Accuchek Inform II Linearities
Hi All!
I want to first warn you all that I am VERY new to this point of care world. Our previous coordinator retired in October and our position was vacant until I officially accepted the job last week. My current position is a hybrid position between POCC and my previous position as hematology lead. I work the hematology bench most days, so that being said, you can imagine that my time is a little limited.
I am currently going through procedures and I had a question regarding Accuchek linearities. Our current procedure says every meter every 6 months. Now, we aren't a super large hospital but we easily have more than 50 meters, some of which aren't off site.
How do you all tackle your linearities? Unforunately as of right now, we do not receive sequestered lot numbers of strips either. Any advice or insight would be greatly appreciated!
| Topic | Replies | Likes | Views | Participants | Last Reply |
|---|---|---|---|---|---|
| iSTAT in NICU -chem 8, CG4 | 5 | 0 | 197 | ||
| Rotem Sigma Validation Help | 1 | 0 | 96 | ||
| Hemochron Sig Elite use outside of manufacturer temperature range | 2 | 0 | 153 |
Hi Kimberly,
Welcome to POC and good luck juggling 2 jobs!
I used to do the every 6 months also. I don't think it's required of waived testing but I was new and confused it with moderately complex testing which does need linearity every 6 months. I have 59 meters (5 off site) and it was a struggle. This is what I have in my policy:
The Laboratory/POCC will be responsible for:
a. New lot numbers of strips
b. All new meters before they are put into use
c. As part of troubleshooting when controls are out of range or validity of results is questioned.
d. Periodically, on a subset of meters (optional).
We have 6 months worth of strips sequestered with the same lot. It is a nightmare for a couple months changing lots so I would suggest you have your supply chain fix that as soon as possible. :)
I learned everything POC from the listserv. If you have any other questions feel free to email me.
lois.snider@stclair.org
The Accuchek Inform II is waived so you definitely don't need to do every 6 months as you do with moderate complexity tests.
We have about 275 meters and we only do them on new meters, new strip lots and to troubleshoot meters that the floors are having issues with. Can't say I remember seeing an Accuchek flunking a linearity in years.
Get yourself set up for a 6 month sequestered lot of strips.... Makes life so much easier!!
Kimberly,
Linearity every 6 months on waived glucose meters are not generally required.
1). Read the product insert and see if the manufacturer require linearity of the meters.
Follow what the manufacturer require. Unless the manufacturer require that you do linearity every 6 months, you are not required to do so, unless you want to.
2) Who inspects you: Joint Commission or CAP. Inquire from the inspecting agency what is required of a waived test glucose meter.
At one time CAP require that calibration verification is done on glucose meters. Not anymore.
Hi Kimberly,
Everyone else's advice is great. I'm going rouge with one additional suggestion.
If your waived testing accreditation is TJC, find out who the 'Waived Testing Chapter' liaison or lead is. Get to know this person. Showing up with Snickers or Hershey bars is not a bad idea even if it's not 'bribe the operators time'.
If your waived testing is under CAP accreditation then assuming the lab compliance officer is your go-to, have you had a sit down with that person since you took over the POC leadership?
In a way I see I'm typing "you don't have to do this alone". Even if you are the sole party assigned by your boss to be responsible for the entire POC Program.
Oh and, once you get the info you are looking for (eg linearity for glucose meters) from your accreditor, remember to go find your written policy and change the content, get signoff from the lab director, if you do have to change anything that previous was being done.
Good Luck!