28 Chapter 28: Ensuring Personnel Compliance

Ensuring that compounding personnel consistently follow established procedures is critical for maintaining the quality, safety, and integrity of non-sterile compounded preparations. The NAPRA Model Standards and associated Guidance Document recommend several interconnected methods:

1. Comprehensive Training and Initial Competency Assessment

• All personnel involved in compounding activities must receive structured training that covers:
  • Compounding techniques.
  • Use of facilities and equipment.
  • Policies and procedures specific to the pharmacy.
  • Health and safety protocols (including PPE use and handling hazardous substances).
• Training should be tailored to the complexity of the compounding (Level A, B, or C).
• An initial competency assessment must be conducted after training. This evaluation may involve:
  • Written tests.
  • Direct observation of compounding activities.
  • Simulated exercises.

Reference: (NAPRA Standards section 5.2, Guidance Document GD-5.2.1)

2. Ongoing Competency Assessment and Refresher Training

• Regular skills reassessment must be performed at least every 12 months.
• Reassessment activities can include:
  • Practical demonstrations.
  • Review of documentation practices.
  • Spot audits during actual compounding activities.
• If performance issues are identified, additional targeted training must be provided, and corrective actions must be documented.

Reference: (NAPRA Guidance GD-5.2.1.1)

3. Clear and Accessible Policies and Procedures

• Policies and procedures for all aspects of compounding must be:
  • Written, detailed, and easy to understand.
  • Readily accessible in the compounding area (e.g., electronic systems, binders).
  • Reviewed every 3 years, or sooner if there are regulatory changes, new evidence, or operational changes.
• Staff must be trained on policy updates promptly.

Reference: (NAPRA Standards 5.3; Guidance GD-5.3.1 and GD-5.3.2)

4. Supervision and Monitoring

• Supervisory roles (e.g., Non-Sterile Compounding Supervisor) are essential for:
  • Observing daily practices.
  • Offering immediate coaching when deviations occur.
  • Performing routine audits (checklists for facility/equipment cleaning, process adherence).
• Supervisors ensure that risk assessments are updated if changes in process or ingredients occur.

Reference: (NAPRA Standards 5.1.2)

5. Documentation of Activities

• All compounding-related activities must be documented, including:
  • Training records.
  • Skills assessments.
  • Daily cleaning logs.
  • Equipment calibration and maintenance logs.
  • Compounding records and any incidents/errors.
• Proper documentation ensures traceability and reinforces accountability among personnel.

Reference: (NAPRA Standards sections 5.1, 5.2, 5.3)

6. Promoting a Culture of Quality and Safety

• Leadership must foster an environment where:
  • Compliance is seen as critical for patient safety.
  • Staff feel encouraged to report errors, near misses, or procedural challenges without fear of punishment.
  • Continuous quality improvement initiatives are supported (e.g., feedback loops, staff suggestion programs).

Reference: (Guidance Document GD-5.1 and GD-5.3)

Summary:

Procedural Compliance Monitoring Checklist for Non-Sterile Compounding:

Training and Competency

• All compounding personnel have completed initial training covering policies, procedures, safety, and compounding techniques.
• Initial competency assessment completed after training (e.g., observation, practical test).
• Annual reassessment of compounding skills is scheduled and documented.
• Refresher training provided promptly if deficiencies are identified.

Policies and Procedures

• Written policies and procedures are available and accessible in the compounding area.
• Policies are reviewed every 3 years or sooner if changes occur.
• Staff have been trained on any updates to policies or procedures.

Supervision and Oversight

• A designated Non-Sterile Compounding Supervisor oversees daily activities.
• Routine audits and spot checks of compounding practices are performed.
• Risk assessments are conducted when compounding practices or ingredients change.

Culture of Quality and Safety

• Staff are encouraged to report errors, near misses, or concerns without fear of reprisal.
• Continuous quality improvement initiatives (e.g., regular feedback, improvement plans) are in place.
• Leadership models a commitment to compliance and patient safety.