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Based on interviews and records reviewed the Hospital failed to follow the policy and procedure for reporting incidents and Serious Reportable Events (SREs) to the department of Public Health for 2 (Patient #2 and Patient #3) of 11 patient records reviewed when Patient #2 had a physical injury resulting from an unknown cause and when Patient #3 had a serious injury associated with the use or function of a device in patient care resulting in additional treatment provided by the Hospital as a result of the device misuse.
Findings include:

Review of the Hospital's Safety Event Reporting policy dated 4/8/2020 indicated that a sentinel event is specific subset of adverse and unexpected occurrence involving death or serious physical or psychological injury or the risk there of. As defined by certain regulatory agencies, some sentinel events must be reported to the agency. BIDMC includes "Serious Reportable Events," (SREs). The policy indicated that the Hospital will immediately report by telephone: Serious physical injury to a patient resulting from an accident or unknown cause. The Hospital will submit a written report within one week of incidents that involve patient death or serious injury associated with the use or function of a device in patient care in which the device is used or functions other than as intended.

1. Patient #2 was a 23 day old infant who had been admitted to the Neonatal Intensive Care Unit for respiratory distress and sepsis evaluation. On 10/2/22 a nurse identified that Patient #2 had a right arm injury with swelling and a small bruise. An x-ray confirmed right brachial fracture. The patient was examined by the attending physician, and it was determined the etiology of the fracture was unclear and there was no observation of atypical positioning or trauma.

During an interview on 6/22/22 at 1:40 P.M. the Director of Patient Safety said that the fracture was not reported because they reviewed the case and felt that the fracture had to do with the posturing of Patient #2.

During an interview on 6/22/22 at 1:50 P.M., the Chief Medical Officer said that he would have assumed Patient #2's fracture would have been reported to DPH.

The Hospital failed to report to The Department of Public Health Patient #2's right brachial fracture, a serious physical injury resulting from an unknown cause as the policy indicates.

2. Record review indicated that Patient #3 was admitted on 7/2/21 with Necrotizing Pancreatitis (a condition where parts of the pancreas die), status post Pancreatic Necrosectomy (a surgical procedure to remove dead tissue.)

Record review indicated that on 10/14/21 Nurse #1 inadvertently connected Patient #3 Tube Feed to the Abramson drain (placed in the peritoneal cavity) instead of the Jejunostomy tube (surgically placed tube directly into the small intestine) resulting in increased pain of Patient #3 requiring increased monitoring and intervention which consisted of placing the Abramson drain to suction for 2 hours then to re-evaluate and an Abdominal CT scan with contrast.

During an interview on 6/22/22 at 9:08 A.M., the Director of Patient Safety said that because there was no harm to Patient #3 and he/she did not require a higher level of care is why it was determined not to be reportable to DPH.

The Hospital failed to report to DPH this incident of device misuse which led to increased pain, medical monitoring and the need for additional treatment and imaging.