Mercy Hospital of Folsom

“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: 50619 Based on interview, clinical record review, and facility policy review, the facility failed to follow policy and procedure when Patient 1 was off the continuous heart monitor (telemetry- a remote heart monitor that captures the heart rate and rhythm) for 28 minutes and Monitor Technician (MT 1) failed to escalate to the primary nurse. This failure resulted in Patient 1 being off telemetry monitoring as ordered, found on the ground without a heartbeat, which may have lead to a delay in rescue or resuscitation, and possibly contributed to Patient 1’s death. Findings: During a review of Patient 1’s “History & Physical (H&P),” dated 1/11/22, the H&P indicated Patient 1 had a history of morbid obesity (being 100 pounds or more overweight) and presented to the emergency room with shortness of breath, cough, and COVID (a respiratory virus). The H&P revealed Patient 1 had acute hypoxic respiratory failure (a sudden and critical inability to breathe preventing the lungs from being able to oxygenate the blood), respiratory distress (difficulty breathing), pneumonia (infection in the lung or lungs), severe sinus tachycardia/atrial flutter (fast and irregular heartbeats), and chest pain. Patient 1 was admitted to the intensive care unit for cardiopulmonary (heart and lung) distress, sepsis (an infection in the bloodstream that can be life-threatening), and lactic acidosis (a serious and potentially fatal buildup of lactic acid in the body due to low oxygen). During a review of “Transfer Orders,” dated 1/18/26, the orders indicated Patient 1 was moved from ICU to a telemetry unit with telemetry monitoring orders initiated on 1/18/22. During a review of Patient 1’s cardiac monitoring tracings, dated 1/27/22 at 3:20 a.m., the tracings indicated the last documented time Patient 1’s heart tracings were noted on the telemetry monitor was at 3:20 a.m. During a review of “ED Physician Note,” dated 1/27/22 and timed at 5:44 a.m., the “ED Physician Note” indicated Emergency Room Medical Doctor (MD) 1 responded to a code blue (heart and/or breathing stopped). The note revealed Patient 1 was on the floor with CPR in progress and Registered Nurse (RN) 1 reported to MD 1 that Patient 1 could have been “down” for up to 30 minutes prior to being found. During a review of “Cross Cover Note,” dated 1/27/22 and timed at 5:26 a.m., the “Cross Cover Note” indicated MD 1 supervised the code blue and Patient 1 was found unresponsive, pulseless, slumped over, sitting on the floor on the side of the bed. The note indicated Patient 1 had a return of spontaneous circulation (ROSC, indicating the heart restarted and was working without needing chest compressions) after about 15 minutes of CPR and Medical Doctor (MD) 2 notified a family member. During a review of the “Code Blue Form,” dated 1/27/22 at 4:55 a.m., the “Code Blue Form” indicated the Code Blue was called at 4:55 a.m., CPR was started at 5:01 a.m., and a pulse was found at 5:14 a.m. with heart rate of 42. The form indicated at 5:23 a.m., pulse was lost and CPR restarted and MD 2 spoke with family at 5:26 a.m. The code ended at 5:33 a.m. when Patient 1 was pronounced deceased. During an interview on 3/24/26 at 3:30 p.m. with Nursing Shift Manager (NSM) 1, NSM 1 stated she was the manager of the telemetry unit at the time of the event in 2022. The NSM 1 stated MT 1 called RN 1 on her work device when RN 1 was performing patient care in another respiratory isolation (an infection control process to prevent contagious spread of respiratory illnesses) patient room. NSM stated there was no documentation of MT 1 escalating to anybody else when the RN 1 was busy with providing care in another patient’s room and unable to answer. During a concurrent interview and record review on 3/25/26 at 3:44 p.m. with Director 1 (DIR) 1, Director (DIR) 2, and Human Resource Assosciate (HR) 1, MT 1’s confidential employee records were reviewed. The records indicated MT 1 was a registered nurse who volunteered to perform monitor technician duties on 1/27/22. The records indicated on 1/27/22, there was a 90-minute timeframe Patient 1 was found to be off the telemetry monitor and MT 1 waited 28 minutes after Patient 1 was off monitor to attempt to notify the primary nurse. The record indicated Patient 1 was found on the floor, unresponsive, a code blue was called, and Patient 1 did not survive. The records indicated that MT 1’s actions were in violation of hospital policy and rose to the level of “gross misconduct”. MT 1 was placed on administrative leave for the next scheduled shift, went on a leave of absence, and submitted a resignation letter. The records indicated MT 1 never returned to work after the incident occurred. During an interview on 3/26/26 at 9:45 a.m. with DIR 1, DIR 1 stated the escalation and chain of command policy was not followed, and MT 1 did not perform according to professional standards and job performance expectations. DIR 1 stated the event was the result of human error. During a review of the facility’s policy and procedure (P&P) titled, “Chain of Command (COC): Communication of Patient Care Concerns,” dated 2/28/2018, the P&P indicated, “POLICY: [Facility name] is committed to providing timely and appropriate care to every patient. Patient care should not be delayed[,] and prompt progression is essential through the chain of command process. B. An effective Chain of Command (COC) clearly defines a line of authority and responsibility through which concerns can be escalated. 1. It includes a formal communication process for prompt handling and resolution of patient concerns. 2. A specific sequence or order of contact is identified. 3. The individuals in the chain of command must be able to use their position and authority to ensure the patient receives the appropriate care. C. All hospital and medical staff should take whatever action is necessary and appropriate to ensure that patients receive quality care. D. Communication regarding patient care concerns should be timely, complete, and accurate and follow the Chain of Command, if necessary, to achieve resolution. E. If an employee or medical staff member believes that the best interests of a patient or the hospital have been, or may be jeopardized, intervention is required. F. The Chain of Command Policy should be followed: 1. In resolving ...clinical (quality of care or safety of a patient is in question) or service issues. 2. To present or report an issue of concern and pass it up the lines of authority until resolution is reached. This escalation is not limited to the facility level and may include notification of system leaders ...AFFECTED DEPARTMENTS: All [facility name] Facilities including, but not limited to, hospitals ...PROCEDURE: A. Examples of when to invoke the Chain of Command include but are not limited to ...6. Communication issues that interfere with patient and family care including ...b. Clinical responsibility ...B. Accountability for initiating the Chain of Command (COC): 1. When a clinician is aware of a potential or actual issue, (s)he is accountable to: a. Provide patient care without delay. b. Make attempts to prevent or resolve the issue (within own scope of responsibility). c. Alert immediate supervisor of the potential or actual issue if unable to elect timely and appropriate response. 2. If still unresolved ...notify the next level of command. Continue escalation until resolution or you have reached the highest level. C. Guidelines for Initiating the Chain of Command (COC) ...2. Do not delay care to the patient. There should be prompt progression through the chain of command to meet patient needs ...Documentation / Reporting Requirements: A ...Documentation should include ...2. Interactions taken on the patient’s behalf. 3. Time of all notifications or attempted notifications. 4. Individuals contacted. 5. Information delivered and response received ...DEFINITIONS: Chain Of Command: refers to an authoritative structure established to resolve administrative, clinical, or other patient safety issue by allowing healthcare clinicians to present an issue or concern through the lines of authority until resolution is reached ...In the healthcare setting, it supports patient safety and enhances patient care. It is an orderly line of authority”.”

“APPROPRIATE TRANSFER CFR(s): 489.24(e)(1)-(2) (1) General If an individual at a hospital has an emergency medical condition that has not been stabilized (as defined in paragraph (b) of this section), the hospital may not transfer the individual unless - (i) The transfer is an appropriate transfer (within the meaning of paragraph (e)(2) of this section); and (ii)(A) The individual (or a legally responsible person acting on the individual’s behalf) requests the transfer, after being informed of the hospital’s obligations under this section and of the risk of transfer. The request must be in writing and indicate the reasons for the request as well as indicate that he or she is aware of the risks and benefits of the transfer. (B) A physician (within the meaning of section 1861(r)(1) of the Act) has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of appropriate medical treatment at another medical facility outweigh the increased risks to the individual or, in the case of a woman in labor, to the woman or the unborn child, from being transferred. The certification must contain a summary of the risks and benefits upon which it is based; or (C) If a physician is not physically present in the emergency department at the time an individual is transferred, a qualified medical person (as determined by the hospital in its bylaws or rules and regulations) has signed a certification described in paragraph (e)(1)(ii)(B) of this section after a physician (as defined in section 1861(r)(1) of the Act) in consultation with the qualified medical person, agrees with the certification and subsequently countersigns the certification. The certification must contain a summary of the risks and benefits upon which it is based. (2) A transfer to another medical facility will be appropriate only in those cases in which - (i) The transferring hospital provides medical treatment within its capacity that minimizes the risks to the individual’s health and, in the case of a woman in labor, the health of the unborn child; (ii) The receiving facility (A) Has available space and qualified personnel for the treatment of the individual; and (B) Has agreed to accept transfer of the individual and to provide appropriate medical treatment. (iii) The transferring hospital sends to the receiving facility all medical records (or copies thereof) related to the emergency condition which the individual has presented that are available at the time of the transfer, including available history, records related to the individual’s emergency medical condition, observations of signs or symptoms, preliminary diagnosis, results of diagnostic studies or telephone reports of the studies, treatment provided, results of any tests and the informed written consent or certification (or copy thereof) required under paragraph (e)(1)(ii) of this section, and the name and address of any on-call physician (described in paragraph (g) of this section) who has refused or failed to appear within a reasonable time to provide necessary stabilizing treatment. Other records (e.g., test results not yet available or historical records not readily available from the hospital’s files) must be sent as soon as practicable after transfer; and (iv) The transfer is effected through qualified personnel and transportation equipment, as required, including the use of necessary and medically appropriate life support measures during the transfer. This Standard is not met as evidenced by: 42291 Based on interview and document review, the Emergency Department (ED) failed to restrict the transfer for 2 of 27 sampled patients (Patient 1 and 11) when: 1. The ED had the capacity and capability to stabilize and treat Patient 1’s emergency medical condition (EMC) for sepsis and septic shock (a potentially life threatening condition that occurs when the body’s response to an infection damages its own tissues) before Patient 1 was transferred to another hospital where Patient 1 required immediate intervention and treatment for septic shock; and 2. The ED had the capacity and capability to first stabilize and treat Patient 11’s EMC for a right sided massive hemothorax (a serious condition in which blood collects in your lungs and rib cage) and associated hemorrhagic shock (a potentially life-threatening condition that occurs from severe bleeding resulting in reduced tissue perfusion preventing cells from adequate nutrients and oxygen) before Patient 11 was transferred to another hospital where Patient 11 required immediate intervention and treatment for hemorrhagic shock. These failures resulted in delay of treatment and stabilization of an immediate EMC prior to transfer for Patient 1 and Patient 11 which contributed to their medical deterioration and had the potential to contribute to poor outcomes and death. 1. A review of Patient 1’s medical record included a note titled “Emergency Documentation - [MD]” which indicated Patient 1 presented to the emergency department on 7/28/23 at 3:13 a.m. with a family member. Patient 1 complained of a 4-5-day history of right upper quadrant abdominal pain with nausea and diarrhea. The note indicated “Pt [Patient 1] diaphoretic (clammy) upon arrival and c/o [complaint of] lightheaded.” Patient 1’s initial vital signs were a temperature 36.7 Celsius (98.1 Fahrenheit), blood pressure 113/81 (BP is the amount of force blood uses to get through arteries- normal approximately 120/80), pulse of 98 (pulse, is the beating of blood through body- normal 60-100 beats per minute (bpm), respiratory rate of 18, (Respiratory Rate is the rate of breaths per minute- normal 12-18 per minute), and SPO2 of 98% (a measurement of how much oxygen your blood is carrying). SIRS criteria (Systemic Inflammatory Response Syndrome, indicates there is inflammation throughout the whole body caused by an infection- is criteria used to indicate the severity of sepsis and septic shock. It is used to guide clinical decision making for the patient), was met with heart rate “greater than 90” and “suspected infection” based on Patient 1’s presenting symptoms. Patient 1’s “stated weight” was 150 pounds or 68.03kg (kilograms- a metric unit of measurement). There was no evidence in the medical record an actual weight from a scale was obtained and documented. A review of a document titled, “Medical Decision Making”, dated 7/28/23 at 5:26 a.m., “CT”( a medical technique used to obtain detailed images of the bodies internal organs) results, “SMV thrombus (the formation of a blood clot in the superior mesenteric vein- a vein that helps carries blood from the intestines to the liver) with likely infarcted jejunum, (narrowing or blockage of one or more arteries that supply blood to the small intestine) likely more bowel at risk.” The document continued, “Heparin (medication used to prevent harmful clots) ... ordered .... Rocephin and Flagyl (antibiotics used to stop the growth of bacteria) ordered for intra-abdominal coverage.” During a further review of the same document indicated “there is/was a high probability of imminent or life-threatening deterioration in the patient’s condition due to cardiopulmonary, [heart and lungs], GI [gastro-intestinal, stomach and gut] comprise without immediate intervention.” The document also indicated, “No IR (Interventional Radiology- a surgical procedure to treat conditions like clots) at [Hospital Name] until 8 am”. During a review of the document, “Laboratory Results”, dated 7/28/23 at 5:26 a.m., the following was noted: WBC: 16.6 k/uL (per cubic milliliter- unit of measure), white blood cells- normal range is 4.5 to 11.00, part of the immune system to fight infections, which is elevated indicating a potential infection); Anion Gap: 23 mEq/L (milliequivalents per liter- unit of measure, Normal range 4mEq/L-12mEq/L a measurement of the acid base balance of blood, levels increase during severe infection) Glucose: 154 mg/dL (milligrams per deciliter- unit of measure, normal range 125mg/dL or lower, sugar found in blood, when fighting infection, the body responds by increasing the glucose); Total Bilirubin: 1.9 mg/dL (Normal range 1.2, tells how well the liver is working); Lactic Acid: 2.3 mg/dL (greater than 2mg/dL indicates there is not sufficient oxygen at the cellular level, high levels are common in sepsis or severe shock) Repeat Lactic acid results at 11:41 a.m.: 9.2 with a note, “Critical value called to and read back by RN 2 in ED at [12:40 p.m.] 7/28/23.” During a review of a document titled, “Hemodynamics and Vitals”, dated 7/28/23 from 3:13 a.m. through 2:25 p.m., revealed Patient 1’s systolic blood pressure (measures the pressure in millimeters of mercury [mmHg- a unit of measure] in the arteries when the heart beats) was as high as 158 and as low as 56. Patient 1’s diastolic blood pressure (measures the pressure in mmHg in the arteries when your heart relaxes between beats) was as high as 104 and as low as 38. Patient 1’s pulse was as low as 58 bpm and as high as 140 bpm. Patient 1’s respiratory rate was as low as 15 bpm and as high as 29 bpm. A review of Patient 1’s “Medication Administration” document, dated 7/28/2023 at 3:42 a.m., indicated the physician ordered one liter (L, unit of measurement) of normal saline (NS, a solution mixed with salt and water) intravenously (IV, within a vein) immediately to infuse at 200 mL/hour for Patient 1. At 5:25 a.m., the physician ordered “Lactated Ringers (LR a solution used for replacing fluids and electrolytes in a person with low blood pressure) 1L IV (one time) STAT (to be given immediately) infuse over 65 minutes.” At 1:36, p.m., the physician ordered an additional liter of “Lactated Ringers 1,000 mL IV x 1 STAT infuse over 65 minutes.” During a review of a document titled “Intake and Output,” dated 7/28/23, Patient 1’s total intake (IV or oral fluid intake) was 3262.2 mL. The total documented output (urine) was 0. There was no evidence Patient 1’s physician was notified of the lack of urinary output for 12 hours. A review of Patient 1’s medical record note titled, “Respiratory”, dated 7/28/23 at 1:49 p.m., noted, “Bi-Level Positive Airway Pressure (BIPAP) “BIPAP per protocol” ...(Used to support breathing through a face mask). The document further indicated at 2:00 p.m., “transferred airway care management to EMS transport team without complications.” The note continues, “At 2:11 p.m., “unable to obtain ABG (Arterial Blood Gas- measures how much oxygen, carbon dioxide and the pH, level of acidity or basicity, is in the blood) at this time, transport here to pick up patient.” A review of a document titled, “Patient Care Report” (ambulance transport note), dated 7/28/23 at 2:41 p.m., approximately 13 hours after presenting to the ED, indicated the following: “Dispatched to ... [name of facility] for a 52 YOM [year old male] who presented to the ED with generalized, worsening abdominal pain x 3 days, CT revealed full occlusion of superior messentric [sic] artery. While in ED patient had multiple episodes of hypotension (low blood pressure), which were treated with a total of 3L NS (normal saline). Patient then became dyspneic (shortness of breath) and was placed on Bipap for ventilator support.”. “Arrived to find patient hypotensive ...pale/cool/diaphoretic, on Bipap ... 9/10 abdominal pain (a numeric scale used to determine a patient’s level of pain with 0 being no pain and 10 being worst pain ever) not relieved by pain meds ... ST [rapid heart rate] on monitor ...”. “Enroute to receiving facility patient began to decompensate requiring Levophed (IV medication used to treat life threatening low blood pressure, maybe referred to as a ‘pressor’) and CPAP (CPAP provides a positive pressure of air through a mask and into the airway which helps keep the airway open) to be started”. A review of a document titled, “Patient Care Report” (ambulance transport note), dated 7/28/23 at 2:41 p.m., included the following vital signs during transport: 2:51 p.m.: 65/31 (BP), 125 pulse, pain- 9/10 2:54 p.m.: 75/59 (BP), 124 pulse, pain- 9/10 3:03 p.m.: 86/63 (BP), heart rate not documented, pain- 9/10 3:05p.m.: 76/51 (BP), 133 pulse, pain- 9/10 3:07p.m.: 81/56 (BP), 131 pulse, pain- 9/10 During a review of a document from the receiving hospital titled, “Final Report”, dated 7/28/24 at 3:40 p.m., the document indicated the following: Patient 1 arrived at the receiving facility complaining of 8/10 abdominal pain and Patient 1 was started on “Levophed and CPAP shortly before arrival”. Upon arrival at the receiving hospital, Patient 1’s vital signs were documented as blood pressure of 117/97, pulse 125 and respiratory rate of 25, SPO2 97%. During a review of the same document under “Procedures” the following was documented: “Given the patient’s presentation with abdominal pain, there is/was a high probability of imminent or life-threatening deterioration (becoming progressively worse) in patients condition due to cardiovascular, metabolic comprise (failure of the heart and other internal organs) without immediate intervention.” Further review of the document dated 7/28/24 at 3:19 p.m., included, “Direct Laryngoscopy/Intubation was performed for airway protection (placement of a flexible plastic tube into the windpipe to maintain an open airway). Further review indicated a “Central Venous Catheter (a thin flexible catheter that is inserted into a large, central vein usually below the collar bone to give intravenous fluids, blood, and drugs) was placed for “emergent access for fluid and drug administration”. Patient 1’s weight was documented as 256.96lbs. or 116.5kg. This was 106.96 lb greater than Patient 1’s stated weight of 150 lbs at the previous ED. Review of the same document under “Laboratory Results”, at 3:33 p.m. the following abnormal laboratory results were documented: WBC: 29.2 k/uL, increasing WBC indicated infection; CO2: 10 mmol/L (millimoles/ Liter- unit of measure- normal range is 22-29 mmol/L (regulates breathing, when low may indicate acidosis, acidic blood); Anion Gap: 31 mEq/L, levels increase during severe infection; Glucose: 396 mg/dL, levels increase with severe infection; Creatinine: 2.85mg/dl (normal range 0.7 -1.3mg/dl- may indicate an acute kidney injury); Lactic Acid: 16.1 mg/dL, levels increase with severe infection; Troponin: 101 mg/mL (normal range 0-0.04mg/ml, elevation is an indicator of heart damage related to shock). The document revealed a second, “CT Angio Abdomen and Pelvis” was performed at 5:33 p.m., and indicated the following, “Patient has known thrombus (blood clot) within the jejunal veins (carry blood to large arteries in the intestines) and thrombosis (blood clot) of entire superior mesenteric vein to its confluence with the splenic vein with thrombus now also extending into the proximal portal vein (more clotting and loss of blood flow) ... Increasing length of involvement of jejunal loops (intestine) as well as also extending towards the proximal ileal loop (intestine) ... The terminal ileum (intestine) is now collapsed” and, “worsening mesenteric fat stranding and edema (swelling) and free fluid in the central mesentery suggesting venous congestion as well as increasing free fluid around the liver and spleen and right lower quadrant.” During a concurrent interview and document review on 4/23/24 at 2:30 p.m., with the Quality Safety Program Manager 2 (QSPM 2), the QSPM 2 indicated their role included collecting and monitoring sepsis data for the hospital. During a review of Patient 1’s medical record, the QSPM 2 indicated Patient 1 “did not rule in (meet criteria for interventions) for severe sepsis [from the hours of] 3:00 a.m. -7:00 a.m.,” and stated at 10:00 a.m. Patient 1 now ruled in for sepsis meeting “two SIRS [criteria] with organ failure, pulse and respiratory rate”. The QSPM 2, acknowledged the repeated lactic acid laboratory value, “indicates severe sepsis”. The QSPM 2 stated Patient 1, “should have had two large bore IV’s as well as blood cultures” as both were part of the facility’s [sepsis] protocol. The QSPM 2 acknowledged no urine output was recorded and indicated urine output needed to be monitored for fluid resuscitation (fluids given IV to restore or replace fluid depleted during illness such as sepsis/shock). The QSPM 2 stated “The sepsis protocol was not followed” and Patient 1 “was not stable for transfer.” During a phone interview on 4/24/24 at 3:15 p.m., with Emergency Department Registered Nurse (EDRN) 1, EDRN 1 stated they were Patient 1’s primary nurse. EDRN1 stated “[Patient 1] was stable at the time of transfer.” EDRN 1 further indicated when he assumed care of Patient 1, Patient 1 had already been in the ED for 4 hours. EDRN 1 stated he was not aware if Patient 1 had a large bore IV or any urinary output as facility policy requires. EDRN1 recalled IR [Interventional Radiology] at the facility had refused Patient 1, so he [EDRN 1] kept asking the physicians, “what are we going to do.” During the same phone interview on 4/24/24 at 3:15 p.m., with EDRN1, he indicated he believed it was up to the physician to follow the sepsis protocol, but he would have advised the physician of the changing vital signs. When asked if EDRN 1 did advise the physician of the changing vital signs, EDRN1 stated “I should have charted more; I don’t remember specifically telling the physician about the changing vital signs.” EDRN1 stated he did not check a manual blood pressure or calculate a mean (mean arterial pressure- used to check if there is enough blood circulating to major organs i.e., heart, and brain) and stated, “the mean was always stable based on the cardiac monitor.” EDRN 1 stated he did not remember if he hung more than 1 liter of IV fluids and indicated fluids administered would be based on an actual weight (scale) and not a stated weight (what a patient stated they weigh). EDRN 1 stated Patient 1 was “on a weight bed.” (bed with a scale). EDRN 1 acknowledged he had been trained on the Sepsis protocol and was aware of placing two large bore IV’s as well as the recommendation for placing a central line and intubating patient along with adequate fluid resuscitation. During an interview on 4/24/24 at 1:55 p.m., with Emergency Department Medical Doctor (EDMD) 1, EDMD 1 states, “sepsis was not the issue, primary problem was a dying bowel.” EDMD 1 further stated “same issues as in the past, occasional IR at (name of facility). EDMD 1 stated, Patient 1 “started crashing between 11:30 a.m. -12:00 p.m ... should have had additional fluids and 2nd line [IV access] ... could have inserted a central line as well as hung [administered] pressors (medication to increase the blood pressure)”. The EDMD 1 did not recall ordering pressors prior to signing Patient 1 out to EDMD 2 at around 2:00 pm. During an interview on 4/24/24 at 4:00 p.m. with EDMD 2, the EDMD 2 indicated Patient 1 should have been treated for sepsis and stated, “You treat no matter the cause when criteria [sepsis/ SIRS] is met.” EDMD 2 stated, Patient 1 “should have had fluids administered at 30ml/kg per hour as well as urine output monitored, and blood cultures done.” EDMD 2 also stated “Pressors should have been hung prior to transfer as [Patient 1] was not stable for transfer.” EDMD 2 stated they, “Saw [Patient 1] as he was being loaded on gurney for transfer.” Patient weight is used to calculate medications and to determine how much IV fluids are needed to provide a fluid resuscitation to treat shock and low blood pressure. Patient 1’s stated weight of 150 lbs or 68.03 kg at the previous ED would have required: 68.03 kg x 30ml/hour for 12 hours would be approximately 24,490 ml of IV fluids. The actual intake documented for Patient 1 from the ED was 3262.2 mL, a 21,227.8 mL deficit and no urine output noted. The Patient 1’s actual weight per scale at receiving facility was documented as 256.96lbs. or 116.8kg, 106.96 lb greater than the initial 150lbs. The weight-based fluid resuscitation for Patient 1’s actual weight would have required: 116.8kg x 30ml/hours for 12 hours would be approximately 42,048 ml of IV fluids. During an interview on 4/24/24 at 3:15 p.m., with the Emergency Department Chief (EDC), the EDC stated if Patient 1 had “earlier intervention it could have improved his outcome.” The EDC further indicated Patient 1 should have had an additional IV inserted for fluids could use “ideal body weight but fluids nor antibiotics would change a dying bowel.” EDC indicated Patient 1’s “probably met SIRS criteria but had [a] dying bowel [that] needs to go to [the] OR [operating room].” A review of the facility policy titled, “Severe Sepsis/Septic Shock Guidelines”, dated 1/26/22, explained, “To provide the physician with a guideline for treating the adult patient (18 years old or greater or as stated in the individual facilities guidelines) who screens positive for severe sepsis and /or septic shock as defined by the Surviving Sepsis Campaign and the CMS SEP-1 Measure definition ...” The policy directed the following for clinical management: “ 1. All adult patients who enter through the emergency department (ED) will have a screening for sepsis within 30 minutes of entering the facility ... 3. Patients who screen negative upon arrival in the ED will be re-screened between one-two hours after initial screening ... 4. Patients who meet severe sepsis or septic shock shall have the Resuscitation bundle and/or the septic shock bundle initiated as outlined below. 5. For initial fluid resuscitation, please start with 2 large bore peripheral IV’s 6. It is recommended that patients who require ongoing volume resuscitation or any vasopressor agents have a central line placed ... 7. For adults with septic shock, we suggest starting vasopressors peripherally (in the arms) to restore...[blood] pressure rather than delaying initiation until central venous access is secured ... 9. Initial lactate greater >2 is to be repeated within 6 hours. 10. Patients who have severe sepsis or septic shock with elevated lactates greater than 4 will have lactate measurements repeated after 30ml/kg fluids completed ... B. Initial Resuscitation Bundle for the Adult ...Two sets of blood cultures (test for organisms in the blood) ... 5. Initiate fluid challenge ... 7. During the first 6 hours of resuscitation the goals of fluid resuscitation should include all of the following as part of the treatment protocol: a. MAP (mean arterial pressure, blood pressure) greater than or equal to 65mmHg b. Urine output greater than 0.5ml/kg/hour c. HR< 110 bpm d. A trend toward normalization of lactate level”. A review of the facility policy titled, “Emergency Medical Treatment and Active Labor ACT (EMTALA) Corporate Policy”, effective 9/25/2018, directed, “Emergency Medical Screening and stabilizing treatment will be provided to all individuals presenting at Dedicated Emergency Departments (DED)” ... The policy further describes, “to stabilize the emergency condition or to transfer the individual appropriately and in conformity with legal and regulatory requirements.” Section M of the policy defines, “Stabilized means with respect to an Emergency Medical Condition, that no material deterioration of the condition is likely within reasonable medical probability, to result from or occur during the Transfer.” ... Section E of the same policy titled, “Emergency Medical Treatment and Active Labor Act (EMTALA) indicates “if the individual has an Emergency Medical Condition, the individual is to be treated in the DED until the condition is stabilized or the individual can be appropriately transferred.” The policy further states: “The hospital will not transfer an individual with an unstablized emergency medical condition. The hospital must provide additional examination and treatment as maybe required to stabilize the emergency medical condition.” ... The hospital provides medical treatment within its capacity to minimize the risks to the individual’s health.” 2. During a review of Patient 11’s electronic medical record (EMR) note titled “Emergency Documentation - [MD]”, dated 3/11/2024 at 12:13 a.m., Patient 11 was brought into the facility’s ED by ambulance. Patient 11 complained of multiple episodes of vomiting, diarrhea, nausea, dizziness, along with two episodes of fainting within the past hour. The note further indicated Patient 11’s lab results included a hemoglobin (protein containing iron that transports oxygen in the red blood cells) of 10 grams/deciliter (g/dl, unit of measurement with 14 to 18 g/dl as the normal range in males) and a hematocrit (percentage by volume of red cells in the blood) of 29.3 (normal percentage in males is 40-54%). A review of Patient 11’s EMR note titled “Medication Administration” dated 3/11/2024 indicated Patient 11 received one liter of NS at 12:33 a.m. and another liter of NS at 1:09 a.m. A review of Patient 11’s EMR note titled “Orders “, dated 3/11/2024, indicated the physician ordered a chest x-ray at 1:05 a.m. for Patient 11 due to shortness of breath, which was completed at 1:59 a.m. and a computed tomography scan (CT scan, series of x-ray pictures for imaging) of Patient 11’s chest at 2:02 a.m., which was completed at 2:26 a.m. A review of Patient 11’s EMR note titled “Emergency Documentation - [MD]”, dated 3/11/2024, indicated Patient 11’s chest x-ray showed a right plural effusion (buildup of too much fluid around the lungs), and Patient 11’s chest CT scan showed a large right plural effusion. The note further indicated the physician performed a thoracentesis (procedure to remove fluid or air around the lung) on Patient 11 but needed to stop due to frank (bright) red blood collected at the site. During a concurrent record review and interview with Emergency Department Registered Nurse (EDRN) 3 on 4/23/2024 at 5:30 p.m.; Patient 11’s EMR note titled “Emergency Documentation - [MD]”, dated 3/11/2024, the note indicated the physician placed a chest tube (a flexible plastic tube inserted into the chest cavity to drain fluid or blood) into Patient 11’s right chest site and two liters of blood were collected. The EDRN 3 stated Patient 11 “ ...looked pale.” The EDRN 3 further stated Patient 11 complained of being dizzy when positioning for the procedure. During a concurrent record review of Patient 11’s EMR note titled, “Orders”, dated 3/11/2024 and interview with Quality Safety Program Manager (QSPM) 2 on 4/24/2024 at 10:10 a.m., the note indicated two units of uncrossed matched (lifesaving universal blood given to patients of unknown blood types) packed red blood cells (PRBCs, blood products transfused to prevent tissue lack of oxygen) were ordered for transfusion immediately with the indication of acute hemorrhage/hemodynamic (how the blood flows through the vessels) instability. The first unit was ordered at 3:48 a.m., and the second unit was ordered at 4:39 a.m. QSPM 2 verified Patient 11 was ordered two units of blood which were to be transfused immediately. During a concurrent record review of Patient 11’s EMR note titled, “General Information”, dated 3/11/2024 and interview with QSPM 2 on 4/24/2024 at 10:20 a.m., QSPM 2 indicated the first unit of blood was started at 5:00 a.m. and finished at 6:00 a.m. There was no documentation of the second unit. QSPM 2 verified Patient 11’s first unit of blood transfusion lasted 60 minutes and the second unit was not transfused. During a concurrent record review of Patient 11’s EMR note titled, “Emergency Documentation - [MD]”, dated 3/11/2024 and interview with Registered Nurse Informatics (RNI) on 4/24/2023 at 1:15 p.m., the note indicated Patient 11 had a total of three liters of blood loss. The note further indicated Patient 11 only received one unit of blood. The RNI confirmed one liter was drained during the thoracentesis procedure and the other two liters were drained with the chest tube insertion, which resulted in a total of three liters of blood loss. RNI further verified only one unit of blood was transfused into Patient 11. During a concurrent record review of Patient 11’s EMR titled, “Emergency Documentation - [MD]”, dated 3/11/2024 and interview with Emergency Department Chief (EDC) on 4/24/2024 at 3:30 p.m., the note indicated the physician ordered two units of uncross-matched PRBCs “now.” The note further indicated Patient 11’s diagnosis was hemothorax (a serious condition in which blood collects in your lungs and rib cage) and hemorrhagic shock. The EDC acknowledged Patient 11’s diagnosis, that “now” was expected to be done immediately, and Patient 11 should have received the two units of PRBCs as ordered. A review of Patient 11’s EMR note titled “Emergency Documentation - [MD]” dated 3/11/2024 indicated Patient 11 was classified as a critical patient due to Patient 11’s low blood pressure. The note further indicated “There is/was a high probability of imminent or life-threatening deterioration in the patient’s condition due to pulmonary and cardiovascular compromise without immediate intervention. During the course of the patient’s stay, serial re-evaluations of their hemodynamic and clinical status were performed because of the recognized potential threat to life or limb in this condition.” A review of Patient 11’s EMR note titled “Hemodynamics and Vitals” dated 3/11/2024 indicated the following: At 12:05 a.m., blood pressure (BP) = 130/71 At 12:35 a.m., BP= 107/54 At 1:00 a.m., BP= 81/42 At 1:30 a.m., BP= 98/61 At 2:20 a.m., BP= 11/51 At 2:30 a.m., BP= 102/48 At 3:00 a.m., BP= 92/48 At 3:30 a.m., BP= 78/44 At 3:45 a.m., BP= 82/52 At 4:00 a.m., BP= 88/56 At 5:15 a.m., BP= 98/48 At 5:30 a.m., BP= 96/51 At 5:45 a.m., BP= 94/44 At 6:00 a.m., BP= 96/51 A review of Patient 11’s ambulance report titled “Patient Care Report”, dated 3/11/2024, indicated Patient 11 was placed in the ambulance at 6:12 a.m. to be transferred to another hospital for care. At 6:29 a.m., Patient 11’s BP dropped to 74/36, Patient 11’s feet were raised, and two L (liters) of NS (normal saline) was given immediately IV. At 6:38 a.m., the ambulance arrived at the accepting facility with the receiving trauma team. A review of Patient 11’s EMR note titled, “Final Report”, dated 3/11/2024, indicated Patient 11 arrived at the accepting facility at 6:38 a.m. and received two units of PRBCs utilizing the Massive Transfusion Protocol (MTP). The note further indicated Patient 11 met trauma activation criteria (mobilization of medical professionals to coordinate care for a patient with traumatic injury) upon arrival and “required immediate and multiple repeat bedside examinations”, and, “I stopped seeing other patients in order to care for this patient and prevent decompensation, system failure, and/or death.” The note indicated Patient 11’s diagnosis was massive right hemothorax and hemorrhagic shock. During an interview with Emergency Department Registered Nurse (EDRN) 4 on 4/25/2024 at 11:20 a.m., EDRN 4 stated an order for uncrossed matched blood to be transfused “now” means immediately have another nurse go to the lab to get the blood and transfuse all of the blood quickly. EDRN 4 further stated the blood should be transfused within 15 minutes per unit of blood. During an interview with Emergency Department Registered Nurse (EDRN) 5 on 4/25/2024 at 12:10 p.m., EDRN 5 stated a MTP is ordered if a patient is actively bleeding in the ED such as if a patient had lost three liters of blood. EDRN 5 further stated the nurse should verify the MTP order with the physician and use the rapid transfusing equipment for the blood products. A review of the facility’s policy titled “Massive Transfusion Protocol,” last revised 3/24/2021, indicated a massive transfusion protocol (MTP) was “established to provide a standard for emergency provision of blood and blood components for patients with unexpected severe hemorrhage .... In an emergency situation and when requested by a physician, blood may be released without a crossmatch or even when a recipient’s blood group and type are known.” The policy further indicated uncrossed matched PRBCs are available within 10 minutes from the phone call to the lab.” A review of the facility’s policy titled “Blood Products Management, last revised 3/24/2021, indicated blood transfusions utilizing the MTP are administrated per “physician direction.” A review of the facility policy titled, “Emergency Medical Treatment and Active Labor ACT (EMTALA) Corporate Policy”, effective 9/25/2018, directed, “Emergency Medical Screening and stabilizing treatment will be provided to all individuals presenting at Dedicated Emergency Departments (DED)” ... The policy further describes, “to stabilize the emergency condition or to transfer the individual appropriately and in conformity with legal and regulatory requirements.” Section M of the policy defines, “Stabilized means with respect to an Emergency Medical Condition, that no material deterioration of the condition is likely within reasonable medical probability, to result from or occur during the Transfer.” ... Section E of the same policy titled, “Emergency Medical Treatment and Active Labor Act (EMTALA) indicates, “if the individual has an Emergency Medical Condition, the individual is to be treated in the DED until the condition is stabilized or the individual can be appropriately transferred.” The policy further states: “The hospital will not transfer an individual with an unstablized emergency medical condition. The hospital must provide additional examination and treatment as maybe required to stabilize the emergency medical condition.” ... The hospital provides medical treatment within its capacity to minimize the risks to the individual’s health.””

“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: 38970 Based on staff interview, medical record and document review, the hospital failed to safely provide nursing services when: A. Experienced nurse staff and nurse leadership failed to provide adequate monitoring, direction and oversight to a new graduate registered nurse (RN 1), with limited experience and competence, who failed to recognize fetal distress in a laboring patient (Patient 1) (Refer to A397); B. RN 1 failed to follow unit policies and procedures for fetal heart rate monitoring and management of labor (refer to A398); and, C. RN 1 failed to administer a high-risk medication used for the induction of labor in accordance with physician order (Refer to A405). These failures placed laboring patients at increased risk for harm and caused a significant delay in response time to Patient 1 exhibiting prolonged signs of fetal distress, resulting in the birth of a nonresponsive baby which required resuscitation efforts and transfer to another hospital for a higher level of care. The cumulative effect of these systemic failures resulted in the inability of the hospital to comply with the Condition of Participation: Nursing Services.”

“PATIENT CARE ASSIGNMENTS CFR(s): 482.23(b)(5) A registered nurse must assign the nursing care of each patient to other nursing personnel in accordance with the patient’s needs and the specialized qualifications and competence of the nursing staff available. This Standard is not met as evidenced by: 38970 Based on interview and record review, the facility failed to ensure a registered nurse (RN 1) with the skills and experience necessary to provide safe competent care was assigned to a patient (Patient 1) who was in active labor and receiving a high alert medication (drugs that bear a heightened risk of causing significant patient harm when they are used in error) for labor induction (intervention that stimulates the onset of labor using artificial methods). This failure resulted in RN 1 failing to recognize prolonged fetal distress, which contributed to a traumatic birth injury. Findings: Review of RN 1’s personnel record indicated RN 1 was hired to the Family Birthing Center (FBC, a labor and delivery unit) on 8/9/22. The file included a document titled “Labor & Delivery Skills Checklist.” The Checklist indicated, “Directions: 1. Orientee: Complete the self-assessment. Obtain the initials and date from your preceptor. 2. Preceptor: Review the self-assessment. Validate items on the list, INITIAL & DATE appropriate column.” The Self-Assessment column on the Checklist was blank. The Preceptor Assessment column had several blank entries next to demonstrated or verbalized competencies. The Preceptor Assessment column indicated initials and the month and day of the assessment but did not indicate the year. The Checklist indicated “Skill Checklist completed by,” and next to it a signature with the date 1/15/23. Further review of RN 1’s personnel file indicated a document titled “Post-Partum/Newborn Skills Checklist.” The Checklist indicated, “Directions: 1. Orientee: Complete the self-assessment ... 2. Preceptor: Review the self-assessment. Validate items on the inventory and place your initial and date in the appropriate column ...” The Self-Assessment column on the Checklist was blank. The Preceptor Assessment column indicated initials and the month and day of the assessment but did not indicate the year. The end of the document indicated “Date Completed 12/27/23 [a future date],” and a signature next to “Director/Clinical Coordinator signature reviewed.” Review of Patient 1’s “History and Physical (H&P)” dated 8/14/23, indicated Patient 1 was admitted to the facility for increased labor contractions at 39 weeks of pregnancy and expected delivery of her first child. The H&P indicated good fetal movement, and an order for “Fetal Monitor per Policy.” During a review of a Physician Note, dated 8/15/23 at 2:26 a.m., the physician note indicated the patient was assessed, the fetal heart rate (FHR) was in the 120’s (normal FHR between 110-160 beats per minute) with variable decelerations (temporary but distinct decreases of the fetal heart rate caused by decreased blood flow during contractions) and ordered to stop the oxytocin (a medication used to promote contractions of the uterus to induce labor) infusion. Review of the nursing assignment for the day shift (7 a.m. to 7 p.m.) on 8/15/23 indicated RN 1 was assigned to the care of Patient 1. The assignment sheet indicated RN 1 was assigned to only Patient 1 that day. During a review of Patient 1’s flowsheet, dated 8/15/23, the flowsheet indicated, at 8:20 a.m., Patient 1 was dilated to 9.5 centimeters (cm, a unit of measure) and at 8:30 a.m., the continuous FHR monitoring exhibited Category 1/Normal Tracings with 3.5 contractions in a ten-minute period. The flowsheet indicated the FHR baseline was 125. During a review of Patient 1’s medication administration record (MAR), dated 8/15/23, the MAR indicated an infusion of oxytocin was restarted at approximately 9:27 a.m. at 2 milliunits (mUnit - a measure of volume) per minute. The MAR indicated the infusion of oxytocin was increased by 2 mUnits approximately every thirty minutes starting at 10:20 a.m. At 12:00 p.m., the MAR indicated the oxytocin infusion had been increased to 10 mUnits per minute. During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated, at 12:28 p.m. Patient 1 started pushing. The flowsheet indicated, at 12:30 p.m. the FHR tracings were Category 2/Intermediate (Category 2 fetal heart tracings include a broad spectrum of abnormalities that may indicate increased stress to the fetus and require intervention such as repositioning, hydration and physician notification) with variable FHR decelerations and significant decelerations present with greater than 50% of the contractions. The flowsheet indicated the FHR baseline was up to 150. The flowsheet contained no documentation to indicate a physician was notified of the increased FHR baseline, the Category 2/Intermediate tracings or the significant decelerations present with greater than 50% of the contractions. During a review of Patient 1’s MAR, dated 8/15/23, the MAR indicated the infusion of oxytocin was increased to 12 mUnits per minute at approximately 12:32 p.m. During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated, at 1:00 p.m. the FHR tracings continued to be Category 2/Intermediate with variable FHR decelerations and significant decelerations present with greater than 50% of the contractions. The flowsheet indicated the FHR baseline continued to be 150. During a review of Patient 1’s MAR, dated 8/15/23, the MAR indicated the infusion of oxytocin was again increased by 2 mUnits to 14 mUnits per minute at approximately 1:05 p.m. During a review of a Physician Note, dated 8/15/23 at 2:04 p.m., the note indicated Patient 1 had been pushing for 90 minutes. The note further indicated the physician would return to check the patient in another 90 minutes unless called back sooner. The note contained no documentation to indicate the physician was aware of the sustained Category 2/Intermediate FHR tracings with variable FHR decelerations, the significant decelerations present with greater than 50% of the contractions, or the increased FHR baseline to 150 beats per minute for the previous 90 minutes. Additionally, the note contained no documentation to indicate the physician had been made aware the oxytocin infusion had been consistently increased to a rate of 14mUnits per minute and was still infusing. During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated, at 2:30 p.m. the uterine contractions were now at 5.5 in a 10-minute period (tachysystole - more than five uterine contractions within 10 minutes, increases the amount of time a fetus is deprived of oxygen) with Category 2/Intermediate FHR tracings and prolonged FHR decelerations (Prolonged decelerations - an abnormal fetal heart rate finding that could indicate a risk of fetal death from lack of oxygen) with greater than 50% of the contractions. The flowsheet indicated broken tracings (where the continuous reading of the fetal heart rate is periodically not detectable on the monitor) due to the patient pushing. The flowsheet indicated the FHR baseline continued to be 150. The flowsheet contained no documentation to indicate a physician was notified of the tachysystole, prolonged decelerations, broken FHR tracings, and continued oxytocin infusion at 14mUnits per minute. During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated the same concerning FHR tracings at 3:00 p.m. and at 3:20 p.m. The flowsheet indicated, at 3:20 p.m. the physician was at the bedside. During a review of a Discharge Summary, dated 8/15/23 at 4:15 p.m., the discharge summary indicated the physician was called to the room and could not hear fetal heart tones. The note indicated the nurse was asked to readjust the monitor and told the physician the FHR was in the 120’s at first, and then 110 when the physician asked again. The note further indicated the patient had stopped pushing, refused to push anymore and the baby was delivered with the assistance of a vacuum procedure (where the vaginal delivery of a baby is performed with the help of a vacuum device). During a review of a Nursing Progress Note, dated 8/15/23 at 6:30 p.m., the note indicated Patient 1 started pushing at 12:28 p.m., the FHR tracings “looked good,” and there were no audible decelerations. The note indicated the nurse went to a lunch break from 2:37 p.m. to 3:07 p.m., and another nurse assumed care. The note further indicated the physician came to the bedside at 3:20 p.m. and after the baby was delivered, the respiratory therapist “ ...took over because the baby wasn’t crying.” During a review of a Nursing Progress Note, dated 8/15/23 at 7:00 p.m., the note indicated the neonatal resuscitation nurse received the newborn, “limp, no color and no respiratory effort.” The note indicated, at nine minutes of life, the baby was moved to the nursery for further monitoring. During a review of a Nursing Progress Note, dated 8/15/23 at 9:10 p.m., the note indicated the infant was transferred to a hospital with a neonatal intensive care unit transport team. During a review of the facility’s policy titled, “Fetal Monitoring Policy,” undated, the policy indicated, “Provider Notification... A. The provider shall be notified when: 1. Fetal heart tones are not detectable...3. Fetal Tachycardia [Fetal heart rate above 160]...5. Category II [two] FHR tracing that is not resolving to Category I [one] 6. Category II FHR tracings with: i. Prolonged deceleration greater than 2 minutes but less than 10 minutes ii. Moderate and/or marked variability with significant decelerations occurring with more than 50% of contractions over a 30 minute period iii. Minimal and/or absent fetal heart rate variability with significant decelerations occurring with more than 30% of contractions over a 30-minute period... 7. Category III [three] tracing.” During further review of the facility’s policy titled, “Fetal Monitoring Policy,” undated, the policy indicated an algorithm for the management of significant Category II fetal heart tracings. The algorithm indicated for an assessment of FHR variability as “Moderate or Marked” with Significant Decelerations with greater than 50% of contractions for 30 minutes, to then provide interventions and notify the physician. During a review of the facility’s policy titled “Labor Management Policy,” last revised 9/23/21, the policy indicated, “Nursing care includes the recognition of abnormal labor or emergency medical conditions that require intervention...Physician Notification: Report the following to physician...5. Persistent or worsening category II tracing or category III FHR tracing.” During a review of the facility’s policy titled, “Cervical Ripening [a process of softening and opening the cervix before labor starts], Induction and Augmentation [the process of stimulating the uterus in order to increase the frequency, duration or intensity],” dated 1/27/22, the policy indicated, “PURPOSE: To provide nursing guidelines and promote a safe and effective use of medications for cervical ripening, induction, and/or augmentation for labor.” The policy further indicated, “Contraindications to Cervical Ripening/Induction/Augmentation of Labor include, but are not limited to the following... 10. Tachysystole... 13. Fetal distress.” During a review of the same facility policy titled, “Cervical Ripening, Induction and Augmentation,” dated 1/27/22, the policy indicated, “7. Oxytocin infusion is titrated to maternal-fetal response to labor. Oxytocin dose is increased only if: a. Less then five contractions in 10 minutes averaged over a 30 minute window... c. The FHR tracing shows no signs of fetal compromise.” During an interview with Nurse Shift Manager (NSM) 2 on 11/28/23 at 1:20 p.m., NSM 2 stated the Team Lead created the daily nursing assignments. NSM 2 stated the Team Lead would consider a nurse’s skill level when making patient care assignments. NSM 2 stated the FBC recently had two new nursing school graduates complete their orientation and training on the unit. NSM 2 stated, the Team Lead would assign themselves as their “buddy” during their shift to provide on-going oversight and support. During an interview with RN 2 on 11/28/23 at 3:55 p.m., RN 2 stated she was a preceptor for newly hired nurses to the FBC and was willing to precept RN 1 only once, because she felt RN 1 lacked understanding and the willingness to learn. RN 2 stated RN 1 should have never been taken off orientation to work on her own, and stated, “She was not ready to be on her own.” RN 2 further stated, “We brought this to our educator, and she knew.” During an interview with the Director of Quality and Patient Safety (DQPS) on 11/29/23 at 10:54 a.m., the DQPS stated RN 1 was not available for interview because she was on a leave of absence. During an interview with RN 6 on 11/29/23 at 1:25 p.m., RN 6 stated she assigned RN 1 to Patient 1 on 8/15/23 as the primary nurse because RN 1 was newly off orientation and needed to experience a delivery. RN 6 stated Patient 1 was not high risk, was close to delivery at the start of the morning shift but the contractions were not strong. RN 6 stated RN 1 did not verbalize concerns throughout the day related to the FHR monitoring. During an interview with NSM 1 on 11/30/23 at 11:45 a.m., NSM 1 stated RN 1 still had a lot of learning to do. NSM 1 stated, because RN 1 was a new nurse graduate, she would follow physician instructions without questioning them. During an interview with the Director of the FBC (DFBC) on 11/30/23 at 2:15 p.m., the DFBC stated the new graduate orientation program for RN 1 was initially planned for 22 weeks, however, RN 1 needed “significantly more time.” DFBC stated she recalled RN 1 finished the new graduate orientation program in May 2023. DFBC stated RN 1 had several preceptors and not all preceptors would sign off on RN 1’s Skills Checklist. DFBC stated some nurses expressed general concerns regarding RN 1’s level of competency, while others provided positive feedback on RN 1’s progress. The DFBC acknowledged the gaps on RN 1’s Skills Checklist, and stated it was her expectation that the unit educator and preceptor meet with the preceptee regularly to evaluate their progress. The DFBC stated she did not have documented evidence the unit educator met with RN 1 to discuss her progression and competency level. During the same interview with the DFBC on 11/30/23 at 2:15 p.m., the DFBC stated RN 1 was only taking care of Patient 1 on 8/15/23. DFBC stated Patient 1 was considered a low-risk patient and an uncomplicated delivery was expected. DFBC stated, when the traumatic birth injury occurred, she reviewed the FHR tracing strips with RN 1 to understand why RN 1 failed to act appropriately to signs of prolonged fetal distress. DFBC stated RN 1 was unable to recognize that anything was wrong with the FHR, and RN 1 stated that that was what it always looked like. When asked if the concerns the DFBC had with the FHR tracing strip were clear, the DFBC stated, “abundantly clear.” The DFBC stated she was surprised that RN 1 was unable to see the prolonged fetal distress on the FHR tracing strip given the many classes RN 1 took that included FHR monitoring. When asked about the level of support and oversight RN 1 received as a new graduate nurse, the DFBC stated, shortly after the completion of RN 1’s orientation, the unit educator went on an extended leave of absence for 2 months. The DFBC stated, during that time, the unit experienced an increase in patient volume and a need to bring on additional contracted nurses. The DFBC stated the focus had shifted to the orientation of the contracted nurses. The DFBC stated this may have contributed to RN 1 receiving less oversight and support. Review of a facility policy titled “Nursing Orientation, Staff Development and Ongoing Competency Validation,” dated 10/26/23, indicated, “The role of the preceptor is to assist in the completion of the orientation checklist; completion of ongoing evaluations with the preceptee, educator and unit leader, utilize the orientation checklist to guide the process; review documentation of the preceptee; and validate competency in key areas.””

“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: 41197 Based on interview, clinical record review and facility policy review, the facility failed to ensure policies for fetal (or fetus - refers to a baby in the womb/prior to birth) monitoring and labor management were adhered to for one of 14 laboring patients (Patient 1) when appropriate assessment and corresponding interventions were not performed to address critical changes in Patient 1’s fetal heart rate (FHR) monitoring. This failure caused a significant delay in response time to Patient 1, exhibiting prolonged signs of fetal distress, and resulted in the birth of a nonresponsive baby (Patient 2) which required stimulation efforts, oxygen support, and transfer to another hospital for a higher level of care. Findings: During a review of Patient 1’s “History and Physical (H&P),” dated 8/14/23, the H&P indicated Patient 1 was admitted to the facility for increased labor contractions at 39 weeks gestation (the period of development of an unborn baby) of pregnancy and expected delivery of her first child. The H&P also indicated good fetal movement and an order to “Fetal Monitor per Policy.” During a review of Patient 1’s flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated on 8/14/23 beginning at 3:30 p.m. an external monitor device was placed on the patient to continuously monitor uterine contractions (when the muscles of the uterus tighten up and then relax to help push the baby out) and the FHR. The flowsheet further indicated 4 moderate contractions in a 10-minute period and Category 1 “Normal Tracings” (Category 1 fetal heart tracings are considered normal, and no intervention is necessary) with a baseline FHR of 130 (heart beats per minute, normal being between 110-160 heart beats per minute), and absent FHR decelerations (temporary but distinct decreases of the fetal heart rate caused by decreased blood flow to the placenta during contractions). During a review of Patient 1’s “Medication Administration” record (MAR) dated, 8/14/23-8/15/23, the MAR indicated an infusion of oxytocin (a medication used to stimulate the frequency and strength of uterine contractions during labor) was initiated on 8/14/23 at approximately 10:36 p.m. During a review of the Patient 1’s flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated monitoring documented every 30 minutes where the FHR tracings continued to exhibit Category 1/Normal tracings and absent FHR decelerations. During a review of Patient 1’s flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 2:00 a.m. on 8/15/23 the continuous fetal monitoring exhibited a change to Category 2/Intermediate Tracings (Category 2 fetal heart tracings include a broad spectrum of abnormalities that may indicate increased stress to the fetus and require intervention such as repositioning, hydration and physician notification) with an FHR of 130 and early, variable (a sudden change in fetal heart rate with a quick return to baseline) decelerations present. The flowsheet indicated 5 uterine contractions in a 10-minute period. The interventions documented indicated oral fluids for hydration were provided to Patient 1, and at 2:15 a.m., the patient had dilated to 7 cm (centimeters, a unit of measurement where the opening of the cervix is measured and 10cm is fully dilated and ready for delivery of the fetus). During a review of a Physician Note, dated 8/15/23 at 2:26 a.m., the physician note indicated the patient was assessed, the FHR was in the 120’s with variable decelerations and ordered to stop the oxytocin infusion. During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 8:20 a.m. on 8/15/23, Patient 1 was dilated to 9.5 cm and at 8:30 a.m., the continuous fetal monitoring exhibited Category 1/Normal Tracings with 3.5 contractions in a ten-minute period. The flowsheet indicated the FHR baseline was 125. During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 9:27 a.m. on 8/15/23, Patient 1 was restarted on the oxytocin infusion and continuously monitored every 30 minutes by Registered Nurse (RN) 1. During a review of Patient 1’s MAR dated 8/15/23, the MAR indicated the infusion of oxytocin was increased by 2 units approximately every thirty minutes starting at 10:20 a.m., and at 12:00 p.m., the MAR indicated the oxytocin infusion had been increased to 10mUnits per minute by RN 1. During a review of a Physician Note, dated 8/15/23 at 12:04 p.m., the physician note indicated Obstetrician (OB - a physician who specializes in caring for people during pregnancy and childbirth) 1 noted Patient 1 was on the oxytocin infusion, was assessed as fully dilated, and would start pushing. The note further indicated a noted Category 1/Normal FHR tracing. During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 12:28 p.m. on 8/15/23, Patient 1 started pushing. The flowsheet contained documentation by RN 1 to indicate at 12:30 p.m., the FHR tracings were Category 2/Intermediate with variable FHR decelerations and significant decelerations present with greater than 50% of the contractions. The flowsheet indicated the FHR baseline was up to 150. During a review of Patient 1’s MAR dated 8/15/23, the MAR indicated the infusion of oxytocin was increased to 12mUnits per minute on 8/15/23 at approximately 12:32 p.m. by RN 1. The flowsheet contained no documentation to indicate RN 1 notified OB 1 of the increased FHR baseline or the significant decelerations present with greater than 50% of the contractions. During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 1:00 p.m., 1:30 p.m., and 2:00 p.m., RN 1 documented the FHR tracings continued to be Category 2/Intermediate with variable FHR decelerations and significant decelerations present with greater than 50% of the contractions. The flowsheet indicated the FHR baseline continued to be 150. During a review of Patient 1’s MAR dated 8/15/23, the MAR indicated the infusion of oxytocin was again increased by 2 units to 14mUnits per minute on 8/15/23 at approximately 13:05 p.m. by RN 1. During a review of a Physician Note, dated 8/15/23 at 2:04 p.m., the physician note indicated Patient 1 had been pushing for 90 minutes. The note further indicated OB 1 would return to check the patient in another 90 minutes unless she was called back sooner. The note contained no documentation to indicate the physician was made aware of the sustained Category 2/Intermediate FHR tracings with variable FHR decelerations, the significant decelerations present with greater than 50% of the contractions, or the increased FHR baseline to 150 beats per minute for the previous 90 minutes. During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 2:30 p.m., RN 1 noted the uterine contractions were now at 5.5 in a 10-minute period (tachysystole - more than five uterine contractions within 10 minutes, increases the amount of time a fetus is deprived of oxygen) with Category 2/Intermediate FHR tracings and prolonged FHR decelerations (Prolonged decelerations - an abnormal fetal heart rate finding that could indicate a risk of fetal death from lack of oxygen) with greater than 50% of the contractions. The flow sheet indicated RN 1 noted broken tracings (where the continuous reading of the fetal heart rate is periodically not detectable on the monitor) due to the patient pushing. The flowsheet indicated the FHR baseline continued to be 150. The flowsheet contained no documentation to indicate a OB 1 was notified of the tachysystole, prolonged decelerations, broken FHR tracings, and continued oxytocin infusion at 14mUnits per minute. During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated RN 1 noted the same concerning FHR tracings at 3:00 p.m. and at 3:20 p.m. The flowsheet indicated at 3:20 p.m., the OB 1 was at the bedside. During a review of a Discharge Summary, dated 8/15/23 at 4:15 p.m., the discharge summary indicated the OB 1 was called to the room and could not hear FHTs (Fetal heart tones). The note indicated the nurse was asked to readjust the monitor and told the physician the FHR was in the 120’s at first, and then 110 when the physician asked again. The note further indicated the patient had stopped pushing, refused to push anymore and the baby was delivered with the assistance of a vacuum procedure (where the vaginal delivery of a baby is performed with the help of a vacuum device). During a review of a Nursing Progress Note, dated 8/15/23 at 6:30 p.m., the note indicated Patient 1 started pushing at 12:28 p.m., the FHR tracings “looked good,” and there were no audible decelerations. The note indicated the nurse went to a lunch break from 2:37 p.m. to 3:07 p.m., and another nurse assumed care. The note further indicated the physician came to the bedside at 3:20 p.m. and after the baby was delivered, the respiratory therapist “ ...took over because the baby wasn’t crying.” During a review of a Nursing Progress Note, dated 8/15/23 at 7:00 p.m., the note indicated the neonatal resuscitation nurse (a nurse who specializes in emergency airway, breathing and circulation of a newborn) received the newborn, “limp, no color and no respiratory effort.” The note indicated at nine minutes of life; the baby was moved to the nursery for further monitoring. During a review of a Nursing Progress Note, dated 8/15/23 at 9:10 p.m., the note indicated the infant was transferred to a hospital with a neonatal intensive care unit (NICU). During an interview with the Director of Quality and Patient Safety (DQPS) on 11/29/23 at 10:54 a.m., the DQPS stated RN 1 was not available for interview because she was on a leave of absence. During an additional interview with the Director of Quality and Patient Safety (DQPS) on 11/29/23 at 3:00 p.m., the DQPS stated OB 1 was declining to be interviewed. During a concurrent interview and record review on 11/30/23 at 10:22 a.m. with OB 2, Patient 1’s FHR tracings, dated 8/15/23, were reviewed. OB 2 stated the tracings at 11:54 a.m. timestamp indicated a FHR baseline in the 140’s. P1 stated the tracings at 12:34 p.m. timestamp indicated Patient 1 may have been pushing with the contractions and it appeared the FHR rose above the normal threshold (above 160 beats per minute) which was “noteworthy.” During the same concurrent interview and record review on 11/30/23, of Patient 1’s FHR monitoring record, OB 2 stated at the 12:50 p.m. timestamp, the strips indicated there were recurrent decelerations happening with more than 50% of the contractions. OB 2 stated recurrent decelerations are a prompt for assessment, intervention, and physician notification by the nurse. OB 2 stated there would be no need to increase the oxytocin at this point because the baby may be showing signs of decreased oxygen and blood flow. Ob 2 stated the FHR tracings showed continued evidence of recurrent and substantial decelerations at the 12:58 p.m., 1:05 p.m., and the 1:14 p.m. timestamp. OB 2 stated these were further prompts of needed intervention and physician notification because the elevated fetal heart rate and the recurrent variable decelerations are indicators of compromised blood flow to the baby. During the same concurrent interview and record review on 11/30/23, of Patient 1’s FHR monitoring record, OB 2 stated at the 2:18 p.m. timestamp, the FHR tracings appeared to be Category 3/Abnormal (Non-reassuring tracings indicative of significant fetal stress and decreased blood flow to the fetus) and would expect this type of FHR tracing to be immediately conveyed to the physician for imminent delivery planning. OB 2 stated at 2:42 p.m. timestamp, the FHR tracings indicated no interpretable readings of the fetal heart rate, the heart rate was not consistent, and the tracing was not reassuring. OB 2 stated it did not appear the significant FHR tracings were recognized due to the timing of the OB 1’s presence at the bedside and vacuum assisted delivery nearly an hour later. During an interview on 11/30/23 at 2:10 p.m. with the Director of the Family Birth Center (DFBC), DFBC stated she reviewed Patient 1’s record after the event took place and could find no documentation to support RN 1 had notified or been in communication with the OB 1 regarding the continuous and concerning FHR tracings. DFBC further stated the absence of communication between the nurse and the physician caused the outcome of a nonresponsive baby to be unexpected. During a review of the facility’s policy titled “Labor Management Policy,” last revised 9/23/21, the policy indicated, “Nursing care includes the recognition of abnormal labor or emergency medical conditions that require intervention.” During further review of the facility’s policy titled “Labor Management Policy,” last revised 9/23/21, the policy indicated, “Physician Notification: Report the following to physician...5. Persistent or worsening category II [2] tracing or category III [3] FHR tracing.” During a review of the facility’s Job Description for the Registered Nurse (RN) for the Family Birth Center department, dated 3/31/22, the job description indicated “Job Specific Duties 1.11 Communication: Communicates clearly and effectively...Includes reporting abnormals or change in patient condition to appropriate personnel in a timely manner.” During a review of the facility’s policy titled, “Fetal Monitoring Policy,” undated, the policy indicated, “Provider Notification A. The provider shall be notified when: 1. Fetal heart tones are not detectable...3. Fetal Tachycardia [Fetal heart rate above 160]...5. Category II FHR tracing that is not resolving to Category I [one] 6. Category II FHR tracings with: i. Prolonged deceleration greater than 2 minutes but less than 10 minutes ii. Moderate and/or marked variability with significant decelerations occurring with more than 50% of contractions over a 30 minute period iii. Minimal and/or absent fetal heart rate variability with significant decelerations occurring with more than 30% of contractions over a 30-minute period 7. Category III tracing.” During further review of the facility’s policy titled, “Fetal Monitoring Policy,” undated, the policy indicated an algorithm for the management of significant Category II fetal heart tracings. The algorithm indicated for an assessment of FHR variability as “Moderate or Marked” with Significant Decelerations with greater than 50% of contractions for 30 minutes, to then provide interventions and notify the physician. During a review of the facility’s policy titled, “Cervical Ripening [a process of softening and opening the cervix before labor starts], Induction [the process or treatment that stimulates childbirth and delivery] and Augmentation [the process of stimulating the uterus in order to increase the frequency, duration or intensity],” dated 1/27/22, the policy indicated, “PURPOSE: To provide nursing guidelines and promote a safe and effective use of medications for cervical ripening, induction, and/or augmentation for labor.” The policy further indicated, “Contraindications to Cervical Ripening/Induction/Augmentation of Labor include, but are not limited to the following: 10. Tachysystole 13. Fetal distress.” During a review of the same facility policy titled, “Cervical Ripening, Induction and Augmentation,” dated 1/27/22, the policy indicated, “7. Oxytocin infusion is titrated [increased or decreased in dose depending on patient response] to maternal-fetal response to labor. Oxytocin dose is increased only if: a. Less then five contractions in 10 minutes averaged over a 30 minute window. c. The FHR tracing shows no signs of fetal compromise.””

“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: 41197 Based on interview, clinical record review and facility policy review, the facility failed to ensure a medication was administered in accordance with a physician’s order and facility policy for one of 14 laboring patients (Patient 1) when an infusion of oxytocin (a medication administered through the vein to promote contractions of the uterus to induce labor) was inappropriately administered by Registered Nurse (RN) 1. This failure resulted in a continuous infusion, increased in dose every thirty minutes, of medication to further intensify uterine contractions that caused oxygen deprivation to a fetus (Patient 2) and resulted in the birth of a nonresponsive baby which required stimulation efforts, oxygen support, and transfer to another hospital for a higher level of care. Findings: During a review of Patient 1’s “History and Physical (H&P),” dated 8/14/23, the H&P indicated Patient 1 was admitted to the facility for increasing labor contractions at 39 weeks gestation of pregnancy and expected delivery of her first child. The H&P also indicated good fetal movement. Continued review of the same H&P, dated 8/14/23, indicated an order to “Fetal Monitor per Policy.” During a review of Patient 1’s flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated on 8/14/23 beginning at 3:30 p.m. an external monitor device was placed on the patient to continuously monitor uterine contractions (when the muscles of the uterus tighten up and then relax to help push the baby out) and the fetal heart rate. The flowsheet further indicated 4 moderate contractions in a 10-minute period and Category 1 “Normal Tracings” (Category 1 fetal heart tracings are considered normal, and no intervention is necessary) with a baseline FHR of 130 (normal being between 110-160 heart beats per minute), and absent FHR decelerations (temporary but distinct decreases of the fetal heart rate caused by decreased blood flow to the placenta during contractions). During a review of Patient 1’s physician orders dated 8/14/23 at 9:49 p.m., an order indicated to administer oxytocin (a medication used to stimulate the frequency and strength of uterine contractions during labor) infusion at 2 milliunits (mUnit - a measure of volume) per minute and increase the infusion by 2 mUnits per minute every thirty minutes “until adequate uterine activity defined as: i. 3-5 contractions in a 10-minute period with a maximum not to exceed 5 contractions in a 10-minute period.” During a review of the same physician order for oxytocin infusion, the order indicated to decrease the infusion rate for “Tachysystole: [more than five uterine contractions within 10 minutes] After 10 MORE MIN, if UC’s [Uterine Contractions] NOT returned to normal, D/C [Discontinue] Oxytocin until UC’s are 5 or less in 10 minutes. DISCONTINUE Instructions: I. Cat II [Category 2/Intermediate fetal heart tracings include a broad spectrum of abnormalities that may indicate increased stress to the fetus and require intervention such as repositioning, hydration and physician notification] with Significant decels [decelerations]... notify provider ii.Cat III Fetal Heart Rate (Category 3 fetal heart tracing is indication of an abnormal fetal status, meaning that the fetus is not getting enough oxygen and can require emergency intervention) and notify provider.” During a review of Patient 1’s “Medication Administration” record (MAR) dated, 8/14/23-8/15/23, the MAR indicated an infusion of oxytocin was initiated on 8/14/23 at approximately 10:36 p.m. at 2mUnits per minute. During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated monitoring documented every 30 minutes from 10:30 p.m. to 11:00 p.m. where the FHR tracings continued to exhibit Category 1/Normal tracings with a FHR baseline of 125-130 and absent FHR decelerations. During a review of Patient 1’s MAR, dated 8/14/23-8/15/23, the MAR indicated the infusion of oxytocin was increased (by 2 units) to 4 mUnits per minute on 8/14/23 at approximately 11:06 p.m. During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 12:00 a.m., FHR tracings continued to exhibit Category 1/Normal tracings with a FHR baseline of 125 and absent FHR decelerations, however the uterine contractions had increased to 6 over a ten-minute period. During a review of Patient 1’s MAR, dated 8/14/23-8/15/23, the MAR indicated the infusion of oxytocin was decreased to 3mUnits per minute on 8/15/23 at approximately 12:01 a.m. During a review of Patient 1’s MAR, dated 8/14/23-8/15/23, the MAR indicated the infusion of oxytocin was decreased again to 2mUnits per minute on 8/15/23 at approximately 12:28 a.m. During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 2:00 a.m. on 8/15/23 the continuous fetal monitoring exhibited a change to Category 2/Intermediate Tracings (Category 2 fetal heart tracings include a broad spectrum of abnormalities that may indicate increased stress to the fetus and require intervention such as repositioning, hydration and physician notification) with an FHR of 130 and early, variable decelerations present. The flowsheet indicated 5 uterine contractions in a 10-minute period. The interventions documented indicated oral fluids for hydration were provided to Patient 1, and at 2:15 a.m., the patient had dilated to 7 cm (centimeters, a unit of measurement where the opening of the cervix is measured, and 10 cm is fully dilated and ready for delivery of the fetus). During a review of Patient 1’s MAR, dated 8/14/23-8/15/23, the MAR indicated the infusion of oxytocin was stopped on 8/15/23 at approximately 2:15 a.m. During a review of a Physician Note, dated 8/15/23 at 2:26 a.m., the physician note indicated Patient 1 was assessed, the FHR was in the 120’s with variable decelerations and ordered to stop the oxytocin infusion. During a review of the same patient flowsheet, dated 8/14/23-8/15/23, the flowsheet indicated at 8:20 a.m. on 8/15/23, Patient 1 was dilated to 9.5 cm and at 8:30 a.m., the continuous fetal monitoring exhibited Category 1/Normal Tracings with 3.5 contractions in a ten-minute period. The flowsheet indicated the FHR baseline was 125. During a review of Patient 1’s MAR, dated 8/15/23, the MAR indicated the infusion of oxytocin was restarted on 8/15/23 at approximately 9:27 a.m. at 2mUnits per minute by Registered Nurse (RN) 1. During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated at 9:27 a.m. on 8/15/23, RN 1 had documented Patient 1 was restarted on the oxytocin infusion. During a review of Patient 1’s MAR, dated 8/15/23, the MAR indicated the infusion of oxytocin was increased by 2 units approximately every thirty minutes by RN 1 starting at 10:20 a.m. At 12:00 p.m., the MAR indicated the oxytocin infusion had been increased by RN 1 to 10mUnits per minute. During a review of a Physician Note, dated 8/15/23 at 12:04 p.m., the physician note indicated Obstetrician (OB - a physician who specializes in caring for people during pregnancy and childbirth) 1 noted Patient 1 was on the oxytocin infusion, was assessed as fully dilated, and would start pushing. The note further indicated OB 1 noted a Category 1/Normal FHR tracing. During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated RN 1 documented at 12:28 p.m. on 8/15/23, Patient 1 started pushing. The flowsheet indicated at 12:30 p.m., RN 1 documented the FHR tracings were Category 2/Intermediate with variable FHR decelerations and significant decelerations present with greater than 50% of the contractions. The flowsheet indicated the FHR baseline was up to 150. During a review of Patient 1’s MAR, dated 8/15/23, the MAR indicated the infusion of oxytocin was increased to 12mUnits per minute on 8/15/23 at approximately 12:32 p.m. by RN 1. Patient 1’s flowsheet contained no documentation to indicate RN 1 notified a physician of the increased FHR baseline, the Category 2/Intermediate tracings or the significant decelerations present with greater than 50% of the contractions. The flowsheet contained no documentation to indicate RN 1 stopped or decreased the oxytocin infusion per physician order. During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated at 1:00 p.m., RN 1 documented the FHR tracings continued to be Category 2/Intermediate with variable FHR decelerations and significant decelerations present with greater than 50% of the contractions. The flowsheet indicated the FHR baseline continued to be 150. During a review of Patient 1’s MAR, dated 8/15/23, the MAR indicated the infusion of oxytocin was again increased by 2 units to 14mUnits per minute on 8/15/23 at approximately 1:05 p.m. by RN 1, not in accordance with physician order. During a review of a Physician Note, dated 8/15/23 at 2:04 p.m., the physician note indicated OB 1 noted Patient 1 had been pushing for 90 minutes. The note further indicated OB 1 would return to check the patient in another 90 minutes unless she was called back sooner. The note contained no documentation to indicate OB 1 was made aware of the sustained Category 2/Intermediate FHR tracings with variable FHR decelerations, the significant decelerations present with greater than 50% of the contractions, or the increased FHR baseline to 150 beats per minute for the previous 90 minutes. Additionally, the note contained no documentation to indicate OB 1 had been made aware the oxytocin infusion had been consistently increased every 30 minutes to a final rate of 14mUnits per minute and was still infusing. During a review of the same patient flowsheet, dated 8/15/23, the flowsheet indicated RN 1 documented at 2:30 p.m., the uterine contractions were now at 5.5 in a 10-minute period (tachysystole - more than five uterine contractions within 10 minutes, which increases the amount of time a fetus is deprived of oxygen) with continued Category 2/Intermediate FHR tracings and prolonged FHR decelerations (Prolonged decelerations - an abnormal fetal heart rate finding that could indicate a risk of fetal death from lack of oxygen) with greater than 50% of the contractions. The flow sheet indicated RN 1 documented broken FHR tracings (where the continuous reading of the fetal heart rate is periodically not detectable on the monitor) due to the patient pushing. The flowsheet indicated the FHR baseline continued to be 150. The flowsheet contained no documentation to indicate RN 1 notified a physician of the tachysystole, prolonged decelerations, broken FHR tracings, and continued oxytocin infusion at 14mUnits per minute, which was not in accordance with physician order. During a review of the same patient flowsheet, 8/15/23, the flowsheet indicated the same concerning FHR tracings documented by RN 1 at 3:00 p.m. and at 3:20 p.m. The flowsheet indicated at 3:20 p.m., the physician was at the bedside. During a review of a Discharge Summary, dated 8/15/23 at 4:15 p.m., the discharge summary indicated OB 1 was called to the room and could not hear fetal heart tones (FHTs). The note indicated the nurse was asked to readjust the monitor and told the physician the FHR was in the 120’s at first, and then 110 when the physician asked again. The note further indicated the patient had stopped pushing, refused to push anymore and the baby was delivered with the assistance of a vacuum procedure (where the vaginal delivery of a baby is performed with the help of a vacuum device). During a review of a Nursing Progress Note, dated 8/15/23 at 6:30 p.m., the note indicated RN 1 documented Patient 1 started pushing at 12:28 p.m., the FHR tracings “looked good,” and there were no audible decelerations. The note indicated the nurse went to a lunch break from 2:37 p.m. to 3:07 p.m., and another nurse assumed care. The note further indicated the physician came to the bedside at 3:20 p.m. and after the baby was delivered, the respiratory therapist “ ...took over because the baby wasn’t crying.” During a review of a Nursing Progress Note, dated 8/15/23 at 7:00 p.m., the note indicated the neonatal resuscitation nurse received the newborn, “limp, no color and no respiratory effort.” The note indicated at nine minutes of life; the baby was moved to the nursery for further monitoring. During a review of a Nursing Progress Note, dated 8/15/23 at 9:10 p.m., the note indicated the infant was transferred to a hospital with a neonatal intensive care unit (NICU). During a concurrent interview and record review on 11/28/23 at 2:29 p.m. with Nurse Shift Manager (NSM) 2, Patient 1’s MAR and flowsheet, dated 8/15/23 were reviewed. NSM 2 confirmed Patient 1’s record indicated the oxytocin infusion was increased by 2 units every thirty minutes with Category 2 tracings present, and stated this was against facility policy. NSM 2 stated it would be important to decrease or stop the oxytocin infusion because the medication causes increased uterine contractions, and this cuts off blood supply to the baby. NSM 2 stated it was also contraindicated (should not be done because it may be harmful) to keep increasing the infusion rate if contractions were greater than 5 in a ten-minute period, or with late or variable recurrent decelerations present with more than 50% of contractions. NSM 2 confirmed Patient 1’s record indicated the oxytocin infusion was increased by RN 1 and never turned off and stated, “that is against policy.” During an interview with the Director of Quality and Patient Safety (DQPS) on 11/29/23 at 10:54 a.m., the DQPS stated RN 1 was not available for interview because she was on a leave of absence. During a concurrent interview and record review on 11/29/23 at 1:25 p.m. with Registered Nurse (RN) 4, Patient 1’s FHR tracings, dated 8/15/23 were reviewed. RN 4 stated there was not a continuous reading of the FHR after the 12:34 p.m. timestamp and the oxytocin should have been decreased or stopped altogether. RN 4 stated continuing or increasing the oxytocin infusion in the presence of increased uterine contractions was also contraindicated. During an additional interview with the Director of Quality and Patient Safety (DQPS) on 11/29/23 at 3:00 p.m., the DQPS stated OB 1 declined to be interviewed. During a concurrent interview and record review on 11/30/23 at 10:22 a.m. with OB 2, Patient 1’s FHR tracings, dated 8/15/23 were reviewed. OB 2 stated the tracings at 11:54 a.m. timestamp indicated a FHR baseline in the 140’s. P1 stated the tracings at 12:34 p.m. timestamp indicated Patient 1 may have been pushing with the contractions and it appeared the FHR rose above the normal threshold (above 160 beats per minute) which was “noteworthy.” During the same concurrent interview and record review on 11/30/23 at 10:22 a.m., of Patient 1’s fetal heart rate (FHR) monitoring record, OB 2 stated at the 12:50 p.m. timestamp, the strips indicated there were recurrent decelerations happening with more than 50% of the contractions. OB 2 stated recurrent decelerations are a prompt of assessment, intervention, and physician notification by the nurse. OB 2 stated there would be no need to increase the oxytocin at this point because the baby may be showing signs of decreased oxygen and blood flow. During the same concurrent interview and record review on 11/30/23 at 10:22 a.m., of Patient 1’s fetal heart rate (FHR) monitoring record, OB 2 stated the FHR tracings showed continued evidence of recurrent and substantial decelerations at the 12:58 p.m., 1:05 p.m., and 1:14 p.m. timestamp. OB 2 stated these were further prompts of a need to decrease or stop the oxytocin infusion rate altogether because the elevated fetal heart rate and the recurrent variable decelerations are indicators of compromised blood flow to the baby. During the same concurrent interview and record review on 11/30/23 at 10:22 a.m., of Patient 1’s fetal heart rate (FHR) monitoring record, OB 2 stated at the 2:18 p.m. timestamp, the FHR tracings appeared to be Category 3/Abnormal (Non-reassuring tracings indicative of significant fetal stress and decreased blood flow to the fetus) and would expect this type of FHR tracing to be immediately conveyed to the physician for imminent delivery planning. OB 2 stated at 2:42 p.m. timestamp, the FHR tracings indicated no interpretable readings of the fetal heart rate, the heart rate was not consistent, and the tracing was not reassuring. OB 2 stated the oxytocin infusion should have been decreased or stopped altogether when the FHR tracings became concerning at the 12:50 p.m. timestamp, and it did not appear the significant FHR tracings were recognized due to the timing of the physician presence at the bedside and vacuum assisted delivery nearly an hour after the 2:42 p.m. timestamp. During an interview on 11/30/23 at 2:10 p.m. with the Director of the Family Birth Center (DFBC), DFBC stated she reviewed Patient 1’s record after the event took place and could find no documentation to support RN 1 had notified or been in communication with the physician regarding the continuous and concerning FHR tracings. DFBC further stated the absence of communication between RN 1 and the physician caused the outcome of a nonresponsive baby to be unexpected and did not realize the oxytocin played a role in the outcome until after an in-depth chart review. During a review of the facility’s policy titled, “Fetal Monitoring Policy,” undated, the policy indicated, “2. Electronic Fetal Monitoring b. Category II [2] FHR - clinically indicated interventions, as ordered by provider, may include but are not limited to...4) Discontinue or decrease oxytocin ....d. Category III [3] (Abnormal) FHR - clinically indicated interventions, as ordered by provider, may include, but are not limited to...5. Discontinue oxytocin ...” During a review of the facility’s policy titled, “Medication Management Administration,” last revised 12/9/2021, the policy indicated that the administration of medication is to be administered using “all of the components of the seven rights for every medication administered,” which includes the right reason for the medication. The policy further indicated orders that include a range of doses are to be followed by “the parameters specified by the physician in writing the order.” During a review of the facility’s policy titled, “Cervical Ripening [a process of softening and opening the cervix before labor starts], Induction [the process or treatment that stimulates childbirth and delivery] and Augmentation [the process of stimulating the uterus in order to increase the frequency, duration or intensity],” dated 1/27/22, the policy indicated, “PURPOSE: To provide nursing guidelines and promote a safe and effective use of medications for cervical ripening, induction, and/or augmentation for labor.” The policy further indicated, “Contraindications to Cervical Ripening/Induction/Augmentation of Labor include but are not limited to the following...10. Tachysystole...13. Fetal distress.” During a review of the same facility policy titled, “Cervical Ripening, Induction and Augmentation,” dated 1/27/22, the policy indicated, “7. Oxytocin infusion is titrated [increased or decreased based on a patient response] to maternal-fetal response to labor. Oxytocin dose is increased only if: a. Less than five contractions in 10 minutes averaged over a 30 minute window... c. The FHR tracing shows no signs of fetal compromise.””