Crosswalk

Revisions to Form CMS-116, Clinical Laboratory Improvement Amendments (CLIA) Application Form
Section # on CMS116
I. GENERAL
INFORMATION

Type of Change

Reason for the Change

Add section prior to this part to say "ALL
Enhances completion of application
APPLICABLE SECTIONS OF THIS FORM
MUST BE COMPLETED."
Add line under Initial Application to collect
"Anticipated Start Date" that includes spaces
for the date.

Enhances completion of application

Insert the following:

Needed for going paperless.

[ ]

RECEIVE FUTURE NOTIFICATIONS VIA EMAIL

Move both Federal Tax Identification Number,
Telephone no, and FAX no. fields up. The new
checkbox about receiving emails could then be
in a field across from the email address field.
Add "(Pick one)" after text for both the Send
Fee Coupon to this Address and the Send
Certificate to this Address sections.
Add a box to collect "Laboratory Director's
Phone Number"

VI.WAIVED
TESTING

Enhances completion of application

Enhances completion of application

To the first section before section VI,
add the word "estimated" before the
word "annual"

Communicates more clearly

Change current language (i.e., Identify the
waived testing (to be) performed. Be as
specific as possible. This includes each
analyte test system or device used in
the laboratory. e.g. (Rapid Strep, Acme
Home Glucose Meter)) to “Identify the

Enhances completion of application

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Section # on CMS116

Type of Change

Reason for the Change

waived testing (to be) performed by
completing the table below. Be as specific as
possible. Include each analyte, test system,
or device used in the laboratory.”

VII. PPM TESTING

VIII. NON-WAIVED
TESTING

Add table for what is needed

Enhances completion of application &
communicates more clearly

Change current language (i.e., Identify the
PPM testing (to be) performed. Be as
specific as possible. e.g. (Potassium
Hydroxide (KOH) Preps, Urine Sediment
Examinations)) to “Listed below are the only
PPM tests that can be performed by a facility
having a Certificate for PPM. Mark the
checkbox by each PPM procedure(s) to be
performed.

Enhances completion of application &
communicates more clearly

Insert checkbox list of PPM testing.

Enhances completion of application &
communicates more clearly

Change current language (i.e., Identify
the non-waived testing (to be)
performed. Be as specific as possible.
This includes each analyte test system
or device used in the laboratory e.g.
(Potassium, Acme Chemistry
Analyzer).) to “Identify the nonwaived testing (to be) performed by
completing the table below. Be as
specific as possible. This includes each
analyte test system or device
used in the laboratory. Use (M) for
moderate complexity and (H) for high
complexity.

Enhance completion of application

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Section # on CMS116

IX. Type of Control

Type of Change

Reason for the Change

Add table for what is needed

Enhance completion of application

Add a new section below the first one
for IX and before the Voluntary
Nonprofit/For Profit/Gonvernment
section to include:
Does this facility have partial or full
ownership by a foreign entity or
foreign government? No ____ Yes
____
If yes, what is the country of origin for
the foreign entity?
_______________________

Enhance completion of application

Under the Government Section:

Enhance completion of application

Add a new row to collect the printed
name of the owner. I suggest calling
this box "PRINT NAME OF OWNER
OF LABORATORY"

Communicate more clearly

In the signature of owner/director of
laboratory field change wording (‘Sign in
ink” to "(Sign in ink or use a secure
electronic signature)".

To allow for a secure electronic
signature.

For the last sentence of the first paragraph,
insert a comma after "In addition"

Editorial correction

Insert a new paragraph for email address:
Email Address: A valid Email Address is

Enhance completion of application
Coincides with change made to Section I

Change “Specify” to:
If 09 is selected, please specify the country
or the province.

Bottom of Page 5 of
currently approved
form

Instructions for
Completion

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Section # on CMS116

GUIDELINES FOR
COUNTING TESTS
FOR CLIA

Type of Change

Reason for the Change

optional and will be used for
communications between the CLIA program
and the laboratory. Selecting the RECEIVE
NOTIFICATIONS VIA EMAIL checkbox,
requires the laboratory to enter a valid Email
Address.

GENERAL INFORMATION

Under II. TYPE OF CERTIFICATE
REQUESTED make the text “Certificate of
Waiver can only perform tests categorized as
waived;*” a bulleted item similar to the
bullet for Certificate for Provider Performed
Microscopy Procedures.

Editorial correction.

Except for the last bullet, re-arrange so that it
is organized by the BOLDED text?

Communicate more clearly

Text changes made to bullets for
histocompatibility, microbiology, cytology,
clinical cytogenetics, and chemistry.

Updated to reflect what is in the State
Operations Manual, Appendix C Survey Procedures and Interpretive
Guidelines for Laboratories and
Laboratory Services

Add new bullet for genetic tests and flow
cytometry.

Updated to reflect what is in the State
Operations Manual, Appendix C Survey Procedures and Interpretive
Guidelines for Laboratories and
Laboratory Services

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