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Based on policy and procedure review, document review, observations, and staff interviews, it was determined the facility failed to maintain an infection control program that minimizes risk of infections associated with procedures performed by the facility as evidenced by the following:

1. The facility failed to follow accepted standards of sterilization and disinfection of surgical instruments. This practice potentially exposes patients unnecessarily to infectious diseases.

2. The facility failed to follow policies and procedures related to immediate use steam sterilization (IUSS) of surgical instruments.

3. The facility's Infection Prevention Program failed to ensure compliance with: sterilization and disinfection practices in the OR related to immediate use steam sterilization (IUSS) and autoclave sterilization of surgical instruments. Failure to ensure compliance with sterilization and disinfection practices can result in surgical patients being potentially exposed to infectious diseases and burns.

4. The facility failed to develop and implement water management policies and procedures to reduce the risk of patient exposure to Legionella and other opportunistic pathogens from the facility water systems.

Refer to A749.
The cumulative effect of the above findings determined the facility was not in compliance with the Condition of Participation for Infection Control.

Based on policy and procedure review, document review, observations and staff interviews, it was determined the facility failed to maintain an infection control program that minimizes risk of infections associated with procedures performed by the facility as evidenced by the following:

Findings included:

Review of the facility policy and procedure entitled, "Use of Substerile Autoclaves", #F-1, revised 09/2016, showed the following related to perioperative personnel guidance for sterilization practices that eliminate immediate use steam sterilization (IUSS):
1. Immediate use steam sterilization (IUSS) cycles are not permitted.
2. Post-sterilization verification - upon completion of the sterilization cycle the user must verify and document that all parameters and internal integrators for the sterilization load has successfully been met.
3. Documentation - sterilization cycles will be documented within the designating tracking log or system.
4. Monitoring - the use of sub-sterile autoclaves will be routinely monitored and tracked. Documentation compliance will be reviewed and reported to the appropriate Surgical Service leaders.

On 03/05/18 at approximately 09:40 AM, a tour was conducted of the Cardiovascular Operating Department, accompanied by the Director of Cardiovascular/Transplant Operating Rooms (CVTOR), which confirmed the department had five autoclaves. A tour of two sub-sterile rooms between CVOR's 7, 8, and 9 revealed a sterilization log dated 03/05/18 for each autoclave. The log had missing documentation related to what instruments were sterilized, why the instruments were sterilized, and the patient label indicating the type of surgery and surgical instruments IUSS was used for. The rooms were each observed to have two oven mitts for removing hot surgical instrument trays from the steam sterilizer and transporting them into the CVOR.

On 03/05/18 at 11:30 AM, an interview was conducted with the Sterile Processing Department (SPD) Director revealed the definition of IUSS was "no shelf life". The Director stated that some sterilization trays receiving IUSS have between 5 and 80 surgical instruments in them. He also stated the facility does not track, trend, or report out IUSS use to Surgical Services leaders.

On 03/07/18 at approximately 09:20 AM, a tour was conducted of all operating rooms in the facility, with the exception of the CVOR, accompanied by the SPD Director, SPD Manager, OR Educator, and OR Manager. While on tour, an interview with the SPD Director and OR Manager, confirmed the following numbers and locations of the facility steam sterilizers/autoclaves that were observed during the tour:
- CVOR - 9 operating rooms and 5 steam sterilizers/autoclaves.
- Main OR -19 operating rooms and 10 steam sterilizers/autoclaves.
- 3F OR - 9 operating rooms and 4 steam sterilizers/autoclaves
- Women's Surgical - 8 operating rooms and 2 steam sterilizers/autoclaves.
- Burn Unit - 1 operating room and 1 steam sterilizer/autoclave.
- A total 22 steam sterilizers are located in the facility OR's (SPD not included).

On 03/07/18 at approximately 10:00 AM, while on tour of the main OR's, an interview was conducted with the OR Manager related to the process steps involved with steam sterilization of surgical instruments. The Manager indicated the following:
1. All loads of surgical instruments must be documented on the Surgical Services Sterilization Log.
2. The log is daily log. There is a log for each day of the month.
3. The staff are to document the OR number, time the cycle ran, identification of the employee performing the sterilization, and what surgical instruments the load contained.
4. Once the sterilization cycle is complete, the oven mittens are used to take the surgical instrument tray out of the steam sterilizer and into the surgical suite.
5. Oven mittens are used because the surgical instrument trays come out of the sterilizer hot.
6. Approximately 160-180 of the operating Registered Nurses (RN's) and Surgical Technicians (ST) perform sterilization of surgical instruments.

On 03/07/18 at approximately 10:05 AM, an interview with the OR educator confirmed the above findings related to IUSS.

On 03/07/19 at approximately 10:45 AM, a review of February 2018 Surgical Services Steam Sterilization daily logs revealed that there were multiple instrument loads with no patient label or indication of what and why the instruments were sterilized. There were also multiple daily logs without documentation of whether the load passed or failed sterilization parameters. The surveyor requested that the facility tabulate the IUSS rate and missing documentation frequency on the daily sterilization logs for Dec. 2017 through Feb. 2018.

On 03/07/18 at approximately 3:00 PM, the SPD Director provided the following information related to IUSS from December 2017 through February 2018:
- IUSS steam sterilization rate in the 9 CVOR's averaged 6.0%; indicating approximately 77 loads of instruments were steam sterilized for immediate use.
- IUSS steam sterilization rate in the 38 OR's, excluding the CVOR, averaged 6.0%.
- In the month of February 2018 the facility performed approximately 2,795 surgeries with an IUSS rate of 6.9 %, indicating approximately 192 loads of instruments were steam sterilized for immediate use.
- Total number of steam sterilization loads with no indication if sterilization parameters were met - 220 (96.6%).
- Total number of steam sterilization loads with no patient label - 150 (66%).
- Total number of steam sterilization loads with no room number - 26 (11%).
- Total number of steam sterilization loads with no time indicated - 41 (18%)
- Total number of steam sterilization loads with no employee identification 19 (8%).
- Total IUSS logs not compliant - 228 (46%).

On 03/08/18 at approximately 3:50 PM, the above findings were confirmed with the SPD Director.

On 03/05/18 at approximately 1:45 PM, a review of the facility policy entitled, "Legionella", #IC-17, and effective 11/2010, showed the following:
1. The Facilities Department is responsible for the development and review of a
Legionella prevention plan and disinfection of potable water in the event a
Legionella case.
2. The Facilities Department will report significant findings of monitoring to the
Infection Prevention Committee on an annual basis.
3. The Infection Prevention Department will assist in the development of the water management plan related to Legionella.

Continued review of the facility Legionella policy failed to reveal the presence of the following, as required by industry standards, for the prevention of Legionella and other opportunistic water pathogens:
- Facility risk assessment to identify where Legionella and other opportunistic waterborne pathogens (e.g. Pseudomonas, Acinetobacter, Burkholderia, nontuberculous mycobacteria, and fungi) could grow and spread in the facility's water system.
- Implementation of a water management program that considers the industry standard and includes control measures such as physical controls, temperature management, disinfectant level control, visual inspections, and environmental testing for pathogens.
- Specification of testing protocols and acceptable ranges for control measures, and documentation of the results of testing and corrective actions taken when control limits are not maintained.

On 03/07/17 at approximately 3:00 PM, an interview with Director of Facilities Management and Senior Engineer Facilities Management, revealed the facility did not currently have a water risk assessment or policy and procedure to reduce the risk of patient exposure to Legionella and other opportunistic pathogens from the facility water systems.

On 03/08/18 at approximately 10:40 AM, a document review of the facility hospital pneumonia's (HAP's) and associated water pathogens from Jan. 2017 - Dec. 2017 revealed the following:
- Legionella - 0
- Pseudomonas - 10
- Acinetobacter - 2
- Burkholderia - 1
- Stenotrophomonas - 4
- Mycobacteria- nontuberculous - 3
- Fungi - Candida albicans - 4, Candida parapsiliosis - 4
A total of 28 hospital acquired pneumonia's were identified in 2017, which have the potential to be acquired from the facility's water.

On 03/08/18 at approximately 10:45 AM, an interview conducted with the facility Infection Preventionist (IP) confirmed the above findings related to the facility's HAP's in 2017. The IP stated that she had not performed an investigation as to the source of the HAP's at the time they were identified and could not say if they were acquired from the facility water. The IP stated she had not reported the 2017 HAP's to the Facilities Department leadership.