According to JCAHO and others, Hematology analyzers must have at least one level of control run every 8 hours, with at least 2 levels run every 24.

If you are using both open and closed modes on an analyzer, this means that you have to use twice as much commercial QC material as you would if you only used one mode.

One way around spending twice as much for commercial controls is to use a patient control. Does anyone do this? We are currently reviewing our policies for using patient controls and we are wondering if and how other labs are doing it.

We now run a random normal patient 3 times in the closed mode, and make sure the variance is low enough for each parameter. We then run it 3 times in the open mode. The mean open mode results must be within a pre-established range of the closed mode results in order to say that the open mode is in control. (Commercial QC is also run in the Closed mode)

We have been doing this only once a day, however, and now are thinking we should have been doing it every 8 hours to be compliant with what I mentioned above in the first paragraph.

Anyone else use a patient-control protocol?

We also use patient controls, not for mode to mode but for the shift QC. After a.m. Maintenance and Commercial QC (for calibration confirmation, we pick 2 bloods. one with low WBC and high HB and one with hige WBC and low HB. Therefore, we can sort of bracket the patient population range. Then we run them 3 times in a Library on the analyzer, hoping for CV <1.0 but it has to be <2.0. Then we run them at 1300,

1800, and 2300.

Our analyzers (Abbott Saphires) do not require a mpode to mode since the pathwas is the same.

hi we use a control which we name drift. we use a pack of expired blood, aliquot it into sample tubes and use this. we use 10 samples to set a range on each analyser and then run that 4 times a day, twice in manual mode alongside our commercial Qc. we only use it to monitor hb,wcc and platelets.

"Our analyzers (Abbott Saphires) do not require a mode to mode since the pathways are the same."

That's what we thought also up to a few inspections ago. We are using BC LHs, which also have a "common pathway" from the blood segmantation valve into the rest of the analyzer - (as do all analyzers I think).

But the fact is the sample first comes from either needle-peircing assembly or a manual sample probe mounted on the BSV. Our inspector says these two modes are different enough to require separate QC. Hence the need for QC every 8 hours on both shifts.

First I ever heard of this. What did CAP say?

The Sapphire does not have a blood sampling valve; the sample probe is the same for both the open and closed modes, so the blood uses the same pathway.

As far as I am aware the regulations say that if the pathway is used for sampling and therefore used for patients results the to ensure the quality of results that pathway should be controlled in regular intervals. So of you only use the probe sampler very occasionaly, then once a day with one level of internal or external qc should suffice. However if you use it regularly then it should be controlled accorfingly.

We run the 5C controls on our BC LH 780 and HMX once a day. We then meet the control requirement for the rest of the day by setting up patient controls (an a.m. and p.m. control). Each control is run every two hours for a total of twelve hours. Once daily we run one of the patient controls in both the primary and secondary mode to ensure that the two modes are in agreement. We also run one of the patient controls on both analyzers to check that our analyzers are in agreement.

We just had a Joint Commission inspection in July and they agreed that our patient QC protocol met their requirements.

If I read you right, Colleen, you are saying that you check mode-to-mode once a day and at a recent JCAHO inspection, you had no trouble. This would be in spite of the pertinent standard that seems to say that each mode needs to be QC'd at least every 8 hours with at least two different levels every 24 hours.

When we had trouble was not at our last inspection but at the one before that 3 1/2 years ago. At that time, we had no QC at all for the open mode. That inspector was the one who pointed out that we were not in compliance. We started doing mode-to-mode, but only once a day like you.

The inspector we had last year didn't really go into it, and of course, we didn't specifically ask him if it was OK to do a mode-to-mode just once a day to QC the open mode.

But we have an inspection coming up and our Hematology manager decided to play it safe. Now of course, the next inspector will probably not ask about it at all!

We get around this by alternating which analyser we use as the one for 'urgents' and only QC the open side for each analyser every other day. We have a magnetic 'urgent' tag that gets swapped over as soon as the new day's controls are validated. It's just making sure people only use the analyser marked URGENT for urgents. We do the same with retics too - only one analyser runs retics each day.

SMILLER,

We did not have an issue at all with the inspector and our practice of only running QC once daily in the secondary mode. This might not have been addressed specifically and as you pointed out different inspectors often focus on different points. Ours focused more on the fact that we were not performing linearity as a calibration validation.

Thank you for bringing up this requirement as we will certainly be looking into it and possibly changing our practices soon as it would be an easy fix.

Hallo, you can take a look here for some ideas, there is a lot free manuals: http://techno-fix.com/New_Manuals.php?s=50

On ‎9‎/‎14‎/‎2011 at 8:28 AM, SMILLER said:

According to JCAHO and others, Hematology analyzers must have at least one level of control run every 8 hours, with at least 2 levels run every 24.

If you are using both open and closed modes on an analyzer, this means that you have to use twice as much commercial QC material as you would if you only used one mode.

One way around spending twice as much for commercial controls is to use a patient control. Does anyone do this? We are currently reviewing our policies for using patient controls and we are wondering if and how other labs are doing it.

We now run a random normal patient 3 times in the closed mode, and make sure the variance is low enough for each parameter. We then run it 3 times in the open mode. The mean open mode results must be within a pre-established range of the closed mode results in order to say that the open mode is in control. (Commercial QC is also run in the Closed mode)

We have been doing this only once a day, however, and now are thinking we should have been doing it every 8 hours to be compliant with what I mentioned above in the first paragraph.

Anyone else use a patient-control protocol?

We run 2 levels per shift on the auto mode plus one level per shift open mode.  we were running less until state inspected us and dinged us for not running enough controls.  JCAHO's next inspector asked why we were running so many controls.  My answer is because state said we had to State can shut us down.. !  I worked the night shift at another facility years ago and they used patient controls.  about 10% of the time the patient control would not be within limits.  Coulter Jr  ya way back 

Note that the original posts were from over 4 years ago.

Since then, we just run a commercial control every 8 hours in both modes. Instead of two boxes of QC used every month, we now use 3.  The extra expense is worth not having to screw around with patient controls!

If we had not had an inspector (several inspections ago) tell us that the two modes were the same as two methods, we would not be running QC in open mode at all on the Coulters.

Scott