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200 EAST MARKET STREET

AKRON, OH null

INFECTION CONTROL PROGRAM

Tag No.: A0749

Based on interview, observation, review of Centers for Disease Control guidance and review of facility documents, the facility failed to employ methods for preventing the transmission of COVID-19. This had the potential to affect patients receiving services from the facility. The facility census was 43 patients at the time of survey.

Findings include:

Observations on the ICU were started at 9:05. At 9:15 AM Staff C (RN) was observed to remove the cloth mask and surgical mask he/she was wearing. Staff C walked behind the nurses station and removed an N95 respirator from a plastic bag hanging on a computer/medication cart. Staff C donned the N95 respirator and proceeded to ICU room 2. The patient in ICU room 2 was in Contact and Airborne isolation precautions plus eyewear.

Outside of the room, Staff C donned gown, gloves and a face shield went into. Prior to exiting ICU 2 Staff C removed the gloves and gown, however, the N95 remained on his/her face.

At 9:23 AM Staff C then walked around the unit, in and out of medication room, and finally to ICU room 1. Staff C stood inside the doorway to the room preparing medications for the patient. At 9:40 AM, with the same N95 respirator on, Staff C proceeded all the way in to ICU room 1 to administer medications.

Staff A was made aware of these observations at 10:20 AM.

Six staff members were interviewed one on one by telephone on 11/17/20 between 12:58 PM and 2:43 PM. The staff included one Infection Control RN, one Respiratory Therapist, three RN's, and one STNA (state tested nurse aide). When asked about the re-use of N95 respirators, one staff member stated he/she was able to re-use the same N95 for seven assigned working days. Five staff members explained the N95 respirator was able to be re-used for only seven calendar days. One staff member stated if they received an N95 on a Thursday, they would request a new one on the following Friday. All staff confirmed they were assigned one N95 respirator at a time, and no staff were aware of the recommended 72 hour rest period.

A review of the Center for Disease Control webpage, "Recommended Guidance for Extended Use and Limited Reuse of N95 Filtering Facepiece Respirators in Healthcare Settings," was completed on 11/19/2020. The review revealed N95 masks were to be donned a maximum of five times in the absence of manufacturer guidelines, and discarded sooner under other circumstances. The webpage listed those circumstances as after aerosol generating procedures or contamination with blood, respiratory secretions and other body fluids.

Additionally the CDC guidance notes "One effective strategy to mitigate the contact transfer of pathogens from the respirator to the wearer could be to issue each HCP who may be exposed to COVID-19 patients a minimum of five respirators. Each respirator will be used on a particular day and stored in a breathable paper bag until the next week. This will result in each worker requiring a minimum of five N95 respirators if they put on, take off, care for them, and store them properly each day. This amount of time in between uses should exceed the 72 hour expected survival time for SARS-CoV2 (https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html).

According to the CDC "Crisis capacity: strategies that are not commensurate with U.S. standards of care but may need to be considered during periods of known N95 respirator shortages. Crisis capacity strategies should only be implemented after considering and implementing conventional and contingency capacity strategies. Facilities can consider crisis capacity when the supply is not able to meet the facility's current or anticipated utilization rate."

Facility document PPE and Room Guidance During Extended Universal Mask Use (revised 08/14/20) was reviewed and revealed if the patient requires aerosol generating procedures (AGP) an N 95, eye protection, gown, and gloves must be worn. The document further specified the N 95 may be placed in a paper bag and reused on COVID recovery patients for up to seven (7) days.

On 9:14 AM on 11/18/20 Staff A responded to questions regarding the facility's decision to re-use and/or extend the use of N 95 respirators. Staff A explained the facility cannot order anything from the ordering system since shortly after the pandemic started. Staff A stated it's supplier based. Staff A stated the facility's supplies are all corporate driven, materials puts their inventory in daily and supplies are shipped to us as needed. Staff A further stated the facility has never been out of supplies. Once the facility goes below a certain amount, new supplies is shipped to them.

At 1:29 PM on 11/18/20 Staff A was asked for information that supported the facility's decision to re-use and/or extend the use of N 95 respirators. Staff A was asked for evidence of a need to implement crisis capacity strategies in accordance with CDC guidelines.

Staff A was asked again for said information related to crisis capacity strategies again on 11/19/20 at 6:22 AM and 10:17 AM. At 11:28 AM Staff A provided information specifically related to the quantities of N 95's allocated to the facility by it's supplier.

On 11/19/29 at 12:32 PM Staff A provided the following response from facility corporate staff: "There is no CDC recommendation on the amount of days an N95 can be used. The CDC guidance gave recommendations of various ways to use N 95's in critical shortage circumstances using, reuse or extended use strategies. The facility determines the processes they will use. This guidance goes all the way to not having any N 95's and how to manage. In other words, hospitals need to evaluate their supply chain, their inventory, burn rate, and then determine the best way to protect staff with their current supply of N 95's" and "our process of 1 mask per patient per 7 days with the instructions on when to change and to check N95 condition prior to each use is based on not only on the hospital inventory but takes into consideration our corporate stockpile."

At 2:29 PM the facility's CEO was asked for any additional evidence of following CDC guidelines for the implementation of crisis capacity strategies. No additional documented evidence was provided by the facility prior to exit.

This finding substantiates Substantial Allegation OH00116998.