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Based on observation and staff interview, it was determined that the facility to ensure that outdated, mislabeled, or otherwise unusable drugs are not available for patient use.

Findings include:

1. During an observation in Post Anesthesia Care Unit (PACU) on 10/21/20 at 12:50 PM, four (4) opened and needle punctured multi-dose vials of Labetalol, labeled "single patient use only" were found in the supply cart located by the PACU nursing area.

a. Upon interview on 10/21/20 at 1:05 PM, Staff #4 the facility practice is to discard the medication after single patient use and stated that "those vials should have been discarded."

2. The above finding was confirmed with Staff #1, Staff #4, and Staff #29.

Based on observation, staff interviews, and document reviews, it was determined that the facility failed to ensure an active hospital-wide infection control program for the prevention, control, and investigation of infections and communicable diseases, including COVID-19.

Findings include:

1. The facility failed to ensure that employees reported the Coronavirus (COVID-19) exposure and signs and symptoms related to COVID-19 to the appropriate leadership and completed COVID-19 symptom monitoring log upon starting their shift. (Cross Refer to Tag A 749)

2. The facility failed to implement and monitor an effective screening process for employees and visitors for the management of COVID-19 Pandemic. (Cross Refer to Tag A 749)

3. The facility failed to ensure that infection control practices and precautions used to prevent the spread of infections, and communicable disease during the COVID-19 Pandemic, are implemented, in accordance with the Centers for Disease Control and Prevention (CDC) guidelines. (Cross Refer to Tag A 749)

4. The facility failed to ensure implementation of policies and procedures addressing infection prevention plan for Coronaviruses (COVID-19). (Cross Refer to Tag A 749)

5. The facility failed to adhere to professionally acceptable standards of practice for hand hygiene. (Cross Refer to Tag A 749)

6. The facility failed to ensure that medications are prepared in a clean environment in accordance with acceptable standards of practice. (Cross Refer to Tag A 750)

7. The facility failed to ensure that reusable protective personal equipment (PPE) are reused and stored properly to prevent cross contamination and transmission of infections. (Cross Refer to Tag A 750)

A. Based on observation, staff interviews, and document reviews, it was determined that the facility failed to ensure that employees reported the Coronavirus (COVID-19) exposure and signs and symptoms related to COVID-19 to the appropriate leadership and completed COVID-19 symptom monitoring log upon starting their shift.

Findings include:

Reference: Facility procedural document titled, "SMC (Shore Medical Center) COVID-19 Fever and Symptom Monitoring Procedure" states, "Procedure: 1. ... All employees (including contracted staff) working at the Hospital will also be required to complete a Symptom Monitoring Log for HCP (Health Care Professionals). This Symptom Log will need to be reviewed and cleared by the employee's Manger and /or Supervisor upon starting their shift. 2. If an employee is experiencing any related symptoms (cough/congestion/sore throat/headache/loss of taste or smell or GI Symptoms) or has an elevated temperature of 100 degrees Fahrenheit or greater, employee will contact their manager, and NOT report to work until cleared by the Employee Health Services Department."

1. Upon interview with Staff #1 on 10/20/20 at 10:10 AM, Staff #1 stated that anyone entering the building, including staff members should be screened and staff members are required to complete a "Symptom Monitoring Log for HCP." Staff #28 stated that anyone who exhibit signs and symptoms related to COVID-19 must report to their appropriate managers or supervisors.

a. Upon interview with Staff #13 on 10/20/20 at 11:15 AM, Staff #13 stated that on 10/7/20, he/she conducted an interview with Staff #28 who tested positive for COVID-19 on 10/7/20. Review of documentation of Staff #28's intake form, stated, "Today's date 10/7/2020 ... What date did the symptoms start? 10/4/20." Staff #13 stated that Staff #28 exhibited symptoms on 10/4/20. However, Staff #28 continued to work on 10/5/20 from 11:20 AM to 9:13 PM and on 10/7/20 from 5:21 AM to 7:39 AM. Staff #29 confirmed that Staff #28 failed to report signs and symptoms to appropriate leadership prior to his/her working shift on 10/5/20.

b. Upon request, Staff #4 failed to provide evidence that symptom monitoring log for Staff #28 on 10/5/20 was completed, reviewed, and cleared by the employee's manager and/or supervisor upon starting his/her shift.

2. Review of Staff #28's work schedule indicated that he/she worked on the following days:
9/25/20 from 11:09 PM to 12:22 AM
9/30/20 from 8:50 AM to 6:29 PM
10/5/20 from 11: 20 AM to 9:13 PM.

a. Upon request for the corresponding Symptom Monitoring Logs for Staff #28, Staff #4 failed to provide evidence the logs had been completed, reviewed, and cleared by the employee's manager and/or supervisor upon starting his/her shift.

3. Review of Staff #12's work schedule indicated that he/she worked on 10/10/20 from 8:54 AM to 11:30 AM. Upon request for the corresponding Symptom Monitoring Log for Staff #12, Staff #4 failed to provide evidence the log had been completed, reviewed, and cleared by the employee's manager and/or supervisor upon starting his/her shift.

4. Review of Staff #30's work schedule indicated that he/she worked on the following days:
9/25/20 from 5:20 AM to 1:59 PM
10/7/20 from 8:18 AM to 4:58 PM

a. Upon request for the corresponding Symptom Monitoring Log for Staff #30, Staff #4 failed to provide evidence the log had been completed, reviewed, and cleared by the employee's manager and/or supervisor upon starting his/her shift.

5. The above findings were confirmed with Staff #1, Staff #4, and Staff #29.

B. Based on observation, staff interview, and document review, it was determined that the facility failed to implement and monitor an effective screening process for employees and visitors for the management of COVID-19 Pandemic.

Findings include:

Reference #1: Facility document titled, "Re: Update- Covid-19 precautions and update to visitor policy states, "VISITATION GUIDELINES ...6 ft social distancing must be maintained in any common areas such as waiting rooms, lobbies, vending area, etc. VSP [Visiting Support Person] PROCESS FOR INPATIENTS: On arriving, visitors will be provided masks and instruction on how to wear. They must also perform hand hygiene. Sanitizing foam or gel will be available. ... Visitors will undergo symptom and temperature checks at the front desk. If they fail the screening, they will not be allowed to enter. Visitors on arrival will need to provide their driver's license and contact. Upon completion they will be provided a write band for visitation authorization. VSP PROCESS FOR THE EMERGENCY DEPARTMENT: ... On arrival to ED, Patient and Support Person will be provided masks and instructions on how to wear. They must also perform hand hygiene. Sanitizing foam or gel will be available. ... Visitors will undergo symptom and temperature checks. ... ."

Reference #2: Facility procedural document titled, "SMC (Shore Medical Center) COVID-19 Fever and Symptom Monitoring Procedure" stated, "Procedure: 1. ... All employees (including contracted staff) working at the Hospital will also be required to complete a Symptom Monitoring Log for HCP (Health Care Professionals). This Symptom Log will need to be reviewed and cleared by the employee's Manager and /or Supervisor upon starting their shift."

1. On 10/19/20 at 9:45 AM, this surveyor walked into the main entrance of the facility. This surveyor's temperature was not taken. Additionally, there was no screening conducted to this surveyor upon entering the facility.

2. During an observation in the main entrance of the facility on 10/19/20 at 9:50 AM, the following was observed:

a. More than three (3) persons walking into the main entrance did not get their temperatures taken and screening was not conducted.

b. There were no signages posted at the main entrance regarding screening procedures.

c. There were no signages posted at the main entrance with instructions to individuals seeking medical care with symptoms of respiratory infections to immediately put on a mask, keep it on during their assessment, cover their mouth/nose when coughing or sneezing, use and dispose of tissues, and perform hand hygiene after contact with respiratory secretions.

d. A man sitting in the main lobby was observed getting escorted into the hospital. When questioned if that person had been screened, Staff #11, the screener, stated, "No ... I am not sure." Staff #11 stated that "there were no COVID-19 screening forms completed, as of this morning and we are not accepting visitors."

3. During an observation in the main entrance to the Emergency Department on 10/19/20 at 12:15 PM, an adult and two (2) young minors were observed entering the department. Screening process including but not limited to temperatures readings were not conducted for the two (2) young minors.

4. During an interview on 10/19/20 at 10:45 AM, Staff #1 stated that employees will get screened by signing an attestation document titled, "COVID-19 Daily Symptom Checks" with a series of questions related to COVID-19, prior to starting their shift, in their working area.

a. Upon request on 10/19/20 at 12:05 PM, Staff #1 failed to provide evidence that Staff #7 had been screened for Covid-19 prior to starting his/her shift on 10/19/20. Upon interview on 10/19/20 at 2:20 PM, Staff #1 stated that Staff #7 was not screened prior to his/her working shift.

b. Upon interview on 10/20/20 at 10:00 AM, Staff #4 stated that Staff #28 worked on the following days: 9/25/20, 9/28/20, 9/30/20, 10/2/20, 10/5/20, and 10/7/20. Two (2) out of six (6) days that Staff #28 worked; Staff #28 did not complete the health symptom logs (COVID-19 Daily Symptom Checks). Upon interview, Staff #4 also stated that Staff #28 also completed the health symptom logs dated on 10/1/20 and 10/6/20. However, Staff #28 did not work on those days. Staff #4 confirmed that the logs were not accurately completed.

c. Upon interview 10/20/20 at 11:00 AM, Staff #4 stated that Staff #31 worked on the following days: 9/23/20, 9/25/20, 9/30/20, 10/1/20, and 10/2/20. Staff #31 did not complete the health symptom log (COVID-19 Daily Symptom Checks) on 9/25/20.

5. The above findings were confirmed with Staff #1 and Staff #29.

C. Based on observation, staff interviews, and document review, it was determined that the facility failed to ensure that infection control practices and precautions used to prevent the spread of infections, and communicable disease during the COVID-19 Pandemic, are implemented, in accordance with the Centers for Disease Control and Prevention (CDC) guidelines.

Findings include:

Reference: Centers for Disease Control and Prevention (CDC), Interim Infection Prevention and Control Recommendations for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic, https://www.cdc.gov/coronavirus/2019-ncov/hcp/infection-control-recommendations.html, updated July 15, 2020 states, "... CDC recommends using additional infection prevention and control practices during the COVID-19 pandemic... Implement Universal Source Control Measures... Source control refers to use of cloth face coverings or facemasks to cover a person's mouth and nose to prevent spread of respiratory secretions when they are talking, sneezing, or coughing. ... HCP (healthcare professionals) should wear a facemask at all times while they are in the healthcare facility, including in breakrooms or other spaces where they might encounter co-workers. ... Encourage Physical Distancing Healthcare delivery requires close physical contact between patients and HCP. However, when possible, physical distancing (maintaining 6 feet between people) is an important strategy to prevent SARS-CoV-2 transmission. Examples of how physical distancing can be implemented for patients include: Limiting visitors to the facility to those essential for the patient's physical or emotional well-being and care (e.g., care partner, parent). Encourage use of alternative mechanisms for patient and visitor interactions such as video-call applications on cell phones or tablets. ...Arranging seating in waiting rooms so patients can sit at least 6 feet apart..."

1. During an observation of the Emergency Department triage area on 10/19/20 at 11:42 AM, Staff #7 was observed without a facemask.

a. At 11:55 AM, Staff #7 was observed transporting a patient from the triage area to the patient's room. Staff #7 did not wear a mask. When questioned on why Staff #7 was not wearing a mask, Staff #8 stated that he/she should have been wearing a mask.

b. At 12:05 PM, a patient was observed in the patient bay, without a mask on. When questioned on why the patient was not wearing a mask, Staff #8 stated that he/she should have been wearing a mask.

c. At 12:10 PM, Staff #5 was observed with his/her facemask worn beneath his/her nose, leaving his/her nose exposed.

2. During an observation of the waiting area of the Emergency Department on 10/19/20 at 11:38 AM, seating arrangements were not arranged to promote social distancing so that patients or visitors can sit at least 6 feet apart.

3. During an observation of the main waiting lobby area on 10/19/20 at 10:05 AM, seating was not arranged to promote social distancing so that patients or visitors can sit at least 6 feet apart.

4. During an observation of the Emergency Department Staff Lounge on 10/19/20 at 12:20 PM, seating arrangements were not arranged to promote social distancing so that staff members can sit at least 6 feet apart.

5. During an observation of the Intensive Care Unit on 10/20/20 at 2:38 PM, the following was noted:

a. There was a signage posted on Room #262 door to use "Special Enteric Contact Precautions" which indicated that all persons entering the room will need to wear gowns and gloves at the door. At 2:39 PM, Staff # 14 was observed having direct patient care in Room #262. Staff #14 failed to wear a gown and the patient was not wearing a mask.

b. Upon interview, Staff #29 stated that Staff #14 should have worn a gown. Staff #29 also stated that unless the patient is medically unable to wear a mask, the patient should have been wearing a mask, during direct patient care.

6. The above findings were confirmed by Staff #1 and Staff #29.

D. Based on observation, staff interview, and document review, it was determined that the facility failed to ensure implementation of policies and procedures addressing infection prevention plan for Coronavirus (COVID-19).

Findings include:

Reference: Facility policy titled, "Infection Prevention for Plan for Coronaviruses" states, "3. ...Patient Placement...Place a patient with known or suspected Coronavirus (i.e., PUI [Patient Under Investigation]) in an AIIR (Airborne infection isolation room (AIIR) that has been constructed and maintained in accordance with current guidelines. Room doors should be kept closed except when entering or leaving the room, and entry and exit should be minimized. SMC will monitor (tissue test) and document the result on the log. ... Only essential personnel should enter the room. Implement staffing policies to minimize the number of HCP who enter the room. ... Log all persons who care for or enter the rooms or care area of these patients. ..."

1. During an observation of the Intensive Care Unit on 10/20/20 at 2:00 PM, the following was observed:

a. A patient in Room #263 was a COVID-19 positive patient, in an Airborne Infection Isolation Room (AIIR).

b. Upon interview, Staff #17 stated that the facility practice is to document and log any employee that enters these types of rooms and sign their names accordingly.

c. Upon request for the corresponding log for the patient in Room #263 on 10/20/20, Staff #17 was unable to provide one. Staff #17 stated that it must have been misplaced.

d. Upon request for the total number of COVID-19 positive patients and patients under investigation from 10/11/20 to 10/20/20, Staff #29 stated that there was a total of twenty (20) patients in the Intensive Care Unit. When requested for the documentation of the employees that entered this type of rooms and signing of their names, Staff #29 was only able to provide 5 logs out of the 20 logs.

E. Based on observation, staff interview, and document review, it was determined that the facility failed to adhere to professionally acceptable standards of practice for hand hygiene.

Findings include:

Reference: Guideline for Hand Hygiene in Health Care Settings: Recommendation of the Healthcare Infection Control Practices Advisory Committee [HICPAC] and the HICPAC/SHEA/APIC/IDSA Hand Hygiene Task Force, published in the CDC (Centers for Disease Control and Prevention) Morbidity and Mortality Weekly Report at MMWR 2002; 51 (No. RR-16) page 32 states,
"Recommendations:
1. Indications for Handwashing and Hand antisepsis
...
C. Decontaminate hands before having direct contact with patients.
...
E. Decontaminate hands before inserting...peripheral vascular catheters, or other invasive devices...
F. Decontaminate hands after contact with a patient's intact skin...
G. Decontaminate hands after contact with ... a patient's nonintact skin
...
I. Decontaminate hands after contact with inanimate objects...in the immediate vicinity of the patient.
J. Decontaminate hands after removing gloves.
...
2. Hand Hygiene Technique
...
B. When washing hands with soap and water, ... rub hands together vigorously for at least 15 seconds, covering all surfaces of the hands and fingers."

1. During an observation on 10/20/20 at 2:40 PM, in preparation for a patient's dialysis procedure, Staff #15 was observed hand washing. After washing his/her hands, Staff #15 grabbed an inanimate object on the floor and placed it in the trash bin and proceeded to don gloves.

2. The above finding was confirmed with Staff #1 and Staff #29.

A. Based on observation, staff interview, and document review, it was determined that the facility failed to ensure that personal protective equipment (PPE) are reused and stored properly to prevent cross contamination and transmission of infections in accordance with the Centers for Disease Control and Prevention (CDC) guidelines.

Findings include:

Reference: The Centers for Disease Control and Prevention (CDC) document titled, "Implementing Filtering Facepiece Respirator (FFR) Reuse, Including Reuse after Decontamination, When There Are Known Shortages of N95 Respirators" updated October 19, 2020, https://www.cdc.gov/coronavirus/2019-ncov/hcp/ppe-strategy/decontamination-reuse-respirators.html states, "...A limited reuse strategy to reduce the risk of self-contamination... One strategy to reduce the risk of contact transfer of pathogens from the FFR to the wearer during FFR reuse is to issue five N95 FFRs to each healthcare staff member who care for patients with suspected or confirmed COVID-19. The healthcare staff member can wear one N95 FFR each day and store it in a breathable paper bag at the end of each shift with a minimum of five days between each N95 FFR use, rotating the use each day between N95 FFRs. This will provide some time for pathogens on it to "die off" during storage [8]. This strategy requires a minimum of five N95 FFRs per staff member, provided that healthcare personnel don, doff, and store them properly each day. As a caution, healthcare personnel should treat reused FFRs as though they are contaminated, while preventing FFR contamination prior to donning by following the precautions... ."

1. During an observation in the Intensive Care Unit on 10/20/20 at 2:12 PM, patient care supplies such as clean pads were found stored next to a brown paper bag labeled with Staff #32's name, outside of Room #263. Upon interview, Staff #17 stated that the brown bag contained a used N-95 respirator and a faceshield. Staff #17 stated that the facility practice was to reuse the N-95 respirator for up to three (3) consecutive days, store in a brown bag in between uses then discard. Staff #17 confirmed that the brown bag should not be stored with clean patient care supplies and failed to reduce the risk of self-contamination by reusing the N-95 respirators for consecutive days.

2. During an observation in the Intensive Care Unit on 10/20/20 at 2:36 PM, a N-95 respirator covered with a surgical mask and a face shield was hanging on the wall, next to the janitor's room. Upon interview, Staff #17 was not sure why those were "hung on the wall" and confirmed that it should not been stored that way.

3. The above findings were confirmed with Staff #1 and Staff #29.

B. Based on observation, staff interview and document review, it was determined that the facility failed to ensure that medications are prepared in a clean environment in accordance with acceptable standards of practice.

Findings include:

Reference: The Center for Disease Control website http://www.cdc.gov/injectionsafety/providers/provider_faqs_med-prep.html, under frequently asked questions about medication preparation states, "Where should I draw up medications? Medications should be drawn up in a designated clean medication area that is not adjacent to areas where potentially contaminated items are placed..."

1. During an observation of a post-procedure room turnover in Operating Room (OR) #2 on 10/21/20 at 12:08 PM, Staff #19 was observed preparing medication on top of the uncleaned tabletop of the automated dispensing cabinet. Upon interview, Staff #19 stated that the next surgical patient was anxious in the Pre-Op area so he/she prepared the medication for administration. Staff #19 stated that he/she prepared medications on top of the anesthesia automated dispensing cabinet and confirmed that it was his/her medication preparation area.

a. Upon interview, Staff #22 stated medication preparation should be wiped down in between cases.

(i) The medication preparation area was not cleaned in between cases.

2. The above findings confirmed by Staff #1 and Staff #29.

Based on staff interviews and review of 3 out of 3 staff training files, it was determined that the facility failed to ensure that staff receive education and training on policies and procedures related to COVID-19.

Findings include:

1. Upon request of the training files for Staff#28, Staff#30 and Staff #12, on 10/19/20 at 11:24 AM, Staff #29 was unable to provide evidence that Staff #28, Staff #30, and Staff #12 received education on COVID-19 including but not limited to work exclusions, symptoms, and screening criteria.

2. Staff #29 confirmed the above findings.