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Based on document review and staff interviews, it was determined the facility failed to ensure compliance with infection control procedures, protocols, and manufacturer instructions for preventative maintenance of surgical instrument sterilizers. The facility performs approximately 7,000 annual surgeries and has eight steam sterilizers.

Findings included:

A review of the facility sterilizer's manufacturers instructions for use (IFU's), showed the facility had 4 Amsco Century Medium Steam Sterilizer's, model #V148H and 4 Amsco Century Small Steam Sterilizer's, model #V116. The facility had a total of 8 surgical instrument steam sterilizers.

7.1.1 Clean Chamber Drain Strainer
Important: The chamber drain strainer must be cleaned at least once a day preferably in the morning before running the first cycle.
1. Remove the drain strainer from the drain in the bottom of the chamber.
2. Remove any obvious debris from the strainer. If necessary, clear the screen in the strainer using a brush, wire or similar tool.
3. Once it has been cleared of obvious debris, reverse flush the strainer under running water.
4. Replace the strainer in the chamber drain

8.3 Weekly Maintenance Procedure: Flush Chamber Drain
1. Flush chamber drain as follows whenever the line becomes clogged:
2. Turn off steam supply valve. Wait until jacket pressure is zero. Wait until chamber has cooled to room temperature.
3. Remove chamber drain strainer (Figure 8-1). Clean strainer using procedures given SECTION 8.2.2, if necessary.
4. Pour a solution of 60 mL (1/4 cup) of Liquid-Jet 2 Instrument Detergent (Contact your local STERIS representative), and 500 mL (1
pint) of hot water into the drain... Should the detergents in Step 3 be unavailable, you may use a hot solution of 15 mL (1 tablespoon)
of trisodium phosphate to 500 mL (1 pint) of hot water.
5. Open door and place strainer back in drains

On 03/13/19 at 1:00 p.m., a tour was conducted of the Sterile Processing Department (SPD), accompanied by the VP of Quality & Safety and Director of Surgical Services. While on tour, an interview was conducted with a Certified Surgical Technologist (CST). The CST was asked for the daily and weekly sterilizer maintenance logs for cleaning and flushing of the sterilizer drain. The CST stated he did not have a log and stated that he thought the STERIS Technician performed that maintenance every 3 to 4 months.

On 03/13/19 at 3:30 p.m., an interview with the Director of Surgical Services confirmed the facility did not have a log documenting required daily cleaning of the sterilizer chamber drain strainer and weekly flushing of the chamber drain, per the manufacturer's instructions for use (IFU's).