IQCP Modification: Facility Move
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Hello everyone,
Has anyone had to modify their IQCP for a move to another facility? We are building a new hospital with plans to move next year.
Did you put something in your quality assessment and plan or quality control plan? Or did you just add additional historical data (temperature logs, etc)?
Thanks!
Ruth Harmala
Point of Carr Coordinator
UP Health System Marquette
ruth.harmala@mghs.org
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You can use some of the information in your current IQCP, but you will need to get specific historical data from the new site. We had a situation where we put an i-STAT in a new location, and the CMS inspector required us to do the eQC validation at that site, as well as gather the data for personnel, environment, etc.
Do I have to collect new historical QC data? The users are not changing, only the environment.
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This was our experience from a CMS inspection of a newly-opened lab. We put an i-STAT in the site, which is set up exactly like the 9 or 10 others. We wrote the IQCP based on the historical data we had for all our i-STATs, which was voluminous. The inspector told us we had to do the 20-day liquid QC to eQC study at this site, as it didn't have its OWN historical data.
Thanks for your input Kathleen! I’ll talk to our regulatory compliance and pathologist to see what they think. I trust what you’re saying I just really don’t want to have to have my operators perform daily QC for 20 days. Again. :)
That makes sense to me though. Getting nonlab people to understand the importance is the hard part.
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Ruth, I am setting up a different site and doing 30 days of QC for IQCP data but the lab staff is running the QC, not the nursing staff. Since I am evaluating the system, I don't feel that all the operators would have to perform it. I will only have one or two designees on a unit run the QC anyway going forward. Ivy
Hi Ivy,
Ok, since it is only the location that is changing, not the operators, it makes sense that they wouldn't have to perform the QC.
Do you not have your operators included in your IQCP as a part of the 'system'?
Ruth, I do mention that the operators on the units may be running the QC in the IQCP but I wouldn't consider them part of the test system itself; perhaps more like part of the process. Frankly have not considered it. I look at the system as the components that produce test results. ivy