St Joseph’s Medical Center of Stockton

“INFECTION PREVENTION CONTROL ABX STEWARDSHIP CFR(s): 482.42 The hospital must have active hospital-wide programs for the surveillance, prevention, and control of HAIs and other infectious diseases, and for the optimization of antibiotic use through stewardship. The programs must demonstrate adherence to nationally recognized infection prevention and control guidelines, as well as to best practices for improving antibiotic use where applicable, and for reducing the development and transmission of HAIs and antibiotic resistant organisms. Infection prevention and control problems and antibiotic use issues identified in the programs must be addressed in collaboration with the hospital-wide quality assessment and performance improvement (QAPI) program. This Condition is not met as evidenced by: 45882 Based on observation, staff interviews, review of employee records and facility policy review, the facility failed to ensure the Condition of Participation for Infection Control was met when the Infection Preventionist did not ensure: 1. The facility’s infection control program included monitoring inspection and cleanliness of mattresses for all 355 of the facility’s 355 licensed beds (refer to A-0750); and, 2. Four of four sampled Environmental Services Staff (EVSS1, EVSS 2, EVSS 3, and Environmental Service Manager [EVSM]) received training and education reflecting the facility policy for the cleaning of mattresses used throughout the facility (refer to A-0775). As a result of these failures, one of four sampled mattresses, ready for use by patients, were found to be soiled and presented a risk for patients acquiring an infection that could endanger their health and safety. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily mandated Condition of Participation for Infection Control.”

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 50121 Based on observation, staff interviews, and facility policy review, the facility’s Infection Prevention Program failed to adequately monitor the hospital environment by ensuing patient beds and mattresses clean for 355 of 355 licensed beds. This failure has the potential to spread infectious diseases to patients if they were placed on beds contaminated with body fluids from other patients. Findings: During a review of Patient 1’s Face sheet (FS), date 5/4/26, the FS indicated Patient 1 was admitted to the facility’s medical-surgical unit in May 2026 with abnormal liver function. During an interview on 5/13/26 at 7:51 a.m. with Patient 1, Patient 1 stated, “I was a patient at the facility in May 2026. My room and bed had an unpleasant odor.” Patient 1 further stated, “The odor was so severe that all my clothing had absorbed the smell of feces after lying on the bed for 24 hours.” During a concurrent observation and interview on 6/30/26, at 11:10 a.m., with a Nurse Manager (NM), an unoccupied patient bed in room 352 was identified. The NM confirmed the bed was ready for patient use. The NM removed the bed linens, revealing a visibly intact green mattress cover (Mattress 1). The mattress cover was unzipped and pulled back to reveal a white inside layer of the cover. The inside layer of the mattress cover displayed a yellowish discoloration located near the center of the surface. The NM confirmed the visible stain on the inside layer of the mattress cover should not be present and indicated the leakage of some type of fluid. The mattress core was then observed. The foam core, visible through a mesh, showed several irregular yellow to yellow-brown stains of varying sizes. The NM confirmed the mattress was not acceptable for patient use due to the visible stains indicating contamination with body fluids. The NM confirmed Mattress 1 should be removed from patient use. During a concurrent observation and interview on 6/30/26, at 11:22 a.m., with Environmental Service Staff (EVSS) 3, Mattress 1 was inspected. EVSS 3 stated EVSS practice did not include unzipping the mattress cover and inspecting the foam core when there were no tears or rips in the mattress cover. EVSS 3 stated when rips, tears or damage were detected, EVSS would call maintenance to remove and replace the mattress. During a concurrent interview and record review on 7/1/26, at 10:25 a.m., with the Director of Environmental Services (DES), the facility’s policy and procedure (P&P) titled, “2.2 Discharge Clean Standard Work Activity Sheet”, dated January 2025, was reviewed. The P&P indicated, “Unzip, inspect Mattress for penetrations, tears/rips, extreme wear, torn seams and tape. Report to your supervisor immediately.” The DES confirmed the P&P indicated the requirement of unzipping mattress liners and inspecting the core foam but stated there was no monitoring that it was done. During an interview on 7/1/26 at 1:30 p.m. with the Infection Prevention Manager/Infection Prevention and Control Officer (IPM/IPCO), IPM/IPCO stated their duties include working with Environmental Services Department regarding infection control policies and procedures. IPM/IPCO stated that their responsibilities did not include training EVSS staff on cleaning methods and best practices for infection control. IPM/IPCO further stated education, training and competency were the department manager’s responsibility, and infection control policies and practices were provided from the facility’s regional offices. IPM/IPOC stated they were not aware how staff were trained to clean beds and mattresses, IPM/IPOC stated they did not monitor the effectiveness of bed and mattress cleaning, stating “It’s not my responsibility.” During an interview 7/2/26, at 9:15 a.m. with Director of Patient Care Services (DPS), DPS stated was unable to locate internally or at the organization’s regional level, the Manufactures Instructions for Use (MIFU, a document prepared by the manufacturer that provides detailed information on the safe and effective use of their products) for Mattress 1 which was requested 7/1/26, at 3:00 p.m. During a review of a Food and Drug Administration (FDA, a federal agency responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation) Safety Communication (SC) document titled, “Damaged or Worn Covers for Medical Bed Mattresses Pose Risk of Contamination and Patient Infection: FDA Safety Communication”, dated April 19, 2013 was reviewed. The FDA SC indicated incorrect cleaning and disinfecting of mattress covers may cause the mattress covers to lose effectiveness in preventing fluid from entering the foam core of the mattress and exposing patients to the risk of infections. During a review of a facility document titled, “Infection Prevention Plan 2026 [name of facility]” (IPP), the IPP indicated, “The purpose of [name of facility] Infection Prevention Plan is to establish, maintain and ensure the implementation of an Infection Prevention Program that encompasses all facility departments and involves all employees ...the mission of the Infection Prevention Program is to establish and maintain accepted infection prevention practices ...the mission is achieved by influencing healthcare provider practices through policy setting, monitoring practices and reporting patient outcomes.” The IPP further indicates, “the facility has designated an Infection Preventionist to oversee the development and day to day implementation of the infection control plan.””

“IC PROFESSIONAL TRAINING CFR(s): [The infection preventionist(s)/infection control professional(s) is responsible for:] (iv) Competency-based training and education of hospital personnel and staff, including medical staff, and, as applicable, personnel providing contracted services in the hospital, on the practical applications of infection prevention and control guidelines, policies, and procedures. This Standard is not met as evidenced by: 45882 Based on staff interviews, review of employee records and facility policy review, the facility’s Infection Prevention Program failed to ensure four of four sampled Environmental Services Staff (EVSS1, EVSS 2, EVSS 3, and Environmental Service Manager [EVSM]) received training and education reflecting the facility policy for the cleaning of mattresses used throughout the facility. This failure has the potential to spread infectious diseases to patients if they were placed on beds contaminated with body fluids from other patients. Findings: During an interview on 6/30/26 at 10:05 a.m. with EVSS 1, EVSS 1 stated they have worked in the department for 90 days. EVSS 1 stated their training and annual competencies for the cleaning of mattresses did not include unzipping the mattress cover and inspecting the mattress’ core foam. During an interview on 6/30/26 at 11:04 a.m. with EVSS 2, EVSS 2 stated they have worked in the department for 26 years. EVSS 2 stated their training and annual competencies for the cleaning of mattresses did not include unzipping the mattress cover and inspecting the mattress’ foam core. During a concurrent observation and interview on 6/30/26, at 11:22 a.m., with EVSS 3, in Room 352, Mattress 1 was inspected. EVSS 3 stated that when cleaning mattresses between patient use, it is not the practice to unzip the mattress cover and inspect the foam core when there are no tears or rips on the mattress cover. EVSS 3 stated if there were rips, tears or damage to the cover, EVSS would call maintenance to remove and replace the mattress. EVSS 3 stated they have worked in the department for one and a half years. EVSS 3 stated their training and annual competencies for the cleaning of mattresses did not include unzipping the mattress cover and inspecting the mattress’ foam core. During an interview on 6/30/26, at 11:33 a.m. with EVSM, EVSM stated they have worked in the department for 10 years. EVSM confirmed their training and competencies for the cleaning of mattresses did not include unzipping the mattress liner and inspecting the mattress’ core foam. During an interview on 7/1/26, at 1:30 p.m. with the Infection Prevention Manager/Infection Prevention and Control Officer (IPM/IPCO), IPM/IPCO stated their duties include working with Environmental Services Department regarding infection control policies and procedures. IPM/IPCO stated that their responsibilities did not include training EVSS staff on cleaning methods and best practices for infection control - specifically how to clean a mattress. IPM/IPCO further stated education, training and competency was the department manager’s responsibility, and infection control policies and practices were provided from the facility’s regional offices. IPM/IPOC stated they were not aware of how staff were trained to clean mattresses. During a concurrent interview and record review on 7/1/26 at 3:15 p.m. with the Human Resources Director (HRD), EVSS employee training and competency records titled, “[name of organization] Environmental Services Initial Training & Competency Validation - Patient Room”, undated, were reviewed for the following employees: EVSS 2: Date of hire (DOH) 12/3/01, department orientation completed 12/1/21; last annual competency on file dated 2/18/26, EVSS 3: DOH 7/8/24, department orientation completed 9/9/24; last annual competency on file dated 2/24, EVSS 4: DOH 9/11/17, department orientation completed 11/25; last annual competency on file dated 1/25, EVSM: DOH 1/25/16, department orientation completed 1/16; last annual competency on file dated 11/25, HRD confirmed the competency records did not include a line item regarding unzipping and inspection mattress foam core for any of the above employees.”

“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: 35598 Based on interview, medical record, and facility document review, the hospital failed to effectively govern the activities and conduct of the hospital staff and processes to provide safe and quality care to all patients presenting for Labor and Delivery as evidenced by: 1. The hospital failed to ensure the Medical Staff provided safe, quality care for patients in labor, and be accountable to the Governing Body (Refer to A-0347); 2. The hospital failed to ensure Nursing Services were organized to meet the needs of patients. (Refer to A-0398 and A-0405); and 3. The hospital failed to ensure that an effective, ongoing, data-driven quality assessment and performance improvement program that included measurable improvement activities was developed, implemented and maintained for patient care activities that ensured clear expectations were established for patient safety. (Refer A- 0283 and A- 0286). These failures contributed to Patient 1 experiencing an infant loss at childbirth and contributed to an unsafe environment for patients presenting to the Labor and Delivery unit to be cared for by staff who were inadequately prepared to interpret fetal monitoring strips and respond when there was immediate need for rescue of a fetus in distress. The cumulative effect of these systemic problems resulted in the inability to comply with the statutorily-mandated Condition of Participation for Governing Body. Findings: On 3/18/2025 at 9:10 a.m., in a concurrent interview and hospital document review with the Hospital President and the Chief Medical Officer, they each acknowledged the medical staff was responsible to oversee the quality and safety of patient care and report to the governing body; and, also, the governing body was ultimately responsible for the quality and safety of hospital patients. According to the, “Medical Staff Bylaws Rules and Regulations”, revisions effective 5/25/23, “...The purpose of the Medical Staff are to:...serve as the primary means for accountability to Board of Managers for the appropriateness of the professional performance and ethical conduct of Practioners on the Medical staff and Allied Health Professionals and to strive toward the continual upgrading of the quality and efficiency of patient care delivered in the Hospital consistent with the state of the healing arts and the resources locally available...”.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 35598 Based on interviews and document reviews the hospital failed to maintain an effective data-driven Quality Assessment and Performance Improvement (QAPI) program for patients presenting to Labor and Delivery as evidenced by: 1. The hospital failed to measure, analyze, and track quality indicators when the facility failed to audit a sufficient number of records based on the high-risk maternal population presenting to the labor and delivery department (Refer to A-0283) and; 2. The hospital failed to investigate and analyze a serious adverse events (AEs) and/or medical errors that resulted in patient harm and/or potential for harm, and failed to set clear expectations for safety related to fetal monitoring and intervention which was a contributing factor that resulted in fetal demise. (Refer to A-0286) The cumulative effects of these systemic problems resulted in the hospital’s inability to maintain an effective quality assessment and performance program in accordance with the statutorily-mandated Conditions of Participation for Quality Assessment and Performance Improvement Program.”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 49419 Based on interview, medical record and facility document review, the Medical Staff failed to provide quality care and ensure the safety of patients presenting to Labor and Delivery when: 1. The Medical Staff failed to be accountable to the governing body for patient quality and safety by ensuring fetal monitoring and labor management was adhered to (Refer to A-0347) and, B. The Medical Staff failed to ensure an effective Quality Assessment and Performance Improvement system to identify and correct serious system problems. (Refer A-0286 and A-0283.) These failures put patients at risk for adverse events, poor patient outcomes including maternal and fetal death, and contributed death of Patient 1’s infant at childbirth. The cumulative effect of these systemic problems resulted in the inability of the hospital to comply with the statutorily-mandated Condition of Participation for Medical Staff.”

“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: 50619 Based on interview, medical record review, and facility policy review, the hospital failed to ensure the effective delivery of nursing services to provide safe and quality care for 1 of 24 sampled patients (Patient 1) when: 1. Assessments and corresponding interventions were not performed to address critical changes in Patient 1 ’ s fetal heart rate (FHR) monitoring (refer to A-0398); 2. Patient 1 who was in active labor (contractions strong, regular, and frequent) was receiving a continuous drip of oxytocin, (drug that stimulates uterine contractions to help with labor and delivery) a high alert medication, (drugs that can cause significant harm if an error occurs) when the FHR tracing was showing decelerations (possible sign of reduced blood flow to the fetus) (refer to A-0398 and A-0405); 3. Patient 1 ‘s oxytocin flowsheet contained no documented evidence of the required every 30 minutes assessment, intervention, and provider notification (Refer to A0398); 4. Patient 1 did not have nursing care plans initiated upon admission and nursing care plans were not individualized for Patient 1 and Patient 4 (Refer to A-0396); 5. Patient 1 ‘s epidural (a type of pain relief method where medication is injected into the space around the spinal cord to numb a specific area of the body, often used during childbirth) did not have the volume of the medication infused documented accordingly to demonstrate Patient 1 received Ropivacaine (a local pain relief medication) . (Refer to A-0405), and 6. Measurable labor and delivery action plan targets with timely deadlines were not set, which resulted in continued lack of nursing staff awareness and education regarding fetal monitoring and interventions (Refer to A-0283 and A-0286). These failures contributed to a Patient 1 suffering from an infant loss at childbirth and contributed to an unsafe environment for patients presenting to the Labor and Delivery unit to be cared for by nursing staff who were inadequately prepared to interpret fetal monitoring strips exhibiting prolonged signs of fetal distress, and respond to immediate need for rescue of a fetus resulting in a fetal demise (death). The cumulative effect of these failures resulted in the hospital’s inability to provide effective, safe and quality nursing services in accordance with the statutorily-mandated Conditions of Participation Nursing Services.”

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 35598 Based on interviews and document reviews the hospital failed to maintain an effective data-driven Quality Assessment and Performance Improvement (QAPI) program when the hospital failed to effectively measure, analyze, monitor specific quality indicators, and develop plans to remediate and educate staff to address ongoing noncompliance to ensure improvements were achieved and sustained for the patient population in the labor and delivery unit that were identified during serious patient safety events that resulted in patient harm. This failure contributed to a lack of evidence-based care reflective of the patient population in the labor and delivery unit of approximately 270- 300 patients monthly with 50% of the patient population categorized as high-risk patients (a pregnancy and childbirth with the mother, baby, or both, are at high risk for complications or adverse events). Findings: During a concurrent interview and document review on 3/20/2025 at 3:10 p.m. with Family Birth Center Director (FBCD), the FBCD stated the document titled “Perinatal All in One Bundles” was the quality plan and audits for the Labor and Delivery unit for the months of July 2024 and each succeeding month through February 2025. According to the FBCD, Bundle II measures included Fetal Heart Monitoring (FHR), Oxytocin Algorithm (a medication used to induce labor), Code O (an alert for an emergency cesarean section- an emergent surgical procedure to deliver a baby through the mother ’ s abdominal wall) and multiple other parts of the quality improvement plan. During a continued concurrent interview and document review on 3/20/2025 at 3:10 p.m. review of the document subtitled, “Category II Bundle Compliance,” the FBCD indicated the denominator was the number of chart audits completed monthly, and the numerator was the compliance rate for all bundles in the category II section. The data was reviewed with the FBCD, and the varying levels of compliance were noted for the Bundle II categories: August of 2024 reflected 100% compliance, September of 2024 was 54.55% compliant, October of 2024 was 63.64% compliant, November of 2024 was 93.33% compliant, December of 2024 reflected 33.3% compliance January of 2025 reflected 100% compliance, and February of 2025 was 63.64% compliant. In further discussion FBCD, FBCD confirmed the Category II outcomes were an accurate reflection of the compliance for labor and delivery. FBCD further indicated the goal for compliance is 90% or better in all measures of the bundle. In a 3/20/25 at 7:07 p.m. meeting with the QD, Chief Executive Officer, Chief Medical Officer, Chief Nursing Officer, and FBCD, it was clarified the training’s for nurses in L&D consisted of 5 tracings on a board, 100% of the tracings presented were considered abnormal findings and were 30 or less seconds (<30) with guiding questions below it. Further, the nurses had to take an online training every year. The FBCD stated there were either 3 or 4 parts of the training however, only one of the parts of the training was done each year. Thus, competency may have been lost over the 3 or 4 years since the training. The FBCD identified components of the actual work conditions for the nurses included the identification of an abnormal FHT moving on the screen, intervening when needed, and reviewing 30 minutes of tracing every time stated a Category. The FBCD acknowledged the training conducted for FHR interpretation competency did not replicate the work conditions of the L&D nurses and there was no change to the post adverse event training. In an interview on 3/21/2025 at 8:30 a.m., with the QD and FBCD, the QD and FBCD confirmed there was no additional evidence of shared learning or changing of Bundle II quality indicators. Review of hospital policy, “Performance Improvement Plan” (PI) 2016, approved 7/2018, last revised 8/23, approved by medical executive committee 9/2024, documented the policy’s purpose: “1.The purpose of the organizational Performance Improvement Plan (PIP) at the facility is to ensure that the Governing Body, medical staff, and professional service staff demonstrate a consistent commitment to deliver safe, effective, and optimal patient care and services in an environment of minimal risk. 2. In keeping with the facilities mission to foster, nurture and perpetuate the concept of a family centered, quality conscious, and cost-effective medical center of excellence, the organizational PI Plan allows for a systematic, coordinated, continuous, and data-driven approach to improving performance focusing upon processes and mechanisms that address these values.” According to the, “Medical Staff Bylaws Rules and Regulations”, revisions effective 5/25/23, Section 12.4.H. for “Integrated Quality Committee (Council) [IQC]”, directed, “... Duties. Review progress of the Quality Improve Process (QIP) on a systematic basis; design measure, assess, and improve performance; evaluate customer satisfaction; monitor and support team progress; provide recognition to teams; educate employees, physicians, EC [Executive Committee] and Board of Managers member in the QI process; integrate quality into daily operations; allocate resources, identify organizational priorities for improvement, and review sentinel events.””

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 35598 Based on interview and record review, the hospital failed to implement an effective Quality Assessment and Performance Improvement (QAPI) response after an adverse event of Patient 1’s fetal demise which occurred in November of 2024 when: 1. The hospital relied on quality improvement (QI) processes which weren’t sufficiently nimble or quick for effective resolution, failed to use existing hospital systems which could have worked or to develop other systems for success, and 2. Labor and delivery action plan targets, with timely deadlines, were not set and not include any thresholds or measurable outcomes to analyze data to inform leadership team if corrective actions are effective in creating a safe environment for patients which resulted in continued lack of staff and physician awareness and education regarding fetal monitoring and interventions. These failures contributed to a Patient 1 suffering from an infant loss at childbirth and contributed to an unsafe environment for patients presenting to the Labor and Delivery unit to be cared for by staff who were inadequately prepared to interpret fetal monitoring strips and respond to immediate need for rescue of a fetus in distress. The State Survey Agency (SA) determined the facility’s noncompliance with one or more requirements of participation had caused or was likely to cause serious injury, serious harm, serious impairment, or death to patients. On 3/20/25 at 7:40 p.m., the SA provided the CMS Immediate Jeopardy (IJ) Template to the Chief Nursing Officer, Chief Medical Officer, Quality Director, Director of the Family Birth Center, and Chief Executive Officer and verbally informed them that IJ existed related to and informed them that IJ existed related to tag A-0286 (CFR 482.21(a) (1) (2)-Quality Assessment and Improvement). The hospital developed and submitted an acceptable action plan that addressed the IJ situation, and the immediacy was removed onsite on 3/20/25 at 9:10 p.m. The hospital implemented immediate corrective actions to address the issues which included: 1. Every nurse in 2024 had additional and required Fetal Monitoring modules. Every nurse working on 3/20/25 had post event training consisting of 5 scenarios of fetal monitoring with escalation. In the next 24 hour period, all charts will be reviewed for compliance with the category 2 escalation algorithm by either the educator or the Director of Family Birthplace. 2.The OB hospitalist along with the charge nurse and primary nurse will review the strips for all patients on Labor and Delivery every two hours to support the attending physicians. This strip review will be documented in the record. The attending physician will be kept informed of any changes or concerns with their patients. If there is a disagreement in the assessment of the fetal monitor interpretation, this will be escalated in real time to the Department Chairman. If there a discrepancy in reading the strips among team members, this will be escalated to the department Chair in real time. 3. Every two hour collaboration will continue until the physician has completed a competency on on fetal monitoring interpretation. Once all physicians have completed the competency, the team review of the strips will go from every 2 hours to every 4 hours and prn. The survey team validated the facility’s corrective actions and the facility provided an acceptable IJ removal plan. The IJ was lifted onsite on 3/21/25 at 5:21 p.m. The facility remained out of complaince at A-0286. Findings: During a concurrent interview and document review on 3/20/2025 at 3:10 p.m. with Family Birth Center Director (FBCD), the FBCD stated the document titled “Perinatal All in One Bundles” was the quality plan and audits for the Labor and Delivery unit for the months of July 2024 and each succeeding month through February 2025. According to the FBCD, Bundle II measures (a set of evidenced based practices which when implemented together, improve patient outcomes) included Fetal Heart Monitoring (FHR), Oxytocin Algorithm (a medication used to induce labor), Code O (an alert for an emergency cesarean section- an emergent surgical procedure to deliver a baby through the mother ’ s abdominal wall) and multiple other parts of the quality improvement plan. During a continued concurrent interview and document review on 3/20/2025 at 3:10 p.m. review of the document subtitled, “Category II Bundle Compliance”, the FBCD indicated the denominator was the number of chart audits completed, and the numerator was the compliance rate for all bundles in the category II section. The data was reviewed with the FBCD, and the varying levels of compliance were noted for the bundle II categories: August of 2024 reflected 100% compliance, September of 2024 was 54.55% compliant, October of 2024 was 63.64% compliant, November of 2024 was 93.33% compliant, December of 2024 reflected 33.3% for compliance, January of 2025 reflected 100% compliance, and February of 2025 was 63.64% compliant. In further discussion with the FBCD on 3/20/2025 at 3:10 p.m. , FBCD confirmed the Category II outcomes were an accurate reflection of the compliance for labor and delivery. FBCD further indicated the goal for compliance is 90% or better in all measures of the bundle. The FBCD stated the labor and delivery department averages between 270-300 deliveries each month, of those approximately 50% are considered to be “high risk”(a pregnancy and childbirth with the mother, baby, or both, are at high risk for complications or adverse events). The FBCD confirmed the number of charts reviewed had not increased from approximately 64 chart audits monthly of all category II bundles after the adverse event in November of 2024 involving Patient 1. During an ongoing document review and interview with FBCD on 3/20/2025 at 3:10 p.m., a document titled “Staff Meeting 2024” was provided by FBCD and the FBCD stated there is one formal staff meeting per year in October with an agenda and “skills days” stations are established to review compliance with all expectations in the labor and delivery unit. In a review of documents from the Staff Meeting or skills days, there was no information regarding compliance with the Bundle II measures. In a continued interview with the FBCD, FBCD confirmed until January 2025, the lack of compliance with the bundles was discussed at an informal, on the nursing unit “safety huddles”, occur 4 times per day, with no formal notes or records of the discussion or who were in attendance. The FBCD indicated “in late January” of 2025, the management team began reaching out to individual Registered Nurses regarding their individual non-compliance with the Oxytocin Algorithm. FBCD further indicated there was no documentation or evidence of these conversations or established expectations to meet compliance goals. During an interview on 3/20/25 at 4:00 p.m., with the Quality Director (QD) and FBCD, QD indicated the quality measures and outcomes along with adverse events are discussed at the “Perinatal Quality/Safety Meeting”, the “Integrated Quality Council” meeting, the “Department of Obstetrics and Gynecology” meeting, and the “Medical Executive Committee” meetings. Review of a document titled, “Department of Obstetrics and Gynecology”, dated January 22, 2025, the document made note the Chair of the Department of Obstetrics and Gynecology (COGN) discussed a plan to add “fetal heart tracing competency” to be required by physicians at the time of appointment. There was no documented evidence of discussion of the adverse event of a fetal demise that occurred in November of 2024. According to the QD there was not a meeting in December as it is a “by-month”, and no meeting was held in December. Review of a document titled, “Integrated Quality Council”, dated November 14, 2024, there was no documented evidence of a discussion of the adverse event related to a fetal demise that occurred on November 12, 2024. The document further indicated it had been “83 days” since the “last serious adverse event in the facility.” The QD confirmed the adverse event of November 2024 was not discussed at this meeting. QD further confirmed that there was not a meeting in December 2024. Further interview and document review with QD and FBCD indicated a similar document titled, “Integrated Quality Council,” dated January 9, 2025, the document indicated it had been “17 days since the last serious event in the facility.” Further review of the meeting minutes indicated there were 3 events in December and 3 events in November “all of which were advanced stage pressure injuries.” There is no mention of the November 12, 2024, adverse event in the labor and delivery department related to the fetal demise. Review of a document titled “Medical Executive Committee Meeting,” dated December 19, 2024, documented “the last safety event was 35 days ago which occurred in the labor and Delivery Department and resulted in a fetal demise ...”. However, the QD and FBCD were not aware of any follow up actions as they stated neither are part of the Medical Executive Committee. In a 3/20/25 at 7:07 p.m. meeting with the QD, Chief Executive Officer, Chief Medical Officer, Chief Nursing Officer, and FBCD, it was clarified the training’s for nurses in L&D consisted of 5 tracings on a board, 100% of the tracings presented were considered abnormal findings and were 30 or less seconds (<30) with guiding questions below it. Further, the nurses had to take an online training every year. The FBCD stated there were either 3 or 4 parts of the training however, only one of the parts of the training was done each year. Thus, competency may have been lost over the 3 or 4 years since the training. The FBCD identified components of the actual work conditions for the nurses included the identification of an abnormal FHT moving on the screen, intervening when needed, and reviewing 30 minutes of tracing every time stated a Category. The FBCD acknowledged the training conducted for FHR interpretation competency did not replicate the work conditions of the L&D nurses and there was no change to the post adverse event training. During a concurrent hospital document review and interview with Chairperson of the Department of Obstetrics and Gynecology (COGD) on 3/21/25 at 12:03 p.m., the COGD stated the facility currently lacks an ongoing monitoring program of competency in interpreting fetal heart monitoring tracings by physicians; however, are in the process of gathering data from those OBGYN ’ s (Obstetrics/Gynecology) in medical groups that do require ongoing monitoring and would be creating a new policy that would, probably annually, document ongoing competency in interpreting fetal heart monitoring tracings. The COGD stated their department expectation was for a doctor to review at least 30 minutes of fetal heart monitoring tracings, in real time, before entering a note in the chart as to the status, and whether the status is Category 1 or higher. Additionally, the COGD stated the expectation was for a doctor to review at least 30 minutes of fetal heart monitoring tracing when the patient was being given oxytocin before documenting status of the labor. The policy and procedure titled, “Code O”, revised 5/2022, directed, “An emergency cesarean delivery will be initiated within the parameter of the definitions described below. The policy stipulates, “All Code ‘O’ deliveries will be reported to the OB/GYN Quality Assurance Committee for review”. According to the, “Medical Staff Bylaws Rules and Regulations”, revisions effective 5/25/23, Section 12.4.H. for “Integrated Quality Committee (Council) [IQC]”, directed, “... Duties. Review progress of the Quality Improve Process (QIP) on a systematic basis; design measure, assess, and improve performance; evaluate customer satisfaction; monitor and support team progress; provide recognition to teams; educate employees, physicians, EC [Executive Committee] and Board of Managers member in the QI process; integrate quality into daily operations; allocate resources, identify organizational priorities for improvement, and review sentinel events.” Review of hospital policy, “Performance Improvement Plan” (PI) 2016, last revised 8/23, approved by medical executive committee 9/2024, documented the policy’s purpose: “1. The purpose of the organizational Performance Improvement Plan (PIP) at the facility is to ensure that the Governing Body, medical staff, and professional service staff demonstrate a consistent commitment to deliver safe, effective, and optimal patient care and services in an environment of minimal risk. 2. In keeping with the facilities mission to foster, nurture and perpetuate the concept of a family centered, quality conscious, and cost-effective medical center of excellence, the organizational PI Plan allows for a systematic, coordinated, continuous, and data-driven approach to improving performance focusing upon processes and mechanisms that address these values.” Review of hospital policy, “Event Reporting and Management” dated 10/24/2023 effective 10/24/2023 indicated “The facility strives to improve the quality and safety of patient care through the following: 1. Identification and evaluation of errors, near misses or hazardous/unsafe conditions that are a threat to patient safety or have the potential to result in patient harm 2. The improvement of systems and processes 3. Open discussion across the organization to share learning and foster a culture of safety.””

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 49419 Based on staff interviews, medical record and document reviews, the medical staff failed to ensure accountability to the governing body for safe and high-quality medical care in accordance with professional standards of practice, medical staff bylaws and rules, governing body bylaws, and Hospital policies for 1 of 24 sampled patients (Patient 1) when: 1. OB (Board Certified Obstetrician) 1 did not review Patient 1’s fetal heart monitoring tracings to determine Patient 1’s Fetal Heart Rate (FHR) status and documented an inaccurate status and, 2. When Patient 1’s fetal status deteriorated, Patient 1 did not have a timely cesarean section (c- section, a surgical operation to deliver a baby by cutting through the abdominal and uterine walls of the mother). These failures resulted in Patient 1 undergoing a delayed c-section and contributed to a fetal demise (the delivery of a fetus showing no signs of life) which may have been preventable. The State Survey Agency (SA) determined the facility’s noncompliance with one or more requirements of participation had caused or was likely to cause serious injury, serious harm, serious impairment, or death to patients. On 3/20/25 at 7:40 p.m., the SA provided the CMS Immediate Jeopardy (IJ) Template to the Chief Nursing Officer, Chief Medical Officer, Quality Director, Director of the Family Birth Center, and Chief Executive Officer and verbally informed them that IJ existed related to Medical Staff tag A-0347 [42CFR 482.22 (b)]. The hospital developed and submitted an acceptable action plan that addressed the IJ situation, and the immediacy was removed onsite on 3/20/25 at 9:10 p.m. The hospital implemented immediate corrective actions to address the issues which included: 1. The OB hospitalist along with the charge nurse and primary nurse will review the strips for all patients on Labor and Delivery every two hours to support the attending physicians. This strip review will be documented in the record. The attending physician will be kept informed of any changes or concerns with their patients. If there is a disagreement in the assessment of the fetal monitor interpretation, this will be escalated in real time to the Department Chairman. If there a discrepancy in reading the strips among team members, this will be escalated to the department Chair in realtime. 2. Every two hour collaboration will continue until the physician has completed a competency on on fetal monitoring interpretation. Once all physicians have completed the competency, the team review of the strips will go from every 2 hours to every 4 hours and prn. The survey team validated the facility’s corrective actions and the facility provided an acceptable IJ removal plan. The IJ was lifted onsite on 3/21/25 at 5:21 p.m. The facility remained out of compliance at A-0347. Findings: During a medical record review of Patient 1’s Triage Note dated 11/12/2024 at 4:00 p.m., Registered Nurse (RN) 2 indicated Patient 1 arrived at the Family Birthing Center on 11/12/24 at 4:00 p.m. stating she had seen her doctor as an outpatient that afternoon and the doctor performed a “membrane sweep” (a procedure to loosen the membranes of the amniotic sac, a thin-walled sac that surrounds the fetus, from the uterus- an organ in the female reproductive system where a fetus develops and grows). The record further indicated Patient 1 stated she had been having contractions (tightening of the uterine muscles during labor) since 2 p.m. During a medical record review of Patient 1’s Triage Assessment Form, dated 11/12/24 at 4:50 p.m., RN 2 indicated Patient 1 was feeling fetal movement, was not leaking amniotic fluids (fluids from within the amniotic sac), was having contractions, and the fetus was appropriately sized for the gestational age (how many weeks and days since conception). During a continued review of Patient 1’s Triage Assessment Form dated 11/12/24 at 4:50 p.m., Patient 1 was noted to have a past medical history of Cerebral Palsy (a disorder that affects body movement and muscle coordination), hernia (a bulging of an organ or tissue through an abnormal opening), and seizures (abnormal electrical activity of the brain); and that Patient 1 was at high risk (increased risk of complications from being pregnant and/or delivering) during the peripartum period (before, during, and immediately after giving birth). Continued review of Patient 1’s Triage Assessment Form dated 11/12/24 at 4:50 p.m., stated the doctor (OB 2) on call for the Medical Group OB 1 is employed by was informed Patient 1 had elevated blood pressures and deep tendon reflexes were 3+ (reflexes noted to be more active than is typical in a pregnant woman and can indicate a medical condition called pre-eclampsia- persistent high blood pressure which is considered an emergency and requires monitoring and interventions). During a medical record review of the History and Physical note, dated 11/12/2024 at 5:55 p.m., written by a Post-Graduate 1 Doctor (PGY 1- an intern in training, the first year after graduating as a doctor) noted the gestational age was 36 weeks and 3 days, the cervix was 2-3 cm (centimeters, a unit of measurement) dilated (the amount of the opening of the cervix with 10 cm of dilation considered to be fully dilated and safe for childbirth), and 70% effaced (the thinning and softening of the cervix in preparation for childbirth). The noted included an ultrasound was performed (a machine using external sound waves to detect internal structures and movement) and showed fetal movement. Fetal heart monitoring tracings were interpreted as “no accelerations (accels- increases in heart rate)” or decelerations (decels- temporary but distinct decreased of the fetal heart rate caused by decreased blood flow to the placenta during contractions) and “moderate variability (a normal fluctuation in FHR and considered a reassuring finding of oxygenation to the fetus), and having irregular contractions. Patient 1 was admitted to the antepartum (time before childbirth) area of the Family Birth Center for observation during latent labor (the earliest phase of labor). During a medical record review of History and Physical, dated on 11/12/24 at 9:40 p.m., written by OB 1, indicated Patient 1 had requested OB 1 come to the hospital to manage her delivery and so OB 1 came. The noted indicated Patient 1 was at 36 weeks and 4 days gestation; had been noted on exam by RN 2 to have a cervix dilated to 3 cm and was 80% effaced; spontaneous, premature rupture of her membranes (membranes of the amniotic sac); fetal heart rate was 150 beats per minute (110 - 160 is considered normal) with moderate variability, reactive (the variability is triggered by something, like increased pressure during a contraction, a normal response during labor). The note indicated contractions were occurring every 2 minutes (more than 5 contractions per 10 minutes in 2 consecutive ten minute intervals is considered uterine tachysystole which increases the amount of time a fetus is deprived of oxygen). There was no evidence deep tendon reflex testing was performed. The note included a plan was to admit to Labor and Delivery (L&D) and have an epidural (insertion of a small tube to allow a pain medication to be delivered into the space surrounding the spinal cord) placed for augmentation of labor (process of stimulating the uterus to increase frequency and intensity of contractions) with oxytocin (oxytocin is a hormone that strengthens uterine contractions), “per protocol”. A review of OB 1’s note, dated 11/12/24 at 11:58 p.m., indicated, OB 1 came to Patient 1’s room after epidural was placed to obtain Patient 1’s consent to insert an Intrauterine Pressure Catheter (IUPC- a device placed into the amniotic space during labor to measure the strength of uterine contractions). According to the note, Patient 1 was noted to be comfortable, feeling contractions, and continuing to leak clear fluid. There was positive fetal movement. FHR was “145 beats per minute with moderate variability, accels noted, no decels. Category 1 (the fetal heart rate tracing are normal and no intervention necessary)”. The note stated the cervix was dilated to 4-5 cm, 90% effaced, station (the position of the baby’s presenting part within the pelvis) was -1 (slightly above the bone landmark). The note indicated the IUPC was placed. The note stated RN 2 had been instructed to start oxytocin at 2 mIU (milli-International Units) per minute (a measure of the amount and rate of a substance or drug to be administered). A review of OB 1’s progress note, dated 11/13/24 at 1:10 a.m., indicated OB 1 was called to the bedside by an RN (RN 2) for the patient having right sided-hip pain. Also noted was the FOB (Father of the Baby) and Patient 1 were thinking about “just doing a c-section”. The note indicated, fetal heart rate was “135 beats per minute, moderate variability, accels noted, no decels, Category 1.” OB 1 performed a sterile vaginal exam and documented Patient 1’s cervix was 6 cm dilated (now in the active phase of labor), 90% effaced, 0 station (fetus lowering into the birth canal). The note stated, “For some reason, oxytocin still not started per RN”, however the contractions were noted to be occuring every 2 minutes per the note. The note revealed a plan for, “Will call CRNA to recheck the epidural. Pt [Patient 1] wants to continue to try [a vaginal delivery].” A review of OB 1’s progress note dated 11/13/24 and timed at 5:05 a.m., included OB 1 was called to Patient 1’s bedside by RN 2, “hoping I can reduce the anterior cervical lip” (cervix is fully dilated but the front edge of the cervix is partially blocking the baby’s head, to reduce the anterior cervical lip means to insert a hand inside the vagina and push against the cervical lip while the patient pushes in an attempt to get the baby’s head past the barrier) but was unsuccessful. The same OB 1 note indicated the FHR was 125 beats per minute with moderate variability and accels were noted along with occasional variable decel . OB 1 documented this as “Category 2” (Category 2 fetal heart tracings that include a broad spectrum of abnormalities that may indicate increased stress to the fetus and require intervention such as repositioning, hydration, and physician notification). According to the note, the plan was to continue to follow and to continue the oxytocin “per protocol”. A review of OB 1’s, “Intrapartum Note: Decision to Incision”, dated 11/13/24 and timed at 7:29 a.m. (late entry), indicated OB 1 was called to Patient 1’s bedside regarding prolonged deceleration (an abnormal decrease in FHR that could indicate a risk of fetal death from lack of oxygen). The note revealed OB 1 arrived to Patient 1’s bedside at 5:16 a.m.; the FHR was 150 beats per minute with moderate variability on the computer screen. The note indicated OB 1 ordered the oxytocin to be turned off and to provide a fluid bolus (give a relatively large amount of fluid quickly through an small tube into the vein). OB 1’s note stated, “Noted fetal heart went down to the 90s but as we turned off the [oxytocin] and increased fluid noted FHR tracing going back up to the 120s, about 20-30 seconds.” OB 1’s note continued, stating he then ordered terbutaline (a medicine used during labor to relax the uterine tissues) to be given immediately and the nurse left the room to retrieve it. The note continued, a fetal scalp lead (attaching a monitoring cable to the scalp of the fetus) was attached “at approximately 5:20 a.m.;” and that in the process of placing the fetal scalp lead the fetal heart rate increased to 120 and then the decel started again. OB 1 documented a need “to move towards a c-section.” Continued review of OB 1’s note, dated 11/13/24 at 7:29 a.m., included, “At 5:21 a.m., [Patient 1] wanted to push and she did want to push and I asked for the vacuum to be opened but never had to use it because after one push at next contraction at 5:23 [a.m.] note fetal heart was not tolerating so we stopped and went back for a c-section”. A concurrent interview and medical chart review with Certified Registered Nurse Anesthetist’s (CRNA) on 03/20/2025 at 12:03 p.m., review of the CRNA ‘s Obstetric Anesthesia Record note, dated 11/13/24 at 5:24 a.m., documented the trial push was completed and at 5:26 a.m. Patient 1 was in the process of being moved to the Operating Room for a stat (immediate) c-section. The CRNA agreed the note stated she had arrived in the L&D room at 5:24 a.m. after being called for a possible c-section. CRNA stated she had shut off the epidural drip and injected ordered pain medicine, which achieved an anesthetic level to T4 (4th thoracic spine bone or the nipple level), CRNA stated T4 was an appropriate anesthetic level for this c-section. CRNA agreed the note indicated Patient 1 started to be moved to the OR (Operating Room) at 5:16 a.m., incision was at 5:34 a.m., and delivery was at 5:36 a.m. In an interview at 4:30 pm on 3/19/25 the Director of the Family Birth Center (FBC D), stated “cut was delayed for 8 minutes as [OB 1] wanted foley catheter inserted”. Continued medical record review of OB 1’s Operative Note dated 11/13/24 and timed at 7:30 a.m. stated, “Operation performed was an Emergency Primary [first c-section for Patient 1] Low Transverse [location of the cut was in the lower part of the uterus] Cesarean Section.” The section for Drains and Tubes noted “Foley [a tube inserted into the bladder for urine to flow through] to gravity [no suction].” A review of OB 1’s, “Operative Note” dated 11/13/24 at 7:30 a.m., documented incision of the abdomen was performed at 5:34 a.m. and delivery was at 5:36 a.m. A review of the Neonatal Pediatrician’s (NNP) Death/Fetal Demise Summary, dated 11/13/24 and timed at 7:15 am, stated, “NICU (Neonatal Care Unit) team were called for presumed Code O [emergency c-section]. Baby was delivered by CS [c-section] due to prolonged and variable decelerations. There were 2 tight cords (two loops of the umbilical cord- a structure that wraps one vein and two arteries into a cord that connects the mother’s blood system to the fetal blood system). Baby was delivered lifeless: no respirations, HR [heart rate], and no no (sic) tone.” APGAR scores [an assessment of a newborn health with five components: color, heart rate, reflexes, muscle tone and respiration; the higher the number the better the component) “were 0, 0, 0, and 0 hence this is a fetal demise [the delivery of a fetus showing no signs of life]”. A review of the Respiratory Therapy Assessment and Treatment note, dated 11/13/24 and timed at 7:44 a.m., stated, “Respiratory resuscitation efforts were made to the newborn but were unsuccessful. Time of death was recorded as 16 minutes post birth.” Late notes and addenda were added to the medical record after the fetal demise by RN 2 and OB 1 and included the following: OB 1’s addendum dated 11/13/24 at 7:29 a.m., was, “Of note, SVE [Sterile Vaginal Examination] was complete [cervix 10 cm dilated] and +3 station [head beginning to emerge from the birth canal] when [Patient 1] wanted to attempt to push.” RN 2’s addendum dated 11/13/24 at 7:38 a.m., was, “[5:14 a.m.] MD at beside with prolonged decel, position changed, Pitocin off and SVE [cervix] 10 cm”. RN 2 addendum dated 11/13/24 at 8:05 a.m., was, “[5:23 a.m.] while prepping [Patient 1] for c-section, [OB 1] attempted to push with [Patient 1] for possible vacuum application [a medical tool that holds the fetal head in suction and allows the doctor to pull the fetus while the mother pushes the baby out to complete a vaginal delivery] with NICU Team present but was not applied.” OB 1 addendum dated 11/13/24 at 8:25 a.m., was, “Additionally, I did ask the nurses to open the C-section room at 05:18 and followed as well all recommendations of staff as the recommendation made.” RN 2 addendum dated 11/13/24 at 8:40 a.m., revealed, “[5:18 a.m.] [OB 1] still at bedside recommended by charge RN [Name] to go back for a c-section at this time.” RN 2 addendum dated 11/13/24 at 8:46 a.m., indicated, “[5:25 a.m.] second recommendation by Charge RN [Name].” OB 1 addendum dated 11/16/24 at 9:35 a.m., was, “Of note, upon entry to the OR pt’s fetal scalp lead was immediately attached and noted FHT ranging from 148 to 190. We did not remove the FHT until pt. was being draped.” A concurrent interview and medical record review was conducted with the FBC D and a Registered Nurse Analyst (RN 4) on 3/17/2025 at 1:14 p.m., FBC D stated Patient 1 had intact membranes upon arrival; and, after being admitted to Observation, was noted to have a premature, spontaneous rupture of her membranes and that rupture of the membranes was an indication for admission to L&D. In addition, FBC D and RN 4 each stated the fetal monitoring tracings between 4:00 p.m. and 6:00 p.m. demonstrated a normal baseline, variability was moderate, there were accelerations and no decelerations, and these all indicated a reassuring clinical status of the fetus. During a continued interview and medical record review with FBC D and RN 4 starting on 3/17/2025 at 1:14 p.m., FBC D stated OB 1’s note on 11/13/24 at 12:30 a.m. of Patient 1’s status as “7/7, station 0,” indicated good progression through labor. FBC D commented that oxytocin had not been started and during the visit, OB 1 ordered the Oxytocin to be started at 2 mIU/hour rather than 1 mIU/hour, which would increase contractions rate, force, or both. During a continued interview and medical record review with FBC D and RN 4 starting on 3/17/2025 at 1:14 p.m., FBC D showed fetal monitor tracings from 11/13/2024 at 3:30 a.m. with decelerations that were prolonged and stated this was the first noted prolonged deceleration, with fetal heart rate of 90 for 40 - 50 seconds. FBC D stated RN 2 documented responses of increasing IV fluids and repositioning Patient 1. RN 4 stated protocol included to turn off the oxytocin and notify the doctor of a change in patient condition. FBC D agreed that was protocol and that RN 2 had neither turned the oxytocin off nor notified a doctor. During a concurrent interview, medical record review, and hospital document review with the Chairperson of the Department of Obstetrics and Gynecology (COGD) and the Chief Medical Office (CMO) dated 3/19/25 at 9:04 a.m., COGD stated that a vaginal sweep is usually performed to increase the odds a patient will start labor and is not usually done until a woman is 39 weeks gestation. COGD considered Patient 1 as a high-risk pregnancy based on Cerebral Palsy, a history of seizures, and a hemispherectomy (a surgical procedure in which one half of the brain is completely removed; partially removed and fully disconnected; or disconnected from the other half of the brain). The COGD stated spontaneous rupture of membranes was an indication for admission to L&D. COGD continued, stating the facility does not have a special privilege for high-risk pregnancies and OB 1 was privileged to perform an emergency c-section. During a concurrent interview, medical record review, and hospital document review with COGD and CMO dated 3/19/25 at 9:04 a.m., COGD stated the fetal heart monitoring tracings, changed starting at about 2 a.m. and then at 3:30 a.m. the fetal heart monitoring showed repeated concerning tracings, some of which were prolonged and reflected fetal distress. COGD stated hospital policy and procedure was for the RN to turn off the oxytocin, contact the doctor, and do maneuvers such as repositioning. COGD and CMO stated that during all chart review, peer review, and quality review, there was no documented evidence that RN 2 had notified OB 1 of Patient 1’s FHR showing Category 2 or signs of fetal distress. During a concurrent medical record and hospital document review and second interview with COGD and CMO on 3/21/25 at 12:03 p.m., the COGD stated the facility currently lacks an ongoing monitoring program of competency in interpreting fetal heart monitoring tracings by practitioners; however, are in the process of gathering data from those OBGYN’s in medical groups that do require ongoing monitoring and would be creating a new policy that would, probably annually, to document ongoing competency in interpreting fetal heart monitoring tracings. The COGD stated Department expectation is for a doctor to monitor at least 30 minutes of fetal heart tracings before entering a note in the chart as to the status and whether the status is Category 1 or higher. Additionally, Department expectation is for a doctor to review at least 30 minutes of fetal heart monitoring tracing when the patient was being given oxytocin before documenting status of the labor. During an interview with Medical Director: Obstetrician, Hospitalist program (MD OBH) and the CMO at 12:05 p.m. on 3/20/25, the MD OBH outlined the roles and responsibilities of the contracted Hospitalist OB-GYN doctors at the facility. The MD OBH stated OB Hospitalists are in house 24 hours a day, 7 days a week and provide a Medical Screening Exam (MSE) upon arrival of patients. The MD OBH stated the hospitalist OB then manages the care of patients either throughout the hospitalization or until an on-call OB for the group arrives. The MD OBH stated the hospitalist OB did not perform an MSE of Patient 1 because PGY 1 was in L&D for the medical group to which Patient 1’s doctor (OB 1) belonged and PGY 1 performed the initial MSE as the History and Physical. In further explaining the role of the hospitalist OB program, MD OBG stated the hospitalist OB is available for emergency needs, discussion with other practitioners, and available to RNs with questions or concerns. The MD OBH stated, the hospitalists are available to be the assistant at an emergency c-section being performed by anyone. The MD OBH stated she had reviewed Patient 1’s case and the hospitalist program had not been contacted by any facility staff or other OBs present regarding the case. During a concurrent interview, review of the medical record, and review of hospital documents with the Quality Nurse, Perinatal Safety Specialist (QN PSS) on 3/19/2025 starting at 2:15 p.m., the QN PSS described her role as looking for cases that meet criteria for health or safety problems. QN PSS stated Patient 1’s case met criteria for an adverse event and automatically triggered peer review per policy. QN PSS stated the fetal monitoring tracings at 9:40 p.m. were at the baseline fetal heart rate; and, stated there were variable decels and one prolonged decel not documented by OB 1. QN PSS stated OB 1 (on note created at 9:40 pm) listed the tracings for that time period as Category 1. From a tracing on 11/12/2024 at 10:50 p.m. QN PSS identified another Category 2 tracing occurred and again there is no evidence of documentation by OB 1, which was inconsistent with Policy and Procedure. Continuing the concurrent interview, review of the medical record, and review of hospital documents with the QN PSS on 3/19/2025 starting at 2:15 p.m., QN PSS continued discussing her review of the tracings and stated the fetal health monitoring tracings on 11/13/2024 at 12:30 a.m. had minimal variability (less variability of the heart rate of the fetus than is normal and is not-reassuring) and prolonged decels late (decelerations of fetal heart rate that are visually apparent, are related to a contraction, and have their lowest heart rate after the peak, strongest pressure, of the contraction) and that prolonged decels late are Category 3. QN PSS pointed out a Category 2 tracing in the fetal heart monitoring strip at 1:00 a.m. QN PSS agreed OB 1’s note on11/13/2024 at 1:10 AM categorized the clinical status of the fetus during that period as Category 1. QN PSS agreed that if OB 1 had reviewed 30 minutes of fetal health monitoring traces when was present in the room and correctly identified the category of the tracing, the status would be Category 2. During continued concurrent interview, medical record review and hospital document review, QN PSS stated there were multiple periods of variables in the tracing starting at 3:00 a.m. QN PSS stated, per policy, when an RN creates a note, the RN is expected to describe what happened during the past 30 minutes. Even if there is only one variable, an RN is expected to document it. QN PSS stated at 5:00 a.m. Patient 1 experienced a prolonged decel and oxytocin was infusing at 4 mIU. Oxytocin was stopped at 5:14 a.m. QN PSS stated the fetus entered terminal bradycardia (a slow heart rate that follows a prolonged deceleration and does not return to a normal heart rate before delivery) at 5:16 a.m. QN PSS confirmed time arrived in OR (5:28 a.m.), time of incision (5:34 a.m.), and time of delivery (5:36 a.m.). QN PSS stated that 34 minutes between a prolonged fetal deceleration to delivery was “too long” and 16 or 28 minutes to facilitate a c-section is too long, and that 5 minutes of a prolonged deceleration with no improvement would warrant an immediate decision to perform an emergency c-section. Review of the facility’s policy titled “High Alert Medications and Selected High Risk Medications (HAMSHRM)”, dated 12/24, indicated, ... “medications considered potentially dangerous or more prone to medication errors and/or sentinel events and those medications that carry a higher risk for ...adverse outcomes ...Oxytocin.” During a review of the facility’s policy titled “Intrapartum Fetal Monitoring Standard (IFMS),” dated 9/23, the IFMS indicated, ... “To provide standardized guidelines for fetal monitoring that are consistent with the National Institute of Child and Human Development NICHD), Association of Women’s Health Obstetric and Neonatal Nurses (AWHONN), and American College of Obstetrics and Gynecology (ACOG) recommendations. The fetal monitoring method and frequency will be determined by the maternal-fetal status, clinical diagnosis, plan of care and associated risk factors, with the goal to achieve an optimal level of fetal surveillance while minimizing unnecessary intervention ...” Further review of the facility’s policy titled “Intrapartum Fetal Monitoring Standard (IFMS),” dated 9/23, the IFMS indicated, ... “6 b. Category II FHR-clinically indicated interventions, as ordered by provider ...Physician notification ...Discontinue or decrease oxytocin ... Reassess the FHR tracing within 30 min., renotification of Provider per Category II algorithm ...Category III (Abnormal) FHR ...Immediate physician notification ...Continuous evaluation of FHR status ...Discontinue oxytocin ...Preparation for possible emergent operative vaginal delivery or emergent cesarean section.” Further review of the facility’s policy titled “Intrapartum Fetal Monitoring Standard (IFMS),” dated 9/23, the IFMS indicated, ... “If the FHR tracing is abnormal, the RN will notify the provider and request that the provider review the FHR tracing ...If the provider is in-house, the RN and provider will review the tracing collaboratively ...If RN and provider do not agree on the interpretation of the FHR tracing, the RN will notify the charge nurse / escalate the chain of command.” According to the “Rules and Regulations”, effective 5/25/23, “Section 8.3A.(1).c. Progress Notes. A progress note should indicate the date and time t hat the visit with the patient occurred, include an assessment of the patient’s current condition and plan for progression f care, and provide meaningful information for reference by other member of the health care team ...” The policy and procedure titled, “Code O”, revised 5/2022, directed, “An emergency cesarean delivery will be initiated within the parameter of the definitions described below. A Code O is to be called when a mother and/or baby are severely compromised and immediate delivery is indicated”. An emergent Code O was defined as, “Immediate threat to life ...in which the delivery must occur within 30 minutes of decision time” and exampled included, “Category III; fetal bradycardia ...”. According to the, “Medical Staff Bylaws Rules and Regulations”, revisions effective 5/25/23, “...The purpose of the Medical Staff are to:...serve as the primary means for accountability to Board of Managers for the appropriateness of the professional performance and ethical conduct of Practioners on the Medical staff and Allied Health Professionals and to strive toward the continual upgrading of the quality and efficiency of patient care delivered in the Hospital consistent with the state of the healing arts and the resources locally available...”.”

“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: 50619 Based on interview and clinical record review, the hospital failed to ensure nursing staff developed timely and individualized care plans for 2 of 24 sampled patients (Patient 1 & Patient 4) when: 1) Patient 1 had no documented evidence of nursing care plan initiation upon admission; 2) a. An individualized care plan for Patient 1, who was identified as high-risk, did not have the “Potential for Maternal/Fetal Injury” care plan nor the “Fall Risk” care plan associated with the having an epidural (an injection of anesthesia and pain medication into the spine that blocks pain associated with childbirth that can cause numbness and lack of sensation in the lower half of the body), and b. an individualized care plan for Patient 4, who had an epidural causing Patient 4 to be at risk for falls and did not have a care plan for falls. These failures had the potential to preclude the interdisciplinary team from meaningful information including treatment goals, care needs, and interventions used to guide clinical care decision making and the intention of better patient outcomes. Findings: 1) Patient 1’s past medical history included Cerebral Palsy (a disorder that affects body movement and muscle coordination), seizures (abnormal activity of the brain), and partial hemispherectomy (a surgical procedure where part of one half of the brain is removed or disconnected). Patient 1 was admitted to the hospital on 11/12/24 with a diagnosis of spontaneous rupture of membranes (the breaking of the amniotic sac, the fluid-filled bag that surrounds and protects the baby during pregnancy), contractions (tightening of the uterine muscle during labor)), and augmentation of labor (process of stimulating the uterus to increase frequency and intensity of contractions during labor), and was considered to be a high-risk pregnancy (pregnancy that is more likely to have complications for mother and/or child). During a concurrent interview and record review on 3/20/25 at 10:44 a.m. with Quality Manager 1 (QM 1), QM 1 acknowledged there was no documentation of a nursing care plan in Patient 1’s medical record upon admission or during the labor process and that the care plan was not initiated until after a baby was born the next day. During an interview on 3/21/25 at 11:54 a.m. with the Director of the Family Birthing Center (FBCD), FBCD stated that care plans need to be completed by the admitting nurse. During a review of the Hospital’s policy and procedure (P&P) titled, “Documentation and Planning for the Care of Patients”, revised February of 2018, the P&P indicated, “...It is the responsibility of all care givers to assess and plan for the individualized and appropriate care to meet the needs of all patients... 15. Scope of daily/shift documentation will be reviewed/updated by all staff that provides care to the patient: a. Registered Nurse 1) Each patient’s need for plan of care related to their admission will be reviewed within the first shift of admission and then at a minimum of once per shift...” During a concurrent interview and record review on 3/21/25 at 11:54 a.m. with the Director of the Family Birthing Center (FBCD), FBCD confirmed that there were no care plans completed for Patient 1 upon admission and care plans of “Grief/Loss” and “Post Partum Patient” were added after the baby was born the next day after admission. 2) a. Patient 1’s past medical history included Cerebral Palsy, seizures, and partial hemispherectomy. Patient 1 was admitted to the hospital on 11/12/24 for premature rupture of membranes, augmentation of labor, and was considered to be a high-risk pregnancy. During a review of Patient 1’s clinical record, dated 11/12/24, the clinical record indicated, Patient 1 had an epidural placed on 11/12/24 at 9:30 p.m. and was considered a high-risk pregnancy due to her diagnosis of cerebral palsy, seizures, and history of a partial hemispherectomy. During a concurrent interview and record review on 3/21/25 at 11:54 a.m. with the Director of the Family Birthing Center (FBCD), FBCD confirmed that Patient 1 should have had the “Potential for Maternal/Fetal Injury” care plan due to being a high-risk pregnancy and the “Fall Risk” care plan due to having an epidural and having Cerebral Palsy. FBCD stated any patient with an epidural is expected to have a “Fall Risk” care plan. b. Patient 4 was admitted to the hospital on 1/20/25 with a diagnosis of spontaneous rupture of membranes. During a review of Patient 4’s clinical record, dated 1/20/25, Patient 4’s clinical record indicated that an epidural was placed on 1/20/25 and that there was no documented fall risk care plan. During a review of hospital P&P titled, “Documentation and Planning for the Care of Patients”, revised February of 2018, directed, “...It is the responsibility of all care givers to assess and plan for the individualized and appropriate care to meet the needs of all patients...” During a review of hospital P&P titled, “Patient Controlled Epidural Analgesia Service During Labor,” revised 8/24, the P&P indicated, “ ...After Insertion of Epidural Catheter: ...F.4. The RN will initiate a care plan for patient fall in the EHR.””

“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: 42291 Based on interview, clinical record review, and facility policy review, the facility failed to ensure policies for fetal (a baby in the womb) monitoring and labor management were adhered to for one of 24 sampled patients (Patient 1) when: 1. Appropriate assessment and corresponding interventions were not performed to address critical changes in Patient 1’s fetal heart rate (FHR) monitoring; 2. Patient 1 who was in active labor (contractions strong, regular, and frequent) was receiving a continuous drip of oxytocin (drug that stimulates uterine contractions to help with labor and delivery), a high alert medication (drugs that can cause significant harm if an error occurs), and was contraindicated when the FHR tracing was showing decelerations (possible sign of reduced blood flow to the fetus); and 3. Patient 1’s oxytocin flowsheet requiring every 30 minutes interventions and assessment documentation and with a subsequent provider notification were not followed by the RN assigned to Patient 1’s care. These failures caused delay in response time to Patient 1, exhibiting prolonged signs of fetal distress and precluded staff from a timely rescue or immediate interventions which contributed to a fetal demise (death). The State Survey Agency (SA) determined the facility’s noncompliance with one or more requirements of participation had caused or was likely to cause serious injury, serious harm, serious impairment, or death to patients. On 3/20/25 at 7:40 p.m., the SA provided the CMS Immediate Jeopardy (IJ) Template to the Chief Nursing Officer, Chief Medical Officer, Quality Director, Director of the Family Birth Center, and Chief Executive Officer and verbally informed them that IJ existed related to and informed them that IJ existed related to Nursing Services tag A-0398 [42CFR 482.23 (b)(6)]. The hospital developed and submitted an acceptable action plan that addressed the IJ situation, and the immediacy was removed onsite on 3/20/25 at 9:10 p.m. The hospital implemented immediate corrective actions to address the issues which included: 1. Every nurse in 2024 had additional and required Fetal Monitoring modules. Every nurse working on 3/20/25 had post event training consisting of 5 scenarios of fetal monitoring with escalation. In the next 24 hour period, all charts will be reviewed for compliance with the category 2 escalation algorithm by either the educator or the Director of Family Birthplace. 2.The OB hospitalist along with the charge nurse and primary nurse will review the strips for all patients on Labor and Delivery every two hours to support the attending physicians. This strip review will be documented in the record. The attending physician will be kept informed of any changes or concerns with their patients. If there is a disagreement in the assessment of the fetal monitor interpretation, this will be escalated in real time to the Department Chairman. If there a discrepancy in reading the strips among team members, this will be escalated to the department Chair in real time. 3. Every two hour collaboration will continue until the physician has completed a competency on on fetal monitoring interpretation. Once all physicians have completed the competency, the team review of the strips will go from every 2 hours to every 4 hours and prn. The survey team validated the facility’s corrective actions and the facility provided an acceptable IJ removal plan. The IJ was lifted onsite on 3/21/25 at 5:21 p.m. The facility remained out of compliance at A-0398. Findings: During a review of Patient 1’s “History and Physical (H&P),” dated 11/12/24 at 5:55 p.m., the H&P indicated Patient 1 was admitted for observation to the facility at 36 weeks and 3 days gestation (the length of time, in days or weeks, that a baby is in the womb) who presented with contractions 5 minutes apart. Patient 1 was in latent labor (the initial stage of labor, where contractions begin, but they may be irregular and not as strong or frequent as in active labor). Continued review of Patient 1’s H&P dated 11/12/24 at 5:55 p.m., indicated Patient 1 had a history of cerebral palsy (brain damage that happens before, during, or shortly after birth, disrupting the brain’s ability to control movement and coordination), was a high-risk pregnancy (the mother or baby, or both, at a higher risk of developing health problems during pregnancy or delivery, requiring closer monitoring and potentially specialized care), hip surgery, hemispherectomy (completely disconnects one half of the brain from the other, helps stop seizures in epilepsy), right leg tendon release (treats pain and deformity) , right ankle tendon release, right wrist fusion (relieve pain) and scoliosis (spine curves abnormally rather than straight). 1. During a concurrent interview and record review on 3/17/25 at 1:25 p.m. with Registered Nurse (RN) 4, a facility navigator for medical chart review, Patient 1’s H&P, dated 11/12/24 at 5:55 p.m. was reviewed. The H&P indicated, Patient 1’s “FHR 130 bpm (beats per minute, normal rate 110 -160 bpm), no accelerations (abrupt increase of at least 15 beats per minute above baseline, lasting at least 15 seconds, but less than 2 minutes), or decels (decelerations - temporary drop of fetal heart rate, drop in blood flow to placenta), moderate variability (normal or Category I FHR tracing).” In a continued concurrent interview and record review on 3/17/25 at 3:25 p.m. with RN 4, Patient 1’s “Nursing Flowsheet (NF)”, dated 11/12/24 to 11/13/24 from 11:30 p.m. to 6:30 a.m. was reviewed. The NF indicated, at 11:30 p.m. FHR “Category II indeterminate” (a fetal heart rate tracing that doesn’t clearly fall into either the reassuring- Category I, or abnormal -Category III, requiring further evaluation and potentially, interventions). Continued concurrent interview and record review on 3/17/25 at 3:25 p.m. with RN 4, of Patient 1’s “NF,” indicated the following: 11/13/24 at 1:00 a.m.: FHR Category I (considered normal and reassuring, indicating fetal well-being, FHR between 110-160 bpm, moderate variability, absence of late or variable decelerations, and may or may not have early decelerations or accelerations). 11/13/24 at 1:11 a.m.: Patient 1’s oxytocin infusion rate started at 1 mU [milliunits unit measure] per minute per Board Certified Obstetrician (OB) 1’s orders. 11/13/24 at 1:30 a.m.: Patient 1’s oxytocin infusion rate increased to 2 mU [milliunits unit measure] per minute. 11/13/24 at 3:00 a.m.: Patient 1’s FHR Category II (deceleration variable) does not meet criteria for significant decelerations. FHR down to 90 for 40-50 seconds. Oxytocin infusion continues at 3 mU/min. No evidence of physician notification documented. 11/13/24 at 3:30 a.m.: Patient 1’s FHR with prolonged decels, significant lasts longer than 3 minutes. Patient 1 was turned, and fluids increased. RN 4 stated, “the expectation is for the nurse to stop oxytocin and physician to be notified. No documentation found that oxytocin was discontinued, or physician notified.” 11/13/24 at 4:00 a.m.: Patient 1’s FHR with variable deceleration, FHR decreased to 90 for 50 seconds. No physician notification documented. Oxytocin at 4 milliUnit per minute continued infusing. 11/13/24 at 4:30 a.m.: Patient 1’s FHR with variable deceleration, FHR decreased to 80. No physician notification documented. Oxytocin at 4 milliUnit per minute continued infusing. 11/13/24 at 4:58 a.m.: OB 1at Patient 1’s bedside, trial push attempted, unable to reduce anterior lip (a swollen or thickened edge of the cervix, usually the front part, that’s still present despite full dilation, potentially hindering the baby’s descent and birth). Patient 1 instructed to not push, to labor down (allows the baby recover). 11/13/24 at 5:00 a.m.: Patient 1’s FHR with prolonged variable deceleration. Oxytocin documented stopped at 05:14 a.m.. 11/13/24 at 5:15 a.m.: Patient 1’s FHR with prolonged variable deceleration. 11/13/24 at 5:30 a.m.: Patient 1’s FHR with prolonged bradycardia (the baby’s heartbeat is below 110 and stays that way for an extended period, potentially indicating fetal distress and requiring immediate medical attention) and does not return to baseline. 11/13/24 at 5:36 a.m.: Cesarean-Section (surgical procedure to remove the fetus) delivery of female baby with Apgars (APGAR scores- an assessment of a newborn with five components: color, heart rate, reflexes, muscle tone and respiration. The higher the number the better the component) were 0, 0, 0, and 0 hence this is a fetal demise (the delivery of a fetus showing no signs of life).” During a concurrent interview and record review on 3/18/25 at 11:45 a.m. with the Family Birth Center Director (FBCD), Patient 1’s FHR tracings, and NF dated 11/12/24 was reviewed, FBCD indicated Patient 1 had prolonged decelerations at 11:52 p.m. for about 4 minutes. The interventions would include repositioning, discontinuing oxytocin (if infusing), IV bolus (increased fluids), and notifying the provider. There was a lack of documented evidence RN provided all necessary interventions and failed to notify the provider of the concerning FHT. Additionally, the FBCD stated that this information was in the “Intrapartum Fetal Monitoring Standard, Algorithm for Category II.” Continued concurrent interview and record review on 3/18/25 at 11:45 a.m. with the FBCD, Patient 1’s FHR tracings and flowsheet dated 11/13/24 was reviewed, FBCD indicated, Patient 1’s FHR at 12:50 to 12:55 a.m. had decelerations and multiple variables (a sign of potential umbilical cord compression or head compression during labor and can indicate fetal distress), the fetal heart rate decreased to the 80’s. FBCD indicated no nursing documentation of the FHR changes and the nurse failed to inform the OB provider. Continued concurrent interview and record review on 3/18/25 at 11:45 a.m. with the FBCD, Patient 1’s FHR tracings and flowsheet dated 11/13/24 at 1:00 a.m. to 5:30 a.m. was reviewed, FBCD indicated OB 1 was at Patient 1’s bedside at 1:04 a.m. and documented Patient 1’s FHR was Category 1 and oxytocin orders had not been started. FBCD stated “Patient 1’s FHR tracing indicated from 1:00 a.m. to 1:05 a.m. variable FHR, and acknowledged that Patient 1’s FHT continued to have abnormal FHT’s and RN 2 should have communicated with OB 1 and the Charge Nurse (CN). Continued concurrent interview and record review on 3/18/25 at 11:45 a.m. with the FBCD, FBCD indicated that the policy for recurrent variable (more than 2 in a row) was to stop oxytocin. FBCD stated that Patient 1’s FHR at 5:28 a.m. was a terminal bradycardia (a fetal heart rate below 100 beats per minute). During a concurrent interview and record review on 3/19/25 at 9:06 a.m. with a Labor and Delivery RN, (RN 1), Patient 1’s FHR, and flowsheet dated 11/12/24 at 4:00 p.m. to 11/13/24 at 6:00 a.m. was reviewed, RN 1 indicated the following: 11/12/24 at 4:00 p.m. to 10:00 p.m. Patient 1 had a Category 1 FHR (normal tracing). 11/12/24 at 11:05 p.m. Patient 1 was sitting up for an epidural. 11/12/24 at 11:30 p.m. Patient 1 was at 4-5 cm (cm centimeter -unit of measure, cervix dilation) cm, 90% effaced (thinning) of cervix, -1station (head position above or below pelvic bones). 11/12/24 at 11:37 p.m. Patient 1 had questionable FHR, RN 1 stated, “the nurse needs to assess and readjust the fetal heart monitor.” There was no nursing documentation to explain the FHR. 11/12/24 at 11:53 p.m. Patient 1’s FHR showed prolonged deceleration. RN 1 stated, the “expectation if oxytocin is infusing to turn it off, turn the patient to the side, give intravenous fluid and oxygen. Notify the physician and get assistance.” No physician notification was documented. 11/13/24 at 12:05 a.m. Patient 1’s documentation showed Patient 1 was turned to the right side; RN 1 stated, “the prolonged decelerations started to get better.” 11/13/24 at 12:30 a.m. Patient 1’s “FHR was improving.” 11/13/24 at 12:56 a.m. Patient 1’s FHR showed variability (possible cord compression). Patient 1 had an abrupt drop in the fetal heart rate. RN 1 stated, “I would want the hospitalist telling me what interventions to take, review the fetal heart strip with me and to tell me the plan of care.” 11/13/24 at 1:01 a.m., OB 1 documents, “Called to pts (Patient 1) bedside by RN states pt [patient] is having a right sided hip pain ...FHT: 135 bpm, moderate variability, accels [accelerations] noted. No decel [decelerations]- Category I ...For some reason, oxytocin not started per RN.” No OB documentation noted of FHR concerns. RN 1 stated, “not sure if OB 1 reviewed the FHR tracing,” which RN 1 indicated Patient 1 FHR showed Category II and oxytocin was not indicated. 11/13/24 at 1:10 a.m. Patient 1’s FHR showed early decelerations. RN 1 stated “could be head compression.” 11/13/24 at 1:11 a.m. OB 1 Ordered to start oxytocin on Patient 1. RN 1 stated “I would not have started oxytocin; [Patient 1] does not have a Category 1 FHR.” 11/13/24 at 1:30 a.m. Patient 1’s oxytocin infusing at 2 mu/min. Patient 1 was dilated at 7 cm. FHR 1 with variable and moderate variability. 11/13/24 at 2:00 a.m. Patient 1’s oxytocin was increased to 4mu/min. Patient 1 was dilated at 8.5 cm. FHR Category II. RN1 stated, “oxytocin is to continue if no significant decelerations, if you have decelerations cannot have 50% or more variability happening.” 11/13/24 at 2:20 a.m. Patient 1’s FHR showed moderate variability and decelerations. No provider notification documented. 11/13/24 at 2:50 a.m. RN 1 stated “I cannot read the FHR, unclear what is happening, the nurse should adjust the fetal monitor to determine variables or prolonged decelerations?” and “Oxytocin should have been turned off.” Oxytocin infusion continued at 4mU per minute. 11/13/24 at 3:12 a.m. Patient 1’s FHR showed prolonged and variable combination tracings. Oxytocin continued at 4mU per minute. 11/13/24 at 3:18 a.m. Patient 1’s IV fluids increased, repositioned to right side. RN 1 stated, “documentation has no indication of provider notification.” Oxytocin continued at 4mU per minute. 11/13/24 at 3:30 a.m. to 4:00 a.m. Patient 1’s FHR showed variables, Patient 1 at 9 1/2 cm and 100% and +1 station. 11/13/24 at 4:17 a.m. Patient 1’s FHR showed variable and prolonged FHR. RN 1 indicated, the provider needs to be notified and make a decision. No provider notification documented. Oxytocin continued at 4mU per minute, 11/13/24 at 4:42 a.m. Patient 1’s FHR showed prolonged decelerations. Oxytocin continued at 4mU per minute. 11/13/24 at 4:50 a.m. Patient 1 at 9 1/2 cm, 100% effaced, +1 station. 11/13/24 at 5:01 a.m. OB 1 in attendance. Patient 1’s FHR showed prolonged decelerations 80’s to 90’s. RN 1 stated “Need to make sure oxytocin is off.” Oxytocin continued at 4mU per minute. 11/13/24 at 5:05 a.m. Patient 1’s FHR showed another prolonged and flat line (no variability), FHR 70, and the FHR does not recover, FHR stays in the 60-70’s with no variability. 11/13/24 at 5:22 a.m. Patient 1 was given terbutaline (medication sometimes used to stop or prevent premature labor in pregnant women) to stop contractions. RN 1 stated “a CODE O (Emergency Cesarean Delivery) should have been called.” The flowsheet and nursing notes contained no documentation to indicate OB 1 was notified of the prolonged decelerations and continued oxytocin infusion at 4 mUnits per minute. During an interview with the FBCD on 3/19/25 at 11:00 a.m, the FBCD stated RN 2 was not available for interview because she was on vacation. During a review of the facility’s policy titled “Admission and Follow-Up Assessment of a Patient in Labor (AFUAPL),” dated 7/17, the AFUAPL indicated, ... “once in labor: ... If FHR abnormalities occur (to evaluate for complications such as cord prolapse or uterine rupture) ...RN monitors, reassesses patient, and documents, according to nursing care plan and intrapartum documentation policy.” During a review of the facility’s policy titled “Intrapartum Fetal Monitoring Standard (IFMS),” dated 9/23, the IFMS indicated, ... “To provide standardized guidelines for fetal monitoring that are consistent with the National Institute of Child and Human Development NICHD), Association of Women’s Health Obstetric and Neonatal Nurses (AWHONN), and American College of Obstetrics and Gynecology (ACOG) recommendations. The fetal monitoring method and frequency will be determined by the maternal-fetal status, clinical diagnosis, plan of care and associated risk factors, with the goal to achieve an optimal level of fetal surveillance while minimizing unnecessary intervention ...” Further review of the facility’s policy titled “Intrapartum Fetal Monitoring Standard (IFMS),” dated 9/23, the IFMS indicated, ... “6 b. Category II FHR-clinically indicated interventions, as ordered by provider ...Physician notification ...Discontinue or decrease oxytocin ... Reassess the FHR tracing within 30 min., renotification of Provider per Category II algorithm ...Category III (Abnormal) FHR ...Immediate physician notification ...Continuous evaluation of FHR status ...Discontinue oxytocin ...Preparation for possible emergent operative vaginal delivery or emergent cesarean section.” Further review of the facility’s policy titled “Intrapartum Fetal Monitoring Standard (IFMS),” dated 9/23, the IFMS indicated, ... “If the FHR tracing is abnormal, the RN will notify the provider and request that the provider review the FHR tracing ...If the provider is in-house, the RN and provider will review the tracing collaboratively ...If RN and provider do not agree on the interpretation of the FHR tracing, the RN will notify the charge nurse / escalate the chain of command.” Further review of the facility’s policy titled “Intrapartum Fetal Monitoring Standard (IFMS),” dated 9/23, the IFMS indicated, ... “Definitions: ... “Prolonged Deceleration - a gradual or abrupt decrease of greater than 15 bpm lasting longer than 2 minutes but less than 10 minutes ...” Further review of the facility’s policy titled “Intrapartum Fetal Monitoring Standard (IFMS),” dated 9/23, the IFMS indicated, ... “Definitions: Indeterminate (EFM) - Tracings in this category are not predictive of abnormal acid-base status, however there are insufficient data to classify them as either category I or category III.” Further review of the facility’s policy titled “Intrapartum Fetal Monitoring Standard (IFMS),” dated 9/23, the IFMS indicated, ... “Definitions: Variability of the Fetal Heart Rate - fluctuations in the baseline FHR ...Variability is defined as: ...Moderate - Amplitude (fluctuations) of 6-25 bpm ...” Further review of the facility’s policy titled “Intrapartum Fetal Monitoring Standard (IFMS),” dated 9/23, the IFMS indicated, ... “Definitions: Variable Deceleration - a deceleration of the heart rate caused by umbilical cord compression and/or head compression ...an abrupt decrease (less than 30 seconds) in FHR of greater than 15 bpm lasting greater than 15 seconds but less than 2 minutes ...” 2. During a review of Patient 1’s document titled “Physician’s Orders (PO)” dated 11/12/24 at 9:21 p.m., the PO indicated “oxytocin start infusion at 1 milliunit/minute. Increase to 2 milliunits/minute after 30 minutes. Advance dosage by 2 milliunits/minute every 30 minutes.” During a review of Patient 1’s document titled “Medication Administration Record (MAR),” dated 11/13/24, the MAR indicated, an infusion of oxytocin was initiated on 11/13/24 at 01:11 a.m. Four hours after initial oxytocin orders written. During a concurrent interview and record review on 3/17/25 at 3:20 p.m. with RN 4, Patient 1’s “Physician Note (PO),” dated 11/12/24 at 11:58 p.m., the PO indicated, “FHT [Fetal Heart Tone] 145 bpm, moderate variability, accels [accelerations] noted. No decel [decelerations] - Category I (normal FHR tracing) ...IUPC (intrauterine pressure catheter, a device placed into the amniotic space during labor in order to measure the strength of uterine contractions) ...Instructed RN to start pitocin per protocol at 2mU.” RN 4 indicated, OB 1 may not have seen the 30 minutes FHR tracing, and the nurse (RN 2) did not document the reason for not starting the oxytocin when ordered. During a concurrent interview and record review on 3/17/25 at 5:00 p.m., with the Family Birth Center Director (FBCD), Patient 1’s MAR and flowsheet dated 11/13/24 at 1:00 a.m. was reviewed, FBCD indicated, Patient 1’s orders for oxytocin was not started as ordered on 11/12/24 at 9:21 p.m. The FMBCD further stated that if there is disagreement between the provider and the nurse, “the nurse can follow the “Chain of Command” policy.” During a concurrent interview with the FBCD on 3/18/25 at 3:55 p.m., the FBCD indicated that prior to starting oxytocin, the laboring patient should have a Category 1 tracing. Patient 1 had recurrent variables or late variables and should not have been started on oxytocin. During a concurrent interview and record review on 3/19/25 at 9:06 a.m. with Labor and Delivery RN 1, Patient 1’s FHR, and Flowsheet dated 11/12/24 4:00 p.m. to 11/13/24 6:00 a.m. was reviewed, RN 1 indicated Patient 1 was not having Category 1 tracings so would not be a candidate for oxytocin at 01:00 a.m.. RN 1 further indicated she would be communicating the FHR tracings with the provider. The flowsheet contained no documentation to indicate OB 1 was notified of Patient 1’s Category II FHR tracings, variables, late variables and continued oxytocin infusion at 4mUnits per minute. The Physician Progress notes contained no documentation to indicate OB 1 was notified of Category II FHR tracings, variable, late variables and/or discontinuing oxytocin infusion. During a review of the facility’s policy titled “IV Oxytocin Induction Augmentation of Labor (IVOIAL),” dated 5/22, the IVOIAL indicated, ... “If after reviewing the fetal heart rate (FHR) strip and course of labor the responsible physician feels that in his or judgement, continued use of oxytocin is the best interest of the mother and baby, the physician should document to that effect in the medical record and order the oxytocin to continue. When there is disagreement, the staff nurse follows facility-specific policy regarding resolution (e.g. chain of command).” Further review of of the facility’s policy titled “IVOIAL,” dated 5/22, the IVOIAL indicated, ... “OB Notification ... The OB will be notified if the registered nurse is unable to complete either the Pre-Assessment and/or the “In-Use” Oxytocin Checklist. Oxytocin will not be started or reinitiated until the OB is notified and documents the rationale for an alternative approach. Review of the facility’s policy titled “High Alert Medications and Selected High Risk Medications (HAMSHRM)”, dated 12/24, indicated, ... “medications considered potentially dangerous or more prone to medication errors and/or sentinel events and those medications that carry a higher risk for ...adverse outcomes ...Oxytocin.” 3. During a review of Patient 1’s document titled “Medication Administration Record (MAR),” dated 11/12/24, the MAR indicated, “Oxytocin ...at 1 milliUnit/minute increase to 2 after 30 minutes. Advance dosage by 2 milliUnits/minute every 30 minutes.” During a review of Patient 1’s document titled “Oxytocin Pre-Use Checklist (OPUC- provides induction guidelines to the RN), dated 11/13/24 at 1:15 a.m., the OPUC indicated ... “20 minutes of Fetal Monitoring complete, Fetal Strip: moderate variability with no recurrent late or variable decelerations (normal FHR).” This documentation was contrary to Patient 1’s FHR tracing showing Category II and which oxytocin infusion may be contraindicated. Further review of Patient 1’s MAR dated 11/13/24, at 01:11, the MAR indicated oxytocin infusion started at 1milliUnit perminute, at 1:30 the oxytocin infusion rate was increased to 2 1milliUnit per minute , at 2:00 a.m. the oxytocin infusion rate was increased to 4 1milliUnit per minute unit and the oxytocin infusion was discontinued at 5:30 a.m. During an interview and record review of the facility’s flowsheet document titled “Oxytocin Pre-Use Checklist”, dated 11/13/24 1:00 a.m. to 5:00 a.m., with the FBCD, the FBCD indicated, RN 2 was documenting “Fetal Strip moderate variability with no recurrent or variable decelerations (normal).” FBCD stated RN 2’s documentation was incorrect; Patient 1 was having multiple variable decelerations and not Category 1 FHR. The flowsheet contained no documentation to indicate OB 1 was notified of Patient 1’s Category II FHR tracings, variables, late variables and continued oxytocin infusion at 4mUnits per minute. During a review of the facility’s policy titled “IV Oxytocin Induction Augmentation of Labor, IVOIAL),” dated 5/22, the IVOIAL indicated, ... “To provide safe and consistent care to the patient undergoing medical or elective induction or augmentation of labor.” Further review of the facility’s policy title “IVOIAL,” dated 5/22 indicated, ... “In-Use Checklist will be completed every 30 minutes, by the L&D RN while oxytocin is administered ...Patient must ... be attached to fetal monitor and a Category I FHR pattern must be obtained before beginning induction and augmentation... The electronic fetal monitoring (EFM) tracing shows no sign of fetal compromise ...Notify physician of signs of fetal compromise” Further review of the facility’s policy title “IVOIAL,” dated 5/22 indicated, ... “During oxytocin administration the nurse documents in the electronic health record, according to the fetal monitoring policy, including indication for augmentation or induction.””

“ADMINISTRATION OF DRUGS CFR(s): 482.23(c)(1), (c)(1)(i) & (c)(2) (1) Drugs and biologicals must be prepared and administered in accordance with Federal and State laws, the orders of the practitioner or practitioners responsible for the patient’s care as specified under §482.12(c), and accepted standards of practice. (i) Drugs and biologicals may be prepared and administered on the orders of other practitioners not specified under §482.12(c) only if such practitioners are acting in accordance with State law, including scope of practice laws, hospital policies, and medical staff bylaws, rules, and regulations. (2) All drugs and biologicals must be administered by, or under supervision of, nursing or other personnel in accordance with Federal and State laws and regulations, including applicable licensing requirements, and in accordance with the approved medical staff policies and procedures. This Standard is not met as evidenced by: 42291 Based on interview, clinical record review, and facility policy review, the facility failed to ensure policies for fetal (a baby in the womb) monitoring, documentation and labor management were adhered to for one of 24 laboring patients (Patient 1) when: 1. Patient 1 who was in active labor (contractions strong, regular, and frequent) was receiving a continuous drip of oxytocin (drug that stimulates uterine contractions to help with labor and delivery) a high alert medication (drugs that can cause significant harm if an error occurs) when the Fetal Heart Rate (FHR) tracing was showing decelerations (possible sign of reduced blood flow to the fetus); 2. Patient 1’s oxytocin flowsheet requiring every 30 minutes interventions and assessment documentation, and provider notification was not followed; and. 3. Patient 1’s epidural (a type of pain relief method where medication, ropivacaine, is injected into the space around the spinal cord to numb a specific area of the body, often used during childbirth) did not have the volume adminstered to Patient 1 documented according to policy. These failures had the potential for Patient 1 to have receieved oxytocin when it was not indicated and had potential to contribute to poor fetal outcome and for Patient 1 to not receiving the ordered dose of epidural medication, which had potential of increasedpain or anesthesia-related complications. Findings: During a review of Patient 1’s “History and Physical (H&P),” dated 11/12/24 at 9:33 p.m., the H&P indicated Patient 1 was admitted for observation to the facility at 36 weeks and 4 days gestation (the length of time (in days or weeks) that a baby is in the womb) who presented for r/o [ruled out] labor and found to have prematurely ruptured membranes (water breaking). Continued review of Patient 1’s H&P dated 11/12/24 at 9:33 p.m., indicated Patient 1 had a history of cerebral palsy (brain damage disrupting the brain’s ability to control movement and coordination), was a high-risk pregnancy (the mother or baby (or both) at a higher risk of developing health problems during pregnancy or delivery, requiring closer monitoring and potentially specialized care), hip surgery, hemispherectomy (disconnects one half of the brain from the other, helps stop seizures in epilepsy), right leg tendon release (treats pain and deformity) , right ankle tendon release, right wrist fusion (relieve pain) and scoliosis (spine curves abnormally rather than straight). 1. During a review of Patient 1’s document titled “Physician’s Orders (PO)” dated 11/12/24 at 9:21 p.m., the PO indicated “oxytocin start infusion at 1 milliunit/minute. Increase to 2 milliunits/minute after 30 minutes. Advance dosage by 2 milliunits/minute every 30 minutes.” During a review of Patient 1’s document titled “Medication Administration Record (MAR),” dated 11/13/24, the MAR indicated, an infusion of oxytocin was initiated on 11/13/24 at 01:11 a.m. Four hours after initial oxytocin orders written. During a concurrent interview and record review on 3/17/25 at 3:20 p.m. with RN 4, Patient 1’s “Physician Note (PN),” dated 11/12/24 at 11:58 p.m., the PN indicated, “FHT [Fetal Heart Tone] 145 bpm, moderate variability, accels [accelerations] noted. No decel [decelerations] - Category I (normal FHR tracing) ...IUPC (intrauterine pressure catheter, a device placed into the amniotic space during labor in order to measure the strength of uterine contractions) ...Instructed RN to start pitocin per protocol at 2mU.” RN 4 indicated, OB 1 may not have seen the 30 minutes FHR tracing and the nurse did not document the reason for not starting the oxytocin when ordered. During a concurrent interview and record review on 3/17/25 at 5:00 p.m., with the Family Birth Center Director (FBCD), Patient 1’s MAR and flowsheet dated 11/13/24 at 01:00 a.m. was reviewed, FBCD indicated, Patient 1’s orders for oxytocin was not started as ordered on 11/12/24 at 9:21 p.m. The FBCD further stated that if there is disagreement between the provider and the nurse, “the nurse can follow the “Chain of Command” policy.” During a concurrent interview with the FBCD on 3/18/25 at 3:55 p.m., the FBCD indicated that prior to starting oxytocin, the laboring patient needs to have a Category 1 tracing. Patient 1 had recurrent variables or late variables and should not have been started on oxytocin. During a concurrent interview and record review on 3/19/25 at 09:06 a.m. with Labor and Delivery RN 1, Patient 1’s FHR, and Flowsheet dated 11/12/24 4:00 p.m. to 11/13/24 6:00 a.m. was reviewed, RN 1 indicated Patient 1 was not having Category 1 tracings so would not be a candidate for oxytocin at 01:00 a.m.. RN 1 further indicated she would be communicating the FHR tracings with the provider. The flowsheet contained no documentation to indicate OB 1 was notified of Category II tracings, variables, late variables and continued oxytocin infusion at 4mUnits per minute. During a review of the facility’s policy titled “IV Oxytocin Induction Augmentation of Labor (IVOIAL),” dated 5/22, the IVOIAL indicated, ... “If after reviewing the fetal heart rate (FHR) strip and course of labor the responsible physician feels that in his or judgement, continued use of oxytocin is the best interest of the mother and baby, the physician should document to that effect in the medical record and order the oxytocin to continue. When there is disagreement, the staff nurse follows facility-specific policy regarding resolution (e.g. chain of command).” Further review of of the facility’s policy titled “IVOIAL,” dated 5/22, the IVOIAL indicated, ... “OB Notification ... The OB will be notified if the registered nurse is unable to complete either the Pre-Assessment and/or the “In-Use” Oxytocin Checklist. Oxytocin will not be started or reinitiated until the OB is notified and documents the rationale for an alternative approach. Review of the facility’s policy titled “High Alert Medications and Selected High Risk Medications (HAMSHRM)”, dated 12/24, indicated, ... “medications considered potentially dangerous or more prone to medication errors and/or sentinel events and those medications that carry a higher risk for ...adverse outcomes ...Oxytocin.” 2. During a review of Patient 1’s document titled “Medication Administration Record (MAR),” dated 11/13/24, at 01:11 a.m. the MAR indicated, “Oxytocin ...at 1 milliunit/minute increase to 2 after 30 minutes. Advance dosage by 2 milliunits/minute every 30 minutes.” During a review of Patient 1’s document titled “Oxytocin Pre-Use Checklist (OPUC), dated 11/13/24 at 1:15 a.m., the OPUC indicated ... “20 minutes of Fetal Monitoring complete, Fetal Strip: moderate variability with no recurrent late or variable decelerations (Normal Category I FHR tracing).” This documentation was contrary to the FHR tracing showing Category II FHR and which oxytocin infusion may be contraindicated. Further review of Patient 1’s MAR dated 11/13/24, at 01:11 the MAR indicated oxytocin started at 1mUnit/min, at 01:30 a.m., rate increased to 2 mUnit/min, at 02:00 a.m. oxytocin rate increased to 4 mUnit/min unit and oxytocin discontinued at 5:30 a.m. During an interview and record review of the facility’s NF document titled “Oxytocin Pre Use Checklist”, dated 11/13/24 01:00 a.m. to 05:00 a.m., with the FBCD, the FBCD indicated, RN 2 was documenting “Fetal Strip moderate variability with no recurrent or variable decelerations (normal).” FBCD stated RN 2’s documentation was incorrect; Patient 1 was having multiple variable decelerations and not Category 1 FHR. During a review of the facility’s policy titled “IV Oxytocin Induction Augmentation of Labor, IVOIAL),” dated 5/22, the IVOIAL indicated, ... “To provide safe and consistent care to the patient undergoing medical or elective induction or augmentation of labor.” Further review of the facility’s policy title “IVOIAL,” dated 5/22 indicated, ... “In-Use Checklist will be completed every 30 minutes, by the L&D RN while oxytocin is administered ...Patient must ... be attached to fetal monitor and a Category I FHR pattern must be obtained before beginning induction and augmentation... The electronic fetal monitoring (EFM) tracing shows no sign of fetal compromise ...Notify physician of signs of fetal compromise” Further review of the facility’s policy title “IVOIAL,” dated 5/22 indicated, ... “During oxytocin administration the nurse documents in the electronic health record, according to the fetal monitoring policy, including indication for augmentation or induction.” 3. During a review of Patient 1’s “Medication Administration Record (MAR),” dated 11/12/24, at 11:01 p.m., the MAR indicated, “Ropivacaine rate at 10 ml/hr (ml-milliliter unit of measure, per hour).” During a concurrent interview and record review on 3/20/25 at 10 a.m., with the Certified Registered Nurse Anesthetist (CRNA), Patient 1’s MAR and Electronic Health Record (EHR) dated 11/12/24 was reviewed. The CRNA indicated she does not record volume infused in the EHR, “is probably in the nurses record how much [Patient 1] received.” During a concurrent interview and record review on 3/20/25 at 10:35 a.m., with the Pharmacy Clinical Coordinator (PCC), Patient 1’s MAR and EHR dated 11/12/24 was reviewed. The PCC indicated ropivacaine medication is available in the unit and the nurse documents in the EHR the total volume infused. The flowsheet contained no documentation to indicate the infusion rate, or the total volume infused at the end of the shift. During a concurrent interview and record review on 3/20/25 at 10:45 a.m., with the FBCD, FBCD indicated, the RN did not follow the facility policy to document the medication infusion rate, and the total volume infused during the shift as it is expected. During review of the facility’s policy titled “Patient Controlled Epidural Analgesia Service During Labor (PCEASDL),” dated 6/2011, the PCEASDL indicated, ... “RN [Registered Nurse will document ... infusion rate...use per shift ...Nursing will waste and document wastage of any epidural solution.””

“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: 35598 Based on interviews, medical record, document and policy review, the hospital failed to effectively organize and deliver safe, quality nursing services to patients in the Emergency Department as evidenced by: A. Based on interview, clinical record review, and facility policy review, the facility failed to ensure policies for intravenous (IV, through the vein) medication administrations and nursing assessments of patients in the Emergency Department (ED) were implemented for two of 35 sampled Emergency Department patients (Patient 1 and 22) when: 1. Midazolam (a medication that is used to help a patient relax or sleep during a medical procedure) was administered to Patient 1 by Registered Nurse 3 (RN-3) without required monitoring in place; 2. No evidence of an initial nursing assessment was done for Patient 1; and 3. No nursing re-assessment was documented after the administration of pain medication for Patient 22 which may have precluded the patient from having effective pain management. These failures resulted in a lack of nursing assessment, evaluation, and monitoring per facility’s policies for Patients 1 and 22 and had potential to delay care and treatment decisions for Patients 1 and 22 (Refer to A0398). Additionally, these failures contributed to Patient 1’s respiratory depression and subsequent death. (Refer to A 0398 and A0410). The cumulative effect of these failures resulted in the hospital’s inability to provide effective, safe and quality nursing services in accordance with the statutorily-mandated Conditions of Participation Nursing Services.”

“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: 39700 Based on interview, clinical record review, and facility policy review, the facility failed to ensure policies for intravenous (IV, through the vein) medication administrations and nursing assessments of patients in the Emergency Department (ED) were implemented for two of 35 sampled Emergency Department patients (Patient 1 and 22) when: 1. Midazolam (a medication that is used to help a patient relax or sleep during a medical procedure) was administered to Patient 1 by Registered Nurse 3 (RN-3) without required monitoring in place; 2. No evidence of an initial nursing assessment was done for Patient 1; and 3. No nursing re-assessment was documented after the administration of pain medication for Patient 22 which may have precluded the patient from having effective pain management. . These failures resulted in a lack of nursing assessment, evaluation, and monitoring per facility’s policies for Patients 1 and 22 and had potential to delay care and treatment decisions for Patients 1 and 22. These failures contributed to Patient 1’s respiratory depression and subsequent death. Findings: 1. Review of Patient 1’s ED Triage (preliminary assessment) Note upon arrival, indicated Patient 1 arrived in the ED on 10/29/23 at 4:55 p.m. by ambulance from home. The note further indicated Patient 1 had weakness, slurred speech, and a history of Congestive Heart Failure (CHF, a chronic condition where the heart is weak and unable to pump blood effectively to the body). Patient 1 was triaged with an emergency severity index of 3 (ESI, a tool used in the emergency department for triage, 3 was considered urgent). Review of Medical Doctor (MD) 1’s note, titled “ED Physician Notes”, dated 10/29/23 at 9:53 p.m. (after Patient 1’s death at 8:24 p.m.) included the following: Patient 1 had a history CHF, ischemic myopathy (heart damage) with an ejection fraction of 28% (amount of blood that pumps out of the heart with normal percentage between 50-70) and daily alcohol ingestion. The note further indicated MD 1’s initial assessment indicated Patient 1 appeared tired, not answering questions, her lower extremities were mottled (uneven discolored patches occurring in low blood flow to the skin) and cold with no pulses. The 10/29/23 note further indicated MD 1 was concerned that Patient 1 was suffering from a possible aortic dissection/thrombus (tearing or clotting of the heart’s main artery that prevents blood flow to organs and can be fatal) and arterial occlusions (a blockage in the artery that prevents blood flow). Patient 1 was taken emergently to the Computed Tomography scan (CT scan) for an aortic angiogram and run off (CT scan where dye is injected and x-rays are taken of the abdomen and leg arteries). Further review of MD 1 note indicated Patient 1 tolerated the CT scan of the abdomen but attempted to “jump off table” during the lower extremity CT scan. MD 1 ordered “Versed [midazolam] 5 milligrams (mg, unit of measurement) IV to facilitate the LE (lower extremity) ...” for CT scan procedure. MD 1’s 10/29/23 note indicated that after the CT was completed, Patient 1 was found not breathing and unresponsive. Cardiopulmonary Resuscitation (CPR, reviving heartbeat and breathing) was initiated. Patient 1 was revived after 20 minutes of CPR and placed on multiple medications to maintain a life sustaining blood pressure. Approximately 1 ½ hours later, Patient 1’s heart stopped again. CPR was reinitiated, but unsuccessful, and Patient 1 was pronounced dead. During a review of Patient 1’s CT scan orders on 1/2/24 at 11:15 a.m., the order indicated a CT scan of the abdomen with runoff was ordered and started on 10/29/23 at 5:35 p.m. The order further indicated a CT scan of the lower extremities was ordered and started on 10/29/23 at 5:58 p.m. During a review of Patient 1’s medication order, written by Medical Doctor Resident (MDR), dated 10/29/23 at 5:53 p.m., the order indicated midazolam 5 mg IV one time use was ordered. The order did not include parameters for how long, or the time, the midazolam should have been administered via IV push to Patient 1 or the monitoring requirements or administration. Review of Patient 1’s Medication Administration Record (MAR, electronic record of ordered medications administered by nursing) for 10/29/23, the MAR indicated midazolam 5 mg was administered IV at 5:56 p.m. by RN 3. Review of Patient 1’s first CPR record, dated 10/29/23, indicated CPR was initiated at 6:06 p.m. Patient 1 was not breathing, and her heart had stopped. Patient 1 was revived with a heartbeat at 6:22 p.m. while on multiple medications to sustain blood pressure and heartbeat. Review of Patient 1’s second CPR record, dated 10/29/23, indicated CPR was reinitiated on at 7:59 p.m. when the heart rate became slow. Patient 1 was pronounced dead at 8:24 p.m. During an interview with Registered Nurse (RN) 4 on 1/2/24 at 1:35 p.m., RN 4 stated that Patient 1 was in the hallway and placed on the monitor (machine that monitors breathing and heart rate, blood pressure, and oxygen saturation [percentage of oxygen in the blood]) waiting to be seen by a physician. RN 4 stated Patient was disconnected from the monitor by MD 1 and taken for a CT scan. RN 4 stated Patient 1 became restless in CT scan, and midazolam 5 mg IV dose was administered by RN 3 to help with restlessness. RN 4 stated the facility had a policy on how to give the midazolam and it’s use required breathing and body oxygen level monitoring but not every situation required this type of monitoring. During an interview with RN 3 on 1/2/24 at 2:45 p.m., RN 3 stated that he administered midazolam 5 mg IV to Patient 1, per order. RN 3 further stated that he administered the medication over 30 to 60 seconds, which was approximately two times faster than recommended per policy and standard of practice. RN 3 confirmed Patient 1 should have been on the monitor when he administered the medication. During a telephone interview with MD 1 on 1/3/24 at 2:15 p.m., the MD 1 stated Patient 1 needed monitoring, and MD 1 stated “not being monitored was a fail [neglect to do something].” MD 1 further stated midazolam was not a poor choice for Patient 1’s restless and anxious behavior but acknowledged a lower dose could have been ordered. During an interview on 1/4/24, at 10:56 a.m. with RN 4, RN 4 stated midazolam IV push (intravenous - drug given through the vein) should have been administered over 2-3 minutes and the patient needed to be on a monitor to assess for the respiratory depression (shallow breathing) and/or adverse effects (harmful) of the medication. During an interview on 1/4/24 at 11:10 a.m. with the ED Manager (EDM), the EDM stated midazolam 4 to 5 mg IV push had frequently been given in the Emergency Department. EDM stated, midazolam caused respiratory depression and therefore the patient needed to have their oxygen saturation and respiratory rate (per minute) monitored during medication administration. EDM stated, midazolam should have been given over at least two minutes and given slowly. EDM stated, the ED had been short on transport monitors (portable monitors that display current heart rate and respiratory rate per minute, blood pressure, and oxygen saturation). During an interview with RN 5 on 1/4/24 at 11:35 a.m., RN 5 stated midazolam should be given over five minutes and the patient needed to be on a monitor to be able to assess for respiratory depression. During a joint interview with the Chief Nursing Officer (CNO) and the Director of Quality (DOQ) on 1/3/24 at 10 a.m., CNO stated midazolam should have been given 1 to 2 mg at a time, and not 5 mg at once. CNO and DOQ both confirmed Patient 1 should have received the medication slowly and while on a monitor. In an interview with Chief Nursing Officer (CNO), on 1/3/24, at 11:26 AM, the CNO stated midazolam was not a first line drug for treatment of agitation and anxiety related to medical environment. The CNO stated there were safer drugs to use. The CNO stated the facility’s policy on “Procedural Sedation” (a policy that ensured safe medication use and monitoring for moderate or deep sedation) did not apply to midazolam use in the CT scan for agitation. Review of the Food and Drug Administration (FDA, a federal agency responsible for protecting the public health by assuring the safe and effective medication use) Black Box Warning (or BBW, the FDA ’ s most stringent warning for drugs which alerts healthcare providers to serious side effects, such as injury or death), last accessed on 1/10/24 via https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4e8c021b-6f4e-4164-be7f-eb5e033718fe , the BBW indicated “Adults and Pediatrics: Intravenous midazolam... has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy [brain damage caused by lack of oxygen] has resulted. Intravenous midazolam... should be used only in hospital or ambulatory care settings ... that provide for continuous monitoring of respiratory and cardiac function, e.g., pulse oximetry. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation [tube used for oxygenation and ventilation], and personnel trained in their use and skilled in airway management should be assured ... The initial intravenous dose for sedation in adult patients may be as little as 1 mg, but should not exceed 2.5 mg in a normal healthy adult ... The initial dose and all subsequent doses should always be titrated slowly; administer over at least 2 minutes and allow an additional 2 or more minutes to fully evaluate the sedative effect...” Review of the facility’s guidelines titled, “Medications Given By IV Push or Rapid Administrations in Adults,” approved by the facility’s Pharmacy and Therapeutics Committee and last revised 3/8/23, indicated that midazolam was only to be given in Intensive Care Units, ED, and procedural areas. It stipulated for “anxiolysis (reduction or treatment for anxiety): give over minimum of 2 minutes”. The guideline instructs, “Monitoring Considerations, respiratory depression, airway obstruction, and/or arrest, CNS (Central Nervous System) depression. Monitoring: Respiratory status (e.g. oxygen saturation). The document included comments, “Use the 1 mg/ml strength for better titration (dose gradually increased until effective). Wait at least 2 minutes after does to fully evaluate the effect ...” Review of the facility’s policy titled “Medication Administration”, last revised on 11/2023, section 8 indicated, “The nurse will not administer any medication without the knowledge of adverse reactions, appropriate dosing, and expected pharmacological response.” 2. A review of Patient 1’s Face Sheet, dated 10/29/23, indicated Patient 1 was triaged at the facility’s ED on 10/29/23 at 4:55 p.m. During a concurrent record review of Patient 1’s Triage Note and interview with the Emergency Department Clinical Educator (EDCE) on 1/4/24 at 11:24 a.m., the note indicated Patient 1 was triaged with an ESI of 3, and then placed in an ED hallway to be seen by a physician and assessed by a nurse. The medical record did not indicate an initial nursing assessment and/or shift nursing assessment. EDCE stated that a patient with an ESI of 3 is required to have a nursing assessment. EDCE acknowledged Patient 1’s initial nursing assessment and/or the following shift’s nursing assessment were not completed. A review of the facility’s policy titled, “Assessment/Reassessment of Patients in the Emergency Department”, last revised on 4/22, indicated, “All patients who present to this facility requesting to see a provider will receive an initial assessment by a registered nurse [RN] ....” The policy further indicated the ED staff will assess and reassess each patient and document the data collected. A nursing assessment is to be performed at the beginning of each shift and a reassessment for the ongoing problem at least every 2 hours. ESI Level 3 patients reassessments included the patient ’ s vital signs (blood pressure, heartbeat, temperature, respirations, blood oxygen saturation level and pain) as frequent as necessary (minimum of every 4 hours), behavioral concerns, and the chief complaint performed on each nursing shift. In addition, re-assessments and/or the need for more frequent assessments may be necessary with a patient ’ s response to nursing/medical intervention (including medication administration(s) and diagnostic testing), pain, recovery from sedation, and/or change in condition (condition improving or deteriorating). 3. During a review of Patient 22’s clinical record titled, “History and Physical”, dated 1/2/24 at 3:29 p.m., written by the Medical Doctor (MD 2), indicated Patient 22 presented to the Emergency Department (ED) with complaints of abdominal pain, fever, and nausea for approximately three days. Patient 22 had a past medical history of chronic (long term) pain. A review of Patient 22’s clinical record titled, “Order Information for Morphine [narcotic medication used to treat severe pain]”, dated 1/2/24 at 3:00 p.m., by MD 3, indicated Morphine 4 milligrams (mg- unit of measurement) IV Push (intravenous - medication given through the vein) was ordered to treat Patient 22’s pain. During a review of Patient 22’s clinical record titled, “Pain Intensity Flowsheet”, dated 1/2/24, during the time frame of 5:00 p.m.-5:59 p.m., indicated Patient 22 was assessed to have 10/10 pain (pain scale assessment tool - 0=no pain and 10=the worst pain). A review of Patient 22’s clinical record titled, “MEDICATION ADMINISTRATION RECORD (MAR) Summary”, dated 1/2/24 at 5:08 p.m., indicated Registered Nurse (RN 5) administered Morphine 4 mg IV Push to Patient 22. A second review of Patient 22’s clinical record titled, “Pain Intensity Flowsheet”, dated 1/2/24, indicated Patient 22’s pain was reassessed during the time frame of 11:00 p.m.-11:59 p.m. During an interview with on 1/3/24 at 1:12 p.m., with the Quality Patient Safety Program Manager (QPSPM), stated pain assessments and vital signs (blood pressure, heart rate per minute, respiratory rate per minute, temperature, and oxygen saturation [amount of oxygen in the blood]) should have been completed every four hours. During a concurrent interview with RN 5 on 1/4/24 at 10:56 AM and clinical record review of Patient 22’s “MAR Summary”, dated 1/2/24, the MAR Summary indicated Patient 22 did not have a pain reassessment for approximately six hours after Morphine was given. RN 5 stated Patient 22’s pain should have been reassessed 30 minutes after IV pain medication was administered to ensure the pain medication was effective. During an interview on 1/4/24 at 11:10 a.m., with the ED Manager (EDM), stated Patient 22’s pain reassessment should have been conducted within 30 minutes after the administration of IV pain medication. During an interview on 1/4/24 at 11:35 a.m., with RN 6, stated Patient 22’s pain should have been reassessed within 30 minutes of receiving IV pain medication to evaluate the effectiveness of the pain medication. During an interview on 1/4/24 at 3:30 p.m., with the Chief Nursing Officer (CNO), stated the nurse should have reassessed the patient’s pain level according to Policy and Procedure (P&P) and at least within two hours after administering pain relieving medication. The CNO stated reassessments were necessary to ensure the pain medication was effective in reducing the patient’s pain to an acceptable level. A review of the facility’s P&P titled, “[HOSPITAL NAME] Medical Management Policy and Procedure SUBJECT: Pain Management”, dated 11/21, indicated, “ ... Pain Assessment and Reassessment ... A measure of pain intensity and personal pain relief will be assessed as follows: ...Routinely every 4 hours while awake ... After each pain management intervention (not greater than one hour after interventions) ...” A review of the facility’s P&P titled, “Assessment/Reassessment of Patients in the Emergency Department”, dated 3/23, indicated, “ ... To evaluate the patient’s response to treatment ... Reassessments and vital signs will be performed as frequently as necessary based on patient’s clinical condition and medical treatments. The standard minimum of documentation ... will be every 4 hours ... Many conditions could occur that require more frequent assessment and/or the need for re-assessment. These may include: ... Response to nursing/medical interventions (e.g.; Medication administration) ... Pain ...”. A review of the facility’s document titled, “NURSE II STAFF JOB DESCRIPTION”, not dated, indicated, “ ... Job Standards ... Performs reassessments/care at intervals as required or appropriate to the patient’s specific needs ... Assesses and manages the patient’s pain ... Evaluating the effectiveness of measures and ... Documenting according to hospital policy ...”. 43943”

“BLOOD TRANSFUSIONS AND IV MEDICATIONS CFR(s): Blood transfusions and intravenous medications must be administered in accordance with State law and approved medical staff policies and procedures. This Standard is not met as evidenced by: 39700 Based on interview, clinical record review and facility policy review, the facility failed to ensure a medication was administered in accordance with facility policy for one of 35 sampled Emergency Department (ED) patients (Patient 1) when midazolam (a medication that is used to help a patient relax or sleep during a medical procedure) was not administered based on facility’s policy. This failure may have contributed to Patient 1’s respiratory depression and subsequent death. Findings: 1. Review of Patient 1’s ED Triage (preliminary assessment) Note upon arrival, indicated Patient 1 arrived in the ED on 10/29/23 at 4:55 p.m. by ambulance from home. The note further indicated Patient 1 had weakness, slurred speech, and a history of Congestive Heart Failure (CHF, a chronic condition where the heart is weak and unable to pump blood effectively to the body). Patient 1 was triaged with an emergency severity index of 3 (ESI, a tool used in the emergency department for triage, 3 was considered urgent). Review of Medical Doctor (MD) 1’s note, titled “ED Physician Notes”, dated 10/29/23 at 9:53 p.m. (after Patient 1’s death at 8:24 p.m.) included the following: Patient 1 had a history CHF, ischemic myopathy (heart damage) with an ejection fraction of 28% (amount of blood that pumps out of the heart with normal percentage between 50-70) and daily alcohol ingestion. The note further indicated MD 1’s initial assessment indicated Patient 1 appeared tired, not answering questions, her lower extremities were mottled (uneven discolored patches occurring in low blood flow to the skin) and cold with no pulses. The 10/29/23 note further indicated MD 1 was concerned that Patient 1 was suffering from a possible aortic dissection/thrombus (tearing or clotting of the heart’s main artery that prevents blood flow to organs and can be fatal) and arterial occlusions (a blockage in the artery that prevents blood flow). Patient 1 was taken emergently to the Computed Tomography scan (CT scan) for an aortic angiogram and run off (CT scan where dye is injected and x-rays are taken of the abdomen and leg arteries). Further review of MD 1 note indicated Patient 1 tolerated the CT scan of the abdomen but attempted to “jump off table” during the lower extremity CT scan. MD 1 ordered “Versed [midazolam] 5 milligrams (mg, unit of measurement) IV to facilitate the LE (lower extremity) ...” for CT scan procedure. MD 1’s 10/29/23 note indicated that after the CT was completed, Patient 1 was found not breathing and unresponsive. Cardiopulmonary Resuscitation (CPR, reviving heartbeat and breathing) was initiated. Patient 1 was revived after 20 minutes of CPR and placed on multiple medications to maintain a life sustaining blood pressure. Approximately 1 ½ hours later, Patient 1’s heart stopped again. CPR was reinitiated, but unsuccessful, and Patient 1 was pronounced dead. During a review of Patient 1’s CT scan orders on 1/2/24 at 11:15 a.m., the order indicated a CT scan of the abdomen with runoff was ordered and started on 10/29/23 at 5:35 p.m. The order further indicated a CT scan of the lower extremities was ordered and started on 10/29/23 at 5:58 p.m. During a review of Patient 1’s medication order, written by Medical Doctor Resident (MDR), dated 10/29/23 at 5:53 p.m., the order indicated midazolam 5 mg IV one time use was ordered. The order did not include parameters for how long, or the time, the midazolam should have been administered via IV push to Patient 1 or the monitoring requirements or administration. Review of Patient 1’s Medication Administration Record (MAR, electronic record of ordered medications administered by nursing) for 10/29/23, the MAR indicated midazolam 5 mg was administered IV at 5:56 p.m. by RN 3. Review of Patient 1’s first CPR record, dated 10/29/23, indicated CPR was initiated at 6:06 p.m. Patient 1 was not breathing, and her heart had stopped. Patient 1 was revived with a heartbeat at 6:22 p.m. while on multiple medications to sustain blood pressure and heartbeat. Review of Patient 1’s second CPR record, dated 10/29/23, indicated CPR was reinitiated on at 7:59 p.m. when the heart rate became slow. Patient 1 was pronounced dead at 8:24 p.m. During an interview with Registered Nurse (RN) 4 on 1/2/24 at 1:35 p.m., RN 4 stated that Patient 1 was in the hallway and placed on the monitor (machine that monitors breathing and heart rate, blood pressure, and oxygen saturation [percentage of oxygen in the blood]) waiting to be seen by a physician. RN 4 stated Patient was disconnected from the monitor by MD 1 and taken for a CT scan. RN 4 stated Patient 1 became restless in CT scan, and midazolam 5 mg IV dose was administered by RN 3 to help with restlessness. RN 4 stated the facility had a policy on how to give the midazolam and it’s use required breathing and body oxygen level monitoring but not every situation required this type of monitoring. During an interview with RN 3 on 1/2/24 at 2:45 p.m., RN 3 stated that he administered midazolam 5 mg IV to Patient 1, per order. RN 3 further stated that he administered the medication over 30 to 60 seconds, which was approximately two times faster than recommended per policy and standard of practice. RN 3 confirmed Patient 1 should have been on the monitor when he administered the medication. During a telephone interview with MD 1 on 1/3/24 at 2:15 p.m., the MD 1 stated Patient 1 needed monitoring, and MD 1 stated “not being monitored was a fail [neglect to do something].” MD 1 further stated midazolam was not a poor choice for Patient 1’s restless and anxious behavior but acknowledged a lower dose could have been ordered. During an interview on 1/4/24, at 10:56 a.m. with RN 4, RN 4 stated midazolam IV push (intravenous - drug given through the vein) should have been administered over 2-3 minutes and the patient needed to be on a monitor to assess for the respiratory depression (shallow breathing) and/or adverse effects (harmful) of the medication. During an interview on 1/4/24 at 11:10 a.m. with the ED Manager (EDM), the EDM stated midazolam 4 to 5 mg IV push had frequently been given in the Emergency Department. EDM stated, midazolam caused respiratory depression and therefore the patient needed to have their oxygen saturation and respiratory rate (per minute) monitored during medication administration. EDM stated, midazolam should have been given over at least two minutes and given slowly. EDM stated, the ED had been short on transport monitors (portable monitors that display current heart rate and respiratory rate per minute, blood pressure, and oxygen saturation). During an interview with RN 5 on 1/4/24 at 11:35 a.m., RN 5 stated midazolam should be given over five minutes and the patient needed to be on a monitor to be able to assess for respiratory depression. During a joint interview with the Chief Nursing Officer (CNO) and the Director of Quality (DOQ) on 1/3/24 at 10 a.m., CNO stated midazolam should have been given 1 to 2 mg at a time, and not 5 mg at once. CNO and DOQ both confirmed Patient 1 should have received the medication slowly and while on a monitor. In an interview with Chief Nursing Officer (CNO), on 1/3/24, at 11:26 AM, the CNO stated midazolam was not a first line drug for treatment of agitation and anxiety related to medical environment. The CNO stated there were safer drugs to use. The CNO stated the facility’s policy on “Procedural Sedation” (a policy that ensured safe medication use and monitoring for moderate or deep sedation) did not apply to midazolam use in the CT scan for agitation. Review of the Food and Drug Administration (FDA, a federal agency responsible for protecting the public health by assuring the safe and effective medication use) Black Box Warning (or BBW, the FDA ’ s most stringent warning for drugs which alerts healthcare providers to serious side effects, such as injury or death), last accessed on 1/10/24 via https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=4e8c021b-6f4e-4164-be7f-eb5e033718fe , the BBW indicated “Adults and Pediatrics: Intravenous midazolam... has been associated with respiratory depression and respiratory arrest, especially when used for sedation in noncritical care settings. In some cases, where this was not recognized promptly and treated effectively, death or hypoxic encephalopathy [brain damage caused by lack of oxygen] has resulted. Intravenous midazolam... should be used only in hospital or ambulatory care settings ... that provide for continuous monitoring of respiratory and cardiac function, e.g., pulse oximetry. Immediate availability of resuscitative drugs and age- and size-appropriate equipment for bag/valve/mask ventilation and intubation [tube used for oxygenation and ventilation], and personnel trained in their use and skilled in airway management should be assured ... The initial intravenous dose for sedation in adult patients may be as little as 1 mg, but should not exceed 2.5 mg in a normal healthy adult ... The initial dose and all subsequent doses should always be titrated slowly; administer over at least 2 minutes and allow an additional 2 or more minutes to fully evaluate the sedative effect...” Review of the facility’s guidelines titled, “Medications Given By IV Push or Rapid Administrations in Adults,” approved by the facility’s Pharmacy and Therapeutics Committee and last revised 3/8/23, indicated that midazolam was only to be given in Intensive Care Units, ED, and procedural areas. It stipulated for “anxiolysis (reduction or treatment for anxiety): give over minimum of 2 minutes”. The guideline instructs, “Monitoring Considerations, respiratory depression, airway obstruction, and/or arrest, CNS (Central Nervous System) depression. Monitoring: Respiratory status (e.g. oxygen saturation). The document included comments, “Use the 1 mg/ml strength for better titration (dose gradually increased until effective). Wait at least 2 minutes after does to fully evaluate the effect ...” Review of the facility’s policy titled “Medication Administration”, last revised on 11/2023, section 8 indicated, “The nurse will not administer any medication without the knowledge of adverse reactions, appropriate dosing, and expected pharmacological response.””

“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: 40903 Based on observation, interview, and record review, the facility failed to ensure safe medication use and storage practices for a census of 109 patients in the Emergency Department (ED) when: 1. Expired IV (IntraVenous- into the vein) saline bags (sterile salt solution) were stored in the Computerized Tomography Scan (CT scan combines a series of images taken from different angles inside the body to identify disease or injury) room 3, and 2. Spiked (tubing was attached to the bag) IV saline bags and opened contrast agents called Isovue-370 (IV contrast materials injected into a vein and used to enhance CT images inside body) were in active patient care area of the CT scan room 3 with no label or marking for open date or time. These failures may contribute to unsafe medication use and improper storage with the potential to cause patient harm. Findings: 1. During a concurrent observation and interview, on 1/2/24, at 10:25 AM, in the facility’s CT scan room 3, accompanied by Radiology Technician 1 (RadT-1), the cabinet next to CT scan machine stored more than seven 1000 mL (“mL” is measure of volume) saline bags with expiration dates ranging from July 2023 to November 2023. RadT-1 acknowledged the findings and stated the products were not used frequently and should have been thrown away. 2a. During a concurrent observation and interview, on 1/2/24, at 10:32 AM, inside facility’s CT scan room 3, accompanied by RadT-1, the IV pole (a rolling hanger used to hold the IV medications) next to CT scan bed was holding two spiked bags of saline 1000 mL without any marking on when or what time it was spiked. RadT-1 acknowledged the findings and stated they didn’t label the bag or tubing with date or time when they first opened them. RadT-1 stated the partial bag of saline was used on a previous case (patient) and they had pre-spiked bags ready for use to speed up the workflow. 2b. During a concurrent observation and interview, on 1/2/24, at 10:32 AM, inside facility’s CT scan room 3, accompanied by RadT-1, two opened vials of Isovue-370 was on the cabinet counter inside the CT scan room 3 without any marking for date/time opened. RadT-1 acknowledged the findings. RadT-1 then quickly tossed one vial in the waste bin as it was almost empty and kept the partially used vial with spiked pin and green cap. RadT-1 stated the Isovue-370 were retrieved from the Automated Dispensing Machine (or ADM, a computerized medication handling system that used for secure drug storage, and accurate dispensing, with drug traceability at various points of care within a hospital) per doctor’s order for each patient. In an interview with Radiology Technician 2 (RadT-2), on 1/4/24, at 10:43 AM, RadT-2 stated once they opened and spiked a bottle of contrast, it was good for 4-6 hours and if not used it was important to label it. In an interview with Pharmacy Clinical Manager (PCM), on 1/4/23, at 10:56 AM, the PCM stated pharmacy inspected all patient care areas that stocked medications including the CT scan’s department central stock area and discrepancies reported to the leadership. The PCM stated the CT scan room 3 was not an area for inspection as it should not have had any stock or stash of IV products. In an interview with Imaging Director (ID), on 1/4/24, at 11:09 AM, in his office, the ID stated CT scan room should not have stored unmonitored supply of IV bags. The ID stated the main supply room stocked IV products and was monitored for outdated medications. The ID stated the department followed hospital policy and labeling with date and time should have been followed. Review of the facility’s policy titled “Medication Storage and Handling”, last revised on 4/2023, the policy indicated “Medications are to be removed from their designated storage area just prior to the time needed for administration to the patient. Only those medications require to meet the immediate needs of the individual patient will be accessed. Medications are not to be removed in anticipation of administration of the medication at a later time and must be for only one patient at a time.” The policy further indicated “Medications prepared for administration during a planned procedure are to be labeled appropriately with ... and beyond use date ...”. Review of the facility’s policy titled “Floor Stock; Medication Management”, last revised on 11/2018, the policy indicated “multi-dose vials used on the nursing units should be discarded after initial use ... “. Review of the facility’s policy titled “IV therapy; Medication Management”, last revised on 10/2020, the policy indicated “tubing on all IVs will be labeled with expiration date and time.””