Lehigh Valley Hospital - Hazleton

“PATIENT RIGHTS: CARE IN SAFE SETTING CFR(s): 482.13(c)(2) The patient has the right to receive care in a safe setting. This Standard is not met as evidenced by: 38776 Based on review of facility documents, medical records (MR), observations, and staff interviews (EMP), it was determined the facility failed to prevent a patient who presented to the facility for suicidal ideation from self-harm for one of one medical records reviewed (MR1). Findings: Review on March 4, 2026, of the facility policy, “Patient Rights And Responsibilities - Administrative,” last reviewed February 2025 revealed “... I. Policy: A. In accordance with The Commonwealth of Pennsylvania Department of Health’s Rules and Regulations for hospitals (103.21), the Joint Commission standards and the CMS guidelines (Section 482.13), Lehigh Valley Health Network provides this policy, in support of patients’ interests and well-being, and to establish the expectations for patients’ responsibilities to the organization. ... III. Procedure: A. LVHN recognizes that its hospitals have certain responsibilities to their patients which include: 1. Patient Rights ... (e.) Delivery of Care Patients have the right to receive care in a safe environment, free from abuse, harassment and neglect. Patients have the right to receive emergency treatment without unnecessary delay. ...” Review on March 4, 2026, of the facility policy, “Contraband - Patient Care Services,” last reviewed November 2024 revealed “... I. Policy: A. It is the policy of LVHN to protect patient constitutional and statutory right to privacy, dignity and freedom from unreasonable search, while addressing the safety of patients, colleagues, and visitors through established guidelines for contraband and restricted articles. B. Patients designated at risk of self-harm to others will be checked for potentially dangerous items ... to facilitate treatment and to prevent injury and elopement in the least intrusive and therapeutic manner available. C. Patients who exhibit behavior that raises a safety concern and behavioral health patients will be searched by Security by means of a metal detector wand. D. Identified items that may contribute to self-harm or harm to others will be confiscated. Because there are numerous items in the hospital (ED, clinical units, Behavioral Health Units) that are potentially dangerous, attempts are made to keep unsafe items to a minimum. II. Definitions: Behavioral Health Patients - patients who present with conditions of actual or potential self-harm or harm to others (including substance abuse) as their primary admitting problem or diagnosis Contraband - Contraband items are defined as any implements that can be used in whole, part, or broken to function as weapons, or otherwise pose threat to injury. Includes, but not limited to weapons (sharp or blunt instruments), medications, illicit drugs, matches, lighters, alcohol, over the counter medications, stolen items. ... III. Procedure: A. Arrival to LVHN Facility 1. Patients who present with conditions of actual or potential self-harm or harm to others (including substance abuse) as their primary admitting problem or diagnosis will be placed in hospital attire. a. All Behavioral Health Patients will be wanded by security prior to disrobing. b. Emergency department staff will have patients presenting with behavioral health complaints completely disrobed (including underwear and jewelry) ... c. Clothes, shoes, jewelry are inventoried and secured by clinical staff to remove contraband Refer to policy: Valuables - Patient Care Services. d. Security to take control of any contraband on patient’s possession. e. Money and jewelry not sent home with family are secured by security in a safe place - Refer to Valuables - Patient Care Services f. All belongings are to be removed from the patient area, including clothes and shoes g. After being placed in hospital attire, behavioral health patients may be re-wanded by security when indicated. ...” Review on March 4, 2026, of MR1 revealed MR1 presented to the facility on February 19, 2026, at 2154 with a chief complaint of suicidal ideation. There was documentation a quick triage was completed, including chief complaint and vital signs. There was no documentation security was notified of MR1’s presentation the to Emergency Department. There was no documentation a 1:1 was placed with the patient. There was no documentation MR1 was assessed for contraband. Continued review of MR1 revealed nursing documentation at 2240 that the patient was not in the waiting room and was found in the waiting room bathroom. The patient reported cutting their neck and wrists with a box cutter. There was documentation the charge nurse was made aware, the box cutter was secured, and the patient was taken immediately to the trauma bay for treatment. The patient sustained a six centimeter (cm) superficial laceration to the neck. The area was cleansed and repaired with skin adhesive. There was a one cm superficial laceration to the right wrist. The area was cleansed and repaired with skin adhesive. There was a two cm laceration to the left wrist. The wound was cleansed and repaired with one suture. The patient was placed on a 1:1 observation, changed into paper scrubs, wanded by security, and personal belongings were secured. Observation on March 4, 2026, of the ED waiting room security surveillance revealed MR1 presented to the facility on February 19, 2026, at approximately 2154. It was observed MR1 was registered at the registration desk, went into the triage room briefly with the triage nurse, returned to the registration desk, and vital signs were obtained. It was observed after vital signs were obtained, MR1 sat in the waiting room unattended with a backpack at approximately 2201. Continued observation revealed MR1 sat in the waiting room until approximately 2230 when the patient got up and entered the waiting room bathroom with their backpack. It was observed during MR1’s time in the waiting room the patient was unattended, and the triage nurse was observed caring for other patients. It was observed at approximately 2240 MR1 was found in the waiting room bathroom by the triage nurse and security. Interview on March 4, 2026, with EMP1, EMP2, and EMP3, at approximately 1230 confirmed the above findings.”

“INTEGRATION OF EMERGENCY SERVICES CFR(s): 482.55(a)(2) [If emergency services are provided at the hospital --] (2) The services must be integrated with other departments of the hospital. This Standard is not met as evidenced by: 38776 Based on review of facility documents, medical records (MR), surveillance observation, and staff interviews (EMP), it was determined the facility failed to evaluate patients requiring emergency psychiatric care in a timely manner for one of one medical record reviewed (MR1). Findings: Review on March 4, 2026, of the facility policy, “Triage System for the Emergency Department - Emergency Medicine,” last reviewed July 2023 revealed “... I. Key Points: 1. Triage identifies who cannot wait to be seen and allows the ED to route patients as expeditiously as possible for definitive care to the appropriate emergency department area according to their priority. 2. Triage collaborates with the charge nurse regarding bed availability, ESI, and severity of patients in the waiting area. 3. Triage is to be considered a priority function. 4. All means of triage should be used to the full capacity as appropriate and available (i.e. virtual triage, bedside triage, waiting room triage, in-person triage). ... II. Purpose: To evaluate patients in the shortest possible period of time, to identify those illnesses or injuries requiring immediate emergency care. ... III. Definitions: ESI Emergency Severity Index: is a five-level emergency department (ED) triage algorithm that provides clinically relevant stratification of patients into five groups from 1 (most urgent) to 5 (least urgent) on the basis of acuity and resource needs (ESI, 2013). Level 1 - Patient requires immediate life-saving intervention. Level 2 - High risk situation, severe pain or distress, altered mental status, agitated psychiatric patient ... Triage - The process of sorting patients by severity of illness or injury and assigning a rating to prioritize treatment. IV Population: Patients seen in the Emergency Department V. Skill Level: Emergency Nurse (per ENA language) ... VI Intervention / Guideline: Guidelines: 1. Patients entering the waiting area will be assessed to determine ESI level. 2. The triage nurse initiates the ED Nursing Flow Sheet and assigns triage status: ESI - 1 ESI - 2 ESI - 3 ESI - 4 ESI - 5 3. Triage when appropriate, initiates emergency nurse guidelines and first aid measures ... 5. ... All patient [sic] assigned an ESI of 2 will be accompanied by an appropriately trained staff member to a treatment area. When it becomes necessary for the triage staff member to accompany a patient to a treatment area, the responsibility for the patient should be assumed by the assigned nurse or charge nurse as soon as possible so that the triage staff member may return to the triage area. ...” Review on March 4, 2026, of the facility document, “Job Description ... Registered Nurse,” no date of last review, revealed “... Job Summary Provides professional nursing care through skillful assessment, diagnosis, outcomes identification, planning, implementation, and evaluation in accordance with facility or department policies and procedures. Directs and manages the care of designated patients. Utilizes effective and appropriate communication styles. Assists in maintaining a safe work environment and maintains clinical and professional competency as appropriate to the population of patients served. Essential Functions ... Assesses, plans, implements, and evaluates the care for designated patients. Recognizes the need for and initiates collaboration/communication with physicians, interdisciplinary team members, and takes actions to proactively resolve patients needs. - Synthesizes available data, information, and knowledge relevant to the situation to make decisions which optimize patient outcomes based on ANA Scope and Standards of Practice and the Code of Ethics. Demonstrates commitment to quality and safety, in accordance with established policies and procedures, utilizing evidence-based practice. ...” Review on March 4, 2026, of the facility policy, “Suicide Assessment and Prevention - Patient Care Services,” last revised August 2023 revealed “... I. Key Points: ... 2. It is the policy to create an environment of care that will foster the accurate identification and successful management of patients who are at risk for suicide or self-destructive behaviors. Patients at risk for suicide require intensive support, close observation, frequent re-assessment, and application of protective measures for their emotional and physical well-being. The scope of this plan begins prior to admission and continues through the patient’s discharge. 3. All patients who are being evaluated or treated for behavioral health conditions as a reason for care will be screened for their risk of self-harm using the Columbia Suicide Severity Rating Screen (C-SSRS) - Attachment A: Columbia-Suicide Severity Rating Scale 4. The C-SSRS assigns a level of risk to the patient. Patients identified as a Suicide Risk will have patient safety measures implemented as defined in the risk stratification/suicide precaution interventions. Patients will have an order for suicide precautions with observation level entered in the EHR. ... II. Purpose: To outline the process for the timely assessment and reassessment of patients’ suicide risk and to provide guidelines for safety interventions. ... IV. Population: Patients who are being evaluated or treated for behavioral health conditions as a reason of care. V. Skill Level: RNs trained in the care of patients VI. Intervention/Guideline: 1. Each patient who presents to the Emergency Room or any other inpatient acute care unit with a behavioral health complaint, suicide attempt, or who presents with suspicious injury will be screened by staff for suicidal ideation utilizing the C-SSRS. 2. Initial suicide risk assessments (C-SSRS) are to be performed by the trained registered nurse, PES/Crisis Workers or Social Workers as part of the triage or pre-admission/admission screening and as part of each discipline specific admission assessment. ...” Review on March 4, 2026, of MR1 revealed MR1 presented to the facility on February 19, 2026, at 2154 with a chief complaint of suicidal ideation. There was documentation vital signs were obtained, the charge nurse was made aware, and the patient was instructed to wait in the waiting room. There was no documentation a suicide risk assessment was completed. There was no documentation the patient was checked for contraband. There was no documentation security was notified of MR1’s presentation the to Emergency Department. There was no documentation a 1:1 was placed with the patient. There was documentation MR1 was assigned an ESI level two. Continued review of MR1 revealed nursing documentation at 2240 MR1 was not in the waiting room, was found in the waiting room bathroom, and reported cutting their neck and wrists with a box cutter. There was documentation the charge nurse was made aware, the box cutter was secured, and the patient was taken immediately to the trauma bay for treatment. Continued review of MR1 revealed MR1 sustained a six centimeter (cm) superficial laceration to neck. Area was cleaned and repaired with skin adhesive. There was a one cm superficial laceration to right wrist. The area was cleansed and repaired with skin adhesive. There was a two cm laceration to left wrist. The wound was cleansed and repaired with one suture. The patient was placed on a 1:1 observation, changed into paper scrubs, wanded by security, and personal belongings were secured. Observation on March 4, 2026, of the ED waiting room security surveillance revealed MR1 presented to the facility on February 19, 2026, at approximately 2154. It was observed MR1 was registered at the registration desk, went into the triage room briefly with the triage nurse, returned to the registration desk and vital signs were obtained. It was observed after vital signs were obtained, MR1 sat in the waiting room unattended at approximately 2201. Continued observation revealed MR1 sat in the waiting room until approximately 2230 when the patient got up and entered the waiting room bathroom. It was observed during MR1’s time in the waiting room MR1 was unattended, and the triage nurse was observed caring for other patients. Interview on March 4, 2026, with EMP1, EMP2, and EMP3, at approximately 1200 confirmed the above findings.”

“MEDICAL STAFF CFR(s): 482.22 The hospital must have an organized medical staff that operates under bylaws approved by the governing body, and which is responsible for the quality of medical care provided to patients by the hospital. This Condition is not met as evidenced by: 38776 Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure on call pediatricians arrived at the hospital within 30 minutes and failed to respond to a nurse’s call for a change in patient condition within 30 minutes (A0347). The failure resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to the patient. On January 24, 2024, the survey team toured the Obstetrics Unit and conducted interviews with staff regarding the new facility process of on call pediatricians were required to stay at the hospital during night and weekend call, and pediatricians working at the practice site must be at the hospital within 30 minutes of call. The unit was toured to observe pediatric coverage, sign in sheets for pediatricians were reviewed, and staff immediate education regarding the change in policy was reviewed to determine compliance for the removal of the immediate jeopardy. The survey team verified these immediate interventions were implemented and confirmed the facility’s IJ was removed January 24, 2024, at 1715. Cross reference 482.22(b)(1)-(3) Medical Staff Organization and Accountability”

“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: 38776 Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure adequate nursing staff to care for patients on the Obstetrics Unit (A0392). The failure resulted in an Immediate Jeopardy (IJ), posing a serious risk of harm to the patient. An IJ was called on January 24, 2024 at 1553. On January 24, 2024, the survey team toured the Obstetrics Unit and observed four registered nurses were working to care for the patients. The survey team conducted interviews with registered nurses regarding adequate nursing staffing. The on-call schedule for Obstetrics leadership was reviewed and the immediate staff education regarding staffing coverage was reviewed to determine compliance for the removal of the immediate jeopardy. The survey team verified these immediate interventions were implemented and confirmed the facility’s IJ was removed January 24, 2024, at 1715. Cross reference 482.23(b) Staffing and Delivery of Care”

“MEDICAL STAFF ORGANIZATION & ACCOUNTABILITY CFR(s): 482.22(b)(1), (2), (3) The medical staff must be well organized and accountable to the governing body for the quality of the medical care provided to the patients. (1) The medical staff must be organized in a manner approved by the governing body. (2) If the medical staff has an executive committee, a majority of the members of the committee must be doctors of medicine or osteopathy. (3) The responsibility for organization and conduct of the medical staff must be assigned only to one of the following: (i) An individual doctor of medicine or osteopathy. (ii) A doctor of dental surgery or dental medicine, when permitted by State law of the State in which the hospital is located. (iii) A doctor of podiatric medicine, when permitted by State law of the State in which the hospital is located. This Standard is not met as evidenced by: 38776 Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure on-call pediatricians arrived at the hospital within 30 minutes for two of five medical records review (MR1 and MR2), and failed to a respond to a nurse’s call for a change in patient condition within 30 minutes for one of five medical records reviewed (MR6). Findings Include: Review on January 24, 2024, of the facility document. “Newborn Resuscitation In The Delivery Room - Patient Care Services,” last reviewed September 2022 revealed “...I. Key Points: ... 4. Neonatal Intensive Care team/Pediatrician is called when maternal and/or fetal condition is present that increase the chance of needing intervention. ... II. Purpose: To clarify roles and responsibilities and to secure necessary resources for the immediate care of the newborn upon birth whether s/he requires routine postnatal care or neonatal resuscitation. ... IV. Population: Newborns who are born within LVHN V. Skill Level: Providers, Nurses, Respiratory Therapists having been trained in neonatal resuscitation VI. Intervention / Guideline: Guidelines/ Procedure: ... 3. At every delivery, there should be at least one individual whose primary responsibility is the infant and who is capable of initiating resuscitation. Protocols established by Neonatal Resuscitation Program will be followed. 4. Notify neonatal resuscitation team (as defined per campus) of deliveries that are anticipated to require neonatal intervention at the time of birth. Direct communication should occur between the perinatal team and the neonatal resuscitation team. Consider neonatal team attendance at deliveries when perinatal conditions that increase the risk of neonatal morbidity or mortality are present*: Maternal Conditions: ... Most urgent (level 2) C-sections ... Fetal/Infant Conditions: ... Category II (obstetrical team discretion) or category III tracing ... * Other conditions not listed above may be considered in which case direct communication with neonatal provider from the obstetrical provider is strongly recommended. ...” Review on January 24, 2024, of the facility document, “Cesarean Delivery Level Recommendations - Patient Care Services,” last reviewed August 2023 revealed “... I. Key Points: 1. Obstetricians are to assign and document the priority/level classification in the medical record. 2. The obstetrician is to communicate the decision to the charge nurse and team. 3. The obstetrician may ask the charge nurse /team to inform anesthesia and neonatology. ... II. Purpose: 1. Situations may arise where different patients have simultaneous indications for cesarean delivery. The classification of cesarean delivery in this document is intended to serve as a guideline for determining the urgency of an individual case and prioritizing delivery. ... 3. Participating disciplines [sic] be notified once the decision to perform a cesarean delivery is made and of the priority classification. Successful communication is contingent upon the recognition and understanding of the vital role that each individual plays in the communication chain ... IV. Population: Obstetrical providers (obstetricians, perinatologists, residents), registered nurses, technical partners, anesthesia services (physicians, CRNA); NICU services (physicians, NNP, respiratory therapists, RN). ... VI. Intervention / Guideline: ... Procedure: 1. Obstetrician identifies patient requiring cesarean delivery and assigns a level of urgency based on guidelines and individual clinical characteristics. The provider discusses situation with patient and documents rationale for decision and level of urgency. 2. Obstetrician informs bedside nurse of this plan and also calls charge nurse/bedside nurse with SBAR communication including patient’s name, room number, plan for cesarean delivery and indication, assigned level of urgency. 3. Obstetrician will speak directly to anesthesiologist if time allows. 4. Charge nurse/bedside nurse ensures that anesthesia and NICU/pediatric services are notified of same. The charge nurse/bedside nurse will mobilize resources to expedite delivery in appropriate timeline. 5. Documentation and care to be provided based on level of urgency: ... b. Level 2 - Urgent - Attempt to perform within 30 minutes from decision to incision whenever possible as unit resources permit - Preoperative documentation including Ticket to OR should be completed, CHG wipes should be used quickly (at least on abdomen), choice of anesthesia and prep made by obstetrician and anesthesiologist. Potential indications: ... Deteriorating category 2 FHT ... 6. Obstetrician documents level of urgency for case in patient medical record. ...” Review on January 24, 2024, of the facility document, “Medical Staff Bylaws,” last reviewed June 13, 2023, revealed “... Article II - Purposes And Responsibilities Section A - Purposes ... 3. The Medical Staff shall monitor the quality of medical care in the Hospitals and take action and make recommendations to the Boards of Trustees in order to effectuate that goal. 4. The Medical Staff shall strive for an acceptable level of professional performance of all practitioners through the appropriate delineation of clinical privileges and/or clinical functions and the ongoing review and evaluation of the performance of practitioners. ... Section B - Responsibilities ... 2. Each member of the Medical Staff shall: (a) Provide his or her patients with care and respond to all requests for consults at the generally recognized professional level of quality and efficiency; (b) Abide by these Medical Staff Bylaws and all other lawful standards, policies, rules and regulations of the Hospitals; ... (d) Provide Clinic coverage and Emergency Department on-call coverage as determined by the Department Chair/Physician in Chief. ...” A request was made for the policy or procedure related to Pediatrician On-call Coverage on January 24 and 25, 2024. None was provided. Interview on January 24, 2024, with EMP1, at approximately 1300 revealed the expectation was Pediatrician’s on-call were expected to arrive at the hospital 30 minutes after they were called for a newborn delivery. EMP1 confirmed it was the expectation Pediatricians were present for the delivery of a newborn. Review on January 24, 2024, of MR3, revealed MR3 was a gravida 1 at 39 weeks admitted for elective induction of labor on January 3, 2024, due to high-risk pregnancy, advanced maternal age, and estimated fetal weight was large for gestational age. Throughout MR3’s admission, induction was attempted with Cytotec, Foley balloon placement, and Oxytocin. There was physician documentation on January 7, 2024, at 0005 MR3 was 4 centimeters dilated but began to experience repetitive late decelerations which did not resolve with position change. There was physician documentation to proceed with a level two cesarean section. There was physician documentation Anesthesia was in house and the pediatrician (CF1) was called to the hospital. There was documentation MR1 was delivered on January 7, 2024, at 0048 with Apgar scores (a standardized assessment tool used to evaluate the health of the newborn immediately after birth) of nine at one minute and nine at five minutes. Continued review of MR3 revealed documentation CF1 arrived in the Operating Room (OR) on January 7, 2024, at 0055. There was operating room documentation CF1 was not present at the time of the delivery. Interview on January 24, 2024, with EMP3, at approximately 1400 confirmed the above findings. Review of MR3 on January 24, 2024, revealed anesthesia documentation dated January 7, 2024, at 0142 noting anesthesia was asked to go to the nursery and assist with MR1 who was coding. Documentation revealed on arrival to the nursery, MR1 was being ventilated by mask. Attempted intubation by the pediatrician (CF1) was unsuccessful. Cardiopulmonary resuscitation (CPR) was initiated. There was documentation anesthesia intubated MR1, oxygen saturation levels improved, however the belly was distended and there was no color change, most likely from previous intubation attempts. There was documentation the endotracheal tube was reinserted, and breath sounds were equal bilaterally, with minimal sound over the belly. There was documentation a nasogastric tube was placed, and the stomach was decompressed. There was documentation CPR continued until the code was called. Review on January 24, 2024, of MR1 revealed MR1 was delivered January 7, 2024, at 0048 via C-section. There was documentation MR1’s Apgar scores were nine at one minute of life and nine at five minutes of life. CF1 arrived at seven minutes of life and noted the baby was vigorous. MR1 was shown to their parents and then taken to the nursery for further care. Continued review of MR1 revealed physician documentation at 15 minutes of life MR1 experienced poor color and pulse oximetry reading was around 75%. There was documentation oxygen was administered and noted poor improvement in oxygen saturation level. Respiratory therapy was called to provide Continuous Positive Airway Pressure (CPAP). Decreased breath sounds were noted in the right lung for clinical suspicion of right tension pneumothorax. A Code Blue was called at 0127. Needle decompression was attempted. CF1 attempted chest tube insertion and was unsuccessful. MR1’s demise was declared on January 7, 2024, at 0210. Interview on January 24, 2024, with EMP3, at approximately 1430 confirmed the above findings. Review on January 25, 2024, of MR4 revealed MR4 presented to the facility at 39 weeks with regular, painful contractions on June 10, 2023, at 1252. There was provider documentation MR4 experienced variable decelerations on June 10, 2023, at 1632. Provider documentation dated June 10, 2023, at 1901, revealed MR4 was to be delivered by C-section after experiencing fetal bradycardia (slow heart rate). There was documentation the infant was delivered and handed off to the newborn team. Continued review of MR4 revealed nursing documentation on June 10, 2023, at 1905 noting the pediatrician (CF2) was not present for delivery and a Pediatric code blue was called. There was documentation the newborn (MR2) required resuscitation and was transferred to a tertiary care facility for NICU level care. There was documentation on June 11, 2023, at 0505 MR2 was reported to be in critical condition and the tertiary care facility requested MR4 transfer to reunite with MR2. There was documentation MR4 was transferred to a tertiary care facility on June 11, 2023, at 0505. Interview on January 25, 2024, with EMP3, at approximately 1300 confirmed the above findings. Review on January 25, 2024, of MR2 revealed MR2 was delivered on June 10, 2023, at 1904 by C-section. There was provider documentation, the pediatrician (CF2) evaluated the baby at 15 to 18 minutes of life. The Apgar scores were zero at one minute and zero at five minutes of life. There was documentation CPR was ongoing. There was documentation MR2 had a right pneumothorax. There was documentation needle aspiration was completed by the transport team, and a right-side chest tube was inserted. There was documentation Epinephrine was administered two to three times and a heartbeat was regained. Continued review of MR2 revealed the following nursing documentation dated June 10, 2023, at 1905. MR2 was brought to the warmer, not breathing, no heart rate noted. At 1905 ventilation was initiated and at 1906 CPR began. A code blue was called. There was documentation at 1909 the Emergency Department (ED) team arrived. Intubation was attempted by the ED physician and was unsuccessful. There was documentation MR2 was suctioned for fluid coming out of the nose and mouth. Intubation was attempted again at 1918 and was unsuccessful. The pediatrician (CF2) arrived at 1926. CF2 attempted intubation and was unsuccessful. There was documentation the NICU team from the tertiary care facility was en route at 1950. Upon arrival to the hospital the NICU team intubated MR2. There was documentation MR2 was transferred to a tertiary care facility NICU on June 10, 2023, at approximately 2359. Continued review of MR2 revealed MR2 was coded again at the tertiary care facility and was pronounced deceased on June 11, 2023, at approximately 1010. Interview on January 25, 2024, with EMP3, at approximately 1330 confirmed the above findings. Review on January 25, 2023, of MR6, revealed MR6 presented to the facility at 39 weeks for induction of labor due to advanced maternal age on July 27, 2023, at 1046. There was documentation on July 28, 2023, at approximately 0000 MR6 was noted to have prolonged fetal heart deceleration to the 70’s and 80’s with slow recovery. There was documentation anesthesia, operating room staff, and pediatrician were notified of fetal heart rate issues. Continued review of MR6 revealed nursing documentation on July 28, 2024, at 0023 noting the pediatrician (CF2) was called several times regarding the fetal strip status and could not be contacted. There was nursing documentation the nursing supervisor and Director of Pediatric were called and made aware. Continued review of MR6 revealed nursing documentation on July 28, 2023, at 0141 noting CF2 returned the nursing call and was made aware of the fetal heart strips. Interview on January 25, 2024, with EMP3, at approximately 1345 confirmed the above findings. EMP3 confirmed CF2 did not respond to hospital call within 30 minutes. EMP3 confirmed it was the facility’s expectation an on-call provider would respond to a change in a patient’s condition within 30 minutes.”

“SYSTEM MEDICAL STAFF NEEDS CFR(s): 482.22(b)(4)(iv) [§482.22(b)(4) - If a hospital is part of a hospital system consisting of multiple separately certified hospitals and the system elects to have a unified and integrated medical staff for its member hospitals, after determining that such a decision is in accordance with all applicable State and local laws, each separately certified hospital must demonstrate that:] (iv) The unified and integrated medical staff establishes and implements policies and procedures to ensure that the needs and concerns expressed by members of the medical staff, at each of its separately certified hospitals, regardless of practice or location, are given due consideration, and that the unified and integrated medical staff has mechanisms in place to ensure that issues localized to particular hospitals are duly considered and addressed. This Standard is not met as evidenced by: 36696 Based on review of facility documents and staff interview, it was determined the facility failed to ensure the Code Blue Committee reviewed all the completed resuscitation records monthly. Findings include: Review on January 24, 2024, of facility, “Medical Staff Bylaws,” dated June 13, 2023, revealed “Unified and Integrated Medical Staff Of The Hospitals Of Lehigh Valley Health Network Medical Staff Bylaws ...Article II-Purposes And Responsibilities Section A-Purpose 1. The medical staff shall be the formal organizational structure through which members shall obtain the benefits and fulfill the obligations of membership on the staff ...Section B-Responsibilities 1. Membership on the Medical Staff implies a responsibility and obligation consistent with full cooperation and participation in all required and necessary activities for the assessment and improvement of the effectiveness and efficiency of medical care provided in the Hospitals, including, but not limited to: a)The evaluation and proctoring of the performance of practitioners and the institution itself through objective, clinically sound criteria; (b)Participation in the processes of peer review, quality assessment, credentialing and corrective action through service upon Medical Staff committees so as to assure that patient care in the Hospitals is monitored continuously; and ...e. Code Blue Committee: (i) Purpose: Review and establish policies and procedures to assure appropriate code team response to cardiopulmonary arrests within the Lehigh Valley Network. (ii) Duties: A. Create and review the resuscitation records used to document therapeutic interventions during the code. B. Meet monthly and review all the completed resuscitation records, evaluate appropriate implementation of ACLS protocols, and refer all codes not conducted per ACLS Guidelines to further review by the “Code Blue Second Review Committee.” C. Insure that an effective process exists for announcement of the code location. D. Insure appropriate equipment is available and readily transportable to the code location. E. Insure qualified personnel comprise the code team. F. Insure all hospital areas are adequately covered by a code response team. ...” Request was made to the facility for the Code Blue Committee meeting minutes from June 2023 until present. None was provided. Interview on January 25, 2024, at approximately 1325, with EMP2, revealed the hospital was not part of the Networks Code Blue Committee so Code Blue’s had not been reviewed as per the Medical Staff Bylaws.”

“MEDICAL STAFF QUALIFICATIONS CFR(s): 482.22(c)(4) [The bylaws must:] (4) Describe the qualifications to be met by a candidate in order for the medical staff to recommend that the candidate be appointed by the governing body. This Standard is not met as evidenced by: 38776 Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure on-call pediatricians had privileges for pediatric endotracheal intubation for one of three credential files reviewed (CF3); and failed to ensure on-call pediatricians had privileges for pediatric chest tube insertion for two of three credential files reviewed (CF1 and CF3). Findings Include: Review on January 24, 2024, of the facility document. “Newborn Resuscitation In The Delivery Room - Patient Care Services,” last reviewed September 2022 revealed “...I. Key Points: ... 4. Neonatal Intensive Care team/Pediatrician is called when maternal and/or fetal condition is present that increase the chance of needing intervention. ... II. Purpose: To clarify roles and responsibilities and to secure necessary resources for the immediate care of the newborn upon birth whether s/he requires routine postnatal care or neonatal resuscitation. ... IV. Population: Newborns who are born within LVHN V. Skill Level: Providers, Nurses, Respiratory Therapists having been trained in neonatal resuscitation VI. Intervention / Guideline: Guidelines/ Procedure: ... 3. At every delivery, there should be at least one individual whose primary responsibility is the infant and who is capable of initiating resuscitation. Protocols established by Neonatal Resuscitation Program will be followed. 4. Notify neonatal resuscitation team (as defined per campus) of deliveries that are anticipated to require neonatal intervention at the time of birth. Direct communication should occur between the perinatal team and the neonatal resuscitation team. Consider neonatal team attendance at deliveries when perinatal conditions that increase risk of neonatal morbidity or mortality are present*: Maternal Conditions: ... Most urgent (level 2) C-sections ... Fetal/Infant Conditions: ... Category II (obstetrical team discretion) or category III tracing ... * Other conditions not listed above may be considered in which case direct communication with neonatal provider from the obstetrical provider is strongly recommended. ...” Review on January 24, 2024, of the facility document, “Medical Staff Bylaws,” last reviewed June 13, 2023, revealed “... Article II - Purposes And Responsibilities Section A - Purposes ... 3. The Medical Staff shall monitor the quality of medical care in the Hospitals and take action and make recommendations to the Boards of Trustees in order to effectuate that goal. 4. The Medical Staff shall strive for an acceptable level of professional performance of all practitioners through the appropriate delineation of clinical privileges and/or clinical functions and the ongoing review and evaluation of the performance of practitioners. ... Section B - Responsibilities ... 2. Each member of the Medical Staff shall: (a) Provide his or her patients with care and respond to all requests for consults at the generally recognized professional level of quality and efficiency; (b) Abide by these Medical Staff Bylaws and all other lawful standards, policies, rules and regulations of the Hospitals; ... (d) Provide Clinic coverage and Emergency Department on-call coverage as determined by the Department Chair/Physician in Chief. ... Article III - Medical Staff Membership Section A - Nature Of Medical Staff Membership Membership on the Medical Staff is a privilege which shall be extended only to professionally competent individuals who continuously meet the qualifications, standards and requirement set forth in these Bylaws. Appointment to the Medical Staff shall confer on the member only such clinical privileges as have been recommended by the Medical Executive Committee and granted by the Boards, in accordance with these Bylaws. ... Article VI - Procedure For Appointment, Reappointment And Clinical Privileges Section A - General Procedure 1. The Medical Staff and Governing Bodies, through their designated peer review committees, including the Department Peer Review Committees, Credential Committee, Medical Executive Committee, and also the Hospital Leadership Committee/Governing Bodies, and any other relevant ad hoc committees that may be appointed by the Medical Executive Committee or Hospital Leadership Committee, shall evaluate each application for appointment or reappointment to Staff, and for clinical privileges, and each request for modification of Staff membership status or clinical privileges, to determine and make recommendations as to whether the quality and efficiency of services ordered or performed by the applicant meets the Medical Staff ’ s standards utilizing the resources of the CEO and his or her Administrative Staff to investigate, validate and analyze the content of each application, under committee direction at each stage of the review process. ... Section D - Clinical Privileges 1. Clinical Privileges: Medical Staff membership and Medical Staff appointment entitles a practitioner to exercise only those clinical privileges specifically granted to him or her by the Governing Bodies upon the report and recommendation of the appropriate Department Chair/Physician in Chief/Peer Review Committee and the Credentials Committee and Medical Executive Committee. Clinical privileges are subject to the continuous scrutiny and recommendation of the Department Chair/Physician in Chief/Peer Review Committee, the Credentials Committee and the Medical Executive Committee. Clinical privileges are granted only by the Governing Bodies based on the decision of the Hospital Leadership Committee. Each practitioner ’ s clinical privileges shall be specific in writing, including, in appropriate cases, the right to admit to inpatient/outpatient facilities. 2. Basis for Privileges: Each application for Medical Staff appointment/reappointment, and each application for additional privileges, must contain a request for the specific privileges desired by the applicant. The initial determination as to clinical privileges shall be based upon the applicant’s education and training, demonstrated competence, referenced, proposed use of Hospital facilities and such other information as may be deemed pertinent and shall include an appraisal and recommendation to the Credential Committee by the appropriate Department Chair/Physician in Chief/Peer Review Committee. ... f. Credentials Committee: (i) Purpose: Review and make recommendations concerning the credentials, membership and clinical privileges of all applicants and members of the Medical Staff and AHPs based on an evaluation of whether the services ordered and performed by applicants and members meet the Medical Staff’s standards of quality and efficiency. (ii) Duties: A. Investigate the qualifications of all applicants with regard to the quality and efficiency of services ordered and performed. B. Assure that criteria for measuring qualifications of prospective or present Staff members are fair, objective, impartial and designed to promote quality care in the Institution. C. Re-evaluate on a regular basis all Staff members as to their compliance with Medical Staff citizenship requirements, qualifications for continued performance of their clinical privileges and duties, and the expansion or reduction thereof. D. Make timely recommendations on all evaluations and re-evaluations to the Medical Executive Committee. ...” Review on January 25, 2024, of CF3 revealed CF3 did not have privileges to perform pediatric endotracheal intubation or pediatric chest tube insertion. Interview on January 25, 2024, with EMP10, at approximately 1200 confirmed the above findings. Interview on January 25, 2024, with EMP3, at approximately 1225 confirmed CF3 was an on-call pediatrician and responded to pediatric code blues requiring intubation and chest tube insertion. Review on January 25, 2024, of CF1 revealed CF1 did not have privileges to perform pediatric chest tube insertion. Interview on January 25, 2024, with EMP10, at approximately 1155 confirmed the above findings. Review on January 24, 2024, of MR1 revealed MR1 was delivered January 7, 2024, at 0048 via C-section. There was physician documentation CF1 arrived at seven minutes of life and noted the baby vigorous. There was physician documentation MR1 was shown to their parents and then taken to the nursery for further care. Continued review of MR1 revealed physician documentation at 15 minutes of life MR1 experience poor color and pulse oximetry reading was around 75%. There was documentation oxygen was administered and noted poor improvement in oxygen saturation level. Continued review of MR1 revealed respiratory therapy was called for providing CPAP and there was noted decreased breath sounds in right lung. There was documentation of suspected pneumothorax at the right side of the lung and a code blue was called on January 7, 2024, at 0127. There was documentation of clinical suspicions of a right tension pneumothorax, needle decompression was attempted, and CF1 attempted and was unable to place the chest tube. There was provider documentation MR1’s demise was declared on January 7, 2024, at 0210. Interview on January 24, 2024, with EMP3, at approximately 1430 confirmed the above findings.”

“STAFFING AND DELIVERY OF CARE CFR(s): 482.23(b) The nursing service must have adequate numbers of licensed registered nurses, licensed practical (vocational) nurses, and other personnel to provide nursing care to all patients as needed. There must be supervisory and staff personnel for each department or nursing unit to ensure, when needed, the immediate availability of a registered nurse for care of any patient. This Standard is not met as evidenced by: 38776 Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure adequate nursing staff to care for patients on the Obstetrics Unit for nine of 14 assignment sheets reviewed. Findings Include: Review on January 24, 2024, of the facility document, “Staffing - Patient Care Services,” last reviewed October 2023 revealed “... I. Policy: The Director is responsible for all scheduling and staffing of his/her respective department on a twenty-four-hour basis. The staffing levels are based on census, patient needs ad personnel qualifications. API is used for scheduling all patient care services (PCS) staff. ... III. Procedure: 1. Schedule a. Schedules reflect staffing patterns that meet patient needs and personnel qualifications. b. If the schedule is completed and a variance remains after exhausting unit specific resources, a plan to manage the staffing needs must be developed by the director. ...” Review on January 24, 2024, of the facility Obstetrics Unit Staffing Budget, no date of review revealed four registered nurses (RN’s) per shift were required 24/7. Review on January 24, 2024, of the Obstetrics (OB) Unit Assignment sheet dated January 6, 2024, revealed three RN’s for the 1900 to 0700 shift. Interview on January 24, 2024, with EMP3, at approximately 1500 confirmed the above findings. Review on January 24, 2024, of MR3 revealed MR3 required a level two emergent c-section requiring two RN’s on January 7, 2024, at approximately 0005. There was documentation two RN’s were present for delivery. Interview on January 24, 2024, with EMP9 confirmed two RN’s were present for MR3’s delivery. EMP9 revealed the third RN was caring for another laboring patient. EMP9 confirmed at that time the three RN’s were working on the Labor and Delivery Unit and the nursing supervisor (PF3) was called to the mother baby unit to care for the Mothers and Babies post delivery. Review on January 25, 2024, of PF3 revealed PF3 did not have Obstetrics training or education records. Interview on January 25, 2024, with EMP3, at approximately 1145 confirmed the above findings. Review on January 24, 2024, of the Mother Baby Unit Census for January 6, 2024, revealed three mother patients and three newborn patients. Interview on January 24, 2024, with EMP3, at approximately 1505 confirmed the above findings. Review on January 25, 2024, of the OB Unit Assignment sheet dated January 9, 2024, revealed three RN’s for the 0700 to 1900 shift and three RN’s for the 1900 to 0700 shift. Interview on January 25, 2024, with EMP3, at approximately 1410 confirmed the above findings. Review on January 25, 2024, of the OB Unit Assignment sheet dated January 10, 2024, revealed three RN’s for the 1900 to 0700 shift. Interview on January 25, 2024, with EMP3, at approximately 1415 confirmed the above findings. Review on January 25, 2024, of the OB Unit Assignment sheet dated January 11, 2024, revealed three RN’s from 0300 to 0700 on the 1900 to 0700 shift. Interview on January 25, 2024, with EMP3, at approximately 1417 confirmed the above findings. Review on January 25, 2024, of the OB Unit Assignment sheet dated January 12, 2024, revealed three RN’s from 0300 to 0700 on the 1900 to 0700 shift. Interview on January 25, 2024, with EMP3, at approximately 1420 confirmed the above findings. Review on January 25, 2024, of the OB Unit Assignment sheet dated January 13, 2024, revealed three RN’s from 1900 to 0300 on the 1900 to 0700 shift. Interview on January 25, 2024, with EMP3, at approximately 1422 confirmed the above findings. Review on January 25, 2024, of the OB Unit Assignment sheet dated January 14, 2024, revealed three RN’s for the 1900 to 0700 shift. Interview on January 25, 2024, with EMP3, at approximately 1425 confirmed the above findings. Review on January 25, 2024, of the OB Unit Assignment sheet dated January 16, 2024, revealed three RN’s from 1900 to 2300 on the 1900 to 0700 shift. Interview on January 25, 2024, with EMP3, at approximately 1427 confirmed the above findings. Review on January 25, 2024, of the OB Unit Assignment sheet dated January 17, 2024, revealed three RN’s for the 1900 to 0700 shift. Interview on January 25, 2024, with EMP3, at approximately 1430 confirmed the above findings.”

“RN SUPERVISION OF NURSING CARE CFR(s): 482.23(b)(3) A registered nurse must supervise and evaluate the nursing care for each patient. This Standard is not met as evidenced by: 38776 Based on review of facility documents, medical records (MR), and staff interview (EMP), it was determined the facility failed to ensure newborn vital signs were checked every 15 minutes at delivery for one of one medical record reviewed (MR1). Findings Include: Review on January 24, 2025, of the facility document, “Newborn Care Protocol - Children’s,” last reviewed April 2023 revealed “II. Purpose: This guideline is a set of predetermined interventions, based on established statutory regulations and professional organization policy, appropriate for newborns, and appropriate for nursing to initiate following the infant’s birth, established to facilitate the care of well newborns requiring inpatient admission. The interventions activated in the standing orders are individualized to the newborn based on criteria. III. Definitions: Well-Newborn: Newborn meeting criteria for admission to Newborn Nursery/Service. IV Population: Newborns born at Lehigh Valley Health Network where a pediatric/neonatal/ family provider is not immediately available to write admission patient care orders. ... VI. Intervention / Guideline: ... Procedure: Newborn Care Protocol ... 19. Vital Sign Frequency: a. L&D vital signs at delivery, Q 15 minutes x 2, Q 30 minutes x 2. ...” Review on January 24, 2024, of MR1 revealed MR1 was delivered January 7, 2024, at 0048 via C-section. There was documentation MR1’s APGAR scores were nine at one minute of life and nine at five minutes of life. There was documentation MR1’s pulse was 160 and respiration rate was 44 on January 7, 2024, at 0050. There was no documentation of vital signs 15 minutes after delivery. Interview on January 24, 2024, with EMP3, at approximately 1430 confirmed the above findings.”