9 Lives Studio
5002 51 Street Cold Lake AB T9M 1P4 · Personal Services
5 inspections
- Risk Management Inspection
1 infraction
- 22. If the facility sterilizes equipment, are all proper sterilization, verification, and documentation processes in place (Critical)?
- The manufacturer's instructions/user manual for the Enbio steam sterilizer remain outstanding. Please provide the full PDF copy of the Enbio steam sterilizer manufacturer's instructions/user manual for review. A PDF copy is preferred; scanned pages are not required. Please provide the full PDF manual for review.Corrected from previous report - The Enbio cycle reports provided for loads 2675, 2857, 2864, and 2923 were reviewed. These records correspond to the load numbers reviewed during the routine inspection and include physical monitoring information, including sterilization temperature, exposure time at sterilization temperature, and pressure. The physical monitoring and load recording requirement is considered corrected based on the documentation reviewed.
- 22. If the facility sterilizes equipment, are all proper sterilization, verification, and documentation processes in place (Critical)?
- Monitoring Inspection
1 infraction
- 22. If the facility sterilizes equipment, are all proper sterilization, verification, and documentation processes in place (Critical)?
- 1. The manufacturer's instructions for the steam sterilizer were not readily accessible at the time of inspection. Manufacturer's instructions for sterilizers must be readily accessible to personal service workers. Please ensure the manufacturer's instructions for the sterilizer are available on site for reference by personal service workers at all times.2. Physical monitoring of records for sterilized loads were not available for review at the time of inspeciton. For each sterilized load, sterilization temperature, exposure time at the sterilization temperature, and pressure, where applicable, must be monitored, verified to have met the manufacturer's specifications, and documented. Please ensure sterlilizer cycle records are maintained and readily accessible for review, including records showing the time, temperature and pressure fo each sterilized load.
- 22. If the facility sterilizes equipment, are all proper sterilization, verification, and documentation processes in place (Critical)?
- Monitoring Inspection
0 infractions
- Monitoring Inspection
1 infraction
- 22. If the facility sterilizes equipment, are all proper sterilization, verification, and documentation processes in place (Critical)?
- New sterilizer is a steam sterilizer Enbio S. After reviewing the Quality Report provided, the corresponding biological indicator, type 5 chemical indicator and bowie tests are not included in said report. Please forward those to this office.
- 22. If the facility sterilizes equipment, are all proper sterilization, verification, and documentation processes in place (Critical)?
- Initial Inspection
0 infractions