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.
The demand for lab directors has increased as the number of non-waived COVID labs continue to grow. For this past year, we had successfully placed high complexity lab directors for all our clients that requested for this service. Our lab director program does not have any recurring monthly fee, the lab will pay a one-time upfront payment roughly equaling to the monthly compensation of the lab director. The lab director and the lab can negotiate the terms of the agreement directly, a template will be provided as a starting point. Allowing the lab director and the lab to negotiate directly ensures the agreement will be beneficial to both parties. We have lab directors that's licensed in states that required separate state license, including: California, Florida, Hawaii and New York.
Michael Yu, MS, MBA, MLS(ASCP)
Michael is the founder and owner of CLIA Lab Consultant where he provides consultation to laboratories and companies world-wide for startup and lab regulations, reimbursement, and testing strategies.