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Based on document reviews, observations, and interviews, it was determined that the Condition of Participation ("CoP") for Governing Body was not met as evidenced by the Governing Body's failure to provide oversight of the hospital as evidenced by the failure to implement all possible strategies to prevent and control the transmission of Coronavirus Disease 2019 ("COVID-19").

Findings:

The Governing Body has failed to provide oversight of the hospital as evidenced by the following:

1. Condition: §482.42 Condition of Participation: Infection Prevention and Control and Antibiotic Stewardship Programs also known as A-0747 - Based on document reviews, observations, and interviews, it was determined that the CoP for Infection Prevention and Control and Antibiotic Stewardship Programs was not met. The hospital failed to implement all possible strategies to prevent and control the transmission of COVID-19 in relation to physical distancing, limiting entry points, monitoring screening of staff, the use of facemasks, and the use of eye protection. See A-0747 for details.

2. Standard: §482.42(a)(2) Infection Control Program also known as A-0749 - Based on observations, interviews and document review, the facility failed to implement the United States Centers for Disease Control's recommendations during the COVID-19 pandemic related to maintaining physical distance, limiting entry points, monitoring staff screening, the use of facemasks, and the use of eye protection. The hospital's failure to ensure physical distancing had been identified on a COVID-19 focused infection control survey on 11/6/2020; therefore, is a repeat deficiency on this survey. See A-0749 for details.

3. Standard: §482.42(c)(1) Leadership Responsibilities (Governing Body) also known as A-0770 - Based on document reviews, observations, and interviews, the hospital's Governing Body failed to ensure that the hospital had systems in place to ensure all possible strategies to prevent and control the transmission of COVID-19 were implemented and monitored. See A-0770 for details.

The cumulative effect of these deficient practices resulted in noncompliance with this CoP.

Based on record review and interview, the hospital failed to ensure a physician's order was obtained for 2 of 6 sampled patients who had been restrained (Patient #1 and Patient #2).

Findings:

MaineGeneral Health Policy: Restraint or Seclusion of Patients stated "Restraint devices may be used only with the order of a physician or other licensed independent practitioner, under the standard conditions where the primary purpose is for non-violent or destructive behavior".

1. Documentation in Patient #1's medical record indicated the patient was restrained on 10/14/2020 at 9:00 AM. There was no evidence in the medical record of a physician's order for this restraint.

2. Documentation in Patient #6's medical record indicated the patient was restrained on 9/3/2020 at 7:35 PM. There was no evidence in the medical record of a physician's order for this restraint.

On 1/5/2021 at approximately 2:00 PM, the above findings were confirmed by the Administrative Director.

Based on document reviews and interview, the hospital failed to ensure a Registered Nurse (RN) was certified in cardiopulmonary resuscitaton (CPR) for 1 of 5 sampled employees (RN #1).

Finding:

MaineGeneral Health Policy: Restraint or Seclusion of Patients stated that the folloing would be part of training: "how to recognize and/or respond to signs of physical and psychological distress in patients who are being held, restrained or secluded as well as first aid techniques and certification or hospital equivalent in the use of CPR".

RN #1's "Basic Life Support" certificate, which includes CPR training, expired on in June 2020. As of 1/7/2021, there was no evidence that RN #1 completed CPR training since her certificate had expired.

On 1/7/2021 at 11:30 AM , the Chief Compliance Officer (CCO) confirmed this finding.

Based on document reviews, observations, and interviews, it was determined that the Condition of Participation ("CoP") for Infection Prevention and Control and Antibiotic Stewardship Programs was not met. The hospital failed to implement all possible strategies to prevent and control the transmission of Coronavirus Disease 2019 ("COVID-19") in relation to physical distancing, limiting entry points, monitoring screening of staff, the use of facemasks, and the use of eye protection.

Findings:

1. Standard: §482.42(a)(2) Infection Control Program also known as A-0749 - Based on observations, interviews and document review, the facility failed to implement the United States Centers for Disease Control's recommendations during the COVID-19 pandemic related to maintaining physical distance, limiting entry points, monitoring staff screening, the use of facemasks, and the use of eye protection. The hospital's failure to ensure physical distancing had been identified on a COVID-19 focused infection control survey on 11/6/2020; therefore, is a repeat deficiency on this survey. See A-0749 for details.

2. Standard: §482.42(c)(1) Leadership Responsibilities (Governing Body) also known as A-0770 - Based on document reviews, observations, and interviews, the hospital's Governing Body failed to ensure that the hospital had systems in place to ensure all possible strategies to prevent and control the transmission of COVID-19 were implemented and monitored. See A-0770 for details.

The cumulative effect of these deficient practices resulted in noncompliance with this CoP.

Repeat Deficiency

Based on observations, interviews and document review, the facility failed to implement the United States Centers for Disease Control (US CDC) recommendations during the Coronavirus Disease 2019 (COVID-19) pandemic related to maintaining physical distance, limiting entry points, monitoring staff screening, the use of facemasks, and the use of eye protection. The hospital's failure to ensure physical distancing had been identifed on a COVID-19 focused infection control survey on 11/6/2020; therefore, is a repeat defiency on this survey. See A-0749 for details.


Findings:

1. During a COVID-19 focused infection control survey, which was completed on 11/6/2020, it was determined that the hospital failed to implement the US CDC's recommendations during the Coronavirus Disease 2019 (COVID-19) pandemic related to physical distancing in three (3) hospital waiting areas.

During this survey, it was determined that the hospital was again not in compliance with US CDC's recommendations related to physical distancing as evidenced by the following:

The US CDC's "Interim Infection Prevention and Control Recommendation for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic", updated 12/14/2020, indicated, "Encourage Physical Distancing...when possible, physical distancing (maintaining at least 6 feet between people) is an important strategy to prevent SARS-CoV-2 transmission...Arranging seating in waiting rooms so patients can sit at least 6 feet apart." Additionally, "For HCP [Health Care Personnel], the potential for exposure to SARS-CoV-2 is not limited to direct patient care interactions. Transmission can also occur through unprotected exposures to asymptomatic or pre-symptomatic co-workers in breakrooms or co-workers or visitors in other common areas...Reminding HCP that the potential for exposure to SARS-CoV-2 is not limited to direct patient care interactions. Emphasizing the importance of source control and physical distancing in non-patient care areas. Providing family meeting areas where all individuals (e.g., visitors, HCP) can remain at least 6 feet apart from each other...".

On 1/4/2021 at 11:35 AM, six (6) chairs were observed in the Emergency Department ("ED") waiting area positioned less than six (6) feet apart. On 1/5/2021 at 11:45 AM, the ED waiting room was again observed and chairs were positioned less than six (6) feet apart. At the time of the observation on 1/5/2021, the Administrative Director of Operations measured two (2) separate sets of chairs and they measured two and half (2.5) feet apart and three (3) feet apart.

On 1/4/2021 at 12:05 PM, two (2) Critical Care Unit ("CCU") staff were observed sitting together, positioned not more than six (6) inches apart, at a single hallway computer terminal and two (2) CCU staff were observed sitting, approximately one (1) foot apart behind the nurses' station at computer workstations.

On 1/4/2021 at 12:05 PM, ten (10) chairs were observed positioned one (1) to two (2) inches apart and a four (4) foot long couch was observed in a Family and Guest Lounge (Room C1408) on the CCU. On 1/5/2021 at 11:37 AM, this area was again observed. At this time, the surveyor along with the Administrative Director of Operations and the CCU Nurse Manager observed ten (10) chairs positioned one (1) to two (2) inches apart and a couch in Room C1408.

On 1/4/2021 at 12:12 PM, two (2) staff were observed sitting positioned approximately two (2) feet apart in the center of the nurses' station on the 1 West Unit.

On 1/4/2021 at 12:30 PM, two (2) nurses were observed sitting together at a computer terminal positioned no more than six (6) inches apart on the 2 West Unit behind the nurses' station.

On 1/5/2021 at 6:28 AM and 7:01 AM, staff were observed sitting together, two to a row, and positioned no more than three (3) inches apart on the shuttle bus.

On 1/5/2021 at 6:43 AM, four (4) staff members were observed in offices within two (2) feet of each other and none were wearing masks.

On 1/5/2021 at 6:56 AM, four (4) staff members were observed in their office. One (1) staff member was standing behind another staff member looking at the computer, and they were positioned within a few inches of each other and neither were wearing a mask.

On 1/5/2021 at 4:00 PM, the Chief Compliance Officer ("CCO") was made aware of the above observations.

2. The US CDC's "Interim Infection Prevention and Control Recommendation for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic", updated 12/14/2020, indicated, "Limit and monitor points of entry to the facility".

On 1/4/2021 at 9:45 AM, the COO stated there were only three (3) entry points to the hospital during COVID-19. These entry points were the main lobby, the main entrance to the ED, and a single Staff Entrance.

On 1/4/2021 at 11:33 AM, an ED Physician pointed out an additional staff entrance utilized by ED staff to go directly into the ED. This entrance was not one that the COO had indicated was an entry into the hospital. The ED Physician indicated staff have badge access to this entrance; staff can utilized a phone application to enter; and staff who do not have a smart phone enter the hospital and complete a screening at a computer workstation within the hospital.

3. The US CDC's "Interim Infection Prevention and Control Recommendation for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic", updated 12/14/2020, indicated, "Screen and Triage Everyone Entering a Healthcare Facility for Signs and Symptoms of COVID-19...symptom screening remains an important strategy to identify those who could have COVID-19 so appropriate precautions can be implemented...Establish a process to ensure everyone (patients, healthcare personnel, and visitors) entering the facility is assessed for symptoms of COVID-19, or exposure to others with suspected or confirmed SARS-CoV-2 infection and that they are practicing source control".

The Maine General Health Employee Screening Tool, stated, "To help maintain a safe workplace, all MaineGeneral employees*, non-employed medical staff, contractors, volunteers and students must use an online (mobile phone or computer) screening tool before they come to work each day".

On 1/4/2021 at 11:33 AM, an ED Physician indicated staff could use an entrance that goes directly into the ED and if someone does not have a smart phone they enter the hospital and complete a screening at a computer workstation within the hospital.

On 1/5/2021 at 6:15 AM, surveyors observed entry points to the hospital to evaluate the screening process. The following was observed:
- At entrance directly into the ED, which was not one of the entrances that the COO had indicated was used for entry into the hospital, six (6) of twenty-two (22) staff entered the hospital without having completed their phone screenings and been cleared to work; and
- At the main ED entrance, one (1) of three (3) staff were observed entering the hospital without having completed their phone screenings.

On 1/5/2021 at 6:58 AM, a Surgeon was interviewed and was asked how he normally does his screening. He stated, "No one has stopped me in months, so I don't know". When asked who he would send his clearance to, he stated, "I don't. I don't have a supervisor".

On 1/5/2021 at 4:00 PM, the COO was made aware of the above..

4. The US CDC's "Interim Infection Prevention and Control Recommendation for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic", updated 12/14/2020, indicated health care personnel should wear a facemask at all times while they are in the healthcare facility and defines health care personnel as the following:

- All paid and unpaid persons serving in healthcare settings who have the potential for direct or indirect exposure to patients or infectious materials, including body substances (e.g., blood, tissue, and specific body fluids); contaminated medical supplies, devices, and equipment; contaminated environmental surfaces; or contaminated air. HCP include, but are not limited to, emergency medical service personnel, nurses, nursing assistants, home healthcare personnel, physicians, technicians, therapists, phlebotomists, pharmacists, students and trainees, contractual staff not employed by the healthcare facility, and persons not directly involved in patient care, but who could be exposed to infectious agents that can be transmitted in the healthcare setting (e.g., clerical, dietary, environmental services, laundry, security, engineering and facilities management, administrative, billing, and volunteer personnel).

According to the MaineGeneral Health sign at the employee entrance, staff must be wearing a mask to move beyond the vestibule.

On 1/5/2121 on eight occasions (6:45 AM, 6:51 AM, 6:52 AM, 6:54 AM, 6:55 AM, 7:02 AM, 7:05 AM, and 7:41 AM) staff members were observed entering the hospital vestibule area without wearing a mask, obtained a mask from the vestibule area, and entered the hospital and/or stairway without placing the mask on their face.

On 1/5/2021 at 6:43 AM, four (4) staff members were observed in offices, within two (2) feet of each other, and were not wearing a facemask per US CDC recommendations.

On 1/5/2021 at 6:56 AM, four (4) staff members were observed in their office. One (1) staff member was standing behind another staff member looking at the computer, within a few inches of each other. All of the staff members were not wearing a mask per US CDC recommendations.

On 1/5/2021 at 7:20 AM, four (4) staff members were observed in their office. The staff members were not wearing a mask per US CDC recommendations.

On 1/5/2021 at 7:30 AM, all surveyors and the COO walked into an office where four staff members were not wearing a mask per US CDC recommendations. When asked about the expectation for wearing a mask, a staff member stated, "Yes, the expectation is to wear a mask and social distance. And, yes, I was not wearing it".

On 1/5/2021 at 2:17 PM, a housekeeper was observed cleaning Room 314 with the patient present in the room. The housekeeper was not wearing a mask per US CDC recommendations. When interviewed, "We were told when and how to wear PPE. For rooms with precautions, I wear a gown, a mask and goggles. If there are no precautions, we are okay to wear just gloves and the mask".

On 1/5/2021 at 4:00 PM, the COO was made aware of the above.

On 1/6/2021 at 2:35 PM, a surveyor interviewed a staff member, who was sitting at her desk without a mask on and with no physical barrier. When asked what the expectation was in regard to wearing a face mask, the staff member stated, "I only need to wear my mask when I leave my desk". On 1/6/2021 at 2:45 PM, the Director of Plant Operations, who supervises the staff member, was interviewed and he stated the staff member was expected to wear a mask when the glass barrier was open.

5. The US CDC's "Interim Infection Prevention and Control Recommendation for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic", updated 12/14/2020, indicated, "Implement Universal Use of Personal Protective Equipment - HCP working in facilities located in areas with moderate to substantial community transmission are more likely to encounter asymptomatic or pre-symptomatic patients with SARS-CoV-2 infection. If SARS-CoV-2 infection is not suspected in a patient presenting for care (based on symptom and exposure history), HCP should follow Standard Precautions (and Transmission-Based Precautions if required based on the suspected diagnosis). They should also: Wear eye protection in addition to their facemask to ensure the eyes, nose, and mouth are all protected from exposure to respiratory secretions during patient care encounters".

According to the Maine Centers of Disease Control and Prevention, Kennebec County, where MaineGeneral Health is located, has been identified as having a high (substantial) community transmission of COVID-19.

On 1/4/2021 at 11:55 AM, RN#3 was observed walking beside one (1) patient in the ED. The staff member was not wearing eye protection per US CDC recommendations.
This finding was confirmed by the ED Medical Director at the time of the observation.

On 1/4/2021 at 12:30 PM, RN#4 was observed in a patient room on 2 West an inpatient unit. The RN was not wearing eye protection per US CDC recommendations.

On 1/4/2021 at 12:40 PM, RN #5 was observed at the bedside of a patient on 2 West an inpatient unit. The RN was not wearing eye protection per US CDC recommendations.

On 1/5/2021 at 11:35 AM, RN#6 was observed in a patient room on 3 West an inpatient unit. The RN was not wearing eye protection per US CDC recommendations.

On 1/5/2021 at 4:00 PM, the COO was made aware of the above observations.

Based on document reviews, observations, and interviews, the hospital's Governing Body failed to ensure that the hospital had systems in place to ensure all possible strategies to prevent and control the transmission of Coronavirus Disease 2019 ("COVID-19") were implemented and monitored. The hospital's failure to ensure physical distancing had been identifed on a COVID-19 focused infection control survey on 11/6/2020l and was found again on this survey.

Finding:

The Governing Body has failed to ensure the hospital had systems in place to ensure all possible strategies to prevent and control the transmission of COVID-19 were implemented and monitored. This was evidenced by the following:

a. During a COVID-19 focused infection control survey, which was completed on 11/6/2020, it was determined that the hospital failed to implement the United States Centers for Disease Control's ("US CDC's") recommendations during the COVID-19 pandemic related to physical distancing in three (3) hospital waiting areas. During this survey, it was determined that the hospital was again not in compliance with US CDC's recommendations related to physical distancing. Please see A-0749 for details.

b. Based on observations, interviews and document review, the facility failed to implement the US CDC's recommendations during the COVID-19 pandemic related to limiting entry points, monitoring staff screening, the use of facemasks, and the use of eye protection. Please see A-0749 for details.