Implementing PTS Diagnostics A1CNow+ instrument

Good morning, Claire.
                                     I performed validation for our outreach program here in New Jersey for that instrument, we as opposed to you, do perform HgbA1c in our hospital and were able to validate them using inhouse patient samples.  In lieu of this what you can do is find validation material through one of the proficiency sample providers (CAP, API), all while contacting your State Department of Health for specific guidance as to what is required.  You will need to guide these folks as to regulatory requirements, as they are not familiar with what is involved, such as applying for a CLIA certificate of waiver, creating a policy and procedure, implementing competency assessment, QC logs, patient test logs and signing up to receive proficiency samples at the required intervals.

Hope this helps.

Hi Claire- We implemented PTS for lipid panels at community events.  We also received the A1c devices for our review, but since they are not meant for screening (in their package insert), our Director felt they would not be suitable for community screening events.