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Case Study – Certified USP 800 Compliance Officer (CUCO)
CUCO Interactive Case Studies
Certified USP 800 Compliance Officer (CUCO)
The Scenario: Conducting an Assessment of Risk (AoR)
A urology clinic within your health system dispenses finasteride 5mg tablets. Finasteride is on the NIOSH List (Table 3) for reproductive risks. The clinic does not have a negative pressure room. As the CUCO, you must conduct an AoR to determine if alternative containment strategies are permissible for dispensing this medication.
Drug, Workflow, and USP <800> Rules
Drug & Workflow Details
- Drug: Finasteride 5 mg tablets (NIOSH Table 3)
- Dosage Form: Intact, film-coated tablets.
- Workflow: Tablets are counted from a stock bottle into a vial using a counting tray. No splitting or crushing occurs.
USP <800> AoR Requirements
An AoR allows for alternative containment strategies if a documented assessment evaluates the: 1. Type of HD, 2. Dosage Form, 3. Risk of Exposure, 4. Packaging, and 5. Manipulation.
Your Task
Task 1: What is the purpose of an Assessment of Risk (AoR) under USP <800>?
Answer:
The purpose is to provide a formal, documented process to evaluate specific, lower-risk hazardous drug activities (e.g., handling intact tablets) and determine if they can be performed safely with alternative containment strategies and work practices, rather than the full, stringent requirements of the chapter.
Task 2: Can this activity be performed outside of full USP <800> containment? Justify your decision.
Answer:
Yes. The drug is on NIOSH Table 3 (reproductive risk only) and is handled in its final, intact dosage form without any manipulation that would create particles (like splitting or crushing). A properly conducted AoR can justify handling it on a general countertop with alternative strategies.
Task 3: What four specific "alternative containment strategies and work practices" must be documented in your AoR?
Answer:
1. PPE: Staff must wear one pair of ASTM D6978 chemo gloves. 2. Designated Area: The activity must be performed on a dedicated counting tray and spatula used only for hazardous drugs. 3. Decontamination: The tray and spatula must be decontaminated, cleaned, and disinfected immediately after use. 4. Staff Training: All staff must receive specific training on the reproductive risks of finasteride, and this training must be documented.
Task 4: Who is responsible for reviewing and approving the AoR, and at what minimum frequency?
Answer:
The designated Compounding Supervisor or a similar role (often the CUCO) is responsible for ensuring the AoR is conducted. The AoR document must be reviewed and documented at least every 12 months and whenever a change in process or dosage form occurs.
The Scenario: Investigating Environmental Contamination
You are the CUCO for a hospital. You receive the semi-annual environmental wipe sampling report for your non-sterile hazardous drug compounding room. The report shows significant surface contamination in an unexpected area, indicating a failure of your containment strategies and work practices. You must investigate the root cause and develop a remediation plan.
Facility Layout & Wipe Sample Report
Facility Layout
The compounding room is a negative pressure C-SEC. The powder containment hood (C-PEC) is on the left wall. The pass-through window for finished products is on the right wall.
Wipe Sample Report (Methotrexate)
| Location | Level | Limit |
|---|---|---|
| Interior of C-PEC | 0.5 ng/cm² | < 1 |
| Floor in front of C-PEC | 0.8 ng/cm² | < 1 |
| Floor in front of Pass-through | 5.2 ng/cm² | < 1 |
Your Task
Task 1: What is the purpose of semi-annual environmental wipe sampling according to USP <800>?
Answer:
Its purpose is to verify the effectiveness of containment strategies and work practices. It is a quality assurance measure to detect residual, invisible hazardous drug contamination on surfaces and identify areas where containment may be failing.
Task 2: Based on the report, where is the most significant contamination, and what does this pattern suggest about the source?
Answer:
The most significant contamination is on the floor in front of the pass-through. Since the levels are acceptable inside and in front of the hood, this pattern strongly suggests the contamination is occurring after the product is compounded, likely during the transport of the finished compound from the hood to the pass-through.
Task 3: What is the most likely workflow problem that is causing this contamination pattern?
Answer:
The most likely problem is a flaw in work practice. Technicians are likely failing to decontaminate the exterior of the final preparation (e.g., the ointment jar or capsule bottle) before removing it from the C-PEC. They are then carrying a contaminated container across the room, allowing residue to fall onto the floor.
Task 4: Develop a Corrective and Preventive Action (CAPA) plan with three key components.
Answer:
- Immediate Correction: Perform a full triple-clean (deactivate, decontaminate, clean) of the entire C-SEC.
- Workflow Change: Revise the SOP to require a mandatory step where the technician wipes down the exterior of the final container with an appropriate agent *inside the C-PEC* before it is moved.
- Training & Re-sampling: Conduct and document immediate retraining for all compounding staff on this new workflow step. Plan for a follow-up wipe sample in 1-3 months to verify the corrective action was effective.
The Scenario: Developing a Comprehensive HD Training Program
A large health system has built a new cancer center. As the CUCO, you are responsible for creating the hazardous drug training and competency program from scratch. The program must cover all roles that interact with HDs, from receiving to administration to disposal, and must be compliant with all USP <800> requirements.
Personnel Roles & USP <800> Rules
Personnel Roles to be Trained
- Receiving Staff (unpack HDs)
- Pharmacy Technicians (compound HDs)
- Nurses (administer HDs)
- Environmental Services (clean HD areas)
USP <800> Training Requirements
All personnel who handle HDs must be trained prior to independent handling. Competency must be demonstrated and reassessed at least every 12 months. Training must include the entity's HD list, SOPs, proper use of PPE, equipment use, spill response, and disposal.
Your Task
Task 1: Why is a "one-size-fits-all" training module inappropriate for this diverse group of employees?
Answer:
It is inappropriate because the nature and risk of handling are different for each role. The training must be role-specific. For example, a receiving clerk needs to know how to handle a damaged shipping tote, while a nurse needs to know how to use a Closed System Transfer Device (CSTD). A generic training module would be insufficient for some roles and overwhelming for others.
Task 2: Design a role-based training curriculum. For Receiving Staff and Environmental Services, describe one specific, critical competency for each.
Answer:
- For Receiving Staff: A critical competency is "Procedure for Handling Damaged HD Totes on Arrival." They must be able to identify a potential spill, secure the container, and notify the pharmacist without exposing themselves or the pharmacy.
- For Environmental Services: A critical competency is "Proper Use of HD-Specific Spill Kits and Inactivation Agents." They must know how to respond to a spill and perform the three-step decontamination process correctly.
Task 3: Beyond a written test, what is a critical hands-on method for assessing the annual competency of a compounding technician?
Answer:
A direct observational audit. The CUCO or a trained supervisor must observe the technician perform a full compounding process using a checklist. This assesses their ability to physically perform critical tasks like proper garbing, aseptic technique, and correct use of the C-PEC, which cannot be measured by a written test alone.
Task 4: What is the "list of hazardous drugs," and what is the CUCO's responsibility related to it?
Answer:
The "list of hazardous drugs" is a facility-specific list of all HDs and dosage forms handled at the site. The CUCO is responsible for developing and maintaining this list based on the NIOSH list. It must be reviewed and updated at least every 12 months, and whenever a new agent or dosage form is added to the formulary. This list is the foundation of the entire HD handling program.
