HospitalInspections.org

Based on observations; interviews with staff, patients, and other stakeholders; and review of documentation including policies, procedures, and 21 medical records, it was determined that the hospital Governing Body failed to operate effectively and to provide necessary oversight and leadership to its Quality Assessment Performance Improvement (QAPI) program and its Infection Prevention and Control (IPC) program.

The findings include:

1. The facility failed to implement and maintain an effective, ongoing, hospital-wide QAPI program when the hospital failed to identify and evaluate performance deficiencies during an outbreak of SARS-COV-2-19 (COVID-19) that began in the building between 03/26/20, when the first positive COVID-19 patient (Patient #1) was transferred to the hospital facility from its nursing home unit, and 04/14/20, when the first hospital patient, previously negative, was diagnosed with COVID-19. Multiple interrelated system failures within the hospital IPC program did not meet minimum standards and these concerns were not sufficiently identified, analyzed, and addressed by the hospital QAPI program during the ongoing outbreak. The system failures within the hospital Infection Prevention and Control (IPC) program continued unabated as the noncompliance was still observed by surveyors and the outbreak was still ongoing when the survey was conducted. There was lack of documented evidence that the IPC program was adequately incorporated into and monitored by the hospital QAPI program during April and May 2020. Cross reference to Tag A-0263 and A-0770.

2. The facility failed to ensure that an active hospital-wide program for the prevention of infections and communicable diseases was implemented and maintained effectively, as evidenced by multiple interrelated failures to prevent and mitigate spread of COVID-19 in the facility. Despite published warnings and guidance and with insufficient preparation, noncompliant infection prevention and control systems, processes and practices continued placing all patients, staff, and visitors at risk for harm and possible death. Cross reference to Tags A-0747, A-0750, and A-775.

The hospital Governing Body failed to ensure a fully functional, prepared and effective infection prevention control program was implemented and maintained; failed to ensure the infection prevention control program was being incorporated into and overseen by hospital QA as required, and failed to ensure sufficient linkage and communication was occurring between and amongst the IC, QAPI, and Governing Body participants. The cumulative effect of these systemic failures left the hospital and all of its patients, staff, and visitors vulnerable to harm and possible death from COVID-19.

Based on observations; interviews with staff, patients, and other stakeholders; and review of documentation including policies, procedures, and 21 medical records, the facility failed to ensure an effective, ongoing, hospital-wide Quality Assessment Performance Improvement (QAPI) program when the hospital failed to evaluate performance deficiencies during the COVID-19 outbreak in the hospital from April to June 2020.

The current survey identified multiple ongoing interrelated system failures within the hospital infection and prevention control program. These concerns were not sufficiently identified, analyzed, or addressed through the hospital QAPI program during an outbreak of COVID-19 that began in the building between 03/26/20, when the first positive COVID-19 patient (Patient #1) was transferred to the hospital facility from its nursing home unit, and 04/14/20, when the first hospital patient, previously negative, was diagnosed with COVID-19. The system failures within the hospital infection prevention and control program continued to be observed by the surveyors at the time of this survey, more than 2 months after the first case was diagnosed. The failure to identify, analyze, and address the system errors resulted in the first hospital-acquired case of COVID-19 within the facility on 04/14/20 and additional patients with hospital-acquired COVID-19 over the next 2 months.

The findings include:

1. Review of the hospital's "Infection Prevention and Control Policy and Procedure Manual" determined that the hospital Infection Control Committee (ICC) reported to the hospital QAPI program (Quality Oversight Committee) and the hospital Medical Staff (Medical Executive Committee).

2. Review of pertinent hospital documentation determined that the hospital Infection Control Committee did not report any COVID-19 related surveillance data to the hospital QAPI program during April or May of 2020 to confirm that the hospital's response to COVID-19 was appropriate and effective. After the outbreak began, with no COVID-19 surveillance reporting received in April or May, the QAPI program failed to evaluate areas within the hospital infection prevention and control program that were later identified and found to be noncompliant during the survey. Cross reference to Tag A-0770.

3. The hospital QAPI program failed to identify, analyze, and correct the improper use of personal protective equipment that remained evident when the survey opened on 6/29/20.

For example:

On 6/30/2020 at 11:00 am, surveyor observed a nurse who placed a yellow isolation gown on backwards exposing the entire front of their clothing. When the Nurse Manager requested the staff member to turn the gown around and wear it appropriately, the nurse stated, "its fine I will just hold it closed", and then proceeded to enter the Persons Under Investigation (PUI) unit with the gown on backwards and untied.

The same day, another staff member, a physical therapist, was observed exiting the PUI unit and engaging in noncompliant practice of sanitizing gloved hands with alcohol-based hand sanitizer. After the physical therapist was made aware of the presence of the surveyor, s/he removed the gloves and disposed of them.

Cross-reference to Tag A-0750.

4. The hospital QAPI program failed to identify, analyze, and correct critical failures in establishing and following isolation precautions to prevent spread of COVID-19 during the outbreak.

For example:

On 06/29/20, surveyors observed that there was no signage at the entrance to the COVID-19 positive unit.

On 06/29/20, surveyors also observed lack of isolation precautions signage for patient rooms where the signage should have been posted due to positive or suspected COVID-19 status.

Cross-reference to Tag A-0750.

5. The hospital QAPI program failed to identify, analyze, and correct a noncompliant and ineffective hospital surveillance process to track staff and patients with infections timely so infected patients could be isolated promptly and staff could be quarantined promptly to limit infectious spread in the building.

For example:

The information was provided to surveyors that the last positive COVID-19 staff member was identified on June 18, 2020. At the time the survey opened, there was no contact tracing initiated for this staff. In an interview on 6/30/2020, the facility's Director of Infection Prevention reported that on 4/2/20 the hospital ended contact tracing for patients who had direct contact with COVID-19 positive healthcare workers.

Record review for Patient #13 determined that the patient tested positive for COVID-19 in mid-June 2020 and remained on the PUI unit for 4 days after the positive test result was available prior to being moved to the COVID-19 positive unit.

Cross-reference to Tag A-0750.

6. The hospital QAPI program failed to identify, analyze, and correct violations of standards of practice for cohorting patients to reduce spread during the outbreak.

For example, the facility failed to provide a timely second COVID-19 test to Patient #13 upon admission to the facility with the first negative test. P13 remained on the PUI Unit for almost a month without the second test. When the second test was performed, P13 was found to be COVID-19 positive. It took 4 more days for P13 to be moved to the COVID-19 positive unit from the PUI unit.

Cross-reference to Tag A-0750.

7. The hospital QAPI program failed to identify, analyze, and address a noncompliant system that should have ensured staff would not and could not work if symptomatic for COVID-19.

For example, staff member #2 (S2) reported that s/he was symptomatic with cough and shortness of breath when s/he reported for work on June 17, 2020. Neither cough nor shortness of breath were present on the facility's entrance screening checklist. S2 worked with patients for a full shift, and on the following day, was tested and received positive COVID-19 test results.

Cross-reference to Tag A-0750.

Despite published warnings and guidance and with insufficient preparation, noncompliant infection prevention and control systems, processes and practices continued placing all patients, staff, and visitors at risk for harm and possible death. The hospital QAPI program was not adequately monitoring and did not adequately oversee the hospital IPC program.

Based on observations; interviews with staff, patients, and other stakeholders; and review of documentation including policies, procedures, and 21 medical records, it was determined that the hospital Medical Staff failed to ensure quality of medical care with insufficient oversight of the hospital QAPI program and insufficient oversight of the hospital Infection Prevention and Control (IPC) program during an outbreak of COVID-19 in the facility between April and June 2020.

The current survey identified multiple ongoing interrelated system failures within the hospital infection and prevention control program. These concerns were not identified or addressed by the hospital QAPI program and directly affected quality of medical care patients received during the COVID-19 outbreak in the facility from April to June 2020. The system failures within the hospital infection prevention and control program continued unabated as the noncompliance continued to be observed by the surveyors and the outbreak was still ongoing when the survey was conducted. The failure to effectively oversee the hospital QAPI program and the hospital Infection Prevention and Control program during the known pandemic left the hospital and all of its patients, staff and visitors vulnerable to harm and possible death from COVID-19 during the outbreak.

The findings include:

1. Review of the hospital's "Infection Prevention and Control Policy and Procedure Manual" determined that the hospital Infection Control Committee (ICC) reported to the hospital QAPI program (Quality Oversight Committee) and the hospital Medical Staff (Medical Executive Committee). In addition, the facility's Medical Director acted as a co-chair on the Infection Control Committee.

2. The hospital Medical Staff failed to identify and correct the improper use of personal protective equipment that was still evident when the survey opened on 6/29/20.

For example:

On 6/30/2020 at 11:00 am, surveyor observed a nurse who placed a yellow isolation gown on backwards exposing the entire front of their clothing. When the Nurse Manager requested the staff member to turn the gown around and wear it appropriately, the nurse stated, "its fine I will just hold it closed", and then proceeded to enter the Persons Under Investigation (PUI) unit with the gown on backwards and untied.

The same day, another staff member, a physical therapist, was observed exiting the PUI unit and engaging in noncompliant practice of sanitizing gloved hands with alcohol-based hand sanitizer. After the physical therapist was made aware of the presence of the surveyor, s/he removed the gloves and disposed of them.

Cross-reference to Tag A-0750.

3. The hospital Medical Staff failed to identify and correct critical failures in establishing and following isolation precautions to prevent spread of COVID-19 during the outbreak.

For example:

On 06/29/20, surveyors observed that there was no signage at the entrance to the COVID-19 positive unit.

On 06/29/20, surveyors also observed lack of isolation precautions signage for patient rooms where the signage should have been posted due to positive or suspected COVID-19 status.

Cross-reference to Tag A-0750.

4. The hospital Medical Staff failed to identify and correct a noncompliant and ineffective hospital surveillance process to track staff and patients with infections in order to isolate or cohort infected patients and quarantine staff promptly to limit infectious spread in the building.

For example:

The information was provided to surveyors that the last positive COVID-19 employee was identified on June 18, 2020. At the time the survey opened, there was no contact tracing initiated for this staff member. In an interview on 6/30/2020 at around 2:00 PM, the facility's Director of Infection Prevention reported that on 4/2/20 the hospital ended contact tracing for patients who had direct contact with COVID-19 positive healthcare workers.

Record review for Patient #13 determined that the patient tested positive for COVID-19 in mid-June 2020 and remained on PUI unit for 4 days after the positive test result was available prior to being moved to the COVID-19 positive unit.

Cross-reference to Tag A-0750.

5. The hospital Medical Staff failed to identify and correct violations of standards of practice for cohorting patients to reduce spread during the outbreak.

For example:

The facility failed to provide a timely second COVID-19 test to Patient #13 upon admission to the facility with the first negative test. P13 remained on the PUI Unit for almost a month without the second test. When the second test was performed, P13 was found to be COVID-19 positive. It took 4 more days for P13 to be moved to the COVID-19 positive unit from the PUI unit.

Cross-reference to Tag A-0750.

6. The hospital's Medical Staff failed to identify and address a noncompliant system that should have ensured staff would not and could not work if symptomatic for COVID-19.

For example, staff member #2 (S2) reported that s/he was symptomatic with cough and shortness of breath when s/he reported for work on June 17, 2020. Neither cough nor shortness of breath were present on the facility's entrance screening checklist. S2 worked with patients for a full shift while symptomatic, and on the following day, was tested and received positive COVID-19 test results.

Cross-reference to Tag A-0750.

Based on review of 6 medical records, hospital policy, unit observations, staff and patient interviews, it was determined that the hospital failed to ensure that nursing staff were providing and/or supervising provision of the expected and appropriate level of nursing care, as evident by failure to perform, supervise, and/or document required hygiene care, as outlined in the hospital policies for 6 out of 6 patients reviewed for provision of hygiene care.

The findings include:

Surveyors reviewed "Guidelines for Patient Care and Documentation - Minimum Requirements" dated July 16, 2020. The following requirements were outlined by the policy: under the section titled "Activity/Hygiene: Q shift (once during a shift), nail care, hair care, grooming etc"; under "Showers: 2-3 days/week & upon request"; under "Bathing: Daily (night shift)"; under the section, "Hourly rounding: Q1h (every hour) 4 P's: pain, potty, positioning, possessions". Furthermore, this document stated, "For all tasks delegated, it is the responsibility of the RN/LPN to verify information and documentation".

Surveyors also reviewed, "Basic Nursing Competency: Performance criteria, 1. Provides AM/PM care to include:
" Bed bath or shower
" Oral Hygiene
" Hair Care
" Shaving
" Toileting
" Dressing patient
" Changing bed linens
" Straightening room
" Peri-care
" Foley Care

During an interview with Staff #9 (S9) on July 16, 2020 at 10:10 am, S9 indicated that showers were given on the unit at least twice weekly during night/early morning hours. The shower schedule posted near the nurse's station on Meisel 2 and reviewed by surveyor on July 16, 2020 at approximately 10:00 AM corroborated the information provided by S9.

Unit observations made by surveyors on July 16, 2020 at approximately 10:00 AM on Meisel 2 included: at least 3 patients had long fingernails with debris under their nails; a male patient was noted to have facial hair that was not cleanly groomed or shaved; several other patients' hair did not have the appearance of being recently brushed.

The following findings resulted from offsite review of 6 medical records requested by surveyors on July 16, 2020:

Patient #16 (P16) was a 75+ year old patient who was admitted to the hospital for further evaluation and treatment of a chronic neurological disorder and possible placement in a long term facility. Assessments completed by nursing listed P16 as 'extensive assistance' for hygiene; however, physical therapy listed the patient as 'minimal assistance'. P16 was also listed as 'incontinent' related to bowel/bladder needs and required one-person staff assistance for care. During P16's 14+ day inpatient admission, no evidence was found to support that the patient received a shower, an assessment for shaving needs, or frequent daily incontinence/peri-care. Mouth care was only found to be documented one time which was on the day prior to discharge. Furthermore, only two bed linen changes were documented over the course of two weeks. Regarding bed baths, 'self-care' was listed on two separate occasions, although the patient was documented as requiring 'one-person assistance'.

Patient #17 (P17) was a 65+ year old patient who was admitted to the hospital from a long term care facility for medication management related to their chronic neurological disease process. P17 was admitted approximately seven weeks ago. The patient was assessed by nursing and physical therapy as requiring supervision for mobility and assistance with hygiene needs. Over the course of the 7 weeks since admission, linen changes were documented with up to 6 days in between, daily baths up to 4 days in between, and mouth care completed with up to 6 days in between. Incontinence care or assistance with toileting was documented inconsistently and sometimes only once daily. Furthermore, only one shower was documented, approximately one month after P17 was admitted.

Patient #18 (P18) was a 90+ year old patient who was admitted to the hospital for psychiatric management of a chronic disease. The patient was assessed by Physical and Occupational Therapy as 'dependent on bathing, toileting and dressing'. Over the course of the 7 weeks since P18's admission, it was documented that the patient was 'assisted with bathing'. However, nursing documentation stated that P18 was "dependent on staff for all ADL's (activities of daily living)". Linen changes were documented with 2 to 5 days in between, mouth care was only documented as performed every 2-5 days, and incontinence care was documented inconsistently and sometimes not even once daily. Furthermore, only one shower was documented, approximately one month after P18 was admitted.

Patient #19 (P19) was an 80+ year old patient who was admitted to the facility for management of behavioral health issues. On day 4 of P19's admission, the Occupational Therapist (OT) documented an initial assessment of P19's performance of activities of daily living (ADL). The OT noted that P19 was independent with activities, such as bathing, feeding, grooming, and dressing. Although physically able to perform tasks independently, P19 had periods of agitation and confusion, which resulted in the use of restraints, therefore leading to P19's dependence upon staff for ADL care. P19 also acquired an acute illness during his/her hospital stay, further prompting P19's reliance on the staff for assistance with activities of daily living.

P19's admission to the facility resulted in a 55-day stay. Review of the medical record determined that staff either documented "Assisted with Bathing, Self-Care, or Shower" under the column marked Hygiene. There was no documentation of a daily bath for 21 days out of 55 days throughout P19's admission. Mouth care was only documented for 13 of the 55 days. P19's bed linen was documented as changed only 9 times during P19's 55 day admission. The first bed linen change was documented on day 7 of P19's admission, with the following bed linen changes documented over a month later, on day 39 of P19's admission.

Patient #20 (P20) was a 75+ year old who presented to the facility for treatment of mental health issues. P20's admission totaled 36 days at the conclusion of the onsite survey. P20 had a recent history of not bathing due to declined mental functioning prior to admission. P20 had an initial assessment documented by an OT on day 1 of admission. The OT noted P20 required supervision and verbal cues to perform ADL's. However, during therapy sessions, there were occasions when the OT noted that P20 required up to total assistance for ADL care.

P20's hygiene documentation showed that P20 had been identified as 'Self-Care' with hygiene on 8 occasions. There was no documentation found to support that an assessment was made for P20's ability to perform personal hygiene care independently or to complete self-care. P20 was noted to be 'assisted with bathing' beginning on day 19 of P20's admission. The staff failed to document the appropriate level of assistance required for P20's ADL care for over 2 weeks after P20 was admitted. This was in direct contradiction to the OT's initial assessment of P20's need for staff supervision and verbal cues during ADL care.

Furthermore, P20 had only one documented shower on day 12 of his/her admission and only one documented performance of mouth care on day 27 of admission. P20's linen was not documented as being changed until day 15 of admission. From days 15-30, linen changes were documented daily or every other day. However, after day 30, P20 had no further documentation of bed linen changes.

Patient #21 (P21) was a 70+ year old who was admitted to the facility for medication management of behavioral health issues. P21 was admitted 35+ days prior and was still inpatient during this survey. P21 was assessed by an Occupational Therapist (OT) after admission which stated P21 would "require assistance activities of daily living -bathing, feeding, grooming, dressing, transfers, and oral care". Although bathing was supposed to be performed daily, documentation showed P21 was only provided assistance with bathing (either direct or toiletry set up) up to 21 times.

P21 had only one shower documented on day 29 of admission. Only 3 bed linen changes were documented during this inpatient admission, with the first documented bed/linen change on day 26 of this admission. During an interview with P21, while on the unit on July 16, 2020 at 10:30 am, P21 stated s/he was assisted with a shower only 3 times during this admission. P21's appearance to surveyors was mildly disheveled, with food stained clothing and unkempt hair.

The nursing staff failed to consistently perform, supervise, and/or document the hygiene care during the above-mentioned patients' stay. The medical records for all 6 patients reviewed lacked documentation of provision of AM/PM oral care, daily bath or twice weekly showers, as per facility policy/procedure guidelines. Furthermore, the medical records above did not indicate if the patients refused daily baths and bi-weekly showers, or any medical reason to preclude a daily bath or shower.

Based on observations; interviews with staff, patients, and other stakeholders; and review of documentation, including policies, procedures, and 21 medical records, it was determined that the facility was out of compliance with the Condition of Participation for Infection Prevention and Control with multiple interrelated system failures.

The hospital's noncompliance with infection prevention and control requirements placed all patients, staff, and visitors at risk: at least 69 patients and 57 staff were documented to have developed COVID-19 infection, and at least 3 patient deaths due to COVID-19 were confirmed through chart review. This resulted in a finding of the immediate jeopardy. The Maryland Office of Health Care Quality (OHCQ) notified the hospital of the immediate jeopardy on 07/01/20 at 10.22 am. The OHCQ received and accepted a plan to remove immediacy on 07/02/20 at 6.00 pm.

The findings include:

1. Infection Prevention and Control program failed to effectively 1) surveil; 2) prevent; and 3) contain or control a hospital outbreak of COVID-19 between April and June 2020. Cross reference to Tag A-0750.

2. The hospital Governing Body failed to ensure a fully functional, prepared, and effective infection prevention control program was implemented and maintained; failed to ensure the infection prevention control program was being managed and overseen by hospital QA as required, and failed to ensure sufficient linkage and communication was occurring between and amongst the IC and QAPI participants. Cross reference to Tags A-0043 and A-0770.

3. Infection Prevention and Control program failed to provide competency-based training and education to direct care and ancillary staff in donning (putting on) and doffing (taking off) as well as use, storage and disinfection of Personal Protective Equipment (PPE). Cross reference to tag A-0775.

4. Infection Prevention and Control program failed to report the hospital outbreak and the deaths of the patients who directly contracted COVID-19 from the facility to the local health officials. Cross reference to tag A-0020.

The cumulative effect of these systemic failures left the hospital and all of its patients, staff, and visitors vulnerable to harm and possible death from COVID-19.

Based on observations, interviews with patients, staff, and other stakeholders, and review of documentation, including policies, procedures, and 21 medical records, it was determined that the hospital failed to ensure an effective Infection Prevention and Control (IPC) program that 1) surveilled, 2) prevented, and 3) contained or controlled a hospital outbreak of COVID-19 that began in the building between 03/26/20, when the first positive COVID-19 patient (Patient #1) was transferred to the hospital facility from its nursing home unit, and 04/14/20, when the first hospital patient, previously negative, was diagnosed with COVID-19.

The hospital's noncompliance with infection prevention and control requirements placed all patients, staff, and visitors at risk: at least 69 patients and 57 staff were documented to have developed COVID-19 infection, and at least 3 patient deaths due to COVID-19 were confirmed through chart review. This resulted in a finding of immediate jeopardy. The Maryland Office of Health Care Quality (OHCQ) notified the hospital of the immediate jeopardy on 07/01/20 at 10:22 AM and a plan that met CMS minimum standards for acceptability was accepted on 07/02/20 at 6:00 PM.

The findings include:

The following guidance on "Preventing Transmission of Infectious Agents in Healthcare Setting" by the Centers for Disease Control (CDC) was in effect at the time of the survey:

"Control of SARS requires a coordinated, dynamic response by multiple disciplines in a healthcare setting. Early detection in cases is accomplished by screening persons with symptoms of a respiratory infection for history of travel to areas experiencing community transmission or contact with SARS patients, followed by implementation of Respiratory Hygiene/Cough Etiquette (i.e., placing a mask over the patient's nose and mouth) any physical separation from other patients in common areas ... At the time of this publication, CDC recommends Standard Precautions, with emphasis on the use of hand hygiene, Contact Precautions with emphasis on environmental cleaning due to the detection of SARS CoV RNA by PCR on surfaces in rooms occupied by SARS patients, Airborne Precautions, including use of fit-tested NIOSH approved N95 or higher level respirators, and eye protection" (CDC, 2020).


1. The first part of an effective infection prevention and control program regards surveillance. There must be systems in place to monitor for early signs of infection in the hospital population and to make timely and accurate notifications to the public health officials in order to address concerns promptly and limit potential spread of infection within and outside of the hospital.

1.1. The hospital is in a shared structure with its nursing home. Review of the medical record for Patient #1 (P1) determined that P1 was transferred from the nursing home to the hospital's High Intensity Care Unit (HICU), which is in the same building, on 03/26/20. The hospital's Nurse Practitioner documented on 03/27/20: "Covid (rule out) - Pt [patient] came from Hall 1 at Levindale in which the other pt in the room now has acute respiratory symptoms. Attending requesting Covid R/o for this patient as well." Further record review determined that P1 tested positive for COVID-19 on 03/31/20. No COVID-19 cases occurring in the hospital prior to this note were identified by the surveyors.

Two days later, the hospital discontinued contact tracing. In interview on 6/30/2020 at 2:00 pm, the facility's Director of Infection Prevention reported that on 4/2/20 the hospital ended all contact tracing for patients who had direct contact with COVID-19 positive healthcare workers. The hospital later provided an email dated 4/2/20, where hospital system staff had summarized their understanding of CDC guidance and concluded that contact tracing was not necessary if all staff started wearing N-95 masks in a construct called universal masking. However, with this reported basis for ending contact tracing, the surveyors observed that not all direct care providers were wearing N-95 masks when working with patients on 06/29/20. The hospital provided a link to the CDC guidance, but when reviewed by surveyors on 07/01/2020 at 1:30 pm, it did not support the hospital conclusion that contact tracing should have been stopped the first week when the first confirmed positive COVID-19 patient was identified in the hospital and reported to the IPC program. The critical step of tracing within the hospital surveillance system ended on 04/02/20.

1.2. Review of the IPC's documentation and interviews with the Director of Infection Prevention on 06/30/2020 and the System Infection Prevention Director on 06/30/2020 revealed that the hospital had a specialized electronic records system for infection prevention and control. However, review of data within the specialized system and interview with the hospital's Director of Infection Prevention revealed and corroborated that the hospital didn't use the system in a manner that would have allowed effective tracking of the outbreak early and promptly. The electronic system allowed for entry of notes to assist in tracking any potential common points of contact in order to isolate and correct possible underlying concerns, but this feature was not utilized by the hospital. For example, there was no particular room, no particular piece of equipment, or no particular staff that was noted in the system that might have been linked to spread and could have, therefore, potentially been addressed to stop additional spread from that common source. At the time of the survey, contact tracing for the last known infected staff member (from 06/18/20) was not initiated until 06/29/20 (date of the survey) after surveyors posed questions of such to the Director of Infection Prevention.

1.3. In addition to the failure to establish and maintain effective internal surveillance processes for tracking of COVID-19 infection spread in the hospital, the hospital Infection Prevention and Control Program failed to comply with state and local requirements to fully and accurately report 1) an infectious outbreak and 2) resultant patient deaths to the local public health officials.

Per the Centers for Disease Control, "Healthcare facilities should have a process for notifying the health department about suspected or confirmed cases of SARS-CoV-2 infection, and should establish a plan, in consultation with local public health authorities, for how exposures in a healthcare facility will be investigated and managed and how contact tracing will be performed" (CDC, 2020).

1) The hospital faxed names of patients to the local health department but did not notify the local health department that the reported patients were acquiring SARS-COV-2-19 (COVID-19) as a result of a hospital outbreak and they were not patients being admitted with COVID-19.

In an interview with the hospital's Director of Infection Prevention on 06/29/20 at approximately 11.00 am, surveyors requested to review documentation of communication between the hospital and the local health department related to reporting of the hospital-acquired positive COVID-19 cases. The facility failed to provide any documentation confirming telephone conversations or electronic communications of hospital-acquired COVID-19 cases to the health department.

Offsite review of pertinent hospital documentation from 06/16/20 revealed that there was an outbreak of COVID-19 in the hospital affecting 55 patients on Brain Health Unit (BHU) and 57 staff members collectively. Per an Infection Prevention and Control program report on 06/16/20 "one resident transferred from Hall 1 (nursing home unit located in the same building with the hospital) to the BHU due to behavioral issues carried the virus over to BHUs". The most recent hospital line listing, reviewed by the surveyors offsite on 07/07/20, contained 69 names of positive COVID-19 patients with the first positive patient identified on the Meisel 2 hospital unit on 04/14/20. With noncompliant infection prevention and control systems evident, the outbreak was still ongoing at the time of the survey.

In an interview on 06/29/20 at approximately 12.00 pm, a Baltimore City Health Department Official #1 (HDO1) stated that the hospital reported names of positive COVID-19 cases via fax; however, these transmissions lacked information identifying the reported cases as hospital-acquired. The impression reported by HDO1 was that the cases were new admissions into the hospital rather than an ongoing outbreak of hospital acquired infections. Per HDO1, on 06/19/20, the local health department received a line listing from the hospital via fax which contained the name of Patient #13 (P13) with the admission date of 05/15/20 and the positive COVID-19 test date of 06/11/20. The lag time between admission and the positive test was indicative of P13 acquiring the infection in the hospital. While the hospital had faxed names of COVID-19 positive patients to the local health department, there was no evidence that the hospital actually reported the outbreak.

2) The hospital failed to report the deaths of the patients who directly contracted COVID-19 within the hospital as required by the local health officials.

Offsite review of pertinent hospital documentation from 06/16/20 revealed that there was an outbreak of COVID-19 in the hospital affecting 55 patients on Brain Health Unit (BHU) and 57 staff members collectively. Per Infection Prevention and Control program report on that date, "one resident transferred from Hall 1 (nursing home unit located in the same building with the hospital) to the BHU due to behavioral issues carried the virus over to BHUs". The most recent hospital line listing, reviewed by the surveyors offsite on 07/07/20, contained 69 names of positive COVID-19 patients with the first positive patient identified on the Meisel 2 hospital unit on 04/14/20. With noncompliant infection prevention and control systems evident, the outbreak was still ongoing at the time of the survey.

Pertinent hospital documentation from 06/16/20 also revealed that 20% of the COVID-19 infected BHU patients died after contracting COVID-19.

The offsite review of patient medical records revealed that Patient #2 (P2), Patient #3 (P3) and Patient #4 (P4) all acquired COVID-19 within the facility between April 2020 and June 2020. All of these patients experienced deteriorating clinical status due to infection and all three subsequently died at the facility within days of testing positive for COVID-19. Infection surveillance documentation from the hospital infection prevention program contradicted this and instead inaccurately documented that the outcome of all of these patients as "unknown".

In an interview on 06/29/20 at approximately 12.00 pm, HDO1 reported that no COVID-19 related deaths had been reported by the hospital to the local health department as of the time of survey (6/29/2020).

1.4. Tracking patient location is both fundamental and important to surveillance within an infection prevention and control program. Twice during survey, surveyors requested a list of in-house patient transfers. As was also true with tracking in the electronic system, the hospital's Director of Quality and Patient Safety stated in an interview on 06/30/20 at around 3:30 PM,that they could not provide this documentation as patient transfers from one room to another within the hospital were not tracked.

Per the Centers for Disease Control (CDC), "Surveillance of both process measures and the infection rates to which they are linked are important for evaluating the effectiveness of infection prevention efforts and identifying indications for change. Data gathered through surveillance of high-risk populations, device use, procedures, and or facility locations are useful for detecting transmission trends. Identification of clusters of infections should be followed by systematic epidemiologic investigation to determine commonalities in persons, places, and time; and guide implementation of interventions and evaluation of the effectiveness of those interventions", (CDC, 2020).

Further corroborating the system failure to adequately surveil the hospital for potential spread, on 6/30/20, approximately three months after the first known hospital case, the Director of Infection Prevention who was responsible for the program, was nonetheless not aware of a new PUI patient on Meisel 1 Unit, which surveyors had identified during an earlier tour of the unit.

2. The second part of an effective infection prevention and control program noted in the Federal requirements is prevention. Hospitals must develop and implement effective systems to prevent outbreaks. The hospital failed to develop an effective process to fully screen staff to ensure that staff would not bring COVID-19 into the hospital.

On 6/30/2020 at 9:00am, review of the screening process for staff reporting for work determined that the screening questions were inadequate to ensure staff reporting to work could not access the building and work if they presented with symptoms associated with COVID-19. Surveyors observed the process of staff screening on entry to the hospital on June 29 and 30, 2020. On entry, staff filled out a check list which was unclear when documenting if they were checking that they did or did not have symptoms, and numerous symptoms associated with COVID-19 were not present on the screening checklist at all.

In an interview on 06/30/20 at 11.30 am, staff member #2 (S2) reported that s/he was symptomatic with cough and shortness of breath when s/he reported for work on 06/17/20. Neither cough nor shortness of breath were present on the screening checklist. S2 reported that s/he worked with patients for a full shift; and then on the following day, was tested for and received positive COVID-19 test results.

Continued review of the staff screening checklist revealed that, in addition to cough and shortness of breath, the checklist also failed to include loss of taste, loss of smell, GI symptoms, or fatigue, all of which are known symptoms associated with COVID-19 infection.
Last, multiple staff reported in interviews that the desk where staff were to be screened when reporting for work was not always staffed during off-hours.

3. The third part of an effective infection prevention control program as defined in the regulations is containment. Once an infectious agent is within the confines of any healthcare facility, there must be systems in place to isolate and control spread. Numerous system failures were evident in the infection prevention and control program related to containment.

3.1 Cohorting describes the practice of isolating patients with like conditions in common units or areas in order to limit exposure of that condition to others. The hospital had designated areas for patients that were COVID-19 positive, patients suspected to be positive or awaiting results to rule out COVID-19 infection and patients that had unknown status designated as PUI. However, the hospital failed to manage cohorting of the patient population in a manner that was compliant with minimum standards of practice.

During interview with Staff #6 (S6) on 06/30/20 at approximately 10:00 am, surveyors asked about the current process of admitting new patients to the hospital. S6 stated that newly admitted patients were admitted to the PUI (Persons Under Investigation) unit. S6 also stated that patients were required to receive a COVID-19 test prior to admission and then to have the test repeated at the hospital, 2-3 days after the admission. If the patient had two negative results, the patient would then be moved to a negative unit; if the patient tested positive, they were moved to the positive/recovery unit.

Surveyors requested to review the hospital policy related to the testing and room placement process described above. When reviewed on 6/30/2020 at 2:30 pm, the hospital policy had an effective date of August 2020 and the Director of Infection Prevention reported the policy was still under development.

Patient #13 (P13) was an 80+ year old patient who was transferred to the hospital from an Emergency Department. P13 was admitted for recurrent falls and confusion with a plan to transfer to the long term care unit once stabilized. The patient was admitted to the PUI unit with the intention of moving the patient once two negative COVID-19 tests were obtained. Offsite record review revealed that only one negative test result was documented for P13, which was completed prior to this admission at the previous facility. No documentation was found to support that the patient was retested by the hospital within 2-3 days after the admission. P13 remained on the PUI unit with one negative test result for approximately one month. After a positive test result was obtained approximately 30 days after the admission, P13 was still not cohorted appropriately for another four days when s/he was finally moved off the PUI to the positive/recovery unit.

Patient #14 was a 65+ year old patient who presented to the hospital for medication management related to a chronic medical condition. P14 was admitted directly to a COVID-19 negative unit and not the PUI unit. Within 6 days of admission, the patient was documented as having a productive cough, chest pain, and diminished lungs sounds. No documentation was found to support that the patient was transferred to the PUI unit or quarantined in place after becoming symptomatic.

In another noncompliant practice related to cohorting, multiple staff (Staff #2, #3, #4) stated in interviews that, when a patient in a shared room tested positive for COVID, the second patient was moved to another room with another patient. The second patient having been exposed to the first patient, now had an unknown COVID-19 status but was moved contrary to nationally recognized guidelines, potentially exposing their new roommate.

On 3/19/2020 the Centers for Disease Prevention and Control published "Interim Infection Prevention and Control Recommendations for Patients with Suspected or Confirmed Coronavirus Disease 2019" which indicated that "it might not be possible to distinguish patients who have COVID-19 from patients with other respiratory viruses. As such, patients with different respiratory pathogens might be cohorted on the same unit. However, only patients with the same respiratory pathogen may be housed in the same room. For example, a patient with SARS-COV-2-19 should ideally not be housed in the same room as a patient with an undiagnosed respiratory infection or a respiratory infection caused by a different pathogen."


3.2 In order to contain spread of an infectious outbreak, health facilities must employ isolation strategies including use of transmission precautions. The hospital failed to effectively communicate each patient's isolation status to all staff so that staff could employ the correct isolation practices when directly interacting with each patient.

CDC guidance provides that transmission precautions, including contact and droplet precautions must be maintained in order to limit the spread of COVID-19. To be effective, isolation precautions must be ordered and implemented timely

The CDC defines transmission based precautions as the second tier of basic infection control and are to be used in addition to Standard Precautions for patients who may be infected or colonized with certain infectious agents for which additional precautions are needed to prevent infection transmission.

In guidance issued on 4/23/20, the CDC reported that transmission of the COVID-19 virus likely occurs from droplet sources and contact with contaminated surfaces. Therefore, droplet and contact precautions were the levels of transmission based precaution necessary to reduce risk for spread of the virus in the healthcare setting.

During 06/29/20 tour of the Meisel 2 Unit, surveyors observed that isolation precaution signage was not posted on doors for patients where the signage was necessary due to positive or suspected COVID-19 status. In another related observation, surveyors noted isolation signage posted at a particular patient room door on the Meisel 2 Unit. The Assistant Nurse Manager of the unit stated that the signage was on this door in error and removed the signage without checking the medical record or clarifying why the signage was hung in error.

In interviews with an EVS tech, the Director for Risk Management, and the hospital President, all reported that ancillary departments (such as EVS, dietary, radiology, transportation, etc.) were only given verbal notification of positive isolation patients. Written notification was not provided. The unreliable system for signage to communicate isolation precautions and reliance on verbal reports for critical isolation information increased the risk for staff to not comply with isolation precautions and increased the risk for further infectious spread.

Record review revealed that Patient #14 (P14), was a 65+ year old patient who presented to the hospital for medication management of a chronic medical condition. Less than a month prior to this admission, P14 tested positive for a multi-drug resistant and highly contagious (by contact) organism at another facility. This type of infection would warrant isolation precaution practices for the patient. No documentation was found to support physician or nursing acknowledgement of this positive result in P14's current record, although this facility and the other facility shared the same electronic medical record system. No contact precaution signage was found on the outside of the patient's room while surveyors were on site on 06/29/20.

3.3 Once isolation precautions are in place, staff must utilize Personal Protective Equipment (PPE) appropriately to contain spread. For PPE use to be effective, staff must implement the correct precautions safely, accurately and consistently, but the hospital failed to ensure that staff utilized PPE in a safe and effective manner.

The CDC defines that isolation contact precautions include "wearing a gown and gloves for all interactions that may involve contact with the patient or the patient's environment. Donning PPE upon room entry and properly discarding before exiting the patient room is done to contain pathogens [and droplet precautions include] wearing a mask when entering the resident room and utilizing single rooms when able."

On 6/29/2020 at 10:30 am, surveyors observed that the hospital utilized reusable yellow cloth gowns. The clean gowns were stored in such a manner that they weren't clearly labelled and readily accessible at all entry and exit points. Dirty gown receptacles were accessible, but were not clearly labelled creating the risk for staff to inadvertently don a dirty gown versus a clean one. In addition, in interviews, multiple staff expressed concern about the risk for other staff reusing contaminated gowns due to the failure to set up clearly labelled gown receptacles.

On 6/29/2020 at 10:30 am, surveyors observed that hand sanitizer was not available on the entry corridor to the COVID-19 positive unit.

On 6/29/2020 at 10:30 am, surveyors observed that there were no trash receptacles at the points for ingress/egress on and off the COVID-19 positive unit.

On 6/29/2020 at 10:30 am, multiple staff reported different processes for entering a wall key code to exiting the positive unit. Some removed their gloves and then pushed the code, others pushed the code with contaminated gloves and then removed their gloves.

On 06/29/20 around 10:30 am, surveyors observed a bag with patient belongings laying on the floor of the corridor of the positive unit. The bag had no label or indicator if it was potentially contaminated. When asked about the bag, direct care staff who was not wearing their mask appropriately, was observed then handling the potentially contaminated bag with ungloved, bare hands.

On 6/30/2020, multiple staff reported that Staff #5 (S5) wore purple gloves into the facility and went from patient to patient without changing gloves and washing hands, and only utilizing alcohol-based sanitizer to clean the same gloves in between patients. On the same day, surveyors observed a physical therapist exiting a PUI (Persons Under Investigation) unit and engaging in the same noncompliant practice of sanitizing gloved hands with alcohol-based hand sanitizer. After the physical therapist was made aware of the presence of the surveyor, s/he removed the gloves and disposed of them.

Gloves must not be washed for subsequent reuse because microorganisms cannot be removed reliably from glove surfaces and continued glove integrity cannot be ensured. Furthermore, glove reuse has been associated with transmission of MRSA and gram-negative bacilli (CDC, 2020).

Surveyor observations on 6/30/20 at 8:45 am and 3:30 pm and staff interviews revealed that staff carried soiled N-95 masks home without placing them into a safe container and with no common method for disinfection of the masks. Cross Reference to Tag A-0775.

On 6/30/2020 at 10:00 am, surveyors observed that Staff #7 (S7) picked up soiled laundry from the PUI unit. S7 placed gloves on but did not gown before removing the dirty laundry and then carried the soiled laundry through the unit while it was in direct contact with their clothes. S7 then exited the PUI unit potentially carrying infectious agent on their clothing that could be spread in other parts of the building.

The interrelated system failures to develop and implement effective systems for surveillance, prevention, and then containment contributed to an insufficient and ineffective hospital response when COVID-19 emerged in the building during March 2020 and resulted in multiple deficient practices which were determined by surveyors on 07/01/20 to present an immediate threat to patient health and safety.

The OHCQ received and accepted a plan from the hospital to remove immediacy on 07/02/20 at 6.00 pm. The plan included the following actions by the hospital:

- Staff re-education and monitoring for adherence to proper hand hygiene, proper PPE utilization, as well as proper donning/doffing practices to begin immediately and be completed by 07/09/20;

- Improved accessibility to and storage of clean isolation gowns implemented on the units on 07/01/20, and floor and receptacles for clean and dirty isolation gowns were labelled appropriately on 06/30/20;

- Hand sanitizer dispenser was installed in the hallway outside of the COVID-19 positive unit on 06/30/20;

- Staff education on proper storage of N95s and use of storage containers to begin immediately and be completed by 07/09/20;

- Complete audit of all rooms was performed on 07/01/20 to assure proper isolation signage was in place, staff education to begin immediately on proper use of isolation signage and be completed by 07/09/20;

- Appropriate signage was posted at the entrance to the COVID-19 positive unit on 06/30/20;

- Daily electronic communication was resumed on 07/01/20 to all hospital department leadership about current positive and PUI patients in the hospital with the expectation to cascade the information down to the front line staff through daily rounds, shift huddles, postings on the units, and shift reports;

- Contact tracing was resumed on 07/01/20;

- Cohorting guidelines were updated to reflect current CDC recommendations on 07/01/20, with education to leadership to begin on 07/02/20;

- Screening checklist update to include all symptoms of COVID-19 listed by CDC and staff re-education on updated screening process to begin immediately and be completed by 07/09/20;

- The system of color-coding employee badges was implemented on 07/01/20 to clearly identify, upon entry to the hospital, which type/size of mask an employee was successfully fit tested for.

Based on review of hospital's policies, procedures, and other pertinent documents, it was determined that the hospital Governing Body failed to ensure effective oversight of the hospital infection prevention and control program when internal reporting of an infectious outbreak with two clusters of infection between April and June 2020, was not fully and accurately reported into facility leadership committees accountable for oversight.

Review of the hospital's "Infection Prevention and Control Policy and Procedure Manual" indicated that the hospital maintained an Infection Control Committee (ICC) that reported on a monthly basis to the hospital Quality Oversight Committee (QOC) and the Medical Executive Committee. As a rule, the Medical Executive Committee reports to the Governing Body.

Review of pertinent hospital documentation determined that ICC did not report any COVID-19 related surveillance data to QOC during April or May of 2020 to confirm that the hospital's response to COVID-19 was appropriate and effective. After the outbreak began, with no COVID-19 surveillance reporting received in April or May, the QA Committee failed to evaluate areas within the hospital infection prevention and control program that were later identified and found to be noncompliant during the survey. Specific areas of concern included:

- Staff practices with PPE were not compliant with minimum standards but this was not addressed by the hospital's Quality Oversight Committee;
- The hospital had no approved policy or procedure in place for cohorting patients and cohorting staff assignments, but this was not addressed by the hospital Quality Oversight Committee;
- With no reasonable rationale, critical surveillance activities were discontinued within one week of identifying the first COVID-19 positive patient in the hospital. Although the QA Committee was accountable for the IP program, the surveillance activities abruptly ended, and were not restored when the outbreak became apparent.

The hospital Governing Body failed to ensure that the hospital's infection prevention control program reported regularly to QAPI and Governing Body and demonstrated the implementation, success, and sustainability of infection prevention and control activities related to COVID-19 outbreak in the hospital during the months of April and May 2020; failed to ensure the infection prevention and control program was being managed and overseen by hospital QAPI program as required; and failed to ensure sufficient linkage and communication was occurring between and amongst the IC, QAPI, and Governing Body participants as related to the above-mentioned outbreak. Cross reference to Tags A-0043, A-0263, A-0747, and A-0750.

Based on observations, interviews with staff, and review of documentation, including policies and procedures, it was determined that the facility failed to provide competency-based training and education to direct care and ancillary staff in donning (putting on) and doffing (taking off) as well as use, storage, and disinfections of Personal Protective Equipment (PPE), and patient transport during the pandemic.

1. Throughout the survey, surveyors observed noncompliant practices with the storage, accessibility and use of PPE.

During an interview with staff member #4 (S4) on June 30, 2020 at 10:45 am, the surveyor requested information regarding training on PPE. S4 was asked how s/he was trained on proper use and storage of their N95 and face shield. The staff member stated, "We can use them up to 3 days and then get a new one. There is a storage bin for recycling at the exit of the hospital." Regarding storage, the staff member stated, "Some staff keep it in their locker and some take it home". The surveyor asked if there were any guidelines for wearing the N95 outside of the unit or hospital including how or what to store it in. S4 stated, "You can get a bag from the office or the supply rooms if you want one". No information was stated regarding training for proper storage to reduce the risk of cross contamination, appropriate usage once staff members are leaving the building or any other reasons to exchange a mask for a new one prior to the 3 days maximum (tears, soiled, etc.).

2. During an interview with Staff member #2 (S2) on June 30, 2020 at 11:30am, the surveyor requested for S2 to describe the training process received for donning and doffing of PPE. S2 stated that all staff watched an online video and took a short test afterwards. S2 also stated that a staff member came to each unit and demonstrated to unit staff in small groups how to don and doff PPE. After the demonstration, unit staff were not required to return the demonstration or be signed off by training staff for competency. When asked if other staff members or leadership/administrators would randomly assess staff for proper technique of donning or doffing, the answer was "no".

In interviews with Staff members #2, 3, 4, multiple staff reported different procedures for removing and storing PPE at the end of each shift. Some described a process where N95 masks were not stored in closed containers to minimize risk for contamination of surfaces in contact with the PPE. Staff reported that bags for N-95 storage are available if staff ask but no staff reported that they asked or utilized any storage container for N-95 masks after each shift they worked. Further, multiple staff were unable to describe any standardized process for proper disinfecting for continued use of PPE.

3. In interview, Staff #2 (S2) was not clear on what the policy was regarding isolation precautions during patient transport. S2 reported that the procedure was unclear and this increased the likelihood for transmission of the infectious agent during the outbreak.

Per Centers for Disease Control (CDC), "Transport of Patients. Several principles are used to guide transport of patients requiring Transmission-Based Precautions. In the inpatient and residential settings these include 1. limiting transport of such patients to essential purposes, such as diagnostic and therapeutic procedures that cannot be performed in the patient's room; 2. when transport is necessary, using appropriate barriers on the patient (e.g., mask, gown, wrapping in sheets or use of impervious dressings to cover the affected area(s) when infectious skin lesions or drainage are present, consistent with the route and risk of transmission; 3. notifying healthcare personnel in the receiving area of the impending arrival of the patient and of the precautions necessary to prevent transmission; and 4. for patients being transported outside the facility, informing the receiving facility and the medi-van or emergency vehicle personnel in advance about the type of Transmission-Based Precautions being used" (CDC, 2020).

The hospital's failure to ensure staff were trained and fully competent in various procedures related to infection prevention and control contributed to an ongoing outbreak of COVID-19 from April to June 2020 where 57 staff and 69 patients were infected, and patients subsequently died.