Procedures across multiple CLIA sites

Some of our procedures, such as the glucometer, we have one standardized procedure for the system. Our main campus created the procedure with input from system site managers. For other procedures that have more facility specific differences, main campus shares a standard draft that  that may be edited by the sites. Approval is by site LD.

...with kid-glove treatment and hope...
In my experience with inpatient and outpatient testing sites, waived and nonwaived complexity testing, I find inpatient testing sites far easier to 'apply as a one size fits all' standardization of P&Ps. And workflows. Plus it's typically one CLIA# covering all those testing sites within one hospital/inpatient setting.

Outpatient challenges for me in sticking to a strict work flow includes: literally the size of the clinic and is there a dedicated POC Station/room/space? the layout of the clinic with many times shared space (shared for different service lines, different staff, different needs for a work flow although could be sharing the same POC test device/kit).

For me/our testing sites, I would not say a struggle for us is using the same P&P and IFU/package insert across all testing sites for the POCT. The tediousness for us seems to be the collection (ex swab or urine specimen) process, where the testing can take place (nursing station vs dedicated POC 'room' such as a utility room, collecting in patient exam room then carrying out the sample - that kind of issue related to work flow. Recent example? antigen test where IFU stated 'do not put the swab back in the packaging sleeve to carry it out of the collection station'. Oh boy - seems easy/simple but the work flows are different between clinics and urgent care space/how patients flow through.

Also kicking into workflow is 'environment of care' and 'infectious disease/epidemiology' stuff like how one can and cannot carry specimens in a hallway and the PPE required. Cover that as able in the P&Ps to be standardized.

I guess bottom line for us is: we have one SOP which is dictated by the IFU although the POC Director could make it more strict. We work on the SOP until there is one that workflows can carry out. And I personally work whatever time it takes with the NM or operators so the workflow is adapted up front to be able to carry out the standard SOP.
 
Hope this helps a bit. It's never been easy and I go through this with each new testing site and existing SOPs.
The difficulty for us is always the competency piece of having the same SOP at different CLIA#s so we ARE, in my opinion, repeating a competency for the sake of 'it's a different CLIA#' but nothing is different in the process/performance of the POC test.
Peggy

We have standardized procedures that all CLIA sites use (in house and off campus).  As Point of Care Testing Coordinators, we create the procedure so all procedural regulations are met.  We have also created a designee page that all CLIA directors sign that gives us and our pathology team designee duties of creating procedures / approving procedures, and things like that so we meet the waived JC leadership standards.

We use one procedure for all the POCT done in both OP and IP areas.  Our procedures are created by us in POCT and kept on our hospital portal so everyone has access to it.