Physician Office Question

Kelly,

I've done oversight in ambulatory which includes faculty group practices and 'MD offices' for quite some time. Most of the questions you ask will be answered depending on what accreditation is going to be used - if it's used - in those testing sites you refer to as 'MD offices'.

Another way of me saying is that it makes zero difference to our POC Program if the waived testing is being performed in an MD office, a campus clinic, or inpatient unit. We follow all the rules of our accreditation across the system because our MD offices are inspected at the same time as our hospitals using the same accreditation for waived testing.

If you are performing nonwaived testing then still, you'd follow those rules of the accreditation.

On the question of the 'team' or I'm the only one overseeing MD offices - that varies so much from what I've experienced in talking to POCCs who must include MD offices. As usual it depends on size of POC Program, etc. And how the departments work together (or not), who holds the CLIA Certificates (MD in office or lab/Pathologist?). MUCH depends on how much the lab administration agrees to supply to the MD offices in terms of your time. I haven't been paid out of a lab budget in 14 years I think but I rarely run into a med tech turned POCC who is paid by another department, as I am. That also makes a difference in the short and the long run of oversight.

We have several Health Centers have waived point of care testing performed by clinics there. At those clinics we follow CAP guidelines regarding record keeping and surveys. For locations that fall outside our mileage zone, we tell those offices that they must obtain a Certificate of Waiver (COW). These locations do not fall under us and must follow CMS guidelines-basically obtain the certificate and follow the package insert directions. I do not have experience with PPM except for what I have read on-line.

There are great resources for both COW and PPM on the CMS website. Search for "certificate of waiver" and CMS PPM (if you just type PPM, it leads to something else and you will have to dig awhile for find the one you are looking for). Both will lead to pdf files.

Our group of 2.5 FTE's handle 72 clinics in addition to our hospital poc testing. Our Pathology medical director makes each site hold their own CLIA with a provider from the practice serving as medical director. 

As Peggy stated standards vary by accreditation agency.  We have some sites that fall under Joint Commission hospital waived testing chapter and others that fall under Joint Commission Laboratory chapter.  We also have COLA.  An example of some of the differences:  Cola requires a 6 month competency for waived testing and JC doesn't.  JC practices under the laboratory chapter of JC get PPMP inspected where our other sites don't.  CMS does not require PPMP to be inspected but you are still supposed to follow all the CLIA regulations.   We don't currently have any of our waived testing accredited by CAP.  

Although not required, our medical director likes us to do at minimum a correlation study with any new waived method.

Thank you all for the information. I greatly appreciate it.

Our lab and hospitals' POC programs are all CAP accredited. And I would like all offices and clinics to follow the same standards even if we do not need to be inspected.

HFAP question - Does anyone know if these offices would be considered part of the "Hospital"? They are owned by the organization but the CLIA certificates are currently under the individual physicians. Would HFAP consider these part of the "HealthCare Facility" Does anyone have any experience with HFAP inspecting clinics or physician's office? 

Any additional thoughts or suggestions would be welcome.

Thanks Again,

Kelly