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Based on document review and interview, it was determined that the Hospital failed to prevent an injury of unkown origin, femur fracture; conduct an investigation; develop a Root Cause Analysis (RCA); and conduct an abuse allegation investigation following an injury of unknown origin of a premature infant.

As a result, it was determined that the Condition of Participation for Patient Rights, CFR 482.13, was not in compliance.

Findings include:

1. The Hospital failed to protect a premature infant from injury. See deficiency at A-144A.

2. The Hospital failed to conduct a timely investigation and develop and implement an action plan to ensure non-reoccurrence. See deficiency at A-144B.

3. The Hospital failed to protect and promote a patient's right to an abuse investigation. See deficiency at A-145.

An immediate jeopardy (IJ) began on 1/12/2020, due to the Hospital's failure to prevent an injury of unknown origin, the femur fracture of a 24-week premature newborn, and failure to conduct a timely investigation to determine the cause and prevent reoccurrence. The IJ was identified on 7/13/2020 at 42 CFR 482.13, Patient Rights and was announced on 7/13/2020 at 11:00 AM during a meeting with the System Director of Regulatory and Safety, Regulatory Manager, Interim Quality Director, Chief Medical Officer, Assistant Chief Nursing Officer, Operations Manager, and the Chief Nursing Officer. The IJ was not removed by the survey exit date of 7/13/2020.

Based on document review and interview it was determined that for 1 of 2 (Pt. #1) patient records reviewed for complaints and grievances, the Hospital failed to follow the time frames for review and response of a patient's grievance.

Findings Include:

1. On 7/7/2020, the policy titled, "Sinai Health System Patient Complaint and Grievance Process", dated April 2018 was reviewed. The policy included, "The Department Director and/or Manager shall complete the review of the Grievance within 7 days and confer with the Patient Advocate or Hospital representative concerning the results and the planned response. The Patient Advocate or Hospital representative shall send or deliver a resolution letter to the patient or their representative which shall summarize the Hospital's review of the Grievance."

2.On 7/8/2020, the "Patient Relations Worksheet", dated 2/26/2020 - 6/26/2020 was reviewed. A grievance, dated 2/26/2020 (route of receipt not documented), included, "After the baby [Pt. #1] was transferred to another hospital, mother alleged that Nurse [E #2], who was caring for the infant one night, handled the baby roughly. She also indicated that [she] saw swelling on the left side of the baby's [Pt. #1] leg. This concern was provided to the baby's [Pt. #1] Neonatologist." Another grievance entry, dated 3/12/2020, (phone call to Pt #1's mother) included, "Patient's mother is alleging baby was handled roughly...After the baby was transferred to another hospital, mother alleged that nurse [E #2], who was caring for the infant one night, handled the baby roughly. She also indicated that [she] saw swelling on the left side of the baby's leg. This concern was provided to the baby's Neonatologist."

3. A grievance acknowledgement letter written was mailed to Pt. #1's mother on March 12, 2020 (15 days after the grievance was received). The letter included, "As discussed, you son's Neonatalogist informed us that you had questions and concerns about the care your son received at [Hospital]. We are coordinating a time for you to come in to speak with us, and one of our physicians, so your questions can be answered..."

4. On 7/8/2020 at 11:35 AM, an interview was conducted with the Systems Outcome Improvement Manager (E #7). E #7 stated that initial verbal contact is attempted with the patient/representative and an acknowledgment letter is mailed to the patient/representative within 48 -72 hours after receiving the complaint. Verbal contact was made with Pt#1's mother on 3/12/2020 (15 days later).

A. Based on document review and interview, it was determined that for 1 of 1 (Pt. #1) patient record reviewed for patient injury, the Hospital failed to provide care in a safe setting by preventing an angulated femur fracture of a premature infant.

Findings include:

1. On 7/8/2020, the guidelines for newborn positioning titled, "Newborn Positioning for the Preterm or sick Neonate in NICU [Neonatal Intensive Care Unit]" reviewed by the Hospital on Jul 2018, was reviewed. The guidelines included, "Each baby should be individually assessed and positioned according to their individual condition, preferences and behavioral cues."

2. On 7/7/2020, the informational sheet titled, "Positioning and Handling Premature Infants" (undated) was reviewed. The informational sheet included, " ...premature babies should be handled gently and carefully."

3. On 7/7/2020, Pt. #1's clinical record was reviewed. Pt. #1 was admitted to the Hospital's NICU on 12/17/19 with a diagnosis premature birth at 24 weeks gestation (weeks of pregnancy) with a birth weight of .690 kilograms (1lb [pounds] 8.34 ounces).
-The nursing note documented by the NICU Nurse (E #3), dated 1/12/2020 at 1349 (1:49 PM), included, "Left upper leg swollen ... [MD #1] at bedside and ordered baby gram (x-ray)."
-The radiology/baby gram (x-ray), dated 1/12/2020, included, "Impression: There is an angulated [type of fracture displacement where the distal portion of the bone points off in a different direction] mid femoral [thigh bone] shaft fracture of the left femur which is new compared to other studies ..." The clinical record did not include a baby gram of Pt. #1's lower extremities prior to 1/12/2020.
-The Discharge summary, dated 1/12/2020, included, "Admission Diagnosis: ELBW [extremely low birth weight/anything less than 1000 grams] newborn C/S [cesarean section], breech presentation [feet downward in the uterus] at birth, RDS [respiratory distress syndrome] of newborn, PDA (patent ductus arteriosus/ heart defect), inguinal hernia [soft tissue bulge in the abdomen], fracture left femur ...Physical exam: neuro/extremities: good tone and move extremities except left extremity swelling of the mid left thigh...Psycho-social 1/12/2020: Spoke to parents. Told them early morning today the baby's left thigh was swollen and an x-ray showed fracture of the left thigh. Told them we will investigate the cause of the fracture. However we cannot take care of the fracture here in [hospital] and have to transfer the baby ..." Pt #1 was transferred to another hospital on 1/12/2020 at 2:36 AM.

4. On 7/13/2020 at 12:10 PM, an interview was conducted with the NICU Nurse Educator (E #9). E #9 stated that Pt. #1's femur fracture could have been avoidable with safe handling.


B. Based on document review and interview, it was determined that for 1 of 1 (Pt. #1) patient record reviewed for injury of unknown origin, the Hospital failed to provide care in a safe setting, by not conducting a timely investigation and developing and implementing an action plan to ensure non-reoccurrence.

Findings include:

1. On 7/7/2020, the policy titled, "Sinai Health System Patient Safety Event Reports and Investigations", dated April 2018, was reviewed. The policy included, "Sentinel Event: A Sentinel Event may be defined as a Patient Safety Event (not primarily related to the natural course of the patient's illness or underlying condition) that reaches a patient and results in death, permanent harm, or severe temporary harm."

2. On 7/7/2020, the policy titled, "Sinai Health System Patient Complaint and Grievance Process", dated April 2018, was reviewed. The policy included, "In response to Sentinel Events, a root cause analysis (RCA) investigation shall be conducted and an action plan shall be identified within 45 business days of an event or becoming aware of an event. The action plan should be developed and implemented based on the analysis findings."

3. On 7/7/2020, Pt. #1's clinical record was reviewed. Pt. #1 was admitted to the hospital on 12/17/19, with a diagnosis premature birth at 24 weeks gestation (weeks of pregnancy) with a birth weight of .690 kilograms (1 pound and 8.3 ounces).
-The nursing notes documented by the NICU Nurse (E #3), dated 1/12/2020 at 1349 (1:49 PM), included, "Left upper leg swollen ...[MD #1] at bedside and ordered baby gram (x-ray).
-The radiology/baby gram (x-ray) dated 1/12/2020, included, "Impression: There is an angulated [type of fracture displacement where the distal portion of the bone points off in a different direction] mid femoral [thigh bone] shaft fracture of the left femur which is new compared to other studies ..." The clinical record did not include a baby gram of Pt #1's lower extremities prior to 1/12/2020.
-The Discharge summary dated 1/12/2020, included, "Psycho-social 1/12/2020: Spoke to parents. Told them early morning today the baby's left thigh was swollen and an X-ray showed fracture of the left thigh. Told them we will investigate the cause of the fracture. However we cannot take care of the fracture here in [hospital] and have to transfer the baby ..." Pt. #1 was transferred to another Hospital on 1/12/2020 at 2:36 PM.

4. There is no evidence that the Hospital conducted a root cause analysis, developed, and implemented an action plan in response to Pt. #1's angulated femur fracture.

5. On 7/7/2020 at 11:52 AM, an interview was conducted with the System Director of Regulatory and Safety (E #1). E #1 stated that a RCA was not conducted for Pt. #1's incident. E #1 stated that Pt. #1's case was handled by the Legal/Risk Department and the Physician Peer Review. E #1 stated that, although the fracture was identified on 1/12/2020, the Regulatory and Safety Department was not notified of Pt. #1's fracture and allegations of the rough handling by the nurse until 2/26/2020. E #1 stated that the computerized risk event report, dated 1/16/2020, did not include documentation of Pt. #1's fracture, rough handling by the nurse or an allegation of abuse. E #1 stated therefore, further investigation was not indicated at the time of the initial incident report. E #1 stated that the clinical staff failed to inform the necessary departments about Pt. #1's fracture. The Hospital did not provide evidence that there were any interventions put in place to re-educate clinical staff on informing the necessary departments about patient injuries.

Based on document review and interview, it was determined that for 1 of 2 (Pt. #1) patient records reviewed for allegations of abuse, the Hospital failed to ensure the patients right to be free from all forms of abuse by conducting an abuse investigation following an allegation of staff rough handling of a premature infant to prevent reoccurrence.

Findings include:


1. On 7/7/2020, the Hospital's policy titled, "Abuse and Neglect", dated 9/5/2019 was reviewed. The policy did not include a procedure for abuse allegation investigations.

2. On 7/9/2020, the Hospital's policy titled, "Response to Allegation of Abuse or Neglect on Hospital Premises", dated July 2020, was reviewed. The policy included, "V. 5. Protection: Any person alleged to have committed abuse or neglect will be removed from patient care until a preliminary investigation is completed. 6. Investigation: After receiving an allegation of abuse or neglect occurring on hospital premises, an internal investigation is initiated by manager, executive leadership, and Patient Safety Department in collaboration with other departments as deemed necessary, and completed as quickly as possible."

3. On 7/7/2020, Pt. #1's clinical record was reviewed. Pt. #1 was admitted to the hospital on 12/17/19 with a diagnosis premature birth at 24 weeks gestation (weeks of pregnancy) with a birth weight of .690 kilograms (1 pound and 8.3 ounces).
-The nursing note documented by the NICU Nurse (E#3), dated 1/12/2020 at 1349 (1:49 PM), included, "Left upper leg swollen ...[MD #1] at bedside and ordered baby gram (x-ray).
-The radiology/baby gram (x-ray), dated 1/12/2020, included, "Impression: There is an angulated [type of fracture displacement where the distal portion of the bone points off in a different direction] mid femoral [thigh bone] shaft fracture of the left femur which is new compared to other studies ..."
-A letter from the state child protective agency, dated 2/7/2020, included, "Currently, I am investigating allegations of child abuse/neglect involving Minor, [Pt. #1] ...DOB [Date of Birth] 12/17/19. Minor was born at your facility."

4. On 7/8/2020, the "Patient Relations Worksheet", dated 2/26/2020 - 6/26/2020 was reviewed. A grievance, dated 2/26/2020 (route of receipt not documented), included, "After the baby [Pt. #1] was transferred to another hospital, mother alleged that Nurse [E #2], who was caring for the infant one night, handled the baby roughly. She also indicated that [she] saw swelling on the left side of the baby ' s [Pt. #1] leg. This concern was provided to the baby ' s [Pt. #1] Neonatologist."

5. On 7/7/2020, the legal memorandum in regards to Pt. #1, dated 2/26/2020, was reviewed. The memorandum included an interview, dated February 19, 2020 (38 days after the incident and 12 days after letter received from child protective agency), with E #2, the nurse who provided care to Pt. #1 during the time that Pt. #1's fracture was identified.

6. On 7/8/2020 at 3:20 PM, another interview was conducted with E #1. E #1 stated that E #2 was not removed from patient care following the allegation of abuse for Pt. #1.

7. On 7/8/2020 at 12:43 PM, an interview was conducted with the System Director of Regulatory and Safety (E #1). E #1 stated that an abuse investigation was not conducted for Pt. #1's case. E #1 stated that Pt. #1's grievance was handled by the Legal/Risk department.