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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 §482.42 Infection Prevention and Control and Antibiotic Stewardship Programs, was out of compliance.

A-0749 The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Based on document review, interviews, and observations, the facility failed to prevent and control the transmission of infection within the hospital. Specifically, the facility failed to isolate symptomatic COVID-19 patients prior to receiving test results in three of four medical records reviewed (Patients #1, 4, and 6). Additionally, the facility failed to ensure the proper use of hand hygiene and personal protective equipment for patients in isolation in the behavioral health unit.

Based on observations, document review, and interviews, the facility failed to prevent and control the transmission of infection within the hospital. Specifically, the facility failed to isolate symptomatic COVID-19 patients prior to receiving test results in three of four medical records reviewed (Patients #1, 4, and 6). Additionally, the facility failed to ensure the proper use of hand hygiene and personal protective equipment for patients in isolation in the behavioral health unit.

Findings include:

Facility policy:

According to the facility policy COVID-19 Plan - Screening and Management: Patients and Visitors at Care Site and Medical Facility Entrances, symptom screening should include the symptoms of fever of 100.0 degrees Fahrenheit or greater, flu-like symptoms/viral prodrome (any combination of chills, repeated shaking chills), subjective fever (sweating, feeling hot/cold), muscle aches, headache, fatigue, new onset of cough, new onset of shortness of breath or difficulty breathing, new onset sore throat, new onset loss of smell, new onset loss of taste, new onset diarrhea, new onset of nausea or vomiting, new onset of congestion or runny nose. Care sites are responsible for each associate that receives training in a language and at a literacy level the associate understands, on the following topics: ii. Policies and procedures on patient screening and management.

According to the facility policy COVID Protocols for All Units Updated 11/23/2022, important reminders of when to isolate include fever above 100.0, emesis, diarrhea, body ache or chills, loss of taste/smell, shortness of breath, and increased oxygen needs. In addition to standard precautions, droplet isolation (a type of isolation used to prevent the spread of germs in respiratory secretions) will be added for patients with suspected or confirmed respiratory illness, including but not limited to influenza, pertussis (a respiratory infection also called whooping cough), and Neisseria meningitides (a respiratory infection). Isolate means to hang an isolation sign outside of the door for droplet precautions and to keep the door closed. Make sure all staff sanitize hands in and out of isolation rooms.

According to the facility policy Hand Hygiene, the purpose is to prevent the spread of disease and healthcare-associated infections by utilizing proper hand hygiene techniques. Gloves are not a substitute for hand hygiene. Gloves are only permitted in patient care areas (i.e., areas in which the care of the patient is given.) Required Action Steps: Wash hands with hospital-approved soap and water as a means to decontaminate hands. Use waterless antiseptic hand sanitizer as another acceptable means of decontamination of hands. Use antimicrobial waterless hand sanitizer product before entering and after leaving patient room or care area. Perform hand hygiene at every opportunity and prior to any direct patient contact even if gloves are to be worn.

According to the facility policy Standard and Isolation Precautions to Prevent and Control Infections, personal protective equipment (PPE): Before leaving the patient's room or bay, remove and discard PPE.

References:

According to the facility's COVID-19 Plan, care sites will provide gloves, an isolation gown or protective clothing, and eye protection to each associate and ensure use in accordance with OSHA'S PPE standards. PPE includes, but is not limited to, gloves, gowns, eye protection, facemasks/procedure masks, respirators, safety glasses with solid side shields, goggles, laboratory coats, surgical caps, and hoods. Allow voluntary use of respirators instead of facemasks.

According to the Centers for Disease Control and Prevention (August 11, 2022) Isolation and Precautions for People with COVID-19, retrieved from: https://www.cdc.gov/coronavirus/2019-ncov/your-health/isolation.html, regardless of vaccination status, isolate from others with COVID-19. Also isolate if sick and suspect COVID-19 but do not yet have test results.

According to the Centers for Disease Control and Prevention document PPE Sequence, retrieved from: https://www.cdc.gov/hai/pdfs/ppe/ppe-sequence.pdf, remove all PPE before exiting the patient room except a respirator, if worn. Use safe work practices to protect yourself and limit the spread of contamination by limiting the surfaces touched and performing hand hygiene. Wash hands or use an alcohol-based hand sanitizer immediately after removing all PPE.

According to the Centers for Disease Control and Prevention (September 23, 2022) Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic, retrieved from
https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html, establish a process to make everyone entering the facility aware of recommended actions to prevent transmission to others if they have any of the following three criteria: A positive viral test for SARS-CoV-2, symptoms of COVID-19, or close contact with someone with SARS-CoV-2 infection (for patients and visitors) or a higher-risk exposure (for healthcare personnel).

1. The facility failed to isolate symptomatic COVID-19 patients in the behavioral health unit according to facility policy and national guidelines.

A. Record review

i. On 12/8/22, a review was conducted of Patient #1's medical record, who was admitted on 11/8/22. This review revealed a COVID Screening form (COVID Screen) dated 11/14/22 where staff documented Patient #1 had reported fatigue and congestion. On 11/15/22, a nurse documented the patient had stated "I will not be taking anything or putting anything into my body because I'm sicker than a dog." On the same day, the patient reported cold symptoms to a social worker. The social worker documented the patient was sneezing and producing green mucus. On the COVID Screen dated 11/15/22, Patient #1 reported feeling a scratchy throat and fatigue. The medical record documented a positive COVID test for Patient #1 on 11/16/22.

A review of documentation of Patient #1's location within the facility from 11/14/22 to 11/16/22 revealed she had not been isolated after reporting these symptoms to staff and on the COVID Screen. Patient #1 had spent time in the shared spaces of the unit on 11/14/22, 11/15/22, and 11/16/22.

This was in contrast to the facility policy COVID Protocols for All Units, which read in addition to standard precautions, droplet isolation should have been added for patients with suspected or confirmed respiratory illness. These findings were also in contrast to the Centers for Disease Control and Prevention's (CDC) guidance titled Isolation and Prevention for People with COVID-19, which read patients should have been isolated when sick with suspected COVID-19 but test results were not yet available.

ii. On 12/8/22 a review was conducted of Patient #4's medical record, who was admitted on 10/25/22. This review revealed a COVID Screen dated 10/28/22 where staff had recorded Patient #4's temperature at 100.8 degrees Fahrenheit. The COVID Screen dated 10/29/22 also recorded patient #4's temperature at 100.8 degrees. The medical record documented a positive COVID test for Patient #4 on 10/30/22.

A review of documentation of Patient #4's location within the facility from 10/28/22 to 10/30/22 revealed he had not been isolated after the fever was recorded on the COVID Screen. Patient #4 had spent time in the shared spaces of the unit on 10/28/22, 10/29/22, and 10/30/22.

These findings were in contrast to the facility policy COVID Protocols for All Units, which read patients should have been isolated for fever above 100.0 degrees. These findings were also in contrast to the CDC's guidance titled Isolation and Prevention for People with COVID-19, which read patients should have been isolated when sick with suspected COVID-19 but test results were not yet available.

iii. On 12/12/22 a review was conducted of Patient #6's medical record, who was admitted on 11/28/22. This review revealed a nursing note from 11/29/22 which documented the patient had reported a severe headache and nausea. The nursing note further documented the patient had a cough and was occasionally producing mucus. The COVID Screen dated 11/29/22 also noted the patient had a cough that was occasionally producing mucus.

A second COVID screen for patient #6 dated 11/29/22 noted a cough and a sore throat. A second nursing note from 11/29/22 noted the patient had called the nurse practitioner to report a temperature of 101.7 degrees, headache, body aches, sore throat, and a cough. The nurse practitioner had ordered a respiratory panel and to place the patient in isolation pending the result. The medical record documented a positive COVID test for Patient #6 later in the day on 11/29/22, and she was subsequently maintained in isolation on the unit.

A review of documentation of Patient #6's location within the facility on 11/29/22 revealed she had not been isolated after the headache, cough, nausea, and sore throat had been reported to staff and recorded on the COVID screen. On 11/29/22, Patient #6 had spent time in the shared spaces of the unit.

These findings were in contrast to the facility policy COVID Protocols for All Units, which read in addition to standard precautions, droplet isolation should have been added for patients with suspected or confirmed respiratory illness. These findings were also in contrast to the CDC's guidance titled Isolation and Prevention for People with COVID-19, which read patients should have been isolated when sick with suspected COVID-19 but test results were not yet available.

B. Interviews

i. On 12/7/22 at 2:39 p.m., an interview was conducted with mental health counselor (Counselor) #1. Counselor #1 stated on the behavioral health unit it was difficult to care for COVID patients in shared spaces as the patients frequently refused to wear masks and enforce social distancing. He further stated the unit had a high risk of COVID transmission. He also said if COVID spread to patients and staff it could harm patients as they could have become ill. Additionally, Counselor #1 stated if essential unit staff had become ill it could have affected patient care as working on a behavioral health unit required special training and skills.

ii. On 12/7/22 at 3:26 p.m., an interview was conducted with a staff member from environmental services (Housekeeper) #2. Housekeeper #2 stated COVID patients should not have been allowed in a group setting because in the behavioral health unit other patients were in the facility involuntarily on legal hospitalization holds. He further stated behavioral health patients frequently refused to wear a mask. Housekeeper #2 said at the beginning of the COVID pandemic the common spaces were frequently cleaned with a spray to reduce the transmission of COVID, but the spraying in the common spaces was no longer done as frequently.

iii. On 12/8/2022 at 12:57 p.m., an interview was conducted with a staff member from environmental services (Housekeeper) #3. Housekeeper #3 stated he attempted to clean the common areas of the unit with the spray to reduce the transmission of COVID, but he was concerned that due to the inability of the behavioral health patients to isolate, wear masks, and maintain distance from others, the common areas became contaminated again as soon as he had completed cleaning. Housekeeper #3 said COVID patients would wander through the unit, without a mask, as frequently as every five minutes.

iv. On 12/8/2022 at 4:49 p.m., an interview was conducted with clinical coordinator (Coordinator) #4. Coordinator #4 stated she remembered Patient #1. She further stated staff encouraged Patient #1 to perform hand hygiene and to wear a mask when she was in the common spaces of the unit. Coordinator #4 said Patient #1 would frequently refuse to wear a mask.

v. On 12/12/2022 at 10:36 a.m., an interview was conducted with the manager of infection prevention and control (Manager) #5. Manager #5 stated the most recent strain of COVID presented primarily as upper respiratory symptoms. The COVID symptoms included cold symptoms such as cough, runny nose, sore throat, and nausea. She explained patients with mild symptoms could have transmitted the illness to others.

Manager #5 explained isolation should have been enforced as soon as patients showed symptoms. She further explained isolation should have been continued until the COVID test returned negative. She stated if the COVID test returned positive, isolation should have been enforced through the quarantine period per facility policy. Manager #5 stated staff had a difficult time enforcing the infection prevention strategies of hand hygiene, masking, and social distancing as behavioral health patients had a tendency to become combative. Manager #5 stated the facility used CDC guidelines to direct COVID policies and procedures.

vi. On 12/8/2022 at 2:31 p.m., an interview was conducted with the regional director of infection prevention (Director) #6. Director #6 stated COVID positive patients required airborne (a type of isolation that stops germs from spreading through the air), droplet, and contact (a type of isolation that prevents germs from spreading from touch) precautions. She said asymptomatic and mildly symptomatic patients could spread COVID. Director #6 explained COVID positive patients should have been in isolation for the first five days of their illness. She further explained mildly symptomatic or asymptomatic patients could be in public spaces after five days of isolation, but only if wearing a mask.

vii. On 12/8/2022 at 4:04 p.m., an interview was conducted with chief executive officer (CEO) #7. CEO #7 stated the facility had an outbreak of COVID at the end of October and at the beginning of November of 2022. CEO #7 explained in response to the outbreak, from 10/30/22 to 11/8/22 the facility separated the COVID patients into an isolated unit. He further explained that before and after those dates the unit was a mixture of behavioral health patients, some of whom were COVID-positive and some of whom were not.

2. The facility failed to ensure the proper use of hand hygiene and personal protective equipment (PPE) when patients were isolated in the behavioral health unit, according to facility policy and national guidelines.

A. Observations

i. On 12/7/22 at 1:33 p.m., observations were conducted in the facility's east and west behavioral health units. These observations revealed sinks and hand sanitizer dispensers were not available for staff directly in the patient care unit. Instead, they were located behind doors that required badge access. Further observations revealed PPE for staff use stored in the nursing stations on both the east and west sides of the building. PPE at both nursing stations included gloves, gowns, hats, and masks. Face shields were included with the PPE stored on the east side of the building; however, there were no face shields, goggles, or other eye protection stored with the PPE at the west nursing station.

This observation was in contrast to the facility's COVID-19 Plan, which read care sites should have provided gloves, an isolation gown or protective clothing, and eye protection to each associate and ensured use in accordance with the Occupational Safety and Health Administration's (OSHA) PPE standards. PPE included, but was not limited to gloves, gowns, eye protection, facemasks/procedure masks, respirators, safety glasses with solid side shields, goggles, laboratory coats, surgical caps and hoods.

ii. On 12/8/22 at 1:59 p.m., observations were conducted of registered nurse (RN) #8 putting on and taking off PPE. RN #8 put on gloves, a gown, a mask, and a face shield. He did not perform hand hygiene prior to putting on the PPE. RN #8 then demonstrated how he would leave the nursing station and walk to a patient's room to provide care for a patient who required isolation. Then, while still wearing the PPE, he walked through the patient care areas, used his badge to access a central area used for patient seclusion, and opened the door with a gloved hand.

While in the patient seclusion area, RN #8 demonstrated how he removed and disposed of his PPE. He then used his badge to access a centralized area used as an office and staff working space (staff core). RN #8 then demonstrated how he used the sink in the staff core to wash his hands.

The observations of RN #8 were in contrast to the Hand Hygiene policy, which read gloves were not a substitution for hand hygiene. Gloves were only permitted in patient care areas. Required action steps included washing hands with soap and water or waterless antiseptic hand sanitizer to decontaminate hands. Hand hygiene should have been performed prior to any direct patient contact even if gloves were to be worn.

The observations of RN #8 were also in contrast to the facility policy Standard and Isolation Precautions to Prevent and Control Infections, which read PPE should have been removed and discarded before leaving the patient's room or bay. The observations were also in contrast to the facility policy COVID Protocols for All Units, which read all staff should have sanitized their hands in and out of isolation rooms.

The observations were also in contrast to the Centers for Disease Control and Prevention (CDC) document PPE Sequence, which required the removal of all PPE prior to exiting a patient room. The document further read safe work practices to limit the spread of contamination included limiting the surfaces touched and performing hand hygiene. Hands should have been washed or an alcohol-based hand sanitizer used immediately after removing all PPE.

B. Interviews

i. On 12/7/22 at 2:20 p.m., an interview was conducted with registered nurse (RN) #9. RN #9 stated at the beginning of the COVID pandemic more PPE was available and the facility was stricter with procedures than they were now. She explained hand hygiene for the unit was available in the staff core, at the nurse's station, and in the medicine preparation room.

ii. On 12/7/22 at 2:39 p.m., an interview was conducted with mental health counselor (Counselor) #1. Counselor #1 stated his process for PPE was to put it on at the nurse's station, walk to the patient's room, provide care, and then leave the room to remove the PPE in the seclusion area, behind the locked door that required a badge to open. Counselor #1 stated he would perform hand hygiene in the staff core. Counselor #1 confirmed he would walk through patient care areas after providing care, and prior to removing the PPE. He further stated improper use of PPE caused a risk of infection.

iii. On 12/7/22 at 3:26 p.m., an interview was conducted with a staff member from environmental services (Housekeeper) #2. Housekeeper #2 stated he was unable to use standard PPE and had to repeatedly request to use a respirator instead of an N95 mask (used to protect the wearer from particles contaminating the face). He stated clinical staff had requested he not wear the respirator in the behavioral health unit, as it would have upset the patients. This statement was in contrast to the facility's COVID-19 Plan, which allowed the voluntary use of respirators instead of facemasks.

Housekeeper #2 explained other units within the hospital were enforcing six feet of social distancing, COVID-positive patients were isolated to a room, and there was increased PPE availability. He further stated he felt that if bedside staff and managers felt protected by the amount of PPE used on the unit, it was expected that the housekeeping staff would feel adequately protected as well. Housekeeper #2 stated he felt scared and stressed to report for work, as he was concerned about bringing a COVID infection home to his family and spreading COVID within the unit as well as to other units in the hospital.

Housekeeper #2 also stated staff from environmental services was not informed if a COVID positive patient was on the unit. He explained as a result of this, he did not know when he should have been wearing his PPE. Housekeeper #3 stated he would ask multiple people on the unit for information, and get different answers from each person asked. He further stated he would occasionally get conflicting information regarding the COVID status of patients from his management team. Housekeeper #3 said the risk of not being informed of the COVID status of patients was spreading the virus.

This interview was in contrast to the CDC's guidance Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic, which required an established process to make everyone entering the facility aware of recommended actions to prevent transmission to others if they had a positive viral test or symptoms of COVID-19.

iv. On 12/8/2022 at 12:57 p.m., an interview was conducted with a staff member from environmental services (Housekeeper) #3. Housekeeper #3 explained COVID status was communicated through conversations with his management team and via isolation signs posted on the patient's door. He stated there had been a few occasions when the isolation sign had not been placed. He explained the risk of not having the sign posted was that he would enter the room without his PPE. By not having his PPE, housekeeper #3 said he was exposing himself to COVID, risking becoming contaminated with the virus, and risking spreading it to others throughout the facility.

This interview was in contrast to the CDC's guidance Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic, which required an established process to make everyone entering the facility aware of recommended actions to prevent transmission to others if they had a positive viral test or symptoms of COVID-19.

The interview was also in contrast to the facility policy COVID Protocols for All Units, which read in addition to standard precautions, droplet isolation should have been added for patients with suspected or confirmed respiratory illness. The policy further read, isolation included hanging an isolation sign outside of the door for droplet precautions.

v. On 12/7/22 at 3:26 p.m., an interview was conducted with a staff member from environmental services (Housekeeper) #10. Housekeeper #10 stated after he was finished cleaning a patient's room in the behavioral health unit, he would remove his PPE in the patient's room, but he would walk through patient care areas to a housekeeping closet, located behind a locked door, to wash his hands. Housekeeper #10 stated he felt there was an insufficient amount of PPE available in the behavioral health unit. Housekeeper #10 stated he had been encouraged to not wear PPE as it upset patients.

Housekeeper #10 also stated he was not well informed when a room he was cleaning had been used by a COVID positive patient. He stated he was not included in conversations among staff when the COVID status of a patient was discussed. Housekeeper #10 further said an isolation sign or a COVID precaution sign should have been hung on the door of the room of a COVID positive patient, but that it sometimes was not there. He explained he felt he was second-guessing the isolation status of the patients.

This interview was in contrast to the CDC's guidance Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic, which required an established process to make everyone entering the facility aware of recommended actions to prevent transmission to others if they had a positive viral test or symptoms of COVID-19.

The interview was also in contrast to the facility policy COVID Protocols for All Units, which read in addition to standard precautions, droplet isolation should have been added for patients with suspected or confirmed respiratory illness. The policy further read isolation included hanging an isolation sign outside of the door for droplet precautions.

vi. On 12/12/2022 at 10:36 a.m., an interview was conducted with the manager of infection prevention and control (Manager) #5. Manager #5 stated the purpose of conducting hand hygiene with either hand sanitizer or soap and water was to prevent and control the spread of germs. She stated if hand hygiene and proper cleaning were not performed, COVID could have possibly lived on surfaces for an hour or two and therefore could have been transmitted to others. Manager #5 further stated an opportunity to increase hand hygiene existed in the behavioral health units. She also stated the risk of improper use of PPE included transmission of disease.

Manager #5 stated a sign should have been placed on the door of every patient who required isolation, as part of the isolation precautions. She said as part of COVID precautions, environmental services staff was required to be notified so they could have conducted enhanced cleaning, especially in the shared setting of a behavioral health unit. Manager #3 explained she believed the notification process to environmental services (EVS) was based on conversation, and not on a computer procedure. She further explained the risk of EVS lacking notification was that the employee may not have worn the proper mask. Manger #5 stated the facility used CDC guidelines to direct COVID policies and procedures.

vii. On 12/12/2022 at 9:20 a.m., an interview was conducted with the senior director of guest services and housekeeping (Senior Director) #11. Senior Director #11 stated COVID education was done by the management team in team meetings held three times a day, or once a shift. He also stated isolation status was marked in the electronic medical record (EMR), and that housekeeping tracked their cleaning in the EMR. He stated housekeepers were notified of a room to have been cleaned via a page, and that on the page it would say contact or airborne precautions. He also stated the facility's practice was to leave the isolation sign on the room's door until after housekeeping had a chance to clean it.

a. On 12/12/22, the facility was asked to provide evidence of how the electronic medical record and the paging system notified housekeepers of the isolation status of COVID-positive patients. The documents provided showed evidence of room cleaning, but did not include an indication of the patient's isolation status.