Loyola University Medical Center

“RESPIRATORY CARE SERVICES CFR(s): 482.57 The hospital must meet the needs of the patients in accordance with acceptable standards of practice. The following requirements apply if the hospital provides respiratory care services. This Condition is not met as evidenced by: 39802 Based on document review and interview, it was determined that the hospital failed to comply with the Condition of Participation 42 CFR 482.57, Respiratory Services. Findings include: 1. The Hospital failed to ensure that there was adequate respiratory therapy staffing and that staff had the required qualifications, to meet the respiratory care needs of the patient populations served. A-1154 An immediate jeopardy (IJ) was identified on 06/18/2025 at 42 CFR 482.57, Respiratory Service, due to the Hospital’s failure to ensure that adequate respiratory care staff were available and qualified to provide respiratory services and treatments to its high volume of patients. The IJ was announced on 06/18/2025 at 4:15 PM during a meeting with the President, the Chief Medical Officer, the Chief Nursing Officer, the Vice President (VP) of Finance, three Chief Quality Improvement Specialists, and the Regional VP of Clinical Excellence, and was not removed by the survey exit date of 06/18/2025. The Hospital’s failure has the potential to pose an immediate threat to the health and safety of all patients in need of respiratory services.”

“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: 39802 Based on document review and interview, it was determined that the Hospital failed to ensure that there was adequate respiratory therapy staffing and that staff had the required qualifications, to meet the respiratory care needs of the patient populations served. Findings include: 1. The Hospital’s Scope of Services titled, “Leadership Plan for Care, Treatment, and Services”, (dated 8/2023), was reviewed, and included, “Description of the Organization: As part of [Hospital] ...with 547 beds ...[Hospital] offers quaternary and tertiary care [highest level] ...Clinical services include: ...respiratory care services ...Respiratory Care Practitioners (RCPs), under the direction of a physician, evaluate, treat and care for patients with breathing disorders ...With an average of 40 ventilated patients a day across ten intensive care units, our Respiratory Care Practitioners accompany physician led teams on round evaluating the patients ...Staff is based on the volume of ordered therapy and the level of acuity for each shift. This service or unit is open/available around the clock, 7 days/week ...Our standard of practice is based on the AARC (American Association of Respiratory Care) standards” 2. The Pediatric, Neonatal, and Adult Point Tally Sheet (revised 5/2025), was reviewed. The point tally sheet uses a staffing metric, based on the AARC (American Association of Respiratory Care) guidelines. The sheet included a column that listed various respiratory procedures/duties that has pre-determined points next to the procedure. The total points are tallied (per respiratory therapist). After the points are tallied, the total number points should be divided by 90 (indicating the “90-point system”). Per interview on 6/16/2025 at 11:50 AM, with the Respiratory Manager (E #1), the goal regarding staffing for the respiratory therapists, is to keep the assignment load less than 90 points. 3. The Respiratory Care Practice II Job Description (dated 8/11/2011), was reviewed and included, “Under the general supervision of the Clinical Resource Manager of Respiratory Care provides intensive and general respiratory care services to neonatal, pediatric, adolescent, adult, and geriatric patients upon receiving written prescriptions from a physician and/or per approved medical center protocol ...” 4. The Neo-Peds Respiratory Care Practice III Job Description (dated 2/19/2014), was reviewed and included, “ ...Coordinates daily staffing assignments to distribute the workload according to the point system to and Department guidelines. Adjust assignments throughout shift to ensure appropriate staffing. Calculates points for the oncoming shift and adjusts staffing as necessary to ensure efficient utilization staff ...Required ...NRP (Neo Resuscitation Program) and PALS [pediatric resuscitation] ...” 5. The “Interim Guidelines for High-Risk Delivery & NICU Transports” (dated 11/22/2021), was reviewed on 6/17/2025, and required, “There will be 24/7 Respiratory (RT) coverage in the Neonatal Intensive Care Unit (NICU). Assignments will be made with designated High-Risk Delivery (HRD) RT to cover NICU and will be identified to NICU Charge Registered Nurse (RN) .... High Risk Deliveries: The High-Risk Delivery Team (HRD) will be called to attend deliveries for any known or anticipated maternal or fetal complications ...” 6. On 6/16/2025, the RT daily staffing sheets/assignments from 5/1/2025-6/16/2025 were reviewed. The assignment sheets included RTs with workloads greater than the recommended “90-points” guidelines on the night shift (11 PM-7 AM) on the following dates: - 6/8, 6/12, 6/13/2025: 5 Respiratory Therapists (instead of the required 9). - 5/2, 5/19, 5/21, 5/25, 5/27, 6/9/2025: 6 Respiratory Therapists (instead of the required 9). - 5/12, 5/15, 5/17-5/18, 5/24-5/30, 6/2-6/3, 6/5- 6/6/2025: 7 Respiratory Therapists (instead of the required 9). - 5/5, 5/7, 5/9-5/10, 5/13, 5/16, 6/4, 6/7, 6/10/2025: 8 Respiratory Therapists (instead of the required 9). In addition, the RT staffing assignment sheets included RTs (adult-trained) who were floated to the NICU on 5/30, 6/3, 6/7, 6/8 and 6/13/2025. RT (adult-trained) staff were floated to the PICU on 5/4, 5/19, 5/23-5/27, 5/30, 6/1-6/2, 6/6-6/10, 6/12-6/13/2025. 7. On 6/17/2025, the personnel files of 12 RTs including the adult-trained RTs that floated to the NICU or PICU, were reviewed. The files lacked the required NRP or PALS certification for the adult-trained RTs who were floated/assigned to either NICU or PICU. 8. On 6/17/2025, the NICU staffing sheets from 5/1/2025-6/16/2025, were reviewed. The daily assignment sheets listed the assigned RT for the NICU. On 6/8/2025, the night shift’s assignment sheet included a note, “No RT for HRD [high risk delivery] or transport”. In addition, the NICU staffing assignments included some RT staff (adult-only trained) who were floated/assigned to the NICU. 9. Incident Reports from 03/01/2025-06/16/2025 were reviewed and included multiple incidents of delayed or missed care due to lack of respiratory staffing. 10. The clinical records of seven additional patients (Pts. #9, 10, and 16-20) selected from incident reports were reviewed for respiratory care and imaging and the following concerns were identified: - Pt. #9 with missed or delayed respiratory nebulizer and airway clearance therapies between 04/24/2025 to 05/12/2025. - Pt. #10 unable to receive MRI scan ordered on 05/02/2025 due to no respiratory staff available to accompany vented patient for imaging procedure. - Pt. #16 with missed or delayed respiratory nebulizer and airway clearance therapies between 05/24/2025 to 06/16/2025 - Pt. #17 with greater than 24 hour delay in completing MRI scan ordered on 06/05/2025., due to lack of respiratory staff available to accompany vented patient. - Pt. #18 with missed nebulizer treatments overnight due to no respiratory staff available on 06/09/2025. 11. On 6/17/2025 at 2:00 pm, the clinical record of a patient (Pt #8) in the 4 Tower Ortho Med/Surg unit (Nebulizer Pilot Unit) was reviewed. Pt #8 was ordered albuterol-ipratropium (respiratory treatment medication) scheduled 4 times a day. The Medication Administration Record from 6/13/2025-6/16/2025 was reviewed for administration of the respiratory medication. On 6/16/2025 at 1:00 PM, the scheduled medication was documented as “missed” and was not given. The assigned nurse (E #6) acknowledged the missed dose and stated that E #6 did not have time to administer Pt #8’s medication since nurses now have the added responsibility of administering nebulizer treatments. 12. On 6/16/2025 at 11:50 AM, an interview was conducted with the Respiratory Manager (E #1). E #1 stated that hospital does not use an external agency at this time, due to a financial decision/financial deficit. E #1 stated that there is not a particular staffing policy for the respiratory department. E #1 stated that, however, the department uses the AARC guideline’s “90-point system”. This guideline sets metrics on the time allocated for various respiratory treatments. E #1 stated that the points are tallied for each treatment and each assigned RT. E #1 stated that for example, each treatment averages around 15 minutes, which would equal to 5 points. E #1 stated that the purpose of the guideline, is to schedule the RTs so that their assignment load does not exceed the “90 points”. E #1 stated that the safest minimum staffing of RTs on the night shift, would be 5-6 at a minimum, but the goal is around 9 RTs. E #1 stated that when there is a critical shortage, then the RTs have to prioritize patient care: asthmatics, patients on ventilators, and Neo/Peds. E #1 stated that there are multiple open positions in the respiratory department. E #1 stated that as an attempt to offset the shortage, the department uses an internal staffing agency. 13. On 6/16/2025 at 10:45 AM, during tour, an interview was conducted with the assigned NICU RT (E #4). E #4 stated that there should always be one RT assigned to the NICU. E #4 stated that RTs assigned to the NICU should have NRP certification (neonatal resuscitation program card). E #4 stated that there has been ongoing staffing shortage with the RTs. E #4 stated that there are times when an adult-trained RT has to be pulled to the NICU to cover. E #4 stated that the shortage is primarily on the night shift (11 PM-7AM). 14. On 6/16/2025 at 11:40 AM, an interview was conducted with the Respiratory Department Educator (E #3). E #3 stated that there are staffing concerns in the RT department, especially on the night shift. 15. On 6/17/2025 at 12:20 PM, a phone interview was conducted with the Respiratory Medical Director (MD #1). MD #1 stated that the respiratory therapists who work in the NICU are required to have the NEO/PEDS certification. MD #1 stated that a Neo/Peds RT should be assigned to the NICU at all times. MD #1 stated that MD #1 along with leadership are aware of a shortage with the RT’s. MD #1 stated that if there is a severe staffing shortage, then calls would be made to see if there is anyone on-call that would come in or if staff would stay over their shift. MD #1 stated that as of late, there has been a more acute change in the staffing shortage and we have responded more acutely. 16. An interview was conducted with Respiratory Therapist (E#8) on 06/16/2025 at approximately 11:55 AM. E#8 stated that if a patient is on a ventilator they must be accompanied by a RT if going to imaging. E#8 stated that respiratory treatments should be administered as ordered. E#8 stated that the expectation is to administer medications within a half an hour before or after the scheduled time.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(8) Unless superseded by State law that is more restrictive-- (i) Each order for restraint or seclusion used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others may only be renewed in accordance with the following limits for up to a total of 24 hours: (A) 4 hours for adults 18 years of age or older; (B) 2 hours for children and adolescents 9 to 17 years of age; or (C) 1-hour for children under 9 years of age; This Standard is not met as evidenced by: 34411 Based on document review and interview, it was determined that for 1 of 1 (Pt #13), clinical record reviewed for violent restraints, the Hospital failed to ensure that the restraint order for a minor was renewed every hour, in accordance with policy. Findings include: 1. The Hospital’s policy titled, “Restraint Use” (dated 9/16/2024), was reviewed and required, “...Obtaining a Restraint Order...Violent and Self-Destructive Behavior. a. Time limited order applies and may not exceed: 1 Hour-for under age 9...Continuation of a Restraint Order. Violent and Self-Destructive Behavior. When the order is about to expire, a nurse must contact the LIP [licensed independent practitioner], report the results of the most recent assessment and request that the order be renewed if appropriate...” 2. The clinical record for Pt #13 was reviewed on 3/25/2025. Pt #13 was admitted to the Pediatric Unit on 3/3/2025. Pt #13 was under the age 9. Pt #13’s physician orders were reviewed. The orders included a restraint order for violent behavior (initiated on 3/6/2025 at 9:37 AM). Subsequent orders for Pt #13’s violent restraints, included orders on 3/6/2025 at 10:45 AM, and 11:43 AM. -Pt #13’s restraint flowsheets included documentation indicating that Pt #13 was in violent restraints beginning on 3/6/2025 at 9:45 AM through 3/6/2025 at 2:30 PM. Pt #13’s last restraint order was on 3/6/2025 at 11:43 AM. There were 2 hourly restraint orders lacking for 12:43 PM and 1:43 PM. 3. On 3/25/2025 at approximately 1:00 PM, an interview was conducted with a Pediatric Intensive Care Unit Registered Nurse (E #13). E #13 stated that for a child under the age of 9, the order for violent restraint needs to be renewed every hour.”

“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: 27125 Based on document review and interview, it was determined that for 1 of 1 patient (Pt. #2) requiring removal of an indwelling catheter, the hospital failed to ensure the nursing decatheterization (removal) protocol was followed. Findings included: 1. The hospital’s nurse driven protocol approved by the medical executive committee - “Discontinuation of indwelling Urinary Catheter per Decatheterization Protocol” was reviewed on 3/24/2025 and required, “Voids [urinate] greater then 200 ml within 6 hours or less. After each void, obtain PVR [post void residual] two times via bladder scan. If bladder scan is greater than 300 ml, proceed with straight catheterization. Repeat as needed.” 2. The daily flow sheets included that the indwelling urinary catheter was removed on 7/27/2024 at 12:00 PM. The urinary totals were as follows: - 7/27/2024 at 5:18 PM - voided 75 ml, bladder scan 290 ml - 7/27/2024 at 11:49 PM - voided 200 ml, bladder scan 285 ml - 7/28/2024 at 4:19 AM - voided 225 ml, bladder scan 186 ml - 7/28/2024 at 10:55 AM - voided 225 ml, bladder scan 550 ml - 7/28/2024 at 1:22 PM - voided 200 ml, bladder scan 433 ml - 7/28/2024 at 3:45 PM - voided 100 ml, bladder scan 630 ml - 7/28/2025 at 5:27 PM - voided 110 ml, bladder scan 572 ml - 7/28/2024 at 8:00 PM - voided 100 ml, bladder scan 643 ml - 7/28/2024 at 10:00 PM - voided 125 ml, bladder scan 686 ml - 7/29/2024 at 12:00 AM - unable to void, discomfort, straight cath 680 ml - 7/29/2024 at 8:00 AM - voided 10 ml, bladder scan 357 ml - 7/29/2024 at 3:00 PM - indwelling catheter inserted per order 3. The registered nurse (E#8), who cared for Pt. #2 during the decatheterization process, was interviewed via telephone on 3/25/2025 at 10:30 AM. E#8 did not recall Pt. #2, but stated that based on the above data Pt. #2 should have been straight cathed (temporary placement) earlier. E#8 stated, “Once the catheter is removed, we wait 6 hours and allow the patient to void. Then we perform a bladder scan. If the amount of urine scanned is greater than 300 ml we will notify the attending service. Then a straight Cath will be done and the process is started over again.””