CSPT - Compounded Sterile Preparation Technician Storage, Handling, and Transport Questions and Answers 1 — Questions and Answers
Question 1: A technician needs to transport a compounded chemotherapy infusion bag from the pharmacy to a nursing unit on a different floor. To comply with USP <800> guidelines, which of the following transport methods is most appropriate?
- Placing the bag in a pneumatic tube system carrier without additional packaging.
- Carrying the infusion bag by hand to ensure it remains upright.
- Placing the bag inside a sealed, impact-resistant container clearly labeled as a hazardous drug. (Correct answer)
- Putting the infusion bag in a standard paper bag to protect patient privacy.
Correct answer: Placing the bag inside a sealed, impact-resistant container clearly labeled as a hazardous drug.
USP <800> requires hazardous drugs (HDs) to be transported in a manner that prevents breakage and leakage. Using a sealed, labeled, impact-resistant container minimizes exposure risk to staff and the environment during transport. [8, 14] Pneumatic tube systems are generally discouraged for liquid HDs due to the risk of breakage and contamination. [7]
Question 2: A pharmacy's refrigerator is used for storing both sterile components and finished CSPs. According to USP <797>, which of the following is a mandatory practice for this storage unit?
- Storing food and beverages is permissible as long as they are on a shelf separate from medications.
- The temperature must be monitored and documented at least once daily on days the pharmacy is open. (Correct answer)
- A standard dormitory-style refrigerator is acceptable if it maintains the correct temperature.
- The refrigerator only needs to be monitored if it contains controlled substances.
Correct answer: The temperature must be monitored and documented at least once daily on days the pharmacy is open.
USP <797> requires that temperature-controlled storage areas, such as refrigerators, have their temperatures monitored and documented daily to ensure that medications are stored within their required stability ranges. [15, 18] This ensures the integrity and safety of the stored components and CSPs. Food and beverages are never permitted in medication storage units.
Question 3: Before moving supplies from the anteroom into the buffer area (ISO Class 7), which of the following is the correct procedure for handling items like bags of IV solution and vials?
- Wiping down the outer surfaces of all supplies with a sporicidal agent or sterile 70% isopropyl alcohol. (Correct answer)
- Removing all items from their cardboard shipping boxes inside the buffer area to reduce traffic.
- Spraying the outside of cardboard boxes with sterile IPA before placing them in the buffer area.
- Placing all supplies directly into the Primary Engineering Control (PEC) to be wiped down.
Correct answer: Wiping down the outer surfaces of all supplies with a sporicidal agent or sterile 70% isopropyl alcohol.
To prevent the introduction of contaminants into the cleanroom suite, all supplies must be uncartoned and have their outer surfaces wiped down with a suitable disinfectant (like sterile 70% IPA) before being passed from the anteroom to the buffer area. [6, 17] Cardboard and other particle-shedding materials are not allowed in the buffer area or PEC.
Question 4: A shipment of medication arrives with the manufacturer's storage instruction listed as "Store at controlled room temperature." According to the USP definition, this corresponds to which temperature range?
- Any temperature between 15°C and 30°C (59°F to 86°F).
- 2°C to 8°C (36°F to 46°F).
- 20°C to 25°C (68°F to 77°F). (Correct answer)
- -25°C to -10°C (-13°F to 14°F).
Correct answer: 20°C to 25°C (68°F to 77°F).
USP General Chapter <659> defines "controlled room temperature" as the temperature thermostatically maintained between 20°C and 25°C (68°F to 77°F). [1, 2, 3] While excursions between 15°C and 30°C are permitted, the core definition is the 20-25°C range. [3, 4]
Question 5: A patient-specific IV bag is returned to the pharmacy after being sent to a nursing unit. Under which circumstance may this CSP be redispensed to another patient?
- If the nurse states that the IV bag was never opened or used.
- If the IV bag is for a common antibiotic that is in short supply.
- If the tamper-evident seal is still intact and it will be used within the hour.
- Under no circumstances; once a CSP leaves the direct control of the pharmacy for a specific patient, it cannot be redispensed to another. (Correct answer)
Correct answer: Under no circumstances; once a CSP leaves the direct control of the pharmacy for a specific patient, it cannot be redispensed to another.
Once a compounded sterile preparation has been labeled for and sent to a specific patient care area, it cannot be returned and redispensed to another patient. The pharmacy can no longer guarantee the proper storage conditions and integrity of the CSP once it has left its control. USP <797> allows for redispensing only if the pharmacy can ensure the CSP remained sterile, pure, and stable, which is virtually impossible after it has been on a patient unit. [6, 7]
Question 6: A hospital pharmacy is considering using its pneumatic tube system to transport CSPs. Which of the following is a critical factor that must be evaluated before implementing this practice?
- The potential for physical agitation and impact forces to compromise the product or container integrity. (Correct answer)
- Whether the system can also be used to transport hazardous drugs without special packaging.
- If the system can deliver a CSP to the nursing unit in under 60 seconds.
- The color of the pneumatic tube carriers used for medications.
Correct answer: The potential for physical agitation and impact forces to compromise the product or container integrity.
USP <797> advises that the physical shaking, acceleration, and impact from pneumatic tube transport can adversely affect certain CSPs, potentially causing protein denaturation or container breakage. [6, 7, 11] Therefore, the pharmacy must evaluate and validate that this transport method does not compromise the quality and integrity of the specific CSPs being sent.
CSPT - Compounded Sterile Preparation Technician Storage, Handling, and Transport Questions and Answers 1
A technician needs to transport a compounded chemotherapy infusion bag from the pharmacy to a nursing unit on a different floor.
To comply with USP guidelines, which of the following transport methods is most appropriate?