SPD Documentation and Record Keeping 3

Question 1

Which standard provides guidance on documentation requirements for steam sterilization in healthcare facilities?

Accepted Answer

AAMI ST79: Comprehensive Guide to Steam Sterilization and Sterility Assurance

Answer

OSHA 29 CFR 1910.1200 (Hazard Communication Standard)

Answer

FDA 21 CFR Part 820 (Quality System Regulation for manufacturers only)

Answer

CDC Guidelines for Environmental Infection Control in Health-Care Facilities

Question 2

What does 'traceability' mean in the context of sterile processing documentation?

Accepted Answer

The ability to link a processed item to the patient, the procedure, and the sterilization cycle in which it was processed

Answer

The ability to track instrument costs from purchase to disposal

Answer

Monitoring which technician cleaned each instrument

Answer

Recording the exact transit route from the decontamination room to the sterile storage area

Question 3

If a sterilizer's printout chart shows a cycle did not reach the required temperature, what action should be taken?

Accepted Answer

Document the failed cycle, quarantine the load, and report to a supervisor for investigation

Answer

Accept the load if the external chemical indicator changed color

Answer

Re-run only the biological indicator before releasing the load

Answer

Release the load if the cycle time was extended to compensate

Question 4

Which type of sterilization monitoring provides the HIGHEST level of assurance that sterilization conditions were achieved?

Accepted Answer

Biological indicators containing resistant spore organisms

Answer

External chemical indicators (Type 1)

Answer

Physical/mechanical monitoring (printout charts)

Answer

Internal Type 3 chemical indicators

Question 5

What is the correct action when a package label becomes illegible or falls off a sterile item before use?

Accepted Answer

Return the item to SPD for reprocessing; it can no longer be released as sterile

Answer

Use the item if the packaging appears intact and undamaged

Answer

Re-label the item using information estimated from similar packages

Answer

Apply a new label with today's date and continue with distribution

Question 6

Why is it important to document the specific sterilizer used (e.g., Sterilizer #2) on every load record?

Accepted Answer

To enable targeted recalls and investigations if a specific sterilizer malfunctions

Answer

To ensure technicians rotate sterilizer use evenly across the department

Answer

To comply with OSHA chemical labeling requirements

Answer

To track which sterilizer processes the most loads for scheduling purposes

Question 7

In sterile processing, what is the purpose of the Bowie-Dick test and how is it documented?

Accepted Answer

It detects air removal efficiency in prevacuum steam sterilizers and results are recorded daily before the first load

Answer

It tests for spore kill in every sterilizer load and results are logged in the biological indicator record

Answer

It measures the concentration of cleaning detergent and is logged in the decontamination record

Answer

It verifies packaging seal integrity and results are filed in the supply purchasing record