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CLIA Certificate for an Additional Site

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CLIA Certificate for an Additional Site Posted: Fri Feb 20, 2015 11:53 am
hi,
We are a group of physicians in a medical office building that has a non-waived CLIA certificate assigned to one provider's office. One of our other offices in the same building would like to perform laboratory testing as well. Since we already have a CLIA certificate at the one office, will we need to apply for a separate CLIA certificate for this site as well?
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deloselab
 
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Re: CLIA Certificate for an Additional Site Posted: Fri Feb 20, 2015 12:09 pm
You will at least need to update your CLIA certificate, possibly obtain a new one. On the application form, it lists those circumstances where a single license may cover multiple physical locations:
V. MULTIPLE SITES (must meet one of the regulatory exceptions to apply for this provision in 1-3 below)
Are you applying for a single site CLIA certificate to cover multiple testing locations?
Indicate which of the following regulatory exceptions applies to your facility’s operation.
1. Is this a laboratory that is not at a fixed location, that is, a laboratory that moves from testing site to testing site, such as mobile unit providing laboratory testing, health screening fairs, or other temporary testing locations, and may be covered under the certificate of the designated primary site or home base, using its address?
2. Is this a not-for-profit or Federal, State or local government laboratory engaged in limited (not more than a combination of 15 moderate complexity or waived tests per certificate) public health testing and filing for a single certificate for multiple sites?
Yes No
3. Is this a hospital with several laboratories located at contiguous buildings on the same campus within the same physical location or street address and under common direction that is filing for a single certificate for these locations?

If none of these apply, you need a new licence, although you may be able to have the same medical director .
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mlzucker
 
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Re: CLIA Certificate for an Additional Site Posted: Mon Feb 23, 2015 12:11 pm
@mlzucker: I was under the impression that the third bullet point from CLIA regarding hospitals in the same physical address also applied to the POL. Is that correct?
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taylorlabnerd
 
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Re: CLIA Certificate for an Additional Site Posted: Mon Feb 23, 2015 12:24 pm
I believe that applies, yes. The same physical address can be on a single CLIA license
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mlzucker
 
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Re: CLIA Certificate for an Additional Site Posted: Mon Feb 23, 2015 12:32 pm
A follow-up question, just to clarify:

How specifically does CLIA define "physical address"? If there are two labs at the same street address but with different suite numbers, are they considered separate addresses (and so, require separate certificates)?
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bwest
 
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Re: CLIA Certificate for an Additional Site Posted: Mon Feb 23, 2015 12:38 pm
For that one, I think you need to contact your state CMS office- the proper contacts are available through a link at cms.gov/CLIA - on the left side click State Agencies.
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mlzucker
 
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Re: CLIA Certificate for an Additional Site Posted: Tue Feb 24, 2015 7:29 am
We agree with the posts from mlzucker regarding the need for multiple CLIA certificates at one physical address. It has been our experience and further clarified by CLIA that as long as the physical address remains the same, you can have multiple suites under the same CLIA number.
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Susan.Cramer
 
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Re: CLIA Certificate for an Additional Site Posted: Thu Feb 26, 2015 7:30 am
Thanks everyone for your responses. It was a helpful discussion.
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deloselab
 
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