In this section:
Primary Reviewer: Clinical Expert
Secondary Reviewer: Governance/Administrative Expert (as needed)
Authority: Sections 330(a)(1), (b)(1)-(2), and (k)(3)(I)(ii)(II)-(III) of the Public Health Service (PHS) Act; and 42 CFR 51c.303(a), 42 CFR 51c.303(p), 42 CFR 56.303(a), and 42 CFR 56.303(p)
Health Center Program Compliance Manual Related Considerations
Documents the Health Center Provides
- Credentialing and privileging procedures for licensed independent practitioners (LIP), other licensed or certified practitioners (OLCP), or other clinical staff.
Note: Credentialing and privileging procedures may be included in Human Resource procedures. - If the health center has a website: The website URL.
- Most recent needs assessment.
- Current clinical staffing profile that lists:
- Name,
- Position,
- FTE,
- Credential (for example, RN, MD),
- Hire date,
- Provider type: LIP, OLCP, or other clinical staff (for example, non-certified medical/dental assistants, community health representatives, case managers),
- Staff who are bilingual or multilingual.
- Files for current clinical staff that contain credentialing and privileging information: four to five LIP files; four to five OLCP files; and, if the health center has other clinical staff, two to three files for those other clinical staff. For the selected files, include:
- Representation from different clinical disciplines and service sites.
- Employees, contractors, and volunteers.
- Providers who do procedures beyond core privileges for their clinical disciplines.
- Providers who have been initially credentialed.
- Providers who have been re-credentialed/re-privileged.
- Any contracts or agreements with outside entities, such as Credentialing Verification Organizations (CVOs), that perform credentialing functions (such as primary source verification).
- If clinical services are provided via Column II or III:
- No more than three written contracts/agreements with provider organizations. Prioritize contracts for any clinical services that are only offered via Column II.
- No more than three written referral arrangements. Prioritize referral arrangements for any clinical services that are only offered via Column III.
- Any additional documentation showing the health center has ensured credentialing and privileging of the contracted and referral providers. For example, documentation showing the health center has reviewed:
- The contracted organization’s credentialing and privileging processes for providers, such as physicians, pharmacists, and dentists;
- The contracted organization’s documentation from a nationally recognized accreditation organization; or
- The contracted laboratory’s documentation of Clinical Laboratory Improvement Amendments (CLIA) compliance.
Notes:
- Select contracts and referral arrangements those that support clinical services (for example, general primary medical care, preventive dental). HRSA recognizes that contracts or referral arrangements for enabling services (for example, transportation, translation, outreach) may not contain provisions for credentialing and privileging.
- 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 Clinical Staffing are different from Contracts and Subawards and Conflict of Interest, even though they may result in some overlap in the contracts/agreements reviewed.
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 ensures that it has clinical staff1 and/or has contracts or formal referral arrangements in place with other providers or provider organizations to carry out all required and additional services included in the HRSA-approved scope of project.2
Site Visit Team Methodology
- Interview CMO, Clinical Director, or equivalent health center leadership about scope of services, current clinical staffing, and recruitment and retention processes.
- Tour at least one to two health center sites where a variety of Column I services are provided.
- Review the current clinical staffing profile.
- Review the health center’s Form 5A for background and alignment of services with clinical staffing. Refer to Required and Additional Health Services documentation for further details on the staffing for services provided via contracts/agreements and written referral arrangements.
Site Visit Findings
- Does the health center’s current clinical staffing makeup (such as employees, volunteers, contracted and referral providers) enable it to carry out the approved scope of project on Form 5A?
Response is either: Yes or No
If No, an explanation is required specifying why staffing is insufficient and for which services.
The health center has considered the size, demographics, and health needs (for example, large number of children served, high prevalence of diabetes) of its patient population in determining the number and mix of clinical staff necessary to ensure reasonable patient access to health center services.
Site Visit Team Methodology
- Interview CMO, Clinical Director and other clinical leadership (for example, Dental Director, Pharmacy Director) about how the number and mix of clinical staff support patient access.
- Review the health center’s most recent needs assessment and Uniform Data System (UDS) Summary Report. Specifically review the number of patients served annually, patient demographics, primary diagnosis, and clinical quality and outcome measures.
- Assess the type and range of services provided through review of the health center’s Form 5A and other resources as appropriate (for example, website, health center presentation during the Entrance Conference, observation during site visit tours, and interviews with clinical leadership).
Site Visit Findings
- Did the health center provide one to two examples of how the mix (for example, pediatric and adult providers) and number (for example, full or part time staff, contracted providers) of clinical staff are responsive to the size, demographics, and needs of its patient population?
Response is either: Yes or No
If No, an explanation is required specifying why any examples did not show how the mix and number of clinical staff are responsive to the health center’s patient population.
- Based on the health center’s most recent UDS, is the number and mix of current staff (considering all sites and all service delivery methods) sufficient to ensure reasonable patient access to health center services?
Response is either: Yes or No
If No, an explanation is required, including specific examples of why there is not reasonable patient access to health center services.
The health center has operating procedures for the initial and recurring review (for example, every 2 years) of credentials for all clinical staff members (licensed independent practitioners (LIPs), other licensed or certified practitioners (OLCPs), and other clinical staff providing services on behalf of the health center) who are health center employees, individual contractors, or volunteers. These credentialing procedures would ensure verification of the following, as applicable:
- Current licensure, registration, or certification using a primary source;
- Education and training for initial credentialing, using:
- Primary sources for LIPs;3
- Primary or other sources (as determined by the health center) for OLCPs and any other clinical staff;
- Completion of a query through the National Practitioner Data Bank (NPDB);4
- Clinical staff member’s identity for initial credentialing using a government-issued picture identification;
- Drug Enforcement Administration (DEA) registration; and
- Current documentation of basic life support training.
Site Visit Team Methodology
- Review the health center’s credentialing procedures for LIPs, OLCPs, and other clinical staff.
Note: Credentialing and privileging procedures may be included in Human Resource procedures. - Review any contracts or agreements the health center has with outside entities, such as CVOs, that perform credentialing functions (such as primary source verification).
- Interview the individuals who conduct or have responsibility for the credentialing of clinical staff to determine:
- Whether education and training for LIPs is confirmed through:
- Primary source verification obtained by the health center, or
- A state licensing body that conducts primary source verification of education and training for LIPs.
- The health center’s methods for tracking timelines for re-credentialing staff, including renewal of licensure and any required DEA registration.
- Whether education and training for LIPs is confirmed through:
Notes:
- If a health center does not have “other clinical staff,” the health center does not have to include such staff in its operating procedures.
- The health center determines whether to have separate credentialing processes for LIPs versus other provider types. For example, the health center determines what specific aspects of the credentialing process (such as verification of current licensure, registration, or certification) might not apply to “other clinical staff.”
- For OLCPs and any other clinical staff, the health center determines what sources to use for verification of education and training.
- In states in which the licensing agency, specialty board, or registry conducts primary source verification of education and training, the health center may use the state’s primary verification of state licensure or board certification as verification of education and training.
Site Visit Findings
- INITIAL CREDENTIALING ONLY: Do the health center’s credentialing procedures require verification of the following for all clinical staff, as applicable, upon hire:
Note: Clinical staff are health center employees, individual contractors, or volunteers and include LIPs, OLCPs and other clinical staff.
- 4.1 Clinical staff member’s identity using a government-issued picture identification?
Response is either: Yes or No
- 4.2 Verification by the health center or the state (licensing agency, specialty board, or registry) of the education and training of LIPs using a primary source?
Response is either: Yes or No
- 4.3 Verification of the education and/or training of OLCPs and, as applicable, other clinical staff using a primary or secondary source, as determined by the health center?
Response is either: Yes or No
If No was selected for any of the above, an explanation is required.
- 4.1 Clinical staff member’s identity using a government-issued picture identification?
- INITIAL AND RECURRING CREDENTIALING PROCEDURES: Do the health center’s credentialing procedures require verification of the following for all clinical staff upon hire AND on a recurring basis:
Note: Clinical staff are health center employees, individual contractors, or volunteers and include LIPs, OLCPs and other clinical staff.
- 5.1 Current licensure, registration, or certification using a primary source for LIPs and OLCPs?
Response is either: Yes or No
- 5.2 Completion of a query through the NPDB?
Response is either: Yes or No
- 5.3 DEA registration, as applicable?
Response is either: Yes or No
- 5.4 Current documentation of basic life support training or comparable training completed through licensure or certification?
Response is either: Yes or No
If No was selected for any of the above, an explanation is required.
- 5.1 Current licensure, registration, or certification using a primary source for LIPs and OLCPs?
The health center has operating procedures for the initial granting and renewal (for example, every 2 years) of privileges for clinical staff members (LIPs, OLCPs, and other clinical staff providing services on behalf of the health center) who are health center employees, individual contractors, or volunteers. These privileging procedures would address the following:
- Verification of fitness for duty, immunization, and communicable disease status;5
- For initial privileging, verification of current clinical competence via training, education, and, as available, reference reviews;
- For renewal of privileges, verification of current clinical competence via peer review or other comparable methods (for example, supervisory performance reviews); and
- Process for denying, modifying or removing privileges based on assessments of clinical competence and/or fitness for duty.
Site Visit Team Methodology
- Review the health center’s privileging procedures for LIPs, OLCPs, and other clinical staff.
Note: Credentialing and privileging procedures may be included in Human Resource procedures. - Interview the individual or committee that completes or has approval authority for privileging of clinical staff to determine:
- How fitness for duty, immunization, and communicable disease status are verified;
- How clinical competence is assessed for initial granting of privileges;
- How clinical competence is assessed for renewal of clinical privileges; and
- What the health center’s processes are for modifying or removing privileges.
Note: If a health center does not have “other clinical staff,” the health center does not have to include such staff in its operating procedures.
Site Visit Findings
- Do the health center’s operating procedures address both the initial granting and renewal of privileges for all clinical staff?
Note: Clinical staff are health center employees, individual contractors, or volunteers and include LIPs, OLCPs and other clinical staff.
Response is either: Yes or No
If No, an explanation is required.
- Do the health center’s privileging procedures require verification of fitness for duty for all clinical staff upon hire AND on a recurring basis?
Note: Clinical staff are health center employees, individual contractors, or volunteers and include LIPs, OLCPs and other clinical staff.
Response is either: Yes or No
If Yes OR No was selected, an explanation is required, including specifying how the health center has verified fitness for duty to ensure all clinical staff have the physical and cognitive ability to safely perform their duties.
- Do the health center’s privileging procedures require verification of the following for all clinical staff upon hire AND on a recurring basis:
Note: Clinical staff are health center employees, individual contractors, or volunteers and include LIPs, OLCPs and other clinical staff.
- 8.1 Immunization and communicable disease status?
Response is either: Yes or No
- 8.2 Current clinical competence?
Response is either: Yes or No
If No was selected for any of the above, an explanation is required.
- 8.1 Immunization and communicable disease status?
-
Does the health center have criteria and processes for modifying or removing privileges based on the outcomes of clinical competence assessments?
Response is either: Yes or No
If No, an explanation is required.
The health center maintains files or records for its clinical staff (for example, employees, individual contractors, and volunteers) that contain documentation of licensure, credentialing verification, and applicable privileges, consistent with operating procedures.
Site Visit Team Methodology
- Interview health center staff about credentialing and privileging records.
- Review the sample of files for current clinical staff that contain credentialing and privileging information (as defined by the health center in its operating procedures).
- Conduct the review of the file sample together with the health center individuals responsible for maintaining credentialing and privileging documentation.
Note: Please use the Examples of Credentialing and Privileging Documentation resource for common documentation methods and sources.
Site Visit Findings
- Based on the review of the sample of current clinical staff files, do the files contain up-to-date (as defined by the health center in its operating procedures) documentation of licensure and credentialing of these clinical staff (employees, individual contractors, and volunteers)?
Response is either: Yes or No
If No, an explanation is required.
- Based on the review of the sample of current clinical staff files, do the files contain up-to-date (as defined by the health center in its operating procedures) documentation of privileging decisions (for example, an up-to-date privileging list for each provider) for these clinical staff (employees, individual contractors, and volunteers)?
Response is either: Yes or No
If No, an explanation is required.
If the health center has contracts with provider organizations (for example, group practices, locum tenens staffing agencies, training programs) or formal, written referral agreements with other provider organizations that provide services within its scope of project, the health center ensures6 that such providers are:
- Licensed, certified, or registered as verified through a credentialing process, in accordance with applicable federal, state, and local laws; and
- Competent and fit to perform the contracted or referred services, as assessed through a privileging process.
Site Visit Team Methodology
- Interview health center staff about credentialing and privileging processes for contracted or referral providers.
- Review no more than three contracts with provider organizations. Prioritize the review of any clinical services that are only offered via Column II.
- Review no more than three written referral arrangements. Prioritize the review of any clinical services that are only offered via Column III.
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 Clinical Staffing are different from Contracts and Subawards and Conflict of Interest, even though they may result in some overlap in the contracts/agreements reviewed.
- Select contracts and referral arrangements that support clinical services (for example, general primary medical care, preventive dental). HRSA recognizes that contracts or referral arrangements for enabling services (for example, transportation, translation, outreach) may not contain provisions for credentialing and privileging.
- If possible, conduct the review of the contracts/agreements, referral arrangements, or related documentation together with health center staff.
- For contracted or referral providers, examples of credentialing and privileging could include assurance that the health center has reviewed:
- The contracted organization’s credentialing and privileging processes for providers, such as physicians, pharmacists, and dentists;
- The contracted organization’s documentation from a nationally recognized accreditation organization; or
- The contracted laboratory’s documentation of Clinical Laboratory Improvement Amendments (CLIA) compliance.
Site Visit Findings
- Does the health center ensure through provisions in contracts or through other means (for example, the contracted organization provides the health center with documentation of Joint Commission accreditation) that contracted services (Form 5A, Column II) are provided by organizations that:
Notes:- Select “Not Applicable” if the health center does not offer any clinical services via Column II.
- For any Column II service that involves a contract with a provider organization, the credentialing and privileging process for the provider may either be conducted by the provider organization or may be conducted by the health center. Individual contractors are credentialed and privileged by the health center (refer to element “c”).
- 12.1 Verify provider licensure, certification, or registration through a credentialing process?
Response is: Yes, No, or Not Applicable
- 12.2 Verify providers are competent and fit to perform the contracted services through a privileging process?
Response is: Yes, No, or Not Applicable
If No was selected for any of the above, an explanation is required.
- Does the health center ensure through provisions in written referral arrangements or through other means (for example, the referral organization provides the health center with documentation of Joint Commission accreditation) that referred services (Form 5A, Column III) are provided by organizations that:
Notes:- Select “Not Applicable” if the health center does not offer any clinical services via Column III.
- For all Column III services, the credentialing and privileging process for providers is external; for example, conducted by the referral provider or referral organization.
- 13.1 Verify provider licensure, certification, or registration through a credentialing process?
Response is: Yes, No, or Not Applicable
- 13.2 Verify providers are competent and fit to perform the referred services through a privileging process?
Response is: Yes, No, or Not Applicable
If No was selected for any of the above, an explanation is required.
Footnotes
1. Clinical staff includes licensed independent practitioners (for example, physician, dentist, physician assistant, nurse practitioner, clinical psychologist), other licensed or certified practitioners (for example, registered nurse, licensed practical nurse, registered dietitian, certified medical assistant, phlebotomist, respiratory therapist, licensed or certified behavioral health support staff), and other clinical staff providing services on behalf of the health center (for example, medical assistants, peer navigators, or community health workers in states, territories, or jurisdictions that do not require licensure or certification).
2. Health centers seeking coverage for themselves and their providers under the Health Center Federal Tort Claims Act (FTCA) Medical Malpractice Program should review the statutory and policy requirements for coverage, as discussed in the FTCA Health Center Policy Manual (PDF - 406 KB).
3. In states in which the licensing agency, specialty board or registry conducts primary source verification of education and training, the health center would not be required to duplicate primary source verification when completing the credentialing process.
4. The NPDB is an electronic information repository authorized by Congress. It contains information on medical malpractice payments and certain adverse actions related to health care practitioners, entities, providers, and suppliers. For more information, visit National Practitioner Data Bank.
5. The CDC has published recommendations and many states have their own recommendations or standards for provider immunization and communicable disease screening. For more information about CDC recommendations, visit CDC: Recommended Vaccines for Healthcare Workers.
6. This may be done, for example, through provisions in contracts and cooperative arrangements with such organizations or health center review of the organizations’ credentialing and privileging processes.