Site Visit Protocol (SVP) Frequently Asked Questions (FAQs)
2022 Update
In 2022, HRSA made minor general changes throughout the SVP to improve consistency. Edits included improving question numbering, formatting, and grammar. Minor changes also included adding additional examples. Changes should not significantly alter or disrupt the way that site visits are conducted. For more information on the most recent updates to the SVP, please visit the 2021 and 2022 Site Visit Protocol Updates webpage for details.
(Added: 5/26/2022)
Health centers with site visits scheduled to begin after May 26, 2022, should use the updated 2022 SVP to prepare for their site visit.
(Updated: 5/26/2022)
2021 Update
The most substantial of 2021 SVP updates are in the Contracts and Subawards section. For health centers with subawards, the SVP now includes an expanded methodology to assess health center oversight of subrecipient compliance (Demonstrating Compliance Element i.) with specific board authority, board composition, and sliding fee discount program requirements.
Site visits will no longer include the diabetes Performance Analysis. If you would like to request technical assistance (TA) related to strengthening a clinical measure and/or quality improvement activities, please contact your Project Officer.
Other SVP updates include small modifications to the list of documents requested for review, refinements of specific methodology sections and site visit questions, and some minor editorial and formatting improvements. For more information, refer to the 2021 and 2022 Summary of Updates.
(Updated: 5/26/2022)
Site Visit and SVP
HRSA conducts site visits for health centers at least once per period of performance. For health centers with a one-year period of performance, your site visit will generally take place two to four months into the new project period. For health centers with a three-year period of performance, the site visit takes place approximately 14-18 months into the new period of performance. However, due to period of performance extensions and other extenuating circumstances, the 14-18 month time period may be adjusted.
(Updated: 5/26/2022)
HRSA will continue virtual site visits throughout fiscal year 2022.
(Updated: 5/26/2022)
The Site Visit Protocol (SVP) is like an “open book” test. It contains methodologies and questions that the HRSA site visit team implement and answer to assess health centers’ compliance with program requirements.
Health centers should thoroughly review methodologies and questions in the Site Visit Protocol (SVP) to prepare for their site visit. Health centers may use the SVP to organize documents according to the documents checklist, samples, and other items reviewed during the site visit. Health centers may also use the SVP to anticipate questions, and prepare answers for the HRSA site visit team.
Health centers are also encouraged to review related site visit resources and the Five Tips for a Successful Operational Site Visit video when preparing for an upcoming site visit.
(Added: 5/26/2021)
The SVP includes an Eligibility Requirements for Look-Alike Initial Designation Applicants section that the HRSA site visit team uses to assess eligibility for health centers seeking LAL ID.
To prepare for the site visit, applicants who seek LAL ID should thoroughly review all eligibility requirements, methodologies and questions in the SVP. LAL ID Applicants may use the SVP to organize documents according to the documents checklist, samples, and other items reviewed during the site visit. Applicants may also use the SVP to anticipate questions, and prepare answers for the HRSA site visit team.
The SVP is like an “open book” test. It contains methodologies and questions, including a specific methodology section about eligibility requirements for LAL ID, that the HRSA site visit team implements and answers to assess health centers’ compliance with LAL ID eligibility and program requirements.
LAL ID health center applicants are encouraged to review the Health Center Program Look-Alike (LAL) Initial Designation (ID) Application Instructions and Resources as well as, Site Visit Resources and the Five Tips for a Successful Operational Site Visit video when preparing for an upcoming site visit.
(Added: 5/26/2021)
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 (any of which may include PII) in order to assess and verify compliance with Health Center Program and Federal Tort Claims Act (FTCA) deeming requirements. Site visit teams are also subject to confidentiality standards, including HIPAA. Consultants who violate such standards are in violation of their contract, and could be subject to Title 18, United States Code, Section 641. If desired, it is permissible for health centers to request that HRSA staff and/or consultants sign additional confidentiality statements. If so, this should be communicated prior to or at the beginning of the site visit to avoid any disruption or delay in the site visit process. In addition, health centers may remove PII from files, records, and other samples provided to the site visit team, so long as enough information remains for the site visit team to assess compliance.
(Added: 5/26/2021)
The site visit team will consider all the information obtained onsite, including through document review, interviews, or samples. The team will document their findings as directed by the Site Visit Protocol (SVP), including any discrepancies, and provide them to HRSA. HRSA will then review the site visit findings and make final compliance determinations.
(Added: 5/26/2021)
The primary purpose of a site visit is to assess whether a health center demonstrates compliance with the statutory and regulatory requirements of the Health Center Program. In addition, 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 requested by health centers or offered by site visit team members will not be recorded as part of the site visit report.
(Added: 5/26/2021)
The health center selects all samples (for example, patient records). If the health center does not provide an adequate sample to assess compliance with program requirements, the site visit team will coordinate with the health center to identify additional documents.
(Added: 5/26/2021)
Health center staff are encouraged to consider the health center’s size and structure and relevancy of documents requested to the health center project. For example, a sample of contracts/agreements is only necessary if the health center delivers health services through contracts/agreements.
Please refer to the Sampling Review Resource Guide as a helpful sampling tool.
(Added: 5/26/2021)
The Site Visit Protocol (SVP) lists documents a health center must provide to support the site visit within each SVP section. Documents are to be provided at least two weeks prior to the start of the site visit. HRSA may provide additional guidance prior to the site visit regarding preparation or document submission.
Confidential documents, such as patient records, may be submitted in advance, or reviewed with the site visit team (for example through “live navigation”) at the time of the site visit. Personally Identifiable Information (PII) should be removed if a health center chooses to upload confidential documentation prior to the site visit. If the health center opts to provide these documents at the time of the site visit, the health center should inform the site visit team in order to account for this as part of the site visit schedule.
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.
A Consolidated Documents Checklist (PDF - 547 KB) is available in the SVP Tools section of the SVP webpage to help health centers prepare.
HRSA also provides the site visit team with relevant documents prior to the visit, as noted in the SVP 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.
(Added: 5/26/2021)
Yes. The name/title of a document may differ from that specified in the SVP. Health centers have discretion in how they name/title their documentation. Documents are reviewed by the HRSA site visit team in order 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 document is called a "procedure" or "protocol" instead of a "policy."
Many demonstrating compliance elements allow for the review of "other documentation" to demonstrate compliance if compliance cannot be demonstrated in documents specifically listed in the SVP.
Certain terminology also 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 that terminology can be viewed as equivalent to the board "approving" the policy.
(Added: 5/26/2021)
Yes, the health center will conduct a live virtual tour for the site visit team of a service site (or, if the health center has multiple service sites, at least two service sites) utilizing video-conferencing software and the health center’s equipment (i.e., phone, tablet, computer camera).
(Added: 5/26/2021)
No. Health centers will not be able to make “quick fixes” during the site visit to address non-compliance findings. Instead, health centers will be able to take advantage of the Compliance Resolution Opportunity (CRO) process and submit documentation through EHBs to demonstrate compliance. If the submission demonstrates compliance with each site visit finding, no condition will be placed on the award/designation. This feature is designed to be a uniform and efficient way to help health centers demonstrate compliance while maintaining the objectivity and integrity of the site visit review process.
(Added: 5/26/2021)
No. Corrections to scope of project must be completed through the EHBs Change in Scope (CIS) process. CIS requests must be approved by HRSA prior to being effective. This process cannot be completed within the timeframe of a site visit.
More information on the change in scope process can be found on the Scope of Project page.
(Added: 5/26/2021)
No. A negative response to an individual SVP finding question under a demonstrating compliance element does NOT automatically indicate a health center has failed to demonstrate compliance with the element. Demonstration of compliance is based on the site visit team’s compliance recommendation to HRSA and the comprehensive analysis of all information associated with the element. As noted above, HRSA makes all final compliance determinations.
(Added: 5/26/2021)
The majority of the demonstrating compliance elements within the Health Center Program Compliance Manual are assessed during a site visit. The Site Visit Protocol (SVP) includes the specific demonstrating compliance elements assessed and states when a compliance element is not assessed via the site visit process. In addition, HRSA reviews health centers for compliance with the remaining demonstrating compliance elements through the Service Area Competition (SAC). Please review the Site Visit Protocol (SVP) and the SVP Resources for more information and to view all demonstrating compliance elements assessed during a site visit.
(Added: 5/26/2021)
The health center will be notified of preliminary non-compliance findings during the site visit exit conference. Health centers may use the Operational Site Visit (OSV) Exit Conference Tracking Resource (PDF - 367 KB), available on the HRSA website, to track these findings.
(Added: 5/26/2021)
No recordings are permitted of the virtual site visit, including site tours, interviews, entrance conferences, and exit conferences.
(Added: 5/26/2021)
No. HRSA will not shorten a period of performance as a result of site visit non-compliance finding(s). Site visits generally occur at the mid-point of a period of performance. Period of performance determinations are made at the time of Service Area Competition (SAC) or Renewal of Designation (RD). Consistent with current practice, a period of performance may 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 period of performance end date. See the Health Center Program Compliance Manual Chapter 2: Health Center Program Oversight for additional information.
(Added: 5/26/2021)
No. The SVP is a standardized tool HRSA uses to support the assessment of health center 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.
(Added: 5/26/2021)
Between the pre-site visit call and the issuance of the site visit report, contact the HRSA Representative for site visit-related questions. Once the site visit report is sent to the health center, contact HRSA through the BPHC Contact Form.
(Updated: 5/26/2022)
HRSA remains committed to regular updates of the SVP and related resources. HRSA consistently collects feedback to ensure the SVP remains useful for the site visit process. HRSA encourages health centers and other stakeholders to provide feedback through existing mechanisms, including post-site visit evaluation questionnaires, and the BPHC Contact Form.
(Updated: 5/26/2022)
Assessment of Specific Health Center Program Requirements
During the site visit, a health center’s policies or procedures will be assessed for compliance with the demonstrating compliance elements in the Health Center Program Compliance Manual. Health centers may choose to include provisions beyond those specified in the Health Center Program Compliance Manual in their policies or procedures. However, in reviewing compliance with respect to implementation of policies or procedures, the site visit reviewer(s) would not assess these additional provisions or standards if they go beyond what is required in the Health Center Program Compliance Manual.
(Added: 5/26/2021)
No. The Examples of Credentialing and Privileging Documentation resource is intended to complement the Site Visit Protocol by providing common examples of credentialing and privileging documentation methods and sources. The intention of the resource is solely to assist the site visit team in their review of a health center's clinical staff file sample. The examples in the Credentialing and File Review Resource are not exhaustive. Provided there is consistency with the Health Center Program Compliance Manual and the health center’s own procedures, the health center determines the specific documentation that will be used to credential and privilege health center providers.
(Updated: 5/26/2022)
During a site visit, health centers that are FTCA deemed are assessed for compliance with the risk management and claims management requirements of the FTCA Program. If a site visit report contains FTCA risk and claims management non-compliance findings, the FTCA Program may develop and share a Corrective Action Plan (CAP) with the health center. The health center is expected to respond to the CAP and address non-compliance findings before the next FTCA deeming cycle. Failure to respond to the CAP may impact future deeming determinations.
(Added: 5/26/2021)
Yes. If a service is not identified on Form 5A in columns II or III, this would be a finding of scope inaccuracy. Health centers should review their Form 5A for accuracy in preparation for their site visit to ensure all contracted or referral services are correctly recorded on Form 5A. Please see the Site Visit Protocol Resource page for additional resources in preparation for your site visit.
(Added: 5/26/2021)
If a contract/agreement is misclassified as a referral arrangement or vice versa, then the site visit team would review the documentation based on what the appropriate column should be and record any non-compliance findings related to provisions that may be lacking from the contract or arrangement in the site visit report.
(Updated: 5/26/2022)
All contracts that support the HRSA-approved scope of project that are paid for in whole or in part with federal award funds are to be included in the list of contracts provided as part of the Contracts and Subawards Operational Site Visit review.
Federal award funds include the Health Center Program (H80) operating grant award, as well as any supplemental funding awarded under section 330 of the PHS Act. Therefore, for the purposes of the SVP methodology, contracts utilizing Health Center Program federal award funds would include supplemental award funds, such as Coronavirus-related supplemental awards (for example, H8C, H8D, H8E, or H8F awards) or other supplemental awards (for example, Primary Care HIV Prevention awards) as long as:
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The contracts are active; or
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The contracts had a period of performance that ended less than 3 years before the site visit.
If contracts funded in whole or in part by supplemental awards are among the five contracts that utilize the largest amounts of federal award funds, then those contracts would be reviewed for the purposes of assessing compliance with contracting and procurement requirements. However, neither the health center nor consultants should single out supplemental-funded contracts or activities for review if they do not meet the SVP sampling criteria. Please refer to the Sampling Review Resource Guide as a helpful sampling tool.
Note: OSVs for look-alikes do not include a review of Contracts and Subawards or Conflict of Interest elements that are specific to Health Center Program federal award funds. Look-alikes that receive other HRSA funding are subject to the specific requirements of those awards; however, compliance with those award requirements is not assessed via the OSV.
(Added: 5/26/2021)
Compliance Resolution Opportunity (CRO) Process
HRSA has a process called Compliance Resolution Opportunity (CRO) to support the timely resolution of areas of non-compliance cited during a site visit. The CRO provides health centers with an opportunity to address non-compliance findings PRIOR to the health center's receipt of the final site visit report.
After the OSV has concluded, HRSA will process the draft site visit report. The health center will receive an EHBs task titled “Urgent Site Visit Report Request”. This task provides an opportunity for health centers to submit additional information/documentation on any areas of non-compliance identified through the site visit. When responding to the task in EHBs, the health center should ensure any documents referenced in the response are attached to the submission. The health center will have 14 calendar days to submit a response to the non-compliance findings contained in the request. There will be no extensions or exceptions.
If HRSA determines that a health center has not demonstrated compliance after the CRO process has ended, such non-compliance will be documented in the final site visit report and a corresponding condition(s) will be issued through a health center's Notice of Award/Notice of Look-alike Designation.
Please see this resource for more information about the EHBs “Urgent Site Visit Report Request” task feature: Correspondence Resolution Opportunity for OSV Structured Technical Assistance Reports.
(Updated: 5/26/2022)
No. The CRO process begins after the site visit ends and HRSA processes the draft site visit report. The health center will receive an “Urgent Site Visit Report Request” task through EHBs, which begins the CRO process.
(Added: 5/26/2021)
If HRSA determines that a health center has not demonstrated compliance with one or more of the elements reviewed through the CRO process, HRSA will develop and present a final site visit report to the health center within 45 days after the site visit. The report will convey the final site visit findings and compliance decisions.
For all areas of non-compliance indicated in the final site visit report, a corresponding condition will be placed on the award/designation. For more information and a full list of conditions, see Progressive Action Conditions Library.
(Added: 5/26/2021)
During the CRO process, a task titled, “Urgent Site Visit Report Request” will be sent to the health center through EHBs. This task will include a link to the draft site visit 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).
(Added: 5/26/2021)
The Compliance Resolution Opportunity (CRO) process will be initiated when 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 request will be sent to and Authorizing Official selected by the HRSA Representative. 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 an EHBs-generated e-mail to either the Project Director or Authorizing Official. 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.
(Updated: 5/26/2022)
Yes. If a health center submits a CRO response before the end of the 14 calendar day timeframe and compliance is still not demonstrated for all or some of the non-compliance findings, a new “Urgent Site Visit Report Request” task will be sent to the health center for additional information/clarification on the remaining non-compliance findings. When a Project Director or Authorizing Official receives does an “Urgent Site Visit Report Request’ task, they will respond to this task via EHBs as soon as possible. This 14 day time frame includes any back and forth submissions between HRSA and the health center, therefore consider this timing when submitting 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.
(Added: 5/26/2021)
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.
(Added: 5/26/2021)
To prepare for a possible “Urgent Site Visit Report Request” task during the CRO process, 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 HRSA Representative. 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.
(Updated: 5/26/2022)