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  5. 2021 and 2022 Site Visit Protocol: Summary of Updates

2021 and 2022 Site Visit Protocol: Summary of Updates

The Health Resources and Services Administration (HRSA) implemented the Health Center Program Site Visit Protocol (SVP) for all Operational Site Visits (OSVs) and look-alike (LAL) initial designation (ID) site visits in January 2018. The SVP is the tool used to assess compliance with Health Center Program requirements. The SVP provides HRSA with information necessary to perform its oversight responsibilities using a standard and transparent methodology that aligns with the Health Center Program Compliance Manual (Compliance Manual).

As part of continuous quality improvement efforts, HRSA collected feedback about the SVP and site visit process from stakeholders, including health centers, strategic partners, site visit team reviewers, and HRSA staff. In response to this feedback, in 2021, HRSA made several updates to increase the SVP’s effectiveness, clarity, consistency, and transparency. No changes were made to the Compliance Manual.

In 2022, HRSA made minor general changes throughout the SVP to improve consistency, such as improving numbering, formatting, and grammar. Minor changes also included adding additional examples. The changes should not significantly alter or disrupt the way that site visits are conducted. There are specific 2022 edits within SVP sections that are marked below with the notation “[2022 SVP].”

Substantial Updates

  • Site Visit Documentation Consolidation: In response to overwhelming positive feedback from stakeholders regarding the provision of almost all documents in advance of the site visit, HRSA has consolidated the “Documents Provided Prior to Site Visit” and “Documents Provided at the Start of Site Visit” into one list. All documents that health centers need to provide for the site visit are now easily found within a single Document Checklist for Health Center Staff within each section. All documents must be provided 2 weeks prior to the start of the site visit.
  • Performance Analysis: This section was removed from the OSV process in February 2021 as part of an effort to streamline OSVs and focus on compliance assessment. If you would like to request technical assistance (TA) related to strengthening a clinical measure and/or quality improvement activities, please reach out to your BPHC Point of Contact.
  • Contracts and Subawards / DCE i. Subrecipient Monitoring: For health centers with subawards, the SVP now includes an expanded methodology to assess the awardee’s oversight of specific subrecipient board authority, board composition, and sliding fee discount program requirements. 
  • Eligibility Requirements for LAL ID Applicants: HRSA aligned the LAL ID eligibility criteria reviewed through the LAL ID site visit process with the eligibility criteria contained in the LAL ID Application Instructions.

General Updates

HRSA made the following general updates throughout the SVP:

  • Minor revisions to documents requested, methodologies, notes, and questions to improve clarity and efficiency of the OSV assessment.
  • Clarifications regarding overlap in sampling between sections.
  • Inclusion of hyperlinks to Related Considerations from the Compliance Manual were added in each section.
  • Corrections related to grammar, formatting, and web links.

Updates by SVP Section

No updates were made to the following site visit sections: Quality Improvement/Assurance, Budget, Program Monitoring and Data Reporting Systems, Board Authority, and Promising Practices.

Throughout the updates, “DCE” is the abbreviation for “Demonstrating Compliance Element”, and the abbreviation for SVP sections containing “Site Visit Findings” questions is “questions”.

Introduction

  • Added references and hyperlinks for Frequently Asked Questions and additional SVP-related resources.
  • Removed use of the term “onsite” to account for other assessment methods (for example, virtual site visits).
  • Clarified that health centers should provide samples representative of their current operations.
  • Clarified that all site visit documentation is available to the entire site visit team for use during any portion of the site visit.

Needs Assessment

  • Clarified question for DCE a. Service Area Identification and Annual Renewal so reviewers consider how health centers utilize patient origin data from a current Uniform Data System (UDS) report when updating Form 5B: Service Sites.

Required and Additional Health Services

  • Added the fiscal expert as the secondary reviewer.
  • Updated methodology for DCE a. Providing and Documenting Services within Scope of Project to explain how to sample patient records for health centers with subrecipients and added a note addressing documenting services in a patient record for services provided by individual health center contractors.
  • Added notes for DCE a. Providing and Documenting Services within Scope of Project to guide reviewers on how to review the samples provided and how to document any discrepancies with Form 5A: Services Provided.
  • Updated question and methodology for DCE a. Providing and Documenting Services within Scope of Project to provide clarifying language with examples on assessing policies or agreements and arrangements for updating patient records for services provided via Form 5A: Services Provided, Columns II and III.
  • Added question to DCE a. Providing and Documenting Services within Scope of Project to require verification of Change in Scope Submission if the Form 5A: Services Provided is not consistent with services offered by the health center at the time of the site visit
  • [2022 SVP] Reordered questions in DCE a. Providing and Documenting Services within Scope of Project so that the health center’s overall scope accuracy is recorded before recording specific Column I, II, or III scope challenges. 

Clinical Staffing

  • Added notes to DCE c. Procedures for Review of Credentials and DCE d. Procedures for Review of Privileges to specify who constitute “clinical staff”.
  • Added question to DCE d. Procedures for Review of Privileges to require an explanation of how fitness for duty is verified to ensure all clinical staff have the physical and cognitive ability to safely perform their duties.
  • Clarified the methodology and questions for DCE f. Credentialing and Privileging of Contracted or Referral Providers by including examples of how a health center might assess contracts and referral arrangements for compliance with credentialing and privileging requirements.

Accessible Locations and Hours of Operation

  • Updated methodology and questions for DCE c. Accurate Documentation of Sites within Scope of Project to provide clarifying language on assessing the accuracy of sites on Form 5B: Service Sites.

Coverage for Medical Emergencies During and After Hours

  • Added a footnote explaining options for health centers in providing samples of patient records prior to or during the site visit.
  • Clarified note referencing the sample of after-hours clinical advice documentation in the patient records.

Continuity of Care and Hospital Admitting 

  • Provided clarifying examples of patient hospital admission documentation.
  • Clarified that record samples need to document the health center’s entire hospitalization tracking process, from admission and follow-up through closure.

Sliding Fee Discount Program

  • Clarified that for any service(s) delivered via Columns II or III, HRSA expects health centers to provide any other supporting documentation not included in the written contracts/agreements, showing how health centers ensure application of the sliding fee discount program for these services.
  • Updated question for DCE a. Applicability to In-Scope Services to clarify note with examples instructing reviewers not to review/consider discounts for supplies and equipment that are not included in the service.
  • Added a question for DCE a. Applicability to In-Scope Services addressing eligibility for patients at or below 200 percent of Federal Poverty Guidelines (FPG).
  • Clarified methodology for DCE b. Sliding Fee Discount Program Policies to outline what HRSA expects reviewers to do when assessing health centers that choose to have a nominal charge for patients at or below 100 percent of the FPG.
  • Clarified question for DCE b. Sliding Fee Discount Program Policies to describe how health centers demonstrate charges are nominal from the perspective of patients with income at or below 100 percent of the FPG.
  • Clarified question for DCE j. Sliding Fee for Column III Services to address services provided via Column III and health center assurance that sliding fee discounts are applied to those services.
  • [2022 SVP] Provided examples in the methodology of DCE h. Informing Patients of Sliding Fee Discounts of mechanisms that may be used to inform patients of the availability of sliding fee discounts. 

  • [2022 SVP] Provided an example in DCE i. Sliding Fee for Column II Services of another means for a health center to ensure the application of discounts. 

  • [2022 SVP] Provided an example in DCE j. Sliding Fee for Column III Services of another means for a health center to ensure the application of discounts. 

Key Management Staff

  • Updated methodology for DCE e. HRSA Approval for Project Director/CEO Changes to utilize associated HRSA Notice of Award/Notice of Look-Alike Designation or consult with federal representative if a change in Project Director/Chief Executive Officer (CEO) occurred or is under review by HRSA.
  • [2022 SVP] Clarified in DCE d. CEO Responsibilities that a W-2 is one of several types of documentation a health center can use to show the direct hire of a CEO/PD.

Contracts and Subawards

  • Updated reviewer assignments. Specifically in cases of subrecipient models, the governance/administrative expert is the primary reviewer and the fiscal expert is the secondary reviewer for DCE i. Subrecipient Monitoring.
  • Clarified the methodologies for DCE b. Records of Procurement Actions, DCE c. Retention of Final Contracts, DCE e. HRSA Approval for Contracting Substantive Programmatic Work, and DCE f. Required Contract Provisions when sampling contracts, both those paid for in whole or in part with federal award regardless of contract amount. 
  • Updated question for DCE f. Required Contract Provisions to reflect a broader review of the sample of contracts supporting the HRSA-approved scope of project.
  • Revised methodology and added questions under DCE i. Subrecipient Monitoring to assess the health center’s monitoring of subrecipient’s compliance with board authority, board composition, and sliding fee discount program requirements.
  • [2022 SVP] Clarified that questions related to monitoring subrecipient’s compliance with nominal charge requirements are not applicable if the subrecipient does not charge patients with incomes at or below 100 percent of the FPG.

Conflict of Interest

  • Switched the primary reviewer to the governance/administrative expert and the secondary reviewer to the fiscal expert.
  • Clarified that the five contracts selected for review are to reflect the health center’s contracts that utilize the highest amount of federal award funds.
  • Updated the methodology for DCE d. Adherence to Standards of Conduct to improve sampling of contracts and procurement documentation using federal award funds.
  • [SVP 2022] Clarified the methodology in DCE d. Adherence to Standards of Conduct to account for look-alikes with a parent, affiliate, or subsidiary. 

Collaborative Relationships

  • Rearranged the order of two questions for DCE b. Collaboration with Other Primary Care Providers to support a more logical interpretation of the questions, and included language to capture additional details on collaborative relationship efforts undertaken by a health center.

Financial Management and Accounting Systems

  • Added footnote to question for DCE c. Drawdown, Disbursement and Expenditure Procedures regarding legislative mandates related to annual appropriations.

Billing and Collections

  • Revised methodology for DCE f. Timely and Accurate Third Party Billing to include improved sampling and data for claims submissions and resubmissions.

Board Authority

  • [2022 SVP] Added a clarifying note in the methodology for DCE c. Exercising Required Authorities and Responsibilities that, for look-alike initial designation applicants and newly-funded health centers that do not have 12 months of board agendas and minutes, all of the most recently available board agendas and minutes from within the past 12 months are reviewed.

Board Composition 

  • Clarified that health centers provide an updated Form 6A: Current Board Member Characteristics or Board Roster for reviewers, if board composition changed since the last application submission to HRSA.
  • Clarified question for DCE a. Board Member Selection and Removal Process to address how the bylaws or other health center documentation demonstrates board member selection or removal.
  • Updated the methodology and question(s) for DCE c. Current Board Composition to address board evaluation of patient representation using UDS and descriptions of board member connections to the community.
  • [2022 SVP] Updated note language in DCE c. Current Board Composition to clarify that Question 9 is “not applicable” only when the health center has both a waiver and no patient board members.

FTCA Deeming Requirements

  • Clarified the documentation for Risk Management DCE e. Individual who Oversees Risk Management allowed for risk management assessments and added a question on risk management training.
  • Updated Claims Management DCE d. History of Claims: Cooperation and Mitigation to provide an additional example of claims-related documentation in a question.
  • [2022 SVP] Clarified the example language in Question 3 to include examples of risk management topics. 

  • [2022 SVP] Added a question to capture training for health center-identified high-risk services, in alignment with DCE b. Risk Management Procedures.

  • [2022 SVP] Updated language in Question 16 to reference a health center’s written claims management procedures. 

Eligibility Requirements for Look-alike Initial Designation Applicants

  • Clarified how LAL ID applicants demonstrate that they currently deliver primary health care services to patients within the proposed service area.
  • Updated document checklist, methodology, and added a question to confirm that the LAL ID applicant operates a permanent service delivery site.
  • Provided additional clarification on how LAL ID applicants demonstrate they own, control, and operate the organization, including assessing whether the applicant contracts for substantive programmatic work.
  • [2022 SVP]: Updated language in the document checklist, methodology, and Question 9 on “substantive role” for greater alignment with the existing Look-alike Initial Designation Instructions.
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