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Based on review of medical records (MR), Corrective Maintenance Work Order, Fall/Injury Event documentation, and interviews with the staff, it was determined the facility failed to ensure infants receiving phototherapy were provided a safe environment free from injury.

This deficient practice affected 1 of 3 records reviewed including PI # 1.

Refer to A0144 for findings.

Based on review of medical records (MR), Corrective Maintenance Work Order, Fall/Injury Event documentation, and interviews with the staff, it was determined the facility failed to ensure:

1. All infants receiving phototherapy were visually observed at all times.

2. All infant isolettes were closed and latched securely for infant safety.

3. Corrective actions were implemented when an event/injury occurred.

This deficient practice affected 1 of 3 records reviewed with orders for phototherapy including (Patient Identifier) PI # 1 and had the potential to affect all infants in the nursery.

Findings include:

1. PI # 1 was admitted to the newborn nursery in stable condition at 40 weeks gestation on 08/10/2020 at 7:18 AM weighing 8 pounds, 1.6 ounces, 19 inches in length, head circumference of 13.5 inches and APGAR (Appearance, Pulse, Grimace, Activity, and Respiration) 9/9.

Review of the Physician Order dated 8/14/2020 at 6:11 AM revealed, "Start double
Phototherapy."

Review of Newborn Notes by EI (Employee Identifier) # 18, Nursery RN (Registered Nurse), dated 8/14/2020 at 6:20 AM revealed, "Phototherapy initiated. Blue light. Bili (Bilirubin) Bed."

Review of Newborn Notes by EI # 10, Nursery RN, dated 8/14/2020 at 12:00 PM revealed, "Remains in nursery in Isolette. Phototherapy continues; Blue light; Bili bed. Axillary temperature 98.3 F (Fahrenheit). Safety Assessment: (Safe Surroundings: Infant placed away from drafts, Back to sleep, Bed Free of loose bedding). Photo Therapy Safety Assessment: (Safety: Eye covering, diaper on, Temperature control)."

Further review of the MR revealed there was no documentation of direct observation of PI # 1 on 8/14/2020 between 12:00 PM and 1:08 PM nor was there documentation of staff monitoring and observing the isolette to ensure the latch was secure to ensure the safety of PI # 1.

Review of Newborn Notes by EI # 8, Nursery RN, dated 8/14/2020 at 1:08 PM revealed, "Baby's security tag alarmed, went to check on infant, found infant on floor in front of isolette (clear plastic enclosed crib). Baby picked up and placed on open bed warmer (bed open to room air with a radiant warmer above and guardrails). Phototherapy discontinued."

Review of Newborn Notes by EI # 8 dated 8/14/2020 at 1:10 PM revealed, "Cardiac monitors applied. Heart rate 164, resp (respirations) 52, O2 Sat (Oxygen Saturation) 99%. Baby active and moving all extremities appropriately." Skin color "pink, crying. Placed on open bed warmer." There was no documentation PI # 1's temperature was assessed.

Review of the Physician Order dated 8/14/2020 at 1:32 PM revealed, "CT (Computed Tomography) Head WO (without) contrast."

Review of Imaging Department CT Head WO Contrast dated 8/14/2020 transcribed at 1:31 PM revealed, "There are findings concerning for small subdural in the parietal-occipital region on the right. This measures up to 3 mm (millimeters)..."

Review of Physician Order dated 8/14/2020 at 3:40 PM revealed, "Place the baby in a secured isolette under phototherapy cardiac, O2 and apnea monitor. Repeat CT Scan Head at 7 PM."

Review of Physician Order dated 8/14/2020 at 7:08 PM revealed, Transfer to High Risk Nursery (different facility) under care of Neonatologist. Send Head CT Scans."

Review of Imaging Department CT Head WO Contrast dated 8/14/2020 transcribed at 7:42 PM revealed, "Stable findings again suggestive of small right subdural hematoma...Overall findings are unchanged from earlier today."

Review of Newborn Notes by EI # 17, Nursery RN, dated 8/14/2020 at 9:38 PM revealed, "Patient transferred to receiving Hospital via critical care transport."

Review of the Fall/Injury Event (92152) dated 8/14/2020 revealed at 1:08 PM on 08/14/2020, EI # 11, Nursery RN reported a "Fall/injury event occurred with injury. No equipment malfunction. Infant in isolette under phototherapy. Locator tag began alarming. When the nurse went to check the band, found infant on floor beside isolette. Baby placed on open bed warmer with cardiac and respiratory monitor applied. Baby active and moving all extremities. No skin tears or lesions. MD notified. CT of head ordered...Number of patients on Unit, 16. Number of Nurses on Unit 4..."

Further review of the Fall/Injury Event (92152) dated 8/14/2020 revealed, "No fall safety precautions in place at time of fall...Severity Level: Severe Harm" and PI # 1 sustained a "3mm subdural hematoma...Follow-Up work completed by (EI # 7) RN, (EI # 2) RN Director of Obstetrics, and (EI # 5) Director of Quality." There was no follow-up documentation provided and no resolution outcomes provided.

Review of the Corrective Maintenance Work Order completed for infant isolette # 3619 completed on 8/17/2020 revealed, "NBN (new born nursery) staff requested incubator (isolette) be tested for proper operation. Incubator (isolette) was evaluated for proper operation and complete visual inspection was performed. No problems were noted with incubator (isolette) at time of inspection. Incubator (isolette) was found serviceable and returned to NBN." There was no documentation the remaining isolettes were evaluated for safety.

On 2/17/2021 at 2:00 PM, the surveyor observed infant isolette # 3619 in the NBN and available for use. Upon inspection, surveyor observed when the door to the isolette is closed but unsecured (unlatched) from the top, the door remains closed by a spring closure until it is physically opened, which requires some degree of force.

An interview conducted on 2/17/2021 at 2:10 PM with EI # 16, Director of Biomedical Services, revealed when he/she retrieved the isolette from the NBN on 8/14/2020 to perform the maintenance check, he/she observed the mattress to the isolette in a reverse trendelenburg position. EI # 16 confirmed the isolette was removed from service for a safety evaluation and no problems were identified. The isolette was found serviceable and returned to the NBN on 8/17/2020.

An interview conducted on 2/18/2021 at 10:02 AM with EI # 8, Nursery RN stated he/she was in the nursery with EI # 11. EI # 8 stated, " I was at the desk. I could not see the floor from where I was sitting at the computer. The alarm is behind me. I turned around away from the computer to check the security system to see which baby's alarm sounded. It took seconds, then I went straight to the (nursery) door and I saw him/her on the floor and picked him/her up and placed him/her on the warmer (bed)." EI # 8 confirmed both EI # 8 and EI # 11 were located behind the nursery window at the time the alarm sounded. No other nurses or staff members were present in the nursery with PI # 1.

An interview conducted on 2/18/2021 at 11:07 AM with EI # 11, Nursery RN, confirmed the head of the Isolette bed was elevated at the time PI # 1 was receiving phototherapy and found on the floor in front of the isolette. EI # 11 confirmed he/she and EI # 8, Nursery RN, were located behind the nursery window at the time the alarm sounded. No other nurses or staff members were present in the nursery with PI # 1.

Based on review of facility policies and procedures, medical records (MR), interviews with staff and Fall/Injury Event Report documentation it was determined the facility failed to;

1. Analyze, and track adverse patient event.

2. Implement corrective actions when an event/injury occurred.

This deficient practice affected 1 of 3 Records reviewed with orders for phototherapy and did include PI # 1 and had the potential to affect all infants in the nursery.

Findings include:

Policy: Event Reporting
Reviewed Date: 11/2018

Definition:
An occurrence is any happening that is not consistent with the routine operation of the hospital or the routine care of a particular patient; any deviation from hospital policy and procedure or any unexpected or untoward event. It may be an event or a situation which may or may not result in an illness or injury to a patient...The proper completion of event reports is a responsibility of every employee.

II Patients:
...C...Any findings, resolution, and or counseling should be documented on Event Report.

D. Upon completion of the investigation of the event and documented resolution, the Event Report is to be closed by the Risk Manager.

...V. Procedures and Guidelines:

...C. Notify Risk Management immediately, via telephone or operator, of any Sentinel Event or Serious Adverse Event.

1. Patient Identifier (PI) # 1 was admitted to the newborn nursery in stable condition at 40 weeks gestation on 08/10/2020 at 7:18 AM weighing 8 pounds, 1.6 ounces, 19 inches in length, head circumference of 13.5 inches and APGAR (Appearance, Pulse, Grimace, Activity, and Respiration) 9/9.

Review of the Fall/Injury Event (92152) dated 8/14/2020 revealed at 1:08 PM on 08/14/2020, EI (Employee Identifier) # 11, Nursery RN (Registered Nurse) reported a "Fall/injury event occurred with injury. No equipment malfunction. Infant in isolette under phototherapy. Locator tag began alarming. When the nurse went to check the band, found infant on floor beside isolette. Baby placed on open bed warmer with cardiac and respiratory monitor applied. Baby active and moving all extremities. No skin tears or lesions. MD notified. CT (Computed Tomography) of head ordered...Number of patients on Unit, 16. Number of Nurses on Unit 4... "

Further review of the Fall/Injury Event (92152) dated 8/14/2020 revealed, "No fall safety precautions in place at time of fall...Severity Level: Severe Harm" and PI # 1 sustained a "3 mm subdural hematoma...Follow-up work completed by (EI # 7) RN, (EI # 2) RN Director of Obstetrics, and (EI # 5) Director of Quality." There was no follow-up documentation provided and no resolution outcomes provided.

An interview conducted on 2/19/2021 at 8:15 AM with EI # 5, Director of Quality, confirmed the Fall/Injury Event was not analyzed and tracked and corrective actions were not implemented.

Based on review of medical records (MR) and staff interviews, it was determined the facility failed to ensure infants were provided a safe environment free from injury and failed to assess an infant's temperature after being found on the floor.

This deficient practice affected PI (Patient Identifier) # 1.

Refer to A0392 for findings.

Based on review of medical records (MR) and staff interviews, it was determined the facility failed to ensure:

1. Infants were visually observed at all times when receiving phototherapy.

2. Infant isolettes were closed and latched at all times for infant safety.

3. A newborn infant's temperature was assessed after being found on the floor in the nursery.

This deficient practice affected 1 of 3 MR's reviewed with orders for phototherapy and did include PI (Patient Identifier) # 1 and had the potential to affect all infants served by the facility.

Findings include:

1. PI # 1 was admitted to the newborn nursery in stable condition at 40 weeks gestation on 8/10/2020 at 7:18 AM weighing 8 pounds, 1.6 ounces, 19 inches in length, head circumference of 13.5 inches and APGAR (Appearance, Pulse, Grimace, Activity, and Respiration) 9/9.

Review of the Clinical Laboratory Report dated 8/14/2020 at 3:51 AM revealed, "Bili T (Total Bilirubin)16.30 mg/dL (milligrams/deciliter). Reference range 0.00 - 11.70. Critical results called to nurse at 4:58 AM."

Review of Physician Order dated 8/14/2020 at 6:11 AM revealed, "Start double
Phototherapy."

Review of Newborn Notes by EI (Employee Identifier) # 18, Nursery RN (Registered Nurse), dated 8/14/2020 at 6:20 AM revealed, "Phototherapy initiated. Blue light. Bili Bed."

Review of Newborn Notes by EI # 10, Nursery RN, (Assigned to PI # 1) dated 8/14/2020 at 12:00 PM revealed, "Remains in nursery in isolette. Phototherapy continues; Blue light; Bili bed. Axillary temperature 98.3 F (Fahrenheit). Safety Assessment: (Safe Surroundings: Infant placed away from drafts, Back to sleep, Bed Free of loose bedding). Photo Therapy Safety Assessment: (Safety: Eye covering, diaper on, Temperature control)."

Review of Newborn Notes by EI # 8, Nursery RN, dated 8/14/2020 at 1:08 PM revealed, "Baby's security tag alarmed. Went to check on infant. Found infant on floor in front of isolette. Baby picked up and placed on open bed warmer. Phototherapy discontinued."

Review of Newborn Notes by EI # 8, Nursery RN, dated 8/14/2020 at 1:10 PM revealed, "Cardiac monitors applied, heart rate 164, respirations 52, O2 (Oxygen) saturation 99%. Baby active and moving all extremities appropriately, skin color pink, crying, placed on open Bed Warmer." There was no documentation PI # 1's temperature was assessed.

Further review of the medical record revealed no documentation PI # 1 was observed between 12:00 PM and 1:08 PM when PI # 1 was found on the floor.

An interview was conducted on 2/18/2021 at 10:02 AM with EI # 8, Nursery RN, who confirmed the nurse assigned to PI # 1 was not in the nursery at the time the alarm sounded. EI # 8 confirmed the isolette should always be locked and a nurse should always be with a newborn receiving phototherapy. EI # 8 confirmed he/she was sitting at the computer when the alarm sounded and turned away from the computer to check the security system to see which baby's alarm sounded. He/she then went to the nursery door and saw PI # 1 on the floor in front of the isolette. EI # 8 confirms that he/she and EI # 11 were in the charting area of the nursery and not in the area where PI # 1 was located when the event occurred.

An interview was conducted on 2/18/2021 at 11:07 AM with EI # 11 Nursery RN who confirmed the nurse assigned to PI # 1 was not in the nursery at the time the alarm sounded. EI # 11 confirms that he/she and EI # 8 were in the charting area of the nursery and not in the area where the Isolette was located when the event occurred.

An interview was conducted on 2/17/20201 with EI # 2, Director of Obstetrics who confirmed all newborns should be observed while receiving phototherapy in a closed and securely latched isolette and no staff member observed PI # 1 at the time he/she was found on the floor in front of the isolette.