The information below comes from the statement of deficiencies compiled by health inspectors and provided to AHCJ by the Centers for Medicare and Medicaid Services. It does not include the steps the hospital plans to take to fix the problem, known as a plan of correction. For that information, you should contact the hospital, your state health department or CMS. Accessing the document may require you to file a Freedom of Information Request. Information on doing so is available here.

CLARK MEMORIAL HOSPITAL 1220 MISSOURI AVE JEFFERSONVILLE, IN 47130 Dec. 8, 2020
VIOLATION: IC PROFESSIONAL RESPONSIBILITIES POLICIES Tag No: A0772
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**

Based on document review, observation and interview, the infection preventionist failed to ensure the hospital 1) implemented supply optimization strategies based on the facility's current supply capacity (contingency); 2) implemented N95 extended use in accordance with CDC (Centers for Disease Control); 3) implemented a safe crisis capacity limited reuse strategy to reduce the risk of self-contamination in reuse of facemask respirators (N95s) in accordance with CDC; and 4) failed to ensure staff adhered to infection control practices for hand hygiene after touching surgical facemasks in 1 facility during the COVID-19 pandemic.

Findings include:

1. Review of facility protocol/procedure indicated the following: Beginning 3/27/2020 (The Hospital) will begin masking of all employees in patient care areas. It is not advised to re-use a tie mask. However, we do realize Team Members may need to adjust a mask. If that is necessary, team members should perform hand hygiene before and after touching the mask.

Review of the document titled Extended Use and Re-use of PPE (personal protective equipment), dated 3/20/20, indicated the following:
Extended use vs Re-Use:
Extended use refers to the practice of wearing the same N95 respirator for repeated close contact encounters with several different patients, without removing the respirator between patient encounters.
Re-use refers to the practice of using the same N95 respirator by one HCP (health care provider) for multiple encounters with different patients but removing it (i.e. doffing) after each encounter.
Data suggest limiting the number of reuses to no more than five uses per device to ensure an adequate safety margin.
Extended Use Process (not all inclusive): Perform hand hygiene. Don appropriate N95 mask... Discard once mask removed.
Re-Use Process. Doffing (Removing) a N95 respirator intended for storage (not all inclusive): Perform hand hygiene. Remove...Place respirator into a clean paper bag...DO NOT use a plastic or biohazardous bag... Label the clean paper bag with your name and the number of "wears" just completed... A clean paper bag should be used each time the respirator is stored, and placed in a designated clean area.

2. A. Review of the CDC webpage https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html, updated November 23, 2020, indicated the following "Strategies for Optimizing the Supply of N95 Respirators":

As of November 23, 2020; Added considerations for returning to conventional capacity practices:
- Conventional capacity strategies: Combined the sections on training on indications for use and proper use of respirators
- Contingency capacity strategies: Added clarifications on extended use
- Crisis capacity strategies: Added clarifications on limited re-use and decontamination, including clarification on a recommendation to limit the number of reuses to no more than five uses (five donnings) per device to ensure adequate respirator performance if no manufacturer guidance is available. Removed the strategy of designating convalescent HCP for provision of care to confirmed or suspected COVID-19 patients.

Surge capacity refers to the ability to manage a sudden increase in patient volume that would severely challenge or exceed the present capacity of a facility...Three general strata have been used to describe surge capacity and can be used to prioritize measures to conserve N95 respirator supplies along the continuum of care.
- Conventional capacity: measures consisting of engineering, administrative, and PPE controls should already be implemented in general infection prevention and control plans in healthcare settings.
- Contingency capacity: measures that may be used temporarily during periods of expected N95 respirator shortages. Contingency capacity strategies should only be implemented after considering and implementing conventional capacity strategies. While current supply may meet the facility ' s current or anticipated utilization rate, there may be uncertainty if future supply will be adequate and therefore, contingency capacity strategies may be needed.
- 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.
CDC ' s optimization strategies for N95 respirator supply offer a continuum of options for use when PPE supplies are stressed, running low, or exhausted. Contingency and then crisis capacity measures augment conventional capacity measures and are meant to be considered and implemented sequentially.

While engineering and administrative controls should be considered first when selecting controls, the use of personal protective equipment (PPE) should also be part of a suite of strategies used to protect personnel...The program should also include provisions for the cleaning, disinfecting, inspection, repair, and storage of respirators used by HCP on the job according to manufacturer ' s instructions.

Practices allowing extended use of N95 respirators, when acceptable, can also be considered.
Contingency Capacity Strategies: EXTENDED USE OF N95 RESPIRATORS: Extended use refers to the practice of wearing the same N95 respirator for repeated close contact encounters with several different patients, without removing the respirator between patient encounters...When practicing extended use of N95 respirators over the course of a shift, considerations should include 1) the ability of the N95 respirator to retain its fit, 2) contamination concerns, 3) practical considerations (e.g., meal breaks), and 4) comfort of the user. Ideally, N95 respirators should be discarded after extended use. If it is necessary to re-use N95 respirators in addition to extended use, please see re-use section under crisis capacity strategies below.
Crisis Capacity Strategies: LIMITED RE-USE OF N95 RESPIRATORS: Re-use refers to the practice of using the same N95 respirator by one HCP for multiple encounters with different patients but removing it (i.e. doffing) after each encounter. This practice is often referred to as "limited reuse" because restrictions are in place to limit the number of times the same respirator is reused...Limited re-use of N95 respirators when caring for patients with [DIAGNOSES REDACTED]-CoV-2 infection might also become necessary. However, it is unknown what the potential contribution of contact transmission is for [DIAGNOSES REDACTED]-CoV-2, and caution should be used...If no manufacturer guidance is available, data suggest limiting the number of reuses to no more than five uses (five donnings) per device by the same HCP to ensure an adequate respirator performance...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. If no manufacturer guidance is available, a reasonable limitation should continue to be five total donnings regardless of the number of hours the respirator is worn.
The surfaces of a properly donned and functioning NIOSH-approved N95 respirator will become contaminated with pathogens while filtering the inhalation air of the wearer during exposures to pathogen laden aerosols. The pathogens on the filter materials of the respirator may be transferred to the wearer upon contact with the respirator during activities such as adjusting the respirator, improper doffing of the respirator, or when performing a user-seal check when redonning a previously worn respirator. One potentially 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 patients with [DIAGNOSES REDACTED]-CoV-2 infection 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 [DIAGNOSES REDACTED]-CoV-2 (the virus that causes COVID-19).4 If this strategy is used, the total number of donnings should still not exceed five times before discarding the respirator, when no manufacturer instructions are provided to indicate otherwise.

3. On 12/8/20, the following was observed during facility tour between approximately 11:00 AM and 12:15 PM:
During interview with staff member N1, Registered Nurse (RN) he/she repeatedly touched the front of their facemask without performing hand hygiene before or after touching.
During interview with staff member N2, RN, he/she repeatedly touched the front of their facemask without performing hand hygiene before or after touching.
At the nurses station of the Critical Care Unit (CCU) two brown paper bags for N95 storage were observed sitting on the desk.
During interview with staff member N5, RN, he/she repeatedly touched the front of their facemask without performing hand hygiene before or after touching.
On 12/8/20, the following was observed during facility tour between approximately 2:00 PM and 3:00 PM:
In the rehabilitation room of the orthopedic unit, sitting in a corner of the room were at least 19 brown paper bags with what appeared to be used PPE (noted were facesheilds, N95s, surgical masks and hair covers) inside the partially opened bags. One used appearing surgical mask was noted lying on the floor. At least 3 of the bags were numbered 1-5 with marks through some of the numbers (appeared to indicate number of uses), other bags had staff names or initials.
During interview with staff member N9, pharmacy staff, he/she showed this surveyor that he/she kept his/her N95 stored in a file drawer at the nurse's station in a plastic biohazard bag.

4. On 12/8/20, the following was indicated in interview beginning at approximately 11:15 AM:
Staff member N1, indicated that staff extend use of N95s by using 1 mask all day during a shift. N1 also indicated N95s are re-used up to 5 uses. N1 indicated in between uses the N95s are stored in a brown bag with a number written on the bag to indicate the number of uses (1-5).
Staff member N2 indicated staff re-use N95s up to 5 times.
Staff member MD1, Physician, indicated N95s were reused and were kept in paper bags between uses. He/she indicated N95s were to be reused 5 times.
Staff member N3, Environmental Services, indicated he/she wears the same N95 all day and stores it in a brown bag when at lunch.
Staff member N4, RN, indicated the only PPE being reused are N95 respirators. He/she indicated that staff are to use the same one all day and store it in a paper bag between uses. He/she indicated the respirator could come off during the day and that is when it would be stored in the bag. He/she indicated that if it were used with a COVID positive patient, he/she would discard the N95 at the end of the day.
Staff member N5 indicated that N95s were stored in brown bags after removal and that they use the same N95 throughout the day/shift. N5 indicated the same N95 could then be reused for following shifts and that he/she had used the same N95 for 2-3 days in a row.

Beginning at approximately 1:30 PM, A2, Infection Preventionist, indicated the following:
The facility's guidelines for reuse of N95s was an extended use with limited reused procedure that called for staff to use the same N95 between all patients so long as no aerosolizing procedures were performed and the respirator was not notably soiled. A2 indicated that between uses the N95 was to be stored in a bag for later reuse, up to 5 times.

Between approximately 2:00 PM and 3:00 PM:
Staff member N7, Occupational Therapy Staff, verified that the brown bags on the floor of the rehabilitation room were the storage bags for N95s/PPE to be reused.
Staff member N9 indicated N95s are reused and stored by individuals between uses. N9 indicated he/she kept his/her N95 in a plastic biohazard bag in a file drawer at the nurse's station.
A1, Chief Nursing Officer, indicated the hospital was currently "in yellow" for their surge plan which meant they were in contingency capacity for PPE use and were not in crisis capacity.