12/03/2021
Inspection, Routine
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04a - Critical |
Instrument Sterilization, Cleaning, Storage: Instrument Cleaning |
Inspector Comments: Heavy-duty, multi-use and waterproof gloves were not available at the autoclave cleaning station.
Corrective Action: The inspector informed the operator of the requirement to have heavy-duty, multi-purpose, and waterproof gloves.
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04b - Critical |
Instrument Sterilization, Cleaning, Storage: Instrument Packaging/Wrapping |
Inspector Comments: Expired needles and grips were observed at the piercing station.
Corrective Action: Every package was torn open by the inspector, package labeling and sterilizer requirements was discussed with facility operator.
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04c - Critical |
Instrument Sterilization, Cleaning, Storage: Sterilized Instruments |
Inspector Comments: The following spore test results were not available: January 2020, February 2020, March 2020, August 2021, September 2021 and October 2021.
Corrective Action: Missing spore test results will be submitted to TCHD.
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02/24/2020
Inspection, Follow-Up
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04a - Critical |
Instrument Sterilization, Cleaning, Storage: Instrument Cleaning |
Inspector Comments: Proper personal protective equipment for employees to wear while cleaning instruments were not available.
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04b - Critical |
Instrument Sterilization, Cleaning, Storage: Instrument Packaging/Wrapping |
Inspector Comments: Multiple packages of tubes and grips at artist Alonso's station was observed to be not labeled with time and date of sterilization. Every package was torn open by the inspector, package labeling and sterilizer requirements was discussed with facility operator.
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04c - Critical |
Instrument Sterilization, Cleaning, Storage: Sterilized Instruments |
Inspector Comments: Facility does not have any spore test information for the sterilizer.
Artist Alonso was observed tattooing a client using instruments from a sterilizer that does not have passing spore test result within the last 30 days by methods of using a commercial biological monitoring system. The tattooing operation was stopped by the inspector and Alonso was instructed to switch to disposable equipments.
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02/12/2020
Inspection, Routine
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01a - Critical |
Body Artist Requirements: BBP Course, HBV Documentation, Reporting |
Inspector Comments: HBV vaccine information or declination was not available for Alonso.
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02a - Critical |
Records and Forms: Facility and Employment Records |
Inspector Comments: Employee information was unavailable for Alonso.
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03c - Critical |
Plumbing Fixtures: Designated Sinks |
Inspector Comments: The instrument cleaning sink had no cold running water.
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04a - Critical |
Instrument Sterilization, Cleaning, Storage: Instrument Cleaning |
Inspector Comments: Proper personal protective equipment for employees to wear while cleaning instruments were not available.
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04c - Critical |
Instrument Sterilization, Cleaning, Storage: Sterilized Instruments |
Inspector Comments: Facility does not have any sterilizer spore test information for the sterilizer in the cleaning room. The last batch performed was December 18, 2019. No instruments at the facility were of that batch.
The sterilizer load log was missing column for "Action taken when appropriate color indicator change did not occur".
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