CSPT - Compounded Sterile Preparation Technician Hazardous Drug Compounding Questions and Answers 1 — Questions and Answers
Question 1: A technician is unpacking a shipment of hazardous drugs (HDs) that has just arrived at the pharmacy. According to USP <800>, what is the minimum Personal Protective Equipment (PPE) required for this task?
- A single pair of regular exam gloves.
- One pair of chemotherapy gloves. (Correct answer)
- A lab coat and a surgical mask.
- Two pairs of chemotherapy gloves and a gown.
Correct answer: One pair of chemotherapy gloves.
USP Chapter <800> requires that personnel unpacking HDs wear appropriate PPE to protect from potential contamination on the exterior of containers. The minimum requirement for this specific task is one pair of chemotherapy gloves that meet the American Society for Testing and Materials (ASTM) standard D6978.
Question 2: When cleaning up a small spill of a hazardous drug (less than 5 mL) in the compounding area, which of the following steps is a critical requirement of the USP <800> guidelines?
- Immediately covering the spill with paper towels and waiting for housekeeping.
- Using a spray bottle with disinfectant to saturate the area.
- Wearing appropriate PPE, including two pairs of chemotherapy gloves, and using a spill kit. (Correct answer)
- Wiping the spill with a dry cloth first, then cleaning with sterile water.
Correct answer: Wearing appropriate PPE, including two pairs of chemotherapy gloves, and using a spill kit.
USP <800> mandates that spills must be cleaned immediately by qualified personnel wearing appropriate PPE. For any HD spill, this includes two pairs of chemotherapy gloves, a gown, and eye protection. A spill kit must be accessible and used to contain and clean the spill effectively and safely. Using a spray bottle is prohibited as it can aerosolize the hazardous drug residue.
Question 3: Which of the following agents is recommended by USP <800> for the deactivation of many hazardous drugs on surfaces before decontamination and cleaning?
- Sterile Water for Injection
- 70% Isopropyl Alcohol
- Sodium Hypochlorite (bleach) or Hydrogen Peroxide (Correct answer)
- Quaternary Ammonium Compounds
Correct answer: Sodium Hypochlorite (bleach) or Hydrogen Peroxide
USP <800> outlines a four-step process for cleaning: deactivation, decontamination, cleaning, and disinfection. Deactivation involves rendering the HD inert or inactive. Agents like sodium hypochlorite and hydrogen peroxide are effective oxidizing agents commonly used for this purpose. While 70% isopropyl alcohol is used for disinfection, it does not deactivate HDs.
Question 4: After compounding a sterile hazardous drug, a technician must dispose of the outer pair of chemotherapy gloves. According to USP <800>, where should these gloves be discarded?
- In a regular trash can located outside the buffer room.
- In a sharps container within the Primary Engineering Control (PEC).
- In a red biohazard bag designated for infectious waste.
- In an approved waste container inside the PEC or a sealable bag for disposal outside the PEC. (Correct answer)
Correct answer: In an approved waste container inside the PEC or a sealable bag for disposal outside the PEC.
USP <800> specifies that all PPE worn when handling HDs is considered contaminated. Chemotherapy gloves used during compounding must be discarded in a waste container approved for trace-contaminated waste located inside the Primary Engineering Control (PEC). Alternatively, they can be placed in a sealable bag inside the PEC and then discarded in an appropriate container outside the PEC.
Question 5: A pharmacy is required to have a designated person responsible for overseeing compliance with USP <800>. Which of the following is a primary responsibility of this individual?
- Performing the final verification of all compounded sterile preparations.
- Conducting annual performance reviews for all pharmacy technicians.
- Ensuring competency of personnel and overseeing environmental control of HD areas. (Correct answer)
- Negotiating drug purchasing contracts with wholesalers.
Correct answer: Ensuring competency of personnel and overseeing environmental control of HD areas.
USP <800> requires each entity to have a designated person who is qualified and trained to be responsible for developing procedures, overseeing compliance with the chapter, ensuring personnel competency in handling HDs, and ensuring that the storage and compounding areas are appropriately controlled and monitored.
Question 6: During sterile hazardous drug compounding, how often must a technician's chemotherapy gloves be changed?
- Only when they become visibly soiled or torn.
- Every 30 minutes or per the manufacturer's recommendations. (Correct answer)
- At the beginning and end of each 8-hour shift.
- After compounding every third preparation.
Correct answer: Every 30 minutes or per the manufacturer's recommendations.
To ensure continuous protection and minimize the risk of contamination, USP Chapter <800> requires chemotherapy gloves to be changed every 30 minutes during compounding, or more frequently if they are torn, punctured, or contaminated, unless the manufacturer specifies a longer duration of use.
A technician is unpacking a shipment of hazardous drugs (HDs) that has just arrived at the pharmacy.
According to USP , what is the minimum Personal Protective Equipment (PPE) required for this task?