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.

ST MARY'S REGIONAL MEDICAL CENTER 93 CAMPUS AVENUE - PO BOX 291 LEWISTON, ME 04243 June 26, 2020
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on data review and interview, the hospital failed to collect adequate data to monitor the effectiveness and safety of services and quality of care throughout the facility; and the governing body failed to specify the frequency and detail of data collection related to COVID-19 infection control.

Finding:

On 6/25/20, the surveyor reviewed quality data including tracking and monitoring via dashboard, Clinical Practice Committee and Infection Control Committee meeting minutes. At approximately 2:00 p.m., the surveyor inquired with the Director of Quality about COVID-19 specific data collection to monitor effectiveness and safety during the pandemic. The surveyor was provided with "PPE COVID-19 Internal Audits", which included data for the ICU and Unit C2 dated 3/30/20 and 3/31/20, as well as an N95 Reuse Audit for the Emergency Department dated 5/1/20.

PPE Donning and Doffing Internal Audit Data:
-3/30/20 - ICU
Donning PPE on entering PUI COVID-19 (gown, mask/respirator, goggles/face shield & gloves) - total met compliance was 3 of 3; doffing PPE 1 of 1 total met compliance and 2 of 2 total met compliance.
ICU data graph outlines Donning and Doffing of PPE on 3/30 (6 individuals) and 4/28 (6 individuals), facility scored themselves 100%.

- 3/31/20 - Unit C-2
Donning PPE - 4 of 4 total met compliance; doffing PPE - 2 of 2 total met compliance (100%)

-N95 Reuse Audit May 2020
ED & BED N95 Audit - 10 events- measures range from 80% to 100% compliance

On the afternoon of 6/26/20, surveyors discussed QAPI data related to COVID-19 and considered the hospital size, totaling 233 licensed beds and 8 units total. The aforementioned audits provided limited data to 3 of 8 units with no plan for continued audits of donning and doffing of PPE, unless "issues arise". Although the facility audits indicate scores of mostly 100%, surveyor observations in the week of 6/22/20 to 6/25/20 were not consistent with the hospital's data from March, April and May 2020, with regard to use of PPE by staff, including face masks and eye protection. Please see A-0749 for details.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on document/data review and inteviews, the hospital's governing body, medical staff, and administrative officials failed to ensure an ongoing program for quality improvement and patient safety related to COVID-19 infection control.

Finding:

On 6/25/20, the surveyor reviewed quality data including tracking and monitoring via dashboard, Clinical Practice Committee and Infection Control Committee meeting minutes. At approximately 2:00 p.m., the surveyor inquired with the Director of Quality about COVID-19 specific data collection to monitor effectiveness and safety during the pandemic. The surveyor was provided with "PPE COVID-19 Internal Audits", which included data for the ICU and Unit C2 dated 3/30/20 and 3/31/20, as well as an N95 Reuse Audit for the Emergency Department dated 5/1/20.

PPE Donning and Doffing Internal Audit Data:
-3/30/20 - ICU
Donning PPE on entering PUI COVID-19 (gown, mask/respirator, goggles/face shield & gloves) - total met compliance was 3 of 3; doffing PPE 1 of 1 total met compliance and 2 of 2 total met compliance.
ICU data graph outlines Donning and Doffing of PPE on 3/30 (6 individuals) and 4/28 (6 individuals), facility scored themselves 100%.

- 3/31/20 - Unit C-2
Donning PPE - 4 of 4 total met compliance; doffing PPE - 2 of 2 total met compliance (100%)

-N95 Reuse Audit May 2020
ED & BED N95 Audit - 10 events- measures range from 80% to 100% compliance

On 6/24/20 at 12:45pm, an interview was conducted with the Infection Preventionist Nurse (IPN). "I understand that monitoring is an important part of my job and I try to go to each unit about once a week. I have kept no documentation of the audits. I have observed the care and storage of N95 masks when they are hanging outside the patient rooms on the wall, on IV poles but haven't seen any lying on a counter/desk". When asked if there was an attempt to provide distance between patients in the ED waiting room as possible, she stated, "I was in the waiting room observing things two weeks ago and it seemed good". When asked about the divider placed in the waiting room, she stated, "I am unclear why it is there". The surveyor explained that the Triage Nurse stated that it was to put patients with Covid symptoms one side and no symptoms on another. The IPN stated, "I was not aware of that measure". In relation to face shield use, the IPN stated, "Face shields are to be used with a known or suspected patient with Covid 19. We have had limited access to goggles, so we have used the re-usable face shields".

On the afternoon of 6/26/20, surveyors discussed QAPI data related to COVID-19 and considered the hospital size, totaling 233 licensed beds and 8 units total. The aforementioned audits provided limited data to 3 of 8 units with no plan for continued audits of donning and doffing of PPE, unless "issues arise". Although the facility audits indicate scores of mostly 100%, surveyor observations in the week of 6/22/20 to 6/25/20 were not consistent with the hospital's data from March, April and May 2020, with regard to use of PPE by staff, including face masks and eye protection. Please see A-0749 for details.
VIOLATION: INFECTION CONTROL Tag No: A0747
**NOTE- TERMS IN BRACKETS HAVE BEEN EDITED TO PROTECT CONFIDENTIALITY**


Based on observations, interviews and document review, it was determined that the Condition of Participation for Infection Control was not met as evidenced by the hospital failure to ensure active hospital-wide programs for the prevention and control infectious diseases. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines reducing the development and transmission of infectious diseases. It was determined the hospital's failure to ensure active hospital-wide programs for the prevention and control infectious diseases constituted an Immediate Jeopardy (IJ) situation. The IJ is defined as a situation in which a recipient of care has suffered or is likely to suffer serious injury, harm, impairment or death as a result of a provider's noncompliance with one or more health and safety requirements.

Findings:

Standard: 482.42(a)(1) also known as A-0749, based on observations, interviews and document review, the hospital failed to maintain an infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings. See A-0749 for details.

The cumulative effect of this deficient practice resulted in noncompliance with this Condition of Participation.

1. The United States Centers for Disease Control and Prevention (US CDC)'s "Interim Infection Prevention and Control Recommendation for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic", updated 6/19/2020, indicated the following related to screening:

- Screen everyone (patients, HCP [Health Care Personnel], visitors) entering the healthcare facility for symptoms consistent with COVID-19 or exposure to others with [DIAGNOSES REDACTED]-CoV-2 infection and ensure they are practicing source control;
- Actively take their temperature and document absence of symptoms consistent with COVID-19. Fever is either measured temperature 100.0F or subjective fever; and
- Ask them if they have been advised to self-quarantine because of exposure to someone with [DIAGNOSES REDACTED]-CoV-2 infection.

And, according to the hospitals "Employee Attestation Form" the following questions are recorded:
-"I have NOT been in close contact with someone known to have or is under unvestigation for COVID-19 unless work related while wearing full PPE, whithin the last 14 days".
-I have NOT had any of the following symptoms in th last 3 days: list of 8 symptoms
-I HAVE taken my temperature today and is it below 100.4 Degrees Fahrenheit or 38 Degrees Celsius.

On 6/22/20 through 6/25/20, surveyors entered the facility each morning and were screened by a staff member in the Emergency Department (ED) vestibule. On 6/22/20 at 9:25 a.m surveyors entered the ED vestibule together, as well as on 6/23/20 a surveyor entered at 7:30 a.m. and another at 8:00 a.m., 6/24/20 surveyors entered together at 7:30 a.m., 6/25/20 a surveyor entered at 7:00 a.m. and another surveyor at 7:30 a.m. For each entry, the screener inquired about COVID-19 related symptoms and took the surveyor's temperature ensuring it was less than 100.4 degrees Fahrenheit. The current CDC guideline was a temperature of less than 100.0 degrees Fahrenheit. No questions related to close contact with someone known to is under investigation for COVID-19 within the last 14 days, per the hospital's protocol.

On 6/25/20 at 7:30 a.m., a surveyor observed 3 patients and 8 employees get screened at the ED vestibule; the screener inquired about COVID-19 symptoms and took temperatures. In all cases observed, the screeners failed to measure body temperature according to CDC guidelines of 100.0 degrees Fahrenheit, and instead screened for less than 100.4 degrees Fahrenheit. Additionally, no questions were asked related to close contact with someone known to is under investigation for COVID-19 within the last 14 days, per the hospital's protocol.

On 6/25/20 at 7:45 a.m., following observations of patients and employees being screened, the surveyor interviewed the Volunteers Services Manager, who oversees the screeners, she stated screeners used to ask more questions related to out-of-state travel and contact with COVID-19 positive persons, but on or about 5/22/20 discontinued to do so at the direction of Incident Command Personnel.

On 6/24/20 at 1:30 p.m., in an interview with the Infection Preventionist regarding the hospital's temperature screening, the surveyor inquired about the use of 100.4 degrees Fahrenheit, rather than the current CDC guideline of 100.0 degrees Fahrenheit, as of 6/19/20. The Infection Preventionist provided the surveyor with a CDC document with no date on it that did indicate a temperature of 100.4 Fahrenheit, and stated the CDC guidelines could have changed since that form came out.

On 6/24/20 at 10:40 a.m., regarding employee screening in an interview with the Director of Quality, she explained: Facility staff were screened at the ED vestibule in person, until 5/11/20 when it was determined by Covenant that staff may conduct their own "Employee Attestation" to reduce screening time at the hospital entrance, completing a hardcopy attestation form, taking their own temperature (must be less than 100.4 degrees Fahrenheit) and answer questions related to symptoms and contact with someone known to have or was under investigation for COVID19 within the last 14 days. The completed Employee Attestation Form is presented to the screener at the ED vestibule and the staff member is granted entry into the hospital. Since 6/2/20, the facility allowed staff to complete an "Electronic Employee Attestation". Not all staff are completing Employee Attestations; staff that do not have their own thermometers will go through the standard screening at the ED vestibule.

2. The US CDCs "Interim Infection Prevention and Control Recommendation for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic", updated 6/19/2020, indicated the following related to physical distancing:

-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 [DIAGNOSES REDACTED]-CoV-2 transmission.
- Arranging seating in waiting rooms so patients can sit at least 6 feet apart.

On 6/23/20 at 10:15 a.m., the surveyor toured the Intensive Care Unit (ICU) with the Director of Inpatient Services and ICU Nurse Manager and together observed an "Interdisciplinary Rounding" that consisted of several staff meeting behind the nurse station. The staff behind the nurse station were observed 2-3 feet apart from each other and not at least 6 feet apart, per Center for Disease Control (CDC) guidelines. Once the Interdisciplinary Rounding ended, 4 staff remained behind the nurse station, seated at computer workstations approximately 3 feet of each other, with no physical distancing between each work area. Further, although all ICU staff were observed wearing masks, they were not wearing eye protection (medical goggles/face shield), per CDC guidelines, with the exception of one nurse who donned Personal Protective Equipment (PPE) prior to entering 1 of 2 COVID-19 positive patient rooms. At the time of the observation and in an interview with the Director of Inpatient Services, the surveyor inquired about physical distancing and eye protection and she responded, "We do the best we can do".

On 6/22/20 at 11:00 a.m., surveyors observations identified 8-10 chairs/loveseats with the following distances between them: Side 1 had approximately 4 inches to 34 inches between seats and Side 2 has approximately 5 inches to 26 inches between seatings. On 6/23/20 at 10:45 AM, an interview with the Triage Nurse confirmed the seating in the emergency room waiting room was less than six feet apart.

On 6/22/20 at 12:10 p.m., joint observations confirmed with the Director of Behavioral Operations of the AB-3 unit saw three social services employees in a hallway between their offices talking within six feet of each other without wearing masks. On 6/22/20 at 12:10 p.m., an interview with Social Worker #1 indicated if they wished to have a mask; they would ask the nurses for one, the other two Social Workers nodded in agreement.

3. The US CDC's "Interim Infection Prevention and Control Recommendation for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic", updated 6/19/2020, indicated the following related to Personal Protective Equipment (PPE):

Respirator or Facemask (Cloth face coverings are NOT PPE and should not be worn for the care of patients with suspected or confirmed COVID-19 or other situations where use of a respirator or facemask is recommended.)
-Put on an N95 respirator (or equivalent or higher-level respirator) or facemask (if a respirator is not available) before entry into the patient room or care area, if not already wearing one as part of extended use strategies to optimize PPE supply. Other respirators include other disposable filtering facepiece respirators, powered air purifying respirators (PAPRs), or elastomeric respirators.
-N95 respirators or respirators that offer a higher level of protection should be used instead of a facemask when performing or present for an aerosol generating procedure. See appendix for respirator definition.
-Disposable respirators and facemasks should be removed and discarded after exiting the patient's room or care area and closing the door unless implementing extended use or reuse. Perform hand hygiene after removing the respirator or facemask.
If reusable respirators (e.g., powered air-purifying respirators [PAPRs] or elastomeric respirators) are used, they should also be removed after exiting the patient's room or care area. They must be cleaned and disinfected according to manufacturer's reprocessing instructions prior to re-use.
-When the supply chain is restored, facilities with a respiratory protection program should return to use of respirators for patients with suspected or confirmed [DIAGNOSES REDACTED]-CoV-2 infection. Those that do not currently have a respiratory protection program, but care for patients with pathogens for which a respirator is recommended, should implement a respiratory protection program.

Eye Protection
-Put on eye protection (i.e., goggles or a disposable face shield that covers the front and sides of the face) upon entry to the patient room or care area, if not already wearing as part of extended use strategies to optimize PPE supply. Personal eyeglasses and contact lenses are NOT considered adequate eye protection.
-Remove eye protection after leaving the patient room or care area, unless implementing extended use.
-Reusable eye protection (e.g., goggles) must be cleaned and disinfected according to manufacturer's reprocessing instructions prior to re-use. Disposable eye protection should be discarded after use unless following protocols for extended use or reuse.

On 6/24/20 at 12:45 p.m., an interview was conducted with the Infection Preventionist Nurse (IPN). "I understand that monitoring is an important part of my job and I try to go to each unit about once a week. I have kept no documentation of the audits. I have observed the care and storage of N95 masks when they are hanging outside the patient rooms on the wall, on IV poles but haven't seen any lying on a counter/desk". When asked if there was an attempt to provide distance between patients in the ED waiting room as possible, she stated, "I was in the waiting room observing things two weeks ago and it seemed good". When asked about the divider placed in the waiting room, she stated, "I am unclear why it is there". The surveyor explained that the Triage Nurse stated that it was to put patients with Covid symptoms one side and no symptoms on another. The IPN stated, "I was not aware of that measure". In relation to face shield use, the IPN stated, "Face shields are to be used with a known or suspected patient with Covid 19. We have had limited access to goggles, so we have used the re-usable face shields".

On 6/24/20 at 2:00 p.m., observations by surveyors confirmed by the Director of Behavioral Operations AB-3 Behavioral Health (BH) Unit identified a security officer, BH nurse, environmental cleaning aide, employee in Recreational Therapy (conversing with another employee), and an employee at the BH desk without facemask coverings, and no employees were wearing eye protection. Many employees did not practice Social distancing in the employee areas i.e. the nurse's stations. Surveyors toured C2 Unit, C3 Unit, Obstetrics, and the Intensive Care Unit (ICU). On the C2 and ICU units, all staff was observed with face masks, no employees were wearing eye protection. C3 and Obstetrics units had employees working on the units without facemasks; no employees were wearing eye protection.

On 6/24/20 at 3:30 p.m., observation by surveyors in the Emergency Department identified several employees working on the unit without facemasks, no employees were wearing eye protection. Observations identified used N95 masks laying on the employee work stations unattended.

4. The US CDC's Guideline for "Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings":
-Develop systems (e.g. triage signage) to identify patients with known or suspected infections that require Airborne Precautions upon entry into ambuatory settings.

On 6/23/20 at 10:05 a.m., observations by surveyors of one of one PUI (Person Under Investigation) for COVID-19 in emergency room #4 identified Patient #1 who arrived at 8:09 a.m. The signage was turned over so there was no way to determine the type of precautions needed for this patient. On 6/23/20 at 10:05 a.m., an interview with the Medical Secretary reported that Patient #1 was on infection control precautions. On 6/23/20 at 10:05 a.m., an interview with Nurse Manager of the emergency room regarding the lack of precaution signage on the door. Surveyors, walked over to Room #4 and the registered nurse in the room was wearing PPE (personal protective equipment) consistent with a patient that would be on droplet or airborne precaution. Nurse Manager of the emergency room turned the sign over to make people aware of the precaution room. She stated, "The precaution sign can be hung up after the nurse leaves the room". The patient was in the room from 8:09 AM until 10:05 a.m. without signage posted on the room door identifying the type of infection precautions necessary to use.
VIOLATION: INFECTION CONTROL OFFICER RESPONSIBILITIES Tag No: A0749
Based on observations, interviews and document review, the hospital failed to maintain an infection prevention and control program, as documented in its policies and procedures, employs methods for preventing and controlling the transmission of infections within the hospital and between the hospital and other institutions and settings.

Findings:

1. The United States Centers for Disease Control and Prevention (US CDC)'s "Interim Infection Prevention and Control Recommendation for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic", updated 6/19/2020, indicated the following related to screening:

- Screen everyone (patients, HCP [Health Care Personnel], visitors) entering the healthcare facility for symptoms consistent with COVID-19 or exposure to others with SARS-CoV-2 infection and ensure they are practicing source control;
- Actively take their temperature and document absence of symptoms consistent with COVID-19. Fever is either measured temperature 100.0F or subjective fever; and
- Ask them if they have been advised to self-quarantine because of exposure to someone with SARS-CoV-2 infection.

And, according to the hospitals "Employee Attestation Form" the following questions are recorded:
-"I have NOT been in close contact with someone known to have or is under unvestigation for COVID-19 unless work related while wearing full PPE, whithin the last 14 days".
-I have NOT had any of the following symptoms in th last 3 days: list of 8 symptoms
-I HAVE taken my temperature today and is it below 100.4 Degrees Fahrenheit or 38 Degrees Celsius.

On 6/22/20 through 6/25/20, surveyors entered the facility each morning and were screened by a staff member in the Emergency Department (ED) vestibule. On 6/22/20 at 9:25 a.m surveyors entered the ED vestibule together, as well as on 6/23/20 a surveyor entered at 7:30 a.m. and another at 8:00 a.m., 6/24/20 surveyors entered together at 7:30 a.m., 6/25/20 a surveyor entered at 7:00 a.m. and another surveyor at 7:30 a.m. For each entry, the screener inquired about COVID-19 related symptoms and took the surveyor's temperature ensuring it was less than 100.4 degrees Fahrenheit. The current CDC guideline was a temperature of less than 100.0 degrees Fahrenheit. No questions related to close contact with someone known to is under investigation for COVID-19 within the last 14 days, per the hospital's protocol.

On 6/25/20 at 7:30 a.m., a surveyor observed 3 patients and 8 employees get screened at the ED vestibule; the screener inquired about COVID-19 symptoms and took temperatures. In all cases observed, the screeners failed to measure body temperature according to CDC guidelines of 100.0 degrees Fahrenheit, and instead screened for less than 100.4 degrees Fahrenheit. Additionally, no questions were asked related to close contact with someone known to is under investigation for COVID-19 within the last 14 days, per the hospital's protocol.

On 6/25/20 at 7:45 a.m., following observations of patients and employees being screened, the surveyor interviewed the Volunteers Services Manager, who oversees the screeners, she stated screeners used to ask more questions related to out-of-state travel and contact with COVID-19 positive persons, but on or about 5/22/20 discontinued to do so at the direction of Incident Command Personnel.

On 6/24/20 at 1:30 p.m., in an interview with the Infection Preventionist regarding the hospital's temperature screening, the surveyor inquired about the use of 100.4 degrees Fahrenheit, rather than the current CDC guideline of 100.0 degrees Fahrenheit, as of 6/19/20. The Infection Preventionist provided the surveyor with a CDC document with no date on it that did indicate a temperature of 100.4 Fahrenheit, and stated the CDC guidelines could have changed since that form came out.

On 6/24/20 at 10:40 a.m., regarding employee screening in an interview with the Director of Quality, she explained: Facility staff were screened at the ED vestibule in person, until 5/11/20 when it was determined by Covenant that staff may conduct their own "Employee Attestation" to reduce screening time at the hospital entrance, completing a hardcopy attestation form, taking their own temperature (must be less than 100.4 degrees Fahrenheit) and answer questions related to symptoms and contact with someone known to have or was under investigation for COVID19 within the last 14 days. The completed Employee Attestation Form is presented to the screener at the ED vestibule and the staff member is granted entry into the hospital. Since 6/2/20, the facility allowed staff to complete an "Electronic Employee Attestation". Not all staff are completing Employee Attestations; staff that do not have their own thermometers will go through the standard screening at the ED vestibule.

2. The US CDCs "Interim Infection Prevention and Control Recommendation for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic", updated 6/19/2020, indicated the following related to physical distancing:

-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.
- Arranging seating in waiting rooms so patients can sit at least 6 feet apart.

On 6/23/20 at 10:15 a.m., the surveyor toured the Intensive Care Unit (ICU) with the Director of Inpatient Services and ICU Nurse Manager and together observed an "Interdisciplinary Rounding" that consisted of several staff meeting behind the nurse station. The staff behind the nurse station were observed 2-3 feet apart from each other and not at least 6 feet apart, per Center for Disease Control (CDC) guidelines. Once the Interdisciplinary Rounding ended, 4 staff remained behind the nurse station, seated at computer workstations approximately 3 feet of each other, with no physical distancing between each work area. Further, although all ICU staff were observed wearing masks, they were not wearing eye protection (medical goggles/face shield), per CDC guidelines, with the exception of one nurse who donned Personal Protective Equipment (PPE) prior to entering 1 of 2 COVID-19 positive patient rooms. At the time of the observation and in an interview with the Director of Inpatient Services, the surveyor inquired about physical distancing and eye protection and she responded, "We do the best we can do".

On 6/22/20 at 11:00 a.m., surveyors observations identified 8-10 chairs/loveseats with the following distances between them: Side 1 had approximately 4 inches to 34 inches between seats and Side 2 has approximately 5 inches to 26 inches between seatings. On 6/23/20 at 10:45 AM, an interview with the Triage Nurse confirmed the seating in the emergency room waiting room was less than six feet apart.

On 6/22/20 at 12:10 p.m., joint observations confirmed with the Director of Behavioral Operations of the AB-3 unit saw three social services employees in a hallway between their offices talking within six feet of each other without wearing masks. On 6/22/20 at 12:10 p.m., an interview with Social Worker #1 indicated if they wished to have a mask; they would ask the nurses for one, the other two Social Workers nodded in agreement.

3. The US CDC's "Interim Infection Prevention and Control Recommendation for Healthcare Personnel During the Coronavirus Disease 2019 (COVID-19) Pandemic", updated 6/19/2020, indicated the following related to Personal Protective Equipment (PPE):

Respirator or Facemask (Cloth face coverings are NOT PPE and should not be worn for the care of patients with suspected or confirmed COVID-19 or other situations where use of a respirator or facemask is recommended.)
-Put on an N95 respirator (or equivalent or higher-level respirator) or facemask (if a respirator is not available) before entry into the patient room or care area, if not already wearing one as part of extended use strategies to optimize PPE supply. Other respirators include other disposable filtering facepiece respirators, powered air purifying respirators (PAPRs), or elastomeric respirators.
-N95 respirators or respirators that offer a higher level of protection should be used instead of a facemask when performing or present for an aerosol generating procedure. See appendix for respirator definition.
-Disposable respirators and facemasks should be removed and discarded after exiting the patient's room or care area and closing the door unless implementing extended use or reuse. Perform hand hygiene after removing the respirator or facemask.
If reusable respirators (e.g., powered air-purifying respirators [PAPRs] or elastomeric respirators) are used, they should also be removed after exiting the patient's room or care area. They must be cleaned and disinfected according to manufacturer's reprocessing instructions prior to re-use.
-When the supply chain is restored, facilities with a respiratory protection program should return to use of respirators for patients with suspected or confirmed SARS-CoV-2 infection. Those that do not currently have a respiratory protection program, but care for patients with pathogens for which a respirator is recommended, should implement a respiratory protection program.

Eye Protection
-Put on eye protection (i.e., goggles or a disposable face shield that covers the front and sides of the face) upon entry to the patient room or care area, if not already wearing as part of extended use strategies to optimize PPE supply. Personal eyeglasses and contact lenses are NOT considered adequate eye protection.
-Remove eye protection after leaving the patient room or care area, unless implementing extended use.
-Reusable eye protection (e.g., goggles) must be cleaned and disinfected according to manufacturer's reprocessing instructions prior to re-use. Disposable eye protection should be discarded after use unless following protocols for extended use or reuse.

On 6/24/20 at 12:45 p.m., an interview was conducted with the Infection Preventionist Nurse (IPN). "I understand that monitoring is an important part of my job and I try to go to each unit about once a week. I have kept no documentation of the audits. I have observed the care and storage of N95 masks when they are hanging outside the patient rooms on the wall, on IV poles but haven't seen any lying on a counter/desk". When asked if there was an attempt to provide distance between patients in the ED waiting room as possible, she stated, "I was in the waiting room observing things two weeks ago and it seemed good". When asked about the divider placed in the waiting room, she stated, "I am unclear why it is there". The surveyor explained that the Triage Nurse stated that it was to put patients with Covid symptoms one side and no symptoms on another. The IPN stated, "I was not aware of that measure". In relation to face shield use, the IPN stated, "Face shields are to be used with a known or suspected patient with Covid 19. We have had limited access to goggles, so we have used the re-usable face shields".

On 6/24/20 at 2:00 p.m., observations by surveyors confirmed by the Director of Behavioral Operations AB-3 Behavioral Health (BH) Unit identified a security officer, BH nurse, environmental cleaning aide, employee in Recreational Therapy (conversing with another employee), and an employee at the BH desk without facemask coverings, and no employees were wearing eye protection. Many employees did not practice Social distancing in the employee areas i.e. the nurse's stations. Surveyors toured C2 Unit, C3 Unit, Obstetrics, and the Intensive Care Unit (ICU). On the C2 and ICU units, all staff was observed with face masks, no employees were wearing eye protection. C3 and Obstetrics units had employees working on the units without facemasks; no employees were wearing eye protection.

On 6/24/20 at 3:30 p.m., observation by surveyors in the Emergency Department identified several employees working on the unit without facemasks, no employees were wearing eye protection. Observations identified used N95 masks laying on the employee work stations unattended.

4. The US CDC's Guideline for "Isolation Precautions: Preventing Transmission of Infectious Agents in Healthcare Settings":
-Develop systems (e.g. triage signage) to identify patients with known or suspected infections that require Airborne Precautions upon entry into ambuatory settings.

On 6/23/20 at 10:05 a.m., observations by surveyors of one of one PUI (Person Under Investigation) for COVID-19 in emergency room #4 identified Patient #1 who arrived at 8:09 a.m. The signage was turned over so there was no way to determine the type of precautions needed for this patient. On 6/23/20 at 10:05 a.m., an interview with the Medical Secretary reported that Patient #1 was on infection control precautions. On 6/23/20 at 10:05 a.m., an interview with Nurse Manager of the emergency room regarding the lack of precaution signage on the door. Surveyors, walked over to Room #4 and the registered nurse in the room was wearing PPE (personal protective equipment) consistent with a patient that would be on droplet or airborne precaution. Nurse Manager of the emergency room turned the sign over to make people aware of the precaution room. She stated, "The precaution sign can be hung up after the nurse leaves the room". The patient was in the room from 8:09 AM until 10:05 a.m. without signage posted on the room door identifying the type of infection precautions necessary to use.
VIOLATION: LEADERSHIP RESPONSIBILITIES Tag No: A0770
482.42(c)(1) Standard: Leadership responsibilities (1) The governing body must ensure all of the following: (i) Systems are in place and operational for the tracking of all infection surveillance, prevention, and control, and antibiotic use activities, in order to demonstrate the implementation, success, and sustainability of such activities.

Based on policies reviewed, observations and interviews, the 482.42(c)(1) Standard: Leadership responsibilities was not met as evidenced by the failure to ensure the hospital had a system in place to track and ensure that all staff understood their responsibilities for compliance with regulatory bodies related to infection prevention and control. The Governing Body has failed to provide oversight of the QAPI and Infection Control programs within the hospital to ensure that the infection prevention program complied, initiated, followed the state and national guidelines for infection control practices.

Findings:

1. On 6/22/20 at 11:15am, surveyor observations identified ED Nurse #2 without a facial covering and ED Nurse #1 with a surgical mask pulled under her chin at the nurse's desk. These 2 nurses were also sitting within 6-8 inches of each other at the nurse's desk.

2. On 6/22/20 at 11:20am, an interview was conducted with ED Nurse #1 and the ED Nurse Manager was present. The survey confirmed what was observed in regard to facial coverings and ED Nurse #1 stated, "We wear masks most of the time, but it gets hot". When asked about an attempt to try and socially distance, Nurse #1 stated, "There have been no changes to the physical work spaces to create some distance".

3. On 6/22/20 at 11:35am, an interview was conducted with the ED Nurse Manager. The ED Nurse Manager stated that the protocol is for all staff to be wearing surgical masks at all times, but the N95 masks are to be used for patients who are here to rule out Covid 19 or who are positive for Covid 19. When not in use, they are to be placed in a small paper bag that is labeled and stored. At the end of their shift, the N95 mask for that day is placed in a larger brown bag and reused after 5 days unless damaged or soiled.

4. On 6/22/20 at 12:30pm Observations made by this surveyor included the following: Throughout the ED work areas, it was observed on more than 3 occasions that a staff member sat very close together (approximately within 1 foot) to work on a computer. ED Nurse #1 took her N95 off and hung up at desk. Two other N95 masks observed on counter of nurses' desk with no name or initials on them. These findings were confirmed by the ED Nurse Manager.

5. On 6/23/20 at 10:00am, observations were made in the Emergency Department. Nurse #1 had a surgical mask under her chin and then moved it over his/her mouth and nose when surveyors entered the unit. There were 3 N95 masks on the nurse's desks which hung on the edge of the counter by what appeared to be a self-adhesive hook and one of the masks was draped over the phone. None of these N95 masks were labeled or dated.

6. On 6/23/20, surveyors asked if there were precautions in the Emergency Department at that time. The ED Nurse Manager verified that Room #4 was on precautions. Surveyors walked over to that room and the nurse in there was wearing PPE consistent with a patient that would be on droplet or airborne precaution. There was no signage outside the room or on the door indicating precautions. The ED Nurse Manager stated, "The precaution sign can be hung up after the nurse leaves the room". The ED Nurse Manager turned the sign around to make people aware of the precaution room, after having surveyor intervention. Evidence from the patients' medical record indicated that the patient was here to rule out Covid 19 and had been "roomed" at 8:18am and had no signage for precautions until 10:15am. The medical record also revealed that the patient was on droplet plus, contact and airborne precautions.

7. On 6/23/20 at 10:30am an interview was conducted with a n ED Triage Nurse. She stated the following, "I wear a surgical mask unless there is a patient presenting with symptoms like a person under investigation (PUI)". When asked about the N95 mask lying on the desk, she stated, "I leave it on my desk until needed".

8. On 6/23/20 at 3:30pm, in an end of day discussion regarding surveyor team concerns of the St. Mary's clinical and non-clinical employees non-compliance of PPE usage, storage and distancing with the St. Mary's leadership team including the President, the CNO and Quality Director, the President asked, "Where would we find the information regarding the proper measures to put in place"? The survey team leader directed the President to the State and National CDC Guidelines.

9. On 6/24/20 at 10:55am, an interview was conducted with the Manager of Volunteer Services. The Manager of Volunteer Services confirmed that the 4 chairs in the vestibule that the screeners and volunteers use are within an inch of each other which doesn't allow for even an attempt at social distancing, she stated, "I know. We had no volunteers until recently and I realize that they are not able to distance at all".

10. On 6/24/20, an interview was conducted with the Director of Quality, stating "There has been no specific training for Covid 19, but education has been ongoing. Not all environmental service employees need Covid training ...it all depends on the staff location. Eye protection is not necessary unless you are working with a suspected or positive Covid 19 patient or doing an invasive procedure".

11. On 6/24/20 at 12:45pm, an interview was conducted with the Infection Preventionist Nurse (IPN). "I understand that monitoring is an important part of my job and I try to go to each unit about once a week. I have kept no documentation of the audits. I have observed the care and storage of N95 masks when they are hanging outside the patient rooms on the wall, on IV poles but haven't seen any lying on a counter/desk". When asked if there was an attempt to provide distance between patients in the ED waiting room as possible, she stated, "I was in the waiting room observing things two weeks ago and it seemed good". When asked about the divider placed in the waiting room, she stated, "I am unclear why it is there". The surveyor explained that the Triage Nurse stated that it was to put patients with Covid symptoms one side and no symptoms on another. The IPN stated, "I was not aware of that measure". In relation to face shield use, the IPN stated, "Face shields are to be used with a known or suspected patient with Covid 19. We have had limited access to goggles, so we have used the re-usable face shields".
VIOLATION: GOVERNING BODY Tag No: A0043
Based on policies reviewed, observations and interviews, the Condition of Participation for Governing Body was not met as evidenced by the failure to ensure the hospital had a system in place to track and ensure that all staff understood their responsibilities for compliance with regulatory bodies related to infection prevention and control. The Governing Body has failed to provide oversight of the QAPI and Infection Control programs within the hospital to ensure that the infection prevention program complied, initiated, followed the state and national guidelines for infection control practices.

Per the providers 2020 Infection Prevention and Control plan, specific to Covid 19, they were to monitor for proper use of PPE, adherence to transmission-based precautions, educate staff to CDC guidelines and use proper infection control practices.

Findings:

On 6/22/20 at 11:15am, surveyor observations identified ED Nurse #2 without a facial covering and ED Nurse #1 with a surgical mask pulled under her chin at the nurse's desk. These 2 nurses were also sitting within 6-8 inches of each other at the nurse's desk.

On 6/22/20 at 11:20am, an interview was conducted with ED Nurse #1 and the ED Nurse Manager was present. The survey confirmed what was observed in regard to facial coverings and ED Nurse #1 stated, "We wear masks most of the time, but it gets hot". When asked about an attempt to try and socially distance, Nurse #1 stated, "There have been no changes to the physical work spaces to create some distance".

On 6/22/20 at 11:35am, an interview was conducted with the ED Nurse Manager. The ED Nurse Manager stated that the protocol is for all staff to be wearing surgical masks at all times, but the N95 masks are to be used for patients who are here to rule out Covid 19 or who are positive for Covid 19. When not in use, they are to be placed in a small paper bag that is labeled and stored. At the end of their shift, the N95 mask for that day is placed in a larger brown bag and reused after 5 days unless damaged or soiled.

On 6/22/20 at 12:30pm Observations made by this surveyor included the following: Throughout the ED work areas, it was observed on more than 3 occasions that a staff member sat very close together (approximately within 1 foot) to work on a computer. ED Nurse #1 took her N95 off and hung up at desk. Two other N95 masks observed on counter of nurses' desk with no name or initials on them. These findings were confirmed by the ED Nurse Manager.

On 6/23/20 at 10:00am, observations were made in the Emergency Department. Nurse #1 had a surgical mask under her chin and then moved it over his/her mouth and nose when surveyors entered the unit. There were 3 N95 masks on the nurse's desks which hung on the edge of the counter by what appeared to be a self-adhesive hook and one of the masks was draped over the phone. None of these N95 masks were labeled or dated.

On 6/23/20, surveyors asked if there were precautions in the Emergency Department at that time. The ED Nurse Manager verified that Room #4 was on precautions. Surveyors walked over to that room and the nurse in there was wearing PPE consistent with a patient that would be on droplet or airborne precaution. There was no signage outside the room or on the door indicating precautions. The ED Nurse Manager stated, "The precaution sign can be hung up after the nurse leaves the room". The ED Nurse Manager turned the sign around to make people aware of the precaution room, after having surveyor intervention. Evidence from the patients' medical record indicated that the patient was here to rule out Covid 19 and had been "roomed" at 8:18am and had no signage for precautions until 10:15am. The medical record also revealed that the patient was on droplet plus, contact and airborne precautions.

On 6/23/20 at 10:30am an interview was conducted with a n ED Triage Nurse. She stated the following, "I wear a surgical mask unless there is a patient presenting with symptoms like a person under investigation (PUI)". When asked about the N95 mask lying on the desk, she stated, "I leave it on my desk until needed".

On 6/23/20 at 3:30pm, in an end of day discussion regarding surveyor team concerns of the St. Mary's clinical and non-clinical employees non-compliance of PPE usage, storage and distancing with the St. Mary's leadership team including the President, the CNO and Quality Director, the President asked, "Where would we find the information regarding the proper measures to put in place"? The survey team leader directed the President to the State and National CDC Guidelines.

On 6/24/20 at 10:55am, an interview was conducted with the Manager of Volunteer Services. The Manager of Volunteer Services confirmed that the 4 chairs in the vestibule that the screeners and volunteers use are within an inch of each other which doesn't allow for even an attempt at social distancing, she stated, "I know. We had no volunteers until recently and I realize that they are not able to distance at all".

On 6/24/20, an interview was conducted with the Director of Quality, stating "There has been no specific training for Covid 19, but education has been ongoing. Not all environmental service employees need Covid training ...it all depends on the staff location. Eye protection is not necessary unless you are working with a suspected or positive Covid 19 patient or doing an invasive procedure".

On 6/24/20 at 12:45pm, an interview was conducted with the Infection Preventionist Nurse (IPN). "I understand that monitoring is an important part of my job and I try to go to each unit about once a week. I have kept no documentation of the audits. I have observed the care and storage of N95 masks when they are hanging outside the patient rooms on the wall, on IV poles but haven't seen any lying on a counter/desk". When asked if there was an attempt to provide distance between patients in the ED waiting room as possible, she stated, "I was in the waiting room observing things two weeks ago and it seemed good". When asked about the divider placed in the waiting room, she stated, "I am unclear why it is there". The surveyor explained that the Triage Nurse stated that it was to put patients with Covid symptoms one side and no symptoms on another. The IPN stated, "I was not aware of that measure". In relation to face shield use, the IPN stated, "Face shields are to be used with a known or suspected patient with Covid 19. We have had limited access to goggles, so we have used the re-usable face shields".
VIOLATION: QAPI Tag No: A0263
Based on data review and interview, the hospital failed to maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program related to COVID-19 infection control.

Finding:

Standards: 482.21 also known as A-0273 [482.21(b)(2)(i) and 482.21(b)(3)] and A-0309 [(482.21(e)], based on document review and interview, the hospital failed to maintain to collect adequate data to monitor the effectiveness and safety of services and quality of care throughout the facility; and the governing body failed to specify the frequency and detail of data collection related to COVID-19 infection control. See A-0273 & A-0309 for details.

The cumulative effect of this deficient practice resulted in noncompliance with this Condition of Participation.

On 6/25/20, the surveyor reviewed quality data including tracking and monitoring via dashboard, Clinical Practice Committee and Infection Control Committee meeting minutes. At approximately 2:00 p.m., the surveyor inquired with the Director of Quality about COVID-19 specific data collection to monitor effectiveness and safety during the pandemic. The surveyor was provided with "PPE COVID-19 Internal Audits", which included data for the ICU and Unit C2 dated 3/30/20 and 3/31/20, as well as an N95 Reuse Audit for the Emergency Department dated 5/1/20.

PPE Donning and Doffing Internal Audit Data:
-3/30/20 - ICU
Donning PPE on entering PUI COVID-19 (gown, mask/respirator, goggles/face shield & gloves) - total met compliance was 3 of 3; doffing PPE 1 of 1 total met compliance and 2 of 2 total met compliance.
ICU data graph outlines Donning and Doffing of PPE on 3/30 (6 individuals) and 4/28 (6 individuals), facility scored themselves 100%.

- 3/31/20 - Unit C-2
Donning PPE - 4 of 4 total met compliance; doffing PPE - 2 of 2 total met compliance (100%)

-N95 Reuse Audit May 2020
ED & BED N95 Audit - 10 events- measures range from 80% to 100% compliance

On the afternoon of 6/26/20, surveyors discussed QAPI data related to COVID-19 and considered the hospital size, totaling 233 licensed beds and 8 units total. The aforementioned audits provided limited data to 3 of 8 units with no plan for continued audits of donning and doffing of PPE, unless "issues arise". Although the facility audits indicate scores of mostly 100%, surveyor observations in the week of 6/22/20 to 6/25/20 were not consistent with the hospital's data from March, April and May 2020, with regard to use of PPE by staff, including face masks and eye protection. Please see A-0749 for details.
VIOLATION: IC PROFESSIONAL TRAINING Tag No: A0775
Based on document review and interviews, the hospital failed to ensure adequate competency-based training and education of all hospital personnel and staff on the practical applications of infection prevention and control guidelines, policies, and procedures related to COVID-19.

Finding:

On 6/22/20 at 11:50 a.m., in an interview with the Systems Director of Infection Control and the Infection Preventionist, who was on orienting to the role, the surveyor inquired about COVID-19 training of clinical and non-clinical staff. The Systems Director of Infection Control stated there had been no formal COVID-19 training, as the pandemic "came on so fast", but there were informal 1:1 and group discussions on units related to Donning and Doffing of Personal Protective Equipment (PPE).

On 6/23/20 at 9:15 a.m., in an interview with the Director of Quality the surveyor inquired about COVID-19 training and she provided the surveyor with staff completion lists of annual "Mandatory Infection Prevention and Control for Clinical and Non-Clinical Staff" tracked through Net-Learn, which was standard infection control curriculum pre-dating COVID-19. The surveyor again inquired about COVID-19 specific training and the Director of Quality stated the facility dispersed "COVID-19 Update", which are email communications generated by Covenant and the closest equivalent to COVID-19 training is the "Donning and Doffing of PPE" per Center for Disease Control (CDC) guidelines that was provided in an informal format to clinical and non-clinical staff.

On 6/23/20, in review of a sample of clinical and non-clinical staff training lists for Donning and Doffing of PPE, the surveyor discovered not all clinical and non-clinical staff received the training:
1. 14 of 34 staff on Unit C2 (Medical Surgical) had not received the Donning and Doffing of PPE training
2. 11 of 33 staff on Unit C3 (Medical Surgical) had not received the Donning and Doffing of PPE training
3. 17 of 18 Security Officers had not received the Donning and Doffing of PPE training
4. 15 of 31 Environmental Services (EVS) had not received the Donning and Doffing of PPE training
5. 0 (zero) Registration staff had received Donning and Doffing of PPE training

On 6/22/20 at 1:45 p.m., in an interview with Staff #15, she stated, "I am in the ED full time as a technician. We have morning huddles, a policy book for COVID specific policies or changes. I do not recall any 1:1 training or classes specific to COVID."

On 6/22/20 at 1:50 p.m., in an interview with Staff #14 from Environmental Services, she stated, "I had no specific COVID 19 training or review of the virus, I simply do whatever the nurses tell me in regard to COVID. We did have to put on and take off PPE."

On 6/23/20 at 11:15 am, an interview was conducted with the Patient Access Manager. She stated, "The education for COVID, it was all done via email".

On 6/23/20 at 2:15 p.m., in an interview with staff #12, she stated, "When COVID-19 hit, the Patient Access Manager talked to the team about a new screening process to ensure the safety of us and the patients. I did not conduct any Net-Learning, we just had updates via email".

On 6/25/20 at 2:40 p.m., in an interview with the Director of Quality, she acknowledged concerns related to COVID-19 training and the surveyor confirmed the finding.