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Health Center Program Site Visit Protocol: Sampling Review Resource Guide

NOTE: This resource complements the Site Visit Protocol (SVP), which is the primary tool for assessing compliance with Health Center Program requirements during Operational Site Visits (OSVs). Refer to the Health Center Program Compliance Manual as the principal resource to assist health centers in understanding and demonstrating compliance with Health Center Program requirements and the SVP for complete guidance on OSVs.

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Purpose

This resource helps health centers understand the sampling process for site visits. Sampling is a selection process where health centers choose a subset of documents for review. The health center provides samples with other specific documents outlined in the Site Visit Protocol (SVP). HRSA encourages health centers to use this resource along with the SVP. 

Note the following:

  • Health center staff selects all samples (for example, patient records).
  • Here are some examples of sample size methodologies:
    • “At least one, but no more than three written contracts/agreements” means the health center chooses whether to provide one, two, or three contracts.
    • “Staffing schedules for up to five service delivery sites” means the health center may select staffing schedules from no more than five service delivery sites.
    • “Half or five (whichever is less) contracts” means a health center that has six contracts provides three, while a health center that has 20 contracts provides five. 
  • Certain commonly used abbreviations in this resource include:
    • “Form 5A: Services Provided (PDF - 195 KB)” abbreviated as “Form 5A.”
    • “Form 5B: Service Sites (PDF - 175 KB)” abbreviated as “Form 5B.”
    • The three columns on Form 5A related to service delivery methods (PDF - 110 KB): 
      • “Column I, Direct (Health Center Pays)” abbreviated as “Column I.”
      • “Column II, Formal Written Contract/Agreement (Health Center Pays)” abbreviated as “Column II.”
      • “Column III, Formal Written Referral Arrangement (Health Center Does NOT Pay)” abbreviated as “Column III.”
  • Staff ONLY select samples relevant to the Health Center Program project. For example, if the health center does not deliver health services through contracts/agreements, then a sample of contracts/agreements does not apply.
  • Staff consider the health center’s size and structure when selecting the number of samples.
  • If the health center does not provide an adequate sample to the site visit team for compliance assessment with program requirements, then the site visit team can select additional samples in coordination with the health center.
  • For some required samples, refer to the SVP for detailed examples.

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Contracts/Referral Arrangements

SVP Section Focus of Review Required Sample Time Period (most recent)
Required and Additional Health Services Validate the actual provision of the various required and additional services via Contracts/Agreements (Column II). For services delivered via Column II of the health center’s current Form 5A (whether or not the service is also delivered via Column I and/or Column III):

  • At least one but no more than three written contracts/agreements for EACH Required and EACH Additional Service. Detailed examples are included in the SVP.
  • To assist in the review, the health center should flag all relevant provisions within contracts/ agreements related to:
    • How the service will be documented in the patient’s health center record; and
    • How the health center will pay for the service.

Note: Use the same sample of contracts/agreements is for the review of Required and Additional Health Services, Clinical Staffing, and Sliding Fee Discount Program.

 Current
Required and Additional Health Services Validate the actual provision of the various required and additional services via Formal Referral Arrangements (Column III).

Note: When preparing the sample of referral arrangements, ensure any supporting systems or procedures related to making, tracking, and managing referrals are also available for review.

 For services delivered via Column III of the health center’s current Form 5A (whether or not the service is also delivered via Column I and/or Column II):

  • At least one but no more than three written referral arrangements for EACH Required and EACH Additional Service. Detailed examples are included in the SVP.
  • To assist in the review, the health center should flag all relevant provisions within referral arrangements related to:
    • The manner by which referrals will be made and managed; and
    • The process for tracking and referring patients back to the health center for appropriate follow-up care (for example, exchange of patient record information, receipt of lab results).

    If these provisions are not present within the referral arrangements, provide additional documentation (for example, health center procedures) that contain those provisions.

Note: Use the same sample of referral arrangements for the review of Required and Additional Health Services, Clinical Staffing and Sliding Fee Discount Program.

 Current
Clinical Staffing Ensure the credentialing and privileging of contracted providers (Column II). No more than three written contracts/agreements with provider organizations drawn from the sample that was pulled for the review of Required and Additional Health Services and Sliding Fee Discount Program. Prioritize the review of contracts for any clinical services that are only offered via Column II.  Current
Clinical Staffing Ensure the credentialing and privileging of referral providers (Column III). No more than three written referral arrangements drawn from the sample that was pulled for the review of Required and Additional Health Services and Sliding Fee Discount Program. Prioritize the review of any referral arrangements for clinical services that are only offered via Column III.  Current
Sliding Fee Discount Program Ensure sliding fee discount provision for in-scope services provided via contracts/agreements (Column II). Same sample of contracts/agreements as Required and Additional Health Services, and provide any other supporting documentation showing how the health center ensures discounts for those selected services.  Current
Sliding Fee Discount Program Ensure sliding fee discount provision for in-scope services provided via formal referral arrangements (Column III). Same sample of referral arrangements as Required and Additional Health Services, and provide any other supporting documentation showing how the health center ensures discounts for those selected services. Current
Contracts and Subawards *Not applicable to look-alikes

Confirm the health center has records for procurement actions paid for in whole or in part under the federal award.

Confirm the health center retains final contracts and related procurement records for procurement actions paid for in whole or in part under the federal award.

 Based on the list of contracts that support the HRSA-approved scope of project: 

  • Sample of five contracts AND related supporting procurement documentation for actions that use federal award funds. Choose the contracts that use the largest amounts of federal award funds.

Note: Use the same sample of contracts/agreements for the review of both Contracts and Subawards and Conflict of Interest.

 Current or ended less than 3 years ago
Contracts and Subawards

Confirm the health center’s contracts that support the HRSA-approved scope of project include required provisions.

 Based on the list of contracts that support the HRSA-approved scope of project: 

  • Sample of five contracts AND related supporting procurement documentation for actions that use federal award funds. Choose the contracts that use the largest amounts of federal award funds.
  • Sample of five contracts that do NOT use federal award funds.
 Current or ended less than 3 years ago
Conflict of Interest *Not applicable to look-alikes EXCEPT those look-alikes that have a parent, affiliate, or subsidiary that is not a state, local government, or Indian tribe as identified in the assessment of element “b.”

Confirm the health center’s procurement records document adherence to its standards of conduct.

Same sample of contracts and related supporting procurement documentation as Contracts and Subawards.

For look-alikes that have parent, affiliate, or subsidiary organizations that are not a state, local government, or Indian tribe: five contracts AND related supporting procurement documentation for procurements that involve the related parent, affiliate, or subsidiary organization.

 Current or ended less than 3 years ago

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Patient Medical Records1

SVP Section Focus of Review Required Sample Time Period

(most recent)
Required and Additional Health Services Confirm the health center is directly delivering required and additional health services (Form 5A Column I). At least one patient record for any service that cannot be verified through the site tours. Current
Required and Additional Health Services Confirm patients receive required and additional health services offered via contracts/agreements (Form 5A Column II). For any service delivered via Column II (whether or not the service is also delivered via Column I and/or Column III):

  • BASED ON THREE REQUIRED SERVICES AND TWO ADDITIONAL SERVICES: a total of three to five patient records for patients who have received services from contracted providers or contracted organizations.2

  • If the health center delivers services through subrecipient agreements, include a total of three to five patient records from each subrecipient, not to exceed a total of five subrecipients. For a health center with more than five subrecipients, select patient records from the subrecipients that receive the largest amounts of Health Center Program subaward funds.

Note: For Column II Services provided by individual contractors who work at a health center Form 5B in-scope site, documentation in the patient record of the services provided would occur in the health center's own patient record system.

 24 months
Required and Additional Health Services Confirm patients receive required and additional health services offered via formal referral arrangements (Form 5A Column III). For any service delivered via Column III (whether or not the service is also delivered via Column I and/or Column II):

  • BASED ON THREE REQUIRED SERVICES AND TWO ADDITIONAL SERVICES: a total of three to five patient records for patients who have received services from referral providers or referral organizations that document the patient’s entire referral process, from initial referral to receipt of care and follow-up by the health center.3

 24 months
Coverage for Medical Emergencies During and After Hours Validate the health center is documenting after-hours calls and any follow-up as necessary.

Three patient records that document after-hours clinical advice including associated documentation of follow-up.

Note: Select samples based on after-hours calls that necessitated follow-up by the health center. 4 If the health center has fewer than three after-hours calls that required follow-up, make up the difference with after-hours call documentation that did not require follow-up.

 Current
Continuity of Care and Hospital Admitting Confirm the health center conducts post-hospitalization tracking and follow-up for its patients.

Five to ten patient records for patients who were hospitalized or who had Emergency Department (ED) visits. Ensure each record clearly documents the health center’s entire hospitalization tracking process. 5

 12 months
Quality Improvement/Assurance Confirm the health center maintains a retrievable health record for each patient, which is consistent with federal and state laws and requirements.

Five to ten patient records that include clinic visit notes or summary of care.6

 Current
Eligibility Requirements for Look-Alike Initial Designation Applicants Confirm the applicant is delivering primary health care services. Five patient records that document the provision of various Required and Additional Health Services.7 Current

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Reports

SVP Section Focus of Review Required Sample Time Period

(most recent)
Quality Improvement/Assurance Confirm the health center produces and shares patient satisfaction data that support decision-making and oversight. Sample of patient satisfaction results. Current
Quality Improvement/Assurance Confirm the health center produces and shares Quality Improvement/Quality Assurance (QI/QA) reports that support decision-making and oversight. Two QI/QA assessments and any related reports resulting from these assessments.  12 months
Contracts and Subawards Confirm the health center has access to contractor records and reports related to health center activities in order to ensure that all activities and reporting requirements are being carried out. Two to three reports or records of the contractor’s health center-related activities drawn from the sample of selected contractors. For example, monthly invoices or billing reports, data on patients served or visits provided. Current or ended less than 3 years ago
Contracts and Subawards *Not applicable for look-alikes

Confirm oversight and monitoring of the subrecipient by the awardee.

 One or more financial and performance reports from the subrecipient. For a health center with five or fewer subrecipients, provide for all subrecipients. For a health center with more than five subrecipients, provide for the five subrecipients that receive the largest amounts of Health Center Program subaward funds. Current period of performance
Conflict of Interest Confirm the health center adheres to conflict of interest standards. Two most recent annual audits and management letters. Most recent
Financial Management and Accounting Systems Confirm the health center has and uses a compliant financial and internal control system. Two most recent annual audits and management letters. Most recent
Financial Management and Accounting Systems Confirm the health center produces reports for the board and key management staff to monitor financial status.

Two periodic financial reports provided to the board and key management staff. 

The most recent interim financial statement. 

 6 months
Program Monitoring and Data Reporting Systems

Confirm the health center produces data-based reports to inform and support internal decision-making and oversight by the health center’s key management staff and by the governing board.8

 One to two internal health center data reports that include information on patient service utilization, trends and patterns in the patient population, and overall health center clinical, financial, or operational performance. For example, dashboards, board packets, reports provided to the Finance or Quality Improvement Committee, routine reports generated by the health center for key management staff.  12 months
Board Authority Confirm the board receives necessary information for decision-making and to carry out its required authorities. Two board packets from different board meetings. 12 months
Board Composition If the health center has an approved waiver, verify that special population input has impacted board decision-making. Documentation (for example board minutes, board meeting handouts, board packets) that provides one or more examples of the use of special populations input in board decision-making. Current period of performance

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Fiscal and Billing Records

SVP Section Focus of Review Required Sample Time Period

(most recent)
Sliding Fee Discount Program Verify the health center is consistently assessing and re-assessing patient income and family size. Sample of 5–10 records, files, or other forms of documentation of patient income and family size. Specifically provide a sample that includes records for:

  • Uninsured and insured patients
  • Initial assessments for income and family size
  • Re-assessments for income and family size
 Current
Financial Management and Accounting Systems *Not applicable for look-alikes

Verify the health center's appropriate use and expenditure of federal award funds.

Sample of source documentation for expenditures made under the federal Health Center Program award, including:

  • Drawdowns under the Health Center Program award with supporting documentation (for example, financial records, receipts, invoices);
  • Last non-payroll drawdown under the Health Center Program award with supporting documentation;
  • If there was a capital-related Health Center Program award drawdown within the last 3 years, the last capital drawdown with supporting documentation; and
  • Copy of the journal entry that records these drawdowns in the general ledger under the Health Center Program award
 Last quarter
Billing and Collections Confirm health center billing claims are submitted in a timely and accurate manner to third-party payors. Sample of at least 21 claims submissions and resubmissions: 

  • Randomly choose 7 claims submissions and resubmissions for patient visits from across at least 3 unique services (for example, routine primary care, preventive dental, behavioral health, obstetrics). Include at least 7 rejected claims.
 Current
Billing and Collections Confirm the health center accurately bills self-pay patients and attempts to collect amounts owed. Sample of at least 15 billing and payment records related to the health center’s charges to patients: 

  • Randomly choose 5 records for patient visits from across at least 3 unique services (for example, routine primary care, preventive dental, behavioral health, obstetrics).
  • Ensure records include: 
    • Patients with incomes at or below 200 percent of the Federal Poverty Guidelines (FPG)
    • If the health center has patients with incomes above 200 percent of the FPG, records for those patients

       
 Current
Billing and Collections Confirm the health center waives or reduces fees or payments due to inability to pay, consistent with its policies and procedures. Sample of two to three billing records where patient fees or payments were waived or reduced. Current
Board Composition Verify board patient member status Sample of one billing record for each patient board member where the board member received at least one in-scope service at an in-scope site that generated a health center visit. 24 months
Eligibility Requirements for Look-Alike Initial Designation Applicants Confirm under what organizational entity or unit billing is conducted. Sample of up to three Medicare or Medicaid claims or other billing documents. The sample should show the organizational entity or unit that conducts the billing. Current

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Provider Files

SVP Section Focus of Review Required Sample Time Period

(most recent)
Clinical Staffing Verify providers are properly credentialed and privileged. Sample of files that contain credentialing and privileging information:

  • Four to five licensed independent practitioners (LIPs) files
  • Four to five other licensed or certified practitioners (OLCPs) files
  • Two to three files for other clinical staff (if the health center has other clinical staff)

The selected files should include:

  • Representation from different clinical disciplines and service sites 
  • Providers directly employed and contracted, in addition to any volunteers
  • Providers who do procedures beyond core privileges for their disciplines 
  • Providers who have been initially credentialed
  • Providers who have been re-credentialed/re-privileged 
 Current

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Staffing Schedules

SVP Section Focus of Review Required Sample Time Period

(most recent)
Coverage for Medical Emergencies During and After Hours Confirm the health center has at least one staff member trained and certified in basic life support present during the health center’s regularly-scheduled hours of operation. Staffing schedules for up to five service delivery sites that identify at least one individual with current certification in basic life support at each site. Current

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Key Health Center Documents

SVP Section Focus of Review Required Sample Time Period

(most recent)
Required and Additional Health Services Confirm the health center enables patients with limited English proficiency (LEP) to have reasonable access to health center services and enables staff to deliver services in a manner that is culturally appropriate for its patient population. One or more examples of key health center documents translated for patients with limited English proficiency (for example, forms and materials used to assess eligibility for the health center’s sliding fee discount program, intake forms for clinical services, instructions for accessing after-hours services).  Current
Federal Tort Claims Act (FTCA) Deeming Requirements

Confirm the health center informs patients that it is a deemed federal PHS employee9

 One or more examples of methods used to inform patients of the health center’s deemed status (for example, website, promotional materials, statements posted within an area of each health center in-scope site that is visible to patients). Current

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Collaboration/Coordination Documentation

SVP Section Focus of Review Required Sample Time Period

(most recent)
Collaborative Relationships Confirm how the health center’s collaborative relationships support:

  • Reductions in the non-urgent use of hospital emergency departments;
  • Continuity of care across community providers; and
  • Access to other health or community services that impact the patient population
 Documentation of one or more established collaborations with other providers and organizations in the health center’s service area, including local hospitals, specialty providers, social service organizations, and organizations that serve special populations. Detailed examples are included in the SVP. Current
Collaborative Relationships Confirm the health center coordinates and integrates activities with other federally-funded, state, and local health service delivery projects and programs in the service area, including other health centers. Documentation of established coordination with other federally-funded, as well as state and local, health services delivery projects and programs serving similar patient populations in the service area. If coordination is not established, documentation of efforts to establish coordination. Documentation must include one or more health centers in the service area. Detailed examples are included in the SVP. Current

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Footnotes:

1Health centers may choose to provide samples of patient records prior to or during the site visit. For example, live navigation of the Electronic Health Record (EHR), screenshots from the EHR, or other patient record formats. If patient records will be provided during the site visit, this should be communicated before the site visit to avoid any disruption or delay in the site visit process.  

2If the same patient has received more than one of these services, the same record can be used for assessing those services. 

3If the same patient has received more than one of these services, the same record can be used for assessing those services.

4For a health center with no after-hours calls that required follow-up (for example, a newly-funded health center that recently started its operations), the site visit team will review operating procedures and interview health center staff to respond to this question. 

5For a health center with no hospitalized patients in the past 12 months (for example, a newly-funded health center that recently started its operations), the site visit team will review operating procedures and interview health center staff to respond to these questions. 

6The same sample of patient records used for reviewing other program requirement areas may also be used for this sample.

7The same sample of patient records used for reviewing other program requirement areas may also be used for this sample. 

8Examples of data health centers may analyze as part of such reports may include patient access to and satisfaction with health center services, patient demographics, quality of care indicators, and health outcomes.

9For example: “This health center receives HHS funding and has federal PHS deemed status with respect to certain health or health-related claims, including medical malpractice claims, for itself and its covered individuals.” For more information, visit the Federal Tort Claims Act (FTCA) website.

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