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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. 
  • Health center staff ONLY select samples relevant to the health center 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.

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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.
  • 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: The same sample of referral arrangements is to be utilized for the review of both Required and Additional Health Services 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 arrangement(s), 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.
  • 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 standard operating procedures) that contain those provisions.

Note: The same sample of referral arrangements is to be utilized for the review of both Required and Additional Health Services and Sliding Fee Discount Program.

 Current
Clinical Staffing Ensure the credentialing and privileging of contracted providers (Column II). No more than three contracts with contracted provider organizations drawn from the sample that was pulled for the review of Required and Additional Health Services. Prioritize the review of any services that are offered only 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. Prioritize the review of any services that are offered only via Column III. Current
Sliding Fee Discount Program Ensure sliding fee discount provision for in-scope services provided via contracts (Column II). Same sample of contracts as Required and Additional Health Services, and provide any other supporting documentation demonstrating 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 demonstrating 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 provided prior to the site visit that support the HRSA-approved scope of project:

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

Note: The same sample of contracts/agreements is to be utilized 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 provided prior to the site visit that support the HRSA-approved scope of project:

  • Sample of five contracts AND related supporting procurement documentation for actions that utilize federal award funds. Choose the contracts that utilize the largest amounts of federal award funds.
  • Sample of five contracts AND related supporting procurement documentation for actions that do NOT utilize 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 related supporting procurement documentation as Contracts and Subawards.

For look-alikes that have a parent, affiliate, or subsidiary that is not a state, local government, or Indian tribe: five contracts AND related supporting procurement documentation for procurements that involve related party(ies) or organization(s).

 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 or through interviews. Current
Required and Additional Health Services Confirm patients receive required and additional health services offered via contractual/formal 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: three to five patient records for patients who have received services from a contracted provider(s)/organization(s).2

  • If the health center delivers a service(s) through a subrecipient agreement(s), include patient records from all subrecipients, 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: three to five patient records for patients who have received service(s) from a referral provider(s)/organization(s) that document the patient’s entire referral process.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.4

Note: The samples will be based on after-hours calls that necessitated follow-up by the health center.5 If the health center has fewer than three after-hours calls that required follow-up, the health center will 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 have been hospitalized or had Emergency Department (ED) visits that clearly document the health center’s entire hospitalization tracking process.6

 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 note(s) and/or summary of care.7

 Current
Eligibility Requirements for Look-Alike Initial Designation Applicants Confirm the applicant is delivering primary health care services. Three to five patient records that document the provision of various Required and Additional Health Services. 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/or the 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 (for example, monthly invoices or billing reports, data run of patients served, visits provided) drawn from the sample of contractors selected from the list provided prior to the site visit. 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. Sample must represent all subrecipients, not to exceed a total of five subrecipients. For a health center with more than five subrecipients, select the financial and performance reports from subrecipients that receive the largest amounts of Health Center Program subaward funds. Current project period
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 utilizes 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, including the most recent interim financial statements. 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 (for example, monthly board reports, dashboards, presentations). Current project period
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 project period

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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 example, financial records, receipts, invoices) that support 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 claims submissions and resubmissions:

  • Choose 7 claims submissions and resubmissions for patient visits reflective of the health center’s major third-party payors from across at least 3 unique services (for example, routine primary care, preventive dental, behavioral health, obstetrics) for a total of at least 21 claims submissions and resubmissions. 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 billing and payment records for charges requested from patients:

  • Randomly choose 5 patient records for patient visits from across at least 3 unique services (for example, routine primary care, preventive dental, behavioral health, obstetrics) for a total of at least 15 patient records.
  • Ensure billing records include:
    • Patients that are eligible for the sliding fee discount program (SFDP) (incomes at or below 200 percent of the Federal Poverty Guidelines (FPG))
    • If applicable, patients that are not eligible for the SFDP (incomes above 200 percent of the FPG)
 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 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. 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 applicable)

The selected files should include:

  • Representation from different disciplines and sites
  • Providers directly employed and contracted, in addition to volunteers (if applicable)
  • Providers who do procedures beyond core privileges for their discipline(s)
  • 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 the individual(s) with current certification in basic life support. 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 example(s) of key health center documents (for example, materials/application used to assess eligibility for the health center’s sliding fee discount program, intake forms for clinical services, instructions for accessing after-hours services) translated for patients with limited English proficiency. 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 example(s) of methods used to inform patients of the health center’s deemed status (for example, website, promotional materials, statements posted within an area(s) of the health center 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 relationship(s) 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, and social service organizations. 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 one or more coordination efforts with other federally-funded, as well as state and local, health services delivery projects and programs serving similar patient populations in the service area. At a minimum, this includes documentation of efforts to establish coordination with one or more health centers in the service area. Current

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Footnotes:

1Health centers may choose to provide samples of patient records prior to or during the site visit. If patient records will be provided during the site visit, this should be communicated prior to 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.

4If the health center has fewer than three after-hours calls that required follow-up, the health center will make up the difference with after-hours call documentation that did not require follow-up.

5For health centers that had no after-hours calls that required follow-up (for example, a newly-funded health center that has just started its operations), a review of operating procedures and results of the interview(s) with health center staff can be used when responding to this question.

6For a health center that has had no patients who have been hospitalized in the past 12 months (for example, a newly-funded health center that has just started its operations), a review of operating procedures and results of the interview with health center staff can be used to respond to these questions.

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

Date Last Reviewed: