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 ALEXIUS HOSPITAL 3933 S BROADWAY SAINT LOUIS, MO 63118 July 12, 2018
VIOLATION: GOVERNING BODY Tag No: A0043
Based on observation, interview, record review, policy review and video review, the facility's Governing Body failed to:
- Ensure the Chief Executive Officer (CEO, appointed by the Governing Body) effectively managed the facility in order to meet applicable regulatory requirements.
- Ensure adequate oversight of patient care as related to the prevention, identification, investigation and reporting of the abuse and/or neglect of one patient (#1).
- Ensure that one patient (#1) with a diagnosis of suicidal ideation, was placed in a psychiatric safe seclusion room (room used to separate a psychiatric patient from others, to protect the patient and those around the patient) during three episodes of seclusion.
- Ensure patients admitted to the Emergency Department (ED) with diagnosis of suicidal ideation, history of suicidal ideation or attempts to harm self or others, were provided care in a safe setting for one of one suicidal patient (#5) observed in the ED that had no documented oversight in the Electronic Medical Record (EMR) by the attending Registered Nurse (RN) and had unsupervised access to contraband (objects that can be used to self-harm).
- Ensure nursing staff adequately assessed and documented that they provided care to the needs of two patients (#4 and #11) while they were in locked seclusion.
- Ensure facility staff developed an effective Quality Assessment and Performance (QAPI) program that included all departments and contracted services to identify trends for opportunities to improve quality, and patient care and safety.

Refer to A 0057 for further details.

These failures had the potential to affect all patients in the hospital. The facility census was 68.

The severity and cumulative effect of these systemic practices resulted in the facility being out of compliance with 42 CFR 482.12 Condition of Participation: Governing Body, and resulted in the facility's failure to ensure quality health care, safety and the prevention of patient abuse and neglect.
VIOLATION: CHIEF EXECUTIVE OFFICER Tag No: A0057
Based on observation, interview, record review, policy review, and video review, the Governing Body (referred to as the "Advisory Board") failed to ensure the Chief Executive Officer (CEO) was responsible for the management and oversight of the entire facility, and included accountability for the effective oversight of the staff to comply with the requirements under the Conditions of Participation for Patient Rights and Quality Assessment and Performance Improvement (QAPI) program. These failures had the potential to adversely affect all patients in the facility. The facility census was 68.

Findings Included:

1. Review of the facility's "Rules and Regulations of the Advisory Board," dated 05/06/2013, showed that the Advisory Board/Governing Body is the legal authority in the hospital and was responsible for the overall planning, directing, control and management of the hospital. The Advisory Board/Governing Body recommends and implements hospital policy, promotes performance improvement, facilitates and encourages quality patient care, and provides for operation of the hospital.

Review of the facility's "Medical Staff Bylaws 2016," showed that the term Chief Executive Officer (CEO) means the President of the hospital designated by the Advisory Board/Governing Body as its direct legal representative responsible for the operational supervision of all of the affairs of the hospital.

Review of the facility's "Advisory Board Meeting Minutes," dated 05/09/18, showed that Staff R, Chief Operating Officer (COO) and previous CEO, requested the Advisory Board Committee to vote in Staff SS, as the Interim CEO for the facility. The board approved Staff SS as the interim CEO.

During an interview on 07/11/18 at 1:00 PM, Staff R, COO, stated that the new interim CEO was from corporate and lived in Philadelphia. He has been to the facility twice since his appointment as CEO on May 9th.

Review of the facility's "Advisory Board Meeting Minutes," dated 06/04/18 and 07/09/18, showed that Staff SS, CEO was not listed as present, absent or present via teleconference for either meeting.

During an interview on 07/17/18 at 9:05 AM, Staff SS, CEO, stated that he has not attended any Advisory Board Meetings and he has never met any members of the Governing Body.

The CEO failed to ensure:
- Adequate oversight of patient care as related to the prevention, identification, investigation and reporting of abuse and/or neglect (A 0144 and A 0145).
- Patients were placed in safe seclusion rooms (A 0144).
- Patients admitted to the Emergency Department (ED) with suicidal ideations, history of suicidal ideations, or attempts to harm themselves or others were provided care in a safe setting (A 0144).
- Nursing staff adequately assessed and documented that they provided care to patients in locked seclusion rooms (A 0144).
- Facility staff developed an effective Quality Assessment and Performance (QAPI) program that included all departments and contracted services to identify trends for opportunities to improve patient care and safety (A 0273, A 0283, A 0309, and A 0315).

The lack of oversight of patient care and safety, as well as the hospital-wide QAPI program by the CEO, resulted in the facility's failure to ensure quality healthcare, safety, and the prevention of patient abuse and neglect.
VIOLATION: QAPI Tag No: A0263
Based on interview, record review and policy review, the facility failed to:
- Accurately collect and report data on Restraints and Seclusion, a high risk, high volume or problem prone area. The inaccurate data collected and reported prevented the facility from the identifying problems, failures, an providing a plan for performance improvements (A 0273).
- Incorporate 24 of 24 contracted services into the hospital-wide Quality Assessment and Performance Improvement (QAPI) Program (A 0283).
- Ensure the Chief Executive Officer (CEO), Medical Staff members and administrative leaders hospital-wide QAPI Program included Environmental Services (Security, Plant Operations, Engineering, Housekeeping) and reported projects related to the improvement of the care and safety of the facility's building and grounds to the QAPI Committee. (A 0309).
- Ensure the Governing Body, Medical Staff, and other leadership provided appropriate resources to the Environmental Services, Plant Operations, and Engineering Departments to sustain their QAPI program. Without an on-going quality improvement program, the Environmental Services, Plant Operations and Engineering Departments could not ensure the quality of construction, maintenance, and repair needs of the facility's buildings, grounds, and non-biomedical equipment (A 0315).

These failures had the potential to adversely affect the quality of care of the facility and the quality, safety and care outcomes of all patients in the facility.

The cumulative effect of this systemic practice resulted in the facility's non-compliance with 42 CFR 482.21 Condition of Participation: Quality Assessment and Performance Improvement Program.

The facility census was 68.
VIOLATION: PROGRAM SCOPE, PROGRAM DATA Tag No: A0273
Based on interviews and record review the facility failed to collect accurate Quality Assessment Performance improvement (QAPI) data on Restraints and Seclusion, a high risk, high volume or problem prone area. The inaccurate data collected and reported allowed the facility's failure to identify problems or provide a plan for performance improvements. This had the potential to affect all patients quality of care. The facility census was 68.

Findings included:

1. Review of the facility's document titled, "Strategic Quality Plan" dated 2018, showed that:
- The single best indicator of the effectiveness of QAPI process was the ability of the facility to self-identify quality issues;
- Implementation of appropriate surveillance and response systems to respond to condition changes; and
- Compliance with mandatory reporting requirements including strict adherence to standardized process, definitions and time frames for submission of accurate and reliable data.

Review of the restraint and seclusion audit log, dated 05/01/18 through 05/31/18 showed restraint and seclusion flowsheet completed correctly which included toileting and fluids every two hours and food offered every four hours was 100% compliance and reported to QAPI.

During an interview on 07/11/18 at 9:45 AM, Staff Q, Quality Manager, stated that after the surveyors findings on the restraint and seclusion flowsheet (refer to A-144), the data was not accurate or reliable.

During an interview on 07/11/18 at 9:50 AM, Staff HH, Quality Vice President, stated that data reported to QAPI needed to be accurate, and reliable, so the facility could select the process for improvements.
VIOLATION: PROGRAM DATA, PROGRAM ACTIVITIES Tag No: A0283
Based on interview and record review, the facility failed to incorporate 24 of 24 contracted services into the hospital-wide Quality Assessment and Performance Improvement (QAPI) Program. This had the potential to affect all patients receiving care in the facility. The facility census was 68.

Findings included:

1. Review of the facility's document titled, "Plan for the Provision of Patient Care" revised 06/2107, showed that:
- The Governing Body and the Chief Executive Officer (CEO) have the responsibility for assuring that all hospital services are in compliance with The Joint Commission, Medicare Conditions of Participation, and Missouri State regulations.
- The Governing Body, in accordance with the hospital's Strategic Quality Plan, assesses all services delivered directly by hospital staff and those services provided under contract.
- These assessments include quality and performance issues, implementation of corrective or improvement activities as well as the monitoring/assessment of such activities.

Review of the facility's document titled, "Strategic Quality Plan" dated 2018, showed that the Strategic Quality Plan was a collaborative effort of the hospital, medical staff and division leadership, which applied to all departments, services and practitioners throughout the hospital.

No analysis of the Contracted Services reported findings, data review, revised action or implementation was documented by the Medical Executive Committee or the QAPI Committee.

During an interview on 07/11/18 at 9:45 AM, Staff Q, Quality Manager, stated that:
- She was new to her position as the QAPI Manager, in charge of the QAPI program.
- She performed project choices, data collection, and data analysis on contracted services.
- She did not include the contracted services into the QAPI Committee or Medical Executive Committee.
- The contracted services reported findings, data review, revised action or implementation were not reported to the QAPI Committee, Medical Executive Committee, or the Governing Body.
- She was unaware that contracted services needed to be included into the QAPI Committee and reported to the Governing Body.

During an interview on 07/11/18 at 9:50 AM, Staff HH, Quality Vice President, stated that everything had to go through the QAPI committee, Medical Executive Committee, and reported to the Governing Body. The QAPI program should have included Contracted Services.
VIOLATION: EXECUTIVE RESPONSIBILITIES Tag No: A0309
Based on interview and record review, the Chief Executive Officer (CEO), Medical Staff members and administrative leaders failed to ensure the Quality Assessment and Performance Improvement (QAPI) Program included Environmental Services (Security, Plant Operations, Engineering, Housekeeping) and reported projects related to the improvement of the care and safety of the facility's building and grounds to the QAPI Committee. This had the potential to affect all patients receiving care in the facility. The facility census was 68.

Findings included:

1. Review of the facility's document titled, "Plan for the Provision of Patient Care" dated 2017, showed the facility's environment of care was supported and monitored through the collective efforts of departments providing safety, life safety, emergency management, hazardous waste and materials management, security, utilities management, biomedical and engineering services. All services are monitored to assure regulatory compliance.

Review of the facility's document titled, "Strategic Quality Plan" dated 2018, showed that:
- It was the core operational responsibility of every executive and every person providing or supporting care in the facility to ensure an environment where care was safe, effective and centered on patients' needs.
- Summaries of performance improvement and patient safety activities will be submitted at least quarterly to the Quality Committee.
- Quality Committee findings will be reviewed at least ten times a year by the Medical Executive committee and four times per year by the Governing Body.
- The Quality Committee oversees ongoing performance monitoring to ensure maintenance of achieved improvements.

No analysis of the Environmental Services reported findings, data review, revised action or implementation was documented by the QAPI Committee.

During an interview on 07/11/18 at 9:45 AM, Staff Q, Quality Manager, confirmed the facility QAPI plan did not include Environmental Services. Staff Q also stated that she was unaware that the Environmental Services needed to be included into the QAPI Committee and reported to the Governing Body.

During an interview on 07/11/18 at 9:50 AM, Staff HH, Quality Vice President, stated that everything had to go through the QAPI committee, Medical Executive Committee, and reported to the Governing Body, and that the QAPI committee should have included Environmental Services.
VIOLATION: PROVIDING ADEQUATE RESOURCES Tag No: A0315
Based on interview, policy review, and review of quality improvement data, the Governing Body, Medical Staff, and other leadership failed to ensure the Environmental Services Department, Plant Operations, and Engineering had enough resources to sustain their quality improvement program. Without an on-going quality improvement program the Environmental Services, Plant Operations and Engineering could not ensure that construction, maintenance, and repair needs of the facility's buildings, grounds, and non-biomedical equipment were met. This can adversely affect the quality of care for all patients in the facility. The facility census was 68.

Findings included:

1. Review of the facility's document titled, "Strategic Quality Plan" dated 2018, showed that it was the responsibility of every executive and every person providing and supporting care in our facilities to ensure an environment where care was safe, effective and centered on patients' needs. Leaders play a major role in creating an environment where staff feels safe and free to engage in performance improvement and understand it was their responsibility to not only report quality and safety issues and concerns, but to "stop the line" if necessary to ensure the right thing gets done.

Observation on 07/09/18 at 3:10 PM, in the Emergency Department (ED), showed multiple unpainted repairs in the walls of the restroom used by patients and visitors.

Observation on 07/10/18 at 9:30 AM, in the Preoperative (preparation area for surgical operations) Department, showed four out of four gurneys with copious amount of visible rust (break down of metal to powder form).

During an interview on 07/11/18 at 2:00 PM, Staff O, Maintenance Interim Consultant, stated that:
- Environmental Services Department, Plant Operations, and Engineering did not have the staff to perform environmental rounds to assess quality and safety issues or concerns of the building and grounds;
- Work orders were completed in paper form, and stored in binders which were not able to be tracked for priority, progress, or completion;
- For example, the ED restroom was repaired, not painted in 02/2018, and the work order was placed in the binder and "lost" which was the reason for not painting the repairs;
- Plant Operations were responsible for non-biomedical equipment, and had no technology to track equipment's condition, repairs, or removal of services;
- He was unaware that the preoperative gurneys had rust and needs for repairs or removal of service; and
- He did not understand why other facilities had technology that tracked work orders and equipment for priority, progress, completion, repairs or removal from service, and this facility did not.