HospitalInspections.org

Based on observations, staff interviews, and review of facility documents and CDC guidelines, it was determined the facility failed to ensure an effective infection control program to prevent and control the spread of infectious diseases, including COVID-19.

Findings include:

1. The facility failed to ensure the contingency plan for N95 respirator use was in accordance with the CDC recommended guidelines. (Refer to Tag A-0749)

2. The facility failed to ensure hospital-wide procedures are developed and implemented in adherence to nationally recognized guidelines. (Refer to Tag A-0772).

3. The facility failed to ensure auditing for adherence includes current protocols the facility adopted for N95 respirator conservation strategies. (Refer to Tag A-0776)

Based on random observations, staff interviews, review of facility documents and Centers for Disease Control and Prevention guidelines, it was determined that the facility failed to ensure the contingency plan for N95 mask use was in accordance with the Centers for Disease Control and Prevention (CDC) guidance for optimizing N95 respirator masks.

Findings include:

Reference #1: CDC website - https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html#contingency, section, "Contingency Capacity Strategies (during expected shortages) ...Extended use of N95 respirators ... When practicing extended use of N95 respirators over the course of a shift, ...N95 respirators should be discarded immediately after being removed. If removed for a meal break, the respirator should be discarded and a new respirator put on after the break. ..."

Reference #2: CDC website - https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html#crisis, section, "Limited re-use of N95 respirators" states, "... During times of crisis, practicing limited re-use while also implementing extended use can be considered. If limited re-use is practiced on top of extended use, caution should be used to minimize self-contamination and degradation of the respirator. ..."

Reference #3: Facility policy titled, "Standard Precautions" in section, "Cleanliness of Work Environment" states, "... Keep other work areas clean and separate clean and dirty items from each other. ..."

1. On 12/15/21 at 10:10 AM, Staff #1, Staff #2 and Staff #3 stated the facility is currently experiencing a COVID-19 outbreak that was identified on 11/12/2021 and staff have been instructed to follow the CDC COVID-19 protocol for limited re-use of N95 respirators.

a. Staff #1 and Staff #2 stated, on 11/30/21 a governing body meeting was held and although they have an adequate supply of N95 respirators, it was determined the increased volume of COVID-19 cases being admitted would deplete their supplies. At this time, a system decision was made to allow staff to reuse one N95 respirator per shift and follow the protocol.

b. Staff #2 provided documentation from the 11/30/21 governing body meeting: "Due to an increase in COVID community transmission [Staff #4's name] (hospital's epidemiologist and hospitalist) in conjunction with Network IP and Supply/Distribution reports that [sic] due to omicron variant and sharp increase in cases that will use N95s as "Extended Use" under CDC contingency use of masks. ..."

c. Upon request, the current written protocol was provided in the policy and procedures binder under "Tab 13" titled, "PPE Conservation Plan (Extended/Reuse of PPE) and reviewed with Staff #1 and Staff #2. The facility document titled, "Infection Prevention ... Guidelines for Reusing an N95 Respirator" states, "1. Obtain a new disposable N95 respirator mask. 2. Write your name on the mask .... 3. Make a tally mark on the strap to indicate this is the first use. 4. The respirator should be inspected before each use to ensure its physical integrity is intact .... 6. After use: .... 7. Place the used N95 respirator into a new paper bag each time .... 8. Place the paper bag in a designated storage area on the unit ... 15. Repeat the process until the mask is used (donned and doffed) 5 times or is discarded at the end of a continuous shift of use. ..."

d. The practices the facility has adopted for staff to utilize for their PPE Conservation Plan (Extended/Reuse) for N95 respirator reuse does not adhere to the CDC "Strategies for Optimizing the Supply of N95 Respirators" guidelines to include 'Extended Use' which indicates discarding the respirators when/if they are removed.

2. On 12/15/21 at 1:00 PM during a tour on the 3 South unit, the dedicated COVID-19 unit, Staff #1, Staff #5 and Staff #8 confirmed staff are provided N95 respirators at the beginning of each shift by their supervisor and should write their names on their respirators. Tally marks should also be written on the respirators tracking donning and doffing up to a maximum of five (5) times for each respirator. Staff are provided paper bags to keep their reused respirators if/when they need to take them off during their working shift. Staff should write their names on the outside of their bags and store them in the designated storage area on the unit.

a. On 12/15 at 1:05 PM, on 3 South, upon interview, Staff #6 confirmed she/he is assigned to care for multiple COVID-19 patients and wears his/her N95 respirator without changing between patients and can re-use the respirator during one (1) continuous shift up to 5 times and place it in a paper bag when not in use.

b. On 12/15 at 1:20 PM, Staff #9 stated she/he was fit-tested for his/her N95 respirator on 12/9/21, wore the respirator for the remaining part of his/her shift and then placed it in a paper bag provided by the facility to store it, and reused the same N95 respirator on a new shift on 12/14/21.

c. At 1:40 PM, Staff #1, Staff #5 and Staff #8 stated all staff should be discarding there N95 respirators at the completion of their shifts. The paper bags are only provided to store their respirators in during working hours if/when they need to take them off.

3. On 12/21 at 11:06 AM on 3 South, Staff #16, confirms she/he cares for multiple positive COVID-19 patients and was instructed to reuse his/her N95 respirator up to 5 times/day and place it in a paper bag to store it when taken off. The respirator is allowed to be re-used if it is in good condition.

a. On 12/21 at 11:19 AM Staff #26 and Staff #27 confirmed they receive a new N95 respirator each shift and can use it up to 5 times. They mark their names on their respirator, put a mark for the number of times used, and place the respirator in a new paper bag every time they are stored in the breakroom.

4. On 12/21 at 11:00 AM, on 3 South, observed on the breakroom table, the unit's designated area, was the following: two (2) coffee cups, two (2) drinking containers, one (1) roll of paper-towels, two (2) stethoscopes, and four (4) empty paper bags provided for N95 respirator storage - three (3) bags were labeled with Staff #12's name, Staff #14's name with date and Staff 15's name with date and one (1) empty-unlabeled paper bag.

a. There was no separation of clean and dirty areas and items to avoid cross-contamination.

5. On 12/21 at 11:20 AM at the 3 North hallway documentation station located outside of the unit, Staff #17, a hospitalist, was wearing a KN95 respirator. Upon interview Staff #17 confirmed she/he does provide care to positive COVID-19 patients and wears an N95 respirator when providing care to positive COVID-19 patients. Staff #17 confirmed her/his N95 respirator is in a paper bag up on 4 North unit at the doctor's documentation station.

a. At 11:30 AM, on 4 North, in the presence of Staff #1, Staff #8 and Staff #17, Staff #17's N95 respirator was found stored in a paper bag at the doctor's documentation station.

b. At 11:32 AM Staff #1 and Staff #8 confirmed the 4 North unit's designated area for all staff to store their reused N95 respirators during shift hours is on hooks in the unit's staff breakroom.

c. At 11:40 AM, a tour of the 4 North breakroom was conducted. One (1) wall had hooks applied to the wall and there was one (1) hook on the back of the door. There were no stored respirator or bags observed in the breakroom. Upon inquiry of how staff hang the paper bags, Staff #1 and Staff #8 stated staff are to place their paper bags into patient belonging bags and hang them by their pull-strings. Staff #1 and Staff #8 could not provide written evidence for this protocol step for staff to follow.

d. At 11:45 AM Staff #14 confirmed she/he was not assigned to COVID-19 patients on this current shift, however, did retrieve and present his/her "unused" N95 respirator. The respirator was in a paper bag, rolled up and crammed into Staff #14's personal belongings shoulder pouch with his/her other personal items. The physical integrity of the respirator was visibly compromised displaying bent, crushed and curled areas effecting all surfaces.

e. At 11:45 AM Staff #20 had his/her initials on the outside of his/her respirator and confirmed she/he keeps it in her pocket when she/he takes it off during the shift.

6. On 12/21 during a tour of the Intensive Care Unit (ICU) with Staff #2, Staff #22, and Staff #28. During the tour Staff #28 confirmed the ICU has dedicated areas for staff to store their reused N95 respirators when placed in paper bags near their assigned patient rooms.

a. At 11:23 AM, Staff #22 confirms she/he cares for multiple positive COVID-19 patients, was instructed to reuse his/her N95 respirator up to 5 times/day and when/if taken off; place it in a provided paper bag, and store it in the designated areas on the unit. The respirator is only allowed to be re-used if it is in good condition.

b. At 11:38 AM Staff #30 confirms she/he cares for multiple positive COVID-19 patients, was instructed to reuse his/her N95 respirator up to 5 times/day and when/if taken off; place it in a provided paper bag, and store it in the designated areas on the unit. The respirator is only allowed to be re-used if it is in good condition.

7. The above findings were confirmed at the times of discovery.

On December 21, 2021, an Immediate Jeopardy (IJ) finding was identified related to Infection Control (Tag A-749), due to reused N95 staff respirators not being properly stored in a designated area to prevent cross-contamination.

The facility was notified of the IJ on December 21, 2021 at 4:05 PM and submitted an acceptable removal plan on December 22, 2021.

On December 22, 2021, the survey team was onsite and verified full implementation of the removal plan, which included, observation of the facility's revised process for the proper storage of reused N95 masks in marked designated areas; staff interviews; and review of staff education. The IJ was removed at 12:10 PM.

On 1/7/2022, at 10:20 AM, the facility was notified that a revision to the IJ included reused N95 respirators not being discarded once removed in accordance with CDC guidelines. A revised IJ Template was provided to the facility. On 1/7/2022, the facility submitted an acceptable removal plan.

On 1/10/22, the survey team was onsite and verified full implementation of the removal plan, which included immediately halting the "limited reuse" of N95 respirators and practicing only "Extended Use." There was verification that the facility disassembled the designated storage areas with removal of reused supplies; process change signage was posted throughout the units; facility staff were educated on the new process; and implementation of the new process was verified through compliance monitoring.

Based on random observations, staff interviews, review of facility's written processes and CDC guidelines, it was determined that the Infection Preventionist failed to ensure hospital-wide "Facial PPE Guide for Patient Interactions" procedures are developed and implemented in adherence to nationally recognized guidelines.

Findings include:

Reference #1: CDC website https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html#contingency section, "Contingency Capacity Strategies (during expected shortages) ...Extended use of N95 respirators ... When practicing extended use of N95 respirators over the course of a shift, ...N95 respirators should be discarded immediately after being removed. If removed for a meal break, the respirator should be discarded and a new respirator put on after the break. ..."

Reference #2: CDC website - https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html#crisis, section, "Limited re-use of N95 respirators" states, "... During times of crisis, practicing limited re-use while also implementing extended use can be considered. If limited re-use is practiced on top of extended use, caution should be used to minimize self-contamination and degradation of the respirator. ..."

1. On 12/21/21 Staff #1, provided the facility's written PPE Conservation Plan for Extended/Reuse of N95 respirators, titled, "Facial PPE Guide for Patient Interactions" and confirmed it is the facility's current process for staff to reuse N95 respirators.

a. Upon review the document states, "... Request a new N95 respirator after 1 continuous shift, after donning/doffing 5 times and/or if a seal is not able to be achieved or if it is physically damaged or visibly soiled. ..." Staff #2 confirmed that the above policy is the current process for the facility's PPE conservation plan for reusing N95 respirator.

b. The facility's above process for extended reuse of an N95 respirator does not comply with the updated CDC guidelines dated, September 16, 2021, which were in effect, and includes reference to the April 9, 2021 update which was also in effect for "contingency capacity strategies." The guidelines' updates clarify: "For extended use of N95 respirators as PPE, clarified that N95 respirators should be discarded immediately after being removed. ...

c. The practices the facility has adopted for a conservation plan for N95 respirator extended/reuse does not adhere to both CDC guidelines for "Strategies for Optimizing the Supply of N95 Respirators, ... Extended Use" that includes discarding N95 respirators when/if they are removed during the course of a shift.

2. On 1/10/22 at 9:40 AM Staff #1 and Staff #2 confirmed the above findings.

Based on staff interviews and review of facility documents, it was determined that the facility's infection control professional failed to ensure staff were adhering to all elements of the protocol the facility adopted for reuse of N95 respirators.

Findings include:

Reference #1: Facility Job Description for Job Title: Infection and Quality Management Coordinator, includes in section Job Duties and Responsibilities, "...11. Evaluates, recommends and institutes measures directed toward safe, cost effective, and quality patient care as it relates to infection control and prevention. ..."

Reference #2: Facility document titled, "Infection Prevention ... Guidelines for Reusing an N95 Respirator" states, "1. Obtain a new disposable N95 respirator mask. 2. Write your name on the mask .... 3. Make a tally mark on the strap to indicate this is the first use. 4. The respirator should be inspected before each use to ensure its physical integrity is intact .... 6. After use: .... 7. Place the used N95 respirator into a new paper bag each time .... 8. Place the paper bag in a designated storage area on the unit ... 15. Repeat the process until the mask is used (donned and doffed) 5 times or is discarded at the end of a continuous shift of use. ..."

1. On 12/15/21 at 3:20 PM, a request was made of Staff #2, the facility's certified infection professional, for audit documentation tools completed for units with positive COVID-19 patients related to adherence to current protocol for personal protective equipment (PPE) and N95 respirator use.

2. On 12/21/21, Staff #2 provided the auditing observation tool utilized for 2021 dates: 11/12, 11/16, 11/19, 11/22, 11/24, 11/26, 11/30, 12/2, 12/17, and 12/20 titled, "Infection Control Isolation Surveillance."

a. The provided audit tools used during observation rounds for the above dates do not include surveillance for staff writing their names on their respirators, tally markings being utilized, physical integrity checks, paper bag use, proper storage, being discarded at the 5-time rule and/or being discarded at the end of a continuous shift.

b. The audit tool has not been adapted to reflect the current protocols in place the facility has adopted for N95 respirators conservation strategies.

3. On 12/21/21 at 4:15 PM Staff #1 and Staff #2 confirmed the above findings.