Cms-576 Organ Procurement Organization (opo) Request For Designa

Department of Health & Human Services
Form Approved
Centers for Medicare & Medicaid Services
OMB No. 0938-0512
___________________________________________________________________________________________________________________________________________________________________________________

I

ORGAN PROCUREMENT ORGANIZATION (OPO) REQUEST FOR DESIGNATION AS AN OPO
Under § 1138 of the Social Security Act
(CMS-576)

I

To Be Completed by CMS Staff Only

OPO’s CMS Certification Number (CCN):
CMS Location (Region) Name:

Related CCN (e.g., for CHOWs/Mergers/Consolidations):

Hospital CCN Number:
CMS Location (Region) Number

Current Fiscal Year End Date:

Date of CMS Receipt:

To Be Completed by the OPO Provider Staff
Name of OPO:
I. Identifying

Information

CMS Certification Number (CCN):

Street Address:
State:

City, County:
Zip Code:

Telephone Number:

Name of OPO CEO or Director:

Area Served by This OPO Provider
List Counties Served (or State if entire State is served):
List All Acute Care Hospitals with the Resources Necessary to Retrieve Organs (i.e. - Operating Rooms, Equipment, Staff)

CMS-576 / OMB Approval Expires XX/XX/20XX

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Department of Health & Human Services
Form Approved
Centers for Medicare & Medicaid Services
OMB No. 0938-0512
___________________________________________________________________________________________________________________________________________________________________________________

ORGAN PROCUREMENT ORGANIZATION (OPO) REQUEST FOR DESIGNATION AS AN OPO
UNDER § 1138 OF THE SOCIAL SECURITY ACT
(CMS-576)
II. Type of Control

Independent

Hospital-Based

Individual

For-Profit

Corporation

Names of OPO Administrative Staff

III. Administration

and Staffing

Partnership

Non-Profit (under §501)

State Government

Federal Government

Title of OPO Administrative Staff

1. Name OPO's Administrator:

Title of OPO 's Administrator:

2. Name of OPO's Medical Director:

Title of OPO's Medical Director:

3. Name of OPO's Program Manager:

Title of OPO's Program Manager:

4. Name of OPO's Donation Coordinator:

Title of OPO's Donation Coordinator:

5. Name of OPO's Organ Procurement Specialist:

Title of OPO's Organ Procurement Specialist:

Provide narrative responses to the following questions regarding your OPO (in a separate document) and
provide all documentation required to support your responses:
IV.

Narrative

1. Submit a plan to show evidence of transition planning to ensure continuity of organ procurement services if a
CHOW takes place.

2. Specify the number of hospitals in your OPO’s service area with which you have agreements and provide
plan for how these hospitals will notified if a CHOW is to take place.
CMS-576 / OMB Approval Expires XX/XX/20XX

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Department of Health & Human Services
Form Approved
Centers for Medicare & Medicaid Services
OMB No. 0938-0512
___________________________________________________________________________________________________________________________________________________________________________________

ORGAN PROCUREMENT ORGANIZATION (OPO) REQUEST FOR DESIGNATION AS AN OPO
UNDER § 1138 OF THE SOCIAL SECURITY ACT
(CMS-576)
3. Describe the role of the OPO in training hospital designated requestor(s) in establishing and implementing
protocols for making routine inquiries about organ donations by potential donors.

4. Provide your organization’s plan for the allocation of donated organs among potential transplant recipients.
5. Describe procedures for complying with OPTN allocation policies.

6. Provide documentation of your coordination activities with transplant programs in the service area.

7. Discuss your organization's arrangements for tissue typing of donated organs.

8. Document your affiliation with tissue banks for the retrieval, processing, preservation, storage and distribution of
tissues to assure that all usable tissues from potential donors are obtained.
9. Discuss and document your accounting procedures and provide an audit letter on letterhead with the name and
address of your accounting firm.
10. Provide your written procedures for screening and testing for HIV and other infectious diseases.
11. Provide your procedures for ensuring the confidentiality of patient records.

12. Discuss and document your activities relating to professional education concerning organ procurement.

CMS-576 / OMB Approval Expires XX/XX/20XX

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Department of Health & Human Services
Form Approved
Centers for Medicare & Medicaid Services
OMB No. 0938-0512
___________________________________________________________________________________________________________________________________________________________________________________

I

ORGAN PROCUREMENT ORGANIZATION (OPO) REQUEST FOR DESIGNATION AS AN OPO
UNDER § 1138 OF THE SOCIAL SECURITY ACT
(CMS-576)

I

ATTESTATION STATEMENT
Whoever knowingly or willfully makes or causes to be made a false statement or representation on this statement, may be prosecuted
under applicable federal or state laws. In addition, knowingly and willfully failing to fully and accurately disclose the information
requested may result in denial of a request to participate, or where the entity already participates, a termination of its agreement or
contract with the state agency or the secretary, as appropriate.

Printed Name of Authorized OPO Representative:

Title of Authorized OPO Representative:

Date:

Signature of Authorized OPO Representative:

PRA Disclosure Statement
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 0938-0512 (Expires XX/XX/20XX). This is a
required information collection. The time required to complete this information collection is estimated to average of 24 hours per response,
including the time to review instructions, search existing data resources, 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.

****CMS Disclosure****
Please do not send applications, claims, payments, medical records or any documents containing sensitive information to the PRA Reports
Clearance Office. Please note that any correspondence not pertaining to the information collection burden approved under the associated OMB
control number listed on this form will not be reviewed, forwarded, or retained. If you have questions or concerns regarding where to submit
your documents, please contact QSOG_OPO@cms.hhs.gov.
CMS-576 / OMB Approval Expires XX/XX/20XX

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Department of Health & Human Services
Form Approved
Centers for Medicare & Medicaid Services
OMB No. 0938-0512
___________________________________________________________________________________________________________________________________________________________________________________

ORGAN PROCUREMENT ORGANIZATION (OPO) REQUEST FOR DESIGNATION AS AN OPO
UNDER § 1138 OF THE SOCIAL SECURITY ACT
(CMS-576)

INSTRUCTIONS FOR COMPLETION OF THE CMS-576 FORM
Submission of this form will initiate the process of obtaining a decision as to whether the Conditions for Coverage: OPOs, are met.
The form provides information and data about the OPO that is necessary to determine compliance with the Conditions and provides a data base
necessary for responding to questions frequently asked by Congress, Federal agencies, and interested members of the public.

General Instructions:
•
•
•
•

Answer all questions as of the current date.

Return the original form and the signed agreement to the CMS Location serving your area and make a copy for your files.

Failure to return this form may result in termination for the service area.

Detailed instructions are given below for questions other than those considered self-explanatory.

Item I: Identifying Information:
•
•
•
•

Medicare CMS Certification Number (CCN): Insert the facility’s six-digit Provider Number.
Leave blank on initial request for designation.
State: The state the OPO is located.

Related CCN: If the OPO is affiliated with any other Medicare provider, insert the related facility’s six-digit Medicare provider number.

CMS-576 / OMB Approval Expires XX/XX/20XX

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Department of Health & Human Services
Form Approved
Centers for Medicare & Medicaid Services
OMB No. 0938-0512
___________________________________________________________________________________________________________________________________________________________________________________

ORGAN PROCUREMENT ORGANIZATION (OPO) REQUEST FOR DESIGNATION AS AN OPO
UNDER § 1138 OF THE SOCIAL SECURITY ACT
(CMS-576)

INSTRUCTIONS FOR COMPLETION OF THE CMS-576 FORM
(continued)
Item II: Type of Control:
•

Check the category(ies) that is most descriptive of the type of organization operating the facility. Check “nonprofit under §501 if the
organization is exempt from Federal income taxation under §501 or the Internal Revenue Code of 1986.

Item III: OPO Administrative and Staffing:
•

Give the name and title of members of the Board of Directors, Advisory Board and staff members.

Item IV: Narrative:
•
•

•
•

Please answer the questions in this section completely and concisely.

Failure to do so may hinder consideration. Attach supporting documentation, such as agreements, statistical data, etc. The documentation
should explain the OPO’s plans or systematic efforts to provide its organ procurement services. The preferable documentation is a copy of
the written agreements with the various hospitals and transplant centers in the service area that list the OPO’s responsibilities and
functions.
If an organization seeking designation as an OPO does not have a written agreement with a given facility, we will accept a letter of intent
from a hospital or transplant center that it will enter into such agreement within not more than 12 months after the OPO’s designation.
If an organization does not have either a written agreement or letter of intent, it must submit other documentation of its working
relationship.

CMS-576 / OMB Approval Expires XX/XX/20XX

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