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530 3RD ST NW

HARLOWTON, MT 59036

INFECTION PREVENT & CONTROL & ABT STEWAR PROG

Tag No.: C1200

Due to the manner and degree of the deficient practice, the facility failed to meet the Condition of Participation for Infection Prevention and Control.

Based on observation, interview, and record review, the facility failed to:

- Establish/Implement a surveillance plan, based on a facility-risk assessment, for identifying, tracking, monitoring and/or reporting of fever, respiratory illness, or other signs/symptoms of COVID-19 for 20, (#s 1-20) of 20 sampled patients. (See C1206)

- Establish/implement a plan which included early detection and management of potentially infectious and symptomatic patients for signs and symptoms of COVID-19, prior to, and during a facility-wide COVID-19 outbreak; which included a plan for routine surveillance testing when routine screening of patient symptoms was not being conducted in order to mitigate the spread of infection for 20 (#s 1-20) of 20 sampled patients. (See C1206).

- Actively monitor and screen all staff at the beginning of their shift for signs/symptoms of COVID-19; and failed to document the absence/presence of such illness for all staff. This deficient practice had the potential to affect all patients receiving care from staff that were not screened prior to providing patient care. (See C1206).

- Implement timely interventions with the appropriate transmission-based precautions including signage on patient rooms regarding need for transmission-based precautions for patients with suspected/confirmed signs and symptoms of COVID-19; and established a clear delineation between clean areas and potentially contaminated areas in order to mitigate the spread of infection for 20 (#s 1-20) of 20 sampled patients. (See C1206).

- Ensure all staff were educated/trained, and appropriately used PPE while providing care between patients with and without COVID-19; and failed to ensure PPE used for extended/reuse was used, cleaned/decontaminated, and properly stored between uses according to national guidelines for infection prevention for 20 (#s 1-20) of 20 sampled patients. (See C1206).

- Establish a facility-wide IPCP including written standards, policies, and procedures that are current and based on national standards for undiagnosed respiratory illness and COVID-19;
Standards, Policies and Procedures. This deficient practice had the potential to affect all patients and facility staff of the facility. (See C1206).

- Establish and implement a system for the tracking of all surveillance, prevention, and control of respiratory illness or other signs/symptoms of COVID-19 for both patients and staff in order to prevent the spread of COVID-19 and failed to demonstrate the success or sustainability of such activities for 20 (#s 1-20) of 20 sampled patients. (See C1225).

The accumulation of these deficient practices likely contributed to the spread of the COVID-19 infection within the facility resulting in a risk to patient safety for 18 (#s 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, and 20) patients related to contracting COVID-19, 1 (#13) for the potential to contract COVID-19; and the death of 1 (#1) patient related to complications associated with COVID-19, totaling 20 patients.

IMMEDIATE JEOPARDY

On 10/15/20 at 4:10 p.m., the facility CEO, Director of Nursing, Chief Medical Officer, and Clinical Director were notified that an Immediate Jeopardy existed in the area of §485.640 Condition of Participation: Infection Prevention and Control, which was related to C1200, C1206, and C1225.

REMOVAL OF IMMEDIACY

An acceptable plan to remove the Immediate Jeopardy was received on 10/21/20 at 11:00 a.m.
The removal of the immediacy was verified onsite by the State Survey Agency on 10/27/20 at 12:40 p.m. Once the immediacy was removed, the deficiency remained at a Condition Level.

Due to the degree of the Standard Levels, the accumulation of the following deficient practices contributed to the Condition Level but did not rise to the level of immediacy (C1204, C1208, and C1239):

Based on observation, interview and record review, the facility failed to:

- Ensure the individual(s) employed as the Infection Prevention and Control Specialist(s) were appointed by the facility's Governing Body based upon the recommendations of its Medical Staff. This deficient practice had the potential to affect all patients receiving care at the facility and staff providing care during a facility-wide outbreak of COVID-19. (See C1204).

- Prepare and serve food and disinfect COVID-19 contaminated dishes in a safe manner to prevent the spread of COVID-19. This deficient practice had the potential to affect all individuals who ate food prepared by the kitchen. (See C1208).

- Ensure all staff were educated and trained on the proper use PPE, and how to safely reuse PPE while providing care for patients during a facility-wide outbreak of COVID-19 to mitigate the transmission of the infection for 20 (#s 1-20) of 20 sampled patients. (See C1239).

INFECTION PREVENT & CONTROL ORG & POLICIES

Tag No.: C1204

Based on interview and record review, the facility failed to ensure the individual(s) employed as the Infection Prevention and Control Specialist(s) were appointed by the facility's Governing Body based upon the recommendations of its Medical Staff. This deficient practice had the potential to affect all patients receiving care at the facility and staff providing care during a facility-wide outbreak of COVID-19. Findings include:

During an interview on 10/14/20 at 3:03 p.m., staff members B stated she was not infection control certified. She said staff member E provided oversight for the infection control program and they worked together, and made decisions together regarding infection control recommendations based on CDC guidelines.

During an interview on 10/15/20 at 12:12 p.m., staff member B stated she was not aware if the MS or GB had approved her as the facility's Infection Preventionist.

During an interview on 10/15/20 at 3:15 p.m., staff member A stated the MS and the GB had not approved the Infection Preventionist(s) for the facility. Staff member B and E were considered the Infection Preventionists for the facility.

During an interview on 10/21/20 at 4:30 p.m., staff member C stated infection control was a function of the DON role. There was no MS review or GB approval for the Infection Preventionist(s).

A request for the MS review and GB recommendations for approval of a/an Infection Control Preventionist(s) for the facility was not provided by the end of the survey.

INFECTION PREVENT & CONTROL POLICIES

Tag No.: C1206

Based on observation, interview, and record review, the facility failed to:

- Establish a facility-wide IPCP including written standards, policies, and procedures that are current and based on national standards for undiagnosed respiratory illness and COVID-19;
Standards, Policies and Procedures. This deficient practice had the potential to affect all patients and facility staff of the facility;

- Established/implement a surveillance plan, based on a facility-risk assessment, for identifying, tracking, monitoring and/or reporting of fever, respiratory illness, or other signs/symptoms of COVID-19 for 20, (#s 1-20) of 20 sampled patients;

- Failed to establish/implement a plan which included early detection and management of potentially infectious and symptomatic patients for signs and symptoms of COVID-19 [see superscript 5], prior to, and during a facility-wide COVID-19 outbreak; which included a plan for routine surveillance testing¹ when routine screening of patient symptoms was not being conducted in order to mitigate the spread of infection for 20, (#s 1-20) of 20 sampled patients;

- Actively monitor and screen all staff ² at the beginning of their shift for signs/symptoms of COVID-19; and failed to document the absence/presence of such illness for all staff. This deficient practice had the potential to affect all patients receiving care from staff that were not screened prior to providing patient care;

- Implement timely interventions with the appropriate transmission-based precautions including signage³ on patient rooms regarding need for transmission-based precautions for patients with suspected/confirmed signs and symptoms of COVID-19; and establish a clear delineation between clean areas and potentially contaminated areas in order to mitigate the spread of infection for 20 (#s 1-20) of 20 sampled patients;

- Ensure all staff were educated/trained, and appropriately used PPE [see superscript 4] while providing care between patients with and without COVID-19; and failed to ensure PPE used for extended/reuse was cleaned/decontaminated and properly stored between uses according to national guidelines for infection prevention for 20, (#s 1-20) of 20 sampled patients.

The accumulation of these deficient practices likely contributed to the spread of the COVID-19 infection within the facility resulting in a risk to patient safety for 18 (#s 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, and 20) patients related to contracting COVID-19, 1 (#13) for the potential to contract COVID-19; and the death of 1 (#1) patient related to complications associated with COVID-19, totaling 20 patients. Findings include:

IMMEDIATE JEOPARDY

On 10/15/20 at 4:10 p.m., the facility CEO, Director of Nursing, Chief Medical Officer, and Clinical Director were notified that an Immediate Jeopardy existed in the area of §485.640 Condition of Participation: Infection Prevention and Control, which was related to C1200, C1206, and C1225.

REMOVAL OF IMMEDIACY

An acceptable plan to remove the Immediate Jeopardy was received on 10/21/20 at 11:00 a.m.
The removal of the immediacy was verified onsite by the State Survey Agency on 10/27/20 at 12:40 p.m. Once the immediacy was removed, the deficiency remained at a Condition Level.

During an interview on 10/14/20 at 10:30 a.m., staff members B and E stated the facility had a total census of 19 patients for the skilled acute care and swing beds; 15 of those patients were positive for COVID-19 (patient #s 3, 4, 5, 6, 7, 10, 11, 12, 14, 15, 16, 17, 18, 19, and 20); four patients were negative (#s 2, 8, 9 and 13), and one patient had died (#1) on 10/13/20 from complications associated with COVID-19 (this patients was not included in the facility census for 10/14/20).

During an interview on 10/15/20 at 10:00 a.m., staff members B and E stated the facility had a total census of 19 patient for the skilled acute care and swing beds; 18 of those patients (#s 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, and 20) were positive for COVID-19 or presumed positive. Two patients (#s 9 and 13) were presumed to be negative for COVID-19.

During an interview on 10/27/20 at 11:00 a.m., staff member B stated the facility had a total census of 16 patients for the skilled acute care and swing beds; 15 of the patients had been removed from TBP, and one patient (#13), was confirmed positive for COVID-19. She stated from the previous census of 19 patients on 10/15/20; one patient (#16) had discharged home, and two patients (#s 7 and 20) had died from complications associated with COVID-19.

During an interview on 10/15/20 at 12:12 p.m., staff member B stated the facility had a total of 17 staff members who were off work related to suspected or confirmed COVID-19. Staff members (O, P, Q, R, S, V, W, Y, Z, EE, FF, GG, JJ, and KK) were currently quarantined and unable to work due to positive confirmed COVID-19; and three additional staff members (II, LL, and MM) were currently on quarantine due to their symptoms and were pending the test results for COVID-19.

1. Standards, Policies and Procedures:

During an interview on 10/15/20 at 12:12 p.m., staff members B, and E stated the facility had developed an Incident Command Unit to review and plan any procedure or process changes needed regarding COVID-19. But they did not develop written facility-wide IPCP standards, policies, and procedures that were current and based on national standards for undiagnosed respiratory illness and COVID-19.

During an interview on 10/15/20 at 4:47 p.m., staff member A stated they did not update the policy and procedures for COVID-19 but worked on getting a command protocol for community-based infection established.

A request for the facility's written IPCP policy and procedures for undiagnosed respiratory illnesses and COVID-19 was not provided by the end of the survey. The Infection Control and Prevention policies which were provided did not include IPCP for COVID-19.

2. Infection Surveillance:

a. Development of an Infection Surveillance Log (See C-1225 for additional findings).

During an interview on 10/15/20 at 12:12 p.m., staff member B stated she had not developed a written log or established a written system which included a surveillance plan for identifying, tracking, and monitoring staff and patients for respiratory illness or other signs/symptoms of COVID-19. She stated she did not have the staff and patient screenings available in a single location. She did not have a method in place to monitor and track staff and patients who were symptomatic and/or had been tested for COVID-19, and a way to monitor those results for implementation and discontinuation of TBP. She stated she did not keep a record of the staff or patients who were tested for COVID-19 and trusted the lab to keep those documents.

A request for the facility's written surveillance plan and/or log for identifying, tracking, and monitoring staff and patients for respiratory illness or other signs/symptoms associated with COVID-19 for undiagnosed respiratory illnesses and COVID-19 was not provided by the end of survey.

b. Development of an Infection Control Plan for COVID-19 based on a Facility-Wide Assessment Tool

During an interview on 10/15/20 at 3:00 p.m., staff member A stated he believed the facility had completed a facility-wide assessment tool "early on" when the pandemic first began but was not aware if they had updated that assessment since it was first developed.

Review of a COVID-19 Planning Checklist, which was not dated, showed a partially completed checklist.

During an interview on 10/21/20 at 3:00 p.m., staff member C stated the documented titled, COVID-19 Planning Checklist, was completed in March 2020.

Review of the facility's QI Meeting Minutes, from 3/25/20, addresses a "Planning Checklist", which showed, "d. Planning Checklist i. Items on checklist were appropriately checked off.
ii. There will be a new list at the beginning of each week."

Review of the facility's QI Meeting Minutes, from 3/26/20, addresses a "Planning Checklist", which showed, "a. Planning Checklist... i. All items on checklist were checked off accordingly."

During an interview and record review on 10/21/20 at 3:30 p.m., staff member C stated the COVID-19 Planning Checklist identified in the QI Meeting Minutes on 3/25/20 and 3/26/20, which was to be completed weekly by the facility, was not completed weekly. There was no further documentation provided to support the facility completed in its entirety a facility-wide assessment tool as established in their QI Meeting Minutes from 3/25/20 and 3/26/20.

c. Routine Surveillance Screening of Patients:

During an interview on 10/14/20 at 12:45 p.m., staff members B and E stated the only screening the facility had implemented to screen patients for signs and symptoms of COVID-19 was a daily temperature. Staff member B stated they had not developed a formal policy or procedure to provide routine surveillance of patients for COVID-19. They only obtained a full set of vitals on patients once weekly for their Care Plan Review. They would review the Care Plans and trend if there was a change in patients' blood pressures or vitals. She said it was not until late July or August that they were aware patients who were positive for COVID-19 may have GI symptoms. So, they started reviewing the Care Plans once a week for any changes in the patients' GI status. Staff member B stated they never formalized a process for what to look for and how often. Staff member B said she had an expectation of the charge nurses, and medication aides to round on patients and see how they are doing, and then chart by exception. She stated the facility never formalized a process for staff to follow to check patients daily for vital signs (other than just a temperature), and signs and symptoms for COVID-19. Staff member E stated anything more would be disruptive to the patients' lives. Staff member E stated she would not order staff to complete a full set of vitals including pulse, SA02, and blood pressure, and/or complete a daily nursing assessment of signs and symptoms for COVID-19. Staff member E said she did not develop a plan or implement any additional surveillance processes to screen patients for signs and symptoms for COVID-19, other than a daily temperature since March. Staff member E stated, "why would you?" Staff member B stated the nursing staff had not been directed to complete any additional vital signs other than the temperature, or monitor the patients daily for any changes in status specifically related to signs and symptoms for COVID-19; even after the facility had patients and staff who had been confirmed positive for COVID-19.

During an interview on 10/14/20 at 1:00 p.m., staff member X stated she did not screen the patients for signs and symptoms of COVID-19, or complete any additional vital signs, other than a daily temperature. She said she would make a notation in the patient's record if something had changed but did not routinely conduct surveillance screening of the patients' symptoms. She stated patients #s 8, 9, and 13, were still presumed to be negative from COVID-19. She stated she had not been informed to complete any additional screening of their vital signs or symptoms to monitor for infection. Staff member X stated she was not currently completing a daily assessment of the patients who were currently positive for COVID-19 to monitor for any significant change in their status. She said she had not completed regular daily assessments of the patients prior to the outbreak for any changes in symptoms which would indicate they had COVID-19. She said it was not an expectation of the facility.

During an interview on 10/15/20 at 3:15 p.m., staff members B and E stated they did not implement any additional screening or surveillance of patients before or after the facility's outbreak. They felt routine screening would be too disruptive for the patients. Only daily temperatures were taken to check for symptoms.

During an interview on 10/19/20 at 12:44 p.m., NF1 stated the facility had not implemented a policy to screen patients for COVID-19, before or after the outbreak.

During an interview on 10/19/20 at 3:33 p.m., NF2 stated the facility had never implemented a policy to screen patients for COVID-19 before or after the outbreak. The facility had not provided guidance to screen patients daily for signs or symptoms of COVID-19. NF2 stated the patients had a temperature taken once a day, but no additional vital signs were obtained except for once a week. NF2 stated staff were not directed by the facility to screen the patients for COVID-19. The nursing staff did not monitor the patients who were positive for COVID-19 for any changes in status, and they did not monitor the patients who were negative for any change in status which would indicate they were positive for COVID-19.

Review of patients #s 1 through 20, from September 2020 to October 2020, did not show routine surveillance monitoring or screening for COVID-19 symptoms was completed for the patients, other than a daily temperature.

[superscript 5] Responding to Coronavirus (COVID-19). (4/30/20). Retrieved October 21, 2020, from https://www.cdc.gov/coronavirus/2019-ncov/hcp/nursing-homes-responding.html showed the following recommendations:
"For patients with new-onset suspected or confirmed COVID-19- Increase monitoring of ill patients, including assessment of symptoms, vital signs, oxygen saturation via pulse oximetry, and respiratory exam, to at least 3 times daily to identify and quickly manage serious infections. Consider increasing monitoring of asymptomatic patients from daily to every shift to more rapidly detect any patients with new symptoms..."

³ Centers for Disease and Control. (CDC). (2020, July 15). Infection Control: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Retrieved October 28, 2020, from https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html
Personal Protective Equipment Training. Showed the following recommendations:

" Re-evaluate admitted patients for signs and symptoms of COVID-19: While screening should be performed upon entry to the facility, it should also be incorporated into daily assessments of all admitted patients. All fevers and symptoms consistent with COVID-19 among admitted patients should be properly managed and evaluated (e.g., place any patient with unexplained fever or symptoms of COVID-19 on appropriate Transmission-Based Precautions and evaluate)."

d. Routine Surveillance Testing of Staff and Patients when a Plan for Routine Surveillance was not developed:

During an interview on 10/14/20 at 3:15 p.m., staff member B stated they had asked all staff to start screening for signs and symptoms of COVID-19. When they became aware about a staff member who had tested positive for COVID-19, they contacted NF3 and NF4. NF3 and NF4 had recommended that they test all their staff twice a week or more frequently depending on symptoms. Staff member B stated this was never mandated by the facility for staff or developed as procedure.

During an interview on 10/15/20 at 12:12 p.m., staff members B and E stated they started screening all patients in July 2020, only for a daily temperature. They also obtained a baseline SA02 on all the patients on 10/5/20, but no further monitoring for COVID-19 was completed for patients. Staff member B stated they had not developed a plan to complete surveillance monitoring for the patients, but they did start reviewing the patients' Care Plans once a week to look for any trends or changes in vital signs. Staff member E stated they felt it was pointless to conduct surveillance testing for COVID-19 since early on the labs were over-ran with testing, and it took such a long time to get test results back. Then in July, the facility offered the community COVID-19 testing; they also inquired with the patients and POAs if they wanted to have "their loved ones" routinely tested for COVID-19. They stated the response from families and POAs was, "absolutely don't test my loved one." She said since the facility had gone into "lock-down phase," they had monthly discussions with the patients and their families, and some families and patients made the decision not to participate in the community surveillance testing which was offered on 7/4/20. The only patients who wanted to be tested and were tested were patients #s 17 and 18. Staff member E said they offered community testing for COVID-19 on 7/4/20, 7/6/20, and 7/27/20. There were no further community offered testing from the facility after 7/27/20. Then in September, staff member E stated the prevalence of COVID-19 in their community started to increase. It was not until 9/24/20, that they asked the staff to be tested. They did not mandate the testing, only made it voluntary. They believed they had about a 30-50 percent participation rate regarding the staff testing. From 7/27/20 until 10/5/20, staff members B and E said they did not offer or perform surveillance testing for the patients. Staff member E said after the facility was made aware of staff member P's primary exposure on 10/2/20, they said they were encouraging staff to be tested. However, staff member B said they did not offer or provide routine surveillance testing for patients after they were aware of the positive staff exposure. Staff member E stated the first patient to be tested for COVID-19 after July, was patient #16, and he was tested because he was symptomatic. Staff members B and E stated after they got the positive COVID-19 test result back for patient #16, they decided to test the rest of the patients. They tested all the patients on 10/5/20, except five patients (#s 7, 10, 15, 19 and 20), because their POAs had refused. Staff member E stated of the 15 patients who were tested, only five test results came back on 10/7/20, which showed patients (#s 3, 14, 16, 17, and 19) were all positive. The rest of the tests results for patients did not come back until 10/9/20. Of those patients tested, all were positive for COVID-19 except patients (#s 2, 8, 9, and 13). Staff member B stated after they had got the positive results back for the patients, they reached out to the POAs who had initially declined to have their family member tested and offered to test them. Staff member E stated at that point all POAs who had initially refused, consented to having their family members tested, and the patients who were not tested on 10/5/20 were tested on 10/7/20. Staff member E stated they continued to provide testing of patients after the facility had an outbreak. Staff member B and E stated they did not offer routine surveillance testing for patients before the facility-wide outbreak of COVID-19 and did not have a plan established to monitor patients and staff for COVID-19.

A request for the written documentation regarding the offered/refused surveillance testing and the patient Care Plans used for weekly infection surveillance for patient (#s 1-20) was not provided by the end of survey.

¹ Centers for Disease and Control. (CDC). (2020, July 15). Infection Control: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Retrieved October 28, 2020, from https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html
Showed the following recommendations:

- "Create a Plan for Testing Patients and Healthcare Personnel for SARS-CoV-2:
Testing for SARS-CoV-2, the virus that causes COVID-19, in respiratory specimens can detect current infections (referred to here as viral testing or test) among patients and HCP in nursing homes. The plan should align with state and federal requirements for testing patients and HCP for SARS-CoV-2 and address:
- Triggers for performing testing (e.g., a resident or HCP with symptoms consistent with COVID-19, response to a resident or HCP with COVID-19 in the facility, routine surveillance)
Access to tests capable of detecting the virus (e.g., polymerase chain reaction) and an arrangement with laboratories to process tests...
- Process for and capacity to perform SARS-CoV-2 testing of all patients and HCP
- A procedure for addressing patients or HCP who decline or are unable to be tested (e.g., maintaining Transmission-Based Precautions until symptom-based criteria are met for a symptomatic resident who refuses testing)."

3. Monitoring and Screening of Staff

During an interview on 10/15/20 at 12:12 p.m., staff member B stated the facility had a total of 17 staff members who were off work related to suspected or confirmed COVID-19. Staff members (O, P, Q, R, S, V, W, Y, Z, EE, FF, GG, JJ, and KK) were currently quarantined and unable to work due to positive confirmed COVID-19; and three additional staff members (II, LL, and MM) were currently on quarantine due to their symptoms and were pending the test results for the COVID-19 testing.

During an observation and interview on 10/14/20 at 10:30 a.m., staff member OO entered the facility to start her shift. She attempted to use the facial recognition temperature screening device, to take her temperature, but it did not recognize her, so she used the handheld thermometer instead. She stated she wrote down what her temperature was on the sheet, then she was going to go to her assigned area and complete the screening questions. She said she was supposed to take the Survey Monkey when she got to work which asked if she had any symptoms consistent with COVID-19. She stated she needed to get to her unit so she could get to a computer and check her email, in order to answer the Survey Monkey questions.

During an interview and observation on 10/14/20 at 11:10 a.m., staff member OO was preparing food items in the kitchen. She stated she had not had time yet to check her email to take the Survey Monkey questions. She stated she planned to answer them when she had time later in the day.

During an interview on 10/14/20 at 11:15 a.m., staff members L, M, and NN stated that they did complete the Survey Monkey questions for their shift that day, but not until after they had been on duty for several hours. Staff member NN stated she had not had time to complete the Survey Monkey yet for that day.

During an interview on 10/14/20 at 12:20 p.m., staff member H stated she had taken her temperature before starting her shift but had not completed the Survey Monkey before she started providing patient care. Staff member H stated she was aware she needed to complete the Survey Monkey questions before she began her shift but had not done so yet.

A review of the facility's staffing schedule for shifts worked, from 9/27/20 to 10/15/20, showed staff member H had worked the following dates: 9/29/20, 9/30/20, 10/1/20, 10/6/20, 10/7/20, 10/8/20, 10/13/20, 10/14/20, and 10/15/20. A review of the facility's Survey Monkey results for surveillance screening of COVID-19, did not show staff member H was provided surveillance screening on the dates that she had worked from 9/27/20 to 10/15/20.

During an interview on 10/14/20 at 12:20 p.m., staff member U stated she did take her temperature when she arrived for her shift but had not taken the Survey Monkey yet.

A review of the facility's staffing schedule for shifts worked, from 9/27/20 to 10/15/20, showed staff member U had worked the following dates: 10/8/20, 10/10/20, 10/11/20, 10/13/20, 10/14/20, and 10/15/20. A review of the facility's Survey Monkey results for surveillance screening of COVID-19, did not show staff member U was provided surveillance screening on the dates that she had worked from 9/27/20 to 10/15/20.

During an interview on 10/14/20 at 1:30 p.m., staff member G stated he took his temperature when he arrived for shift and wrote it down in the log. He stated he was not asked surveillance screening questions before he started his shift and was not even aware he was supposed to complete a Survey Monkey questionnaire before he started his shift. He stated he worked for a travel agency and did not know he was supposed to check the facility email to take the Survey Monkey questions. He stated he had worked as a traveler for the facility for several weeks and had never been screened for signs or symptoms of COVID-19, other than taking his temperature when he started his shift.

A review of the facility's staffing schedule for shifts worked, from 9/27/20 to 10/15/20, showed staff member G worked the following dates: 9/29/20, 9/30/20, 10/3/20, 10/4/20, 10/7/20, 10/8/20, 10/12/20, 10/13/20, and 10/14/20. A review of the facility's Survey Monkey results for surveillance screening of COVID-19, did not show staff member G was provided surveillance screening on the dates that he worked from 9/27/20 to 10/15/20.

A review of the facility's staffing schedule for shifts worked, from 10/14/20 to 10/15/20, and of the facility's Survey Monkey results for surveillance screening of COVID-19, showed the following additional staff members worked 10/14/20 and/or 10/15/20, and were not provided surveillance screening for COVID-19: Staff members I, J, V, Y, BB, RR, and SS.

During an interview on 10/14/20 at 3:40 a.m., staff member B stated staff were expected to take their own temperature or use the facial recognition system immediately before they began their shift. They were then expected to log into their email when they got to their unit and complete a Survey Monkey which asked the surveillance screening questions. If they answered "yes" to any of the questions on the Survey Monkey, a notification was sent to her. She stated she did not usually check those notifications until around 11:00 a.m., each day. She said if any staff answered "yes" to the any of the questions, she would follow up with them. Staff member B stated there was not someone available to take the staff members temperatures, or ask the staff members the screening questions, so they relied on staff to be accountable and to notify herself or staff member E if they were not feeling well during their shifts. Staff member B did not reconcile the worked staff schedule with the daily results of the Survey Monkey responses in an attempt to follow up with staff and provide education if the survey was not completed.

During an interview on 10/19/20 at 12:44 p.m., NF1 stated staff member W worked on 10/2/20, and seemed fine; then on 10/5/20, staff member W "was not fine." Staff member W looked sick and had asked for Tylenol for a headache. NF1 stated staff member B was notified that staff member W was not feeling well, but staff member B did not remove her from providing patient care. NF1 said staff member W also worked on 10/6/20. NF1 said staff member B had been made aware that staff member W was not feeling well. Staff member B had inquired if staff member W had completed the Survey Monkey screening questions for that shift, and staff member W said that she had a fever and headache. Staff member W was not removed from her shift and was allowed to continue to provide patient care.

A review of the facility's staffing schedule for shifts worked, from 9/27/20 to 10/15/20, showed staff member W worked on 10/5/20 and 10/6/20, the day shifts starting at 5:45 a.m. On the schedule was a hand-written note which showed staff member W went home on 10/6/20 at 1:00 p.m.

A review of staff member W's Survey Monkey responses from 10/5/20, showed she did not answer the Survey Monkey questions until 9:10 a.m., and her shift started at 5:45 a.m. Her responses were as follows:
- Question #1, "Do you have a known direct COVID exposure?" Response: "Yes".
- Question #2, "Do you have a fever?" Response: "Yes". Staff member W was allowed to continue to work the complete day shift on 10/5/20; even though her survey questions showed she had a fever and known direct exposure to COVID-19.

A review of staff member W's Survey Monkey responses, dated 10/6/20, showed she did not answer the Survey Monkey questions unitl 6:18 a.m., and her shift started at 5:45 a.m. Her responses were as follows:
- Question #1, "Do you have a known direct COVID exposure?" Response: "Yes."
- Question #2, "Do you have a fever?" Response showed, "No."

During an interview on 10/15/20 at 12:30 p.m., staff member B stated staff member W had told her she only had a headache and that she did not have a fever on 10/5/20. She stated she did not send her home based on her symptoms. Staff member B was not aware that staff member W had a fever on 10/5/20. Staff member B said staff member W started her shift on 10/6/20 at 5:45 a.m., and took the Survey Monkey at 6:18 a.m., she said staff member W had also had a normal temperature that morning. Staff member W claimed that she had not taken any Tylenol to reduce any fever on 10/6/20. She said staff member W was then notified on 10/6/20 around 1:00 p.m. that she had tested positive for COVID-19. Staff member B stated they sent staff member W home at that time. Staff member B said they were told differently, later, by staff member W that she had taken Tylenol before her shift on 10/6/20.

During an interview on 10/19/20 at 3:33 p.m., NF2 stated they were never screened by the facility for signs or symptoms associated with COVID-19. NF1 said they took their own temperature every shift but were not aware they were to complete a Survey Monkey to screen for symptoms of COVID-19.

During an interview on 10/15/20 at 1:30 p.m., staff members A and E stated they had made the decision to remove the screening question which inquired if staff had worked or traveled to areas with a high infection rate, because they felt it was too personal of a question to ask individuals. They stated this decision was made during a recent Incident Command Meeting and did not feel that it applied to their community or staff.

² Centers for Disease and Control, C. (2020, July 15). Infection Control: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Retrieved October 28, 2020, from https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html
Showed the following recommendations:

- "Screen all HCP at the beginning of their shift for fever and symptoms of COVID-19.
Actively take their temperature and document absence of symptoms consistent with COVID-19. If they are ill, have them keep their cloth face covering or facemask on and leave the workplace.
- Fever is either measured temperature >100.00 degrees F or subjective fever. Note that fever may be intermittent or may not be present in some individuals, such as those who are elderly, immunosuppressed, or taking certain medications (e.g., NSAIDs). Clinical judgement should be used to guide testing of individuals in such situations.
- HCP who work in multiple locations may pose higher risk and should be encouraged to tell facilities if they have had exposure to other facilities with recognized COVID-19 cases."

4. Transmission-Based Precautions

a. Implementation of Isolation Precautions and posting of TBP Signage for Known/Suspected COVID-19 when Cohorting was not Possible:

During an observation on 10/14/20 at 12:00 p.m., of the patient care unit located on the second floor, the second-floor unit had a total of seven patients cohoused on the same unit in separate rooms. One patient (#1), had passed away on 10/13/20 from complications associated from COVID-19. Four of those patients (#s 10, 15, 16, and 20), were confirmed positive for COVID-19, and three patients (#s 8, 9, and 13), were presumed to be negative. There were no visibly posted isolation or TBP signs on the patient rooms who were positive. The patients who tested positive for COVID-19 were not cohorted from the patients who were presumed negative. The main corridor off the unit had two large swinging doors which were closed, there was no visible signage identifying the need for TBP while on the second-floor unit. There was a second door onto the unit, which was opened, and lead past the kitchen dish and food services windows, through the dining room, and onto the unit with the cohoused patients. There were no doors available to close between the unit and the main dining room. There was not a clear delineation between the dining room and the unit or signs posted to indicate the need for TBP between the communal dining room and the unit which housed the patients positive for COVID-19. It was observed on different occasions, several staff members entered the unit from the open door in the dining room and did not adhere to TBP when entering and exiting the unit. Observations of staff members H and U who were providing care for the patients on the unit, would leave the unit and walk through the dining ro

INFECTION PREVENT SURVEIL & CONTROL OF HAIs

Tag No.: C1208

Based on observation and interview, the facility failed to prepare and serve food and disinfect COVID-19 contaminated dishes in a safe and effective manner to prevent the spread of COVID-19. This deficient practice had the potential to affect all individuals who ate food prepared by the kitchen. Findings include:

a. Disinfection of Contaminated Dishes

During an observation and interview on 10/14/20 at 11:15 a.m., at the dish washing station there were clear plastic water mugs with blue lids and straws in the dishwasher. There was a red plastic apron hanging from a rack located by the dirty dish receiving window, and a black plastic apron hanging on the other end of the rack approximately 12 inches apart. Staff members B and N stated the mugs were from the patient rooms, including the patients positive for COVID-19. The mugs were collected by the nursing staff once a day and put into a red biohazard bag and placed through the dirty dish receiving window in the kitchen. The nursing staff were supposed to notify the kitchen staff that there were dirty dishes from patient rooms, but that did not always occur. Staff member N stated the red apron was to be worn when the kitchen staff washed the contaminated dishes from patient rooms who had COVID-19. The red apron should be disinfected with bleach between each use and hung up on the rack to dry. The black apron was then to be worn by the kitchen staff when putting away the clean dishes.

During an interview on 10/14/20 at 11:20 a.m., staff members L, M, NN, and OO stated they wear the red apron and gloves when washing contaminated dishes. The staff members said after they remove the contaminated dishes from the red biohazard bag, they have to walk by the clean dishes at the far end of the dish station, then open and walk through the kitchen entrance, then through another set of swinging doors and throw away the contaminated bag in a biohazard receptacle in the patient triage room. They are then to return to the kitchen and wash their hands. They said the door handles do not get disinfected daily. They said they did not have a garbage receptacle closer to throw away the contaminated biohazard bags, and the red apron used by the kitchen staff when washing contaminated dishes was not always disinfected between each use. They said they were to use a bleach and water dilution to disinfect the red apron. The staff members stated they did have access to disposable plastic gowns, but they were not using those at that time. They were not sure why.

b. Food Prepared and Served in Unsafe Manner

During an observation and interview on 10/14/20 at 11:30 a.m., there were two meal carts. One cart had vertically opening doors, which could close. The doors to this cart were open and there were meal trays on the cart. The meal trays had a cookie sitting on a napkin on the meal service trays. The cart doors were open. There was a second cart which was open to air and did not have a cover. On the second cart were prepared meal trays which had plastic ware and a cookie sitting on a napkin. The cookies were not covered, and the cart was not covered. Both carts were open and sitting next to the dish station entrance/exit. Staff members L, M, N, NN, and OO stated they did not have a cover for the second meal cart. They said the meal trays on the first cart were for the patients on the first floor, and the uncovered second cart was for the patients on the second floor. They stated all food items being served to patients should be kept covered. They did not cover cookies on the meal trays.

During an observation on 10/14/20 at 12:00 p.m., staff members H and U were serving the patients on the second floor their afternoon meal service. Staff member U was wearing a surgical mask, goggles and gloves. Staff member U brought a meal tray from the kitchen service window, through the dining room and onto the second floor unit which housed patients positive for COVID-19. The cookies were not covered, and the plastic ware was open to air. Staff member H was wearing a surgical mask, goggles, a reuseable gown, and gloves. Staff member H picked up the cookie and placed it on top of the Styrofoam food container, then picked up the plastic ware in her other hand, and entered the patient rooms with the food. Staff member U did not properly doff/don the contaminated gowns change her surgical mask or goggles between patient rooms. Staff member U did not wash her hands between each exchange of the meal trays. Staff member U wore the same goggles and surgical mask between each meal tray pass.

During an interview on 10/14/20 at 1:00 p.m., staff member N stated all food items being served to the patients should be covered. She stated the cookies should have been covered and was not sure why they were not.

LEADERSHIP RESPONSIBILITIES

Tag No.: C1225

Based on interview and record review, the facility's Infection Preventionist(s) failed to establish and implement a system for the tracking of all surveillance, prevention, and control of respiratory illness or other signs/symptoms of COVID-19 for both patients and staff in order to prevent the spread of COVID-19, and failed to demonstrate the success or sustainability of implemented activities. This deficient practice likely contributed to the spread of the COVID-19 infection within the facility resulting in a risk to patient safety for 18 (#s 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, and 20) patients related to contracting COVID-19; 1 (#13) for the potential to contract COVID-19; and the death of 1 (#1) patient related to complications associated with COVID-19, totaling 20 patients. Findings include:

IMMEDIATE JEOPARDY

On 10/15/20 at 4:10 p.m., the facility On 10/15/20 at 4:10 p.m., the facility CEO, Director of Nursing, Chief Medical Officer, and Clinical Director, were notified that an Immediate Jeopardy existed in the area of §485.640 Condition of Participation: Infection Prevention and Control, which was related to C1200, C1206, and C1225.

REMOVAL OF IMMEDIACY

An acceptable plan to remove the immediate jeopardy was received on 10/21/20 at 11:00 a.m.
The removal of the immediacy was verified onsite by the State Survey Agency on 10/27/20 at 12:40 p.m. Once the immediacy was removed, the deficiency remained at a Condition Level.

During an interview on 10/14/20 at 10:30 a.m., staff members B and E stated the facility had a total census of 19 patients for the skilled acute care and swing beds; 15 of those patients were positive for COVID-19 (patient #s 3, 4, 5, 6, 7, 10, 11, 12, 14, 15, 16, 17, 18, 19, and 20); four patients were negative (#s 2, 8, 9 and 13), and one patient had died (#1) on 10/13/20 from complications associated with COVID-19 (this patients was not included in the facility census for 10/14/20).

During an interview on 10/15/20 at 10:00 a.m., staff members B and E stated the facility had a total census of 19 patients for the skilled acute care and swing beds; 18 of those patients (#s 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 14, 15, 16, 17, 18, 19, and 20) were positive for COVID-19 or presumed positive. Two patients (#s 9 and 13) were presumed to be negative for COVID-19.

During an interview on 10/27/20 at 11:00 a.m., staff member B stated the facility had a total census of 16 patients for the skilled acute care and swing beds; 15 of the patients had been removed from TBP, and one patient (#13), was confirmed positive for COVID-19. She stated from the previous census of 19 patients on 10/15/20; one patient (#16) had discharged home, and two patients (#s 7 and 20) had died from complications associated with COVID-19.

During an interview on 10/14/20 at 3:03 p.m., staff member B said certain elements of the surveillance tracking could be obtained, but they were in different areas, and she would have to find them. She said they had not maintained a written universal system for the tracking of all surveillance, prevention, and control of respiratory illness or other signs/symptoms of COVID-19 for either the patients or the facility staff.

During an interview on 10/15/20 at 12:12 p.m., staff member B stated the facility had a total of 17 staff members who were off work related to suspected or confirmed COVID-19. Staff members (O, P, Q, R, S, V, W, Y, Z, EE, FF, GG, JJ, and KK) were currently quarantined and unable to work due to positive confirmed COVID-19; and three additional staff members (II, LL, and MM) were currently on quarantine due to their symptoms and were pending the test results for COVID-19.

During an interview on 10/15/20 at 12:12 p.m., staff members B and E stated they had not developed a written log or established a written system which included a surveillance plan for identifying, tracking, and monitoring staff and patients for respiratory illness, or other signs/symptoms of COVID-19. Staff member E said she did not have the patients' or the staff screenings and testing available in one single location which was quickly accessible. Staff member B said she did not have a universal method in place to monitor and track staff and patients who were symptomatic and/or had been tested for COVID-19, and did not have a way to monitor those elements for success and sustainability. She said she did not keep a record of the staff or patients who were tested for COVID-19 and trusted the lab to keep those documents.

During an interview on 10/15/20 at 4:47 p.m., staff members A and E stated the facility developed an Incident Command folder, and information was distributed to members of the Incident Command team through daily huddles. Staff member A stated each hospital department reported individually to the Incident Command team, but they did not have any indicators for COVID-19, and they did not have that much trend(able) information related to COVID-19. The Incident Command team did not maintain a system for the tracking of the surveillance conducted for COVID-19.

A request for the facility's written surveillance plan and/or log for identifying, tracking, and monitoring staff and patients of respiratory illness or other signs/symptoms associated with COVID-19 for undiagnosed respiratory illnesses and COVID-19 was not provided by the end of survey.

Review of the facility's Incident Command Meeting Minutes from 3/25/20 through 10/6/20, did not show an operational system was in place for the tracking of all surveillance of COVID-19.

LEADERSHIP RESPONSIBILITIES

Tag No.: C1239

Based on observation and interview, the facility failed to ensure all staff were educated and trained on the proper use of PPE, and how to safely reuse PPE¹ while providing care for patients during a facility-wide outbreak of COVID-19 to mitigate the transmission of the infection for 20, (#s 1-20) of 20 sampled patients. Findings include:

During an observation on 10/14/20 at 11:50 a.m., the second-floor unit had a total of seven patients cohoused on the same unit in separate rooms. Four of those patients (#s 10, 15, 16, and 20) were confirmed positive for COVID-19, three patients (#s 8, 9, and 13) were presumed to be negative, and one patient (#1) had passed away on 10/13/20 from complications associated with COVID-19. Staff members H and U were providing patient care to the patients on the second-floor unit. They were re-using the same cloth gowns between themselves for each patient and were not changing/disinfecting their goggles or face masks after providing care between a patient who was positive for COVID-19 and patients who were negative.

During an interview on 10/14/20 at 12:15 p.m., staff member H stated she was a contracted agency staff and had been working at the facility off and on for a couple months. She did not receive education or training from the facility on the proper use of PPE or the reuse of the cloth gowns, goggles, and surgical masks.

During an interview on 10/14/20 at 12:17 p.m., staff member U stated she had worked for the facility for several years. She said she had participated in a training several months ago on how to don/doff PPE, and they did a return demonstration, but the facility did not provide any additional education after the facility-wide outbreak of COVID-19, and had not provide education or training on how to safely reuse the provided PPE, including the cloth gowns, surgical masks, and goggles.

During an interview on 10/14/20 at 1:00 p.m., staff member X stated she used the same gowns that were hanging on the patients' doors. She stated she did not always change her mask and goggles when providing care for the patients on the unit. She said she had been provided training by the facility on how to don and doff PPE, but she had not been provided any further education on proper PPE usage and PPE reuse since the outbreak.

During an observation on 10/14/20 at 1:30 p.m., the first-floor patient care unit had 11 total patients cohoused in separate rooms on the unit. Ten of those patient (#s 3, 4, 5, 6, 7, 11, 12, 14, 17, 18, and 19) were confirmed positive for COVID-19; and one patient (#2)was negative. There were re-usable cloth gowns and disposable gowns hanging on the doors for each patient on the unit. Staff member G was wearing a surgical mask and goggles.

During an interview on 10/14/20 at 1:30 p.m., staff member G said the gowns hanging on the doors for each patient were meant to be used for that patient. He had not been trained on how to properly reuse the gowns. The staff member said he wore the same mask and goggles between the patients on that unit and had not been provided additional education from the facility on how to safely reuse the provided PPE. He said he was a contracted agency staff and had been working at the facility for a couple of weeks. He said he had not been provided training on this facility's process and protocols of how to properly use PPE and how to safely reuse the provided PPE.

During an interview on 10/19/20 at 3:33 p.m., NF2 said the facility had a training on the proper use of PPE but was not able to attend. NF2 said they were not provided follow up education or training on how to properly use and reuse PPE before or after the outbreak. NF2 said they did not feel comfortable with the way the gowns were being re-used, staff were using the same gowns as each other, and they were never trained on how to safely re-use or wash the gowns. NF2 also said staff were not changing their masks or goggles between positive and negative patient rooms. NF2 said the CNAs were terrified, because they were not sure which PPE to use. NF2 said the staff working during the outbreak did not know if they should wear an N95 mask or a surgical mask, or even if they were supposed to wear goggles. NF2 felt the facility had not provided the staff with enough training on the proper use of PPE and how to safely, and properly reuse designated PPE. There was a code in the ER and staff had to provide CPR to a patient who had respiratory distress without the proper filters on the resusitation bags. Not all the staff who provided care on the units and in the ER were trained on the proper way to don/doff PPE and which PPE was necessary during a "code" in the emergency department.

During an interview on 10/15/20 at 12:12 p.m., staff member B stated the facility had provided a training on proper PPE use for staff "early on" during the pandemic. The facility had not provided staff additional training or education on the proper PPE use or how to safely reuse designated PPE at the time of the facility's outbreak of COVID-19. She thought the contracted agency staff they had hired were already trained on the proper use of PPE. She said they did not provide the contracted staff additional education or training on the proper use of PPE or how to reuse designated PPE.

¹ Centers for Disease and Control. (CDC). (2020, July 15). Infection Control: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Retrieved October 28, 2020, from https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html
Personal Protective Equipment Training. Showed the following recommendations:

"Employers should select appropriate PPE and provide it to HCP in accordance with OSHA PPE standards (29 CFR 1910 Subpart I): HCP must receive training on and demonstrate an understanding of:
- when to use PPE
- what PPE is necessary
- how to properly don, use, and doff PPE in a manner to prevent self-contamination
- how to properly dispose of or disinfect and maintain PPE
- the limitations of PPE.
- Any reusable PPE must be properly cleaned, decontaminated, and maintained after and between uses. Facilities should have policies and procedures describing a recommended sequence for safely donning and doffing PPE."