Franklyn

Another approach is to use a machined aluminum block drilled for your probe. With a little experimentation you can duplicate the thermal characteristics of the venerable bottle of glycerol, yet avoid the spills and re-fills that plague this old-tech approach. Some monitoring system vendors (CIMTechniques, Veriteq) manufacture them for their products and they are fairly cheap.

We are a BIG Six Sigma institution with more black belts walking around than you can shake a stick at. After being part of numerous projects I can tell you that it is nothing more than an organized approach to identifying and solving a problem and establishing ways to measure success of failure. I have used LEAN, FMEA and other rapid improvement techniques as part of 6Sig projects and have had pretty good success overall. No matter what "plan" or "method" you employ it will fail without support up and down the organization. The changes need to be driven from the top, down but will only succeed from the bottom, up. Buy in, throughout the organization, is imperative to getting it to work. Good Luck.

We switched to Rhophylac just recently. Our major reason was cost reduction. Ortho raised their prices, changed their pricing scheme and bowed out of all the purchasing groups which had the net effect of raising the cost even more. Oddly enough, our Pharmacy brought up the idea of a switch to reduce confusion and get the 30mcg dose out of the Pharmacy and into the blood bank (out of their hair). We have seen no real difference in the products other than what has already been mentioned. Ortho is going to price and "non-innovate" themselves out of business at this rate...

Greetings Everyone, I have found this forum to be of great value and interest. That is directly because of all the top notch folks that participate so openly. After nearly a decade as a Quality Officer I have taken a new position as an Applications Analyst and will be greatly curtailing my participation in these forums as I will have other responsibilities to meet. I wanted to thank you all for your time and contributions. I intend to point my successor to this forum as soon as one is selected. It is my intention to maintain my AABB membership and status as an AABB assessor, but I will need to pass my "Quality Geek from Chicago" flag to another. Thank you all,

Any manual system (data in or data out - as in reading from a label) is prone to error. People see what they expect or want to see. It is this simple fact that has pushed the industry towards standard barcodes like ISBT 128 and a future that may involve RFID. The only errors I really see these days are data entry.read errors of the type you describe. Yes, depending on the scenario they can be FDA reportable, but that doesn't prompt me to perform an RCA as I already 'know' that it was a biological system failure. These errors also seem to be cyclical. They happen in clusters and the bells and alarms go off and for a while everyone has a heighten sense of 'be careful'. After a while this state wears off and a new cluster appears. As long as there are people involved in a control step there is an opportunity for error. Even when two techs review and sign-off on a product label during manufacture you can (and I have) find an error involving a single wrong digit or transposed number. I am sorry, but I don't have a simple answer for you. People make mistakes and as long as they conscientiously followed the process we have to be able to accept that. I think the four simple questions posted by "BloodBankTalk" are an excellent exercise to walk through and, unfortunately, the culture at your institution will impact how you proceed. Too often folks try to put out a waste paper basket fire (dust bin fire) with a helicopter and end up slapping on a bandage that actually makes the process more cumbersome and prone to error. Good Luck to you.

Your post doesn't elaborate on what kinds of issues you are trying to perform a root cause analysis on, but just as an aside I must express an opinion that a root cause analysis is really only a useful endeavor when you are trying to locate and correct a system problem. Unfortunately, some errors are completely biological in nature and do not lend themselves well to a detailed 'root cause' process. I do not perform such analysis on every error reported but rather do so only when a pattern of error emerges. If one tech makes the same error over and over then that tech has a problem. If several techs make the same error (repeatedly) then I may have a system problem that will benefit from such an analysis. Just my two cents worth...

If you purchase, store and dispense tissue products within you own facility you need not register with the FDA. If, however, you harvest, process, manufacture or transfer products between institutions, you are required to register. If you need to transfer a tissue to another facility, have your vendor help (transfer it back to the vendor and let them transfer it to the other institution. If you think of "tissue" as analogous to blood (I know, a dangerous comment) the registration issues are parallel. Good Luck.

Much of the above are external indicators. They have value but splitting external vs internal wastage is a good thing. Inaccurate results reported. Turn around times. QC and Maintenance review. Reagent wastage rates. Your indicators need to include things YOU can impact, too.

My last several FDA inspections have been smooth and uneventful. I have had a few pips in my time, but after reading all of this I believe I have been VERY lucky with the inspectors we have drawn. I hope our luck continues to hold...

I know I sound like a broken record, but for about $2500 you can purchase a portable refrigerator from Helmer. The lifespan of the device is easily 10 years or more, so reducing surgical waste due to improper storage by two units per year pays for the device over that span. They come with temp charts and audible alarms and eliminate the chatter and regulator noise of cooler validation and provide a better level of service (an open cooler on the OR floor results in lost product - and open door on the refrigerator results in a piercing alarm the 'usually' results in somebody closing the door).

The OR Room temperature is not monitored in real time (by the blood bank), yet, that is a future refinement we can look at once we upgrade our centralized alarm system to v6.0 However, we rarely see the temp drift below 20 Degrees C, oddly enough, so if they actually use the rotator we have a lot less medical waste. It is still worlds better than a paper chart and permits us to remotely store platelets for big cases. As for overkill? Absolutely not. Coolers may be cheaper but we would need a lot of them, they do not readily lend themselves to q4 hour documentation of temperature, they are easily lost or misdirected and if the lid is left open they do not alarm (and your validation is rendered moot by someone that forgets to close the lid). We originally used coolers and came up with this solution over a decade ago and there is just no comparison. It certainly costs more 'up front' but long term it is so much more cost effective and efficient that there is just no comparison. We transfuse over 60,000 products a year and provide support for some really bloody surgeries. Providing an increased level of comfort to anesthesia and the surgeons is just good customer service and our wastage numbers are incredibly low for an institution of our size and volume. For example we have transfused nearly 8,000 units of plasma so far this fiscal year with total wastage at 0.7% and apheresis wastage at 1% (we cannot return products to our vendor, so that number better be low). We just never anticipated the rotators would be so popular so we didn't budget for more than 3. We will add some additional units in the future. Remember, the rotators we purchased, in part, to give the surgical staff a clearly designated spot to put platelets and cryo other than tossing it into the refrigerator. If you save a couple of apheresis units from refrigeration, you have paid for the rotator! My co-worker, Ricardo, and I are leading a round table discussion at ASCLS this summer to talk about the blood banks role in solid organ transplant and we will be discussion our portables as part of that.

There are a bunch of systems on the market and I thought I had looked at all of them, but "Nu-Tracker" is a new one to me. The industry is so new and there are so many start-ups it can be really hard to make a choice. There is another thread around here someplace were the discussion was about numerous systems. Do a search, it may be worth your time.

For BIG cases (messy transplants, trauma's or cardiac cases) we will dispatch a dedicated, portable, refrigerator that has a shaker mounted on top. The refrigerator has a special temperature data logger that records the internal temp and the room temp concurrently at 5 minute intervals. The shakers were added to three of our nine portables in an effort to reduce the number of times platelets get tossed in a refrigerator (give the OR staff someplace to put the platelets...) unfortunately we still see improperly stored platelets and now the surgeons fight over who gets a portable with a rotator. The little things are over $1000 each, so they require capital funding. I have attached a photo in case anyone is curious.

We just send it out, once per year, to one of the companies that can issue calibration certificates. Sorry, but I don't recall the name. It is not very expensive and pretty quick-easy-painless to do.

Just break it down and start small. The JC Tissue regs simply apply inventory management controls and traceability requirements that have been standard fare in blood banks for decades, to tissue products. That is all they do. The regs do not impact solid organs or non-biologic implants (like stents). Unless your facility is active harvesting and manufacturing tissues, it is straight forward inventory management and doesn't even require an MT staff to make it work.

We have several brands in use and have bought them from Grainger. They provide the specs (+/- degrees) and we just choose one that falls within our specs. While I have never had to make an adjustment, most of these thermometers to allow the user to tweak the reading. It is usually a set-***** arrangement but would allow you to compensate for drift. Oddly enough, the language filters will not let me use the common word that describes a "a simple machine of the inclined-plane type consisting of a spirally threaded cylindrical rod that engages with a similarly threaded hole" - go figure

Anytime you examine a system for accuracy, completion, compliance, etc.. you can log it as an audit. That doesn't mean you should count them, as the additional documentation that is required may not be worth the schedule entry. Most blood banks reconcile their inventory routinely and if there are any discrepancies they are addressed immediately. Rarely is this brought to the attention of the manager or medical director unless there is a serious issue uncovered. When I look at audits I look for a formal summary and presentation to the manager and medical director with signatory review by those individuals. This documents that the audit was done and the results delivered to the responsible individuals. Seems like a lot of fuss for a routine inventory method so I only document, via my occurrence management system, when discrepancies or errors are discovered.

We do approx 35,000 screens a year and have both an Echo and a Galileo. The Galileo has greater through put (much bigger batches) but isn't as quick as the echo. The echo is about 20 minutes faster per batch but the batches are smaller. We run our ID panels, trauma case stats or other emergencies on the echo and everything else on the Galileo. Both instruments are in production use and each can server as a backup for the other as needed.

We put one together a few years ago (minimum blood order schedule, the Docs can always order more...). We got the list of surgical patients for a 9 month period and linked that to RBC use day of surgery and the next day and grouped that by specialty and procedure. We were then able to come up with a schedule that meets the needs of something like 85% of all cases. The Blood Bank reviews the schedule and verifies that we have a valid sample and blood available for each case. The Blood Bank can initiate the order if none exists. The goal is avoid surprises and delays in surgery which increases patient satisfaction and safety. It does, however, take staff. I strongly suggest any MSBOS be based on hard data. The "feelings" of what the surgeons needed for each case were so far off from the facts it was amazing.

We are on track to hit 35,000 type and screens this year. We have one Galileo and One Echo with both instruments in use (e.g. the Echo is not a "backup" analyzer). Seems to work just fine for us. The Echo is faster than the Galileo, so it is great for STATs and antibody workups but the throughput of the Galileo is much greater than that of the Echo so it is our workhorse for batch testing and routine work. If Immucor ever retro-fits the incubator from the Echo into the Galileo, the Galileo would become a truly awesome analyzer!

I just finished writing a document control system for our facility using MS Access as the front end. I evaluated the up/time downtime and electronic copies scenarios and the solution I came up with has these aspects: The original documents are in paper with Ink signatures. This includes annual review documents. They are in a protected location (e.g. the managers office) and thus available for use during disasters where the electrical, network or computer systems are not accessible. This solves the 'electronic signature' issue in our mixed network environment and provides a backup/downtime copy. In normal use, the table of contents is linked to each users area of responsibility as defined in the user module. So a Blood Bank tech sees blood bank docs and a chemistry tech doesn't (but they do see chemistry docs). The TOC is available via any PC in the lab. The electronic table of contents is searchable by SOP number, title or keyword(s). The electronic copies are secured PDFs that cannot be printed or copy/pasted from. They can be displayed on the screen and that is it. The attachments can be in a variety of formats (as need dictates) and can be printed as we need many of them for use as forms. Only users with certain access levels can 'check out' and create new drafts of defined polices. There is more to it than that, but all of these aspects (and more) are included in commercial systems. We are just having problems getting administration to cut loose a quarter-mil in the current fiscal crisis. I really liked Title21, which was one of the systems we would like to buy when someone can cough up some cash. I have seen other facilities use 'read only' documents with a hyperlinked TOC very successfully. It all depends on how techno-saavy you are.

Same here.

Here is a copy of what we are currently doing. PATH GEN 1107 Change Control.pdf PATH GEN 1107 Change Control Request-Attachment 1.pdf

This is commonly called a "fire and ice" test and there are a few ways of doing it but the basic description is correct. You warm the probe until the unit alarms and cool it till it alarms. If you are just doing a static temperature check (not an alarm system) you can calibrate it at a single point in the range for which that probe is used. So, for example, you can calibrate a probe in a 1 - 6 degree refrigerator at 4 degrees and be just fine.

My problem with using someone else's temperature readings is that, rarely, can they produce calibration or validation records for the temperature monitoring equipment. If you are using that temp - you need to re-calibrate at least annually. When I mention that to our EVS guys their eyeballs start to spin and smoke comes out of their ears...