In this section:
Primary Reviewer: Clinical Expert
Secondary Reviewer: Fiscal Expert
NOTE: The Fiscal Expert also reviews the contracts/agreements and arrangements to support the Clinical Expert with the assessment of scope of project accuracy for element “a.”
Authority: Section 330(a)-(b), Section 330(h)(2), and Section 330(k)(3)(K) of the Public Health Service (PHS) Act; and 42 CFR 51c.102(h) and (j), 42 CFR 56.102(l) and (o), and 42 CFR 51c.303(l)
Health Center Program Compliance Manual Related Considerations
Documents the Health Center Provides
- Sample 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).
- FORM 5A, COLUMN I:
- For services delivered via Column I of the health center’s current Form 5A:
- A list of Form 5B service sites to be toured. Select sites where a variety of Column I services are provided.
- If the health center has more than one service site, the list must include at least two health center service sites.
- If a Column I service cannot be verified through a site tour: Documentation of service provision in a current patient record. Note: Use live navigation of the Electronic Health Record (EHR), screenshots from the EHR, or other patient record formats.1
- For services delivered via Column I of the health center’s current Form 5A:
- FORM 5A, COLUMN II: For services delivered via Column II (whether or not the service is also delivered via Column I and/or Column III):
- For health centers with Column II services that occur at any locations that are not Form 5B service sites: Health center internal procedures that address how information in patient health center records is documented (for example, lab results, x-ray results).
- Contracts/Agreements:
- At least one but no more than three written contracts/agreements for EACH Required and EACH Additional Service: For any required or additional service noted as a Column II service on Form 5A, at least one written contract. If there is more than one contract for the same service, each contract would be included in the sample, up to a maximum of three contracts. For example:
- Primary Care Services is listed in Column II. The health center maintains four separate contracts for individual contracted providers. The sample would include a maximum of three of these contracts for Primary Care Services.
- Preventive Dental is listed in Column II. The health center maintains one contract for its preventive dental services. The sample would include one contract for Preventive Dental.
- 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 for the review of Required and Additional Health Services, Clinical Staffing, and Sliding Fee Discount Program. The sampling methodologies for Required and Additional Health Services are different from Contracts and Subawards and Conflict of Interest, even though they may result in some overlap in the contracts/agreements reviewed.
- At least one but no more than three written contracts/agreements for EACH Required and EACH Additional Service: For any required or additional service noted as a Column II service on Form 5A, at least one written contract. If there is more than one contract for the same service, each contract would be included in the sample, up to a maximum of three contracts. For example:
- Patient Records:
- Based on three Required Services and two Additional Services: A total of three to five health center patient records for patients who have received required and additional health services in the past 24 months from contracted providers or contracted organizations.
- If the same patient has received more than one of these services, the same record can be used for assessing those services.
- If a health center delivers services through subrecipient agreements:
- For a health center with five or fewer subrecipients, select a total of three to five patient records from each subrecipient.
- For a health center with more than five subrecipients, select patient records from the five subrecipients that receive the largest amounts of Health Center Program subaward funds, for a total of three to five patient records from each subrecipient.
- Based on three Required Services and two Additional Services: A total of three to five health center patient records for patients who have received required and additional health services in the past 24 months from contracted providers or contracted organizations.
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Notes:
- For Column II Services provided by individual contractors who work at a health center Form 5B site, documentation in the patient record of the services provided would occur in the health center's own patient record system.
- Use live navigation of the EHR, screenshots from the EHR, or other patient record formats.
- FORM 5A, COLUMN III: For services delivered via Column III (whether or not the service is also delivered via Column I and/or Column II):
- For health centers with Column III services: Health center operating procedures for tracking and managing referred services.
- Referral Arrangements:
- At least one but no more than three written referral arrangements for EACH Required and EACH Additional Service: For any required or additional service noted as a Column III service on Form 5A, at least one written referral arrangement. If there is more than one referral arrangement for the same service, each written arrangement would be included in the sample, up to a maximum of three written arrangements. For example:
- Intrapartum Services is listed in Column III. The health center maintains four separate arrangements for these services in its service area. The sample would include a maximum of three of these written arrangements for Intrapartum Care Services.
- Diagnostic Laboratory Services is listed in Column III. The health center maintains one referral arrangement with a local hospital to provide these services. The sample would include one written arrangement for Diagnostic Laboratory Services.
- 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.
- At least one but no more than three written referral arrangements for EACH Required and EACH Additional Service: For any required or additional service noted as a Column III service on Form 5A, at least one written referral arrangement. If there is more than one referral arrangement for the same service, each written arrangement would be included in the sample, up to a maximum of three written arrangements. For example:
- Note: Use the same sample of referral arrangements for the review of Required and Additional Health Services, Clinical Staffing, and Sliding Fee Discount Program.
- Patient Records:
- Based on three Required Services and two Additional Services: A total of three to five health center patient records for patients who have received required and additional services in the past 24 months from referral providers or referral organizations. Ensure each record clearly documents the patient’s entire referral process, from initial referral to receipt of care and follow-up by the health center.
- If the same patient has received more than one of these services, the same record can be used for assessing those services.
- Based on three Required Services and two Additional Services: A total of three to five health center patient records for patients who have received required and additional services in the past 24 months from referral providers or referral organizations. Ensure each record clearly documents the patient’s entire referral process, from initial referral to receipt of care and follow-up by the health center.
- Note: Use live navigation of the EHR, screenshots from the EHR, or other patient record formats.
Note: Refer to the Sampling Review Resource Guide to help select the samples for Required and Additional Health Services.
Compliance Assessment
Select each element below for the corresponding text of the element, site visit team methodology, and site visit finding questions.
The health center provides access to all services included in its HRSA-approved scope of project 2 (Form 5A: Services Provided) through one or more service delivery methods,3 as described below:4
- Direct: If a required or additional service is provided directly by health center employees5 or volunteers, this service is accurately recorded in Column I on Form 5A: Services Provided, reflecting that the health center pays for and bills for direct care.
- Formal Written Contract/Agreement: 6 If a required or additional service is provided on behalf of the health center via a formal contract/agreement between the health center and a third party (including a subrecipient),7 this service is accurately recorded in Column II on Form 5A: Services Provided, reflecting that the health center pays for the care provided by the third party via the agreement. In addition, the health center ensures that such contractual agreements for services include:
- How the service will be documented in the patient’s health center record; and
- How the health center will pay for the service.
- Formal Written Referral Arrangement: If access to a required or additional service is provided and billed for by a third party with which the health center has a formal referral arrangement, this service is accurately recorded in Column III on Form 5A: Services Provided, reflecting that the health center is responsible for the act of referral for health center patients and any follow-up care for these patients provided by the health center subsequent to the referral.8 In addition, the health center ensures that such formal referral arrangements for services, at a minimum, address:
- 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).
Site Visit Team Methodology
- Along with the Project Director/CEO and other relevant staff, review the accuracy of the health center’s Form 5A.
- Interview CMO and other clinical staff responsible for all service delivery methods (Columns I, II, and III).
- Tour sites where a variety of services are provided directly by the health center (Column I). If the health center has more than one service site, tour at least two service sites.
- FORM 5A, COLUMN I: Confirm that each service delivered via Column I is being directly provided by the health center through:
- The tours of the health center service sites;
- Interviews of clinical staff during the site tours; or
- If a Column I service cannot be verified through the site tour or interviews, review of at least one health center Column I patient record.
- 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):
- For any contracted service that occurs at a location other than a health center Form 5B site (for example, lab results, x-ray results), review the health center’s internal procedures that address documentation of information in the patient’s health center record.
- Review of Contracts/Agreements:
- Review at least one but no more than three written contracts/agreements for EACH Required and EACH Additional Service: For any required or additional service noted as a Column II service on Form 5A, review at least one written contract. If there is more than one contract for the same service, each contract would be included in the sample, up to a maximum of three contracts. For example:
- Primary Care Services is listed in Column II. The health center maintains four separate contracts for individual contracted providers. The sample would include a maximum of three of these contracts for Primary Care Services.
- Preventive Dental is listed in Column II. The health center maintains one contract for its preventive dental services. The sample would include one contract for Preventive Dental.
- Review at least one but no more than three written contracts/agreements for EACH Required and EACH Additional Service: For any required or additional service noted as a Column II service on Form 5A, review at least one written contract. If there is more than one contract for the same service, each contract would be included in the sample, up to a maximum of three contracts. For example:
- Review of Patient Records:
- Based on three Required Services and two Additional Services: Review a total of three to five health center patient records for patients who have received these services in the past 24 months from contracted providers or contracted organizations.
- If the same patient has received more than one of these services, the same record can be used for assessing those services.
- If a health center delivers services through subrecipient agreements:
- For a health center with five or fewer subrecipients, review a total of three to five patient records from each subrecipient.
- For a health center with more than five subrecipients, select patient records from the five subrecipients that receive the largest amounts of Health Center Program subaward funds. Review a total of three to five patient records from each subrecipient.
- Based on three Required Services and two Additional Services: Review a total of three to five health center patient records for patients who have received these services in the past 24 months from contracted providers or contracted organizations.
- Note: For Column II Services provided by individual contractors who work at a health center Form 5B site, documentation in the patient record of the services provided would occur in the health center's own patient record system.
- 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):
- Review the health center’s operating procedures for tracking and managing referred services.
- Review of Referral Arrangements:
- Review at least one but no more than three written referral arrangements for EACH Required and EACH Additional Service: For any required or additional service noted as a Column III service on Form 5A, review at least one written referral arrangement. If there is more than one referral arrangement for the same service, each written arrangement would be included in the sample, up to a maximum of three written arrangements. For example:
- Intrapartum Services is listed in Column III. The health center maintains four separate arrangements for these services in various communities in their service area. The sample would include a maximum of three of these written arrangements for Intrapartum Care Services.
- Diagnostic Laboratory Services is listed in Column III. The health center maintains one referral arrangement with a local hospital to provide these services. The sample would include one written arrangement for Diagnostic Laboratory Services.
- Review at least one but no more than three written referral arrangements for EACH Required and EACH Additional Service: For any required or additional service noted as a Column III service on Form 5A, review at least one written referral arrangement. If there is more than one referral arrangement for the same service, each written arrangement would be included in the sample, up to a maximum of three written arrangements. For example:
- Review of Patient Records:
- Based on three Required Services and two Additional Services: Review a total of three to five health center patient records for patients who have received these services in the past 24 months from a referral providers or referral organizations.
- If the same patient has received more than one of these services, the same record can be used for assessing those services.
- Based on three Required Services and two Additional Services: Review a total of three to five health center patient records for patients who have received these services in the past 24 months from a referral providers or referral organizations.
Notes:
- Use the same sample of contracts/agreements and referral arrangements for the review of Required and Additional Health Services, Clinical Staffing, and Sliding Fee Discount Program.
- The sampling methodologies for Required and Additional Health Services are different from Contracts and Subawards and Conflict of Interest, even though they may result in some overlap in the contracts/agreements reviewed.
- The purpose of this part of the site visit is to validate that the health center has an accurate Form 5A that reflects how the health center currently provides in-scope services.
- The sample provided by the health center would reflect the services the health center is currently providing.
- Use live navigation of the Electronic Health Record (EHR), screenshots from the EHR, or other patient record formats.
- If services reviewed in the sample differ from what is reflected on the health center’s Form 5A (for example, a contract or referral arrangement is provided in the sample but is not reflected on the health center's current Form 5A), the site visit team will still proceed with reviewing the sample and note the discrepancies in their site visit findings. This includes noting if any services in the sample are conducted outside the scope of project and are other lines of business.
- When reviewing the contracts or referral arrangements for enabling services (for example, transportation, translation, outreach) provided via Column II or III, compliance is demonstrated even if the contracts or referral arrangements do not address all of the provisions (for example, documentation in the patient record, follow-up care) required for clinical services (for example, general primary medical care, preventive dental).
- In the Sliding Fee Discount Program (SFDP) section, assess and document any findings on the structure or availability of a health center’s SFDP as it relates to the services on Form 5A. For example, the health center is providing an additional service directly, but the service is NOT discounted through the health center’s SFDP.
- Review the follow-up from hospital admissions or hospital visits in the Continuity of Care and Hospital Admitting section.
Site Visit Findings
- Considering all services on Form 5A across all Columns, are services recorded on Form 5A consistent with how they are offered by the health center?
Response is either: Yes or No
- IF NO: Did the health center submit Change in Scope requests to HRSA to correct all Form 5A inconsistencies?
Response is either: Yes or No
If Yes OR No, specify the inconsistencies observed and whether the relevant Change in Scope requests were submitted to HRSA to correct the accuracy of Form 5A.
- FORM 5A, COLUMN I: Is the health center directly providing all services on its current Form 5A, Column I?
Note: Select “Not Applicable” if the health center does not offer any services via Column I.
Response is: Yes, No or Not Applicable
If No, an explanation is required, including specifying any inconsistences between services provided directly by the health center and those recorded on Form 5A, Column I.
- FORM 5A, COLUMN II:
Note: Select “Not Applicable” if the health center does not offer any services via Column II.
- 4.1 Does the health center maintain formal written contracts/agreements for services on its current Form 5A, Column II?
Response is: Yes, No or Not Applicable
- 4.2 Do the health center’s contracts/agreements document how the health center will pay for the services?
Response is: Yes, No or Not Applicable
- 4.3 Do the health center’s contracts/agreements or supporting internal procedures document how information about the services will be provided to the health center for inclusion in health center patient records?
Response is: Yes, No or Not Applicable
- 4.4 Did the health center provide patient records from the past 24 months that document receipt of specific contracted services?
Response is: Yes, No or Not Applicable
- 4.1 Does the health center maintain formal written contracts/agreements for services on its current Form 5A, Column II?
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If No OR Not Applicable was selected for any of the above, an explanation is required providing details on the specific services.
- FORM 5A, COLUMN III:
Note:S elect “Not Applicable” if the health center does not offer any services via Column III.
- 5.1 Does the health center maintain formal written referral arrangements for services on its current Form 5A, Column III?
Response is: Yes, No or Not Applicable
- 5.2 Do the health center’s formal written referral arrangements or other documentation (for example, health center procedures) include provisions that address:
- How 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)?
Response is: Yes, No or Not Applicable
- 5.3 Do the heath center patient records include information from these referrals (for example, lab results) and appropriate follow-up care?
Response is: Yes, No or Not Applicable
- 5.1 Does the health center maintain formal written referral arrangements for services on its current Form 5A, Column III?
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If No OR Not Applicable was selected for any of the above, an explanation is required providing details on the specific services.
Health center patients with limited English proficiency (LEP) are provided with interpretation and translation (for example, through bilingual providers, on-site interpreters, high quality video or telephone remote interpreting services) that enable them to have reasonable access to health center services.
Site Visit Team Methodology
- Review the Uniform Data System (UDS) patient demographic data.
- Review the sample of translated health center documents.
- Review access to interpretation services (for example, on-site interpreters, contracts for interpretation services).
- Interview health center clinical leadership and providers about patient language needs (for example, most common primary languages spoken by the patient population) and the role of cultural competency in the delivery of health center services (for example, training of front desk and clinical staff in cultural knowledge, attitudes, and beliefs of patient population).
Site Visit Findings
- Does the health center provide access to interpretation for health center patients with LEP?
Response is either: Yes or No
If No, an explanation is required.
- Did the health center provide examples of key documents currently in use that are translated into different languages for its patient population and that enable patients to access health center services?
Response is either: Yes or No
If No, an explanation is required.
The health center makes arrangements and/or provides resources (for example, training) that enable its staff to deliver services in a manner that is culturally sensitive and bridges linguistic and cultural differences.
Site Visit Team Methodology
- Review the UDS patient demographic data.
- Review the sample of translated health center documents.
- Review access to interpretation services (for example, on-site interpreters, contracts for interpretation services).
- Interview health center clinical leadership and relevant staff about patient language needs (for example, most common primary languages spoken by the patient population) and the role of cultural competency in the delivery of health center services (for example, training of front desk and clinical staff in cultural knowledge, attitudes, and beliefs of patient population).
Site Visit Findings
- Did the health center provide an example of how it delivers services in a manner that is culturally-appropriate for its patient population (for example, culturally-appropriate health promotion tools)?
Response is either: Yes or No
If No, an explanation is required.
Footnotes
1. Health centers may choose to provide samples of patient records before or during the site visit. If patient records will be provided during the site visit, this should be communicated to the site visit team before the site visit to avoid any disruption or delay in the site visit process.
2. In accordance with 45 CFR 75.308 (Uniform Administrative Requirements: Revision of Budget and Program Plans), health centers must request prior approval from HRSA for a change in the scope or the objective of the project or program (even if there is no associated budget revision requiring prior written approval). This prior approval requirement applies, among other things, to the addition or deletion of a service within the scope of project. These changes require prior approval from HRSA and must be submitted by the health center as a formal Change in Scope request. Visit the Scope of Project website for further details, including the Form 5A Service Descriptors (PDF - 315 KB) listed on Form 5A: Services Provided.
3. The Health Center Program statute states in 42 U.S.C. 254b(a)(1) that health centers may provide services “either through the staff and supporting resources of the center or through contracts or cooperative arrangements.” The Health Center Program Compliance Manual uses the terms “Formal Written Contract/Agreement” and “Formal Written Referral Arrangement” to refer to such “contracts or cooperative arrangements.” For more information on documenting service delivery methods within the HRSA-approved scope of project on Form 5A: Services Provided, visit Form 5A Column Descriptors (PDF - 110 KB). Other Health Center Program requirements apply when providing services through contractual agreements and formal referral arrangements. Such requirements are addressed in other chapters of the Manual where applicable.
4. See [Health Center Program Compliance Manual] Chapter 9: Sliding Fee Discount Program for more information on sliding fee discount program requirements and how they apply to the various service delivery methods.
5. For purposes of the HRSA-approved scope of project (Form 5A: Services Provided), HRSA/BPHC utilizes Internal Revenue Service (IRS) definitions to differentiate contractors and employees. Typically, an employee receives a salary on a regular basis and a W-2 from the health center with applicable taxes and benefit contributions withheld.
6. See [Health Center Program Compliance Manual] Chapter 12: Contracts and Subawards for more information on program requirements around contracting.
7. For purposes of the HRSA-approved scope of project (Form 5A: Services Provided), services provided via “contract/formal agreement” are those provided by practitioners who are not employed by or volunteers of the health center (for example, an individual provider with whom the health center has a contract; a group practice with which the health center has a contract; a locum tenens staffing agency with which the health center contracts; a subrecipient organization). Typically, a health center will issue an IRS Form 1099 to report payments to an individual contractor. See the Federal Tort Claims Act (FTCA) Health Center Policy Manual (PDF - 406 KB) for information about eligibility for FTCA coverage for covered activities by covered individuals, which extends liability protections for eligible “covered individuals,” including governing board members and officers, employees, and qualified individual contractors.
8. For purposes of the HRSA-approved scope of project (Form 5A: Services Provided), access to services provided via “formal referral arrangements” are those referred by the health center but provided and billed for by a third party. Although the service itself is not included within the HRSA-approved scope of project, the act of referral and any follow-up care provided by the health center subsequent to the referral are considered to be part of the health center’s HRSA-approved scope of project. For more information on documenting service delivery methods within the HRSA-approved scope of project on Form 5A: Services Provided, visit Form 5A Column Descriptors (PDF - 110 KB).