Crosswalk

Revisions to Form CMS-116 v. 3/20/2024, OC and CLIA updates
Clinical Laboratory Improvement Amendments (CLIA) Application Form
Section # on CMS-116

Type of Change

Reason for the Change

Global

Replaced language in ALL CAPS with sentence case

Global

Updated all field labels to sentence case

Global

Replaced Roman numerals with numbers & letters

Page 1, top of form

Updated: All applicable sections of this form must be completed.
To: Complete all form sections that apply. Please type or print legibly.

Page 1, bottom of form

Moved the PRA statement to the last page of the form (page 9)

Page 1, What happens next

Updated: Registration Certificate
To: Certificate of Registration

To align language with other
certificate types

Remove all boxes related to the mailing/billing address
Replace with CLIA fee coupon email address.

In efforts to transition to
paperless certificates/fee
coupons
In efforts to transition to
paperless certificates/fee
coupons
In efforts to transition to
paperless communication and
certificates/fee coupons.

Section I. General Information
Mailing/Billing address
Corporate address

Remove all boxes related to the corporate address.

Email address

Owner

Remove the check box to receive notifications including electronic
certificates via email.
Replace with 2 more boxes for additional email addresses.
Add the Name of Owner and the Owner’s phone number

Credentials

Remove credentials.

Send fee coupon to this address

Remove: "Send fee coupon to this address" along with the checkboxes

For readability & to align with
CMS form standards
To align with CMS form
standards
For usability & to align with
CMS form standards
To remove passive voice &
add “type or print” language
from the instructions page
Aligns with how we handle
other CMS forms

To assist during LD changes
and with enforcement issues.
Must review actual documents
sent in providing
qualifications/credentials.
In efforts to transition to
1

Section # on CMS-116

Type of Change

Send certificate to this address

Remove: "Send certificate to this address" along with the checkboxes

For Office Use Only

Moved to the top right-hand side of the form.

Section II. Type of Certificate
Requested
Page 2

Reason for the Change
paperless certificates/fee
coupons
In efforts to transition to
paperless certificates/fee
coupons
Better use of space

Replaced: (Check only one) Please refer to the accompanying
instructions for inspection and certificate testing requirements)
With: Check only one. Select your certificate type based on the highest
level of test complexity performed by your laboratory. A laboratory
performing non-waived tests can choose Certificate of Compliance or
Certificate of Accreditation based on the agency entity you want to
survey your laboratory.

Moved this language into the
form from instructions for
clarity. Changed “agency” to
“entity” for clarity.

Certificate of Waiver

Added: can only perform tests categorized as waived*

Moved this language into the
form from instructions for
clarity

Certificate of Waiver

Make this a NOTE after Certificate of Waiver.
Note: Laboratory directors performing non-waived testing (including
PPM) must meet specific education, training and experience under
subpart M of the CLIA regulations. Edited: Proof of these qualifications
for the laboratory director must be submitted with this form application.
Added: can only perform tests categorized as PPM, or tests categorized
as PPM and waived tests*

For clarity & consistency.

Certificate for Provider Performed
Microscopy Procedures (PPM)
Certificate of Compliance
Certificate of Accreditation

Added: can perform tests categorized as waived, PPM and moderate
and/or high complexity tests if the applicable CLIA quality standards
are met after a CLIA survey.
Added: can perform tests categorized as waived, PPM and moderate
and/ or high complexity non-waived tests if the laboratory is currently
accredited by an approved accreditation organization.

Moved this language into the
form from instructions for
clarity
Moved this language into the
form from instructions for
clarity
Moved this language into the
form from instructions for
clarity
2

Section # on CMS-116
Certificate of Accreditation

General

Section III. Type of Laboratory
Instructions
Instructions

Section IV. Hours of Laboratory
Testing
Hours of Laboratory Testing
Multiple sites?
Section V. Multiple Sites
Instructions

Type of Change

Reason for the Change

Updated: Indicate which of the following organization(s) your
laboratory is accredited by for CLIA purposes, or for which you have
applied for accreditation for CLIA purposes.
To: If you’re applying for a Certificate of Accreditation, you must
provide evidence of accreditation by an approved accreditation
organization for CLIA purposes, or evidence that you applied for
accreditation, within 11 months after you receive your Certificate of
Registration. Which organization(s) is your lab accredited by (or you
applied for accreditation from) for CLIA purposes?

For plain language & clarity

Added footnote: If your accreditation organization isn’t listed, contact
your local State Agency for instructions.
*Get a current list of waived and PPM tests from your State agency.
Specific test system categorizations can also be found at
Accessdata.fda.gov/scripts/cdrh/cfdocs/ cfCLIA/clia.cfm.

Moved this language into the
form from instructions for
clarity. The state agency does
not provide lists.

Updated instructions at the top of the section: Check the one that most
closely describes your facility type:
Add to the bottom of the list: Is the laboratory located within a CMScertified healthcare facility (facilities with asterisk*)? Add a checkbox
for Yes or No.
Add: If yes, list CMA Certification Numbers (CCNs):

For plain language & clarity

Updated instructions: List times when laboratory testing is performed in
HH:MM format
Remove “check here and attach the additional information using the
same format.

For plain language & clarity

Updated: Must meet one of the regulatory exceptions to apply for this
provision in 1-3 below.
To: You can only qualify for the multiple site provision (more than one

Moved this language into the
form from instructions for
clarity

To facilitate expanding
laboratory services during a
public health emergency

Not necessary information

3

Section # on CMS-116

Instructions
Instructions

Instructions

Type of Change
site under one certificate) if you meet one of the CLIA requirements
described in 42 CFR 493. 493.35(b)(1-3), 493.43(b)(1-3) and
493.55(b)(1-3). Hospice and HHA could qualify for an exception.
You must have a CLIA certificate for each location unless you meet one
of the CLIA exceptions described in 42 CFR 493.35(b)(1-3),
493.43(b)(1-3) and 493.55(b)(1-3).

Reason for the Change

Edited: If yes, complete the remainder rest of this section
Update: Indicate which of the following regulatory exceptions applies to
your facility’s operation.
To: Indicate which one of the following regulatory exceptions applies to
your facility's operation.
Updated: Questions 1-3
1.
Is this a laboratory that’s not at a fixed location? That is, a
laboratory that moves from testing site to testing site (such as a 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?............. Yes
No
If yes, you must include a list of temporary testing sites with this CMS116 Form. If a mobile unit provides the testing, record the vehicle
identification number(s) (VINs) and attach it to the form.
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
If yes, provide the number of sites under the certificate and list name,
address and test performed for each site below.
3.
Is this a hospital with multiple laboratories located at contiguous
buildings on the same campus within the same physical location or
street address and under common direction filing for a single certificate
for these locations?............................................ Yes No
If yes, provide the number of sites under this certificate and list name or
department, location within hospital and specialty/subspecialty areas

Plain language
To help clarify instructions.

For clarity & to reduce
number of required responses.

4

Section # on CMS-116

Type of Change
performed at each site below.

Reason for the Change

To: 3 statements
Indicate which one of the following regulatory exceptions applies to
your facility’s operation.
This is a laboratory that’s not at a fixed location that moves from testing
site to testing site (such as a 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.
If selected, you must include a list of temporary testing sites with this
CMS-116 Form. If a mobile unit provides the testing, record the vehicle
identification number(s) (VINs) and attach it to the form.
This is 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.
If selected, provide the number of sites under the certificate and list
name, address and test performed for each site below.
This is a hospital with multiple laboratories located at contiguous
buildings on the same campus within the same physical location or
street address and under common direction filing for a single certificate
for these locations.
If selected, provide the number of sites under this certificate and list
name or department, location within hospital and specialty/subspecialty
areas performed at each site below.
Instructions

Updated: If yes, a list of temporary testing sites must be included on or
attached to this Form CMS-116. If a mobile unit is providing the
laboratory testing, record the vehicle identification number(s) (VINs)
and attach to the application.
To: If yes, you must include a list of temporary testing sites on or

For plain language & clarity

5

Section # on CMS-116

Instructions

Instructions
Instructions
Section VI. Waived Testing
Section VI. Waived Testing
Instructions

Instructions
Chart
VII. PPM Testing
VII. PPM Testing
Instructions
Instructions

Instructions

Type of Change
attached to this CMS-116 Form. If a mobile unit provides the laboratory
testing, record the vehicle identification number(s) (VINs) and attach it
to the form.
Edited: 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?

Reason for the Change

Plain language

Edited: If additional space is needed, Need more space? Check here
and attach the additional information using the same format.
Removed: In the next three sections, indicate testing performed and
estimated annual test volume.

For plain language & clarity

Updated to: Waived Testing to Be Performed
Removed: Identify the waived testing (to be) performed by completing
the table below.

To add clarity
To remove form clutter. This
language is redundant to the
table headers & does not add
clarity to instructions.
For plain language & clarity

Edited: If additional space is needed, Need more space? Check here
and attach the additional information using the same format.
Have text wrap within each box

Updated to: PPM Testing to Be Performed
Edited: Listed below are the only PPM tests that can be performed
by a facility having with a Certificate for PPM. Mark the checkbox
by each PPM procedure that will to be performed.
Edited: For laboratories applying for a Certificate of Compliance or
Certificate of Accreditation, also include PPM test volume in the
specialty/subspecialty category and the “total estimated annual test
volume” in section VIII.
Edited: If additional space is needed, Need more space? Check here
and attach the additional information using the same format.

To remove form clutter. This
instruction is redundant to the
section headers.

This allows for a complete
Analyte/Test Name
/Manufacturer listing.
To add clarity
For plain language & clarity
“Also” is redundant to
“include”
For plain language & clarity
6

Section # on CMS-116
VIII. Non-Waived Testing
VIII. Non-Waived Testing
Instructions

Type of Change
VIII. Non-Waived Testing to Be Performed
Removed: applying for a Certificate of Compliance or a Certificate
of Accreditation.

Reason for the Change
To add clarity
Redundant to the instruction
that only labs applying for
these certificates must
complete this section
Moved this language into the
form from instructions for
clarity

Instructions

Added to the end of instructions for the first table in this section:
Specific test system categorizations can be found at:
Accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/clia.cfm.

Instructions

Edited: If additional space is needed, Need more space? Check here
and attach the additional information using the same format.

For plain language & clarity

Other Testing to Be Performed
Non-waived test volumes

Added new section header: Other Testing to Be Performed Non-waived
test volumes

Instructions

Added bullet formatting

Instructions

Edited: Place a Check (✓) in the box preceding for each
specialty/subspecialty in which the laboratory performs testing.
Updated: (For additional guidance on counting test volume, see the
instructions included with this application package.)
To: Go to Guidelines for Counting Tests on page 9 for more details.

To better signal to applicants
that the questions that follow
are for other tests
To help applicants better
navigate instructions
For plain language & clarity

Instructions

For plain language & clarity

Instructions

Edited: If applying for a Certificate of Accreditation, indicate the name
of the Accreditation Organization beside the applicable
specialty/subspecialty for which you’re are accredited for CLIA
compliance

For plain language & clarity

Instructions

Added: The Accrediting Organization column should reflect
accreditation information for CLIA purposes only, e.g., CAP, etc.

Moved this language into the
form from instructions for
clarity

X. Director Affiliation with Other
Laboratories

7

Section # on CMS-116
Instructions
Instructions
Signature
Instructions

Type of Change

Reason for the Change

Edited: If the director of this laboratory serves as director for additional
laboratories that are separately certified, please complete this the
following section.
Added: Note: For a Certificate for PPM, Certificate of Compliance
or Certificate of Accreditation, an individual can serve as the
director for no more than five certificates.

For plain language & clarity

Edited: Any person who intentionally violates any requirement of
section 353 of the Public Health Service Act as amended or any
regulation promulgated thereunder shall be imprisoned for not more
than 1 year or fined under title
18, United States Code or both, except that if the conviction is for a
second or subsequent violation of such a requirement such person shall
be imprisoned for not more than 3 years or fined in accordance with title
18, United States Code or both.
Consent: The applicant hereby agrees that such laboratory identified
herein will be operated in accordance with applicable standards found
necessary by the Secretary of Health and Human Services to carry out
the purposes of section 353 of the Public Health Service Act as
amended. The applicant further agrees to permit the Secretary, or any
Federal officer or employee duly designated by the Secretary, to inspect
the laboratory and its operations and its pertinent records at any
reasonable time and to furnish any requested information or materials
necessary to determine the laboratory’s eligibility or continued
eligibility for its certificate or continued compliance with CLIA
requirements.

For clarity and plain language.
Rather than adding specificity,
the original legalese makes it
more difficult for folks to
understand what they’re
agreeing to.

Moved this language into the
form from instructions for
clarity

To: Any person who is convicted of intentionally violating any
CLIA requirements under section 353(1) of the Public Health
Service Act may be imprisoned or fined or both.
Consent: The applicant agrees that the laboratory identified in this
application will be operated according to the standards set by the
Secretary of Health and Human Services to carry out the purposes
of section 353 of the Public Health Service Act as amended. The
applicant agrees to permit the Secretary, or any designated Federal
officer or employee, to inspect the lab and its operations and its
pertinent records at any reasonable time, and to furnish any
8

Section # on CMS-116

Instructions

Instructions
Instructions

Type of Change
requested information or materials necessary to determine the lab’s
eligibility for its certificate or compliance with CLIA
requirements.
Added: Note: “Owner” means any person who owns any interest
in a laboratory, except for an interest in a lab whose stock and/or
securities are publicly traded. (The purchase of shares of stock or
securities on the New York Stock Exchange in a corporation
owning a lab would not make a person an owner for the purpose
of this regulation.)
Edit: Print name of Laboratory Director
To: Print name of Laboratory Director/Owner
Remove: Print name of Laboratory Owner
Added heading: How to Submit Your Form

Reason for the Change

Added this language into the
form for clarity

For clarity with the signature
line

For plain language & clarity
& consistency with other
CMS forms
Edited: Completed 116 applications must be sent to your local State
To make this important
Agency. Do not send any payment with your completed 116 application. instruction clearer & directive.
STATE AGENCY CONTACT INFORMATION CAN BE FOUND
AT:
https://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Downloads/CLIASA.pdf
To: Send your completed CMS-116 Form to your local State Agency.
Don’t send any payment with your form.
Find your State Agency contact information at
CMS.gov/Regulations-andGuidance/Legislation/CLIA/Downloads/CLIASA.pdf

Instructions Page
General

Moved the edited contents of this page to be a cover sheet for the CMS116. Edits remove language that’s redundant to form instructions and
labels. Edits also remove clarifying details that have been moved into
the form as part of this update. and reorganizes general background info
with clear headings.

To align with other CMS
forms.

Edited: CLIA requires every facility that tests human specimens for the
purpose of providing information for the diagnosis, prevention or

For plain language & clarity
& to add definition of CLIA
9

Section # on CMS-116

Type of Change
Reason for the Change
treatment of any disease or impairment of, or the assessment of the
acronym
health of, a human being to meet certain Federal requirements.
If your facility performs tests for these purposes, it is considered,
under the law, to be a laboratory. Facilities only collecting or
preparing specimens (or both) or only serving as a mailing service are
not considered laboratories. CLIA does not apply to a facility that
only performs forensic testing. CLIA applies even if only one or a
few basic tests are performed, and even if you are
not charging for testing. In addition, the CLIA legislation requires
financing of all regulatory costs through fees assessed to affected
facilities.
The CLIA application (Form CMS-116) collects information about
your laboratory’s operation which is necessary to determine the fees
to be assessed, to establish baseline data and to fulfill the statutory
requirements for CLIA. This information will also provide an overview
of your facility’s laboratory operation. All information submitted should
be based on your facility’s laboratory operation as of the date of form
completion.
NOTE: WAIVED TESTS ARE NOT EXEMPT FROM
CLIA. FACILITIES PERFORMING ONLY THOSE TESTS
CATEGORIZED AS WAIVED MUST APPLY FOR A CLIA
CERTIFICATE OF WAIVER.
To:
Clinical Laboratory Improvement Amendments (CLIA) requires every
facility that tests human specimens for the purpose of providing
information for the diagnosis, prevention or treatment of any disease or
impairment of, or the assessment of the health of, a human being to
meet certain federal requirements.
If your facility performs tests for these purposes, it’s considered under
the law to be a laboratory (lab). CLIA applies even if your lab
performs only one or a few basic tests, and even if you’re not
charging for testing. The CLIA legislation requires financing of all
regulatory costs through fees assessed to affected facilities.
The CLIA application (Form CMS-116) collects information about
your lab’s operation to determine the fees to be assessed, establish
baseline data, and fulfill the statutory requirements for CLIA. This
information will also provide an overview of your facility’s lab
10

Section # on CMS-116

Type of Change
operation. Any information you submit should be based on your
facility’s laboratory operation as of the date you complete the form.
Note: Waived tests aren’t exempt from CLIA. Facilities that only
perform tests categorized as waived must apply for a CLIA
certificate of waiver.
Facilities that only collect or prepare specimens (or both) or only
serve as a mailing service aren’t considered labs. CLIA doesn’t
apply to a facility that only performs forensic testing.
Removed:
I. GENERAL INFORMATION
For an initial applicant, check “initial application”. For an initial
survey or for a recertification, check “survey”. For a request to change
the type of certificate, check
“change in certificate type” and provide the effective date of the
change. For all other changes, including change in location, director,
lab closure, etc., check “other changes” and provide the effective date
of the change.
CLIA Identification Number: For an initial applicant, the CLIA
number should be left blank. The number will be assigned when the
application is processed. For all other applicants, enter the 10-digit
CLIA identification number already assigned and listed on your
CLIA certificate.
Facility Name: Be specific when indicating the name of your facility,
particularly when it is a component of a larger entity, e.g., respiratory
therapy department in XYZ Hospital. For a physician’s office, this
may be the name of the physician. NOTE: the information provided
is what will appear on your certificate.
Email Address: A valid Email Address will be used for
communications between the CLIA program and the laboratory.
Selecting the RECEIVE NOTIFICATIONS INCLUDING
ELECTRONIC CERTIFICATES VIA EMAIL
checkbox requires the laboratory to enter a valid Email Address.
Physical Facility Address: This address is mandatory and must reflect
the physical location where the laboratory testing is performed. The
address may include a floor, suite and/or room location, but cannot be
a Post Office box or Mail Stop.

Reason for the Change

Redundant to form
instructions & labels.
This language adds length to
form and contributes to
perceived complexity without
adding any clarity.

11

Section # on CMS-116

Type of Change

Reason for the Change

If the laboratory has a separate mailing and/or corporate address
(from the Facility Address), please complete the appropriate sections
on the form.
Mailing Address: This address is optional and may be used if the
laboratory wants to direct the mailing of the CLIA fee coupon and/or
CLIA certificate to an alternate location, such as an accounts payable
office. A Post Office box number or Mail Stop number may be used
as part of the Mailing Address for this form.
Corporate Address: This address is optional and may be used if the
laboratory wants to direct the mailing of the CLIA fee coupon
and/or CLIA certificate to another location, such as the main
headquarters or home office for the laboratory. A Post Office box
number or Mail Stop number may be used as part of the Corporate
Address for this section.
Form Mailing: Select the address (Physical, Mailing, Corporate)
where the CLIA fee coupon and CLIA certificate are to be mailed.
For Office Use Only: The date received is the date the form is
received by the state agency or CMS regional office for processing.
Edited: Proof of these requirements for the laboratory director must be
submitted with the application.
To: Proof of laboratory director qualifications must be submitted with
this form.
Edited: Individuals who attended foreign schools must have an
evaluation of their credentials determining equivalency of their
education to education obtained in the United States. Failure to submit
this information will delay the processing of your application.

For consistency with same
language on page 1

Plain language and clarity

To: People who attended foreign schools must have their credentials
evaluated to determine U.S. education equivalency. Failure to submit
this information will delay the processing of your application.
Replaced heading: Reminders - Before submitting the Form CMS116:
With new heading: How to submit Form CMS-116
Replaced numbers with bullets:

Plain language and to align
with other CMS forms.
For plain language best
12

Section # on CMS-116

Type of Change
•
Include the current or estimated annual test volume.
•
For Certificate for PPM, Certificate of Compliance, or
Certificate of Accreditation, include the laboratory
director qualifications.
•
Do not send any money with your application.
•
Send the completed Form CMS-116 to the appropriate State
Agency (https://www.cms.gov/Regulations-and-Guidance/
Legislation/CLIA/Downloads/CLIASA.pdf).
Added heading: What happens next
Edited: Once the completed Form CMS-116 has been returned to
the applicable State agency and it is processed, a fee remittance
coupon will be issued. The fee remittance coupon will indicate
your CLIA identification number and the amount due for the
certificate, and if applicable the compliance (survey) or validation
fee.

Reason for the Change
practices. Numbers denote
steps in a process or a
hierarchy, and this list is
neither.

Plain language and to align
with other CMS forms.
Plain language and clarity

To: Once you submit Form CMS-116 and your State Agency
processes the form, you’ll receive a fee remittance coupon. The
fee remittance coupon will show your CLIA identification
number and the amount due for the certificate, and any
compliance (survey) or validation fee that applies.
Added heading: Get help & more information
Edited: If you are applying for a Certificate of Compliance or
Certificate of Accreditation, you will initially pay for and receive
a Registration Certificate. A Registration Certificate permits a
facility requesting a Certificate of Compliance to perform testing
until an onsite inspection is conducted to determine program
compliance; or for a facility applying for a Certificate of
Accreditation, until verification of accreditation by an approved
accreditation organization is received by CMS.

Plain language and to align
with other CMS forms.
Plain language and clarity

To: If you’re applying for a Certificate of Compliance or
Certificate of Accreditation, you’ll initially pay for and receive a
Registration Certificate. A Registration Certificate permits a
13

Section # on CMS-116

Type of Change
facility requesting a Certificate of Compliance to perform testing
until an onsite inspection is conducted to determine program
compliance; or for a facility applying for a Certificate of
Accreditation, until CMS receives verification of accreditation by
an approved accreditation organization.
Select your certificate type based on the highest level of test
complexity performed by your laboratory. A laboratory performing
non-waived tests can choose Certificate of Compliance or Certificate
of Accreditation based on the agency you wish to survey your
laboratory.

II. TYPE OF LABORATORY

When completing this section, please remember that a facility holding
a:
• Certificate of Waiver can only perform tests categorized
as waived;*
• Certificate for Provider Performed Microscopy Procedures
(PPM) can only perform tests categorized as PPM, or tests
categorized as PPM and waived tests;*
• Certificate of Compliance can perform tests categorized as
waived, PPM and moderate and/or high complexity tests
provided the applicable CLIA quality standards are met
following a CLIA survey; and
• Certificate of Accreditation can perform tests categorized as
waived, PPM and moderate and/ or high complexity nonwaived tests provided the laboratory is currently accredited by
an approved accreditation organization. (If your CMS-approved
accreditation organization is not listed, contact your local State
Agency for further instructions.)
*A current list of waived and PPM tests may be obtained from your
State agency. Specific test system categorizations can also be found
on the Internet at:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/
cfCLIA/clia.cfm.
Removed:

Select the type that is most descriptive of the location where
the laboratory testing is performed.
If selecting ‘mobile laboratory’ (code 19), a mobile

Reason for the Change

Moved into form instructions

Moved into form instructions

Redundant to instructions in
form

14

Section # on CMS-116

HOURS OF ROUTINE
OPERATION

I. MULTIPLE SITES

Type of Change

laboratory is defined as a movable, self-contained
operational laboratory with its own personnel, equipment,
and records. For record keeping purposes, include, on a
separate sheet of paper, the vehicle identification numbers
(VINs) of all vehicles used for mobile laboratory testing.
If selecting ‘Practitioner Other’ (code 22), this type includes
practitioners such as dentists, chiropractors, etc.
Removed:

Reason for the Change

Redundant to instructions in
form

Provide only the times when actual laboratory testing is
performed in your facility. Please use the HH:MM
format and check box marked ‘24/7’ if laboratory testing is
performed continuously, e.g., 24 hours a day, 7 days a week.
Do not use military time.
Moved into form instructions
You can only qualify for the multiple site provision
(more than one site under one certificate) if you meet
one of the CLIA requirements described in 42 CFR 493.
493.35(b)(1-3), 493.43(b)(1-3) and 493.55(b)(1-3)
Hospice and HHA could qualify for an exception.
Removed:
I. WAIVED TESTING

Redundant to instructions in
form

Indicate the estimated total annual test volume for all
waived tests performed.
II.

PPM TESTING

Indicate the estimated total annual test volume for all PPM
tests performed.
I. NON-WAIVED TESTING
(INCLUDING PPM)

The total Estimated Annual Test volume in this section includes all
non-waived testing, including PPM tests previously counted in section
VII.

Moved into form instructions

Removed:
Follow the specific instructions on page 3 of the Form CMS-116 when
completing this section for test counting information.

Redundant to instructions in
form
15

Section # on CMS-116

Type of Change
(Note: The Accrediting Organization column should reflect
accreditation information for CLIA purposes only; e.g., CAP, etc.).
Specific test system categorizations can also be found on the Internet
at: http://www.
accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/clia.cfm.
Removed:
I. TYPE OF CONTROL
Select the type of ownership or control which most appropriately
describes your facility.

Reason for the Change
Moved into form instructions

Redundant to instructions in
form

DIRECTOR OF ADDITIONAL LABORATORIES
List all other facilities, including Certificate of Waiver, for which
the director is responsible and that are under different certificates.
II.

Note that for a Certificate for PPM, Certificate of Compliance or
Certificate of Accreditation, an individual can only serve as the
director for no more than five certificates.
Owner means any person who owns any interest in a laboratory
except for an interest in a laboratory whose stock and/or securities
are publicly traded. (That is e.g., the purchase of shares of stock or
securities on the New York Stock Exchange in a corporation
owning a laboratory would not make a person an owner for the
purpose of this regulation.)

Moved into form instructions

Moved into signature block
instructions

16