Franklyn

I have been looking at tissue systems for the last two years (long story) the industry is VERY new but the major products currently available are (I cannot remember the name of one of them, sorry): Tracks4Life Tissue Track Core Rosebud QSight (Owens and minor) And Mediware has one too. Just Google the names to find the websites. I have been looking at these to build a tissue services lab in the current blood bank and it was recently complicated by desire to pull other implanatables into the mix (artificial knees, screws, pins, breast implants, etc). It has become very complicated very quickly and the system that will best work for you depends on your scale and scope. Make certain to ask a lot of questions and ask for what "other facilities" they had done (fill in the blank) at. Many of the vendors will tell you their system can "interface with..." but on detailed inquiry you learn that they are certain they can do that but haven't had the opportunity yet.

You guys are all making me jealous. We are in Chicago and, evidently, we are still restricted to stone knives and bearskins when it comes to FBI fingerprints. Luckily, it wasn't too hard to get the ink off of my fingers when we were finished :tongue:

We are using the Veriteq brand loggers, but there has been an explosion of vendors as of late so you have a lot of choices. The loggers are recording the temp every five minutes. That permits us to generate beautiful and easy to read graphs for the time periods the units were out of the blood bank. This makes it much easier to investigate if we have evidence of the contents being out of the specified range. In the loggers I use, I can record around 35 days worth of temperature readings in the loggers memory at that frequency.

Very Good point! I am at a registered (not licensed) facility and my answer was, obviously from that perspective. I imagine it would really sting to loose your complete inventory considering how much all the products on the shelves are worth...

I would document it as a procedural exception and get my medical director to approve it. 9 degrees C for two hours is within the 10 degree threshold for transport and 2 hours is not a very long time. I wish the FDA would either expand the storage limits for RBCs to 0 to 10 deg. C or limit it to 1-6 deg. C as the current standard is confusing and, in my opinion, not based in fact. If a unit can be at 1-10 for 8 hours on a plane, truck or train, why cannot it not sit in my refrigerator at the same temp for the same time period?

Portable refrigerators and data loggers. The ONLY way to go! (IMHO)

We originally had a 60 minute TAT goal but we were able to prove that such a goal was not really reasonable within our facility. My TAT for uncomplicated (antibody screen negative) crossmatches is now 75 minutes with a goal of 90% (all locations). We are a nearly 800 bed facility with automation (Galileo) and a disturbingly high percentage of our received samples are STAT (some days more than 50%, I really love the STAT crossmatch requests on preaddmission surgery samples where the patient isn't scheduled for the actual surgery for another two weeks...). The Galileo has a 40 minute cycle time (approx.), add that to the time in the centrifuge and misc. handling and we have a window of about 10 minutes in which to complete the crossmatch. One telephone call or problem and the 60 minute TAT is out the window. Our TAT was from sample receipt to the first unit becoming ready to issue but, with the advent of electronic crossmatching, we look at recepit to antibody screen result. This change really helped us improve our TAT statistics. My suggestion is to work up the numbers, see what they actually are and then set your goal.

The FBI is "in the process of converting to an electronic system." We had to work with our local FBI office and they, at least, had no means to accommodate us electronically. We have a fellow on site with the paper cards and ink as recently as October. My facility has a scanner already, we just were not permitted to use it.

My facility has required fingerprints and background checks on all employees for quite a while now, but the fingerprints are obtained electronically and processed by the state. In this case, the fingerprinting is part of an FBI background check, which is somehow different than that performed by the state government. The FBI does not yet obtain fingerprints electronically, they still do them via the old fashioned paper and ink method and then scan those cards in to the database. So, your tax dollars at work is why you need to get your fingers dirty in order to work where you have unrestricted access to any kind of radioactive source.

The goal of voluntary accreditation agencies, like the AABB, is to continually raise the bar and in doing so improve overall quality. Sometimes they get it right and sometimes they don't. On more than one occaision I have found myself chanting "follow the money" to figure out why some rego or other was put in place. Retaining our AABB accrediation has required effort, but once the processes were in place maintaining and moving forward was no big deal. But to get back on the topic at hand, in our case we decided to avoid the entire storage vs. transport issue and moved from the little (validated) igloos to portable refrigerators with data loggers and alarms. You see, just becasue the blood bank performed due diligence and validated a cooler for 8 hours of storage doesn't mean that the staff in the operating room, where the cooler is sitting, are doing the same. Ever walked into the OR and found your cooler on the floor with the lid open? There goes your validation... We have had folks forget to plug-in the portable refrigerators when they arrived and then tape over the alarm buzzer to quiet it down when it started screaming. So if we are to be thorough and do everything we can to ensure the blood that returns can go back into inventory, we need temperature log data. The loggers we chose are by "Veriteq" and the sell several flavors. You will pay about double to get one with a NIST certificate, but they are easy to calibrate against a NIST standard when they arrive and save the money. They have an internal and external probe so they can be utilized in a very flexible manner. They are also smaller, cheaper and easier to use than paper chart wheels. There are now a bunch of vendors selling loggers. Look at your application, the $$$ and life cycle (veriteqs have a 10 year battery). We use a probe on an external lead in liquid to monitor temperature as the "air temp" can fluctuate wildly and not acurately reflect the temperature of the stored blood (the compressor kicks on and the air temp plummets). Of course, just to point out the obvious, nothing will help you when a unit is removed, placed on the counter for an hour and then returned to the cooler/refrigerator. If you don't have a non-reversable indicator (like a hemotemp) you will never be able to detect that. I am looking forward to RFID approval as it will have much of this built in. It will add to the total cost, but we will no longer need to buy anything extra and we won't have to guess.

We have been looking at the RayCell for while now. As previous stated it is expensive. It cannot irradiate the same volume (per batch) as a mid sized source based irradiator can. It also requires water for cooling, so it must be part of a designated cooling loop like those used for walk-in refrigerators, etc. There is a warm-up period (it is not intended to be "on" constantly) and if an Xray tube fries it can be a while to replace or repair. I, personally, don't think it is ready for prime time and I am hoping that with the change in NRC policy that somone else comes up with a better mouse trap. Decomissioning and replacing a source based irradiator is NOT cheap, so it behooves us to make certain the replacement is up to snuff. I think our estimate to decomission and replace with a RayCell came up to about a half million dollars. I think it is safe to say we will not be doing it this year...

We permit up to 4 hours for platelets and plasma under normal issue scenarios. Platelets and plasma issued to surgery can be out much longer because we have remote storage, including rotators.

I fought this battle with a past FDA inspector and, it seems, repeatedly with each new inspector. We perform dosimetry for the entire liquid volume of the canister. That maps and gives the dosage delivered at various points in the canister assuming MAXIMUM capacity. Maximum capacity, outside of dosimetry testing, is impossible to achieve (with blood products stuffed in the canister there will always be air pockets, etc. so the denisty will be less). So, if my dosemitry at max passes, anything I can fit in the canister in actual use will receive the required, minimun dose. In the old JL Shepard days we put in the film strip and then filed the canister with water. These days we get this really cool insert packed full of micro-chips, but it is the same deal. I hope this helps a bit.

In Illinois it merely requires a "trained a competent" individual. Hospital policy requires a nurse or Dr., but even they do not follow the spirit of that "rule."

The need for a separate "Blood Bank ID Bracelet" is total dependent on on your patient care culture. I have assessed institutions that used a single hospital ID band to great effect and in other institutions (like my own) we have to have a second system because the first one (hospital ID band) is not respected as concretely as it needs to be in our patient care culture. Train your bedside transfusionists (e.g. nurses) Train them well Test them Re-test Repeat it every year as part of their annual competency testing. My two cents worth...

Don't forget to gently mix the product prior to reading the temperature. In liquids, temperature is not necessarily consistent with agitation. Thats why you have to stir the container of ice and water when calibrating in that fashion. I cannot put a finger on what we are doing differently, but our IR therms have not drifted outside of the +/- 1 degree C range in their entire history within the department and we calibrate them against an NIST therm that we send out annually for certification. Odd that you would see such a discrepancy... do you have a procedure that clearly describes how to use the IR Therm? Something that would allow consistency in training and eliminate or reduce that variable?

I check the calibration on my digital thermometers yearly, not monthly or even quarterly. I assume you are referring to the table in 21 CFR 606.60 which defines the frequency of calibration for digital thermometers as monthly. Part of the problem with the CFR is that it hasn't been updated in quite a while and time and technology march on. The manufacture usually has a recommend frequency of calibration with devices of this type and while digital inputs (once upon a time) experienced a lot of drift, such is no longer the case. We did not file for a variance for 21 CFR 606.60, we just made certain our documentation is in place. Our most Recent FDA inspection was in June of this year, our inspector did look at our calibration records for thermometers and refrigerators and we did not receive a 483. Typically, if you can document and validate your process, proving it is in control, there is no issue. Of course, we are a registered (not licensed) blood bank and transfusion service. That could have an impact as the FDA looks at licensed manufactures a little differently. So your mileage may vary.

Both the AABB and CAP standards have been expanded from +/- 1 to +/- 2 degrees C ranges and, even better, many of the current crop of IR thermometers are accurate to +/- 1 degree or better.

IR thermometers are commonly user by heating and air conditioning companies. As such you can purchase them rather cheaply from suppliers like Grainger or McMaster Carr. They do have their limitations, but can be really handly suckers to be sure...

Our practice is the same, the system is validated and we will tube anything anywhere on campus BUT RhIg. The product doesn't tolerate the ride very well.

Although I know we often use the terms interchangeably, but because I am a geek I feel this deep seated need to clarify You do not need to validate an IR thermometer, you merely need to calibrate it. We calibrate our IR Thermometers against our NIST at multiple points between -30 and 30 degrees C. The only caveats on calibration are that IR thermometer beams are adsorbed by liquid. So you cannot shoot a waterbath and get a valid temp. You can, however, shoot it at heat blocks, drawers and shelves, liquid filled blood bags, etc. We have been using an IR thermometer for about 10 years now and calibrate it annually against an NIST source with a +/- 1 degree C acceptable range. They are real gems to have.

I am curious as to what other facilities are doing, especially since the COI is a bit ambiguous in its wording. How many of you our there are adding sterile saline as an aid to pooling cryo units? We have had a long standing practice of using 50cc's as an adjunct when pooling cryo and I haven't seen any other facility to that. It adds one more item to the documentation on manufacture and increases the cost. So, do ya'll pool cryo au naturale or do you add saline?

I have both Helmers and Jewettes. We bought a bunch of Jewettes back in 1999 and they have run like champs, however, Jewette was bought out by Thermo a short time back and I don't have any first hand experience with the new owners products. The Helmer we recently acquired is working pretty well, too. No complaints thus far. Another brand you may want to look at is Sanyo - they have broken into the market as well. Gem makes a good product, too. Most Blood Bank refrigerators are not "off the shelf" items. The unit is, quite literally, built when the order is received. So quality can vary hugely within a single product line (good days and bad on the old assembly floor?). Whatever you buy, make certain your method of monitoring it is up to snuff.

We have noticed that the Galileo will pickup anti-cardio lipin antibodies in certain patient populations and we frequently pickup an antibody very early in its development. While we do not consider these to be "inconsistent" reactions they do add some noise when you have a positive screen on the Galileo and nothing on a panel. We created a code to identify these types of patients and I expect my medical director will publish an abstract on it sometime in the future.

I have had this question before. We stated a minimum time in our SOP based on the manufacturers insert for the scrub we used. We also stated that the sweep second hand on a wrist watch or wall clock was sufficient and, due to the nature of the step calibration was not required. If you put it in a carefully worded statement that is part of your policy, there is not much to gripe about. There are no regulatory requirements for calibrating this kind of a timer (that I am aware of).