CMS/i-STAT Comparability Requirement Interpretation and Implementation
25 followers
0 Likes
Hello POCC Colleagues,
I am interested in learning how other organizations are interpreting and operationalizing the recent CMS focus on instrument comparability requirements under 42 CFR ยง493.1281(a) as it relates to Point-of-Care Testing. According to recent communication from Abbott following discussions with CMS, the expectation appears to be that laboratories maintain a documented process demonstrating comparison of all patient-testing instruments at least twice per year, while method-to-method comparisons may be performed using a single representative instrument from each method.
Our understanding is that CMS has not changed the regulation itself, but surveyors may be placing increased emphasis on how laboratories document and demonstrate compliance with instrument-to-instrument comparability requirements. Abbott also indicated that activities such as liquid QC, calibration verification, proficiency testing, competency assessments, or other documented quality processes may be acceptable if they incorporate all patient-testing instruments and are performed at least twice annually.
For those who have discussed this with CMS, CAP, The Joint Commission, COLA, DNV, or state inspectors:
1. How are you interpreting the requirement for large fleets of POCT devices such as Abbott i-STAT, or similar systems?
2. Are you performing formal instrument-to-instrument patient sample comparisons on every device twice annually, or are you using an alternative documented process?
3. Have surveyors specifically accepted QC, calibration verification, proficiency testing, competency assessments, or other quality activities as evidence of compliance?
4. Have any organizations received clarification directly from CMS or their accrediting agency regarding acceptable approaches?
5. For high-volume health systems with hundreds of POCT devices, what process has been deemed survey-ready and sustainable?
I would appreciate hearing how others are approaching this requirement, particularly any experiences during recent CMS, CAP, or Joint Commission surveys.
Thank you in advance for sharing your experiences and interpretations.
Best regards,
Angel Lorenzo, MLT(ASCP)
Point of Care Coordinator
Virtua Health
I am interested in learning how other organizations are interpreting and operationalizing the recent CMS focus on instrument comparability requirements under 42 CFR ยง493.1281(a) as it relates to Point-of-Care Testing. According to recent communication from Abbott following discussions with CMS, the expectation appears to be that laboratories maintain a documented process demonstrating comparison of all patient-testing instruments at least twice per year, while method-to-method comparisons may be performed using a single representative instrument from each method.
Our understanding is that CMS has not changed the regulation itself, but surveyors may be placing increased emphasis on how laboratories document and demonstrate compliance with instrument-to-instrument comparability requirements. Abbott also indicated that activities such as liquid QC, calibration verification, proficiency testing, competency assessments, or other documented quality processes may be acceptable if they incorporate all patient-testing instruments and are performed at least twice annually.
For those who have discussed this with CMS, CAP, The Joint Commission, COLA, DNV, or state inspectors:
1. How are you interpreting the requirement for large fleets of POCT devices such as Abbott i-STAT, or similar systems?
2. Are you performing formal instrument-to-instrument patient sample comparisons on every device twice annually, or are you using an alternative documented process?
3. Have surveyors specifically accepted QC, calibration verification, proficiency testing, competency assessments, or other quality activities as evidence of compliance?
4. Have any organizations received clarification directly from CMS or their accrediting agency regarding acceptable approaches?
5. For high-volume health systems with hundreds of POCT devices, what process has been deemed survey-ready and sustainable?
I would appreciate hearing how others are approaching this requirement, particularly any experiences during recent CMS, CAP, or Joint Commission surveys.
Thank you in advance for sharing your experiences and interpretations.
Best regards,
Angel Lorenzo, MLT(ASCP)
Point of Care Coordinator
Virtua Health
3 Replies
Reply
Subgroup Membership is required to post Replies
Join POCT Listserv now
Suggested Posts
| Topic | Replies | Likes | Views | Participants | Last Reply |
|---|---|---|---|---|---|
| CMS/i-STAT Comparability Requirement Interpretation and Implementation | 3 | 0 | 280 | ||
| iSTAT CG8 cartridges oderables | 3 | 0 | 240 | ||
| Point of Care Education Needs | 5 | 1 | 360 |
We were told that we have to correlate each device every six months and that correlating a percent of the total fleet was not acceptable. According to the feedback we were given, QC material was acceptable for the device-to-device correlation, but our gold standard must be correlated to the chemistry analyzer. We were also told that QC must be performed on each device, for each cartridge type, every month. Prior to the change, we were QC'ing cartridge lots upon arrival and monthly, but only on one instrument and were evaluating updating our IQCP to state cartridge QC upon receipt of new lot/new shipment only. We are still trying to formulate a practical plan to QC each i-STAT every month, how we are going to train end users, etc. . .
It is a headache, and I still do not have a good grasp on how we are going to manage this change on top of all our other responsibilities (there are only two of us!)
Point of Care Coordinator
Virtua Health
We designate one primary i-STAT per CLIA site and use that for correlations with all cartridge types. These are instruments permanently located in each of our four hospital labs.
What is the accrediting body for your lab? 2 of our labs are TJC and 2 are CLIA compliance. We were told by TJC that linearity was not required every six months, because the iSTATs are factory calibrated. However, our CLIA inspector at another site was adamant that we must perform linearity at least every six months, so we don't even have guidance that matches between those two agencies.
We will primarily use QC for correlations for all devices except the primary, which will be correlated to the main analyzer with a 10-patient comparison for each cartridge type/analyte run on both. I'm also evaluating the practicality of data I can pull from an Epic report for expanded patient correlation. The report pulls results for anyone that has iSTAT and lab testing performed within a 2-hour window.
The additional cost to revalidate each of our instruments was significant and I don't know how sustainable it is, cost or labor-wise, to maintain the current fleet size with the new (to us) requirements.