CMS-116 Assistant

The CMS-116 Assistant completes the CLIA application for a new laboratory through a conversation. You describe the lab in your own words, by typing or speaking, and it fills the official Form CMS-116 (Rev. 03/24) from cms.gov: facility and director information, certificate type, type of laboratory, hours of testing, multiple sites, waived, PPM and non-waived testing, type of control and the director's other laboratories. It confirms each answer, asks only for what is missing, and keeps a live checklist of what each certificate type requires.

 

It is designed for new laboratories of every complexity, physician office labs, independent and reference labs, hospital outreach and ancillary testing sites, and the consultants and administrators who prepare CLIA paperwork for them.

 

The demo above uses a fictitious laboratory. Names, addresses, phone numbers and tax ID shown are made up.

 

What it handles

• All four certificate types: Waiver, Provider-Performed Microscopy (PPM), Compliance and Accreditation

• Accreditation by CAP, COLA, The Joint Commission, AABB, ACHC, A2LA or ASHI, by specialty

• Test menus uploaded from Excel or CSV, with panels split into individually counted tests

• Specialty and subspecialty assignment with CMS codes, from Bacteriology 110 to Clinical Cytogenetics 900

• Annual test volumes counted by the CMS rules and rolled up for the Section VIII table

• "SEE ATTACHED" on the last line of any list that overflows the form, plus an Excel attachment

 

Why the attachment matters

Section VIII of Form CMS-116 has room for eight non-waived tests, and Section VI has fourteen waived tests. A moderate or high complexity lab often runs dozens. The assistant fills the form as far as it goes, writes SEE ATTACHED with a count of the remaining tests on the last row, checks the "additional space is needed" box, and builds an Excel attachment listing every analyte, test system, manufacturer, complexity, subspecialty, accrediting organization and annual volume in the same format.

 

Frequently asked questions

 

Does it fill the official CMS-116? Yes. It fills the current fillable Form CMS-116 (Rev. 03/24) published by CMS, so the result is the same form State Agencies receive. If CMS releases a new revision, the new form can be loaded in its place.

 

Which labs can use it? New laboratories of any complexity applying for a Certificate of Waiver, PPM, Compliance or Accreditation. It also handles change applications such as a new director, a change of certificate type or a change of address.

 

How does it count annual test volume? It follows the counting guidelines in the CMS-116 instructions. Each non-calculated chemistry analyte counts separately, each measured CBC analyte counts with the differential as one test, and calculations, quality control and proficiency testing are not counted. Panels such as a CMP, CBC or type and screen are split into their counted tests automatically.

 

What happens when the test list is too long for the form? The last available row says SEE ATTACHED with the number of remaining tests, the "additional space is needed" box is checked, and an Excel attachment lists every test in the same format as the form.

 

Does it submit the application or sign it? No. The owner or director signs the form in ink or with a secure electronic signature, and it is sent to the State Agency with the director's qualification documents. No payment is sent with the application; the State Agency issues a fee coupon after processing.

 

Can I talk to it instead of typing? Yes. Tap the microphone and answer out loud in Chrome or Edge, or type. Either way it reads back what it captured so you can confirm or correct it.

 

Related tools: Grant Radar · Free Agent Radar · Phlebotomy Wait Time Tool

 

Opening a new lab? Book a 1-hour consultation or call 517-375-2670.