CLIA certification is mandatory for facilities testing clinical specimens for diagnosis, treatment, or disease prevention, but not required for those only collecting specimens for external testing. There are four certification types, each valid for two years, and specific procedures are outlined for application, changes, and termination of certificates. Facilities must ensure compliance with CLIA requirements, particularly if operating multiple locations, as each requires a separate certificate.

1. CLIA
RENEWAL
www.hrx.company
Frequently Asked Questions

2. How do I know if I need CLIA certification?
CLIA certification is required for facilities that
test clinical specimens for the purpose of
diagnosis, treatment, or prevention of disease.
If your facility only collects specimens to
be sent out for testing at another facility, then
CLIA certification is not required for your
facility. Laboratories performing research only
testing, laboratories operated directly by
the Federal Government
There are four certification types, depending
on the type of testing performed: Certificate of
Waiver, Certificate of PPM, Certificate of
Compliance or Certificate of Accreditation. All
certifications are valid for a 2 year period.

3. Where do I get the CLIA
application?
The CMS-116 application is available on the
CLIA website, www.cms.gov/clia Click on
“How to Apply for a CLIA certificate” on the
left side of the screen, then the CMS-116
application is found under “Related Links”
at the bottom of the page.

4. How do we
make changes
(i.e. address,
Lab Director,
name,
ownership,
etc.) to our CLIA
certificate?
The CLIA program will accept changes to the CLIA
certificate upon request. A request can be
submitted by a faxed document. The request must be
written on your laboratory/company letterhead and include
the facility's CLIA number.
Please note that requests for a change of Laboratory
Director for Certificates of Provider-Performed Microscopy
Procedures (PPMP) and/or Certificates of Compliance
(CoC) require additional documentation of laboratory
director qualifications which must be submitted with the
change request.

5. Why does my facility
address not appear on
the invoice?
The invoice will only contain the mailing
address of the facility. If there was a separate
mailing address listed, then that will be the
address shown on the invoice. If there was
no separate mailing address listed, then the
facility address will appear on the invoice.

6. What are the
different fee
timeframe as
per different
certificate?
Certificate Type: Fee Timeframe:
Certificate Type: Fee Timeframe:
Certificate Type: Fee Timeframe:
Waiver 6 months before the expiration date
PPMP 6 months before the expiration date
Compliance Survey fee: 12 months before expiration date

7. When will I
receive my new
CLIA
Certificate?
Renewed CLIA certificates will be mailed
approximately two weeks prior to your current
expiration date if full payment of CLIA fees is
received. Initial CLIA certificates will be mailed
approximately two weeks after full payment of
CLIA fees is received.

8. Can I have more than 1
location under the same
CLIA number?
CLIA certificates are location specific. Therefore, if
you perform testing at more than one location then
you will have more than one CLIA certificate.
Unless you qualify for a multi-site site exception
and complete a CMS 116 application for the
multi-site exception.
Each CLIA certificate represents a laboratory, and
each laboratory is responsible for complying
with the applicable CLIA requirements.

9. I am no longer
performing
laboratory
testing in my
office. How do I
terminate my
CLIA certificate?
Requests to terminate your CLIA
certificate must be submitted in writing
to ISDH. Include laboratory name, CLIA
number, name of the laboratory director
and/or owner, the reason your certificate
should be terminated, the effective date
of termination, your laboratory contact
information and the signature of the
laboratory director or his/her designee.

10. Contact Number Email ID Location
info@hrx.company877-770-2023 244 Madison Ave, Suite 1150
New York NY 10016