In this section:
Primary Reviewer: Governance/Administrative Expert
Secondary Reviewer: Clinical Expert
Authority: Section 330(k)(2) and Section 330(k)(3)(J) of the Public Health Service (PHS) Act; and 42 CFR 51c.104(b)(2-3), 42 CFR 51c.303(k), 42 CFR 56.104(b)(2), 42 CFR 56.104(b)(4), and 42 CFR 56.303(k)
Health Center Program Compliance Manual Related Considerations
Documents the Health Center Provides
- Service area reports or analysis documentation.
- Most recent needs assessment and documentation (for example, studies, resources, reports) used to develop the needs assessment.
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 identifies and annually reviews its service area1 based on where current or proposed patient populations reside as documented by the ZIP codes reported on the health center’s Form 5B: Service Sites. [In addition, these service area ZIP codes are consistent with patient origin data reported by ZIP code in its annual Uniform Data System (UDS) report (for example, the ZIP codes reported on the health center’s Form 5B: Service Sites would include the ZIP codes in which at least 75 percent of current health center patients reside, as identified in the most recent UDS report).]
Note
HRSA does not assess health center compliance with the portion of element “a” in brackets during the site visit. HRSA assesses compliance with the portion of element “a” in brackets during its review of the health center’s competing continuation application (Service Area Competition (SAC) or Renewal of Designation (RD)).
Site Visit Team Methodology
- Interview Project Director/CEO and other key management staff about the health center’s service area analysis process.
- Review the service area reports or analysis documentation.
- Review the health center’s Form 5B.
Site Visit Findings
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Does the health center use patient origin data from its most recent UDS report when recording or updating ZIP codes on its Form 5B site entries?
Response is either: Yes or No
If No, an explanation is required (for example, Form 5B ZIP codes reflect newer data available to the health center).
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Is this service area review process completed at least annually?
Note: A health center’s annual service area review may be conducted in a number of ways; for example, as part of a competitive application or as a separate activity during the year, such as review of annual UDS patient origin data or other data on where patients reside.
Response is either: Yes or No
If No, an explanation is required.
The health center completes or updates a needs assessment of the current or proposed population at least once every 3 years,2 for the purposes of informing and improving the delivery of health center services. The needs assessment utilizes the most recently available data3 for the service area and, if applicable, special populations and addresses the following:
- Factors associated with access to care and health care utilization (for example, geography, transportation, occupation, transience, unemployment, income level, educational attainment);
- The most significant causes of morbidity and mortality (for example, diabetes, cardiovascular disease, cancer, low birth weight, behavioral health) as well as any associated health disparities; and
- Any other unique health care needs or characteristics that impact health status or access to, or utilization of, primary care (for example, social factors, the physical environment, cultural/ethnic factors, language needs, housing status).
Site Visit Team Methodology
- Review the most recent needs assessment and documentation (for example, studies, resources, reports) used to develop the needs assessment.
- If the health center is part of a larger organization (for example, a health department, mental health or social service agency), review whether the needs assessment provides data that are relevant to the Health Center Program project and specific enough to inform the delivery of health center services.
- Interview Project Director/CEO and other key management staff about how the health center uses the needs assessment.
Site Visit Findings
- Does the health center complete or update a needs assessment of the current population at least once every 3 years?
Response is either: Yes or No
If No, an explanation is required.
- Is the needs assessment based on the most recently available data for the service area and, if applicable, special populations?
Response is either: Yes or No
If No, an explanation is required.
- Does the needs assessment address all of the following:
- Factors associated with access to care and health care utilization (for example, geography, transportation, occupation, transience, unemployment, income level, educational attainment);
- The most significant causes of morbidity and mortality (for example, diabetes, cardiovascular disease, cancer, low birth weight, behavioral health) as well as any associated health disparities; and
- Any other unique health care needs or characteristics that impact health status or access to, or utilization of, primary care (for example, social factors, the physical environment, cultural/ethnic factors, language needs, housing status).
Response is either: Yes or No
If No, an explanation is required.
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Did the health center provide at least one example of how it utilized the results of its needs assessment to inform and improve the delivery of health center services?
Response is either: Yes or No
If No, an explanation is required.
Footnotes
1. Also referred to as “catchment area” in the Health Center Program implementing regulation in 42 CFR 51c.102.
2. Compliance may be demonstrated based on the information included in a Service Area Competition (SAC) or a Renewal of Designation (RD) application. Note that in the case of a Notice of Funding Opportunity for a New Access Point or Expanded Services grant, HRSA may specify application-specific requirements for demonstrating an applicant has consulted with the appropriate agencies and providers consistent with Section 330(k)(2)(D) of the PHS Act. Such application-specific requirements may require a completed or updated needs assessment more recent than that which was provided in an applicant’s SAC or RD application.
3. In cases where data are not available for the specific service area or special population, health centers may use extrapolation techniques to make valid estimates using data available for related areas and population groups. Extrapolation is the process of using data that describes one population to estimate data for a comparable population, based on one or more common differentiating demographic characteristics. Where data are not directly available and extrapolation is not feasible, health centers should use the best available data describing the area or population to be served.