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Based on the nature of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42, INFECTION CONTROL, 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 interviews, document review and observations the facility failed to implement and follow Centers for Disease Control (CDC) guidance to prevent possible transmission of the infectious disease, the novel Coronavirus (COVID-19). Specifically, the facility failed to implement transmission-based precautions for a Patient Under Investigation (PUI) for COVID-19. In addition the facility failed to ensure staff were educated and knowledgeable in the use of personal protective equipment (PPE) and other precautionary measures to care for a PUI or COVID-19 positive patient.

Based on interviews, document review and observations, the facility failed to implement and follow Centers for Disease Control (CDC) guidance to prevent possible transmission of the infectious disease, the novel Coronavirus (COVID-19). Specifically, the facility failed to implement transmission-based precautions for a Patient Under Investigation (PUI) for COVID-19. In addition, the facility failed to ensure staff were educated and knowledgeable in the use of personal protective equipment (PPE) and other precautionary measures to care for a PUI or COVID-19 positive patient.

Findings include:

Facility policies:

According to the Personal Protective Equipment (PPE) policy, PPE includes protective laboratory clothing, disposable gowns, disposable gloves, eye protection, and face masks. Protective equipment will be supplied and available in each clinical area or department as required.

According to the Precautions and Isolation policy, Standard precautions are used for all patient care to protect healthcare providers from infections and prevent the spread of infection. These include hand hygiene after touching contaminated items and before and after patient contact. Droplet precautions are for patients known or suspected to be infected with pathogens transmitted by respiratory droplets generated by a patient who is coughing, sneezing or talking, including COVID-19. Precautions include signage on the patient's room regarding the need for transmission based precaution, source control (mask the patient), single room isolation, PPE including gloves, gown, mask, goggles or face shield.

The Infection Disease Outbreak/ Pandemic and Investigation policy read, the facility will follow CDC guidelines for PPE and transmission-precautions. Emphasis will be provided regarding appropriate precautions including effective hand hygiene. Patients complaining of symptoms are to be confined to their rooms. Following screening, the patient will be isolated or quarantined pending results. The patient and staff will be educated on transmission precautions, including utilization of appropriate PPE. All departments will be made aware of the need to maintain isolation.

References:

According to The Center of Disease Control (CDC) Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019 (COVID-19) in Healthcare Settings, updated July 15 2020, Healthcare personnel (HCP) should adhere to standard and transmission-based Precautions when caring for patients with the SARS-CoV-2 infection. Recommended infection prevention and control practices when caring for a patient with suspected or confirmed SARS-CoV-2 Infection: HCP who enter the room of a patient with suspected or confirmed SARS-CoV-2 Infection should adhere to standard precautions and use a N95 or equivalent or higher level respirator, or facemask if a respirator is not available, gown, gloves, and eye protection. HCP should perform hand hygiene before and after all patient contact and before putting on and after removing PPE, including gloves. HCP should perform hand hygiene by using ABHS (alcohol-based hand solutions) or washing hands with soap and water for at least 20 seconds.

Employers should select appropriate PPE and provide it to HCP. HCP must receive training on and demonstration and understanding of when to use PPE, what PPE is necessary, how to properly don, use and doff PPE, how to properly dispose of or disinfect and maintain PPE. The PPE recommended when caring for a patient with suspected or confirmed COVID-19 includes the following: respirator or facemask (put on an N95 respirator or facemask if respirator is not available before entry into the patient room); eye protection (put on eye protection i.e. goggles or a face shield which covers the front and sides of the face upon entry to the patient room or care area), gloves (put on clean non-sterile gloves upon entry into the patient room or care area), gowns (put on a clean isolation gown upon entry into the patient room or area).

Dedicated medical equipment should be used when caring for patients with suspected or confirmed SARS-CoV-2 infection. As a measure to limit HCP exposure and conserve PPE, facilities could consider dedicated HCP to care for patients with suspected or confirmed SARS-CoV-2 infection. Dedicated means HCP are assigned to care only for these patients during their shift.

According to the Centers for Medicare and Medicaid Memo QSO-20-20 dated March 23, 2020, the Focused Infection Control Survey is available to every provider in the country to make them aware of Infection Control priorities during this time of crisis. For acute and continuing care: Are staff performing hand hygiene when indicated? Determine if staff appropriately use PPE, including a facemask, gloves, isolation gown, and eye protection when caring for a patient with new acute cough or symptoms of an undiagnosed respiratory infection. Determine if appropriate transmission-based precautions are implemented, including signage on the patient's room regarding need for transmission-based precautions, PPE use by staff, dedicated or disposable noncritical patient-care equipment (e.g. blood pressure cuffs).

The User Instructions for the 3M 9501+ KN95 Particulate Respirator read, use limitations and warnings: The wearer must first be trained in the proper use and fit tested before using this respirator. Do not use with other conditions that prevent a good seal between the face and the sealing edge of the respirator. Failure to follow all instructions on the use of this respirator can reduce respirator effectiveness and may result in illness or permanent disability. Fitting Instructions: Position the respirator under the chin and full each strap over the ear. Place the fingertips of both hands at the top of the metal nosepiece and mold the nosepiece to the shape of the nose bridge. The seal of the respirator on the face should be checked by the wearer prior to entering the work area. It is very important to press the nosepiece firmly to the nose bridge to form a good seal.

1. The facility failed to ensure staff implemented transmission-based precautions and utilized PPE when caring for a PUI for COVID-19 in accordance with CDC guidance and facility policy in order to prevent the spread of COVID-19.

a. According to the CDC guidance for healthcare settings, staff were recommended to wear PPE when caring for a patient under investigation or diagnosed with COVID-19. The recommended PPE included isolation gown, gloves, eye protection such as goggles or face shield, and an N95 respirator or facemask if respirator was not available. The CDC also recommended staff to perform hand hygiene before and after patient contact.

b. Multiple observations conducted on 10/27/20 revealed staff either did not wear, or did not correctly wear, the recommended PPE when entering the room of a patient who exhibited active respiratory symptoms and was PUI for COVID-19.

i. On 10/27/20 at 6:08 a.m., an observation was conducted of an inpatient adult treatment unit. Observations revealed a sign on the door of patient room #110 which read, "Isolation Precautions. See the nurse." The sign did not specify the type of transmission-based precautions in place for the patient.

At 6:10 a.m., Mental Health Specialist (MHS) #4 entered room #110 to conduct a safety observation of the patient. MHS #4 wore only a surgical mask into the room. He walked into the patient room, touched the trash bag, and entered the bathroom area. MHS #4 remained in the patient room for several minutes, then exited the room and walked into another patient room without performing hand hygiene. According to the facility policy, MHS#4 should have worn the PPE for droplet precautions which included isolation gowns, gloves, eye protection, and mask.

During the observation, Nursing Supervisor (Supervisor #1) stated Patient #5 who was in room #110 was under investigation for COVID-19. She stated he was placed on isolation precautions and limited to his room after he exhibited an acute cough.

ii. On 10/27/20 at 10:12 a.m., a second observation was conducted of staff providing care to Patient #5. MHS #5 entered Patient #5's room to conduct a safety observation. She wore only a surgical mask when she entered the room. She remained in the room for eight seconds. She then exited the room and walked into the milieu area, where three other patients were seated. Additionally, MHS #5 did not perform hand hygiene when she exited room #110. According to the facility policy, MHS#4 should have worn the PPE for droplet precautions which included isolation gowns, gloves, eye protection, and mask.

After MHS #5 left the area, Patient #5 opened his door and attempted to leave his room. MHS #5 came back to the room and stood inside the doorway to the room. She again only wore a surgical mask while interacting with the patient. MHS #5 remained in the doorway with the door open and spoke with Patient #5 for several minutes. MHS #5 then exited the patient's doorway and returned to the milieu area. She was not observed to perform hand hygiene at any time during or after her interaction with the patient.

iii. On 10/27/20 at 10:25 a.m., Registered Nurse (RN) #2 was interviewed. RN #2 stated Patient #5 was a 71-year-old who was admitted on 10/23/20 who experienced homelessness and had a medical history of COPD (chronic obstructive pulmonary disorder, a lung disease which causes obstruction of the airway). She stated Patient #5 was placed on isolation precautions on 10/24/20 after he exhibited an active cough and reported body aches. RN #2 stated the patient was still actively coughing and a COVID-19 test had been performed and the results were pending.

iv. On 10/27/20 at 3:02 p.m., MHS #5 was observed at the unit nurse's station as she gave report on Patient #5 to another mental health specialist. Patient care supplies, which included articles of PPE and a plastic bin which contained multi-use patient care equipment were observed on top of a cabinet in the nurse's station. MHS #5 pointed to the PPE and vital sign equipment and stated, "This is his area apparently." The plastic bin containing vitals equipment was not present during previous observations conducted on the unit.

Approximately ten minutes later, MHS #5 was observed donning PPE to conduct a safety observation of Patient #5. MHS #5 donned an isolation gown, hair cover and shoe covers. She then donned a KN95 respirator on top of the surgical mask she had been wearing throughout her shift. The edges of the KN95 were observed touching the surface of the surgical mask rather than MHS #5's skin.

As MHS #5 walked to room #110 to conduct the safety observation, the KN95 fell off of her face, causing her to readjust it over the surgical mask.

The observed use of the KN95 respirator was in contrast to the manufacturer's instructions for use, which read the respirator was not to be used with other conditions which prevented a good seal between the face and the respirator. The instructions further read the user was to conduct a seal test of the respirator prior to use to ensure effectiveness.

The observation contradicted facility policy and CDC guidance for PPE use. According to CDC and facility policy, either a surgical mask or an N95 respirator were to be worn when entering the room of a PUI patient. Neither the CDC or the facility policy recommend the use of KN95 over a surgical mask.

c. Interviews revealed facility staff were not adequately educated or knowledgeable on the implementation of transmission-based precautions for PUI and COVID-19 positive patients. Staff interviews revealed inconsistent and contradictory understanding of facility policies and CDC guidance regarding PPE use and the actions required to limit possible exposure and transmission of COVID-19 in the facility.

i. On 10/27/20 at 10:25 a.m., RN #2 was interviewed. RN #2 stated since Patient #5 was placed on isolation precautions, staff had used PPE such as shoe covers, hair covers, gowns and gloves when they provided care to the patient. However, she stated staff did not use eye protection prior to the date of the interview. RN #2 stated she had to find a face shield that morning because there were no face shields available on the unit, and stated she believed the previous nurses had not worn eye protection when they entered the patient's room.

RN #2 stated it was the responsibility of the nurse who placed the patient on isolation precautions, or the nurse supervisor, to ensure necessary PPE was available to staff.

RN #2 stated if a MHS conducted a safety observation and remained six feet away from the patient, the MHS did not have to wear PPE into the room. She stated she did not know if other staff, including therapists and physicians, wore PPE into the patient's room. This was in contrast to CDC guidance and facility policy, which stated all healthcare personnel who provided care to a PUI or COVID-19 positive patient were to wear PPE when they entered the patient's room or patient care area.

RN #2 stated she had not received education or training on how to care for a PUI or COVID-19 positive patient. She stated it was assumed nurses knew this information.

ii. On 10/27/20 at 2:18 p.m., RN #3 was interviewed. RN #3 stated if a patient exhibited symptoms or was positive for COVID-19, staff would wear an N95 respirator to provide care. She stated the respirator would be worn throughout the staff member's shift, and could either be discarded or kept for a few days. RN #3 then stated she did not know if the N95 respirator was required, but it was her preference to wear one. RN #3 stated she had not been fit tested for an N95 respirator.

RN #3 stated all necessary PPE was stored at nurse's station or in the supervisor's office. She stated isolation carts containing PPE would not be kept in the patient hallway because it presented a safety hazard.

RN #3 stated she had seen face shields available for staff use, but did not know if eye protection was required to care for a PUI patient. This was in contrast to CDC guidance and facility policy, which required eye protection to be worn to care for a PUI or COVID-19 positive patient.

RN #3 stated she had not received training or education on how to care for a PUI or COVID-19 positive patient. She stated she followed her knowledge and experience as a nurse, and stated if a patient needed isolation precautions she would notify the house supervisor and follow the supervisor's instructions.

RN #3 stated PPE was necessary to care for a PUI or COVID-19 positive patient to prevent the spread of disease, and she stated there was a risk to everyone in the facility if protocols related to PPE were not followed.

iii. On 10/27/20 at 2:47 p.m., MHS #6 was interviewed. MHS #6 stated she had previously cared for a patient who was suspected to have COVID-19. She stated the patient did not have a sign on the door to indicate transmission-based precautions, and staff learned the patient was on isolation precautions through verbal report. This was in contrast to facility policy and CDC guidance which required the use of signage to indicate transmission-based precautions.

MHS #6 stated if a patient exhibited symptoms of COVID-19, staff were to wear a gown, gloves, mask, shoe covers, and eye protection when they entered the patient's room. She stated the MHS caring for the patient would be responsible to conduct the patient safety observations every 10 minutes, and she stated PPE was to be donned and doffed each time a safety observation was performed. MHS #6 stated this was done to prevent the possible spread of germs.

This was in contrast to the observations of MHS #4 and #5, who did not wear PPE to conduct a safety observation of a PUI patient. This was also in contrast to the interview with RN #2, who stated a MHS did not have to wear PPE to conduct a safety observation if the MHS remained six feet away from the patient.

iii. On 10/27/20 at 3:15 p.m., an interview was conducted with MHS #5. MHS #5 stated staff usually only wore a surgical mask to care for patients, but she placed the KN95 respirator over her surgical mask to care for Patient #5 so she would not have to take the surgical mask off. She stated she typically wore masks this way. MHS #5 stated she did not know if the respirators were supposed to be worn over the surgical mask since she did not care for many COVID-19 positive patients.

MHS #5 stated she did not wear PPE when she conducted safety observations for Patient #5 in the morning because she forgot and she was accustomed to going from room to room without any PPE. MHS #5 stated she had been wearing full PPE to care for Patient #5 since that morning when RN#2 reminded her to wear required PPE.

iv. On 10/27/20 at 4:06 p.m., RN #7 was interviewed. RN #7 stated she had previously cared for two patients on the children's inpatient treatment unit who were suspected of COVID-19. RN #7 stated an isolation cart would be used to store all required PPE near the patient's room or outside of the patient's door. This was in contrast to the interview with RN #3, who stated necessary PPE was kept at nurse's station or the supervisor's office because use of an isolation cart near the patient's room presented a safety hazard.

d. Interviews with facility leadership revealed staff responsible to oversee infection prevention did not ensure transmission-based precautions and PPE use were implemented to care for Patient #5 according to facility policy and CDC guidance.

i. On 10/28/20 at 1:03 p.m., the Infection Control Coordinator (Coordinator #8) was interviewed. Coordinator #8 stated she also was the nursing supervisor for the acute inpatient treatment units. She confirmed Patient #5 was considered a PUI on 10/27/20.

Coordinator #8 stated if a patient exhibited signs or symptoms of COVID-19, she was responsible to go to the unit, speak with staff, and inform them of required actions. She stated she would designate one person to interact with the PUI in order to minimize exposure, and she would also ensure all staff knew how to care for the patient. Coordinator #8 stated the nursing supervisor was responsible to ensure PPE was provided to staff and available for use when caring for a PUI or COVID positive patient.

Coordinator #8 stated she and the other nursing supervisors provided global education to the staff on COVID-19 precautions. She stated the global education did not include return demonstrations for the donning and doffing of PPE, and stated only when she brought PPE to a unit with a PUI patient she would then observe staff to ensure the PPE was put on and taken off correctly.

Coordinator #8 stated if a patient was PUI or COVID-19 positive, staff would put a sign on the door to indicate the precautions in place for the patient. She did not know if the correct signage was present on Patient #5's door when he was on isolation on 10/27/20.

Coordinator #8 stated the steps required to care for a PUI patient included designating one staff member to go in and out of the room in order to avoid exposing other people. She stated this was usually the LPN or the RN on the unit. Coordinator #8 stated the designated staff member would complete necessary patient care tasks including bringing meals, administering medications, and conducting the patient safety observations every 10 or 15 minutes. Coordinator #8 stated on 10/27/20, RN #2 was the designated staff member who was assigned to perform patient care tasks for Patient #5.

This was in contrast to observations and interviews conducted with facility staff, which revealed staff did not implement the designation of a single staff member to complete patient care tasks in order to limit staff exposure to the PUI patient.

Coordinator #8 confirmed on 10/26/20, she was the supervisor for the adult units however she did not know who the designated staff was or what PPE was used to care for the patient on that day.

Coordinator #8 stated the PPE required to care for a PUI patient was shoe covers, gown, gloves, mask, face shield or goggles, and hair cover according to CDC guidance. She stated the required PPE was to be worn by anybody who entered the room. Coordinator #8 stated a N95 mask had to be worn at all times while in a PUI patient's room. She stated the KN95's which were observed in use on 10/27/20 were less effective than N95 respirators. She stated the KN95's were to be worn touching the skin and could not be worn over a surgical mask.

Coordinator #8 stated staff used designated vital sign equipment for patients on isolation precautions. She stated the vital sign equipment was kept in a locked closet in the patient's room and was not brought out of the room. This was in contrast to observation, which revealed staff kept the designated vital sign equipment at the nurse's station rather than in the patient's room.

ii. On 10/28/20 at 2:56 p.m., Director #9 provided the isolation sign which according to facility policy was to be placed on the door of a PUI. The isolation sign read, Droplet Precautions: Everyone must clean their hands including before entering and when leaving the room. Make sure their eyes, nose and mouths are fully covered before room entry. The isolation sign provided was not the sign observed on Patient #5's door on 10/27/20.