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The facility failed to have active hospital-wide programs for the surveillance, of other emerging infectious diseases (COVID-19). The facility failed to demonstrate adherence to nationally recognized infection prevention and control guidelines for COVID 19 pandemic related to screening individuals entering the facility, this resulted in the surveyors identifying an immediate jeaporady situation on 11/16/2020 at 4:25 PM . The lack of thorough screening resulted in staff coming to work ill, the likelihood of the spread of the SARS-CoV-2 virus that causes COVID-19 to individuals in the facility. Contraction of the COVID-19 may result in complications that cause serious injury, harm or death.
In addition the facility failed to have a coordinated surveillance of COVID 19 positive cases and to ensure that infection prevention and control problems and issues identified in the program were addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program.
See the standards below:

A-749- the facility failed to assure 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;
A-0772 - The infection prevention and control program (IPCP) policies and procedures (P&P) did not adhere to national guidelines related to COVID-19 screening and IPCP surveillance.
A-773- The facility did not assure that the infection preventionist (IP) took responsibility to document full surveillance activities.
A-774- The facility did not assure that the infection preventionist (IP) was responsible for the communication and collaboration with QAPI related to IC issues
A-775- The facility did not assure that infection preventionist (IP) was responsible for IPCP education.

Based on observation interview and record review the facility failed to assure 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;

Findings Include

Upon entry to the facility on 11/16/2020 at approximately 7:45 AM, the surveyors found that the screeners (staff who screen people who enter for symptoms of COVID-19) only screened visitors and outpatients by taking their temperatures. Employees entered the hospital without any screening. When asked about this practice the screener stated, the employees were screened on their assigned units or offices.

An interview and concurrent tour of the Adolescent Care Unit (ACU) beginning at approximately 9 AM was conducted with ACU Administrative Staff 2. When asked how staff were screened for COVID-19 infection ACU Administrative Staff 2 showed me where staff enter the unit and self-screen, taking their temperature and then recording it on "ACU Staff Temperature Log" dated 11/16/2020. There were columns that included the time, staff's name, temperature and screening questions. Three (3) of 13 staff did not answer the screening questions. Administrative Staff 2 provided the "Infection Control Plan Covid-19 ACU inpatient" policy dated 06/15/2020. It read in pertinent part: "ACU Staff ...Staff to be temperature checked when reporting to work and to be faxed to [Employee Health Staff 30] by 1000 (AM). In addition, staff will be screened by charge nurse (exposure questions). Staff must inform supervisor if ill and/or exposed to Covid-19 infected person ...Staff should advise supervisors if caring for loved one with Covid-19 ...Staff determined to be at risk for Covid-19 infection will be sent for testing and sent home ...The Safety Officer, Employee liaison and infection control will be notified immediately ...." (Sic).

On 11/16/2020 at approximately 10:30 AM, entered the nutritive services office suite. I was screened with a temperature check only. No one asked any screening questions and I was not directed to fill out a screening form. When asked how nutritive service staff were screened for COVID-19, Nutritive Service Staff 31 stated they took their temperature only when they arrived in the nutritive services office. Nutritive Service Staff 31 provided a form they filled out titled, "Employee FSW sign in Sheet TMC FOOD SERVICE date 11/16/20" They recorded the name of individual and the temperature. If any were over 100.1 they sent the employee to the emergency department or home. When asked for a specific policy they followed for screening, Nutritive Service Staff 31 and interviewed Nutritive Service Staff 32 stated they did not have one.

During an interview on 11/16/2020 beginning at 10:25 AM, when asked what the facility policy and procedure was for screening individuals entering the facility, the infection preventionist (IP-1) stated they did not have a specific policy other than the most current CDC guidance. IP-1 stated screening should include checking the individual's temperature and asking questions to determine if the individual had been exposed to or had symptoms of COVID-19. IP-1 stated general screening occurred at the main entrance and the emergency department (ED); however surveyors observed several other entrances the employees used that were not monitored. Employees were allowed to enter and then were on the "Honor system" to self-screen once they arrived at their assigned unit. When asked if the IPCP surveillance included review of screening information, IP-1 stated, "No." He stated there were no plans that he knew of for IPs to oversee the screening process. He stated that earlier this year they had limited entrance to the facility through the main entrance and ED only. Screening at that time was thorough including temperatures and screening questions; however in August 2020 the administration told the Incident Command Team (ICT) to "Stand Down". After that each unit was to create their own policies and procedures (P&Ps) to manage COVID-19.

Based on observation, interview and record review the facility failed to assure the Infection Preventionist (IP) took responsibility for the hospital to implement the infection prevention and control program (IPCP) policies and procedures (P&P). The facility failed to adhere to national guidelines for COVID-19 screening and IPCP surveillance. By not having anyone accountable for assuring that national guidelines and IPCP P&Ps were followed facility wide individuals who may have had COVID-19 symptoms were allowed into the facility and staff were allowed to work while ill potentially perpetuating the spread of COVID-19 infection. The facility failure to screened all patients, staff, and visitors placed the entire hospital at great risk for spreading and contracting the COVID 19 virus. Contraction of the COVID-19 may result in complications that cause serious injury, harm or death.

An IJ called on 11/16/2020 at 16:25 in the present of the CEO, Executive Vice President, Medical Director and other leadership staff.
1st IJ abatement plan received on 11/17/2020 was unacceptable at 13:20

2nd IJ abatement plan was acceptable on 11/17/20 at 14:20.

Implementation of IJ abatement plan was validated and completed on 11/18/20 at 7:45 AM

Findings include:

1). Upon entrance to the facility on 11/16/20 at 7:45 AM surveyors observations concurrent with an interview with Screener Staff 29 revealed hospital employees entering the facility at the centralized entrance [Main Entrance] were not being screened but waved through as long as they were wearing a face mask and badge. The employees entered without any screening. According to Staff 29, hospital employees have digital keys that allow them to enter the hospital at other entrances. Staff 29 stated, "The staff are to be screened at their specific assigned units. The visitor's and outpatients temperatures are checked and the COVID-19 screening questions are not asked."

When the surveyors went to the different units and departments each had their own way of screening. For example:
a). On 11/16/2020 at 9 AM, upon entering the Adolescent Care Unit (ACU) Administrative APU Staff 2 took the surveyor's temperature and asked the screening questions. When asked what P&Ps they followed, Administrative APU Staff 2 stated they created their own P&Ps that followed CDC guidelines. When asked if the IP participated in developing these P&Ps, Administrative APU Staff 2 stated, "No."

b). On 11/16/2020 at 10:42 AM, upon entering the Food Services department a staff person took the surveyor's temperature however did not ask any screening questions. When asked how they screened Nutritive Service Staff 31 stated, "When Food Service staff came to work their temperatures were taken and recorded. We have no screening questions and did not have a policy separate for the general facility policy.

c). The Clinical Laboratory had a form titled "Employee Daily Temperatures" dated 11/9/2020. The form had four sections one for Supervisors, MLA's, MLA's/MT's and Night shift. There was column for their name, position, pre-temp time, post-temp and time. There were no screening questions asked or documented on the form.

d). During the initial tour of the Obstetrics (OB) unit concurrent with an interview on 11/16/2020 at 9:40 AM, the OB administrative (Admin) Staff 27 was questioned on the type of COVID 19 screening being done for the staff on her unit. She explained that upon entry to the unit, the staff checks their temperatures and enters the data into a binder. Upon review of the binder, only staff names and temperatures were documented. OB administrative Staff 27 indicated she did not implement the COVID-19 screening questions on her unit. OB Admin Staff validated her staff were only being screened at the unit at the start of their shift.

e). At the beginning of the initial tour of the medical-surgical unit (MSU) at 9:45 a.m. on 11/16/20, a nursing administrative staff member (Nurse Admin 20) stated that access to the unit was from two main doors that connect to the two main hallways of the MSU. According to Nurse Admin 20, every employee has a digital key to open the doors to the MSU and all the doors in the hospital. When asked how the screening procedure was for all staff working on the unit, Nurse Admin 20 added that employees were to check their temperature upon arrival on the unit, enter the result on the MSU Employee Temperature Log, write their name, the time and date, and the route the temperature was taken (by digital or forehead). There was no indication that employees on the unit were screened by travel, exposure, and/or respiratory symptoms (of Covid-19) other than by temperature. According to data posted in the conference of the hospital on 11/16/20, the community where the hospital is located had a positivity rate of 12.3% and rising.

f). On 11/16/2020 at 10:45 AM during the initial tour on the Intensive Care Unit (ICU) concurrent with an interview, Charge Nurse Staff 26 was questioned about COVID 19 screening. She validated the ICU was 100% designated for COVID-19 positive patients. Charge Nurse Staff 26 explained the staff were checking their temperatures upon entry into the unit. She confirmed the COVID-19 screening questions recommended by CMS and CDC implemented on her unit.

g). On 11/16/2020 at 10:58 AM, an initial tour of the radiology department was conducted concurrent with an interview with Radiology Admin Staff 21. The Radiology Admin Staff 21, approached the surveyor with a productive cough and was wearing a vented cloth mask. The surveyor questioned the Radiology Admin Staff 21 about her cough and vented cloth mask. The Radiology Admin Staff replied, "I have been sick for three weeks. I went to the emergency room 3 times and they cannot figure out what is wrong with me. I have been wearing the vented cloth mask for many months. No one ever questioned me about the mask before." When asked if she had consulted with the employee health nurse, she replied, "This is my personal business, I did not tell them anything. I called off sick for three days already for this illness." When questioned about what type of COVID-19 screening was being done in the radiology unit she replied, "The staff checks their temperatures individually and email the reading to me daily." When asked about the COVID-19 screening questionnaire she indicated, "The questionnaire was used for staff on her unit."

h). During an interview on 11/16/2020 at 11:15 AM, Radiology Staff 22 was asked about the department's COVID 19 screening process. She explained her shift started at 7:00 AM and she had not had a chance to check her temperature today. Staff 22 explained the screening process and indicated, "Whenever I have time during the shift I would check my temperature and email the result to the manager." When asked if she received any COVID-19 screening questionnaire she responded, "No." Staff 22 was requested to print out the temperature emails for one week. Upon review, many of the emails were sent to the manager at various times during the shift. One email had two temperatures submission for two different days and the email was 3 days late. Staff 22 verbalized that she had forgotten to timely email the temperature readings to her manager.

i). During an interview on 11/16/20 at 11:30 AM, Radiology Staff 23 explained the screening process. He verbalized, whenever he has time during his shift, he will check his temperature and email it to his manager. Staff 23 was asked if his temperature was checked and if his COVID-19 screening questionnaire had been answered today, Staff 23 responded "No."

j). On 11/16/2020 at 1:40 PM a tour of the pharmacy unit was conducted with Pharmacy Admin Staff 24. When he to explain the screening process on his unit, he stated that the staff checks their temperatures and document the information in a binder. Upon review of the documents, two staff members did not document their temperatures at the start of their shift. Pharmacy Admin Staff 24 verbalized that the expectation was for all staff to check their temperature daily at the start of their shifts. When questioned about the COVID 19 screening questionnaires he verbalized, "We do not use any COVID 19 screening questionnaires in the pharmacy." Pharmacy Admin Staff validated his staff were only being screened at the unit at the start of their shift.

During an interview on 11/16/2020 beginning at 10:25 AM, when asked what the facility policy and procedure was for screening individuals entering the facility, the infection preventionist (IP-1) stated they did not have a specific policy other than the most current Center for Disease Control (CDC) guidance. IP-1 stated screening should include checking the individual's temperature and asking questions to determine if the individual had been exposed to or had symptoms of COVID-19. IP-1 stated general screening occurred at the main entrance and the emergency department (ED); surveyors observed several other unmonitored entrances used by the employees. IP-1 stated employees were allowed to enter the facility and then were on the "Honor system" to self-screen once they arrived at their assigned unit or department. When asked if the IPCP surveillance included review of the screening process or the data collected during screening, IP-1 stated, "No." He stated there were no plans that he knew of for IPs to oversee the screening process or to include the data obtained in the surveillance program. IP-1 stated that earlier this year they had limited entrance to the facility through the main entrance and ED only. Screening at that time was thorough including temperatures and screening questions; however in August 2020 the administration told the Incident Command Team (ICT) to "Stand Down". After that each unit was supposed to create their own policies and procedures (P&Ps) to manage COVID-19. When asked if the IP was involved in developing or creating the P&Ps for different units and departments of the hospital he stated, "No." He stated with so many changes in the CDC guidelines the hospital decided to just follow the most current CDC guidelines.
In a separate interview on 11/16/2020 at 12:52 PM with employee health nurse, she validated that staff cannot wear vented masked in the hospital. She explained the hospital only allowed fit tested approved mask while at work. The employee health nurse confirmed she had not had any reports of an employee being sick for three weeks in the Radiology Department. She explained, "The hospital expectation is for the employees to report their illnesses to my department. The sick calls are not monitored."

During an interview on 11/16/2020 at 3:15 PM with the front entrance Screener Staff 29, she explained she was instructed to only check the temperatures upon entry into the hospital. She verbalized, "The screening questions stopped a few months ago. The hospital used to ask the screening questions prior to entry into the hospital. We were told to stop." Staff 29 explained, "The staff should have their temperatures checked in their departments, we only check the visitors."

Conducted an interview on 11/17/20 at 11 AM with the CNO and he stated, "The hospital made a decision a few months ago to stop the COVID-19 screening questionnaires based on a decreased in the community COVID-19 infection rates."

On 11/16/2020, a reviewed of the Employee Screening and Covid-19 Employee Exposure Management dated 4/1/2020 revealed:
Employee screening is not mandatory for all employees.
Employee should stay home if sick.
Supervisors give oversight to the screening process for their team.

On 11/16//2020, reviewed of a copy the screening policy posted on the wall in the hallway where the screening log was located, revealed that screening for non-clinical staff will be at a "centralized screening point" located at the east main entrance during regular business hours from 8:00 AM to 5:00 PM, Monday through Friday.


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2). During an interview concurrent a record review on 11/16/2020 beginning at 10:25 AM, when asked to describe the surveillance process, IP-1 stated he and IP-2 spent three hours per day going through each inpatient's medical record to determine if they had any symptoms of any infection including COVID-19, reviewed patient COVID-19 screening, physician orders and laboratory reports. This was how he did surveillance. He counted numbers of COVID-19 positive patients, which department they were in, and onset date. He stated he did not include staff in surveillance. When a patient tested positive he made a list and hand delivered it to the employee health office and sent the list to the public health nurse's (PHN) office. PHN did contact tracing on the patients. The surveillance form was in an electronic format on his computer. The information did not include the date of possible exposure, symptoms or asymptomatic. It did include the date the patient tested positive and the department they were in. This surveillance information did not include contact tracing, placement of the patient, or resolution date (recovered, sent to lower level of care or death). IP-1 stated that since the facility re-opened outpatient services their COVID-19 infections have exploded. So much so that he did not have time to conduct all infection prevention and control tasks. The facility hired two contract staff- one IP and one occupational health staff. He stated it was all he could do to keep up with counting the numbers of COVID-19 infections. He stated the hospital wide inpatient census today was 27 and 10 of those were admitted due to COVID-19. They have had no Hospital Acquired Infections (HAI). IP-1 stated their surveillance program was focused on HAIs not community acquired infections.

Based on interview and record review the facility did not assure that the IP took responsibility to document full surveillance activities. This deficient practice made it difficult for the COVID-19 management team to have all information available to make informed decisions to prevent the spread of COVID-19.

Findings include:

On 11/16/2020 beginning at 10:25 AM, when asked to describe the surveillance process, IP-1 stated he and IP-2 spent three hours per day going through each inpatient's medical record to determine if they had any symptoms of any infection including COVID-19, reviewed patient COVID-19 screening, physician orders and laboratory reports. He stated that was how he did surveillance. He counted numbers of COVID-19 positive patients, which department they were in, and onset date. He stated he did not include staff in surveillance. When a patient tested positive he made a list and hand delivered it to the employee health nurse and sent the list to the public health nurse's (PHN) office. PHN did contact tracing on the patients and employee health was supposed to do contact tracing of staff. When asked if the IPCP then received follow-up data from the employee health nurse and PHN to include in the hospital surveillance documents, he stated, "No." When asked to see the documentation of the surveillance the IP conducted he stated the surveillance form was in an electronic format on his computer. The information did not include symptoms or date of possible exposure. It did include the date the patient tested positive and the department they were in the doctor's name and the patient's diagnosis. This surveillance information did not include contact tracing, placement of the patient which room they were in or roommates, or resolution date (recovered, sent to lower level of care or death). IP-1 stated that since the facility re-opened outpatient services in August 2020 their COVID-19 infections had exploded. So much so that he did not have time to conduct all infection prevention and control tasks. The facility hired two contract staff- one IP and one employee health staff. He stated it was all he could do to keep up with counting the numbers of COVID-19 infections. He stated the hospital wide inpatient census today was 27 and 10 of those were admitted due to COVID-19. The numbers of individuals tested at the hospital on 11/16/2020 was 561 so far 75 of those tested positive. He said keeping track was almost impossible.They have had no Hospital Acquired Infections (HAI). IP-1 stated their surveillance program was focused on HAIs not community acquired infections. When asked how the facility conducted surveillance of staff infections, IP-1 stated the employee health was responsible for keeping track of staff.

During an interview on 11/16/2020 at 12:52 PM, when asked how she did surveillance Employee health nurse stated she was a contact employee since July 2020. She stated she did not do surveillance of employees that test positive for COVID-19 and she did not conduct contact tracing of employees. When asked how employee health knew if a staff called in sick or had COVID-19, she stated she would not know if the staff did not call her directly or if the staff supervisor did not tell her.

Review of the facility P&P titled "2018 Infection Control and Prevention Plan reference # CMS §482.42 effective date 7/26/2019 and was facility wide P&P. Read in pertinent part:
"The IP practitioner serves as the chair and the committee is responsible for the program overview and recommends infection prevention and control interventions for medical and nursing staff ...E. Reporting Structure ...2. Surveillance ...Surveillance methodologies include but are not limited to the following: 1. Identifying baseline information about frequency and types of HAIs ... 3. Developing a system for identifying, reporting and analyzing the incidence and causes of HAIs. d. In addition to targeted surveillance, single occurrences and or outbreaks related to any unusual or virulent pathogenic organism are evaluated ...h. Surveillance data are maintained in Excel data sheet and the NHSN [National healthcare safety network] database. Management of the data is performed by the IP practitioner ..."

Based on interview and document review the facility did not assure that the Infection Preventionist (IP) was responsible for the communication and collaboration with Quality Assurance Performance & Improvement (QAPI) related to Infection Control (IC) issues

Findings include

During an interview on 11/17/202 at 10:35 AM, when asked how the IP communicated with QAPI on identified infection control problems or possible problems including their increase in COVID-19 positive patients, IP-1 stated he reported the number of HAI infections and COVID-19 positive infections to the IC committee and QAPI in a report. He stated IP did not attend the QAPI meetings and was not involved in analyzing data or creating corrective action plans.

During an interview on 11/17/2020 at 9:10 AM, when asked how IP communicated and collaborated with QAPI the QAPI director stated they since the Incident Command Team (ICT) disbanded in August 2020, the communication between IP and QAPI has diminished quite a bit. QAPI director stated she is not included in the QAPI meetings anymore. She stated that overall Communication has not been happening. "It seems we are working in silo's"

Review of the facility P&P titled "2018 Infection Control and Prevention Plan reference # CMS §482.42 effective date 7/26/2019 and was facility wide P&P. Read in pertinent part:
"E. Reporting Structure:
1. The IPCC [infection prevention and control committee] provides quarterly reports or as required regarding its program and activities to [THE FACILITY] Quality Services Committee which included members of the [facility board], medical staff and Nursing leadership.
2. Appropriate reports of surveillance data are sent to the department directors to share with staff.
3. Infection Prevention and Control minutes and reports are distributed to the IPC committee.
4. A quarterly report will be sent to the Chief of Quality Services to distribute to the appropriate hospital committees.
5. If an Infection prevention and control problem is attributed to a particular area, this report will be sent to the department supervisor for resolution.
6. It is the responsibility of the IPC committee members to communicate to their division and obtain input for issues and report back to the committee."

Based on interview and document review the facility failed to assure the infection preventionist (IP-1) was responsible for infection prevention and control program (IPCP) education. This deficient practice had the potential for IPCP training not to meet national standards.

Findings include:

During interviews on 11/16/2020 at 10:25 AM, when asked how the IP assured infection prevention and control training and competency of staff was done, IP-1 stated the education department did all training including infection control training. He stated the IP did not monitor staff practices or keep track of training or competencies related to IPCP.

During an interview on 11/17/2020 at 2:20 PM, when asked how staff were trained for infection prevention and control techniques including management of COVID-19 infections, EDU-N stated during orientation each staff received general IPCP training. The facility had an online training system, RELIAS, that included COVID-19 training. EDU-N stated she created a new module for each CDC update for COVID-19. There have been so many updates that it was difficult keeping up with creating the necessary training. Staff take these modules on their own. The staff supervisors or she can run reports from RELIAS to assure staff have completed training. EDU-N stated the education program is disjointed in that each department keeps track of their own employee records. She stated the Education department did not assess staff competencies. It was up to the department managers to assure staff were competent. She stated that when she finished a training session related to infection control such as hand hygiene, she required the student to return demonstrate their understanding of the training.

Review of the facility P&P titled "2018 Infection Control and Prevention Plan reference # CMS§482.42 effective date 7/26/2019 and was facility wide P&P. Read in pertinent part: "3. Control ...H. Staffing/Qualification/Education/Competency. 1. One full time Infection Preventionist, One Employee Health Provider, One Director of IP &EH are available at FDIHB. 2. The IPC is allotted 90% of time schedule for Infection Prevention and Control activities. The Remaining 10% is for education and other required services ...."