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Based on the manner and degree of standard level deficiencies 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.

Based on interviews, the facility failed to establish a nurse staffing committee that met the requirements of the CCR 1011-1 Chapter 4 Part 14.6 (A)-(F). In addition, the facility failed to ensure applicants showed compliance with Colorado Adult Protective Services Data Systems (CAPS check) prior to hiring staff who provided direct care to at-risk adults in three out of three employee files reviewed who were hired after January 1, 2019.

Findings include:

References:

STANDARDS FOR HOSPITALS AND HEALTH CARE FACILITIES CHAPTER 4 - GENERAL HOSPITALS 6 CCR 1011-1
Part 14.6 Nurse Staffing Committee (A) Each hospital shall establish a nurse staffing committee, either by creating a new committee or assigning the nurse staffing functions to an existing hospital staffing committee.

STANDARDS FOR HOSPITALS AND HEALTH CARE FACILITIES CHAPTER 2 - GENERAL LICENSURE STANDARDS 6 CCR 1011-1 Part 2.5.4 (B) Licensees must show compliance with the Colorado Adult Protective Services Data System (CAPS Check) requirements set forth in section 26-3.1-111, C.R.S.

2020 Colorado Revised Statutes Title 26 - Human Services Code Article 3.1. Protective Services for Adults at Risk of Mistreatment or Self-neglect Section 26-3.1-111. Access to CAPS - employment checks read, (1) The general assembly finds and declares that individuals receiving care and services from persons employed in programs or facilities described in subsection (7) of this section are vulnerable to mistreatment, including abuse, neglect, and exploitation. It is the intent of the general assembly to minimize the potential for employment of persons with a history of mistreatment of at-risk adults in positions that would allow those persons unsupervised access to these adults. As a result, the general assembly finds it necessary to strengthen protections for vulnerable adults by requiring certain employers to request a CAPS check by the state department to determine if a person who will provide direct care to an at-risk adult has been substantiated in a case of mistreatment of an at-risk adult.

Subsection six read, (6) (a) (I) On and after January 1, 2019, prior to hiring or contracting with an employee who will provide direct care to an at-risk adult, an employer described in subsection (7) of this section shall request a CAPS check by the state department pursuant to this section to determine if the person is substantiated in a case of mistreatment of an at-risk adult.
Subsection seven read, (7) The following employers shall request a CAPS check pursuant to this section: (a) A health facility licensed pursuant to section 25-1.5-103, including those wholly owned and operated by any governmental unit.

1. The facility failed to have a nurse staffing committee of at least 60% participation of clinical nurse staff that developed and oversaw a master nurse staffing plan for the hospital and met all of the requirements in Chapter 4 Parts 14.6 and 14.7.

i. Upon request, the facility was unable to provide evidence of a nurse staffing committee.

ii. On 5/31/23 at 11:51 a.m., an interview with registered nurse (RN) #9 was conducted. RN #9 revealed she was not aware of the need for a nurse staffing committee. RN #9 stated there was not a nursing staffing committee at the facility.

iii. On 5/31/23 at 11:53 a.m., an interview with RN #10 revealed she was not aware of a nursing staffing committee at the facility.

iv. 5/30/23 at 5:05 p.m., an interview with the chief nursing officer (CNO) #8 was conducted. CNO #8 verified there was currently no formal nurse staffing committee. CNO #8 explained having a nurse staffing committee was important because it gave front line staff a voice and more empowerment and ownership in the entire process of creating a nurse staffing plan.

2. The facility failed to ensure all staff employed after January 1, 2019 received a CAPS check prior to working with at-risk adults.

a. Review of personnel files revealed a lack of CAPS checks being completed. Examples include:

i. Review of the personnel file for certified surgical technician (CST) #2 revealed the facility hired him as a traveler on 9/12/22. The review did not reveal any documentation in which a CAPS check had been completed.

ii. Review of the personnel file for registered nurse (RN) #11 revealed the facility hired her as a traveler on 10/17/22. The review did not reveal any documentation in which a CAPS check had been completed.

iii. Review of the personnel file for (CST) #5 revealed the facility hired her as a traveler on 8/1/22. The review did not reveal any documentation in which a CAPS check had been completed.

b. On 5/31/23 at 2:30 p.m., an interview was conducted with human resources director (HRD) #12, who stated CAPS checks had not been completed as she was operating under the assumption that the travelers' agency was conducting the CAPS checks and there was no verification of this process in place. She further stated performing background checks was important to ensure a person was worthy of taking care of patients in a safe manner.

The facility was unable to provide evidence CAPS checks were completed on the above employees prior to exit of the survey.

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

C-0962 Standard: Governing Body or Responsible Individual. 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 interviews and document reviews, the governing body failed to provide direct oversight and 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 control (IC). Additionally, the governing body failed to ensure leadership overseeing the sterile processing department (SPD) were trained and qualified to perform their specific job duties.

Based on interviews and document reviews, the governing body failed to provide direct oversight and 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 control (IC). Additionally, the governing body failed to ensure leadership overseeing the sterile processing department (SPD) were trained and qualified to perform their specific job duties. (Cross-reference C1206 and C1306)

Findings include:

Facility references:

The Scope of Services read the facility has numerous committees whose goal is continual improvement in the processes surrounding patient care and safety. These committees include but are not limited to Quality and Patient Safety, Department meetings (all departments), Surgery, Environment of Care, Risk Management, and Infection Prevention. The facility is committed to excellence in patient care. Our staff exhibit a high degree of professional competence and we are assured this through continuing education. Each department creates staffing plans to meet the needs of our patients within the scope of professional licensing and training as determined for their individual departments. The facility provides patient-centered care through ongoing evaluation of services provided through performance improvement activities and annual review of services and focuses on high-quality patient-centered care.

The District Bylaws read all powers, privileges, and duties vested in or imposed upon the District by law shall be exercised and performed by and through the Board. The Board may delegate to officers, employees, and agents of the District any or all administrative and ministerial powers. It is hereby expressly declared that the Board shall have the following powers and duties: To confer upon any appointed officer or employee of the District the power to choose, remove or suspend employees or agents upon such terms and conditions as may seem fair and just and in the best interests of the District. To create standing or special committees and to delegate such power and authority thereto as the Board deems necessary and proper for the performance of such committee's functions and obligations. The Director's Performance of Duties: A Director of the District shall perform all duties of a Director, including as a member of any committee of the Board upon which the Director may serve, in good faith, in a manner which the Director reasonably believes to be in the best interests of District, and with such care as an ordinarily prudent person in a like position would use under similar circumstances. In performing the Director's duties, the Director shall be entitled to rely on information, opinions, reports, or statements. Programs and groups upon whose information opinions, reports, and statements a Director is entitled are: One or more officers or employees of the District whom the Director reasonably believes to be reliable and competent and matters which the Director reasonably believes to be within such person's professional knowledge or expertise. The Board may appoint a manager or administrator. The manager or administrator shall have general supervision over the administration of affairs, employees, and business of the facility and shall be charged with hiring and discharging of employees and the management of facility properties.

The Quality Management Program read, patient care, service processes, and outcomes are measured through the use of quality indicators and data collection techniques. Analysis of collected data is used to determine levels of performance and quantify variation in processes and outcomes. Ultimate accountability is with the Governing Board which has direct oversight of the quality and safety of care delivered within the facility. The Quality & Patient Safety Plan facilitates the identification of key functions of the organization; the assessment of the quality, safety, and appropriateness of these functions; and the generation of measurable improvements. Quality and Patient Safety sets benchmarks in quality of care, implements patient safety mitigation strategies, eliminates harm, and optimizes outcomes and experience. The organization will utilize state and national patient outcome reports to compare the hospital's performance with other organizations and support and meet requirements and initiatives of government and accreditation bodies. This is accomplished in coordination with the facility committee and department leaders.

The Quality Management Program monitors patient experience, clinical services, occurrences, and various administrative services. The clinical services component of the program includes services such as infection control, patient safety, clinical quality measures, and initiatives, process improvement projects, and quality control. The ultimate authority, responsibility, and oversight of the Quality Management Program is overseen by the facility's Board of Directors (the Board) who retains authority and accountability for all quality activities. The Board will take an active role in the continual improvement of quality and safety at the facility. The Board reviews and approves the quality initiatives annually, and receives and acts upon reports presented to it by the QM Program. The facility uses the following sources and criteria to identify and prioritize quality initiatives in the organization: event reports, sentinel events, serious adverse events, patient safety issues, published evidence-based practice, and hospital-acquired conditions.

1. The board of directors (governing body) failed to ensure the QAPI program, in collaboration with the IC program, implemented, monitored, and maintained methods for preventing and controlling the transmission of infections and limiting the usage of IUSS (immediate use steam sterilization) within the surgical services department.

a. Review of the 2022 and 2023 meeting minutes for the Board of Directors, Quality and Patient Safety Council, Infection Prevention Committee, Environment of Care Committee, and Surgery Committee revealed no evidence the governing body oversaw and collaborated, reviewed, and analyzed infection control processes within the surgical services department and the SPD.

i. Upon request, the facility was unable to provide evidence quality and IC measures were established, implemented, and monitored using nationally recognized evidence-based interventions and measures (benchmarks) in the surgical services department and the SPD.

This was in contrast to the Quality Management Program which read, the governing body will provide authority, responsibility, and oversight for the Quality Management Program. The Program also read, the governing body maintained authority and accountability. Additionally, the Program instructed that the governing body would be actively involved in all quality activities at the facility.

b. On 5/31/23 at 2:58 p.m., an interview was conducted with chief nursing officer (CNO) #8. CNO #8 stated her role included managing quality, risk, and infection prevention at the facility. CNO #8 stated there was a lack of collaboration between the SPD and the IC program to ensure the usage goal of IUSS aligned with national IC guidelines and standards of practice. CNO #8 stated the lack of collaboration between the SPD and IC program was identified after surveyors arrived on-site at the facility. CNO #8 stated remediation and corrective actions were needed within the QAPI and IC programs to ensure performance improvement projects and activities were established and monitored within the surgical services department and the SPD. CNO #8 further stated she was not aware of any specific IC surveillance or audits performed within the SPD.

c. On 6/5/23 at 8:37 a.m., an interview was conducted with chief executive officer (CEO) #15. CEO #15 stated he had been appointed administrative authority by the governing body to oversee facility operations, the senior leadership team, and facility committees. CEO #15 further stated he attended facility committee meetings on behalf of the governing body. CEO #15 stated he was not aware there was a lack of collaboration between the QAPI program, the IC program, the surgical services department, and the SPD.

CEO #15's interview was in contrast to the District Bylaws which read, the governing body may appoint an administrator who would supervise administration affairs, employees, and interactions within the facility. The administrator would oversee the management of the facility and all facility programs and committees.

2. The governing body failed to ensure the director of surgical services was qualified and educated to oversee the SPD and SPD staff.

a. Personnel file reviews for the director of surgical services (DSS) #1 showed no evidence of training for surgical instrument reprocessing and sterilizing. In addition, the job description for the Director of Surgical Services did not delineate what qualifications or training were required in order to conduct SPD oversight.

b. On 5/24/23 at 1:38 p.m., an interview was conducted with DSS #1. DSS #1 stated he oversaw the SPD. DSS #1 stated he was responsible for establishing performance indicators within the surgical services department and the SPD. DSS #1 stated he had not received formal sterile processing training or education on how to reprocess surgical instruments before he became the surgical services director at the facility.

c. On 6/5/23 at 8:37 a.m., an interview was conducted with chief executive officer (CEO) #15. CEO #15 stated he provided oversight over the management of the facility.

CEO #15 stated he was unaware DSS #1 did not have formal SPD training. CEO #15 stated SPD training, experience and knowledge were necessary qualifications for leadership who oversaw the SPD. CEO #15 stated unqualified, inexperienced, and uneducated staff should not have been delegated responsibilities or oversight when they did not have the proper qualifications and or education. CEO #15 stated doing so could have resulted in harm to the patient.

CEO #15's interview was in contrast with the District Bylaws which read the administrator was appointed by the governing body and was responsible for ensuring reliable and competent personnel with the required knowledge or expertise were hired.

Based on the manner and degree of the standard level deficiencies referenced to the Condition, it was determined the Condition of Participation: §485.635 Provision of Services, was out of compliance.

C-1049 All drugs, biologicals, and intravenous medications must be administered by or under the supervision of a registered nurse, a doctor of medicine or osteopathy, or, where permitted by State law, a physician assistant, in accordance with written and signed orders, accepted standards of practice, and Federal and State laws. Based on observations and interviews, the facility failed to ensure all patients had a visible means of identification in order to verify their identity in seven out of seven patients observed during an observation of a medication administration.

Based on observations and interviews, the facility failed to ensure all patients had a visible means of identification in order to verify their identity in seven out of seven patients observed during an observation of a medication administration.

Findings include:

Facility policy:

According to the Patient Identification Policy, residents in the extended care area of the hospital will be identified by photos located in the front of their medical record. Furthermore, prior to the administration of any medication, treatment, therapy, procedure, dietary meal, transport, or transfer to another facility, the healthcare provider will identify the patient at the bedside using two patient identifier process.

1. The facility failed to ensure a process was in place for staff to identify a patient through a visible means of identification placed on the patient.

a. On 5/22/23 at 3:59 p.m., an observation was conducted on the inpatient acute care unit to observe licensed practical nurse (LPN) #13 perform medication administration to a patient in the unit. After logging into the electronic medical record (EMR) and looking at the medication administration record (MAR), LPN #13 logged into the Pyxis machine (a machine that contains medications for administration) and removed the medication. LPN #13 then took the medication to the patient and administered the medication to the patient. The patient did not have a name band on, and as a result, LPN #13 was unable to use a visual means to identify the patient for medication administration. The observation further revealed none of the patients in the inpatient acute care unit wore a name band or any type of identification.

b. On 5/22/23 at 3:59 p.m., an interview was conducted with LPN #13. LPN #13 stated patients at the facility did not wear name bands. She stated in order to identify patients, staff used a picture on the computer to identify the patients. LPN #13 stated the importance of using two patient identifiers when administering medications was to help prevent the patient from receiving the wrong medication.
c. On 5/22/23 at 3:29 p.m., an interview was conducted with RN #14. RN #14 stated it was important for nurses to use two patient identifiers when administering medications to keep from mixing up the patients. RN #14 stated the risk of not using two patient identifiers in medication administration was the patients could receive the incorrect medication and there could be bad side effects and potential death to the patient who received the incorrect medication.

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

C-1206 The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings. Based on observations, document reviews, and interviews, the facility failed to ensure infection prevention and control measures were implemented in order to maintain a clean and sanitary environment to avoid transmission of infection. Specifically, the facility failed to ensure staff followed the manufacturer's instructions for use (IFU), national guidelines, and facility policies for decontamination of surgical instruments and reprocessing endoscopes in two of two observations of the sterile processing department (SPD). In addition, the facility failed to ensure staff in the SPD were oriented, trained, and competent to perform reprocessing and sterilization of surgical instruments and endoscopes. Also, the facility failed to use immediate use steam sterilization (IUSS, sterilization process utilizing the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field) in urgent clinical situations only and not for convenience or as a substitute for sufficient instrumentation per facility policy and national guidelines.

Based on observations, document reviews, and interviews, the facility failed to ensure infection prevention and control measures were implemented in order to maintain a clean and sanitary environment to avoid transmission of infection. Specifically, the facility failed to ensure staff followed the instructions for use (IFU), national guidelines, and facility policies for decontamination of surgical instruments and reprocessing endoscopes in two of two observations of the sterile processing department (SPD). In addition, the facility failed to ensure staff in the SPD were oriented, trained, and competent to perform reprocessing and sterilization of surgical instruments and endoscopes. Also, the facility failed to use immediate use steam sterilization (IUSS, sterilization process utilizing the shortest possible time from the item being removed from the sterilizer to the aseptic transfer onto the sterile field) ) in urgent clinical situations only and not for convenience or as a substitute for sufficient instrumentation per facility policy and national guidelines.

Findings include:

Facility policies:

The Care and Cleaning of Surgical Instruments and Power Equipment policy read, manufacturer's recommendations will be followed in the care and handling of surgical instruments and power equipment. Initial decontamination of instruments will begin immediately after the completion of any invasive procedure. Instruments will be submerged in warm water with an enzymatic detergent and cleaned and rinsed while submerged to prevent contamination and splashing of infectious material. Submersion of the instruments should be a minimum of one minute and a maximum of 20 minutes. Note: Prolonged soaking of instruments may damage instrument surfaces and decrease instrument life.

The Sterilization in the Surgical Setting policy read, to process instruments properly, the practitioner will understand the principles of de-contamination and sterilization and will have the necessary equipment to carry out these principles. They are as follows: a physical design for separating decontamination and processing procedures, ventilation, temperature, humidity, appropriate protective attire, and cleaning procedures.

The Gastrointestinal Lab (GI Lab) Scope of Services policy read, a continuous program of in-service education and periodic evaluation of skills for all personnel is maintained to ensure that the quality of care provided is current with the developments in the medical nursing and infection control fields.

The High-Level Disinfection of Endoscopic (an instrument which can be introduced into the body to give a view of internal parts) Equipment and Accessories policy regarding leakage testing read, fill the sink with clean water, detach the air/water channel-cleaning adapter, suction valve and biopsy valve from the endoscope, connect the MU-1 leakage tester to the air source, turn on the air source and set the airflow regulator to High if you are using a light source, depress the pin inside the connector cap to confirm that air is being emitted, confirm that the leakage tester's connector cap and venting connector are dry, connect the leakage tester's connector cap to the venting connector on the endoscope, completely immerse the endoscope in water, observe for 30 seconds while angulating the bending section in all directions, if a continuous series of bubbles emerge from any location, remove the endoscope from the water and contact Olympus for further instructions.

The facility policy Surgical Services: Sterilization in the Surgical Setting read, IUSS will be carefully selected to meet specialty clinical situations. IUSS will be used only when insufficient time was available to sterilize an item by the preferred pre-packaged method. These items will be used immediately.

References:

According to the ANSI (American National Standards Institute)/AAMI (Association for the Advancement of Medical Instrumentation) ST79:2017/(R)2022 & Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities:

(pg 21) The decontamination area/room should: be physically separate from all other processing areas and from areas in which clean or sterilization procedures are carried out, with any connecting doors and pass-through window remaining closed; be accessible from a service corridor; have a door providing access to the clean workroom; have three-section sinks that are approximately 36 inches deep, include attached solid counters or adjacent work surfaces on which to place soiled and clean items separately, are large enough to allow a tray or container basket of instruments to be placed flat for pretreatment or manual cleaning, and have two-section sinks available for soaking and rinsing prior to cleaning; have a source of critical water for final rinsing; be designed for the following workflow: from the receiving of soiled items; to the removal of linens, fluids, trash; to manual decontamination tasks; to the automatic washer or pass-through window.

(pg 34) Preparation for decontamination of instruments should begin at the point of use. To prevent the formation of biofilm (a layer of bacteria that grows on and sticks to the surface of a structure) and to reduce the risk of corrosion, cleaning, and decontamination should occur as soon as possible after instruments and equipment are used.

(pg 63) Immediate-use steam sterilization (IUSS) should not be used for purposes of convenience or as a substitute for sufficient instrumentation. Instrument inventories should be sufficient to meet the anticipated surgical volume and to ensure that there is enough time to complete all critical elements of reprocessing. IUSS should be kept to a minimum and should be used only in urgent clinical situations.

According to the Association of Perioperative Registered Nurses (AORN) Guidelines for Perioperative Practice, 2021: 5.2 (pg 197) Perform leak testing before manual cleaning and before the endoscope is placed into cleaning solutions. Performing leak testing before cleaning verifies the integrity of the endoscope and helps prevent damage that might occur during the cleaning process if the endoscope has been compromised. Angulating the bending section of the distal end exposes the surfaces to maximum extension and helps reveal leaks.

According to the AORN article IUSS: How to Be Survey Ready published (10/23/19): Immediate Use Steam Sterilization should be used for emergent situations and situations where patient care items cannot be packaged, sterilized, or stored before use.

According to the Association of Perioperative Registered Nurses (AORN) Guidelines for Perioperative Practice, 2023:

Recommendation 3.5 (pg 227) Endoscopic processing areas, including satellite areas should have: a minimum of two decontamination sinks or sink basins, preferably three, that are deep and wide enough to allow complete submersion of the endoscope without tight coiling.

Recommendation 8.4.1 (pg 106) Include the following in the decontamination room design: three decontamination sinks or one sink with three divisions.

Recommendation 6.4 (pg 420) Keep instruments moist until they are cleaned by either saturation with an enzymatic pretreatment product or a towel moistened with water placed over the instruments. Do not use saline.

According to the AORN eGuidelines for Perioperative Practice: Instrument Cleaning (2012-2023):

Part 15.1 Provide education and verify competency of team members with responsibilities for cleaning and care of instruments used in surgery. It is the responsibility of the health care organization to provide initial and ongoing education and to verify the competency of perioperative team members. Initial and ongoing education of perioperative personnel about cleaning and care of instruments facilitates the development of knowledge, skills, and attitudes that affect safe patient care.

Part 15.1.1 Provide education and verify competency for specific knowledge and skills related to cleaning and care of surgical instruments including the following: location and understanding of manufacturers' IFUs for the reusable surgical instrument or medical device, decontamination equipment, cleaning chemicals and disinfectants, inspection equipment, and cleaning verification tools; organizational procedures for decontamination and cleaning verification. Ongoing development of knowledge and skills and documentation of personnel participation is a regulatory requirement for both hospital and ambulatory settings.

According to the Olympus EVIS Exera II IFU Gastrointestinal Videoscope guideline, the medical literature reports incidents of cross-contamination from improper cleaning, disinfection, or sterilization. The IFU read: do not attach/detach the water-resistant cap(s) or the leakage tester while immersed. Attaching/detaching under water could allow the water to enter the endoscope, resulting in endoscope damage. It is strongly recommended that all individuals engaged in reprocessing closely observe all instructions given in this manual and the manuals of all ancillary equipment, and have a thorough understanding of the following items, professional health and safety policies of your hospital, instruction manuals of the endoscope accessories and all the other reprocessing equipment's, structure and handling of endoscope and accessories, handling of pertinent chemicals.

According to the Olympus Reprocessing Guide for OER-PRO scopes poster, observed hanging above the endoscope reprocessing sink, Leakage Testing under step #7, detach the auxiliary water tube and attach leakage tester, turn on the air source and confirm the expansion of the bending section, immerse entire endoscope in clean water, perform leakage test, angulate tip during the test, remove from water, turn off air source and detach leakage tester from the air source, after the tip has deflated, detach leakage tester from the endoscope.

According to the Arthrex Surgical Instruments IFU, at the point of use, soiled instruments must be removed from trays and moistened to prevent debris from drying before transportation to the reprocessing area for cleaning procedures. Soaking in enzyme solutions facilitates cleaning, especially in devices with complex features and hard-to-reach areas (lumens, etc.). These enzyme solutions as well as enzymatic foam sprays break down protein matter and prevent blood and protein-based material from drying on devices. Manufacturer's instructions for preparation and use should be explicitly followed. Devices should be contained and transported in a closed, puncture-proof device to ensure safety.

The General Reprocessing Instructions for KARL STORZ Products (USA) (pg 5) read, place the instruments in containers and soak no longer than one hour with a neutral pH (pH 6.0 to 8.0) enzymatic cleaning solution (e.g., Enzol, Metrizyme, or equivalent, diluted to proper concentration per manufacturer's instructions) immediately after use to prevent blood, protein and other contaminants from drying onto the instruments. Wipe the instruments thoroughly with a lint-free, disposable cloth, preferably moistened with an enzymatic cleaning solution.

According to the V. Mueller IFU Products and Services General Surgical Instrument Cleaning and Prevacuum Sterilization Guide, IUSS was not recommended as a routine practice. The IFUs instructed to refer to the ANSI/AAMI ST79 for requirements on when to perform and how to control IUSS.

The Stryker Reprocessing IFU, preparation for cleaning (pg 3) read, preparation for cleaning is to begin at the point of use, after use (within a maximum of 2 hours post-operatively) remove gross soil using absorbent paper wipes. Intensive rinsing of the reusable instruments with fluent water or transfer of the medical devices into a bath with an aldehyde-free disinfectant solution is highly recommended. Transport to the processing area and prepare for cleaning.

1. The facility failed to ensure staff was reprocessing instruments in accordance with facility policy, national guidelines, and manufacturer's IFU.

A. Observations of the decontamination area revealed IFUs were not followed when decontaminating surgical instruments and leak testing endoscopes.

i. On 5/23/23 at 12:15 p.m., observations of the SPD were conducted. During the observations, sterile processing technician (SPD Tech) #2 was observed spraying surgical instruments with enzymatic spray upon arrival to the decontamination room (an area equipped with tools and systems used to remove contaminants from equipment). SPD Tech #2 then removed a red biohazard bag covering a blue back table drape that contained contaminated a Stryker camera, light cord, scopes, and major instrument tray, as well as a Storz laparoscopic tray from the operating room (OR). SPD Tech #2 sprayed the contaminated camera, light cord, scopes, and surgical instruments with an enzymatic pre-cleaner while the instruments remained on the back table.

a. During the observation of SPD Tech #2, he stated contaminated instruments from the OR were not sprayed with a pre-enzymatic cleaner in the OR because surgeons did not like the odor left in the room. SPD Tech #2 stated instead, contaminated instruments were sprayed upon arrival to the decontamination room.

This was in contrast with the IFU of Stryker and Storz Instrumentation, which read, instruments were to be sprayed at the point of use prior to transport to the decontamination room.

The observations in SPD were also in contrast to the facility's policy Surgical Services: Sterilization in the Surgical Setting, which read the manufacturer's recommendations would be followed in the care and handling of surgical instruments and powered equipment and initial decontamination of instruments would begin immediately after the completion of any invasive procedures.

This was also in contrast to the AORN Guidelines for Perioperative Practice which instructed to keep instruments moist until they were cleaned either by saturation with an enzymatic pretreatment product or a towel moistened with water placed over the instruments.

ii. SPD Tech #2 then removed the soiled instruments from the back table and placed them on a decontamination counter next to the sink. SPD Tech #2 then filled the sink with water and enzymatic detergent, placed the soiled instruments into the sink, and began to manually clean the instruments. During the observation of SPD Tech #2, it was noted that no clock or timer was present in the area and that the soaking of instruments was not timed. When SPD Tech #2 completed manual cleaning of instruments he placed these instruments back on the contaminated portion of the counter.

a. During this observation, SPD Tech #2 explained instruments were expected to soak in a combination of enzymatic cleaner and water for five to ten minutes prior to handwashing each instrument individually to loosen existing bioburden (potential infectious material present on or in a device or surgical instrument). SPD Tech #2 explained there was no clock or timer in the room for him to use while timing the soaking of instruments. SPD Tech #2 explained he would usually pull his cell phone out of his pocket, set an alarm or timer, and place the phone back into his shirt pocket.

This was in contrast to the facility policy of Care and Cleaning of Surgical Instruments and Power Equipment which read, submersion of the instruments should have been for a minimum of one minute and a maximum of twenty minutes. The policy also noted that prolonged soaking of instruments may have damaged instrument surfaces and decreased instrument life.

iii. During the observations, it was noted that the SPD only had one sink. As a result, SPD Tech #2 was observed washing and rinsing instruments in the same sink without disinfecting the sink after each process.

This was in contrast with ANSI/AAMI's ST 79 recommendation to have a three-sink decontamination system or a minimum of a two-sink system for soaking and rinsing. The standard continued by explaining designing the room to provide adequate space for necessary equipment reduced the potential for cross-contamination and enhanced safe work practices and efficiency.

This was also in contrast with the AORN Guidelines for Perioperative Practice which instructed to include the following in the decontamination room design: three decontamination sinks or one sink with three divisions.

iv. On 5/23/23 at 12:29 p.m., certified surgical technician (CST) #4 was observed reprocessing a colonoscope (a flexible fiber-optic instrument inserted through the anus in order to examine the colon) in the SPD. CST #4 filled the sink with water, hooked up the leakage tester, and placed the scope into the water. CST #4 then turned on the leakage tester after the scope was submerged and observed the colonoscope for leaks or bubbles. CST #4 failed to angulate the tip of the endoscope during the leak testing process. CST #4 then turned off the leakage tester, disconnected the leakage tester from the colonoscope while the scope was submerged in the water, and began the manual disinfection process by adding enzymatic detergent to the sink water.

This observation was in contrast to the Olympus Reprocessing Guide for OER-PRO scopes guidance poster, which instructed to turn on the air source and confirm the expansion of the bending section prior to immersing the endoscope in clean water. The poster also instructed to angulate the tip of the endoscope during the test.

These observations were also in contrast to the facility policy High-Level Disinfection of Endoscopic Equipment and Accessories, which instructed to angulate the bending section of the colonoscope in all directions while submerged in water.

This observation was also in contrast to the Olympus Endoscope Reprocessing IFU which read, do not detach the water-resistant cap(s) or the leakage tester while immersed. Detaching underwater could allow the water to enter the endoscope, resulting in endoscope damage.

B. Interviews

i. On 5/23/23 at 11:51 a.m., an interview was conducted with CST #5. CST #5 explained the process of reprocessing a contaminated endoscope once it was in the SPD. CST #5 stated the first step was to connect the leakage tester to the scope and place the scope in a sink of clean water. CST #5 stated the next step involved turning on the leakage tester once the scope was submerged to watch for any tiny bubbles that would indicate a leak. CST #5 further explained if no leak was detected the next step was to disconnect the leakage tester and begin manual disinfection of the scope.

During the interview, CST #5 did not mention angulating the bending portion of the colonoscope while performing the leakage test, which was in contrast to the High-Level Disinfection of Endoscopic Equipment and Accessories, which instructed to angulate the bending sections in all directions.

CST #5's interview was also in contrast to the Olympus Endoscope Reprocessing IFU which read, do not detach the leakage tester while immersed. The poster continued by explaining detaching under water could allow the water to enter the endoscope, resulting in endoscope damage.

ii. On 5/23/23 at 12:07 p.m., an interview was conducted with SPD endoscope reprocessing technician (Tech) #3. Tech #3 explained how to reprocess a contaminated endoscope once it was in SPD. Tech #3 stated his first step was to fill the reprocessing sink with water and then connect the leakage tester to the scope. Once the leakage tester was connected he would submerge the scope in the sink of water, turn on the leakage tester and watch for small bubbles that would indicate a leak, if no leak was detected, disconnect the leakage tester and begin manual disinfection of the scope.

During the interview, Tech #3 did not mention angulating the bending portion of the colonoscope while performing the leakage test, which was in contrast to the High-Level Disinfection of Endoscopic Equipment and Accessories policy regarding Leakage Testing which instructed to angulate the bending sections in all directions.

Tech #3's interview was also in contrast to the Olympus Reprocessing Guide for OER-PRO scopes guidance poster, which instructed to turn on the air source and confirm the expansion of the bending section prior to immersing the endoscope in clean water. The poster also instructed to angulate the tip of the endoscope during the test.

Tech #3's interview was also in contrast to the Olympus Endoscope Reprocessing IFU which read, do not detach the leakage tester while immersed. Detaching underwater could allow the water to enter the endoscope, resulting in endoscope damage.

This was in contrast to the Olympus EVIS Exera II IFU Gastrointestinal Videoscope IFU which read, do not detach the water-resistant cap(s) or the leakage tester while immersed. The IFU continued by explaining detaching under water could allow the water to enter the endoscope, resulting in endoscope damage.

iii. On 5/23/23 at 4:11 p.m., an interview was conducted with SPD Tech #2. SPD Tech #2 stated all manufacturer's IFU for surgical instruments in the facility were kept in a binder titled 'IFU' in the sterile processing department. Upon review of the IFU binder with Tech #2, it revealed not all manufacturer's IFU for surgical instruments used in the facility were in the binder.

iv. On 5/24/23 at 1:38 p.m., an interview was conducted with the director of surgical services (DSS) #1. DSS #1 explained his roles and responsibilities as the surgical services director, which included being responsible for maintaining the manufacturer's IFU binder. DSS #1 verified the IFU binder was not up to date or complete. DSS #1 also discussed the importance of cleaning, disinfecting, and reprocessing surgical instruments, equipment, and endoscopes in accordance with the manufacturer's IFU and if not done properly it could cause harm to patients, contamination problems such as E-coli (type of bacteria), and damage equipment. DSS #1 also stated it was important to completely rinse all of the enzymatic cleaners from instruments, equipment, and endoscopes because it could cause cross-contamination and breakdown of critical equipment if not rinsed completely.

2. The facility failed to ensure staff was trained and determined to be competent to reprocess and sterilize surgical instruments and endoscopes. The facility failed to provide evidence of competency and training in SPD.

A. Observations of staff in the sterile processing department (SPD) revealed staff was conducting reprocessing and sterilization tasks in contrast to the manufacturer's IFU, facility policy, and without receiving competencies to determine if the staff member was deemed competent to provide services in the SPD.

i. On 5/23/23 at 12:15 p.m., SPD Tech #2 was observed reprocessing contaminated instruments from the OR. During the observations, SPD Tech #2 was observed spraying the contaminated instruments with enzymatic spray upon arrival to the decontamination room. SPD Tech #2 removed the soiled instruments from the back table and placed them on a decontamination counter next to the sink. SPD Tech #2 then filled the sink with water and enzymatic detergent, placed the soiled instruments into the sink, and began to manually clean the instruments. During the observation of SPD Tech #2, it was noted that no clock or timer was present in the area and that the soaking of instruments was not timed. When SPD Tech #2 completed manual cleaning of instruments he placed these instruments back on the contaminated portion of the counter.

This observation was in contrast to the following guidance:

According to the IFU of Stryker and Storz Instrumentation, instruments were to be sprayed at the point of use prior to transport to the decontamination room.

According to the facility's policy Surgical Services: Sterilization in the Surgical Setting, the manufacturer's recommendations would be followed in the care and handling of surgical instruments and powered equipment and initial decontamination of instruments would begin immediately after the completion of any invasive procedures.

According to the AORN Guidelines for Perioperative Practice, instruments should have been kept moist until they were cleaned either by saturation with an enzymatic pretreatment product or a towel moistened with water placed over the instruments.

According to the facility policy Care and Cleaning of Surgical Instruments and Power Equipment, submersion of the instruments should have been for a minimum of one minute and a maximum of twenty minutes. The policy also noted that prolonged soaking of instruments may have damaged instrument surfaces and decreased instrument life.

ii. On 5/23/23 at 12:29 p.m., Certified Surgical Technologist (CST) #4 was observed reprocessing a colonoscope. CST #4 filled the sink with water, hooked up the leakage tester to the scope, and submerged the scope in the sink of water. CST #4 was observed turning the leakage tester on after the colonoscope was already submerged. During this observation, CST #4 failed to angulate the bending rubber of the colonoscope looking for leaks or bubbles. CST #4 then turned off the leakage tester, disconnected the leakage tester from the colonoscope while the scope was submerged in the water, and began the manual disinfection process by adding enzymatic detergent to the sink water.

This observation was in contrast to the Olympus EVIS Exera II IFU Gastrointestinal Videoscope IFU that read, do not detach the water-resistant cap(s) or the leakage tester while immersed. Detaching underwater could allow the water to enter the endoscope, resulting in endoscope damage. It was strongly recommended that all individuals engaged in reprocessing closely observe all instructions given in this manual and the manuals of all ancillary equipment, and have a thorough understanding of the following items: professional health and safety policies of the hospital, instruction manuals of the endoscope accessories and all the other reprocessing equipment, structure and handling of endoscope and accessories, and handling of pertinent chemicals.

B. Document Review

i. Review of the personnel files for SPD Tech #2, SPD Tech #3, CST #4, CST #5, CST #6, and DSS #1 revealed no competencies or training for reprocessing instruments or endoscopes.

This was in contrast to the Gastrointestinal Lab Scope of Services policy which read, a continuous program of in-service education and periodic evaluation of skills for all personnel is maintained to ensure that the quality of care provided is current with the developments in the medical nursing and infection control fields.

This was also in contrast to the AORN eGuidelines which instructed to provide education and verify competency of team members with responsibilities for cleaning and care of instruments used in surgery.

C. Interviews

i. On 5/30/23 at 11:38 a.m., an interview with SPD/Endoscope Reprocessing Tech #3 was conducted. Tech #3 stated he was a firm believer SPD was the backbone of the OR and if not done correctly, sterility could not be guaranteed and infection rates could be impacted. Tech #3 also stated he was not a certified SPD tech. He started working as a tech in 1980 and received on-the-job training. He explained he was not provided any SPD training or competencies at the facility since he started working there.

Tech #3 stated training and providing competency for staff who reprocessed instruments and endoscopes was important because if instruments and endoscopes were reprocessed by untrained personnel, equipment and in particular endoscopes could have been damaged. Tech #3 further said damaged endoscopes used on other patients could have led to patient infections. Tech #3 explained observations and interviews he had seen throughout the survey made him realize staff was not reprocessing surgical instruments and endoscopes correctly.

ii. On 5/25/23 at 2:45 p.m., an interview with CST #7 was conducted. CST #7 stated he did not receive any formal training in SPD for processing endoscopes, equipment, or instruments. CST #7 further stated he had not completed any SPD or endoscope reprocessing competencies at the facility since starting work there ten weeks prior. CST #7 stated competencies were important because lack of training could result in injury or infection to patients or staff.

iii. On 5/24/23 at 1:38 p.m., an interview with DSS #1 was conducted. DSS #1 stated he worked as the director of surgical services for six years. DSS #1 explained staff competencies for endoscope and instrument reprocessing were expected to be completed annually, however, this process had not been completed upon the survey. DSS #1 stated Olympus representatives provided in-services to staff upon request but had not been to the facility in six months.

iv. On 5/30/23 at 12:51 p.m., an interview with CNO #8 was conducted. CNO #8 stated competencies were important because they determine how much staff knew about doing their job and whether they were capable of performing duties according to facility policies, national guidelines, and the manufacturer's IFU. CNO #8 further explained yearly competencies were required to ensure staff was re-educated on subjects they are exposed to infrequently. CNO #8 stated yearly competencies should have been required in the SPD. She further stated this need was not identified prior to the survey.

3. 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. A review of the facility's surgical instrument inventory revealed the facility had two laparoscopic instrument sets and two major instrument sets available for surgeries.

ii. A review of the IUSS log from 2/2/23 through 5/23/23 revealed staff conducted IUSS on 27 different occasions. Further review of the IUSS log with the surgery schedule revealed on three dates there were more cases scheduled than there were surgical instrument trays in inventory, resulting in the use of IUSS of surgical instrument trays to meet the caseload.

a. A review of the IUSS log on 2/7/23 revealed a laparoscopic surgical instrument set (instruments used for minimally invasive procedures) and a "major set" (specially designed instruments used to carry out specific actions during an operation) underwent IUSS. According to the surgery schedule, two laparoscopic cholecystectomy procedures (a minimally invasive surgical procedure used for the removal of the gallbladder) and one laparoscopic hernia repair (a bulging of an organ or tissue through an abnormal opening) procedure were scheduled on 2/7/23; however, the facility only had two laparoscopic instrument sets and two major sets in its inventory, resulting in the facility reprocessing a laparoscopic set and a major set by using IUSS in order to meet the needs of the third case.

b. A review of the IUSS log on 2/14/23 revealed a laparoscopic instrument set and a major set underwent IUSS. According to the surgery schedule, three laparoscopic hernia repair procedures were scheduled on 2/14/23; however, the facility only had two laparoscopic instrument sets and two major sets in its inventory. This resulted in the facility reprocessing a laparoscopic set and a major set by using IUSS in order to meet the needs of the third case.

c. A review of the IUSS log on 3/7/23 revealed a laparoscopic instrument set and a major set underwent IUSS. According to the surgery schedule, a laparoscopic cholecystectomy, a laparoscopic hernia repair, and an exploratory laparoscopy (a minimally invasive method of diagnosing abdominal disease through direct inspection of the abdominal organs) were scheduled on 3/7/23; however, only two laparoscopic instruments sets and two major sets were available in the facility's inventory. This resulted in the facility reprocessing a laparoscopic set and a major set by using IUSS in order to meet the needs of the third case.

This document review was in contrast with the manufacturer's IFU of the instruments used in laparoscopic cholecystectomies and laparoscopic hernia repair procedures. According to the V. Mueller IFU Products and Services General Surgical Instrument Cleaning and Prevacuum Sterilization Guide, IUSS was not recommended as a routine practice. The IFUs instructed to refer to the ANSI/AAMI ST79 for requirements on when to perform and how to control IUSS.

According to the ANSI/AAMI ST79:2017/(R)2022 & Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive Guid

Based on the manner and degree of standard level deficiencies referenced to the Condition, it was determined the Condition of Participation, §485.641 Quality Assessment and Performance Improvement Programs, was out of compliance.

C-1306 QAPI Program Design and scope. The CAH's QAPI program must: Be ongoing and comprehensive. Involve all departments of the CAH and services (including those services furnished under contract or arrangement). Based on interviews and document review, the quality assurance performance improvement (QAPI) program failed to ensure the sterile processing department (SPD) established, implemented and maintained performance improvement indicators based on national guidelines and benchmarks. Furthermore, the facility failed to ensure adverse patient safety events were reported in order to identify contributing factors and implement preventative actions.

Based on interviews and document review, the quality assurance performance improvement (QAPI) program failed to ensure the sterile processing department (SPD) established, implemented and maintained performance improvement indicators based on national guidelines and benchmarks. Furthermore, the facility failed to ensure adverse patient safety events were reported in order to identify contributing factors and implement preventative actions.

Findings include:

Facility policies:

According to the Risk Management Occurrence Reporting Policy, an incident/occurrence is any event or situation that adversely affects or threatens to affect the well being of patients. Employees who become aware of an occurrence need to notify the appropriate director, administrator on-call, or directly to risk management and complete an occurrence report via electronic reporting system. Occurrences to be reported include but are not limited to surgical/anesthesia events and process or systems failure.

According to the Occurrence Investigation and Analysis Policy, once risk management has discovered the cause(s) of an occurrence through investigation, the problem can be analyzed. Then a solution can be developed which will help avoid similar occurrences in the future. Applying the proper remedies will decrease the possibility of similar occurrences happening in the future. Efficient analysis can be achieved by studying possible solutions to the problem and determining alternatives (remedies) that can be applied to prevent recurrence of this type of occurrence.

According to the Quality Management Program Policy, the organization will measure and monitor quality outcomes and implement appropriate changes using the following guidelines: Performance compared to up-to-date external sources (benchmarking), support and meet requirements and initiatives of governmental and accreditation bodies. These include meeting minimum standards of care as those are defined and the organization will utilize state and national patient outcome reports to compare the hospital's performance with other organizations.

References:

According to the ANSI (American National Standards Institute)/AAMI (Association for the Advancement of Medical Instrumentation) ST79:2017/(R)2022 & Amendments A1, A2, A3, A4 (Consolidated Text) Comprehensive Guide to Steam Sterilization and Sterility Assurance in Healthcare Facilities:

(pg 63) Immediate-use steam sterilization (IUSS) should not be used for purposes of convenience or as a substitute for sufficient instrumentation. Instrument inventories should be sufficient to meet the anticipated surgical volume and to ensure that there is enough time to complete all critical elements of reprocessing. IUSS should be kept to a minimum and should be used only in urgent clinical situations.

According to the AORN article IUSS: How to Be Survey Ready published (10/23/19): Immediate Use Steam Sterilization should be used for emergent situations and situations where patient care items cannot be packaged, sterilized, or stored before use.

1. The facility failed to ensure the SPD identified, investigated, and implemented measures to prevent negative outcomes and minimize the use of immediate use steam sterilization (IUSS).

a. Document review

i. A review of incident reports from 5/1/22 to 5/22/23 revealed only one incident from the sterile processing department (SPD), which involved a surgical needle being found in a sterilized tray of instruments.

ii. The quality meeting minutes from January 2022 through April 2023 were reviewed and revealed IUSS percentages were reported to the committee in April 2022 and again in April 2023. The April 2022 meeting minutes revealed the target goal for IUSS was less than 15% and had a three month average for the first quarter of 11.6%. There was no indication of interventions to reduce the percentage of IUSS or how 15% was chosen as the target goal.

In contrast, the April 2023 meeting minutes revealed the target goal had been increased to 30% and read the facility had trended down to 15%. This was contradictory to the report in April 2022 which showed the rate was 11.6%, resulting in an increase in IUSS cases from the prior year.

iii. The board of directors meeting minutes from May 2020 through April 2023 were reviewed. The review revealed there was no discussion about SPD or report to this group regarding any incident reporting or IUSS use from surgical services.

iv. The surgical service staff meeting minutes from July 2022 through December 2022 were reviewed. The review revealed there was no discussion about SPD or report to this group regarding any incident reporting or IUSS use from surgical services.

v. The surgery committee meeting minutes from January 2023 through May 2023 were reviewed. The review revealed there was no discussion about SPD or report to this group regarding any incident reporting or IUSS use from surgical services.

vi. The risk management meeting minutes from November 2022 through March 2023 were reviewed. The review revealed there was no discussion about SPD or report to this group regarding any incident reporting or IUSS use from surgical services.

vii. The medical executive committee meeting minutes from May 2022 through April 2023 were reviewed. The review revealed there was no discussion about SPD or report to this group regarding any incident reporting or IUSS use from surgical services.

viii.. The infection prevention meeting minutes from October 2022 through May 2023 were reviewed. The review revealed there was no discussion about SPD or report to this group regarding any incident reporting or IUSS use from surgical services.

b. Interviews

i. On 5/25/23 at 2:44 p.m., an interview was conducted with certified surgical technician (CST) #7. CST #7 stated he was a traveler and worked for the facility approximately 10 weeks. CST #7's definition of an occurrence was anything that comes down to patient safety such as sentinel events. CST #7 stated occurrences specific to surgical services were anything that contaminated the sterile field or anything that delayed patient care. CST #7 stated he had no training upon arrival to the facility regarding occurrence reporting. CST #7 stated his process for occurrence reporting was to notify his supervisor.

ii. On 5/31/23 at 2:58 p.m., an interview was conducted with chief nursing officer (CNO) #8, who stated her role included managing quality, risk, and infection prevention at the facility. CNO #8 stated the occurrence reporting policy was reviewed with new employees during the initial onboarding phase of the job. New employees were taught an occurrence was any situation that was unusual, including near misses and good catches.

CNO #8 stated staff were expected to report instances of IUSS in an occurrence report. CNO #8 stated she was aware that SPD was under-reporting occurrences, but was unable to provide a reason for this. She stated all employees had access to the electronic reporting system used for occurrence reporting.

Furthermore, CNO #8 was unable to provide information regarding how the benchmarking percentage used for the IUSS goal was determined. CNO #8 stated determining the benchmark for IUSS and occurrence reporting tracking was under the responsibility of the director of surgical services (DSS) #1. CNO #8 stated remediation and corrective actions were needed within the QAPI and IC programs to ensure performance improvement measures and activities were established and monitored within the surgical services department and the SPD.

iii. On 5/24/23 at 1:39 p.m., an interview was conducted with DSS #1. DSS #1 stated there was a program in place for reporting occurrences. DSS #1 stated occurrence examples in the surgical services area included torn wrappers on the instrument cases, bioburden (blood or tissue) on the instruments following cleaning and sterilization, and breaks in the sterile field in the operating room. DSS #1 stated his expectation was for employees to notify him when occurrences happened. DSS #1 stated he then would review the occurrence to determine if more education was needed.

When asked about occurrences for the prior six months, DSS #1 stated there was one occurrence for a disposable needle that was not disposed of. DSS #1 stated all other events were handled at the time it was brought to his attention. DSS #1 then stated there was a goal to reduce the immediate use steam sterilization (IUSS) to less than 20%, however, it was not tracked through occurrence reporting.

DSS #1's interview was in contrast with CNO #8's expectation of reporting instances of IUSS as an incident report.

Not filing occurrence reports for variances in practice, including the use of IUSS, was in contrast to the risk management occurrence reporting policy which read employees who became aware of an occurrence needed to notify the appropriate director, administrator on-call, or risk management and complete an occurrence report via the electronic reporting system.