i-STAT New lot of Liquid QC (Tricontrols)
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When i get new lots of Liquid QC, level 1, 2, and /or 3, i run them on a Chem 8+ cartridge 3 times.
Does anyone do the same?
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Nope. What is the reasoning behind this? Do you do this for new lots of other types of control materials?
Jeremy Williford, PBT (ASCP)
Point of Care Support Specialist, Clinical Laboratory Services
South Georgia Medical Center
2501 N Patterson St. | Valdosta, GA 31602
229.433.4804 (office) | 229.259.4836 (fax)
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An item we have to contend with next year. Don’t POCCs have enough to worry about!
After IQCP, here comes another one.
Has anyone been made aware of this new Federal Regs 21 CFR Part 866.
I am forwarding this to you regarding the Flu kits currently in use ( non instrument ) mostly in clinics and physician offices.
FDA is reclassifying antigen based kits intended to detect influenza directly from clinical specimens that are currently regulated as Class I. into Class II with special controls.
The order is effective February 13, 2017
Flu may be misdiagnosed due to the poor performance of these kits.
Compliance by manufacturer is given a 1 year timeframe to bring their devices into compliance
“Just when you think we are safe to go back in the water dun..da..dan.dan…..”
Pet Maniquis, MPA, MT(ASCP) POCS (AACC)
Laboratory Point-of Care Coordinator
Providence Medical Center/ Saint John Hospital
8929 Parallel Parkway, Kansas City, KS 66112
Ph: 913-596-4727; Fax: 913-596-4728
PManiquis@primehealthcare.com
My last lab director had me do this for new lot of controls. take the mean and SD and compare to value assignment sheets. I think that was just an extra step she wanted to do.
when you do get new lots of QC for the istat, what are the steps you do to put them to use?
I run them once, when first received, as they are assayed controls.
Sounds like something that might be considered best practice, but I can't think of a regulation that is tied to, with those kind of specifics.
An unassayed control would, of course, be a different story.
Many lab directors are quick to apply stationary analyzer "best practice" to handhelds/POC devices. Not always wise, or practical. One major distinction being that large analyzers can be calibrated/adjusted, if you would like to tweak the recovery of your QC mean. Handhelds are generally factory-calibrated and cannot be adjusted. Each handheld "analyzer" (I use that term loosely) is going to recover a slightly different mean/setpoint for an assay and a particular lot of QC. Point being, running QC multiple times before implementation might be considered "best practice" but there really isn't anything you can do about the data you generate (if you don't like it), other than take the handheld out of service. And you may be removing a device that is essentially perfectly fine and performing as it is designed to, within the manufacturer's limits.
Well said James! I would only add that whatever one's policy is regarding acceptable QC ranges (accepting assayed values, or running multiple tests and crunching numbers to tighten the range).....just be sure that your process is described in a policy and signed off by your medical director.
Thank you JAMES and MARY!!
Pet,
Is there a link to this final rule/order for influenza testing?
We do a 5 day study on iSTAT controls to verify the manufacturer's range.
Ivy, on what cartridge would you run the controls on? for example tricontrol level 1 and you have chem8+, EG7, E3,and G3 cartridges. would you run the new lot of control on all the cartridges?
Sent via Groupsite Mobile.
I do run on each cartridge type since there are some variations between type and lot sequences. It just gives me more data to beef up my IQCP reasoning. ivy