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

C- 1204 Infection prevention and control program organization and policies. The CAH must demonstrate that:(1) An individual (or individuals), who is qualified through education, training, experience, or certification in infection prevention and control, is appointed by the governing body, or responsible individual, as the infection preventionist(s)/infection control professional(s) responsible for the infection prevention and control program and that the appointment is based on the recommendations of medical staff leadership and nursing leadership; Based on document review and interviews, the facility failed to ensure the Infection Control Coordinator was qualified through training or experience.

C-1208 - The infection prevention and control includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health authorities; Based on observation, interview and document review, the facility failed to follow the infection control plan for infection prevention. Specifically, the facility failed to ensure healthcare personnel and visitors wore source control to prevent the spread of COVID-19 while in the facility and while caring for patients, in alignment with the Center for Disease Control (CDC) guidelines. Additionally, the facility failed to ensure staff were screened to be asymptomatic for symptoms of COVID-19 prior to working their scheduled shifts.

Based on interviews and document review the facility failed to have an active facility-wide program, for surveillance, prevention of infections.

Findings include:

References:

The Infection Prevention Plan read, the program was designated to ensure the safety of patients, residents, staff and visitors within its healthcare environment. The process is based on published guidelines from professional societies, as well as guidance from healthcare accreditation organizations. Policies and procedures will be based on recognized CDC guidelines. The program maintained a culture of safety that promotes zero tolerance for both the occurrence of preventable HAIs and for noncompliance with established infection prevention and control practices. The scope of the plan was facility wide that interfaces with all departments and services. The structure and authority included an infection control coordinator (ICC) a medical staff representative and at least one member from each main department in the facility. The committee was to meet quarterly and as necessary and to approve infection prevention policies and procedures. The plan required a risk assessment to be performed which established the priorities, goals and objectives for the program. The IP committee was to evaluate the effectiveness of the interventions on an as needed bases no less than annually. The evaluation addressed emerging and re-emerging healthcare issues in the community. The evaluation assesses the success or failure of the interventions for preventing and controlling infections. Prevention of HAIs was done through education of patients, residents, staff and visitors about infection prevention and control, procedure review and evaluation, maintain a system to monitor and improve adherence to hand hygiene and precaution policies, determine whether precautions are appropriate in individual patients by conducting infection control rounding, ensure adequate preparation for surge of infectious patients, communicate with pharmacy review committee in regards to antibiotic utilization practice patterns and antimicrobial stewardship actions, participate in construction renovation planning and activities and plan for emergency management if infectious patients (pandemic). Education and training of healthcare workers was required by the plan to include hospital infection control orientation and mandatory in-service programs. The development and implement a system for surveillance of infection to include identifying baseline information about the frequency and type of HAIs, recognized clusters or signification deviations from endemic level, develop a system for identifying, reporting and analyzing the incidence and cause of HAIs, performing a risk assessment of the needs for the institution at least on a yearly bases, preparing staff and physicians to identify and report early any clusters of patient with similar symptoms to the ICC. The surveillance required, central-line related blood stream infections and clostridium difficile-associated diarrhea. Control ongoing transmission of HAIs and develop corrective measures to reduce the risk of acquiring infections by investigating adherence issues to infection prevention procedures/practices. All committee members will participate in training related to infection prevention. According to the plan, the facility was required to provide adequate human and material resources, both personnel and non-personnel to achieve the goals of reducing HAIs.

2021 Infection Prevention and Control Risk Assessment read, location risk were listed as: communicable disease was an expected risk and vaccine-preventable illness in an under-vaccinated population was likely. Potential HAIs listed: lack of antimicrobial stewardship was expected and lack of isolation equipment and patients unable to comply with hand hygiene were likely. Airborne pathogens was listed as expected. Employee risks were listed as: inadequate annual tuberculous testing was listed as expected and annual n-95 fit testing, respirator testing, and ineffective screening of contract and agency personnel were likely. Environmental risk factors were listed as: inadequate number of isolation rooms, ineffective planning for infection control measures to take for construction, renovation or scheduled disruption of essential utilities was listed as likely. Improper procedures followed during construction and lack of hand sanitizer was listed as likely.

1. The facility failed to ensure the Infection Control Plan to include the risk assessment for 2021 was implemented to ensure the safety of patients, residents, staff and visitors within its healthcare environment.

a. On 10/5/21 at 11:38 a.m., an interview was conducted with ICC #3. ICC #3 stated she worked as a Registered Nurse on the unit and then spent 16 hours per week on infection control. ICC #3 stated her role as the ICC was to ensure the Infection Control Plan was implemented to include the risk assessment and work on reporting infections to national healthcare safety network to include Central line-associated bloodstream infection (CLABSI) and catheter-associated urinary tract infection (CAUTI), antibiotic stewardship, surgical site infections (SSI), sepsis prevention and education staff on donning and doffing personal protective equipment. ICC #3 then stated she was responsible for education to employees related to anything infection control related.

ICC #3 stated she worked with education to do annual training for staff which included respirator fit testing. According to ICC #3 the annual training was usually conducted in October, but had not been schedule for 2021 and was unsure when the training was to take place. ICC #3 stated she had not had any infection control committee meetings since 2019. ICC #3 stated she was tracking SSI, yet the facility did not have any surgical services it provided.

ICC #3 stated she was unable to provide evidence of additional infection prevention training. Additionally, she stated her subscription to The Association for Professionals in Infection Control and Epidemiology (APIC) had lapsed and was unable to access training.

b. The facility as unable to provide any infection control benchmarks, surveillance or tracking and trending.
When asked for any of the interventions for the IP plan, the facility was unable to provide any.
When asked for any interventions from the risk assessment, again, the facility was unable to provide any.

Based on document review and interviews, the facility failed to ensure the Infection Control Coordinator was qualified through training or experience.

Findings include:

References:

The Infection Control Coordinator (ICC) Job Description read, in addition to regular Registered Nurse (RN) duties, the ICC is responsible for developing and maintaining an effective, system wide infection control program. This position will monitor and evaluate the prevalence of healthcare associated infections. Supports teamwork essential for compliance with regulatory agency standards through surveillance, effective prevention and control activities specific to a variety of practice settings, and accurate reports. Assist in developing and implementing program initiatives, policies and education related to infection prevention. The ICC hours may be scheduled as available and determined by the Chief Nursing Officer (CNO).

1. The facility failed to ensure the ICC was trained and had experience to perform and oversee facility wide infection prevention program.

a. Document review revealed the ICC was unable to provide evidence of infection control training and experience.

i. The Infection Control Coordinator (ICC) #3's personnel file was reviewed. In the personnel file there was no evidence of infection control training, or evidence of experience performing the role.

ii. The job description for the ICC role read, the ICC was responsible for developing and maintaining an effective, system wide infection control program, but did not include training or experience expectations.

iii. ICC #3 provided a certificate of completion for evidence of infection control training. The certificate read, the Infection Control and Risk Assessment (ICRA) Construction Trades Best Practice Awareness Training Qualification Program developed by the United Brotherhood of Carpenters and Joiners of America's International Training Fund.

Additionally, ICC #3 provided a screenshot of courses in which she was enrolled, however, she was unable to provide evidence of completed training.

b. Interviews revealed the ICC did not have experience or training.

i. On 10/5/21 at 12:22 p.m., Director of Quality (Director) #2 stated she had provided all certificates ICC #3 had provided the facility which was located in her personnel file. Director #2 stated ICC #3 did not have previous experience in infection prevention prior to her role as the ICC.

ii. On 10/5/21 at 11:38 a.m., ICC #3 was interviewed. ICC #3 stated she was unable to provide evidence of additional infection prevention training. Additionally, she stated her subscription to The Association for Professionals in Infection Control and Epidemiology (APIC) had lapsed and was unable to access training.

Based on observation, interview and document review, the facility failed to follow the infection control plan for infection prevention. Specifically, the facility failed to ensure healthcare personnel and visitors wore source control to prevent the spread of COVID-19 while in the facility and while caring for patients, in alignment with the Center for Disease Control (CDC) guidelines. Additionally, the facility failed to ensure staff were screened to be asymptomatic for symptoms of COVID-19 prior to working their scheduled shifts.

Findings include:

References:

The Infection Prevention Plan read, the program was designated to ensure the safety of patients, residents, staff and visitors within its healthcare environment. The process is based on published guidelines from professional societies, as well as guidance from healthcare accreditation organizations. Policies and procedures will be based on recognized CDC guidelines. The program maintained a culture of safety that promotes zero tolerance for both the occurrence of preventable HAIs and for noncompliance with established infection prevention and control practices. The scope of the plan was facility wide that interfaces with all departments and services. The structure and authority included an infection control coordinator (ICC) a medical staff representative and at least one member from each main department in the facility. The committee was to meet quarterly and as necessary and to approve infection prevention policies and procedures. The plan required a risk assessment to be performed which established the priorities, goals and objectives for the program. The IP committee was to evaluate the effectiveness of the interventions on an as needed bases no less than annually. The evaluation addressed emerging and re-emerging healthcare issues in the community. The evaluation assesses the success or failure of the interventions for preventing and controlling infections.

Prevention of HAIs was done through education of patients, residents, staff and visitors about infection prevention and control, procedure review and evaluation, maintain a system to monitor and improve adherence to hand hygiene and precaution policies, determine whether precautions are appropriate in individual patients by conducting infection control rounding, ensure adequate preparation for surge of infectious patients, communicate with pharmacy review committee in regards to antibiotic utilization practice patterns and antimicrobial stewardship actions, participate in construction renovation planning and activities and plan for emergency management if infectious patients (pandemic). Education and training of healthcare workers was required by the plan to include hospital infection control orientation and mandatory in-service programs. The development and implement a system for surveillance of infection to include identifying baseline information about the frequency and type of HAIs, recognized clusters or signification deviations from endemic level, develop a system for identifying, reporting and analyzing the incidence and cause of HAIs, performing a risk assessment of the needs for the institution at least on a yearly bases, preparing staff and physicians to identify and report early any clusters of patient with similar symptoms to the ICC. The surveillance required, central-line related blood stream infections and clostridium difficile-associated diarrhea. Control ongoing transmission of HAIs and develop corrective measures to reduce the risk of acquiring infections by investigating adherence issues to infection prevention procedures/practices. All committee members will participate in training related to infection prevention. According to the plan, the facility was required to provide adequate human and material resources, both personnel and non-personnel to achieve the goals of reducing HAIs.

2021 Infection Prevention and Control Risk Assessment read, location risk were listed as: communicable disease was an expected risk and vaccine-preventable illness in an under-vaccinated population was likely. Potential HAIs listed: lack of antimicrobial stewardship was expected and lack of isolation equipment and patients unable to comply with hand hygiene were likely. Airborne pathogens was listed as expected. Employee risks were listed as: inadequate annual tuberculous testing was listed as expected and annual n-95 fit testing, respirator testing, and ineffective screening of contract and agency personnel were likely. Environmental risk factors were listed as: inadequate number of isolation rooms, ineffective planning for infection control measures to take for construction, renovation or scheduled disruption of essential utilities was listed as likely. Improper procedures followed during construction and lack of hand sanitizer was listed as likely.

1. The facility failed to implement the Infection Control Plan, to include the risk assessment for 2021, to ensure occurrences of preventable HAIs and for noncompliance with established infection prevention and control practices were implemented.

a. On 10/5/21 at 11:38 a.m., an interview was conducted with the Infection Control Coordinator (ICC) #3. ICC #3 stated she worked as a Registered Nurse on the patient care units the majority of her time. ICC #3 then stated in 2021 she increased her infection control work and had currently spent 64 hours per month/16 hours per week on infection control, with the majority of her time spent on COVID-19.

ICC #3 stated her role as the ICC was to ensure the Infection Control Plan was implemented to include the risk assessment and work on reporting infections to the National Healthcare Safety Network (NHSN) to include Central line-associated bloodstream infection (CLABSI) and catheter-associated urinary tract infection (CAUTI), antibiotic stewardship and surgical site infections (SSI).

i. Review of the Infection Control Plan was done with ICC #3. ICC #3 stated she had not implemented the plan or the risk assessments due to a lack of time, education and resources. ICC #3 also stated she had not had any infection control committee meetings since 2019 due to a lack of resources and time to dedicate to infection control.

This was in contrast to the Infection Control Plan which required quarterly meetings and the job description for the ICC which read the ICC was responsible for developing and maintain an effective, system-wide infection control program.

ii. On review of time sheets provided by the facility from February 2021 to October 2021, ICC #3 had not worked 64 hours per month, as the ICC due to staffing needs on the inpatient units.

Examples included:

In June of 2021, ICC #3 worked 58.78 hours designated of infection control for the month. In July of 2021, ICC #3 worked 30 hours designated for infection control and for August, September and October of 2021- no hours were worked for infection control.

This was in contrast to interview with the Director of Quality who stated ICC #3 was to spend 16 hours per week on infection control tasks.

iv. ICC #3 continued her interview and stated she was also responsible for education to employees related to anything infection control related.

ICC #3 was unable to provide any training related to infection control which she had conducted in 2021. ICC #3 did however provide a "COVID-19 Book". Review of the book revealed: emails to staff with new COVID-19 guidelines as they were changed and implemented. There was also donning and doffing of PPE education which had been conducted 10/6/2020.

ICC #3 stated she was unable to provide evidence of infection prevention training. Additionally, she stated her subscription to The Association for Professionals in Infection Control and Epidemiology (APIC) had lapsed and was unable to access training.

b. As of 10/6/21, the facility was unable to provide evidence of how the infection control plan had been implemented for 2021 and how infection control was a facility wide program for the surveillance and prevention of infection prevention.




















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2. The facility failed to ensure staff were screened for COVID-19 and asymptomatic prior to working.

a. Interviews revealed staff were expected to perform COVID-19 symptom screening independently and there was no oversight of the process from facility leadership or the Infection Control Coordinator (ICC)

i. On 10/5/21 at 11:38 a.m., the Infection Control Coordinator (ICC) #3 was interviewed. ICC #3 stated she was in charge of infection control at the facility. She stated staff were responsible to screen themselves for COVID-19 upon entering the facility and to go to their manager if they answered "yes" to any symptoms on the screening log. ICC #3 stated she did not know if staff were doing their screening or going to their manager. She stated she was not reviewing the log to ensure compliance, nor was anyone in the facility.

ICC #3 stated if staff had an unprotected COVID-19 exposure of a cough, according to facility guidelines, they should not work. She stated the rationale was to prevent the spread of COVID-19 infection due to the exposure or symptoms. ICC #3 stated CNO #1 created the staff screening guidelines for symptoms to report and the process to notify their manager or supervisor. She stated if CNO #1 had questions, then she would notify ICC #3. ICC #3 stated if staff went to their supervisor with symptoms and the supervisor had questions, they would reach out to CNO #1, not ICC #3. ICC #3 stated the decision was made to have continuity of staff to answer the questions as the rationale for supervisors to ask the CNO questions regarding COVID-19 instead of ICC #3. ICC #3 stated CNO #1 or Chief Medical Officer (CMO) #4 made the final decision if staff were able to work if symptomatic or had to go home to be tested.

ICC #3 stated she was allotted 16 hours a week for infection prevention tasks at the hospital. She stated this was a recent increase, and was previously allowed eight hours per week. ICC #3 stated there was no infection control committee and there hadn't been and infection control committee meeting since 2019, even though there had been a pandemic since 2020. She stated if staff worked while positive with COVID-19, she would not know about it. She stated CNO #1 knew if staff were positive with COVID-19 and their vaccination status. ICC #3 stated she did not perform any contact tracing at the facility. She stated the local health department would perform any needed contact tracing.

ICC #3 stated even though monitoring healthcare infections was part of her job, the facility made the decision for her to not do it, but instead to streamline the process to a staff member who was more available such as CNO #1.

ii. On 10/5/21 at 9:35 a.m., Registered Nurse (RN) Manager (Manager) #5 was interviewed. Manager #5 stated the facility had a process to screen staff and all staff were aware of symptoms of COVID-19 in which they were not allowed to present to work. Manager #5 stated no one at the facility performed the screening and no one at the facility monitored the screening logs to ensure staff were screening when they arrived at work and were not working while having symptoms of COVID-19. She stated she hoped it was getting done. Manager #5 stated staff were more diligent with screening for symptoms of COVID-19 prior to getting vaccinated. She stated it was still possible for staff to get COVID-19 even if they had been vaccinated, which was the rationale for the continued need for screening for symptoms. Manager #5 stated screening was still necessary to prevent staff from working with COVID-19 and spreading the disease. Manager #5 stated if staff filled out the screening form and were symptomatic, they had been instructed to notify their immediate supervisor to have a further discussion to determine next steps such as getting tested for COVID-19, going home to quarantine or being allowed to work.

Manager #5 reviewed the staff screening log. On 10/2/21 a staff member documented she had a cough and was on the schedule and worked the same shift. On 9/14/21 another employee marked yes for a cough and worked her shift. Manager #5 stated she was unable to determine if the supervisor had been notified of the staff symptoms or the next steps had been determined since there was no documentation in the screening log.

iii. On 10/4/21 at 2:11 p.m., Chief Nursing Officer (CNO) #1 was interviewed. CNO #1 stated staff were expected to perform COVID-19 symptom screening when they arrived at the facility. CNO #1 stated she had recently sent out several reminders for staff to complete the screening when they entered the facility, however, CNO #1 stated she did not monitor staff compliance with filling out the screening log or working with COVID-19 symptoms. She stated staff had been instructed to reach out to their supervisor if they had any symptoms on the screening log such as cough, shortness of breath or unprotected exposure to someone with a confirmed COVID-19 case. CNO #1 stated she had been working as a staff nurse caring for patients for the last six weeks due to staffing shortages and some administrative things were placed on the backburner due to this.

iv. On 10/6/21 at 8:30 a.m., Director of Quality (Director) #2 stated the facility did not have a policy related to staff screening. Director #2 was able to provide emails which had been sent out to facility staff to screen for symptoms of COVID-19 by CNO #1 on 3/13/20, 5/3/21 and 9/10/21.

b. The staff screening log was reviewed. Staff were to screen if they had a temperature, a cough, shortness of breath or an unprotected exposure to a person with confirmed COVID-19. The log revealed staff did not screen each time they reported to their facility for their scheduled shift. Additionally, staff reported symptoms and worked their shift. There was no documentation in the log if the supervisor was notified of symptoms. Examples include:

i. On 9/14/21, 9/21/21 and 10/2/21 RN #8 documented she had a cough. RN #8's name was on the schedule to work the shift she had a cough. The screening log had no documentation a supervisor was notified, she was told not to work or evaluated and deemed appropriate to work.

ii. On 9/16/21 RN #9 documented she had a cough. RN #9's name was on the schedule to work the shift she had a cough. The screening log had no documentation a supervisor was notified, she was told not to work or evaluated and deemed appropriate to work.

iii. From 9/1/21 to 9/30/21 there were 30 incidents in which a staff member documented they had a cough on the screening log with no indication if they were assessed and determined appropriate to work or were instructed to get tested for COVID-19.

iv. According to the "Should I Stay or Should I Go" Guidelines dated 11/4/20, staff should stay at home if a cough was worsening after two days or if they developed a fever. There were no instructions what staff should do for shortness of breath.

v. On 10/2/21, there were six nurses scheduled to work, there was no evidence in the log three of the six nurses screened themselves for COVID-19 upon entering work.