SPD Documentation and Record Keeping 2 — Questions and Answers
Question 1: Which document provides manufacturer-validated instructions for cleaning, disinfecting, and sterilizing a specific medical device?
- The hospital's infection control policy manual
- The instrument's Instructions for Use (IFU) (Correct answer)
- OSHA's Bloodborne Pathogen Standard
- The sterile processing department's employee handbook
Correct answer: The instrument's Instructions for Use (IFU)
The manufacturer's Instructions for Use (IFU) contain validated reprocessing parameters and must be followed to ensure effective decontamination and sterilization of that specific device.
Question 2: What information should be documented when a loaner instrument set is received in the SPD?
- Only the name of the surgeon requesting the set
- Receipt date, vendor name, count, condition of instruments, and IFU availability (Correct answer)
- The cost of the set and the scheduled return date
- The number of times the set has previously been sterilized
Correct answer: Receipt date, vendor name, count, condition of instruments, and IFU availability
Documenting receipt date, vendor, count, instrument condition, and IFU availability ensures loaner sets are properly tracked, inspected, and reprocessed according to validated instructions before use.
Question 3: In SPD, what does a 'chemical indicator' (CI) record in the sterilization documentation confirm?
- That the biological indicator showed no growth after incubation
- That the package was exposed to sterilization conditions during the cycle (Correct answer)
- That the instruments passed visual inspection before packaging
- That the correct disinfectant concentration was used during cleaning
Correct answer: That the package was exposed to sterilization conditions during the cycle
Chemical indicators change color or form when exposed to sterilization parameters (e.g., heat, steam, EO gas), confirming the package experienced the sterilization process, though they do not confirm sterility.
Question 4: Which record-keeping practice supports a 'sterility assurance' program in an accredited facility?
- Documenting only failed cycles to minimize paperwork
- Maintaining records of every sterilization load including physical, chemical, and biological monitoring (Correct answer)
- Keeping records only when implantable devices are sterilized
- Relying solely on employee memory for low-volume cycles
Correct answer: Maintaining records of every sterilization load including physical, chemical, and biological monitoring
A complete sterility assurance program requires records of physical printouts, chemical indicator results, and biological indicator outcomes for every load to demonstrate consistent compliance.
Question 5: When sterilizing implantable devices, what additional documentation requirement typically applies?
- A surgeon signature is required before the load is run
- Biological indicator results must be reviewed and documented before the implant is released (Correct answer)
- Implantable items require only a Class 5 chemical indicator, with no BI needed
- Implantable documentation is optional if the instrument is from a reputable manufacturer
Correct answer: Biological indicator results must be reviewed and documented before the implant is released
For implantable devices, AAMI and accreditation standards require that a biological indicator be run with the load and results reviewed before the item is released for use.
Question 6: What should an SPD technician do if they discover an incomplete or missing sterilization load record?
- Fill in the missing fields from memory to complete the record
- Report the discrepancy to a supervisor and follow the facility's corrective action protocol (Correct answer)
- Discard the record and create a new one with estimated data
- Continue processing without addressing the incomplete record
Correct answer: Report the discrepancy to a supervisor and follow the facility's corrective action protocol
Incomplete records are a compliance and patient safety issue; the correct action is to report the discrepancy to a supervisor and follow the facility's established corrective action protocol.
Question 7: What is the primary purpose of a sterilizer maintenance log?
- To record the names of technicians who are certified to operate the sterilizer
- To document preventive maintenance, repairs, and calibration to ensure equipment is functioning properly (Correct answer)
- To track the purchase price and depreciation schedule of the sterilizer
- To list all items sterilized in the unit over its service life
Correct answer: To document preventive maintenance, repairs, and calibration to ensure equipment is functioning properly
A maintenance log documents scheduled preventive maintenance, repairs, and calibration events, providing evidence that the sterilizer is operating within validated performance specifications.
SPD Documentation and Record Keeping 2
Which document provides manufacturer-validated instructions for cleaning, disinfecting, and sterilizing a specific medical device?