Completing CLIA and state application

CMS 116 the CLIA application form is a required form to operate clinical labs within the U.S. (with a couple exceptions), if it is a non-waived lab the CMS-209 CLIA laboratory personnel report is also required. Some states require state application forms to be completed as well. CMS and state agencies do offer guidelines and help in completing those forms then why is it necessary to pay a consultant to complete those forms for the lab. Those forms while simple are legal documents, therefore just like any legal documents it’s best to have someone with knowledge and experience with the process to verify accuracy and completeness. Another critical reason to have a lab consultant review those forms is when CLIA/State forms are not complete correctly, the lab will need to submit corrections. Oftentimes correcting errors on one form require the lab to revise another field on a different form if the lab failed to recognize the required correction the form gets rejected and another revision will need to be submitted. In the resubmission process, the lab loses track of the revision made and when the CLIA/state inspector comes for inspection there are discrepancies between what the lab is doing and the information provided on forms that were submitted. Discrepancy not only leads to citations, but it creates a bad impression for the inspector as he/she wonders if the lab can’t fill out those forms correctly then what else can be wrong.