Franklyn

Good point. Some package inserts will say, literally, "Store at Room Temp" and do not provide a range. In that case room temp is whatever you make it. Some, however, specify specific ranges that are often very broad. If the range is so broad (like the above example), through a data logger out there and just document it once per month (a surgical suite below 65 or about 78 would probably result in screaming surgeons). Keep it simple.

Hmmm... Blood Bank can be tough for choosing good indicators (something that has impact and which you, in turn, can impact with changes in process). A few that come to mind are: TAT for antibody ID completion and/or antigen negative units being available Correct and complete antibody ID on first pass Internal wastage statistics of various types FDA Reportable error rates Non-FDA reportable labeling error rates (corrected prior to issue) Products available for release when needed This is my short list of what rapidly comes to mind. I hope something in there is useful.

Hey Thad! Nice to see you on the forum! We have used the translogic system (in various incarnations) for more than 15 years. The only thing we do not tube is RhIgG (too much agitation - it gets 'frothy' and we worry about loss of potency). We do not use the memory foam but our products to not travel the torturous route that they do at Thads facility. We have, on occaision, had a floater 'bump' a unit to incorrect location but it isn't all that common. Our biggest issue is on big cases, if the nurses do not retrive the blood from the station fast enough we can fill it up and shut it down. That can get pretty ugly pretty quickly.

I haven't looked at Rees's offerings since we switched back in 2006; but just about every Environmental Monitoring system out there has a wireless option of some kind and often more than one. We have a mix of wired and wireless inputs on our system, too. My wired inputs are virtually bulletproof but the wireless inputs can, on occasion, loose communication with the system. The system tells you this (it alarms) but it is one possible source of failure. If you go wireless make certain the monitoring hardware on the refrigerator has its own memory to store readings data and then re-transmit it to the system when connectivity is restored. When wireless was was very new (remember the early b-series?) a friend of mine setup a wireless network in his home. Everything went well until the late fall when we discovered that whenever his furnace turned on his network went down! Granted, the current stuff is much better (we are up to version n) but electro-magnetic interference can still take down a wireless connection and hospitals are FULL of EM sources!

One the system is installed, calibrated and validated there is very little to do to monitor the system. Our system automatically produces a daily events report that lists any and all alarm events and allows us to audit the response by the staff to alarm events. That way we can make certain that all alarms are investigated and documented adequately. Twice per year we recalibrate and alarm test (which is also a mini-validation) to verify that our units are reading the temperature correctly and that the alarm parameters have not been changed. That is it. There is no daily, manual, temperature check and the system documents the temperature of all monitored units every 15 minutes. Hospital wide we have over 300 items on the system, only about 35 of which belong to the blood bank. We also use the system to monitor when refrigerator doors are opened (trauma units in use) and other labs monitor CO2 saturation and LN2 levels.

We used the Rees system from 1991 to 2006 and then switched to CIMScan by CIMTechniques. As a longtime Rees scientific customer I can tell you that the system works as described, but is a closed and proprietary system. So everything must be bought from Rees, installed by Rees and calibrated/validated by Rees. It gets a bit expensive if you want to add new items to the system. CIMTechniques is a smaller company but is not proprietary. You can monitor whatever you want and can add probes to the system yourself if you are so inclined. Choosing a monitoring system is a big task and what you choose needs to take into consideration the cost of future expansion, annual service costs and customer service. When you get right down to it, these are the only marked differences between the various vendors. I caution you to avoid wireless. Everyone loves wireless and it is very sexy by tech standards but it is not as bullet-proof as a simple wire pair. If you really want to be all inclusive in you RFP, Include CIMTechiques and Veriteq in your list of vendors, too. I could go on for pages about alarm systems but the big points are to look at the cost of expansion, simplicity of alarm testing and calibration/validation. In those aspects CIMScan has the competition beat, but Rees still has the market share.

Howdy!

We validate in house and with one exception always have. There are some nice software packages that will do it for you, but most vendors supply a script that you can use at your discretion to stress test the system. However, 21 CFR 11 deals with electronic signatures and not, necessarily, computer system validation. So my question, to answer your question, is are you validating a home-rolled system that uses electronic signatures or trying to make certain your LIS has the ability to properly document electronic signatures?

You have to be very careful about what you put in your policy because whatever you say, you are STUCK with! Prior to harvest, at our facility, the donor must sign a storage consent that clearly spells out the terms and length of storage. If the patient is deceased (per the SS death index, hospital records, death certificate, etc.) we do not, necessarily, ask for the death certificate as we can determine if a patient is deceased by other means and merely document that we have, indeed, confirmed that the patient is deceased. If we have reached our five year limit we then contact the physician and patient (if surviving) and request permission to destroy or transfer ownership of the cells. Storing those cells has a significant cost and if the patient is unwilling to allow us to destroy or transfer the cells (e.g. research or to an outside storage facility of their choice) we need to bill them for the storage on an annual basis. Again, this is all spelled out in the storage consent that must be signed prior to harvest. The only hiccups we have run into are physicians who want to use the cells for research (with or without patient consent) and family members that want to retain the cells in case a sibling needs future transplantation. We are talking BIG BUCKs for storage, so that needs to be worked out within your institution and do not forget to run it past the lawyers.

All of our refrigerators with integrated thermometers are calibrated for this use rather than keeping bottle thermometers in them. Each of these units is on the list for annual recalibration and we can produce the records of the recalibration on demand. However, depending on the size of the refrigerator, you may need a top and bottom thermometer and not all refrigerators/freezers have them - so keep that is mind and consider the value of validating the single point reading for accuracy. As for inspection problems, we haven't had any in almost a decade of doing it this way.

In my experience, the NIST therms break most often during use when you are trying to manuver the long glass tube into or around equipment. It just isn't a good fit and takes a long time to do at great risk to the thermometer. We purchased a NIST calibrated thermometer that we send out for annual re-calibration. It really isn't all that expensive and the thermometer we purchased has a wide range (something like -50 C to 100 C). We then use it to calibrate our own electronic thermometer/meter with multiple test probes. We calibrate each probe at a variety of temps (-30 for FFP, 0 to 6C for blood, 37 for water baths etc.) and then use the electronic thermometer for all our other calibration needs. Breakage of the NIST has been eliminated and it is MUCH easier to calibrate equipment displays when you have a flexible lead with a remote display. The brand we have used is "Fluke" and the unit was less than $300. We have approximately 100 thermometers (including equipment displays) to calibrate annually and anything that sped up and simplified that chore was welcome. We could send out the electronic meter for professional calibration but have declined to do so out of consideration for the comfort level of assessors. The old timers just like to see a liquid in glass thermometer and we just want the get through the assesments with as little drama as possible.

The problem with on-line procedures is that if they can be printed you end up with uncontrolled documents floating around in the pockets of your bench staff. We are in the progress of rolling our own document control system (we would love to buy one of the very nice commercial systems but that falls into the "enterprise wide" bucket and the budget is too tight to take the plunge). Our home rolled system outputs PDF documents that cannot be printed or copied as the "public and electronic" procedure manual. The actual document are in DOC format but only accessible to senior staff. Our method will be a hybrid but we are looking forward to the change from paper manuals. Particularly for "GEN" documents (like safety SOPs) where you need to update multiple copies in multiple labs whenever something changes.

Your mileage will vary by your system. Many tissue products (freeze dried bone chips being the easiest example) are single lot, multi-vial products and Sunquest still doesn't handle them as seamlessly as you might like. Furthermore, as I stated previously, if the Blood Bank is dispensing tissue you have the best chance to make "shoe-horning" tissue into a blood bank system. We will be using a hybrid model that includes managed cabinets - how would you system handle those? Don't forget that part of the JC reg includes regulatory oversight so how do you audit that all tissues requiring reconstitution have the lot/volume/date and time recorded? Even if that is a "clinical issue" at your facility somebody has to have oversight for it. At my facility that is the blood bank and the easiest way to peek into surgery is via a dedicated system that interfaces with Surginet and 'extracts' that information for audit purposes. I really don't want to get into a "yes it will/no it won't" debate - every facility is unique in it's internal politics, volume, workflow and complexity and what works for one facility may not work for another. I assessed a small hospital once that managed equipment in a way that I could not believe would work, and I dug through the records and talked to staff looking for problems and found none. Their method would have been an unmitigated failure where I work but they were able to comply flawlessly. I think this is another of those scenarios.

It all comes down to the JC - they have published (two years ago) regulations regarding tissue management within hospitals. The requirements are nearly verbatim those of blood in birth to death tracking and processing, but lack the testing issues as the products are most often purchased from a vendor. The regs also have a requirement for a compliance oversight by a single individual or group. As the blood bank is already an expert in this sort of tracking (really just inventory management and doesn't even require an MT as no testing is involved) all eyes turned to us. We really don't want the headache, but we are in the thick of developing the long and short term process changes to, eventually, bring all tissues and implants under the auspices of a "tissue services" lab established by the blood bank. At present, we only handle solid organs (e.g. livers and kidneys) - this would expand on that. BTW - we defined solid organs in our blood bank system several years ago as part of this project. Salvages vessels, in particular, are difficult to manage. So we do have a lot of experience with the shortcomings of trying to fool a blood bank computer system into managing tissues.

Blanket statements are often inaccurate and after over a year of wrestling with tissue services in my institution I must disagree with that statement. While it is almost certainly possible define tissue products in the blood bank system, the fit is often kludgey and poor and the efficacy will really depend on your LIS system and workflow/process model. Sunquest, for example, does a poor job handling single lot/multi unit items (like RhIgG) and while they have made great improvements I still cringe whenever we talk about defining such an item in Sunquest. Many tissue items (and don't forget pins and screws, etc) are just that kind of item. If the blood bank is to receive orders for ALL tissue products and dispense them only at request then you have the best chance at getting tissues in a blood bank system to work. If you are going to use managed cabinets to remotely stock and control certain kinds of tissues, it is not such a good fit and will require a lot of work-arounds. If you are going to completely decentralize tissues you haven't a chance of a snowball in Guam of getting tissues in a blood bank system to work.

I found a proposal from May of 2008 and the tissue software we looked at and the cost of the software (not including requirements like hardware and a MSSQL license, etc.) was Approx. $25K with an annual service contract cost of just under $10k Quite a bit less than the $200k I expected.

That really varies... Tracs4Life can be hosted by the vendor or installed within your corporate firewall. So you actual cost will vary depending on which of the system dependencies you already have in-house, what you have to buy, which service package you are going with, etc. Since there is so much wheeling and dealing done I am not comfortable giving you a price, but I always, mentally, ball park $200K as a base amount for any IT system. If it is less, I am pleasantly surprised.

Pretty much the same thing. Coolers must be validated to maintain temperature within the specified ranges for defined periods of time. For portable ice chest style coolers that falls into the 1-10 degrees C for transport and 1-6 degrees for storage. A truly misleading and confusing regulation pulled from the FDA. I think you are safer to look at 1-6 degrees and have a mechanism to record (document) temperature q4 hours.

JudiK hit the nail on the head. If your internal policy defines your standard format and the documentation demonstrates that you are adhering to that format, it should be a non-issue and nothing but an opinion from another facility. Step one on any regulation with abiguity is to define your terms. We have had go-arounds with CAP and AABB folks in the past regarding annual review dates. The standards require "annual review" - so we defined annual review to mean review completion by the end of the month, one year from the last review. So if you last reviewed the document Jan 5, 2008 it is next due for completion of review by Jan 31, 2009. Anytime in January 2009 meets the definition. Some folks feel it has to be one year to the date and by clearly defining what "annual" means in our institution it became a dead issue.

We are actually in discussion with the Tracs 4 Life folks. Their system came out on top of our comparison matrix but conflicting projects have stalled our progress and we still aren't certain if we will be purchasing their system. Personally, I hope we do, but the final decision will be made much farther up the food chain.

We document a Gap Analysis audit between the two version of the standards and then look at the SOPs that may be impacted by the change. Anything that falls out, gets summarized in the audit and updated through the normal change control process.

Aren't you over complicating this? If your annual dosemitry and timer calibrations are up to snuff, you already know that the "correct dose" is being delivered by the irradiator. What you want to do is validate, upon receipt, that each new lot number is functioning as expected. There is usually an indicator shipped with each box/lot - first document that the indicator documents the received stickers as valid for use. Now put a sticker from the "old" lot number and a stick from the "new" lot number on a unit (this can be done during normal workflow) and nuke em. They should compare favorably, if they do the new lot has passed receipt verification and If they don't the new lot "fails" and needs to be returned to the vendor or some other corrective action needs to be pursued. Your dosemitry mapping should very precisely tell you where the radiation is being delivered and the physics of it are concrete. If you have a calculator and a calendar you can perdict dosage for years in the future. All the "Rad Sure" stickers due is give you a visual clue that you have, indeed, irradiated the unit so that you do not irradiate it again in error. At least that is my take on it. I am at a registered facility (not a licensed facility) so your requirements may vary.

Check out the Ikea catalog online. They have several items that may fit the bill for you.

All blood bank systems require a patient for you to allocate products to (select) for issue. How it lets you handle the crossmatching varies by system, but the problems and work arounds of generic "trauma patients" are nearly universal. My site uses Sunquest and has the same shortcoming. I wrote an MS Access application that the staff can use to generate all the paperwork and labels and it allows them to use the barcode scanners to input the unit data. As a database it also stores every unit number we issue as uncrossmatched. The staff loves it because it is fast and almost goof-proof. One checkbox (emergency issue) and all the datafields default except for the unit data and they can use the barcode gun for that. Click "print" and it is ready to go. When the patient is finally in the system the units get processed there as the final record.

The new "Tissue Management" regs apply the same sort of inventory management requirements blood banks have lived with for years, to tissue products. As there is no testing, it is just inventory management with receipt to death tracking that includes inspections at key points, Manufacturer, Lot#, Exp date tracking, etc. It doesn't need an MT to do it, but the blood banks expertise is an (almost) exact fit. There are so many players using tissue, however, that developing a model that fits you institution is the real trick...