Anaheim Global Medical Center

“PATIENT RIGHTS: GRIEVANCES CFR(s): 482.13(a)(2) The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure one of eight sampled patients (Patient 3) had their grievance promptly processed in accordance with the hospital’s P&P. This failure created a risk of unresolved safety and quality-of-care concerns and the potential for substandard patient care. Findings: During a review of the hospital’s P&P titled, “Complaints and Grievance, Patient” dated 9/2023, the P&P showed: * Grievance - a formal or informal written (written communication is always considered a grievance) or verbal complaint (when a verbal complaint about patient care is not resolved at the time of the complaint by staff present) by a patient or patient’s representative, regarding any of the following: .... b. Abuse or neglect * Upon receipt of a patient/patient’s representative complaint, the Department Director/Manager/designees, or individual in charge of the department for that shift, will review the issue with those involved and try to resolve it. ..... * Quality/Risk Management Director/Manager/designee will review the database of complaints at least weekly to assure follow-up * A follow up letter will be sent to the patient/patient representative within seven days, which may include name of hospital contact, steps taken on behalf of the patient to investigate the grievance, results of the grievance process, date of completion. * When a grievance will not or cannot be resolved or the investigation is not or will not be completed within the seven-day time frame, the patient or patient’s representative will be informed within those seven days that follow-up will be provided in the form of a written response within 30 days. A random grievance was selected from grievance log to evaluate whether the hospital followed its grievance-handling process. The selected grievance involved Patient 3. During a review of Patient 3’s closed medical record on 6/10/26, the medical record showed Patient 3 was admitted to the hospital on 3/11/26 and was discharged on 3/25/26. During a review of the Progress Notes dated 3/12/26 at 1251 hours, the Progress Notes showed Patient 3 informed to the social worker Patient 3 was raped yesterday between 1400 hours and 1600 hours. Additional documentation showed the allegation was reported and documented by the nursing staff and the police department was also notified by the charge nurse. On 6/10/26 at 1205 hours, the CNO/CCO was asked to provide the grievance response letter for Patient 3. During an interview with the CNO/CCO on 6/10/25 at 1400 hours, the CNO/CCO stated Patient 3 reported the incident on 3/12/26. The CNO/CCO acknowledged that the incident was not considered a grievance and confirmed that the grievance process was not followed.”

“PATIENT RIGHTS: INFORMED CONSENT CFR(s): 482.13(b)(2) The patient or his or her representative (as allowed under State law) has the right to make informed decisions regarding his or her care. The patient’s rights include being informed of his or her health status, being involved in care planning and treatment, and being able to request or refuse treatment. This right must not be construed as a mechanism to demand the provision of treatment or services deemed medically unnecessary or inappropriate. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure pressure injury related to a device was informed to one of eight sampled patients (Patient 2)’s family member. This failure posed a risk of violating Patient 2’s rights. Findings: During a review of Patient 2’s closed medical record on 6/10/26, the medical record showed Patient 2 was admitted to the hospital on 4/16/26 and was discharged on 4/28/26. During a review of the Consultation dated 4/15/26, the Consultation showed Patient 2 had a history of being nonverbal and intellectual disability. During a concurrent interview and Patient 2’s medical record review on 6/11/26 at 0810 hours, with the Regional Director of Behavioral Health, the Regional Director of Behavioral Health stated Patient 2 developed hospital acquired pressure injury to the back of the bilateral ankles due to the hard restraints. During a review of the Progress Notes dated 4/16/26 at 1702 hours, the Progress Notes showed Patient 2 was admitted to the unit. During a review of the Behavioral Restraint/seclusion Flowsheet, the Behavioral Restraint/seclusion Flowsheet showed Patient 2 was in four-points hard restraints (bilateral wrists and ankles) on following dates: * On 4/16/26 from 1315 to 1700 and 1720 to 2130 hours. * On 4/17/26 from 1130 to 2145 hours * On 4/19/26 from 1845 to 0000 hours * On 4/20/26 from 1830 to 2200 hours * On 4/22/26 from 1130 to 1430 and 1700 to 2045 hours. * On 4/23/26 from 0930 to 1315 and 1525 to 2200 hours. * On 4/24/26 from 0950 to 1340 hours. * On 4/24/26 from 1630 to 4/25/26 at 0030 hours. * On 4/25/26 from 0748 to 1348 and 1915 to 2145 hours. * On 4/26/26 from 0745 to 1130, 1355 to 1700, and 2000 to 2345 hours. During a review of the Skin Assessment dated 4/17/26 at 2030 hours, the Skin Assessment showed red marks in the restraint areas noted on bilateral arms and legs. During a review of the Photograph dated 4/26/26, the Photograph showed bilateral skin impairments on the back of both ankles. The skin impairment showed linear tear mark with redness. During a review of the Skin Care Plan dated 4/27/26 at 1241 hours, the Skin Care Plan showed Patient 2 was at risk for impaired skin integrity due to skin abrasions on back of ankle (Achilles tendon) and wound on left lower leg. During a review of Patient 2’s medical record, the medical record failed to show documentation the hard restraints related pressure injury to the back of bilateral ankles was informed to Patient 2’s family member. During an interview with the CNO/CCO and Patient Safety Officer on 6/11/26 at 1146 hours, the CNO/CCO and Chief Quality and Patient Safety Officer 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: 35310 Based on interview and record review, the hospital failed to ensure the nursing staff documented the adverse event in the medical record when the ED patient self-harmed for one of eight sampled patients (Patient 1). This failure posed the risk of substandard healthcare outcomes for the patients in the hospital. Findings: During a review of medical record for Patient 1 on 6/10/26, Patient 1’s medical record showed Patient 1 was admitted to the hospital on 4/13/26 and was discharged on 5/4/26. During a review of the ED Provider Aware Note dated 4/13/26 at 1059 hours, the ED Provider Aware Note showed Patient 1 presented to the ED on a 5150 hold for GD. Upon further evaluation, Patient 1 took a sharp object lacerations and made a laceration of left and right leg and superficial lacerations to left arm and left cheek. During an interview and concurrent medical record review with the ED Director on 6/10/26 at 1109 hours, the ED Director stated they watched the video footage. The ED Director stated Patient 1 was in C-side due to legal hold status where a mental health worker monitored up to four patients. The ED Director stated RN 3 who was assigned to care for Patient 1 left C-side area for medication, and MHW 1 left the C-side area as well. When asked, the ED Director stated she conducted investigation from watching video footage and was able to provide timeline of the event. During a review of the Timeline of Events, the Timeline of Events showed on 4/13/26 at 1026 hours, Patient 1 was placed in C-side area in ED. RN 3 went outside to remove and prepare the medication. At this time, the MHW walked out of the side. As RN 3 was entering the room to administer the medication, it was observed Patient 1 was in the process of self-harming with a metal object. During a review of the Progress Note by RN dated 4/13/26 at 1130 hours, the Progress Note showed the RN assisted ED doctor with laceration repair of bilateral lower extremity. However, the remainder of the medical record failed to show any description of above the event. During an interview with the ED Director 4/13/26 at 1130 hours, the ED Director acknowledged RN 3 did not document to describe the above event in Patient 1’s medical record.”

“PATIENT RIGHTS: FREE FROM ABUSE/HARASSMENT CFR(s): 482.13(c)(3) The patient has the right to be free from all forms of abuse or harassment. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure the sexual assault was reported to the CDPH within 24 hours after the detection for one of eight sampled patients (Patient 3). This failure posed the risk of delaying the investigation of the event and of violating the patient’s rights. Findings: Review of the hospital’s P&P titled Adverse Event Reporting revised 9/2023, showed it is the hospital’s policy to report an adverse event to the CDPH no later than five days after the event has been detected; or if the event is an ongoing urgent or emergent threat to the welfare, health, or safety of patients, personnel, or visitors, not later than 24 hours after the adverse event has been detected. Review of the CDPH AFL 21-40 dated 11/12/21, showed the detection of or allegation of sexual assault is considered an ongoing or emergent threat and must be reported within 24 hours. In addition, the regulations specify the hospital is subject to an onsite investigation when CDPH determines that an adverse event or complaint is an ongoing threat of imminent danger of death or serious bodily harm. Review of Patient 3’s closed medical record on 6/10/26, showed Patient 3 was admitted to the hospital on 3/11/26 and was discharged on 3/25/26. Review of Progress Notes dated 3/12/26 at 1251 hours, showed Patient 3 informed to the social worker that Patient 3 was raped between 1400 to 1600 hours yesterday. Further review of Patient 3’s medical record showed the allegation was reported and documented by the nursing staff and the police department was also notified per the charge nurse. On 6/10/26 at 1205 hours, the CNO/CCO was asked to provide the evidence of reporting the sexual assault allegation to the CDPH. On 6/10/26 at 1400 hours, the CNO/CCO stated the above sexual abuse allegation was not reported to the CDPH within 24 hours after the detection of the allegation.”

“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: 35310 Based on interview and record review, the hospital failed to ensure nursing staff obtained a physician’s order for the use of restraints for one of eight sampled patients (Patient 2). This failure placed the patient at risk for unsafe care and poor clinical outcomes. Findings: During a review of the hospital’s P&P titled “Restraint and Seclusion,” dated 3/2024, the P&P showed: * The physician, NP, PA are authorized to order restraints. In emergencies, restraints can be initiated by a nurse at which time a physician order must be obtained as soon as possible after the emergency has subsided but no later than one hour from initiation. * Restraint or seclusion will be terminated at the earliest possible time regardless of the time length of the order. If a patient is released from restraint or seclusion and later exhibits behavior that can only be handled through the use of restraint or seclusion, a new order must be obtained prior to reinitiating the use of restraint or seclusion. During a review of Patient 2’s closed medical records on 6/10/26, the medical record showed Patient 2 was admitted to the hospital on 4/16/26 and was discharged on 4/28/26. During a review of the orders dated 4/15/26 at 2314 hours, the orders showed an to apply hard restraints to Patient 2’s bilateral wrists and ankles. During a review of the Restraints Flowsheets dated 4/15/26, the Restraints Flowsheets showed Patient 2 was on four-point (bilateral wrists and bilateral ankles) hard restraints from 2315 to 2345 hours. During a review of the Restraints Flowsheets dated 4/16/26, the Restraint Flowsheet showed Patient 2 was on four points (bilateral wrists and bilateral ankles) hard restraints from 1315 to 1700 hours. However, further review of Patient 2’s medical record failed to show the physician’s order for those restraints. During a concurrent interview and Patient 2’s medical record review on 6/11/26 at 1140 hours, with the ED Director, the ED Director stated they thought the restraints order for violent behaviors was good for 24 hours. During an interview with the CNO/CCO and Chief Quality and Patient Safety Officer the on 6/11/26 at 1146 hours, the CNO/CCO and Chief Quality and Patient Safety Officer acknowledged the above findings.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(9) Restraint or seclusion must be discontinued at the earliest possible time, regardless of the length of time identified in the order. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure the removal of the four-point hard restraints at the earliest possible time was documented for one of eight sampled patients (Patient 2). This failure resulted in the potential for not protecting the ‘s right to be free from restraints. Findings: Review of the hospital’s P&P titled Restraint and Seclusion under Monitoring of the in Restraint or Seclusion under E. Termination of Restraint or Seclusion dated 3/2022, showed the following: * When the condition or symptoms that warranted the use of restraint or seclusion are no longer present (the patient is no longer violent or self-destructive, the unsafe situation no longer exists, the patient’s behavior is no longer a threat to self, staff members or others), restraint/seclusion is to be discontinued. * Restraint or seclusion will be terminated at the earliest possible time regardless of the time length of the order. If a patient is released from restraint or seclusion and later exhibits behavior that can only be handled through the use of restraint or seclusion, a new order must be obtained prior to reinitiating the use of restraint or seclusion. During a review of Patient 2’s closed medical record on 6/10/26, the medical record showed Patient 2 was admitted to the hospital on 4/16/26 and was discharged on 4/28/26. During a review of the Orders dated 4/15/26 at 2314 hours, the Orders showed an order to place hard restraints on Patient 2. During a review of the Restraints Safety/Rationale/Response/Type/Status dated 4/15/26, the Restraints Safety/Rationale/Response/Type/Status showed: * At 2315 hours, the hard restraints to bilateral wrists and ankles were initiated. * At 2330 hours, the hard restraints to bilateral wrists and ankles were still on. * At 2345 hours, the hard restraints to bilateral wrists and ankles were still on. During a review of Patient 2’s medical record, the medical record failed to show the document of removal of the hard restraints. During a concurrent interview and Patient 2’s medical record review on 6/11/26 at 1140 hours, with the ED Director, the ED Director verified the above findings.”

“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: 35310 Based on interview and record review, the hospital failed to ensure one of eight sampled patients (Patient 2) was monitored for the use of restraints as per the hospital’s P&P as evidenced by: 1. Nursing staff did not notify the physician of Patient 2’s hospital-acquired pressure injury related to hard restraints. 2. A wound consultation for Patient 2’s hospital-acquired pressure injury was not placed as required by the hospital’s P&P. 3. There was no nursing documentation describing the skin impairment to the bilateral ankles when the photograph of the wound was obtained for Patient 2. 4. Patient 2’s documentation of the skin assessments were inconsistent throughout the hospitalization. 5. Patient 2’s skin injury was not documented on the restraint flowsheet under the required monitoring elements. These failures had the potential to result in unsafe care and adverse clinical outcomes for patients. Findings: During a review of the hospital’s P&P titled “Restraint and Seclusion under Monitoring of the Patient in Restraint or Seclusion,” dated 3/2022, the P&P showed: * Patients placed in restraint for violent or self-destructive behavior will be evaluated/monitored through continuous in-person observation at least every 15 minutes, or more frequently if necessary, according to the parameters listed below. * Monitoring of a patient in restraints will include, at the frequency indicated above: a. whether the restraint has been appropriately applied (check for signs of injury, skin integrity maintained, adequate sensation). During a review of Patient 2’s medical record on 6/10/26, Patient 2’s medical record showed Patient 2 was admitted to the hospital on 4/16/26 and was discharged on 4/28/26. During a review of the Behavioral Restraint/seclusion Flowsheet showed Patient 2 was on four points hard restraints (bilateral wrists and ankles) on following dates: * On 4/16/26 from 1315 to 1700 and 1720 to 2130 hours. * On 4/17/26 from 1130 to 2145 hours * On 4/19/26 from 1845 to 0000 hours * On 4/20/26 from 1830 to 2200 hours * On 4/22/26 from 1130 to 1430 and 1700 to 2045 hours. * On 4/23/26 from 0930 to 1315 and 1525 to 2200 hours. * On 4/24/26 from 0950 to 1340 hours. * On 4/24/26 from 1630 to 4/25/26 at 0030 hours. * On 4/25/26 from 0748 to 1348 and 1915 to 2145 hours. * On 4/26/26 from 0745 to 1130, 1355 to 1700, and 2000 to 2345 hours. During a concurrent interview and Patient 2’s record review on 6/11/26 at 0810 hours, with the Regional Director of Behavioral Health, the Regional Director of Behavioral Health stated Patient 2 developed a hospital-acquired pressure injury to the posterior bilateral ankles caused by hard restraints. 1. During a review of the hospital’s P&P titled “Skin Care/Pressure Injury,” dated 1/2024, the P&P showed the physician will be notified whenever a pressure injury is discovered. During a review of the Skin Assessment dated 4/17/26 at 2030 hours, the Skin Assessment showed red marks at the restraint ’ s areas noted on bilateral arms and legs. During a review of the Photograph dated 4/26/26, the Photograph showed the bilateral skin impairment on back of the ankle. The skin impairment showed linear tear mark with redness. During a review of the Skin Care Plan dated 4/27/26 at 1241 hours, the Skin Care Plan showed Patient 2 was on risk of impaired skin integrity due to skin scrapped on back of ankle (Achilles tendon) and wound on left lower leg. Further medical record failed to show the hard restraints related pressure injury to the back of bilateral ankles was notified to Patient 2’s responsible physician. 2. During a review of the hospital’s P&P titled “Skin Care/Pressure Injury,” dated 1/2024, the P&P showed: * The assessment of all identified pressure injuries will be documented on the “Ana-Pressure Injury” tab Pressure Injury Treatment Order will be initiated with a physician’s order and/or consultation with the Wound Care Nurse. * For questions on wounds identified as Stage III or greater, unstageable, or deep tissue injury, the designated Wound Care Nurse should be contacted to evaluate the wound. * The Administrative House Supervisor (AHS) will have the primary responsibility for contacting the Wound Care Nurse and coordinating the consultation. * The primary care nurse will be responsible for communicating with the AHS in the event the consultation has not been performed timely. The NPIAP (the National Pressure Injury Advisory Panel) defined the following. * A pressure injury is localized damage to the skin and/or underlying soft tissue usually over a bony prominence or related to a medical or other device. * Stage 3 pressure injury is defined as a full-thickness skin loss in which fat tissue is visible in the ulcer. Slough and/or eschar may be visible. Fascia, muscle, tendon, ligament, cartilage and/or bone are not exposed. * Stage 4 pressure injury is defined as a full-thickness skin and tissue loss with exposed or directly palpable muscle, tendon, ligament, or bone in the ulcer. Slough and/or eschar may be visible. * Unstageable Pressure Injury is defined as an obscured full-thickness skin and tissue loss in which the extent of tissue damage within the ulcer cannot be confirmed because it is obscured by slough or eschar. If slough or eschar is removed, a Stage 3 or Stage 4 pressure injury will be revealed. * Deep Tissue Pressure Injury is defined as persistent non-blanchable deep red, maroon or purple discoloration. The wound may evolve rapidly to reveal the actual extent of tissue injury, or may resolve without tissue loss. During a review of the Photograph dated 4/26/26, the Photograph showed the bilateral skin impairment on back of the ankle. The skin impairment showed linear tear mark with redness. During a review of the Skin Care Plan dated 4/27/26 at 1241 hours, the Skin Care Plan showed Patient 2 was on risk of impaired skin integrity due to skin scrapped on back of ankle (Achilles tendon) and wound on left lower leg. Further medical record failed to show the wound consultation was placed for the hard restraint-related pressure injury to the back of bilateral ankles. 3. During a review of the hospital’s P&P titled “Skin Care/Pressure Injury,” dated 1/2024, the P&P showed: * Skin integrity will be re-assessed each shift for all acute medical-surgical inpatients and documented on the electronic health record. For behavior health, skin assessment is re-assessed twice a day. * To promote consistency in wound measurement, measure wounds by the following method: - The length of the wound is the longest measurement on the vertical axis (the longest measurement on the axis from the patient’s head to the patient’s feet). - The width of the wound is the longest measurement on the horizontal axis (the longest measurement on the axis from one side of the patient to the other). - The wound depth is the deepest measurement directly perpendicular to the plane of the wound. * The assessment of all identified pressure injuries will be documented on the “Ana-Pressure Injury” tab Pressure Injury Treatment Order will be initiated with a physician’s order and/or consultation with the Wound Care Nurse. Review of the Photograph dated 4/26/26, showed the bilateral skin impairments on back of both ankles. The skin impairment showed linear tear mark with redness. During a review of the Skin Care Plan dated 4/27/26 at 1241 hours, the Skin Care Plan showed Patient 2 was on risk of impaired skin integrity due to skin scrapped on back of ankle (Achilles tendon) and wound on left lower leg. However, further review of Patient 2’s medical record failed to show the nursing staff documented the wound’s description. 4. Review of the hospital’s P&P titled Skin Care/Pressure Injury dated 1/2024, showed the skin integrity will be re-assessed each shift for all acute medical-surgical inpatients and documented on the electronic health record, For behavioral health patients, skin assessment will be re-assessed twice a day. Review of the Skin Assessment showed the following: * On 4/17/26 at 1100 hours, Patient 2’s skin was intact. * On 4/17/26 at 2030 hours, Patient 2’s skin was intact with red marks at the restraint ’ s areas on bilateral arms and legs. * On 4/18/26 at 1133 hours, Patient 2’s skin was intact. * On 4/19/26 at 0121 hours, Patient 2 had skin breakdown. * On 4/19/26 at 0849 hours and on 4/20/26 at 0000 and 0942 hours, Patient 2’s skin was intact. * On 4/21/26 at 1141 hours, Patient 2’s skin was intact. * From 4/21/26 at 1810 hours to 4/27/26 at 0940 hours, Patient 2 had skin wound Review of the Photograph dated 4/26/26, showed bilateral skin impairment on back of the ankles with linear tear marks and redness. During a review of the Skin Assessment dated 4/27/26 at 1635 hours, the Skin Assessment showed Patient 2 had skin wounds to the right ankle and left lower leg. During a review of the Skin Care Plan dated 4/27/26 at 1241 hours, the Skin Care Plan showed Patient 2 was at risk of impaired skin integrity due to skin scrapped on the back of ankle (Achilles tendon) and wound on left lower leg. 5. During a review of the hospital’s P&P titled “Restraint and Seclusion under Monitoring of the Patient in Restraint or Seclusion,” dated 3/2022, the P&P showed the following: * Patients placed in restraint for violent or self-destructive behavior will be evaluated/monitored through continuous in-person observation at least every 15 minutes, or more frequently if necessary, according to the parameters listed below. * Monitoring of a patient in restraints will include, at the frequency indicated above: a. whether the restraint has been appropriately applied (check for signs of injury, skin integrity maintained, adequate sensation). During a review of the Behavioral Restraint/seclusion Flowsheet showed Patient 2 was on four-points hard restraints (bilateral wrists and ankles) on following dates: * On 4/16/26 from 1315 to 1700 and 1720 to 2130 hours * On 4/17/26 from 1130 to 2145 hours * On 4/19/26 from 1845 to 0000 hours * On 4/20/26 from 1830 to 2200 hours * On 4/22/26 from 1130 to 1430 and 1700 to 2045 hours. * On 4/23/26 from 0930 to 1315 and 1525 to 2200 hours. * On 4/24/26 from 0950 to 1340 hours. * On 4/24/26 from 1630 to 4/25/26 at 0030 hours. * On 4/25/26 from 0748 to 1348 and 1915 to 2145 hours. * On 4/26/26 from 0745 to 1130, 1355 to 1700, and 2000 to 2345 hours. During a review of the Skin Assessment dated 4/17/26 at 2030 hours, the Skin Assessment showed red marks at the restraint ’ s sites and on bilateral arms and legs. During a review of the Photograph dated 4/26/26, the Photograph showed bilateral skin impairment on back of the ankle. The skin impairment showed linear tear mark with redness. During a review of the Skin Care Plan dated 4/27/26 at 1241 hours, the Skin Care Plan showed Patient 2 was at risk of impaired skin integrity due to skin scrapped on back of ankle (Achilles tendon) and wound on left lower leg. During a review of the Behavioral Restraint/Seclusion Flowsheet, the Behavioral Restraint/Seclusion Flowsheet failed to show Patient 2’s skin impairment under the assessment of restraint appropriately applied (no injury, skin integrity maintained, sensation adequate). During an interview with the CNO/CCO and the Chief Quality and Patient Safety Officer on 6/11/26 at 1146 hours, the CNO/CCO and Chief Quality and Patient Safety Officer, they acknowledged the above findings.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(14) If the face-to-face evaluation specified in paragraph (e)(12) of this section is conducted by a trained registered nurse, the trained registered nurse must consult the attending physician or other licensed practitioner who is responsible for the care of the patient as soon as possible after the completion of the 1-hour face-to-face evaluation. This Standard is not met as evidenced by: 35310 Based on interview and record review, the hospital failed to ensure the physician or LIP was consulted after completion of the one-hour face-to-face evaluation by RN upon applying hard restraints for one of eight sampled patients (Patient 2). This failure posed a risk of substandard patient outcomes. Findings: During a review of the hospital’s P&P titled “Restraint and Seclusion under Monitoring of the Patient in Restraint or Seclusion,” “Section VI, Procedure B - Specific Requirements for Ordering Restraint or Seclusion for a Violent or Self-Destructive Patient,” dated 3/2022, the P&P showed when restraint or seclusion is used for the management of violent or self-destructive behavior the patient must be seen face-to-face within one hour after the initiation of the intervention, by a physician or RN who has been trained in accordance with the requirements of this policy. If the face-to-face evaluation is conducted by an RN, the RN must consult the attending physician who is responsible for the care of the patient as soon as possible after completing the evaluation. The consultation should include a discussion of the findings of the one-hour face-to-face evaluation, the need for other interventions or treatment, and the need to continue or discontinue the use of restraint or seclusion. The physician should provide guidance on ways to help the patient regain control. This consultation must occur with the physician prior to the next renewal order. During a review of Patient 2’s closed medical record on 6/11/26 at 0810 hours, the medical record showed Patient 2 was admitted to the hospital’s unit on 4/16/26 at 1702 hours and was discharged on 4/28/26. During a review of the Behavioral Restraint/seclusion Flowsheet, the Behavioral Restraint/seclusion showed Patient 2 was on four-points hard restraints (bilateral wrists and ankles) on following dates: * On 4/16/26, from 1315 to 1700 and 1720 to 2130 hours. * On 4/17/26, from 1130 to 2145 hours * On 4/19/26, from 1845 to 0000 hours * On 4/20/26, from 1830 to 2200 hours * On 4/22/26, from 1130 to 1430 and 1700 to 2045 hours. * On 4/23/26, from 0930 to 1315 and 1525 to 2200 hours. * On 4/24/26, from 0950 to 1340 hours. * On 4/24/26, from 1630 to 4/25/26 at 0030 hours. * On 4/25/26, from 0748 to 1348 and 1915 to 2145 hours. * On 4/26/26, from 0745 to 1130, 1355 to 1700, and 2000 to 2345 hours. Review of the above documentation showed RNs completed the required one-hour face-to-face evaluation. Further medical record review showed no evidence the responsible physician or LIP was consulted after the RN completed these evaluations, as required by the hospital’s P&P. During an interview with the CNO/CCO and Chief Quality and Patient Safety Officer on 6/11/26 at 1146 hours, the CNO/CCO and Chief Quality and Patient Safety Officer acknowledged the above findings.”

“VENTILATION, LIGHT, TEMPERATURE CONTROLS CFR(s): 482.41(c)(4) There must be proper ventilation, light, and temperature controls in pharmaceutical, food preparation, and other appropriate areas. This Standard is not met as evidenced by: 35310 Based on observation, interview and record review, the hospital failed to ensure the proper temperature control in the ED as evidenced by: 1. Temperatures in ED was consistently higher than P&P requirements. 2. Temperature in ED was inconsistently measured and documented. 3. There was a lack of documentation of interventions and evaluation when the temperature was out of range in ED. These failures posed the risk of providing unsafe environment to patients, staff, and visitors in ED. Findings: During a review of the hospital’s P&P titled “Climate Control and Temperature Readings,” dated 9/21/23, the P&P showed the hospital followed ASHRAE Standard and showed the following: * The Facilities Department is responsible for maintaining desired ambient temperatures throughout all buildings. The hospital identifies the requirements of temperature and the authorities having jurisdiction. When required, individual departments are responsible for recording accurate relative temperature readings and corrective actions responses. * The Emergency Department should be between 69.8 and 75.2 degrees F. * Engineers will ensure that all temperature and humidity changes are reported back to the unit or requester. If equipment is unable to maintain temperature or humidity, the corrective actions taken and the non-compliance, information shall be reported to the Department affected and the Facilities Department Manager. 1. During a tour of the ED on 6/10/26 at 0949 hours, with the Maintenance Lead and the ED Director, three portable ACs (one at the main ED- AC #1, one at the nursing station- AC # 2, and one at C-side of the ED - AC #3) were observed. The Maintenance Lead stated the AC in ED had been down for more than a year. During a tour of the ED, the following were identified: * AC #1 showed 76 degrees F. * AC #2 showed 80 degrees F. * AC #3 showed 75 degrees F. During a follow up tour of the ED on 6/10/26 at 1354 hours, with the Maintenance Lead and ED Director, the followings were identified: * AC #1 showed 79 degrees F. * AC #2 showed 82 degrees F. * AC #3 showed 79 degrees F. On 6/10/26 at 1359 hours, the Maintenance Lead measured the temperature of the following area with the facility’s thermometer: * The wall of the registration was 82.9 degrees F. * Physician’s Charting Room was 86 degrees F. * Room 5 was 82.5 degrees F. A concurrence interview and observation were conducted on 6/10/26 at 1405 hours. Patient 7 was in Room 5 receiving an ultrasound procedure, with a family member. Patient 7 and the family member stated they were both very hot in Room 5. Patient 7’s family member stated Patient 7 came to the ED due to a fever. During Patient 7’s medical record review on 6/10/26, The medical record showed the Vital Signs dated 6/10/26 at 1115 hours, showing Patient 7’s temperature was 101 degrees F. 2. During a tour of the ED on 6/10/26 at 0949 hours, with the Maintenance Lead and ED Director, the Maintenance Lead stated the facility department was responsible for measuring the temperature in ED and document in the log. The Maintenance Lead stated during weekends the temperature in ED was not measured and documented. Review of the Temperature Recording from 5/27/26 to 6/10/26, showed the temperature was not measured or documented on 5/28, 5/30, 5/31, 6/2, 6/4, 6/6, and 6/7/26. 3. During a tour of the ED on 6/10/26 at 0949 hours, with the Maintenance Lead and ED Director, the Maintenance Lead verified the temperature in ED was out of range. The Maintenance Lead stated additional fans and portable ACs could be added to lower the temperature in ED. The Maintenance Lead stated the temperature would be rechecked, but the corrective action and re-checking of temperature would not be documented. During an interview and record review on 6/10/26 at 1016 hours, with the Regional Director of Facility, the Regional Director of Facility acknowledged there was no system in place to ensure documentation of corrective actions and reevaluation when the temperature in ED was out of range.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 40483 Based on observation, interview, and record review, the hospital’s GB failed to ensure the safe and effective operation of the hospital. The GB failed to provide oversight and to ensure the hospital maintained essential services necessary to meet patient care needs. Specifically, the hospital’s GB failed to ensure the hospital maintained the current State of California Clinical and Public Health laboratory license from Lab Field Services between 5/5/2026 and 5/12/2026, resulting in a complete loss of in-house diagnostic testing services. With a hospital census of 102 patients, all 102 patients had the potential to be affected by this failure. These failures resulted in an Immediate Jeopardy (IJ) situation and placed all patients at risk for serious harm. 1. On 5/6/26 at 1711 hours, the surveyor notified the Regional CEO and the CNO/CCO that an Immediate Jeopardy (IJ) existed related to the loss of laboratory services. The IJ was abated on 5/12/26 at 1658 hours. The GB failed to ensure the Condition of Participation (CoP) for Laboratory Services was met. Cross reference to A576. 2. The GB failed to ensure the hospital maintained maintain the current State of California Laboratory Field Services (LFS) laboratory license, resulting in the inability to perform point-of-care testing and timely laboratory services for four of 20 sampled patients (Patients 1, 3, 4 and 15). Cross reference to A582. 3. The GB failed to ensure the hospital maintained a current state of California Laboratory Field Services (LFS) Laboratory license, which would allow them to operate as a 24-hour on-site emergency laboratory services to provide care for their patients. Cross Reference to A583. During an interview with the CEO on 5/19/26 at 0815 hours, the CEO stated that the hospital’s GB members included the Regional CEO, the CNO/CCO, the Governing Body Chair, and the Chief of Staff. The CEO stated the GB met every other month and received reports from the CEO and CNO/CCO during those meetings. The CEO reported that the last GB meeting occurred on 3/31/26. When asked about laboratory services, the CEO stated an ad hoc meeting was convened on 5/5/26, the day the lab license was lost due to forfeiture. No actions were taken prior to that date to prevent the loss of licensure or the resulting disruption of essential laboratory services. The cumulative effect of these systemic problems resulted in the inability of the hospital to provide safe and effective laboratory services to the patients, demonstrating that the GB did not ensure the safe and effective operation of the hospital.”

“LABORATORY SERVICES CFR(s): 482.27 The hospital must maintain, or have available, adequate laboratory services to meet the needs of its patients. The hospital must ensure that all laboratory services provided to its patients are performed in a facility certified in accordance with Part 493 of this chapter. This Condition is not met as evidenced by: 40483 Based on observation, interview, and record review, the hospital failed to ensure the availability of laboratory services to meet the needs of its patients, resulting in Immediate Jeopardy (IJ) and noncompliance with the CoP for Laboratory Services. With a hospital census of 102, all 102 patients had the potential to be affected by the hospital’s inability to perform required waived and non-waived laboratory testing, which created a risk for delayed diagnosis, delayed treatment, deterioration in patient condition, serious harm, or death. 1. On 5/6/26 at 1711 hours, the Regional CEO and CNO/CCO was notified of an IJ due to the following deficient practices related to the laboratory services: The hospital failed to maintain required laboratory services due to the loss of its State of California Clinical and Public Health Laboratory license on 5/5/26. The hospital did not have a current State of California Clinical and Public Health laboratory license from lab field services beginning on 5/5/26 until renewal/reinstatement on 5/12/26. This inactive/forfeiture of their LFS license meant the hospital Emergency Department (ED) could not perform required diagnostics while walk in emergency patients continued to present. This lack of point of care testing created a potential delay in treatment and diagnosis for ICU patients, Medical, Surgical and Telemetry Patients, OR patients, or patients with unstable conditions requiring any waived and non-waived laboratory tests. During this period, the ED and inpatient units were unable to perform waived and non-waived testing, including point-of-care glucose checks, I-STAT arterial blood gases, and time-sensitive STAT testing such as CMP or CK. This failure delayed critical diagnoses and treatments, placing patients at risk of serious harm, impairment, or death. On 5/5/26, the hospital’s in-house clinical laboratory lost their State of California Clinical and Public Health laboratory license through forfeiture and had to both reapply and pay for a reactivated license. The hospital’s State of California Clinical and Public Health laboratory license expired on 3/6/2026. The hospital was given a 60-day grace period to apply for renewal and pay the 4,000-dollar fee for the license. The hospital did not renew the license and pay the 4,000-dollar non-refundable renewal fee. California Department of Public Health, laboratory field services sent a letter on 5/5/26, notifying the hospital of their failure to renew the laboratory license and resulted in its loss of the laboratory license. This letter showed without the license, the clinical laboratory must cease performing all waived and non-waived testing on California specimens at hospital. Review of 20 sampled patients’ medical records showed the delayed STAT results, inability to perform POC glucose testing, and patients refusing venous blood draws, which further delayed treatment. Staff reported unclear instructions, and ED and nursing personnel relied on fire department glucometers for emergent glucose checks. Laboratory staff acknowledged continuing to spin, aliquot, and prepare specimens without a valid license, and reported no guidance from management. The hospital lacked a contingency or emergency laboratory plan, which resulted in samples being sent off-site, causing further delays and compromised patient care: delays of STAT lab results due to the blood samples having to be sent out to a different laboratory, delays and lack of results due to the inability to conduct point of care testing for blood sugar; and refusal by patients to have blood drawn instead of the blood sugar point of care testing. On 5/5/26, the hospital was unable to follow its lab P&P titled Laboratory Point of Care Testing dated 3/10/22, which included maintaining a current LFS Laboratory license. This license allowed the hospital to perform point of care testing on all hospital patients including those presenting at the ED, which included blood glucose, urine pregnancy tests, and I-STAT for arterial blood gases. The hospital was also unable to perform in-house lab testing of time sensitive STAT specimens such as CMP and CK. These STAT labs had to be sent to a sister hospital, Hospital 2 which delayed processing and result time. On 5/6/26, Staff Nurses reported unclear or absent guidance regarding point-of-care glucose testing. Nursing and ED staff reported reliance on the fire department glucometers for emergent cases such as Diabetic Keto Acidosis and Hypoglycemia. Walk-in ED patients continued to present conditions requiring laboratory diagnostic tests the hospital could not safely perform, including point of care tests for blood sugar. On 5/6/26, Laboratory staff acknowledged they continued spinning, making aliquots, and processing laboratory specimens (CBC, CMP, ammonia) despite the forfeited LFS Laboratory license. Laboratory staff reported unclear guidance from the laboratory management regarding processing specimens prior to sending the specimens to a different laboratory for testing. The hospital did not have a formal P&P (contingency or emergency preparedness plan) for what to do in the event of the inability to provide laboratory services to their patients. A sample of patients showed the hospital was unable to perform point-of-care testing for blood sugar and I-STATs. These tests had to be completed as part of CMP blood draws (which did not provide immediate results). On 5/12/26 at 1658 hours, the Regional CEO, the Chief Quality and Patient Safety Officer, and the CNO/CCO provided the surveyor with the finalized accepted plan of action. The IJ was abated on 5/12/26. Cross reference to A582. 2. The hospital failed to ensure they maintained a current State of California Laboratory Field Services (LFS) laboratory license, which would allow them to operate as a 24-hour laboratory on-site emergency laboratory services to provide care for their patients. Cross reference to A583. 3. The hospital failed to show a method for the determination between the medical staff and the pathologist regarding which tissue specimens required a macroscopic (gross) examination, and which required both macroscopic and microscopic examinations. Cross reference to A586 The cumulative effect of these systemic problems resulted in the inability of the hospital to provide safe and effective laboratory services to the patients.”

“ADEQUACY OF LABORATORY SERVICES CFR(s): 482.27(a) The hospital must have laboratory services available, either directly or through a contractual agreement with a certified laboratory that meets the requirements of part 493 of this chapter. This Standard is not met as evidenced by: 40483 Based on observation, interview, and record review, the hospital failed to maintain the current State of California Laboratory Field Services (LFS) laboratory license, resulting in the inability to perform point-of-care testing and timely laboratory services for four of 20 sampled patients (Patients 1, 3, 4 and 15) as evidenced by: 1. Failure to ensure the availability of essential laboratory services necessary to meet patient care needs as the hospital failed to maintain a valid State of California Clinical and Public Health Laboratory License. The hospital did not hold an active license from the California Department of Public Health, Laboratory Field Services (LFS) from May 5, 2026, until its renewal/reinstatement on May 12, 2026. 2. The immediate cessation of all point-of-care blood glucose testing (Accu-Chek), which provides rapid, real-time blood sugar data necessary for timely clinical decision-making. As a result, the hospital was unable to perform point-of-care glucose testing for any patients requiring blood glucose monitoring. Two of 20 sampled patients (Patient 1 and Patient 15) missed required blood glucose monitoring and subsequently missed insulin administration, placing the patients at risk for unstable or uncontrolled blood sugar levels, potential hyperglycemia, and preventable adverse outcomes. 3. Failure to follow their laboratory Point of Care Testing and Turnaround Times for Laboratory Results policy, which would have allowed qualified RNs could continue to perform point of care testing for blood sugars (Accu-Chek’s) for two patients of 20 sampled patients ( Patient 3 and Patient 4) who presented to the Emergency Department with AMS, Sepsis or Diabetes Mellitus (type 1 or type 2) type symptoms. 4. The hospital failed to label and date with time of collection 16 out of 24 collected patient specimens as per the hospital’s P&P. These failures had the potential for a delay in detecting and treating the medical problems for patients who were receiving the care in the hospital. Findings: Review of the hospital’s P&P titled Hospital Plan for Provision of Patient Care dated March 2025 showed the section of the Department: Laboratory showing the laboratory services are available 24 hours per days, 7 days per weeks. Specimens collected from patient of all ages, both inpatient and outpatients. The laboratory is able to process any test ordered. Tests performed in-house are assessed based on patient services type, urgency of result availability to decrease LOS; complexity/cost of performing test, qualification of staff to perform complexity of test per CLIA guidelines. The laboratory performs testing on blood, urine, stool, body fluids and culture specimens in the specialty area of hematology, chemistry, urinalysis, serology, immunology, immunohematology and microbiology. The laboratory performs testing based on priority level assigned by physician, including STAT, timed and routine priorities. During a review of the P&P titled “Laboratory Point of Care Testing,” dated 3/10/22, the P&P showed the purpose of the policy is to provide and maintain quality point-of-care laboratory services in a manner compliant with applicable regulations and accreditation standards .... Hospital 1 will maintain a current CLIA Laboratory Certification of Accreditation, or Certificate of Compliance applicable, and a current LFS laboratory License ...Tests shall be conducted in the designated areas at the hospital which may include blood glucose via Accu-chek (Waived), I-STAT for Arterial Blood Gas (ABG), and urine pregnancy tests (Waived) ....The laboratory director delegates waived testing competencies to RNs who have been competency tested by the laboratory staff ..... All staff performing point-of-care testing shall notify the ordering physician within one hour of any critical results obtained and document the notification in the chart ... Review of the hospital’s P&P titled Turnaround Times for Laboratory Results dated 3/23/21, showed STAT orders are results within one hour of collections. Review of the hospital’s P&P titled STAT Test Availability dated 3/23/21, showed the following tests are available within a turn-around time of one hours after receipt in the laboratory when ordered with a STAT priority: * CK * Comprehensive Metabolic Profile 1. During a review of Hospital 1’s State of California Clinical and Public Health LFS laboratory license, it showed it expired on 3/6/26. During a review of the letter from California Department of Public Health, LFS dated 5/5/26, it showed a 60-day grace period to renew the license had been given; however, the renewal was not received. The clinical laboratory license had been forfeited. The letter directed the hospital to cease all testing and showed that reactivation would require submission of a new application and renewal fee. 2. a. During a review of Patient 1’s medical record on 5/12/26. The medical record showed Patient 1 was admitted on 5/1/26 and left Against Medical Advice (AMA) on 5/7/26. During a review of Patient 1’s H&P dated 5/2/26, the H&P showed Patient 1 was admitted to the hospital with a history of diabetes with an initial ED workup blood sugar of 310 mg/dl (normal range is 70-99 mg/dl), and a noncompliant chronic left foot ulcer. The Treatment Plan showed insulin sliding scale (ISS) and Lantus (insulin used to control blood sugar). Review of Patient 1’s orders showed an order dated 5/2/26, for insulin sliding scale (ISS) and blood glucose point- of- care testing (POCT). This order was discontinued upon Patient discharge on 5/7/26. During a review of Patient 1’s POCT blood glucose results, they showed the following: * On 5/2/26 at 0608 hours, the test results showed a glucose POCT of 239 mg/dl * On 5/2/26 at 1107 hours, the test results showed a glucose POCT of 318 mg/dl. * On 5/2/26 at 1640 hours, the test results showed a glucose POCT of 258 mg/dl * On 5/3/26 at 1049 hours, the test results showed a glucose POCT of 425 mg/dl * On 5/3/26 at 1632 hours, the test results showed a glucose POCT of 341 mg/dl * On 5/3/26 at 1959 hours, the test results showed a glucose POCT of 234 mg/dl * On 5/4/26 at 1145 hours, the test results showed a glucose POCT of 312 mg/dl * On 5/4/26 at 1632 hours, the test results showed a glucose POCT of 276 mg/dl * On 5/4/26 at 2300 hours, the test results showed a glucose POCT of 175 mg/dl During a review of Patient 1’s MAR dated 5/4/26 at 2000 hours, the MAR showed 15 units of lispro (rapid-acting insulin), the last time he received any insulin. No further POCT for blood glucose was performed for Patient 1. No further insulin ordered given to Patient 1, from the evening of 5/4/26 through the patient’s discharge on 5/7/26. During a review of RN 2’s end-of-shift nursing note dated 5/5/26, the documentation showed that according to administration, no gluco-checks (POCT for blood sugar) were available and only blood draws could be used to check the blood glucose. Patient 1 was informed of this change and refused. RN 2 documented that Patient 1 was educated on the risks and benefits of having his blood glucose checked, but the patient continued to refuse. During an interview on 5/8/26 at 1340 hours, with RN 2, RN 2 verified he worked on 5/5/26 and was providing care to Patient 1. RN 2 stated he knew Patient 1 was diabetic and had been non-compliant with his care. RN 2 stated Patient 1 had been refusing blood draws but had been accepting the POCT for his blood sugar and the insulin administration. RN 2 stated the purpose of POCT for blood sugar was to give an immediate result which, if necessary, could be treated with the medically prescribed insulin. RN 2 stated Patient 1 had been prescribed insulin on a sliding scale, dose-dependent on the POCT reading. RN 2 stated POCT for blood sugar provided the nursing staff with the most immediate and accurate results, and was easier for the patient, It was a fingerstick rather than a blood draw from the patient’s vein. It was less invasive and caused the patient less pain. It was a rapid test, and you had your results and could treat the patient. RN 2 stated unlike a blood draw which had to be drawn, collected and processed by the lab which could take an hour even as a STAT, the POCT for blood sugar told you what was happening to a patient now so you could treat now. The blood draw told you what happened then, and blood sugar could change, especially when a patient ate. It could be different in 1 hours ’ time. For someone who was trending high like him, I needed to know his blood sugar now, so I could treat it, if needed. RN 2 stated on 5/5/26, the management had removed the POCT machines, but they were not initially informed of the reason. RN 2 stated they were preparing to perform the POCT for blood sugar on Patient 1 when the Charge Nurse informed them the hospital was no longer allowing RNs to perform POCT testing for blood sugar on patients. RN 2 stated he was informed patients would need to have their blood drawn instead. RN 2 stated they went in to tell Patient 1 this new information. RN 2 stated Patient 1 was not receptive and refused a venous blood draw. RN 2 stated Patient 1 had a psychiatric diagnosis, had been refusing all blood drawings, but had been accepting the POCT for his blood sugar until that point. RN 2 stated Patient 1 became upset and threatened to leave Against Medical Advice (AMA). RN 2 stated they tried to educate Patient 1 about the change in testing method but found it difficult because they themselves were not aware of the rationale for the removal of the POCT machines. RN 2 stated they provided education, but Patient 1 continued to refuse all blood draws, the proposed replacement method for checking blood sugar. RN 2 stated they were worried about Patient 1. Patient 1 had blood sugars ranging from 200 to 400 and now the hospital had removed his means to immediately test Patient 1’s blood sugar. Without these POCT values, RN 2 stated they could not provide any insulin to Patient 1 to treat possible blood sugar spikes. RN 2 stated without the POCT machines, they could not test Patient 1 and did not give the patient any more prescribed, dose and POCT dependent, insulin. RN 2 stated they had not given the prescribed insulin to Patient 1 on 5/5/26 without knowing the patient’s blood sugar. RN 2 stated now “all they could do was watch for symptoms.” RN 2 stated this removal of the POCT machines due to the hospital’s loss of its laboratory license caused him concern for Patient 1’s well-being. b. A review of Patient 15’s medical record was initiated on 5/13/26. Patient 15’s medical record showed the patient was admitted to the hospital on 2/23/26 and discharged on 5/8/26. During a review of Patient 15’s H&P dated 2/24/26, the H&P showed Patient 15 was admitted to the hospital with a diagnosis of hyperglycemia, with an initial ED workup blood sugar at 237 mg/dl, The Plan showed insulin sliding scale (ISS) and Lantus. Review of Patient 15’s MAR showed an order dated 4/27/26 for Insulin sliding scale (ISS) and blood glucose point of care testing (POCT). This order was discontinued via the patient’s discharge. Review of Patient 15’s most recent POCT blood glucose results showed the following: * On 5/1/26 at 2105 hours, the test results showed a glucose POCT of 190 mg/dl (Abnormally high) * On 5/2/26 at 0609 hours, the test results showed a glucose POCT of 112 mg/dl (Abnormally high) * On 5/2/26 at 1140 hours, the test results showed a glucose POCT of 139 mg/dl (Abnormally high) * On 5/2/26 at 1617 hours, the test results showed a glucose POCT of 141 mg/dl (Abnormally high) * On 5/4/26 at 1119 hours, the test results showed a glucose POCT of 127 mg/dl (Abnormally high) * On 5/4/26 at 1553 hours, the test results showed a glucose POCT of 109 mg/dl * On 5/4/26 at 2029 hours, the test results showed a glucose POCT of 156 mg/dl (Abnormally high) * On 5/5/26 at 0625 hours, the test results showed a glucose POCT of 174 mg/dl (Abnormally high) During a review of the tests results of a Comprehensive Metabolic Panel (CMP) on 5/5/26 at 1018 hours, the CMP result showed a glucose level of 162 mg/dl (Abnormally high) During a review of Patient 15’s MAR dated 5/5/26, the MAR showed 24 hours of this task had not been performed, with the red “X” for the insulin sliding scale units of Lispro insulin. No further POCT for blood glucose was performed for Patient 15. On 5/5/26, 5/6/26 and 5/7/26, orders for glucose levels as part of AM lab draws were placed but were not drawn, they were listed as canceled on 5/5/26 and 5/6/26. For 5/7/26, they were still pending collection. During a review of RN 5 documentation on 5/6/26 at 1607 hours, RN 5 documented unable to perform POCT for blood sugar due to administration order. Lab was closed per admin and could not process POCT for blood sugar . All glucose checks had to be done through blood draws and sent out to Hospital 2. The patient refused to have blood drawn, stating I just don’t want it. Risk of no glucose checked explained to the patient. Unable to administer insulin due to not having parameters to follow. Patient appeared asymptomatic to hypoglycemia or hyperglycemia. During an interview with RN 5 on 5/15/26 at 0830 hours, RN 5 stated he worked on 5/5/26, on day shift. RN 5 stated he had been assigned Patient 15. RN 5 stated he was now aware of what happened with the laboratory losing its license and, as a result, the nursing staff being unable to perform rapid glucose checks for diabetic patients. RN 5 stated on 5/5/26, he was unaware of the rationale; he only knew around 1000 hours, the POCT glucometers had been removed from the unit. RN 5 verified Patient 15 had refused blood draws to check his blood glucose that day. RN 5 verified what had been entered into the patient’s chart regarding his refusal for a blood draw instead of the POCT for blood sugar. RN 5 stated he provided education to Patient 15, but he still refused the blood draw used as a POCT replacement blood sugar test. RN 5 stated a blood draw was not the same as POCT testing and really wasn’t a substitute for the other. POCT gave real-time results-what was happening now to a patient and a lab draw was slow and gave delayed results. RN 5 stated blood sugar results could change in the time you wait. This could potentially cause problems with a patient’s health. POCT was a less invasive test, using a fingerstick, whereas a blood draw took a larger sample of blood and could cause more pain or trauma to a patient. RN 5 stated some patients did not like to be poked with a needle. RN 5 stated, “I did not give him any insulin that day. I could not, because I did not know what his blood sugar levels were.” He refused the blood draws. RN 5 stated the loss of the laboratory license caused a stressful situation on his unit and had the potential to become much worse. 3. a. During a review of Patient 4’s medical record on 05/06/26 at 1405 hours, the medical record showed the patient came to the ED on 5/5/26 at 1057 hours and discharged on 5/5/26 at 1230 hours During a review of Patient 4’s ED Provider Aware Note dated 5/5/26 at 1109 hours, the ED Provider Aware showed Patient 4 was admitted to the ED at 1057 hours from a SNF with reported hypoglycemia, and a BS on arrival of 39 mg/dl. Blood cultures were sent. The patient was to be started on IV Zosyn (an antibiotic) and Vanco (antibiotics) for Sepsis ... Per the lab, the lab was not able to run any laboratory tests at this time. Patient would be transferred for a higher level of care ... At 1130 hours: Patient was accepted for transfer to Hospital 2. At 1315 hours, the patient was transferred to Hospital 2.... Patient was critically ill with a high probability of imminent or life-threatening deterioration. Review of the Altera Visit Record showed the following: * The glucose POCT was ordered on 5/5/26 at 1120 hours, collected at 1120 hours, and resulted at 1123 hours. The glucose POCT was 104 mg/dL (normal range is from 70 - 110 mg/dL). * The Comprehensive Metabolic Panel (CMP) ordered STAT on 5/5/26 at 1102 hours, collected at 1102 hours, and resulted at 1621 hours. The CMP result showed the following: - Potassium: 3.0 mEq/L (normal range is from 3.5 to 5.1 mEq/L) - Glucose: 24 mg/dl (normal range is from 74-109 mg/dL) * The Lipase level was ordered STAT on 5/5/26 at 1102 hours, collected at 1102 hours, and resulted at 1621 hours. The Lipase level was <3 U/L (normal range is from 11 - 82 U/L). * The Troponin High Sensitive level was ordered STAT on 5/5/26 at 1102 hours, collected at 1102 hours, and resulted at 1813 hours. The Troponin High Sensitive level was 27.8 ng/L (normal range is from 2 - 20 ng/L). * The Brain Natriuretic Peptide level was ordered STAT on 5/5/26 at 1102 hours, collected at 1102 hours, and resulted at 1821 hours. The Brain Natriuretic Peptide level was 923 pg/mL (normal range is from 0 to 100 pg/mL). During a review of RN notes of 5/5/26 at 1131 hours, the RN notes showed “at 1120 bs was 104 after d50.” The RN notes showed on 5/5/26 at 1206 hours, Hospital 1 contacted 911 due to internal disaster per charge nurse and ED Director. At this time, staff were unable to process lab work; antibiotic was not given. During a review of the Transfer Summary and Certification dated 5/5/26 at 1245 hours, the Transfer Summary and Certification showed Patient 4 was transferred to Hospital 2 ER, with ALS due to transfer was in the patient’s best interests. The benefits of transfer was diagnostic tests/procedures/treatment indicated were not available. On 5/6/26 at 1515 hours, an interview was conducted with the ED Director. The ED Director stated she was working in the ED on this date. The ED Director stated this was the date the clinical laboratory had lost its license. The ED Director stated the loss of the laboratory license prevented the nursing staff in the ED from using the POCT glucometers. The ED Director stated on 5/5/26 around 1030 hours, the POCT glucometers were removed from the ED. The ED Director stated she was familiar with this patient. The ED Director stated Patient 4 presented to the ED brought by ambulance in by the Fire department. The patient came in hypoglycemic, with a blood sugar of 39 mg/dL. The ED Director reviewed Patient 4’s medical record and verified the documented performed POCT for blood sugar was actually performed by the fire department and the ED nurse documented it as completed in his medical record. The ED Director stated they needed to know his blood sugar before they could transfer him, so the ED nurse asked the fire department (ambulance) to perform the test for them. The ED Director stated the ED nurse could not reassess Patient 4’s blood sugar because of the current issue with the laboratory and that they could not use the glucometers. The glucometers had been removed from the ED. The patient had also been given an amp of Dextrose 50 (D50), and they needed to assess if the patient responded to the medication. The ED Director stated the fire department (ambulance) rechecked Patient 4’s blood sugar and it was better at 104 mg/dL, but now Patient 4’s blood pressure was low. Patient 4 was to be transferred to Hospital 2 for higher level of care, but he became unstable to transport by the fire department (ambulance). The ED Director stated Patient 4 had become unstable so 911 was called and used lifeline with a critical care nurse (CCT RN). The ED Director stated Patient 4 was to receive both vasopressin (a medication used to treat life-threatening low blood pressure) and Levophed (a medication used to treat lift-threatening low blood pressure), which required both titration and monitoring. A hospital needs a working clinical laboratory to do all these treatments for Patient 4. The ED Director stated the hospital did not have one so Patient 4 was transferred to a higher level of care. The ED Director was asked if the lack of a working clinical laboratory delayed Patient 4’s treatment. The ED Director answered yes and added the ED also had to ask the fire department (ambulance) to collect an ordered I-STAT Arterial Blood Gas (ABG) on him as well. With the clinical laboratory down, the ED could not do that as a POCT either. b. During a review of Patient 3’s medical record on 5/6/26 at 1405 hours, Patient 3’s medical record showed Patient 3 came to the hospital ED on 5/5/26 at 1308 hours and discharged on 5/5/26 at 1534 hours. Review of the ED Triage Aware Note dated 5/5/26 at 1314 hours, showed Patient 3 came to the ED with hyperglycemia. The patient’s BS level was 400 mg/dL in field. The patient’s ESI level was 2. Review of the ED Provider Aware Note dated 5/5/26 at 1319 hours, showed the laboratory was down. Patient 3 with hyperglycemia and new onset Diabetes Mellitus, would need to be transferred for a higher level of care. Review of the Patient Orders showed Comprehensive Metabolic Panel (CMP) ordered STAT on 5/5/26 at 1316 hours. The Patient Orders showed the CMP was “pending collection” on 5/5/26 at 1317 hours. Review of the Patient Results showed the following: * On 5/5/26 at 1638 hours, the Comprehensive Metabolic Panel (CMP) results showed the patient’s potassium level was 3.1 mEq/L, the patient’s chloride level was 111 mEq/L (normal range is from 98 to 107 mEq/L), and the patient’s glucose level was 85 mg/dl. The results showed an over three-hour processing time for the STAT results. * On 5/5/26 at 1655 hours, the patient’s glucose POCT was 92 mg/dL (normal range is from 70-110 mg/dL). During a review of the Transfer Summary and Certification, the Transfer Summary and Certification showed Patient 3 was transferred to Hospital 2 on 5/5/26 at 1520 hours. The benefits of transfer were diagnostic tests/procedures/treatment indicated not being available. During an interview with the ED Director on 5/6/26 at 1515 hours, the ED Director stated she was working in the ED on this date. She stated this was the date the clinical laboratory had lost its license. The ED Director stated the loss of the laboratory license prevented nursing staff in the ED from using the POCT glucometers. She stated on 5/5/26 around 1030 hours, the POCT glucometers were removed from the ED. The ED Director stated she was familiar with this patient. She stated Patient 3 presented to the ED brought by ambulance. Patient 3 came in hyperglycemic, with a field blood sugar of 400 mg/dL. The ED Director stated the ED had informed the ambulance that the hospital was on diversion, but they brought Patient 3 to them anyway. She stated that with the lab down, they were not able to perform the normal tests for newly diagnosed Diabetes Mellitus, including the POCT. The ED Director stated they diagnosed the problem, but with the lab down, they did not have the capacity to care for Patient 3 and began the transfer process to Hospital 2. Because there was no ability to complete a POCT for blood sugar, the MD ordered a STAT CMP, which included the blood glucose, and the ED administered fluids and provided care to the best of their ability without a functioning clinical laboratory. The ED Director stated laboratory draws were completed but resulted at Hospital 2. The ED Director verified a three-hour timeframe for the STAT CMP. She stated that if they had a working lab, they could have performed a POCT, which would have been much faster. She verified the delayed results and stated that without a working laboratory, Hospital 1 could not perform the necessary diagnostic tests for Patient 3. The ED Director stated they stabilized Patient 3, started IV fluids, assessed vitals, but had to transfer the patient to Hospital 2. She stated Hospital 2 had a working clinical laboratory where the necessary tests could be performed timely. The lack of a working lab slowed down both testing and treatment because they were unable to test for the elevated 400 mg/dL blood sugar and had to transfer the patient. The ED Director stated all that work took extra time. 4. During a review of the hospital’s P&P titled Specimen Procurement, Labeling, Transportation & Handling dated 3/23/21, the P&P showed the purpose is to ensure proper procurement, identification, transportation, and handling of patient samples received for testing. The following procedure must be followed: All primary specimen containers must be labeled with two identifiers (patient name and medical record number) at the time of collection at the patient’s bedside. The initials of the person obtaining the specimen and the date and time the specimen was obtained must also be included on all specimen labels. Unlabeled or improperly labeled specimens will not be accepted for laboratory testing. A concurrent tour to the clinical laboratory and interview was conducted on 5/8/26 at 1038 hours, with CPT 4 and the CNO/CCO. During the tour of the clinical laboratory, a rack with 24 blood specimen tubes with blue tops was observed at room temperature. A review of the 24 blood specimen tubes was conducted with CPT 4 and with the CNO/CCO observing. Sixteen blue-top blood specimen tubes were observed to not have a date and time written on the label. The label had a printed patient name and medical record number (MRN) but only had the employee number and initials of the person who collected the specimen. CPT 4 stated these 24 blood specimen tubes were drawn prior to the laboratory’s closure on 5/5/26. CPT 4 stated these 24 blood specimen tubes were drawn as extra blood tubes to be used if the CLS needed more blood for a test or to perform any additional ordered tests. CPT 4 stated this type of collected blood specimen tube was stable at room temperature for three days. CPT 4 stated the expectation was to follow the policy. CPT 4 stated the lab staff was expected to use labels with the name and medical record number of the patient. CPT 4 stated the expectation was then to write on the label the date and time the specimen was collected and then add initials and the employee number of the lab staff who collected the specimen. CPT 4 stated the purpose of the date and time was to determine whether a specimen was still viable for use or expired and unusable. CPT 4 verified that 16 of the 24 blue-top blood specimen tubes did not have a date and time written on the label. CPT 4 verified that 16 of the 24 blue-top blood specimen tubes had a label with the printed patient name and medical record number (MRN) but only had the employee number and initials of the person who collected the specimen, with no date or time recorded. CPT 4 stated the purpose of having the date and time on the label was to demonstrate that the collected blood specimen was still viable and not expired. CPT 4 stated that without this information, the lab staff did not know if these specimens were still viable for testing or expired and needing to be discarded. CPT 4 stated that since these 16 specimens were without dates and times, they could not be used and would have to be presumed expired and thrown away. During an interview with the CNO/CCO on 5/19/26 at 1219 hours, the CNO/CCO was made aware of the above findings.”

“EMERGENCY LABORATORY SERVICES CFR(s): 482.27(a)(1) Emergency laboratory services must be available 24 hours a day. This Standard is not met as evidenced by: 40483 Based on interview and record review, the hospital failed to ensure they maintained the current State of California Laboratory Field Services (LFS) laboratory license, which would allow them to operate as a 24-hour on-site emergency laboratory services to provide care for their patients. This failure had the potential to delay diagnosis and treatment, cause deterioration in patient condition, or result in serious harm or death. Findings: On 3/6/26, Hospital 1’s clinical laboratory license expired. Hospital 1 was given a 60-day grace period to apply for renewal and pay the $4,000 renewal fee. The hospital did not renew the license or pay the required non-refundable fee. On 5/5/26, Hospital 1’s in-house clinical laboratory lost its State of California Clinical and Public Health laboratory license through forfeiture and had to submit a re-application and payment for a reactivated license. The license was approved and reactivated on 5/12/26. Hospital 1 was without a license to operate as a clinical laboratory from 5/5/26 through 5/12/26, approximately seven days. During this time, it was unable to act as an emergency 24-hour laboratory. All specimens could only be collected by the Registered Nurses or the Respiratory Therapists for the Arterial Blood Gases (ABGs) and sent to a different hospital’s clinical laboratory for processing from 5/5/26 until 5/12/26. Review of the letter sent by the California Department of Public Health, Laboratory Field Services dated 5/5/26, showed that the California Department of Public Health notified Hospital 1 that they had failed to renew their clinical laboratory license which had resulted in the loss of the laboratory license. The letter showed that without the license, the clinical laboratory must cease performing all waived and non-waived testing on California specimens at Hospital 1. On 5/5/26, Hospital 1 was unable to perform any in-house lab testing and was no longer operating as a 24-hour laboratory on-site to provide care for their patients. Review of the hospital’s P&P titled Laboratory Point of Care Testing dated 3/10/22, showed the hospital will maintain a current CLIA Laboratory Certificate of Accreditation, or Certificate of Compliance applicable, and current LFS laboratory license. On 5/5/26, the hospital was unable to follow its laboratory P&P titled “Laboratory Point of Care Testing,” dated 3/10/22. The P&P required maintaining a current LFS laboratory license. This license allowed the hospital to perform point-of-care testing on all hospital patients, including ED patients, for blood glucose, urine pregnancy tests, and I-STAT for arterial blood gases. Time-sensitive STAT specimens such as CMP and CK had to be sent to Hospital 2 for processing, located approximately eight miles away from Hospital 1, which resulted in delayed processing and result times. During a concurrent interview and hospital’s documentation review on 5/6/26 at 0800 hours, with the Laboratory Manager, the Laboratory Manager stated Hospital 1’s clinical laboratory was not currently performing any laboratory tests. The Laboratory Manager verified he received the California Department of Public Health, Laboratory Field Services letter and provided it to the CNO and the CEO at the morning meeting. The Laboratory Manager stated that per the received letter, the hospital’s laboratory had to cease performing all waived and non-waived tests on California specimens at this site. The Laboratory Manager stated this clinical laboratory was not functioning as a clinical laboratory. The Laboratory Manager stated all specimens had to be collected by the nursing staff, and then a courier had to pick them up and take them to Hospital 2 for processing and resulting. The Laboratory Manager was asked if his department had an emergency preparedness plan for what to do in the event of the laboratory being out of service for any reason. The Laboratory Manager stated he did not have any policy or plan for laboratory emergency preparedness. The Laboratory Manager was asked if a contract existed between Hospital 1 and Hospital 2 for laboratory services. The Laboratory Manager stated the two hospitals were under the same company, and he was not aware of a contract between the two. On 5/8/26 at 0800 hours, a request was made for a contract between Hospital 1 and Hospital 2’s laboratory services. The CNO/CCO and Chief Quality and Patient Safety Officer stated the two entities were “sister hospitals” and part of the same company, and a contract between them for laboratory services was not needed. On 5/12/26 at 1608 hours, as part of the hospital’s mitigation plan, a contract for laboratory services between Hospital 1 and Hospital 2 was provided, with an effective date of 5/5/26, signed and dated by the Regional CEO.”

“POLICIES FOR LABORATORY SERVICES CFR(s): 482.27(a)(4) The medical staff and a pathologist must determine which tissue specimens require a macroscopic (gross) examination and which require both macroscopic and microscopic examinations. This Standard is not met as evidenced by: 40483 Based on interview and record review, the hospital failed to show a method for the determination between the medical staff and the pathologist regarding which tissue specimens required a macroscopic (gross) examination, and which required both macroscopic and microscopic examinations. This failure created a risk for misclassification of surgical specimens, delayed diagnosis, missed pathology, and compromised patient safety. Findings: During a review of the hospital’s P&P titled “Surgical Specimens for Limited Pathological Examination (Gross Only),” dated 6/18/21, the P&P showed the purpose is to establish a list of specimens that due to their nature or site of origin is excluded from microscopic evaluation. Specimens usually examined as “gross only”: * Foreign bodies * Orthopedic hardware * Removed medical devices * Tonsils and adenoids (patients age 17 years and younger) * Nails from digits * Nasal septal bone and cartilage * Bone and tissue from hammertoes and bunions During a review of the Surgical Pathology Requisition Tissues/Bone Marrow Exam form, it showed check boxes for selecting tissue for frozen section and special studies. It also showed check boxes for bone marrow, including aspiration (clot), biopsy (core), flow cytometry (lavender-top tube), and cytogenetics (green-top tube). It did not include a check box to select macroscopic (gross) and microscopic examinations. On 5/14/26 at 1100 hours, an interview and review of the hospital’s P&P was conducted with the Regional Lab Director/Acting Lab Manager at Hospital 1, the Regional Lab Director/Acting Lab Manager verified this was the only policy the hospital had regarding macroscopic examination. The Regional Lab Director/Acting Lab Manager stated there was no policy regarding the determination of both macroscopic and microscopic examinations. The Regional Lab Director/Acting Lab Manager also reviewed the Surgical Pathology Requisition form and verified the form did not include any option to denote a selection for macroscopic (gross) and microscopic examinations. During an interview on 5/14/26 at 1120 hours, Pathologist 1 stated he was the Laboratory Medical Director and primary pathologist for the hospital. Pathologist 1 verified he worked out of Hospital 2, but specimens from Hospital 1 were sent to him for examination. Pathologist 1 verified there was no policy or procedure that showed how or what items were sent for examination as both gross and microscopic, as determined by both the medical staff and the pathologist. Pathologist 1 stated that an extra policy was unnecessary and that it was understood he would review certain items grossly, but if he needed to examine a specimen microscopically, he would do so. Pathologist 1 stated that as the pathologist, it was understood that it was up to him which specimens he would examine grossly or microscopically. Pathologist 1 stated there did not need to be a policy, a procedure, or a designated selection on the form. Pathologist 1 stated he was familiar with the surgical pathology form sent with the specimen. When asked if the form had information regarding the choice of gross or microscopic examination, Pathologist 1 stated “no,” and that he made the determination himself. During an interview with the CNO/CCO on 5/19/26 at 1219 hours, the CNO/CCO was made aware of the above findings.”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 29558 Based on observation, interview, and record review, the hospital failed to ensure the GB was responsible for the conduct of the hospital as evidenced by: 1. The GB failed to ensure the contracted dialysis service was provided in a safe and effective manner. Cross reference to A084. 2. The GB failed to oversee the contracted dialysis service when the contracted dialysis service was initiated and provided to the hospital patient via an unlicensed vendor (Dialysis 1). Cross reference to A083. 3. The hospital failed to ensure the P&P for Professional Practice Ongoing Professional Practice Evaluation (OPPE) was implemented when there was no documented evidence of an annual OPPE for MD 1 and the OPPE documentation was currently missing for all 202 medical staff members. Cross reference to A049. The cumulative effect of these systemic failures resulted in the hospital’s inability to provide quality healthcare in a safe environment for the patients.”

“MEDICAL STAFF - ACCOUNTABILITY CFR(s): 482.12(a)(5) [The governing body must] ensure that the medical staff is accountable to the governing body for the quality of care provided to patients. This Standard is not met as evidenced by: 22553 Based on interview and record review, the hospital failed to ensure the P&P for Professional Practice Ongoing Professional Practice Evaluation (OPPE) was implemented when there was no documented evidence of an annual OPPE for MD 1 and the OPPE documentation was currently missing for all 202 medical staff members. This failure created the risk for substandard outcomes for patients receiving care from the medical staff. Findings: During a review of the hospital’s P&P titled Professional Practice-Ongoing (OPPE) & Focused (FPPE) reviewed on September 2023, the P&P showed to ensure the Medical Staff and Allied Health Professional Staff, through its activities, assesses the professional practice and competence of its members via a systemic process. The purpose is to ensure that appropriate and timely peer review is performed and that patient care provided within the facility meets and/or exceeds the community standards. The OPPE is an adjunct program to the current peer review process that provides the medical staff with the ability to identify professional practice trends that impact quality of care and patient safety on an ongoing basis. Annually, an OPPE Report Card for each practitioner scheduled for review will be prepared with data that has been collected, collated, and transcribed onto the Report Card by the Quality Management Department. During a review of MD 1’s credential file with the Director of Medical Staff Services on 11/4/25 at 1132 hours, MD 1’s credential file showed no documented evidence of an annual Ongoing Professional Practice Evaluation (OPPE). The Director of Medical Staff Services stated the OPPE documentation was currently missing for all 202 members of the Medical Staff and Allied Health Professional Staff.”

“CONTRACTED SERVICES CFR(s): 482.12(e) The governing body must be responsible for services furnished in the hospital whether or not they are furnished under contracts. The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services. This Standard is not met as evidenced by: 22553 Based on interview and record reviews, the hospital failed to ensure the GB provided oversight of contracted inpatient dialysis agency when the contracted dialysis service was initiated and provided to the hospital patient via an unlicensed vendor (Dialysis 1). This failure had the potential to result in the increased risk of health outcomes for the patients receiving dialysis services in the hospital. Findings: During a review of the hospital Governing Board Bylaws adopted on 9/1/17, the Governing Board Bylaws showed Article III, the Governing Board assumes full legal authority and responsibility for operations of the organization. The Governing Board shall act as the separate governing body of the hospital (including acting as the governing body of the hospital for purposes of Title 22 of the California Code of Regulations) (“Governing Board”) and shall retain full business, professional and administrative responsibility for the services rendered at the hospital. During a review of the Dialysis Services Agreement, the Dialysis Services Agreement showed this Dialysis Service Agreement effective as of 10/25/25, is entered into by and between the hospital and Dialysis 1 (“Agency”). Further review of the Dialysis Services Agreement showed: * Article I, Definition - Dialytic Services means any and all health care services provided by Agency (Dialysis 1) to Hospital patients who require hemodialysis or peritoneal dialysis. The Dialytic Services shall be provided by registered nurse and/or other duly licensed certified individual who are appropriately trained and qualified. * Article II, Agency Responsibilities - Dialytic Services: in accordance with the written order of the patient’s attending physician, and subject to consent authorization from the patient or patient’s legal representative, if the hospital requests Dialytic Services from Agency in the hospital’s sole discretion, Agency shall provide Dialytic Services to hospital patients for scheduled and emergency services. - Agency shall be responsible for insuring prior to performing Dialytic Services that each patient has in his or her medical record an adequate written order from a physician for such services. - Agency shall, in accordance with Hospital policies, cause to be promptly prepared and filed with the Hospital’s medical records department, reports of all examinations, procedures, and other services performed in the Hospital. - Agency shall retain responsibility for the day-to-day supervision and control of Agency nurses and the administration of Dialytic Services. Agency shall ensure that Dialytic Services are rendered in compliance with Applicable Laws and current methods and practices within the Hospital’s community. - In the performance of services required under this agreement, Agency and its nurses and staff shall know and adhere to Hospital’s policies, rules and regulations. - Any and all of Agency’s personnel who provide Dialytic Services under this Agreement must be approved by the Hospital before such personnel provide services at Hospital. Before providing any patient care at Hospital on behalf of Agency, each RN who provides Dialytic Services at Hospital must apply for, be granted and retain health professional privileges in accordance with the Medical Staff Bylaws, Rules and policies. Agency also shall review each nurse’s competency prior to permitting such nurse to perform Dialytic Services at Hospital. - Agency shall require, maintain, provide, and have promptly available for Hospital’s review the following documents for each Agency nurse providing services hereunder: licensure, evidence of current certification Basic Life Support (BLS), health status, annual PPD skin test, and documented training on OSHA standards for blood borne pathogen. * Article VII, General Provisions - To the extent required to be in conformance with Applicable Law, Hospital retains professional and administrative responsibility for the services rendered hereunder. During an interview on 10/28/25 at 1051 hours, with the CNO, the CNO stated the hospital had a new contracted dialysis agency that started inpatient dialysis services on 10/26/25 for Patient 1 and Patient 2. The CNO stated the new contracted dialysis services became effective on 10/25/25 after midnight. The hospital provided two undated agreements (the Business Associate Agreement and the Dialysis Services Agreement) signed by the hospital’s corporate (CFO) and Dialysis 1’s CEO. During a concurrent interview with the CNO and the CEO, the hospital leadership confirmed they reviewed and approved those agreements on 10/24/25. During an interview with Dialysis 1 Nurse Manager on 10/28/25 at 1414 hours, Dialysis 1 Nurse Manager verified Dialysis 1 did not have a CCN, or license numbers. During a concurrent interview and review of Patient 1’s medical record with Dialysis 1 Nurse Manager on 10/29/25 at 1130 hours, Dialysis 1 Nurse Manager stated that Dialysis 1 had operated as an agency providing the hospital inpatient dialytic services. Dialysis 1 Nurse Manager stated that a separate entity, Dialysis 2 was registered as a chronic dialysis clinic but shared the same owner and business address with Dialysis 1. Dialysis 1 Nurse Manager stated that, due to the high patient care needs specifically the dialysis requirements from four KPC Global hospital inpatients, Dialysis 1 was actively working on completing the required RN personnel files, and this process was only partially completed. Dialysis 1 Nurse Manager reviewed Patient 1’s Hemodialysis Treatment Flowsheet dated 10/27/25 and confirmed that RN 5, a dialysis nurse employed by Dialysis 2, performed the dialysis treatment and used the Flowsheet from Dialysis 2 to document Patient 1’s care. The Nurse Manager stated RN 5 did not fully complete the Hemodialysis Treatment Flowsheet. On 10/31/25 at 0620 hours and 11/3/25 at 1115 hours via email correspondence, the hospital verified that the acute inpatient dialysis was referring to both emergent and maintenance dialysis for inpatient. The hospital was notified that the contracted dialysis vendor, Dialysis 1 was not licensed to provide dialysis services.”

“CONTRACTED SERVICES CFR(s): 482.12(e)(1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. This Standard is not met as evidenced by: 22553 Based on observation, interview, and record review, the hospital failed to ensure the contracted dialysis service was provided in a safe and effective manner as evidenced by: 1. There was no license, certificate, or health status available for review for a dialysis nurse (RN 5) when on 10/27/25, Patient 1’s dialysis treatment was performed by the dialysis nurse. 2. The dialysis nurses did not provide and document the dialysis treatment for two of two sampled patients (Patients 1 and 2) as per physician’s order and per the P&P. 3. There was no documented evidence of maintenance for the dialysis machine prior to its use on the patients. These deficiencies created a risk for patient safety and substandard patient care. Findings: During a review of the hospital’s P&P titled Dialysis, Patient Preparation and Access to Service reviewed February 2021, the P&P showed the Dialysis Personnel Responsibilities include the dialysis personnel will give a verbal report to RN following the treatment, will document the treatment and the patient response on the patient chart. The Dialysis Company Responsibilities are Dialysis Services will provide competent personnel, maintain files, and forwarding updates periodically; the dialysis company will be responsible for the maintenance of equipment. On 10/29/25 at 1130 hours, Dialysis 1 Nurse Manager provided the Job Drescription - Staff Nurse that had no name of agency or company listed on the Job Drescription - Staff Nurse form and stated the job description applied for Dialysis 1’s staff nurses. Review of the Job Drescription - Staff Nurse showed: * The RN is responsible for administering direct and indirect patient care to ESRD patients. The RN is under the general direction of the Charge Nurse and Director of Nursing or Clinical Manager. * The Duties and Responsibilities section showed: - Patient Treatment Activities: is responsible for proper management of the dialysis treatment of all patients under his/her care, assumes full responsibility for management of his/ her own patients’ assignment; obtain and carry out physician orders promptly and precisely. - Patient Care Activities: to implement individual patient care as prescribed by the physician and evaluate outcomes on an on-going basis; understand and evaluate lab values and EKG’s; observe and evaluate patient’s signs, symptoms and reactions to therapy and implement appropriate actions; report appropriate findings or observations to the Charge Nurse and the attending physician; instruct patient or relatives concerning home care in accordance with physician’s instructions; records nursing needs and information elicited from patients on nursing care plan to assure continuity of care; keep complete and accurate documentation of all record in a timely manner; perform and document initial nursing assessments in newly admitted patients on own shift. 1. During a concurrent interview and review of Patient 1’s medical record with Dialysis 1 Nurse Manager on 10/29/25 at 1130 hours, Dialysis 1 Nurse Manager stated Dialysis 1 had operated as an agency providing hospital inpatient dialytic services. Dialysis 1 Nurse Manager stated a separate entity, Dialysis 2 was registered as a chronic dialysis clinic but shared the same owner and business address with Dialysis 1. Dialysis 1 Nurse Manager stated, due to high patient care needs, specifically the dialysis requirements of four KPC Global hospital inpatients, Dialysis 1 was actively working on completing required RN personnel files, and this process was only partially completed. Review of Patient 1’s medical record showed the patient was admitted to the hospital on 10/25/25. Patient 1 had a medical history of ESRD and was on TTS dialysis schedule. During a review of the physician’s orders for dialysis dated 10/26/25, the physician’s order showed the Blood Flow Rate of 300 ml/min and an Ultrafiltration goal of 2.5 L. During a concurrent interview and review of the Hemodialysis Treatment Flowsheet for Dialysis 2 dated 10/27/25 with Dialysis 1 Nurse Manager, Dialysis 1 Nurse Manager stated RN 5, who completed the Hemodialysis Treatment Flowsheet, was not a Dialysis 1’s staff nurse but was employed by Dialysis 2. 2. During a review of the hospital’s P&P titled Correcting or Amending Medical Records reviewed April 2021, the P&P showed for correction of Error (written), the entry author shall draw a single line through the error, the usage of any type of correction fluid (e.g. White -Out) shall not be utilized in lieu of the procedure stated above; the entry author shall note the reason for change, the date and time of change, and authenticate the note. a. Review of Patient 1’s medical record was conducted with Dialysis 1 Nurse Manager on 10/29/25. Patient 1’s medical record showed the patient was admitted to the hospital on 10/25/25. Patient 1 had a medical history of ESRD and was on TTS dialysis schedule. * During a review of the physician’s orders for dialysis dated 10/26/25, the physician’s order showed the Blood Flow Rate of 300 ml/min and an Ultrafiltration goal of 2.5 L. Review of the Hemodialysis Treatment Flowsheet for Dialysis 2 dated 10/27/25, showed the following: * The section of Pre Labs was left blank. * The sections of “DID YOU PROVIDE COMMUNICATION ON THE LIST BELOW,” “PATIENT EDUCATION,” “HEPATITIS INFORMATION,” “PRINT CLEARLY CDK HD RN,” “RO#,” “CLEANING,” “Report to Hospital RN ... Primary RN Name ... Date ... Time ...,” “MD NAME,” were left blank. * The “Fluid Removed” column was left blank. * The “Pre-Weight (Kg)” and “Post - Weight (Kg)” section showed “N/A.” * The Access Problem section showed “Poor Flow.” Dialysis 1 Nurse Manager stated the Hemodialysis Treatment Flowsheet was missing information regarding the pre-lab results, communication and patient education, hepatitis information, name of the CKD HD RN, RO number, cleaning, report to the hospital RN, and MD’s name. Additionally, there was no documented evidence showing the hospital RN was communicated about the patient’s access problem. The patient’s pre- and post-treatment weights were not documented, without justification. The “Fluid Removed “ column was left blank without justification, indicating the ultrafiltration goal was not documented as met. * During a review of a physician’s order for dialysis dated 10/27/25, it showed that the dialysis treatment was scheduled for 10/28/25. The physician’s order showed Dialysate Flow Rate as of 600 ml/min; dialyzer would be Optiflux 180NR (F180NR), and the Dialysate Potassium (K) as of 3 mEq/L. Review of another physician’s order for dialysis dated 10/28/25 at 0824 hours, showed to provide the dialysis treatment on 10/28/25. The physician’s order showed Dialysate Flow Rate as of 600 ml/min, the Dialyzer would be Optiflux 180NR, and the Dialysate potassium (K) as of 2mEq/L. During a concurrent interview and review of the “Hemodialysis Treatment Flowsheet,” dated 10/28/25, with Dialysis 1 Nurse Manager, Dialysis 1 Nurse Manager confirmed the Hemodialysis Treatment Flowsheet showed the following: * The Dialysate Flow Rate of 300 ml/min instead of 600 ml/min. * Dialyzer was F160 instead of the ordered Optiflux 180 NR (F180NR), * RN 4 used correction fluid (White-Out) to alter entries in the “Total UF” column for the periods between 1819 hours to 1901 hours and the entry the time of 1950 hours, * The sections of “Pre-Weight (Kg)” and “Post-Weight (Kg)” were left blank, without justification. * The entries entered into the “Notes and comments” section were not legible. b. During a review of Patient 2’s medical record on 10/29/25, Patient 2’s medical record showed Patient 2 was admitted to the hospital on 10/25/25. Patient 2 had a medical history of ESRD and was on TTS dialysis schedule. During a review of the physician’s dialysis order dated 10/27/25 at 1320 hours, the physician’s order showed the Dialysate Flow Rate as of 600 ml/min, the Blood Flow Rate as of 300 ml/min, and the Dialyzer would be Optiflux 180NR (F180NR). During an interview and review of the Hemodialysis Treatment Flowsheet on 10/29/25 1130 hours, with Dialysis 1 Nurse Manager, the Dialysis 1 Nurse Manager confirmed the Hemodialysis Treatment Flowsheet showed the following documented treatment parameters that deviated from the physician’s order without justification * The Dialysate Flow Rate was documented as 300 ml/min, but the physician ordered the Dialysate Flow Rate as of 600 ml/min. * The Blood Flow Rate was documented as 350 ml/min, but the physician ordered the Blood Flow Rate as of 300 ml/min. * Dialyzer was documented as F160 (F160NR), but the physician ordered the dialyzer as of Optiflux 180 NR (F180NR). * The post-weight section was left blank, without justification. 40483 3. During a review of hospital’s P&P titled Medical Equipment Management Plan (“EQMP”) dated October 2023, the hospital’s P&P showed medical equipment management is essential in providing safe patient care as part of the hospitals mission. Implementation of and adherence to this plan will help ensure a safe environment for patients, staff and visitors who use or come in contact with medical equipment .... The hospital inspects and maintains medical equipment by performing activities ... Before initial use of medical equipment on the medical equipment inventory, the hospital performs safety, operational and functional checks ... Hospital owned equipment, before initial use, Biomed Engineering performs electrical safety, functional/operational checks, risk management, incoming inspection documentation ....Rentals-Authorized Rental companies are pre-assessed bi-annually for competency and patient safety via on-site inspection ....Other rental company equipment must be checked in through Biomedical Engineering for an incoming inspection. During a concurrent interview and observation on 10/28/25 at 1115 hours, with RN 6, RN 6 was observed in Patient 1’s room programming a portable dialysis machine. RN 6 stated he was not employed by the hospital, but working for a dialysis company that was Dialysis 2. RN 6 stated he was at the hospital to provide dialysis services to Patient 1. RN 6 stated he was using a portable dialysis machine (Tablo). RN 6 stated he did not bring the portable dialysis machine with him but got it from the basement of the hospital. RN 6 stated he was unsure if the machine was owned by the hospital or was rented to the hospital by his company. RN 6 stated he was currently programming the computer on the dialysis machine and would be ready to provide dialysis to Patient 1 at 1200 noon. RN 6 stated he was unsure if it had been checked for safety prior to his use. During a concurrent interview and observation on 10/28/25 at 1205 hours, with RN 6, RN 6 was again observed in Patient 1’s room programming the portable dialysis machine. RN 6 stated he was having difficulty with the machine. RN 6 stated he was uncertain whether the machine was owned by the hospital or rented to the hospital by the company he worked for. RN 6 stated the dialysis machine was not working and had low water pressure readings. RN 6 stated he could not troubleshoot the issue and confirmed there was only one dialysis machine available. There was no additional machine to use in place of the malfunctioning one to provide Patient 1 with her ordered dialysis. RN 6 stated he would remove the machine from the room. He stated the machine needed to be serviced and that another nurse from the company would arrive later that day to provide dialysis to Patient 1. During a concurrent observation and interview on 10/28/25 at 1630 hours, with RN 4. RN 4 stated she worked for a separate company called name of Dialysis 2 and was not an employee of the hospital. RN 4 stated she was here to provide dialysis services to two patients, Patient 1 and Patient 2 at this hospital. RN 4 was observed setting up the portable dialysis machine. RN 4 stated it was in Patient 1’s room when she arrived and currently was in working condition. RN 4 stated she was unaware if it had been safety checked prior to this use. Safety check was not something she did. During a review of Patient 1’s dialysis flowsheet dated 10/28/25 at 1600 hours, the dialysis flowsheet showed Patient 1 received dialysis from RN 4 from 1729 to 2030 hours. During a concurrent interview and observation on 10/30/25 at 0815 hours, with the House Supervisor, a tour of the hospital dialysis room was conducted. In the dialysis room, 1 portable dialysis machine was found with a sticker showing 603610 Friday on the front of the machine. The House Supervisor verified only 1 portable dialysis machine in the room. The House Supervisor stated the hospital had process to ensure equipment was safety to use on patients. It would have been vetted through Biomed and the biomedical engineer would have checked to make certain the equipment was safe to use. Once vetted, a sticker would have been in place, with a date for a PM (preventive maintenance). The House Supervisor stated he did not know if the machine belonged to the hospital or an outside vendor. The House Supervisor stated a sticker on the machine would also show ownership. The House Supervisor verified the dialysis machine had no sticker with any information for a safety check or showing the machine equipment belonged to the hospital or an outside vendor. On 10/30/25 at 1313 hours, an interview was conducted with the Biomedical Engineer. The Biomedical Engineer stated his position was to, in part help ensure the medical equipment in use in the hospital was functioning correctly. The Biomedical Engineer stated part of his job was to inspect and safety check equipment purchased by the hospital and/or equipment brought in from an outside source (vendors) prior to use on patients. The Biomedical Engineer dated once it was safety checked, if it belonged to the hospital, it got inventoried and a sticker with a date for its next preventive maintenance. If it was a vendor provided machine, it was safety-checked and given a sticker to show it had been checked for safe use on patients. The Biomedical Engineer was asked if he was familiar with the new (Tablo) Portable Dialysis Machine being used at the hospital. The Biomedical Engineer stated was unaware of the new dialysis machine. The Biomedical Engineer stated he had not performed a safety check before to its use. The Biomedical Engineer stated he did not know the history or the maintenance on the machine and had no idea if it was safe to use on patients or not.”

“WRITTEN DESCRIPTION OF SERVICES CFR(s): 482.27(a)(2) A written description of services provided must be available to the medical staff. This Standard is not met as evidenced by: 35310 Based on observation, interview, and record review, the hospital failed to ensure a P&P was developed to guide the staff on processing STAT laboratory testing orders under an arrangement with an outside facility (Hospital A’s laboratory services). This created the risk of delayed treatments for the patients. Findings: Review of the hospital’s P&P titled Turnaround Times for Laboratory Results dated 3/23/21, showed the following: * Test Orders With Routine or Timed Priorities: TAT is usually eight hours for routine orders. Timed test results are available within one hour of collection when testing is performed at the hospital. STAT orders are resulted within one hour of collection. * CORE Lab General Testing Reports are usually available within 24 hours of receipt. Reference Lab TAT is usually less than seven days for orders with priorities of Routine or Timed. On 3/26/25 at 0925 hours, the laboratory department was toured with the Regional Director of Laboratory Services and Phlebotomist 1. A specimen bin labeled “Hospital A” was observed in the refrigerator. Phlebotomist 1 stated the specimen would be sent to Hospital A for processing. On 3/26/25 at 1211 hours, an interview and concurrent review of Patient 5’s medical record was conducted with the CNO and Regional Director of Laboratory Services. Review of the physician’s order dated 3/25/25 at 1045 hours, showed to perform Retic and LDH blood testing STAT. Review of the Orders and Results showed the following: a. The blood sample for Retic testing was collected on 3/25/25 at 1200 hours. Hospital A’s laboratory received the blood sample on 3/25/25 at 1628 hours (4 hours and 28 minutes after the collection). The test result was available on 3/25/25 at 1633 hours. b. The blood sample for LDH was collected on 3/25/25 at 1055 hours. Hospital A’s laboratory received the blood sample on 3/25/25 at 1628 hours (5 hours and 33 minutes after the collection). The test result was available on 3/25/25 at 1640 hours. On 3/26/25 at 1211 hours, an interview was conducted with the Regional Director of Laboratory Services. The Regional Director of Laboratory Services stated the CORE Lab referenced in the P&P referred to Hospital A’s laboratory. The Regional Director of Laboratory Services also stated the Retic and LDH testing would be sent out to Hospital A’s laboratory. The Regional Director of Laboratory Services stated the contracted delivery service transported specimens four times a day, but there was no specific delivery time, as the company makes rounds to multiple hospitals. The Regional Director of Laboratory Services and CNO acknowledged that there was no written P&P to guide staff on processing STAT testing that was sent to an outside facility. On 3/27/25 at 0913 hours, the CNO verified 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: 36703 Based on interview and record review, the hospital failed to ensure the hospital’s P&P for code blue was followed for one of three sampled patients (Patient 2). This failure had the potential for the patient not to receive the timely and effective care needed during the critical situation. Findings: Review of the hospital’s P&P titled Resuscitation of Patient dated December 2020 showed the following forms will be completed for each resuscitation: Code Blue records, evaluation of Code Blue, Event Notification, and EKG monitoring strips. The Director/ Charge Nurse/Administrative House Supervisor will take responsibility for, or delegate completion of the record and other facilities designated forms. Review of Patient 2’s medical record was initiated on 10/14/24 at 1050 hours with the Quality Manager. Patient 2’s medical record showed the patient was admitted as an inpatient to the hospital on 10/1/24. Review of Patient 2’s Code Blue note dated 10/10/24 at 1015 hours, showed Patient 2 was found to have agonal respirations and desaturations overnight. Patient 2 was also found to be hypotensive and was started on Levophed (a medication used to treat low blood pressure). Patient 2 was intubated with a 7.5 cm cuffed tube at 24 cm and had equal breath sounds bilaterally. Patient 2 tolerated the procedure well with no immediate complications. On 10/14/24 at 1415 hours, an interview was conducted with the Quality Manager. The Quality Manager stated debriefing after Patient 2’s code blue event was not done. The Quality Manager stated she was unable to find the EKG monitoring strips that were done during Patient 2’s code blue event in Patient 2’s medical records. On 10/14/24 at 1534 hours, the above findings were shared and acknowledged by the Quality Manager.”

“CONTRACTED SERVICES CFR(s): 482.12(e) The governing body must be responsible for services furnished in the hospital whether or not they are furnished under contracts. The governing body must ensure that a contractor of services (including one for shared services and joint ventures) furnishes services that permit the hospital to comply with all applicable conditions of participation and standards for the contracted services. This Standard is not met as evidenced by: 36703 Based on interview and record review, the hospital failed to ensure a contract agreement with an active vendor who was providing services for patient care. This failure had the potential for the risk of substandard services being provided in the hospital. Findings: On 9/13/24 at 1448 hours, a review of the hospital’s contracted services was initiated with the CNO. A sample review of contacted services for specialty beds showed the hospital had three separate vendors. Vendor A was the main service provider for specialty beds. Vendors B and C were back-up vendors for specialty beds. When asked to provide the contract agreements for Vendors A, B and C, only contract agreements for Vendors A and B were provided. On 9/16/24 at 0940 hours, the CNO verified the hospital had not received any specialty beds from Vendors A, B or C since 3/15/24 due to credit holds. The CNO stated the GB was aware of the issue and dealt with resolving individual credit holds in a fluid manner on a month-to-month basis based on priorities since 3/15/24. However, Vendors A, B and C were still on hold. On 9/16/24 at 1117 hours, the above concern was shared and acknowledged by the CNO. Vendor C’s contract agreement to provide specialty beds for the hospital was not provided. The CNO acknowledged the credit holds was an ongoing concern which was not addressed since 3/15/24 for Vendors A, B and C.”

“CONTRACTED SERVICES CFR(s): 482.12(e)(1) The governing body must ensure that the services performed under a contract are provided in a safe and effective manner. This Standard is not met as evidenced by: 36703 Based on interview and record review, the hospital failed to ensure services provided under contracted vendors were provided in a safe and effective manner by establishing complete and regularly scheduled contract evaluations for the vendors in the hospital. This failure had the potential for the risk of substandard services being provided in the hospital. Findings: Review of the hospital’s P&P titled Organization-Wide Quality Assessment and Performance Improvement Program dated May 2024 showed senior leadership will perform evaluations of clinically contracted services in collaboration with the respective department director and report the results of the evaluation through the QAPI Committee structure to the MEC and the GB. Review of the Governing Board Meeting Minutes date 7/25/24, showed the evaluation of contracted services from the period of 1/1 thru 12/31/21 was the most recent data reviewed by the committee. However, it was not updated to reflect the current active contracts and evaluations of the contracted service. On 9/13/24, a review of the hospital’s vendor contract evaluation was initiated. The following selection of contract evaluations was requested or reviewed. The following was identified: - Vendors A, B and C did not have contract evaluations for the provision of specialty air mattresses with the hospital. - Vendor D’s last contract evaluation was performed on 6/27/22. - Vendor E’s last contract evaluation was performed on 2/23. On 9/16/24 at 1038 hours, an interview was conducted with the CNO, Quality Manager, the Vice President of Supply Chain, and Materials Manager. When asked if there was a set schedule for ensuring all contracted vendors were evaluated regularly for a safe and effective manner, the CNO stated recently there was changes in the leadership and the process for contract evaluations needed to be addressed. The CNO stated each department in the hospital dealt directly with corporate for any issues with the vendor in that department. The CNO stated, for example, Vendors D and E were overseen by the nursing department. The CNO stated Vendor E’s contract evaluation was supposed to be done annually. However, the CNO was not able to provide a schedule of contract evaluations for the sampled vendors reviewed. The Vice President of Supply Chain stated she reviewed Vendors A, B, and C. If there were issues reported from the hospital, she talked to the vendor right away. The Vice President of Supply Chain stated it was a straight communication from the hospital to her and then to the vendor. When asked for documented evidence of a system of contract evaluation for vendors A, B and C, none was provided. On 9/16/24 at 1115 hours, the above concerns were shared and acknowledged by the CNO and Quality Manager.”

“CONTRACTED SERVICES CFR(s): 482.12(e)(2) The hospital must maintain a list of all contracted services, including the scope and nature of the services provided. This Standard is not met as evidenced by: 36703 Based on interview and record review, the hospital failed to ensure the contract list was site-specific within the hospital’s health system to include a complete list of all contracted services for the hospital. This failure had the potential for the risk of substandard services being provided in the hospital. Findings: On 9/16/24 at 1015 hours, a review of the hospital’s contracted services was conducted with the CNO and Quality Manager. Review of the hospital’s contracted list showed Vendors A, B, C, and E were missing from the list provided during the survey. When asked, the Quality Manager stated Vendor A was listed on another version of the list as long as the prompt for summoning the list included another facility type within the health system. The Quality Manager verified there was not a complete list of contracted services specific for the hospital within the health system. On 9/16/23 at 1115 hours, the above findings were shared and acknowledged by the CNO and Quality Manager.”

“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: 29558 Based on observation, interview, and record review, the hospital failed to ensure to comply with the 24 CFR 489.24, special responsibilities of Medicare hospitals in emergency cases. These failures had the potential to result in poor health outcomes and serious adverse events to the patients receiving the ED services. Findings: 1. The hospital failed to ensure the MSE was provided in a timely manner to determine whether or not the EMC existed for five of 21 sampled patients (Patients 3, 9, 10, 12, and 13). Cross reference to A2406. 2. The hospital failed to ensure the necessary stabilizing treatment was provided within the capabilities of the hospital for nine of 21 sampled patients (Patients 1, 10, 12, 13, 14, 17, 19, 20, and 21). Cross reference to A2407. 3. The hospital failed to ensure the ED staff appropriately transferred nine of 21 sampled patients (Patients 1, 2, 5, 6, 10, 14, 19, 20, and 21). Cross reference to A2409.”

“EMERGENCY ROOM LOG CFR(s): 489.20(r)(3) [The provider agrees,] in the case of a hospital as defined in §489.24(b) (including both the transferring and receiving hospitals), to maintain a central log on each individual who comes to the emergency department, as defined in §489.24(b), seeking assistance and whether he or she refused treatment, was refused treatment, or whether he or she was transferred, admitted and treated, stabilized and transferred, or discharged. §489.24 The provisions of this regulation apply to all hospitals that participate in Medicare and provide emergency services. This Standard is not met as evidenced by: 37548 Based on interview and record review, the hospital failed to ensure the Emergency Department Logs were maintained when the mode of arrival, chief complaint, and disposition were not documented in the Emergency Department Log for 19 nonsampled patients (Patients 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 41, 42, 43, and 44). This failure had the potential to result in the hospital not being able to accurately track the care provided to the patients who presented to the ED for treatment for their emergency medical conditions. Findings: Review of the hospital’s P&P titled EMTALA - Central Log Policy dated March 2023 showed in part: * All hospitals must maintain the Central Log in an electronic or paper format. * The logs must contain at a minimum: the name of the individual; the date, time and means of individual’s arrival; the individual’s age; the individual’s sex; the individual’s record number; the nature of the individual’s complaint; the individual’s disposition; the individual’s time of departure; and whether the individual refused treatment, was refused treatment, was transferred, was admitted and treated, was stabilized and transferred, was discharged, or expired. * A log entry for all individuals who have come to the hospital seeking medical attention or who appear to need medical attention must be made by the appropriate individual. 1. On 11/13/23, review of the Emergency Department Logs for June, August, and November 2023 showed the Emergency Department Logs were not completed in its entirety as the mode of arrival, chief complaint, and disposition were not documented in the Emergency Department Logs for Patients 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, and 36. On 11/15/23 at 1410 hours, during an interview with the Chief Quality and Patient Safety Officer, the Chief Quality and Patient Safety Officer acknowledged the findings and confirmed the Emergency Department Log had not been maintained. 38764 2. Review of the hospital’s Emergency Department Logs for May and September 2023 showed the Emergency Department Logs were not completed in its entirety as the mode of arrival, chief complaint, and disposition were not documented in the Emergency Department Logs for Patients 41, 42, 43, and 44. On 11/14/23 at 1443 hours, an interview and concurrent record review was conducted with LVN 1 and Quality Manager 1. Quality Manager 1 acknowledged there was missing information about the patients in the Emergency Department Logs.”

“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: 37548 Based on observation, interview, and record review, the hospital failed to ensure the MSE was provided in a timely manner to determine whether or not the EMC existed for five of 21 sampled patients (Patients 3, 9, 10, 12, and 13) as evidenced by: 1. For Patient 12, the ED staff did not expedite the custodial patient care upon arrival to the ED as per the hospital’s P&P. 2. The Department of Security Services/Public Safety did not consistently implement the P&P for screening the patients presenting to the ED for the ED services. 3. For Patient 13, the ED staff did not provide the interpreter service for Patient 13, did not assign the triage category to Patient 13 as ESI Level 2, and did not ensure the pain management for Patient 13 as per the hospital’s P&Ps. 4. For Patient 9, the ED staff did not implement the P&P for triage of pregnant patients. 5. For Patients 3 and 10, the ED staff did not implement the P&P for the management of a suicidal patient. a. For Patient 10, the ED staff did not notify the physician that Patient 10 was identified at risk for suicide, did not conduct a contraband search, did not conduct a thorough examination of the environment for items that could be harmful, including completing the Suicide Safety Checklist, and did not ensure the Close Observation Flowsheet was completed, which consisted of documenting the patient’s location and the patient’s behavior every 15 minutes. b. For Patient 3, the ED staff did not consistently assess the patient for suicidal risk. These failures had the potential to result in poor clinical outcomes and serious adverse events to the patients receiving the ED services. Findings: Review of the hospital’s P&P titled EMTALA - Medical Screening Examination and Stabilization Policy dated March 2023 showed in part: * An EMTALA obligation is triggered when an individual comes to a dedicated emergency department (DED)and the individual or a representative acting on the individual’s behalf requests an examination or treatment for a medical condition, or a prudent layperson observer would conclude from the individual’s appearance or behavior that the individual needs an examination or treatment of a medical condition. * If a law enforcement official requests hospital emergency personnel to provide medical clearance for incarceration, the Hospital has an EMTALA obligation to provide an MSE to determine if an EMC exists. * Triage entails the clinical assessment of the individual’s presenting signs and symptoms at the time of arrival at the hospital in order to prioritize when the individual will be screening by a physician or other QMP. * There is no delay in the provision of an MSE or stabilizing treatment if: (i) there is not an open bed in the DED; (ii) there is not sufficient caregivers present to render the MSE and/or stabilizing treatment; and (iii) the individual’s condition does not warrant immediate screening and treatment by a physician or QMP. 1. Review of the hospital’s P&P titled Triage and Assessment of Patients dated October 2023 showed in part: * All patients presenting to the Emergency Department seeking emergency care shall be initially assessed by an Emergency Department Physician or qualified Registered Nurse. * This is a means to help expedite the care of the patient by decreasing patient delays, relieving congestion in critical treatment areas, regulating the flow of patient care, and assuring that patients will be seen based on their acuity. * Triage involves a rapid patient assessment that provides an assignment of an acuity level for each patient presenting to the ED. The triage level is designed to minimize morbidity, disfigurement, pain, emotional distress, and client dissatisfaction with their emergency care. Review of the hospital’s P&P titled Custodial Patients - County of Orange dated March 2021 showed in part: * The hospital has under contract agreed to provide medical services to custodial patients. * Field Referrals: - A Law Enforcement Officer may present the requested medical care for a patient directly from the field rather than from the jail. - The Emergency Department physician and nursing staff are to expedite custodial patient care, recognizing that minimal exposure to ancillary staff, other patients, and visitors is advantageous. On 11/14/23 at 1045 hours, a tour of the ED was conducted with the Chief Quality and Patient Safety Officer. During an observation of the exterior of the ED main entrance and ambulance bay, two Law Enforcement Officers were observed walking toward the ambulance bay and escorting Patient 12 in handcuffs. The patient was instructed to sit on a chair immediately outside of the ambulance bay entrance. Within a few minutes after arrival, one of the Law Enforcement Officers was observed entering the ED main entrance. Then, the Law Enforcement Officer was observed returning to the outside and completing a form. During a concurrent interview with Registration Staff 1, Registration Staff 1 stated the Law Enforcement Officer had informed the Registration Staff of Patient 12’s arrival. Registration Staff 1 stated when the Law Enforcement Officer presented with a custody patient, the Patient Custody Questionnaire had to be completed by the Law Enforcement Officer; once the Patient Custody Questionnaire form was completed, the Patient Custody Questionnaire form would be given to the Triage Nurse. Review of a blank copy of the Patient Custody Questionnaire showed, “THIS FORM IS TO BE COMPLETED BY ARRESTING/TRANSPORTING OFFICER.” The form showed various sections to be completed, including patient identification, arrest information, name of city police department, and officer identification. The form did not show a section for documenting if the custody patient was taken to the ED for the sole purpose of getting medical clearance for incarceration and/or if the custody patient required an examination or treatment for a medical condition. On 11/14/23 at 1051 hours, Patient 12 was observed continued sitting outside of the ED with the Law Enforcement Officers; Patient 12 had not been attended to by any clinical staff and the patient had not been triaged. In a concurrent interview with Registration Staff 1, Registration Staff 1 stated the custody patients would sit and wait outside of the ED until triaged by the nurse. When asked who would monitor the custody patients while they were outside waiting to be triaged, Registration Staff 1 stated the clinical staff would not monitor the custody patients. Registration Staff 1 stated there was at least one public safety officer outside the ED at all times and the Law Enforcement Officers would also monitor the patients. In a concurrent interview, the Chief Quality and Patient Safety Officer stated the custody patient should not have been sitting outside of the ED awaiting to be triaged. On 11/14/23 at 1105 hours, an interview was conducted with Triage Nurse 1. When asked if Patient 12 had been triaged, Triage Nurse 1 stated the custody patient had not been triaged. Triage Nurse 1 stated Patient 12 was there for a medical clearance. On 11/14/23 at 1114 hours, Triage Nurse 1 was observed being outside and triaging Patient 12. During a concurrent interview, Triage Nurse 1 stated Patient 12 reported he had been punched by the police earlier that morning. On 11/14/22 at 1534 hours, an interview and concurrent review of Patient 12’s medical record was conducted with Quality Manager 2, the Clinical Informaticist, and the Clinical Analyst. Patient 12’s medical record showed Patient 12 came to the ED on 11/14/23 at 1056 hours. Review of the ED Triage Aware Note dated 11/14/23 at 1142 hours, showed Patient 12’s chief complaint was head injury. Patient 12 was triaged at 1114 hours. The patient was brought in for medical clearance. The patient stated the patient was punched in the face. Review of the ED Provider Aware Note dated 11/14/23 at 1133 hours, showed Patient 12 had been brought for an “evaluation prior to booking.” The patient was struck with fist by the officer on the “left side of face head no loss of consciousness denies any nose bleeding earache but does have some mild left facial pain.” The patient had “some slight facial tenderness along the left intraorbital region for pain CT scan the patient refuses.” The discharge diagnosis was facial contusion. On 11/15/23 at 1412 hours, the Chief Quality and Patient Safety Officer acknowledged that Patient 12’s initial assessment upon arrival to the ED should have been expedited. 2. Review of the hospital’s P&P titled Manual Screening Using Hand-Held Metal Detector dated July 2023 showed in part: * Weapons may include firearms, knives, needles, and metallic blunt objects. * The Department of Security/Public Safety and Hospital staff trained in the usage of hand-held metal detectors (HHMD) will require screening for everyone entering the Emergency Department waiting room, except when not possible due to emergency patient care needs or in order to meet EMTALA or other applicable Emergency Department/Hospital regulatory requirements. * The level of search detail will depend on the type of potential threat to the Hospital as determined by Security manager and appropriate hospital representative. * The screening or patients and individuals will not be voluntary but exist as a condition of entering the Emergency Department. * If an individual refuses or otherwise fails to comply with the security screening, the Department of Security Services and the House Supervisor will be notified to determine the appropriate action. On 11/13/23 at 0920 hours, a tour of the ED was conducted with the Nursing Educator, Quality Manager 1, and the Director ED. Public Safety Officer 1 was observed being outside the ED main entrance. When asked about the process for screening individuals presenting to the ED, the Public Safety Officer provided conflicting information about the process. Initially, the Public Safety Officer stated that all individuals entering the ED required screening (e.g., patients and visitors). The Public Safety Officer stated that the ER Item’s Log had to be completed for individuals that had been searched and weapons had been identified; the weapons would be stored in lockers that were located by the ambulance bay. In a subsequent interview, the Public Safety Officer stated individuals requesting to be seen in the ED, did not require screening prior to entering the ED. Review of the ER Item’s Log dated 10/24 through 11/13/23, showed at least four ED patients (Patients 37, 38, 39, 40) had been screened and their belonging logged in the ER Item’s Log. The ER Item’s log showed the following “Item Description,” none of which were identified as weapons or items of potential threat to the hospital: * For Patient 37, “Bag with wallet chain/ETC.” * For Patient 38, “Black Nike/Bag.” * For Patient 39, “5 Bags.” * For Patient 40, “Back Back [sic] Blue.” On 11/14/23 at 1051 hours, during an interview with Public Safety Officer 2, Public Safety Officer 2 stated not all individuals entering the ED had to be screened. Public Safety Officer 2 stated the screening was based on “judgement” of the Public Safety Officer. Review of the ER Item’s Log dated 11/14/23, showed that a baby “Stroller” had been logged in the ER Item’s Log. On 11/14/23 at 1055 hours, the Chief Quality and Patient Safety Officer acknowledged the hospital’s P&P for screening was not being implemented consistently and there was a potential for delay in examining and/or treating the patient. 3. Review of the hospital’s P&P titled Triage and Assessment of Patients dated October 2023 showed in part: * The purposes are to provide for the initial assessment and categorization of a patient’s condition when presenting to the Emergency Department and to ensure that every patient receives efficient and appropriate medical care based on his/her Emergency Severity Index (ESI) level, an evidence-based triage tool. * A five-category ESI consists of ESI Levels or Triage Levels 1, 2, 3, 4, and 5. ESI Level 1 is assigned to a patient with an acuity of “Resuscitative/Life Threatening.” ESI Level 2 is assigned to a patient with an acuity of “Emergent.” or with conditions that require immediate care. ESI Level 3 is assigned to a patient with an acuity of “Urgent.” ESI Level 4 is assigned to a patient with an acuity of “Semi-Urgent.” ESI Level 5 is assigned to a patient with an acuity of “Non-Urgent.” * The Attachment B showed examples of ESI level 2 or Triage Level 2 (high-risk situations) include patient currently in pain or distress; or clinical observation and/or a self-reported pain rating of seven or greater on a scale of 0 to 10. Review of the hospital’s P&P titled Pain Management Assessment and Reassessment dated March 2023 showed in part: * The pain assessment tools used at the hospital include the numeric 0-10 pain intensity scale. “The Numeric Intensity Scale is: 1-3 = Mild Pain, 4-6 = Moderate Pain, 7-10 = Severe Pain.” * When pain is identified, the patient is treated or referred for treatment. Review of the hospital’s P&P titled Interpreter Services for Patients (Limited English Proficiency, Deafness, Speech, Hearing Impairment, Visual Impairment or Blindness) dated April 2021 showed in part: * [Name of hospital] endeavors to communicate information to patients in a comprehensive manner to insure informed consent, compliance, and to promote education. * Non-qualified clinical or administrative staff may not serve as a medical interpreter. * Language assistance and interpreter services will be provided 24 hours/7 days a week at no cost to the patient. On 11/14/23 at 1045 hours, during a tour of the ED with the Chief Quality and Patient Safety Officer, Patient 13 was observed sitting in the ED lobby, the patient’s head was down, and the patient’s right hand was over his right ear. In a concurrent interview, Registration Staff 1 stated Patient 13 presented to the ED with ear pain. Review of the short registration form showed the section of “Reason for visit/Razon por su visita: dolor muy fuerte en el oido (very strong pain in the ear).” Registration Staff 1 confirmed Patient 13 was non-English speaking or Language A speaking only. When asked if an interpreter had been used when registering the patient, Registration Staff 1 stated no. On 11/14/23 at 1122 hours, during an interview with Triage Nurse 1, Triage Nurse 1 stated Patient 13 was triaged by Triage Nurse 1. Triage Nurse 1 confirmed an interpreter was not used for Patient 13. On 11/14/22 at 1510 hours, an interview and concurrent review of Patient 13’s medical record was conducted with Quality Manager 2, the Clinical Informaticist, and the Clinical Analyst. Review of the ED Triage Aware Note dated 11/14/23 at 1150 hours, showed the following: * Patient 13 was triaged at 1114 hours. * Patient 13’s chief complaint was ear pain. “Pt (patient) states right ear pain 8/10 and difficulty hearing in the right ear.” * Patient 3 was categorized with an ESI Level of 4 (Semi-Urgent) which was not consistent with the hospital’s P&P. As per the hospital’s P&P, a patient with a self-reported pain level of 8 out of 10, should have categorized with an ESI Level of 2. * The Arrival Information section showed the “Spoken Language Preferred:” and “Reading Language Preferred:” was non-English language (Language A). * The sections of Safety and Nutrition Screening, Illness Risk, Abuse Screen, and Suicide Homicide Screening was conducted for Patient 13. Further review of the nursing documentation did not show the ED staff had addressed the patient’s pain, including communicating with the physician about the patient’s severe pain level. Review of the ED Provider Aware Note dated 11/14/23 at 1128 hours, showed Patient 13 was seen by the physician on 11/14/23 at 1128 hours. Patient 13 presented with complaints of the right ear pain. “The patient felt as if something blew into his ear while he was driving no other acute complaints. Symptom occurred this morning no sore throat or fever no direct trauma history.” Review of the section of Discharge/Admit/Transfer section of the Flowsheets-All Other dated 11/14/23 at 1214 hours, showed “D/c (discharge) instructions reviewed, and education provided...No further questions, concerns, or apprehension at this time. The instruction was reviewed with the patient. The patient verbalized understanding.” The patient was discharged home on 11/14/23 at 1215 hours. In a concurrent interview, the Clinical Informaticist and the Clinical Analyst confirmed there was no documentation showing an interpreter was used by the nursing staff and/or the physician that conducted the MSE for Patient 13. The above findings were shared with Quality Manager 2, the Clinical Informaticist, and the Clinical Analyst. 4. Review of the hospital’s P&P titled Obstetrical Patients, Triage Of dated April 2023 showed in part: * All Obstetrical patients presenting to the Emergency Department will be triaged by the ED triage nurse utilizing an initial quick assessment tool, ED Rapid Triage for Obstetrical Patients form (Appendix A). This form provides a systematic, concise, and focused initial assessment of labor and other obstetric and non-obstetrical complaint in a pregnant patient presenting in the emergency department. * The ED Rapid Triage for Obstetrical Patient form promotes faster response for medical screening evaluation and treatment to urgent situations that are potentially obstetrical-fetal condition or maternal-medical condition. On 11/15/22 at 1100 hours, an interview and concurrent review of Patient 9’s medical record was conducted with the Clinical Informaticist, the Clinical Analyst, and the Chief Quality and Patient Safety Officer. Patient 9’s medical record showed Patient 9 came to the ED on 6/7/23. Review of the ED Triage Aware Note dated 6/7/23 at 1043 hours, showed Patient 9 presented to the ED with a chief complaint of “pregnancy problem” and “C/O (complaint of) NO FETAL TONE.” When asked to review the ED Rapid Triage Form for Patient 9, the Clinical Informaticist and the Clinical Analyst stated the form was not found. In a concurrent interview, the Chief Quality and Patient Safety Officer acknowledged Patient 9 had not been triaged as per the hospital’s P&P. 5. Review of the hospital’s P&P titled Suicide Risk Screening, Assessment, and Patient Management dated January 2021 showed in part: * The purpose is to identify patients at risk for suicide and to assure that their immediate safety needs are met in the most appropriate care setting within the scope of services provided by the organization. * Staff will address the patient’s immediate safety needs and provide the most appropriate setting for safety. * When a patient is identified at risk for suicide, the staff will ask the patient to remove all clothing (e.g. belts, shoe laces) and do a contraband search of his/her belongings in order to remove any items that could be harmful (sharp objects, alcohol, drugs, rope, plastic bags, etc.) out of the patient’s reach. The screening staff member shall place the patient on “suicide precaution” immediately, and the attending physician will be notified. * Prior to placing the patient at risk for suicide in any rooms and/or treatment areas, a thorough examination of the environment will be done to ensure that patients do not have access to items that could be harmful (sharp objects, plastic bags, cleaning solvents, etc.). * If patient scores high lethality according to the Suicide Risk Screen, place the patient on a 1:1, notify physician, and obtain an order for this 1:1 as soon as possible. a. On 11/15/22 at 1023 hours, an interview and concurrent review of Patient 10’s medical record was conducted with the Clinical Informaticist, the Clinical Analyst, and the Chief Quality and Patient Safety Officer. Patient 10’s medical record showed Patient 10 came to the ED on 8/20/23. Review of the ED Triage Aware Note dated 8/20/23 at 0038 hours, showed Patient 10 was triaged at 0034 hours. Patient 10 was brought in by the patient’s family member for suicide thoughts. The patient’s family member stated the patient “tried hitting her head, hanging, and running into traffic.” The patient had a history of cutting her wrist and inner thighs. Review of the ED Provider Aware Note dated 8/20/23 at 0152 hours, showed the physician saw the patient on 8/20/23 at 0152 hours. The physician had reviewed and confirmed the nurse’s notes for patient’s medication, allergies, medical history, and surgical history. Patient 10 had suicidal ideation. In a concurrent interview, the Clinical Informaticist and the Clinical Analyst confirmed there was no documentation of the following: * The nursing staff notified the physician that Patient 10 was identified at risk for suicide. * The nursing staff conducted a contraband search. * The nursing staff conducted a thorough examination of the environment for items that could be harmful, including completing the Suicide Safety Checklist. * The nursing staff ensured the Close Observation Flowsheet was completed, which consisted of documenting the patient’s location and the patient’s behavior every 15 minutes. The findings were shared with the Chief Quality and Patient Safety Officer. 38764 b. Review of Patient 3’s medical record showed the patient came to the ED on 5/20/23. Review of Patient 3’s ED Triage Aware Note dated 5/20/23 at 1151 hours, showed Patient 3 was triaged on 5/20/23 at 1151 hours. The Chief Complaint Quote section showed the patient felt “a little suicidal yesterday.” Review of Patient 3’s CSSR Scale flowsheet with an entry date of 5/20/23 at 1337 hours, showed Patient 3 did not have any thoughts of killing himself in the past month. Review of Patient 3’s ED Provider Aware Note dated 5/20/23 at 1404 hours, showed Patient 3 was seen by the ED provider on 5/20/23 at 1404 hours. Patient 3 stated the patient felt suicidal yesterday, but the patient had no suicidal ideation today. On 11/14/23 at 1021 hours, an interview and concurrent record review of Patient 3’s medical record was conducted with LVN 1 and Quality Manager 1. LVN 1 and Quality Manager 1 acknowledged the above findings. Quality Manager 1 stated the manager would have thought the primary care nurse of the patient would have read the documentation of the assessment findings of the triage nurse for Patient 3.”

“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: 38764 Based on observation, interview, and record review, the hospital failed to ensure the necessary stabilizing treatment was provided within the capabilities of the hospital for nine of 21 sampled patients (Patients 1, 10, 12, 13, 14, 17, 19, 20, and 21) as evidenced by: 1. For Patient 1, the ED staff did not implement the hospital’s P&P related to the activation of code stroke in the ED. a. The ED staff did not perform a point of care testing for blood sugar for Patient 1 as per the hospital’s P&P. b. The ED staff did not notify a neurologist after Patient 1 was evaluated of having a stroke as per hospital’s P&P. c. The ED staff did not monitor and assess Patient 1 consistently when the patient was receiving the alteplase (thrombolytic, a medication used to treat a stroke caused by a blood clot or other obstruction in a blood vessel) infusion as per the hospital’s P&P. 2. The ED staff failed to use appropriate daily check log for the external contents of the adult crash cart. 3. The ED staff (RN 3) did not implement the hospital’s P&P related to the use of glucometer when entering the operation ID to perform the quality control testing and check the patient’s blood glucose level. 4. The ED staff did not implement the hospital’s P&Ps related to reassessment of the patients based on the patient’s ESI and/or the pain management and reassessment for Patients 13, 14, 17, 19, 20, and 21. 5. For Patient 12, the ED staff did not provide discharge instructions for the patient as per the hospital’s P&P. 6. The triage nurse was not available at all times as per the hospital’s P&P when Patient 10 had been taken care by the triage nurse. These failures had the potential to result in poor health outcomes and serious adverse events to the patients receiving the ED services. Findings: 1. Review of the hospital’s P&P titled Stroke Team, ED Activation Of dated March 2023 showed for all ED patients with signs and symptoms of stroke of less than 24 hours from the time of onset, activation of Stroke Team will run as follows: * “CODE Stroke Team” will be activated as soon as an evaluation is made by the ED physician. * Point of Care testing for Blood Glucose will be completed immediately. If patient arrived via EMS, it is ok to use EMS blood glucose result as long as it is documented in the EHR. * Stroke documentation is completed in the EHR, except for the tPA Monitoring Record which is kept on paper and is continued in the ICU upon admission and if the patient is transferred for a higher level of care, a copy of the tPA Monitoring Record is transferred with the patient and all monitoring is continued throughout the transport. * “ Timeframe goals:... Arrival to Neurologist notification: 15 minutes.” Review of Patient 1’s medical record showed the patient came to the ED on 10/16/23. Review of Patient 1’s ED Triage Aware Note dated 10/16/23 at 2334 hours, showed Patient 1 was triaged on 10/16/23 at 2322 hours. Patient 1 arrived in the ED in a private vehicle. The patient’s chief complaint was right-sided weakness with headache. The onset of the complaint was 10/1623 at 2145 hours. Code stroke was called at 2335 hours. a. Further review of Patient 1’s medical record failed to show a documentation showing a point of care testing for blood glucose was performed for the patient. On 11/14/23 at 1443 hours, an interview and concurrent interview was conducted with LVN 1, Quality Manager 1, and the Chief Quality and Patient Safety Officer. LVN 1 and the Chief Quality and Patient Safety Officer verified the above findings. On 11/15/23 at 1039 hours, an interview was conducted with Quality Manager 1 and the Director ED. The Director ED was asked who would perform a POCT blood glucose for a patient when a code stroke was activated in the ED. The Director ED stated any ED staff who was available, would be able to perform a POCT blood glucose test for a patient. The Director ED was asked what the purpose of a POCT blood glucose test was for a patient during a code stroke. The Director ED stated to rule out if a patient was having a hypoglycemia. The Director ED stated hypoglycemia signs and symptoms could mimic a stroke condition. b. Review of Patient 1’s medical record did not show documented evidence showing a neurologist was notified for Patient 1 by an ED staff as per the hospital’s P&P. On 11/14/23 at 1443 hours, an interview and concurrent record review of Patient 1’s medical record and hospital’s P&P was conducted with LVN 1, Quality Manager 1, and the Chief Quality and Patient Safety Officer. LVN 1, Quality Manager 1, and the Chief Quality and Patient Safety Officer verified the above findings. Quality Manager 1 stated the hospital no longer had neurology services and the hospital’s P&P had been recently updated to show the changes. c. Review of the hospital’s P&P titled Thrombolytic Therapy (IV) - Alteplase (Activase) dated November 2020 showed all the patients receiving will have a frequent monitoring of vital signs and frequent neuroassessments. This will be documented on the Stroke tPA Monitoring Record (Appendix D). Review of the Stroke tPA Monitoring Record showed to monitor vital signs and neurochecks every 15 minutes for two hours, to start at the administration time of the bolus dose of the medication. Review of Patient 1’s MAR Report showed the following: - On 10/17/23 at 0100 hours, alteplase 9 mg IV bolus (single dose of medication administered over a short period of time) was administered to the patient. - On 10/17/23 at 0113 hours, alteplase 81 mg IV piggyback (a small bag of solution attached to a primary infusion line) was administered to the patient. Review of Patient 1’s Assessment and Cares ED showed the following; - On 10/17/23 at 0100 hours, the bolus of the tPA was given to the patient, - On 10/17/23 at 0105 hours, the infusion of the tPA was started for the patient, - On 10/17/23 at 0143 hours, the infusion of the tPA was discontinued before transferring the patient to Hospital A. Review of Patient 1’s Vital Signs Measurement showed Patient 1’s vital signs were assessed on 10/16/23 at 2334 hours; and 10/17/23 at 0112, 0128, and 0143 hours. Review of the NIH Stroke Scale showed Patient 1’s NIH Stroke Scale was 9 on 10/17/23 at 0100, 0113, 0118, and 0133 hours. Further review of Patient 1’s medical record failed to show the Stroke tPA Monitoring Record showing a frequent monitoring of vital signs and frequent neuroassessments was performed for Patient 1 as per the hospital’s P&P. On 11/15/23 at 1020 hours, an interview was conducted with Quality Manager 1. Quality Manager 1 verified the above findings. Quality Manager 1 stated there was no documentation to show a frequent monitoring of vital signs and frequent neuroassessments was performed consistently on Patient 1 during the administration of the alteplase. 2. Review of the hospital’s P&P titled Crash Cart - Inspection, Availability, Maintenance, & Exchange dated April 2023 showed the availability of external items shall be monitored daily by nursing staff/ancillary department staff as evidenced by documentation on the Crash Cart Daily Log. The verification of cart supplies and defibrillator check can be done by any licensed or unlicensed staff person that has been verified competent to complete the cart check. Review of the Adult Crash Cart External Contents Daily Check Log and the Pediatric Crash Cart External Contents Daily Check Log for the month of November 2023 showed the instructions include to verify the items in par level indicated by placing a check in the appropriate box. Review of the Adult Crash Cart External Contents Daily Check Log showed the supplies included a CO2 (carbon dioxide) cable with an airway adapter and adult resuscitation bag (BVM with a CO2 detector). Review of the Pediatric Crash Cart External Contents Daily Check Log showed the supplies included a CO2 cable and a pediatric resuscitation (bag/valve and mask). As described above, the Adult Crash Cart External Contents Daily Check Log and the Pediatric Crash Cart External Contents Daily Check Log did not show the same items which would be verified as the contents on a crash cart. On 11/13/23 at 0921 hours, a tour of the ED was conducted with the Nursing Educator. The external contents of the adult crash cart were observed including a bag-valve mask and a defibrillator. The Nursing Educator was asked how often the adult crash cart had been checked by the ED staff. Review of the daily check log form showed check marks from 11/1 to 11/13/23; however, the title of the form was the Pediatric Crash Cart External Contents Daily Check Log. When the Nursing Educator was asked why the Pediatric Crash Cart External Contents Daily Check Log was used for the daily check of the adult crash cart, the Nursing Educator stated the staff could have pulled the wrong log for the adult crash cart. The Nursing Educator acknowledged the daily check log for the adult and pediatric crash cart had different contents. 29798 3. Review of the Procedure section of the hospital’s P&P titled Point of Care Testing, Accu-check Inform II Blood Glucose Monitor dated January 2021 showed the following: * Turn on the Accu-Check Inform II meter. * Enter the staff operator ID by means of scanning badge or manual entry. * Note: If the staff operator ID is not accepted, attempt to re-enter it. If it is still rejected, contact the supervisor or Point of Care Coordinator. Do not attempt to perform tests under another operator’s ID. On 11/13/23 at 1135 hours, an interview was conducted with RN 3. When asked about the process of calibration of the glucometer, RN 3 stated RN 3 would enter the employee’s identification number to calibrate the glucometer. When asked if RN 3 had calibrated the glucometer today, RN 3 stated RN 3’s employee ID number has not been working for one week. RN 3 further stated RN 3 would ask the charge nurse or one of her peers to enter their employee ID number and then RN 3 would proceed with checking the patient’s blood glucose level. Review of the Accucheck section of RN 3’s 2023 Annual Emergency Department RN Competency showed RN 3 was evaluated as having some experience and might require assistance; and RN 3 had a follow-up evaluation which showed the RN was competent in performing the task independently. However, there was no documented evidence to show the evaluator’s initial and the method on how to validate RN 3’s competency; and there was no documented evidence to show the method on how to conduct the follow-up evaluation for RN 3’s competency. 4. Review of the hospital’s P&P titled Triage and Assessment of Patients dated October 2023 showed in part: * Purpose: to provide for the initial assessment and categorization of a patient’s condition when presenting to the Emergency Department. To assist emergency personnel in providing care based on a priority of need. To ensure that every patient receives efficient and appropriate medical care based on his/her Emergency Severity Index (ESI) level, an evidenced-based triage tool. To provide guidelines for the Registered Nurse follow when functioning in their capacity. * Policy: The triage assessment will be completed by the bedside RN for patients who are immediately placed into the treatment area. Based on that initial assessment, the Triage Nurse will place the patient into one of five categories of the triage rating system. This is a means assuring that patients will be seen based on their acuity. * Triage level 3: Conditions that could progress to a serious problems requiring but not immediate care, utilizing two or more resources, as defined by the ESI. Vital signs will be taken at least every two hours until evaluated by emergency physician. * Triage level 4: Conditions that the patient presents with a condition that has a low potential for deterioration or complications. It is anticipated that one resource is needed to treat patient, as defined by the ESI. Vital signs will be taken at a minimum of every two hours until seen by emergency physician. * Patients should be reassessed upon change in status. For Levels 3, 4, and 5, patients should be reassessed every two hours and with significant change in status. Review of the hospital’s P&P titled Pain Management Assessment and Reassessment dated March 2023 showed in part: * Purpose: To assure that patients receive an assessment and management of their pain consistent with the scope of care, treatment, and service provided by the organization in its various care settings. * Policy: The hospital recognizes the individual’s right to appropriate pain assessment/management taking into account personal, cultural, and ethnic beliefs. The patient and family can expect the patient in pain to be assessed and treated promptly, effectively and for as long as pain persists. The pain assessment tools used at the hospital include the numeric 0-10 pain intensity scale. “The Numeric Intensity Scale is: 1-3 = Mild Pain, 4-6 = Moderate Pain, 7-10 = Severe Pain.” * Procedure: - When pain is identified, the patient is treated or referred for treatment. - Patient will be assessed at minimum every shift. Pain assessment may include severity, onset, quality, alleviating factors, and provoking factors if applicable. Pain assessment includes to ask the patient if he/she has a current complaint of pain or has chronic pain and to assess if there is a potential for pain. - Patient is reassessed with new reports of pain, following procedures, or activities that are expected to cause pain. Pain is reassessed following medication given for pain that is consistent with route of medication administration. * Points of Emphasis: The patient’s self-report is the single most reliable indicator of the existence and intensity of acute pain. Neither behavior nor vital signs can substitute for a self-report. a. On 11/13/23 at 1630 hours, an interview and concurrent record review of Patient 14’s medical record was conducted with the Chief Quality and Patient Safety Officer and the Clinical Informaticist. Patient 14’s medical record showed the patient came to the ED on 7/2/23 at 0920 hours and transferred to other hospital on 7/2/23 at 1546 hours. Review of the triage report dated 7/2/23, showed Patient 14 was brought in by from home with the chief complaint of flu like symptoms. The patient was triaged at 0925 hours. The patient’s ESI level was three. Review of Patient 14’s nursing flow sheet dated 7/2/23 at 0925 hours, showed the patient’s vital signs were assessed. The patient’s oxygen saturation was 91% room air. Review of the ED Provider Aware Note electronically signed by the physician on 7/2/23 at 1343 hours, showed Patient 14 was seen by the physician on 7/2/23 at 1146 hours. The patient’s complaint was “shortness of breath.” Patient 14 was on 2 liters of oxygen via nasal cannula at home at all times. However, when the patient’s family member checked the patient’s oxygen saturation level at home, the patient’s oxygen saturation levels were in the 80’s and the required 4 liters of oxygen via nasal canula to increase the patient’s oxygen saturation to the mid 90’s. Review of Patient 14’s Visit Record showed the nursing staff assessed Patient 14 on 7/2/23 at 0938 and 1522 hours. Further review of Patient 14’s medical record showed nursing reassessment including Patient 14’s vital signs were not completed as per the hospital’s P&P. The Chief Quality and Patient Safety Officer verified the findings. b. On 11/14/23 at 0940 hours, an interview and concurrent review of Patient 17’s medical record was conducted with the Chief Quality and Patient Safety Officer and the Clinical Informaticist. Patient 17’s medical record showed the patient came to the ED on 7/10/23 at 1340 hours and left AMA on 7/10/23 at 1749 hours. Review of the triage report dated 7/10/23 at 1349 hours, showed the patient was brought in by police for medical clearance, with chief complaint of abdominal pain. The patient’s ESI level was four. Review of the ED Provider Aware Note dated 7/10/23 at 1643 hours, showed Patient 17 was seen by the physician on 7/10/23 at 1644 hours. The patient was brought in by the police for medical clearance for an umbilical hernia (19.5 cm). The patient had abdominal pain with the pain level of seven out of 10. Further review of Patient 17’s medical record showed Patient 17’s pain level was six out of 10 on 7/10/23 at 1730 hours. There was no documented evidence to show the nursing reassessment including pain level was performed every two hours as per the hospital’s P&P. There was no documented evidence to show Patient 17 was treated for pain as per the hospital’s P&P. The Chief Quality and Patient Safety Officer verified the findings. c. On 11/14/23 at 1120 hours, an interview and concurrent record review of Patient 19’s medical record was conducted with the Chief Quality and Patient Safety Officer and the Clinical Informaticist. Patient 19’s medical record showed the patient came to the ED on 10/8/23 at 0552 hours and transferred to another hospital on 10/8/23 at 0957 hours. Review of the triage report dated 10/8/23 at 0553 hours, showed Patient 19 was brought in by ambulance to the ED with chief complaint of abdominal pain. Patient 19 was triaged on 10/8/23 at 0553 hours. The patient’s pain level was 10 out of 10. The patient’s ESI level was three. Review of the ED Provider Aware Note dated 10/8/23 at 0556 hours, showed Patient 19 was seen by the physician on 10/8/23 at 0556 hours. Further review of Patient 19’s medical record showed Patient 19 received pain medication on 10/8/23 at 0824 and 0929 hours. However, there was no documented evidence to show the nursing reassessment was completed every two hours, or the patient’s pain was reevaluated as per the hospital’s P&P. The Chief Quality and Patient Safety Officer verified the findings. d. On 11/14/23 at 1315 hours, an interview and concurrent record review of Patient 20’s medical record was conducted with the Chief Quality and Patient Safety Officer and the Clinical Informaticist. Patient 20’s medical record showed the patient came to the ED on 10/11/23 at 1917 hours and was transferred to other hospital on 10/12/23 at 0608 hours. Review of the patient’s triage report dated 10/11/23 at 1920 hours, showed Patient 20 was brought in by ambulance with a chief complaint of suspected alcohol intoxication. The patient was triaged on 10/11/23 at 1920 hours. The patient’s ESI level was three. Review of the Flowsheets-Vitals showed Patient 20’s vital signs was completed on 10/11/23 at 1920, 2155, 2339 hours; and 10/12/23 at 0154 hours. However, there was no documented evidence to show the nursing reassessment were performed for Patient 20 every two hours as per the hospital’s P&P. The Chief Quality and Patient Safety Officer verified the findings. e. On 11/14/23 at 1525 hours, an interview and concurrent record review of Patient 21’s medical record was conducted with the Chief Quality and Patient Safety Officer and the Clinical Informaticist. Patient 21’s medical record showed the patient came to the ED on 10/13/23 at 2309 hours and transferred to other hospital on 10/14/23 at 1426 hours. Review of the triage report dated 10/13/23 at 2321 hours, showed Patient 21 was triaged on 10/13/23 at 2245 hours. The patient’s chief complaint was abdominal pain. The patient’s pain level was five out of 10. The patient’s ESI level was three. Review of Patient 21’s nursing flowsheet showed Patient 21’s vital signs were completed on 10/13/23 at 2321 and 2359 hours; and on 10/14/23 at 0200, 0400, 0600, 0800, and 1400 hours. The patient’s vital signs were not consistently checked every two hours as per the hospital’s P&P. In addition, the nursing flowsheet did not show the nursing assessment was consistently performed every two hours as per the hospital’s P&P. The Chief Quality and Patient Safety Officer verified the findings. 37548 f. On 11/14/22 at 1510 hours, an interview and concurrent review of Patient 13’s medical record was conducted with Quality Manager 2, the Clinical Informaticist, and the Clinical Analyst. Review of the ED Triage Aware Note dated 11/14/23 at 1150 hours, showed the following: * Patient 13 was triaged at 1114 hours. * Patient 13’s chief complaint was ear pain. “Pt (patient) states right ear pain 8/10 and difficulty hearing in the right ear.” Further review of the nursing documentation did not show the ED staff addressed the patient’s pain including communicating with the physician about the patient’s severe pain level. Review of the ED Provider Aware Note dated 11/14/23 at 1128 hours, showed Patient 13 was seen by the physician on 11/14/23 at 1128 hours. Patient 13 presented with complaints of the right ear pain. Review of the section of Discharge/Admit/Transfer section of the Flowsheets-All Other dated 11/14/23 at 1214 hours, showed the patient was discharged home on 11/14/23 at 1215 hours. There was no documentation showing the patient’s pain level had been reassessed after the MSE or prior to being discharged home. The above findings were acknowledged by the Clinical Informaticist and the Clinical Analyst. 5. Review of the hospital’s P&P Custodial Patients - County of Orange dated March 2021 showed in part: * [Name of Facility] has under contract agreed to provide medical services to custodial patients. * Appropriate Aftercare Instructions should be completely written. Only very brief and general verbal instructions should be given to the patient. All written instructions should be given to the Law Enforcement Officer. On 11/14/22 at 1534 hours, an interview and concurrent review of Patient 12’s medical record was conducted with the Quality Manager 2, the Clinical Informaticist, and the Clinical Analyst. Review of the ED Provider Note dated 11/14/23 at 1133 hours, showed Patient 12 had been brought the police for an “evaluation prior to booking.” The patient was struck with fist by the officer on the “left side of face head no loss of consciousness denies any nose bleeding earache but does have some mild left facial pain...CT scan the patient refuses.” The discharge diagnosis was facial contusion. In a concurrent interview, the Clinical Informaticist and the Clinical Analyst confirmed there was no documentation showing Patient 12 had been given aftercare instructions as per the hospital’s P&P. 6. Review of the hospital’s P&P Triage and Assessment of Patients dated October 2023, showed in part: * Triage Procedure: - Availability of Triage: Triage is available on a 24-hour basis. All patients presenting to the Emergency Department seeking emergency care, except for those patients who are immediately placed in the treatment area, shall be initially assessed by an Emergency Department Physician or qualified Triage Nurse. The charge nurse is responsible for ensuring that an RN qualified to perform the triage assessment is available at all times. On 11/15/22 at 1023 hours, an interview and concurrent review of Patient 10’s medical record was conducted with the Clinical Informaticist, the Clinical Analyst and the Chief Quality and Patient Safety Officer. Patient 10’s medical record showed Patient 10 came to the ED on 8/20/23. Review of the ED Triage Aware Note electronically signed by Triage Nurse 2 showed Patient 10 was triaged on 8/20/23 at 0034 hours. Patient 10 was brought in by the patient’s family members for suicide thoughts. The patient’s family member stated the patient “tried hitting her head, hanging, and running into traffic.” Further review of Patient 10’s medical record showed the patient was placed on suicide precautions and required 1:1 observation. Review of the nursing progress notes documented by Triage Nurse 2 on 8/20/23 at 0219 hours, showed “Pt currently has no assign [sic] nurse and is being taken care by Traige [sic] nurse due to short staff. Currently No bed available pt is sitting in a chair with Sitter near by.” Review of the Discharge/Admit/Transfer documented by Triage Nurse 2 on 8/20/23 at 0607 hours, showed Patient 10 was transferred to psychiatric facility on 8/20/23 at 0550 hours. Further review of Patient 10’s medical record failed to show documented evidence the ED nursing staff conducted a contraband search and ensured the Close Observation Flowsheet was completed, which consisted of documenting the patient’s location and the patient’s behavior every 15 minutes. Cross reference to A2406, example # 5a. In a concurrent interview, the Chief Quality and Patient Safety Officer confirmed the findings and stated the triage nurse should not have a patient assignment and the Chief Quality and Patient Safety Officer acknowledged the hospital’s triage P&P had not been implemented.”

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1)-(2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 38764 Based on interview and record review, the hospital failed to ensure the ED staff appropriately transferred nine of 21 sampled patients (Patients 1, 2, 5, 6, 10, 14, 19, 20, and 21) as evidenced by: 1. The ED staff did not arrange the transportation properly for Patient 1 when transferring the patient to a higher level of care as per the hospital’s P&P. 2. The ED staff did not complete the Transfer Summary and Certification forms when transferring Patients 1, 2, 5, 6, 10, 14, 19, 20, and 21 to other hospitals as per the hospital’s P&P. These failures had the potential to result in poor clinical outcomes and serious adverse event to the patients receiving ED services. Findings: 1. Review of the hospital’s P&P titled Transfer of Patients for Higher Level of Care/Specialty Care dated March 2023 showed once a transfer is accepted, under the direction of the ED Physician, the ED nursing staff/support staff will arrange transportation best suited to the medical needs of the patient. Patient 1’s medical record showed the patient came to the ED on 10/16/23 at 2321 hours. Review of Patient 1’s ED Provider Aware Note dated 10/17/23 at 0040 hours, showed a physician from Hospital A accepted the patient at 0130 hours. Review of Patient 1’s Assessment and Cares ED dated 10/17/23 showed the following: - At 0145 hours, the patient left the ED with the paramedics. - At 0154 hours, the patient was transferred to Hospital A. The ambulance for the patient had been waiting for approximately 20-30 minutes and Hospital A had accepted the patient. The paramedics did not want to wait, and the paramedics would take the patient to Hospital A. On 11/14/23 at 1443 hours, an interview and concurrent record review of Patient 1’s medical record and hospital’s P&P was conducted with LVN 1, Quality Manager 1, and the Chief Quality and Patient Safety Officer. LVN 1, Quality Manager 1, and the Chief Quality and Patient Safety Officer acknowledged the above documentation. LVN 1, Quality Manager 1, and the Chief Quality and Patient Safety Officer was asked to describe the process when coordinating a transportation for a patient who required to be transferred to a higher level of care. The Chief Quality and Patient Safety Officer stated there should be an accepting facility/physician before a transportation would be arranged for the patient. The Chief Quality and Patient Safety Officer stated the mode of transportation for the patient would be determined by the ED physician. When the Chief Quality and Patient Safety Officer was asked about Patient 1’s transportation to Hospital A, the Chief Quality and Patient Safety Officer stated the 911 transport was contacted by the ED staff. However, the patient was not yet ready to be transferred since there was no accepting physician for the patient. On 11/14/23 at 1546 hours, an interview was conducted with the Director ED and Quality Manager 1. The Director ED acknowledged the ED staff activated the 911 transport for Patient 1 without an accepting physician/hospital for the patient. On 11/15/23 at 0939 hours, a follow-up interview was conducted with the Director ED and Quality Manager 1. The Director ED was asked to describe the process on contacting a 911 transport for a patient requiring a transfer to a higher level of care facility. The Director ED stated all ED staff could call a transportation for a patient with the direction of the ED physician. The Director ED was asked who contacted 911 transport for Patient 1. The Director ED stated, according to RN 1 who was the charge nurse, the ED physician requested the unit secretary to call a 911 transport for the patient and the unit secretary was assisted by RN 2. On 11/15/23 at 1020 hours, an interview was conducted with Quality Manager 1. Quality Manager 1 stated, according to OC-EMS, the 911 transport arrived in the ED on 10/17/23 at 0046 hours and the transport left the ED at 0151 hours. 2. Review of the hospital’s P&P titled EMTALA-Transfer Policy dated March 2023 showed the following: * The transferring physician is responsible for determining the appropriate mode of transportation, equipment, and attendants for the transfer in such a manner as to be able to effectively manage any reasonably foreseeable complication of the individual’s condition that could arise during the transfer. * The procedure for the transfers of individuals who are not medically stable includes the following: - Send medical records including a documentation of the individual’s vital signs which should be taken immediately prior to transfer and documented on the Transfer Summary and Certification form. - The Transfer Summary and Certification must be completed for every patient who is transferred to another separately licensed hospital. The Transfer Summary and Certification form and the patient’s medical record must be sent with the patient at the time of the transfer. The copy of the Transfer Summary and Certification form shall be retained by the transferring hospital and incorporated into the patient’s medical record. a. Patient 1’s medical record showed the patient came to the ED on 10/16/23 at 2321 hours and transferred to Hospital A on 10/17/23 at 0154 hours. Review of Patient 1’s Transfer Summary and Certification form signed by the physician on 10/17/23 at 0136 hours and by the patient on 10/17/23 at 0135 hours, showed the section of “Transfer is in patient’s best interests. The patient had an unstable medical condition, but the benefits of discharging or transferring the patient outweigh the risks to the patient” was checked. However, the form did not show a documentation of vital signs for Patient 1 in the Patient Condition section of the form. On 11/14/23 at 1443 hours, an interview and concurrent record review of Patient 1’s medical record and hospital P&P was conducted with LVN 1, Quality Manager 1 and the Chief Quality and Patient Safety Officer. The Chief Quality and Patient Safety Officer acknowledged there was no documentation of Patient 1’s vital signs in the patient’s Transfer Summary and Certification form. b. Patient 5’s medical record showed the patient came to the ED on 9/1/23 at 1050 hours and transferred to other hospital on 9/1/23 at 1547 hours. Review of Patient 5’s ED Provider Aware Note dated 9/1/23 at 1052 hours, showed the patient was transferred to another acute care hospital for admission for observation due to syncopal episode, elevated troponin level, and persistent hypoglycemia. On 11/14/23 1049 hours, an interview and concurrent record review of Patient 5’s medical record was conducted with LVN 1 and Quality Manager 1. LVN 1 and Quality Manager 1 acknowledged the above documentation. The LVN 1 and Quality Manager 1 was asked to show documentation of Patient 5’s transfer summary and certification form. The Quality Manager 1 stated she would check the form for the patient from the medical records department. On 11/15/23 at 1350 hours, a follow-up interview was conducted with Quality Manager 1. Quality Manager 1 acknowledged the manager was unable to find a documentation of Patient 5’s transfer summary and certification form. c. Patient 2’s medical record showed the patient came to the ED on 5/19/23 at 0319 hours and transferred to other hospital on 9/1/23 at 0430 hours. Review of Patient 2’s ED Triage Aware Note dated 5/19/23 at 0339 hours, showed the patient had a chief complaint of pregnancy problem. The ED Triage Aware Note was signed by a licensed nurse on 5/19/23 at 0405 hours. Review of Patient 2’s Transfer Summary and Certification form showed the following: * The section of “Transfer is in patient’s best interests. The patient had an unstable medical condition, but the benefits of discharging or transferring the patient outweigh the risks to the patient” was checked. * No time documented to show when the physician signed the Provider Certification section of the form. * The section of “Appropriate medical records of examination and treatment of the patient were provided at the time of transfer as follows:” failed to show the physician’s record, laboratory results, diagnostics, EKG, and nursing records were checked. On 11/14/23 at 0930 hours, an interview and concurrent record of Patient 2’s medical record was conducted with LVN 1 and Quality Manager 1. LVN 1 and Quality Manager 1 acknowledged the above findings. Quality Manager 1 was asked why there were no medical records provided at the time of transfer as described above. Quality Manager 1 stated the patient was in active labor and required to be transferred immediately to a higher level of care. d. Patient 6’s medical record showed the patient came to the ED on 9/6/23. Review of Patient 6’s ED Provider Aware Note dated 9/6/23 at 0231 hours, showed the disposition of the patient was transferred to Hospital B and the name of physician from Hospital B who accepted the patient for the transfer. Review of Patient 6’s Transfer Summary and Certification form signed by the physician on 9/6/23 at 0554 hours. The form included the receiving facility would be Hospital B and the name of accepting physician. However, the name of the accepting physician was not consistent to the information as described in the ED Provider Aware Note. There were two different names of the accepting physician documented in Patient 6’s medical record. On 11/13/23 at 1625 hours, an interview and concurrent record of Patient 6’s medical record was conducted with LVN 1 and Quality Manager 1. Quality Manager 1 acknowledged the accepting physician information for Patient 6 was not consistent as described on the above findings. 29798 e. On 11/13/23 at 1630 hours, an interview and concurrent record review of Patient 14’s medical record was conducted with the Chief Quality and Patient Safety Officer and the Clinical Informaticist. Patient 14’s medical record showed the patient came to the ED on 7/2/23 at 0920 hours and transferred to other hospital on 7/2/23 at 1546 hours. Review of Patient 14’s Transfer Summary and Certification signed by the physician on 7/2/23 at 1500 hours, showed the following: * The section of “Stable. The patient has an emergency medical condition, but the condition is stable” was checked. * The section of “Transfer is in patient’s best interests. The patient has an unstable medical condition” was checked. * The section of Transfer Requirement did not show the name of the receiving facility. * The section of “Appropriate medical records of the examination and treatment of the patient are provided at the time of transfer” were left blank. * The section of “The physician has determined that appropriate means of transportation for transfer” was left blank. The Chief Quality and Patient Safety Officer verified the findings. f. On 11/14/23 at 1120 hours, an interview and concurrent record review of Patient 19’s medical record was conducted with the Chief Quality and Patient Safety Officer and the Clinical Informaticist. Patient 19’s medical record showed the patient came to the ED on 10/8/23 at 0552 hours and transferred to another hospital on 10/8/23 at 0957 hours. Review of the Transfer Summary and Certification form showed the following: * The physician signed the form on 10/8/23. However, the time was not documented. * The section of “Stable. The patient has an emergency medical condition, but the condition is stable” was checked. * The section of “Transfer is in patient’s best interests. The patient has an unstable medical condition” was checked. The Chief Quality and Patient Safety Officer verified the findings. g. On 11/14/23 at 1315 hours, an interview and concurrent record review of Patient 20’s medical record was conducted with the Chief Quality and Patient Safety Officer and Clinical Informaticist. Patient 20’s medical record showed the patient came to the ED on 10/11/23 at 1917 hours and was transferred to other hospital on 10/12/23 at 0608 hours. Review of the Transfer Summary and Certification form signed by the physician on 10/12/23 at 0453 hours, showed the following: * The section of “Transfer Requirements” of the Transfer Summary and Certification form did not show the name of the receiving physician. * The Patient Transfer Consent section did not show the signature of the patient or legally responsible individual signing on patient’s behalf. The Chief Quality and Patient Safety Officer verified the findings. h. On 11/14/23 at 1525 hours, an interview and concurrent record review of Patient 21’s medical record was conducted with the Chief Quality and Patient Safety Officer and the Clinical Informaticist. Patient 21’s medical record showed the patient came to the ED on 10/13/23 at 2309 hours and transferred to other hospital on 10/14/23 at 1426 hours. Review of the Transfer Summary and Certification form showed the physician signed the form on 10/14/23. However, there was no documented evidence to show the time physician signed the form. The Chief Quality and Patient Safety Officer verified the findings. 37548 i. Review of the hospital’s P&P titled 72 Hour Hold-Application and Patient Advisement dated March 2021, showed both copies of the 72-Hour Hold Form are placed on the patient chart if admitted to the hospital. If transferred, send the original and one copy to receiving facility and keep one copy for the emergency department record. Review of the hospital’s P&P Suicide Risk Screening, Assessment, and Patient Management dated January 2021 showed applicable patients and (where appropriate) their families - regardless of risk level - will be provided with information on how to access assistance in a crisis such as a crisis hotline. There is no defined time frame in which this information must be provided, but it should be provided before discharge or transfer from organization’s care. On 11/15/22 at 1023 hours, an interview and concurrent review of Patient 10’s medical record was conducted with the Clinical Informaticist, the Clinical Analyst, and the Chief Quality and Patient Safety Officer. Patient 10’s medical record showed Patient 10 came to the ED on 8/20/23 at 0022 hours. Review of the ED Provider Aware Note dated 8/20/23 at 0152 hours, showed Patient 10 was medically “cleared for psych eval. Evaluated by CAT team. Placed on 5150. Patient was subsequently transferred for psych admission.” Review of the Transfer Summary and Certification form signed by the physician on 8/20/23 at 0539 hours, showed the following: * Patient 10 was transferred to a behavioral health hospital on 8/20/23 at 0550 hours. * The section of “Transfer is in patient’s best interests. The patient has an unstable medical condition” was checked. * The Patient’s Request/Refusal/Consent to Transfer section failed to show the signature of the patient or the patient’s legal responsible individual. There was no documentation the 72-Hour Hold was provided at the time of transfer. In a concurrent interview, the Clinical Informaticist and the Clinical Analyst confirmed the Patient’s Request/Refusal/Consent to Transfer section was not signed by Patient 10 or by the patient’s legal responsible individual. There was no documentation showing the patient’s family member were not available to sign. The Clinical Informaticist and the Clinical Analyst stated the 72- Hour Hold form was not found in the patient’s medical record. The Clinical Informaticist and the Clinical Analyst confirmed there was no documentation showing Patient 10 or the patient’s family member was provided with the information on how to access assistance in a crisis such as a crisis hotline before transfer the patient as per the hospital’s P&P. The Chief Quality and Patient Safety Officer stated the patient’s family members should have signed on the Patient’s Request/Refusal/Consent to Transfer section of the Transfer Summary and Certification form. The Chief Quality and Patient Safety Officer acknowledged the findings.”