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To expand on Lcsmrz: Regarding the IQ and OQ, your staff (including quality) would need to reveiw and approve the validation plan prior to the execution and make any additional requests to ensure that the validation is comprehensive enough to identify any possible issues. I would think that the execution of the validation would need to occur on the premises, though with computers, if its on a server, obviously any terminals in other locations would have a wee bit smaller of a validation most likely as they're just connecting to the primary program where ever it is housed. The validating company would need to follow the usual sort of validation processes, such as documenting deviations, getting prior approval (by their quality and yours) prior to making ammendments to the validation or system, etc. After the validations are completed, your organization would need to review the documentation once more and sign off as adequate (or request more changes, etc) prior to the validation being complete. As for the PQ, really, thats something I think you'd want to do yourself. That's your method of integrating the operation fo the system into your own organization's processes and workflow to ensure it will work out and not start a whole host of unintentional forest fires. Its also one of the better ways you'll elarn what SOPs need to be revised to reflect the new system. I know I always think I have it all covered and find just one more thing that was buiried somewhere that I missed fixing during the PQ. I couldn't agree more with others, that as much as it frequently sucks, doing your own IT validation can be a blessing in that you learn quirks of a system you might not otherwise get a handle on for years at the cost of saving the time of one or more of your own employees. Can be a tough call depending on current workloads. Even if you have a vendor do it, I would recommend having someone "tag along" with the vendor to get an idea on what they're doing and pick up a few things, especially if you've never worked with them before and are uncertain as to how closely they follow the validation. I have worked with vendors who wrote a validation plan, which I reviewed and approved in advance, only to find later on down the line that they played a wee bit loose (read as skipped whole steps, lost the concept of rounding values and basic math, etc) with their own validation. The whole thing resulted in weeks of extra work and alot of frustrating back and forth meetings as mroe and more people up the chain in both organizations got involved. Could have happened with our own staff certainly, but adding an external company added that extra touch of insanity to it all. Your mileage may vary of course. Good luck to you in the new software!

I am goign to recommend you refer to the following thread: http://www.bloodbanktalk.com/forum/showthread.php?t=3438 There was extensive discussion rgearding temperature monitoring or products and samples, what to monitoring, how to monitor it and even some discussion rgearding alarms that myself and others have provided alot of information on that I believe will be of assistance. Hope that helps! David

Hi Rashmi, Personally, I'd take the conservative side and go with the air probe since that will give me information about temperature fluctuations that would adversely affect the smaller volume materials far sooner than it would affect the larger product volumes. By time something affected a probe within a 250mL solution, the smaller tubes might already be adversely affected an unsuitable for use, and would likely require a great deal more documented justification during a material review board to use them after a temperature event. In short, from my personal take on things, it sounds like what you're doing is sufficient. About the only thing that might be a quibble point with an auditor is the time delay on the alarm. That said, so long as your continuous monitoring documentation shows minimal temperature extremes even within that time delay, I don't think there would be much room for argument against the current practice beyond personal preferences, which really shouldn't enter into a regulatory discussion fi there is no regulation/standard to fall back on. Again, your mileage may vary, David

At first blush, I think it requires a license, but perhaps I'm not seeing something as well. It might be worth contacting that individual you spoke to at the FDA again and asking if they could refer you to the applicable documentation allowing the shipment without a license. It also never hurts to get their response in writing.

In my experience we've utilized a 33% glycerol solution with an overal solution volume equivalent to the smallest volume stored in the refrigeratio/freezer. When dealing with solutions volumes that are exceedingly difficult (sample tubes come to mind), we'd utilize an air probe as the variations in air temperature were come close to correspondnig to that smaller solution volumes and would result in a more conservative response in the event of a temperature deviation. As mentioned in the MHRA response above, the core temp monitoring does reduce alot of the pesky alarms that might result from door openings and air cycling events, and provides information that correlates to that of the stored materials themselves. Air temp does fluctuate more, resulting in more paperwork usually to document what happened, though you could put some alarm delays to compensate that, though one should be prepared to either document a justification for the delay periods or be prepared to have a consistent answer for the delay duration when asked by an investigator. The word consistent is the key in that previous sentence, nothing worse than three people giving three answers for the delay periods, hence why its never a bad thing to have it documented somehwre, such as the temperature mapping documentation or a validation somewhere. For core temps, no delay is usually the expectation, and I've seen a number of inspectors who prefer the alarm set points occur just before the min/max storage temp is reached to allow for a timely response in the event that products/materials must be moved to a new storage location.

FMEA works pretty well, and really, using all of these together tends to work best as there are always inherent weaknesses in everything and mixing/matching tends to compensate for a weakness in the RCA method used. Granted, one can over do it if common sense is lost and obsession sets in. Not that any of us have time for obsessive paperwork on top of everythign else. Regarding FMEA, I've always been a big fan of one more value in addition tot he two mentioned: How likely is it that if an error occurs, you will notice it. The value for this is inverted compared to the other two values mentioned: low number for an error being super easy to discover (such as you push the red button and the machine explodes) and a high number for an error not likley to be noticed until its too late (and I wish I had a witty joke for this one, but I'm still working on my first coffee, so we'll have to settle for disappointment, or relief since I know how bad my jokes are). As above, multiply them out and target the highest items. As always, mileage may vary.

Off the top of my head, I'm not aware of specific instances of humidity requirements within a donor center, but if there are any particular requirements it would be dependent on the equipment and supplies in your area. If there is a humidity requirement for any equipment or supplies, it should be documented on the manufacturer's instructions. Vague information on the manufacturer's instructions should be followed up with the manufacturer, requesting their responses be returned to you in writing, in accordance with AABB Standards 3.3 and 5.1.4 (for equipment and supplies respectively) and 21 CFR 606.60 and 606.65 (again equipment and suplies respectively) which requires following manufacturer'rs written instructions. Hope that helps!

It was that very sentence you quoted that I was hanging onto with hope. Regards, David

Reading the applicable sections of the guidelines I found online (the 2008 first edition, which I'm hoping is the most current, and which sadly did not come with a copy of the letter you mentioned from 5/22/2009), it seems directed specifically towards hospital blood banks/transfusion services relating to remote storage of product for issuance from the coolers (or portable fridges), such as ERs I'm assuming. Does the letter identify something more specific regarding coolers as "remote storage" for the purposes of blood collection prior to transport to the manufacturing/processing facilty? If it wasn't obvious, I'm more involved in the blood collection process and am trying to see if this is applicable to that side of the operation. Regards, David

Terri, Do you happen to know where that is in a regulation from NYSDOH or was it something verbally provided by an inspector from NY?

May the wind be at our backs, our friends close at hand with a smile and the clueless under the sea. Or something like that.

Yeah, I remember how opaque and broadly worded some of the EU stuff can be worded. Besides some interaction with EU reqs due to plasma shipment overseas, I spent a year working in the UK. Rather miss it. But enough about my traveling insanity... Honestly, the details about that particular inspector is more than a bit disturbing, and I'm shooting under the line of the first few words that escaped me on reading that. If someone flat out admits to not knowing what they're assessing, they should step down in favor of someone who does, or barring that, learn about the subject matter themselves so they do have a clue. Just my opinion, but having run an audit program for an organization, I'll be the first to admit I didn't know everything about everything, and even by time I left that position I still wouldn't have made any such claim. I never thought I was deluded enough to believe it, nor a good enough liar to pull that off with a straight face anyways. But, knowing that I put in a great deal of time and effort to gain an understanding of the basics of those topics I was less knowledgable of, cultivated a network of individuals (independent and otherwise) of the process with which I could bounce questions off of to ensure I had a clue, and kept an open mind and ear when discussing things with those I audited. If nothing else, I learned something new (and personally I'm happier for learning something new every day) and I like to think the in the end the audits were of greater value for that. Regardless, with the particular inspector at hand, even as the lead inspector, I can't imagine he doesn't report to somebody, either a direct supervisor if he works for a regulatory body (MHRA, etc) or the head of the inspection program if the person is a volunteer assessor (such as AABB). Taking such concerns, and I think if nothing else the admission of incomprehension qualifies as more than valid, to that responsible individual will hopefully provide some beneficial results. Then again, life doesn't always hold to common sense, but we can hope and dream, can't we? As for the matter of change for the sake of change, I couldn't agree more. Unless a change is being made to meet a regulatory requirement, address a process weakness, improve control/monitoring or incorporate a necessary change (new equipment, new facilities, etc), then doing it is usually a waste of time. Worse, even if the change has minimal impact, positive or negatve, the change will result in a period of process instability as staff adjust, resulting in an increased liklihood for errors to occur, even if the error has no impact on the health/safety of patients and is just the bare basic 'not following SOPs as written'.

While I will not argue that there are numerous examples of inspectors/assessors who lack the requisite knowledge to perform an assessment of blood banks and transfusion services (among other things), not to mention there are those who suffer from delusions of godhood given to them by the mantle of authority (and sadly some who suffer both inadequacies at once), there are mirror versions of those individuals in charge of blood banks and transfusion services. Claims of "I know best, I have a degree in (insert whatever degree you want here" is no more valid than, "I know quality better than you". In my mind, the ultimate goal of any inspection or assessment is the sharing of knowledge, to learn from each perspective to make a better process for the preservation of health of those we provide for. Everyone wants to do the right thing and takes pride in their work, even the incompetent ones (or so I'd like to hope and believe baring evidance to the contrary), and that is the starting point for discussion. Building from that shared kernal, even if it takes a great deal of time and conversation, will usually bring about improvements overall (though there may be some hair pulling and choice colorful phrases along the way, in private or otherwise). Ask for regulatory references, sometimes that gets some of bull out of the way and drops the instances of personal preference and opinion. Ask the inspector for examples of other places they have visited that had the same system that did meet the requirements; why reinvent the wheel if unnecessary? And finally, sometimes you might be able to get an inspector to offer possible suggestions. Will they all work/fit? No, but sometimes things can be tweaked to fit the particular circumstances you work in. For those cases where the individuals involved are just cmoplete shut away from the concept of reality and buried in the mire of their own personal delusions of grandeur, speak to their superiors. Make formal complaints with specific examples of detailed evidance (and no, "(S)He's an idiot" is not adequate enough much as we'd like it to be). People who rant are usually written off as unhappy ranters without valid claims. Direct evidance though given rationally is harder to ignore in general, and if the evidance comes in from multiple organizations, before too much longer the bad seed is usually offered a different door (not always, but hopefully). And it never hurts to learn more and expand our knowledge in our industry. BY that I don't just mean the day to day practices in the lab, for those who work in the lab, or the changging regulations for those who are nispectors. Quality and regulations is as much a part of our industry and the lab work and its not going to change. We need to build our awareness of it. Conversely, if you're an inspector, it is just as necessary to gain an understanding of whatever industry it is you are inspecting. It only makes practical sense to do the job right on both sides the first time out and at elast have a conversation that doesn't require translator to get at what the other person is trying to say. Do you need to be an expert, heck no, but a little knowledge goes a long way and gives some impression you care about what you're doing. Regarding the notion of System X or Y having been in place for however many years, really, I've never seen that statement as anything of value. Tradition is a wonderful song from Fiddler on the Roof, but it is hardly the foundation for keeping a system in place. At one time we used to bleed people, obviously the claim of holding to the practice as acceptable since "we've always done it that way" is hardly a valid one for that practice. Any system, no matter how old, can likely be improved. Technology changes, the practices change, the way we do business changes, nothing in the universe is unchanging (well, except death and taxes). As such, at one point or another, its possible as the situation surrounding anything changes, that the system can be improved, even if it's just a little thing, like adding electronic data entry as opposed to a personal check (or maybe just the opposite if the computer sucks or predates the 80s for instance). Anyways, enough of my soapbox, I'm sure I've put enough people to sleep by this point. In the end, its just my two cents on the topic and worth it's weight in electrons. David

Glad I can bring up a couple of new items that might help out. Even better if they help get you some needed resources for lab improvement (don't we always hope for that?). David

Training is always important, with discussion on the implications of the error if it went through undetected (though with single characters off, the chance is low, btu nothing is ever 0, especially not with Murphy's Law). In my experience though, training/knowledge of staff is not really a primary cause of the vast majority of errors. Other thigns you might want to look at are: 1. When the errors began, was there any process change/new implementation that occurred aroudn the same time that may have impacted the process? Changes to the process can lend itself to peoplebeing confused betwene old/new processes and just in general, with people keeping the new activities in mind, lend itself to increases in error. 2. Examine the process overall. Sometimes the process or the paperwork used in the process, is laid out or ordered in a manner that lends itself to an increase in errors. Something might be missing on a form for example. Assuming there has been no process changes (relating to #1 above) and the number of errors were stable previously, this may not be the issue. 3. Related to #1 above, but is there new staff in place in training? That can lend itself to an increase in errors just as much as a new process. Much as we love to think having a new trainee /and/ a mentoring trainer both looking at the work, the impact on the workflow by acting as double duty can sometimes result in errors. 4. Is there a way of adding a new control point to the process? If all the above are not inherently involved in the process, and nothing else is available to reduce the errors, then a control point needs to be in place to catch errors before they become reportable. Add a second review check, electronic verification (if such a thing is possible with the process), etc. I know these are rather general comments, but hopefully they're not utterly useless.