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Based on the manner and degree of the standard-level deficiencies cited 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 must demonstrate that: 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 interviews, observation and document review, the facility failed to follow Centers for Disease Control (CDC) guidance related to universal source control to prevent transmission of the infectious disease COVID-19. Specifically, facility staff failed to implement measures to ensure patients wore masks while in the facility.

Based on interviews, observations and document review, the facility failed to follow Centers for Disease Control (CDC) guidance related to universal source control to prevent transmission of the infectious disease COVID-19. Specifically, facility staff failed to implement measures to ensure patients wore masks while in the facility.

Findings include:

Facility policies:

The COVID-19 PPE Use and Conservation policy read, Patients will be given a surgical mask daily and on arrival. Every morning a member of the nursing staff will provide each patient with a procedure mask. Patients are educated on the importance of mask use and are encouraged to wear the mask in the milieu. At the end of day patients are to dispose of their mask in an identified location. If a patient is not wearing their mask in the milieu and does not want to wear the mask, please ask the patient to leave the mask in its bag or store in a safe place. Included in the policy's reference was the Centers for Disease Control.

The Management of Patients with Known or Suspected COVID-19 policy read, patients that have current confirmed or suspected COVID-19 will be isolated and standard infectious disease protocols as well as additional measures to prevent the potential spread of the virus will be instituted. For asymptomatic patients on a unit with a PUI (Person Under Investigation) or COVID-19 positive patient, maintain all normal operations to include masks are required for all patients.

References:

The facility's Infection Control Plan and Program read, the purpose of the program is to establish a comprehensive program to ensure the organization has a coordinated process in place to reduce the risks of endemic and epidemic healthcare acquired infections. The program provides a framework for surveillance, prevention and control of infections. The development of policies and interventions is guided by recommended practices of the Association of Professionals in Infection Control (APIC) the Centers for Disease Control (CDC) and others. Policies are designed to reduce the risk of acquiring and transmitting infections among patients, employees, medical staff, volunteers and visitors. The Safety, Environment of Care and Infection Control Committee will review and approve all policies and procedures related to the Infection Prevention Program and assure infection control policies are the most up-to-date and evidence based practices. The Infection Prevention and Control Program is guided and implemented by CDC guidelines which are implemented and followed.

The facility's Analysis of Infection Prevention and Control Data identified the COVID-19 pandemic as a high risk factor and priority area for the infection prevention program. The Action Plan related to COVID-19 read, goals included to limit and minimize unprotected exposure to pathogens throughout the hospital and strategies included require use of surgical masks for all staff and encourage use of masks for all patients.

The facility's Mask Log Protocol read, please use this document as a guide for how to complete the Patient Mask Log. Overnight staff print the Mask Log and add unit, date and all patient names. The log is then passed off to daytime staff. If a patient wakes up for the day prior to overnight staff leaving staff are to offer a mask and complete the log at that time. Every patient must be offered a mask every morning which is to be documented on the Mask Log. Staff are to complete the log entirely. If the patient refuses to accept a mask, document the reason for refusal (this may require asking additional questions to understand the patient's reasoning). If the patient does not provide a reason you may document "patient refused." If a patient refuses to accept the mask, staff must provide education about the importance of mask usage). Date and time of education should also be noted. Patient Mask Logs should be placed in the Nurse Leadership box at the end of every day.

The facility's Community Guidelines- COVID-19 Updates read, Mask Wearing: all persons within the facility, staff and patients, are being asked to wear a mask while indoors. This is for your own safety as well as those around you. Refusal to wear a mask will be documented daily on the Mask Log. Face Mask Use: Face masks are provided to everyone upon entry to our building. Everyone will be provided a face mask each morning; please keep your mask on at all times. Masks may be removed when you are sleeping, in your room alone, or are eating.

The Center of Disease Control (CDC) Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic, updated 2/2/22 read This guidance applies to all U.S. settings where healthcare is delivered, including home health. Recommended routine infection prevention and control (IPC) practices during the COVID-19 pandemic. Implement Source Control Measures: Source control refers to use of respirators or well-fitting face masks or cloth masks to cover a person's mouth and nose to prevent spread of respiratory secretions when they are breathing, talking, sneezing, or coughing.

Source control is recommended for everyone in a healthcare setting. This is particularly important for individuals, regardless of their vaccination status, who live or work in counties with substantial to high community transmission or who are not up to date with all recommended COVID-19 vaccine doses.

The CDC Clinical Questions about COVID-19: Questions and Answers, updated 4/8/22, read Do CDC's interim infection prevention and control recommendations for COVID-19 apply to psychiatric hospitals and other behavioral health facilities? Yes. To keep patients and HCP healthy and safe CDC's infection prevention and control guidance applies to all settings where healthcare is delivered. Challenges and potential solutions specific to behavioral health settings might include: Source Control. Challenge: For some patients, the use of well-fitting source control (respirators, facemasks or cloth masks) might cause distress or pose an additional danger to themselves or others. Some patients may be unable or unwilling to use them as intended. Potential Solutions: Consider allowing patients at low risk for misuse to wear facemasks or cloth masks with a preference for those with short ear-loops rather than longer ties. Consider use of facemasks or cloth masks during supervised group activities.

1. The facility failed to implement measures to ensure patients wore face masks in the facility in accordance with CDC guidance for universal source control to prevent the spread of COVID-19.

a. According to the CDC guidance for healthcare settings for COVID-19, source control was recommended for everyone in healthcare settings and the guidance applied to psychiatric hospitals and other behavioral health facilities.

b. Multiple observations conducted between the dates of 5/2/22 and 5/5/22 revealed patients did not wear face masks while on the treatment unit and in common areas.

i. On 5/2/22 a tour of the facility's four inpatient treatment units was conducted.

On the adolescent treatment unit, six patients were observed sitting in the common dayroom on one side of the unit watching television. Six additional patients were observed sitting together in the common dayroom on the other side of the unit. None of the twelve patients were observed to wear a mask.

On the dual diagnosis treatment unit, four patients were observed standing together and talking in the common dayroom of the unit. An additional female patient was observed sitting in the dayroom and a male patient was observed standing at the nurse's station speaking with staff. None of the six patients wore a mask.

On the active duty military and first responders unit, approximately 15 patients were observed sitting together in a group room with a staff member facilitating an activity. The patients were sitting side by side within six inches of each other. None of the patients were observed to wear a mask.

On the adult mental wellness unit, 8 patients were observed in the common dayroom of the unit. None of the patients wore a mask.

ii. Observations of the facility's treatment units were conducted on 5/4/22.

At 10:25 a.m. the active duty military and first responders unit was observed. Four patients were observed lined up at the nurse's station. Two additional patients were observed sitting next to each other in the common dayroom watching television. None of the patients were masked.

At 11:05 a.m. the dual diagnosis treatment unit was observed. Three patients were observed sitting in the common dayroom, and other patients were observed entering a group room. None of the patients wore a mask.

At 11:10 a.m. the adolescent unit was observed. One patient was observed sitting at nurse's station and two patients were sitting next to each other at a table in the dayroom. None of the patients wore a mask.

iii. Observations of the facility's treatment units were conducted on 5/5/22.

At 8:00 a.m. the dual diagnosis treatment unit was observed. Four patients were observed sitting at a table in the dayroom and a fifth patient was sitting at nurse's station. None of the patients were observed to wear a mask.

iv. Throughout the observations conducted at the facility between 5/2/22 and 5/5/22 staff were not observed at any time to offer patients a mask or ask patients to put on a mask.

v. During observations conducted on 5/5/22 on the adult wellness unit, the patient census was reviewed. According to the patient census, the patient in room 41B was in a blocked room and was on contact and droplet isolation precautions. According to the Director of Nursing (DON) #5, who was present during the observation, the patient was on isolation precautions because he was confirmed to have COVID-19.

According to facility policy, when a patient was isolated due to current confirmed or suspected COVID-19, the actions for asymptomatic patients on the unit with the COVID-19 positive patient was to maintain all normal operations which included masks were required for all patients.

c. Interviews with facility staff revealed facility policies and protocols were developed in an effort to ensure patients used face masks for source control in the facility.

i. On 5/4/22 at 10:30 a.m., Patient Care Technician (PCA) #1 was interviewed. PCA #1 stated staff were to wear a mask at all times, and he stated this was important to maintain everyone's safety. He stated it was optional for patients to wear a mask. He stated staff were to offer a mask to each patient every morning, and if a patient refused the staff member would educate the patient the mask was intended for their safety. He stated a PCA was responsible to record this process on a mask log.

PCA #1 stated the log was completed to record if the patient was given the option to wear a mask, if the patient refused, the reason why the patient refused, and the name of the staff member who completed these actions.

PCA #1 stated the facility used to require patients to wear masks, and he stated when masks were required most patients were compliant with wearing masks. He stated there was no formal transition from masks being required to masks being optional for patients, however he stated staff now treated mask use as up to the patient's discretion.

This was in contrast to facility policies and guidelines, which read masks were to be provided to all patients and were to be worn while in the facility, and normal operations included masks were required.

ii. On 5/4/22 at 11:14 a.m., Registered Nurse (RN) #2 was interviewed. RN #2 stated staff offered patients a mask every day. She stated the PCA completed the mask log to document this action and also documented whether the patient accepted or refused a mask and the reason why. She stated all patients were to be asked to wear a mask.

iii. On 5/4/22 at 12:05 p.m., the Infection Control Nurse (IC) #3 and Chief Operating Officer (COO) #4 were interviewed. IC #3 stated the facility followed the CDC's national standards for infection control when developing policies and practices for the facility. She stated one of the focus areas for the hospital's infection control plan for 2022 was COVID-19.

IC #3 stated the policy regarding mask use for patients was to offer patients a mask every morning and collect the mask at the day. She stated if patients refused to wear a mask this was documented by staff. IC #3 stated staff were to offer and encourage mask use to patients multiple times throughout their hospitalization.

IC #3 stated the mask log was kept for every patient on each unit. She stated the process to promote mask use for patients was staff asked patients every morning if they wanted to wear a mask, and if the patient responded yes staff would provide a mask.

IC #3 stated the intent of the mask log was to demonstrate the facility maintained awareness of COVID-19 and made efforts to keep patients and staff safe. She stated although many patients refused to wear a mask it was important to ensure masks were available and encouraged for patients and the mask log documented these efforts. IC #3 stated the completed mask logs were collected by nursing leadership on each unit and were reviewed by the nursing leadership to ensure the logs were complete. She stated the process for the mask logs was implemented because when patients refused to wear a mask it was a high priority to track how staff were offering masks and handling patient refusals.

IC #3 stated the facility's processes to promote mask wearing as source control, to include staff offering masks to patients, providing education regarding mask use, and documenting refusal to wear a mask on the mask logs, had not been revisited to determine whether the processes were being implemented or were effective.

d. Review of the mask logs provided by the facility for 2/1/22 to 5/4/22 for all inpatient units revealed lack of evidence staff implemented the above protocols in order to ensure patients wore face masks in the facility.

i. The mask logs revealed multiple dates in which staff did not document patient refusal of a face mask or education provided to the patient regarding the importance of source control to prevent spread of COVID-19. As example:

The mask logs for March for the active duty military and first responders unit revealed on 3/25/22 and 3/22/22 staff documented all patients refused a mask, however the fields for "Refusal Reason," "Education Provided" and the name of the staff who completed the log were not complete. On 3/23/22 staff documented all patients refused a mask, however the fields for "Refusal Reason" and "Education Provided" only read Not Applicable.

The mask logs for April for the adult wellness unit revealed on 4/25/22 staff documented all patients refused to wear a mask, and the "Refusal Reason" documented for all patients was identical, reading "I haven't gotten sick since I've been here." On 4/15/22 staff documented Not Applicable for the "Refusal Reason" and "Education Provided."

ii. In addition, the mask logs revealed multiple dates in which staff did not document any information regarding efforts to ensure patients were offered and wore face masks for source control. As example:

The mask logs for April for the active duty military and first responders unit revealed on 4/13/22, 4/15/22, 4/17/22, 4/18/22 and 4/27/22 the mask log was not completed to document staff offered face masks to patients or provided education regarding the importance of face masks as source control, nor was there evidence any patients refused to wear a mask for those dates.

The mask logs for March for the same unit revealed on 3/5/22, 3/8/22, 3/10/22 and 3/19/22 there was no evidence staff offered face masks to patients, provided education regarding face masks, or documented any patients who refused to wear a mask. The mask log for 3/8/22 was present and had a list of patient names for that day, however the only thing written on each page of the logs was a large question mark.

The mask logs for the adult wellness unit for February revealed on 2/6/22 there was no evidence staff offered face masks to patients, provided education regarding face masks, or documented any patients who refused to wear a mask.

The mask logs for April for the adolescent unit revealed on 4/1/22, 4/2/22 and 4/12/22 there was no evidence staff offered face masks or provided education regarding the importance of face masks, nor was there evidence any patients refused to wear a mask. The mask logs for these dates were present, but none of the fields except patient name were completed.

iii. A second interview was conducted with IC #3 and COO #4 on 5/5/22 at 10:43 a.m. IC #3 stated the areas of the mask log which were to be completed was the patient's response when offered a mask, whether the patient refused a mask, the date and time education regarding mask use was provided to the patient. IC #3 stated staff were instructed to complete the entire log each day.

IC #3 then reviewed the mask logs for 2/1/22 to 5/4/22. She stated for the dates in which the fields for "Refusal Reason" or "Education Provided" were left blank it was not possible to verify whether the staff had completed those actions. She stated for the dates in which staff documented Not Applicable for "Refusal Reason" or "Education Provided" she did not understand why staff documented in this way, because it was not correct to say those actions were not applicable and it was not possible to determine whether staff completed the actions or not.

IC #3 and COO #4 stated it was important for staff to document the reason patients refused a mask in order to identify why patients did not want to wear masks, and to discuss different ways to support and encourage patients to wear masks. IC #3 stated it was also important to document whether education was provided because staff were expected to inform patients of the importance of wearing masks.

COO #4 and IC #3 stated ultimately the facility wanted all patients to wear masks and the goal was for universal source control in the facility as long as patients were able to wear a mask. IC #3 stated it was important for patients to wear masks for source control to reduce the spread of COVID-19 infection. She stated this was especially important if there was a patient who had or was suspected to have COVID-19 on the unit. IC #3 stated there were patients in the facility who were at higher risk for illness if they contracted COVID-19, such as patients with medical comorbidities like diabetes or hypertension.

COO #4 and IC #3 stated patients overall at the facility did not want to wear masks, and staff had accepted most patients were likely to refuse to wear a mask.

e. Interviews with patients at the facility revealed staff did not implement measures outlined in facility policies and protocols to ensure patients wore face masks at the facility. Patient interviews further revealed patients did not receive consistent information regarding the facility's policies and expectations for patients to use face masks for source control.

i. On 5/2/22 at 10:55 a.m., Patient #3 was interviewed. Patient #3 stated they had been at the facility for one week. They stated they had not been asked to wear a mask while at the facility. They stated they were told only staff, but not patients needed to wear a mask.

ii. On 5/4/22 at 10:49 a.m., Patient A was interviewed. Patient A stated he had been at the facility for 18 days. He stated it seemed to be up to patients' personal choice to wear masks, and he stated he had observed the majority of patients did not wear a mask. He stated he believed staff spoke to him at intake regarding mask use, however he stated staff had not brought up the topic of wearing a mask with him since he admitted. He stated it was not his experience that staff asked patients every day to wear a mask and this was not part of the daily routine.

iii. On 5/5/22 at 8:00 a.m., Patient B was interviewed. Patient B stated she had been at the facility for three days. She stated she did not believe staff provided her with a mask when she arrived at the unit. She stated staff had offered her and a few other patients a mask on the morning of the interview, however she was not offered a mask the day before the interview.

iv. On 5/5/22 at 8:17 a.m., Patient C was interviewed. Patient C stated she had been at the facility for four days. She stated staff did provide some education about the benefit of wearing masks, but she had only been offered or asked to wear a mask on the day of the interview. She stated she thought only staff were expected to wear masks.

v. On 5/5/22 at 8:30 a.m., Patient D was interviewed. Patient D stated he had been at the facility for six days. He stated masks were offered to patients but patients were not asked to wear masks. Patient D stated he was not offered a mask every day and had been offered a mask two or three times since he arrived. He stated he did not remember any specific education being provided to him regarding wearing a mask.

vi. Of the five patients who were interviewed, four patients stated they were agreeable to wear a mask while in the facility if this was the facility's policy or if staff asked them to do so.