future upgrade. Overall, based on reactivity, strengths and weaknesses, I would go with solid phase. We published our validation study in an AABB abstract back in 2004 (I believe). If you are interested, you can dig it up and read all the gory details at your leisure.

We do the same at my facility. We confirm that the only antibody present is anti-D, and allow the physician to presume that it is due to the administration of RhIg. While we haven't found any extra antibodies that I am aware of, we have uncovered several cases of patients "sharing" their insurance card which produced a history of multiple blood types and ABOs - so we always perform the ABO/Rh and Antibody screen to be certain.

Paper or electronic? We use both types but it is a little hard to post a hard copy document.

Darn Tootin' There is a finite amount of staff time available for any project. Management must be willing to allocate the time so that the project can be completed, particularly when bench staff are an integral part of the project! Any improvement project is driven from the top, down. They only succeed, however, from the bottom, up.

I have to agree! I have been through LEAN, Six Sigma, FMEA, etc and any structured method of looking at a process is of value. But just because it wasn't invented for health care doesn't make it any less valuable. In the QA/QM spectrum, health care is still living in the boonies and needs to catch up. A bit of adaptation and creativity is all you really need to apply any of the systems to your operation. I have not found FMEAs to be very useful and Six Sigma really comes down to the project lead and carefully defining the scope of your project. Lean looks at the whole process at a higher level and doesn't get bogged down in the details. However, I attended an Ortho presentation on LEAN and felt I had wasted 4 hours of my day - I had a background in Lean prior to attending and I was LOST in their lecture. The reason why the various FOTW fail is lack of buy-in and support by all the players. Period. If you are going to make an effort to improve things, you need to commit to it and be willing to get out of your comfort zone and ask the "why" questions. It is never easy but usually very worth it.

Sunquest will not be fully ISBT 128 ready until v6.4, which has no current release date. I contacted the AABB regarding compliance with their ISBT 128 standards and it was suggested that we purchase and use pre-printed ISBT 128 labels. So they must be acceptable by the AABB. The whole ISBT issue is a real headache as the May 2008 deadline is an AABB thing, not an FDA thing. The ARC will not be ISBT 128 compliant for at least two more years (70% of our supply is from the ARC) while Lifesource (ITXM) will go live on April 8th, 2008 (30% of our supply). I anticipate a LOT of labeling errors until this all gets sorted out. Does anyone know if you can mix ISBT 128 and codabar labels on the same unit? Don't tell me "NO" until you have physically tried it. I don't have any means of testing it but it theory it should work. That might make things a bit easier, provided it doesn't run afoul of some other regualtion...

We have looked at this validation software in the past and the only reason why we haven't purchased it was lack of capital. I have, however, used home-rolled scripts as part of a build and validation with great success. Yes, you need to test the software as it will be used but no you do not need to use the (validation) software for ongoing data entry. The software takes the place a live body (call it a robot, if you will) and sends pre-defined scenario to the system and captures screen shots at each point. So it provides all the documentation you could every want and the software we looked at flagged unexpected results as well. My refrigeration alarm system used a built in validation module that validates the software of the system in an analogous manner. The resulting documentation is greatly in excess of what I would have done myself, but it is finished in about 30 minutes and is FDA approved. If you can get your management team to invest in one of these system you have my undying envy because they can be HUGE time savers and will not run you afoul of regulations provided you generate and review sufficient documentation of each step in the validation.

Variations in temperature within a refrigerator, or even a vessel, are common, predictable and preventable. Within my own facility every thermometer in the vessel (e.g. Digital display temp, Nist Traceable probe and alarm system) fall within a maximum 1 degree spread, everytime, period. Thermodynamics address variations in temperature within a vessel - two easy techniques are to rubber band all the probes together so that they are all reading from approximately the same location (do not let them touch the sides of the containment vessel) and simple agitation homogenizes the contents of the vessel. Variations between top and bottom temperatures are a function of airflow, how full the refrigerator is, shelves vs. drawers and thermal mass. All issues that should be addressed by a validation of the storage device. I, personally, am a BIG fan of buying a fluke meter and having it calibrated once per year. You can buy multiple probes, they are durable, relatively cheap and provide resolution to 0.1 or 0.01 degrees or more based on what you buy.

We perform a twice yearly alarm test that validates the calibration of each remote probe and that the unit is alarming correctly. The AABB requires such testing on a "periodic" basis, which we determined to complete twice per year. We used to do it quarterly, but I managed to change that. We use an NIST traceable electronic thermometer and document that the centralized alarm system and the local refrigerator display (if present) all read within +/- 1 degree C. Then we test that the alarms activate at the correct high/low temperatures as defined by our SOP. This used to require the old "fire and ice" testing but with our new system we have avoided that on anything monitored centrally. It takes one staff member less than a shift to calibrate and test all 30+ refrigerators, freezers and storage chambers.

The AABB, etc. no longer require daily "physical" checks of refrigerators and freezers as long as the temperature is documented q4 hours and there is a tested/validated alarms system. At my own facility we have done away with the daily log. However, we still generate a daily report of the previous days alarm events to verify, daily, that all alarm events were responded to appropriately and documented as required. So, we basically traded one piece of paper for another. We could view the report on the screen, of course, but as it is a shared responsibility the report just pops out on a printer in the lab every morning and the tech in charge is responsible for reviewing and and following up on any missing information. We have been doing it that way for years... We bought our first centralized alarm system around about 1993. Using a collection of databases and computer applications we have eliminated a BUNCH of paper, but I am not hopeful for a completely paperless system in the near future. Sometimes, paper logs are just the easiest way to solve a problem (and sometimes create a new one )

Fresinius had a new one a couple of years ago, but it wasn't yet FDA approved and I really don't know its current status.

You are definitely in a pickle! By the letter of the law, the physician can sign for an exception to just about anything provided he/she uses sound medical judgement and obtains informed consent from the recipient. Your choice to store at -80 almost precludes your ability to change your mind later and definitely puts the patient at risk for engraftment failure at transplant. The only way I see out of this is to have the doc sign on the dotted line and have detailed consent notes with the recipient to minimize liability. I assume there is no change of recollecting the patient?

We use a home rolled database system to track and trend all quality concerns. Items deemed to be "near miss" or "critical incidents" are flagged as such for easy retrieval at any later date. Items with the possibility of patient impact are reported to Risk Management and the RISK tracking number is included in our database filing. All "Near Misses" go to Risk and Quality (at various levels) for review.

Bloody good question - I wish I had an answer... The same question applies to thawed cryo and pre-pooled cryo, upon thaw the label doesn't change. Does anyone use a "fresh plasma" label to relabel thawed FFP?

The FDA has not licensed RFID for use with blood products at this time. They (the FDA) is concerned that repeat exposure to the radio frequencies used "could" adversely affect the product. There was a great lecture on the topic at the AABB Conf in California last October that I was able to attend. Testing is currently underway to get FDA approval, but the issue isn't the adhesive, the issue is the high frequency signals that the products will be scanned with while in use with RFID. IF guess the FDA Luddites imagine a sort of hand held microwave emitter is used with RFID and would "cook" the products.

RFID is not yet approved for use with Blood Products. So you will not get much response on that question. The FDA permits blood to be stored between 1-10 Deg C in transit, but requires storage to be between 1-6 Deg C with documentation of the storage temperature every 4 hours. Some hospitals use coolers, some use remote refrigerators or, in our case, we use portable refrigerators and data loggers rather than coolers and ice. I hope this is a start toward getting your answers.

We have used adhesive labels for years. I remember testing and validating a bunch of label stock for the purpose from our vendor and we did find one that stuck well enough to use in the refrigerator and was still removable. It just took a bit of effort to find. Our labels are printed by Uarco.

I can accept the logic of labeling as a "lesser" product. That makes sense but I, personally, would still be a bit cautious in pursuing that practice. As I understand it, the reimbursement for Fresh thawed plasma is different than that of 5 day plasma. So you would loose a bit on reimbursement revenue by such a practice.

You may be able to get away with just a robust validation if you are not generating any custom ISBT labels. The DigiTrax add-on will bring ISBT compliance sooner, but Misys has promised full implementation with v6.4 due out sometime next year. We are applying for a variance with the AABB because of the lack of native support by Misys. Bringing in a third party vendor (DigiTrax) is not optimal (in our opinion).

A variance is still required (at this time) because the location of the anti-coagulant on the ISBT 128 label is in the wrong position as specified in 21 CFR 640.120

We have multiple systems starting with the Bloodloc at specimen draw, moving through history checks of ABOs in the system and ending with two health care providers (one being the transfusionist) verifying patient ID at the bed side. The Bloodloc is a pain, and we have WAY tweaked the system to fit a facility our size, but we have actively identified and prevented multiple possible mis-transfusions through patient mis-identifications. So it has done it's job.

ISBT 128 implementation was just further complicated by the american red crosses announcement that they would be delay approx. 22 months in their implementation of ISBT 128.

We stock both Fresh and 24 hour plasma and treat them as interchangable products. The definitive answer to this question really needs to come from the FDA (not CAP, AABB and most certainly not me). I do not know of anyone that has actually pitched the question to the FDA, but they are quite particular about labeling and I feel is it better to error on the cautious side. We, too, relabel once the "Thawed Fresh" product has expired and extend the expiration date/time.

The difference between fresh thawed plasma and 5 day plasma is the presence (or absence) of the labile factors. When you thaw the product it has those factors and should be labeled as "Thawed Fresh Plasma" - 24 hours later those factors are gone and the product becomes "Thawed Plasma". To thaw and immediately label as "Thawed Plasma" would be mislabeling the product (IMHO) and as a CAP and AABB assessor I would also issue a deficiency or citation (depending on the regulatory body) for such a practice. The reason for labeling 24 hours plasma differently is related to this thought process. We do not distinguish (therapeutically) between the products EXCEPT for babies. Our medical directors and the baby-docs have agreed to the thawed fresh plasma variety for exclusive use on infants.

We also use PEG as our alternate manual method for capture (ECHO and Galileo) and, while we do have a manual capture capacity, prefer that over reading the plates manually. However, getting rid of PEG as an alternate is not really a good idea. Capture is very sensitive and you will get positive screens on patients for whom you do not identify an antibody. Repeating the screen in PEG after eliminating the presence clinically signification (and manually detectable) antibody and getting a negative result is the best way to resolve those patients that we have found. Oddly enough, a number of those mystery antibodies occur in patients with anti-cardiolipin (sp?) antibodies OR end up with an identifiable antibody later. We are looking at this for possible abstract fodder.