Ambulatory POCT Sites

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The question here is about ensuring CLIA/CMS compliance with waived testing in Physician Office Laboratories. How do you ensure compliance with your Physician Office Laboratories? How often do you visit? 

I'm looking for what is your standard practice is and any tips or tricks you might have with your POLs.
Thanks in advance!
Erika

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The physicians' offices have their own licenses and are responsible for compliance. We do not oversee them. We only oversee our hospital-owned outpatient facility. 

I act as a resource for the practices and try to set them up to be compliant, but I don't have any of their instruments/tests interfaced.  I could only lock out operators through individual instruments, but once they're in I can't lock them for annual competency, so I just try to work with them and the clinic managers sending email reminders and letting them know the CLIA requirements.  

I have all managers that can book a new employee with me to train.  Some do, some don't. I have each clinic down for their anniversary when exams are due and when the lab director listed on the CLIA license needs to review the policies.  Most everything I do is electronic so I don't have to run around, but I do try to visit and check in or perform a quick audit.  I have organized a spreadsheet of about 12 clinics I help manage the laboratory and all my exams are electronic.  Let me know if you would like me to email you any examples. It's quite a lot!

We have about 35 ambulatory sites and 2 surgi centers across 3 states that we are resources/oversee in addition to our inpatient sites.  We have all their instruments interfaced through our QML and everyone follows the same POCT procedures that we create.  They each have their own CLIAs except for the ones that are in our hospital building, they fall under our Lab CLIA.  We are lucky that we have the support of the Ambulatory Directors so we don't have unknown testing popping up. 
We have POCT superusers at each site and they are our eyes and ears. They are usually a MA and they do a great job with the extra responsibility.  They make sure the staff completes the new operator training (if they don't come to POCT new employee orientation), and competencies and when someone is locked out they are on it.  We don't get to all the sites as much as we would like be we do try to get to each one a couple of times a year.
My tip would be to be accessible to the super user and the manager.  Make sure they know they can contact you with any question no matter how small because it's a lot easier to answer a small question than fix a big problem that's the result of an incorrect process or information.

To tag onto Adonica’s post, our super users also are trained to review QC and sign off at the end of the month on all QC and maintenance logs.

Like Adonica, could be a Medical Assistant. Some are RNs.

Through visits to audit, virtual calls, emails, I’m supporting those “test site managers” and through them, the compliance comes. I am flexible how frequently I visit, based on distance from me and staff turn over/leadership turnover… how “good” the “test site manager” is.

Thank you to all! Our POCT menu is growing and so is the individual POL site menus. I see room for improvement is documentation for compliance. I really like the idea of virtual calls with super users and/or managers. Too much time on the road does hit us hard in other needed tasks. You all have me thinking!!!!

We have 2 50% and one full time POCC's and we visit appx. 110 sites every month. It is a heavy load plus we do all the training for all test and competency on all of them. We cover 4 different hospitals and the other 110 sites are different physician practices spread out over 6 counties. We also do 6 month audits on every place over and above our normal check ins. I must say it keeps us pretty busy.

Lynn Cunningham! That is quite the workload!  Do you also have in house platforms to maintain/validate/train/do competency for?
Kudos!

No, we have people come down to our training room and do their competency. We do have 1 educator that helps us with the ACT's on two different units. I'm the only 4 year degree so I have to do all of the competencies on the moderate complexity testing. This would be Blood Gases, ACT, and Creatinine's. So I have to travel to all the sites and do their competencies along with my regular duties.

Erika, I'll share a couple of examples of how I use virtual meetings. TEAMS from my PC or work laptop works much easier than pre-pandemic when I had to use a tele-com type camera/computer from a conference room.  

If I build a group 'meeting', depending on the purpose of the call, I seed it with experience test site managers (TSMs) who are comfortable talking to other operators/TSMs. I direct/facilitate but try for peer-to-peer discussion on problem solving that works for one clinic and may in another.

If I see non-compliance during an on-site visit, if I have to follow-up and can't get there due to distance, I'll invite the TSM, any operator involved in the non-compliance if the TSM wants me to handle retraining, and if the TSM tells me they get zero support from their RN Supervisor I mandatory invite them also. 
Sometimes I just need to have the TSM for a 1:1. I ask in advance for scans of the testing site latest QC logs, etc. whatever will help make the case on how to correct noncompliance. Share screen. At least in our version of TEAMS I don't have a white board but my free personal zoom account now has one so I may try that out!

It's possible most folks just think of virtual in terms of doing remote training. That's how I used it pre-pandemic, too, and with TEAMS I've found more ways to travel less. However, no communication technique (where I work anyway) substitutes for being a presence the operators and leaders at that ambulatory get to know a bit.

Good Morning!
I have a hospital team and a separate clinic team.  The clinic team of 2 (soon to be three) oversees approx 145 waived, COC, and PPM clinics across the state.  Waived and PPM clinics get quarterly visits with increased visits if there are issue noted during a single visit.  COC obviously get visited once a month.  In the waived locations, we have a key operator that we direct most information to and they pass this information along (the clinic manager is always copied).  We have a Teams site for questions that either my hospital or clinic team can assist with in real time.  For training, all new hires get COMPASS modules and a live teams training as a cohort.  For annuals, they get the online COMPASS module.  
The testing platforms/formulary are standard across all regions/all locations.   Documentation of all waived testing and QC is electronic and all instruments are interfaced (older locations are on the list to be interfaced shortly).
Non compliance begins with re-education and is followed up by an electronic submission to our non conforming events software, RL Solutions.  These are reviewed by leadership and is how we track and trend.

That being said, waived compliance can be difficult when you are not there daily.  Turnover in the clinics is often high and you might lose key operators often.  I ask my team to increase touchpoints to the clinics when they feel that there is a clinic struggling.  Some never need us. Keeping good rounding logs helps you keep it straight.
Hope this helps!
Mary Hammel

  • I have around 72 ambulatory sites that perform waived testing only.
  • I have clinics under multi-site licenses based on specialty and location. 
  • I "round" (inspect) them at least once a year and based on the result (percentage) they get another visit from me if indicated. 

As for how to keep them complaints that is the million dollar question :) 
You make yourself known in the sites and to the leadership and build relationships. Then when they have questions and/or need some help they will feel more confident to come to you. 
I do a POCT overview presentation to all clinic staff at Ambulatory Orientation and then train them on the top 3 POCT on day 2 (of 4). For all the other tests they go through training slides (with videos of performing a QC and Patient test) for all tests and take a quiz.
If managers request I will also go out to the site and train any staff member onsite on all POCT.

Good Luck and feel free to reach out to me if you have any other questions.
Anastasia Augustine
POC Testing Specialist
anastasia.augustine@vmfh.org

We will begin the ambulatory side adventure soon also.  For those of you interfacing your POLS, what are you using? So many practices are used to to doing things their own way and who know where they are putting their results! We use RALS for our acute care side. Also curious as to how you are handling non-waived testing you might find.  I really do not know yet how many offices we are looking at, but thinking to devote 2 FTE's for this service.  My guess is around 150 but not sure if they all have testing, I have myself and 2.5 FTE's for our 6 hospital, 3 med centers, and a few urgent cares.  We do all training for moderate employees (1500 of them) and currently train all waived except glucose.  Just a little nervous about adding more!!!
Thanks
Kim

Hi Kim,
Some of us join you virtually in being a little nervous with what you describe!

My experience setting up or assimilating practices is usually not the same as when the POC Professional is working from position of a clinical lab dept. In a way I've had a tiny edge with assimilating off-sites since I work in a department dedicated to the clinics' operations. Which is the reason I left clinical chemistry/POC as a 'lab' employee. Feel free to email me as you go along if something comes up outside stuff you want to post which is 'not exactly lab'.

All of our POCT that is interfaced is only interfaced using RALS. That is waived and nonwaived inpatient/ED/campus clinics/ambulatories/remote clinics. The one difference was in 2020 when we put waived POC Molecular instruments inside the labs to perform COVID.

With so many 'Dr.'s offices' using EMRs which are not the same as the big ones used in hospital/lab systems, and frequent use of waived manual kits in office practices, I immediately thought what I'd do is compose a questionaire (fact finding) to Practice Managers. Find out as much as you can from your lab leadership on what all is getting assimilated/'bought'/acquired through ownership because it's possible that other departments (eg Nursing) is also doing what you will have to do and that can get very confusing to the office leaders. It's important to know on your end if this is an ownership or a partnership. That helps you sort out/strategy for 'the chain of command' you'll have to use to report compliance/noncompliance.

Also when it comes to CLIA Certificates - find out about 'ownership' each CLIA listed on the original applications. Unless each POL remains under their original ownership, you'll have to consider re-applying to inform about new ownership. 

We are much smaller than most of you all but we have 16 total clinics. 4 are moderately complex, 2 are PPM, and 10 waived clinics. (2 are CLIA Mod Complex and the other 2 are COLA).  I visit the Mod Complex clinics monthly. All of the other sites I visit typically every 6 months unless I am having issues with compliance at that location. Then they see me more frequently. : )   I do all of the training/competencies for PPM and Mod Complex testing. I do waived testing training for our clinic that is attached here to our hospital, but I have lead nurses that do the waived training for all of the outlying clinics. I, however, receive all of the training sheets to keep here on record. By the way it is just me as POCC at this point, but we just got approval to add another because I am in need of some help! If anyone is in the market let me know! LOL We do not have anything interfaced with our clinics but we do use RALS here in the hospital for our glucometers and iSTATS. We have Pochi-100i's in two of our Mod Complex clinics and weekly I am able to look at the lot-to-date report of QC in between my monthly visits. 

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