CPOM Module 13, Section 4: Training and Competency Assessments for Compounding Staff
MODULE 13: STERILE & NON-STERILE COMPOUNDING OPERATIONS

Section 13.4: Training and Competency Assessments for Compounding Staff

Learn how to build a robust training program that goes beyond initial instruction, focusing on the required gloved fingertip testing, media-fill tests, and ongoing competency assessments to ensure staff proficiency.

SECTION 13.4

From Knowledge to Mastery: Architecting a World-Class Competency Program

Building a Team Where Excellence is a Verifiable Skill, Not an Assumption.

13.4.1 The “Why”: Competency as the Ultimate Measure of a Manager’s Success

We have established the compounding facility as an engineered ecosystem and the workflow as its operational engine. However, even the most advanced aircraft is useless without a skilled pilot, and the most sophisticated surgical suite is dangerous in the hands of an untrained surgeon. In the world of pharmaceutical compounding, your staff are the pilots and surgeons. Their proficiency, discipline, and skill are the final—and most important—determinants of patient safety. This makes the training and competency program the single most critical investment an operations manager can make. A manager’s ultimate success is not measured by the sophistication of their facility, but by the demonstrable, verifiable competence of their team.

It is a common but dangerous fallacy to equate “training” with “competency.” Training is the transfer of knowledge and the demonstration of a skill. Competency is the proven, repeatable ability of an individual to perform that skill flawlessly, under real-world conditions, according to established standards. Showing someone how to garb is training. A successful gloved fingertip test is proof of competency. Explaining aseptic technique is training. A successful media-fill test is proof of competency. As a manager, you are not running a training program; you are running a competency assurance program.

This distinction is not semantic; it is the philosophical core of a high-reliability organization. An organization that relies on assumed competence will eventually fail. An organization that demands proven competence builds a culture of accountability and safety. The USP chapters provide the framework for this by mandating specific, performance-based tests—gloved fingertip sampling and media-fill testing—that move assessment from the theoretical to the practical. These are not academic exercises; they are the licensure exams for working in your cleanroom.

This section provides the architectural blueprint for building such a program. We will deconstruct the three essential pillars: didactic learning, hands-on skill development, and the rigorous competency assessments that validate them. We will take a masterclass-level deep dive into the practical execution of gloved fingertip sampling and media-fill testing, moving beyond the “what” to the “how” and “why.” You will learn not just how to administer these tests, but how to interpret their results, how to use them as a tool for targeted retraining, and how to integrate them into a continuous quality improvement cycle. Your goal is to build a system that produces not just trained technicians and pharmacists, but certified, competent operators in whom you, your organization, and your patients can place absolute trust.

Retail Pharmacist Analogy: The Immunization Certification Program

Think about the process of becoming a certified immunizer. It is a perfect, small-scale model of a robust competency program, moving systematically from knowledge to proven skill.

  • Didactic Training (The Foundational Knowledge): First, you completed a comprehensive home-study course. You read about vaccine-preventable diseases, immunology, vaccine storage requirements, and the management of anaphylactic reactions. At the end, you had to pass a written examination to prove you had absorbed this foundational knowledge. This is the equivalent of studying the USP chapters and your pharmacy’s P&Ps.
  • Hands-On Skill Development (The Supervised Practice): Next, you attended a live seminar. An instructor demonstrated the proper technique for drawing up a vaccine and administering an intramuscular injection into a practice pad. Then, you had to perform the technique yourself under the instructor’s direct supervision. They corrected your hand placement and your angle of injection. This is the equivalent of supervised aseptic technique training in a PEC.
  • Competency Assessment (The “Final Exam”): Finally, you had to perform the entire process on the instructor or a fellow pharmacist—a live “test.” You had to correctly select the vaccine, draw up the precise dose, choose the correct injection site, and administer it flawlessly. This successful, documented injection was your “media-fill test.” Separately, your CPR certification, requiring a hands-on demonstration on a mannequin, was your “gloved fingertip test” for that specific skill. Only after passing all three phases were you deemed “competent” and certified.
  • Ongoing Competency: Your certification is not permanent. You are required to complete continuing education on immunizations and maintain your CPR certification to prove that your knowledge and skills remain current. This is the principle of ongoing, periodic competency assessment.

Building a compounding competency program follows this exact, logical progression. You must first provide the knowledge, then guide the practice, and finally, verify the skill with objective, performance-based testing before an employee is ever allowed to compound for a patient. As the manager, you are the program director for this critical certification.

13.4.2 Architecting the Training Program: The Three Pillars of Proficiency

A successful training program is not a single event, but a structured curriculum built on three distinct but interconnected pillars. A failure to adequately address any one of these pillars will result in a program that produces staff who are knowledgeable but unskilled, or skilled but inconsistent. As a manager, you must design a program that systematically builds a foundation of theoretical knowledge, translates it into practical skills through supervised practice, and validates it all through objective assessment.

The Structure of a Compounding Training Curriculum

1
Pillar 1: Didactic Learning (The “Book Smarts”)

This is the foundational phase where personnel learn the “why” behind the “what.” It involves the study of written materials and theoretical concepts. This phase must be completed before any hands-on training begins.

Core Curriculum:
  • Required Reading: Assign the full text of USP <795>, <797>, and <800>, as applicable to the employee’s role. Assign all relevant internal Policies & Procedures (P&Ps).
  • Media-Based Learning: Utilize training videos (from sources like ASHP or CriticalPoint), webinars, and slide presentations covering key topics.
  • Key Topics: Principles of aseptic technique, microbiology, facility design and airflow, proper use of PECs, calculations, BUD determination, and documentation requirements.
Verification Method:

A comprehensive, open-book written examination. The goal is not memorization, but demonstration of understanding. Additionally, a signed and dated attestation form must be placed in the employee’s file, stating they have read and understood all assigned materials.

2
Pillar 2: Hands-On Skill Development (Supervised Practice)

This phase translates theory into practice under the direct supervision of a qualified trainer. The trainee should “return demonstrate” each skill until they can perform it consistently and correctly.

Core Skills Checklist:
  • Hygiene and Garbing: Demonstrate proper hand washing technique and the full garbing sequence.
  • Cleaning and Disinfection: Demonstrate the correct procedures for cleaning the PEC and other surfaces using the proper agents and techniques.
  • Aseptic Manipulations: This is the most intensive part. Trainees must demonstrate proficiency in:
    • Properly swabbing vial tops and injection ports.
    • Correctly handling needles and syringes to prevent touch contamination.
    • Drawing from vials without coring the stopper.
    • Breaking open glass ampules safely and using a filter needle.
    • Working within the PEC to maintain “first air” for all critical sites.
  • Equipment Operation: Demonstrate correct use of all relevant equipment (e.g., electronic balances, repeat pumpers, TPN compounders).
Verification Method:

A detailed skills checklist, signed and dated by the trainer for each demonstrated skill. This serves as the objective record that supervised practice occurred.

3
Pillar 3: Competency Validation (The Performance Tests)

This is the final, objective validation phase. The trainee must successfully pass a series of performance-based tests without supervision to prove they have mastered the required skills and can be trusted to compound independently.

Core Validation Tests:
  • Gloved Fingertip and Thumb Sampling: Must be performed three times with zero CFUs initially before being allowed to compound for patients.
  • Media-Fill Test: Must successfully perform a media-fill test that simulates the most complex manipulations they will be expected to perform. The result must be zero growth.
Verification Method:

The official lab reports for the gloved fingertip samples and the documented, incubated media-fill test results. These pass/fail records are the final gateway to independent compounding and are the most critical documents in the employee’s training file.

13.4.3 Deep Dive: Gloved Fingertip and Thumb Sampling (GFTS)

The GFTS is a direct, microbiological assessment of an individual’s hand hygiene and garbing technique. It is designed to answer one simple question: After washing your hands and putting on sterile gloves, are your gloved hands actually sterile? The human hand is a primary source of contamination, and this test provides objective data on how well a person’s technique isolates the sterile glove from the skin underneath and the non-sterile environment outside.

Proper Sampling is Everything

The validity of a GFTS result depends entirely on the sample being taken correctly. The sample must be taken immediately after the person has completed their hand hygiene and garbing, and before they disinfect their gloves with sterile 70% IPA. Applying IPA first would kill any surface bacteria and render the test useless. As a manager, you must observe this process to ensure it is being performed correctly.

The GFTS Procedure: A Step-by-Step Guide
  1. Preparation: The trainer or observer labels two agar plates (one for the left hand, one for the right) with the employee’s name, the date, and which hand is being sampled.
  2. Garbing: The employee performs the full hand hygiene and garbing procedure as defined in the P&P, ending with the donning of sterile gloves.
  3. Sampling: The employee immediately presents their hands. They gently press the pads of all five digits (four fingers and thumb) of their left hand onto the surface of the corresponding agar plate. They then repeat the process for their right hand on the second plate.
  4. Incubation: The plates are incubated under conditions appropriate for promoting microbial growth (typically 30-35°C for bacteria and 20-25°C for fungi).
  5. Reading Results: After the required incubation period (typically 48-72 hours), the plates are examined for any microbial colonies. Each visible spot or colony is counted as one Colony-Forming Unit (CFU).
Masterclass Table: Interpreting and Acting on GFTS Results
Test Result (Total CFUs for Both Hands) Status Managerial Action and Rationale
0 PASS (Optimal) This is the goal. The employee has demonstrated excellent technique. Document the successful result. For initial qualification, the employee must achieve this result on three separate, consecutive occasions.
1 to 3 PASS (Acceptable) While not perfect, this result is below the USP action level. It indicates a minor, incidental contamination. Document the successful result, but consider it an opportunity for a brief review of technique with the employee, especially if they are consistently getting non-zero results.
> 3 FAIL (Action Level Exceeded) This is a critical failure. The employee cannot compound independently. Your action must be immediate and documented:
  1. Review: Perform a direct, one-on-one observation of the employee’s entire hand hygiene and garbing process. Look for specific failure points (e.g., touching non-sterile surfaces after hand washing, improper glove donning).
  2. Retrain: Provide immediate, targeted retraining on the identified weak points.
  3. Re-Test: The employee must undergo another full GFTS. They cannot be considered competent until they successfully pass (≤ 3 total CFUs).

13.4.4 Deep Dive: Media-Fill Testing (The Ultimate Challenge)

The media-fill test, also known as an aseptic processing simulation, is the capstone examination for a sterile compounder. It is designed to be a comprehensive challenge of their ability to maintain sterility throughout the entire compounding process. By using a sterile microbial growth medium (like Tryptic Soy Broth or TSB) instead of actual drugs, the test creates a worst-case scenario: if even a single microbe is introduced at any step, it will have the ideal food source to grow and reveal itself as visible cloudiness (turbidity) in the final product.

As a manager, you must design a media-fill test that is representative of the most complex and difficult manipulations your staff are expected to perform. A pharmacy that only prepares simple IV drips will have a different test than one that prepares complex multi-additive parenteral nutrition.

Manager’s Playbook: Designing a Robust Media-Fill Test

A good media-fill test should incorporate a variety of manipulations to challenge the operator. Your test procedure should require the employee to:

  1. Aseptically handle multiple components (e.g., several vials of media).
  2. Perform multiple transfers into a final container (e.g., an empty IV bag).
  3. Use a variety of equipment, such as different syringe sizes.
  4. If applicable to your practice, the test should include challenging tasks like breaking a glass ampule and using a filter needle, or reconstituting a powder vial.
  5. The entire process should last long enough to simulate a real compounding session and create opportunities for fatigue-related errors.
The Media-Fill Procedure and Interpretation
  1. The Test: The employee, under observation, performs the entire simulated compounding procedure as defined in the P&P.
  2. Incubation: The final container(s) are incubated for a total of 14 days. This is typically done for 7 days at room temperature (20-25°C) followed by 7 days at a warmer temperature (30-35°C) to encourage the growth of both fungi and bacteria.
  3. Observation: The containers are visually inspected for turbidity against a black and white background on day 7 and on day 14.
  4. The Result: The test is a simple pass/fail. Any visible turbidity at any point during the 14-day incubation constitutes a failure. A successful test must show no microbial growth at all.
Responding to a Media-Fill Failure

A media-fill failure is a significant quality event and requires immediate and thorough investigation. It proves that under simulated conditions, the employee’s technique is not sufficient to guarantee sterility. The response must be systematic:

  • Immediate Disqualification: The employee must be immediately disqualified from performing any sterile compounding.
  • Root Cause Analysis: The manager must conduct a thorough investigation. If the test was observed, what potential breaks in technique were noted? Was there an issue with the environment (e.g., an action level excursion on the day of the test)? Was the media itself potentially contaminated?
  • Comprehensive Retraining: The employee must undergo a full retraining program, starting from didactic learning through supervised practice, with a specific focus on the suspected failure points.
  • Successful Re-qualification: The employee must successfully pass another, often more challenging, media-fill test before they can be requalified for sterile compounding. This entire process—failure, investigation, retraining, and re-qualification—must be meticulously documented in their training file.

13.4.5 The Ongoing Mandate: Building a Culture of Continuous Competency

Initial qualification is not the end of the journey; it is the beginning. Aseptic skill is perishable. Without constant reinforcement and periodic re-evaluation, technique can drift, and bad habits can form. USP mandates an ongoing competency assessment program to combat this skill decay and to ensure that your team maintains its high level of proficiency over time.

As a manager, your role is to build a system and a culture where this ongoing assessment is viewed not as a punitive measure, but as a professional responsibility, akin to a pilot’s recurrent simulator training. It is the mechanism by which your team stays sharp, and your operation stays safe.

Masterclass Table: Ongoing Competency Assessment Schedule
Assessment Type Frequency for Cat 1 & 2 Compounding Frequency for Cat 3 Compounding Managerial Focus
Visual Observation of Hand Hygiene and Garbing Annually Every 6 months This is a simple but powerful tool. Directly observe the employee and check their technique against a formal checklist. It is your best opportunity to provide real-time coaching and correct minor deviations before they become major problems.
Gloved Fingertip and Thumb Sampling Annually Every 6 months This provides the ongoing, objective data for your most critical garbing skill. Trend the results for each employee. Is someone consistently getting 1-2 CFUs? They may be a candidate for proactive retraining.
Media-Fill Test Annually Every 6 months The recurrent “final exam” that re-validates an individual’s overall aseptic processing capability.
Visual Observation of Aseptic Technique Ongoing/Periodically Ongoing/Periodically Beyond the formal media-fill, make it a regular practice to observe your staff during actual compounding. Do they remember to swab vial tops every time? Are they maintaining first air? This informal audit provides invaluable insight into daily practice.
Didactic Review and Written Assessment Annually, and as needed when P&Ps change. Every 6 months, and as needed. Knowledge also requires refreshment. An annual written test ensures staff remain current on USP standards and internal policies, especially as they are updated over time.
The Competency and Training File: Your Ultimate Record of Proof

The culmination of this entire process is a comprehensive, well-organized training and competency file for each employee. This file is your primary evidence to an inspector from the Board of Pharmacy, The Joint Commission, or the FDA that you have a robust program and a competent staff. It is a living document that should be continuously updated.

Essential Contents of the File:
  • Initial and ongoing didactic training records and exam results.
  • Signed acknowledgements for reading all required USP chapters and P&Ps.
  • Completed hands-on skills training checklists.
  • All historical GFTS lab reports (pass and fail).
  • All historical media-fill test documentation (pass and fail).
  • Records of any failures, the subsequent root cause investigation, and the documented retraining and successful re-qualification.
  • Annual competency assessment checklists and visual observation forms.

By maintaining this file meticulously, you are not just fulfilling a regulatory requirement; you are codifying your commitment to a culture of safety and excellence.