4 hour rule

[Brenda K Hutson]

I know this has been discussed on this website before; perhaps more than once. But as I was reading the Technical Manual to obtain the specific reference, it appeared to read differently than previous times (and according to my understanding).

That is the 4-hour rule for transfusion.

I was always taught that the blood had to be transfused "within 4 hours of leaving the Transfusion Service." And I think that was previously supported. The Technical Manual currently reads: "It must either be infused within 4 hours of the time it was spiked, or it must be discarded."

Now perhaps that "assumes" a prompt delivery and initiation; but I think we all know that does not always occur. A more liberal statement like this can make it problematic to:

1. Know what to look for when performing audits of these times to ensure it is not > 4 hours

2. Have data to support your position to transfusionists (which is what I was just looking for so I could include it in my conversation with a Nurse regarding a transfusion)

Any thoughts on this issue?

Thanks,

Brenda Hutson, CLS(ASCP)SBB

[Eagle Eye]

I believe the current statment is to include the units issued in cooler.

[Dr. Pepper]

Brenda, we have also used the time of issue to start the countdown. I remember hearing at a seminar that the 4 hour limit was never established by any kind of experimental data, but rather just what "seemed reasonable". The idea being to avoid bacterial proliferation, it looks like AABB is now inferring that the bags should be sterile up to the moment of spiking, and that is when innoculation can occur, as opposed to having a few bugs laying low in the bag until warming offers them more opportunity to get up and going (as well as getting in via the filter).

My take is why reinvent the wheel? 4 hours from issue should be long enough to get the blood into almost all patients. Do you really need that extra 15 minutes or so? You won't be lying to the nurse if you quote from the Tech Manual. Just don't tell them it wasn't the 17th edition!

[LCoronado]

We fought and lost this argument with nursing a while back, so our policy now states that the transfusion must be completed within four hours of the start time. However, we also adhere strictly to a 30 minute rule from the dispense time to the start time and monitor this just as closely; an incident report is written if either policy is violated.

[Brenda K Hutson]

So a couple of things come to mind:

1. I have found that Nursing will usually "have" to comply if shown documentation of regulations; not just their interpretation. I went through this at 1 place and I think I contacted the AABB and was advised that it was from the "time of issue." But again, it is not worded clearly now.

2. So let's say your Nurse comes to pick up the blood at 0800; you never get it back (30 mins. or any other time); you audit the process and find out that they documented that they "began" the transfusion at 1000 and completed it at 1400. Going by your guidelines, that would be acceptable?? And I am not speaking of the hypothetical; this is from experience. Just a thought.......

Brenda Hutson, CLS(ASCP)SBB

We fought and lost this argument with nursing a while back, so our policy now states that the transfusion must be completed within four hours of the start time. However, we also adhere strictly to a 30 minute rule from the dispense time to the start time and monitor this just as closely; an incident report is written if either policy is violated.

[SMILLER]

We fought and lost this argument with nursing a while back, so our policy now states that the transfusion must be completed within four hours of the start time. However, we also adhere strictly to a 30 minute rule from the dispense time to the start time and monitor this just as closely; an incident report is written if either policy is violated.

We have pretty much the same policy here.

Scott

[PAWHITTECAR]

At my institution it would be an occurence because it was not started within 30 minutes of issue. My policy for nursing states that the transfusion must begin within 30 minutes of the blood being issued and then complete no more that 4 hours after started.

[Brenda K Hutson]

And I think that is the important clarification needed in the Procedure. That it is not just:

1. Blood must be returned in < 30 minutes, and

2. Blood must be transfused within 4 hours of spiking the unit

If just those 2 things, there is a big gap of possibilities inbetween. Your procedure puts it all together.

Brenda

At my institution it would be an occurence because it was not started within 30 minutes of issue. My policy for nursing states that the transfusion must begin within 30 minutes of the blood being issued and then complete no more that 4 hours after started.

[estiner]

Our hospital has the same policy of starting within 30 min and transfused within 4 hrs - if not a variance is written and an investigation is made as to why the policy was not followed.

[LCoronado]

So a couple of things come to mind:

1. I have found that Nursing will usually "have" to comply if shown documentation of regulations; not just their interpretation. I went through this at 1 place and I think I contacted the AABB and was advised that it was from the "time of issue." But again, it is not worded clearly now.

2. So let's say your Nurse comes to pick up the blood at 0800; you never get it back (30 mins. or any other time); you audit the process and find out that they documented that they "began" the transfusion at 1000 and completed it at 1400. Going by your guidelines, that would be acceptable?? And I am not speaking of the hypothetical; this is from experience. Just a thought.......

Brenda Hutson, CLS(ASCP)SBB

Definitely not acceptable because of the 2 hour gap from issue to start. This would result in an incident report being filed.

[David Saikin]

I also contacted AABB on this issue and was informed the 4 hrs begin at time of issue . . .

[Eoin]

Here in Ireland we have regulations that it must be started within "30 minutes of removal and completed within 4 hrs" from controlled storage (i.e. suitably monitored and alarmed storage). This is traced through our blood tracking program. If it is returned outside 30 mins from removal, the fridge door won't open and they have to contact the lab staff. The unit is then removed by us from circulation. We have had times when Tx has been halted becausethe IV canulae has failed, but they know to speed up the rate when restarted or dump what is left at 4 hrs. We use packed cells exclusively, so no problem with the volume to go in, even in the low-weight patient, or the renally compromised patient (with suitable diuretic therapy).

Times outside this generates a non-conformance within the hospital. Outside 6 hrs is a mandatory report to the National Haemovigilance Office.

Cheers

Eoin

[THBrazz]

Our system requires the transfusion to begin within 30 minutes from the time of issue and transfused within 4 hours. Outliers are documented by variance reporting.

[James Smith]

CSTM (Canadian Soc for TM) Standards for Hospital Transfusion Services v3.0 2011 gives 5.8.4.1 "Administration of red cells shall be completed within 4 hours from the time of removal from a temperature-controlled environment". To keep it simple it's been extended to all products in our hospital and my guess is that all use this here.

[tbostock]

Our policy is 4 hours from the time of issue, and they do not have to start it within 30 mins. They were keeping it up on the floor for over 20 minutes, and were confusing this 30 min time frame that they were supposed to start it with a 30 minute time frame to return it. We started a while back using return temp instead of time, and were wasting a lot of units. So now we sign it out, and they have 4 hours from the time it leaves us. So if they are having a problem with an IV for example, and they get it worked out in an hour, they still have 3 hours to transfuse.

[Deny Morlino]

Same here as Terri

[Brenda K Hutson]

So in other words, once it leaves your dept., they have "bought it." No Returns, if I read you correctly?

I know they are trying to get away from an "allowable" amount of time outside of the Blood Bank for them to be able to return it, but in reality, it could be >10C in a short time. We sent a unit up last week but the "X#@! Nurse pulled the very last number off of the patient's Blood Bank Armband (the # that is supposed to be totally under the plastic and unavailable to even pull off) so she could place it on the pick-up slip to send for the blood; so that when the blood got to the floor, the Nurse (hopefully a different one than the one that pulled the number off in the first place), called to say there was no armband # on the patient to compare against the paperwork; and asking if they could still transfuse the blood. So we said NO, send it back; the patient will have to be redrawn, rebanded and the Testing repeated. So the blood was returned within maybe 15 mins. from leaving our dept. but came back at 12C. So in addition to all of their other issues, they also wasted a unit of O NEG RBCs.

Brenda

Our policy is 4 hours from the time of issue, and they do not have to start it within 30 mins. They were keeping it up on the floor for over 20 minutes, and were confusing this 30 min time frame that they were supposed to start it with a 30 minute time frame to return it. We started a while back using return temp instead of time, and were wasting a lot of units. So now we sign it out, and they have 4 hours from the time it leaves us. So if they are having a problem with an IV for example, and they get it worked out in an hour, they still have 3 hours to transfuse.

[Mabel Adams]

Would be good if we had some real science to back up these rules wouldn't it? Somebody in 1950 felt like over 4 hrs was too long. And now we have to balance the effects of TACO for running the blood faster or the effect on the nitrite and storage lesion of units after 4 hrs at RT compared to straight out of the fridge. Or maybe with modern bugs like MRSA we shouldn't go that long? No one knows. I hate being rigid about something because we have always done it this way and it makes us feel better. We abide by the regs of course, but I would still prefer good science.

[aafrin]

Would be good if we had some real science to back up these rules wouldn't it? Somebody in 1950 felt like over 4 hrs was too long. And now we have to balance the effects of TACO for running the blood faster or the effect on the nitrite and storage lesion of units after 4 hrs at RT compared to straight out of the fridge. Or maybe with modern bugs like MRSA we shouldn't go that long? No one knows. I hate being rigid about something because we have always done it this way and it makes us feel better. We abide by the regs of course, but I would still prefer good science.

Couldn't agree more.

I have one allied question, when we divide red cells into two aliquots, issue one for slow transfusion to patient, retaining the other for subsequent transfusion, the expiry date changes to 24 hours since the aliquoting is done under open system - why not 4 hours as here also the unit was spiked?

[Eoin]

The four hours out of refrigeration is because of bacterial growth rates as unit warms up, so there is probably some scientific basis for the regs, but I agree - a new study with published data from it would be great.

Cheers

]Eoin

[Deny Morlino]

SBB project perhaps?

[AMcCord]

Couldn't agree more.

I have one allied question, when we divide red cells into two aliquots, issue one for slow transfusion to patient, retaining the other for subsequent transfusion, the expiry date changes to 24 hours since the aliquoting is done under open system - why not 4 hours as here also the unit was spiked?

The open system split units you are holding for later transfusion are stored in the refrigerator until needed, allowing the 24 hr outdate of the split units. Once a split unit is removed from the frig to room temp the outdate changes (because, in theory, any hypothetical bacteria who gained access during the split process are warming up and begin multiplying).

So... once that split unit is removed from the refrig for transfusion, the expiration time becomes 4 hours from the time the split unit is removed from the refrig EXCEPT if the 24 hr expiration time assigned from the point of splitting the original unit is reached first. The unit is expired at that point, whether it's been out ot the frig for 4 hrs or just 15 minutes.

Edited January 29, 2013 by AMcCord
clarification...I hope

[OxyApos]

Just another bit of info for the American audience...the most common brand of transfusion filters for red cells and other components states that it is only to be used for up to 4 hours for contamination purposes. This starts the clock on the unit at 4 hours. Doesn't help with the nurses who haven't spiked the unit before then but its been out of the blood bank for over 30 minutes. I've had all of the above scenarios..units out for 10 minutes but the patient room is overheated so therefore, so it the unit...units our 45 minutes but meet temp requirements...etc.

[AMcCord]

Good point with the filter time at 4 hours. That was another issue we had to work on with nursing service. They need to be thinking about that time factor before starting a second unit - use the old filter or get a new one?

[OxyApos]

That 4 hour is from the package insert to the filters. Our Infection Control department has just about decided that all units get an individual filter because its so hard to juggle 2 units in exactly 4 hours.