Ensuring the quality and safety of compounded sterile preparations (CSPs) does not end once the manipulations are complete. A robust quality assurance program, culminating in a meticulous final product verification by the pharmacist, is a non-negotiable component of sterile compounding that serves as the last line of defense against medication errors and contamination. This process involves everything from routine environmental monitoring and personnel testing to the critical final check of the CSP itself. For PharmD students, mastering the principles of quality assurance and final product verification is a fundamental responsibility for ensuring patient safety. This MCQ quiz will test your knowledge on these crucial aspects of sterile compounding.
1. A comprehensive quality assurance (QA) program in sterile compounding is designed to:
- A. Primarily increase the speed of the compounding process.
- B. Document pharmacist productivity for performance reviews.
- C. Provide ongoing verification that the compounding environment and personnel maintain the required standards for producing safe and sterile preparations.
- D. Fulfill only the requirements for billing and reimbursement.
Answer: C. Provide ongoing verification that the compounding environment and personnel maintain the required standards for producing safe and sterile preparations.
2. The final verification of a compounded sterile preparation (CSP) before it is dispensed is the ultimate responsibility of the:
- A. Pharmacy technician who compounded the product.
- B. Pharmacist.
- C. Nurse who will administer the product.
- D. Patient receiving the product.
Answer: B. Pharmacist.
3. Media-fill testing is performed to validate the aseptic technique of compounding personnel. A successful test is indicated by:
- A. The development of turbidity (cloudiness) in the growth medium after incubation.
- B. No visible microbial growth in the growth medium after incubation for 14 days.
- C. The compounder’s ability to complete the test within 10 minutes.
- D. A successful bubble point test of the media-fill unit.
Answer: B. No visible microbial growth in the growth medium after incubation for 14 days.
4. Gloved Fingertip and Thumb Sampling (GFT) is conducted immediately after a compounder has donned sterile gloves and before disinfecting them with sterile IPA. This test is designed to assess:
- A. The dexterity of the compounder.
- B. The effectiveness of the hand hygiene and garbing procedure.
- C. The sterility of the gloves inside their packaging.
- D. The effectiveness of the PEC’s HEPA filter.
Answer: B. The effectiveness of the hand hygiene and garbing procedure.
5. Environmental monitoring includes viable air sampling to determine the number of colony-forming units (CFUs) in the air. For an ISO Class 7 buffer room, the action level is typically:
- A. >0 CFUs per cubic meter
- B. >1 CFU per cubic meter
- C. >10 CFUs per cubic meter
- D. >100 CFUs per cubic meter
Answer: C. >10 CFUs per cubic meter (Action levels can be defined by the facility but this is a common reference point).
6. Surface sampling is performed periodically on surfaces inside the PEC and in the cleanroom. If a surface sample from inside an ISO Class 5 PEC exceeds the action level (typically >3 CFUs), what is required?
- A. The result should be ignored if the air sampling passed.
- B. The result should be documented, the cause investigated, and corrective action, such as re-cleaning and re-sampling, must be taken.
- C. The entire cleanroom must be shut down for a month.
- D. The HEPA filter must be replaced immediately.
Answer: B. The result should be documented, the cause investigated, and corrective action, such as re-cleaning and re-sampling, must be taken.
7. During final product verification, the pharmacist visually inspects the CSP against a light and dark background. This step is crucial for identifying:
- A. The correct pH of the solution.
- B. The correct drug concentration.
- C. Particulate matter, cored vial fragments, precipitation, or other physical incompatibilities.
- D. The presence of bacterial endotoxins.
Answer: C. Particulate matter, cored vial fragments, precipitation, or other physical incompatibilities.
8. Which of the following is a critical step in the final verification process before a CSP is released?
- A. Asking the technician if they think it was made correctly.
- B. Comparing the final compounded product label against the original prescriber’s order.
- C. Assuming all calculations performed by the compounding software are correct.
- D. Smelling the final product to check for contamination.
Answer: B. Comparing the final compounded product label against the original prescriber’s order.
9. Sterility testing of a CSP is required when:
- A. The CSP is prepared for a single patient for immediate use.
- B. The CSP is a Category 1 or 2 preparation with a standard, short Beyond-Use Date (BUD).
- C. The compounding facility wants to assign a BUD longer than what is prescribed by USP <797> default limits, or for certain high-risk/Category 3 batches.
- D. The CSP contains a colored drug.
Answer: C. The compounding facility wants to assign a BUD longer than what is prescribed by USP <797> default limits, or for certain high-risk/Category 3 batches.
10. The bacterial endotoxin test (BET), often performed using Limulus Amebocyte Lysate (LAL), is used to detect:
- A. Live bacteria
- B. Fungal spores
- C. Pyrogens (fever-causing substances) from the cell walls of gram-negative bacteria
- D. Viruses
Answer: C. Pyrogens (fever-causing substances) from the cell walls of gram-negative bacteria
11. A pharmacist is verifying a TPN solution. They notice a fine white precipitate has formed. What is the most likely cause and the appropriate action?
- A. It is a normal occurrence; dispense the bag.
- B. It is likely a calcium-phosphate precipitate; the bag must be quarantined and rejected.
- C. The bag was not mixed well; shake vigorously and dispense.
- D. The precipitate will dissolve upon administration; dispense the bag.
Answer: B. It is likely a calcium-phosphate precipitate; the bag must be quarantined and rejected.
12. The “Compounding Record” for a specific CSP must be reviewed during final verification. This document should contain all of the following EXCEPT:
- A. The ingredients used, including their manufacturers, lot numbers, and expiration dates.
- B. The name of the person who compounded the CSP and the pharmacist who verified it.
- C. A generalized recipe for how to make any CSP.
- D. The calculations performed for the preparation.
Answer: C. A generalized recipe for how to make any CSP. (This belongs in the Master Formulation Record).
13. What is the purpose of pressure differential monitoring between the buffer area and the ante-area?
- A. To ensure the temperature is consistent between the rooms.
- B. To verify that air is flowing from the cleaner area to the less clean area, preventing influx of contaminants.
- C. To measure the total particle count in the air.
- D. To test the integrity of the HEPA filter.
Answer: B. To verify that air is flowing from the cleaner area to the less clean area, preventing influx of contaminants.
14. A pharmacist is verifying an intravenous admixture and notices a tiny, dark speck floating in the bag. What is this an example of?
- A. Chemical contamination
- B. Microbial contamination
- C. Physical contamination (particulate matter)
- D. Therapeutic incompatibility
Answer: C. Physical contamination (particulate matter)
15. If a pharmacist discovers a calculation error during the final verification of a CSP that has already been made, what is the correct action?
- A. Correct the label and dispense the product to avoid waste.
- B. Dispense the product and inform the nurse to adjust the infusion rate.
- C. Quarantine the product, label it as incorrect, and have it properly remade.
- D. Ignore the error if it is less than a 10% difference.
Answer: C. Quarantine the product, label it as incorrect, and have it properly remade.
16. How often should personnel compounding sterile products undergo competency re-evaluation, including gloved fingertip sampling and media-fill testing?
- A. Only upon initial hiring.
- B. Every 5 years.
- C. At least annually for low- and medium-risk compounding, and semi-annually for high-risk compounding (under historical risk levels); competency is re-assessed periodically (e.g., annually) under the new category system.
- D. Only if an error occurs.
Answer: C. At least annually for low- and medium-risk compounding, and semi-annually for high-risk compounding (under historical risk levels); competency is re-assessed periodically (e.g., annually) under the new category system.
17. The pharmacist’s final check includes verifying the correct diluent was used. Using an incorrect diluent can lead to:
- A. Only a change in the color of the final product.
- B. Drug precipitation, inactivation, or formation of toxic byproducts.
- C. A guaranteed increase in drug potency.
- D. No significant consequences.
Answer: B. Drug precipitation, inactivation, or formation of toxic byproducts.
18. What does “release testing” refer to in the context of sterile compounding quality assurance?
- A. Releasing a staff member from their compounding duties.
- B. Tests that are performed on a CSP (e.g., sterility, endotoxin) before it is released from the pharmacy for patient administration.
- C. Testing the air quality in the room.
- D. Verifying the correct patient has been selected.
Answer: B. Tests that are performed on a CSP (e.g., sterility, endotoxin) before it is released from the pharmacy for patient administration.
19. Why is it important to verify the integrity of the container (e.g., IV bag, syringe) during the final check?
- A. To ensure the label adheres correctly.
- B. To check for leaks, punctures, or defects that could compromise the sterility of the contents.
- C. To make sure the container is the right color.
- D. To estimate the final volume.
Answer: B. To check for leaks, punctures, or defects that could compromise the sterility of the contents.
20. A pharmacist is verifying a batch of pre-filled syringes. They should check:
- A. Only one syringe from the batch, assuming all are identical.
- B. Each individual syringe for correct volume, labeling, and absence of defects/particulates.
- C. Only the Compounding Record for the batch.
- D. The total volume of all syringes combined.
Answer: B. Each individual syringe for correct volume, labeling, and absence of defects/particulates.
21. A “failed” gloved fingertip test (i.e., CFU count above action level) indicates a problem with:
- A. The HEPA filter.
- B. The compounder’s hand hygiene and/or garbing and gloving technique.
- C. The cleaning procedure for the PEC.
- D. The sterility of the growth medium.
Answer: B. The compounder’s hand hygiene and/or garbing and aseptic technique.
22. During final verification, a pharmacist notices that the lot number of the drug vial recorded on the compounding record does not match the lot number on the empty vial presented with the final product. What is the correct action?
- A. Correct the lot number on the record and dispense the product.
- B. Assume it was a typo and dispense the product.
- C. Quarantine the product and investigate the discrepancy to ensure the correct drug and concentration were used.
- D. Ask the technician to find the vial with the matching lot number.
Answer: C. Quarantine the product and investigate the discrepancy to ensure the correct drug and concentration were used.
23. The “syringe pull-back method,” where the plunger is pulled back to the volume of drug that was supposed to be added, is:
- A. A reliable and recommended method for verifying drug additions.
- B. An unreliable method that is prohibited for verification as it does not confirm the actual drug or volume added.
- C. Only used for hazardous drug compounding.
- D. The only method available for verification.
Answer: B. An unreliable method that is prohibited for verification as it does not confirm the actual drug or volume added.
24. In a quality assurance program, “preventive maintenance” for equipment like pumps and automated compounders is important to:
- A. Ensure the equipment looks clean.
- B. Ensure continued accuracy and proper functioning, preventing errors.
- C. Fulfill the manufacturer’s warranty only.
- D. Increase the speed of compounding.
Answer: B. Ensure continued accuracy and proper functioning, preventing errors.
25. Which of the following is a critical part of the label verification for a CSP?
- A. Checking that the font is easy to read.
- B. Ensuring the patient’s name, drug name, dose, route, and beyond-use date are all correct and match the order.
- C. Verifying the cost of the CSP.
- D. Making sure the label is not wrinkled.
Answer: B. Ensuring the patient’s name, drug name, dose, route, and beyond-use date are all correct and match the order.
26. A pharmacist is verifying an amber-colored IV bag containing a light-sensitive drug. Part of the quality check is to ensure:
- A. The bag is not amber, as this indicates contamination.
- B. The bag is appropriately protected from light as required.
- C. The drug has changed color, which is expected.
- D. The bag is stored at room temperature.
Answer: B. The bag is appropriately protected from light as required.
27. End-product testing for pyrogens is especially critical for:
- A. CSPs prepared in small volumes.
- B. CSPs prepared in an ISO Class 5 environment from sterile ingredients.
- C. CSPs prepared from non-sterile ingredients or those with a high risk of microbial contamination.
- D. All topical preparations.
Answer: C. CSPs prepared from non-sterile ingredients or those with a high risk of microbial contamination.
28. An effective QA program requires robust documentation for all of the following EXCEPT:
- A. Personnel training and competency assessments.
- B. Environmental monitoring results.
- C. The personal opinions of the pharmacy staff about the workflow.
- D. Equipment calibration and maintenance logs.
Answer: C. The personal opinions of the pharmacy staff about the workflow.
29. During visual inspection, a pharmacist notes that a solution that should be clear is hazy or cloudy. This could indicate:
- A. Proper mixing of ingredients.
- B. A physical incompatibility or precipitation.
- C. The drug is at the correct concentration.
- D. The solution is sterile.
Answer: B. A physical incompatibility or precipitation.
30. Which element is critical for ensuring accountability and traceability in sterile compounding?
- A. Discarding all records after 24 hours.
- B. Having multiple pharmacists check the same product without clear roles.
- C. A complete compounding record that documents every step, ingredient, and person involved in making a specific CSP.
- D. Using only verbal communication for order clarification.
Answer: C. A complete compounding record that documents every step, ingredient, and person involved in making a specific CSP.
31. The Limulus Amebocyte Lysate (LAL) assay is based on the clotting reaction of blood cells from which animal?
- A. The horseshoe crab
- B. The rabbit
- C. The zebrafish
- D. The rhesus monkey
Answer: A. The horseshoe crab
32. For a CSP prepared in a batch, what is a key quality assurance step?
- A. Assuming all units in the batch are identical without checking.
- B. Performing release testing (e.g., sterility, potency) on a representative sample as required, and ensuring procedures are validated to produce uniform units.
- C. Labeling only one unit from the batch.
- D. Storing the batch at room temperature regardless of stability.
Answer: B. Performing release testing (e.g., sterility, potency) on a representative sample as required, and ensuring procedures are validated to produce uniform units.
33. If a CSP requires sterility testing, it must be ________ until the test results are known to be negative.
- A. Immediately dispensed to the patient
- B. Stored at room temperature
- C. Quarantined and not dispensed
- D. Discarded
Answer: C. Quarantined and not dispensed
34. A pharmacist verifying a pediatric CSP must pay extra-close attention to:
- A. The color of the IV bag.
- B. The final concentration and volume, as small errors can lead to large dose deviations in small patients.
- C. Whether the drug is a brand name or generic.
- D. The time of day it was compounded.
Answer: B. The final concentration and volume, as small errors can lead to large dose deviations in small patients.
35. A quality assurance program should include a clear policy for:
- A. How to handle and report compounding errors and adverse drug events.
- B. How to bypass all safety checks to work faster.
- C. How to avoid documenting any deviations from procedure.
- D. How to ensure only pharmacists perform cleaning duties.
Answer: A. How to handle and report compounding errors and adverse drug events.
36. Verifying the correct diluent is critical. For example, which drug must NOT be diluted with Dextrose due to precipitation?
- A. Amphotericin B (conventional)
- B. Phenytoin
- C. Ampicillin
- D. Cefazolin
Answer: B. Phenytoin (Amphotericin B must be diluted in Dextrose, not saline. Phenytoin must be diluted in Normal Saline, not Dextrose).
37. When verifying an order for a hazardous drug, the pharmacist ensures all USP <800> handling precautions were followed. This is an example of ensuring:
- A. Only patient safety.
- B. Only compounder safety.
- C. Both patient and compounder/environmental safety.
- D. Only cost-effectiveness.
Answer: C. Both patient and compounder/environmental safety.
38. The “look-alike, sound-alike” (LASA) issue is a major safety concern. During final verification, the pharmacist must:
- A. Assume the technician always picks the correct drug.
- B. Carefully compare the vial used with the original order, paying close attention to the drug name and strength.
- C. Only check the expiration date.
- D. Rely on the color of the vial cap to verify the drug.
Answer: B. Carefully compare the vial used with the original order, paying close attention to the drug name and strength.
39. A “closed system drug-transfer device” (CSTD) is a quality and safety tool used during:
- A. The compounding and administration of hazardous drugs to prevent exposure.
- B. The final visual inspection of all CSPs.
- C. The cleaning of the cleanroom.
- D. The transportation of non-hazardous drugs.
Answer: A. The compounding and administration of hazardous drugs to prevent exposure.
40. A pharmacist is checking a compounded syringe of heparin. It is critical to verify:
- A. That the syringe is the correct color.
- B. That the concentration (e.g., 10 units/mL vs 10,000 units/mL) and total dose are correct to prevent a catastrophic error.
- C. That the patient has a history of bleeding.
- D. That the heparin was stored in the refrigerator.
Answer: B. That the concentration (e.g., 10 units/mL vs 10,000 units/mL) and total dose are correct to prevent a catastrophic error.
41. The BUD of a CSP is based on sterility and stability. What is stability in this context?
- A. The ability of the compounder to remain stable during a long shift.
- B. The time period during which the CSP maintains its original physical, chemical, and therapeutic properties.
- C. The stability of the patient’s underlying condition.
- D. The financial stability of the pharmacy.
Answer: B. The time period during which the CSP maintains its original physical, chemical, and therapeutic properties.
42. A critical part of the final verification is ensuring the CSP label is clear, accurate, and contains appropriate auxiliary labels, such as:
- A. “For Oral Use Only”
- B. “Refrigerate,” “For IV use only,” “Light Sensitive,” or “Hazardous Drug”
- C. “May cause drowsiness” for all IV products
- D. “Shake Vigorously Before Use” for all solutions
Answer: B. “Refrigerate,” “For IV use only,” “Light Sensitive,” or “Hazardous Drug”
43. If a media-fill test is positive (shows microbial growth), what must occur?
- A. The result is documented and ignored.
- B. The compounder must be retrained and successfully pass another media-fill test before they can resume sterile compounding.
- C. The entire pharmacy must be shut down.
- D. The compounder is promoted to a supervisory role.
Answer: B. The compounder must be retrained and successfully pass another media-fill test before they can resume sterile compounding.
44. What is the pharmacist’s role regarding the “look-back” process if a compounded product is recalled?
- A. To ignore the recall notice.
- B. To identify all patients who may have received the recalled product and work with the healthcare team to notify them and manage any potential consequences.
- C. To only notify the pharmacy manager.
- D. To discard all medications in the pharmacy.
Answer: B. To identify all patients who may have received the recalled product and work with the healthcare team to notify them and manage any potential consequences.
45. Which of the following describes an appropriate method of verifying drug volume added to an IV bag?
- A. The syringe pull-back method
- B. Having a second person watch the compounding process
- C. Reviewing the empty vial and the volume markings on the used syringe presented with the final product
- D. Weighing the final product and comparing it to a calculated expected weight (gravimetrics)
Answer: D. Weighing the final product and comparing it to a calculated expected weight (gravimetrics) (This is a technology-based method; C is the traditional manual method).
46. Quality in sterile compounding extends to the proper labeling and handling of medications after they leave the pharmacy. This includes ensuring:
- A. The IV bag is stored at the patient’s bedside for convenience.
- B. It is stored under the correct conditions (e.g., refrigeration, light protection) on the nursing unit.
- C. Any nurse can administer any IV medication to any patient.
- D. The medication can be used beyond its BUD.
Answer: B. It is stored under the correct conditions (e.g., refrigeration, light protection) on the nursing unit.
47. A quality assurance program must have a system for handling deviations and errors. The primary purpose of this system is:
- A. Punitive action
- B. Process improvement and error prevention
- C. Billing documentation
- D. Ignoring all deviations
Answer: B. Process improvement and error prevention
48. When verifying a CSP, the pharmacist confirms that all calculations were performed correctly. This is especially important for:
- A. All CSPs, but particularly for high-alert medications and pediatric or neonatal doses.
- B. Only hazardous drugs.
- C. Only non-hazardous drugs.
- D. Only drugs that are colored.
Answer: A. All CSPs, but particularly for high-alert medications and pediatric or neonatal doses.
49. The overall quality of a sterile compounding program is most dependent on:
- A. The brand of sterile gloves used.
- B. The size of the pharmacy.
- C. A culture of safety and meticulous adherence to well-designed policies and procedures by all personnel.
- D. The speed at which products can be made.
Answer: C. A culture of safety and meticulous adherence to well-designed policies and procedures by all personnel.
50. The final “release check” or verification by a pharmacist is a professional obligation that serves as:
- A. An unnecessary delay in patient care.
- B. A critical safety check to protect the patient from potential harm from a compounding error.
- C. A task that can be delegated to a non-pharmacist.
- D. A way to increase the cost of the medication.
Answer: B. A critical safety check to protect the patient from potential harm from a compounding error.