Alternative Proficiency Assessment?

21 followers
0 Likes

How do you manage proficiency testing for non-waived analytes that are tested both in the Core Lab and also in POC?  As an example:  your Core Lab runs sodium on their chemistry analyzer (plasma) and you also run sodium on POC i-Stats.  Are you required to perform alternative proficiency assessments (run by testing personnel) on the i-Stats or just semi-annual method comparisons (which can be performed by the POC Coordinator)?

5 Replies

Hi, you can do an i-STAT Chemistry-5 (verification) survey or do correlations between iSTAT and lab. Example run a few patient samples before they are spun and used in lab (or extra tube) that have chemistry and H&H ordered and compare iSTAT results to Lab chemistry and Hematology instruments.

Hello Angie,

The semi-annual method comparisons performed by POCC can be used as an Alternative Assessment.  I add a cover page for the comparison identifying the testing as an Alternative Assessment, too. The purpose of semi-annual method comparisons with the main lab or POCT instrument comparisons are to ensure every instrument or method are working properly.  If you are performing a proficiency with the iSTAT, testing personnel should                                    be rotated. You do not need an Alternative Assessment if you also have a CAP proficiency on the same testing.  Method comparisons are still required semi-annually.

We're supposed to "integrate all alternative performance assessment specimens within the routine laboratory workload, where applicable", so it seems like we should try to have testing personnel run the tests, if possible.

For my Hemochron INR: I ask the Cath Lab staff to pull a little extra from the line, run their testing, and transfer the rest into a blue top.  Then I have the lab staff run the PT/INR on the tube.  I just pick a day for them to do this.  If they don't get enough patients willing to participate in the study, I take the device to our busiest draw station and try to get patients willing to participate there.  I'm running the POC tests in the draw station, but I feel like I've done the best I can to meet the intent of the requirement.  All of this is in a policy signed by our medical director. 

HI
Who are you using for proficiency testing in the Core Lab?  You can have 2 platforms performing the same analyte but have different survey material.
  • Each nonwaived regulated analyte should have its own survey or alternate assessment method that meets CLIA/CMS minimum guidelines or your certifying agency i.e. CAP or COLA guidelines.
  • Proficiency testing should be integrated into the routine lab workload and be performed by staff who routinely test patient specimens. (CAP COM.01600)
  • Biennial analyzer to analyzer testing can be performed by any laboratory personnel.
  • As the POC, I perform the analyzer-to-analyzer testing for the glucometers and use the CAP quality cross check surveys for the moderately complex tests as unknowns for competency assessments.
This is a link to CMS proficiency testing guidelines:
https://www.cms.gov/regulations-and-guidance/legislation/clia/downloads/cliabrochure8.pdf

All of our labs are CAP accredited, and we use the CAP surveys for our PT.  I always thought alternative proficiency assessments were just for tests that don't have a survey available (ex. for the Medtronic HMS Plus heparin assay), but I was looking through the CAP Checklist Requirement Q&A's (in Accreditation Resources section of e-LAB Solutions Suite) and came across this:
Attachment.
image.png
This makes it sound like the POC analyzers would require APA.  If this is the case, those samples must be analyzed by testing personnel (vs. method comparison which can be tested by the POCC).  I sometimes wish there was a separate accreditation body just for POC... 

Reply
Subgroup Membership is required to post Replies
Join POCT Listserv now
Angie Yost
2 months ago
5
Replies
0
Likes
21
Followers
498
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
40317
Jeremy MacDonald
2 days ago
FOB - moving away from POC
Brian Castle
3 days ago
100487
Jeremy MacDonald
2 days ago