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Tag No.: A0749
Based on observations of care on two units, staff interviews, and on-ste and off-site review of policies and procedures, 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) non-compliant storage of Personal Protective Equipment (PPE) in the pediatric Emergency Department and Medical Intensive Care Unit; 2) staff failure to adhere to universal source control measures and wear a facial mask/covering in the clinical area; and 3) failure to timely screen patients and visitors for COVID-19 symptoms upon entry to the Emergency Department.
Findings include:
1) The following guidance from the Centers for Disease Control and Prevention (CDC) was in effect at the time of survey on 09/02/2020 under "Recommended Guidance for Extended Use and Limited Reuse of N95 Filtering Facepiece Respirators in Healthcare Settings":
"If reuse of N95 respirators is permitted, respiratory protection program administrators should ensure adherence to administrative and engineering controls to limit potential N95 respirator surface contamination (e.g., use of barriers to prevent droplet spray contamination) ... Healthcare facilities should develop clearly written procedures to advise staff to take the following steps to reduce contact transmission:
...
- Hang used respirators in a designated storage area or keep them in a clean, breathable container such as a paper bag between uses. To minimize potential cross-contamination, store respirators so that they do not touch each other and the person using the respirator is clearly identified. Storage containers should be disposed of or cleaned regularly." (CDC, 2020)
On 09/02/20, surveyors reviewed the hospital policy titled "COVID-19: Interim Mitigation Policy for Extended Use and Re-Use of N95 Respirators". Under section "Procedure. I", the policy stated: "N95 respirators should be stored in a designated storage area in a breathable container between uses (example: paper bag with handles) ..."
On 9/2/2020 at approximately 10:30 am, surveyors conducted observations in the Pediatric Emergency Department (ED). The surveyors observed a bulletin board with hanging brown paper bags with handles. The charge nurse communicated to the surveyors that the reusable PPE for the staff was stored in paper bags on a bulletin board for that shift. The charge nurse stated that when staff left for the day, the reusable PPE was stored under the cabinet for the next use. The surveyors observed a rolled up disposable PPE gown placed in one brown paper bag on the board. It should be noted that the hospital only utilized disposable single-use gowns on the units. All disposable single-use PPE should be discarded by staff after removal. When asked about the observed rolled-up disposable PPE gown on the board, the charge nurse stated this was a bag that belonged to a staff member on the previous shift. The charge nurse was unable to determine if this gown was clean or dirty. Improper storage of the disposable PPE in the designated storage area for re-usable PPE without the ability to clearly identify if the PPE was clean or dirty increased the risk of contamination of re-usable PPE.
On 9/3/2020 at approximately 10:00 am, the surveyors conducted observations on the Medical Intensive Care Unit (MICU). The surveyors observed a large portable white board on the unit. The unit manager explained that this area was utilized by staff to store their reusable PPE. There were several labeled brown paper bags noted on the board. The surveyors also observed a plastic biohazard bag and a plastic patient belongings bag located on the board which were utilized for storage of the staff's reusable PPE. In response to the inquiry by surveyors if the plastic bags were used for storage of reusable PPE, the unit manager stated that the staff were supposed to use brown paper bags with handles so they can be hung. The hospital's current procedure did not include use of plastic bags for the storage of reusable PPE. Biohazard bags are specific to biohazard items within a facility and are not used for non-biohazard items.
The hospital failed to ensure that staff adhered to appropriate PPE storage procedures.
2) The following CDC guidelines were in place at the time of survey on 09/02/20 under "Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic":
"CDC recommends using additional infection prevention and control practices during the COVID-19 pandemic, along with standard practices recommended as a part of routine healthcare delivery to all patients ... These additional practices include:
Implement Universal Source Control Measures
Source control refers to use of cloth face coverings or facemasks to cover a person's mouth and nose to prevent spread of respiratory secretions when they are talking, sneezing, or coughing. Because of the potential for asymptomatic and pre-symptomatic transmission, source control measures are recommended for everyone in a healthcare facility, even if they do not have symptoms of COVID-19 ... HCP (health care providers) should wear a facemask at all times while they are in the healthcare facility, including in breakrooms or other spaces where they might encounter co-workers." (CDC, 2020)
Surveyors confirmed through the electronic communication with the hospital's Director of Regulatory Compliance on 09/16/20 that on 04/17/20 the hospital began requiring all employees to wear facial coverings in common areas in addition to clinical areas.
Surveyors conducted observations of care on the Medical Intensive Care Unit (MICU) on 09/02/20. Review of the census of MICU on the day in question determined that 3 of 10 patients were positive or suspected for COVID-19.
On arrival to MICU, the surveyor team witnessed a male provider who had walked on to the unit without a mask or facial covering and was turning a corner. The same provider was later seen on the unit wearing a facial covering.
During the same unit observation, just prior to surveyors leaving the unit, a female medical staff member was observed walking around the unit with the face mask pulled down under the chin with both nose and mouth exposed.
Both observations of the clinical members being non-compliant with universal source control requirements occurred in the clinical areas where the providers could encounter or be in close proximity to other staff members.
3) The following CDC guidance was in effect at the time of the survey on 09/02/20 under "Healthcare Facilities: Managing Operations During the COVID-19 Pandemic": Limit visitors to the facility to only those essential for the patient's physical or emotional well-being and care... Assess visitors for fever and other COVID-19 symptoms before entry to the facility." (CDC, 2020)
During observations of care throughout the hospital, surveyors determined that the facility had a COVID-19 screening process for patients and visitors with screening staff located at the main entrance of the facility and at other entry points into the hospital. These staff members would screen patients and visitors for symptoms of COVID-19 and would offer a facial mask to those patients and visitors who were presenting without one.
During Emergency Department (ED) entrance area observation on 09/03/20, it was determined that there was a lack of COVID-19 screening available at the four ED entry points. In addition, there was no signage alerting patients and visitors to visitation restrictions.
Interviews were conducted with the registrar and the ED manager to inquire about the lack of COVID-19 screening of patients and visitors on entry to ED. It was reported that upon arrival to the ED, a registrar asked patients questions about travel exposure. Patients and their visitors would then be seated in the ED waiting room awaiting to be screened by a triage nurse. The triage nurse would screen patients for COVID-19 symptoms, verbally inform patients and their visitor(s) of restricted visitation, and give a brochure to patients and their visitor(s) of restriction. This process allowed for patients and visitors in the ED who had already been screened for COVID-19 symptoms to be exposed to other unscreened patients and visitors who were still awaiting triage.
On 09/03/2020 between 2:00 pm and 4:00 pm, the following observation was made by the surveyor in the Emergency Department waiting room: a patient sitting in a wheelchair without a mask. This unmasked ED patient (EDP1) was talking to another individual who was wearing a facial covering and appeared to have been with or familiar to EDP1. EDP1 displayed no visual signs of respiratory difficulty, no facial abnormality, or obvious signs of distress, that would prevent the patient from wearing of a mask or other face covering, as evident by EDP1 talking and laughing with the other individual present in the waiting area. EDP1 had on a hospital identification bracelet indicating that the patient had been registered prior to the surveyor's arrival in the ED. Despite this initial staff contact, EDP1 remained unmasked.
The surveyor interviewed the ED Registrar (S3) about this observation and what the protocol was for patients arriving without facial coverings. S3 stated that they were not aware that the patient didn't have on a mask. When asked if registrar staff provided masks to patients that came in without a facial covering, the registrar stated "I do not, that was something the triage nurse would handle."
The above-mentioned observations and interview further confirmed the non-compliant process of delayed COVID-19 screening of patients and visitors who presented to the Emergency Department. The delayed COVID-19 screening and a missed opportunity to offer a facial covering to patients and visitors entering the ED as part of the universal source control increased the risk of COVID-19 infection spread in the ED waiting room.