HospitalInspections.org

Based on observation, staff interview, review of Centers for Disease Control and Prevention (CDC) guidance, and review of facility documents, it was determined that the facility failed to ensure that infection control policies and guidelines are implemented to prevent and control the transmission of communicable diseases.

Findings include:

1. The facility failed to ensure that reporting guidelines to public health agencies are implemented in accordance with facility policy. (Cross-refer to Tag 749-A)

2. The facility failed to ensure that all visitors are screened for COVID-19 in accordance with facility policy and procedure. (Cross-refer to Tag 749-B)

3. The facility failed to ensure that all staff adhere to their hand hygiene policy. (Cross-refer to Tag 749-C)

4. The facility failed to ensure that all employees properly wear face coverings to prevent and control the transmission of infections. (Cross-refer to Tag 749-D)

5. The facility failed to ensure that all employees are properly fit tested for an N-95 respirator to prevent and control the transmission of infection. (Cross-refer to Tag 749-E)

6. The facility failed to ensure that enhanced precaution signage are implemented in the Emergency Department [ED] in accordance with facility policy. (Cross-refer to Tag 749-F)

7. The facility failed to ensure that infection control practices are implemented in accordance with nationally recognized guidelines. (Cross-refer to Tag 749-G)

A. Based on staff interview, review of facility policies, and review of facility documents, it was determined that the facility failed to ensure reporting to public health agencies are implemented, for four (4) of four (4) COVID-19 positive Health Care Personnel (HCP) in the Central Supply unit; and for (4) four of (4) four COVID-19 positive HCP in the Cardiac Catheterization Lab, in accordance with facility policies.

Findings include:

Reference #1: Facility policy titled, "IC-COVID-19 Outbreak Investigation" states, "Definitions, Health Care Personnel (HCP) includes direct care providers, and persons not directly involved in patient care... Epi-linkage among HCP is defined as having the potential to have been within 6 feet for 15 minutes or longer while working in the facility during the 14 days prior to the onset of symptoms; Policy, Thresholds for Reporting to Public Health ... [greater than or equal to] 2 cases of confirmed COVID-19 in HCP with epi-linkage."

Reference #2: Facility policy titled, "Biological Event-Influx Patient of Patients/Infectious Disease Plan" states, "... Procedure: A. Internal Notification and Communication ... 3. Members of the Safety and Infection Prevention Committees will work closely with the hospital administration, New Jersey Department of Health (NJDOH), and other Public Health Agencies ... E. Notification and Consultation with NJDOH and other External Agencies: 1. The NJDOH must be notified immediately in any the event [sic] of an exposure to ... COVID-19 infection by the Infection Control Preventionist or by the Administrator on duty. ... 2. The Local and County Health Department will be notified by the Infection Control Preventionist..."

1. On 1/12/2021 at 11:05 AM, Staff #5 stated that the infection control guidelines followed by the facility, are the Centers for Disease Control and Prevention (CDC) State Guidelines, Association for the Advancement of Medical Instrumentation (AAMI) for the Operating Room (OR), and Occupational Safety and Health Act (OSHA).

2. On 1/12/2021 at 11:15 AM, upon review of facility document titled, "Employees Out of Work," for the period of 11/16/2020 - 12/31/2020, the following pattern was noted:

a. Reason for leave: Employee Name: Staff #43; Reason of Leave: COVID-19; Department: CCL [Cardiac Cath Lab]; Start Date [of leave]: 12/4/2020

b. Reason for leave: Employee Name: Staff #44; Reason of Leave: COVID-19; Department: CCL [Cardiac Cath Lab]; Start Date [of leave]: 12/8/2020

c. Reason for leave: Employee Name: Staff #45; Reason of Leave: COVID-19; Department: CCL [Cardiac Cath Lab]; Start Date [of leave]: 12/8/2020

d. Reason for leave: Employee Name: Staff #46; Reason of Leave: COVID-19; Department: CCL [Cardiac Cath Lab]; Start Date [of leave]: 12/8/2020

e. Reason for leave: Employee Name: Staff #47; Reason of Leave: COVID-19; Department: CS [Central Supplies/Medical Supplies]; Start Date [of leave]: 12/16/2020

f. Reason for leave: Employee Name: Staff #48; Reason of Leave: COVID-19; Department: CS [Central Supplies/Medical Supplies]; Start Date [of leave]: 12/16/2020

g. Reason for leave: Employee Name: Staff #49; Reason of Leave: COVID-19; Department: CS [Central Supplies/Medical Supplies]; Start Date [of leave]: 12/17/2020

h. Reason for leave: Employee Name: Staff #50; Reason of Leave: COVID-19; Department: CS [Central Supplies/Medical Supplies]; Start Date [of leave]: 12/18/2020

3. On 1/13/2021 at 12:20 PM, during staff interviews the following was revealed:

a. When questioned if the cluster of COVID-19 HCP in the CCL and CS departments was identified as an outbreak, Staff #3 stated that they identified the clusters and did contact tracing, but did not report the outbreak to the Local/County Health Department.

b. Staff #5 stated that each individual HCP was reported to the Local/County Health Department; however, they were not reported as clusters, as the source of COVID-19 acquired, was from the community, not from the facility.

4. These findings were confirmed with Staff #3 and Staff #5.

B. Based on observation, staff interview, and review of facility policy and procedure, it was determined that the facility failed to ensure that all visitors are screened for COVID-19 in accordance with facility policy.

Reference #1: Facility policy titled, "Safety/Security Policy and Procedure" (formulated 3/2020) states, "Procedure: 1.1 Security Department will follow any and all given guidelines by department of infection control ... 1.2 Security Officer (S.O.) posted in Main entrances will check for temperature using the HIK vision thermal camera. 1.3 S.O. will ask approved Infection control screening questions to all entering facilities [sic] for procedures and any plus one accompaniment."

Reference #2: Facility policy titled, "Safety/Security Policy and Procedure" (formulated 2/2020 and revised 6/2020 and 10/2020) states, "Policy: The Security Department of St. Mary's General Hospital shall screen every patient, visitor and employee upon entering the hospital. Procedure: 1. Patient and Visitors will be asked the following questions upon entering: Do you currently have any of the following, -Cough or sore throat? -Shortness of breath or difficulty breathing, -Fever of 100.0 degrees Fahrenheit or chills? -Fatigue, Muscle Body aches or Headache? -New loss of taste or smell? -Sore throat, congestion or runny nose? Nausea, Vomiting and/or Diarrhea?"

1. During an observation on 1/13/2021 at 9:45 AM, in the Main Entrance of the facility, Staff
#31 (a security officer), was observed stepping away from his/her post at the front desk, where screening for COVID-19 was being conducted.

a. The Valet was then observed coming forward and stepping in for Staff #31.

b. An individual entered through the Main Entrance Door and he/she stopped in front of the Valet and asked for directions. The Valet pointed to his/her right and the individual continued in that direction.

i. The individual was not directed to stop in front of the HIK vision thermal camera.

c. At no point did the Valet ask the individual any of the approved infection control screening questions.

2. During an interview with Staff #2 on 1/13/2021 at 9:50 AM, this surveyor requested the name of the Valet. Staff #2 stated that the Valet was not one of their employees. They are contracted to valet cars.

3. On 1/13/2021 at 10:45 AM, upon interview with Staff #51, the Head of Security stated that valets are contracted employees and are not trained to screen individuals coming into the facility, and confirmed that the Valet should not have been standing at the Security Officer's post.

4. The above findings were confirmed with Staff #2 and Staff #51.

C. Based on three (3) of three (3) observations of hand hygiene activities, staff interview, and review of facility policy and procedure, it was determined that the facility failed to ensure that all staff adhere to the facility's hand hygiene policy.

Findings include:

Reference: Facility policy titled, "Hand Hygiene" states, " Purpose: To decrease the risk of infection by appropriate hand hygiene. Policy: Handwashing/hand hygiene is generally considered the most important single procedure for preventing healthcare-associated infections. ... II. Procedure: A. Hand washing: In areas with access to a sink: ... 4. Wet hands and forearms with water. 5. Apply amount of product recommended by manufacturer. 6. Rub hands together vigorously at least 15-20 seconds, covering all surfaces of hands and fingers. ... 7. Rinse hands with water completely. 8. Dry with paper towel. 9. Use paper towel to turn faucet off."

1. On 1/13/2021 at 11:20 AM, upon entering the Central Supply Unit, Staff #5 was observed washing his/her hands at the sink. Staff #5 wet his/her hands with water and applied soap. He/she rubbed his/her hands together for approximately ten (10) seconds.

a. At 11:50 AM, upon exiting the Central Supply unit, Staff #5 was observed washing his/her hands at the sink. Staff #5 wet his/her hands with water and applied soap. He/she rubbed his/her hands together for approximately nine (9) seconds.

b. The above findings were confirmed with Staff #2.

2. On 1/13/2021 at 1:10 PM, during a tour of the Progressive Care Unit (PCU), the following was observed:

a. At 1:40 PM, Staff #38 was observed washing his/her hands at the sink. Staff #38 wet his/her hands with water and applied soap. He/she rubbed his/her hands together for approximately five (5) seconds, and then turned the faucet off with bare hands. He/she then dried his/her hands with a paper towel.

b. The above findings were reviewed with Staff #5 and Staff #32.

D. Based on four (4) of four (4) observations, staff interview, and review of facility policy, it was determined that the facility failed to ensure that all employees wear face coverings properly to prevent and control the transmission of infections.

Findings include:

Reference: Facility policy titled, "Facility Infection Prevention and Control" states, "Scope: This policy applies to patients, visitors, and employees working in hospital departments or other work settings that are considered non-patient care or non-clinical areas. ...The Center of Disease Control & Prevention (CDC) recommends face coverings be worn by everyone ... 3. Examples of inadequate source control include: a. A face cover which does not reliably cover both nose and mouth."

1. During a tour of the facility on 1/12/2021 at 1:30 PM, in the corridor outside of Unit 6W, Staff #17 was observed wearing a cloth mask with the top mask tied and secured on the top portion of his/her head. The ties on the bottom portion of the mask were hanging loosely in front of his/her chest. Staff #5 instructed Staff #17 to tie the mask behind his/her neck. Staff #17 refused stating, "this is not a patient care area."

2. During a tour of the Emergency Department (ED) on 1/12/2021 at 2:00 PM, Staff #40 (an ED Registrar), was observed wearing a surgical mask below his/her nose.

a. At 2:30 PM, in the Cafeteria, Staff #30 was observed wearing a surgical mask under his/her chin, exposing his/her nose and mouth.

b. The above findings were confirmed with Staff #5.

3. On 1/13/2021 at 10:05 AM, in the Cafeteria, Staff #42 (an Anesthesiologist), was observed wearing a surgical mask below his/her nose.

a. The above findings were confirmed with Staff #2.

E. Based on review of one (1) of six (6) employee files, staff interview, and review of facility documents, it was determined that the facility failed to ensure that all employees are properly fit tested for an N-95 respirator, to prevent and control the transmission of infection.

Findings include:

Reference #1: Facility policy titled, "Respiratory Protection Program" states, "Purpose: To provide health care workers (HCW) protection against patients with airborne diseases ... Policy: ... 3. Qualitative baseline fit testing using saccharin/bitter aerosol around the seal of the respirator is required to approximate airborne exposure to infectious diseases. ... Personnel: ... Any employee who cannot be successfully fit tested or has respiratory health contraindications will not be allowed to care for patients in Airborne Precautions."

Reference #2: Facility policy titled, "Isolation Manual" states, " ... 2. Transmission-Based Precautions: ... d. Enhanced Precautions-Enhanced precautions are used to rule out or for confirmed Coronavirus-19 (COVID-19); are used when microorganisms spread through close respiratory or mucous membrane contact with respiratory secretions ... 2. Healthcare personnel must don surgical/N-95 mask before entering the room ..."

1. On 1/12/2021 and 1/13/2021, six (6) employee health records were reviewed for the following staff members: Staff #18, Staff #44, Staff #46, Staff #47, Staff #52, and Staff #53.

a. Review of facility document titled, "Qualitative Fit Test Form" for Respirator Type 3M, N95, 9205, dated 12/1/20, and found in the Employee Health Record for Staff #18, revealed the following:

i. For the "Talking-Rainbow Passage (60 seconds)" section, partial pass was checked off with a handwritten note that stated, "ok with surgical mask."

ii. For the "Bending over (60 seconds)" section, partial pass was checked off with a handwritten note that stated, "ok with surgical mask."

iii. A pre-printed statement at the bottom of the form stated, "Based on the information provided on this form, I certify that the employee named on this form can wear the respiratory protective equipment listed above."

iv. The form was signed and dated by Staff #5, the staff member administering the test.

b. On 1/12/2021 at 11:30 AM, during interview, Staff #3 and Staff #5 stated that to be considered successfully fit tested, an employee would be documented as "pass," and that fit testing is either pass or fail. There is no partial fit.

c. At 1:40 PM, during an interview, Staff #18 confirmed that he/she was fit tested last month and was told by the staff conducting the fit test that he/she was a "partial fit." Staff #18 stated, "I still tasted the solution. If I move my head around, my mask is loose."

i. Staff #18 reported that on their unit there is one COVID-19 positive patient on isolation precautions, and he/she was assigned to care for this patient.

3. On 1/12/2021 at 2:45 PM, the above findings were confirmed with Staff #3 and Staff #5.

F. Based on observation of one (1) of one (1) COVID-19 positive patient in the Emergency Department [ED], medical record review, staff interview, and review of facility policy, it was determined that the facility failed to ensure that enhanced precaution signage is implemented for COVID-19 positive patients in accordance with facility policy.

Findings include:

Reference: Facility policy titled, "Isolation Manual" states, "... 2. Transmission-Based Precautions: ... d. Enhanced Precautions - Enhanced Precautions are used to rule out or for confirmed Coronavirus-19 (COVID-19); ... 1. Enhanced Precautions sign is placed on the door ..."

1. On 1/12/2021, during a tour of the ED, the following was revealed:

a. At 11:10 AM, Patient #15 was identified as a COVID-19 positive patient.

i. At 2:10 PM, outside of Room #4, where Patient #15 was roomed, there was no signage outside the door to indicate that Patient #15 was on Enhanced Precautions.

2. This was brought to the attention of Staff #5, and it was confirmed that Enhanced Precautions signage was missing.

G. Based on observation, staff interview, and review of facility documents, it was determined that the facility failed to ensure that infection control practices are implemented in accordance with nationally recognized guidelines.

Findings include:

Reference: The Centers for Disease Control and Prevention (CDC) document titled, "Interim Infection Prevention and Control Recommendations for Healthcare Personnel during the Coronavirus Disease 2019 (COVID-19) Pandemic; Updated December 14, 2020" states, " ... 2. Recommended infection prevention and control (IPC) practices when caring for a patient with suspected or confirmed SARS-CoV-2 infection: ... Healthcare Personnel who enter the room of a patient with suspected or confirmed SARS-COV-2 infections should adhere to Standard Precautions and use a NIOSH-approved N95 or equivalent or higher respirator (or facemask if a respirator is not available), ... Gowns: Put on a clean isolation gown upon entry into the patient room or area. ... Remove and discard the gown in a dedicated container for waste or linen before leaving the patient room or care area."

1. On 1/12/2021 at 11:05 AM, Staff #5 stated that the infection control guidelines, the facility follows for infection prevention, is Centers for Disease Control and Prevention [CDC], Association for the Advancement of Medical Instrumentation [AAMI] for the Operating Room [OR], Occupational Safety and Health Act [OSHA], and State Guidelines.

2. On 1/13/2021 at 12:30 PM, during a tour of the Intensive Care Unit [ICU] with Staff #32, the following was observed:

a. Patient #18, in Room #354, was placed on Enhanced Isolation Precautions for confirmed COVID-19 infection. Enhanced Precautions signage was posted outside the room.

i. Staff #35 was observed in Room #354. He/she emptied the trash, exited the room, and proceeded to walk down the hallway.

ii. Staff #35 failed to discard his/her gown before leaving the patient room.

b. At 1:00 PM, Staff #32 confirmed that Staff #35 should have removed his/her gown prior to leaving the patient's room.

3. On 1/13/2021 at 1:10 PM, during a tour of the Progressive Care Unit (PCU), in the presence of Staff #32, the following was observed:

a. The following patients were on Enhanced Isolation Precautions for confirmed COVID-19 Infection:

i. Patient #20 in Room #314

ii. Patient #21 in Room #316

iii. Patient #22 in Room #322

b. Signage was posted outside of each of the above-mentioned patient rooms for Enhanced Precautions, stating, "Enhanced Precautions: ...Surgical mask or N-95 Respirator..."

c. Upon review of the facility policy titled, "Isolation Manual," the following was stated: "...d. Enhanced Precautions - Enhanced precautions are used to rule out or for confirmed Coronavirus-19 (COVID-19); are used when microorganisms spread through close respiratory or mucous membrane contact with respiratory secretions. ... 2. Healthcare personnel must don surgical/ [or] N-95 mask before entering the room."

i. The policy is not in compliance with the CDC guidelines.

d. At 2:10 PM, during interview, Staff #5 stated that all staff who enter an isolation room for a COVID-19 positive patient must wear an N-95 mask and surgical mask. He/She is unsure as to why the signage indicates that the PPE requirement for mask use is an N-95 or surgical mask. He/she confirmed the PPE requirement is both, not either/or. Staff #5 added that the language in the signage was confusing. In addition, Staff #5 stated that the facility has ample supply of N-95 masks.

4. The above findings were confirmed with Staff #5 and Staff #32.


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