CMS-10221 Site Investigation for Independent Diagnostic Testing Fa

Form Approved
OMB No. 0938-1029
Expires: XX/XXXX

DEPARTMENT OF HEALTH AND HUMAN SERVICES
CENTERS FOR MEDICARE & MEDICAID SERVICES

INDEPENDENT DIAGNOSTIC TESTING FACILITIES—SITE INVESTIGATION
42 CFR § 410.33
Date Ordered:
Date of First Visit:

Time:

Date of Second Visit:

Time:

1. REASON FOR VISIT
Initial/Change

Revalidation

Hearing & Appeal

Ad Hoc

2. FACILITY INFORMATION
Fixed

Mobile

Indirect

Facility Name

National Provider Identifier (NPI)

Name of Authorized Representative(s) or Interviewee(s)

Name of Authorized Representative(s) or Interviewee(s)

Name of Authorized Representative(s) or Interviewee(s)

Name of Authorized Representative(s) or Interviewee(s)

Practice Location (Physical Street Address)

City

State

Zip Code

Business Telephone Number

3. FACILITY INSPECTION
A. PERFORMANCE STANDARD 410.33(g)(3)
Performance Standard 410.33(g)(3) requires IDTFs to maintain a physical facility on an appropriate site.
(PHOTOGRAPH REQUIRED)
Office Suite-Mall
Office Suite-Office Building
Other.Please describe:

Private Residence

1. Is the IDTF located on an appropriate site?

Warehouse
Yes

No

N/A

Yes

No

N/A

Yes

No

N/A

Yes

No

N/A

Yes

No

N/A

If No or N/A, describe:
2. Is the IDTF disability accessible?
If No or N/A, describe:
3. Were there patients in the facility during the inspection?
If No or N/A, describe:
4. If this IDTF is at a fixed location, does the facility contain adequate space
for testing, including all tests listed on the enrollment application, facilities
for hand washing, adequate patient privacy accommodations, and storage
of business and medical records?
If No or N/A, describe:
5. If this IDTF is a mobile facility, does the mobile unit have access to facilities
for hand washing, adequate patient privacy accommodations, and a home
office location for the storage of business and medical records?
If No or N/A, describe:
Form CMS-10221 (Rev. XX/XXXX)

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B. PERFORMANCE STANDARD 410.33(g)(4)
Performance Standard 410.33(g)(4) requires IDTFs to have all applicable diagnostic testing equipment available at
the physical site (excluding portable diagnostic testing equipment).
1. Does the IDTF maintain a catalog of portable diagnostic equipment,
including diagnostic testing equipment serial/registration numbers, at the
physical site?

Yes

No

N/A

Yes

No

N/A

Yes

No

N/A

Yes

No

N/A

If No or N/A, describe:
2. Did the IDTF make the portable equipment or mobile unit(s) available for
inspection?
If No or N/A, describe:
3. Does the IDTF maintain a current inventory of diagnostic equipment,
including diagnostic testing equipment serial/registration numbers?
If No or N/A, describe:
4. Has the IDTF provided updates to the MACs regarding equipment changes
in accordance with existing regulation?
If No or N/A, describe:

C. PERFORMANCE STANDARD 410.33(g)(5)
Performance Standard 410.33(g)(5) requires IDTFs to maintain a primary business phone under the name of the
business.
1. Is the business telephone located at the IDTF or within the home office
for the mobile IDTF?

Yes

No

N/A

Yes

No

N/A

If No or N/A, describe:
2. Is the business telephone number listed in local telephone directory or
is it available through directory assistance?
If No or N/A, describe:

D. PERFORMANCE STANDARD 410.33(g)(6)
Performance Standard 410.33(g)(6) requires IDTFs to have comprehensive liability insurance in the amount
$300,000 per facility.
1. Did the IDTF provide proof of insurance upon request?

Yes

No

N/A

If No or N/A, describe:

E. PERFORMANCE STANDARD 410.33(g)(7)
Performance Standard 410.33(g)(7) states that IDTFs must agree not to directly solicit patients; this includes, but is
not limited to, a prohibition on telephone, computer, or in-person contacts.
How does the IDTF solicit new business? Describe:

Form CMS-10221 (Rev. XX/XXXX)

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F. PERFORMANCE STANDARD 410.33(g)(8)
Performance Standard 410.33(g)(8) requires IDTFs to maintain a protocol regarding beneficiaries’ complaints.
1. Does the supplier have a written complaint resolution procedure
established?

Yes

No

N/A

If No or N/A, describe:

G. PERFORMANCE STANDARD 410.33(g)(9)
Performance Standard 410.33(g)(9). The IDTF must openly post the standards outlined in § 410.33(g) for review by
patients and the public.
1. Has the IDTF posted the standards found at 42 CFR § 410.33 in the IDTF or
home office for a mobile IDTF?

Yes

No

N/A

If No or N/A, describe:

H. PERFORMANCE STANDARD 410.33(g)(11)
Performance Standard 410.33(g)(11) requires IDTFs to have their diagnostic equipment calibrated and maintained
per manufacturer’s equipment instructions and in compliance with applicable manufacturer’s suggested
maintenance and calibration standards.
1. Does the IDTF have proof that diagnostic equipment has been, self or
manually, calibrated and maintained per equipment instructions in
accordance with manufacturer’s instructions?

Yes

No

N/A

Yes

No

N/A

If No or N/A, describe (required):
2. Did the IDTF provide a copy of the maintenance log upon request?
If No or N/A, describe:

I. PERFORMANCE STANDARD 410.33(g)(12)
Performance Standard 410.33(g)(12) requires IDTFs to have technical staff on duty with the appropriate credentials
to perform the tests.
1. Can the IDTF furnish the applicable Federal/State licenses and/or
certifications for the individuals performing these services?

Yes

No

N/A

Yes

No

N/A

Yes

No

N/A

Yes

No

N/A

Yes

No

N/A

If No or N/A, describe:
2. Can technical staff identify the supervising physician(s)?
If Yes, list name(s) of supervising physician(s) that was provided by the
technician.
If No or N/A, describe:
3. Is the supervising physician(s) identified by the technical staff on site?
If No or N/A, describe:
4. Did the IDTF provide a written list of the technician(s) that will be
furnishing services at this IDTF upon request?
If No or N/A, describe:
5. Did the IDTF provide a written list of the supervising physician(s) that will
be supervising services at this IDTF upon request?
If No or N/A, describe:

Form CMS-10221 (Rev. XX/XXXX)

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J. PERFORMANCE STANDARD 410.33(g)(13)
Performance Standard 410.33(g)(13) requires IDTFs to have proper medical record storage and be able to retrieve
medical records upon request within 2 business days.
1. Can the IDTF retrieve medical records within 2 business days?

Yes

No

N/A

Yes

No

N/A

If No or N/A, describe:
2. Does the IDTF have proper medical records storage?
If No or N/A, describe:
3. How are the records stored?
On-site

Electronically

Storage Facility

Other:

K. PERFORMANCE STANDARD 410.33(g)(14)
Performance Standard 410.33(g)(14) requires IDTFs to permit CMS or it’s Contractors to conduct unannounced
on-site inspections to confirm the IDTF’s compliance.
1. Is the IDTF accessible during regular business hours?

Yes

No

N/A

Yes

No

N/A

If No or N/A, describe:
2. Does the facility maintain posted hours of operation?
a. If Yes, list hours of operation below:
Monday

Tuesday

Wednesday

Thursday

Friday

Saturday

Sunday

b. If No or N/A, describe:

L. PERFORMANCE STANDARD 410.33(g)(15)
Performance Standard 410.33(g)(15) states that with the exception of hospital-based and mobile IDTFs, a fixed-base
IDTF is prohibited from the following:
•

Sharing a practice location with another Medicare-enrolled individual or organization;

•

Leasing or subleasing its operations or its practice location to another Medicare-enrolled individual or
organization; or

•

Sharing diagnostic testing equipment used in the initial diagnostic test with another Medicare-enrolled
individual or organization.

1. Does the IDTF share its practice location?

Yes

No

N/A

Yes

No

N/A

Yes

No

N/A

If Yes, describe:
2. Does the IDTF share diagnostic equipment?
If Yes, describe:
3. Does the IDTF lease or sublease its operation or its practice?
If Yes, describe:

Form CMS-10221 (Rev. XX/XXXX)

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4. ADDITIONAL QUESTIONS FOR INSPECTOR
a. Was the inspector able to complete the site visit?

Yes

No

N/A

Yes

No

N/A

If No or N/A, describe:
b. Additional Comments

c. Beyond what is disclosed in this site visit worksheet, was there any
evidence obtained during the site visit that could indicate that the
supplier is not in compliance with the provisions in 42 CFR 410.33?
If Yes, describe:
d. Photographs Required
Refer to the contractor’s statement of work.
e. Inspector’s Information and Signature

I prepared this document, which is the report of my inspection of the noted facility pursuant to their
enrollment in the Medicare program. This report is a true and accurate account of the events that occurred
and transpired on the date(s) reported herein that this site visit was performed. I am capable and willing
to testify as a witness at a hearing about the content of this report. The foregoing information is based on
my personal knowledge or is information provided to me in my official capacity. I declare under penalty or
perjury that this information is true and correct to the best of my knowledge and belief.
Executed this

day of

, 20

Signature of Declarant

Printed Name

Organization

According to the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a
valid OMB control number. The valid OMB control number for this information collection is 0938-1029. The time required to complete this
information collection is estimated to average 2 hours per response, including the time to review instructions, search existing data resources,
and gather the data needed, and complete and review the information collection. If you have comments concerning the accuracy of the time
estimate(s) or suggestions for improving this form, please write to: CMS, 7500 Security Boulevard, Attn: PRA Reports Clearance Officer, Mail
Stop C4-26-05, Baltimore, Maryland 21244-1850.
Form CMS-10221 (Rev. XX/XXXX)

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