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Based on the nature of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42, INFECTION CONTROL, was out of compliance.

A-0749 The hospital infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. Based on observations, interviews and document review, the facility failed to employ methods to prevent and control the transmission of COVID-19 within the facility. Specifically, the facility did not ensure healthcare personnel (HCP) who were symptomatic for COVID-19 were excluded from work according to Centers for Disease Control (CDC) guidelines, public health orders (PHO) and facility policy, in order to prevent the transmission of COVID-19.

Based on observations, interviews and document review, the facility failed to employ methods to prevent and control the transmission of COVID-19 within the facility. Specifically, the facility did not ensure healthcare personnel (HCP) who were symptomatic for COVID-19 were excluded from work according to Centers for Disease Control (CDC) guidelines, public health orders (PHO) and facility policy, in order to prevent the transmission of COVID-19.

Findings include:

Facility policies and professional references in managing COVID-19:

1. The Employee Exposure and Return to Work Guidance During COVID-19 Response policy read, Any employee who is exposed to, has symptoms consistent with, or is positive for COVID-19 should immediately be evaluated to stay out of work and/or return to work using the approved healthcare guidance. The facility endorses the symptom-based strategy for assessing return to work for employees with symptoms of or confirmed COVID-19. The algorithm in Appendix 2 should be followed after an employee is out of work due to being COVID-19 symptomatic or found to be COVID-19 positive via test (symptomatic or asymptomatic).

Appendix 2 contained an algorithm titled Employee Return to Work Guidance for COVID-19: Symptom-Based Guidance for Symptomatic or Confirmed COVID-19 Employee. Employee reports/ screens with respiratory symptoms and/or fever greater than or equal to 101.4 and/or other known COVID-19 symptoms (i.e. loss of taste or smell, body aches, etc.) OR employee has confirmed positive COVID-19 test. Stay at or return home and self isolate. On day 10, evaluate for Return to Work Criteria: 10 days have passed since start of symptoms AND no fever for at least 24 hours without use of antipyretics AND improving symptoms. If all criteria met, work with employee health for return to work plan. If all criteria not met, repeat daily until all criteria met.

The CDC Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic, updated 12/14/20, read, Properly manage anyone with suspected or confirmed SARS-CoV-2 (COVID-19) infection or who has had contact with someone with suspected or confirmed SARS-CoV-2 infection. Healthcare personnel (HCP) should be excluded from work and should notify occupational health services to arrange for further evaluation. For HCP, the potential for exposure to SARS-CoV-2 is not limited to direct patient care interactions. Transmission can also occur through unprotected exposures to asymptomatic or pre-symptomatic co-workers in breakrooms or co-workers or visitors in other common areas.

The CDC Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection, updated 8/10/20 read, Symptom-based strategy for determining when HCP can return to work. HCP with mild to moderate illness who are not severely immunocompromised: At least 10 days have passed since symptoms first appeared and at least 24 hours have passed since last fever without the use of fever-reducing medications and symptoms (e.g., cough, shortness of breath) have improved.

In some instances, a test-based strategy could be considered to allow HCP to return to work earlier than if the symptom-based strategy were used. However, as described in the Decision Memo, many individuals will have prolonged viral shedding, limiting the utility of this approach. The criteria for the test-based strategy are HCP who are symptomatic: Resolution of fever without the use of fever-reducing medications and improvement in symptoms (e.g., cough, shortness of breath), and results are negative from at least two consecutive respiratory specimens collected at least 24 hours apart (total of two negative specimens) tested using an FDA-authorized molecular viral assay to detect SARS-CoV-2 RNA.

The CDC Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19, updated 12/14/20 read, Because of their often extensive and close contact with vulnerable individuals in healthcare settings, a conservative approach to HCP monitoring and work restrictions is recommended to prevent transmission from potentially contagious HCP to patients, other HCP and visitors.

The CDC Symptoms of Coronavirus, updated 12/22/20 read, people with COVID-19 have had a wide range of symptoms reported, ranging from mild symptoms to severe illness. People with these symptoms may have COVID-19: 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, diarrhea.

The Fourth Amended Public Health Order 20-36, updated 1/4/2021 read, Individuals who are sick or are experiencing flu-like symptoms should get tested for COVID-19. If an individual has tested positive for COVID-19 and/or has developed symptoms of COVID-19, including early or mild symptoms (such as cough and shortness of breath), they should be in isolation (staying away from others). In most cases, individuals are released from isolation when they are fever-free, without medication, for twenty-four (24) hours, other symptoms have improved, and at least ten (10) days have passed since symptoms first appeared. Disease Prevention Measures for Employees: 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.

The Ninth Amended Public Health Order 20-29, updated 1/12/2021, read Voluntary or Elective Surgeries and Procedures may be performed in hospitals, or any other setting where health care services are provided in accordance with the priorities, requirements, and specific criteria below. Exclude symptomatic employees from work activities according to the CDC ' s "Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection (Interim Guidance)." In most cases, someone is released from isolation when they are fever-free, without medication, for 24-72 hours, other symptoms have improved and 10 days have passed since their first symptom.

1. The facility failed to ensure HCP who reported symptoms consistent with COVID-19 were excluded from work according to the CDC Return to Work criteria, PHO and facility policy, to prevent the spread of COVID-19.

a. According to the CDC Criteria for Return to Work for Healthcare Personnel with COVID-19 Infection, the symptom-based strategy for HCP to return to work included 10 days had passed since symptoms first appeared. The test-based strategy for HCP to return to work included negative results from at least two consecutive COVID-19 tests collected at least 24 hours apart.

According to PHO 20-29, symptomatic employees were to be excluded from work activities according to CDC Return to Work Guidance, which in most cases included when 10 days had passed since the employee's first symptom.

According to facility policy, the facility endorsed the symptom-based strategy for assessing return to work for employees with symptoms of or confirmed COVID-19.

b. The facility provided a line list, which was used by the facility Employee Health Nurse (Employee Health) #3 to monitor HCP who reported symptoms or tested positive for COVID-19.

i. Review of the line list revealed multiple instances in which HCP reported to work without fulfilling the CDC Return to Work criteria for HCP. Specifically, HCP were allowed to return to work on the basis of one negative test result, without observing either the symptom-based strategy which required 10 days from onset of symptoms, or test-based strategy which required two negative tests collected at least 24 hours apart. Examples included:

On 12/6/20 a HCP in environmental services (EVS) reported cough, congestion, low grade fever, headache and fatigue. The HCP was tested for COVID-19 with a single negative test result on 12/8/20. The HCP was allowed to return to work on 12/9/20, three days after the onset of symptoms.

On 12/18/20 a registered nurse (RN) on an inpatient unit reported symptoms of headache, fatigue, sore throat, runny nose and congestion. The RN was tested for COVID-19 with a single negative test result on 12/19/20. The RN was allowed to return to work on 12/21/20, three days after the onset of symptoms.

On 1/2/21 an RN in the Emergency Department reported symptoms of sore throat, congestion, chest heaviness and body aches. The RN was tested for COVID-19 with a single negative test result on 1/5/21. The RN was allowed to return to work on 1/8/21, six days after the onset of symptoms.

On 1/4/21 RN #1, who worked on the Intensive Care Unit (ICU) reported symptoms of headache, fatigue and sore throat. According to the line list, RN #1's spouse was positive for COVID-19. RN #1 was tested for COVID-19 with a single negative test and was allowed to return to work on 1/6/21, two days after the onset of symptoms.

c. Interviews with facility staff revealed HCP were allowed to return to work after they reported symptoms consistent with COVID-19 without fulfilling the CDC Return to Work criteria and the facility policy.

i. On 1/12/21 at 1:37 p.m., RN #1 was interviewed. RN #1 stated she communicated with Employee Health #2 when her husband tested positive for COVID-19. She stated she informed Employee Health #2 she went to an urgent care center for a rapid COVID-19 test. RN #1 stated she received a negative test result and was allowed to return to work three days later when she felt better.

RN #1 stated the symptoms she reported to Employee Health #2 were headache, sore throat and fatigue. She stated she attributed the symptoms to strep throat (a bacterial infection which causes sore or scratchy throat). However, RN #1 stated she was not tested or diagnosed for strep throat.

ii. On 1/12/21 at 4:24 p.m., Employee Health #2 was interviewed. Employee Health #2 stated she was responsible to oversee employee health for all HCP employed by the facility, and her role included to manage testing and return to work for staff who had COVID-19 or symptoms of COVID-19. Employee Health #2 stated the facility followed policies and standards provided by the facility's corporate system.

Employee Health #2 stated when a HCP reported symptoms, she would discuss the HCP's symptoms and potential exposure and would recommend the HCP be tested for COVID-19. She stated if a HCP's test results were negative, she would follow a return to work matrix for non-COVID-19 illness and allow the HCP to return to work when their symptoms improved. She stated this matrix was provided by the infection preventionist from another facility.

iii. The facility provided the Non-COVID Respiratory Viral Illness Matrix and Return to Work Guidelines for 2019-2020. According to the matrix, if a HCP had respiratory symptoms without fever, the HCP was allowed to return to work at least 24 hours after the start of signs or symptoms and when coughing, sneezing and nose blowing were less than four times per hour and would not interrupt patient care or work. HCP with respiratory symptoms and fever were allowed to return to work 6 days after the start of illness, when the HCP did not have fever for 24 hours, and coughing, sneezing and nose blowing were less than four times per hour.

The Non-COVID Respiratory Illness matrix did not align with the CDC Return to Work Guidance, which read HCP could return to work when 10 days had passed since the onset of symptoms, the HCP was fever-free for 24 hours without the use of fever-reducing medication, and the HCP's symptoms were improved.

Employee Health #2 stated the matrix was implemented and utilized prior to the beginning of the COVID-19 pandemic. She stated she did not know what guidelines were used to develop the matrix, or how it was determined the matrix remained appropriate to use during the COVID-19 pandemic.

Employee Health #2 stated any return-to-work protocols for HCP with symptoms of COVID-19 should be based on the CDC guidelines.

iv. On 1/13/21 at 3:32 p.m., Infection Preventionist #3 was interviewed. Infection Preventionist #3 stated one of her responsibilities was to provide guidance related to infection control to Employee Health #2. She stated her role in the facility's COVID-19 response was to ensure policies and procedures aligned with CDC guidelines and national standards for infection control.

Infection Preventionist #3 stated HCP reported any concerning symptoms for COVID-19 to Employee Health #2. She stated the HCP would then be tested for COVID-19, and if the HCP had a negative test result, they would return to work following the facility's "normal" return to work guidelines. She stated the facility's return to work guidance was developed through the facility's corporate system.

Infection Preventionist #3 stated the criteria outlined in the Non-COVID Respiratory Viral Illness matrix would apply to a HCP with a cold or influenza, and was implemented yearly during the respiratory illness season.

Infection Preventionist #3 stated the facility adhered to the CDC symptom-based strategy for HCP to return to work. However, she stated this was only utilized if a HCP was confirmed COVID-19 positive with a positive test result. She stated if a HCP reported symptoms of COVID-19, but had one negative test result and improved symptoms two days later, the HCP would return to work.

This was in contrast to the CDC return to work criteria for HCP, which read the symptom-based strategy for HCP to return to work required 10 days from the onset of symptoms, and the facility algorithm Employee Return to Work Guidance for COVID-19, which read for HCP who were symptomatic or positive for COVID-19 the HCP would isolate at home for 10 days before returning to work.