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Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.608 Compliance With Federal, State, and Local Laws and Regulations was out of compliance.

C-0814 Standard: Compliance With State and Local Laws and Regulations All patient care services are furnished in accordance with applicable State and local laws and regulations. Based on observations, document review, and interviews the facility failed to ensure surgical services were provided to acceptable standards of practice. Specifically, the facility failed to ensure a smoke evacuation device was used in the operating room during procedures that produced surgical smoke.

Based on observations, document review, and interviews the facility failed to ensure surgical services were provided to acceptable standards of practice. Specifically, the facility failed to ensure a smoke evacuation device was used in the operating room during procedures that produced surgical smoke in one of on observation of a surgical procedure which surgical smoke was produced.

Findings include:

Facility policy:

The Surgical Smoke policy read, when surgical smoke is generated during operative or other invasive procedures by prolonged use of heat-producing instruments (eg, electrosurgical units [ESU], lasers), the smoke will be captured and filtered through the use of smoke evacuators, or in-line filters positioned on suction lines. The scope of this policy states it is to provide guidance to perioperative personnel for creating an environment that reduces the exposure of patients and perioperative personnel to surgical smoke. The perioperative registered nurse (RN) will document the use of surgical plume evacuation equipment and other devices used to evacuate plume during operative or other invasive procedures on the intraoperative record.

References:

According to House Bill 18-1399, retrieved from
https://leg.colorado.gov/sites/default/files/documents/2018A/bills/2018a_1399_01.pdf - The bill requires hospitals with surgical services and ambulatory surgical centers to adopt a policy to prevent human exposure to surgical smoke. Surgical smoke is a gaseous byproduct produced by energy-generating surgical medical devices. On or before March 1, 2019, the Colorado department of public health and environment shall promulgate rules regarding requirements for surgical smoke evacuation policies. A policy adopted in accordance with the bill applies to surgical procedures performed on or after July 1, 2019.

Section 1. In Colorado Revised Statutes, add 25-3-118 as follows: 25-3-118. Regulation of surgical smoke - requirement to adopt a policy - rules - definitions - applicability.
(1) On or before July 1, 2019, a hospital with surgical services or an ambulatory surgical center, licensed in accordance with this Article 3, shall adopt a policy to prevent human exposure to surgical smoke. The policy must include the requirement to use a surgical smoke evacuation system whenever a procedure generates surgical smoke.
(2) On or before March 1, 2019, the department shall adopt rules establishing requirements for surgical smoke evacuation policies and to otherwise ensure compliance with the requirements of this section.
(3) As used in this section: (a) "surgical smoke" means the gaseous byproduct produced by energy-generating devices including surgical plume, smoke plume, bio-aerosols, laser-generated airborne contaminants, or lung-damaging dust. (b) "surgical smoke evacuation system" means smoke evacuators, laser plume evacuators, plume scavengers, or local exhaust ventilators that capture and neutralize surgical smoke at the site of origin and before surgical smoke can make ocular or respiratory contact.

According to the Association of Operating Room Nurses (AORN) National Guidelines for Surgical Smoke 2021 under the General Duty Clause 1.1, Section 5(a) of the Occupational Safety and Health Act of 1970, employers are required to provide their employees with a place of employment that is "free from recognizable hazards that are causing or likely to cause death or serious harm to employees."

1.3 Controlling exposures to hazards and toxic substances is the fundamental method of protecting workers. The hierarchy of controls can be used as a systematic approach to identify the most effective method of risk reduction: eliminating the hazard (eg. avoiding use of smoke-generating surgical devices).

2.4.3 Surgical smoke concentration of fine particles accumulates to an unhealthy level within the first few seconds after surgical smoke production starts, and individuals closest to the site of surgical smoke generation are at the highest risk of exposure. However, exposure to surgical smoke has been demonstrated for all members of the surgical team.

2.2.1 Use a smoke evacuator system that contains an ultra-low particulate air (ULPA) filter with an activated carbon filter when surgical smoke is anticipated.

2.5 In addition to possible perioperative staff risk of exposure to surgical smoke, the risks of surgical exposure to the patient during minimally invasive procedures may include, reduced visibility of the surgical site during the procedure, potential delays during the procedure, and absorption of smoke by-products like carbon monoxide.

2.5.3 Do not release unfiltered surgical smoke into the OR during minimally invasive procedures.

According to the instructions for use (IFU) Suction Instruments and Tubing products, Yankauer suction instruments are indicated to evacuate fluid or debris during open surgery.

1. The facility failed to ensure ESU units (a medical device used to cut and coagulate tissues) were used in accordance with a state house bill, facility policy, and nationally recognized guidelines. Specifically, the facility failed to ensure a smoke evacuation system (a filtration system to reduce exposure to surgical smoke) used to evacuate and filter surgical smoke (a smoke byproduct composed of biological particles, cells, and toxic chemicals) was implemented during surgical procedures.

a. Observations

i. On 7/18/23 at 10:23 a.m., an observation of a left check lesion excision surgery performed by Surgeon #10 was conducted. During the observation, electrocautery was used without the use of a smoke evacuator while surgical smoke was present. The surgical scrub technician was observed holding a Yankauer suction tip close to the surgical site in an attempt to suction visible surgical smoke.

This was in contrast to the Surgical Smoke policy, which read, the hazardous surgical smoke produced when using ESUs would be eliminated through the use of a surgical smoke evacuation system.

This was also in contrast with the Yankauer IFU which did not include guidance that the Yankauer could be used as a surgical smoke evacuation device.

b. Document review

i. A review of patient #5's medical record revealed electrocautery was used however, there was no documentation of surgical plume evacuation equipment or other devices used to evacuate smoke during the procedure.

This was in contrast to facility policy Surgical Smoke which read, the perioperative RN would document the use of surgical plume evacuation equipment and other devices used to evacuate plume during operative or other invasive procedures on the intraoperative record.

c. Interviews

i. On 7/18/23 at 2:08 p.m., an interview with scrub technician (Tech #8) was conducted. Tech #8 stated surgical smoke evacuation was important because surgical smoke could cause cancer. Tech #8 further explained anyone in the room, including the patient, surgeon, nurse, anesthesia provider (medical staff who puts patients to sleep), and scrub technician were at risk of surgical smoke inhalation.

ii. On 7/19/23 at 11:47 a.m., an interview with circulating nurse (Circulator #9) was conducted. Circulator #9 stated surgical smoke inhalation was a risk to everyone in the room because it contained carcinogens (cancer-causing agents) similar to cigarette smoke. Circulator #9 also stated smoke evacuators were used at the discretion of the surgeon or during open (the cutting of skin and tissue so the surgeon has full view of the structures or organs) and laparoscopic (surgery which used small cuts and a thin rod camera to visualize internal organs) surgeries.

iii. On 7/19/23 at 5:08 p.m., an interview with operating room director (Director) #2 was conducted. Director #2 stated smoke evacuators were used during open procedures with incisions greater than three inches, laparoscopic surgeries, and orthopedic surgeries. Director #2 stated Yankauer suction instruments were used during minor procedures to suction surgical smoke unless the surgeon or another member of the surgical team wanted to use a smoke evacuation device. Director #2 stated smoke evacuation was important because it could cause cancer and anyone in the operating room was at risk of inhaling it.

This was in contrast to the surgical smoke policy which read when surgical smoke was generated during operative or other invasive procedures by prolonged use of heat-producing instruments the smoke would be captured and filtered through the use of smoke evacuators.

This was also in contrast to the AORN guidelines which guided to not release unfiltered surgical smoke into the OR during minimally invasive procedures.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation: §485.627 Organizational Structure, was out of compliance.

C-0962 The CAH has a governing body or an individual that assumes full legal responsibility for determining, implementing and monitoring policies governing the CAH'S total operation and for ensuring that those policies are administered so as to provide quality health care in a safe environment. Based on document reviews and interviews, the governing body failed to provide direct oversight to ensure surgical services were provided in a safe manner and in accordance with professional standards of practice in the areas of quality assurance and performance improvement (QAPI) and infection prevention (IP).

Based on document reviews and interviews, the governing body failed to provide direct oversight to ensure surgical services were provided in a safe manner and in accordance with professional standards of practice in the areas of quality assurance and performance improvement (QAPI) and infection prevention (IP). (Cross-reference C-1200)

Findings include:

References:

The District Bylaws read, the Board (governing body) shall have all the general powers contained in Sections 32-1-1001 and 1003, C.R.S., including but not limited to, the power to manage, control and supervise all of the business and affairs of the District. Notwithstanding, and in addition to the above-stated powers, the Board shall oversee the creation of processes and programs that foster safety and quality of care in District facilities and regularly monitor and evaluate the effectiveness of these processes and programs. The Administrator shall implement and organize management and administrative functions throughout the Hospital and any other health care facility or service operated by the District, including the establishment of clear lines of responsibility and accountability within departments and between department heads and administrative staff.

The Infection Prevention Program read, the hospital IP Program is a part of the hospital Quality Assurance/Risk Management Program (QA/RM). The IP Program is designed to prevent nosocomial infections within the hospital where possible and to safeguard against the acquisition of employment-related infections in hospital employees and medical staff. Program components include physicians notifying the IP Coordinator of any patients seen in the clinic post-hospital stay, who may have developed nosocomial infections. The IP Coordinator will then investigate these and bring information to the medical staff meeting for a determination of cause of the infection. The IP Coordinator documents the determinations, recommendations and corrective actions. A report of this is a part of the meeting minutes.

The Quality Management Plan read, the purpose of the Quality Management Plan is to provide ongoing high-quality health care services that promote quality, safety and meet or exceed regulatory standards with a compassionate approach. To provide superior comprehensive services within our facility, quality will be viewed as top priority throughout the continuum of care. The Quality Plan will include all clinical and non-clinical areas within the facility. The Board of Directors will have the ultimate responsibility for assuring the provision of effective activities related to delivering quality patient care and quality assurance. All services are included in the quality and risk management (QRM) efforts. The QRM Committee will act as a clearinghouse for issues, data, or information from the following departments: Surgery, Infection Control, Risk Management, Education. The Committee will report and/or make recommendations directly to the Board of Directors. Data will be collected on processes or outcomes from activities that involve high volume, high risk or problem prone areas. Along with baseline needs, current processes will be evaluated through a Concurrent Review process: identification of problem, data collection, data analysis, corrective action identification-implementation-evaluation, and continuous improvement over time.

1. The governing body failed to ensure the QAPI program, in collaboration with the IP program, implemented and maintained methods to prevent and control the transmission of infections, investigated surgical site infections (SSIs) and limited the usage of IUSS (immediate use steam sterilization) within the surgical services department and the sterile processing department (SPD).

A. Document Review

i. Review of the facility's IUSS logs dated 7/25/22 to 7/10/23 revealed IUSS was performed 83 times. Of those 83 times, 35 documented the reason for conducting IUSS was due to cases being scheduled back to back.

ii. Review of the facility's Surgical Site Infection log from 7/22 to 7/23 revealed 11 patients were identified with SSIs, however, there was no evidence of internal investigations for causative factors noted.

iii. Review of the 2022 and 2023 meeting minutes for the Board of Directors, Medical Staff Committee, Quality and Risk Management Committee, and operating room (OR) staff meetings revealed no evidence the governing body oversaw and collaborated, reviewed, and analyzed infection control processes related to the investigation of SSIs.

iv. Upon request, the facility was unable to provide evidence quality and IP measures were established, implemented, and monitored using nationally recognized evidence-based interventions and measures (benchmarks) for the investigation of SSIs within the surgical services department and the SPD.

This was in contrast to the Quality Management Plan which read, the Quality Plan would include all clinical and non-clinical areas within the facility. Data would be collected on processes or outcomes from activities that involved high volume, high risk or problem prone areas. The Committee would report and/or make recommendations directly to the Board of Directors. The Board of Directors would have the ultimate responsibility to assure the provision of effective activities related to delivering quality patient care and quality assurance.

B. Interviews

i. On 7/19/23 at 4:01 p.m., an interview was conducted with infection preventionist (Preventionist) #3. Preventionist #3 stated she did not know what the term IUSS meant. Preventionist #3 also stated she did not have a role within the SPD because the OR team managed the department themselves. When asked what steps were taken to ensure infections did not come from the OR, Preventionist #3 stated she did not do investigations for internal causative factors. Preventionist #3 further stated it was important to know if infections came from the OR to determine if the equipment used during surgeries was processed and cleaned correctly, if staff scrubbed in (performed in-depth and rigorous hand washing prior to conducting surgery) properly, and if supplies were sterile. Additionally, Preventionist #3 stated the facility could cause harm to patients if the investigation process was not changed.

ii. On 7/19/23 at 5:08 p.m., an interview was conducted with OR director (Director) #2. Director #2 stated the OR kept a log of surgical instruments processed with IUSS cycles, which was to be used to track instruments back to patients' medical records if SSIs occurred. Director #2 stated the IUSS log was not reviewed to determine if instruments that underwent IUSS were used on patients who developed SSIs. Director #2 also stated patients with SSIs were at risk of additional surgical procedures, replacement of surgical implants, antibiotic use, and extended hospital stays. Additionally, Director #2 stated she was not aware of the number of surgical site infections the facility had within the last year.

iii. On 7/20/23 at 10:10 a.m., an interview was conducted with Pathologist #4. Pathologist #4 stated the facility should have implemented a cascade of procedures to evaluate why infections occurred in surgical patients. Pathologist #4 also stated an internal review of cases should occur to determine if patients had developed nosocomial (hospital acquired) infections.

iv. On 7/20/23 at 8:01 a.m., an interview was conducted with quality and risk management director (Director) #5. Director #5 stated SSIs were not included in the monthly report that was presented in the Medical Staff and Board of Directors meetings. Director #5 also stated she was not aware of how Preventionist #3 monitored IP in the OR. Furthermore, Director #5 stated she was not aware of when the last SSI was reported.

v. On 7/24/23 at 3:00 p.m., and interview was conducted with chief clinical officer (Officer) #6, who was a member of the governing body. Officer #6 stated Preventionist #3 reported to Director #5, who then reported to her. Officer #6 also stated she did not realize SSIs were not reported at Medical Staff meetings. Additionally, Officer #6 stated it was the governing body's responsibility to be aware of and question staff regarding infection rates, studies, and audits.

vi. On 7/24/23 at 12:30 p.m., an interview was conducted with chief executive officer/administrator (Administrator) #7, who was a member of the governing body. Administrator #7 stated Officer #6 reported to him, and he reported to the governing body. Administrator #7 also stated it was important for the facility to have good infection control. Additionally, Administrator #7 stated the governing body was responsible to oversee administration and they depended on himself and staff to ensure they received the information they needed to give guidance and direction.

This was in contrast to the governing body bylaws which read, the board would oversee the creation of processes and programs that fostered safety and quality of care in district facilities and regularly monitored and evaluated the effectiveness of these processes and programs. The administrator implemented and organized management and administrative functions throughout the hospital and any other health care facility or service operated by the district, and included the establishment of clear lines of responsibility and accountability within departments and between department heads and administrative staff.

Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation: §485.640 Infection Prevention and Control and Antibiotic Stewardship Programs, was out of compliance.

1200/1150 - The CAH must have active facility-wide programs, for the surveillance, prevention, and control of HAIs and other infectious diseases and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic-resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in coordination with the facility-wide quality assessment and performance improvement (QAPI) program.

Based on interviews and document review, the facility failed to ensure nationally recognized infection control guidelines, manufacturer's instructions for use (IFU), and facility policies were implemented and followed to monitor and control the transmission of surgical site infections (SSI). Specifically, the facility failed to use immediate use steam sterilization (IUSS) (a sterilization process utilizing the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field) in emergency situations only and not for convenience or as a substitute for insufficient amounts of surgical instruments. Additionally, the facility failed to ensure an active facility-wide infection prevention (IP) program, in coordination with the quality assurance and performance improvement (QAPI) program, was maintained for the surveillance, prevention, and investigation of SSIs.

Findings include:

Facility policies:

The Sterilization, IUSS policy read, immediate use steam sterilization will be used only in cases of defined emergency when no other option is available and there is insufficient time to process by the preferred wrapped or container method intended for terminal sterilization.

The Infection Surveillance and Reporting policy read, in order to identify possible problem areas and nosocomial (hospital-acquired) infections, the Infection Prevention nurse will be notified by Risk Management of any surgical site infections that are reported. Additionally, completed medical record review are presented at the medical staff meetings for review. The consulting pathologist in conjunction with the Chief of Medical Staff assess these cases in regard to their proper management and epidemic potential. The consulting pathologist documents recommendations for corrective action if any and signs the report. The physician of record in cases determined nosocomial is notified by the Infection Prevention Coordinator. The Infection Prevention Coordinator provides a report of significant findings for the next Quality Assessment and Risk Management meeting.

References:

The Infection Prevention Program read, the hospital Infection Prevention Program is a part of the hospital Quality Assurance/Risk Management Program (QA/RM). The Infection Prevention Program is designed to prevent nosocomial infections within the hospital where possible and to safeguard against the acquisition of employment-related infections in hospital employees and medical staff. Program components include physicians notifying the Infection Prevention Coordinator of any patients seen in the clinic post-hospital stay, who may have developed nosocomial infections. The Infection Prevention Coordinator will then investigate these and bring information to the medical staff meeting for a determination of cause of the infection. The Infection Prevention Coordinator documents the determinations, recommendations and corrective actions. A report of this is a part of the meeting minutes.

According to the Infection Control/Employee Health Nurse job description, the position overview included: detecting and recording information about hospital-acquired infections through surveillance activities, monitors hospital activities that influence and detect hospital acquired infections, and investigates identified infection problems.

The Quality Management Plan read, the purpose of the Quality Management Plan is to provide ongoing high-quality health care services that promote quality, safety and meet or exceed regulatory standards with a compassionate approach. To provide superior comprehensive services within our facility, quality will be viewed as top priority throughout the continuum of care. The Quality Plan will include all clinical and non-clinical areas within the facility. The Board of Directors will have the ultimate responsibility for assuring the provision of effective activities related to delivering quality patient care and quality assurance. All services are included in the quality and risk management (QRM) efforts. The QRM Committee will act as a clearinghouse for issues, data, or information from the following departments: Surgery, Infection Control, Risk Management, Education. The Committee will report and/or make recommendations directly to the Board of Directors. Data will be collected on processes or outcomes from activities that involve high volume, high risk or problem prone areas. Along with baseline needs, current processes will be evaluated through a Concurrent Review process: identification of problem, data collection, data analysis, corrective action identification-implementation-evaluation, and continuous improvement over time.

According to the Association of periOperative Registered Nurses (AORN) Journal (2019), pg 772, AORN Guideline for Sterilization, provided by the facility, ensuring that reusable surgical instruments and medical devices have been sterilized is an important factor in preventing surgical site infections. Immediate-use steam sterilization should never be used as a substitute for inadequate inventory or poor planning.

According to V. Mueller Products and Services General Surgical Instrument Cleaning and Sterilization Guide, Immediate Use Steam Sterilization is not recommended as a routine practice.

According to Stryker Heavy Duty Battery Powered and Electric Heavy Duty Systems Care Instructions, Stryker does not recommend IUSS for routine sterilization of medical devices. IUSS should only be used when individual devices require immediate sterilization and use.

According to Konig Surgical Instruments instructions for use, the use of "flash" sterilization is not recommended, as it may shorten the life of instruments.

According to Association for Professionals in Infection Control and Epidemiology (APIC) Infection Preventionist's Guide to the OR, 2018, section 8, provided by the facility, the department is encouraged to collaborate with the perioperative team to compare evidence-based surgical site infection prevention measures during all periods of the surgical journey (preoperative, intraoperative, and postoperative) to the care provided to the patient in questions, to determine any causes and contributing factors.

1. The facility failed to ensure IUSS was only utilized for emergency purposes and not out of convenience or to meet the needs of the surgery schedule.

A. Document review

i. Upon review of the facility's IUSS logs dated 7/25/22 to 7/10/23, it was noted IUSS was used 83 times. Of those 83 times, 35 documented the reason for conducting IUSS was due to cases being scheduled back to back. Examples included:

a. During the month of June 2023 there were four incidents of IUSS performed due to cases being scheduled back to back. The instruments and sets that underwent IUSS included: System 8 (a cordless powered instrument used to drill and cut bone) which underwent IUSS three times, one knee tray, one hip tray, and one oscillating saw (a power tool used to make very small, rapid motions side-to-side in order to make small cuts).

b. During the month of May 2023 there were four incidents of IUSS conducted due to cases being scheduled back to back. The instruments and sets that underwent IUSS included: one oscillating saw, one knee arthroscopy tray (a set of surgical instruments used to visualize and treat problems inside of the knee joint), and a Trimano attachment (a positioning system used in shoulder surgeries) which underwent IUSS twice.

c. During the month of January 2023 there were four incidents of IUSS conducted due to cases being scheduled back to back. The instruments and sets that underwent IUSS included: a cysto set (instruments used to examine the inside of the urinary tract system) and TUR set (instruments used to cut the urinary tract system) which underwent IUSS twice, one Fiber Tak passer (instrument used to hold sutures), one Arthro Cutter (surgical scissors), one knee tray, one System 8, and one Demayo (a surgical patient positioning used during knee replacement surgery).

This was in contrast to AORN guidance which read, immediate-use steam sterilization should never have been used as a substitute for inadequate inventory or poor planning.

B. Interviews

i. On 7/17/23 at 2:06 p.m., an interview with sterile processing technician (Tech) #1 was conducted. Tech #1 explained IUSS was only supposed to be used for specific situations. These situations included when surgical instruments or items were accidentally contaminated during surgeries, when the indicator strips (chemical indicator strip that provides distinct color change when exposed to the sterilization process) were not present with instruments, or when a hole or tear was noted in the wrapping. Tech #1 stated the facility used IUSS way more than she liked and IUSS should have been used for emergencies only. Tech #1 further explained the operating room was busy and there were not enough instruments for the number of cases scheduled.

ii. On 7/19/23 at 5:08 p.m., an interview with the operating room director (Director) #2 was conducted. Director #2 stated IUSS should only have been used in emergency situations. Director #2 then stated IUSS was most often used on orthopedic surgery days because the facility did not have enough instruments for the number of surgeries scheduled.

This was in contrast to the Sterilization and IUSS policy which read, IUSS would be used in cases of defined emergencies when no other option was available and there was insufficient time to process by the preferred wrapped or container method intended for the terminal sterilization.

This was also in contrast to the Association of Operating Room Nurses (AORN) national guidelines provided by the facility which read, IUSS should never have been used as a substitute for inadequate inventory or poor planning.

iii. On 7/19/23 at 4:01 p.m., an interview with infection preventionist (Preventionist) #3 was conducted. Preventionist #3 stated she did not know what the term IUSS, also known as flashing, meant. Preventionist #3 also stated she did not have a role within the sterile processing department because the OR team managed the department themselves.

This was in contrast to the Infection Control/Employee Health Nurse job description, which listed the following job overview: to detect and record information about hospital-acquired infections through surveillance activities, monitor hospital activities which influenced and detected hospital-acquired infections, and investigate identified infection problems.

2. The facility failed to ensure the infection prevention (IP) program, in collaboration with the quality assurance and performance improvement (QAPI) program, maintained an active facility-wide infection control program and quality program for the surveillance, prevention, and control of surgical site infections (SSI). Specifically, SSIs were not investigated for potential facility causative factors.

A. Documentation Review

i. Upon review of the facility's Surgical Site Infection log from 7/22 to 7/23, there were 11 patients identified with SSIs from surgeries performed at the facility, however, there was no evidence of internal investigation of causative factors related to the surgical site infections noted. For example:

a. According to the Surgical Site Infection log, Patient A had a cesarean section (surgical delivery of a baby through an incision in the abdomen) on 5/18/23. Patient A was seen in clinic on 5/26/23 for a developing wound infection and a non-healing incision site. No wound drainage testing was noted, however, the patient was placed on the antibiotic Keflex and followed up in clinic after antibiotics were completed. There was no evidence from the log of an investigation for potential facility causative factors.

b. According to the Surgical Site Infection log, Patient B had right shoulder surgery on 5/15/23. Patient B was seen in the clinic on 6/11/23 with an incision opening and drainage. Patient B reported having the same pain since surgery. The clinic explored the wound and cleaned it with antibacterial fluid. Patient B was then started on the antibiotic Vancomycin. There was no evidence from the log of an investigation for potential facility causative factors.

c. According to the Surgical Site Infection log, Patient C had breast excision surgery on 3/8/23. Patient C was seen in the clinic on 3/23/23 for SSI with drainage. Patient C was then started on the antibiotic Clindamycin. There was no evidence from the log of an investigation for potential facility causative factors.

ii. Upon review of the facility's Medical Staff Meeting minutes from 7/8/22 to 5/12/23, there was no evidence of an investigation of causative factors related to surgical site infections noted for nine of nine meetings held during the timeframe reviewed.

iii. Upon review of the facility's Infection Prevention and Employee Health Monthly Report from 2/23 to 7/23, there was no evidence of an investigation of causative factors related to surgical site infections noted for six of six meetings held during the timeframe reviewed.

iv. Upon review of the facility's Quality and Risk Management Committee meeting minutes from 7/8/22 to 4/20/23, there was no evidence of discussion about SSIs or an investigation of causative factors related to SSIs noted for five of five meetings held during the timeframe reviewed.

v. Upon review of the facility's Board of Directors Regular Meeting minutes from 8/9/22 to 5/30/23, there was no evidence of an investigation of causative factors related to surgical site infections noted for 24 of 24 meetings held during the timeframe reviewed.

This was in contrast to the Infection Prevention Program which read, the IP coordinator would investigate nosocomial infections and bring the information to the medical staff meeting for a determination of a cause of the infection.

This was also in contrast to the Infection Prevention/Employee Health Nurse job description which read, the IP nurse/coordinator was responsible to detect and record information about hospital-acquired infections through surveillance activities, monitor hospital activities that influence and detect hospital-acquired infections, and investigate identified infection problems.

B. Interviews

i. On 7/19/23 at 4:01 p.m., an interview with the infection preventionist (Preventionist #3) was conducted. Preventionist #3 stated she did not have a role within the sterile processing department because the operating room team managed it themselves. Preventionist #3 explained she was notified about postoperative patient infections after surgical patients went to their follow-up appointments with either their surgeon or a primary care physician (PCP). Preventionist #3 entered the patients with postoperative infections onto her SSI log after receiving phone calls from those doctors' offices. When asked what steps were taken to ensure infections did not come from the OR, Preventionist #3 stated she did not do internal investigations for causative factors.

Preventionist #3 said it was important to know if infections came from the OR to determine if the equipment used during surgeries was processed and cleaned correctly, if staff scrubbed in (performed in-depth and rigorous hand washing prior to conducting surgery) properly, and if supplies were sterile. Preventionist #3 also explained the facility was doing a disservice to the patient and could have caused more harm than good if the investigation process was not changed. Preventionist #3 said SSIs were discussed during medical staff meetings which included OR staff members.

This was in contrast with the Medical Staff Meetings reviewed, which revealed no evidence of investigations of the causative factors related to SSIs. Additionally, this was in contrast to the Infection Prevention Program policy which read, the Infection Prevention Coordinator would investigate nosocomial infections and bring the information to medical staff meetings for a determination of the cause of the infection.

This was also in contrast to the Infection Prevention/Employee Health Nurse job description which read, the IP nurse/coordinator was responsible to detect and record information about hospital-acquired infections through surveillance activities, monitor hospital activities that influence and detect hospital-acquired infections, and investigate identified infection problems.

ii. On 7/19/23 at 5:08 p.m., an interview with the operating room director (Director) #2 was conducted. Director #2 stated the operating room kept a log of IUSS cycles and the instruments used in the IUSS cycles to be able to track the items back to patients' medical records in case of an SSI. Director #2 stated the IUSS log was only used for tracking purposes and was not reviewed to determine if instruments that underwent IUSS were used on patients who developed SSIs. Director #2 explained most surgical site infections were attributed to patient hygiene or health issues. Director #2 also stated patients with SSIs were at risk of additional surgical procedures, replacement of surgical implants, antibiotic use, and extended hospital stays. Director #2 stated she was not aware of the number of surgical site infections the facility had in the last year and that the infection preventionist kept track of all SSIs.

iii. On 7/20/23 at 8:01 a.m., an interview with Quality and Risk Management Director (Director #5) was conducted. Director #5 stated SSIs were documented by the Infection Preventionist on an SSI log. Director #5 stated she did not recall seeing SSIs documented on the Medical Staff Committee meeting reports. Director #5 stated she could not remember when the last SSI was reported. Director #5 explained the Infection Preventionist reports were expected to be reported at the Quality and Risk Management Committee, Medical Staff meetings, and Governing Board meetings.

This was in contrast to the Quality Management Plan which read, the purpose of the Quality Management Plan was to provide ongoing high-quality health care services that promoted quality, safety and met or exceeded regulatory standards. The Quality Plan would include all clinical and non-clinical areas within the facility. Data would be collected on processes or outcomes from activities that involved high volume, high risk or problem prone areas.

iv. On 7/20/23 at 10:10 a.m., an interview with Pathologist #4 was conducted. Pathologist #4 stated he worked as a consultant and reviewed medical records every two months that were presented to him by Preventionist #3. Pathologist #4 further explained he did a standard evaluation of admission lab work, results of any cultures taken of wounds, and which antibiotics the patient was placed on, if any. Pathologist #4 stated the facility should have implemented a cascade of procedures to evaluate why infections occurred in surgical patients. Pathologist #4 stated there should have been an internal review of cases to determine if patients had developed nosocomial (hospital acquired) infections.