Crosswalk

Crosswalk for Changes to Clinical Laboratory Improvement Amendment
(CLIA) Application for Certification (CMS-116)

Section # on Type of Change Rational for Change
CMS-116

I GENERAL
INFORMATION Add: word ‘Closure’ to Communicate more clearly

‘Other Changes’

Add: ‘Effective Date’ to Improve data accuracy

‘Closure/Other Changes’

Add: ‘Corporate Address’ Improve mailing accuracy

Information to form

Add: ‘Send Certificate to Improve mailing accuracy

This Address’ and direct to

Specific address

Add: ‘Send Fee Coupons to Improve mailing accuracy

This Address’ and direct to

Specific address

II TYPE OF CERTIFICATE

REQUESTED Add: explanatory instructions Enhance completion of Application

to front of Application

IV HOURS OF OPERATION Add: option to report 24/7 Facilitate data entry of testing hours

Lab testing

V MULTIPLE SITES Revise: explanatory instructions Communicate more clearly

Revise: clarify Exceptions by Communicate more clearly

using regulatory language

Add: collect VINs for vehicles Enhance program oversight

Identified as Mobile labs

VIII NONWAIVED TESTING Revise: explanatory instructions Enhance completion of application

Add: numeric lab codes with Enhance completion of application

(sub)specialties

BOTTON OF PAGE 4 Add: instructions for lab to Enhance submission of form to CLIA

Mail completed form to CLIA appropriate CLIA office

State agency

The remainder is minor updates on the accompanying Instructions for Completion based on changes to the CMs-116 form and on suggestions from CLIA’s State agency and CMS regional offices users.