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Based on unit observations, review of policies and procedures, and interviews with hospital staff, it was determined that the hospital failed to ensure that staff employed methods for preventing and controlling the transmission of SARS-CoV-2 (COVID-19) infection within the hospital, as evidenced by: 1) failure to place appropriate transmission-based precaution signage on patient rooms; and 2) lack of hand sanitizer dispensers within close proximity to the entryway of two patient rooms assigned to COVID-19 positive patients.

The findings include:

1. In guidance last updated on 10/28/20, the Centers for Disease Control and Prevention (CDC) reported that transmission of the COVID-19 virus likely occurs from droplet sources and contact with contaminated surfaces. Therefore, droplet and contact precautions are the levels of transmission based precaution necessary when caring for COVID-19 positive patients to reduce risk of virus spread in the healthcare setting (CDC, 2020).

The CDC defines Transmission-Based Precautions, among them droplet precautions, as the second tier of basic infection control which are to be used in addition to Standard Precautions for patients who may be infected or colonized with certain infectious agents for which additional precautions are needed to prevent infection transmission.

CDC guidance also provides that transmission precautions, including contact and droplet precautions, must be maintained in order to limit the spread of COVID-19 (2020). To be effective, isolation precautions must be ordered, implemented timely, with applicable signage located at the entryway of a patient's room. Patients are placed on isolation precautions in order to assist in the prevention of the transmission of microorganisms, such as antibiotic-resistant bacteria or viruses. Having appropriate isolation precaution signage in place helps to ensure staff compliance with wearing the required Personal Protective Equipment (PPE), thus aiding in preventing transmission of microorganisms to persons outside of the patient's room.

During unit observations of the hospital's COVID-19 positive unit on January 28, 2021 at approximately 10:00 a.m., the surveyor was informed that all of the 19 rooms on the unit were on Transmission-Based Precautions due to the COVID-19 virus. All rooms should have had appropriate isolation precaution signage, which would have notified the staff of the need for a face shield/goggles, surgical mask/N95 respirator, gown, and gloves prior to entering the patient's room.

The surveyor observed that some of the patient rooms identified the type of isolation precaution via a handwritten lettering transcribed onto the over-the-door PPE dispenser in black marker. There were also rooms where isolation precaution signage was not posted on doors. The surveyor also observed several rooms which had appropriately displayed signage identifying the type of transmission-based precautions in implementation.

Despite the fact that the unit was designated for COVID-19 patients, it was still necessary to ensure that staff was aware of all transmission-based precautions a patient may require.

2. The following CDC guidance was in effect at the time of the survey on January 28, 2021 under "Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic":
2. Recommended infection prevention and control (IPC) practices when caring for a patient with suspected or confirmed SARS-CoV-2 infection. Personal Protective Equipment [PPE]. Hand Hygiene.
- HCP [Health Care Provider] should perform hand hygiene before and after all patient contact, contact with potentially infectious material, and before putting on and after removing PPE, including gloves. Hand hygiene after removing PPE is particularly important to remove any pathogens that might have been transferred to bare hands during the removal process.
- HCP should perform hand hygiene by using ABHS [alcohol based hand sanitizer] with 60-95% alcohol or washing hands with soap and water for at least 20 seconds. If hands are visibly soiled, use soap and water before returning to ABHS.
- Healthcare facilities should ensure that hand hygiene supplies are readily available to all personnel in every care location. (2021)

On January 28, 2021, during unit observations on the COVID-19 positive unit, the surveyor noted that two patient rooms located just inside the barrier created to separate COVID-19 positive patients from COVID-19 negative patients, did not have hand sanitizer dispensers. The dispensers were located just outside of the barrier, having been cut-off during the barrier's installation.

Having hand sanitizer dispensers within close proximity to the patient's room serves as a reminder for the need of frequent hand hygiene practices and improves staff adherence to the infection control practices.

Concurrently, the Infection Preventionist (IP) who accompanied the surveyor during observations acknowledged the need for the hand sanitizer dispensers to be within close proximity to the patient room door.

The cumulative effect of these failures increased the risk of transmission of infectious microorganisms within the facility and placed all patients, staff, and visitors at risk of contracting COVID-19.

Based on unit observations, review of policies and procedures, and interviews with hospital staff, it was determined that the hospital failed to develop and implement infection prevention and control policies and procedure that adhered to the nationally recognized guidelines to mitigate the transmission of SARS-CoV-2 (COVID-19) infection within the hospital, as evidenced by: 1) staff donning (putting on) and doffing (removing) the same reusable cloth gown throughout the shift; 2) staff doffing contaminated isolation gowns outside of the patient rooms on the COVID-19 positive unit; and 3) an overflowing soiled linen/gown hamper located in the hallway of the COVID-19 positive unit.

1. On January 28, 2021, surveyors reviewed the Center for Disease Control (CDC) website at https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/isolation-gowns.html. Review indicated that, as of January 21, 2021, the CDC moved the strategy of prioritization of isolation gowns from crisis capacity to contingency capacity:

Crisis capacity strategies are not commensurate with standard U.S. standards of care but may need to be considered during periods of known gown shortages. Crisis capacity strategies should only be implemented after considering and implementing conventional and contingency capacity strategies. Facilities can consider crisis capacity strategies when the supply is not able to meet the facility's current or anticipated utilization rate. The CDC advises the risks to Health Care Providers (HCP) and patient safety must be carefully considered before implementing a gown reuse strategy. Disposable gowns generally should not be reused, and reusable gowns should not be reused before laundering, because reuse poses risks for possible transmission among HCP and patients that likely outweigh any potential benefits. Similar to extended gown use, gown reuse has the potential to facilitate transmission of organisms among patients. However, unlike extended use, repeatedly donning and doffing a contaminated gown may increase risk for HCP self-contamination." (CDC, 2021)

Additionally, the CDC guidelines under "Isolation Precautions. Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007)" stated: "Do not reuse gowns, even for repeated contacts with the same patient." (2007)

During unit observations on the COVID-19 positive unit on January 28, 2021 that began at 10:00 a.m., the surveyor noted that there were cloth isolation gowns hanging on the outside of the door to each patient room, including unoccupied patient rooms. Several staff members were observed donning the cloth isolation gowns that were seen hanging on the doors to all of the patient rooms prior to entering the room to provide care. Gowns were doffed in the hallway and returned to the hooks secured to the door. The surveyor was told that these gowns were patient-specific and disposed of at the end of the shift.

The surveyor observed a cart placed in the middle of the hallway with two types of clean isolation gowns: disposable and reusable cloth.

The surveyor interviewed one of the staff nurses on this unit who stated that Personal Protective Equipment (PPE) was readily available when needed and identified no barriers to obtaining PPE.

The surveyor asked the facility's Infection Preventionist (IP) who accompanied the surveyor during observations about the availability of gowns. The IP stated that the facility had an ample supply of reusable isolation gowns and a contract with an external laundry service to clean the cloth isolation gowns.

Based on the surveyor observation of the gowns, both reusable and disposable, readily available and the response of the IP, it did not appear that the facility was utilizing crisis capacity strategies to conserve isolation gowns for staff use; therefore, consideration should not have been given to the practice of reusing isolation gowns before laundering.

2. Review of the CDC guidance under " Guideline for Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings (2007) " revealed the following recommendations:

1. "Before leaving the patient's room or cubicle, remove and discard PPE".

2. "Isolation gowns should be removed before leaving the patient care area to prevent possible contamination of the environment outside the patient's room."

Additionally, the CDC issued the following recommendations under "Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic":

2. Recommended infection prevention and control (IPC) practices when caring for a patient with suspected or confirmed SARS-CoV-2 infection. Personal Protective Equipment. Gowns. Put on a clean isolation gown upon entry into the patient room or area. Change the gown if it becomes soiled. Remove and discard the gown in a dedicated container for waste or linen before leaving the patient room or care area. Disposable gowns should be discarded after use. Reusable (i.e., washable or cloth) gowns should be laundered after each use. (2020)

During observations of the COVID-19 positive unit on January 28, 2021 at approximately 10:30 a.m., the surveyor noted that there were no isolation waste receptacles available in the hallway. The surveyor observed a staff member (S1) exiting an isolation room with a disposable gown still on. Since there were no receptacles available in the hallway, it meant that the staff was prepared to go into another room without removing and exchanging the PPE. The surveyor asked S1 if the staff was going into the next room without exchanging the PPE. S1 replied that he/she was told this was acceptable as the unit was strictly for patients who were on COVID-19 isolation precautions. The surveyor then inquired to both the Infection Preventionist (IP) and S1 if the entire unit had been designated as a Hot Zone (area in which PPE is continually worn in and out of patient room with allowed removal during breaks and at the end of the work day). The IP replied it was not; however, designating the unit as a Hot Zone
was something that could be considered. This meant that the only Hot Zone was the direct patient care area (the patient's room), and staff should have removed the contaminated PPE inside, before exiting the room.

The surveyor also observed that other staff in the hallway of this unit and at the nurse's station during the tour were not wearing full PPE. These staff members were only wearing eye protection and a surgical mask.

Permitting staff to be fully donned in contaminated PPE while traveling to various locations outside of the direct patient care area, while other staff are donned in limited PPE (face shield and surgical mask), could place infectious organisms outside of the patient's room, resulting in an exposure to those organisms.

3. The following CDC guidelines were in effect at the time of the survey on January 28, 2021 under "Guidelines for Environmental Infection Control in Health-Care Facilities":

Routine handling of contaminated laundry: A. Handle contaminated textiles and fabrics with minimum agitation to avoid contamination of air, surfaces, and persons (36,293,355,356). Category IC (OSHA: 29 CFR 1910.1030 § d.4.iv); B. Bag or otherwise contain contaminated textiles and fabrics at the point of use (293). Category IC (OSHA: 29 CFR 1910.1030 § d.4.iv)... C. Covers are not needed on contaminated textile hampers in patient-care areas" (CDC, 2019). It should be noted that patient-care areas are defined as any area within a healthcare facility where patients are examined and treated, commonly referred to as the patient's room.

Additionally, the CDC issued the following recommendations under "Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic":

2. Recommended infection prevention and control (IPC) practices when caring for a patient with suspected or confirmed SARS-CoV-2 infection. Personal Protective Equipment. Gowns. Put on a clean isolation gown upon entry into the patient room or area. Change the gown if it becomes soiled. Remove and discard the gown in a dedicated container for waste or linen before leaving the patient room or care area. Disposable gowns should be discarded after use. Reusable (i.e., washable or cloth) gowns should be laundered after each use. (2021)

During a tour of the unit on January 28, 2021 that began at 10:00 a.m., the surveyor noted two uncovered linen hampers at opposite ends of the hallway. The linen hampers were designated for soiled cloth isolation gowns. Soiled isolation gowns in one of the two hampers were spilling over the sides of the container, further promoting an opportunity for microorganisms to contaminate the immediate environment. Additionally, the hospital failed to adhere to the nationally recognized standards and keep the soiled gown hampers in patient rooms, readily available for gown removal prior to exiting the patient room.

Concurrently, the Infection Preventionist acknowledged the need for the linen bins to be covered and emptied timely to prevent overflow.

The cumulative effect of these failures increased the risk of transmission of infectious microorganisms within the facility and placed all patients, staff, and visitors at risk for contracting COVID-19.