Health Center Program Compliance Frequently Asked Questions (FAQ)
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The term “site visit” in these FAQ refers to:
- Operational Site Visits (OSVs) conducted for awardees
- OSVs conducted for look-alikes
- Initial Designation (ID) site visits conducted for look-alike applicants
The information in these FAQ only relates to requirements and processes of the HRSA Health Center Program.
Site visit process
HRSA conducts operational site visits for health centers at least once per period of performance. For health centers with a 1-year period of performance, the operational site visit generally takes place 2 - 4 months into the new period of performance. For health centers with a 3-year period of performance, the operational site visit takes place approximately 12-16 months into the new period of performance. However, HRSA may adjust the 12 to 16 month time period due to extenuating circumstances.
(Updated: 9/22/2023)
HRSA will continue the implementation of both virtual and in-person site visits throughout fiscal year 2023. HRSA will inform a health center prior to the site visit as to whether it will be a virtual or in-person visit.
(Updated: 3/8/2023)
The Site Visit Protocol (SVP) is like an "open book" test. It contains methodologies and questions that the HRSA site visit team uses and answers to assess health centers' compliance with program requirements.
Health centers should fully review methodologies and questions in the SVP to prepare for their site visit. Health centers may use the SVP to organize documents, samples, and other items reviewed during the site visit. Health centers may also use the SVP to prepare answers for the HRSA site visit team.
Health centers are also encouraged to review related Site Visit Resources when preparing for an upcoming site visit.
(Updated: 3/8/2023)
The Site Visit Protocol 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 fully 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 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 uses 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 Personally Identifiable Information [PII]) in order to assess and verify compliance with Health Center Program 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. Health centers may request that HRSA staff or consultants sign additional confidentiality statements. If so, a health center should communicate this to the site visit team before 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.
(Updated: 7/1/2024)
The site visit team will consider all the information obtained during the site visit, 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, analyze any discrepancies, and make final compliance determinations.
(Updated: 3/8/2023)
The 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. During a site visit, consultants may offer or respond to a health center's request to share recommendations or technical assistance that fall outside the scope of the compliance review.
The site visit report will not record recommendations and technical assistance information requested by health centers or offered by site visit team members.
(Updated: 3/8/2023)
The health center selects all samples (for example, patient records). 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.
The site visit team will not review documents provided after the close of the first day of the site visit for the compliance assessment.
(Updated: 3/8/2023)
HRSA encourages health center staff 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.
Refer to the Sampling Review Resource Guide as a helpful sampling resource.
(Updated: 3/8/2023)
A health center must provide the documents listed in each section of the Site Visit Protocol (SVP) to the site visit team. Health centers provide documents at least two weeks before the start of the site visit. HRSA may provide additional guidance on preparation or document submission before the site visit.
Health centers may submit confidential documents, such as patient records, in advance or review them with the site visit team at the time of the site visit. If a health center chooses to upload confidential documentation before the site visit, the health center must remove Personally Identifiable Information (PII). 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 within the site visit schedule.
The site visit team will not review documents provided after the close of the first day of the site visit for the compliance assessment.
A Consolidated Documents Checklist (PDF - 561 KB) is available in the Site Visit Tools section of the SVP webpage to help health centers prepare.
HRSA also provides the site visit team with relevant documents before the visit, as noted in the Operational Site Visit Documents Provided by HRSA.
(Updated: 3/8/2023)
Yes, the name or title of a document may differ from that specified in the Site Visit Protocol. 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."
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.
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 HRSA considers that terminology as equivalent to the board "approving" the policy.
(Updated: 3/8/2023)
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) using video-conferencing software and the health center's equipment (for example, phone, tablet, computer camera).
(Updated: 3/8/2023)
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 the Electronic Handbooks (EHBs) to demonstrate compliance. If the submission demonstrates compliance with each site visit finding, HRSA will not place a condition on the award or designation. HRSA designed this feature 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.
(Updated: 3/8/2023)
Health centers must complete corrections to scope of project through the Electronic Handbooks (EHBs) Change in Scope (CIS) process. HRSA must review and approve CIS requests before they are effective. The site visit team will not consider documents provided after the close of the first site visit day in the compliance assessment.
More information on the CIS process is on the Scope of Project page.
(Updated: 3/8/2023)
No, a negative ("no") response to an individual Site Visit Protocol 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. HRSA makes all final compliance determinations.
(Updated: 3/8/2023)
HRSA assesses the majority of the demonstrating compliance elements within the Health Center Program Compliance Manual during a site visit. The Site Visit Protocol (SVP) includes the specific demonstrating compliance elements that are 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) and Renewal of Designation (RD) applications. Review the SVP and the Site Visit Resources for more information and to view all demonstrating compliance elements assessed during a site visit.
(Updated: 3/8/2023)
The site visit team will notify the health center of preliminary non-compliance findings during the site visit exit conference. A health center may use the Operational Site Visit (OSV) Exit Conference Tracking Resource (PDF - 268 KB) to track these findings.
(Updated: 3/8/2023)
No, HRSA does not permit recordings of any portion of any site visit. However, a health center is permitted to take notes during the site visit and the Operational Site Visit (OSV) Exit Conference Tracking Resource (PDF - 268 KB) is a helpful site visit resource. In addition, the health center will receive a final site visit report after the site visit.
(Updated: 3/8/2023)
No, HRSA will not shorten a period of performance as a result of site visit non-compliance findings. Site visits generally occur at the mid-point of a period of performance. HRSA makes period of performance determinations at the time of Service Area Competition (SAC) or Renewal of Designation (RD).
Consistent with current practice, HRSA may shorten a period of performance 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 use available remedies, including terminating all or part of the federal award or designation before the health center's current period of performance end date. Refer to the Health Center Program Compliance Manual Chapter 2: Health Center Program Oversight for additional information.
(Updated: 3/8/2023)
No, the Site Visit Protocol is not policy guidance. The SVP is a standardized tool HRSA uses to support the assessment of health center compliance with Health Center Program requirements. The SVP is based upon and contains the demonstrating compliance elements from the Health Center Program Compliance Manual. 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.
(Updated: 3/8/2023)
Between the pre-site visit call and the issuance of the site visit report, contact the Federal Representative for site visit-related questions. Once the site visit report is sent to the health center, use the BPHC Contact Form to address any related questions.
(Updated: 3/8/2023)
HRSA remains committed to regular updates of the Site Visit Protocol and related resources. HRSA consistently collects feedback to ensure the SVP remains useful for the site visit process. HRSA encourages feedback through the post-site visit evaluation questionnaires and the BPHC Contact Form. To submit feedback on the SVP through the BPHC Contact Form, select "Site Visit Protocol General Inquiry" under the "Policy" section.
(Updated: 3/8/2023)
The Compliance Resolution Opportunity (CRO) is HRSA's process 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 before 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 Electronic Handbooks (EHBs) task titled "Urgent Site Visit Report Request." This task provides an opportunity for health centers to submit additional information and documentation on any areas of non-compliance identified through the site visit. When responding to the task in the 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, HRSA will document such non-compliance in the final site visit report and will issue corresponding conditions to the health center through a Notice of Award or Notice of Look-alike Designation.
Refer to 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: 3/8/2023)
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 the Electronic Handbooks (EHBs), which begins the CRO process.
(Updated: 3/8/2023)
HRSA develops and presents 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, including any non-compliance findings not resolved through the CRO.
For all areas of non-compliance indicated in the final site visit report, HRSA will issue a corresponding condition to the health center through a Notice of Award or Notice of Look-alike Designation. For more information and a full list of conditions, refer to the Progressive Action Conditions Library.
(Updated: 3/8/2023)
During the CRO process, a task titled "Urgent Site Visit Report Request" will be sent to the health center through the Electronic Handbooks (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.) Non-compliance findings documented in the report 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 health center's response to the task should include the documentation noted in the Progressive Action Conditions Library for the corresponding non-compliance findings.
(Updated: 3/8/2023)
Yes, if a health center submits a CRO response before the end of the 14 calendar day timeframe and the health center still has not demonstrated compliance for all or some of the non-compliance findings, HRSA sends a new "Urgent Site Visit Report Request" task to the health center for additional information and 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 the Electronic Handbooks (EHBs) as soon as possible. This 14-day timeframe includes any back and forth submissions between HRSA and the health center; therefore, the health center should consider this timing when submitting documentation. HRSA will not provide a deadline extension beyond the 14 calendar days. HRSA will NOT consider information shared via methods other than the EHBs "Urgent Site Visit Report Request" task submission (for example, phone calls, e-mails) in its final compliance assessment.
(Updated: 3/8/2023)
All health center personnel registered with grant privileges in the Electronic Handbooks (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.
(Updated: 3/8/2023)
HRSA initiates the Compliance Resolution Opportunity (CRO) process when it sends an "Urgent Site Visit Report Request" task to the health center's Project Director through the EHBs. If the EHBs does not list the Project Director, the Federal Representative will select an Authorizing Official to whom to send the request. Such requests will appear in the EHBs Pending Tasks list as an "Urgent Site Visit Report Request" task. An EHBs-generated e-mail to either the Project Director or Authorizing Official will also notify the health center. 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: 3/8/2023)
To prepare for a possible "Urgent Site Visit Report Request" task during the CRO process, health centers must ensure that the contact information (e-mail and phone number) in the EHBs for the Project Director is up-to-date and accurate to receive the task. The Federal Representative will initiate the EHBs "Urgent Site Visit Report Request" task. The request will come from "HRSA GEMS": oitgems@hrsa.gov. Health centers can add this e-mail address to a "safe senders" or contacts list to avoid messages potentially going to a junk folder.
(Updated: 3/8/2023)