Children’s Hospital of Orange County

“PATIENT RIGHTS: CONFIDENTIALITY OF RECORDS CFR(s): 482.13(d)(1) The patient has the right to the confidentiality of his or her clinical records. This Standard is not met as evidenced by: 36703 Based on observation and interview, the hospital failed to ensure the confidentiality and security of patient medical records when an unattended workstation in the ED remained open in a high traffic area. This failure created the potential for unauthorized access to protected health information. Findings: Review of the hospital’s P&P titled Patient Rights and Responsibilities dated 2/12/25, showed the hospital will ensure the patient’s privacy and confidentiality. On 8/14/26 at 0940 hours, a tour of the PICU hallway in front of Patient 5’s room was conducted with the Senior Critical Care Manager, the Assistant Manager Critical Care and the Regulatory Affairs Coordinator 1. A workstation computer was open with sensitive patient information while being unattended by staff. The mobile workstation was located in the hallway with high traffic flow of staff and patients. The Senior Critical Care Manager, the Assistant Manager Critical Care, and the Regulatory Affairs Coordinator 1 acknowledged the findings.”

“BLOOD TRANSFUSIONS AND IV MEDICATIONS CFR(s): Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure the nursing staff performed the blood transfusion for one of five sampled patients (Patient 2) as per the hospital’s P&P as evidenced by: 1. The temperature was not monitored as part of VS during the blood transfusion for Patient 2 as per the hospital’s P&P. 2. Blood transfusion was completed within 2 hours for Patient 2 when P&P showed to transfuse over 2 to 3 hours. 3. There was no documented blood transfusion rate for first 15 minutes per hospital’s P&P. These failures posed the risk for potential complications, including undetected changes in the patient’s condition, delayed interventions, and overall compromised patient safety during the blood transfusion process. Findings: Review of the hospital’s P&P titled Blood Products: Obtaining Consent and Administration dated 5/2025, showed the following: * Vital signs (VS) [temperature, heart rate, respiratory rate, and blood pressure] are obtained and documented in iView within the 30 minutes prior to initiating transfusion, 15 minutes after initiation, hourly during transfusion, and at completion of transfusion. * Refer to Appendix B: Administering Blood Products for dose, rate, and filter options. * Appendix B Administering Blood Products. For RBC, to transfuse each unit two to three hours. May be transfused more rapidly in case of emergency. * It is recommended that routine, non-emergent transfusions be started slowly and under close observation. For example, for the first 15 minutes started at 50 % of the desired rate and then increase to the desired rate. On 8/14/26, Patient 2’s open medical record was reviewed. Patient 2’s medical record showed Patient 2 was admitted to the hospital on 5/9/26. 1. Review of the Orders dated 8/13/26 at 0930 hours, showed to transfuse one unit of red blood cell. Review of Transfusion Report Form dated 8/13/26, showed the blood transfusion was started at 1054 hours and ended at 1230 hours. Review of the VS dated 8/13/26, showed the following: * At 1050 hours, Patient 2’s VS was measured including temperature. * At 1100 hours, Patient 2’s VS was measured without temperature. * At 1115 hours, Patient 2’s VS was measured including temperature. * At 1215 hours, Patient 2’s VS was measured without temperature. * At 1230 hours, Patient 2’s VS was measured including temperature. 2. Review of the Orders dated 8/13/26 at 0930 hours, showed to transfuse one unit of red blood cell as routine. Review of Transfusion Report Form dated 8/18/26, showed the blood transfusion was started at 1054 hours and ended at 1230 hours (for one hour and 36 minutes). During an interview and record review with CNS 3 on 8/14/26 at 1302 hours, CNS 3 stated the blood transfusion was ordered as routine not emergency. 3. Review of the Blood Product Transfusions dated 8/13/26 at 1230 hours, showed 300 ml of red blood cell was administered. However, further medical record review failed to show the blood transfusion rate for first 15 minutes and after that. During an interview and record review with CNS 3 on 8/14/26 at 1302 hours, CNS 3 verified the above findings.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 37663 Based on interview and record review, the hospital failed to ensure the PA had the privilege to order a blood transfusion for one of 13 sampled patients (Patient 5). This failure posed an increased risk of substandard health outcomes for the patient. Findings: On 4/6/26 at 1121 hours, an interview and record review for Patient 5 was conducted with CNS 1 in the presence of the Director of Regulatory Affairs and Regulatory Affairs Coordinator 2. Patient 5’s medical record showed Patient 5’s was admitted to the hospital on 3/26/26. Review of Patient 5’s medical record showed on 4/2/26 at 0200 hours, the PA ordered to transfuse 8 ml of RBC STAT for anemia or symptoms of anemia. CNS 1 was asked about Patient 5’s anemia and related symptoms. CNS 1 stated that, according to the PA’s note, the indication for the blood transfusion was the admission H/H levels from 3/26/26, which were 13.7 and 38.6 gm/dL; on 4/1/26, the H/H level had decreased to 11.7 and 33.6 gm/dL. CNS 1 and the Director of Regulatory Affairs were asked if the PA was permitted to order a blood transfusion under the hospital’s Medical Rules and Regulation. Director of Regulatory Affairs stated that they would look into it. Review of the hospital’s Medical Staff Rules and Regulations dated October 2021, showed AHP (Allied Health Professional) categories to apply for privileges or services as approved by the Medical Executive Committee and the Board of Directors...Dependent AHP (Provides services under approved job description and under the supervision and direction of a Medical Staff Member): include Physician Assistant ... On 4/6/26 at 1632 hours, an interview and record review was conducted with the Director of Medical Staff in the presence of the Director of Regulatory Affairs and Regulatory Affairs Coordinator 2. The Director of Medical Staff stated and confirmed that the PA did not have the privilege to order a blood transfusion.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(10) The condition of the patient who is restrained or secluded must be monitored by a physician, other licensed practitioner or trained staff that have completed the training criteria specified in paragraph (f) of this section at an interval determined by hospital policy. This Standard is not met as evidenced by: 29558 Based on interview and record review, the hospital failed to follow the hospital’s P&P for monitoring one of 13 sampled patients (Patient 2) while Patient 2 was in violent restraints. This failure posed an increased risk of substandard health outcomes for the patient. Findings: Review of the hospital’s P&P titled Restraints and Seclusion dated 2/27/2026, showed the purpose is to ensure the use of restraint and seclusion is safe, appropriate and applied after least restrictive interventions have been attempted...Violent restraints are the application of restraints where a patient exhibits violent or self-destructive behaviors jeopardizing the immediate physical safety of the patient, staff or others...A manual hold is applied during emergencies to prevent injury to the patient or others...An example of violent restraints are tough cuffs which are applied to the wrists...Patient Observation for Violent restraints and Seclusion...Patient must be under increased observation. Document increased observation every 15 minutes or more frequently, including respiratory status, CMS (Circulation, Motion, Sensation) of extremities, psychological status and any signs of injury. On 4/3/26 at 1315 hours, a review of Patient 2’s medical record was initiated. Patient 2’s medical record showed the patient was admitted to hospital on 4/1/26. Review of Patient 2’s nurse restraint note dated 4/2/26 at 1214 hours, showed attempted to de-escalate Patient 2 who stated was going to leave. Patient 2 removed IV by self, attempted elopement. Security called and Patient 2 began swinging and kicking. A manual hold was implemented. Review of the doctor’s orders dated 4/2/26 at 1207 hours, showed an order for violent restraints 9-17 years for Patient 2 with a stop time of 1406 hours on 4/2/26. Review of the orders also showed the following: Reason: harm to others, Harm to self, type of violent restraint Tough cuff, applied to Right Upper Extremity (RUE) and Left Upper Extremity (LUE). Review of the doctor’s orders dated 4/2/26 at 1400 hours, showed a renewal order for violent restraints 9-17 years for Patient 2 with a stop time of 1559 hours on 4/2/26. Review of the orders also showed the following: Reason: harm to others, Harm to self, type of violent restraint Tough cuff, applied to Right Upper Extremity (RUE) and Left Upper Extremity (LUE). Review of Patient 2’s every 15 minutes Restraint monitoring dated 4/2/26 showed the following: * At 1229 hours, Patient behavior, circulation, motion, sensation, fit and safety was documented as assessed for Patient 2 while in violent restraints. * At 1244 hours, Patient behavior, circulation, motion, sensation, fit and safety was documented as assessed for Patient 2 while in violent restraints. * At 1259 hours, Patient behavior, circulation, motion, sensation, fit and safety was documented as assessed for Patient 2 while in violent restraints. * At 1300 hours, Patient behavior, circulation, motion, sensation, fit and safety was documented as assessed for Patient 2 while in violent restraints. * At 1314 hours, Patient behavior, circulation, motion, sensation, fit and safety was documented as assessed for Patient 2 while in violent restraints. Patient 2 remained in violent restraints until documented as removed on 4/2/26 at 1540 hours. After 1314 hours, no additional every 15-minute restraining monitoring assessments were documented. On 4/3/26 at 1315 hours, an interview and concurrent record review was conducted with the Clinical Practice Specialist in Mental Health (CNS 2). CNS 2 reviewed the P&P titled Restraints and Seclusion and verified it was applicable to Patient 2’s care. CNS 2 stated the expectation was for the staff nurses to follow the policy monitoring patients in violent restraints. CNS 2 verified according to the policy, patient was to be assessed every 15 minutes and then expected to be documented in these assessments in the patient’s electronic health record (EHR). CNS 2 reviewed the doctor’s orders dated 4/2/26 at 1207 hours and verified Patient 2 had an order for violent restraints 9-17 years for Patient 2 with a stop time of 1406 hours on 4/2/26. CNS 2 reviewed the doctor’s orders dated 4/2/26 at 1400 hours and verified Patient 2 had a renewal order for violent restraints 9-17 years for Patient 2 with a stop time of 1559 hours on 4/2/26. CNS 2 reviewed Patient 2’s every 15-minute restraint monitoring dated 4/2/26 for the hours of 1229, 1244, 1259, 1300 and 1314. CNS 2 stated the purpose of monitoring Patient 2 in violent restraints was to watch the patient’s behaviors and assess whether the restraints were still necessary. CNS 2 stated violent restraints could be dangerous, and assessing a patient every 15 minutes helps maintain a patient’s safety. CNS 2 stated patients should only be in violent restraints for least amount of time and removed as quickly as possible. CNS 2 stated the monitoring was expected to be charted in the Patient 2’s medical record by the nursing and mental health staff. CNS 2 verified on 4/2/26 after 1314 hours, no additional every 15-minute restraining monitoring assessments were documented in Patient 2’s medical record. On 4/3/26 at 1700 hours, the Director of Regulatory Affairs was made aware of these findings.”

“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: 37548 Based on interview and record review, the hospital failed to follow their P&P and the physician’s order for one of 13 sampled patients (Patient 1) regarding accurate intake and output monitoring and documentation in the electronic health record. This failure had the potential to negatively impact Patient 1’s clinical management and overall safety. Findings: Review of the hospital’s P&P Intake and Output Assessment dated 4/26/2025, showed the purpose is to guide nursing in measuring and recording intake and output. Input is defined as fluid or solids taken into the body and Output substances that leave the body. Procedure: Measure and document all intake and output throughout and at the end of each shift. Measure and document the enteral intake (via mouth or tube) of all meals by documenting the percentage of intake consumed. On 4/1/26 at 1320 hours, a review of Patient 1’s medical record was initiated. Patient 1’s medical record showed the patient was admitted to hospital on 2/22/26. A review of Patient 1’s H&P dated 2/22/26, showed the patient was admitted for chronic intractable non-bloody (NBNB) emesis, abdominal pain and a 5-pound weight loss in 2 weeks. Review of Patient 1’s physician’s orders dated 2/22/26 at 1129 hours, showed an order for accurate intake and output (I&O). Review of the Nutrition/Diet intake showed the following: - On 2/23/26 from 0000-2359 hours, Patient 1 was documented diet for age and as Nothing Per Orifice (NPO) for feeding method. - On 2/24/26 from 0000-2359 hours, Patient 1 was documented diet for age and as Per Orifice (PO) for feeding method. No percentage of the meal eaten (by po) was documented for breakfast or lunch. 75 percent of the diet (meal eaten by po) was documented for dinner. - On 2/25/26 from 0000-2359 hours, Patient 1 was documented diet for age and as Per Orifice for feeding method. No percentage of the diet (meal eaten by po) was documented for breakfast, lunch or dinner. - On 2/26/26 from 0000-2359 hours, Patient 1 was documented diet for age and as Per Orifice for feeding method. No percentage of the diet (meal eaten by po) was documented for breakfast, lunch or dinner. - On 2/27/26 from 0000-2359 hours, Patient 1 was documented diet for age and as Per Orifice for feeding method. No percentage of the diet (meal eaten by po) was documented for breakfast, lunch or dinner. - On 2/28/26 from 0000-2359 hours, Patient 1 was documented diet for age and as Nothing Per Orifice for feeding method. - On 3/1/26 from 0000-2359 hours, Patient 1 was documented diet for age and as Per Orifice for feeding method. No percentage of the diet (meal eaten by po) was documented for breakfast, lunch or dinner. - On 3/2/26 from 0000-2359 hours, Patient 1 was documented diet for age and as Nothing Per Orifice for feeding method. Review of Patient 1’s diet orders showed the following: - On 2/22/26, NPO to start on 2/22/26 2331 hours - On 2/23/26. Diet for Age (Regular) on 2/23/26 1225 hours - On 2/26/26 at 0651 hours, a future NPO order was written to start after midnight (beginning on 0001 hours of 2/27/26) - On 2/27/26 at 2000 hours a future NPO order was written to start after midnight (beginning on 0001 hours of 2/28/26) - On 3/1/26 at 1310 hours, a future NPO order was written to start after midnight (beginning on 0001 hours of 3/2/26) On 4/2/26 at 1455 hours, an interview was conducted with RD 1. RD 1 stated the purpose of documenting intake and output was to assess patient’s nutritional status. RD 1 stated Dietitians reviewed the nursing meal intake documentation and meal percentages to formulate their nutritional recommendations and interventions for patients. RD 1 stated RD 1 was familiar with Patient 1. RD 1 did verify Patient 1 had reported a 5-pound weight loss in 2 weeks. RD 1 stated that RD 1 saw Patient 1 for the ordered nutritional consultation. RD 1 stated RD 1 assessed Patient 1’s nutritional status and made recommendations for interventions. On 4/2/26 at 1400 hours, an interview and concurrent record review was conducted with the Clinical Practice Specialist in Mental Health. The Clinical Practice Specialist in Mental Health reviewed Patient 1’s physician’s orders dated 2/22/26 at 1129 hours and verified Patient 1 had an order for accurate intake and output (I&O). The Clinical Practice Specialist in Mental Health reviewed and verified Patient 1’s had NPO orders for 2/22/26, 2/27/26, 2/28/26 and 3/2/26. The Clinical Practice Specialist in Mental Health reviewed Patient 1’s Nutrition/Diet intake flowsheet for the meals of breakfast, lunch and dinner from dates 2/22/26 through 3/2/26. The Clinical Practice Specialist in Mental Health also reviewed the P&P titled Intake and Output Assessment and verified it was applicable to Patient 1’s care. The Clinical Practice Specialist in Mental Health stated the expectation was for the staff nurses to follow the policy for measuring and recording a patient’s intake and output. The Clinical Practice Specialist in Mental Health verified according to the policy, Patients were to have their intake, which included food (po) intake, assessed and recorded as a percentage of the meal eaten for each meals. Those meals included Breakfast, Lunch and Dinner. All three should have a percentage documented. The nursing staff was expected to document those intake assessments in the patient’s electronic health record (EHR). The Clinical Practice Specialist in Mental Health stated the expectation was for the staff to also document if the patient was NPO per order at the time. The Clinical Practice Specialist in Mental Health acknowledged an order by the physician for those intake and output assessment to be completed accurately. The Clinical Practice Specialist in Mental Health stated accurately meant no blanks and if NPO, then the documentation should reflect that order. The Clinical Practice Specialist in Mental Health verified no dietary intake percentages were recorded on the following: - On 2/24/26 from 0000-2359 hours, no percentage of the meal eaten by Patient 1 was documented for breakfast or lunch. - On 2/25/26 from 0000-2359 hours, no percentage of the meal eaten by Patient 1 was documented for breakfast, lunch or dinner. - On 2/26/26 from 0000-2359 hours, no percentage of the meal eaten by Patient 1 was documented for breakfast, lunch or dinner. The Clinical Practice Specialist in Mental Health stated the nursing staff should have assessed and documented the percentage of intake for those dates or document Patient 1’s refusal to eat. On 4/3/26 at 1700 hours, the Director of Regulatory Affairs was made aware of these findings.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 37663 Based on observation, interview, and record review, the hospital failed to ensure that nursing staff performed hand hygiene between JT and IV medication administration for one of 13 sampled patients (Patient 6). This failure increased the risk of potential complications, including central line associated infections. Findings: Review of the hospital’s P&P titled Hand Hygiene dated 3/22/26, showed hand washing is the single most effective means of preventing the spread of infection...Healthcare personnel must use careful hand hygiene technique to protect themselves as well as the patients. Hand hygiene should be performed after touching blood, body fluids, secretions, excretions, contaminated items or surfaces whether gloves are worn or not. Hand hygiene should be performed between tasks and procedures on the same patient to prevent cross contamination of body sites. On 4/2/26 at 1040 hours, RN 3 was observed donning PPE and administering medication to Patient 6, who was on MRSA isolation precautions. Patient 6 was observed in a crib with eyes closed, with a tracheostomy connected to a mechanical ventilator, tube feeding infusing and an IV fluid running. During medication administration, RN 3 reviewed Patient 6’s e-MAR for simethicone (a medication used to manage flatulence) to be administered via JT, and lorazepam (an anti-anxiety medication) to be administered intravenously through a central line. RN 3 was observed administering simethicone through the JT using a syringe, and then proceeded to administer lorazepam IV using a separate syringe through the IV pump, while wearing the same pair of gloves. RN 3 did not perform hand hygiene or change gloves prior to administering the IV lorazepam. Following the observation, RN 3 was interviewed and stated that hand hygiene and glove changes were not necessary. On 4/2/26 at 1055 hours, during an interview conducted with CNS 3 and the Senior Critical Care Manager, in the presence of the Director of Regulatory Affairs, CNS 3 stated that the RN should perform hand hygiene and change gloves between JT and IV medication administration. The findings were shared with CNS 3, the Senior Critical Care Manager, and the Director of Regulatory Affairs.”

“ADEQUATE RESPIRATORY CARE STAFFING CFR(s): 482.57(a)(2) There must be adequate numbers of respiratory therapists, respiratory therapy technicians, and other personnel who meet the qualifications specified by the medical staff, consistent with State law. This Standard is not met as evidenced by: 37663 Based on interview and record review, the hospital failed to ensure adequate numbers of qualified RTs and other personnel during the night shift of 6/14/25, according to the Respiratory Therapyst’s Staffing Plan. This failure had the potential to compromise the patient care and treatment, Findings: On 7/8/25 at 1304 hours, an interview was conducted with the Director of Regulatory Affairs, Director Respiratory Services, and Manager 3. Manager 3 stated on 6/14/25, for the night shift (7 pm to 7 am), they had 26 RTs scheduled. Two hours prior to the start of the shift, six RTs called in sick. The backup plan for the needed RTs for 12-hour night shift was to ask for the day shift RT staff for volunteers to stay over for four hours and utilize the RTs who were scheduled but did not take patients, including two off-unit resources, two breakers, and the RTs assigned to L&D unit who were reassigned to the NICU with workload instead. The NICU CRCP was assigned to deliveries (L&D 1) and assisted in two deliveries before 0130 hours. The night RCP Educator worked that night to take over the PICU/CVICU Charge. The RCP Team Lead was the house supervisor of the hospital’s RT. Review of the NOC Shift Assignment Sheet dated 6/14/25, was conducted with the Director of Regulatory Affairs, Manager 3, and the Director of Respiratory Services. The NOC Shift Assignment showed a Team Lead; Breaker 1 and 2, Resource, and L&D 1 were blank. The Director of Respiratory Services and Manager 3 stated two RTs stayed over from the day shift (7am to 7pm) to work four hours for the night shift. One RT left at 2340 hours, on 6/14/25, and one RT left at 0216 hours on 6/15/25. The RCP Educator was the CRCP of the PICU/CVICU and left at 0300 hours, on 6/15/25. The NICU CRCP took over the patient assignment for one RT and also had L&D 1. The Team Lead took over the CRCP of NICU and the PICU/CVICU. The Director of Respiratory Services and Manager 3 were unable to answer who took the other RT’s workload assignment. Review of the L&D deliveries for the night shift of 6/14/25, showed one delivery at 2242 hours and another at 0109 hours. Manager 3 and the Director of Respiratory Services stated another RT covered the patients assigned to L&D 1 in the NICU while L&D 1 attended the deliveries. They could not provide documentation on the RT assignment sheet showing patient coverage for L&D 1 during the deliveries. Manager 3 and the Director of Respiratory Services confirmed that the Team Lead (RT House Supervisor) took on the role of CRCP for both the NICU and PICU/CVICU. They stated they dissolved some of the patient workload by 2300 hours and distributed the patients to other RTs after the second RT left at midnight. They could not provide documented evidence of the RT’s patient assignment after the second RT left. Review of the Hospital’s Plan for the Delivery of Care (Scope of Services) Patient care Department: Respiratory and Pulmonary Services, undated, showed the Respiratory Services uses an acuity-based model of staffing levels and measured productivity. RVUs based on validated procedural time standards are used for all areas as a monitor to schedule an adequate number of therapists for the ordered workload. Staffing is adjusted throughout the shift to meet changes in the acuity and census of the units. Respiratory Services has a staffing standards of RCPs, a Unit Charge RCP per assigned unit, and a House or relief Lead RCP. Patient assignments are based on an acuity system. One RVU equals 10 minutes. Each procedure is time weighted toprovide appropriate time management for the assigned practitioners. This provides the RCP with time enough to validate the order, deliver the treatment, per or post patient assessment, and document. This allows for fleile staffing response which adjusts to changes in the number of procedures or acuity of the patients. RVU Staffing Guideline: The Respiratory Services Staffing Guideline is a guide for staffing and workload decisions, in alignment with staffing regulations and recommendations. In response to changes in acuity, volume, or another system challenges, Respiratory Care leaders may utilize discretion and judgement when adjusting staffing decision outside of these guidelines. - Based on the total number of RVUs. - Average workload is 60 RVUs per RCP. - Unit Charge should be assigned 18 to 24 RVUs as necessary. - ED RCP staffing is adjusted based on the ED patient volumes. Staffing Guidelines for Inpatient Units: - 1 RCP: 40 to 45 RVUs - 1 RCP + 1 UL (Unit Lead): Less than 84 RVUs - 2 RCPs + 1 UL: 85 to 144 RVUs - 3 RCPs + 1 UL: 145 to 204 RVUs - 4 RCPs + 1 UL: 205 to 264 RVUs - 5 RCPs + 1 UL: 265 to 324 RVUs - 6 RCPs + 1 UL: 325 to 384 RVUs Contingency Plan: - Refer to the P&P when demand for services exceeds the supply of RCPs. Review of the RCP and RVUs on 6/14/25, for the Night Shift: - Total for NICU (4 South and Small Baby units): 392 RVUs (3920 minutes). - RT A: 64 RVUs (640 minutes) - RT B: 60 RVUs (600 minutes) - RT C: 75 RVUs (750 minutes) - RT D: 61 RVUs (610 minutes) - RT E: 59 RVUs (590 minutes) - RT F: 64 RVUs (640 minutes) - RT Lead: 16 RVUs (160 minutes) The Director of Respiratory Services and Manager 3 discussed the assigned RVUs of the RCPs in the NICU. The Director of Respiratory Services stated the RVU was the calculated time RT spent with the patient, including the number of treatments, patient care assignments, and workload. The target goal average would be 600 minutes (60 RVU) per shift. The workload dropped after 2300 hours, for example, the BID treatments. The Director of Respiratory Services and Manager 3 could not show the patient reassignment and recalculation of the RVU after 2300 hours for the NICU to show the workload had dropped to less than 392 RVU. On 7/9/25 at 1300 hours, an interview and record reviews were conducted with the Director of Respiratory Services, RT Educator, and the Director of Regulatory Affairs. The Director of Respiratory Services stated they were not short of staff, she was not called, and they did not need to use the Contingency Plan. There were no free L&Ds 1 and 2, the RTs assigned to the L&D did not have deliveries after 0130 hours. The RTs had a good team, they worked together, other RTs would cover if the L&D RTs were called for deliveries. On 7/9/25 at 1700 hours, a telephone interview was conducted with the RCP Team Lead. The RCP Team Lead stated they were able to recruit the RTs from the day shift. The Team Lead stated the day shift Team Lead should notify the manager for the night shift staffing. For the RT staffing after the recruited RTs and the RT Educator left after midnight, the Team Lead stated he took over the NICU and PICU/CVICU Charge RCP and acted as a resource; the PICU was also busy, he helped with the critical patient, transported the patient to CT scan, and figured out the staffing for the next shift. They were able to dissolve tasks for the one RT workload and were able to distribute the patients when the RTs left. For where it would show what tasks were dissolved and the patient reassignment, the Team Lead stated the Unit Lead would track who would get the patient; and the tracking was not recorded and was discarded at the end of the shift. The Team Lead stated the RT staffing was short when the RTs left and he used the contingency plan. On 7/10/25 at 1130 hours, a review of the PICU/CVICU’s RVUs for 6/14/25 at 1951 hours, was conducted with Manager 3. The total RVUs were 481 (over 97 RVUs). Manager 3 stated the RVUs were recalculated after 2300 hours (over 80 RVUs), but the recalculation was undated and lacked a specific time. The RT and RVUs were as follows: - RT G: 66 RVUs (660 minutes); 58 RVUs (580 minutes) - RT H: 74 RVUs (740 minutes); 66 RVUs (660 minutes) - RT I: 70 RVUs (700 minutes); 69 RVUs (690 minutes) - RT J: 68 RVUs (680 minutes); 68 RVUs (680 minutes) - RT K: 68 RVUs (680 minutes) - RT L: 66 RVUs (660 minutes) - RT AM: 69 RVUs (690 minutes) Manager 3 verified the total RVU for PICU/CVICU was 481 (over 97 RVUs) at 1951 hours. The recalculated RVU was 464 (over 80 RVUs). On 7/10/25 at 0908 hours, the RCP staffing concern was shared with the Director of Regulatory Affairs and Manager 3. The RT Educator left at 0200 hours.”

“RESPIRATORY SERVICES CFR(s): 482.57(b)(4) All respiratory care services orders must be documented in the patient’s medical record in accordance with the requirements at §482.24. This Standard is not met as evidenced by: 37663 Based on interview and record review the hospital failed to ensure the patient’s medical record for intubation procedures were completed for three of eight sampled patients (Patients 2, 3 and 4). This posed an increased risk of substandard healthcare outcomes to the patients. Findings: Review of the hospital’s Medical Staff Rules and Regulations dated 10/2021 showed the following: Responsibility for the Record: The patient’s Attending Practitioner and each practitioner involved in the care of the patient shall be responsible for preparing a complete and legible medical record for each patient. Progress Note: The date and time of the Progress Note shall be entered by the Attending Physician who is familiar with the patient, and more often when warranted by the patient’s condition, when there is a significant change in the patient’s status, or following a procedure performed by the physician. This is in addition to any progress notes written by the residents. The Progress Note should provide a chronological picture of the patient’s progress and be sufficient to permit continuity of care and transferability. The Progress Note should delineate the course and results of the treatment. 1. On 7/8/25 at 1534 hours, Patient 2’s medical record was reviewed with the Director of Regulatory Affairs, Director of Respiratory Services, and Manager 3. Patient 2’s medical record showed Patient 2 was admitted to the hospital on 3/3/25, for cardiology and pulmonary consultation. Review of the RT’s documentation dated 6/15/25 at 0009 hours, showed the RT assisted the physician with ETT intubation, and Patient 2 was orally intubated. Review of the NICU Progress Notes for Patient 2’s ETT Intubation Procedure did not show the Procedure Note for the Endotracheal Intubation performed on 6/15/25 at 0009 hours. Review of the NICU Progress Note dated 6/15/25 at 0926 hours, prepared by Physician 1, showed the following: - Respiratory support: ventilation from 6/15/25, FIO2 0.5 to 0.6, RR 35, PIP 24 cm H2O, Peep 8 cm H2O, PS 10 cm H2O, Mode: SIMV. - Current Problems and Diagnosis: Respiratory failure on 6/15/25 at 2350 hours, ETT intubation, the patient was intubated for respiratory failure with 3.5 ETT on the 4th attempt. - Confirmed with pedicap, good O2 saturation level, and pending chest x-ray. - Plans: Intubated on 6/15/25, due to increased breathing work (IWOB) and FIO2 requirement. Currently on SIMV/PS 24/8, PS 10, x 35, FIO2 50-60%. Review of the previous ETT Intubation Note for Patient 2 dated 6/6/25 at 1541 hours, showed the following sections were not completed: - Indication - Consent - Premedication: list of medication names (physician’s preference), see MAR for doses and sequence. - Procedure: after preoxygenation, cords were visualized by laryngoscopy, type of blade used, type of ETT (cuffed/uncuffed) used, route (oral or nasal). - Confirmation of placement: list of types/ways ETT placement confirmation. - Complications - Name of the physician who performed the procedure, time & date. The Director of Regulatory Affairs was asked to show the Procedure Note for Patient 2’s ETT intubation details on 6/15/25 at 0009 hours, when the physician attempted 4 times before the patient was intubated and sedation used if it was needed. The Director of Regulatory Affairs could not show documentation of Patient 2’s ETT intubation Procedure Note on 6/15/25 at 0009 hours. The Director of Respiratory added to look at the MAR to find the medication used for sedation. 2. On 7/8/25 at 1540 hours, Patient 3’s medical record was reviewed with the Director of Regulatory Affairs, Manager 3 and the Director of Respiratory Services. Patient 3 was admitted to the hospital’s NICU on 6/14/25 at 1909 hours, and was intubated at 2113 hours. On 7/9/25 at 1308 hours, review of Patient 3’s medical record was conducted with the RCP Educator, Director of Regulatory Affairs, and the Director of Respiratory Services. Patient 3 was placed on CPAP at Hospital B’s L&D and was intubated on 6/14/25 at the hospital’s NICU by a neonatologist. Review of Patient 3’s H&P examination created on 6/15/25 at 0106 hours, showed the following: Patient 3 was admitted immediately following delivery at Hospital B for prematurity and respiratory failure. Current problems and diagnoses: Respiratory failure less than 28 days old. Onset date was 6/14/25. Respiratory support in the delivery room consisted of PPV (Positive Pressure Ventilation) and CPAP (Continuous Positive Airway Pressure) + 6. Admitted to the NICU on CPAP + 6, FIO2 30%. The infant was intubated, and after intubation, the FIO2 improved from 40% to 21%. The RCP Educator stated he could not find the Procedure Note for Patient 3’s ETT intubation for 6/14/25. 3. On 7/8/25 at 1535 hours, Patient 4’s medical record was reviewed with the Director of Regulatory Affairs, Manager 3 and the Director of Respiratory Services. Patient 4 was admitted to the hospital’s NICU on 6/14/25 at 1908 hours. Patient 4 was intubated at 2148 hours. Patient 4 was placed on CPAP at Hospital B’s L&D and was orally intubated on 6/14/25, at the hospital’s NICU by a neonatologist. Review of Patient 4’s H&P examination created on 6/15/25 at 0126 hours, showed under the section of Birth, the baby was transferred to the Hospital’s NICU, on CPAP, immediately following the delivery, on ventilator support. The section for Current Problems and diagnosis showed Respiratory failure less than 28 days old. Onset day was 6/14/25. Under the comments section showed respiratory support in delivery room consisting of PPV (Positive Pressure Ventilation) and CPAP (Continuous Positive Airway Pressure) + 6. Due to increased FIO2 requirement, the infant was intubated and given surfactant ... Plan: Intubate for surfactant administration and increase CO2. Continue SIMV wean as tolerated. The RCP Educator stated the intubation documentation was in the progress note, it was an emergent intubation. On 7/9/25 at 1315 hours a telephone interview was conducted with the NICU Medical Director, Director of Regulatory Affairs and Manager 3. The NICU Medical Director stated the Procedure Note should be documented on the patient’s Electronic Medical Record. The documentation would be exported as a separate procedural note, sometimes when exported would glitch to the progress note. The procedure was documented on the procedure note or the neonatal. It showed a Procedure Note as the heading. Complication, number of attempts, and abnormal findings should be detailed in the documentation. The Attending physician or the Fellow could intubate the patient. The findings were shared with the Director of Regulatory Affairs, RCP Educator, and the Director of Respiratory Services.”

“PATIENT CARE ASSIGNMENTS CFR(s): 482.23(b)(5) A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient’s needs and the specialized qualifications and competence of the nursing staff available. This Standard is not met as evidenced by: 37663 Based on interview and record review, the hospital failed to ensure one RN who floated to NICU met the basic requirements for the NICU RN. This failure posed the increased risk of substandard health outcomes to the patients cared for in the NICU. Findings: Review of the Hospital Plan for the Delivery of Care (Scope of Service) Department/Unit Plan dated 10/26/23, showed the Patient Care Department is the Neonatal Intensive Care Unit. The section of Scope of Service showed the ages of patients are the high-risk infants whose medical and/or nursing needs exceed the care given in a newborn nursery or acute care unit that have been continuously cared for in another nursery, NICU, or from home may be admitted into the hospital’s NICU. The section of Qualifications of Staff showed the Registered Nurse is to oversee and participate in the successful delivery of quality patient care to the NICU patient by assessing, planning, implementing, and evaluating patient care. The RNs are NRP and PALS certified and perform all duties within the scope of licensure utilizing the nursing process. On 12/4/24 at 1300 hours, review of NICU NOC (4 South) Patient Assignment Night Shift 7 pm to 7:30 am was conducted with the Director of NICU. The Director of NICU was asked for the RN who floated to the NICU (4 South) on 11/9/24. The Director of NICU stated RN 4 floated to the NICU from the 4th floor Medical Unit. The Director of NICU was asked for the patients to which RN 4 was assigned. The Director of NICU stated RN 4 floated to NICU was assigned to two patients. On 12/4/24 at 1550 hours, an interview and concurrent record review of RN 4’s certification or training record was conducted with the Director of Regulatory Affairs, Director of HR Compliance & Associate Relations, Senior Disability Case Manager, Nurse Manager 5, Nurse Manager 4, Nurse Manager 6, Nurse Educator 1, Nurse Educator 2, and HR Manager 3. The Director of HR Compliance & Associate Relations, Senior Disability Case Manager, Nurse Manager 5, Nurse Manager 4, Nurse Manager 6, Nurse Educator 1, Nurse Educator 2, and HR Manager 3 were asked to show the NRP certificate for RN 4. The Director of HR Compliance & Associate Relations, Senior Disability Case Manager, Nurse Manager 5, Nurse Manager 4, Nurse Manager 6, Nurse Educator 1, Nurse Educator 2, and HR Manager 3 could not show RN 4’s certificate or training record for NRP. The finding was shared with the Director of Regulatory Affairs and Director of NICU.”

“PATIENT RIGHTS:PARTICIPATION IN CARE PLANNING CFR(s): 482.13(b)(1) The patient has the right to participate in the development and implementation of his or her plan of care. This Standard is not met as evidenced by: 37663 Based on interview and record review, the hospital failed to ensure the patient’s family was informed of the treatment plan regarding to using midazolam (aanxiolytic) for cast removal and re-suturing for one of four sampled patient (Patient 1). This failure posed the increased risk for the patient’s family member not to understand the planned procedure’s risk and problems that might be encountered during the procedure. Findings: Review of the hospital’s P&P titled Patient Rights and Responsibilities dated 2/24/22, showed the following: * Policy: - Patient’s Rights and Responsibilities: Receive information about your health status, diagnosis, prognosis, course of treatment, prospects for recovery and outcomes of care (including unanticipated outcomes) in terms you can understand. You have the right to effective communication and to participate in the development and implementation of your plan of care; participate in ethical questions that arise in the course of your care, including issues of conflict resolution, withholding resuscitative measures, and forgoing or withdrawing life-sustaining treatment. On 11/6/24 at 1137 hours, an interview and concurrent review of Patient 1’s medical record was conducted with the Director of Regulatory Affairs, Director of Emergency Services, and ED Clinical Nurse Specialist. Patient 1’s medical record showed Patient 1 was admitted in the ED on 10/6/24 at 1149 hours, for the splint or cast check. Review of the ED Note-Physician dated 10/6/24, showed at 1327 hours, Medical Provider 3 saw Patient 1. The Physical Examination section showed the cast to the left lower extremity was cracked above the ankle, cast material on the right toes was swelling apart, and cast on the left upper extremities was intact. The Differential Diagnosis section showed Patient 1 encountered for the cast take down and repair. The medical decision making would consult the plastic surgery for recasting. The Re-examination/Re-evaluation sections showed at 1543 hours, the Plastic Surgery (Medical Provider 2) consult was at the bedside to replace the cast; at 1606 hours, attempted to replace the cast under Versed (same as midazolam), Patient 1 was unable to tolerate procedure, and would perform conscious sedation under ketamine (anesthetic). The Disposition section showed Patient 1 care was transitioned to Medical Provider 5. Review of the ED orders showed to midazolam 3.3 mg/0.66 ml inj. nasal one time, stat, start on 10/6/24 at 1332 hours and stop at 1332 hours. Review of Medical Provider 4 note dated 10/6/24, showed at 1628 hours, Patient 1 was re-examined or re-evaluated. Medical Provider 2 was at the bedside. Patient 1 was unable to tolerate suture of wound and casting with intranasal Versed. Medical Provider recommended IV line for procedural sedation with ketamine. Review of Patient 1’s MAR showed midazolam 3.3 mg/0.66 ml intranasal one-time stat was administered for the patient on 10/6/24 at 1529 and 1642 hours. Review of the Medical Provider 2 note dated 10/16/24, showed consultation for cast falling off. There was no documentation Patient 1’s family member was informed of the treatment plan of cast removal and use of Versed via inhalation. On 11/6/24 at 1355 hours, the Director of Regulatory Affairs, Director of Emergency Services, and ED Clinical Nurse Specialist was asked to show Patient 1’s family member was informed of the planned treatment cast removal with the use of Versed inhalation. The ED Clinical Nurse Specialist could not show documented evidence Patient 1’s family member was informed of the planned treatment of cast removal with the use of Versed.”

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 37663 Based on observation, interview, and record review, the hospital failed to ensure the patients received care in the safe setting as evidenced by: 1. The hospital staff failed to ensure the hospital’s P&Ps were implemented for one of four sampled patients (Patient 1) as evidenced by: a. The ED RN failed to perform the initial assessment for the patient as per the hospital’s P&P. b. The ED RN did not perform the focused reassessments every two hours for the patient as per the hospital’s P&P. c. The ED RN failed to ensure the patient was assessed before and after the pain medication was administered as per the hospital’s P&P. d. The ED RN failed to ensure the patient was monitored when the midazolam medication was administered as per the hospital’s P&P. e. Medical Provider 2 failed to ensure Patient 1 received adequate pain medication during the procedure when the LLE flap was sutured during the bilateral cast removal and replacement procedures. f. Medical Provider 2 failed to ensure the treatment plan was discussed with the attending physician prior to the suture repair, casting bilateral lower extremities with procedural sedation treatment plan for Patient 1. 2. Medications found unsecured in the ED. These failures posed an increased risk of substandard health outcomes for the patients. Findings: 1. Review of the hospital’s P&P titled Patient Rights and Responsibilities dated 2/24/22, showed the patients and their guardians or caregivers have the rights to: - Considerate and respectful care, and to be made comfortable. You have the right to expect respect for your cultural, psychosocial, spiritual, personal values, beliefs, and preferences. - Appropriate assessment and management of your pain, information about pain, pain relief measures and to participate in pain management decisions. You may request or reject the use of any modalities to relieve pain, including opiate medication, if you suffer from severe chronic intractable pain. The doctor may refuse to prescribe the opiate medication, but if so, must inform you that there are physicians who specialized in the treatment of severe chronic pain with methods that include the use of opiates. Review of the hospital’s Emergency Department Standards of Care dated 8/26/24, showed in part: * Standard of Care Overview: Standards of Care define nursing practice and the minimum care a patient can expect to receive during their stay in the ED. The RN is responsible for standards of care delivery, which can be delegated to appropriate clinical staff within their scope of practice. * Standard 1: Assessment - The RN collects comprehensive data to the patient’s health and or the situation. - Patients will receive an initial assessment, which includes a head-to-toe examination. Findings will be documented in the medical record. - Reassessments are focused on abnormal findings or problems identified in the initial assessment, changes in clinical status, interventions or procedure, and evaluations or response to intervention or treatment. All reassessments must be documented. Reassessments are performed and documented based on ESI score outlined under assessment and reassessment in the ED: ESI 3, every 2 hours. - Pain is assessed using age-appropriate pain scale. A documented intervention is required for pain score of 4 or greater. - A pain score is reassessed within 1 hour after an intervention, with ongoing assessment and intervention as needed. * Standard 4: Planning - Patient or Family Education takes place throughout the emergency department visit. Education includes the plan of care and medication side effects, benefits, and dosage. * Standard 5: Implementation - Vital Signs are documented based on the patient’s ESI: ESI 3 every 2 hours. - Cardiopulmonary monitoring is used to evaluate the patient’s heart and respiratory rate or rhythm determination. * Standard 6: Evaluation - Ongoing Assessments: Subsequent focused assessments will be completed and documented and documented every 2 hours or more frequently as needed. - Pain is assessed and documented utilizing age and developmentally appropriate pain scale every 2 hours or more frequently as indicted by condition. - Provide patient or family preferred pain management intervention for procedural pain, when appropriate. * Standard 9: Communication - The RN communicates effectively in all areas of professional practice. On 11/6/24 at 1137 hours, an interview and concurrent review of Patient 1’s medical record was conducted with the Director of Regulatory Affairs, Director of Emergency Services, and ED Clinical Nurse Specialist. Patient 1’s medical record showed Patient 1 was admitted in the ED on 10/6/24 at 1149 hours, for the splint or cast check. Patient 1 was assessed with ESI level 3 (urgent). The patient was discharged on 10/6/24 at 1950 hours. a. Review of the ED RN initial assessment for Patient 1 was conducted with the Director of Emergency Services and ED Clinical Nurse Specialist. The Director of Emergency Services and ED Clinical Nurse Specialist was asked to show the initial head to toe nursing assessment for Patient 1. The Director of Emergency Services and ED Clinical Nurse Specialist stated there was no documented head to toe assessment for the patient. The Director of Emergency Services stated at 1206 hours, the Triage Nurse performed a nursing assessment. However, there was no initial assessment of head to toe documented. b. Review of the ED RN reassessment for Patient 1 was conducted with the Director of Emergency Services and ED Clinical Nurse Specialist. The Director of Emergency Services and ED Clinical Nurse Specialist was asked to show the ED RN’s documentation of Patient 1’s focused reassessment every 2 hours. The Director of Emergency Services and ED Clinical Nurse Specialist stated there was no focused reassessment for Patient 1 performed every 2 hours. c. Review of the hospital’s P&P titled Pain Management dated 9/23/21, showed the following: * Policy: All patients have the right to have their pain managed using a multimodal approach of pharmacological and non-pharmacologic measures. All treatment is based upon behavioral and psychological parameters reported by staff, the patient and/or caregiver. Pain assessments are completed upon admission, per unit standards, at the time of transfer, or more frequently as indicated by patient condition. Goal of pain treatment or intervention should be a pain score of 3 or less or a decrease in the pain score. The hospital utilizes the pain assessment scales including Faces, Legs, Activity, Cry, Consolability (revised FLACC) that is appropriate for patients 2 months to 7 years of age, for non or preverbal patients, patients that are sedated or developmentally delayed of any age. * Assessment: - Utilize pain assessment tool or ask the patients if they are in pain; accept their subjective report of pain. - Be sure to assess patient’s pain when they are moving, not just when lying in bed or sitting on a chair. - Assess site of patient’s pain or discomfort. Include inspection, palpation, and range of motion of involved joints if applicable. Assess for physical, behavioral, and emotional signs and symptoms of pain, including moaning, crying, whimpering, vocalization, decrease activity, change in usual behavior, facial expression, guarding body part, muscle tension, restlessness, exhaustion, abnormal gait, diaphoresis. irritability or change in mental status especially confusion or agitation, which may be a sign of unrelieved pain, anxiety and fear can lead to elevated pain perception. * Reassessment: - Reassess initial pain score of 4 or more, within 30 minutes for IV analgesics, or within 1 hour for oral analgesics or non-pharmacologic interventions for effectiveness. - A repeat pain score of 4 or greater requires the start of another Pain Air cycle with intervention and reassessment within 1 hour of current elevated pain score. - Evaluate for presence of analgesic side effects (such as excessive somnolence, respiratory depression, nausea and vomiting). * Documentation: - Patient and caregiver education. - Pain scale used for pain assessment. - Pain assessment including rating, at minimum of every 4 hours, and after each intervention. - Vital signs and SpO2, if ordered. - Pharmacologic and non-pharmacologic interventions provided in response to increase pain score. On 11/6/24 at 1355 hours, interview and concurrent review Patient 1’s record was conducted with the Director of Emergency Services and ED Clinical Nurse Specialist. Review of the ED Note-Physician dated 10/6/24, showed at 1327 hours, Medical Provider 3 saw Patient 1. The Physical Examination section showed the cast to the left lower extremity was cracked above the ankle, cast material on the right toes was swelling apart, cast on the left upper extremities was intact. The Differential Diagnosis showed Patient 1 encountered for cast take down and repair. The medical decision making was to consult plastic surgery for recasting. The re-examination/Re-evaluation sections showed at 1543 hours, Medical Provider 2 consult was at the bedside to replace the cast; at 1606 hours, attempted to replace cast under Versed, Patient 1 was unable to tolerate the procedure, and conscious sedation under ketamine would be performed. The Disposition section showed Patient 1 care was transitioned to Medical Provider 5. Review of the ED orders showed to administer acetaminophen-hydrocodone bitartrate (narcotic analgesic) 3 mg/6 ml elixir oral one-time stat, starting on 10/6/24 at 1401 hours. Review of Patient 1’s MAR showed the patient received acetaminophen-hydrocodone (Lortab) 3 mg/6 ml elixir oral on 10/6/24 at 1416 hours. On 11/6/24 at 1427 hours, during an interview with the Director of Emergency Services and ED Clinical Nurse Specialist, the Director of Emergency Services and ED Clinical Nurse Specialist was asked to show evidence of the ED RN documentation for monitoring Patient1’s pain before and after pain medication was administered. The Director of Emergency Services and ED Clinical Nurse Specialist stated there was no documentation the ED RN monitored the patient pain scale before and after the pain medication was administered for the patient. d. Review of the hospital’s P&P titled Intranasal Medication (INM) Administration for Anxiolysis dated 12/8/22, showed the following: * Policy: intranasal medications that may be ordered for procedural anxiolysis or minimal sedations, may include midazolam. A provider order is required for INM. A RN may administer intranasal medication. * Procedure: - Ensure the six rights of medication safety. - Prior to administration, attach cardiorespiratory monitor, pulse oximetry, and blood pressure cuff to patient; and obtain baseline vital signs (BP, HR, RR, and O2 saturations). - Monitoring: Continuously monitor patient’s HR, RR, pulse oximetry during administration and for 1 hour post administration; obtain vital signs at the time of administration, 15 minutes post administration, 1 hour post administration, and prior to discontinuing continuous monitoring. - Document in the medical record the medication administration, vital signs, and any procedural complications. Review of the ED Note-Physician dated 10/6/24, showed at 1327 hours, Medical Provider 3 saw Patient 1. The Physical Examination section showed the cast to the left lower extremity was cracked above the ankle, cast material on the right toes was swelling apart, cast on the left upper extremities was intact. The Differential Diagnosis showed Patient 1 encountered for cast take down and repair. The medical decision making was to consult plastic surgery for recasting. The re-examination/Re-evaluation sections showed at 1543 hours, Medical Provider 2 consult was at the bedside to replace the cast; at 1606 hours, attempted to replace cast under Versed, Patient 1 was unable to tolerate the procedure, and conscious sedation under ketamine would be performed. The Disposition section showed Patient 1 care was transitioned to Medical Provider 5. Review of Medical Provider 4 note dated 10/6/24, showed at 1628 hours, Patient 1 was re-examined or re-evaluated. Medical Provider 2 was at the bedside. Patient 1 was unable to tolerate suturing of wound and casting with intranasal Versed. Medical Provider 2 recommended IV line for procedural sedation with ketamine. Review of the orders showed to administer midazolam 3.3 mg/0.66 ml nasal one-time stat starting on 10/6/24 at 1332 and 1556 hours. Review of Patient 1’s MAR dated 10/6/24, showed midazolam 3.3 mg/0.66 ml (IN) intranasal was administered to the patient at 1529 hours and 1642 hours. On 11/6/24 at 1530 hours, the Director of Regulatory Affairs, Director of Emergency Services, and ED Clinical Nurse Specialist was asked to show documented evidence Patient1’s monitoring when the midazolam was administered to the patient during the procedure of cast removal. The ED Clinical Nurse Specialist stated there was no vital signs monitoring for the patient during the administration of midazolam. The ED Clinical Nurse Specialist was asked if Patient 1 attached to a cardiorespiratory monitor. The ED Clinical Nurse Specialist stated no, he could not find documentation to show the patient was attached to a cardiorespiratory monitor. e. Review of the hospital’s P&P titled Procedural Sedation/Analgesia by Non-Anesthesiologists dated 1/17/23, showed the following: * This policy applies to all qualified providers who order, administer, or supervise sedation. * Analgesia involves the use of a medication to provide relief of pain of pain through the blocking of pain receptors in the peripheral and or central nervous system. The patient does not lose consciousness but does not perceive pain to the extent that may otherwise prevail. * Sedation: minimal, moderate or deep sedation or analgesia unless otherwise specified. Summary of moderate sedation levels are as follows: Responsiveness: purposeful response to verbal or tactile stimulation. Airway: No intervention required. Spontaneous Ventilation: Adequate Cardiovascular functions are usually maintaining. * Moderate Sedation: Sedation Level 2, a drug-induced depression of consciousness during which patient responds purposefully to verbal commands, either alone or accompanied by light tactile stimulation (reflex withdrawal from a painful stimulus is not considered purposeful response). No interventions are required to maintain a patent airway, and spontaneous ventilation is adequate. Cardiovascular function is usually maintained. Review of Appendix B, Sedation and Analgesia Dosing Guidelines (for Procedural Sedation) showed for ketamine, consider a benzodiazepine (anti-anxiety) with ketamine and an anti-secretory for pediatrics, 0.005 mg/kg IM or IV. Review of the RN’s Flowsheet documentation for Patient 1’s Suture Repair, Casting with Procedural Sedation Casting bilateral lower extremities, monitoring using ketamine IV showed the following: - At 1801 hours, the patient’s O2 saturation was 95%. The artificial airway management section showed the RT performed bag or valve ventilation, and the RT assessment was completed. - At 1802 hours, the procedure was started. Ketamine 14 mg IVP was given for Patient 1. The patient’s HR was 118 bpm. The patient’s RR was 25 breaths per minute. The patient’s O2 saturation was 94%. The patient’s ETCO2 was 49 mmHg (normal range is 35 - 45 mmHg). The patient’s sedation scale was 3 (drowsy). The patient’s skin color assessment had circumoral cyanosis. - At 1803 hours, the patient’s O2 saturation was 95 %. - At 1805 hours, the patient’s O2 saturation was 91 %. The procedural sedation scale was 2 (slightly drowsy, easily aroused). - At 1807 hours, the patient’s HR was 132 bpm. The patient’s RR was 30 breaths per minute. The patient’s O2 saturation was 74%. The patient’s ETCO2 was 51 mmHg (high). The procedural sedation scale was 2. - At 1810 hours, the patient’s HR was 128 bpm. The patient’s RR was 16 breaths per minute. The patient’s O2 saturation was 98%. The patient’s ETCO2 was 45 mmHg. The procedural sedation scale was 2. - At 1815 hours, the patient’s HR was 164 bpm. The patient’s RR was 22 breaths per minute. The patient’s O2 saturation was 93%. The patient’s ETCO2 was 40 mmHg. The FLACC assessment was 7; and the patient had frequent to constant quivering chin, clenched jaw, kicking, squirming, crying steadily, and content. The procedural sedation monitoring sedation score was 1 (awake and alert). The patient’s skin color was pink. - At 1820 hours, the patient’s HR was 177 bpm. The patient’s RR was 24 breaths per minutes. The patient’s O2 saturation was 95% breaths per minute. The patient’s ETCO2 was 26 mmHg (low). The procedural sedation score was 1 (awake and alert). - At 1825 hours, the patient’s HR was 167 bpm. The patient’s RR was 24 breaths per minute. The patient’s O2 saturation was 96%. The patient’s ETCO2 was 32 mmHg. The procedural sedation score was 1. - At 1830 hours, the patient’s HR was 172 bpm. The patient’s RR was 21 breaths per minute. The patient’s O2 saturation was 96%. The patient’s FLACC Score was 8; the patient was frequent to constant quivering chin, clenched jaw, kicking, squirming, crying steadily, difficult to console or comfort. The patient’s ETCO2 was 42 mmHg. The procedural sedation score was 1. - At 1900 hours, the patient’s FLACC score was 8 and the patient had frequent to constant quivering chin, clenched jaw, kicking, squirming, crying steadily, difficult to console, or comfort. - At 1920 hours, the patient’s FLACC score was 0; no particular expression, normal position, relaxed, moves easily, no cry, content. The Director of Emergency Services and ED Clinical Nurse Specialist was asked what the goal level for moderate sedation was. The ED Clinical Nurse Specialist stated the goal was 2. The ED Clinical Nurse Specialist was asked what the sedation level score of 1 was. The ED Clinical Nurse Specialist stated the sedation level 1 was the baseline when the patient was awake and alert. On 11/7/24 hours at 1655 hours, an interview and concurrent record review was conducted with ED RN 3, the Director of Regulatory Affairs, Director of Emergency Services and ED Clinical Nurse Specialist. ED RN 3 was asked about the monitoring of the procedural sedation for Patient 1. ED RN 3 stated Patient 1 became hypoxic and had cyanosis on his face when Medical Provider 4 gave the patient ketamine IV. RT 1 and the Medical Provider 4 ventilated Patient 1 by ambubag. Medical Provider 4 repositioned the patient. The RT and Medical Provider 4 held the head while ambubagging the patient. Jaw thrust maneuver was performed but she could not remember who performed the jaw thrust. ED RN 3 stated Medical Provider 5 was called and said not to give anymore ketamine and if the patient could not complete the procedure the patient had to go to OR. On 11/7/24 at 1307 hours, a telephone interview was conducted with Medical Provider 4, the Director of Regulatory Affairs, Director of Emergency Services and ED Clinical Nurse Specialist. Medical Provider 4 was asked about the procedural sedation for Patient 1. Medical Provider 4 stated she was at the procedural sedation for Patient 1’s resuturing and cast replacement, she administered the ketamine IV and made sure the patient’s airway, cardiovascular function, and vital signs were ok. Medical Provider 4 stated Medical Provider 5 was called in the room and did not want to give anymore ketamine IV to the patient. Medical Provider 4 was asked about sedation level 1 and FLACC 7/pain assessment for Patient 1 while the suturing and cast replacement procedure was being done. Medical Provider 4 stated Medical Provider 2 performed the suturing and cast replacement and that should be a question for her. On 11/7/24 at 1601 hours, an interview and concurrent record review was conducted with Medical Provider 1, Medical Provider 2, and the Director of the Regulatory. Medical Provider 2 was asked about the flap resuturing and replacement of bilateral cast procedure performed for Patient 1. Medical Provider 2 stated she gave Patient 1 lidocaine (a local anesthetic) j-tip and documented the list of the medications on her notes. However, she did not document she gave lidocaine for the patient during the procedure. f. Review of the hospital P&P titled Roles and Supervision of Medical Student dated 3/28/19, showed the following: * Definitions: - Residents and Fellows: Physicians who are engaged in graduate medical education in pediatric medicine and who participate in patient care under the supervision of the attending physicians and licensed independent practitioners. Residents and fellows are responsible for asking for help from the supervising physician or appropriate licensed practitioner for the service they are rotating on when they are uncertain of diagnosis, how to perform a diagnostic or therapeutic procedure, or how to implement an appropriate plan of care. - Attending: An identifiable, appropriately-credentialed and privileged attending physician or licensed independent practitioner who is ultimately responsible for the management of the individual patient and for the supervision of the residents and fellows involved in the care of the patient. The attending delegates portions of care to residents and fellows based on the needs of the patient and the skills of the residents and fellows. * Policy: Clinical responsibilities: Residents and fellows are part of a team of providers caring for patients. The team includes an attending and may include other licensed independent practitioners, other trainees and medical students. Residents and fellows may provide care in both the inpatient and outpatient settings. They may serve on a team providing direct patient care, or may be part of a team providing consultative or diagnostic services. Each member of the team is dedicated to providing excellent patient care. - Resident and fellows evaluate patients, obtain the medical history and perform physical examinations. They may develop a differential diagnosis and problem list. Using this information, they develop a plan of care in conjunction with other trainees and the attending. They may participate in procedures performed at the bedside, in the OR or procedure suite under appropriate supervision. They may participate in prescription of orthoses and prosthesis with attending supervision. Residents and fellows should discuss the patient’s status and plan of care with the attending and the team regularly. All residents and fellows help provide for the educational needs and supervision of any junior residents and medical student. * Procedure: In all cases, the attending physician is ultimately responsible for the provision of care by residents and fellows. When there is any doubt about the need for supervision, the attending should be contacted. * Supervision of Consults: Residents may provide consultation services under the direction of supervisory residents including fellows. The attending of record is ultimately responsible for the care of the patient and thus must be available to provide direct supervision when appropriate for optimal care and or as indicated by individual program policy. Review of the hospital’s Medical Staff Rules and Regulation dated October 2021 showed the following: * Policy on Supervision of Residents - Each resident is responsible for communicating to their attending physician significant issues as they relate to patient care. Such communication must be documented in the record. All outpatients in the ED and clinics for which the attending physician is responsible should be seen by or discussed with, the attending physician at that initial visit. This must be documented in the chart via a progress note by the attending physician or reflected in the resident’s note to include the name of the attending physician and the nature of the discussion. All notes must be signed and dated. Review of Medical Provider 2’s outpatient note for Patient 1 showed visit date was 10/6/24. The Physical Exam section showed “RLE: cast with cracks and bite marks at the toes, removed, suture line appears intact with some bleeding/oozing during examination while the patient was thrashing about...LLE: cast with circumferential defect around the ankle, mobile, when removed there is oozing from the dorsal flap site with damaged sutures and nearly free dorsal flap.” The Assessment/Plan section showed status post conscious sedation procedure and suturing of the LLE, cast removal and replacement of the bilateral lower extremities. On 11/7/24 at 1601 hours, an interview and record review was conducted with Medical Providers 1 and 2, and the Director of Regulatory Affairs. Medical Provider 2 was asked if she discussed the planned treatment for Patient 1 with her attending, the planned treatment using midazolam for cast removal, resuturing of skin flap, and the procedural sedation for resuturing, and casting of bilateral lower extremities. Medical Provider 2 stated she sent her progress notes to the plastic attending on the day of the procedure. However, the documentation did not show the procedures performed for Patient 1 were discussed with the attending. Medical Provider 1 stated the practice with his residents, the residents would discuss with him the plan of care and he would redirect the residents accordingly. The findings were verified and shared with the Director of Regulatory Affairs. 45560 2. Review of the hospital’s P&P titled Storage and Security of Medications dated 1/28/21, showed under section I, Purpose: To establish a safe and effective system for the storage and security of medications and chemicals, in accordance with Stated and Federal regulations. Medications will be secured in locked storage areas and accessible only to authorized hospital personnel. On 11/6/24 at 1022 hours, a tour of the ED was conducted with the Director of Emergency Services and ED Clinical Nurse Specialist. During the walkthrough and observation of the department, two prefilled syringes of lidocaine 4mg/0.4ml were observed left unattended in the nurse’s work cubby located near exam room 19. Exam room 19 was observed to be occupied by a patient. When asked the purpose of the syringes, the ED Clinical Nurse Specialist stated the lidocaine was used to numb the area where an IV line was placed on a patient. When asked if the medication should have been left unsecured, the Director of Emergency Services stated no. On 11/7/24 at 1650 hours, the Director of Regulatory Affairs was notified of the findings.”