Saint Mary’s Regional Medical Center

“MEDICAL STAFF - BYLAWS AND RULES CFR(s): 482.12(a)(4) [The governing body must] approve medical staff bylaws and other medical staff rules and regulations. This Standard is not met as evidenced by: 41848 Based on interview, clinical record review, and document review, the facility failed to ensure verbal orders were signed by the ordering provider within 48 hours as per facility policy and Medical Staff Rules and Regulations for 8 of 29 sampled patients (Patients #12, #13, #16, #18, #24, #26, #27, and #2) and failed to review the Medical Staff Bylaws at least biennially. Findings include: Patient #12 Patient #12 was admitted to the facility on 02/26/24, with a diagnosis of acute hypoxic respiratory failure. Patient #13 Patient #13 was admitted to the facility on 02/25/24, with a diagnosis of acute on chronic respiratory failure. Patient #16 Patient #16 was admitted to the facility on 02/26/24, with a diagnosis of non-ST-elevation myocardial infarction. Patient #18 Patient #18 was admitted to the facility on 02/22/24, with a diagnosis of acute left hip and low back pain. A verbal order report provided by the facility documented: - Patient #12 had a verbal order not yet signed by the provider and the verbal order had been entered 55 hours prior. - Patient #13 had a verbal order not yet signed by the provider and the verbal order had been entered 64 hours prior. - Patient #16 had a verbal order not yet signed by the provider and the verbal order had been entered 52 hours prior. - Patient #18 had verbal orders not yet signed by the provider. Two verbal orders had been entered 58 hours prior and one verbal order was entered 151 hours prior. 43310 Patient #24 Patient #24 was admitted to the facility on 02/21/24, with a diagnosis of coronary artery disease. Patient #26 Patient #26 was admitted to the facility on 02/23/24, with a diagnosis of lymphoma. Patient #27 Patient #27 was admitted to the facility on 02/19/24, with a diagnosis of sigmoid volvulus. A verbal order report provided by the facility documented: - Patient #24 had a verbal orders not yet signed by the provider. One verbal order was entered 72 hours prior, two verbal orders were entered 71 hours prior, three verbal orders were entered 79 hours prior, and one verbal order was entered 134 hours prior. - Patient #26 had a verbal order not yet signed by the provider and the verbal order had been entered 118 hours prior. - Patient #27 had a verbal order not yet signed by the provider and the verbal order had been entered 213 hours prior. 35217 Patient #2 Patient #2 was admitted to the facility on 02/23/24, with a diagnosis of altered mental status and pneumonia. A verbal order report provided by the facility documented: - Patient #2 had a verbal order not yet signed by the provider and the verbal order had been entered 118 hours prior. The facility document titled “Medical Staff Rules and Regulations,” reviewed 06/25/19, documented verbal or telephone orders would be authenticated by the prescriber within 48 hours. The facility policy titled “Orders: Physician and Allied Health Professional (Electronic, Written, Verbal/Telephone, Receipt, Transcription, and Verification),” revised 02/2024, documented the prescribing physician would authenticate verbal/telephone orders within 48 hours. On 02/29/24 at 10:11 AM, the Director of Nursing - Intensive Care Unit (DON - ICU) verbalized the facility process was for providers to sign verbal orders within 30 days. The DON - ICU confirmed the orders had not been signed by the provider and the facility practice of signing verbal orders within 30 days contradicted the facility policy. A review of the hopsital’s Medical Staff Bylaws revealed the last date the Bylaws were approved was 06/03/21. Page 67 in the Medical Staff Bylaws documented, bylaws shall be reviewed at least biennially. On 02/28/24, the Director of Medical Staff Services confirmed the most recent date of adoption or approval of the hospital’s entire Medical Staff Bylaws was 06/03/21. The CEO identified the Medical Staff Bylaws as current. The Director of Medical Staff initially confirmed on 2/27/24 the Medical Staff Bylaws provided were the most recently reviewed. On 2/28/24 at 4:45 PM the Director reported no updates had been made since 2021. The Director of Medical Staff explained many items needed to be changed, removed and updated in the bylaws but the Director was waiting for a template from the corporate level that would work. On 2/29/24 the Director of Medical Staff provided a Medical Executive Committee, Executive Session Meeting Minutes dated 10/18/22 indicated a resolution to the bylaws for “ vaccination/testing requirements resolution aligns the bylaws with hospital requirements “ . The resolution was approved “ until such time the Bylaws are again reviewed, and all changes are approved as one. “ The Bylaws documented review was completed at least biennially. The Bylaws indicated Medical Staff Rules and Regulations and Policies would supplement the Bylaws but would not conflict with the Governing Board Bylaws or the Medical Staff Bylaws. There was no documented evidence the Bylaws, Rules and Regulations were reviewed in its entirety since 06/03/21. The rules and regulations referenced the NICU which is no longer in service, it referenced residents orders and referral to the University School of Medicine policy but no longer has a contract with the referenced School of Medicine.”

“PATIENT RIGHTS: RESTRAINT OR SECLUSION CFR(s): 482.13(e)(4)(i) The use of restraint or seclusion must be-- (i) in accordance with a written modification to the patient’s plan of care. This Standard is not met as evidenced by: 41848 Based on interview, clinical record review, and document review, the facility failed to ensure a patient’s plan of care was updated to include the necessary use of restraints for 1 of 29 sampled patients (Patient #19). Findings include: Patient #19 Patient #19 was admitted to the facility on 02/21/24, with a diagnosis of malignant neoplasm of esophagus. A Nursing Note, dated 02/21/25 at 6:05 PM, documented soft restraints had been applied to the patient. A Telephone Order, dated 02/21/24, documented soft restraints to the right upper extremity, left upper extremity, left lower extremity, and right lower extremity for interference with medical treatment. The care plan lacked documentation of the restraints, interventions to decrease the use of restraints, or patient/representative goals related to the need for restraints. On 02/28/24 at 3:57 PM, the Medical Surgical Unit Supervisor confirmed the clinical record for Patient #19 lacked a care plan related to the use of restraints. The facility policy titled “Restraints: Non-Violent Behavior,” revised 09/2022, documented all pertinent information would be documented in the electronic medical record including an appropriate care plan would be added to the patient’s electronic medical record for each restraint episode, updated as appropriate, and completed upon discontinuation of restraints.”

“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: 41848 Based on interview, clinical record review, and document review, the facility failed to ensure orders for restraints were entered timely and restraint documentation was initiated timely for 3 of 29 sampled patients (Patient #17, #19, and 25). Findings include: Patient #17 Patient #17 was admitted to the facility on 02/09/24, with a diagnosis of acute pulseless electrical activity cardiac arrest. The Restraint Flowsheet for Patient #17 documented soft restraints to bilateral wrists were initiated on 02/09/24 at 10:00 AM. A verbal order for the restraints was entered on 02/09/24 at 1:59 PM. On 02/28/24 at 5:03 PM, the Director of Nursing - Medical/Surgical Acute confirmed the order had not been obtained within one hour of initiation of the restraints. Patient #19 Patient #19 was admitted to the facility on 02/21/24, with a diagnosis of malignant neoplasm of esophagus. A Nursing Note, dated 02/21/24 at 6:05 PM documented soft restraints were applied to the patient. A telephone order for soft restraints to the patient right upper extremity, left upper extremity, left lower extremity, and right lower extremity was entered by a Registered Nurse on 02/21/24 at 7:05 PM. The order was not signed by the physician until 02/24/24 at 9:11 AM. The Restraint Flowsheet for Patient #19 did not include documentation of restraints until 02/21/24 at 8:00 PM. On 02/28/24 at 3:57 PM, the Unit Supervisor of Medical Surgical Acute and the Manager of Oncology and Wound Care confirmed the documentation on the Restraint Flowsheet was not initiated until 8:00 PM and a Nursing Note indicated the restraints had been applied at 6:05 PM. 43310 Patient #25 Patient #25 was admitted to the hospital on 02/22/24, with a diagnosis of cardiac arrest. The Restraint Flowsheet for Patient #25 documented on 02/22/24 at 3:00 PM, soft restraints had been applied to the patients right and left wrist. A verbal order for soft restraints to the patient’s right and left wrist was entered by a Registered Nurse on 02/22/24 at 5:13 PM, and signed by a physician on 02/2/24 at 5:34 PM. On 02/28/24 at 4:26 PM, the Director of Nursing - Intensive Care Unit (DON - ICU) confirmed Patient #25’s electronic medical record (EMR) lacked documented evidence orders were obtained within a few minutes of the application of soft wrist restraints to Patient #25’s left and right wrist. The DON-ICU confirmed Patient #25 was admitted to the Intensive Care Unit (ICU) on 02/22/24 and documentation on the patients Restraint Flowsheet was first entered at 3:00 PM. The DON-ICU confirmed a physician’s order to apply the soft wrist restraints was documented as created on 02/22/24 at 5:13 PM, and signed by a physician at 5:34 PM, over two hours after the application of the restraints to Patient #25’s wrist. The facility policy titled “Restraints: Non-Violent Behavior,” revised 09/2022, documented if restraints were applied by a Registered Nurse, the attending physician would be consulted as soon as possible an no longer than one hour after initiation and an order would be obtained. A written order based on an examination of the patient by the physician would be entered into the patient’s medical record within 24 hours of initiation of restraint. Available restraint flow sheets, order forms, and narrative notes would be used to document all pertinent information in the electronic medical record including assessment and care provided, the patient’s behavior, circumstances leading to the use of restraints, interventions and alternatives attempted and utilized, and the patient’s response to interventions.”

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 41848 Based on interview, clinical record review, and document review, the facility failed to ensure a care plan for pain was initiated for patient’s with complaints of severe pain for 3 of 29 sampled patients (Patient #14, #16, and #18). Findings include: Patient #14 Patient #14 was admitted to the facility on 02/24/24, with a diagnosis of acute hypoxic respiratory failure. Pain Assessments for Patient #14 documented the patient had complaints of pleuritic chest pain, generalized pain, and leg pain. The patient’s pain level was reported as high as a 10 out of 10. The clinical record for Patient #14 lacked a care plan to address the patient’s reports of pain. On 02/28/24 at 1:39 PM, the Unit Supervisor for Medical Surgical Acute confirmed Patient #14’s clinical record lacked a care plan for pain. Patient #16 Patient #16 was admitted to the facility on 02/26/24, with a diagnosis of non ST elevation myocardial infarction. Pain Assessments for Patient #16 documented the patient reported back pain and the patient’s reported pain was as high as a nine out of 10. The clinical record for Patient #16 lacked a care plan to address the patient’s reports of pain. On 02/28/24 at 2:15 PM, the Unit Supervisor for Medical Surgical Acute confirmed Patient #16’s clinical record lacked a care plan for pain. Patient #18 Patient #18 was admitted to the facility on 02/22/24, with a diagnosis of acute left hip and low back pain. The clinical record for Patient #18 lacked a care plan to address the patient’s reports of pain. On 02/28/24 at 3:27 PM, the Unit Supervisor for Medical Surgical Acute confirmed Patient #18 was admitted with a diagnosis of pain and the clinical record lacked a care plan for pain. The facility policy titled “Adult Pain Management,” revised 09/2013, documented the patient would define their goals for pain relief and participate in a plan of care to achieve these goals.”