EPOC QC
5 followers
0 Likes
We utilize the EPOC instruments at our facility and we now have 12 instruments. According to Siemens, QC only needs to be performed in duplicate when we receive a new lot# or shipment of Epoc cards. At the present time, we are running monthly QC on all twelve of our EPOC instruments according to our IQCP. This is getting way too expensive. What type of study would I need to do to eliminate the monthly QC and revise our IQCP plan?
9 Replies
Reply
Subgroup Membership is required to post Replies
Join POCT Listserv now
Suggested Posts
| Topic | Replies | Likes | Views | Participants | Last Reply |
|---|---|---|---|---|---|
| Piccolo express | 3 | 0 | 247 | ||
| Quantra | 5 | 0 | 326 | ||
| PPM Procedures/Resources | 5 | 0 | 242 |
The reason for the IQCPs is to justify when we choose to depart from the CMS/ CLIA dictate of "QC should be run every day of patient testing".
When we did our IQCP evaluation for our EPOCs, we had to run QC for 30 days and show that they were consistent enough that we could "just" run them once a month.
I don't think you can eliminate the monthly QC. While the EPOC operator's manual tells us how to validate new supplies, it also states:
"9.2 Recommended Quality Control for epoc System
Follow federal, state and local requirements for quality control testing."
This would fall back to what I was told by TJC rep.
To me, it makes sense that we would perform monthly QC, if for no other reason than to continue to assure that the cards have been stored properly and are reliable.
Last year we revisited this process and looked closely at the manufacturer claims. We realized that the internal QC that is performed with each patient test is sufficient to satisfy the "run QC every day of patient testing" CMS/CLIA rule. After discussing it with CAP, Siemens, and our medical director, we were able to eliminate the monthly QC. Now we just run QC in duplicate on each new shipment of cards and perform lot-to-lot comparisons. Here's what we have in our IQCP (a lot of it came verbatim from the Siemens EPOC System Manual):
"Test card shipping temperatures are verified to be satisfactory using temperature monitors in the shipping carton. From each lot in each shipment of cards, at least two (2) levels of fluid controls are analyzed using any verified reader. Results are considered acceptable if they fall within the manufacturer range. Additionally, lot-to-lot comparisons are performed on all new lots of test cards. Results are considered acceptable if they fall within Total Allowable Error limits defined by CLIA. Automated internal quality control procedures are performed electronically during the initialization of the EPOC reader when connecting with an EPOC host and immediately before testing process each time a test is run. An initial battery of tests covering 2 different levels over the dynamic range is performed by the EPOC Reader every time it connects with an EPOC Host. In addition, QC tests are performed by the EPOC Reader on the card and on the operator process after card insertion during initialization. QC tests are performed to assess the card and sensors’ conformance during the calibration interval before the sample is introduced. During sample measurement, QC tests are performed to monitor the operator procedure and sample integrity during and after sample introduction. Together these tests provide a broad spectrum protection against erroneous operation of the EPOC system. Per the manufacturer, electronic QC is automated so no user procedures are required."
Edited to add: We are a high-volume facility, and we order a new shipment of cards at least once per month. So by default we are still doing QC every month, just not on every single device. We also keep color-changing temperature indicators on a sampling of the card boxes where they are stored to ensure the temperature never falls out of the proper range.
That's exactly what we are thinking too! What study did you perform to eliminate the monthly QC for the change in the IQCP?
We didn't perform a new study to eliminate the monthly QC. We did, however, amend our risk assessment to add the paragraph I copied in my previous post.
But then...when it comes time for competency assessments, how is the 'monitoring QC performance' by each user assessed? Ask them what they would do if they have an EQC failure?