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1111 6TH AVE

DES MOINES, IA 50314

QAPI

Tag No.: A0263

Based on document review and staff interviews, the hospital administrative staff failed to:

1. Incorporate identified problems with patients developing Hospital Acquired Pressure Injuries (HAPI) into the hospital's organization wide Quality Improvement program and ensure the hospital's Board of Trustees received information regarding HAPI rates in the hospital after the hospital's quality improvement staff had identified concerns. Please refer A-283 for additional information.

2. Ensure the hospital staff promptly performed a Root Cause Analysis (RCA) following an instance of an unidentified male gaining unauthorized access to the Neonatal Intensive Care Unit (NICU), feeding a baby and changing the baby's diaper, before nursing staff removed the unidentified male from the NICU. Please refer to A-286 for additional information.

The cumulative effect of the systemic failure and deficient practices resulted in the hospital's inability to effectively carry out the responsibilities of the hospital to ensure patients received appropriate care and treatment in a safe setting and ensure quality health care provided to patients. The Hospital's administrative staff identified an average census of 2,626 patients in the hospital.

QUALITY IMPROVEMENT ACTIVITIES

Tag No.: A0283

45864

Based on document review and staff interview, the hospital's administrative staff failed to ensure the hospital Quality Improvement (QI) staff incorporated 1 of 1 identified area of concern (hospital acquired pressure injuries) into the hospital's organization wide QI program and provided education to bedside care nursing staff for 1 of 1 Quality Improvement program. Failure to incorporate hospital acquired pressure injuries, after hospital staff identified concerns regarding hospital acquired pressure injuries, resulted in the hospital's Quality Improvement program and Board of Trustees lacking knowledge of the problems with hospital acquired pressure injuries, and failure to provide education resulted in the nursing staff lacking education to assist in preventing hospital acquired pressure injuries. The hospital's administrative staff identified 31 patients with hospital acquired pressure wounds in October 2021.

Findings include:

1. Review of the Quality Assurance & Performance Improvement Plan, revised by the Board of Governors 10/2021, revealed in part, "...To improve daily by integrating performance improvement learning to all disciplines throughout the hospital to ensure understanding, collaboration and demonstration of patient safety and quality...."

2. Review of the Pressure Injury Prevention Committee Minutes, dated 9/30/21 revealed the hospital staff identified 9 patients developed hospital acquired pressure injuries (HAPI, wounds patients develop in the hospital as a result of the hospital staff not preventing pressure on the patient's body, which later develops into a wound) in July 2021. The hospital staff identified 18 patients with a HAPI in August 2021. The hospital had a HAPI rate of 8.42 pressure injuries per 1,000 patient discharges. The hospital staff's quality goal was 2.10 pressure injuries per 1,000 patient discharges.

3. Review of the Pressure Injury Prevention Committee Minutes, dated 10/26/21, revealed the hospital staff identified 21 HAPI in September 2021. The hospital had a HAPI rate of 7.47 pressure injuries per 1,000 patient discharges "... which continues to be significantly higher than the goal of 2.10 pressure injuries per 1,000 patient discharges."

4. Review of the Pressure Injury Prevention Committee Minutes, dated 11/23/21, revealed the hospital staff identified 31 HAPIs in October 2021. The hospital had a HAPI rate of 9.41 pressure injuries per 1,000 patient discharges "... which continues to be significantly higher than the goal of 2.10 pressure injuries per 1,000 patient discharges."

5. Review of the Pressure Injury Prevention Committee Minutes, dates 12/28/21, revealed the hospital staff identified 16 HAPIs in November 2021. The hospital had a HAPI rate of 7.29 pressure injuries per 1,000 patient discharges "... which continues to be significantly higher than the goal of 2.10 pressure injuries per 1,000 patient discharges."

6. Review of the Clinical Quality and Safety Committee (the hospital wide quality improvement committee) meeting minutes, dated 8/4/21, 9/1/21, 10/6/21, 11/3/21, 12/1/21, 1/5/22, and 2/2/22; revealed the meeting minutes lacked evidence the Clinical Quality and Safety Committee reviewed the hospital's HAPI rate or addressed the hospital's elevated HAPI rate in the hospital's organization wide Quality Improvement program.

7. Review of the Board Quality & Value Committee (the quality committee of the hospital's governing body) meeting minutes, dated 6/17/21, 8/19/21, 10/21/21, and 12/16/21; revealed the meeting minutes lacked evidence the Board Quality & Values Committee reviewed the hospital's HAPI rate or addressed the hospital's elevated HAPI rate at the hospital's Governing Body level.

8. During an interview on 2/3/22 at 8:38 AM, the Clinical Nurse Specialist for Acute Care acknowledged the hospital's Pressure Injury Prevention Committee identified concerns regarding the incident of hospital acquired pressure injuries. The Clinical Nurse Specialist for Acute Care acknowledged that the Clinical Quality and Safety Committee failed to include HAPIs in the hospital's organization wide Quality Improvement program and that the hospital staff failed to inform the hospital's Board Quality & Value Committee of the hospital's problems with HAPIs. The Clinical Nurse Specialist for Acute Care indicated the hospital staff had developed plans to provide education to nursing staff to reduce the incidence of HAPIs, but the hospital staff had not provided the education, due to a lack of staffing resources necessary to complete the education.

9. During an interview on 2/3/22 at 4:14 PM, the Director of Quality and Patient Safety indicated that the hospital staff had provided training to nurses to reduce the incident of HAPIs and placed a laminated sheet of information in every patient room to staff on. The Director of Quality and Patient Safety provided additional information on 2/7/22 at 7:15 AM, but the additional information lacked evidence the Quality Improvement staff took action to monitor and track HAPIs as part of the hospital's organization wide Quality Improvement program.

10. During an interview on 2/3/22 at 11:00 AM, Registered Nurse (RN) J revealed that RN J was working on 9 South as a bedside care nurse. RN J lacked knowledge of the education the Director of Quality and Patient Safety indicated the nursing staff received.

11. Observations on 2/3/22 at 12:00 PM in room 875, accompanied by the Clinical Nurse Specialist for Acute Care, revealed the room lacked the laminated sheet of information that the Director of Quality and Patient Safety indicated was located in each room. Further observations in room 896 also revealed the room lacked the laminated sheet of information that the Director of Quality and Patient Safety indicated was located in each room. The Clinical Nurse Specialist for Acute Care acknowledged the findings.

PATIENT SAFETY

Tag No.: A0286

Based on observations, document review and staff interviews, the acute care hospital's administrative staff failed to ensure a timely root cause analysis (RCA) was performed for an adverse patient safety event for 1 of 1 reviewed unauthorized visitor in the NICU, to fully analyze the causes and failed to implement a monitoring process to ensure the actions implemented were effective to prevent unauthorized individuals entrance into the hospital and neonatal intensive care unit (NICU). Failure to prevent unauthorized individuals entrance into the hospital and/or the NICU may result in a significant patient safety event such as abduction, patient harm, and or death. The acute care hospital administrative staff identified 2 hospital entrances open 24/7 (East Tower Entrance and Emergency Department (ED) Entrance), 1 entrance open limited hours (Main Entrance) and 1 NICU entrance.

Findings include:


1. Review of a document received on 2/2/22 from the Clinical Coordinator Risk Management, "Event Summary" revealed in part, "... [Patient #1] Date of event: 12/27/21 Time of event [11:30 PM] ... Reported by [staff RN C]...Event Description: Male entered the NICU after [Staff RN C] walked out the front door. Male entered room 4002. Nurse, [Staff RN B] entered room and male stated he was the father of the baby. Male put gown and gloves on. Male changed baby's diaper and fed baby. Nurse felt uncomfortable with the male and asked charge nurse [Staff RN A], to come to room. Charge nurse called mom to ask her about the father. Father was with mother in the Ronald McDonald Room. [Staff RN A] immediately asked male to leave room and escorted him to the waiting room. [Staff RN A] stayed with male but he became anxious and took off down the stairs. Parents arrived from the Ronald McDonald Room. Baby was bathed, bed was changed, and baby was moved to a new room. Security and houses supervisor were called after male left ..."

2. During an interview on 1/26/22 at 1:28 PM, the Director of the NICU reported an unauthorized male entered the NICU on 12/27/21 at approximately 11:19 PM when Staff RN C exited the NICU unit at the end of her shift. The male caught the door before it fully closed and walked into the NICU. Staff RN C called the NICU from her cell phone, prior to leaving the building, to let NICU staff know an unidentified male had entered. The Director of NICU reported there was no one staffed at the NICU entrance to monitor the entrance after 11:00 PM to verify credentials and wristbands to authorize entry of visitors. The NICU staff located the male in Patient #1's room and failed to check for an identification band to ensure the male was Patient #1's father. The unauthorized male was in Patient #1's room for a proximately an hour, had fed Patient #1 and changed a soiled diaper prior to nursing staff's discovery that he was not Patient #1's father. Charge RN A asked the male to leave and escorted the unauthorized male to the waiting room outside the locked NICU. The unauthorized male appeared nervous and escaped down the stairs. The Director of the NICU reported following this event many corrective actions had been put into place so that no unauthorized person could ever make entry again. The NICU door is now staffed 24/7 and everyone's credentials are checked. Parents must wear their matching bands that are linked to their baby. Nurses rechecked the matching ID bands when the parent arrived to the baby's room. The enhanced identification processes, the need to notify public security and the House Supervisor immediately when an untoward situation is identified was discussed at daily huddles for weeks. The Director of the NICU reported the nursing staff had all been actively involved in the changes, are 100% committed to ensuring this is a never event, and are shocked and dismayed this ever happened. The Director of the NICU verbalized she talked with parents daily since the event to ensure staff checked armbands and that they were screened at the entry to the NICU. She identified this as an undocumented and informal process and had not developed formal monitoring to identify problems or the effectiveness of the corrective actions implemented.

3. During an interview on 1/31/22 at 2:50 PM, the Director of Facilities and Public Safety reported he first became aware of the "absolutely egregious" event of the unauthorized male making entry into the NICU and handling a baby, early in the morning of 12/28/2022. The Director of Facilities and Public Safety immediately started a preliminary investigation, contacted the Des Moines Police Department, viewed security video footage, and worked with the supervisors responsible for the screeners and Security Staff D to enhance security. As identified on video and confirmed during interview, Security Staff D talked with the male after entering the East Tower entrance, asked why the unidentified male was here, and Security Staff d was told the unidentified male's son was in the NICU. Security Staff D screened the male for Covid symptoms but failed to check for an ID band and did not notify the NICU that a parent was on the way up to the NICU. The Director of the NICU verified the male was able to make entry by "piggybacking" when a RN exited the NICU and the door closed slowly enough that the male standing outside the NICU was able to slip in before the door fully closed. The Director of Facilities and Patient Safety is working to educate staff about this security issue. The Director of Facilities and Public Safety provided and reviewed a lengthy detailed timeline of phone calls, meetings, discussions, and emails of the investigation and corrective actions in process since the event on 12/27/21 to 1/25/2022. The Director of Facilities and Public Safety reported he was not aware of any monitoring of the corrective actions, such as the enhanced screening, ID checking and logging of all staff and visitors entering the hospital to identify any problems with the actions implemented and ensure the actions implemented are effective.

4. During an interview on 2/1/22 at 9:00 AM, Screening Supervisor reported he provided training to all new screeners and walked around to all the screening areas Monday through Friday to ensure the process taking place correctly. On the night of the incident, Security Staff D did not ask the male to see the identification band. The screener, Security Staff D, was not required to call the NICU and notify the NICU staff that a parent was on their way to the NICU, unlike the current practice. Screening Supervisor verbalized all screeners have been trained in the enhanced security protocols including identification checks and visitor log in. The Screening Supervisor revealed he had not implemented any monitoring to identify any problems with the actions implemented and to ensure they were effectively performed. This surveyor requested the Screening Supervisor to produce the logs for 1/26/22, 1/27/21, 1/31/22, and 2/1/22, all dates this surveyor presented to the hospital.

The Screening Supervisor returned on 2/1/22 at 11:15 AM with log for the dates requested. This surveyors name appeared on the visitors log on 1/26/22 and 1/31/22. This surveyors name was not found on the logs for 1/27/22 or 2/1/22. Upon entrance on 1/27/22, this surveyor was asked to show their ID, but the screener did not write the surveyor's information down. On 2/1/22, this surveyor was not asked to show their ID. The Screening Supervisor voiced disappointment and again verified there was no audit or monitoring in place to ensure the screening process was performed accurately, to identify any problems with the screening process, and to ensure the actions implemented were effective in the identification of all individuals who entered the hospital.


5. Review of an email dated 12/29/2021 at 5:40 PM, from the Interim Chief Nursing Officer (CNO) to the Clinical Coordinator of Risk Management and Director of Quality and Patient Safety reveled in part, "... Can we do an RCA [Root Cause Analysis, an in depth evaluation of how processes failed, which can identify opportunities for the hospital staff to prevent a recurrence of similar situations] for the incident please? ... [Patient #1] ..."

6. Review of an email dated Monday, January 3, 2022 at 2:32 PM from the Clinical Coordinator Risk Management revealed in part... "[Director, NICU] and [Director, Facilities & Public Safety] We need to set up an RCA regarding this incident..."

7. Review of document "NICU Interviews" schedule, revealed the interviews scheduled as follows:
January 7, 2022- Charge Nurse RN A, Market Director for Women's and Children, Director, NICU
January 11, 2022- Security Staff D
January 12, 2022- Staff RN B, Director, NICU
January 24, 2022- Staff RN C, Director, NICU

Staff interviews for the Root Cause Analysis were conducted 10 to 27 days following the event.


8. Review of the document "MercyOne Des Moines Medical Center Neonatal Intensive Care Incident 12/27/21" dated 1/27/22, revealed in part, "... Documentation of timeline regarding NICU Incident on 12/27/21 as dictated by ... manager of security ... Example of Patient Visitor Logs as kept by MercyOne Des Moines Medical Center for East Tower Entrance ... interview list of individuals involved ... Process change on patient wristbands and security bands gong forward in NICU ... Corrective Action Plan for organizational security - overall security changes."


9. Review of the corporate policy "Sentinel Event Reporting/Root Cause Analysis Process", effective February 2019, revealed in part, "... Upon occurrence of a possible Sentinel Event (unexpected occurrence involving death or serious physical or psychological injury, or the risk thereof), the Accreditation Specialist and Risk Manager shall be immediately notified ... Risk Management will advise Administration and proceed with an investigation to determine if the event is truly sentinel in nature. Representatives from Risk Management, Medical Staff, Human Resources, Performance Excellence, Quality Management and direct and ancillary care areas will be asked to participate in this preliminary analysis as needed .... purposes of Root Cause Analysis are to identify all possible reasons why the event occurred; determine system and individual failure modes which contributed to the event; to develop risk reduction plans and strategies; and to develop measurements to determine effectiveness of those risk reduction plans ... Executive Leader, Risk Manager, Director of Quality and Patient Safety will work collaboratively with Performance Excellence timeline for implementation of action plans and/or Human Resources to prepare a corrective action plan, develop, and monitor progress relative to each failure mode identified ... Non-sentinel event ... will be reviewed by Risk Management, Performance Excellence and Quality Management to identify opportunities to reduce system and human error which might result in future sentinel events. A detailed Root Cause Analysis ... may be undertaken at the discretion of this group for certain critical near misses, precursors, or other safety events. ..."

The policy lacked an expected time line for the implementation and completion of a Root Cause Analysis and may have resulted in a delay in implementation.


10. During an interview on 2/2/22 at 2:30 PM, the Director of Risk Management reported the RCA began with the interviews that were initiated on 1/7/22 and completed on 1/24/22 (almost a month after the incident occurred). The action plan and first meeting of the RCA team had been set for 1/31/22 (over a month after the incident occurred). The RCA team had not met, at the time of the surveyor's entrance on 1/26/22, to identify all possible reasons why the event occurred; determine system and individual failure modes which contributed to the event; to develop risk reduction plans and strategies; and to develop measurements to determine effectiveness of those risk reduction plans. The Director of Risk Management reported this event was not identified as a sentinel event as it did not meet the Joint Commission's definition of reportable events. Leadership considered this a very serious event that should not have happened and required a RCA. The Director of Risk Management verbalized a RCA is typically initiated within a few days of the event. In this case the holiday (New Years Day), staff availability, no patient harm had occurred and the Director Facilities and of Public Security and the Director of the NICU had implemented processes to prevent unauthorized entry in future, all played into the delay of the RCA.


11. During an interview on 2/2/2022 at 2:40 PM, the Director of Quality and Patient Safety reported a RCA is usually initiated within days of the event and completed within days to weeks (as opposed to starting almost a month after the event). This RCA was delayed due to multiple factors. It had been determined it was not a sentinel event, department managers were doing their own investigation into the events, and the prioritization of other issues at the time of this event. The Director of Quality and Patient Safety verified the RCA currently remained in process. The Director of Quality and Patient Safety acknowledged that a thorough analysis to identify all possible reasons why the event occurred, determine system and individual failure modes which contributed to the event, and development of measurements to determine the effectiveness of the corrective actions put into place had not taken place and/or been developed and implemented. The Director of Quality and Patient Safety acknowledged she was not aware of any monitoring taking place to ensure actions already implemented by the Director of the NICU, Director of Facilities and Public Safety and the Screening supervisor were effective.


12. During an interview on 2/3/22 at 12:55 PM the CNO acknowledged a delay in the implementation of a Root Cause Analysis for the incident on 12/27/21 in which an unauthorized male gained access into the NICU, fed and changed an infant's diaper. In addition, more than a month later, no monitoring had been put into place to identify any problems with the action plans implemented by the involved departments and to monitor the action plan effectiveness.

RN SUPERVISION OF NURSING CARE

Tag No.: A0395

45863

Based on document review, staff interviews, and observations, the Hospital's administrative staff failed to ensure the nursing staff provided adequate supervision, assessment, and evaluation of care for 10 of 10 reviewed patient records, 1 of 1 reviewed open record (Patient #10) and 9 of 9 reviewed closed records (Patient #2, Patient #3, Patient #4, Patient #5, Patient #6, Patient # 7, Patient #8, Patient #9, Patient #11). Failure to provide adequate nursing supervision, assessment, and evaluation of care resulted in the nursing staff failing to provide adequate patient care, which could result in unidentified new or existing health care conditions that could lead to prolonged illness or death for the patient. The Hospital's administrative staff identified an average monthly census of 2,626 inpatients from January 2021 to January 2022.

Findings include:

1. Review of the policy "Patient Assessment and Reassessment", review date 12/2018 revealed in part, " ...assessment of all body systems pertinent to the care of the patient. For inpatients, this will include a full systems assessment."

2. Review of the nursing practice protocol "Skin Assessment and Care (Adult): Includes Pressure Injury Prevention and Basic Wound Care", revised 1/2021, revealed in part "Integumentary Assessment on admission and transfer, at least every 12 hours, and any patent status change ... two nurses conduct the admission skin assessment to ensure accuracy ... document admission skin assessment, noting any skin abnormalities, wounds, or pressure injury that is present on admission".

3. Review of medical records on 2/3/2022, revealed 10 of 10 patients, 1 open medical record (Patient #10) 9 closed medical records (Patient #1, Patient #2, Patient #3, Patient #4, Patient #5, Patient #6, Patient #7, Patient #8, Patient #9), lacked evidence a second nurse had performed the skin assessment, as required by the hospital's policy.

4. During an interview on 2/2/22 at 11:30 AM, RN H acknowledged the nursing staff had failed to perform the skin assessment with 2 nurses.

5. Review of the policy, "Patient Assessment and Reassessment," reviewed 12/2018, revealed in part, "Based on assessment and risk screening findings, appropriate interventions are implemented and/or referrals made when specialized services or more in-depth assessments are needed."


6. Review of the Nursing Practice Protocol, "Skin Assessment and Care (Adult): Includes Pressure Injury Prevention and Basic Wound Care", revised 1/2021, revealed in part, " ... Perform Braden Scale with the first assessment performed on admission." " ... Initiate appropriate interventions based on Braden score."

Braden Scale used for predicting pressure sore risk was developed for early identification of patients at risk for forming pressure sores. Braden Scale includes mild, moderate and high risks, any Score 12 or less requires a wound care nurse consult.


7. Review of the medical records revealed 1 out of 10 patients (Patient #8) lacked a documented Braden Scale score. 4 out of 10 patients (Patient #3, Patient #4, Patient #8, and Patient # 9) had a Braden Scale 12 or less. The nursing staff failed to follow the hospital's nursing practice protocol to prevent pressure injury to the patient.

8. During interview on 2/2/22 at 9:29 AM, with Wound Care RN F (WOCN, a nurse with additional, specialized training in the treatment and management of wounds) F, acknowledged the wound care nurses could not follow up on patients referred for the WOCNs' specialized care, as the hospital had too few WOCN certified nurses to allow the WOCNs to follow up on the patients as required.


9. During interview on 2/3/22 at 12:30 PM with the Manager of Inpatient and Outpatient Wound Service Department, revealed the WOCNs can not sometimes see patients with pressure wounds for a few days, since the WOCNs can not always get to see every patient referred for their services, and sometimes a patient will discharge from the hospital before the patient was seen by a WOCN. The hospital lacked a system to effectively communicate which patients needed a WOCN consult and the WOCNs had not seen.

10. During interview on 2/3/22 at 1:00 PM, RN K acknowledged the nursing staff lacked sufficient time to perform all of the nursing interventions, including turning and repositioning patients to prevent patients from developing pressure wounds, especially with critically ill patients and patients who can not turn themselves in bed. The nursing staff can only perform the bare minimums of patient care, as the nursing staff are too busy, and miss providing patients baths, turning patients, performing nursing assessments, and documenting the nursing care provided to patients.