pH Testing

18 followers
0 Likes

Looking for guidance regarding pH strip testing complexity. 

3 Replies

Mario,  are you asking if its waived or non-waived?  Its most likely waived but without listing the specific brand and type/kit you're not going to get any definitive answers.

The Manufacturer's literature would state it somewhere, you could also look it up on the FDA's website:
 https://www.accessdata.fda.gov/Scripts/cdrh/cfdocs/cfCLIA/search.cfm#:~:text=Enter%20any%20combination%20of%20fields,Help%20Download%20Files

All qualitative dipstick pH testing is categorized as a waived test:
Attachment.
image.png
 

Ditto on Jeremy's response ... it is most likely waived, and the manufacturers literature should state the complexity.

CMS also maintains a link to the FDA searchable database of testing complexity. It gives you multiple ways to search.

https://www.cms.gov/medicare/quality/clinical-laboratory-improvement-amendments/cartegorization

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/search.cfm

Reply
Subgroup Membership is required to post Replies
Join POCT Listserv now
Mario Olivo
9 months ago
3
Replies
0
Likes
18
Followers
458
Views
Liked By:
Suggested Posts
TopicRepliesLikesViewsParticipantsLast Reply
switching POC glucose from Roche Inform II to Nova Stat Strip
Rosemary Gray
about 15 hours ago
61321
Rosemary Gray
about 1 hour ago
Replacement Procedure for Quidel's Rapid Strep on the Sofia 2
Joyce Timson
2 days ago
20296
Joyce Timson
about 20 hours ago
Physician Requisition Orders for Point of Care testing
Jo Win
2 days ago
10476
Jo Win
1 day ago