Requirements Post-Move

[Brenda K Hutson]

Sorry I haven't participated in awhile; much going on including our Hospital moving into "new" Hospital last week. It is just right next to the old building so was not that big of a move.

Anyway, question regarding equipment requirements post-move; specifically, centrifuges and cellwashers. We did have our outside vendor perform Tach. and Timer checks on them, however, the question now is whether to repeat the internal checks such as appropriate spin times, etc.

For those of you who have moved equipment from one facility to the next, I would be interested in knowing the extent to which you perform Quality Control, specifically on centrifuges and cellwashers.

The only other time I did that, we repeated everything.

Thanks,

Brenda Hutson, CLS(ASCP)SBB

[Lcsmrz]

I define "moving" equipment as the need to unplug. Once moved, I requalify it by performing a set of function and performance checks, and document the exercise for posterity.

For serofuges, I checked the RPMs, timers and spin cals. For cellwashers, I changed tubing and rechecked the dispensing and button formation.

[Malcolm Needs ☆]

If we move any equipment, even if it is within the Laboratory, Quality requires us to perform a full Change Control.

We try not to move anything; ever!

[reidhospbb]

When we moved into our new facility a year ago, everything was revalidated including monitoring of refrigerators. Our move was a little over two miles. With a move no matter how near or far, it is an opportunity for every piece of equipment to suffer minor damage that affects its operation.

[clmergen]

Wow that is a lot of work. If I move centrifuges around the department, I don't do anything but turn it on. Moving between buildings I would do a few more checks in case of damage.

Years ago I worked in a hospital that was destroyed by a tornado. The laboratory equipment all survived. As I moved it into a temporary location the next day, I called all of the manufacturers on what checks to do. They all said, plug it in, turn it on, run QC. If it works, you are good to go.

[RR1]

In the UK we are expected to perform quite thorough instrument checks after a move. In addition our component storage equipment would need re-mapping for temperature distribution.As Malcolm stated, this would all have to go through a formal change control process

[hunb]

In the UK we are expected to perform quite thorough instrument checks after a move. In addition our component storage equipment would need re-mapping for temperature distribution.As Malcolm stated, this would all have to go through a formal change control process

Sounds like it would be better to purchase new equipment every time something needs moving!

I am getting ready to move equipment in our Transfusion service about eight miles to a new location. We have our Biomedical department re-certify the RPM and timer checks and I will perform serofuge concentration QC and cellwasher QC. I see no reason to perform temperature re-mapping on storage units. If the Blood Bank refrigerator is not able to maintain temp. then It will be taken out of use. It sounds as if the regulatory burden in the UK is more stringent in regards to equipment and process control. I extend my sympathies.

[RR1]

After you have performed temperature mappings and see hot and cold spots within cabinets, it becomes quite worrying about how we use to store our blood in the past ( not that I get sleepless nights over this !). Moving equipment could damage internal fans and disrupt the exchange gases within the cooling system, so that overall function could be impaired.

Thanks for the sympathy, it can be a little trying at times- but some of us do appreciate the reasoning behind having to do these checks, maintaining patient safety is basically what it's all about.

Of course your FDA might soon catch on to all of this....and require you guys to have to perform this too!!!!!!!!

[Malcolm Needs ☆]

After you have performed temperature mappings and see hot and cold spots within cabinets, it becomes quite worrying about how we use to store our blood in the past ( not that I get sleepless nights over this !). Moving equipment could damage internal fans and disrupt the exchange gases within the cooling system, so that overall function could be impaired.

Thanks for the sympathy, it can be a little trying at times- but some of us do appreciate the reasoning behind having to do these checks, maintaining patient safety is basically what it's all about.

Of course your FDA might soon catch on to all of this....and require you guys to have to perform this too!!!!!!!!

Much as I hate to agree with Rashmi over this one (not because I hate to agree with Rashmi per se, but because I don't want to have to perform the temperature mapping). The move can completely ruin an incubator, fridge, freezer, water-bath, etc (but it is a pain to have to do it)!!!!!!

:bored::bored:

[clmergen]

Sure if you dropped the equipment or ran it into a wall the equipment might get damaged. But simply moving it from one place to another shouldn't damage anything. If Clinical Engineering takes a piece of equipment for repair, I only validate what was repaired. I don't re-validate the piece of equipment as if it were brand new. That just seems like a waste of time. Of course if it was mandated I would do it, but not until is was mandated.

So if you pull a refrigerator out from the wall to clean behind it, you would need to re-map the temps?

[RR1]

It depends on how substantial a move it is. Just pulling a fridge out to clean behind- shouldn't disrupt the refrigerant to any degree where as moving long distances up and down stairs, being tilted through doorways etc could do this, in addition to damaging compressors.

A move/ change would require the change control process to be documented and this should state what degree of validation and testing would be required for all items of equipment with documented rationale behind the decisions made.

We have to annually map our storage equipment anyway, and also after repairs to fans/ compressors or other significant parts.

[Malcolm Needs ☆]

Well said!

[RR1]

Well said!

PLEEEASE...keep taking those tablets Malcolm!!!!!!!!!!!

[adiescast]

When we moved our lab, almost two years ago, we did performance qualitfication on every piece of equipment that we moved. If you are AABB accredited, your assessor should look for that.

[jlemmons]

All of this makes my head hurt. We are in the process of renovating and next week will be moving everything (3 refrigerators, 1 freezer, 2 Provues, etc. to a room next to where we are. Then three weeks later, the 2 Provues and 2 refrigerators plus the serofuges will move back to that area while the oters stay in the new area. It's a mess. I don't want to think about revalidating anything right now, but guess I will.

[Malcolm Needs ☆]

jlemmons, you have my sincere sympathy.

:comfort::comfort:

[RR1]

All of this makes my head hurt. We are in the process of renovating and next week will be moving everything (3 refrigerators, 1 freezer, 2 Provues, etc. to a room next to where we are. Then three weeks later, the 2 Provues and 2 refrigerators plus the serofuges will move back to that area while the oters stay in the new area. It's a mess. I don't want to think about revalidating anything right now, but guess I will.

It doesn't sound like you're moving the equipment very far, in which case keep the validation simple. Just check your temps are OK and test the alarms are working, and fridges sited correctly. For the centrifuges just check spin speeds and time settings have not been altered and everything is working. I presume you are in the US, in which case you don't need to fridge map anyway.

Good luck!

[Eoin]

ISO requires that all equipment be re-validated and all tests re-qualified. BIG, BIG job. We moved Lab in August to new build - temp mapping of an Issue Fridge showed a slight problem - crack in refrig line coming out of the compressor- so maybe there is method in their madness. Also you have to show how the cold chain is maintained during the move for products and reagents. You have my sypmathy.

Regards

Eoin

[adiescast]

We had an interesting result when we validated a new walk in refrigerator: the compressor shut down when the alarm sounded. We discovered this on validation (nothing to do with temperature mapping. That came out beautifully). When I called the company, they said that it was industry standard. I asked what industry and they tried to tell me blood banking. I told them no blood banker in their right mind would tell them to have the compressor shut down (and I mean complete shut down; it had to be specifically re-started - I started to say "manually" but you don't actually have to go crank the pump!) when the temperature alarm sounded. I never got any satisfaction from them. WE have had to install a third party monitoring system and rely on that alarm instead.

[Malcolm Needs ☆]

I know this is cheeky (and it shouldn't have to be quoted in such a thing), but what did your specification say prior to ordering the fridge?

I repeat, though, this kind of thing shouldn't have to be in a specification for a blood fridge (but it is not there, it does give a get out clause for the provider).

One has to be so blank, blank careful these days (although I would say that the fridge was not sold as "fit for purpose" anyway).

[adiescast]

That was the other half of my problem. When they said they were building the new lab, I asked for a walk in to save space. I expected to provide specifications and participate in the decision of what device would be installed. Next thing I know, there is a walk in refrigerator installed in my section. They didn't ask me anything. Of course they never got around to talking about my plumbing needs either, which resulted in a lack of drains for the cell washers and for the Galileo, in spite of the fact that I kept asking about that. Obviously I am not "cheeky" enough!

[Malcolm Needs ☆]

That was the other half of my problem. When they said they were building the new lab, I asked for a walk in to save space. I expected to provide specifications and participate in the decision of what device would be installed. Next thing I know, there is a walk in refrigerator installed in my section. They didn't ask me anything. Of course they never got around to talking about my plumbing needs either, which resulted in a lack of drains for the cell washers and for the Galileo, in spite of the fact that I kept asking about that. Obviously I am not "cheeky" enough!

Sounds a bit like "we are providing the finance, so we also provide the ideas", irrespective of the fact that "they" knew nothing, and yet did not ask the expert on the spot!

I sympathise.

Sound familiar to anyone else???????????????!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!

:cool::cool::cool::cool::cool:

[Mabel Adams]

If a refrigerator is repaired, how long must it operate before you can put blood back in it? Is there a US regulation regarding a specific time or do we just need to be convinced it will hold temp?

[L106]

I am not aware of any US regulation regarding how soon you can use a blood refrigerator after it has been repaired.

Personally, I like to let it run for 2 days. If the temp recording charts indicate that it's holding its temp properly, then we do the alarm check on the refrig. If everything looks OK, we will move the blood into it (and keep an eye on it to make sure it is holding the proper temp.)

It is our policy that we check the alarm system once a month for at least 3 months. Once the alarm system has functioned properly for at least 3 consecutive months, we then change the schedule to check the alarm quarterly (ie: once every 3 months.)

[Brenda K Hutson]

The usual minimum "practice" that I have always been familiar with is 24 hours. But I also am not aware of a specific regulation.

Brenda Hutson

If a refrigerator is repaired, how long must it operate before you can put blood back in it? Is there a US regulation regarding a specific time or do we just need to be convinced it will hold temp?