CSLB General Building (B) — All Questions

Which organism is used in biological indicators for steam sterilization, and why?

• a.Geobacillus stearothermophilus, because its spores are highly resistant to moist heat✓
• b.Bacillus atrophaeus, because its spores are highly resistant to moist heat
• c.Clostridioides difficile, because it is a common healthcare pathogen
• d.Staphylococcus aureus, because it survives on dry surfaces

Biological indicators use a highly resistant spore population that is harder to kill than the microorganisms found on devices, and Geobacillus stearothermophilus fills that role for steam, hydrogen peroxide, and ozone. Bacillus atrophaeus is used for ethylene oxide and dry heat. Vegetative pathogens such as staphylococci and clinical spore formers such as C. difficile are far less resistant and are never used as process challenge organisms.AAMI ST79

A department is setting its biological monitoring policy for a steam sterilizer used for routine loads. How frequently should a biological indicator be run?

• a.Monthly, and after any repair
• b.At least daily on each day the sterilizer is used, preferably in every load, and always in loads containing implants✓
• c.Only in loads containing implants
• d.Annually, as part of preventive maintenance

Biological monitoring at least once each day of use is the minimum expectation, with every-load monitoring recommended because it narrows the recall population if a failure occurs. Implant loads always require a biological indicator in a process challenge device, and the load is quarantined until the result is read. Monthly and annual intervals leave far too many loads unverified.AAMI ST79

A Class 1 chemical indicator is applied to the outside of every wrapped tray. What does it tell the user?

• a.That all critical parameters of the cycle were met
• b.That the contents are sterile and safe for patient use
• c.That the package has been exposed to a sterilization process and distinguishes processed from unprocessed packages✓
• d.That air was successfully removed from the chamber

Class 1 process indicators, such as autoclave tape and preprinted pouch indicators, only distinguish processed from unprocessed items and do not measure whether the cycle was adequate. Confirming that all critical variables were met is the role of Class 5 integrating indicators, and air removal is verified by a Class 2 Bowie-Dick test. Sterility is never established by any single indicator.AAMI ST79

Which class of chemical indicator reacts to all critical variables of the sterilization cycle and has performance correlated to a biological indicator?

• a.Class 1, process indicator
• b.Class 3, single-variable indicator
• c.Class 4, multi-variable indicator
• d.Class 5, integrating indicator✓

Class 5 integrating indicators respond to all critical variables of the cycle and are calibrated against the stated values of the reference biological indicator, which is why they are commonly placed in process challenge devices and in implant loads alongside a biological indicator. Class 3 responds to one variable and Class 4 responds to two or more but not all. Class 1 only shows external exposure.AAMI ST79

A technician finds a box of chemical indicators labeled for use only in a cycle of 270 degrees F for 4 minutes. What type of indicator is this?

• a.An emulating indicator designed and verified for one specific cycle, reacting to all critical variables at the stated values of that cycle✓
• b.An indicator used only in ethylene oxide sterilizers
• c.An indicator that replaces the daily biological indicator
• d.An external indicator used to identify the sterilizer number

Class 6 emulating indicators are cycle specific, meaning an indicator labeled for 270 degrees F and 4 minutes may be used only for that cycle, and they respond to all critical variables at the stated values. They exist for multiple sterilization methods, not just ethylene oxide. No chemical indicator of any class replaces biological monitoring, and identifying the sterilizer is a labeling function.AAMI ST79

A supervisor asks a technician to assemble a process challenge device for the daily biological indicator test. What is a process challenge device?

• a.A device that measures chamber pressure independently of the sterilizer gauges
• b.A test assembly that presents a challenge to the sterilization process equal to or greater than the most difficult item routinely processed, containing a biological or chemical indicator✓
• c.A tray of instruments used only for training new technicians
• d.A software module that records cycle data for traceability

A PCD, such as a commercial test pack or a homemade AAMI test pack, places the indicator in the hardest-to-sterilize location so that a passing result gives confidence that easier items were also processed. The design must challenge the process at least as much as the routine load. Pressure verification, training, and electronic record keeping are separate functions unrelated to the definition of a PCD.AAMI ST79

Where should the process challenge device be placed in a steam sterilizer chamber for routine biological monitoring?

• a.On the top shelf at the rear of the chamber
• b.In the geometric center of the load, surrounded by the densest packs
• c.In the area identified as the most difficult for the sterilant to reach, typically on the bottom shelf near the front over the drain✓
• d.Outside the chamber, taped to the sterilizer door

Air is heaviest and settles low near the drain, so the front bottom of the chamber is the recognized cold spot for a steam sterilizer and is where the PCD is placed. Testing an easy location would give a falsely reassuring result. The exact placement follows the sterilizer manufacturer instructions, and an indicator outside the chamber tests nothing.AAMI ST79

Which of the following are physical monitors of a sterilization cycle?

• a.Autoclave tape and pouch indicators
• b.Spore strips and self-contained vials
• c.Integrating indicators placed inside packs
• d.Time, temperature, and pressure readings on gauges, digital displays, and cycle printouts✓

Physical monitors are the sterilizer's own instrumentation and recording output, and the operator must review and initial the printout or record for each cycle before the load is released. Tape and pouch indicators are chemical Class 1, and integrating indicators are chemical Class 5. Spore strips and vials are biological indicators.AAMI ST79

A biological indicator from this morning's steam load is positive. What is the first action?

• a.Take the sterilizer out of service and immediately recall and quarantine the items from that load and from every load back to the last negative biological indicator✓
• b.Repeat the test at the end of the shift and continue processing loads in the meantime
• c.Discard the indicator as a false positive, since spore vials are unreliable
• d.Notify the operating room that items may have been unsterile but allow already distributed items to be used

A positive biological indicator means the process cannot be assumed to have been lethal, so the sterilizer is removed from service and every load processed since the last negative result is retrieved, quarantined, and reprocessed. Continuing to run loads or waiting to retest extends the exposure to patients. Positives are investigated, not assumed to be false, and previously distributed items must be located, not released for use.AAMI ST79

After a positive biological indicator, the sterilizer is inspected, a probable cause is corrected, and testing resumes. What is generally required before the sterilizer returns to routine service?

• a.A single passing chemical indicator in a full production load
• b.Three consecutive cycles with negative biological indicators in an empty chamber, and for dynamic-air-removal sterilizers three passing Bowie-Dick tests as well✓
• c.One passing biological indicator run in a fully loaded chamber
• d.A signed statement from the operator that the load appeared normal

Requalification after a failure or a major repair uses three consecutive empty-chamber cycles with negative biological indicators, with Bowie-Dick testing added for dynamic-air-removal sterilizers, to demonstrate the equipment is reliably performing again. A chemical indicator does not demonstrate microbial lethality, and one biological indicator in a production load is not sufficient evidence of restored performance. Operator observation is not a qualification method.AAMI ST79

An implant is processed in a terminal steam cycle with a rapid-readout biological indicator. When may the implant be released?

• a.Immediately, if the Class 5 integrating indicator inside the tray has changed
• b.At the end of the shift, regardless of the biological indicator result
• c.Only after the biological indicator result is available and negative, except in a documented emergency✓
• d.Only after 48 hours of incubation, with no exceptions

Implant loads are quarantined until the biological indicator reads negative, because a failure would place a permanently implanted device in a patient. Emergency release before the result is available is permitted only when it is documented and the surgeon is informed, and the result is tracked to completion. A Class 5 indicator supports early release decisions in an emergency but does not by itself satisfy the requirement, and modern rapid-readout indicators give results in far less than 48 hours.AAMI ST79

A recall requires the department to trace every package from a suspect cycle. What information must the load record contain?

• a.Only the date and the technician initials
• b.Only the sterilizer number and the cycle type
• c.Only a list of the departments the items were sent to
• d.Sterilizer identification, cycle or load number, date and time, contents of the load, cycle parameters, operator identification, and the results of physical, chemical, and biological monitoring✓

Complete load documentation permits a targeted recall, links a specific package to a specific cycle, and demonstrates that monitoring was performed and reviewed. Each package also carries a lot control label with the sterilizer, cycle, and date so it can be matched back to the record. Partial records leave gaps that force a much broader and more disruptive recall.AAMI ST79

A nurse reports that a tray opened in the operating room contained an internal chemical indicator that did not change. What is the correct action?

• a.Do not use the tray, return it for reprocessing, and investigate the cycle records and the rest of the load✓
• b.Use the tray if the external tape changed color, since two indicators are redundant
• c.Use the tray but document the indicator failure afterward
• d.Replace the indicator and reseal the tray in the operating room

An internal indicator that failed to change means sterilant may not have reached the interior of the package, so the tray is treated as unsterile and reprocessed while the load records and remaining packages are reviewed. External tape only shows the package was exposed to a process, so it cannot override an internal failure. Resealing or using the tray and documenting later places the patient at risk.AAMI ST79

How should the daily Bowie-Dick test cycle be run?

• a.In a fully loaded chamber, to reflect real conditions
• b.In an otherwise empty chamber, in the first cycle of the day after a warm-up cycle, at 270 to 275 degrees F for the time specified by the test manufacturer, usually not exceeding 4 minutes✓
• c.In any cycle of the day, as long as the result is recorded
• d.Together with a biological indicator, so both tests share the same cycle

The Bowie-Dick test is run in an empty chamber so the only challenge to air removal is the test pack itself, and a warm-up cycle first brings the chamber and jacket to operating condition. Exposure time follows the test manufacturer instructions and is typically limited to about 3.5 to 4 minutes, because overexposure can produce a false pass. Running it in a production load or combining it with biological monitoring invalidates the intent of the test.AAMI ST79

What is the correct handling of the control biological indicator that accompanies a test lot?

• a.It is placed in the sterilizer alongside the test indicator
• b.It is discarded because it is not part of the record
• c.It is not sterilized, is incubated with the processed indicator from the same lot, and must show growth for the test to be valid✓
• d.It is stored in a refrigerator until the end of the month

The unprocessed control proves the spore population is viable and that the incubator and reading method are working, so it must turn positive while the processed indicator turns negative. If the control fails to grow, the test result is invalid regardless of what the processed indicator shows. Sterilizing the control defeats its purpose, and it must come from the same lot and be incubated at the same time.AAMI ST79

Which statement best describes the regulatory and standards landscape for sterile processing?

• a.Only the Food and Drug Administration has any authority over reprocessing practices
• b.Only state health departments set requirements for sterile processing departments
• c.Standards such as ANSI/AAMI ST79 are legally binding federal law in every state
• d.Multiple bodies apply: the FDA clears devices and their reprocessing instructions, OSHA regulates worker safety, CDC publishes guidelines, CMS and accrediting organizations survey practice, and ANSI/AAMI standards define recognized practice✓

Sterile processing sits at the intersection of device regulation, occupational safety law, public health guidance, accreditation, and voluntary consensus standards, and departments are held to all of them. ANSI/AAMI ST79 is a voluntary consensus standard rather than statute, but it is widely adopted as the standard of care and is cited by surveyors. Some states have added their own certification and staffing requirements, which supplement rather than replace federal and accreditation expectations.CDC

A sterilizer has just been relocated to a new position in the department. What testing is required before it processes patient loads?

• a.A single Bowie-Dick test on the first day of use
• b.Installation and requalification testing, including three consecutive negative biological indicator cycles in an empty chamber, plus three passing Bowie-Dick tests for dynamic-air-removal sterilizers✓
• c.No testing, because the sterilizer passed all tests before it was moved
• d.Only a leak test performed by the service technician

Relocation, installation, and major repairs all trigger full qualification testing because the utilities, leveling, and connections have changed. The accepted protocol is three consecutive empty-chamber cycles with negative biological indicators, with Bowie-Dick testing added for dynamic-air-removal units. A service leak test or a single daily test is not a substitute for qualification.AAMI ST79

A recall is initiated after a sterilization failure. Which action is part of a proper recall procedure?

• a.Retrieve only the items still on the sterile storage shelves
• b.Notify the affected departments verbally and take no further action
• c.Identify every item processed since the last negative biological indicator, retrieve and quarantine them, notify risk management and infection prevention if any were used on patients, and document the investigation and corrective action✓
• d.Reprocess the affected items and release them without documenting the event

An effective recall traces every package from the affected cycles using load records and lot control labels, pulls them from storage and from the procedural areas, and escalates when items have already been used so patient follow-up can be considered. The event, the root cause analysis, and the corrective actions are documented as part of the quality program. Limiting the search to shelf stock or skipping documentation defeats the purpose of traceability.AAMI ST79