Leadcare QA

Any options to d/c testing and send out?  I know we had strong pushes from vendors to offer on-site testing at clinics, but in the end the most efficient thing to do was to send to a government-funded local county lab, who needs to track any elevated value anyway.  On-site testing seemed to be way more trouble than it was worth.  Sorry, I know that's not what you're asking for, but just looking at from all angles.

We have been doing this test in our reference lab. The state of NM has made lead testing a requirement. In looking at compliance, it just wasn't getting done, probably because parents are reluctant for the venipuncture on their kiddos. The system just purchased 6 of the devices without letting POCT know until they wanted us to implement. We let them know of the issues, and they felt it was worth it. We're considering a few things to try and ensure quality. One would be to get a sample from our reference lab and run it on one or more of the devices. We're still trying to figure out logistics. The other is to get an Epic report for the POCT lead results and see if follow up was done on the high ones. The sites are not willing to purchase proficiency testing, and since it is not required we can't make them. The biggest issue, I feel, is the preanalytical one, and potential contamination before the finger stick. Our training is stressing this. If anyone has any other ideas, I'd love to hear them.

Your first comment stated "problems with the device", so maybe one solution would be to step up QC frequency?  Curious as to what adding proficiency testing would do for an analytical issue, that you couldn't accomplish by more frequent QC.  But if the real issue is specimen collection, neither QC nor proficiency testing is likely to help, no?

CarePoint Solutions (host of the Listserv) has two dogs in this fight... 

1.)  CarePoint has a higher-metric QC formulation for the LeadCare II that we supply to federal proficiency testing orgs.  It would require a 510(k) and commercialization, but given all of the sensor accuracy issues and recalls, do you guys see a need/market for a refrigerated blood based external reference standard for the LeadCare?  A control material with superior matrix and better precision than the current QC and perhaps backed by a peer group comparison?  I'm thinking a monthly QC frequency approach to supplement the aqueous controls shipped with the test sensors would be of value?

2.) Given the pre-analytical nature of the sample collection risk... CarePoint's Pro-QCP Quality Assurance Utility sounds like an ideal solution. It guides lab managers through a custom, comprehensive risk assessment, identifying sources of error in their test process and suggesting proven risk mitigation strategies to address them.  CarePoint doesn't offer a Pro-QCP module for the LeadCare II yet, but I'll see if we can prioritize its development.

Forgive the ad hoc market research, but would value front line feedback on either initiative...