HospitalInspections.org

Based on staff interviews and review of facility policy and procedure, it was determined that the facility failed to ensure that medication room inspections on COVID-19 positive patient units were completed by the contracted pharmacy consultant.

Findings include:

Reference: Facility policy titled, "Medication Room Inspections" states, "... Each nursing station/ medication room/ exam rooms... will be inspected monthly by the consultant pharmacists. Purpose: To ensure that nursing stations/ medication rooms/ exam rooms... are clean and medications are stored in a safe manner according to State and Federal requirements... ."

1. Upon interview on 1/18/22 at 11:30 AM, Staff #16 stated that pharmacy personnel do not enter designated COVID-19 positive patient care units.

a. Upon interview on 1/18/22 at 1:15 PM, Staff #1 stated that the facility had a contract with a pharmacy consultant to conduct monthly medication room inspections.

b. Upon interview on 1/19/22 at 2:06 PM, in the presence of Staff #1, Staff #23 and Staff #24, who identified themselves as consultant pharmacists, stated that they do not conduct monthly medication room inspections on designated COVID-19 positive units due to infection control issues.

2. Upon request on 1/19/22, Staff #23 and Staff #24 failed to provide a written memo, protocol, or policy stating that the medication room inspections should be suspended on COVID-19 positive patient care units.

3. On 1/19/22 at 3:00 PM, review of the monthly "Medication Room Inspection" reports was conducted with Staff #24. There were no inspection reports for the Lincoln Gym and King Cottage, two (2) designated COVID-19 positive patient care units. Staff #24 confirmed that the medication room inspection was never conducted in the Lincoln Gym, a temporary unit, and had not been completed in King Cottage, a permanent unit, in over a year.

4. Upon interview on 1/19/22 at 2:15 PM, Staff #1 stated that the medication room inspections should be conducted on all patient care units on a monthly basis, in accordance with facility policy. Staff #1, Acting Chief Executive Officer, indicated that he/she was not aware that these inspections were not being completed on all units.

Based on observation, staff interview and review of facility policies and procedures, it was determined that the facility failed to ensure that adequate emergency equipment was immediately available and maintained in a COVID-19 positive patient care unit.

Findings include:

Reference #1: Facility policy titled, "Monitoring Emergency Equipment" states, "... Emergency equipment consists of the Emergency Oxygen tank, the Emergency Bag with its contents, Suction Equipment, AED [Automated External Defibrillators] and Personal Protective Equipment (PPE)... If equipment is not present, not intact, not charged... notify the SON [supervisor of nurses] and follow up with Clinical Support Services... Document on the 24-hour report until the equipment is repaired or replaced... ."

Reference #2: Facility policy titled, "Medical Emergencies" states, "... All crash carts located on nursing units are to be checked by licensed nursing staff every shift. Automatic Defibrillator is to be checked every shift... In patients areas, the RN [registered nurse] checks every shift and completes the logs on the crash cart and the 24-hour report... All emergency equipment will be regularly inspected through the Clinical Support Services Department monthly... ."

1. During a tour of the Lincoln Gym, a COVID-19 positive patient care unit, on 1/18/22 at 11:50 AM, it was observed that an AED and suction were not immediately available for use in an emergency.

a. This finding was confirmed by Staff #3 and Staff #16 on 1/18/22 at 11:55 AM.

(i) On 1/18/22 at 3:00 PM, Staff #1 provided pictures to show that the AED and suction were replaced and immediately available in the Lincoln Gym patient care unit.

2. Upon interview on 1/19/22 at 1:20 PM, Staff #1 stated that the Lincoln Gym has been utilized as an overflow patient care area for COVID-19 positive patients since 12/30/21.

a. Upon request on 1/19/22 at 1:20 PM, Staff #1 and Staff #20 failed to provide the emergency equipment logs and 24-hour reports for the crash cart, and the Clinical Service Department reports for the emergency equipment located in the Lincoln Gym.

b. On 1/19/22 at 1:25 PM, Staff #1, Staff #20, and Staff #25 confirmed that the emergency equipment located in the Lincoln Gym had not been inspected, as required by facility policy.

Based on observations, staff interviews, and review of facility policies and procedures, it was determined that the Governing Body failed to develop and implement a respiratory protection program, in accordance with Occupational Safety and Health Administration (OSHA) standards that includes: development of a contingency plan for N95 respirator mask reuse, N95 fit testing of employees, and proper donning and doffing of N95s.

Findings include:

The facility failed to develop and implement a respiratory protection program, in accordance with Occupational Safety and Health Administration (OSHA) standards, that includes development of a contingency plan for N95 reuse, N95 fit testing of employees, and proper donning and doffing of N95s. (Cross Refer to Tag 0315)

Based on observations, staff interviews, review of OSHA guidelines, and review of CDC guidance, it was determined the Governing Body failed to develop and implement a respiratory protection program, in accordance with Occupational Safety and Health Administration (OSHA) standards, that includes development of a contingency plan for N95 reuse, N95 fit testing of employees, and proper donning and doffing of N95s.

Findings include:

Reference #1: Occupational Safety and Health Administration (OSHA) (29 CFR 1910.134) https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.134 states, " ... A respirator shall be provided to each employee when such equipment is necessary to protect the health of such employee. The employer shall provide the respirators which are applicable and suitable for the purpose intended. The employer shall be responsible for the establishment and maintenance of a respiratory protection program... Procedures for proper use of respirators in routine and reasonably foreseeable emergency situations; 1910.134(c)(1)(v)... Training of employees in the proper use of respirators, including putting on and removing them, any limitations on their use, and their maintenance... ."

1. Upon interview on 1/18/22 at 2:15 PM, Staff #1, Staff #4, and Staff #5 indicated that they were unaware that a Respiratory Protection Program was required. Staff #1, Staff #4, and Staff #5 confirmed that the facility has not developed a Respiratory Protection Program.

2. During a tour of the Lincoln Gym on 1/18/22 at 11:18 AM, the following was observed:

a. The Lincoln Gym is a dedicated COVID-19 positive unit with a current census of eleven (11) COVID-19 positive patients. All staff members on the unit were observed wearing a Makrite 9500-N95 respirator.

b. Staff #10 and Staff #11 were observed wearing surgical masks underneath their Makrite 9500-N95 respirators, which is not in accordance with manufacturer's guidelines.

(i) Upon interview at 12:00 PM, Staff #12 stated that he/she wore a surgical mask underneath the N95 because it was rubbing against his/her nose and made it uncomfortable.

3. During a tour of the Kings Cottage on 1/18/22 at 12:20 PM, the following was observed:

a. Kings Cottage is a COVID-19 positive unit with a current census of eight (8) COVID-19 positive patients. All staff members on the unit were observed wearing a Makrite 9500-N95 respirator.

b. Staff 12 and Staff #13 were observed wearing a surgical mask underneath their Makrite 9500-N95 respirators, which is not in accordance with manufacturer's guidelines.

4. On 1/18/22 at 12:45 PM, Staff #16 and Staff #17 confirmed that Staff #10, Staff #11, Staff #12, and Staff #13 were wearing their N95 respirator masks improperly.

5. On 1/18/22 at 1:08 PM, a request was made to Staff #1 for evidence of N95 fit testing of staff. The facility was unable to provide evidence that staff were fit tested or received a medical evaluation to use the provided N95 respirators.

a. Upon interview on 1/18/22 at 1:10 PM, Staff #1 stated that N95s were used according to manufacturer's instructions. Staff #1 stated that he/she knew fit testing was needed but was unable to acquire a vendor to perform N95 fit testing.

b. Staff #1 confirmed that fit testing for N95 respirators was not completed for any staff.

Reference #2: Centers for Disease Control and Prevention (CDC): https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html#crisis states, " ... 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. ... ."

1. On 1/18/22 at 12:43 PM, during a tour of the staff doffing area in Kings Cottage, three (3) Makrite 9500-N95 respirators were found lying uncovered on a closet shelf.

2. Upon interview on 1/18/22 at 12:35 PM, Staff #26 stated that when he/she removes the N-95 mask for a break, he/she removes the mask in the doffing area and places the mask on the open shelf or hook in that area. Staff #26 stated that he/she would reuse that mask after his/ her break. Upon further questioning, Staff #26 confirmed that he/she does not put the used N-95 mask in a paper bag, but only hangs it on the hook or on the shelf uncovered.

3. Upon interview on 1/18/22 at 12:40 PM, Staff #27 stated that he/she doffs the mask in the doffing area prior to any break and leaves the mask on the shelf.

4. Upon interview on 1/19/22 at 10:13 AM, Staff #1 confirmed that the facility has an adequate supply of N95s respirators and that there are currently no supply shortages. Staff #1 stated that N95 respirators were being reused from the initial Personal Protection Equipment (PPE) shortage and was not reevaluated with Infection Prevention since the beginning of the pandemic.

5. Upon request, the facility was unable to provide a documented contingency plan for N95 reuse. Upon interview on 1/19/22 at 2:18 PM, Staff #1, Staff #4, and Staff #5 stated that the facility should not be reusing N95 respirators because they have not developed a contingency plan as to why N95 respirator masks need to be reused.

Based on staff interviews, review of facility policies and procedures, and review of four (4) of four (4) personnel files (#15, #18, #19, #22), it was determined the facility failed to ensure all nurses responsible for quality assurance activities receive a job description indicating job responsibilities, orientation, and performance assessment reviews.

Findings include:

Reference #1: Facility policy titled, "Orientation" states, "I. Policy A. The Orientation process is begun on the first day of employment. The new hire receives an orientation to his/her work environment, his/her job responsibilities... II. Responsibility and Procedure A. Personnel... The Personnel Department initiated the orientation process by providing the new employee with the following information: 1. An Orientation Checklist outlining information to be reviewed with the new employee by his/her Department Head, Supervisor, or designee... ."

Reference #2: Facility policy titled, "Staff Performance Assessment" states, "... Procedure... All newly hired full or part time members (inclusive of classified titles) and staff members who are promoted or reassigned another supervisor must receive a performance agreement within two (2) weeks of effective date of the action... ."

1. Upon interview at 10:00 AM, Staff #1 stated that four (4) licensed practice nurses (LPNs) were currently working in adjusted roles as quality improvement (QI) for nursing and not in direct patient care.

2. During an interview with Staff #22 at 12:44 PM, the following was revealed:

a. Staff #22 stated that the job description given to him/her for the new position was titled, "Licensed Practice Nurse," the same as his/her previous role as a LPN, and was not updated with additional job responsibilities.

b. Staff #22 confirmed that the new role did not include direct patient care. He/she stated that the new role includes performing nursing audits for medication rooms, treatment rooms, charts, medication books, and to re-educate registered nurses (RNs) on medication reconciliation.

c. Staff #22 stated that there was no formal orientation conducted and no yearly performance assessment conducted for this new role.

3. Review of the personnel records for Staff #15, Staff #18, Staff #19, and Staff #22 lacked evidence of updated job descriptions, orientation, and performance assessment reviews.

4. Upon request, the facility was unable to provide updated job descriptions, orientation checklists, or performance assessment reviews for Staff #15, Staff #18, Staff #19, and Staff #22.

5. The above finding was confirmed with Staff #1 on 1/19/22 at 2:18 PM.

Based on observation, staff interviews, document review and review of manufacturer's guidelines, and OSHA regulations, it was determined the facility failed to ensure the development and implementation of an adequate infection control program that seeks to control the potential transmission of COVID-19 within the facility.

Findings include:

The facility failed to ensure: 1. a respiratory protection program was developed for the use of Makrite 9500-N95s, in accordance with manufacturer's guidelines; 2. staff wear N95 respirators in accordance with manufacturer's guidelines; 3. N95 respirators are stored in the staff doffing area in a numbered brown paper bag, and are labeled with the staff's name and date, in accordance with facility policy; 4. a contingency plan for reuse of N95 respirators, in accordance with Centers for Disease Control and Prevention (CDC) guidelines was developed. (Cross Refer Tag 0749).

Based on observation, staff interviews, review of manufacturer's guidelines, and review of OSHA regulations, it was determined the facility failed to ensure: 1.) a respiratory protection program was developed for the use of Makrite 9500-N95s, in accordance with manufacturer's guidelines; 2.) staff wear N95 respirators in accordance with manufacturer's guidelines; 3.) N95 respirators are stored in the staff doffing area in a numbered brown paper bag, and are labeled with the staff's name and date, in accordance with facility policy; 4.) a contingency plan for reuse of N95 respirators, in accordance with Centers for Disease Control and Prevention (CDC) guidelines was developed.

On 1/19/22, Staff #1 was notified that the above findings resulted in an Immediate Jeopardy (IJ). A copy of the completed IJ template was provided to the facility on 1/19/22 at 2:20 PM. An IJ removal plan was received from the facility on 1/25/22.

Findings include:

1.) Reference: Manufacturer's guidelines for Makrite 9500-N95 states, " ... 3. Before occupational use of this respirator, a written respiratory protection program must be implemented meeting all the local government requirements. In the United States, employers must comply with OSHA Administration (OSHA) (29 CFR 1910.134) which includes medical evaluation, training and fit testing."

Reference #2: Occupational Safety and Health Administration, https://www.osha.gov/laws-regs/regulations/standardnumber/1910/1910.134 states, " ... A respirator shall be provided to each employee when such equipment is necessary to protect the health of such employee... The employer shall be responsible for the establishment and maintenance of a respiratory protection program... This paragraph requires the employer to develop and implement a written respiratory protection program with required worksite-specific procedures and elements for required respirator use... ."

During a tour of the Lincoln Gym on 1/18/22 at 11:18 AM, the following was observed:

The Lincoln Gym is a COVID-19 positive unit with a current census of eleven (11) COVID-19 positive patients. All staff members on the unit were observed wearing a Makrite 9500-N95 respirator.

Upon interview at 11:56 AM, Staff #10 and Staff #11 confirmed that they were not fit tested for use of their Makrite 9500-N95 respirator.

During a tour of the Kings Cottage on 1/18/22 at 12:20 PM, the following was observed:

Kings Cottage is a COVID-19 positive unit with a current census of eight (8) COVID-19 positive patients. All staff members on the unit were observed wearing a Makrite 9500-N95 respirator.

Upon interview at 12:39 PM, Staff #12 confirmed that he/she was not fit tested for use of his/her Makrite 9500-N95 respirator.

Upon request on 1/18/22, the facility was unable to provide evidence that staff were fit tested or received a medical evaluation to use the provided N95 respirators.

Upon interview on 1/18/22 at 1:10 PM, Staff #1 confirmed that fit testing for N95 respirators were not completed for any staff.

Upon interview on 1/18/22 at 2:15 PM, Staff #1, Staff #4 and Staff #5 stated that the facility has not developed or implemented a respiratory protection program, in accordance with Makrite 9500-N95 manufacturer's guidelines.

2.) Reference: Makrite 9500-N95 Manufacturer's Instruction for Use states, "Respiratory Fitting Instruction... Step 2: Press the respirator firmly against your face with the nosepiece on the bridge of your nose... Step 5... Please carefully follow these fitting instructions during each use to achieve proper fit."

On 1/18/22 at 11:18 AM, during a facility tour of Lincoln Gym, Staff #10 and Staff #11 were observed wearing surgical masks underneath their Makrite 9500-N95 respirators, which is not in accordance with manufacturer's guidelines. Wearing the surgical mask prevents the N95 from achieving a proper air seal.

On 1/18/22 at 12:20 PM, during a facility tour of Kings Cottage, Staff #12 and Staff #13 was observed wearing a surgical mask underneath their Makrite 9500-N95 respirator, which is not in accordance with manufacturer's guidelines. Wearing the surgical mask prevents the N95 from achieving a proper air seal.

On 1/18/22 at 12:45 PM, Staff #16 and Staff #17 confirmed the above findings.

3.) Reference: Facility policy titled, "Use and Re-Use of N95/KN95 Respirator" states, " ... 5. After use, place the N95 respirator in a paper bag, close and label the bag with #1, the staff name and date of use... 10. It is the responsibility of each staff issued the N95 respirator to keep them and the paper bags in their possession, in a clean area for reuse."

On 1/18/22 at 12:43 PM, during a tour of the staff doffing area in Kings Cottage, three (3) Makrite 9500-N95 respirators were found lying uncovered on a closet shelf.

The above finding was confirmed with Staff #3, Staff #16, and Staff #17 on 1/18/22 at 12:43 PM.

Upon interview on 1/18/22 at 12:35 PM, Staff #26 stated that when he /she removes the N-95 mask for a break, he/she removes the mask in the doffing area and places the mask on the open shelf or hook in that area. Staff #26 stated that he/she would reuse that mask after his/ her break. Upon further questioning, Staff #26 confirmed that he/she does not put the used N-95 mask in a paper bag but only hangs it on the hook or on the shelf uncovered.

Upon interview on 1/18/22 at 12:40 PM, Staff #27 stated that he/she doffs the mask in the doffing area prior to any break and leaves the mask on the shelf.

4.) Reference #1: Strategies for Optimizing the Supply of N95 Respirators, Updated Sept. 16, 2021, https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/index.html#crisis states, "Situational update as of May 2021: The supply and availability of NIOSH-approved respirators have increased significantly over the last several months. Healthcare facilities should not be using crisis capacity strategies at this time and should promptly resume conventional practices... Once availability of NIOSH-approved respirators returns to normal, healthcare facilities should promptly resume conventional practices... ."

Reference #2: Facility policy titled, "Use and Reuse of N95 Respirator", states, " ... Procedure: 1. Use N95 respirators when working in any area with COVID 19 positive patients, with any patients who are Persons Under Investigation (PUI) for Covid 19, or any persons in Post Admission quarantine. 2. When supplies get low, the DCEO and DON will decide, in collaboration with Infection Prevention staff (IP), when to begin re-use of the respirators. ... A. IP will notify Nursing... ."

On 1/18/22 at 12:43 PM, during a tour of the staff doffing area in Kings Cottage, three (3) Makrite 9500-N95 respirators were found lying uncovered on a closet shelf.

Upon interview on 1/18/22 at 12:35 PM, Staff #26 stated that when he/she removes the N-95 mask for a break, he/she removes the mask in the doffing area and places the mask on the open shelf or hook in that area. Staff #26 stated that he/she would reuse that mask after his/ her break. Upon further questioning, Staff #26 confirmed that he/she does not put the used N-95 mask in a paper bag, but only hangs it on the hook or on the shelf uncovered.

Upon interview on 1/18/22 at 12:40 PM, Staff #27 stated that he/she doffs the mask in the doffing area prior to any break and leaves the mask on the shelf.

Upon interview on 1/19/22 at 10:13 AM, Staff #1 confirmed that the facility has an adequate supply of N95s respirators and that there are currently no supply shortages. Staff #1 stated that N95 respirators were being reused from the initial Personal Protection Equipment (PPE) shortage and was not reevaluated with Infection Prevention since the beginning of the pandemic.

Upon request, the facility was unable to provide a documented contingency plan for N95 reuse. Upon interview on 1/19/22 at 2:18 PM, Staff #1, Staff #4, and Staff #5 stated that the facility should not be reusing N95 respirators because they have not developed a contingency plan as to why N95 respirator masks need to be reused.