F0880

E

Failure to Follow COVID-19 PPE, Isolation, Testing, and Test-Expiration Requirements During Outbreak

Lincolnton, North Carolina Survey Completed on 02-12-2026

Penalty

No penalty information released

Summary

The deficiency involves the facility’s failure to follow its own infection prevention and control policies and current CDC guidance during an ongoing COVID-19 outbreak. The facility policy required staff entering rooms of residents with suspected or confirmed COVID-19 to use an N95 or higher-level respirator, gown, gloves, and eye protection. One resident who tested positive for COVID-19 was placed on transmission-based precautions (TBP) with a door sign specifying gown, gloves, N95, and eye protection. A nurse aide entered this resident’s room wearing a gown, gloves, and mask but without eye protection, and there was no eye protection available on the PPE caddy outside the room. The nurse aide stated she believed her eyeglasses counted as eye protection. The infection prevention (IP) nurse, ADON, Administrator, and Regional Nurse all confirmed that full PPE, including eye protection, was required and that staff had been educated, but they could not explain why the nurse aide did not comply.

The facility also failed to ensure appropriate PPE use during COVID-19 specimen collection. CDC interim guidelines for collecting and handling clinical specimens for COVID-19 require an N95 or higher-level respirator, eye protection, gloves, and gown for healthcare providers collecting specimens or working within 6 feet of patients suspected to be infected. The facility did not have a policy addressing PPE for COVID-19 specimen collection. During observation of resident COVID testing, one unit manager collecting nasal swabs wore an N95, gown, and gloves but did not wear eye protection, while another unit manager handling the specimens in the hallway wore an N95 and gloves. The IP nurse and ADON stated that full PPE, including eye protection, should be worn for COVID testing and that the facility had an adequate supply of face shields. The unit manager who collected the specimen reported she was unsure if eye protection was required and only obtained face shields after consulting someone from corporate.

The facility failed to follow CDC return-to-work criteria for staff with COVID-19 and did not maintain adequate records of staff testing. The facility’s policy referenced CDC interim guidance for managing healthcare personnel with COVID-19 infection, which requires at least 7 days since symptom onset with a negative viral test within 48 hours prior to return (or 10 days if testing is not performed or if the day 5–7 test is positive), and, if using antigen tests, negative tests on day 5 and again 48 hours later. Review of the facility’s COVID-positive staff log showed 12 staff had tested positive, and 9 returned to work before 10 days from symptom onset without documentation of negative tests on both day 5 and day 7. The IP nurse stated staff were tested with antigen tests on day 5 and allowed to return to work on day 7 if that test was negative, and that she did not perform or document a second test on day 7. She also stated staff performed self-testing, that tests were placed in the break room or taken home, and that there was no process to track when staff tested, whether they tested as required, or whether tests were performed according to manufacturer instructions. The facility Physician and Administrator stated the facility should follow its infection control policies and CDC guidance, and the Administrator acknowledged there was no oversight or logging of staff COVID test results.

The facility also failed to maintain TBP for COVID-positive residents in accordance with its policy and CDC guidance. The facility’s policy required residents with mild to moderate illness who were not moderately to severely immunocompromised to remain on TBP for at least 10 days after symptom onset, with additional criteria for severe illness and for test-based strategies requiring two negative tests 48 hours apart. Review of the COVID-positive resident log showed that multiple residents were removed from TBP after 7–9 days from symptom onset, rather than after the full 10 days. The IP nurse stated residents were tested with antigen tests on day 5 and, if negative, were removed from TBP after 7 days; if positive on day 5, TBP continued for 10 days. She reported she did not perform a second test on day 7 before discontinuing TBP and was unaware that two negative tests 48 hours apart were required when using a testing strategy. She also stated that TBP orders were entered for 10 days in the electronic system but were not discontinued when residents were taken off precautions earlier.

Additionally, the facility used expired COVID-19 test kits for resident and staff testing during the outbreak and did not follow manufacturer expiration dates. Observations in the staff break room showed boxes of two different brands of COVID tests with expiration dates already passed. The IP nurse stated three brands of COVID tests, all with listed expiration dates that had passed, were used for staff and resident testing during the outbreak and that she believed the tests could be used for six months beyond the printed expiration date. Customer service representatives for each test manufacturer confirmed that the lot numbers in question did not have extended expiration dates, that the printed expiration dates were final, and that tests used after those dates would not be considered accurate or valid, with potential for false negative or false positive results. The Health Department nurse stated the facility had recently contacted them about using expired tests and that the department was working on guidance. The facility Physician stated that using expired COVID tests could affect test efficacy, that the protein in the test solution breaks down over time, and that expired tests could produce false negative results.