Introduction

In this section:

Purpose

The purpose of Health Resources and Services Administration (HRSA) site visits1 is to support effective monitoring of the Health Center Program. Operational Site Visits (OSVs) provide an objective assessment to verify the status of each Health Center Program recipient or look-alike’s compliance with the statutory and regulatory requirements of the Health Center Program. In addition, HRSA conducts site visits to assess and verify the eligibility and compliance of look-alike initial designation applicants for initial designation determinations. For the purposes of this document, the term “health center” refers to entities that apply for or receive a federal award under section 330 of the Public Health Service (PHS) Act (including section 330 (e), (g), (h) and (i)), section 330 subrecipients, and organizations designated as look-alikes.

HRSA uses the Health Center Program Compliance Manual (“Compliance Manual”) to determine whether health centers have demonstrated compliance with the statutory and regulatory requirements of the Health Center Program. The Health Center Program Site Visit Protocol (SVP) is based on the Compliance Manual and adds standard and transparent methodologies for assessing compliance with Health Center Program requirements during OSVs and look-alike initial designation (ID) site visits. The SVP includes the same compliance elements as those in the Compliance Manual.2

During a site visit, at the health center’s request, the site visit team may share recommendations or limited technical assistance on areas of health center operations that are outside the scope of the compliance review. Such recommendations or technical assistance information will not be included in the final site visit report.

HRSA conducts OSVs approximately at the mid-point of each health center’s period of performance.

Health centers should use the Compliance Manual, the SVP, and other site visit resources to prepare for site visits and to regularly assess and ensure ongoing compliance with the Health Center Program. 

Refer to Health Center Program Compliance Frequently Asked Questions (FAQ) and Site Visit Resources for resources to help health centers prepare for site visits.

Site visit report and compliance determinations

HRSA shares the site visit report with the health center within 45 days after the visit. The report conveys the site visit findings and final compliance determinations. In circumstances where HRSA determines that a health center has failed to demonstrate compliance with one or more of the Health Center Program requirements, HRSA will place one or more conditions on the health center’s award or designation.3

The Federal Tort Claims Act (FTCA) Program also uses the site visit report to support FTCA deeming decisions and to identify technical assistance needs for FTCA-deemed health centers. Unresolved Health Center Program conditions related to clinical staffing and/or quality improvement/assurance requirements that apply to both Health Center Program and FTCA deeming, may impact FTCA deeming if they are not resolved by the time that HRSA makes annual FTCA deeming decisions. Health centers that have questions about the FTCA Program or FTCA deeming requirements may use the BPHC Contact Form or call 1–877–464–4772.

Health centers and look-alike initial designation applicants should review the site visit report and the Compliance Manual for guidance on resolving non-compliance findings4, and may contact their assigned HRSA Federal Representative or use the BPHC Contact Form for additional information or assistance. 

Site visit protocol structure and terminology 

Each Compliance Manual chapter that addresses Health Center Program requirements has a corresponding section in the SVP. 

Structure

  • Statute and Regulations: The supporting statute and regulations for the associated program requirements, as well as links to the associated chapter and Related Considerations in the Compliance Manual.
  • Primary and Secondary Reviewers: The member of the site visit team who serves as the primary reviewer for that SVP section, based on expertise (governance/administrative, fiscal, or clinical), and a suggested secondary reviewer who may add expertise and assistance as needed. The site visit team collaborates on compliance assessments.
  • Documents 5the Health Center Provides: The list of documents a health center provides to the site visit team before the site visit.6 The health center provides these documents at least 2 weeks before the start of the site visit.7 HRSA may provide additional guidance, including a Required Documents and File Naming Convention (PDF - 1 MB) resource, before the site visit to support site visit preparation and document submission.
    • In cases where a sample (for example, sample of patient records) is referenced in the list of documents to be provided by the health center, the health center is expected to provide (or "pull") the sample.
      • When the SVP allows for a range in the sample size, the health center should take into account its size and complexity when determining sample size.
      • The health center should provide samples that are representative of its current Health Center Program project operations.
      • If the HRSA site visit team is unable to assess a Health Center Program requirement using the health center’s sample, the team may complete additional sampling in coordination with the health center.
    • Many demonstrating compliance elements allow for the review of "other documentation" to demonstrate compliance if health centers cannot demonstrate compliance in documents specifically listed in the SVP.
    • The name or title of a health center document may differ from that specified in the SVP. Health centers have discretion in how they name or title their documentation. The HRSA site visit team reviews documents to assess compliance with the program requirements. Compliance determinations are based on document content.
      • For example: Where the SVP asks the health center to provide a "board-approved policy," HRSA would assess compliance based on evidence of board approval and on the content of the document, regardless of whether the health center calls the document a "procedure" or "protocol" instead of a "policy."
    • Certain terminology in health center documents may vary as long as it meets the intent of the demonstrating compliance element.
      • For example: Board meeting minutes may note that the board "accepted" a policy, and HRSA considers that terminology as equivalent to the board "approving" the policy.
    • Documents not provided by the close of the first day of the site visit will not be considered in the compliance assessment by the site visit team.
  • Compliance Assessment:
    • Demonstrating Compliance Elements: The same elements from the Compliance Manual that describe how health centers would demonstrate their compliance with the applicable Health Center Program requirements.8
    • Site Visit Team Methodology: Methods the site visit team uses to assess compliance. Methods include but are not limited to reviews of policies and procedures, samples of files and records, site tours, and interviews.9 All documentation provided to the site visit team, whether by HRSA or by the health center, is available to the entire site visit team and can be used for any portion of the site visit.
    • Site Visit Findings: Questions, based on the related methodologies, answered by the site visit team to document its compliance assessment. HRSA uses these responses, which are included in the health center’s site visit report, to determine the health center’s compliance with Health Center Program requirements.

Terminology

  • “Health Center Program federal award” refers to all funding received under the Health Center Program, including supplemental funding. For example, Expansion awards and Quality Improvement Fund awards.
  • Commonly used scope of project abbreviations include:
    • “Form 5A: Services Provided (PDF - 195 KB)” abbreviated as “Form 5A.”
    • “Form 5B: Service Sites (PDF - 81 KB)” abbreviated as “Form 5B.”
    • The three columns on Form 5A related to service delivery methods (PDF - 110 KB):
      • “Column I, Direct (Health Center Pays)” abbreviated as “Column I.”
      • “Column II, Formal Written Contract/Agreement (Health Center Pays)” abbreviated as “Column II.”
      • “Column III, Formal Written Referral Arrangement (Health Center Does NOT Pay)” abbreviated as “Column III.”

Footnotes

1. Per Uniform Administrative Requirements, Cost Principles, and Audit Requirements for Federal Awards: Monitoring and reporting program performance (2 CFR 200.329), HRSA “may conduct in-person or virtual site visits, as warranted.” In addition, 2 CFR 200.337 states that, “The Federal agency or pass-through entity, Inspectors General, the Comptroller General of the United States, or any of their authorized representatives, must have the right of access to any records of the recipient or subrecipient pertinent to the Federal award, to perform audits, execute site visits, or for any other official use. The right also includes timely and reasonable access to the recipient’s or subrecipient’s personnel for the purpose of interview and discussion related to such documents or the Federal award in general.”

2. Note that because the Compliance Manual has additional introductory chapters that are not in the SVP, the Compliance Manual chapter numbers differ from the SVP chapter numbers.

3.For additional information on how HRSA pursues remedies for non-compliance, including progressive action, refer to Health Center Program Compliance Manual, Chapter 2: Health Center Program Oversight">Chapter 2: Health Center Program Oversight.

4.Look-alike initial designation applicants must be compliant with all Health Center Program requirements at the time of application and should refer to the look-alike Initial Designation application for further guidance on how HRSA will address findings of non-compliance at a pre-designation OSV.

5.When the SVP references documentation, for example “policy,” “procedures,” “disclosures,” or “standards,” it is referring to written documents. 

6.Site visit teams, including consultants, are authorized representatives of HRSA and thus may review a health center’s policies and procedures, financial or clinical records, and other relevant documents, in order to assess and verify compliance with Health Center Program and FTCA deeming requirements. Site visit teams are also subject to confidentiality standards, including Health Insurance Portability and Accountability Act (HIPAA). Consultants who violate such standards are in violation of their contract, and could be subject to Title 18, United States Code, Section 641. While it is permissible for health centers to request that HRSA staff and consultants sign additional confidentiality statements, this should be communicated to HRSA and the site visit team before the site visit to avoid any disruption or delay in the site visit process.

7.Health centers may choose to provide samples of patient records before or during the site visit. If patient records will be provided during the site visit, this should be communicated to the site visit team before the site visit to avoid any disruption or delay in the site visit process.

8. A small subset of elements are not assessed during a site visit because HRSA assesses them by other means (for example, competitive application review, look-alike Renewal Designation application review, HRSA Division of Grants Management Office (DGMO) review).

9.Interviews with health center staff are intended to supplement and assist the site visit team in its review of policies, procedures, and other documentation.

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