**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY** Based on observation, staff interview, record review, and facility policy review the facility failed to maintain an effective infection control and prevention program by failing to monitor COVID 19 screening process logs to ensure accurate and within normal limit temperature measurements of 97 degrees Fahrenheit (F) to 99.5 degrees F. Specifically, all residents, staff members, vendors, and visitors entering the facility campus were checked for an increase in temperature over 99.5 F. and symptoms of COVID 19. Review of the temperature measurements recorded on the screening process logs revealed there were temperature measurements out of normal range that could indicate a symptom of COVID 19 illness. The deficient practice had the potential to increase the risk of exposure and/or contracting the COVID 19 virus or its variants. On 02/14/22 at 3:15 PM, the Administrator was provided a copy of the CMS Immediate Jeopardy (IJ) Template and notified that the failure to ensure the infection control and prevention program was implemented correctly to prevent exposure and the spread of the COVID 19 virus by improperly screening staff, visitors, and vendors prior to entering the facility campus, constituted an IJ at F880. The immediate jeopardy was determined to first exist on February 14, 2022 when the facility failed to identify errors in the COVID 19 screening process through February 15, 2022. The deficient practice remained at a E (pattern with no actual harm and potential for more than minimal harm) scope and severity following the removal of the immediate jeopardy. The facility presented an Allegation of Compliance (AOC) plan of correction on February 15, 2022 at 11:20 AM indicating that the facility put a plan into place to remove the immediacy. Staff interviews, record reviews, policy and procedure reviews and review of the training, and education was completed during the survey to verify the immediate corrective actions taken by the facility were implemented. The Credible Allegation of Compliance included the following: Criterion 1: Screening long for 2/14/22 was audited and all individuals with a temperature above the threshold were rechecked. All temperatures rechecked were within normal range. All screening team members currently working were immediately educated on the correct screening procedures to include correct temperature ranges and explaining the screening procedure to everyone being screened. They were also immediately educated on the correct cleaning process before and after each use per manufacturer's guidelines. All staff currently working educated on the screening process including to notify screener if they answer yes to any of the questions and the steps they need to take if their temperature is above the threshold. All thermometers were replaced with new ones and the open date recorded to be able to follow manufacturer's guidelines for calibration. Criterion 2: Screening logs for the past 7 days were audited and no other temperatures above the threshold were noted during that period of time. Criterion 3: Team members who work the check point, but were not working on 2/14/22, the team members on vacation, out on leave or out sick will receive additional training prior to the start of their next shift. Training to include: . The appropriate procedure to follow when temperatures read greater than 99.5 degrees Fahrenheit. . The appropriate way to calibrate the thermometers per manufacturer's guidelines. . Instructed to verbally alert all arrivals to read screening questions and alert screener if they answer yes to any questions. . The appropriate cleaning process before and after each use per manufacturer's guidelines. All team members who were not working on 2/14/2022, team members on vacation, out on leave or out sick, will receive the additional training prior to the start of their next shift. All team members will receive training on the screening upon hire. Updated the screening form to include space to document temperature re-checks. Criterion 4: The Assistant Director of Environmental Services or designee will audit the screening logs for compliance per day for two weeks, then once a day for one week and then weekly. Results of the audits will be reported through the QAPI program on a monthly basis. Criterion 5: Date of Compliance 2/15/22 Findings include: Based on a review of the manufacturer's guidelines for the Extech Non-Contact Forehead IR Thermometer Model IR200 dated 2015 indicated: .For the most accurate results, make reading with an ambient (room) temperature of 73 to 82, make sure skin is dry and no hair interferes with the measurement, avoid touching and/or scratching the infrared surface, always use clinical thermometer to verify abnormal temperature measurements, and clean the lens area by gently blowing with compressed air and use a damp swab to wipe the lens . If the meter has been stored in a cold or hot environment, allow it at least 20 minutes to acclimate to room temperature before making measurements . Steam, dust, smoke, frost, oil, grime, etc. can obscure measurements . Please disinfect the housing and lens of this device before and after use .Allow the device to dry for at least 10 to 15 minutes after cleaning before use . Annual calibration should be performed to verify meter performance and accuracy . Review of the manufacturer's guidelines for the [NAME] No touch plus forehead NTF3000 thermometer dated 2015 indicated: .The thermometer is intended for household use only . Temperature elevation may signal a serious illness, especially in adults who are old, frail, or have weakened immune system. Please seek professional advice immediately when there is a temperature elevation and if you are taking temperature on: Patients over 60, Patients having diabetes mellitus or a weakened immune system, cancer, etc . Fever guidance feature . The screen displays green suggests no fever, a yellow screen suggests moderate fever, and a red screen suggests high fever. 10 audible beeps indicate temperatures above 99.4 to alert that the patient may have a fever . Patient should be inside 30 minutes before taking a measurement, the patient should not drink, eat or be physically active before/while taking the measurement, remove dirt, or hair from forehead before taking measurement; hair fringes may cause higher readings . The thermometer is initially calibrated at the time of manufacture. If the thermometer is used according to the use instructions . Care and Cleaning - the thermometer should be cleaned in between uses . According to review of the electronic version John Hopkins Medicine dated 2022 it was indicated .Normal body temperature varies by person, age, activity, and time of day. The average normal body temperature is accepted as 98.6°F (37°C). Some studies have shown that the normal body temperature can have a wide range, from 97°F (36.1°C) to 99°F (37.2°C) Review of the facility's COVID-19 Security Check Point Screening Refresher training dated 03/19/21 revealed the screening process was .All team members, vendors, and visitors entering the facility campus must be screened upon arrival, every time they come in. Upon arrival, it is the security check point team's responsibility to check the individual's temperature and ask the screening questions .Screening individuals before they enter the campus is an effective strategy for reducing the risk of exposure to the virus throughout the community, screening has proven to help prevent the spread of disease within a community, screening is a requirement of both CMS and DHEC . Visitors - As of 03/10/21 visitors were permitted to visit healthcare areas . Per CMS and DHEC guidelines, all visitors are required to go through screening process . Individuals observed to have any symptoms related to COVID-19 should not be permitted on campus . Temperature Check - If the temperature reads 99.5 degree or higher: Ask the individual to pull over to the side, wait 2-3 minutes and recheck the temperature, If the 2nd check is still above 99.5 call the Charge Nurse and ask them to come out to check an oral temperature, The Charge Nurse will take the temperature orally. If the temperature remains 99.5 degrees or higher, the individual will not be allowed to enter campus. If it is a visitor, inform them that they will not be able to access the campus and then notify the Charge Nurse in the area they were going to visit. Please make sure the thermometer is cleaned in between each use . If the individual's temperature is below 99.5 degrees and they have answered No to all of the screening questions, give them a dot sticker with the prescribed color of the day, indicating the individual had passed the screening . Vendors - In addition to asking the screening questions and checking temperature, please complete the vendor check in log with their name, temperature reading, and company, for visitors, complete on the visitor log . Review of the facility's policy titled, Infection Control and Response COVID-19 not dated, indicated .Screening - All traffic into the campus is diverted to the East side, where security station will be in place. All team members, visitors, and vendors will have their temperature checked, as well as be screened with questions regarding potential exposure, upon arrival on campus. -Those whose temporal reading registers higher than 99.5 degrees Fahrenheit will be checked via an oral thermometer by a nurse. At this second stage, those who register higher than 99.5 degrees will not be granted access to the community. -Team members will document by signature that they have been asked the screening questions and that their temperature is recorded. Team members who report to work with signs and symptoms of acute respiratory illness or influenza-like illness will be instructed to return home and to seek medical evaluation via telemedicine . Review of the facility's policy titled, COVID-19 Testing Policies and Procedures dated 09/27/21 indicated .In an effort to mitigate the risk of exposure and transmission of COVID-19 within licensed healthcare areas, the facility (name) has developed the following procedures. These procedures align with the requirements of 42 CFR 483.80 (h) . Review of the facility's policy titled, Infection Control and Communicable Disease Prevention dated October 2016 indicated the purpose of the policy was .promote resident and employee safety at all times. All employees will promote the prevention of infections, contagious, and communicable diseases by following precautions set forth by the CDC, DHEC, and the facility (name) . The facility failed to ensure visitors, vendors, and residents were properly screened according to CDC/CMS guidelines for COVID 19 virus and its variants. Specifically, on 02/14/22 at 10:00 AM, five surveyors in separate vehicles, were stopped at the campus entrance for COVID 19 screening, while remaining inside the vehicle. The attendant asked the drivers to sign a form with the driver's name and record the temperature after being measured by the attendant. The attendant had not asked any COVID 19 exposure or symptom questions before removing the sign in form from the driver. The first surveyor driver measured a temperature of 99.1, the second driver measured a temperature of 99.7, the third driver measured a temperature of 99.8, the fourth driver measured a temperature of 100.0, and the fifth driver measured a temperature of 101.0. All five surveyor drivers were then directed to enter the campus for parking and then enter the facility. No other guidance or questions were provided. The survey team was met by facility staff at the skilled Nursing building entrance door and escorted to the conference room, located outside the resident care area. There was no resident contact made during that time. After entering the conference room, infection control and Prevention investigation was started to determine if there had been potential deficient practice. In review of the screening sign in sheets used to record the measured temperatures dated for 02/14/22 revealed a vendor vehicle that had entered prior to the first surveyor vehicle had a measured temperature of 100.2 F. Further investigation revealed per the facility policy when a driver had a measured temperature over 99.5 F., the attendant should ask the driver to pull to the side of the entrance, outside of the campus and call the charge nurse and the charge nurse would then orally recheck the driver's temperature. If the driver's temperature remained above 99.5 F., the driver would not be allowed to enter the campus. In further review of the screening sign in sheets it was revealed that the facility had multiple abnormal measured temperatures documented that had not been rechecked and the driver was permitted to enter the campus. On 02/14/22 at 11:17 AM, in an interview with Registered Nurse (RN) 1 and RN 2 stated that COVID 19 screening on all residents, staff and visitors were performed daily. They stated the screening consisted of temperature measurement and sign in form completed at the campus gate. They stated there were no COVID-19 positive residents in the facility at the time of survey and on admission, the resident would be placed in isolation for five days as a precautionary measure. RN 1 and RN 2 stated the facility had 100 percent of the residents vaccinated. On 02/14/22 at 11:54 AM, an observation was made at the screening gate outside of the facility at the entrance of the campus. Six cars were observed, and the following was identified: The first car observed was a staff member and the attendant approached the car, handed the clipboard to the driver, and asked the driver to sign in, then the attendant obtained the drivers temperature via no touch thermometer scan and recorded the temperature on the sign in form. The second car observed was a staff member and the same process as above was performed by the attendant. The third car observed was a staff member and the same process as above was performed by the attendant. The fourth car observed was a visitor and the same process as above was performed by the attendant. The fifth car was a visitor, and the same process as above was performed by the attendant. The six car was a vendor, and the same process was performed as above and in addition there was no key badge offered. The thermometer was not cleaned in between each use as recommended by the manufacturer care instructions. Ref: Extech user's manual dated 2015. On 02/14/22 at 11:54 AM, in an interview with the Screening Gate Attendant (SGA) 1 it was stated the first step of the process was to have the driver of the vehicle sign in on the proper form (vendor form, visitor form, or healthcare form). The SGA 1 stated the next step was to take the driver's temperature and record the temperature on the designated form. The SGA 1 stated resident's residing in the Assistant Living (AL), cottages, and housing on the campus did not have to be screened. It was stated some of the cars have stickers to show which cars can be let through the campus without being screened and the attendants use more than one thermometer in case one is damaged. The SGA 1 further stated she had not calibrated the thermometers and had not been trained on how to calibrate the thermometers or what to do if a thermometers were not working properly. The SGA 1 stated she was not aware of how to tell if the thermometer was not working properly. She further stated she only filled in when security needed help and not everyone performing the screenings know how to troubleshoot the thermometers. The SGA 1 stated she was trained informally on what to do by the other staff that worked at the screening gate. It was observed at the time of the interview there was a total of five thermometers located in the screening station (Extech brand and [NAME] brand). Interview with the Assistant Director of Environmental Services (ADES) at 12:16 PM on 02/14/22 in the conference room revealed not all screening gate attendants were trained on the screening process, calibration, and troubleshooting of the thermometers. The ADES stated the policy was if the temperature measured 99.5 or higher it was policy to call the charge nurse and re check the temperature prior to letting the driver enter the campus. The ADES stated he was not aware of when and how often the thermometers were calibrated or checked for proper working order. The ADES stated he was responsible for the screening station at the entrance of the campus. The ADES stated it would be up to the attendant's personal judgement to determine if the thermometers were working properly or not. He further stated if the temperature was too low or too high continually that should show it was not working properly. When asked was there a range for too low and too high the ADES stated it was a personal judgement on the screener to determine that information. The ADES stated the healthcare staff should enter through the [NAME] entrance because there was a screening kiosk with a concierge staff present. The ADES stated all healthcare staff that would be interacting with residents should enter through the [NAME] entrance and the survey team should have also been directed to enter at that entrance. When asked about the other residents residing on the campus who did not have to be screened, he stated there were only a few on campus and those people were not screened because they were not residents in the skilled Unit. When asked if those residents could enter the skilled area of the building without staff knowledge, the ADES stated yes, they could. In interview with Director of Operations on 02/14/22 at 12:17 PM revealed he stated if the temperature measurements were out of range, the attendant would cross out the first temperature recorded on the form and recheck the temperature and record the new one under the crossed-out temperature and initial. Interview on 02/14/22 at 3:15 PM with the Administrator, Director of Operations (DOO) in the conference room revealed they were not aware of the infection control screening concerns identified by the survey team. They stated they agreed that the drivers entering the campus whose temperatures were out of range per facility policy should have been asked to pull the vehicle to the side of the entrance and have the charge nurse re check/assess the driver prior to entering the campus. The Administrator and the DOO stated the survey team findings did show there was a problem with the facility's process. They both stated they have always received alerts when a staff or visitor's temperature was out of range, and that was how they knew the process was working. However, the Administrator and the DOO expressed they had not been formally monitoring the screening process logs related to the temperature recordings on the sign in form. They further stated they no longer asked COVID 19 symptom questions because they had placed those questions on the sign in forms and that meant when the driver signed the form, they were attesting to not having symptoms of COVID 19. When asked how the facility ensured symptoms of COVID 19 were reported to the appropriate person and that the questions listed on the sign in forms were read and understood, they stated, We see your point and was not sure how that could be ensured. On 02/15/22 at 10:38 AM in an interview with the Administrator, DOO, and President in the Administration office it was revealed the President and the DOO wanted to ask questions and offer additional information related to the facility's screening process. The DOO stated he felt the vendors and the visitor screening forms should not have been reviewed by the survey team because those forms were irrelevant to the identified concerns. He furthered stated the reason for not including the vendors and the visitors in the review of the screening process was that the vendors were given badges to only enter certain areas of the building and the vendors would not be around skilled residents. The Administrator confirmed that the facility administration could not ensure that the vendors and/or the visitors would not enter the area of the building where residents reside without anyone's knowledge. The DOO stated he felt there was no deficient practice because of substantial compliance of the process. It was explained to the Administrator, DOO, and the President that the deficient practice identified was that the screening process had not worked efficiently according to the regulation and facility policy and potentially placed residents residing in the facility at risk for exposure and contracting the COVID 19 virus or its variants. Based on a review of the Daily Screening forms- dated from 02/07/22 through 02/14/22 the following information was identified: Normal Temperature range per best practice. For a typical adult, body temperature can be anywhere from 97 F to 99 F. 02/07/22 22 out of 233 temperatures were measured under 97 F. and one of 233 was measured over 99.5 at 100.7 F. with no re-checks documented on the forms. 02/08/22 29 out of 319 temperatures were measured under 97 F. and one temperature was not recorded. 02/09/22 40 out of 297 temperatures were measured under 97 F. 02/10/22 27 out of 287 temperatures were measured under 97 F. and one temperature was not recorded. 02/11/22 38 out of 261 temperatures were measured under 97 F. 02/12/22 23 out of 136 temperatures were measured under 97 F. 02/13/22 30 out of 130 temperatures were measured under 97 F. 02/14/22 34 out of 210 temperatures were measured under 97 F. one temperature was not recorded, and seven were measured over 99.5 F. with no re-checks documented on the forms. Visitor Sign In forms dated from 02/07/22 through 02/13/22 27 out of 224 were measured under 97 F. four were not recorded, and one was measured over 99.6 F. without rechecks recorded. 286 total of 2097 = 14% error rate Healthcare Sign In forms dated from 02/07/22 through 02/13/22 22 out of 178 were measured under 97 F. two were measured over 99.5 F. without rechecks recorded and one was not recorded. 12% error rate Vendor Sign In forms dated from 02/07/22 through 02/13/22 43 out of 391 measured under 97 F. nine were measured over 99.5 F. without rechecks recorded, and seven were not recorded. 11% error rate Total of 2663 screenings over a seven-day period, 370 were abnormal or not recorded. 14% overall. On 02/16/22 the Allegation of Compliance (AOC) for the IJ in infection control COVID 19 screening was verified and there were no identified concerns. A request was made for screening sign in forms from 02/14/22 through 02/16/22 to verify compliance. The following items were verified: -The Daily Screening - Team Members sign in forms dated from 02/15/22 through 02/16/22 were reviewed and the following was noted: On 02/15/22 there were a total of 326 screenings performed. Out of the 326 screenings; 27 temperatures measured under 97 F. and out of those 27; 2 were not rechecked. There were 6 temperatures measured over 99.5 F. and out of those 3; 1 was not rechecked. The Visitor Sign In forms dated 02/15/22 revealed a total of 56 screenings. Out of the 56 screenings; 4 temperatures measured under 97 F., and all were rechecked. There were no temperatures that measured over 99.5 F. The Vendor Sign In forms dated 02/15/22 revealed a total of 58 screenings. Out of the 58 screenings; 1 temperature measured under 97. F and was rechecked. There were no temperatures measured over 99.5 F. There was a total of 440 screenings and out of the 440 there were 38 abnormal temperatures. Out of the 38; 3 temperatures were not rechecked which resulted in a 0.6% error rate, with much improvement from the initial survey findings. On 02/16/22 there were no abnormal temperatures left without being rechecked. Observations and random staff interviews were completed and retraining for the COVID 19 screenings and facility policy revisions were provided by Administration as stated in the AOC. Educational material and staff sign in sheets were reviewed and were complete. Observation on 02/16/22 at 9:00 AM at the entrance gate of the campus, the screening staff were reminding drivers of the symptom questions, measuring temperatures, and recording. The information was recorded on the forms and signed by the driver. There were five staff members at the entrance screening gate. Observation on 02/16/22 at 10:06 AM at the entrance of the campus, screening staff were reminding drivers of the symptom questions listed and measuring and recording temperatures on the screening forms. Screening staff were observed cleaning thermometers after each use. Transportation Staff 1 was interviewed on 02/16/22 at 10:11 AM and it was stated that he received additional screening in-service training on 02/15/22 of the new screening policy updates. Certified Nursing Assistant (CNA) 1 was interviewed on 2/16/22 at 10:15 AM and she stated that she was designated to take oral temperatures if any driver entering the gate had a temperature above 99.5 degrees or below 97 degrees. CNA 1 stated that she received in-service training on the new screening policy updates. Interview with the Administrator in the conference room on 02/16/22 at 10:18 AM revealed the facility had not been monitoring for temperatures below 97 F and confirmed that it would be a good idea to monitor for temperatures below 97 to determine if the thermometer were in proper working order. She stated there were Assisted Living (AL), Human Resource staff, Security and IT staff that were being screened in the main building at the concierge desk. The Administrator stated there were AL residents that want to visit residents in the skilled unit, and those persons would be screened in the AL area at the kiosk next to the concierge desk and would be given a printed badge after passing the screening to show the person had been screened. The Administrator confirmed all staff were educated on the screening policy and procedure, old thermometers were replaced with new ones, and the screening sign in sheets were being monitored daily since the survey findings. A QAPI interview with the Administrator held on 02/17/22 at 11:42 AM revealed the Administrator confirmed the facility had failed to identify a quality deficiency related to the Infection Control and Prevention Program by not monitoring the effectiveness of the COVID 19 screening process which could have created a risk to resident's health and wellbeing by potentially exposing and/or spreading the COVID 19 virus and its variants. The Administrator confirmed that the facility was aware that there were staff recorded low temperatures measuring under 97.0 F. and had not been aware there were any concerns with the functioning of the thermometers. She further stated all of the thermometers had been replaced as part of the AOC.