Clinics with only CLIA waived license-Program Details
I recently took a job as the Point of Care person for a Medical Group with about 50-60 clinics that have POCT-CLIA waived license only-No accreditation so no regulatory inspections. Before I came on they standardized all the kits/devices for of them and made up all new control and patient logs. Right now I am working on "guidelines" since their only POCT procedure tells the operators to read package inserts for all instructions and I think that people need to have something more like a procedure written out for them. There compliance with what they need to do was at 17% and has gotten up to 67% so there is a lot more work to be done. Right now I am basically starting this program up from the ground since there has not been much oversight.
If anyone has these types of clinics can you let me know what your program looks like I would greatly appreciate it. Or if you have any words of wisdom I will take those too! Feel free to email me off line anasta6902@comcast.net
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Anastasia - I am only an advisor to our health system physician practices - the nurses have a 'Lab' committee, and they deal with policy/procedure and competency. I have a question for you - since your clinics have only CoW's (Certificates of Waiver), does the Medical Group have one Lab Director that signs all of the CoW's? Or does each clinic have its' own Lab Director and they sign their own CoW?
I know each office (clinic) must have its own CLIA certificate, but our nurses would love to have an online procedure manual; with one Lab Director signing the procedures online.
How are you handling this?
Our organization is comprised of two hospitals (Labs with Certificates of Accreditation) and 7 clinics that possess Certificates of Waiver. Our organization has a policy approved by our Medical Executive Committee that delegates oversight for all policy and procedure approval (initial and ongoing) to our laboratory Medical Director. All clinics are standardized and all guidance documents are available on-line. All test methodologies are validated and managed by our hospital lab regardless of location.
It sounds like your facility is not tied to a hospital, but the governing board for your Medical Group could delegate oversight through their executive group/board. You indicated that you have no regulatory inspections, but I would caution you that if there was a patient complaint filed with your state, they can and will perform an investigation/inspection that could take them into the realm of waived testing.
States vary, so don't be afraid to reach out to your state health department on licensure to be sure you are in compliance with state requirements. They typically are an excellent resource willing to help.