Children’s Hospital Colorado - Colorado Springs

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 50313 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.13 Patient’s Rights, was out of compliance. A-0168 The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. Based on interviews and documents reviewed, the facility failed to ensure staff obtained a provider’s order for a patient to be physically restrained in one of one records reviewed for patients who were physically restrained in the emergency department (ED). A-0175 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. Based on interviews and documents reviewed, the facility failed to ensure staff evaluated a restrained patient according to facility policy in one of one records reviewed for patients who were physically restrained in the ED. A-0178 When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen face-to-face within 1-hour after the initiation of the intervention (i) By a (A) Physician or other licensed practitioner; or (B) Registered nurse who has been trained in accordance with the requirements specified in paragraph (f) of this section. Based on interviews and documents reviewed, the facility failed to ensure a patient was evaluated face-to-face by an authorized practitioner, or registered nurse (RN) with education and training, within one hour of restraint initiation according to facility policy. This failure was identified in one of one records reviewed for patients who were physically restrained in the ED.”

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 50313 Based on the manner and degree of the standard level deficiency referenced to the Condition, it was determined the Condition of Participation §482.42 INFECTION CONTROL, was out of compliance. A-0750 The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities. Based on observations, interviews, and document review, the facility failed to implement appropriate infection control measures in the milk and formula lab and stock room after a sewage line became clogged and overflowed into the area.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(5) §§482.13(e)(5) - The use of restraint or seclusion must be in accordance with the order of a physician or other licensed practitioner who is responsible for the care of the patient and authorized to order restraint or seclusion by hospital policy in accordance with State law. This Standard is not met as evidenced by: 50313 Based on interviews and documents reviewed, the facility failed to ensure staff obtained a provider’s order for a patient to be physically restrained in one of one records reviewed for patients who were physically restrained in the emergency department (ED). (Patient #3) Findings include: Facility policy: The Restraint and Seclusion: Violent policy read, restraint/seclusion is only to be used to ensure the safety of the patient, team member or others. The facility does not use standing orders or as needed (PRN) orders for restraint or seclusion. Only an authorized practitioner with hospital privileges has the authority to order, initiate, apply, assess, remove and discontinue violent restraints and seclusion. An order is required within one hour of application of violent restraints. The initial order for restraint or seclusion must not exceed one hour without an order for continued restraint or seclusion from an authorized practitioner. 1. The facility failed to ensure an authorized practitioner ordered restraints within one hour of restraint application according to facility policy. A. Document Review i. A review of Patient #3’s medical record revealed Patient #3 presented to the ED on 9/3/25 with a chief complaint of aggressive behavior. On 9/6/25 at 11:37 a.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for banging objects, hitting and kicking, restless and self-destructive behaviors. Staff requested an order from a provider for restraints at 11:37 a.m. There was no evidence a provider order was placed for the restraint application. On 9/7/25 at 11:41 a.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for head banging, hitting and kicking, and self-destructive behaviors. Staff requested an order from a provider for restraints at 11:45 a.m. There was no evidence a provider order was placed for the restraint application. On 9/8/25 at 10:13 a.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for behaviors including agitation, head banging, and hitting and kicking. Staff notified a provider that Patient #3 was restrained. There was no evidence a provider order was placed for the restraint application. On 9/13/25 at 6:59 p.m., the restraint flowsheet revealed staff Patient #3 in violent restraints for agitation, head banging, hitting and kicking, and self-destructive behaviors. Staff requested an order from the provider for restraints at 6:59 p.m. There was no evidence a provider order was placed for the restraint application. On 10/14/25 at 8:52 p.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for behaviors including agitation, head-banging, and hitting and kicking. At 9:41 p.m., the provider was notified that Patient #3 had been placed in violent restraints. There was no evidence a provider order was placed for the restraint application. These medical record reviews were in contrast with the Restraint and Seclusion: Violent policy which read, an order was required within one hour of application of violent restraints. Only an authorized practitioner with hospital privileges had the authority to order violent restraints and seclusion. B. Interviews i. An interview was conducted on 1/22/26 at 2:18 p.m. with registered nurse (RN) #2. RN #2 stated all patients placed in violent restraints required a provider’s order within one hour of restraint application. RN #2 stated it was important for a provider to place the order, to determine if the restraint was the appropriate intervention, and to determine whether the restraint should have been continued or discontinued. ii. An interview was conducted on 1/26/26 at 1:20 p.m. with the ED medical director (Director) #1. Director #1 stated staff should have obtained a provider’s order when applying violent restraints. Director #1 stated it was important for a provider to determine whether a medical condition was causing the patient’s behavior. Additionally, Director #1 stated providers’ orders were important to ensure patient safety and the correct level of restraint. Director #1 stated the risk of not obtaining a provider’s order for restraint included negative medical consequences for the patient, or the provider being unaware of the patient’s medical condition. These interviews were in contrast with the medical record review for Patient #3, which revealed staff placed Patient #3 in violent restraints without a provider’s order.”

“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: 50313 Based on interviews and documents reviewed, the facility failed to ensure staff evaluated a restrained patient according to facility policy in one of one records reviewed for patients who were physically restrained in the emergency department (ED). (Patient #3) Findings include: Facility policy: The Restraint and Seclusion: Violent policy read restraint/seclusion is only to be used to ensure the safety of the patient, team member or others. Monitoring of patients in restraint or seclusion is accomplished through continuous in-person observation by a trained team member. Unless contraindicated by the individual’s condition, such monitoring includes efforts to interact with the individual. Monitoring and documentation include: type and location of the restraining device(s) is documented; rationale for restraint (observed condition or behavior) is assessed on an ongoing basis and documented; and alternatives to and less restrictive forms of restraint considered or used by the caregiver are documented. Evaluation of the patient by a trained team member occurs and is documented at the initiation of restraint and every 15 minutes thereafter and at discontinuation. The evaluation includes the following, unless it is inappropriate for the type of restraint employed: signs of any injury associated with applying restraint or seclusion, nutrition and hydration, circulation and range of motion in the extremities, vital signs, hygiene and elimination, physical and psychological status and comfort, and readiness for discontinuation of restraint or seclusion. 1. The facility failed to ensure staff evaluated a restrained patient every 15 minutes according to facility policy. A. Document Review i. A review of Patient #3’s medical record revealed Patient #3 presented to the ED on 9/3/25 with a chief complaint of aggressive behavior. On 9/3/25 at 10:28 p.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for behaviors including spitting, biting, head banging, hitting, and kicking. Staff discontinued the restraints at 11:08 p.m. There was no evidence staff conducted restraint evaluations every 15 minutes while the patient was restrained from 10:28 p.m. to 11:08 p.m., a period of 40 minutes. On 9/8/25 at 10:13 a.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for behaviors including head banging, hitting, and kicking. Staff conducted 15-minute restraint monitoring and evaluation assessments at 10:13 a.m., 10:15 a.m., 10:30 a.m., and 10:45 a.m. Staff discontinued the restraints at 11:04 a.m. There was no evidence staff conducted restraint evaluations every 15 minutes from 10:45 a.m. to 11:04 a.m., a period of 19 minutes. On 10/6/25 at 11:52 a.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for presenting an imminent risk of harm to self and others. Staff conducted 15-minute restraint monitoring and evaluation assessments at 12:00 p.m., 12:30 p.m., and 12:45 p.m. Staff discontinued the restraints at 12:47 p.m. There was no evidence staff conducted restraint evaluations every 15 minutes from 12:00 p.m. to 12:30 p.m., a period of 30 minutes. These medical record reviews were in contrast with the Restraint and Seclusion: Violent policy which read, evaluation of the patient by a trained team member should have occurred at the initiation of restraint and every 15 minutes thereafter and at discontinuation. The evaluation should have included signs of any injury associated with application of the restraint or seclusion, nutrition and hydration, circulation and range of motion in the extremities, vital signs, hygiene and elimination, physical and psychological status and comfort, and readiness for discontinuation of restraint or seclusion. B. Interviews i. An interview was conducted on 1/22/26 at 10:55 a.m. with registered nurse (RN) #4. RN #4 stated restrained patients required a one to one level of observation, and should have been assessed every 15 minutes while restrained. RN #4 stated patients should have been assessed for skin breakdown, injury, respiratory status, and circulation while restrained. RN #4 stated it was also important to determine whether restraints were the appropriate intervention, or if the restraints could have been discontinued. ii. An interview was conducted on 1/22/26 at 2:18 p.m. with RN #2. RN #2 stated restrained patients should have been under continuous visual observation. RN #2 stated it was important for staff to monitor patients closely for signs of deescalation and for the ability to be safely released from restraints. RN #2 stated nurses should have performed an initial assessment and then assessed the restrained patient every 15 minutes until the restraints were discontinued. RN #2 stated the 15 minute evaluations should have included checks for nutrition and hydration, respiratory status, circulation, and signs of injury. RN #2 stated the risk of not conducting 15 minute evaluations included patient neglect, patient injury, including loss of circulation, and psychological trauma for the patient. These interviews were in contrast with the medical record review for Patient #3, which revealed staff did not evaluate Patient #3 every 15 minutes while restrained.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(12) When restraint or seclusion is used for the management of violent or self-destructive behavior that jeopardizes the immediate physical safety of the patient, a staff member, or others, the patient must be seen face-to-face within 1-hour after the initiation of the intervention -- o By a-- - Physician or other licensed practitioner; or - Registered nurse who has been trained in accordance with the requirements specified in paragraph (f) of this section. This Standard is not met as evidenced by: 50313 Based on interviews and documents reviewed, the facility failed to ensure a patient was evaluated face-to-face by an authorized practitioner, or registered nurse (RN) with education and training, within one hour of restraint initiation according to facility policy. This failure was identified in one of one records reviewed for patients who were physically restrained in the emergency department (ED). (Patient #3) Findings include: Facility policy: The Restraint and Seclusion: Violent policy read, restraint/seclusion is only to be used to ensure the safety of the patient, team member or others. Face-to-face assessment occurs within one hour of initiation of restraint/seclusion. Only an authorized practitioner with hospital privileges has the authority to order, initiate, apply, assess, remove and discontinue violent restraints and seclusion. Restraint or Seclusion Order and Face-to-Face Assessment: As soon as possible, but no longer than one hour after the initiation of restraint, the RN consults with an authorized practitioner about the patient’s physical and psychological status and obtains an order (verbal or written) and a face-to-face assessment is completed. If a patient is released from restraint or seclusion, or the order(s) for that episode expires, an authorized practitioner must see and assess the patient before issuing a new order and completing a new face-to-face assessment. An authorized practitioner, or if not immediately available, an RN with education and training to perform a face-to-face assessment, performs and documents a face-to-face assessment of the patient’s physical and psychological status as soon as possible, but within one hour from the time of the initiation of the restraint. When the face-to-face assessment is conducted by a registered nurse or an advanced practice provider, that personnel must consult with the attending physician when the assessment is completed. The face-to-face assessment and documentation include the patient’s immediate situation, the patient’s behavior, the appropriateness of the intervention measures, the patient’s reaction to the intervention, the patient’s medical and behavioral condition, any complications resulting from the intervention, and the need to continue or terminate the intervention. 1. The facility failed to ensure an authorized practitioner, or RN with education and training, performed face-to-face evaluations for a restrained patient within one hour of restraint initiation according to facility policy. A. Document Review i. A review of Patient #3’s medical record revealed Patient #3 presented to the ED on 9/3/25 with a chief complaint of aggressive behavior. On 9/3/25 at 10:28 p.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for behaviors including spitting, biting, head banging, hitting, and kicking. There was no evidence an authorized practitioner, or RN with education and training to perform a face-to-face assessment, conducted a face-to-face evaluation of Patient #3 within one hour of restraint initiation. On 9/3/25 at 11:36 p.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for self-destructive behaviors and head banging. There was no evidence an authorized practitioner, or RN with education and training to perform a face-to-face assessment, conducted a face-to-face evaluation of Patient #3 within one hour of restraint initiation. On 9/8/25 at 10:13 a.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for behaviors including agitation, head banging, and hitting and kicking. Staff requested a face-to-face assessment from the provider at 10:13 a.m. There was no evidence an authorized practitioner, or RN with education and training to perform a face-to-face assessment, conducted a face-to-face evaluation of Patient #3 within one hour of restraint initiation. On 9/8/25 at 11:30 a.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for behaviors including head banging, hitting, and kicking. Staff requested a face-to-face assessment from the provider at 11:30 a.m. There was no evidence an authorized practitioner, or RN with education and training to perform a face-to-face assessment, conducted a face-to-face evaluation of Patient #3 within one hour of restraint initiation. On 9/13/25 at 6:59 p.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for agitation, head banging, hitting and kicking, and self-destructive behaviors. Staff requested a face-to-face assessment from the provider at 6:59 p.m. There was no evidence an authorized practitioner, or RN with education and training to perform a face-to-face assessment, conducted a face-to-face evaluation of Patient #3 within one hour of restraint initiation. On 10/13/25 at 1:58 p.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for behaviors including head butting staff, hitting, kicking, and head banging. Staff requested a face-to-face assessment from the provider at 1:58 p.m. There was no evidence an authorized practitioner, or RN with education and training to perform a face-to-face assessment, conducted a face-to-face evaluation of Patient #3 within one hour of restraint initiation. On 10/14/25 at 8:52 p.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for behaviors including agitation, head-banging, and hitting and kicking. Staff requested a face-to-face assessment from the provider at 9:41 p.m. There was no evidence an authorized practitioner, or RN with education and training to perform a face-to-face assessment, conducted a face-to-face evaluation of Patient #3 within one hour of restraint initiation. On 10/25/25 at 7:47 p.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for behaviors including head banging, hitting, and kicking. A behavioral health specialist note revealed a provider did not complete a face-to-face assessment during or after the restraint application on 10/25/25. There was no evidence an authorized practitioner, or RN with education and training to perform a face-to-face assessment, conducted a face-to-face evaluation of Patient #3 within one hour of restraint initiation. On 10/28/25 at 9:17 p.m., the restraint flowsheet revealed staff placed Patient #3 in violent restraints for being an imminent risk of harm to self. Staff requested a face-to-face assessment from the provider at 9:44 p.m. There was no evidence an authorized practitioner, or RN with education and training to perform a face-to-face assessment, conducted a face-to-face evaluation of Patient #3 within one hour of restraint initiation. B. Interviews i. An interview was conducted on 1/26/26 at 2:11 p.m. with associate clinical manager of the ED behavioral health unit (Manager) #5. Manager #5 stated the facility had recently changed their policy to allow RNs with education and training to complete face-to-face evaluations for restrained patients if the providers were unavailable. Manager #5 stated RNs at the facility had not yet received education and training, therefore, it remained the provider’s responsibility to conduct the face-to-face evaluations for restrained patients. Additionally, Manager #5 stated when Patient #3 was admitted to the facility, the policy did not authorize RNs to perform face-to-face evaluations for restrained patients. Manager #5 also stated it was important for providers to conduct face-to-face evaluations for restrained patients in order to address the patients’ medical concerns. Manager #5 stated providers should have assessed whether the restraints were appropriate for the patient, or if any medical interventions were needed to address the patient’s symptoms. Additionally, Manager #5 stated a head injury or a change in the patient’s condition could have been missed if the providers did not complete face-to-face evaluations for restrained patients. ii. An interview was conducted on 1/26/26 at 1:30 p.m. with the ED medical director (Director) #1. Director #1 stated the providers relied on safety trained staff to determine when less invasive deescalation measures were not effective, and to determine if restraints were needed for staff or patient safety. Director #1 stated providers typically conducted a face-to-face evaluation after staff notified the provider that a patient required restraints. Director #1 stated face-to-face evaluations were important to ensure patients were safe during the restraint application. Director #1 also stated the evaluations should have included whether the level of restraint was appropriate, if the patient had any negative medical consequences from being restrained, if there were injuries, an assessment of the patient’s respiratory function, and whether any medications were needed. Director #1 stated a patient’s safety was at risk if the providers did not conduct face-to-face evaluations according to the facility’s policy. These interviews were in contrast with the medical record review for Patient #3, which revealed face-to-face evaluations were not conducted within one hour after Patient #3 was restrained.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 50313 Based on observations, interviews, and document review, the facility failed to implement appropriate infection control measures in the milk and formula lab and stock room after a sewage line became clogged and overflowed into the area. Findings include: Facility policies: The Water Release Responsibility policy read, this policy was developed to minimize damage to building materials and contents, and to control growth of potentially dangerous microorganisms in the event of a water release. A water release is any water event where water impacts areas outside of the source and touches ceiling tiles, carpet, drywall, and/or soffit (hard lid ceiling). Including sewage backups that extend outside of the source room. Timely and correct response to a water release is critical to prevent progressive material damage, amplification of microorganisms (tiny, living organisms which can cause infections), and to minimize potential adverse health effects. The industrial hygienist is responsible for evaluating affected areas to determine the scope of damage and the remediation scope of work, and participating in the permit process. All team members are responsible for immediately reporting any evidence of water damage (cracking or peeling paint; stains, leaks, or obvious wet spots) and reporting the water release by describing the release, giving the location, and describing the impact to patients and/or equipment. For any water release event reported, the Control Center will document the water release by creating an Urgent Work Request, which also identifies the mechanic dispatched to the affected area. Remediation actions are dependent on the extent of water damage and the type of materials affected. Remediation includes a detailed assessment of water-damaged materials, determination of corrective actions to either dry in place or remove damaged materials, followed by the build-back of the affected space. The industrial hygienist, assisted by facilities, will perform a water release assessment using information from witnesses of the water release, moisture monitoring instruments, and visual observations. All assessment activities will be performed under strict infection controls as determined by the industrial hygienist. Data gathered from the assessment will be used to define the scope of remediation. The remediation scope will be documented in the permit process. Remediation will not begin until a permit is reviewed and approved by Facilities Operations, Safety, Environment of Care (EOC), Epidemiology, and Planning, Design, and Construction (PDC). The Facilities: Construction Activities policy read, the following provides for the prevention of hospital-associated infection during construction, renovation, and/or invasive maintenance procedures. All renovations in critical areas or invasive maintenance procedures will be coordinated with the following departments, beginning at the design phase and continuing through the commissioning phase. The departments include: Department of Epidemiology, Environmental Services (EVS), Safety, Property Planning Department, Facilities Operations (FO), Administration, and staff from the area under construction as well as from other affected departments. An Infection Control Risk Assessment (ICRA) must be done prior to the start of any construction Work. The following procedures are for the prevention of hospital-associated infection during construction, renovation, and/or invasive maintenance procedures. The primary pathogens occurring during construction are fungi, especially Aspergillus (can cause a fungal lung infection) and Rhizopus (a rare, severe, and often fatal fungal infection affecting immunocompromised (improper immune function) people causing rapid tissue necrosis (death) in the sinuses, brain, lungs, or skin), and Legionella bacteria (can cause fever, chills, headache and muscle aches or a pneumonia (infection of the lungs) with high fever, cough, diarrhea and confusion), which are primarily transmitted from the environment to patients via the airborne route. The high-risk patients include those with altered immune functions, patients receiving high-dose steroids, and organ transplant recipients. Staff and visitors, under certain circumstances, are also susceptible to airborne contamination. These steps emphasize and are addressed via the permitting process: coordinate planning between facilities staff, Epidemiology, and the construction contractors to develop an ICRA. Barrier separation of the construction area, dust control, properly functioning ventilation, use of portable High-Efficiency Particulate Air (HEPA) filtration units, terminal cleaning of the construction area, temporary housing of high-risk patients, minimizing exposure of high-risk patients to contamination, and use of portable HEPA filter vacuum sweepers. 1. The facility failed to implement appropriate infection control measures in the milk and formula lab and stock room after a sewage line became clogged and overflowed into the area. A. Observations i. Observations conducted in the milk lab on 1/20/26 at 2:21 p.m. revealed staff preparing formula and human milk for infants in the neonatal intensive care unit (NICU). During these observations, an odor of sewage was present. Further observations revealed laminate cabinets storing canisters of formula with separated laminate, swelling of the composite wood, breached caulking along walls and cabinets, and gaps along the wall and cabinet surfaces. Additional observations in the milk lab storage room revealed white dust covering equipment, formula, and supplies. B. Document review i. A review of an incident revealed a sewer/water line burst on 1/15/26 and flooded the milk and formula lab and stock room. ii. Work Requests a. A Work Request dated 1/15/26, for “Plumbing/Leaks,” was requested by clinical nutrition supervisor (Supervisor) #3. This work request problem type read, ceiling leak. The request was tagged as routine priority and was dispatched to the facilities team. The work request notes on 1/15/26 read, the wet and damaged insulation was removed, a fan above the ceiling was installed, contaminated baby formula was removed, and the walls and countertops were wiped down. The notes on 1/16/26 read, damaged ceiling tiles were removed and a fan was put above the ceiling. This work request was in contrast with the Water Release Responsibility policy which read, a water release was any water event where water impacted areas outside of the source and touched ceiling tiles, carpet, drywall, and/or soffit (hard lid ceiling). Including sewage backups that extended outside of the source room. For any water release event reported, the Control Center should have documented the release by creating an Urgent Work Request. b. A Work Request dated 1/22/26 read, replace cabinets and countertops in prep area. C. Interviews i. An interview was conducted on 1/20/26 at 2:02 p.m. with formula human milk tech (Tech) #6. Tech stated when they were working in the milk lab on 1/15/26, sewage water began pouring into the milk lab and storage area. Tech #6 stated the volume of water required staff to use towels in an attempt to clean up the water, and that water got into a microwave, and a cabinet filled with formula. Tech #6 stated they placed an internal ticket to report the issue. Tech #6 stated a plumber was dispatched to the milk lab and storage area, but the plumber focused on the storage area first and did not enter the milk lab for approximately two hours. Tech #6 stated the water smelled of raw sewage, and when staff raised concerns, they were instructed by their leadership to continue preparing milk in the lab. Tech #6 stated at one point after the event on 1/15/26, maintenance personnel at the facility accessed the ceiling and replaced ceiling tiles while the staff were preparing milk. Tech #6 stated the microwave, formula, and cabinet that had been contaminated with water were not disposed of. Tech #6 stated the lab continued to smell of raw sewage after 1/15/26. When staff raised concerns, Tech #6 stated they were given portable fans in an attempt to mitigate the odor. Tech #6 stated the use of fans might have spread bacteria during milk and formula preparation, placing patients who consumed milk and formula at risk for infection. ii. An interview was conducted on 1/21/26 with plumber (Plumber) #7. Plumber #7 stated they were paged to go to the milk lab storage area on 1/15/26. Plumber #7 stated they entered the milk lab approximately two to three hours after the water event occurred. Plumber #7 stated milk lab staff communicated water had been pouring into the lab, and staff were cleaning up water with towels. Plumber #7 stated the source of the water was a clogged sewage line, resulting in an overflow of water. Plumber #7 stated they removed ceiling tiles in the milk lab, noting that three of the ceiling tiles were wet. Plumber #7 stated they did not replace the ceiling tiles until the following day, on 1/16/25. Plumber #7 stated there was a risk of infection from the water overflow. Plumber #7 stated they did not obtain a work permit, and did not contain the area. This interview was in contrast with the Water Release Responsibility policy which read, the industrial hygienist, assisted by facilities, should have performed a water release assessment using information from witnesses of the water release, moisture monitoring instruments, and visual observations. All assessment activities should have been performed under strict infection controls as determined by the industrial hygienist. The industrial hygienist was responsible for evaluating affected areas to determine the scope of damage and the remediation scope of work, and participating in the permit process. This interview was also in contrast with the Facilities: Construction Activities policy which read, all renovations in critical areas or invasive maintenance procedures should have been coordinated with the Department of Epidemiology, EVS, Safety, Property Planning Department, FO, Administration, and staff from the area under construction. An ICRA should have been done prior to the start of any construction work. The permitting process should have addressed barrier separation of the construction area, dust control, properly functioning ventilation, use of portable HEPA filtration units, terminal cleaning of the construction area, temporary housing of high-risk patients, minimizing exposure of high-risk patients to contamination, and use of portable HEPA filter vacuum sweepers. iii. An interview was conducted on 1/27/26 at 8:37 a.m. with clinical nutrition supervisor (Supervisor) #3. Supervisor #3 stated they were notified of a water leak on 1/15/26 and entered the milk lab at approximately 3:31 p.m. Supervisor #3 stated they assisted staff to use towels to wipe water on the walls and countertops. Supervisor #3 stated there was water “raining” from the ceiling in the milk lab supply room. Supervisor #3 stated staff continued to prepare milk during the water release event. Supervisor #3 stated they learned the source of the water was a clogged toilet, and after learning the source, they did not instruct staff to cease milk production in the milk lab. Supervisor #3 stated they were not instructed by facility operations, epidemiology, or the industrial hygienist to stop milk production in the milk lab. Supervisor #3 stated they had the authority to stop milk production if they had safety concerns and they should have clarified whether this was necessary. Supervisor #3 stated they did not know if continuing milk production in the lab after the water release created a patient safety risk. Supervisor #3 stated the facility should not have replaced ceiling tiles while techs were mixing milk because the milk could have been contaminated. Supervisor #3 stated staff complained of a sewage odor in the lab the following day, 1/16/26. Supervisor #3 stated they contacted EVS and clarified that a terminal clean (a thorough deep cleaning and disinfection of equipment, surfaces, and the entire room) of the milk lab had been completed on 1/15/26. Supervisor #3 stated they returned to the milk lab two days after the water release, on 1/17/26, and observed streaks on the walls and white powder covering flat surfaces. Supervisor #3 stated they were concerned that areas of the milk lab had not been cleaned and requested an additional terminal clean. Supervisor #3 stated the milk lab should have been a clean and aseptic (sterile, sanitized, or otherwise clean of infectious organisms) environment. Supervisor #3 stated there was a patient safety risk if bacterial contamination occurred in the milk lab. iv. An interview was conducted on 1/21/26 at 3:06 p.m. with infection preventionist (IP) #9. IP #9 stated they were notified on the evening of 1/15/26 of a water release in the milk storage room. IP #9 stated they were not notified water entered into the milk lab. IP #9 stated they met with a facility manager on 1/16/26 and conducted observations in the milk storage room. IP #9 stated they observed a small amount of moisture above the ceiling tiles and on the drywall. IP #9 stated they recommended using a fan for the moist area, throwing out the formula, and conducting three terminal cleans of the area. IP #9 stated they were not aware staff reported water running down the walls and coming down from the ceiling. IP #9 stated if they had been aware of the volume of water released, they would have recommended clearing out the entire storage room. If they had been notified water entered the milk lab, IP #9 stated they would have instructed staff to cease milk production in the lab due to a risk of contamination. IP #9 stated if caulking was breached with water, the cabinets, countertop, and backsplash should have been removed. IP #9 stated if the dry wall was wet, the dry wall should have been cut out. IP #9 stated there was a risk of ingesting germs or becoming sick due to the source of the water release. This was in contrast with the interview with Tech #6 who stated the facility did not dispose of formula, cabinetry, or a microwave contaminated with water. iv. An interview was conducted on 1/27/26 at 10:21 p.m. with industrial hygienist (Hygienist) #8. Hygienist #8 stated they were out of town when the water release occurred on 1/15/26. Hygienist #8 stated if the facility had a concern requiring an industrial hygienist, the facility should have partnered with one of the facility’s contracted consulting companies. Hygienist #8 stated they were not notified about the water release until 1/20/26 (five days later). Hygienist #8 stated if they had been at the facility on 1/15/26, they would have entered the milk lab and supply room immediately to isolate the leak, assess the damage, clean up the water, and contain the area. After the water entered the milk lab, Hygienist #8 stated the area should have been closed off and contained until the area was assessed. Additionally, Hygienist #8 stated the heating, ventilation, and air conditioning (HVAC) system should have been closed off to ensure a safe and sanitary environment. Hygienist #8 stated ceiling spaces contained fungal spores and bacteria. Hygienist #8 stated staff should not have used fans in the milk lab or supply room without containing the area with zipper doors (a plastic barrier used to help contain dust and contaminants), turning off the HVAC, and using HEPA filters. Hygienist #8 stated there was a risk fans used after the water release may have spread bacteria and fungal spores into other areas of the facility. Hygienist #8 stated because the area remained in use and was not closed off, there was risk of contaminated milk, mold and fungal infections, and a risk of patient or staff illness. Hygienist #8 stated the facility should have removed wet drywall, removed carpeting, and removed baseboards. This interview was in contrast with the 1/15/26 work request notes which indicated the facility removed water-damaged ceiling tiles and placed a fan above the ceiling. This interview was also in contrast to the interview with Tech #6 who stated staff were present and preparing milk during the water release, and during ceiling tile removal and repair after the water release.”

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 52287 Based on interviews and document review, the facility failed to comply with the Medicare provider agreement as defined in §489.20 and §489.24 related to Emergency Medical Treatment and Labor Act (EMTALA) requirements. 1. The facility failed to meet the following requirements under the EMTALA regulations: A-2406: Appropriate Medical Screening Examination. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction. Based on interviews and documents reviewed, the facility failed to comply with the EMTALA. Specifically, the facility failed to provide an appropriate medical screening examination (MSE) for a patient who presented to the emergency department (ED) to rule out an emergency medical condition (EMC) according to facility policy. This failure was identified in one of two obstetric (OB) patients’ medical records reviewed. (Patient #20) (Cross-reference A-2407) A-2407: Stabilizing Treatment. (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either-- (i) Within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. Based on interviews and documents reviewed, the facility failed to comply with the EMTALA. Specifically, the facility failed to ensure an obstetric patient was transferred when their needs exceeded the capabilities of the facility, according to facility policy. This failure was identified in one of two obstetric patients’ medical records reviewed. (Patient #20) (Cross-reference A-2406)”

“MEDICAL SCREENING EXAM CFR(s): 489.24(a) & 489.24(c) (a) Applicability of provisions of this section. (1) In the case of a hospital that has an emergency department, if an individual (whether or not eligible for Medicare benefits and regardless of ability to pay) “comes to the emergency department”, as defined in paragraph (b) of this section, the hospital must- (i) Provide an appropriate medical screening examination within the capability of the hospital’s emergency department, including ancillary services routinely available to the emergency department, to determine whether or not an emergency medical condition exists. The examination must be conducted by an individual(s) who is determined qualified by hospital bylaws or rules and regulations and who meets the requirements of §482.55 of this chapter concerning emergency services personnel and direction; and (ii) If an emergency medical condition is determined to exist, provide any necessary stabilizing treatment, as defined in paragraph (d) of this section, or an appropriate transfer as defined in paragraph (e) of this section. If the hospital admits the individual as an inpatient for further treatment, the hospital’s obligation under this section ends, as specified in paragraph (d)(2) of this section. (2)(i) When a waiver has been issued in accordance with section 1135 of the Act that includes a waiver under section 1135(b)(3) of the Act, sanctions under this section for an inappropriate transfer or for the direction or relocation of an individual to receive medical screening at an alternate location do not apply to a hospital with a dedicated emergency department if the following conditions are met: (A) The transfer is necessitated by the circumstances of the declared emergency in the emergency area during the emergency period. (B) The direction or relocation of an individual to receive medical screening at an alternate location is pursuant to an appropriate State emergency preparedness plan or, in the case of a public health emergency that involves a pandemic infectious disease, pursuant to a State pandemic preparedness plan. (C) The hospital does not discriminate on the basis of an individual’s source of payment or ability to pay. (D) The hospital is located in an emergency area during an emergency period, as those terms are defined in section 1135(g)(1) of the Act. (E) There has been a determination that a waiver of sanctions is necessary. (ii) A waiver of these sanctions is limited to a 72-hour period beginning upon the implementation of a hospital disaster protocol, except that, if a public health emergency involves a pandemic infectious disease (such as pandemic influenza), the waiver will continue in effect until the termination of the applicable declaration of a public health emergency, as provided under section 1135(e)(1)(B) of the Act. (c) Use of dedicated emergency department for nonemergency services. If an individual comes to a hospital’s dedicated emergency department and a request is made on his or her behalf for examination or treatment for a medical condition, but the nature of the request makes it clear that the medical condition is not of an emergency nature, the hospital is required only to perform such screening as would be appropriate for any individual presenting in that manner, to determine that the individual does not have an emergency medical condition. This Standard is not met as evidenced by: 52287 Based on interviews and documents reviewed, the facility failed to comply with the Emergency Medical Treatment and Labor Act (EMTALA). Specifically, the facility failed to provide an appropriate medical screening examination (MSE) for a patient who presented to the emergency department (ED) to rule out an emergency medical condition (EMC) according to facility policy. This failure was identified in one of two obstetric (OB) patients’ medical records reviewed. (Patient #20) (Cross-reference A-2407) Findings include: Facility policies: The EMTALA policy read, the MSE must be appropriate to the individual’s presenting signs and symptoms, as well as the capability and capacity of the facility. The Obstetrical Patient Triage and Care in the Emergency Department policy algorithm attachment read, patients presenting with an obstetrical complaint will be stabilized and transferred to a facility with obstetric services. If the patient is greater than 16 weeks, the ED performs an MSE, including an external genitourinary (reproductive and urinary systems) examination. 1. The facility failed to ensure an MSE was performed on an obstetrical patient who presented to the ED to rule out an EMC. A. Document Review i. A live medical record review was conducted on 1/22/26 at 12:02 p.m. with accreditation specialist (Specialist) #1. Medical record review revealed Patient #20, a 29-year-old, 33-week pregnant patient, presented to ED triage on 9/11/25 at 8:37 a.m. with complaints of vaginal bleeding, leakage of fluid, and lower abdominal pressure. Review of Provider #3’s assessment notes revealed Patient #20 had been diagnosed with pregnancy and vaginal bleeding. Provider #3’s plan read Patient #20 was to present to OB triage at an adjacent facility, with an additional note which read the other facility was “aware” of Patient #20. Patient #20 was discharged at 9:10 a.m. The medical record failed to reveal Provider #3 had assessed Patient #20’s vaginal bleeding, fluid leakage, and fetal heart tones (FHTs) (used to assess the well-being of the fetus). This lack of MSE was in contrast to the EMTALA policy which read, the MSE must be appropriate to the individual’s presenting signs and symptoms, and the Obstetrical Patient Triage and Care in the ED policy algorithm attachment which read, the ED performed an MSE to include an external genitourinary examination for patients greater than 16 weeks pregnant. The medical record review also failed to reveal discharge instructions for Patient #20 to present to OB triage at the adjacent facility, apart from the plan mentioned in the provider’s note. This was in contrast to the Obstetrical Patient Triage and Care in the ED policy algorithm attachment, which read, patients who presented with an obstetrical complaint would be stabilized and transferred to a facility with obstetric services. ii. A medical record review revealed Patient #16, a 17-year-old patient, presented to ED triage on 11/22/25 at 12:37 p.m. with complaints of back pain, diarrhea, cramping, and vaginal bleeding. Based on the history provided by Patient #16, staff determined they were between 36 to 40 weeks pregnant. Medical record review revealed Patient #16’s diagnosis was pregnancy with active labor. Provider #3’s documentation revealed a point-of-care ultrasound (POCUS) had been performed, which positively identified a pregnancy and also assessed FHTs. Patient #16 was transferred to an adjacent facility for obstetric services. This was in contrast to Patient #20’s medical record review, which failed to reveal Provider #3 had assessed Patient #20’s FHTs, had ruled out an EMC, or stabilized and transferred Patient #20 to a facility with obstetric services. B. Interviews i. An interview was conducted on 1/22/26 at 12:41 p.m. with registered nurse (RN) #2. RN #2 stated an MSE was completed to ensure patients were medically stable. RN #2 stated FHTs were assessed to verify a viable pregnancy and used to determine whether an emergency intervention was required. RN #2 stated FHTs were also used to confirm if the patient was stable for transfer. RN #2 further stated failure to assess FHTs could have resulted in the death of both the patient and the fetus. ii. An interview was conducted on 1/22/26 at 1:36 p.m. with Provider #3. Provider #3 stated every patient received an MSE, however, obstetrical imaging and diagnostics were performed once the patient was transferred to another facility. Provider #3 stated the MSE for Patient #20 had not included an external vaginal examination. This was in contrast to the Obstetrical Patient Triage and Care in the ED policy algorithm attachment, which read, the ED performed an MSE to include an external genitourinary examination. Provider #3 further stated they had not performed an ultrasound or assessed FHTs on Patient #20, as this was typically performed by the OB facility once the patient was transferred. This statement was in contrast to Patient #16’s medical record review, which revealed Provider #3 had performed an ultrasound to assess FHTs. This was also in contrast to the EMTALA policy which read, the MSE must be appropriate to the individual’s presenting signs and symptoms, as well as the capability and capacity of the facility. iii. An interview was conducted on 1/26/26 at 1:30 p.m. with the ED medical director (Director) #4. Director #4 stated an MSE would be conducted on a patient within the facility’s capabilities. This was in contrast to the medical record review, which revealed Patient #20 had not received an appropriate MSE to rule out an EMC.”

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 52287 Based on interviews and documents reviewed, the facility failed to comply with the Emergency Medical Treatment and Labor Act (EMTALA). Specifically, the facility failed to ensure an obstetric patient was transferred when their needs exceeded the capabilities of the facility according to facility policy. This failure was identified in one of two obstetric patients’ medical records reviewed. (Patient #20) (Cross-reference A-2406) Findings include: Facility policies: The EMTALA policy read, if an individual is determined to have an EMC and the facility lacks the capability to stabilize the EMC, the facility must arrange an appropriate transfer. The Obstetrical Patient Triage and Care in the Emergency Department policy read, patients presenting with an obstetrical complaint will be stabilized and transferred to a facility with obstetric services. 1. The facility failed to ensure an obstetric patient was stabilized within the capabilities of the facility and transferred according to facility policy. A. Document Review i. A live medical record review was conducted on 1/22/26 at 12:02 p.m. with accreditation specialist (Specialist) #1. Medical record review revealed Patient #20, a 29-year-old 33-week pregnant obstetrical (OB) patient, presented to ED triage on 9/11/25 at 8:37 a.m. with complaints of vaginal bleeding, leakage of fluid, and lower abdominal pressure. Review of Provider #3’s assessment notes revealed Patient #20 had been diagnosed with pregnancy and vaginal bleeding. Medical record review failed to reveal stabilizing treatment provided to Patient #20 for vaginal bleeding, leakage of fluid, and lower abdominal pressure. Patient #20 was discharged from the facility at 9:10 a.m. This was in contrast to the Obstetrical Patient Triage and Care in the Emergency Department policy, which read, patients who presented with an obstetrical complaint would be stabilized and transferred to a facility with obstetric services. This was also in contrast to the EMTALA policy, which read, if an individual was determined to have an EMC and the facility lacked the capability to stabilize the EMC, the facility must arrange an appropriate transfer. ii. A medical record review revealed Patient #16, a 17-year-old patient, presented to ED triage on 11/22/25 at 12:37 p.m. with complaints of back pain, diarrhea, cramping, and vaginal bleeding. Based on the history provided by Patient #16, the staff determined they were between 36 to 40 weeks pregnant. Medical record review revealed Patient #16’s diagnosis was pregnancy with active labor. Patient #16 was transferred to an adjacent facility for obstetric services. This was in contrast to Patient #20’s medical record review, which failed to reveal Patient #20 had been stabilized within the capabilities of the facility and transferred to a facility with obstetric services. B. Interviews i. An interview was conducted on 1/22/26 at 1:36 p.m. with Provider #3. Provider #3 stated Patient #20 had received an assessment of vital signs and a physical examination, which had not included an external vaginal examination. Provider #3 stated the facility did not have the capability to treat patients if they were in fetal distress. Provider #3 stated OB patients with fetal distress should have been transferred to a facility with the obstetric capabilities. Provider #3 stated they did not believe Patient #20 was unstable and discharged them with the understanding they would go to OB triage at an adjacent facility. ii. An interview was conducted on 1/26/26 at 1:30 p.m. with the ED medical director (Director) #4. Director #4 stated it was not within the facility’s capability to intervene if a patient was in fetal distress. Director #4 further stated OB patients should have been stabilized and transferred to a facility with the capability to care for the patient and fetus. This was in contrast to the medical record review for Patient #20, which revealed stabilizing treatment had not been provided and Patient #20 had been discharged.”