HSPA Regulations and Standards Compliance 3 — Questions and Answers
Question 1: What standard addresses safe ethylene oxide sterilization in healthcare?
- AAMI ST79
- AAMI ST41 (Correct answer)
- OSHA 1910.1030
- CDC Disinfection Guideline
Correct answer: AAMI ST41
AAMI ST41 covers ETO sterilization safety and effectiveness in healthcare facilities.
AAMI ST41 covers installation, operation, monitoring, and safety requirements. OSHA also regulates ETO workplace exposure limits (1 ppm TWA, 5 ppm STEL).
Question 2: What is AORN's role in sterile processing standards?
- AORN directly regulates SPD
- AORN publishes perioperative practice guidelines relevant to instrument handling and sterilization (Correct answer)
- AORN only sets OR nursing standards
- AORN certifies SP technicians
Correct answer: AORN publishes perioperative practice guidelines relevant to instrument handling and sterilization
AORN publishes evidence-based guidelines that complement AAMI standards and impact SPD practices.
AORN guidelines cover instrument handling from point of use through reprocessing. They are referenced by regulatory surveyors alongside AAMI standards.
Question 3: What are OSHA permissible exposure limits for glutaraldehyde?
- 0.05 ppm ceiling limit (Correct answer)
- 0.5 ppm ceiling limit
- 5 ppm TWA
- No OSHA limits exist
Correct answer: 0.05 ppm ceiling limit
OSHA has a ceiling limit of 0.05 ppm, meaning this concentration should never be exceeded.
As a ceiling limit, 0.05 ppm should never be exceeded at any point. Many facilities have replaced glutaraldehyde with less toxic alternatives like OPA or peracetic acid systems.
Question 4: What documentation must be maintained for biological indicator testing?
- Only positive results
- Complete records of every BI test including date, sterilizer ID, cycle number, BI lot, result, and operator (Correct answer)
- Monthly summaries suffice
- Documentation is optional
Correct answer: Complete records of every BI test including date, sterilizer ID, cycle number, BI lot, result, and operator
Complete documentation of every BI test is required for traceability and compliance.
Records must include date, time, sterilizer ID, cycle number, BI lot and expiration, indicator type, incubation conditions, results, control results, operator, and corrective actions.
Question 5: What is a 'recall' in sterile processing?
- Returning defective instruments to manufacturer
- Retrieving and quarantining items from a load when monitoring indicates sterilization failure (Correct answer)
- Recalling staff from break
- Sending instruments back for recleaning
Correct answer: Retrieving and quarantining items from a load when monitoring indicates sterilization failure
A recall involves retrieving all items from a suspect sterilization load when monitoring indicates potential failure.
Triggered by positive BI results, sterilizer malfunctions, or failed indicators. The process includes quarantine, retrieval, notification, reprocessing, investigation, and documentation.
Question 6: What certification does HSPA offer for sterile processing technicians?
- No formal education required
- CRCST certification requiring education, passing exam, and continuing education (Correct answer)
- Only a bachelor's degree
- Certification is voluntary
Correct answer: CRCST certification requiring education, passing exam, and continuing education
HSPA administers CRCST certification requiring education, examination, and continuing education.
Requirements include high school diploma, 400+ hour SP education program, passing the CRCST exam, and 12 CE credits annually. Many states now require certification by law.
HSPA Regulations and Standards Compliance 3
What standard addresses safe ethylene oxide sterilization in healthcare?