Mclaren Flint

“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: 53399 Based on interview and record review, the facility failed to obtain an order for physical restraints for 1 (P-10) of 3 restrained patients reviewed resulting in the loss of patient rights and increased likelihood of poor outcomes. The findings include: On 03/24/2026 at 1130 P-10’s medical record was reviewed with Intensive Care Nurse Manager Staff K. 02/27/2026 at 1541 Registered Nurse Staff T documented “Patient attempted to charge at security.” and “hard restraints were applied. “ A review of the medical record failed to identify a physician order for restraint application for P-10. Staff K acknowledged that a Physician order is a requirement for the application of restraints, and that an order to restrain P-10 was not present within the medical record. According to facility policy “Use of Restraint and Seclusion” Effective 03/26/2024 states, In an emergent situation, and when a Licensed Practitioner is not readily available, a Registered Nurse (RN) competent in the use of restraint may initiate restraint or seclusion based on an appropriate assessment of patient needs. “The RN immediately notifies a Licensed Practitioner and requests a telephone or written order. The order ordinarily shall be obtained either during application or immediately thereafter. The RN shall provide information about the patient’s physical and psychological status while obtaining the order. If the Licensed practitioner does not order the restraint, the restraint shall be removed.” “The use of restraint ordinarily shall be ordered by the Licensed Practitioner who is responsible for the care of the patient. If a Licensed practitioner other than the attending Licensed Practitioner orders the restraint, the attending Licensed Practitioner shall be consulted as soon as possible.””

“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: 45246 Based on interview and record review, the facility failed to ensure that registered nurses developed individualized care plans for two patients (P-1 and P-4) of 10 patients reviewed, resulting in the potential for unidentified patients’ care needs/changes in care, incomplete care plan documentation and possible negative outcomes for these two patients. Findings include: P-1 Review of the P-1’s medical record, on 04/14/25, revealed that she was a 81-year-old female admitted to the facility on 12/07/24 with chief complaints of increasing fatigue and infected chest wound. P-1 had a history of a suprasternal wound, breast cancer, coronary artery disease, diabetes, chronic anemia, hypertension (elevated blood pressure), atrial fibrillation (an irregular and often very rapid heart rhythm that can lead to blood clots, stroke and heart failure), and chronic kidney disease stage III- IV. During hospitalization patient had two surgical procedures: on 12/10/24- chest wound debridement, and on 12/17/24- chest wound debridement with a muscle flap, wound vac (device that assists with negative pressure wound therapy) and JP drain (a closed-suction medical device that is commonly used as a post-operative drain for collecting bodily fluids from surgical sites) application and wound closure. P-1 was transferred to the inpatient rehabilitation unit (IPR) on 12/18/24 for recovery. On 12/30/24 she was discharged from facility to a subacute rehab (SAR). During the patient’s stay at IPR she continued to be consulted by Infectious Disease (ID) for her extensive history of chest wound infections and for IV (intravenous) antibiotic therapy. Plastic surgery was following the patient regarding post-surgical wound care, wound VAC and JP drain. The physician’s note dated 12/27/24 at 2112 had the following: “Positive for chest pain. Patient discussed with nursing staff as well as IPR physician. Assessment/ Plan. 1. Osteomyelitis of the sternum status post sharp excisional debridement. Continue antibiotics as per ID and wound care as per plastic surgery.” On 04/16/25 during further P-1 medical record review the following nursing-initiated care plans were identified during patient’s stay in IPR from 12/18/24 to 12/30/24: Self-care deficits, Rehab impaired mobility and Nutritional deficit. No plans of care were established for P-1 regarding her post-operative chest pain, wound care needs or infection prevention. On 04/16/25 at approximately 1200 during patients’ medical record review, Manager of Patient care services, Staff M, was asked if her expectations were that staff nurses were addressing patient specific needs in the care plans. She stated “yes”. P-4 Review of the P-4’s medical record, on 04/16/25, revealed that he was a 77-year-old male with a past medical history of ESRD (end stage renal disease) on peritoneal dialysis (for 3 years), A-fib (atrial fibrillation), heart failure, type 2 diabetes, chronic hypertension (elevated blood pressure), COPD (chronic obstructive pulmonary disease), urethral strictures, history of seizures and anemia who presented to the facility’s emergency department on 3/19/24 after a fall. Patient was admitted to the facility on 03/19/24, underwent nephrology, infectious disease, urology, endocrinology, cardiology and neurological evaluations throughout his stay. He was stabilized and transferred to the inpatient rehabilitation unit (IPR) on 03/26/25 for recovery. Patient transitioned from peritoneal dialysis to hemodialysis during his stay at IPR on 04/13/25. Neurology consulting physician’s note dated 04/11/25 1347 indicated: rapid response stroke alert was called this morning when patient was noted to have a seizure-like episode. Apparently, patient stated he complained of a headache and then his wife stated that his eyes rolled back and he was noted to have some intermittent tremors. He was unresponsive for a brief period of time. Physician’s note dated 04/15/25 1333 revealed: “Seen and examined up in bed. Patient (P-4) was placed in a 4-point restraints last night. Sitter at bedside. Patient was given Haldol and 2 doses of Seroquel. Spoke with internal medicine, patient is not appropriate for IPR. Patient will be transferred to acute care. Patient did have dialysis yesterday and again today”. Further P-4 medical record review for patient’s stay in IPR from 03/26/25 to 04/15/25 revealed no documented care plans and teaching for the patient/family regarding new dialysis modality (hemodialysis) and a change in condition due to new “seizure-like episode”. Though the care plan for the use of restraints for P-4 was established, there was no plan of care in place and/or education for patient/family regarding use of antipsychotic medications (like Seroquel and Haldol) and their side effects. On 04/15/25 at 1030 during an interview with the registered nurse, Staff L, she was asked regarding patient centered plan of care documentation. Staff L stated that she “would not double chart” care plans when she already takes care of patients and documents it. Facility’s policy “Nursing Process and Documentation” effective 06/02/18 and revised 12/13/22, was reviewed and revealed: “1. Purpose 1.1. To document the assessment, diagnoses, planning, interventions and patient response to care in acute and critical care settings via the ONE [facility name] electronic health record (EHR) at subsidiaries utilizing this system. 4.3. The RN is responsible for patient assessment, data interpretation, diagnoses, and development of plan of care through establishment of related nursing care interventions. 4.3.1. To identify patient needs and care priorities, the RN integrates information from various assessments, history, and other disciplines. The family and/or significant others are included as a source of information related to assessment and planning of care, when appropriate. 4.3.2. Assessment is initiated on presentation to the health care setting and is continuous throughout the episode of care. 4.3.3. The RN formulates diagnoses and interacts with patient and/or caregivers to establish goals and develop a plan of care. 4.3.4. Discharge planning is initiated on admission and is ongoing throughout the episode of care.””

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 45246 Based on interview and record review, the facility failed to ensure that registered nurses adhered to the facility’s policies and procedures regarding patients’ discharge documentation for two patients (P-1 and 8) of 10 patients reviewed, resulting in the potential for unidentified patient care needs, incomplete discharge records, and possible negative outcomes for these two patients. Findings include: P-1 Review of the P-1’s medical record, on 04/14/25, revealed that she was a 81-year-old female admitted to facility on 12/07/24 with chief complaints of increasing fatigue and infected chest wound. P-1 had a history of a suprasternal wound, breast cancer, coronary artery disease, diabetes, chronic anemia, hypertension (elevated blood pressure), atrial fibrillation (an irregular and often very rapid heart rhythm that can lead to blood clots, stroke and heart failure), and chronic kidney disease stage III- IV. Patient was transferred to inpatient rehab on 12/18/24 and discharged to SAR (subacute rehabilitation facility) on 12/30/24. Further review of P-1 medical record revealed no nursing documentation on 12/30/24 that discharge instructions were provided to patient/family and their understanding of it. Also, there was no evidence of nursing transfer/discharge note with documentation of patient destination, time of discharge, necessary communication (report) to the receiving facility and if all required records were sent with the patient. On 04/15/25 at 1030 during an interview with a registered nurse, Staff L, she was asked if she remembers taking care of the P-1 on 12/30/24. The nurse stated that she remembered the patient but could not recall that day. Staff L was asked to describe her responsibility regarding patients’ discharge. Staff L stated that she usually goes over the patient’s discharge paperwork, making sure all the medications were reconciled, also checks the provider’s orders. When asked if she reviewed the discharge instructions/paperwork with P-1, she said she did not remember. She also added that usually she would not do that if a patient was discharged to the other facility, she would just call the facility and give report. When asked if she documents who she spoke to at the receiving facility, she said, “not the name, just document that I called”. Further, Staff L was queried if she called receiving facility for P-1. She stated she did not remember. On 04/15/25 at 1050 inpatient rehabilitation unit Nurse Manager, Staff K, was interviewed. She was asked if her expectations were for staff nurses to follow facility’s policies and procedures. She stated yes. P-8 Medical record review on 04/16/25 for P-8 revealed that patient was a 53-year-old male with no past medical history who presented to facility on 12/16/24 as a stroke alert. Patient had acute onset of balance issues, right sided weakness and aphasia (a language disorder that affects communication after a stroke or brain injury) while at work. He was found to have left-sided basal ganglion intraparenchymal hemorrhage (stroke). PT/OT (physical and occupational therapy) and speech were consulted. IPR (inpatient rehabilitation) was also consulted and upon their evaluation deemed P-8 a good candidate for inpatient rehab. He was transferred to the rehab unit on 12/22/24. P-8 was discharged to SAR (subacute rehabilitation facility) on 01/15/25 at 1915. Further review of the patient medical record did not reveal a nursing transfer/discharge note with documentation of patient destination, time of discharge, necessary communication (report) to the receiving facility and if all required records were sent with the patient. On 04/16/25 at 1403 during an interview with the facility’s Chief Nursing Officer, Staff B, she was asked if her expectations were that all staff nurses followed facility’s policies and procedures. She stated yes. Facility’s “Continuum of Care: Discharge Planning” policy, effective 08/01/21 and reviewed 09/24/24, was reviewed and revealed: “1. Purpose 1.1. To provide an integrated multidisciplinary approach to the specific continuing needs of patients post hospitalization for patients receiving care in a subsidiary utilizing the ONE [facility name] electronic health record (EHR) system. 5.2. Discharge Process 5.2.1. All patients discharged are provided with written instructions created via the discharge process in the EHR for post hospital care which may include, but are not limited to: 5.2.1.1. Medications, including new prescriptions 5.2.1.2. Food/drug interaction 5.2.1.3. Treatment and dietary instructions 5.2.1.4. Pain and symptom management 5.2.1.5. Supplies and equipment 5.2.1.6. Diagnostic testing 5.2.1.7. Outpatient therapies 5.2.1.8. Instructions for follow-up care 5.3. Referrals to Community Resources. 5.4. After ascertaining that all discharge instructions are clearly understood and appropriate follow-up plans are determined, the RN documents the patient/responsible caregiver understanding of the discharge instructions, in the EHR. 5.5. Upon discharge or transfer, the RN documents a discharge/ transfer note which may include the patient’s discharge medications, destination, time of discharge, mode of transport, and family accompaniment. 5.11. Registered Nurse/SW/CM will provide/facilitate necessary communication and forms required for placement of the patient in a nursing home, rehabilitation or sub-acute facility.””

“DISCHARGE PLANNING- TRANSMISSION INFORMATION CFR(s): Discharge of the patient and the provision and transmission of the patient’s necessary medical information. (b) The hospital must discharge the patient , and also transfer or refer the patient where applicable, along with all necessary medical information pertaining to the patient’s current course of illness and treatment, post-discharge goals of care, and treatment preferences, at the time of discharge, to the appropriate post-acute care service providers and suppliers, facilities, agencies, and other outpatient service providers and practitioners responsible for the patient’s follow-up or ancillary care. This Standard is not met as evidenced by: 45246 Based on interview and record review, the facility failed to provide all necessary/ pertaining medical discharge information to a receiving facility and patient/ family for one patient (P-1) of 10 patients reviewed, resulting in patient, family, and receiving facility not having complete information upon discharge and possible negative outcomes to the patient. Findings include: Review of P-1’s medical record, on 04/14/25, revealed that she was a 81-year-old female admitted to facility on 12/07/24 with chief complaints of increasing fatigue and infected chest wound. Infectious disease provider consulting note dated 12/08/24 2017 indicated that P-1 “is being seen by wound clinic and also ID (Infectious Disease) clinic for sternal bone manubrium osteomyelitis with MRSA (methicillin-resistant Staphylococcus aureus) and Enterococcus faecalis (species of bacteria that is naturally found in the intestines). Per records patient has been following with surgery at [another facility name], she has a history of breast cancer in 1980s which was treated with left-sided mastectomy and afterwards right sided mastectomy too, she had a recurrence of the cancer and did receive radiation therapy, last session was in July, 2023. Patient had a Mediport (an implantable device, placed under the skin, used to give therapy or withdraw blood) in the chest wall for many years and she had erosion in the soft tissue and chest wall, it was removed and she has been following with the surgeon, she underwent excision and debridement of the midline chest wall wound down to the bone and removal of necrotic bone of sternum, the bone culture grew MRSA (Methicillin-resistant staphylococcus aureus)and Enterococcus faecalis (a species of bacteria that is naturally found in the intestines) from 10/25/2024, patient has been following with wound care center at [facility name] they referred the patient to ID clinic for management of IV antibiotics for sternal osteomyelitis. On last office visit she was started on IV Daptomycin (antibiotic) for 6 weeks via PICC line (a long, thin tube that’s inserted through a vein in the arm and passed to the larger veins near the heart). Per records, patient supposed to complete therapy on December 12 (2024). Patient currently on Vancomycin, Cefepime and Metronidazole (antibiotics) then [sic] ID consult requested.” During the stay in the facility P-1 underwent two surgical procedures. Plastic surgeon, Staff O, was following up with the patient after her last procedure on 12/17/24. On the day of patient’s discharge from the facility, plastic surgeon, Staff O, documented at 12/30/2024 0711: Orders: “Culture Aerobic with Gram Stain. I changed the dressing from the drain site, I got the culture, I discussed with the patient nurse that she needed to “ [sic] infectious disease physician about this”. Review of physicians’ orders revealed: Culture Aerobic with Gram Stain, Action Date/Time: 12/30/2024 0711, Electronically Signed By: Staff O (plastic surgeon). Electronically Signed by Staff L, nurse in care for P-1, at 12/30/2024 0725. Patient was discharged to SAR (subacute rehabilitation facility) later that day, on 12/30/24. On 04/15/25 at 1030 during interview with registered nurse, Staff L, she was asked if she remembers taking care of the P-1 on 12/30/24. The nurse stated that she remembered the patient but could not recall that day. Staff L was asked to describe her responsibility regarding patients’ discharge. Staff L stated that she usually goes over the patient’s discharge paperwork, making sure all the medications were reconciled, also checks the provider’s orders. She added that during patients’ admission they see specialty physicians and she makes sure that all discharge follow up information was included. When asked if she reviewed the discharge instructions/paperwork with P-1, she said she did not remember. She also added that usually she would not do that if a patient was discharged to the other facility, she would just call the facility and give report. When asked if she documents who she spoke to at the receiving facility, she said, “not the name, just document that I called”. Further, Staff L was queried if she called receiving facility for P-1 and communicated pertinent information. She stated she did not remember. Staff L also was asked if she remembered plastic surgeon, Staff O, discussing any culture orders with her on 12/30/24. Nurse stated “no”. She added that after patients’ discharge nursing staff would not be aware of the results anyway. Further record review revealed discharge documentation that was provided to the accepting facility. No information was provided in discharge paperwork regarding infectious disease services follow up after patient’s hospitalization (P-1 was consulted by the ID providers and had an extensive history of wound infections). Further, no information was provided to the patient, patient’s family or receiving facility regarding pending culture that was collected by a provider, Staff O, on 12/30/24 prior to P-1’s discharge (denying the patient right to know their own test results). No information was provided to the receiving facility (SAR) regarding the follow up on the culture results and who should be contacted. P-1 medical record revealed that “wound culture 12/30/2024 - grew Enterobacter cloacae (bacteria can cause many infections in hospital and clinical settings)”. There was a facility’s office clinic note dated 01/06/25 1400: “Patient (P-1) is at SNF (skilled nursing facility) [name]. She finished Daptomycin IV as ordered on 12/30/24 for sternal osteomyelitis. Writer received a call from facility Nursing Supervisor saying when the patient admitted 12/30/24 there was a very small scabbed area at the distal end of the chest incision which had a dry wound base. Since admission, this scab came off the incision and there is copious amounts of purulent drainage. Dr. [name] notified and reviewed culture obtained by surgery (Staff O) day of discharge from hospital on 12/30/24. Recommends treatment with PO (oral) Cipro (Ciprofloxacin- antibiotic) 500 mg BID (twice a day) x 14 days and schedule ID follow-up on 01/16/25 to re-evaluate”. P-1 was re-admitted back to the facility on 01/06/25 at 2309. Facility’s “Continuum of Care: Discharge Planning” policy, effective 08/01/21 and reviewed 09/24/24, revealed: “1. Purpose 1.1. To provide an integrated multidisciplinary approach to the specific continuing needs of patients post hospitalization for patients receiving care in a subsidiary utilizing the ONE [facility name] electronic health record (EHR) system. 5.2. Discharge Process 5.2.1. All patients discharged are provided with written instructions created via the discharge process in the EHR for post hospital care which may include, but are not limited to: 5.2.1.1. Medications, including new prescriptions 5.2.1.2. Food/drug interaction 5.2.1.3. Treatment and dietary instructions 5.2.1.4. Pain and symptom management 5.2.1.5. Supplies and equipment 5.2.1.6. Diagnostic testing 5.2.1.7. Outpatient therapies 5.2.1.8. Instructions for follow-up care 5.3. Referrals to Community Resources 5.3.1. Instructions are provided to the patient/family and/or the organization/outside agency or individuals responsible for the patient’s continuing care. 5.11. Registered Nurse/SW/CM (social worker, case manager) will provide/facilitate necessary communication and forms required for placement of the patient in a nursing home, rehabilitation or sub-acute facility. 5.12. Appropriate medical record documentation shall be provided to the receiving facility. The CM/SW will initiate provision of copied medical records/pertinent information. Health Information Management (HIM) provides copies of all pertinent clinical information that accompanies the patient at time of transfer to another facility which may include, but are not limited to: 5.12.1. Transfer summary 5.12.2. Copy of recent (within last 30 days) chest x-ray report (Skilled Nursing Facility only) 5.12.3. History and Physical 5.12.4. Laboratory results 5.12.5. Surgical reports 5.12.6. Consultation notes.””

“NURSING SERVICES CFR(s): 482.23 The hospital must have an organized nursing service that provides 24-hour nursing services. The nursing services must be furnished or supervised by a registered nurse. This Condition is not met as evidenced by: 48030 Based on interview and record review, the facility failed to ensure nursing staff adhered to the policies and procedures of the hospital for 1 (P-1) of 20 patients reviewed for neurologic examinations following an unwitnessed fall with head injury, resulting in P-1’s death. Findings include: See Specific Tags: A-0398 - Failure to follow hospital policies and procedures of the hospital.”

“RADIOLOGIC SERVICES CFR(s): 482.26 The hospital must maintain, or have available, diagnostic radiological services. If therapeutic services are also provided, they, as well as the diagnostic services, must meet professionally approved standards for safety and personnel qualifications. This Condition is not met as evidenced by: 48030 Based on interview and record review, the facility failed to ensure CT (computed tomography)-scan technicians adhered to the policies and procedures of the hospital for 1 (P-1) of 20 patients reviewed for timeliness of STAT (immediate/urgent) inpatient CT-scans, resulting in the delay of diagnosing a life-threatening brain injury, which resulted in P-1’s death. Findings include: See Specific Tags: A-0529 - Failure to maintain available radiologic services according to the needs of the patients.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 48030 Based on interview and record review, the facility failed to ensure nursing staff adhered to the policies and procedures of the hospital for 1 (P-1) of 20 patients reviewed for neurologic examinations following an unwitnessed fall, resulting in P-1’s death. Findings include: Record review of P-1’s medical record revealed P-1 had an unwitnessed fall on 09/27/2024 at 1145. P-1 told staff she hit her head. At 1607 the patient was found with a change in neuro status including non-reactive pupils and not responsive to commands. At 1709 a “code stroke” was called after the head CT scan was completed at 1636. The only nursing flowsheet documentation between the fall and change of status was as follows: 1145 - GCS 14, alert confused (TIME OF FALL) 1150 - CT scan head ordered STAT 1317 - Changed PureWik, IV flushed 1607 - VS - BP 224/98, HR 80, 96%, GCS 6, Neuro exam (unable to assess), pupils non-reactive (right and left) 1624 - Glucose 130 1636 - CT-Scan head completed STAT 1709 - Code Stroke Chart review revealed there was no documentation of neuro checks or increased monitoring after the unwitnessed fall until 1607. During an interview with the nurse (Staff HH) on 10/17/2024 at 1011 it was revealed she was assigned to care for P-1 on the day of P-1’s fall. When queried if she tried to call anyone from management to help facilitate getting the CT-scan done sooner, Staff HH revealed, “I don’t have time to run around looking for phone numbers.” When queried if she was monitoring P-1 closely for her neurological status after the fall, Staff HH revealed “yes, but I forgot to chart” and “she seemed at her baseline until she was found unresponsive in her room.” On 10/16/2024 at 1500 an interview with the Director of Patient Safety and Clinical Risk (Staff U) was conducted and revealed she was “familiar with this case” regarding P-1. Staff U stated a Root Cause Analysis (RCA) investigation is scheduled for 10/31/2024 (over a month post incident). Staff U revealed that the Radiology Technician that delayed the CT-scan was terminated. When queried if any changes have been made by the facility to ensure this type of incident does not occur again, Staff U revealed “you would have to ask the leaders” of the Units. On 10/16/2024 at 1552 an interview with the Nurse Manager (Staff P) for 9-South, (the unit where P-1 fell) occurred. Staff P explained she spoke with Staff HH again the following Monday about the fall and reviewed the Post Fall Checklist with her and found that neurological checks were not completed every two hours. When queried if this was a concern that the neurological assessments had not been completed by Staff HH every 2 hours after the unwitnessed fall, Staff P responded, “well the physician did not order additional neuro checks”. When queried what changes have been implemented since the fall, Staff P explained she has been discussing in the daily staff huddles “how to escalate a delay in a STAT order and to let management know in real time”. When queried if she could provide a list of employees that received this education and a copy of the education provided, Staff P revealed she did not have anything in writing, it was all done verbally at huddles. There was no evidence of education regarding interventions, including neurological monitoring post fall, how to escalate CT department concerns, or the delay in identification of a “code stroke”. On 10/17/2024 at 1500 review of Policy #PC-116, titled “Fall Prevention and Management” review date 4/19, Section 5, Post Fall Management, 5.32. “Complete the Post Fall Huddle Form and notify Manager/Nursing Supervisor”. Review of the Post Fall Huddle form, which is included in the Policy #PC-116, page 7, reveals a checklist titled “Complete items listed below for all falls:”, “Implement neuro checks and document in the 24-hour nursing daily focused assessment (every 2 hours x 48 hours if fall is not witnessed or per physician order).””

“SCOPE OF RADIOLOGIC SERVICES CFR(s): 482.26(a) [§482.26 Condition of Participation: Radiologic Services The hospital must maintain, or have available, diagnostic radiologic services...] §482.26(a) Standard: Radiologic Services The hospital must maintain, or have available, radiologic services according to the needs of the patients. This Standard is not met as evidenced by: 48030 Based on interview and record review, the facility failed to ensure CT (computed tomography)-scan technicians adhered to the policies and procedures of the hospital for 1 (P-1) of 20 patients reviewed for timeliness of STAT (immediate/urgent) inpatient CT-scans, resulting in patient death. Findings include: On 10/16/2024 at 1345 record review revealed P-1 fell on 9/27/2024 at 1145, a STAT CT-scan was ordered at 1150 and was not completed until 1636. CT scan results showed a large subdural hematoma with complications and the patient expired at 1830. During an interview with the nurse (Staff HH) on 10/17/2024 at 1011 it was revealed she was assigned to care for P-1 the day of the fall. Staff HH revealed after the fall she called CT-scan and spoke with the CT-tech (Staff FF) and told him about the order for STAT CT for P-1 “after a fall”. Staff HH explained after about an hour P-1 was still not taken for CT-scan, so she called and spoke with Staff FF again who explained he was doing the scans for priority outpatient biopsies. On 10/16/2024 at 1500 an interview with the Director of Patient Safety and Clinical Risk (Staff U) was conducted and revealed she was “familiar with this case” regarding P-1 and the delay in P-1’s STAT CT scan. Staff U revealed a Root Cause Analysis (RCA) investigation regarding the delay is scheduled for 10/31/2024 (over a month post incident). Staff U revealed that the Radiology Technician that delayed the CT-scan was terminated. When queried if any changes have been made by the facility to ensure this type of incident does not occur again, Staff U stated “you would have to ask the leaders” of the Units. On 10/16/2024 at 1523 an interview was conducted with the Manager of Radiology (Staff L), Radiology Supervisor (Staff K) and a Radiology Supervisor (Staff K). Staff L explained she was notified of P-1’s delayed CT at 1830 on 09/27/2024 from the Director of Radiology (Staff GG). Staff L revealed she called and spoke with the CT-techs around 1845-1900 and asked Staff K to speak with the staff about the incident. Staff K revealed he spoke with Staff FF and Staff Z (the CT techs who were working at the time of P-1’s STAT CT orders) and Staff FF told him “I had outpatients to do, they were timed exams, and I had to get them done.” Staff K confirmed, STAT exams always come first so he was unclear why Staff FF would have done the outpatients first. When queried what changes have been implemented since the incident to prevent this type of delay from happening again, Staff L revealed she spoke with each technician and “reviewed how to prioritize workflow” and she will be including education about prioritization at their next employee meeting on 10/23/2024 (almost 1 month after P-1’s delayed CT scan and death). When queried if she could provide evidence of corrective actions such as a list of people she had spoken with inlcuding, the time, date and the information reviewed, Staff L revealed “no, they were just verbal 1:1 conversations, I do not have anything in writing.” Review of facility policy “Diagnostic Imaging Order Priority and Completion” effective 07/2015 revealed under Procedures “1. STAT orders for imaging studies are prioritized ahead of all timed and routine inpatient and outpatient studies. It is the goal of Diagnostic Imaging to respond to all STAT orders within 60 minutes of order entry...””

“Condition of Participation: Pharmaceutical Se CFR(s): 482.25 §482.25 Condition of Participation: Pharmaceutical Services. The hospital must have pharmaceutical services that meet the needs of the patients. The institution must have a pharmacy directed by a registered pharmacist or a drug storage area under competent supervision. The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service. This Condition is not met as evidenced by: 50585 Based on observation, interview, and record review, the facility failed to meet the Condition of Participation for Pharmaceutical Services by failing to maintain a clean medication storage area, resolve a controlled substance medication discrepancy promptly, review medication allergies before allowing the medication to be dispensed and administered, and ensure outdated medications were not available for use in the patient care areas resulting in the potential for the spread of infectious agents, misappropriation of controlled substances, less than optimal patient care outcomes, and a patient experiencing a medical emergency. Findings include: See specific tags: A-0491: Failure to ensure a clean location for storing medications A-0494: Failure to promptly resolve a controlled substance discrepancy A-0500: Failure to ensure medications were appropriately assessed for allergies before allowing the medication to be entered into the dispensing system A-0505: Failure to ensure outdated medications were not available for use in patient care areas”

“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: 47415 Based on interview and record review, the facility failed to promptly investigate a grievance for 1 (P-4) of 3 grievances reviewed, resulting in the loss of the patient’s right to a prompt resolution of a grievance, and the potential for less-than-optimal outcomes. Findings include: On 7/10/24 at 1400, record review of patient experience documentation dated 3/1/24 at 1640 revealed a phone call was received from P-4 stating she had surgery on 2/15/24, and she was concerned she did not receive an abdominal binder prior to discharge, the recovery room staff left her in the bathroom with no assistance to dress, her black shirt was wet at time of discharge and when she arrived home she noticed she was bleeding heavily from one of the abdominal incisions, and had to call an ambulance to take her back to the emergency room for evaluation. On 7/10/24 at 1430, record review of the complaint and grievance logs revealed an entry for P-4 categorized as a complaint on 3/1/24. On 3/8/24 patient experience (email) documentation revealed that P-4 called back asking why no one has contacted her regarding her concerns. Documentation in patient experience emails revealed P-4 received a phone call from the Recovery Room Manager on 3/8/24 and Director of Surgical Services on 3/18/24, indicating P-4’s concerns were discussed during calls. The above stated concerns reported by P-4 initially on 3/1/24, were categorized as a grievance, and entered in the facility’s “Safety First” process on 4/15/24. On 9/11/24 at 1000, an interview with Staff ZZ revealed that P-4’s concerns were not recognized or handled as a grievance until 4/15/24. On 9/11/24, review of policy titled, “Patient Complaint and Grievance Policy” (SE 004) dated revised 11/8/23 revealed: “Grievance - A written or verbal expression of dissatisfaction with the resolution of a complaint or communication received after discharge. This does include allegations of abuse, neglect, or harm ... All grievances ordinarily shall be documented within McLaren Safety First under the Feedback module. Documentation ordinarily shall include the allegation as stated by the patient/representative, a summary of the investigation, the actions taken to resolve the complaint, date of completion, date(s)/time(s) of verbal and written communications, and the attached document(s) of written response ...All grievances ordinarily shall require a written response to the patient/representative acknowledging receipt of the complaint/concern within 7 business days of original receipt if not related to serious injury, harm, impairment, or death. The response ordinarily shall be written in clear and easily understandable language, and tailored to the complainant’s age, language, and ability to understand.”

“SUPERVISION OF CONTRACT STAFF CFR(s): 482.23(b)(6) All licensed nurses who provide services in the hospital must adhere to the policies and procedures of the hospital. The director of nursing service must provide for the adequate supervision and evaluation of all nursing personnel which occur within the responsibility of the nursing service, regardless of the mechanism through which those personnel are providing services (that is, hospital employee, contract, lease, other agreement, or volunteer). This Standard is not met as evidenced by: 45245 Based on interview and record review, the facility failed to ensure that nursing staff documented meal intake for one (P-1) of three patient records reviewed, resulting in the potential for less than optimal outcomes for all patients receiving meals at the facility. Findings include: A review of P-1’s medical record was conducted on 09/10/24 at approximately 1430 with 9 South manager Staff F and revealed that P-1 was admitted on 09/02/2023 for nausea, persistent vomiting, and high blood pressure. P-1 left against medical advice (AMA) on 09/07/2023. Staff F was requested to demonstrate documentation of P-1’s meal intake. Two entries were displayed in “ml” format. Staff F was questioned what this represented. Staff F stated that this is documentation of liquids the patient drank. Staff F was next requested to demonstrate the diet orders for P-1. Staff F displayed “Regular Diet” orders. Staff F was questioned if P-1 received meals during his stay. Staff F replied that she was positive that P-1 was fed, due to his diabetic condition, but that she was disappointed that no meal intake was recorded. No other documentation was located in the medical record which indicated that P-1 was provided or consumed meals during the visit.”

“PHARMACY ADMINISTRATION CFR(s): 482.25(a) [§482.25 Condition of Participation: Pharmaceutical Services .....The medical staff is responsible for developing policies and procedures that minimize drug errors. This function may be delegated to the hospital’s organized pharmaceutical service.] §482.25(a) Standard: Pharmacy Management and Administration The pharmacy or drug storage area must be administered in accordance with accepted professional principles. This Standard is not met as evidenced by: 50585 Based on observation, interview, and record review, the facility failed to ensure a clean location for storing medications resulting in the potential for less-than-optimal outcomes for all patients admitted to the patient care area. Findings include: On 9/10/2024 at 1030, the medication refrigerator in the medication room on the 12 South patient care area was observed. The bottom surface of the refrigerator contained dirt, debris and rust. The bin labeled IV Returns (bin used to store intravenous solutions pending return to pharmacy) located on the bottom surface of the refrigerator contained dirt and debris. At the time of this observation, Nurse Manager Staff N was queried and acknowledged the condition of the medication refrigerator storage area. On 9/11/2024 at 1020, the Director of Pharmacy Staff NN was interviewed about who is responsible for cleaning the medication refrigerators, and they responded “Pharmacy” for the inside and “Housekeeping” for the outside of the refrigerator. Staff NN acknowledged the condition of the refrigerator after observing a photo of the dirt, debris, and rust in the medication refrigerator. Upon review of the facility’s policy “Storage of Medication in Patient Care Areas,” dated 3/2024, it revealed that “Pharmacy Services in collaboration with nursing, respiratory, radiology, medical and administrative staff ensure that medications stored outside of the Pharmacy Department are stored safely and securely and in accordance with professional practice standards consistent with Federal and State regulations” and “Patient care areas maintain a properly controlled medication storage area and a functionally separated preparation area that is clean and orderly.””

“PHARMACY DRUG RECORDS CFR(s): 482.25(a)(3) Current and accurate records must be kept of the receipt and distribution of all scheduled drugs. This Standard is not met as evidenced by: 50585 Based on observation, interview, and record review, the facility failed to promptly resolve a controlled substance discrepancy for 1 of 1 unresolved discrepancies observed, resulting in the potential for less-than-optimal patient care outcomes. Findings include: On 9/10/2024 at 1120, the screen on the automated dispensing machine screen in the Post Anesthesia Care Unit revealed that a medication count discrepancy was present. At the time of this observation, Nurse Manager Staff R was queried about the discrepancy, and she revealed that the discrepancy was for hydromorphone 2 mg injection (Schedule II opioid controlled substance). The automated dispensing machine inventory for hydromorphone 2 mg injection was expected to be 6 syringes but the actual count was 5 syringes. The discrepancy verbiage from the screen revealed that the discrepancy occurred on 9/9/2024 at 1402. On 9/10/2023 at 1130, Nurse Manager Staff R was interviewed on the policy for resolving controlled substance discrepancies, they stated that they “usually receives an e-mail communication and hasn’t been to their office today to review e-mails.” On 9/11/2024 at 1030, Director of Pharmacy Staff NN was interviewed about the process for resolving controlled substance discrepancies. They acknowledged that the discrepancy should be resolved by the end of the shift. For this discrepancy, they stated that a “staff member was coming into the facility (on 9/11/2024) at 1100” to resolve the discrepancy (about 45 hours after the discrepancy was initiated). Upon review of the facility’s policy “Controlled Substance and Prevention of Drug Diversion,” dated 1/9/2024, the policy revealed that “Discrepancies identified during a shift count or inventory verification counts must be resolved immediately, if possible but no later than the end of the shift. Any discrepancies that remain unresolved at the end of the shift must be reported to the immediate supervisor and the director of pharmacy.””

“DELIVERY OF DRUGS CFR(s): 482.25(b) §482.25(b) Standard: Delivery of Services In order to provide patient safety, drugs and biologicals must be controlled and distributed in accordance with applicable standards of practice, consistent with Federal and State law. This Standard is not met as evidenced by: 50585 Based on interview and record review, the facility failed to follow standards of practice to ensure medications were assessed for allergies before allowing the medication to be entered into the medication dispensing system for 1 (P-3) of 1 patient resulting in P-3 experiencing a medical emergency. Findings include: A review of P-3’s medical record revealed that P-3 was admitted to the facility on 11/3/2023. The patient’s history and physical record revealed that P-3 was allergic to Symbicort, clindamycin (hypertension), and sulfa drugs. The type of reaction, severity, or side effects were not noted for both Symbicort and sulfa drug medication allergies and were not clarified before any medications were ordered entered into the medication dispensing system. The Physician Assistant Staff RR history and physical note on 11/3/2023 at 0542 revealed the plan for treating P-3 ’ s chronic obstructive pulmonary disease included “Pt asymptomatic no cough, shortness of breath present” and “continue home medications - albuterol, fluticasone-salmeterol, Spiriva.” On 11/4/2023 at 0728, the Pulmonology progress note revealed that the assessment and plan for P-3 included “Patient reports that he is on Spiriva and Wixela (fluticasone propionate - salmeterol) inhaler at home. Albuterol inhaler as needed. No recent exacerbations.” Additional medical record review revealed that on 11/3/2023 at 0221, Physician Assistant Staff RR ordered budesonide-formoterol (Symbicort) 2 puffs twice a day to start at 11/3/2023 at 0900. On 11/3/2023 at 0227, Pharmacist Staff W verified the Symbicort medication order. Both Staff RR and Staff W received an alert about the allergy and both individuals entered “prescriber’s judgement” as the reason for overriding the alert for Symbicort allergy. P-3 received three doses of Symbicort on 11/3/2023 at 0858, 11/3/2023 at 1930, and 11/4/2023 at 0804. On 11/5/2023 at 0006, P-3 experienced shortness of breath and a rapid response was called (when a rapid response is called providers immediately go to patient bedside to address the patient’s deteriorating condition). On 11/5/2023 at 0021, the medication order for Symbicort was discontinued. On 11/8/2023 at 1522, the facility staff updated P-3’s allergy information in the electronic medical record by adding Symbicort’s generic name (budesonide-formoterol) to the allergy checks with reactions including respiratory distress, blood pressure abnormal - severe, and itching. On 11/8/2023 at 1723, reactions under the trade name (Symbicort) allergy (i.e., allergy entered previously) were updated by the facility’s staff to include reactions of respiratory distress, blood pressure abnormal - severe, and itching. The other allergies in P-3’s medication profile, clindamycin (Hypertension) and sulfa drugs were present but not changed. On 9/11/2024 at 1030, Director of Pharmacy Staff NN was interviewed and stated that Physician Assistant Staff RR overrode the electronic medical record alert and selected “prescriber’s judgement” as the reason for the override. Staff NN stated that Pharmacist Staff W verified the order and overrode the alert and selected “prescriber’s judgement” as the reason for the override. A review of the facility’s policy “Pharmacist Review of Medication Orders,” dated 2/2024 revealed that Medication orders are reviewed for the following: “real or potential allergies or sensitivities; contraindications; and any concerns, issues or questions identified by the pharmacist during the order review are clarified with the prescriber prior to medication dispensing and documented in accordance with hospital policy.” According to the American Society of Health-system Pharmacist’s technical assistant bulletin “Drug Distribution and Control,” dated 11/1981, “A pharmacist must review and interpret every medication order and resolve any problems or uncertainties with it before the drug is entered into the dispensing system. This means that he must be satisfied that each questionable medication order is, in fact, acceptable. This may occur through study of the patient’s medical record, research of the professional literature, or discussion with the prescriber or other medical, nursing, or pharmacy staff.” According to the American Society of Health System Pharmacist’s “Minimum Standard for Pharmacies in Hospitals,” dated 2013, “All medication orders shall be prospectively reviewed by a pharmacist and assessed in relation to pertinent patient and clinical information before the first dose is administered or made available in an automated dispensing device, except in emergent situations in which the treatment of the patient would be significantly compromised by the delay that would result from pharmacist review of the order. Any questions regarding an order shall be resolved with the prescriber prior to administration, and any action taken as a result of this intervention should be documented in the patient’s medical record. Information concerning changes shall be communicated to the appropriate health professionals caring for the patient.””

“UNUSABLE DRUGS NOT USED CFR(s): 482.25(b)(3) §482.25(b)(3) - Outdated, mislabeled, or otherwise unusable drugs and biologicals must not be available for patient use This Standard is not met as evidenced by: 50585 Based upon observation, interview and record review, the facility failed to ensure outdated medications were not available for use in 1 of 1 patient care areas resulting in less-than-optimal outcomes for all patients admitted to the patient care area. Findings include: On 9/10/2024 at 1055, the Respiratory Therapy cart on the 5 South Medical Intensive Care unit was observed and two ampules of lidocaine 4% for injection, 5 milliliters each with an expiration date of 7/1/2024 were found in a bin inside the cart. On 9/10/2024 at 1100, Respiratory Therapist Staff E was queried, and they acknowledged the expiration dates. Upon review of the facility’s policy “Outdated and Unusable Medication,” dated 2/1/2024, the policy revealed that “Unusable Medications: Medication that is outdated, recalled, defective contaminated, broken or deteriorate, mislabeled (improper, illegible, missing or worn) and any other situation that renders the product unsuitable for administration or use.” The policy also revealed that “Unusable medications identified on a patient care unit during medication area inspection or by clinical/support staff are returned to the pharmacy for proper disposition.””

“OPERATING ROOM POLICIES CFR(s): 482.51(b) Surgical services must be consistent with needs and resources. Policies governing surgical care must be designed to assure the achievement and maintenance of high standards of medical practice and patient care. This Standard is not met as evidenced by: 38269 Based on observation, interview and record review, the facility failed to ensure staff complied with facility policies and nationally accepted standards of practice, resulting in the potential for the spread of infection, and poor outcomes for all surgical patients. Findings include: On 09/10/2024 between the times of 1000 and 1240, during observations in the surgical services/operating rooms (OR), and sterile corridors, five male staff were observed in the restricted area wearing Skull caps (disposable surgical caps intended to cover ears and hair). At 1130 Staff W Director of perioperative services was asked if skull caps were an acceptable practice, and if the five male staff were following the expected standards of practice. Staff W stated, “No, the skull caps do not completely contain their hair. The anesthesia tech has facial hair not covered, and his hair is hanging out of the skull cap.” Staff W then confirmed the five staff members were indeed wearing skull caps with exposed hair at the nape, as well as side-burn hair which was not covered. On 09/10/2024 at 1150, Staff W was asked to look through the window of operating room nine, where a female staff member was sitting at the head of a patient stretcher. The female staff at the head of the stretcher was identified by Staff W, as an ear nose and throat (ENT) physician. The ENT was observed to be wearing a cloth bonnet, with a hospital issued disposable bouffant covering half of the cloth bonnet. Staff W was queried as to what the policy was on wearing cloth bonnets and laundering practices. Staff W stated, “Yes, cloth caps can be worn if they are covered by a disposable bouffant cap. I can see that a lot of the cloth hat is not covered. It looks like the bouffant has slipped back. I am not sure how they are laundered.” The tour proceeded to the nursing station where four female staff (two scrub techs, one registered nurse, and one perfusionist), were observed to be wearing cloth bonnets under disposable bouffant. All four staff observed had a bouffant over the back portion of the cloth bonnets leaving the front portion of the cloth bonnet exposed. All four staff were queried in the presence of their director and manager, who launders the cloth bonnets. The perfusionist stated, “They don’t get laundered, because we cover them with a bouffant.” The registered nurse described how she laundered her bonnets at home, and neither scrub technician responded. Staff W confirmed that the process being followed for laundering was not acceptable. On 09/11/2024 at 1035, during an interview with Staff PP (Chief Medical Officer) the findings noted above were reviewed and Staff PP confirmed the observations did not follow national standards of care and the facility’s policy. On 09/10/2024 at 1400, review of Policy No: SS-03, Title: Protocol for Proper Operating Room / PACU / Anesthesia / CPD / ENDO Attire, Revised date: 06/2015, Reviewed: 05/2022. 4.4. Surgical attire should be laundered in a health care accredited laundry facility. Home laundering is not monitored for quality, consistency, or safety. Typical home laundering practices do not eradicate organisms commonly found in the hospital environment. Exposure of healthcare personnel and their family members to blood and other potentially infectious materials may result from improper handling and decontamination of surgical attire. 4.11. Disposable scrub hats or surgical hoods that completely cover all possible head and facial hair are to be worn by all personnel entering the operating room’s restricted and semi restricted areas. 4.12. Because hair can harbor bacteria, skull caps that fail to cover side hair above the ears, hair, and at the nape of the neck are unacceptable; A disposable bouffant cap must be worn. 4.13. Cloth caps must cover and contain all hair, should be laundered daily and be COMPLETELY covered with a disposable bouffant cap. Reference: AORN (Association of Operating Room Nurses) Guidelines for perioperative practices.”