CMS-116 (10/07) Crosswalk

Crosswalk for Changes to Clinical Laboratory Improvement Amendment of 1988
(CLIA) Application for Certification (CMS-116)

Section # on Type of Change Rational for Change
Current CMS-116
(10/07)

I GENERAL
INFORMATION Add: Space to collect Communicate more effectively

EMAIL ADDRESSES

Add: more space to To accommodate dates
For office use only

II TYPE OF CERTIFICATE

REQUESTED Move NOTE: from Enhance completion of Application

Instruction for Completion and reduce errors when completing
to front of Application

III TYPE OF LABORATORY Add: boxes to Physician Office To establish if lab is a shared lab

VI WAIVED TEST Add: Identify waived test To include analyte test systems
performed or device used in laboratory

VII PPM TEST Add: Identify PPM test To be specific about test performed
performed

IX TYPE OF CONTROL Add: boxes to each type To determine type of control

The remainder is minor updates on the accompanying Instructions for Completion based on the suggestions from State agency and CMS regional offices users.