Boston Children’s Hospital

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 41143 The Hospital was out of compliance for the Condition of Participation for Nursing Services. Findings included: Based on record review and interview, The Hospital failed to ensure 1.)a medication was administered in accordance with a practitioner order for one Patient (1) out of a total sample of 10 patients. Patient #1 was administered enoxaparin, an anticoagulant medication (a medication used to prevent blood clots), prior to a surgical bedside procedure against practitioner orders and the Patient experienced significant bleeding following the procedure. 2.) One Patient (#4) out of a total sample of ten patients received a Point of Care Test (POCT) for glucose (a fingerstick test done at the bedside to assess blood glucose levels) as ordered by the Physician. Patient #4 subsequently suffered hypoglycemia (low blood glucose) requiring emergency administration of IV glucose. Cross Reference: 482.23(b)(3) - A registered nurse must supervise and evaluate the nursing care for each patient. (395) 482.23(c) - Standard: Preparation and Administration of Drugs (405)”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 45980 Based on record review and interview, The Hospital failed to ensure 1 Patient (4) out of a total sample of ten patients received a Point of Care Test (POCT) for glucose (a fingerstick test done at the bedside to assess blood glucose levels) as ordered by the Physician. Patient #4 subsequently suffered hypoglycemia (low blood glucose) requiring emergency administration of IV glucose. Findings include: Review of Patient #4’s medical records, indicated that he/she presented to the Hospital on 11/11/24 from and outside hospital (OSH) with stridor (noisy breathing that occurs to obstructed air flow through a narrow airway), bilateral choanal stenosis (a rare congenital condition where the nasal passages are blocked or narrowed), and failure to thrive. Patient #4 presented with difficulty feeding and poor weight gain, now nasogastric (NG) dependent (a patient who relies on NG tube for nutrition or medication delivery) for further investigation of his/her upper airway. Review of the Progress Note documented by the resident physician signed by the Attending Physician, dated 2/21/25 at 6:56 A.M., indicated that Patient #4 was planned for a peripherally inserted central catheter (PICC) placement, nasojejunal (NJ) tube (a device used to administer nutrition to a patient’s small intestine) placement due his/her to current NJ tube being dislodged and lumbar puncture (LP) in interventional radiology (IR) today. The note indicated the plan was to continue on intravenous (IV) fluids until the NJ tube was placed and feeds could be restarted. The note further indicated to assess Patient #4’s blood glucose every three hours while on IV fluids. Review of Patient #4’s Care Plan documentation from 2/20/25 at 11:53 A.M., indicated a blood glucose plan for hypoglycemia with a situational awareness critical contingency plan to include that if NJ tube is dislodged, tube must be replaced in fluoroscopy, if unable to immediately replace patient should receive dextrose containing IV fluids. Review of Patient #4’s medical record indicated that there was a physician order entered on 2/20/25 at 4:45 P.M., to monitor point of care (POC) glucose testing every three hours while the Patient was not receiving NJ feeds. Further instructions in the order indicated if the POC glucose is less than 55, notify provider and give D10 bolus as well as obtain critical hypoglycemia labs. Review of Patient #4’s medical record indicated that a blood glucose was checked on 2/21/25 at 11:05 A.M., resulting at 83. Review of the medial record indicated that a Basic Metabolic Panel (BMP) was completed while in IR at 2:00 P.M., with blood glucose resulting at 123. Review of the medical record indicated that IV fluids were discontinued by the Anesthesiologist in the PACU on 2/21/24 at 3:59 P.M. Review of the Nursing Note dated 2/21/25 at 7:55 P.M., indicated that Patient #4 returned from IR to the ICU at 6:30 P.M. The nursing note further indicated that upon returning to the unit Patient #4’s blood glucose was 39 necessitating a D10 bolus (IV administration of dextrose (glucose) solution). The nursing note indicated that the NJ tube was clamped with a plan for x-ray exam to verify the new NJ tube placement. During an Interview on 4/3/25 at 3:23 P.M., the Associate Chief, Division of Critical Care said that when a patient is in IR/Post Anesthesia Care Unit (PACU) care is temporarily transferred to Anesthesia who is responsible for what orders are implemented during this time. She said while a patient is in the PACU nursing staff should continue to monitor the patient as ordered unless changed by the Anesthesiologist. The Associate Chief, Division of Critical Care further indicated that the expectation was for nursing staff to continue checking Patient #4’s blood sugar as ordered while in the PACU. During an interview on 4/3/25 at 1:20 P.M., the Director, Clinical Regulatory Compliance and Patient Safety said a safety event report was submitted for review on Patient #4’s hypoglycemia event on 2/21/25. She said an investigation was completed and determined a lapse in communication between provider teams. She said fluid administration was discontinued by Anesthesiology in the PACU in preparation for transfer to the unit. She said that education was only disseminated to the provider teams due to lack of communication with the plan of care from the inpatient providers to the procedural providers in response to Patient #4 event. The Hospital failed to ensure POCT glucose testing was completed as ordered by the physician for Patient #4 while off NJ feeds while in IR/PACU, resulting in the Patient having a low blood glucose level of 39 after returning to the ICU.”

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 41143 Based on record review and interview, the Hospital failed to ensure a medication was administered in accordance with a practitioner order for one Patient (1) out of a total sample of 10 patients. Patient #1 was administered enoxaparin, an anticoagulant medication (a medication used to prevent blood clots), prior to a surgical bedside procedure against practitioner orders and the Patient experienced significant bleeding following the procedure. Review of the Hospital policy titled “Authorized Medication Administration Policy/Procedure”, dated 3/4/2025, indicated the following: -Clinicians are aware of desired therapeutic actions, proper dosages, contraindications, and side effects when administering medications. -Registered Nurses (RN) can reschedule missed or late medication doses based on individual patient needs, clinical indication, and patient schedule. -The licensed clinician with the authority to administer the medication verifies that no known contraindications exist prior to administration. -Prior to medication administration the administering clinician discusses any unresolved concerns about the medication with the prescriber and/or other staff involved in the patient’s care (if necessary). -General preparation: 1. Verify medication order on the electronic Medication Administration Record (eMAR). Review of the Hospital policy titled “Authorized Medication Prescribing Policy/Procedure”, dated 3/4/2025, indicated the following: -Any changes to written orders, including delaying an already ordered therapy (e.g., holding a medication until levels come back or until blood cultures are drawn), are documented in the electronic health record (EHR) and not accepted verbally. Patient #1 was transferred to the Hospital for admission on 12/3/24 from an outside hospital with a diagnosis of short bowel syndrome (a rare malabsorption disorder of the small intestine caused by damage or shortening). Review of Patient #1’s medical record indicated the Patient was admitted to the Hospital on 12/3/24 for management of short bowel syndrome related to bowel necrosis (tissue death) and for the management of ongoing intestinal failure. On 12/4/24, a gastrointestinal (GI) consult was requested by the general surgery service Nurse Practitioner (NP) for management of Patient #1’s short bowel syndrome and a hematology consult was requested for management of a non-occlusive thrombus (blood clot) in the Patient’s left lower extremity’s external iliac vein. The Hematology NP examined Patient #1 and recommended prophylactic anticoagulation with enoxaparin and to consult hematology regarding anticoagulation if the Patient required surgery or other invasive procedures. The GI service conducted a rectal suction biopsy (a procedure in which a small instrument is inserted into the rectum to obtain a small tissue sample) on Patient #1 at the bedside. Patient #1’s medical record indicated on 12/5/24 at 9:31 A.M. Patient #1 was ordered for enoxaparin 2.32mg (milligrams) subcutaneously every 12 hours with instructions to hold doses for 12 hours prior to any surgical procedure. On 12/6/24 at 8:31 A.M. the general surgery NP documented GI would repeat the rectal suction biopsy that day as the initial biopsy sample was too superficial. On 12/6/25 at 9:00 A.M. an order was entered into Patient #1’s EHR to obtain a rectum tissue sample and examination and was acknowledged by RN #2 at 9:14 A.M. On 12/6/24 at 9:59 A.M., it was documented by RN #2 that Patient #1 would have a repeat rectal biopsy that day. Written procedural consent for the rectal suction biopsy for Patient #1 was obtained from the Patient’s father on 12/6/24 at 10:18 A.M. RN #2 administered a 2.32 mg dose on 12/6/24 at 10:26 A.M. The biopsy tissue exam requisition indicated the biopsy tissue sample was collected on 12/6/24 at 11:00 A.M. On 12/6/24 at 2:30 P.M. Patient #1 was assessed by RN #2 to have blood clots in his/her stooling in his/her diaper, and GI was called for intervention. Patient #1’s hemoglobin dropped to 5.8 from 10.8 on 12/4/24 (normal range 9.6 - 13.2) and Patient #1 required the transfusion of packed red blood cells to treat his/her significant blood loss. During an interview with the lead General Surgery NP on 4/2/25 at 1:50 P.M., she said the rectal biopsy sample collected from Patient #1 on 12/4/24 did not contain enough cells for tissue examination. She said it was decided on 12/5/24 by GI to perform another rectal suction biopsy on Patient #1 on 12/6/24. She said typically when a bedside procedure is planned for a patient, the team performing the procedure will inform the attending service who will then notify the nursing staff. She said the GI team was unaware Patient #1 was ordered for enoxaparin prior to performing the rectal suction biopsy on 12/6/24. During an interview with the GI surgeon on 4/2/25 at 2:10 P.M., she said the rectal suction biopsy was performed on Patient #1 on 12/4/24 to evaluate for evidence of Hirschsprung’s Disease (a disease involving missing nerve cells in the muscles of the large intestine causing difficulty passing stool). She said the GI team was notified later in the day on 12/5/24 that the biopsy sample obtained from Patient #1 was insufficient and it was decided then to obtain a repeat rectal suction biopsy sample. She said she was not sure how the plan to perform a bedside procedure is communicated to the nursing staff working on the inpatient unit. She said the GI team (herself and a GI fellow) was bedside on the morning of 12/6/24 with RN #2. She said the GI team was unaware of Patient #1 being ordered for anticoagulation. She said consent was obtained for the procedure for Patient #1 and the GI team returned later to perform the rectal suction biopsy. She said after performing the procedure, Patient #1 was discovered to have bleeding, and her team was paged back to the unit for management of the Patient. During an interview with RN #1 on 4/3/25 at 7:30 A.M., She said she was the primary nurse for Patient #1 on the evening/night of 12/5/24. She said GI had not decided on her shift (12/5/24 7:00 P.M. - 7:00 A.M.) when the second rectal suction biopsy would be performed for Patient #1. She said nursing will receive messages when bedside procedures are planned for patients. She said typically surgical teams will round on patients during the morning. She said on the Hospital EHR and eMAR higher priority medications such as enoxaparin are flagged with a red color. She said in order to read additional instructions for a medication (such as a hold parameter) the RN administering the medication will need to access further into the eMAR in order to read the instructions. She said when using the Hospital’s mobile devices to access the eMAR, it is possible to miss any additional directions or instructions for medications. During an interview with RN #2 on 4/3/25 at 12:15 P.M., she said she took over Patient #1’s care on the morning of 12/6/24. She received in report from RN #1 that Patient #1 had started on enoxaparin and was unsure of when the rectal suction biopsy would be performed. She said at 9:00 A.M. on 12/6/24, she entered Patient #1’s room and the GI team was in the Patient’s room prepping for the biopsy; GI told RN #2 to not to give the enoxaparin until after the procedure was complete. She said GI had left Patient #1’s room, and after some time she was unsure if the procedure was going to happen and administered the enoxaparin to Patient #1. She said GI returned to the unit and was going to perform the rectal suction biopsy, a brief timeout was held bedside with GI and RN#2, but GI was unaware she had administered the enoxaparin to the Patient. She said following the rectal suction biopsy, she monitored Patient #1 for signs of bleeding, and when she observed rectal bleeding from the Patient, she notified GI. She said when medication orders have additional instructions (such as holding the medication prior to a procedure) they are not always visible on the Hospital’s eMAR mobile devices. The Hospital failed to ensure medication was administered as ordered for Patient #1, who was administered enoxaparin prior to a surgical bedside procedure against practitioner orders and the Patient experienced significant bleeding following the procedure.”