Childrens Hospital of Wisconsin

“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: 44431 Based on record review and interview the facility failed to follow physician order sets for the time of administration and monitor patients for at least 30 minutes following infusion for 2 (Pt. #1 and Pt. #4) of 5 patients receiving iron infusions and failed to obtain vital signs every 30 minutes during infusion for 3 (Pts. #1, #4, #6) of 5 patients receiving iron infusion in a total of 10 medical records reviewed. Findings: A review of the facility policy titled, “Screening, Assessment, Reassessment, and Documentation of a Patient,” effective date 06/02/2025 revealed, “Purpose: Every child and family are assured of receiving a defined level of comprehensive, quality care as specified by the core philosophies of patient care and nursing...Patient care staff performs assessments...within their scope of practice...Vital signs must be completed and documented at least as often as the frequency indicated in the provider order.” A review of Pt. #1’s medication treatment orders for iron therapy on 12/31/2025 revealed, “Vital Signs: Routine, every 30 minutes...VS prior to infusion. Changes in VS indicate an infusion reaction. If noted, stop infusion and follow appropriate protocol...Patient must remain in infusion area for at least 30 minutes after first 3 doses.” A review of Pt. #1’s iron infusion rate and dosage orders revealed they were to receive 300 mg (milligrams) in a 300 ML (milliliter) bag of (NS) (Normal Saline) IV...”For Anemia (low iron) (non-renal causes) (kidney): administer at a rate up to 3.3mg/min. or otherwise based on total dose...for doses >200mg to 300 mg administer over 90 minutes.” A review of Patient #1’s medical record revealed Patient #1 arrived on 12/31/2025 at 1:37 PM for her second iron infusion. Vital signs were documented at 1:37 PM and 2:18 PM. There was no evidence vital signs were completed every 30 minutes per physician order. The iron infusion was started at 1:55 PM and completed at 2:33 PM. The medication was infused over 38 minutes, not 90 minutes per physician order. Patient #1 was discharged at 2:33 PM. There was no evidence the patient was observed in the infusion area for at least 30 minutes following the completion of the medication. A review of Patient #4’s medication treatment orders for iron therapy revealed they were to receive 200 mL = 200 mg of iron of 1 mg/ml infused over 60 minutes. A review of Patient #4’s medical record revealed Patient #4 arrived on 12/31/2025 at 10:15 AM for an iron infusion. Vital signs were documented at 10:44 AM and at 11:58 AM. There was no evidence vital signs were completed every 30 minutes. The iron infusion was started at 10:44 AM and stopped at 11:09 AM due to an adverse reaction, restarted at 11:24 AM and completed at 12:10 PM. The medication was infused over 46 minutes, not 60 minutes per physician order. Patient #4 was discharged at 12:10 PM. There was no evidence the patient was observed in the infusion area for at least 30 minutes following the completion of the medication. A review of Patient #6’s medical record revealed Patient #6 arrived on 01/27/2026 at 2:02 PM for his second iron infusion. Vital signs were documented at 2:02 PM, 2:24 PM and 3:32 PM. There was no evidence vital signs were completed every 30 minutes per physician order. The iron infusion was started at 2:32 PM and completed at 3:06 PM. An interview was conducted with Supervisor D on 1/28/2026 at 10:45 AM. When asked if the expectation was that all patients receiving iron transfusions have vital signs assessed every 30 minutes, Supervisor D said, “Yes, it should be.” During interviews conducted with Infusion RNs F and G on 01/27/2026 from 12:20 PM to 1:00 PM both stated medication is given according to the individual therapy plan which identifies the rate, amount and route of administration. There is no written unit protocol for iron infusions. When asked how fast Iron can be given, all staff indicated it can be run as fast as in 15 minutes but they don’t run it that fast and give all iron infusions over 30 minutes unless it is the first dose and then it is run in over an hour. An interview was conducted with Infusion Manager C on 01/28/2026 at 8:30 AM who stated, “We found that RN’s were not regularly requiring the 30 minute waiting period after the infusion is complete.” Manager C stated the expectation is that vital signs will be taken every 30 minutes. “We also determined that there needs to be more clarification with order sets and possibly premedicating patients prior to the start of the iron infusion.””

“MEDICAL RECORD SERVICES CFR(s): 482.24(c)(1) All patient medical record entries must be legible, complete, dated, timed, and authenticated in written or electronic form by the person responsible for providing or evaluating the service provided, consistent with hospital policies and procedures. This Standard is not met as evidenced by: 44431 Based on observation, record Review and interview the facility failed to document pre and post procedure pain assessments for 7 (Patient #4, #5, #7, #8, #9, #10 and #11) Patients out of 11 Patient medical records reviewed. Findings: Review of Facility Policy effective date of 08/03/2022, titled, “Procedures - Patient Preparation and Assessment for Procedures,” revealed, “Assessing and relieving pain is the responsibility of all healthcare professionals (HCPs) caring for children. Procedures are to be considered biopsychosocial experiences for the child rather that simply tasks to be completed by a health care professional...effective comfort management during procedures depends on collaboration and planning between the child, the family , and various members of the health care team...Ambulatory: A plan must be in place for managing patient distress and comfort if the procedure is likely to produce pain and or anxiety....Patient will be screened for pain prior to and after procedure. If the patient’s pain or anxiety is not well controlled during the procedure, the procedure should be temporarily stopped (if safe) while the process is evaluated and the patient is given additional support (pharmacologic and/or non-pharmacologic)...Screen for Pain: Ambulatory:...RN (Registered Nurse) will screen for pain prior to the procedure...During the procedure:....Evaluate tolerance/acceptability of procedure: Pause if the patient is not tolerating the procedure well--HCPs are expected to stop/pause the procedure (as appropriate) in order to advocate for the patient....signs the things may not be going as well as possible...needing to restrain the child as opposed to supporting the child,..a crying child...After the Procedure: Screen for pain following the procedure and document result....if pain screen is positive, perform a pain assessment and provide interventions as appropriate...if the patient is unable to tolerate procedure without significant distress or there is concern for their safety, it may be appropriate to defer the procedure or adjust the level of sedation.” Review of Facility Policy effective date of 07/13/2022, titled, “Assessment, Reassessment, Documentation of a Patient,” revealed, “Patient care staff performs assessments and completes documentation for all patients who receive care and treatment...Information is documented as soon as possible after assessment/intervention/evaluation of the patient...Patient Assessment and Required Documentation: Intial data will be gathered at the point of entry into the [Facility] system...The purpose of completing the initial assessment is to....identify the patient’s immediate and emerging needs relative to physiological status including pain...Determine the care the patient requires.” On 11/13/2024 from 8:00 AM -10:20 AM during Medical Record Review with Imaging Manager E, pre or post procedure pain assessments were not completed for Pt’s #4, #5, #7, #8, #9, and #10 who had all received G/J (Gastrostomy/Jejunostomy) (tube placed in the stomach or intestines) tube replacements and no pre or post procedure pain assessment was completed for Pt. #11 who had received bilateral knee injections for rheumatoid arthritis. In an interview on 11/13/2024 at 1:27 PM Manager E stated, “No pain was assessed and it should have been. Our normal practice is to do a pain assessment with a set of vitals.””