CLIA Certificate of Waiver

Here is my take on your questions, although it's probably best to ask CLIA directly.
1. As far as I can tell from the CLIA regulations, there is no requirement at all for a CW--it could be a nurse, physician, tech, etc.
2. The address on the patient results should be the clinic address, since that is where the testing is occurring.

Thank you!  I did reach out to my CLIA representative, but they were not much help with the reporting part.

HI Ashley,
Kathleen is correct. The CLIA waiver holder does not need to be a pathologist or even an MD, though it is nice to have that! Result reporting should contain performing lab address (which should be the same as your CLIA).

We have several offsite locations that have their own CLIA and have set up performing labs for all of them (so that when the result is reported their specific lab director info, CLIA number and address are included in the report). 
Thanks,
Erin

Hi Ashley - here are my thoughts (I work ambulatory/clinics):

 1.Director:  For a CW can a nurse, physician (other than a pathologist) be the director on the CLIA license?
Yes, at least in the State of TX we've had many MDs with current TX medical license get approval to be the CLIA LD; we also have had Physician Assistants although not a nurse/RN.
2. Results:  If the place has a CW, whose address should be on the patient's results in the medical record?  The address that is on the CLIA address or can the supporting hospital's address me on the results?
Wow, that's an interesting question! I will tell you how it is 'here' but please check with your State CLIA office to be sure you are in compliance. If the POC order/result is unsolicited (coming through performing the test on a connected device, the EMR documentation will show the CLIA# but we have some CLIA#s using 'exemptions' where more than one physical address is tied to a 'laboratory name' on that CLIA. Also if it's a manual test where  (manual ordering and resulting) EPIC enter/edit is used to document the result then the physical address of the testing site will be where the patient is seen/visiting.
Hope this helps more than confuses further!

We have consolidated some of our CW clinics to a multi-site CLIA certificate.  

For certificate of Waiver, the CLIA director  do not necessarily have to be a pathologist. The CLIA director for Waived certificate  can be a physician, nurse or medical tech.  ( For non-waived, the CLIA director has stricter qualification requirements).  Our clinics  each have their own CLIA  Waived certificate and we try to get the head physician in the office  to be the CLIA director. 

The address  where the test is occurring should be listed on the lab testing report.  
Although several clinics can be in one CLIA waived certificate, we opted to make sure each clinic have their own certificate. Some are compliant and some are not.  The other clinics do not want their certificate jeopardized by the non-compliant clinics. . 

I also have a question about a CoW.  If we have 2 or 3 different outpatient testing sites (Wound Care, Employee Health and Cardiac Rehab in the same building, do they each need their own Clia Certificate of Waiver and each their own director or can they all be listed on one Cow?

If they all have the same address and are on the same campus, you can have one CoW to cover them all. Then the one CLIA medical director would be responsible for all sites. You also have the option of getting each of them their own CLIA. I would make sure that your state regulations don't override the CLIA regs first, though.

If they all have the same address and are on the same campus, you can have one CoW to cover them all. Then the one CLIA medical director would be responsible for all sites. You also have the option of getting each of them their own CLIA. I would make sure that your state regulations don't override the CLIA regs first, though.

Deb I'm hopping on but know you are in CA so am reluctant to advise! The outpatient testing sites I have 'in the same building' do not use their own CLIA Certificate. I have one CLIA# 'per building'. 
My info could be outdated (in addition to not applying in CA!) but we used to go by 'rule of thumb' that CLIA did not want 2 different CLIA#s in the same building as long as the owners were the same, management is the same (I don't mean local in terms of same supervisor or manager, I mean like the same hospital management is over 'all' the clinics in the building).
Another way of looking at it is if the info you have to enter into the application applies to 'all' the clinics in the building then it's OK to have one CLIA# they all use. On the testing menu we list out all the tests combined across the building.

Deb, 
I would recommend that you inquire with your  own state CLIA what they require. They are the ones who may inspect you.  They might have a different requirement from the rest of the country.    Kathleen and I have the same requirements, it looks like.   I am following Kansas CLIA regs. You can have same CLIA for more than one clinic  if they are  in the same building or campus.  I was told by the inspector that the location determines if you should have separate CLIA certificate or not.  

Thank you everyone for your replies!  Luckily at least regarding this issue, Cali regulations are the same as all your states!  With all of your help, I was able to solve our issue.  Thanks again!