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The Condition of Participation: Quality Assessment and Performance Improvement Program was out of compliance:

Findings included:

1.) The Hospital failed to ensure, for one patient (Patient #1) of ten patients sampled, to monitor the effectiveness of corrective actions following Patient #1's adverse patient events.

Refer to TAG: A-0273.

2.) The Hospital failed for six patients (Patients #2, #3, #4, #5, #7, & #10) to ensure Quality Assessment and Performance activities conducted a thorough analysis, and implemented preventive actions (corrective action Plan) following adverse patient events.

Refer to TAG: A-0286.

3.) The Hospital Governing Body failed for one patient (Patients #8) to ensure their Quality Assessment and Performance Program reflected monitoring of radiologic services furnished under contract (agreement) for effectiveness.

Refer to TAG: A-0308.

4.) The Hospital's Governing Body (Board of Directors), medical staff, and administrative officials failed for eight (8) patients (Patient #1, #2, #3, #4, #5, #7, #8 & #10) in a sample of ten (10) patients to ensure responsibility and accountability for ensuring an ongoing program of quality improvement and patient safety; and that improvement (corrective) actions were evaluated.

Refer to TAG: A-0309.

5.) The Hospital's Governing Body (Board of Directors), medical staff, and administrative officials failed for one (1) patient (Patient #2) in a sample of ten patients, responsibility, and accountability to allocate adequate resources for measuring, assessing, improving, and sustaining the Hospital's performance and reducing risk to patients.

Refer to TAG: A-0315.

Based on records reviewed and interviews the Hospital failed to ensure, for one patient (Patient #1) of ten patients sampled, to monitor (audit) the effectiveness of corrective actions following Patient #1's adverse patient events.

Findings included:

The Medical, Dental Staff Bylaws of Franciscan Hospital for Children, dated 7/2020, indicated the purpose of the Medical, Dental staff to emphasize the quality of medical care.

The Policy titled: Quality Improvement Plan and Annual, Evaluation, dated 1/2020, indicated the Board of Directors (Governing Body) had overall responsibility for the quality of patient care and safety; and the Patient Care Assessment Committee (PCAC), as delegated by the Board of Directors, was responsible for monitoring and receiving reports, and delegation of quality improvement implementation efforts (monitoring) to the Council for Performance Excellence. The Medical, Dental Staff Bylaws of Franciscan Hospital for Children, indicated the Council for Performance Excellence, was responsible for organization-wide quality and the Quality and Safety Committee, as designated responsibility from the Council for Performance Excellence was dedicated to monitoring the effectiveness of the Safety Program.

1.) Regarding Patient #1:

A.) Regarding Patient #1 & Ventilator Settings:

History and Physical, dated 10/6/2020, indicated Patient #1 was admitted to the Hospital, with a history of respiratory failure, had a tracheostomy (a surgical hole through the front of the neck and into the windpipe for breathing), requiring ventilator (breathing machine) support, for ventilator weaning and caregiver education.

The Document titled Respiratory, Ventilator Event, 1/21/2021, indicated Patient #1 was admitted to the Hospital on the incorrect ventilator settings for twenty-four hours.

During an interview at 1:30 P.M. on 8/17/2021, the Quality Vice President said the Hospital was just starting the plan to cross-cover the Provider, Registered Nurse and Respiratory Therapist Huddle [i.e., the Provider, Registered Nurse, Respiratory Therapist, and transport team, from the sending hospital were present for report; they would review and reconcile ventilator settings and provider orders at the patient bedside].

During an interview, at 11:00 A.M. on 8/18/2021, the Quality Vice President said immediate corrective action included (the expectation) that the Hospital Provider and Respiratory Therapist reviewed and reconciled with the transport team Respiratory Therapist, ventilator settings during the Huddle (bedside transport report on admission) and that the corrective action was in place, now. The Quality Vice President said the Hospital was not monitoring (the effectiveness of the corrective action i.e., the Hospital did not monitor that the Hospital Provider was present at the Huddle to ensure correct ventilator settings).

During an interview, at 2:00 P.M. on 8/18/2021, Staff Nurse #1 said it was rare for doctors (Providers) to be at the bedside with transfers (present for the patient transfer Huddle).

During an interview, at 2:00 P.M. on 8/20/2021, Staff Registered Nurse #2 and #3 representing the medical units, said Providers were typically and usually not present (for the patient transfer Huddle).

The Hospital provided no documentation to indicate they implemented nor monitored the effectiveness of a corrective action plan following Patient #1's adverse patient event eight months after the event, to review and reconcile ventilator settings at the patient bedside.

B.) Regarding Patient #1 & Silver Nitrate (topical medication):

Nurse's Note, dated at 9:00 P.M. on 2/24/2021, indicated Patient #1's gastrostomy (an opening into the stomach from the abdominal wall, made surgically for the introduction of food) tube granuloma site showed bleeding, Silver Nitrate (an anti-infective, and used to cauterize infected tissues around a skin wound, and create a scab to help stop bleeding from a minor skin wound) was found to have leaked out from the gastrostomy tube stoma, and staining was noted on Patient #1's skin.

During an interview, at 1:30 on 8/17/2021, the Quality Vice President said a nurse noted a reddened area, the day after, a Silver Nitrate application to Patient #1's granuloma (thickening of skin due to chronic inflammation, at the gastrostomy site). The Quality Vice President said it was unclear if the reddened area was second degree burns. The Quality Vice President said Patient #1 was transferred to an acute care hospital due to respiratory distress and it was unclear if the respiratory distress was due to Patient #1's respiratory condition or the Silver Nitrate event. The Quality Vice President said the Hospital investigated, updated their Silver Nitrate policy, and provided training to ten selected Registered Nurses to administer Silver Nitrite. The Quality Vice President said the Hospital had not audited (monitored for the effectiveness of their corrective actions.

The Hospital policy titled Silver Nitrate Application, dated 6/14/2021, indicated trained nurses can apply Silver Nitrate.

Based on records reviewed and interviews the Hospital failed for six patients (Patients #2, #3, #4, #5, #7, & #10) to ensure Quality Assessment and Performance activities conducted a thorough analysis, and implemented preventive actions (corrective action plan) following adverse patient events.

Findings included:

The Medical, Dental Staff Bylaws of Franciscan Hospital for Children, dated 7/2020, indicated the purpose of the Medical, Dental staff to emphasize the quality of medical care.

The Policy titled: Quality Improvement Plan and Annual, Evaluation, dated 1/2020, indicated the Board of Directors (governing Body) had overall responsibility for the quality of patient care and safety; and the Patient Care Assessment Committee (PCAC), as delegated by the Board of Directors, was responsible for monitoring and receiving reports, and delegation of quality improvement implementation efforts to the Council for Performance Excellence. The Medical, Dental Staff Bylaws of Franciscan Hospital for Children, indicated the Council for Performance Excellence, was responsible for organization-wide quality analysis, improvement of care and services consistent with standards and compliant with regulation and the Quality and Safety Committee, as designated responsibility from the Council for Performance Excellence was dedicated to implementation of the Safety Program.

Regarding Patient #2:

Based on records reviewed and interviews the Hospital failed to conduct a thorough investigation regarding Patient #2's stage three wound, adverse patient event.

Hospital Report, dated 6/22/2021, indicated the Patient #2 was admitted to the Hospital and noted to have a clean, dry and intact duoderm dressing in place on the left side of Patient #2's neck under the tracheostomy (a surgical hole through the front of the neck and into the windpipe for breathing) ties.

The History and Physical, dated 6/10/2021, indicated the Provider noted Patient #2 had a small skin tear on the left neck covered with duoderm (dressing). The History and Physical indicated no plan of care for the skin tear.

Patient #2's Medical Record indicated no Provider admission orders on 6/10/2021, for wound care.

Nurse's Note, dated 6/13/2021, indicated Patient #2 had a stage three (3) pressure wound with a large amount of purulent (puss), an odorous dressing and small amount of bleeding [stage three decubitus ulcers are full thickness skin loss involving damage or necrosis of subcutaneous tissue (the tissue below the skin) that may extend down to, but not through, underlying fascia (tissue below the skin].

The Nursing Care Plan indicated no documentation regarding Patient #2's wound care needs.

During an interview at 1:30 P.M. the Quality Vice President said the nurse took a verbal order from the transport team to not take of the dressing off, that was in place until it falls off and three days later the wound developed into a stage three (3) wound. The Quality Vice President said the Hospital conducted an Apparent Cause Analysis (a base line review conducted by the Nurse Manager) and did not conduct a Root Cause Analysis (thorough investigation) because the Risk Manager was in transition and the Wound Care Nurse was onboarding. The Quality Vice President said corrective action included nursing skin assessments on admission. The Quality Vice President said the Hospital was not monitoring this corrective action.

The Hospital provided no Hospital investigation regarding the verbal order received by the Registered Nurse on Patient #2's admission to the Hospital. The Hospital provided no investigation regarding updating Patient #2's nursing care plan. The Hospital provided no investigation regarding the lack of Provider orders in the care of Patient #2's wound prior to the identification of Patient #2's stage three wound.

Regarding Patient #3

Based on records reviewed and interviews the Hospital failed to conduct a thorough investigation following Patient #3's attempted suicide, adverse patient event.

The Hospital Report, dated 7/30/2021, indicated Patient #3 was observed to wrap a sports bra around his/her neck.

The Emergency Restraint or Seclusion Form, dated at 2:00 P.M. on 7/30/2021, indicated self-strangulation and aggression towards staff as the behavior requiring emergency use of restraint.

During an interview, at 11:00 A.M. on 8/19/2021, the Behavioral Health Director said Patient #3 had a history of suicide risk and bra around Patient #3's neck was a suicide gesture in an episode of dysregulation. The Behavioral Health Director said that Patient #3's weekly multidisciplinary care plan did not reflect the event. The Behavioral Health Director said that the Hospital did not investigate the event because the event was considered a restraint, assaultive episode and did not trigger for review.

During an interview, at 12:00 P.M. on 8/19/2021, the Quality Vice President said the Hospital did not review Patient #3's event (attempted suicide) because the event was not filed as Patient Safety Event and was filed as an Employee Safety Event to Occupational Health (employee health services) for an employee injury during the event.

Patient #3's medical record indicated no documentation of an update to a nursing plan of care regarding Patient #3's attempted suicide, on 7/31/2021.

The Hospital provided no documentation to indicate the Hospital investigated Patient #3's attempted suicide.

Regarding Patient #4:

Based on records reviewed and interviews the Hospital failed to conduct a thorough investigation following Patient #4's alleged medication overdose, including documentation of qualified personnel that transported Patient #4 from the Hospital to an emergency room, and documentation of Provider evaluation.

The Hospital policy titled Patient Discharge, Patient Transfer, dated 6/2021 indicated appropriate personnel transported the patient according to the condition of the patient. The Hospital policy titled Patient Discharge; Patient Transfer indicated no documentation to define the qualifications of appropriate transport personnel.

The Hospital Report, dated 7/19/2021, indicated Patient #4 had an on-unit overdose attempt with six Clonidine pills, (anxiety medication, in severe cases the patient may briefly lose consciousness or even go into a coma, an overdose can be fatal). Patient #4 stated he/she wanted to die, and Patient #4 was sent out for evaluation.

During an interview, at 2:00 P.M. on 8/18/2021, the Behavioral Health Director and Quality Vice President said the Hospital transported Patient #4 by ambulance for medical evaluation after Patient #4 self-reported that he/she ingested pills. The Quality Vice President said it was unknown if the on-call Pediatrician saw (evaluated) Patient #4 prior to transport to the emergency room. The Quality Vice President said that there was no specific (Provider) order for the transport on 7/17/2021. The Quality Vice President said the nurses took a verbal order for the transfer. The Quality Vice President said the Hospital sent Patient #4 to an acute care hospital emergency room for evaluation. The Quality Vice President said it was unknown if the Hospital transported Patient #4 with BLS or ACLS; (appropriate personnel to manage Patient #4's airway according to the condition of Patient #4) as this was not documented. The Quality Vice President said BLS, Basic Life Support staff, do not insert breathing tubes, intubate, (ACLS, Advanced Cardiac Life Support, do manage breathing tubes, intubate).

Nurses Note, dated 7/19/2021 indicated no documentation that a Registered Nurse received a verbal order to transfer Patient #4.

Medical record review did not indicate a timely Provider documentation of the event with the determination to transport Patient #4 to an emergency room for a medication overdose evaluation.

Regarding Patient #5:

Based on records reviewed and interview the Hospital failed be aware of Patient #5's stage three wound.

The Provider Progress Note, dated 7/2/2021 & 7/6/2021, indicated Patient #5 had a stage three wound.

During an interview, at 10:30 A.M. on 8/20/2021, the Quality Vice President said that the Hospital was unaware of Patient #5's stage three wound because the stage three wound was not reported into the Hospital's safety event reporting system until 8/5/2021.

Regarding Patient #7:

Based on records reviewed and interviews the Hospital failed to conduct a thorough investigation and educated Patient #7's father regarding safe transfers of patients with gastronomy tubes resulting in Patient #7 requiring a transfer to an acute care hospital for surgical re-placement of the gastronomy tube.

The Hospital Report, dated 7/12/2021, indicated Patient #7's gastronomy (an opening into the stomach from the abdominal wall, made surgically for the introduction of food) tube became dislodged while being transferred back to bed from a wheelchair by Patient #7's father.

The Certificate of Transfer, dated 7/12/2021, indicated the Hospital transferred Patient #7 to an acute care Hospital for surgical re-insertion of the dislodged gastronomy tube.

During an interview, at 10:30 A.M. on 8/20/2021, Nursing Informaticist #1, said that parents of patients with gastronomy tubes were taught patient transfer.

During an interview, at 10:30 A.M. on 8/20/2021, the Quality Vice President said the Hospital did not investigate, did not know if the Nurse Manager reviewed the event and there was no follow-up that the father was educated.

Nurse's Notes indicated no documentation that nursing educated Patient #7's father regarding safe transfers of patients with gastronomy tubes.

Regarding Patient #10:

Based on records reviewed the Hospital failed to document the appropriate personnel to transport Patient #10.

The Event Noted, dated at 9 :26 P.M. on 7/22/2021, indicated a Patient #10, with a history of a recent event requiring intubation, had an episode of acute respiratory distress with labored breathing and decreased oxygenation requiring oxygen. The Event note indicated due to acuity and new onset of symptoms, hypoxia, and inability for full work-up and monitoring in a non-medical psychiatric unit, Patient #10, was transferred by ambulance to an acute care hospital for further evaluation.

Medical record review indicated no documentation to indicate appropriate personnel transported Patient #10, according to the Patient Discharge, Patient Transfer Policy.

Based on records reviewed and interviews the Hospital Governing Body failed for one patient (Patients #8) to ensure their Quality Assessment and Performance Program reflected monitoring of radiologic services furnished under contract (agreement) for effectiveness.

Findings included:

The Mobile Medical Diagnostic Services Terms and Agreement, dated 7/1/2016, indicated a contract between the Hospital and Mobile Medical Diagnostic Services for radiologic (x-ray) services. The Mobile Medical Diagnostic Services contract indicated that a Radiologic Technologist would be onside at the Hospital within one (1) hour of the initial request and was expected to perform radiographs as requested by the Hospital.

Hospital Report, dated 7/17/2021, indicated the Mobile Medical Diagnostic Services was telephoned and notified that Patient #8 required a chest x-ray. The Hospital report indicated Mobile Medical Diagnostic Services responded that they were unable to contact their on-call technician and the technician they were able to contact was not trained on the Franciscan radiology equipment and the chest x-ray was not obtained.

Provider Order, dated 7/16/2021 at 4:00 P.M., indicated an order for a portable STAT (perform immediately) chest x-ray for Patient #8's increased ventilator (breathing machine) support and hypoxemia (low blood oxygen). The Provider Order indicated the x-ray Status as Ordered and did not indicate the Status as Taken.

During an interview, at 1:00 A.M. on 8/17/2021, Nursing Informaticist #1 said that the Hospital was tracking contracted times.

The Hospital Governing Body provided no documentation to indicate Mobile Medical Diagnostic Services met the agreement to provide radiologic services within one (1) hour of the initial request.

Based on records reviewed and interviews the Hospital's Governing Body (Board of Directors), medical staff, and administrative officials failed for eight (8) patients (Patient #1, #2, #3, #4, #5, #7, #8 & #10) in a sample of ten (10) patients to ensure responsibility and accountability for ensuring an ongoing program of quality improvement and patient safety; and that improvement (corrective) actions were evaluated.

Findings included:

The Hospital failed to ensure, for one patient (Patient #1) of ten patients sampled, to monitor (audit) the effectiveness of corrective actions following Patient #1's adverse patient events.

The Hospital failed to conduct a thorough investigation regarding Patient #2's stage three wound, adverse patient event.

The Hospital failed to conduct a thorough investigation following Patient #3's attempted suicide, adverse patient event.

The Hospital failed to conduct a thorough investigation following Patient #4's alleged medication overdose, including documentation of qualified personnel transported Patient #4 from the Hospital to an emergency room, and documentation of Provider evaluation.

The Hospital failed be aware of Patient #5's stage three wound.

The Hospital failed to conduct a thorough investigation and educated Patient #7's father regarding safe transfers of patients with gastrostomy (an opening into the stomach from the abdominal wall, made surgically for the introduction of food) tube resulting in Patient #7 requiring a transfer to an acute care hospital for surgical re-placement of the gastronomy tube (an opening into the stomach from the abdominal wall, made surgically for the introduction of food).

The Hospital failed for one patient (Patients #8) to ensure their Quality Assessment and Performance Program reflected monitoring of radiologic services furnished under contract (agreement) for effectiveness.

The Hospital failed to document the appropriate personnel to transport Patient #10.

Based on interview the Hospital's governing, medical staff, and administrative officials failed for one (1) patient (Patient #2) in a sample of ten patients, responsibility, and accountability to allocate adequate resources for measuring, assessing, improving, and sustaining the Hospital's performance and reducing risk to patients.

Findings included:

During an interview at 1:30 P.M. the Quality Vice President said the nurse took a verbal order from the transport team to not take of the duoderm (dressing) that was in place until it falls off and three days later the wound developed into a stage three (3) wound [Stage three decubitus ulcers are full thickness skin loss involving damage or necrosis of subcutaneous tissue (the tissue below the skin) that may extend down to, but not through, underlying fascia (tissue below the skin]. Quality Vice President said the Hospital conducted an Apparent Cause Analysis (a base line assessment by the Nurse Manager review) and did not conduct a Root Cause Analysis (thorough investigation) because the Risk Manager was in transition and the Wound Care Nurse was onboarding. The Quality Vice President said corrective action included nursing skin assessments on admission. The Quality Vice Present said the Hospital was not monitoring this corrective action.