HospitalInspections.org

Based on the manner and degree of standard level deficiency referenced to the Condition, it was determined the Condition of Participation §485.640 Condition of Participation: Infection Prevention and Control and Antibiotic
Stewardship Programs was out of compliance.

C-1206- The infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the CAH and between the CAH and other healthcare settings. Based on interviews and document reviews, 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 or positive 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.

C-1208- The infection prevention and control includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and that the program also addresses any infection control issues identified by public health authorities. Based on document review and interviews, the facility did not report a suspected outbreak of COVID-19 among facility healthcare personnel (HCP) to public health authorities according to Centers for Disease Control (CDC) guidance, facility policy and local public health orders (PHO), in order to establish a plan to manage and investigate the potential outbreak.

C-1231-The infection prevention and control professional(s) is responsible for: The development and implementation of facility-wide infection surveillance, prevention, and control policies and procedures that adhere to nationally recognized guidelines. Based on document review and interviews, the facility failed to ensure a process was in place to screen all healthcare personnel (HCP) for symptoms of COVID-19 to prevent the transmission of COVID-19 according to Centers for Disease Control (CDC) guidance and facility policies.

C-1239- The infection prevention and control professional(s) is responsible for: Competency-based training and education of CAH personnel and staff, including medical staff, and, as applicable, personnel providing contracted services in the CAH, on the practical applications of infection prevention and control guidelines, policies and procedures. Based on document review and interviews, the facility failed to ensure staff responsible to oversee the health of healthcare personnel (HCP) at the facility were educated on public health guidance and facility processes related to COVID-19 to prevent the transmission of COVID-19. The failure created the potential for the spread of COVID-19 at the facility.

Based on interviews and document reviews, 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 or positive 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:

The Infection Control for COVID-19 policy read, if suspected or confirmed SARS-CoV-2 infection: providers and staff, do not work. Notify manager and employee health.

The COVID Return to Work policy read, to provide a guideline determining when and how a healthcare worker can safely return to work post COVID infection. Mild illness- individuals who have any of the various signs and symptoms of COVID-19, e.g. fever, cough, sore throat, malaise, headache, muscle pain, without shortness of breath, dyspnea or abnormal chest imaging. The return to work criteria for HCP with SARS-CoV-2 Infection: Symptom-based strategy read, HCP with mild to moderate illness: at least 10 days have passed since symptoms first appeared, at least 24 hours have passed since last fever without fever-reducing medications, and symptoms (e.g. cough, shortness of breath) have improved.

The criteria for test-based strategy are, for HCP who are symptomatic: Resolution of fever without the use of fever-reducing medications, and improvement in symptoms and results are negative from at least two consecutive respiratory specimens collected at least 24 hours apart. For HCP who are not symptomatic, results are negative from at least two consecutive respiratory specimens collected at least 24 hours apart.

The Employees COVID Work Flow read, if employees have symptoms, contact director, no work and COVID test are indicated. The Director COVID Work Flow read, if directors have symptoms, contact employee health, no work and COVID test are indicated.

The Employee Health COVID Work Flow read, for a healthcare worker with positive COVID test and symptoms, after 10 days from the date of symptoms and 24 hours without fever the worker can return to work.

References:

The CDC Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 Infection, updated 8/10/20, read, Who this is for: Occupational health programs and public health officials making decisions about return to work for healthcare personnel (HCP) with confirmed SARS-CoV-2 infection, or who have suspected SARS-CoV-2 infection (e.g., developed symptoms of COVID-19) but were never tested for SARS-CoV-2. 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 Test-Based Strategy for Determining when HCP Can Return to Work.

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 =24 hours apart (total of two negative specimens) tested using an FDA-authorized molecular viral assay to detect SARS-CoV-2 RNA. HCP who are not symptomatic: Results are negative from at least two consecutive respiratory specimens collected =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 Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic, updated 11/4/20, 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 Interim U.S. Guidance for Risk Assessment and Work Restrictions for Healthcare Personnel with Potential Exposure to COVID-19, updated 12/3/20, 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. Occupational health programs should have a low threshold for evaluating symptoms and testing HCP. Any HCP who develop fever or symptoms consistent with COVID-19 should immediately self-isolate and contact their established point of contact, e.g. occupational health program, to arrange for medical evaluation and testing.

The Fourth Amended Public Health Order 20-35 Safer at Home Dial (PHO 20-35), updated 10/27/20 read, all 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. 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 Critical Business includes Healthcare Operations such as hospitals, clinics and walk in health facilities.

1. The facility failed to ensure HCP who reported symptoms consistent with COVID-19 or were positive for 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, and the facility's COVID Return to Work policy, the symptom-based strategy for HCP to return to work included 10 days had passed since symptoms first appeared, at least 24 hours had passed since last fever without fever-reducing medications, and symptoms had improved. The test-based strategy for HCP to return to work included resolution of fever without fever-reducing medications, improvement in symptoms, and negative results from at least two consecutive COVID-19 tests collected at least 24 hours apart.

According to PHO 20-35, employers shall require employees to stay home when showing any symptoms or signs of sickness.

B. The facility provided a line list and illness log, which the Employee Health Nurse (Employee Health #5) used to monitor HCP who reported symptoms consistent with COVID-19 or who tested positive for COVID-19. Review of the illness logs revealed multiple instances in which HCP reported to work while symptomatic or without fulfilling the CDC Return to Work criteria for HCP with confirmed or suspected COVID-19.

Examples included:

a. Review of the illness log revealed, on 11/13/20 Patient Financial Services Technician (Technician) #1 reported symptoms of headache, nausea, body aches, fatigue, chills and diarrhea. Technician #1 declined a COVID-19 test.

i. Review of Technician #1's timecard revealed Technician #1 returned to work on 11/17/20, four days after she reported symptoms consistent with COVID-19. According to the Return to Work Criteria, she would not be allowed to return until 11/23/20 since she refused to get two negative COVID-19 tests.

b. The illness log revealed, on 11/16/20 Technician #2 reported symptoms of elevated temperature, nausea, diarrhea, fatigue, headache and chills. On 11/17/20, it was documented Technician #2 had an improvement in nausea but continued body aches and chills. The illness log read Technician #2 could work the following day with a medical mask.

i. Review of Technician #2's timecard revealed Technician #2 returned to work on 11/18/20, two days after the appearance of symptoms consistent with COVID-19. According to the Return to Work Criteria, she would not be allowed to return until 11/26/20 or two negative COVID-19 tests.

ii. Chief Nursing Officer (CNO) #8 provided an email sent to her on 11/18/20 from Revenue Cycle Director (Director) #3 which read, Technician #2 did not have a test for COVID-19, but a medical provider determined another condition may have caused Technician #2's symptoms. CNO #8 was unable to provide evidence to corroborate the alternate illness determination or a physician release for Technician #2 to return to work while she had symptoms of COVID-19.

iii. According to the line list of HCP who tested positive for COVID-19, Technician #2 subsequently tested positive for COVID-19 on 11/25/20.

c. On 11/17/20 the facility compliance officer reported symptoms of fatigue, congestion and nausea. The illness log read the compliance officer was given a medical mask to wear for 10 days and was educated on when to get a COVID-19 test and when to stay home. It is unclear what guidance the compliance officer was given because according to the Return to Work Criteria, he would not be allowed to return until 11/27/20 or two negative COVID-19 tests.

i. The facility compliance officer sent an email to the CEO (CEO) #15 on 12/9/20. The email confirmed with the exception of 11/26/20 and 11/27/20, the compliance officer worked all of his regularly scheduled days in the month of November. The compliance officer was not excluded from work after he reported symptoms consistent with COVID-19 according to CDC guidance and facility policy.

d. On 11/19/20 Director #3 reported symptoms of sore throat and dry cough. The illness log revealed, Director #3 had cold symptoms for two days prior to reporting symptoms to the facility.

i. Review of the HCP COVID-19 screenings, which were conducted when HCP reported to the facility for work, revealed screenings were completed for Director #3 on 11/17/20, 11/18/20 and 11/19/20, which indicated she worked at the facility for two days after she began to experience symptoms consistent with COVID-19.

ii. According to the illness log, Director #3 left work on 11/19/20 to get a COVID-19 test and returned to work while waiting for the COVID-19 test result. Director #3 received a positive test result for COVID-19 later in the day while she was still at work. The facility allowed Director #3 to continue to work while symptomatic and waiting for her COVID-19 test results which was in conflict to CDC guidance, PHO, and facility policy, which read HCP who developed symptoms or tested positive for COVID-19 were to immediately self-isolate and were not to work.

e. On 11/19/20 an environmental services HCP reported symptoms of congestion, fatigue, sore throat, chills, headache, nausea and dry cough. The illness log revealed the HCP planned to work the following day with a medical mask.

i. Review of the HCP's timecard revealed he remained on-call and reported to work on 11/20/20, one day after he reported symptoms consistent with COVID-19. The HCP was on call 11/21/20 and worked 11/22/20 and 11/23/20.

ii. On 12/10/20 at 10:00 a.m., CEO #15 stated the environmental services HCP was tested for COVID-19 on 11/20/20 and received a negative test result. CEO #15 was unable to provide evidence Employee Health #5 was aware of the negative test result before she allowed the HCP to return to work, nor was there evidence of a second negative COVID-19 test as required by the CDC test-based strategy for Return to Work Criteria.

C. Interviews with facility staff revealed HCP were allowed to work after they reported symptoms or a positive COVID-19 test result without fulfilling the CDC Return to Work criteria.

i. On 12/8/20 at 4:25 p.m., Technician #1 was interviewed. Technician #1 confirmed she worked on-site at the facility and interacted directly with both patients and other HCP as part of her job duties. Technician #1 stated on the evening of 11/12/20 she had symptoms of COVID-19 which she reported to Employee Health #5 the following day. She stated on 11/16/20 she spoke with Employee Health #5 and was instructed she could return to work on 11/17/20 because she had been symptom free for 24 hours. Technician #1 stated she was not tested for COVID-19 at the time because she believed her symptoms were not caused by COVID-19 and she was not advised to get tested.

This conflicted with the CDC guidance and facility policy for the symptom-based return to work criteria, which required ten days from the time symptoms appeared, 24 hours since last fever, and improvement in symptoms before HCP suspected of COVID-19 returned to work.

ii. On 12/10/20 at 1:54 p.m., Director #3 was interviewed. Director #3 stated she oversaw 15 HCP at the facility in multiple departments and stated she interacted daily with her direct reports. Director #3 stated if her staff felt ill, they were required to notify her and stay home from work. She stated if HCP had symptoms consistent with COVID-19 they also were to notify the employee health nurse. Director #3 stated the employee health would then manage any needed testing and work restrictions for the HCP.

Director #3 stated on 11/17/20 she began to have symptoms similar to the common cold, including a cough. Even though she understood the process for staff with symptoms to stay home and contact employee health, Director #3 stated she did not contact Employee Health #5 to report her symptoms and reported to work the following day on 11/18/20. Director #3 stated she reported her symptoms to the facility screener, but stated nothing happened and she was allowed to enter the facility and work her shift while experiencing symptoms of COVID-19.

Director #3 stated she had the same symptoms again on 11/19/20 and again, she reported to work. She stated she left work the morning of 11/19/20 to get tested for COVID-19 and returned to work while she waited for the test results. Director #3 stated while she was at work she was notified she had COVID-19. She stated she informed Employee Health #5 she was positive with COVID-19, and Employee Health #5 provided her with an N95 respirator (a respiratory protective device designed to achieve efficient filtration of airborne particles) and told her she could continue to work. Director #3 stated CNO #8 approached her later in the day and directed her to leave the facility and go home.

Director #3's interview conflicted with CDC guidance, facility policy, and PHO, all of which required HCP who had symptoms consistent with COVID-19 to self-isolate, report the symptoms to employee health, and not work. Neither the CDC guidance nor facility policy included instructions for HCP who tested positive for COVID-19 to wear an N95 mask and continue to work.

D. Interviews with facility leadership revealed leaders were aware HCP who were suspected or positive for COVID-19 were allowed to work in contradiction to CDC guidance, PHO, and facility policy. However, the facility did not take action or implement process changes to correct the issue.

i. On 12/9/20 at 8:11 a.m., CNO #8 was interviewed. CNO #8 stated she was aware Employee Health #5 provided incorrect guidance to HCP regarding COVID-19 work restrictions. CNO #8 stated on 11/20/20 multiple staff from the Patient Financial Services department discussed their concerns about HCP in the department who were allowed to work while sick. She stated staff included Director #3 and Technician #2 as examples of HCP who they were concerned about working while sick.

CNO #8 stated she was informed Director #3 was told she could work despite a positive test result for COVID-19. CNO #8 stated when she questioned Employee Health #5 about allowing COVID-19 positive HCP to work, Employee Health #5 revealed she followed the incorrect guidance from the CDC. She stated Employee Health #5 followed the CDC's guidance for crisis staffing, however CNO #8 confirmed the facility was not in crisis standards of care. She stated Employee Health #5 had been in her role for only two weeks and had not been adequately trained or educated to procedures related to COVID-19.

CNO #8 stated HCP were not allowed to work if they had symptoms or were positive for COVID-19. She stated she provided verbal education to Employee Health #5 regarding facility processes for COVID-19, however she was unable to provide evidence of this education.

Based on document review and interviews, the facility did not report a suspected outbreak of COVID-19 among facility healthcare personnel (HCP) to public health authorities according to Centers for Disease Control (CDC) guidance, facility policy and local public health orders (PHO), in order to establish a plan to manage and investigate the potential outbreak.

Findings include:

Facility policy:

The facility's Infection Control for COVID-19 policy read, reporting: The facility will notify the state public health department or county public health department of the following: patients or staff with suspected or confirmed COVID-19; 3 or more patients or staff with new-onset respiratory symptoms within 72 hours of each other.

References:

The CDC Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic, updated 11/4/20, read, healthcare 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 contact tracing will be performed.

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.

The Fourth Amended Public Health Order 20-35 Safer at Home Dial (PHO 20-35), updated 10/27/20 read, all 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: 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. A Critical Business includes Healthcare Operations such as hospitals, clinics and walk in health facilities.

1. The facility failed to notify local public health authorities of an outbreak of COVID-19 among facility HCP according to CDC guidance and public health orders (PHO).

a. The CDC guidance 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 public health department outbreak guidance, contact the local health department and cooperate in any disease outbreak investigations.

b. Review of the facility's line list and illness logs, which were used to monitor HCP who reported symptoms consistent with COVID-19 or who tested positive for COVID-19, revealed between the dates of 11/1/20 and 12/3/20, there were multiple clusters of HCP who reported symptoms consistent with COVID-19 and/or tested positive for COVID-19.

Examples included:

i. Between 11/2/20 and 11/4/20, four HCP tested positive for COVID-19, three of whom were symptomatic.

ii. Between 11/7/20 and 11/8/20, three HCP tested positive for COVID-19, two of whom were symptomatic.

iii. On 11/13/20, three HCP reported symptoms consistent with COVID-19, including cough, body aches, headache, diarrhea, chills, sore throat or nausea.

iv. On 11/23/20, two HCP in the same department tested positive for COVID-19, both of whom were symptomatic.

v. On 11/25/20, three HCP tested positive for COVID-19, all of whom were symptomatic.

vi. Between the dates of 11/1/20 and 12/3/20, 24 HCP in total tested positive for COVID-19 and one HCP was designated a probable case. Nine of these HCP worked in the separately licensed long-term care facility, however facility leadership confirmed there were HCP who had worked in both the facility and the adjoining long-term care facility. This created the potential for facility HCP to be exposed to COVID-19 positive HCP in the long-term care facility.

c. On 12/10/20 at 2:59 p.m., a meeting was conducted with facility leadership, surveyors, local public health authorities, and state public health authorities. During the meeting, Infection Preventionist (IP) #7 stated "one or two" HCP had worked in both the facility and the attached long-term care facility.

d. The facility provided an email sent to all facility staff on 12/4/20 at 1:52 p.m. which confirmed the flexing of staff. The email read, facility staff had been flexed from other departments as necessary to address staffing needs, which included patient care technicians(PCTs) who were sent from the hospital to the long-term care facility to address certified nursing assistant (CNA) shortages.

e. Interviews with the facility infection preventionist revealed the clusters of HCP who reported symptoms and/or tested positive for COVID-19 were not reported to local and state public health authorities as an outbreak according to PHO, to establish a plan for how exposures in the facility would be managed.

i. On 12/8/20 at 11:00 a.m., IP #7 was interviewed. IP #7 stated the facility used a shared document to notify the local public health authorities when staff or patients tested positive. IP #7 stated there had been several employees who tested positive on the same day. She stated those cases were reported individually to the local public health authority, but the clusters were not reported as an outbreak. IP #7 stated there had been positive cases of COVID-19 in multiple areas, including the facility clinic and in hospital ancillary services.

ii. On 12/10/20 at 7:46 a.m., IP #7 provided email correspondence between the facility and local and state public health authorities. On 12/9/20 IP #7 and the local public health authority emailed the state public health authority to inquire if there was a requirement for the facility to report clusters of respiratory illness or positive COVID-19 tests as outbreaks. The state public health authority responded on the same day and confirmed providers were to report known or suspected outbreaks in health care facilities and defined outbreaks as instances in which more than one person was ill. The state public health authority defined a confirmed outbreak as two or more confirmed cases of COVID-19 in a facility with onset in a 14 day period.

This correspondence confirmed the clusters of HCP at the facility who reported symptoms and/or tested positive for COVID-19 between 11/1/20 and 12/3/20 met the criteria for a confirmed outbreak as defined by state public health guidance, and was required to be reported as an outbreak.

Based on document review and interviews, the facility failed to ensure a process was in place to screen all healthcare personnel (HCP) for symptoms of COVID-19 to prevent the transmission of COVID-19 according to Centers for Disease Control (CDC) guidance and facility policies.

Findings include:

Facility policies:

The Infection Control for COVID-19 policy read, screen and triage everyone entering for signs and symptoms of COVID-19. Limit and monitor points of entry to the facility. Screen everyone including HCP entering the healthcare facility for symptoms consistent with COVID-19. If suspected or confirmed SARS-CoV-2 infection: providers and staff, do not work. Notify manager and employee health. References for the policy included the CDC.

The facility Screening for Staff process read, the facility is requiring all staff be screened for COVID-19 prior to starting every shift and/or on arrival to the facility. All staff are required to be screened prior to the start of their shift and/or on arrival to the facility. There are no exceptions to this screening. Screening is an active process and will include symptoms of COVID-19, presence of fever, and exposure to others with suspected or confirmed COVID-19.

References:

The CDC Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic, updated 11/4/20 read, screen and triage everyone entering a healthcare facility for signs and symptoms of COVID-19. Although screening for symptoms will not identify asymptomatic or pre-symptomatic individuals with SARS-CoV-2 infection, symptom screening remains an important strategy to identify those who could have COVID-19 so appropriate precautions can be implemented. Limit and monitor points of entry to the facility. Establish a process to ensure everyone (patients, healthcare personnel, and visitors) entering the facility is assessed for symptoms of COVID-19, or exposure to others with suspected or confirmed SARS-CoV-2 infection and that they are practicing source control. Properly manage anyone with suspected or confirmed SARS-CoV-2 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.

1. The facility failed to implement and enforce a process to screen all HCP for symptoms of COVID-19 according to CDC guidance. The facility did not ensure HCP who reported to work prior to the arrival of the facility screener were screened, did not monitor entry points to the building, and did not audit or monitor the screening process to ensure it was effective.

a. Review of HCP screening logs, which were used to screen HCP for symptoms and exposure to COVID-19, revealed multiple instances in which HCP were not screened according to facility policy and CDC guidance.

Examples included:

i. Review of a timecard for an environmental services HCP revealed the HCP worked on 11/20/20, 11/22/20 and 11/23/20. There was no evidence in the HCP screening logs the HCP was screened on 11/20/20 or 11/22/20. The HCP was screened on 11/23/20, and reported symptoms including cough, chills, muscle aches, and sore throat. According to the HCP's timecard for 11/23/20, he worked 12 hours despite reporting multiple symptoms consistent with COVID-19.

ii. Review of a timecard for Patient Financial Services Technician (Technician) #1 revealed she reported to work on 11/5/20 at 5:24 a.m. and 12/2/20 at 5:28 a.m. There was no evidence in the HCP screening logs Technician #1 was screened for symptoms of COVID-19 on these days.

iii. Review of the timecard for Registered Nurse (RN) #4 revealed she reported to work on 11/5/20 at 5:31 a.m., 11/23/20 at 5:26 a.m. and 12/2/20 at 5:30 a.m. There was no evidence in the HCP screening logs RN #4 was screened for symptoms of COVID-19 on these days.

iv. Review of the timecard for Technician #10 revealed she worked on 11/23/20, 11/24/20, 11/25/20, 12/7/20, and 12/9/20. Technician #10 clocked in between 5:30 and 5:35 a.m. on those dates. There was no evidence in the HCP screening logs Technician #10 was screened for symptoms of COVID-19 on these days.

b. Interviews with facility staff revealed multiple HCP who arrived at work before the facility screener arrived were not screened for symptoms of COVID-19 prior to their shift. In addition, HCP who reported symptoms consistent with COVID-19 to the facility screener were not sent home or referred to employee health and were allowed to enter the building for work. Finally, HCP who entered the facility through unmonitored entrances were not screened for symptoms prior to their shift.

i. On 12/8/20 at 10:47 a.m., Facility Screener (Screener) #13 was interviewed. Screener #13 stated all HCP must be screened for COVID-19 at the main entrance or at the entrance to the Emergency Department (ED). She stated HCP answered questions regarding symptoms of COVID-19 and had their temperature taken by the automatic temperature scanner. Screener #13 stated she then recorded the results in the screening log.

Screener #13 stated if HCP reported symptoms or anything irregular, she would contact Employee Health #5 and instruct the HCP to wait behind a screen at the main entrance to prevent the HCP from potentially spreading infection.

ii. On 12/8/20 at 10:50 a.m., RN #4 was interviewed. RN #4 stated she sometimes arrived to work between 5:20 and 5:30 a.m. She stated if the facility screener was not present at the entrance when she arrived, she would self-screen using the automatic temperature scanner. Her interview was in contrast to her timecard and the screening log which showed gaps in screening.

iii. On 12/8/20 at 4:25 p.m., Technician #1 was interviewed. Technician #1 stated one of her job duties was to register patients when they arrived at the facility for surgery. She stated four days each month she arrived at 5:30 a.m. to register surgery patients. She stated on the mornings she arrived at 5:30 a.m. she would self-screen when she entered the building by walking by the automatic temperature scanner. She stated she self-screened because the facility screener did not arrive until 6:00 a.m. Technician #1 stated she "might" then go back when the screener arrived to complete a full screening.

iv. On 12/10/2020 at 2:31 p.m., Technician #10 was interviewed. Technician #10 stated she also registered patients when they arrived for surgery. She stated when she came to work at 5:30 a.m. she used the automatic temperature scanner to self-screen and would answer the questions on the screening log. Her interview was in contrast to her timecard and the screening log which showed gaps in screening.

Technician #10 stated screening was important to prevent the spread of COVID-19. She stated HCP could spread COVID-19 to other HCP or to patients. Technician #10 stated the facility served a primarily elderly community and COVID-19 could be especially detrimental to the community.

v. The interviews with RN #4, Technician #1 and Technician #10 were in contrast to the facility Screening for Staff process, which read all staff without exceptions were required to be actively screened on arrival to the facility, to include symptoms of COVID-19, presence of fever, and exposure to others with suspected or confirmed COVID-19. The facility process did not include a process for HCP to self-screen when they entered the building.

The interviews also conflicted with CDC guidance, which instructed facilities to establish a process to ensure everyone who entered the facility including HCP was assessed for symptoms of COVID-19.

vi. On 12/10/20 at 1:54 p.m., Director #3 was interviewed. Director #3 stated on 11/17/20 she had symptoms similar to the common cold, which included a cough. She stated she reported her symptoms to the facility screener when she came to work on 11/18/20, but nothing happened and she was allowed to enter the facility. Director #3 stated she had the same symptoms when she came to work on 11/19/20.

Review of the HCP screening logs revealed on 11/18/20 Director #3 was screened, yet the screener did not indicate the presence of any symptoms despite Director #3's statement she reported her symptoms. According to the screening logs, on 11/19/20 Director #3 was screened, and the screener indicated the presence of a cough. Director #3 was allowed to enter the facility to work instead of being instructed to leave the facility and follow up with employee health. This was in contrast to facility policy and CDC guidance, which read HCP with suspected COVID-19 should not work and should notify employee health services.

vii. On 12/11/20 at 7:59 a.m., Kitchen Supervisor (Supervisor) #11 was interviewed. Supervisor #11 stated she or another dietary HCP unlocked the facility's main entrance each morning. She stated since the main entrance was locked when she arrived for work, she entered through a different outside entrance, would clock in and then perform a self-screen for COVID-19 at the main entrance. She stated she used the automatic temperature scanner to self-screen, however she stated the scanner did not always work. Supervisor #11 stated this had always been her process.

This was in contrast to CDC guidance, which instructed facilities to limit and monitor points of entry to the facility, and establish a process to ensure everyone who entered the facility was assessed for symptoms of COVID-19

c. Leadership interviews revealed the facility did not monitor the screening process to ensure all HCP were screened for symptoms of COVID-19, and did not limit and monitor entry points to the building in order to ensure HCP did not enter the facility without being screened.

i. On 12/10/20 at 1:54 p.m., Director #3 was interviewed. Director #3 stated as a manager she had never checked to ensure HCP who reported to her were screened prior to their work shift according to facility policy. She stated she did not know whether any of her staff bypassed the screenings, however she was aware members of her staff who came in at 5:30 a.m. conducted a self-screening, but stated she didn't know if self-screening was acceptable.

ii. On 12/11/20 at 7:31 a.m., the Plant Operations Director (Director) #12 was interviewed. Director #12 stated he oversaw HCP in environmental services, dietary, and facility maintenance departments. Director #12 stated he did not know who unlocked the main entrance door in the morning, but he believed the facility screeners unlocked the door when they arrived at 6:00 a.m. He stated he had staff who arrived to work at 4:30 a.m. and would enter and be screened for COVID-19 at the emergency department.

Director #12 stated he did not check the HCP screening logs to ensure HCP who reported to him were screened for symptoms of COVID-19. He stated he believed CNO #8 reviewed the screening logs.

Director #12 stated he had seen staff come through a different entrance and go to the main entrance to be screened, and he instructed his staff not to do this because if HCP entered through a side door and were contagious, they could spread infection through the whole hospital.

Director #12's interview conflicted with Supervisor #11's interview who stated she entered through the outside entrance, proceeded to the main entrance to self-screen for COVID-19 and then unlocked the main entrance door.

iii. On 12/10/20 at 10:43 a.m., the Medical Staff Coordinator (Coordinator) #9 and the Director of Quality, Risk and Transformation (Director) #14 were interviewed. Coordinator #9 stated she and Director #14 were responsible to oversee the process to screen HCP for COVID-19.

Coordinator #9 stated HCP should enter and be screened at the main entrance to the facility. She stated HCP who arrived before 6:00 a.m. should enter and be screened at the entrance to the ED. This conflicted with the interviews with RN #4, Technicians #1 and #10, and Supervisor #11, who all stated they self-screened when they arrived to work before 6:00 a.m. Director #14 stated she was surprised HCP were not following this process.

Coordinator #9 stated the screeners should notify the HCP's supervisor and Employee Health #5, and to direct the HCP to leave the building if they reported symptoms or had an elevated temperature when they were screened.. Coordinator #9 stated the HCP were to follow this process if they reported two or more symptoms. However, Director #14 corrected her and stated even if HCP only reported one symptom, they were to leave the facility. Director #14 acknowledged there was "some confusion" on the screening process.

Director #14 stated the facility followed CDC guidance. She stated screening was important to control the environment of the facility, ensure there were no sick people working or receiving services, and decrease employee infection.

Coordinator #9 stated nobody had audited the process to screen HCP for COVID-19.

Based on document review and interviews, the facility failed to ensure staff responsible to oversee the health of healthcare personnel (HCP) at the facility were educated on public health guidance and facility processes related to COVID-19 to prevent the transmission of COVID-19. The failure created the potential for the spread of COVID-19 at the facility.

Findings include:

Facility policies:

The Infection Control for COVID-19 policy read, if suspected or confirmed SARS-CoV-2 infection: providers and staff, do not work. Notify manager and employee health.

The COVID Return to Work policy read, to provide a guideline determining when and how a healthcare worker can safely return to work post COVID infection. Mild illness- individuals who have any of the various signs and symptoms of COVID-19, e.g. fever, cough, sore throat, malaise, headache, muscle pain, without shortness of breath, dyspnea or abnormal chest imaging. Return to work criteria for HCP with SARS-CoV-2 Infection: Symptom-based strategy. HCP with mild to moderate illness: at least 10 days have passed since symptoms first appeared, at least 24 hours have passed since last fever without fever-reducing medications, and symptoms (e.g. cough, shortness of breath) have improved.

The criteria for test-based strategy are, for HCP who are symptomatic: Resolution of fever without the use of fever-reducing medications, and improvement in symptoms and results are negative from at least two consecutive respiratory specimens collected at least 24 hours apart. For HCP who are not symptomatic, results are negative from at least two consecutive respiratory specimens collected at least 24 hours apart.

The Employees COVID Work Flow read, if employees have symptoms, contact director, no work and COVID test are indicated. The Director COVID Work Flow read, if directors have symptoms, contact employee health, no work and COVID test are indicated.

The Employee Health COVID Work Flow read, for a healthcare worker with positive COVID test and symptoms, after 10 days from the date of symptoms and 24 hours without fever the worker can return to work.

References:

The CDC Criteria for Return to Work for Healthcare Personnel with SARS-CoV-2 (COVID-19) Infection, updated 8/10/20, read, Who this is for: Occupational health programs and public health officials making decisions about return to work for healthcare personnel (HCP) with confirmed SARS-CoV-2 infection, or who have suspected SARS-CoV-2 infection (e.g., developed symptoms of COVID-19) but were never tested for SARS-CoV-2. 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

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 =24 hours apart (total of two negative specimens) tested using an FDA-authorized molecular viral assay to detect SARS-CoV-2 RNA. HCP who are not symptomatic: Results are negative from at least two consecutive respiratory specimens collected =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 12/3/20, 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. Occupational health programs should have a low threshold for evaluating symptoms and testing HCP. Any HCP who develop fever or symptoms consistent with COVID-19 should immediately self-isolate and contact their established point of contact, e.g. occupational health program, to arrange for medical evaluation and testing.

The CDC Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic, updated 11/4/20, read, Properly manage anyone with suspected or confirmed SARS-CoV-2 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 facility's Employee Health Nurse job description read, the Employee Health Nurse is responsible for pre-employment screening, immunization/ testing, injury/ health assessments, return to work exam authorizations, and Health and Safety training. Essential Duties: monitor employee work-related illness and assess, develop and implement strategies to prevent work-acquired illness and expedite return to work. Participates in surveillance programs designed to identify and monitor risks to the employee's health. Perform communicable disease exposure follow-up.

1. The facility failed to ensure staff responsible to oversee health assessments, return to work authorizations, and communicable disease follow-up for facility HCP were educated and competent to monitor HCP who reported symptoms and/or tested positive for COVID-19.

A. According to the CDC Criteria for Return to Work for Healthcare Personnel with COVID-19 Infection, and the facility's COVID Return to Work policy, the symptom-based strategy for HCP to return to work included 10 days had passed since symptoms first appeared, at least 24 hours had passed since last fever without fever-reducing medications, and symptoms had improved. The test-based strategy for HCP to return to work included resolution of fever without fever-reducing medications, improvement in symptoms, and negative results from at least two consecutive COVID-19 tests collected at least 24 hours apart.

The Employee Health COVID Work Flow read, HCP with symptoms of COVID-19 were not to work, and HCP who were positive for COVID-19 could return to work 10 days after the onset of symptoms.

B. The facility provided a line list and illness log, which the Employee Health Nurse (Employee Health #5) used to monitor HCP who reported symptoms consistent with COVID-19 or who tested positive for COVID-19. Review of the illness logs revealed multiple instances in which HCP reported to work while symptomatic or without fulfilling the CDC Return to Work criteria for HCP with confirmed or suspected COVID-19. (Cross Reference C-1206)

Examples included:

a. Review of the illness log revealed, on 11/13/20 Patient Financial Services Technician (Technician) #1 reported symptoms of headache, nausea, body aches, fatigue, chills and diarrhea. According to the illness log, Technician #1 was advised of when to stay at home and when to go to the Emergency Department or clinic. There were no details on what guidance was provided to Technician #1 from Employee Health #5. Technician #1 declined a COVID-19 test.

Review of Technician #1's timecard revealed Technician #1 returned to work on 11/17/20, four days after she reported symptoms consistent with COVID-19. According to the Return to Work Criteria, she would not be allowed to return until 11/23/20 since she refused to get two negative COVID-19 tests.

b. The illness log revealed, on 11/16/20 Technician #2 reported symptoms of elevated temperature, nausea, diarrhea, fatigue, headache and chills. On 11/17/20, it was documented Technician #2 had an improvement in nausea but continued body aches and chills. The illness log read Technician #2 could work the following day with a medical mask.

i. Review of Technician #2's timecard revealed Technician #2 returned to work on 11/18/20, two days after the appearance of symptoms consistent with COVID-19. According to the Return to Work Criteria, she would not be allowed to return until 11/26/20 or two negative COVID-19 tests.

ii. Chief Nursing Officer (CNO) #8 provided an email sent to her on 11/18/20 from Revenue Cycle Director (Director) #3 which read, Technician #2 did not have a test for COVID-19, but a medical provider determined another condition may have caused Technician #2's symptoms. CNO #8 was unable to provide evidence to corroborate the alternate illness determination or a physician release for Technician #2 to return to work while she had symptoms of COVID-19.

iii. According to the line list of HCP who tested positive for COVID-19 revealed Technician #2 subsequently tested positive for COVID-19 on 11/25/20.

c. On 11/17/20 the facility compliance officer reported symptoms of fatigue, congestion and nausea. The illness log read the compliance officer was given a medical mask to wear for 10 days and was educated on when to get a COVID-19 test and when to stay home. It is unclear what guidance Employee Health #5 gave to the compliance officer because according to the Return to Work Criteria, he would not be allowed to return until 11/27/20 or two negative COVID-19 tests.

i. The facility compliance officer sent an email to the CEO (CEO) #15 on 12/9/20. The email confirmed with the exception of 11/26/20 and 11/27/20, the compliance officer worked all of his regularly scheduled days in the month of November. The compliance officer was not excluded from work after he reported symptoms consistent with COVID-19 according to CDC guidance and facility policy.

d. On 11/19/20 Director #3 reported symptoms of sore throat and dry cough. The illness log revealed, Director #3 had cold symptoms for two days prior to reporting symptoms to the facility.

i. Review of the HCP COVID-19 screenings, which were conducted when HCP reported to the facility for work, revealed screenings were completed for Director #3 on 11/17/20, 11/18/20 and 11/19/20, which indicated she worked at the facility for two days after she began to experience symptoms consistent with COVID-19.

ii. According to the illness log, Director #3 left work on 11/19/20 to get a COVID-19 test and returned to work while waiting for the COVID-19 test result. Director #3 received a positive test result for COVID-19 later in the day while she was still at work. The facility allowed Director #3 to continue to work while symptomatic and waiting for her COVID-19 test results which was in conflict to CDC guidance, PHO, and facility policy, which read HCP who developed symptoms or tested positive for COVID-19 were to immediately self-isolate and were not to work.

e. On 11/19/20 an environmental services HCP reported symptoms of congestion, fatigue, sore throat, chills, headache, nausea and dry cough. The illness log revealed the HCP would consider going to the respiratory clinic and planned to work the following day with a medical mask.

i. Review of the HCP's timecard revealed he remained on-call and reported to work on 11/20/20, one day after he reported symptoms consistent with COVID-19. The HCP was on call 11/21/20 and worked 11/22/20 and 11/23/20.

ii. On 12/10/20 at 10:00 a.m., CEO #15 stated the environmental services HCP was tested for COVID-19 on 11/20/20 and received a negative test result. CEO #15 was unable to provide evidence Employee Health #5 was aware of the negative test result before she allowed the HCP to return to work, nor was there evidence of a second negative COVID-19 test as required by the CDC test-based strategy for Return to Work Criteria.

C. Interviews with facility staff and leadership revealed staff who were responsible to oversee employee health and monitor HCP suspected or positive for COVID-19 were not educated to public health guidance or facility policies.

i. On 12/9/20 at 8:11 a.m., CNO #8 was interviewed. CNO #8 stated she was aware Employee Health #5 provided incorrect guidance to HCP regarding COVID-19 work restrictions. CNO #8 stated on 11/20/20 multiple staff from the Patient Financial Services department discussed their concerns about HCP in the department who were allowed to work while sick. She stated staff included Director #3 and Technician #2 as examples of HCP who they were concerned about working while sick.

CNO #8 stated she was informed Director #3 was told she could work despite a positive test result for COVID-19. CNO #8 stated when she questioned Employee Health #5 about allowing COVID-19 positive HCP to work, Employee Health #5 revealed she followed the incorrect guidance from the CDC. She stated Employee Health #5 followed the CDC's guidance for crisis staffing, however CNO #8 confirmed the facility was not in crisis standards of care. She stated Employee Health #5 had been in her role for only two weeks and had not been adequately trained or educated to procedures related to COVID-19. CNO #8 stated Employee Health #5 continued taking shifts as a floor nurse when she took over employee health responsibilities.

CNO #8 stated no HCP were allowed to work if they had symptoms or were positive for COVID-19. She stated she provided verbal education to Employee Health #5 regarding facility processes for COVID-19, however she was unable to provide evidence of this education.

ii. A second interview was conducted with CNO #8 on 12/10/20 at 4:27 p.m. CNO #8 stated Employee Health #5 was educated to her job duties when she began in her role, however there was no written documentation to verify Employee Health #5's education. CNO #8 stated there was no framework or competency tools utilized to ensure Employee Health #5 was knowledgeable to manage HCP who had symptoms or tested positive for COVID-19. CNO #8 acknowledged the training Employee Health #5 received was lacking.

CNO #8 stated the RN Case Manager (Case Manager) #6 was currently filling in for Employee Health #5. She stated Case Manager #6 spent time with Employee Health #5, however in hindsight the time was not adequate to ensure Case Manager #6 was able to fulfill employee health duties. She stated the handoff to Case Manager #6 was likely poor.

iii. On 12/9/20 at 11:14 a.m., Case Manager #6 was interviewed. Case Manager #6 stated she had filled in for Employee Health #5 for one week. She stated she was responsible to follow up with HCP who tested positive or reported symptoms of COVID-19. Case Manager #6 stated it was important to ensure HCP did not work while sick because COVID-19 was highly contagious, and the facility needed to ensure staff and patients were safe.

Case Manager #6 stated she had never been involved with employee health duties prior to filling in for Employee Health #5. Case Manager #6 stated Employee Health #5 met with her to explain employee health processes. However, she acknowledged because Employee Health #5 was new to her position, the processes were not precise, and she stated Employee Health #5 was "flying by the seat of her britches" to understand those workflows.

Case Manager #6 stated HCP with symptoms were instructed to stay at home until they received results for a COVID-19 test. She stated tests were conducted to verify whether HCP were positive or negative for COVID-19 before she allowed them back into the workplace. She stated HCP needed one negative result for COVID-19 in order to return to work. This was in contrast to CDC guidance and facility policy, which read the test-based strategy for HCP to return to work required two negative test results for COVID-19 collected at least 24 hours apart.

Case Manager #6 stated the previous week a HCP approached her at work and informed her she had a positive COVID-19 test result. She stated the HCP was at work and started to have symptoms, and remained at work to undergo a COVID-19 test at the facility's laboratory. Case Manager #6 stated when the HCP informed her of the symptoms and test result, she ensured the HCP was wearing an N95 respirator and put on her own N95 respirator. She stated she took the HCP to the main entrance to check her temperature, and then to her office to discuss the HCP's symptoms. After she took the HCP to different areas of the facility with a positive COVID-19 diagnosis, she then directed the HCP to leave the facility and go home.

Case Manager #6 stated if a HCP developed symptoms at work they were advised to put on an N95 respirator and contact their manager. She stated she was not aware of a policy or process for staff who developed symptoms at work. Case Manager #6 stated the direction for HCP to wear an N95 if they were suspected of COVID-19 was a recommendation based on her instincts.

iv. There was no guidance in the facility's policies to instruct HCP suspected or positive for COVID-19 to wear an N95 in the facility, or to check an HCP's temperature at the main entrance if the HCP reported symptoms or a positive test result at work. The facility policy and workflows read, if a HCP had symptoms or was suspected for COVID-19, the HCP was not to work. Case Manager #6's interview also conflicted with CDC guidance for work restrictions, which read any HCP who develop fever or symptoms consistent with COVID-19 should immediately self-isolate.

v. On 12/11/20 at 8:06 a.m., IP #7 was interviewed. IP #7 stated she was responsible to provide education and support related to infection control policies to HCP. She stated she reviewed policies and documents with Employee Health #5 to familiarize her with processes related to COVID-19. However, IP #7 stated she was not able to provide much oversight to Employee Health #5, as it was a busy time and she was attending to infection prevention needs in the separately licensed long-term care facility.

IP #7 stated she was not aware Employee Health #5 allowed HCP who had symptoms or were positive for COVID-19 to work.