Glucose Meter Reportable Ranges

19 followers
0 Likes

We currently use the Nova StatStrip Hospital Meter at our instituation. The reportable range that we have been using for 10+ years for our adult meters is 60 - 450 mg/dL even though the meter can technically measure from 10 - 600 mg/dL. This aligns with the lower critical value that we have set as less than 60. Recently we have had units request that their meters measure lower than 60 mg/dL and we are curious if our ranges align with other institutions.

What reportable range do you use at your institutions?
Why did you choose this range?
Do you use the same reportable range for adults and neonates?

Thank you for your help!

7 Replies

Per CLIA and other regulatory agency – reportable range (is also known as Linearity or AMR (Analytical Measurement Range) is based on the result that your meter can recover using a KNOWN material like LINEARITY MATERIAL that your meter company suggest you will be using.

Reference Range (normal range) – is what your Medical Director approved to be.

Critical Ranges (age, sex and other criteria) – is based on National Standards that you want to adapt and is approved by your medical director. This is when Reference will be different for Peds, Critical ill, male and female will be different. This is be derive in collaboration with your Diabetic education, Lab and other department but it needs to be in your policy and approve by your medical director. These ranges will them be use to build in your EMR so that rules can be created base on this and it triggers critical result notification.

Sincerely,
Alma
“Far and away the best prize that life offers is the CHANCE to work hard at work worth doing” – Theodore Roosevelt

Alma Calzado-Knudson, MBA, CLS, MT (ASCPi & AMT)
Manager, Lab Quality and Point of Care Testing
Student Education Coordinator
[cid:image001.png@01DC0CF7.F08BA010]
[cid:image002.png@01DC0CF7.F08BA010]1531 Esplanade Chico CA 95926
•530-332-7360 (Main Lab) l 530-332-7362 (Direct) l 254-722-5388 (Mobile) / [cid:image003.png@01DC0CF7.F08BA010] 530-893-6809
• alma.calzadoknudson@enloe.org
“Together you and I will Each Accomplish More as we WORK towards achieving a common goal – Patient Safety and Satisfaction”

Hi Adelina,
Our hospital uses the following:
Adult reference range (same for male or female): 70 - 110
Critical low: 40, Critical high: 450
Reportable Range: 10 - 600
I wasn't a part of the validation, but I looked at our validation data and it looks like the reportable range was verified using a linearity kit from the vendor.
We do not test neonates here.
Hope this helps : )

Hi
Our hospital
Reportable Range 10-550  we just couldn't validate up to 600 that was many years ago and before my time :)
Critical Low: <40 adults through neonates 
Critical High: (Adults):  >400
NOVA Linearity material has 5 levels through the measurable range and if you can recover the range then you could lower the reportable range.  Get the okay from the Med Director and Validate - I'm sure NOVA technical support would be helpful.

Our ranges were sourced through a number published guidelines: ADA, AAP, Current Clinical Chemistry texts books just to name a few.


We also use a Reportable Range of 10-600 since the linearity kit verifies the meters ability to detect those.  We run linearity on every new meter.  So our meters will report results up to those levels.  
Now our Critical Range is for adults <55 and >400.  

Our medical director had us perform a study with 20 Nova StatStrip meters
and 50 "patients". Some samples were left on the table overnight (or
longer) and some were spiked.
We took the highest low and the lowest high as the AMR. All of the meters
were able to read down to at least 17 and up to 587 or higher.

We performed linearity studies when first implemented (2018) and we confirmed our AMR is 10-600 mg/dL. We don't perform linearity studies on every new meter. We complete performance verification on every new meter and perform interface validation on every new meter, in test environment before switching to production in our LIS.
Our critical ranges are <54 and >400 for adults and peds. We revised our critical low value a year ago to align with 2023 ADA guidelines.

We use the reportable range of 20-500 as that is what we were able to verify when the meters went into use. 
Critical Low: <40
Critical High: >500 Adults, >200 Neonates

Reply
Subgroup Membership is required to post Replies
Join POCT Listserv now
Adelina Wright
4 months ago
7
Replies
0
Likes
19
Followers
640
Views
Liked By:
Suggested Posts
TopicRepliesLikesViewsParticipantsLast Reply
POC ammonia test
Jake Fray
2 days ago
00161
Jake Fray
2 days ago
Glucose Meter Strip Validations
Adelina Wright
2 days ago
40320
Jeremy MacDonald
2 days ago
FOB - moving away from POC
Brian Castle
3 days ago
100488
Jeremy MacDonald
2 days ago