Health Center Program Site Visit Protocol: Frequently Asked Questions

  1. What is the purpose of the Health Center Program Site Visit Protocol?

    The Health Center Program Site Visit Protocol (SVP) is the tool for assessing compliance with Health Center Program requirements during Operational Site Visits (OSVs). The SVP provides HRSA with the information necessary to perform its oversight responsibilities using a standard and transparent methodology that aligns with the Health Center Program Compliance Manual. The SVP is used in the conduct of OSVs for current Health Center Program awardees and look-alikes, as well as for organizations seeking initial look-alike designation.

  2. Will HRSA shorten a health center project period length as a result of OSV findings?

    HRSA will not shorten a project period as a result of OSV non-compliance finding(s). OSVs generally occur at the mid-point of a project period. Project period determinations are made at the time of service area competition or renewal of designation awards. Consistent with current practice, a project period will be shortened when a health center fails to adequately address conditions through the Progressive Action process or when HRSA determines that an immediate enforcement action is necessary. In such cases, HRSA may utilize available remedies, including terminating all or part of the federal award/designation before the health center’s current project end date. See Chapter 2: Health Center Program Oversight of the Health Center Program Compliance Manual for additional information.

  3. When will my operational site visit (OSV) be conducted?

    HRSA conducts OSVs for health centers at least once per project/designation period. For health centers with a one-year project/designation period the OSV will take place two to four months into the new project period. For health centers with a three-year project/designation period, the OSV will take place 14-18 months into the new project period. HRSA strongly encourages all health centers to review and utilize both the Compliance Manual and the Site Visit Protocol and related resources to prepare for site visits and to help regularly assess and assure ongoing compliance with the Health Center Program.

  4. Can consultants provide technical assistance to health centers during OSVs?

    The primary purpose of an OSV is to assess whether a health center demonstrates compliance with the statutory and regulatory requirements of the Health Center Program. However, during the OSV, a health center may request or consultants may share recommendations or technical assistance on various areas of optimizing health center operations that fall outside the scope of the compliance review. Recommendations and/or technical assistance information offered by site visit team members will not be recorded as part of the site visit report.

  5. How are samples selected for review during the Operational Site Visit? – NEW

    Within the Site Visit Protocol, in cases where a sample (e.g., 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 and have it ready for the HRSA site visit team at the start of the site visit. When the Site Visit Protocol allows for a range in the sample size, the health center should take into account its size and complexity when determining sample size. If the sample provided by the health center is not sufficient to allow the HRSA site visit team to assess the program requirement, the team may complete additional sampling in coordination with the health center.

  6. How will site visit reviewers assess whether a health center is following operating procedures?

    The “demonstrating compliance” elements within the Compliance Manual include a list of items that must be addressed in operating procedures in order to demonstrate compliance. The methodologies within the SVP also specifically note where a site visit reviewer must review documentation that demonstrates that operating procedures are being implemented and/or utilized. Implementation or utilization of operating procedures generally would be assessed through the review of records, files, etc., as noted in the SVP.

  7. What elements of the Health Center Program Compliance Manual are assessed for compliance via the OSV process?

    Nearly all of the elements within the Health Center Program Compliance Manual are assessed during an OSV. Please review the SVP and related tools and resources available at https://bphc.hrsa.gov/programrequirements/svprotocol.html to view all elements assessed during an OSV.

  8. What happens if my health center has findings of non-compliance?

    HRSA will develop and present a site visit report to the health center within 45 days after the site visit. The report will convey the site visit findings and final compliance determinations.

    If HRSA determines that a health center has not demonstrated compliance with one or more of the elements reviewed via the OSV, as indicated in the final site visit report, a corresponding condition will be placed on the award/designation. More information and a full list of conditions is available at: https://bphc.hrsa.gov/programrequirements/conditions-library.html.

  9. If a health center has a policy or procedure that includes additional provisions or standards that go beyond what is required in the Compliance Manual, would the health center demonstrate compliance based on adherence to what the Compliance Manual requires, or based on adherence to the health center’s own policy or procedure?

    During the OSV, a health center’s policies or procedures will be assessed for compliance with the demonstrating compliance elements in the Compliance Manual. Health centers may choose to include provisions beyond those specified in the Compliance Manual in their policies or procedures, however in reviewing compliance with respect to implementation of policies or procedures, the site visit review would not assess these additional provisions or standards if they go beyond what is required in the Compliance Manual.

  10. How can health centers prepare for an upcoming OSV or look-alike initial designation site visit?

    Health centers (current awardees and look-alikes) or applicants applying to receive initial look-alike designation should thoroughly review methodologies and questions in the SVP. It can be used to help organize the documents, samples and other items that will be reviewed during the OSV.

    The SVP is like an “open book” test. The SVP contains the methodologies that the site visit reviewers will use as well as all of the questions the reviewers will answer to assess health center compliance. Health centers are also encouraged to review the related SVP resource tools when preparing for an upcoming site visit. See: https://bphc.hrsa.gov/programrequirements/svprotocol.html.

  11. What documentation must a health center provide prior to or during the site visit?

    The SVP lists within each section documents that a health center must provide to support the site visit. The SVP specifically identifies which documents the health center is expected to provide to the site visit team prior to the site visit and which documents need to be available when the site visit team arrives onsite.

    HRSA also provides the site visit team with relevant documents prior to the visit, as noted in the SVP Site Visit Resources. In order to ensure consistency and manage burden on the health center, site visit teams are not to request documentation beyond what is identified in the SVP.

    A Consolidated Documents Checklist for Health Center Staff is available in the SVP Tools section of the SVP website to help health centers prepare. Please see: https://bphc.hrsa.gov/programrequirements/svprotocol.html.

  12. Should the SVP be used for policy guidance?

    No, the SVP is a standardized tool to support the conduct of onsite assessments of health centers’ compliance with Health Center Program requirements. The SVP is not policy guidance. The Health Center Program Compliance Manual is the streamlined and consolidated source for policy guidance developed to assist health centers in understanding and demonstrating compliance with Health Center Program and Federal Tort Claims Act (FTCA) deeming requirements. Please refer to the Health Center Program Compliance Manual for policy guidance on maintaining compliance with Health Center Program requirements.

  13. How is the FTCA Risk Management and Claims Management section of an OSV report used by HRSA?

    During an OSV, all health centers that are currently FTCA deemed will be assessed for compliance with the Risk Management and Claims Management requirements of the FTCA Program. If an OSV report contains FTCA risk and claims management findings, the FTCA Program will develop and share a Corrective Action Plan with the health center. The health center must respond to the Corrective Action Plan and address findings before the next FTCA deeming cycle. Failure to respond to the Corrective Action Plan may impact future deeming determinations.

  14. Where do I direct questions about the 340B portion of the OSV?

    Questions regarding the 340B portion of the OSV can be directed to 340Bcompliance@hrsa.gov. If health centers have general questions regarding the 340B Program, they may contact the Call Center: ApexusAnswers@340bpvp.com or by phone: 1-888-340-2787.

Date Last Reviewed:  December 2018