In this section:
Primary Reviewer: Governance/Administrative Expert
Secondary Reviewer: Fiscal and Clinical Expert (as needed)
Authority: Section 330(k)(3)(H)(ii), and 330(k)(3)(I)(i) of the Public Health Service (PHS) Act; 42 CFR 51c.104(b)(4), 42 CFR 51c.303(p), 42 CFR 56.104(b)(5), and 42 CFR 56.303(p); and 45 CFR 75.308(c)(1)(ii)(iii)
Health Center Program Compliance Manual Related Considerations
Documents the Health Center Provides
- Health center organization charts with names and titles of key management staff (if updated since last application submission to HRSA).
- Position descriptions of key management staff (if updated since last application submission to HRSA).
- Any contracts for key management staff.
- If the health center has key management staff vacancies:
- Human Resources procedures relevant to recruiting and hiring of key management staff.
- Documentation associated with filling key management staff vacancies (for example, job advertisements or revised position descriptions).
- Project Director/CEO employment agreement.
- Project Director/CEO’s W-2 or, if a W-2 has not yet been issued, documentation of receipt of salary directly from the health center (for example, pay stub).
- Any additional documentation of key management reporting structures.
- If the health center has a co-applicant: Co-applicant agreement (if updated since last application submission to HRSA).
- If the current Project Director/CEO has changed since the start of the current period of performance:
- The Notice of Award (NOA)/Notice of Look-Alike Designation (NLD) approving the current Project Director/CEO; OR
- If the prior approval request for the current Project Director/CEO is still under review by HRSA, the documentation of the request.
Compliance Assessment
Select each element below for the corresponding text of the element, site visit team methodology, and site visit finding questions.
The health center has determined the makeup of and distribution of functions among its key management staff1 and the percentage of time dedicated to the Health Center Program project for each position, as necessary to carry out the HRSA-approved scope of project.
Site Visit Team Methodology
- Review Form 2: Staffing Profile, and the position descriptions or contracts for key management staff.
- Review the health center organization charts.
- Interview the health center’s key management staff to determine how key functions are distributed and carried out.
Site Visit Findings
- Can the health center justify how the distribution of functions and allocation of time for each key management position are sufficient to carry out the approved scope of the health center project? For example, is there a clear justification for a part-time Project Director/CEO or for the lack of a dedicated CFO position?
Response is either: Yes or No
If No, an explanation is required, including describing why the distribution of functions and allocation of time for each key management position are insufficient to carry out the scope of project.
The health center has documented the training and experience qualifications, as well as the duties or functions, for each key management staff position (for example, in position descriptions).
Site Visit Team Methodology
N/A – HRSA does not review health center compliance with this element during the site visit. HRSA assesses compliance with this element during its review of the health center’s competing continuation application (SAC or RD).
Site Visit Findings
N/A – HRSA does not review health center compliance with this element during the site visit. HRSA assesses compliance with this element during its review of the health center’s competing continuation application (SAC or RD).
The health center has implemented, as necessary, a process for filling vacant key management staff positions (for example, vacancy announcements have been published and reflect the identified qualifications).
Site Visit Team Methodology
- Review the health center organization charts and compare to current key management staff. Note if there are any vacancies.
- If a key management staff vacancy is noted:
- Review Human Resources (HR) procedures relevant to recruiting and hiring of key management staff and documentation associated with filling the vacancy; and
- Interview staff responsible for health center hiring/HR functions.
Site Visit Findings
- Does the health center have any vacant key management positions?
Response is either: Yes or No
- IF YES: Will the health center implement or has the health center implemented a process for filling this position?
Response is: Yes, No, or Not Applicable
If No, an explanation is required, including specifying which position(s) are vacant.
The health center’s Project Director/CEO2 is directly employed by the health center,3 reports to the health center’s governing board4 and is responsible for overseeing other key management staff in carrying out the day-to-day activities necessary to fulfill the HRSA-approved scope of project.
Site Visit Team Methodology
- Review the health center organization charts.
- Review the position descriptions or contracts for key management staff and any additional documentation of key management reporting structures.
- Review the Project Director/CEO’s W-2 or, if a W-2 has not yet been issued by the health center, documentation of receipt of salary directly from the health center.
- Review the Project Director/CEO employment agreement.
- For public agencies with a co-applicant board, review the co-applicant agreement.
- Interview Project Director/CEO about the position and responsibilities.
Site Visit Findings
- Is the Project Director/CEO directly employed by the health center?
Note: A health center could demonstrate compliance by presenting the Project Director/CEO’s W-2, employment agreement, pay stub, or some other type of documentation of direct employment by the health center.
Response is either: Yes or No
If No, an explanation is required.
- Does the Project Director/CEO report to the health center board?
Note: In a public agency with a co-applicant board where the public agency employs the Project Director/CEO, the Project Director/CEO may report both to the co-applicant board and to another board or individual within the public agency.
Response is either: Yes or No
If No, an explanation is required.
- Does the Project Director/CEO oversee other key management staff in carrying out the day-to-day activities of the health center project?
Response is either: Yes or No
If No, an explanation is required.
NOT APPLICABLE FOR LOOK-ALIKE INITIAL DESIGNATION APPLICANTS
If there has been a post-award change in the Project Director/CEO position,5 the health center requests and receives prior approval from HRSA.
Site Visit Team Methodology
- If there has been a change in the Project Director/CEO position since the start of the current period of performance:
- Review the Notice of Award (NOA)/Notice of Look-Alike Designation (NLD) approving the current Project Director/CEO; OR
- If the Project Director/CEO prior approval request is still under review by HRSA, review the documentation of the request.
Site Visit Findings
- Has there been a change in the Project Director/CEO position since the start of the current period of performance?
Notes:
- Only select “Yes” for situations in which the Project Director/CEO:
- Was absent from the project for any continuous period of 3 months or more; or
- Reduced time devoted to the project by 25 percent or more from the level that was approved at the time of award.
- Only select “Not Applicable” if this is a Look-Alike Initial Designation Site Visit.
Response is: Yes, No, or Not Applicable
- Only select “Yes” for situations in which the Project Director/CEO:
- IF YES: Is there a Notice of Award (NOA)/Notice of Look-Alike Designation (NLD) from HRSA approving this change or did the health center provide documentation that the prior approval request is still under review by HRSA?
Response is: Yes, No, or Not Applicable
If No, an explanation is required.
Footnotes
1. Examples of key management staff may include Project Director/CEO, Clinical Director/Chief Medical Officer, Chief Financial Officer, Chief Operating Officer, Nursing/Health Services Director, or Chief Information Officer.
2. While the position title of the key person who is specified in the award/designation may vary, for the purposes of the Health Center Program, [the Health Center Program Compliance Manual Chapter 11: Key Management Staff] uses the term “Project Director/CEO” when referring to this key person. Under 45 CFR 75.2, the term “Principal Investigator/Program Director (PI/PD)” means the individual(s) designated by the recipient to direct the project or program being supported by the grant. The PI/PD is responsible and accountable to officials of the recipient organization for the proper conduct of the project, program, or activity. For the purposes of the Health Center Program, “Project Director/CEO” is synonymous with the term “PI/PD.”
3. Public agency health centers utilizing a co-applicant structure would demonstrate compliance with the statutory requirement for direct employment of the Project Director/CEO by demonstrating that the public agency, as the Health Center Program awardee/designee of record, directly employs the Project Director/CEO. Refer to related requirements in [Health Center Program Compliance Manual] Chapter 19: Board Authority regarding public agencies with co-applicants.
4. Refer to related requirements in [Health Center Program Compliance Manual] Chapter 19: Board Authority regarding the selection and dismissal of the Project Director/CEO by the health center board as part of its oversight responsibilities for the Health Center Program project.
5. Such changes include situations in which the current Project Director/CEO will be disengaged from involvement in the Health Center Program project for any continuous period for more than 3 months or will reduce time devoted to the project by 25 percent or more from the level that was approved at the time of award [see