GEM Validating pH Range

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Hi there, 

Can anyone give any insight on how your institutes brought your pH linearity range down to the technical range of 6.8 or what third party materials did you use? The validation solution from Werfen only allowed us to get down to 6.9 and a couple of our units are concerned we couldn't get it lower. 

Thank you for any help! 

Brittany Behrendt, POCC 
brittany.behrendt@childrensmn.org

2 Replies

Hello,

Thank you for your message. I am out of office and will return tomorrow 7/7. I will respond to all inquires upon my return.

Carly

Carly Bilek MLS (ASCP)CM

Laboratory, Point of Care Coordinator

cbilek@methodisthospitals.org

Southlake Campus

8701 Broadway

Merrillville, IN 46410

219-644-3987

Northlake Campus

600 Grant Street

Gary, IN 46402

(219) 886-6915

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GEM Validating pH Range
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Hi there,

Can anyone give any insight on how your institutes brought your
pH linearity range down to the technical range of 6.8 or what
third party materials did you use? The validation solution from
Werfen only allowed us to get down to 6.9 and a couple of our
units are concerned we couldn't get it lower.

Thank you for any help!

Brittany Behrendt, POCC
brittany.behrendt@childrensmn.org

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Your lab director can define what is acceptable for AMR verification. For the lower limit, you can have your lab director state something like this in the SOP: "Calibration verification materials used for each instrument and analyte shall include low, midpoint, and high concentration levels. For verification of the Analytical Measurement Range (AMR) using purchased linearity materials or instrument calibration materials, observed results must be within ±20% of the manufacturer's assigned value at the upper limit and ±50% of the manufacturer's assigned value at the lower limit, or within the analyte's established Total Allowable Error (TAE), as applicable.

If these acceptance criteria cannot be achieved, or if their application is impractical for certain analytes (e.g., analytes measured at extremely low concentrations), alternative acceptance criteria may be established and approved by the Laboratory Director for the specific analyte."

at my former place I worked. We had this policy and I do believe this to be regulatory sound. 

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