Visit and facility information
Date ordered, the dates and times of the first and second visits, the reason for the visit, the facility type, name, NPI, the people interviewed, the practice location and the business telephone number.
CMS-10221
Independent Diagnostic Testing Facilities-Site Investigation
- Agency
- CMS
- Revision
- Rev. 01/2024
- Fillable fields
- 170
- Pages
- 5
- Official source
- CMS form page
- Checked
- October 20, 2026
Form CMS-10221: Independent Diagnostic Testing Facilities Site Investigation
Form CMS-10221, Independent Diagnostic Testing Facilities Site Investigation, is a Centers for Medicare & Medicaid Services worksheet for a site visit to an Independent Diagnostic Testing Facility (IDTF). It cites 42 CFR § 410.33, and each of its inspection questions sits under a performance standard from § 410.33(g) that the form quotes.
The person doing the visit records the reason for it, the facility's details, and a yes, no or N/A answer to each question, from the physical site and equipment to insurance, complaints, staff, medical records and shared space. The last section asks whether the visit could be completed and ends with the inspector's signed declaration that the report is true and accurate.
The form estimates an average of 2 hours per response. You can fill it out free in your browser on this page and download the result without an account.
What's on Form CMS-10221
Site and equipment, (g)(3) and (g)(4)
The type of site, with a photograph required, then questions on accessibility, space for testing, hand washing, patient privacy and record storage, and the catalog and inventory of diagnostic equipment with serial or registration numbers.
Phone, insurance and solicitation, (g)(5) to (g)(7)
Where the business telephone is and whether it is listed, whether the IDTF gave proof of comprehensive liability insurance, which the form gives as $300,000 per facility, and how it solicits new business.
Complaints, posted standards and equipment care
Standards (g)(8), (g)(9) and (g)(11): a written complaint resolution procedure, whether the § 410.33 standards are posted, and proof that equipment is calibrated and maintained, with the maintenance log.
Staff, records and access, (g)(12) to (g)(14)
Licenses and certifications of staff, the supervising physicians, whether medical records can be retrieved within 2 business days and how they are stored, and the posted hours of operation for each day.
Shared space and inspector questions
Standard (g)(15) on sharing a practice location or equipment and leasing, then whether the inspector completed the visit, comments, any other evidence, photographs and the inspector's signature.
Most questions are answered Yes, No or N/A, with space to describe a No or N/A answer.
How Form CMS-10221 is filled out
- 1
Record the visit
Enter the date ordered, the date and time of the first visit and of a second visit if there is one, and check the reason for the visit.
- 2
Identify the facility
Check fixed, mobile or indirect, then enter the facility name, NPI, the representatives or people interviewed, the practice location and the business phone.
- 3
Answer each standard
Check Yes, No or N/A for every question and describe any No or N/A answer. The form says a photograph is required for the site under standard (g)(3).
- 4
Note hours and records
List the posted hours for each day of the week and check how records are stored: on site, electronically, at a storage facility or other.
- 5
Close the report
Answer whether the visit could be completed, add comments, and note any other evidence of noncompliance with 42 CFR 410.33. For photographs, the form refers to the contractor's statement of work.
- 6
Sign the declaration
Fill in the day and month it was executed, then the signature of the declarant, printed name and organization.
Why fill Form CMS-10221 on indox
You get the real form, filled in a browser tab, with nothing standing between you and the finished PDF.
- Fill the form right in your browser, no software to install
- Free to fill and free to download, with no account
- The official blank straight from the CMS, not a copy someone retyped
- Works on a phone, tablet or computer
Where it goes and what the form says
Where it goes
The form does not print a submission address. For photographs it refers to the contractor's statement of work.
Legal basis
The form cites 42 CFR § 410.33 and quotes each performance standard from § 410.33(g) above its questions.
Shared locations
The form quotes standard (g)(15): apart from hospital-based and mobile IDTFs, a fixed-base IDTF is prohibited from sharing a practice location or testing equipment with another Medicare-enrolled individual or organization, or leasing or subleasing its operations or location to one.
Time to complete
The form estimates an average of 2 hours per response, including reviewing instructions, gathering the data and completing the form. Its OMB number is 0938-1029.
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Who uses Form CMS-10221?
The form is a site visit report about an IDTF, signed by the inspector who made the visit.
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Questions about Form CMS-10221
Who fills out Form CMS-10221?
The form is written as an inspection report. Its last section is the inspector's information and signature, declaring that the report is a true and accurate account of the site visit.
What does IDTF stand for?
Independent Diagnostic Testing Facility, as the form's title spells out. The form cites 42 CFR § 410.33 for these facilities.
What reasons for a site visit does the form list?
Four: initial or change, revalidation, hearing and appeal, and ad hoc.
What insurance does the form ask about?
The form quotes standard 410.33(g)(6), which it says requires comprehensive liability insurance in the amount of $300,000 per facility, and asks whether the IDTF provided proof of insurance on request.
How fast does the form say medical records have to be retrieved?
The form quotes standard 410.33(g)(13): proper medical record storage and retrieval of records on request within 2 business days.
Are photographs part of the visit?
The form marks a photograph as required for the facility site under standard (g)(3). Under Photographs Required, it says to refer to the contractor's statement of work.