CSSD - Central Sterile Services Department Documentation and Regulatory Compliance Questions and Answers Flashcards
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What is the purpose of a 'corrective action report' (CAR) in a CSSD quality management system?
Answer: To document a process failure, identify its root cause, and record the corrective steps taken to prevent recurrence
A corrective action report documents a process failure or nonconformance, investigates the root cause, and records the corrective actions implemented to prevent the problem from recurring.
What information must be included on a package label according to AAMI ST79 labeling requirements?
Answer: Lot control number, sterilizer number, load number, and expiration date or cycle date
AAMI ST79 requires package labels to include lot control information — at minimum the sterilizer number, load number, and cycle date — to support traceability and recall in the event of a sterilization failure.
Which federal agency regulates the registration and use of sterilants and high-level disinfectants as pesticides in US healthcare?
Answer: EPA
The EPA regulates sterilants and disinfectants classified as pesticides (e.g., glutaraldehyde, peracetic acid) under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), requiring registration and label compliance.
What is the purpose of an 'implant log' in CSSD documentation?
Answer: To document the sterilization load and biological indicator results for every load containing an implant before the implant is released for use
An implant log documents the sterilization load number, BI results, and cycle data for every load containing an implant; implants must not be released until a passing BI result is confirmed, per AAMI ST79.
What does the term 'manufacturer's instructions for use' (IFU) mean in the context of CSSD reprocessing?
Answer: The device manufacturer's validated, written directions for cleaning, disinfecting, and sterilizing a specific device
The manufacturer's IFU provides the only validated reprocessing method for a specific device, and CSSD staff are legally and professionally required to follow it to ensure safety and device functionality.
According to Joint Commission standards, when a sterilization failure is confirmed, what is the first priority for CSSD leadership?
Answer: Initiating a recall of all potentially non-sterile items from the affected load and notifying the appropriate clinical staff and infection control
Patient safety requires that a confirmed sterilization failure trigger an immediate recall of potentially non-sterile items and notification of clinical staff and infection control so that patient exposure can be assessed and managed.