Cuvette discrepancies

[Gail in Ca]

I thought I'd share my latest experience with my self testing.
I received my new cuvettes, and they are the 3 channel instead of 5 channel. I got the new protime machine that uses both, so I thought I would change to the 3 because it uses less blood, and so I thought would be better for me.
Anyway, I tested and my INR was a point higher than the week before as tested on my 5 channel cuvette. So, having a couple 5's left, I tested again on the other hand, result for both:
cuvette 3- 4.0
" 5-3.1. I called QAS and found that no one knew about the possible differences between the two, but they got on it. A nurse called me and said it was probably just a fluke and to do it again the next day. Next day similar results
cuvette 3-3.9
" 5-2.8. After talking to ITC, it was found that my lot had already been tagged as a possible problem one ( but not with that problem), so she has sent new cuvette 3's to me. Today, inr is 2.3 with the new ones.
I didnt have anymore 5's to compare, as they were supposed to come with the 3's but didn't. I am a bit bothered by these results, which ones are the closest to my real INR?
Just another fun day with coumadin management!!
Gail

 

[RobThatsMe]

Hi Gail,

I think you are the first on here to use the new 3 chamber cuvettes for the Protime unit. So, tag your it... PLease keep us posted on the outcome of this. My unit is still the 5 chamber one, and I do not plan on having it converted to the 3 chamber model, since I have no problem collecting my blood sample. Also I think the 5 chamber may be more accurate for the self calibration that it goes through. Maybe Lance or Brian can shed more light on this topic for us.

Happy Holidays!

Rob

 

[QAS]

Cuvettes

Cuvettes

Dear Gail,

The next time you are due to get supplies, please call me so that I can send you some samples of the ProTime 5's to compare with the new one's. The accuracy should be the same, as they have been tested and approved by the FDA. I've tested both units and have gotten the same results, so maybe ITC had a bad lot or something. Sorry for any complications you have experienced.

Lance

 

[mbalfour]

More details, please on 3-channel

More details, please on 3-channel

Lance:

I'll be ordering supplies very shortly. Please give some more details about the five vs. three channel Cuvettes. What are the details about the machine refurbishment? Will the five channel cuvette be phased out eventually? Why is this change being made?

Happy Holidays to all.

 

[QAS]

Hello,

The difference between the five channel cuvette vs. the three channel is it uses about half the amount of blood. What they have done is taken away the triplicate test in exchange for a lesser blood sample. People that are not having trouble with the five channel, probably shouldn't change. ITC, the manufacturer, is the one that sells the upgrade, and we have nothing to do with the cost here at QAS. In regards to accuracy, most everyone has found, including the FDA, that the results have been consistant between the two cuvettes. If you do get the upgrade, the monitor has the ability to determine which cuvette was inserted, so you have the option of using both. Please call us with any further questions, and we will be back to normal business hours as of Wednesday, January 2.

Lance

 

[mbalfour]

Lance:

Thanks for the information. I've had no problem with the 5-channel cuvettes and I'm sort of partial to the concept of averaging three channels for greater accuracy. I'll be staying with the existing instrument and the 5-channel cuvettes.

As a point to debate, the experimental spread of readings with the 1-channel cuvette has to be greater than that obtained by averaging three readings with each blood sample on the 5-channel cuvette. I'm sure that the spread on the 1-channel cuvette meets FDA guidlines, but I would guess that the
5-channel is more accurate yet.

Best New Years Wishes.

 

[Gail in Ca]

Good discussion

Good discussion

Thanks for all your imput on this 3 vs 5 channel
topic.
Lance sent me yet another lot no. for both and I tested again using both but on different hands like before.
The 3 channel inr- 2.8, the 5 channel inr-2.5,
so this is better. I find it interesting still that the 3 channel is consistantly higher than the 5 channel, even if by .3.
I have contacted my cardiologist about which one he would prefer I use. I sure like having to deposit less blood, but I tend to agree with you here that the 5 channel would be more accurate,as this is what the company touted when I got it, that it was more accurate because of the multi testing instead of just one.
Will continue to post my double results online.
TTFN, Gail

 

[RobThatsMe]

Hi Gail,

Thanks for the information I have been watching this with interest.

I do have a question for you. When you to your tests, do you make a new incision with a tenderlet on another finger for each sample? I am asking this because I was told from their nurse that the 2 minute time per test is critical, not to draw more blood from the same incision, but make a new incision if I have to retest due to a sampling error.

Thanks,

Rob

 

[Zipper]

Getting Insurance to Pay ????

Getting Insurance to Pay ????

Hi Rob,

I'll see my Cardio Jan. 31st and will discuss with him the denial of my Blue Shield to pay for this unit....in the meantime...can ayone tell me HOW they got their ins. to pay ??? Maybe I can share something with my Doc to get it reconsidered....All replies welcome..

Thanx...and I hope everyone has a great new year with hopes and dreams fulfilled.

Zipper *~*

 

[RobThatsMe]

Hi Zipper,

My insurance company did not approve it without my case first being reviewed by the medical review board for the insurance company.

I worked with Lance from QAS, and provided him with all the information that he asked for, so that they could put together all the information required by the insurance company. I also talked with a nurse that was on the medical reivew board, explained my request to her, then followed up with a letter explaining the reasons why I wanted to purchase the unit. I also sent a copy of the letter to Lance to include with the packet of information.

Some of my reasons were:

1. I had a mechanical aortic valve and require INR testing every 2 weeks for the rest of my life due to having to take Coumadin. The cost was $45 for the lab and $18 for the blood draw.. Total was $63.00 every 2 weeks for the rest of my life, which the insurance company was paying. That would equal $1,638 a year, which is more than the unit costs. The tests for the unit, once purchased, only cost around $10.00 per test.
The insurance company would get a payback after one year of me using the unit, and continue to save cost from then on.

2. I travel for 90% of my job. It is extremely difficult to get to a lab for testing on a regular basis when working. I now take the unit with me, and test from my hotel room.

Those are the main points used in my letter to the insurance company.

Hope this helps,

Rob

 

[QAS]

Medical Necessity for ProTime

Medical Necessity for ProTime

Hello everyone--

Here are some of the guidelines that insurance companies use to determine medical necessity:

1.Why do you feel the monitor is needed?
2.What problems do you have with lab testing?
3.Have you had any problems with bleeding or clotting in the last year?

Questions to help expand on these circumstances---------
1.Fingerstick vs. venous draw---How many attempts are needed to draw blood? Do you have bruises, how large? What sites are being used, elbow, arm, hand, scalp? Is an arterial draw needed?
Infants and frail elderly patients need to save veins for more critical use. Frequent draws make venous access difficult or impossible.
2. Homebound--assistance of one or more persons is needed before patient can leave house.
3. Remote location---how many miles to the lab? Does weather make roads impassable? Using a draw station, results take over 24 hours.
4. Jeopardizes the patient's job---Are you missing many hours of work? How frequent is the testing ordered? How frequently are you actually testing? Do you travel away from the lab location? How long and how often are you away from the lab area?
5. Unstable INR----Is the INR out of range? Is the Coumadin dose changed frequently? Can they send record of INR results and Coumadin dose changes?

In most cases, we have to establish one or more of these things in order to get a monitor approved. I hope this helps, and take care.

Lance

 

[Zipper]

Ammo! lol

Ammo! lol

Hi Rob and Lance,

Thank you so much for the additional info....I have printed it ou and will discuss it with my cardio on my Jan. 31st visit..I'd prefer to have it covered by my insurance (of course) but am considering the purchase regardless. I will persue this avenue and see what develops.

Your help, attention, and caring is VERY much appreciated.

Regards,

Zipper/Joan *~*

 

[Gail in Ca]

2 cuvettes, same inr ( finally)

2 cuvettes, same inr ( finally)

Just to update on latest testing. I tested once on left hand with 5 channel- inr 2.7. Then tested on rt hand with 3 channel -inr 2.7! I have always done the 2 tests with different hands, never with the same hand twice in a row.
So, now I must decide whether to stay with the 5 channel or use less blood and go with the 3.
My cardio said he doesn't have a preference. However, he doesn't know much about these machines, I am the only one at a large clinic that has my own!
I am also thinking if I do go with the 3 channel, I would keep some 5's always on hand to double check the 3's if the reading is way off.
I still question why it took 3 different lots to finally get readings that were within the .4 error range.
Isn't this a fun discussion???
Ha Ha Ha,
Gail
P.S. GO RAIDERS!!!

 

[Gail in Ca]

5 channel for me

5 channel for me

I have decided to stick with the 5 channel.
I feel it would be more accurate and have certainly had less problems with results.
The last time I tried the 3 channel it said error not enough blood and it was to the top, even had left over in the little container after the machine sucked it up. so, that was the last straw and I decided the 5 channel is best for me.
Gail

 

[Hank]

5 Channel Cuvettes

5 Channel Cuvettes

Hi Gail and All,

Personally, I see nothing better about the 3 channel cuvettes. I have always had the 5 channel and I honestly do not even notice the slightly larger sample size it requires.

Once you have gone to the effort (which is minimal) to stick yourself in the finger, who cares if it's one drop, two drops, or whatever! It's gonna keep leaking out of my body till I put a bandaid on it anyway.

I don't think I'll ever change from the 5 channel.