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Based on the nature of the standard level deficiency, it was determined §482.42 Condition of Participation: Infection Prevention and Control and Antibiotic Stewardship Programs 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 observations, interviews and document review, the facility failed to employ methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Specifically, the facility failed to follow State Public Health Department (State PHD) guidance provided in order to contain an outbreak of COVID-19 in the facility.

Based on document review and interviews, the facility failed to ensure a registered nurse supervised and evaluated nursing care for all patients. Specifically, nursing staff failed to ensure a patient was bathed, had catheter and perineal care and was turned according to policies and unit standards or care in 1 of 1 patients who required ADL assistance records reviewed (Patient #2).

Findings include:

Facility policies:

According to the policy titled Guidelines for Nursing Care, all patients should be bathed daily and showered every other day if there are no contraindications.

According to the policy titled Guidelines for Nursing Care, bedfast patients should be repositioned at least once every two hours and staff should document when repositioning occurs.

1. The facility failed to ensure nursing care was provided to each patient which included bathing, hygiene care and every two hours turn and repositioning for a patient with quadriplegia.

Interviews:

a. An interview was conducted on 12/2/2020 at 1:32 p.m., with Registered Nurse (RN #1) who cared for Patient #2. RN #1 stated that she was assigned Patient #2 on 8/8/2020 and 8/9/2020. RN #1 stated patients should be bathed every other day. This was in contrast to the policy which read Patients should be bathed daily. RN #1 stated perineal care and urinary catheter care was performed during the bath, and the care was documented in the medical record. RN #1 stated it was the responsibility of the registered nurse assigned to care for the patient to ensure bathing, urinary catheter cleaning, and perineal care were performed and documented in the medical record. RN #1 was unable explain the gaps of care documented in Patient #2's record.

b. An interview was conducted with Chief Nursing Officer (CNO #2) and Nurse Manager (Manager #3), on 12/2/2020 at 4:55 p.m. CNO #2 stated patients unable to bathe themselves should be bathed every other day. CNO #2 stated if a patient was not bathed within the two day timeframe, the nurse should document an explanation. CNO #2 stated nursing staff were expected to perform and document perineal care and urinary catheter cleaning every shift (two times every 24 hours). CNO #2 stated that quadriplegic patients should be repositioned at a minimum of once every two hours.

Record review:

c. A record review was completed for Patient #2 who suffered from quadriplegia (a condition in which arms and legs were completely or partially paralyzed). Patient #2 required nursing to perform care since she was quadriplegic. The record revealed Patient #2 was only bathed 5 times during her admission at the facility from July 16, 2020 to August 12, 2020. According to the policy, Patient #2 should have been bathed every day during her stay unless there were contraindications.

i. The record revealed, no documented evidence Patient #2 was bathed from July 19, 2020 to July 28, 2020 (a 9-day period without being bathed). Nothing in the record offered an explanation for the lack of bathing in this timeframe.

ii. There was no documented evidence Patient #2 was bathed from July 29, 2020 until August 2, 2020 (a 4 day period without being bathed).

iii. There was no documented evidence Patient #2 was bathed from August 3, 2020 until August 7, 2020 (a 4 day period without being bathed).

iv. None of the missed bathes had documented contraindications to explain the missing nursing care.

d. The record review revealed Patient's #2's urinary catheter was not cleaned during the day in 12 of 26 days. According to RN #1's interview, catheter care should be provided when the patient was bathed. According to the policy, patient should be bathed every day. According to CNO #2's interview, catheter care should be performed every shift or twice a day.

e. The record review revealed the facility failed to provide perineal care (washing the external genitalia and surrounding area) on 11 out of 26 days. According to RN #1's interview, perineal care was performed when the patient was bathed. According to the policy, patients should be bathed every day.

f. Record review revealed the facility failed to reposition Patient #2 once every two hours on three out of 26 days. For example, the chart indicated that the patient was not turned from 11:00 a.m. to 7:00 p.m. on July 20, 2020.

Based on observations, interviews and document review, the facility failed to employ methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Specifically, the facility failed to follow State Public Health Department (State PHD) guidance provided in order to contain an outbreak of COVID-19 in the facility.

Findings include:

Facility policies:

According to the Infection Control Plan for COVID-19, the hospital will follow their state guidelines for reporting suspected or confirmed cases of COVID-19.

According to the Infection Control and Prevention, the goal is to ensure the organization has a functioning process to minimize the risks of Healthcare Associated Infections (HAI) in patients and health care workers and to optimize use of resources through a strong preventive program. The policy and procedures are based on the Centers for Disease Control (CDC) guidelines, State regulations, and Centers for Medicare and Medicaid Services. The hospital implements strategies to achieve Infection Control Plan goals by implementing enhanced transmission precautions based on the mechanism of potential transmission and exposure screening and immunity testing of LIP's, staff, student/trainees, and volunteers which are collected and reported within the Infection Prevention and Control Program. State specific requirements are followed.

References:

According to the CDC's Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic updated November 4, 2020 provides guidance for healthcare facilities in the United States. Under Section one, Recommended routine infection prevention and control (IPC) practices during the COVID-19 pandemic, under the subheading titled Create a Process to Respond to SARS-CoV-2 Exposures among HCP and others read, health care facilities should have a process for notifying the health department about suspected or confirmed cases of SARS-CoV-2 infection, and should establish a plan, in consultation with local public health authorities, for how exposures in a healthcare facility will be investigated and managed and how contract tracing will be performed.

Contact tracing should be carried out in a way that protects the confidentiality of affected individuals and is consistent with applicable laws and regulations. HCP and patients who are currently admitted to the facility or were transferred to another healthcare facility should be prioritized for notification. These groups, if infected, have the potential to expose a large number of individuals at higher risk for severe disease, or in the situation of admitted patients, are at higher risk for severe illness themselves.

Under Section Two, Recommended Infection Prevention and Control (IPC) practices when caring for a patient with suspected or confirmed SARS-CoV-2 infection, under the subheading titled Establish Reporting within and between Healthcare Facilities and to Public Health Authorities read, communicate and collaborate with public health authorities. Facilities should designate specific persons within the healthcare facility who are responsible for communication with public health officials and dissemination of information to HCP.

According to the CDC's Managing Investigations During an Outbreak, updated 7/31/20, a COVID-19 outbreak indicates potentially extensive transmission within a setting or organization. An outbreak investigation involves several overlapping epidemiologic, case, and contact investigations, with a surge in the need for public health resources. More emphasis on active case finding is recommended, which can result in more contacts than usual needing testing and monitoring. Definitions for COVID-19 Outbreaks are relative to local context. A working definition of "outbreak: is recommended for planning investigations. A recommended definition is a situation that is consistent with either of two sets of criteria: During (and because of) a case investigation and contact tracing, two or more contacts are identified as having active COVID-19, regardless of their assigned priority. Two or more patients with COVID-19 are discovered to be linked, and the linkage is established outside of a case investigation and contact tracing.

The Second Amended Public Health Order 20-36 COVID-19 Dial (PHO 20-36), 11/20/20 read, Critical Businesses and Critical Government Functions, as defined in Appendix A and Section IV.C of this Order should follow all of the requirements in this Order for their sector, and any applicable CDPHE guidance, unless doing so would make it impossible to carry out critical functions. All Businesses and Government Functions shall follow the protocols below: Employers and sole proprietors shall take all of the following measures within the workplace to minimize disease transmission, in accord with the CDPHE Guidance. Implement symptom monitoring protocols, conduct daily temperature checks and monitor symptoms in employees at the worksite to the greatest extent possible, or if not practicable, through employee self-assessment at home prior to coming to the worksite. If two or more employees have symptoms of COVID-19, consult CDPHE's outbreak guidance, contact your local health department and cooperate in any disease outbreak investigations.

Employers shall take all of the following measures regarding employees to minimize disease transmission require employees to stay home when showing any symptoms or signs of sickness, which include fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, and diarrhea and connect employees to company or state benefits providers. A list of Critical Businesses is contained in Appendix A of this Order. A Critical Business. Any business, including any for profit or non-profit, regardless of its corporate structure, engaged primarily in any of the commercial, manufacturing, or service activities listed below, should follow all requirements in this Order for their sector, and any applicable CDPHE guidance, unless doing so woud make it impossible to carry out critical functions. ... Critical Businesses must comply with the guidance and directives for maintaining a clean and safe work environment issued by the Colorado Department of Public Health and Environment (CDPHE) and any applicable local health department. Critical Businesses must comply with Distancing Requirements and all PHOs currently in effect to the greatest extent possible and will be held accountable for doing so. A Critical Business includes Healthcare Operations such as hospitals, clinics and walk in health facilities.

1. The facility failed to follow CDC, Public Health Order (PHO) 20-36 and State Public Health Department (State PHD) Guidance in order to mitigate an outbreak of COVID-19 within the facility.

a. The CDC guidelines for Infection Prevention and Control Recommendations for Healthcare Personnel During the COVID-19 Pandemic read, health care facilities should have a process for notifying the health department about suspected or confirmed cases of COVID-19, and should have an established plan, in consultation with local public health authorities, for how exposures would be investigated and managed and how contract tracing would be performed. The PHO read, if two or more employees had symptoms of COVID-19, the facility should consult the State PHD outbreak guidance and contact the local health department and cooperate in any disease outbreak investigations and follow their recommendations.

b. According to the Positive Patient List, two patients tested positive for COVID-19 on 11/15/20. According to the CDC's Managing Investigations During an Outbreak, two positive patients was considered an outbreak. According to CDC guidance, confirmed COVID-19 cases should be reported to the health department for contact tracing and further guidance.

i. From 11/30/20 to 12/3/20, interviews were conducted with Infection Control Registered Nurse (RN #3). RN #3 stated she had reached out to the State PHD on 11/16/20 to report the two COVID-19 positive patients. RN #3 stated she did not receive directives from the state PHD regarding the outbreak until 11/25/20. This was in contrast to the documented email from the State PHD providing guidance to the facility on 11/18/20.

c. On 11/18/20, the State PHD highly recommended the facility test for COVID-19 in order to identify and isolate any potential asymptomatic or pre-symptomatic individuals before they had the opportunity to spread the virus. The state PHD highly recommended the facility test all patients in the facility who had not been positive with COVID-19 in the last 90 days. The State PHD also recommended all staff get tested, but at least all staff who worked on the third floor and had exposure to COVID-19 positive patients.

d. On 11/25/20, the epidemiology team from the State PHD, local public health department, and facility leadership which included Chief Executive Officer (CEO #4) had a discussion regarding the recommendations provided on 11/18/20. The State PHD reiterated again, all patients should be tested for COVID-19. Again, the State PHD recommended all staff who worked on the third floor and those who had contact with the previous positive patients should be tested. As of 11/25/20, seven days after the State PHD provided guidance, the facility had not yet started testing staff members.

e. An interview was conducted with CEO #4 and Chief Clinical Officer (CCO #5) on 12/3/20 at 10:00 a.m. CEO #4 acknowledged she received guidance from the State PHD on 11/18/20. However, CEO #4 stated she perceived the guidance as a conversation instead of State PHD recommendations. CEO #4 acknowledged the State PHD identified themselves as representing the State PHD.

f. On 11/28/20, the facility began testing staff members. This was 10 days after the initial instructions from the State PHD and 13 days from the intial outbreak.

g. On 12/1/20, after five additional positive patients were identified, the State PHD provided guidance and recommendation for the facility to continue testing staff every three days (two times per week) until no new COVID-19 positive cases were identified. The State PHD additionally, recommended the facility add staff who worked on the fourth floor to be tested.

h. On 12/3/20 at 10:03 a.m., a meeting was held with facility leadership, surveyors and the State PHD. The facility was not able to provide evidence all identified staff members were tested. During the meeting, the State PHD became aware there had been nine COVID-19 positive patients for the month of November. All nine COVID-19 positive patients had not been reported to the State PHD. The State PHD again recommended the facility test staff members who had worked on the third and fourth floor and any staff member who had contact with a positive patient since the start of November. The State PHD recommended staff be tested twice a week, and patient testing should continue for all patients in the facility twice a week except for the COVID-19 positive patients and any patients that were positive with COVID-19 within the last 90 days.

i. On 12/3/20 at 3:31 p.m. , RN #3 was interviewed. RN #3 stated the process to ensure all staff who had contact with the COVID-19 positive patients since 11/15/20 was being refined. RN #3 stated the testing for employees who needed testing had not been 100%.

j. On 12/3/20 at 4:01 p.m., a second interview was conducted with CEO #4 and CCO #5. During the interview, it was determined that one of the patient's who tested positive for COVID-19 had been assigned a room on the second floor for a couple of days and was taken to the COVID unit on the fourth floor for testing. This meant there had been a COVID-19 exposure on the second floor. The COVID-19 exposure on the second floor had not been reported to the State PHD.

k. On 12/4/20 guidance was provided to the facility from the State PHD to include all staff except administration to be tested.

l. On 12/7/20, the Employee Testing spreadsheet was reviewed. All identified COVID-19 exposed staff had not yet been tested since the facility had started testing on 11/28/20. Examples of staff COVID-19 exposures include:

i. On 11/18/20, Registered Nurse (RN #6) worked with two COVID-19 positive patients in rooms 402 and 412.

ii. On 11/23/20, Certified Nursing Assistant (CNA #7) worked with a COVID positive patient in room 402.

iii. On 11/24/20, CNA #7 worked with another COVID-19 positive patient in room 305.

iv. On 11/22/20, CNA #8 worked with two positive COVID-19 patients in rooms 304 and 305.

RN #6, CNA #7 and CNA #8 had not been tested after the exposure to COVID-19 positive patients. The lack of actions conducted by the facility were in contrast to the recommendations provided. After the discussion with facility leadership on 11/25/20, all patients in the facility were tested for COVID-19. Since guidance was provided on 11/18/20, 11/25/20, 12/1/20 and 12/3/20, the facility failed to follow facility policy and the PHO 20-36 by not following state specific requirements in order to prevent the spread of COVID-19 between patients and staff.

m. On 12/7/20 a meeting was held with facility leadership, surveyors and State PHD. During the meeting, CEO #4 and CCO #5 stated not all staff in the facility had been tested for COVID-19. They stated dietary staff had not been tested since they did not consider them as staff who needed to be tested. The State PHD stated the facility had been instructed to test all staff except administration. Therefore, the facility did not comply again with recommendations related to staff testing.