Form 3 Checklist for Adding a New Service Delivery Site - Clean

Checklist for Adding a New Service Delivery Site

Assurances:

OMB No.: 0915-0285. Expiration Date: XX/XX/20XX

• I certify that the following statements related to the preparation of this Change in Scope (CIS) request are true, complete and accurate:

• This CIS request is complete and responsive to all applicable criteria relating to the CIS checklist. Refer to http://www.bphc.hrsa.gov/programrequirements/scope.html for all applicable policies and guidance.

• The health center consulted with its Project Officer prior to submitting this CIS request.

• The proposed CIS implementation date is at least 60 days from the submission date to HRSA. Note: HRSA recognizes that there may be circumstances where submitting a CIS request at least 60 days in advance of the desired implementation date may not be possible; however, the goal is to minimize these occurrences through careful planning.

• The health center’s governing board approved this CIS request prior to submission to HRSA, as documented in board minutes (must be made available upon request).

• The health center has examined the potential impact of this CIS under the requirements of other programs as applicable (e.g., 340B Program, FTCA). Refer to: https://www.bphc.hrsa.gov/programrequirements/pdf/potentialimpactofcisactions.pdf

• The health center understands that HRSA will consider its current compliance with Health Center Program requirements and regulations (i.e., the status and number of any progressive action conditions) when making a decision on this CIS request. See Health Center Program Compliance Manual, Chapter 2: Health Center Program Oversight for more information on progressive action. Refer to: https://bphc.hrsa.gov/programrequirements/compliancemanual/index.html

• I will ensure the health center complies with the following statements related to the implementation of this Change in Scope (CIS) request, if approved:

• All Health Center Program requirements (http://www.bphc.hrsa.gov/programrequirements/index.html) will apply to this CIS. Note: Compliance with Health Center Program requirements across sites and services will be assessed through all appropriate means, including site visits and application reviews.

• This CIS will be undertaken directly by or on behalf of the health center for the benefit of the current or proposed health center patient population, and the health center’s governing board will retain oversight over the provision of any services and/or sites.

• This CIS will be accomplished without additional Health Center Program Federal award funding (for awardees only) and will not shift resources away from carrying out the current HRSA-approved scope of project.

• The impact of this CIS will be reflected in the total budget submitted with the health center’s next annual competing or non-competing or designation application.

• This CIS will be implemented and verified within 120 days of receiving the NoA or HRSA notification approving the change.

• This CIS will not diminish the patient population’s access to and quality of services currently provided by the health center.

• The health center will take all applicable steps related to the requirements of other programs impacted by this change in scope request. Refer to https://www.bphc.hrsa.gov/programrequirements/pdf/potentialimpactofcisactions.pdf

Change in Scope Questions:

Is this request to add a site linked to another recently submitted, in progress or planned CIS request? (e.g., the health center will be moving operations to this new site and will submit a CIS request to delete a current site; the health center will provide a service not currently in scope at this site and will submit a CIS request to add the service)

Y/N – require text box explanation if Y

1. NEED AND RATIONALE: Discuss why and how the addition of the proposed site will address unmet need by maintaining or increasing access and maintaining or improving quality of care for the patient population.

1. Provide evidence that the proposed site will address unmet need by maintaining or increasing access to care for the population that will utilize the new site. Provide data only for the new site.

Total unserved low-income population in the proposed service area _____

Source __________

If these data/source are not consistent with the UDS Mapper map and data table, please explain: ____________

Total number of patients projected to be served annually:

New patients____

Existing patients____

Of the total projected patients, anticipated % of patients with incomes at or below 200% of the Federal Poverty Guidelines: ____

Briefly explain how these projections were derived: ____________

Required Attachment: UDS Mapper Map & Data Table

Optional Attachment: Other Supporting Need Documentation

NOTE: The UDS Mapper Map and Data Table are required and should be used to support the explanations provided in this CIS request; upload any additional need data/documentation as necessary. HRSA will use UDS Mapper data to assess unmet need and service area overlap. If UDS Mapper Map and Data Table are not yet available, attach other relevant and comparable documentation which supports this request. UDS Mapper: http://www.udsmapper.org. For a UDS Mapper sample to support a CIS request, click here (placeholder for external resource).

2. What is the unmet need/justification for the proposed site? Select all that apply

• This is a comparable replacement site for an existing site awarded via a funding opportunity (e.g., New Access Point) that is no longer available. Note: The proposed site must serve the same zip codes and be comparable in terms of patient capacity to the site originally proposed in the approved application.

Provide the relevant application number: ___

• The proposed service area has a Health Center Program (grantees and look-alikes) penetration rate for the low-income (below 200% of the Federal Poverty Guidelines) population at or below 25% as evidenced by the attached UDS Mapper data (i.e., 75% or more of the proposed service area’s low-income population is not served under the Health Center Program).

• The health center is exceeding capacity at a current location(s).

• The health center is already serving a high number of patients from the proposed service area.

• An existing provider is closing a site and/or no longer offering services to the patient population in the area.

• One or more of the health center’s existing sites is under renovation and a temporary service site is needed until the renovations are complete. Note: if the temporary site will no longer be utilized once the existing site(s) re-opens, a CIS request to delete the temporary site from scope must be submitted.

• Other Need/Special Circumstance (e.g. high level of chronic conditions in the low income population, gaps in coverage among different population groups, special population, limited service site need)

3. Provide a brief discussion, as appropriate, for the selection of the proposed site in terms of:

• Relevant background information (e.g., adding site in response to: operational site visit finding, health center strategic plan, special funding obtained)

• Reason for location type (e.g., permanent, mobile)

• Rationale for site hours of operation (e.g., part-time versus full-time)

• Rationale for types of services to be offered at the site (e.g., medical, oral , mental health)

• Description if the proposed site will offer limited services (e.g., dental-only, behavioral health-only) or services to limited patient groups (e.g., school-aged children), of:

• How all individuals who present for services at this site will have access to the full scope of health center required and additional services; and/or

• How all individuals who are not among the limited group served by the site and who present at this site for care will be referred to other appropriate health center sites to receive services not available at the proposed site.

Requires narrative response.

Proposed Date of Site Addition: mm/dd/yyyy

Note: Please review Program Assistance Letter 2014-10: Updated Process for Change in Scope Submission, Review and Approval Timelines and Policy Information Notice 2008-01: Defining Scope of Project and Policy for Requesting Changes. In cases where a health center is not able to determine the exact date by which a CIS will be fully accomplished, BPHC will allow up to 120 days following the date of the CIS approval Notice of Award (NoA) or look-alike Notice of Look-Alike Designation (NLD) for the health center to implement the change (e.g., open the site). Review the Program Assistance Letter 2009-11: New Scope Verification Process for more information.

2. SERVICE AREA: Explain the proposed service area, existing safety net resources, and how the proposed new site will complement and not duplicate these existing resources.

Based on UDS Mapper Map and Data Table information, will the site serve all or part of a service area currently served by another health center grantee or look-alike and/or of another primary care safety net provider (rural health clinic, critical access hospital, health department, etc.)? Yes or No. Checkboxes for Yes options to allow multiple selections; No skips narrative; Any Yes response requires narrative response.

• No

• Yes – the site will serve a newly identified sub-group/underserved population (e.g., people experiencing homelessness, populations with limited English proficiency within the service area), whose health care needs are not being met.

• Yes – the site will serve an area where unmet need exceeds the capacity of the existing health center site(s) and/or other safety net providers.

• Yes – the site will serve a population where the distance and travel time to the nearest safety-net provider site, (e.g., health center grantee or look-alike, rural health clinic, critical access hospital) is a barrier for patients to access care. Note: UDS Mapper is the best tool for identifying the nearest Health Center Program grantee or look-alike. Distance should be measured as the distance (in miles) from the address of the proposed service site to the nearest Health Center Program grantee or look-alike service sites. Use the UDS Mapper Distance tool and/or Google Maps to determine (1) the distance in miles between sites and (2) travel time by driving or public transportation, as appropriate (e.g., if at least 30% of the patient population uses public transportation as the main source of transportation to work, provide travel time based on public transport as opposed to providing travel time by car/drive time).

  • Distance in miles: _____

  • Travel time in minutes: _____

Required for any Yes response:

Based on this answer and attached UDS Mapper data and other needs assessment documentation that shows other health centers and service providers and their penetration rates, address any service area overlap and how the proposed site will complement existing services and programs so as to minimize the potential for unnecessary duplication and/or overlap in services, sites or programs.

Requires narrative response.

Note: Upload any relevant letters of support from all health centers serving the same service area in the next section

3. COLLABORATION WITH HEALTH CENTERS AND OTHER SAFETY NET PROVIDERS

For the purposes of this question, collaborative relationships are those that contribute to one or both of the following goals relative to the proposed site:

(1) maximize access to required and additional services within the scope of the health center project for patients that will be served at the proposed site; and/or

(2) promote the continuity of care of patients that will be served at the proposed site by coordinating with the services and activities of other federally funded, as well as State and local, health services delivery projects and programs serving the same or a similar patient population (e.g., other health centers, rural health clinics, hospitals, health departments).

1. Describe the established and/or proposed collaboration with other health centers and safety net providers (e.g., health departments, rural health clinics, hospitals) within and adjacent (e.g., neighboring ZIP codes) to the service area for this proposed site and how this collaboration will benefit the proposed patient population to be served.

Requires narrative response.

2. Attach documentation of collaboration, including any agreements (e.g., MOA, MOU, contract), relevant and specific to the proposed site which support the response to 3a. If documentation could not be obtained, describe the outreach made to these service area providers concerning this proposed site and the result of this outreach.

Optional narrative response:

Optional attachment: Documentation of Collaboration

4. SITE OWNERSHIP/OPERATION (not required if site operated directly by health center)

FOR SITES OPERATED BY CONTRACT: If the proposed site is operated by a third party on behalf of the health center through a written contractual agreement between the health center and the third party (i.e., the health center is contracting with a third party for part or full operation of this service site):

• Provide the rationale for operating the site through a contract (as opposed to the health center operating the site directly); and

• Explain why this third-party organization was selected to operate the proposed site (e.g., contractor’s capabilities and resources, experience with health center patient population).

Requires narrative response

No attachment requested/required

Resources:

Procurement Standards: http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=0386f369acd20f0e943466135faeed0b&r=PART&n=pt45.1.75#sg45.1.75_1324_675_1325.sg2

Contract: A contract is used for the purpose of obtaining goods and services for the health center’s own use and creates a procurement relationship with the contractor. Characteristics indicative of a procurement relationship between the health center and a contractor are when the contractor:

1. Provides the goods and services within normal business operations;

2. Provides similar goods or services to many different purchasers;

3. Normally operates in a competitive environment;

4. Provides goods or services that are ancillary to the operation of the federal program; and

5. Is not subject to compliance requirements of the federal program as a result of the agreement, though similar requirements may apply for other reasons.

For more information on determining whether an agreement for the disbursement of federal program funds casts the party receiving the funds in the role of a subrecipient or a contractor, please review 45 CFR 75.351. Please note that contractors are not able to qualify as federally qualified health centers. See http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=0386f369acd20f0e943466135faeed0b&r=PART&n=pt45.1.75

FOR SITES OPERATED BY SUBRECIPIENTS: If the proposed site is operated by a third party on behalf of the health center through a written subrecipient agreement between the health center and the subrecipient organization (i.e., the health center is providing a subaward to the organization to perform a substantive portion of the grant-supported program or project for the operation of the proposed site):

• Provide the rationale for operating the site through a subaward (as opposed to the health center operating the site directly);

• Describe actions taken to confirm that the subrecipient organization complies with all Health Center Program requirements and the terms and conditions of the federal award; and

• Describe actions for ongoing monitoring of the subawardee (as indicated in the attached subrecipient agreement) to ensure maintenance of Health Center Program requirements and the terms and condition of the federal award.

Requires narrative response

Required attachment: Subrecipient agreement

Resources - Subrecipient Monitoring and Management:

http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=0386f369acd20f0e943466135faeed0b&r=PART&n=pt45.1.75#sg45.1.75_1344_675_1350.sg4

• Subaward: An award provided by a pass-through entity to a subrecipient for the subrecipient to carry out part of a federal award received by the pass-through entity. It does not include payments to a contractor or payments to an individual that is a beneficiary of a federal program. A subaward may be provided through any form of legal agreement, including an agreement that the pass-through entity considers a contract.

• Pass-Through Entity: A non-federal entity that provides a subaward to a subrecipient to carry out part of a federal program.

• Subrecipient: A non-federal entity that receives a subaward from a pass-through entity to carry out part of a federal program and is accountable to the recipient for the use of the funds provided but does not include an individual that is a beneficiary of such program. A subrecipient may also be a recipient of other federal awards directly from a federal awarding agency.

• Characteristics which support the classification of the non-federal entity as a subrecipient include when the non-federal entity:

• Determines who is eligible to receive what federal assistance;

• Has its performance measured in relation to whether objectives of a federal program were met;

• Has responsibility for programmatic decision making;

• Is responsible for adherence to applicable federal program requirements specified in the federal award; and

• In accordance with its agreement, uses the federal funds to carry out a program for a public purpose specified in authorizing statute, as opposed to providing goods or services for the benefit of the pass-through entity.

For more information on determining whether an agreement for the disbursement of federal program funds casts the party receiving the funds in the role of a subrecipient or a contractor, please review 45 CFR 75.351. See http://www.ecfr.gov/cgi-bin/retrieveECFR?gp=&SID=0386f369acd20f0e943466135faeed0b&r=PART&n=pt45.1.75

Subrecipients are generally eligible to receive FQHC reimbursement under Medicaid and Medicare, 340B Drug Pricing, and FTCA coverage. However, such benefits are not automatically conferred and may require additional actions and approvals (e.g., submission and approval of a subrecipient deeming application).

Public Burden Statement: Health centers (section 330 grant funded and Federally Qualified Health Center look-alikes) deliver comprehensive, high quality, cost-effective primary health care to patients regardless of their ability to pay. The Health Center Program application forms provide essential information to HRSA staff and objective review committee panels for application evaluation; funding recommendation and approval; designation; and monitoring. The OMB control number for this information collection is 0915-0285 and it is valid until XX/XX/XXXX. This information collection is mandatory under the Health Center Program authorized by section 330 of the Public Health Service (PHS) Act (42 U.S.C. 254b). Public reporting burden for this collection of information is estimated to average 2 hours per response, including the time for reviewing instructions, searching existing data sources, and completing and reviewing the collection of information. Send comments regarding this burden estimate or any other aspect of this collection of information, including suggestions for reducing this burden, to HRSA Reports Clearance Officer, 5600 Fishers Lane, Room 14N136B, Rockville, Maryland, 20857 or paperwork@hrsa.gov.