Crosswalk

Revisions to Form CMS-116, Clinical Laboratory Improvement Amendments (CLIA) Application Form
Section # on CMS-116
I. GENERAL INFORMATION
EMAIL ADDRESS
PRA Statement bottom of page 1

V. MULTIPLE SITES

VIII. NON-WAIVED TESTING

Type of Change

Reason for the Change

In first section, added a checkbox for "Change in Laboratory
Director”.
Revised the language for this checkbox from "Receive future
notifications via email" to "Receive notifications including
electronic certificates via email"
Revised the last sentence to remove the link to
[email protected]. Questions or concerns
regarding where to submit CLIA documents should be sent to
either the State Agency CLIA contacts
(https://www.cms.gov/regulations-andguidance/legislation/clia/downloads/cliasa.pdf) or the CLIA
Operations Branch Contacts
(https://www.cms.gov/files/document/clia-operations-branchcontacts.pdf).
For the first bullet, added the sentence “A list of temporary
testing sites must be included on or attached to the Form CMS116.”

Enhances completion of the
application
Clarifies how emails will be used.

Add "the" before the word "remainder" in the text proceeding
the Yes checkbox.
For the second bullet, added a comma after the word "State"
Removed the second instance of a duplicate sentence.
Sentence removed was “If additional space is needed, check
here and attach additional information using the same format.”
Include text box similar to Section VII.”

Editorial correction

To the last sentence, remove extra space after A2LA. Added a
space before CAP and added a comma after COLA.

Editorial correction

Clarifies who to contact for
questions about the CMS-116 and
where to submit the CMS-116

Communicates more clearly what is
needed.

Editorial correction
Enhances completion of the
application

Section # on CMS-116
IX. TYPE OF CONTROL

Instructions for Completion

Type of Change

Reason for the Change

Revised the question from:
"Does this facility have partial or full ownership by a foreign
entity or foreign government?"
to:
"Does this facility have partial or full ownership or control by
a non-United States-based government or entity?”

Communicates more clearly what is
needed.

In addition, the text was bolded.

Enhances completion of the
application
Communicates more clearly what is
needed.

Revised the bullet for documentation of education from
“Education (copy of Diploma, transcript from accredited
institution, CMEs),” to “Education (documentation necessary
to ensure CLIA personnel qualifications are met, e.g., diploma,
transcript)”
Revised the last sentence under Email Address from:

Selecting the RECEIVE NOTIFICATIONS VIA EMAIL checkbox,
requires the laboratory to enter a valid Email Address.

Clarifies how emails will be used.

To:
Selecting the RECEIVE NOTIFICATIONS INCLUDING
ELECTRONIC CERTIFICATES VIA EMAIL checkbox
requires the laboratory to enter a valid Email Address.

For the first sentence under Corporate Address, removed the
comma after the words "such as"

Editorial correction

For the last sentence under III.TYPE OF LABORATORY,
removed the comma after the words "such as".

Editorial correction

For the sections VII. PPM TESTING, VIII.NON-WAIVED
TESTING, IX.TYPE OF CONTROL, and X.DIRECTOR OF
ADDITIONAL LABORATORIES, moved the underlining so
that only the heading was underlined.

Editorial correction

Section # on CMS-116

Type of Change

Reason for the Change

For the section VIII.NON-WAIVED TESTING, added the
sentence “Specific test system categorizations can also be
found on the Internet at:

Enhances completion of the
application

For the first sentence under X.DIRECTOR OF ADDITIONAL
LABORATORIES, added the text ", including Certificate of
Waiver,".

Communicates more clearly what is
needed.

Under X.DIRECTOR OF ADDITIONAL LABORATORIES,
revised “"Certificate of PPM," to “"Certificate for PPM,"
Added this language after Section X:
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.)
In the header, corrected the spelling of the word
"SUBSPECIALITIES” to "SUBSPECIALTIES".

Editorial correction

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCLIA/clia.cfm."

TESTS COMMONLY
PERFORMED AND THEIR
CORRESPONDING
LABORATORY
SPECIALTIES/SUBSPECIALITIES

Enhances completion of the
application

Editorial correction

Section # on CMS-116

GUIDELINES FOR COUNTING
TESTS FOR CLIA

Type of Change

Reason for the Change

Under the heading General Immunology (220), revised:
“Antigen/Antibody (hepatitis, herpes, rubella, etc.)
Complement (C3, C4)
Immunoglobulin
HIV” to:
“Antibody (herpes, rubella, etc.)
Complement (C3, C4)
Hepatitis (Antigen/Antibody)
HIV (Antigen/Antibody)
Immunoglobulin”

Enhances completion of the
application

At the bottom of page 9, removed the sentence "Other nonwaived tests and their specialties/ subspecialties can be found
at https://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Downloads/SubjecttoCLIA.pdf
and https://www.cms.gov/Regulations-andGuidance/Legislation/CLIA/Downloads/lccodes.pdf."
Under the bullet for histocompatibility, revised the words
“cross match” to one word "crossmatch".

Links are obsolete and not
maintained by the CMS CLIA
program.

Revised “Genetics tests should be placed in the specialty or
subspecialty where they fit best, according to the methodology
of the test.” to “Genetics testing platforms are used in many of
the testing specialties/subspecialties. The laboratory should
select the specialty or subspecialty according to the analyte the
test is identifying.”

Editorial correction
Technical correction to reflect
current interpretation.
Enhances completion of the
application