Health Care Part 5: Ensuring Qualified Staff and Service Standards in Health Centers

Authority

Sections 330(a)(1), (b)(1)-(2) of the PHS Act; and 42 CFR 51c.303(a), 42 CFR 51c.303(p), 42 CFR 56.303(a), and 42 CFR 56.303(p)

Requirements for Health Care Services

Health centers, as vital components of the health care system, are obligated to meet specific requirements to ensure they deliver high-quality care to their communities. These standards, derived from the Public Health Service (PHS) Act and the Code of Federal Regulations (CFR), focus on the scope, accessibility, and quality of services provided. For Health Care Part 5, the critical mandates revolve around service provision and staffing qualifications.

• Comprehensive Service Provision: Health centers must furnish all designated required primary and approved additional health services1. These services should be delivered through the health center’s own employed staff and resources. Where necessary, contracts or cooperative agreements can supplement in-house capabilities to ensure a full spectrum of care.

• Accessible and Prompt Service Delivery: Health care services must be readily available and accessible to the population within the health center’s defined service area. This accessibility includes prompt service delivery, tailored to the urgency and appropriateness of the medical need. Furthermore, health centers are responsible for ensuring continuity of care for all residents within their catchment area, fostering long-term health management and patient trust.

• Qualified and Competent Staff: To uphold the quality of health care, centers must employ staff who are demonstrably qualified. Qualifications are determined by a combination of formal training and practical experience, ensuring that all personnel are capable of effectively executing their assigned responsibilities within the health center environment.

Demonstrating Compliance with Health Care Standards

To demonstrate adherence to these crucial health care requirements, a health center must meet the following criteria:

1. Comprehensive Service Capacity: The health center needs to guarantee it possesses adequate clinical staff2, or has established contracts or formal referral arrangements with external providers or organizations. This infrastructure must be capable of delivering all required and additional services that are part of its HRSA-approved scope of project.3 This ensures that all promised services are actually available to patients.

2. Adequate Staffing Levels: The health center must strategically determine its staffing levels and composition. This determination should be based on a thorough consideration of the patient population’s size, demographics, and specific health needs. For example, a center serving a large pediatric population or an area with high diabetes prevalence must adjust its clinical staff numbers and specializations accordingly to guarantee patients reasonable access to all necessary health center services.

3. Rigorous Credentialing Procedures: Operating procedures for both initial and recurring review (e.g., biennially) of credentials for all clinical staff are essential. This includes Licensed Independent Practitioners (LIPs), Other Licensed or Certified Practitioners (OLCPs), and all other clinical staff, whether employees, contractors, or volunteers. These credentialing procedures must verify the following:

   • Current Licensure, Registration, or Certification: Verification must be conducted using a primary source to confirm the staff member’s legal authorization to practice.
   • Education and Training: For initial credentialing, education and training must be verified. Primary sources are required for LIPs4, while primary or other reliable sources (as defined by the health center) are acceptable for OLCPs and other clinical staff.
   • National Practitioner Data Bank (NPDB) Query: A mandatory query through the NPDB5 must be completed to check for any history of malpractice payments or adverse actions.
   • Identity Verification: For initial credentialing, the clinical staff member’s identity must be confirmed using a government-issued photo ID to prevent fraud and ensure accurate records.
   • Drug Enforcement Administration (DEA) Registration: Where applicable, verification of DEA registration is necessary for staff authorized to prescribe controlled substances.
   • Basic Life Support (BLS) Training: Current documentation of BLS training must be on file, ensuring staff are prepared for basic emergency situations.

4. Robust Privileging Procedures: Similar to credentialing, health centers must have operating procedures for the initial granting and renewal (e.g., biennially) of privileges for all clinical staff (LIPs, OLCPs, and other clinical staff). These privileging procedures must address:

   • Fitness for Duty, Immunization, and Communicable Disease Status:6 Verification of fitness for duty, current immunizations, and screening for communicable diseases is crucial to protect both patients and staff.
   • Initial Clinical Competence Verification: For initial privileging, current clinical competence must be verified through training, education, and, when available, reference reviews from previous employers or supervisors.
   • Renewal of Clinical Competence Verification: For privilege renewal, ongoing clinical competence must be confirmed via peer review or other comparable methods, such as supervisory performance reviews, ensuring continuous quality of care.
   • Process for Privilege Actions: A clear process must be in place for denying, modifying, or removing privileges based on assessments of clinical competence and/or fitness for duty, ensuring accountability and patient safety.

5. Clinical Staff Records Maintenance: The health center must maintain comprehensive files or records for all clinical staff (employees, contractors, and volunteers). These records must contain up-to-date documentation of licensure, credentialing verification, and granted privileges, aligning with established operating procedures for easy access and audit.

6. Oversight of Contracted and Referred Providers: If the health center utilizes contracts with provider organizations (e.g., group practices, staffing agencies) or formal referral agreements for services within its scope of project, it is responsible for ensuring7 that these external providers meet specific standards:

   • Licensure, Certification, or Registration: Contracted and referred providers must be licensed, certified, or registered according to all applicable Federal, state, and local laws. This must be verified through a thorough credentialing process conducted by the health center or through verification of the external organization’s processes.
   • Competency and Fitness for Contracted/Referred Services: The health center needs to assess and ensure that contracted or referred providers are competent and fit to deliver the services they are contracted or referred to provide, often assessed through a privileging process or review of the external organization’s privileging process.

Related Considerations for Health Center Operations

Health centers possess some discretion in implementing these requirements, allowing for tailored approaches to meet their specific operational contexts:

• Staffing Composition and Levels: Health centers determine their optimal staffing mix (e.g., the balance of nurse practitioners, physician assistants, and physicians) and staffing levels (including full-time and part-time positions) based on patient needs and service demands.
• Credentialing and Privileging Authority: The health center decides who holds the authority to grant approvals for credentialing and privileging decisions within the organization, ensuring appropriate oversight and accountability.
• Credentialing Implementation: Health centers have flexibility in how they implement credentialing. They may choose to contract with a Credentials Verification Organization (CVO) to manage credentialing tasks or manage the process internally with their own staff. They can also establish different credentialing processes for LIPs versus other provider types, based on complexity and risk.
• Clinical Competence and Fitness Assessment: Health centers determine the methods used to assess the clinical competence and fitness for duty of their staff. For clinical competence, this might involve internal peer review by health center providers or contracting with external organizations for peer review services.
• Privilege Decisions and Corrective Actions: Consistent with their privileging criteria, health centers decide whether to deny, modify, or remove staff privileges. They also determine whether to incorporate an appeals process for these decisions and whether to implement corrective action plans as alternatives or in conjunction with privilege modifications or removals.
• Provider and Organizational Disallowance: Health centers, according to their contracts and cooperative agreements, decide whether to disallow specific individual providers or organizations from delivering health services on the health center’s behalf, maintaining control over the quality and safety of care provided under their scope of project.

Footnotes

1. These terms are defined in section 330(b) of the Public Health Service (PHS) Act. For more information, see Scope of Project website.

2. Clinical staff includes licensed independent practitioners (for example, Physician, Dentist, Physician Assistant, Nurse Practitioner), other licensed or certified practitioners (for example, Registered Nurse, Licensed Practical Nurse, Registered Dietitian, Certified Medical Assistant), and other clinical staff providing services on behalf of the health center (for example, Medical Assistants or Community Health Workers in states, territories or jurisdictions that do not require licensure or certification).

3. Health centers seeking coverage for themselves and their providers under the Health Center 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).

4. 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.

5. 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, see National Practitioner Data Bank.

6. 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, see CDC: Recommended Vaccines for Healthcare Workers.

7. 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.