Deliverable preview
See how a WaivedLab filing packet is organized.
This in-browser sample shows the structure, checkpoints, and supporting tables a client may receive. The exact documents depend on the clinic, state, filing route, and accepted scope.
Sample only
Entirely fictitious, redacted, and not valid for filing.
“Sample Wellness Clinic LLC,” every person, address, identifier, device entry, date, and status below is invented or visibly redacted. This is not a completed CMS-116, not a client record, not proof of eligibility, and not an agency-approved packet. No patient information is used or needed.
Packet cover + control sheet
One page that identifies the case, included documents, open items, and who must act next.
Applicant
[FICTITIOUS] Sample Wellness Clinic LLC
Location
[REDACTED SAMPLE ADDRESS], Texas
Proposed workflow
Point-of-care testing performed onsite
Packet status
DRAFT — CLIENT REVIEW REQUIRED
Current checkpoint
Client must verify every fact, confirm exact test systems, resolve highlighted questions, and sign the applicable agency form. WaivedLab has no submission authorization at this stage.
Application field map
A review-friendly summary that maps intake facts to the applicable application before signature.
| Application area | Sample entry | Review status |
|---|---|---|
| Facility name | Sample Wellness Clinic LLC | Client to confirm |
| Physical address | [REDACTED SAMPLE ADDRESS] | Client to confirm |
| Certificate type | Certificate of Waiver | Route to confirm |
| Testing start date | [SAMPLE DATE] | Client to confirm |
| Ownership / responsible parties | [FICTIONAL / REDACTED] | Signature required |
In a live engagement, the actual agency form—not this sample table—is included for the client's line-by-line review and signature.
Planned test-system verification table
The analyte alone is not enough. Each exact manufacturer, model, and intended use must be checked.
Planned test
[SAMPLE ANALYTE]
Exact test system
[MODEL NOT YET CONFIRMED]
Disposition
HOLD — device verification needed
Planned test
[SAMPLE ANALYTE 2]
Exact test system
[FICTIONAL DEVICE]
Disposition
VERIFY in FDA CLIA database
A test name, category, or marketing description does not establish waived status. A live packet must use the exact test system and current official sources.
State routing + fee checklist
A concise list of the applicable manual filing channel, required state forms or applications, fees, and items that still need confirmation.
- Federal or CLIA-exempt state route identified for the clinic location
- Current agency contact and official filing instructions linked
- Known federal and state fees separated from the WaivedLab service fee
- Additional state forms, applications, licenses, or registrations listed when applicable
- Processing estimates labeled as agency estimates—not promises
Sample status: routing illustration only. Official instructions and current fees must be reconfirmed for the real clinic immediately before filing.
Signature + authorization gate
Two distinct client controls prevent an inquiry or unfinished draft from becoming a submission.
Gate A
Review and signature
The authorized clinic representative verifies the packet and signs the agency form. WaivedLab never signs on the applicant's behalf.
Gate B
Manual sender + authorization
The written scope identifies who sends the signed packet through the required manual channel. Any WaivedLab transmission requires separate written authorization for that identified filing.
Submission + follow-up log
After authorization, the operational record shows what was sent, where it went, and what happens next.