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

    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 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. Get more information and a full list of conditions.

  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. 

  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 webpage to help health centers prepare.

  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. NEW: What is the purpose of the 2019 SVP Update?

    As part of continuous quality improvement efforts, HRSA collected feedback about the SVP and OSV process from stakeholders, including health centers, strategic partners, site visit team reviewers, and HRSA staff. In response to this feedback, HRSA made several updates to increase the SVP’s effectiveness, clarity, consistency, and transparency.

    No changes were made to the Compliance Manual or to how a health center can demonstrate compliance with Health Center Program requirements.

  15. NEW: What revisions are made in the 2019 SVP?

    The 2019 SVP updates include modifications to the types of documentation requested from health centers, refinement of some of the OSV methodologies, and clarification of several OSV questions. Updates also include minor editorial and formatting improvements. For more detail, see 2019 Site Visit Protocol: Summary of Updates (PDF - 197 KB).

  16. NEW: How is this update different from the September 2018 SVP Update?

    The September 2018 SVP updates focused on aligning the SVP with the August 2018 Health Center Program Compliance Manual Bipartisan Budget Act (BBA) updates. Rather than changes to Health Center Program policy, the 2019 SVP updates are a part of HRSA’s commitment to continuous quality improvement of the OSV process and are based on stakeholder feedback.

  17. NEW: Will HRSA make future updates to the SVP?

    HRSA remains committed to regular updates of the SVP to ensure that it remains useful and is responsive to stakeholder feedback. HRSA encourages health centers and other stakeholders to provide their feedback through existing mechanisms, such as post-site visit evaluation questionnaires and the Stakeholder Satisfaction Survey.

  18. What are the changes to the Health Resources and Services Administration’s (HRSA) process for conducting Operational Site Visits (OSV) this year?

    • In calendar year 2019, a health center’s designated Project Officer will not attend the site visit, nor will they have a role in the determination of compliance. The health center’s Project Officer will arrange a pre-site visit call among the health center, the site visit consultant team, and the individual who will serve as the on-site HRSA Representative.
    • HRSA has implemented a new process, called Compliance Resolution Opportunity (CRO), to support the timely resolution of areas of non-compliance found on-site during an OSV. CRO provides health centers an opportunity to address non-compliance findings prior to HRSA issuing the site visit report and placing conditions on the award/designation due to a failure to demonstrate compliance. Specifically, CRO provides a 14 calendar day window for health centers to address OSV findings by submitting evidence of compliance via the HRSA Electronic Handbook (EHBs). CRO submission(s) will be reviewed and assessed before the final site visit report is issued.
  19. How does the CRO process work?

    After the OSV is concluded, the on-site HRSA Representative (not the designated Project Officer) will contact the health center’s Project Director through a EHBs Urgent Site Visit Report Request task to request additional information/documentation on any areas of non-compliance identified through the OSV. When responding to the task in EHB, please ensure that any documents referenced in your response are attached to the submission. The health center will have 14 calendar days to submit a response to the findings contained in the request. There will be no extensions or exceptions.

    Please see this resource for more information about the EHBs Urgent Site Visit Report Request task feature: Compliance Resolution Opportunity for OSV Structured Technical Assistance Reports.

  20. How will HRSA notify the health center if there are any compliance findings during the OSV?

    The health center will be notified of non-compliance findings during the OSV exit conference. Health centers may use the OSV Exit Conference Tracking Resource (PDF - 801 KB), available on the HRSA website, to track these findings.

  21. Are “quick fixes” allowed during the OSV?

    No. Health centers will not be able to make “quick fixes” during the OSV to address non-compliance findings. Instead, following the updated OSV process, health centers will be able to take advantage of the new CRO process and submit documentation via an Urgent Site Visit Report Request task in EHBs to demonstrate compliance. This new feature is designed to be a uniform and efficient way to help health centers demonstrate compliance while maintaining the objectivity and integrity of the OSV on-site review process.

  22. Will the designated Project Officer participate in the exit conference?

    No. In order to maintain objective compliance determinations, the designated Project Officer will not participate in the exit conference.

  23. How will the health center know that it has received an Urgent Site Visit Report Request task?

    If HRSA identifies any findings of non-compliance, an Urgent Site Visit Report Request task is sent to the health center’s Project Director through EHBs. If the Project Director is not listed in EHBs, the HRSA Representative will select an Authorizing Official to whom the request will be sent. Such requests will appear in the EHBs Pending Tasks list as an “Urgent Site Visit Report Request” task. The health center will also be notified through a EHBs-generated e-mail to either the Project Director or Authorizing Official. The request will come from ‘HRSA GEMS’: oitgems@hrsa.gov.

  24. How will the health center know which areas have not sufficiently demonstrated compliance and how they can demonstrate compliance?

    The Urgent Site Visit Report Request task will include a link to the draft OSV report that documents the consultants’ narrative related to any non-compliance findings. (Note that the health center cannot make changes to the report.) Compliance findings are based on the Health Center Program Compliance Manual which is available to assist health centers in understanding how to demonstrate compliance with Health Center Program requirements. The response to the task should include the documentation noted in the Progressive Action Conditions Library for the corresponding non-compliant element(s).

  25. Does the CRO process allow for multiple responses from the health center?

    Yes. If a health center submits a response before the 14 calendar day timeframe has expired and compliance is still not demonstrated for all or some of the findings, the Urgent Site Visit Report Request task will be returned to the health center for additional information/clarification on the remaining non-compliance findings. When a Project Director or Authorizing Official receives an Urgent Site Visit Report Request task, they should respond to this task via EHBs as soon as possible. This 14-day time period includes any back and forth period between HRSA and the health center, please consider this timing when you submit your documentation. No deadline extension will be provided beyond 14 calendar days. Information shared via methods other than the EHBs Urgent Site Visit Report Request task submission (e.g., phone calls, e-mails) will NOT be considered in HRSA’s final compliance assessment.

  26. Can scope of project corrections be made on-site during the OSV or during the CRO process?

    No. Corrections to scope of project must be completed through the EHBs Change in Scope (CIS) process and reviewed by the HRSA Project Officer. Formal CIS requests must be approved by HRSA and verified by the health center prior to being effective.More information on the change in scope process can be found the Scope of Project page.

  27. Can the Urgent Site Visit Report Request task be initiated while on-site? Will the 14 days start after the last day of the visit?

    No. The 14-day timeframe will begin when the Urgent Site Visit Report Request task is sent to the health center.

  28. Can the Urgent Site Visit Report Request task be sent to other staff at the health center?

    All health center personnel registered with grant privileges in EHBs will receive copies of the Urgent Site Visit Report Request task, but only the Project Director or Authorizing Official will be able to submit a response to HRSA.

  29. What can a health center do in advance to prepare for an Urgent Site Visit Report Request task?

    To prepare for a possible Urgent Site Visit Report Request task, health centers should ensure that the contact information (e-mail and phone number) in EHBs for the Project Director is up-to-date and accurate. The EHBs Urgent Site Visit Report Request task will be initiated by the on-site HRSA Representative, who is NOT the health center’s designated Project Officer. The request will come from ‘HRSA GEMS’: oitgems@hrsa.gov. The health center can add this e-mail address to a “safe senders” or contacts list to avoid messages potentially going to a junk folder.

  30. How can health centers check and/or change the Project Director in EHBs?

    Health centers can check and change the Project Director in EHBs using the process identified in the resource guide (PDF - 301 KB) and the EHBs Help page HRSA BPHC exit disclaimer on this topic.

  31. What steps can a health center take to have a successful OSV?

    There are several steps a health center can take to have a successful OSV. Please review the Health Center Program Site Visit Protocol and this video: Five Tips for a Successful Operational Site Visit.

  32. Since my designated Project Officer is not conducting the OSV, am I able to ask him/her questions about the OSV process, including questions about the EHBs Urgent Site Visit Report Request task received from the on-site HRSA Representative?

    No. If you receive an Urgent Site Visit Report Request task in EHBs regarding your OSV, do NOT contact your designated Project Officer. The on-site HRSA Representative (not the designated Project Officer) will contact the health center’s Project Director through the EHBs in order to request additional information on areas of non-compliance identified through the OSV. The designated Project Officer should only be contacted regarding items such as CIS and other non-OSV compliance related questions.

  33. If a health center has existing, unresolved conditions related to Health Center Program requirements, how will this impact the OSV?

    Current unresolved conditions may impact the OSV. These areas, if found non-compliant during the OSV, will NOT be eligible for the CRO process and will not be included in an Urgent Site Visit Report Request task. Health centers are advised to respond to and resolve outstanding conditions as soon as possible before the site visit. Contact the designated Project Officer with questions about responding to unresolved conditions before the OSV.

  34. Who does the health center work with to address conditions on its award/designation after the site visit report has been issued?

    Following the release of the site visit report, the health center will work with the designated Project Officer. The designated Project Officer will discuss with the on-site HRSA Representative the findings from the OSV, including any findings that were not addressed/resolved through the CRO process and resulted in conditions. The designated Project Officer will call the health center about conditions and the diabetes Action Plan within 15 days of the release of the Notice of Award/Notice of Look-alike Designation communicating any conditions.

Date Last Reviewed:  July 2019