Adventist Health Reedley

“PATIENT RIGHTS: NOTICE OF RIGHTS CFR(s): 482.13(a)(1) A hospital must inform each patient, or when appropriate, the patient’s representative (as allowed under State law), of the patient’s rights, in advance of furnishing or discontinuing patient care whenever possible. This Standard is not met as evidenced by: 47205 Based on interview and record review, the hospital failed to ensure patient’s rights were upheld for eight of 15 sampled patients (Pt 17, Pt 26, Pt 30, Pt 21, Pt 23, Pt 27, Pt 20, and Pt 19), whose preferred language was documented as a language other than English and there was minimal or no documentation indicating that an interpreter was used during their registration, consent processes or subsequent clinical interactions during their hospitalization. This failure placed the patients at risk for not understanding their rights, treatment options, procedures, or consent elements, which had the potential to lead to misinformed decisions, reduced participation in care planning and potential negative health outcomes. Inadequate communication also limits a patient’s ability to meaningfully engage in their care as required under federal regulations, professional standards and the hospital’s Policy and Procedure (P&Ps). Findings: During a concurrent interview and record review on 7/14/24 at 1:12 p.m. with Emergency Department (ED) Manager (MGR) 1, Pt 17’s “ED Provider Note (EPN-a clinical document summarizing a patient’s ED visit),” dated 7/14/26 and “Face Sheet (FS- a document that contains a summary of a patients’ personal information),” dated 7/14/26, were reviewed. The “EPN” indicated, Pt 17 was brought in by ambulance (BIBA) to the ED on 7/14/26 for complaint of (c/o) abdominal pain and nausea ...” MGR 1 stated Pt 17’s “FS” indicated Pt 17’s preferred language was “Spanish.” During a concurrent interview and record review on 7/14/24 at 1:15 p.m. with MGR 1 and DIR 1, Pt 17’s “Conditions of Registration (COR- an agreement outlining the patient’s responsibilities and the hospital’s policies)” form dated 7/14/26, was reviewed. The COR indicated Pt 17 signed an English version of the COR on “ ... 7/14/26 at [5:33 a.m.] ...” with the “Witness Signature and Title” section signed by a Patient Access (registration department) employee on “ ...7/14/26 at 05:34 (5:34 a.m.) ...” MGR 1 stated the Translation/Interpreter Statement” section of Pt 17’s COR was not completed and/or signed. During a concurrent interview and record review on 7/15/26 at 10:15 a.m., with Registered Nurse (RN) 1, Pt 26’s “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 6/16/26 and the “FS,” dated 6/19/26 were reviewed. The H&P indicated Pt 23 “ ... [was] admitted to the hospital Swing Bed Unit (SBU- a regular inpatient bed that can flexibly transition (“swing”) between acute care and skilled nursing care) for further PT/OT (Physical Therapy/Occupational Therapy) eval (evaluation) and IV (intravenous- into a vein) nafcillin (antibiotic) [treatment] until 7/31/26 ...” RN 1 stated the “FS” indicated Pt 23’s preferred language was “Spanish.” The “EPN” indicated, Pt 26 came to the ED on 7/13/26 for c/o nausea, vomiting, abdominal pain, and Tachycardia (a dangerously fast heartbeat) ...” MGR 1 stated the “FS” indicated Pt 26’s preferred language was “Spanish.” During a concurrent interview and record review on 7/15/26 at 10:20 a.m. with MGR 1, Pt 26’s “COR” form dated 7/13/26, was reviewed. The COR indicated Pt 26 signed an English version of the COR on “ ... 7/13/26 at [11:47 p.m.] ...” with the “Witness Signature and Title” section signed by a Patient Access employee on “ ...7/14/26 at 00:12 (12:12 a.m.) ...” MGR 1 stated the “Translation/Interpreter Statement” section of Pt 26’s COR was not completed and/or signed. During a concurrent interview and record review on 7/15/24 at 10:34 a.m. with MGR 1, Pt 30’s “EPN,” dated 7/15/26 and the “FS,” dated 7/14/26 were reviewed. The EPN indicated Pt 30 came to the ED for c/o “ ... headache after hitting her head on the car window when her family quickly swerved the car today about an hour prior to arrival. Also complaining of neck pain, left shoulder pain radiating to hand, right shoulder pain, and right hip pain radiating to foot. Additional complaint of chest pain and shortness of breath which started after this incident. Associated with nausea ...” MGR 1 stated the “FS” indicated Pt 30’s preferred language was “Spanish.” During a concurrent interview and record review on 7/15/24 at 10:40 a.m. with MGR 1, Pt 30’s “COR,” form dated 7/14/26 was reviewed. The COR indicated Pt 30 signed a on a Spanish version of the COR with the “Witness Signature and Title” section signed by a Patient Access (registration department) employee on “ ...7/14/26 at (7:52 a.m.) ...” MGR 1 stated the “Translation/Interpreter Statement” section of Pt 30’s COR was not completed and/or signed. During a concurrent interview and record review on 7/15/24 at 11:21 a.m. with MGR 1, Pt 21’s “ED Physician Note,” dated 7/14/26 and the “FS,” dated 7/14/26 were reviewed. The ED Physician Note indicated Pt 21’s “ ... Chief Complaint c/o hiccups x 1 weeks, chest pain ... unable to sleep due to hiccups ... seen by PCP (Primary Care Provider (your main healthcare professional) ... without follow up ...” MGR 1 stated the “FS” indicated Pt 21’s preferred language was “Spanish.” During a concurrent interview and record review on 7/15/24 at 11:30 a.m. with MGR 1, Pt 21’s “COR,” form dated 7/14/26 was reviewed. The COR indicated Pt 21 signed a on a Spanish version of the COR with the “Witness Signature and Title” section signed by a Patient Access (registration department) employee on “ ...7/14/26 at (7:25 a.m.) ...” MGR 1 stated the “Translation/Interpreter Statement” section of Pt 21’s COR was not completed and/or signed. During a concurrent interview and record review on 7/16/24 at 9:44 a.m. with RN 1, Pt 23’s “H&P,” dated 6/16/26 and the “FS,” dated 6/19/26, were reviewed. The H&P indicated Pt 23 “ ... [was] admitted to the hospital SBU for further PT/OT (Physical Therapy/Occupational Therapy) eval (evaluation) and IV (intravenous- into a vein) nafcillin (antibiotic) [treatment] until 7/31/26 ...” RN 1 stated the “FS” indicated Pt 23’s preferred language was “Spanish.” During a concurrent interview and record review on 7/16/24 at 9:52 a.m. with RN 1, Pt 23’s “COR,” form dated 6/14/26 was reviewed. The COR indicated Pt 23 signed on a Spanish version of the COR with the “Witness Signature and Title” section signed by a Patient Access employee on “ ...6/14/26 at (9:14 p.m.) ...” RN 1 stated the “Translation/Interpreter Statement” section of Pt 23’s COR was not completed and/or signed. During a concurrent interview and record review on 7/16/24 at 10:09 a.m. with RN 1, Pt 27’s “H&P,” dated 7/13/26 and the “FS,” dated 7/13/26 were reviewed. The H&P indicated Pt 27 “ ... [was] BIBS got c/o cough x 2 days ...” admitted to the hospital for treatment for “ ...RLL (Right Lower Lobe) pneumonia ...” RN 1 stated the “FS” indicated Pt 27’s preferred language was “Spanish.” During a concurrent interview and record review on 7/16/24 at 10:13 a.m. with RN 1, Pt 27’s “COR,” form dated 7/12/26 was reviewed. The COR indicated Pt 27 signed on an English version of the COR with the “Witness Signature and Title” section signed by a Patient Access employee on “ ...7/12/26 at (6:59 p.m.) ...” RN 1 stated the “Translation/Interpreter Statement” section of Pt 27’s COR was not completed and/or signed. During a concurrent interview and record review on 7/16/24 at 10:31 a.m. with RN 1, Pt 20’s “H&P,” dated 6/20/26 and the “FS,” dated 6/19/26 were reviewed. The H&P indicated Pt 20 “ ... [was] admitted to the hospital SBU for rehabilitation ...” RN 1 stated the “FS” indicated Pt 20’s preferred language was “Spanish.” During a concurrent interview and record review on 7/16/24 at 10:37 a.m. with RN 1, Pt 20’s “COR,” form dated 6/19/26 was reviewed. The COR indicated Pt 20 gave “verbal consent ...” on a Spanish version of the COR ...” with the “Witness Signature and Title” section signed by a Patient Access (registration department) employee on “ ...6/19/26 at (5:54 p.m.) ...” RN 1 stated the “Translation/Interpreter Statement” section of Pt 20’s COR was not completed and/or signed. RN 1 stated if a patient gives verbal consent, and is not able to sign for himself, the form should be signed by two employees. RN 1 stated this section of the COR was not completed or signed per hospital P&P. During an interview on 7/16/26 at 10:40 a.m. with ED Director (DIR) 1, DIR 1 stated the Patient Access department leadership team confirmed that they do not have employees on the hospital certified interpreter list nor do the employees ask a certified employee assist in the registration process. DIR 1 also confirmed that the Patient Access leadership team do not require staff to use the contracted interpreter services company during registration with a non-English speaker. DIR 1 stated his expectation is that non-English speaking patients should be provided verbal and/or written communication in the patient’s preferred language in accordance with hospital P&P’s. DIR 1 stated the COR form should have been provided in Spanish to the Spanish speaking patient. DIR 1 explained staff have the option of using a certified employee or the contracted video/telephone interpreter service when communicating with a non-English speaking patient. DIR 1 explained a hospital employee is considered a certified interpreter once they have demonstrated, by a testing process, the ability to speak, and/or read and write in a non-English language. DIR 1 stated the hospital maintains a list of these certified employees that can be called upon to assist in interpreting throughout the hospital, as needed. DIR 1 further stated it is his expectation that staff would provide a COR form in the patient’s preferred language and that staff would document use of an interpreter when completing any forms and/or during interaction with the patient. During a concurrent interview and record review on 7/16/24 at 10:45 a.m. with Registered Nurse (RN) 1, Pt 19’s “History & Physical [H&P- an assessment from physician including medical history and exam],” dated 6/3/26 and the “FS,” dated 6/2/26 were reviewed. The H&P indicated “ ...Pt 19 was admitted to the hospital Swing Bed Unit (SBU- a regular inpatient bed that can flexibly transition (“swing”) between acute care and skilled nursing care) for “ ...functional mobility and soft tissue wound management ...” RN stated the “FS” indicated Pt 19’s preferred language was “Spanish.” During a concurrent interview and record review on 7/16/24 at 10:50 a.m. with RN 1, Pt 19’s “COR,” form dated 6/2/26 was reviewed. The COR indicated Pt 19 signed an English version of the COR on “ ... 6/2/26 at [2:21 p.m.] ...” with the “Witness Signature and Title” section signed by a Patient Access (registration department) employee on “ ...6/2/26 at (2:39 p.m.) ...” RN 1 stated the “Translation/Interpreter Statement” section of Pt 19’s COR was not completed and/or signed. During an interview on 7/16/26 at 11:08 a.m. with the Chief Nursing Officer (CNO), the CNO stated she confirmed with the Systems Director of Patient Access that the Patient Access staff are not required to be certified because the staff is collecting non-medical data from the patient. The CNO stated her expectation is all patients assessed to need language assistance would be served in the identified language of preference, they [the patients] have this right. During a review of the hospital’s P&P titled, “Patient Rights,” dated 5/28/26, the P&P indicated, “ ...POLICY SUMMARY/INTENT: In the provision of healthcare services to patients, the Facility demonstrates recognition and support of patient rights. Although no list of patient rights can assure their protection, the healthcare entity intends to reflect consideration of those rights to the extent possible. In turn, the healthcare entity holds expectations for the behavior of its patients and other guests. POLICY: COMPLIANCE - KEY ELEMENTS: A. General: 1. The rights and responsibilities of patients are provided in writing to the patient or the patient’s representative at the time of admission or as soon as possible thereafter. When patients are incompetent, medically incapable, unable to communicate, or are unemancipated minors, the patient ‘s representative may exercise the patient’s rights on the patient’s behalf. In response to patients’ needs and requests, the organization provides services within its capacity, stated mission, and applicable laws and regulations ... B. Patient Rights: ... 4. Information: a. The hospital supports the provision of information to patients or designated representatives that enables the making of healthcare decisions. Patients will receive information about their illness, health status, course of treatment, prospects for recovery and outcomes of care (including unanticipated outcomes) in terms they can understand. Patients have the right to participate in the development and implementation of their plan of care. Patients have the right to participate in ethical questions that arise in the course of their care, including issues of conflict resolution, withholding resuscitative services, and forgoing or withdrawing life-sustaining treatment ... 18. Communication: ... a. Through its interpreter services, the hospital is committed to providing information to patients and their guests in a language or communication method that can be understood...” During a review of the hospital’s P&P titled, “Language Assistance Program - Interpretation and Hearing Impaired,” dated 11/21/24. The P&P indicated, “ ... POLICY SUMMARY/INTENT: Adventist Health - (AH) will take reasonable steps to ensure that persons requiring language assistance services (such as oral language assistance or written translation) and who have Limited English Proficiency (LEP) will have meaningful access and an equal opportunity to participate and understand services, activities, programs and other benefits involving medical conditions and treatment. Assistance will be offered for the communication of information contained in vital documents, including but not limited to, waivers of rights, consent to treatment forms, financial and insurance benefit forms, etc. All interpreters, translators and other aids needed to comply with this policy shall be provided without cost to individuals who are hearing, speech, and visually impaired. Patients/clients and their families will be informed of the availability of such assistance free of charge. Language assistance will be provided using competent bilingual staff, providers, staff interpreters, contracts or formal arrangements with local organizations providing interpretation or translation services, or technology and telephonic interpretation services. All staff will be provided notice of this policy, and staff that may have direct contact with LEP individuals will be trained in effective communication techniques, including the effective use of an interpreter. Regular reviews of the language access needs of our patient populations, as well as updates and monitoring of the implementation of this policy, will be completed... DEFINITIONS: 1. Interpreter: An individual who is fluent in English and in the necessary second language, and can accurately speak, read, and readily interpret the necessary second language, or a person who can accurately sign and read sign language. Interpreters need to be able to translate the names of body parts and to competently describe symptoms and injuries in both languages. 2. Interpretation: Refers to spoken language 3. Translation: Refers to written language 4. Qualified Interpreter: Identified as proficient in sign language and in the languages of the population of the geographical area serviced who can translate the names of body parts, injuries, and symptoms ... 6. Language Line Services: Contracted telephone interpreter service ...POLICY: COMPLIANCE - KEY ELEMENTS: A. IDENTIFYING LEP PERSONS AND THEIR LANGUAGE 1. Initial assessment of communication needs will be made during the admission process, inpatient, outpatient, and emergency services. 2. Staff will identify the language and communication needs of the LEP person. Various methods may be used, such as verbal, language identification cards (or I speak cards, available online at ...), or posters to determine the language. [Brand Name Interpreter Device] “Language Identification Chart.” Staff will then determine the best method of interpreting through one of the available options, live qualified interpreter, video remote interpreter (Brand Name Interpreter Device), or over the phone interpreter (Brand Name Interpreter Device)... D. PROVIDING NOTICE TO LEP PERSONS: 1. [hospital network locations and staff] will inform LEP persons of the availability of language assistance, free of charge, by providing written notice in languages LEP persons will understand ...” During a review of the hospital’s P&P titled, “Model Policy: Consent and Informed Consent - California,” dated 3/6/25, indicated, “ ...POLICY SUMMARY/INTENT: Address when consent and informed consent must be obtained as well as to describe the process for obtaining consent and documenting it was given ... Definitions: ... 5. Consent for general medical care: Required for the general medical care provided to patients admitted to the hospital for inpatient or outpatient services, including services provided in the emergency department that do not meet the emergency exception... D. Conditions of Registration: 1. Upon admission or as soon thereafter as reasonably possible the patient or a patient’s legal representative (if patient lacks capacity) will be asked to give consent to the general medical care and the general terms and conditions for receiving care from the health care facility. This will be presented in the Conditions of Registration form. This form not only authorizes general medical and nursing care to be provided, it also establishes financial responsibility. a. If patient is not able to sign at the time of admission and a legal representative is not available, the Conditions of Registration form should be signed as soon as the patient has capacity, or a legal representative is available. I. Interpreters: 1. If a patient or their legal representative cannot communicate with the practitioner because of language or communication barriers, the practitioner, with the health care facility’s assistance, should arrange for an interpreter. The interpreter’s responsibilities will include translating the information regarding the recommended medical treatment that the patient or the patient’s legal representative needs to receive before deciding whether to give consent, as well as instructions regarding medical care. 2. Vital documents, including consent forms, presented by the health care facility staff to a patient must be written in a language that the patient can understand, or translated into such a language with an appropriate qualified interpreter. 3. See Systemwide Policy: Language Assistance Program: Interpretation and Hearing Impaired. J. Witnessing: 1. The role of the witness: a. The role of the person asked to serve as the signature witness is limited to the attestation of the signatures. The witnessing person should not answer questions relating to the informed consent the patient may have about the proposed surgery or procedure and should refer all such questions back to the practitioner. 2. Documentation: a. The witness should legibly print their name, sign the document and note the date and time the witness signed the document ...” During a review of professional reference titled, “Clinicians’ Obligations to Use Qualified Medical Interpreters When Caring for Patients with Limited English Proficiency,” dated 3/2017, (retrieved from https://journalofethics.ama-assn.org/article/clinicians-obligations-use-qualified-medical-interpreters-when-caring-patients-limited-english/2017-03) indicated, “ ... Access to language services is a required and foundational component of care for patients with limited English proficiency (LEP) ... In the United States, patients with LEP have a legal right to access health care in their preferred language ...””

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 40644 Based on interviews and record review, the hospital failed to ensure that licensed nursing staff developed and maintained an individualized care plan (CP-a document that outlines a patient’s health conditions, treatments, and other information to guide care and ensure continuity) for one of 30 sampled patients (Patient 9). The care plan did not accurately reflect Patient (Pt) 9’s specific monitoring needs for hypoglycemia (low blood sugar) in a newborn despite the mother (Pt 10) having gestational diabetes mellitus (GDM - high blood sugar related to pregnancy that increases the infant’s risk for low blood sugar) as required by hospital policy. This failure created the potential for miscommunication amongst staff concerning the need to assess Pt 9 for hypoglycemia and posed a risk for a delay in recognition and treatment of low blood sugar for the infant. Findings: During a concurrent interview and record review on 7/16/26 at 10:15 a.m. with the Manager of OB (MOB-Obstetrics, which is care for pregnant women), Pt 9 and Pt 10’s “Electronic Medical Record (EMR-digital patient chart),” dated 7/13/26 was reviewed. The EMR document titled, “Obstetrics Progress Note,” indicated, Pt 10 was a 30-year old woman who came to the hospital for a planned cesarean (surgical delivery) of her baby with GDM. The MOB stated that for gestational diabetics who do not need insulin (medicine to lower blood sugar), doctors often stop checking the mother’s blood sugar after delivery because gestational diabetes is considered resolved (gone) and in these cases, the focus is mainly on monitoring the newborn. The MOB reviewed the blood glucose results in the EMR for Pt 9 which indicated nursing staff performed blood glucose checks according to their policy. The EMR document titled, “Orders Plan - Infant Adaptation to Extra-Uterine Life, MCP. Nursing,” the document indicated the infants nursing care plan (CP) did not include documentation indicating Pt 9 was born to a mother with GDM or required monitoring for hypoglycemia. The MOB stated, “The infant’s care plan did not include hypoglycemia monitoring, which is a problem.” The MOB stated that the purpose of a Care Plan was to support consistent care across shifts by identifying problems, goals and interventions. The MOB stated that the CP should show the shared goals and actions so all team members can focus on the same priorities for the patients. The MOB stated there should have been a care plan for monitoring the infant for hypoglycemia. During an interview on 7/16/26 at 11:10 a.m. with the Associate Patient Care Executive (APCE ), the APCE stated the purpose of the care plan was “To go over with patient, goals and resolution. Infants of diabetic mothers are at a higher risk for hypoglycemia, and that needs to be documented in the plan of care. There absolutely should have been a care plan.” During a review of the hospital policy titled, “PIC INTERDISCIPLINARY CLINICAL DOCUMENTATION,” dated 12/21/15, the policy indicated, “ ...POLICY SUMMARY/INTENT: To guide the user in the completion of clinical documentation consisting of Patient Data Profile (PDP), Assessment/Reassessment, Plan of Care, Interventions, and Treatments ...AFFECTED DEPARTMENTS/SERVICES: Medical Surgical, Intensive Care Unit (ICU), Perinatal Services ... 4. Plan of Care: ...The care plan facilitates interdisciplinary communication and continuity of care by identifying patient problems, prioritization of needs, goals, interventions, and patient response to interventions ...ii. As individual patient needs are identified, those needs are addressed in the patient’s plan of care as a problem/condition/situation ...iv. The plan of care is a live document and as such, the patient’s progress toward goals will be evaluated ongoing and the plan of care revised when indicated in order to facilitate the resolution of identified problems/needs ...e. Time Frames: i. Patient shall have a plan of care initiated within 24 hours of admission ...f. Prioritization: An RN once per shift will do prioritization of care preferably at the time of the initial shift assessment, by ranking the problem; Primary or Secondary in the Problem List ...” During a review of the hospital policy titled, “MODEL POLICY: IDENTIFICATION, SCREENING AND MANAGEMENT OF NEWBORNS AT RISK FOR HYPOGLYCEMIA,” dated 6/07/2023, the policy indicated, “ ...9. MANAGEMENT OF ASYMPTOMATIC (no symptoms) INFANTS WITH HYPOGLYCEMIA RISK FACTORS- Birth - 24 hours of age: a. Protocol for asymptomatic neonate - 40 mg/dl (a measurement) or greater blood glucose value: i. Encourage skin-to-skin contact and frequent breastfeeding. ii. POC pre-feed glucose shall be retested within 3 hours of previous result and continued for 12-24 hours ...” During review of professional resource “Nursing Reports,” an article titled, “Care Plan Writing in Nursing Education: Challenges, Competence, and Clinical Preparedness,” dated April 2025 retrieved from https://pmc.ncbi.nlm.nih.gov/articles/PMC12030564/, the article indicated, “ ... By systematically identifying patient problems, planning interventions, and evaluating outcomes, care plans improve interdisciplinary communication among healthcare teams, ensure continuity of care across shifts, and promote cost-effective, ethical, and safe patient care in current clinical settings. Aligned with the nursing process, care plans guide students in applying evidence-based knowledge, refining their critical thinking, clinical judgment, and professional autonomy. As such, writing care plans is a key learning activity that bridges theory and practice, preparing students for the complexities of clinical environments ...””

“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: 47205 Based on interviews and record review, the hospital failed to ensure licensed nurses (LNs) adhered to the hospital’s policies and procedures (P&P) when six of eight sampled patients (Pt) Pt 16, Pt 18, Pt 22, Pt 24, Pt 25, and Pt 29)), did not a have complete, focused, physical assessment documented in accordance with hospital P&Ps. This failure had the potential for Pt 16, Pt 18, Pt 22, Pt 24, Pt 25, and Pt 29 to have delayed treatment and a decline in health status. Findings: During a concurrent interview and record review on 7/14/26 at 1:57 p.m. with Emergency Department (ED) Manager (MGR) 1, Pt 16’s “ED Provider Note (EPN-a clinical document summarizing a patient’s ED visit),” dated 7/14/26 and “Face Sheet (FS- a document that contains a summary of a patients’ personal information),” dated 7/14/26 were reviewed. The “EPN” indicated, Pt 16 came to the ED on 7/14/26 for complaint of (c/o) knee pain “Patient reports that 9 months ago she was being released from jail when she had fallen and hit her knee ...” MGR 1 stated a nursing assessment had not been documented. MGR 1 stated it was her expectation that staff adhered to hospital P&P’s and that at minimum staff should be documenting a focused assessment (detailed nursing assessment of specific body system (s) related to the presenting problem or other current concern(s)) to analyze and address the patient’s needs. During a concurrent interview and record review on 7/14/26 at 2:07 p.m. with MGR 1, Pt 18’s “EPN,” dated 7/14/26 and “FS,” dated 7/14/26 were reviewed. The “EPN” indicated Pt 18 came to the ED on 7/14/26 for c/o “ ... head injury [S/P-“after” or “following” a prior medical event, treatment, or procedure] fall occurring 30 minutes prior to arrival [PTA] ...” MGR 1 stated a nursing assessment had not been documented. During a concurrent interview and record review on 7/14/26 at 2:34 p.m. with MGR 1, Pt 22’s “EPN,” dated 7/14/26 and “FS,” dated 7/14/26 were reviewed. The “EPN” indicated, Pt 22 came to the ED on 7/14/26 for “ ...c/o diarrhea for the last couple of wks [weeks] ...” MGR 1 stated a nursing assessment had not been documented. During a concurrent interview and record review on 7/15/26 at 9:30 a.m. with MGR 1, Pt 24’s “EPN,” dated 7/14/26 and “FS,” dated 7/14/26 were reviewed. The “EPN” indicated, Pt 24 came to the ED on 7/14/26 for c/o “ ... Vomiting for 4 days and yesterday started w/ [with] chills and fever headache. Had right kidney transplant 4/15/26 ...” MGR 1 stated a nursing assessment had not been documented. During a concurrent interview and record review on 7/15/24 at 9:40 a.m. with MGR 1, Pt 25’s “EPN,” dated 7/14/26 and “FS,” dated 7/14/26, were reviewed. The “EPN” indicated, Pt 25 came to the ED on 7/14/26 for c/o “ ... abdominal pain ...” MGR 1 stated a nursing assessment had not been documented. During a concurrent interview and record review on 7/15/24 at 9:53 a.m. with MGR 1, Pt 29’s “EPN,” dated 7/14/26 and “FS,” dated 7/14/26 were reviewed. The “EPN” indicated, Pt 29 came to the ED on 7/14/26 for complaint of (c/o) “ ... left knee swelling for 2 weeks after falling off of an e-bike ... [Pt 29] left AMA [Against Medical Advise] ... [on her initial visit to the ED] and wants x-ray results ...” today. MGR 1 stated a nursing assessment had not been documented. During an interview on 7/16/24 at 11:08 a.m. with the hospital Chief Nursing Officer (CNO), the CNO stated it is her expectation that staff adhere to hospital P&P’s. The CNO stated her ED nurse leadership team identified an individual RN was responsible for the missing patient assessment documentation as expected and required by hospital P&P. The CNO stated this RN received education and clarification of expectations regarding patient assessments in the ED. The CNO stated ED nurse leadership reinforced documentation expectations with all staff at their regular daily staff huddles this morning, and an email communication was sent to the remaining affected staff. The CNO stated ED nurse leadership will continue to monitor compliance. During a review of the hospital’s P&P titled, “POLICY: PIC Interdisciplinary Clinical Documentation,” dated 2/21/15, the P&P indicated, “ ...Document ID: 12619...To guide the user in the completion of clinical documentation consisting of Patient Data Profile (PDP). Assessment/Reassessment, Plan of Care, Interventions and Treatments ...POLICY: COMPLIANCE - KEY ELEMENTS ... A. All patients receiving care will have an assessment of their physical, psychosocial, and social needs performed by licensed members of the healthcare team utilizing the following: 1. Patient Data Profile (PDP) will be utilized for initial assessment in all clinical departments. The PDP is to be completed on admission for all patients admitted to inpatient units. Outpatients will complete the PDP as appropriate to the patient’s need. 2. Key components of PDP include a nutritional, abuse, and infection control screens, pain management assessment; learning needs assessment, and discharge planning. The assessment information obtained on PDP will be used in providing care and treatment. a. Responsibility: Licensed or non-licensed personnel may collect the information included on the PDP with the exception of these areas which must be completed/assessed by a Registered Nurse (RN): ... 3. The Patient Assessment/Reassessment will provide a comprehensive mechanism for the documentation of patient assessments utilizing a problem-oriented systems approach, which emphasizes a focus on deviation from defined parameters. This will be utilized for initial assessments and reassessments ...” During a review of the hospital’s P&P titled, “POLICY: PIC Interdisciplinary Clinical Documentation,” dated 12/21/15, the P&P indicated, “ ...Document ID: 12643 ...POLICY SUMMARY/INTENT: To demonstrate the use of the Outpatient PDP, patient assessment and reassessment and interventions in the development and documentation of the individual patient’s plan of care ... POLICY: COMPLIANCE - KEY ELEMENTS A. The Outpatient Data Profile will be utilized in the initial assessment for all out-patients ... 1. The information obtained will be used in formulating patient care, and the basis for reassessment. a. For Outpatients, the PDP will be addressed by the Registered Nurse down to and including learning needs ... B. The Patient assessment/reassessment is problem focus, reflecting the patient’s current condition, needs and/or admitting information and is used to develop an individual plan of care. Assessments are performed and documented by the following disciplines as needed, within their scope of practice ...” During a review of the hospital’s P&P titled, “Standards of Care, Emergency Department,” dated 7/1/26, the P&P indicated, “ ...Addendum I Standards of Care Emergency Department (ED) Standard I. Assessment ...Assessments/Reassessments ... All patients will have an initial assessment and prioritized treatment per Emergency Severity Index (ESI) ... Key elements of assessment include, at minimum: Chief complaint ...A focused assessment/reassessment will be complete on each patient, or more frequently in change of status and provider order. ... Standard VI, Evaluation ... The RN evaluates the effectiveness of care through assessment and observation of the patient’s physical condition and behavior, signs and symptoms of illness, and response to treatment and care ...””

“COMPLIANCE WITH 489.24 CFR(s): 489.20(l) [The provider agrees,] in the case of a hospital as defined in §489.24(b), to comply with §489.24. This Standard is not met as evidenced by: 42321 Based on interview and record review, Hospital A failed to stabilize and keep safe one of twenty patients (Patient (Pt) 1) when Pt 1 was brought into the Emergency Department (ED) by ambulance (BIBA) on 11/23/24 on a 5150 hold (a Welfare and Institutions code that allows for the involuntary detention of an adult experiencing a mental health crisis) for suicidal ideations (thoughts, fantasies, or contemplations about ending one’s own life) and after being examined by a physician, being placed in a room and monitored by a sitter, Pt 1 ran past staff and left the ED with staff knowledge and staff did not notify security to assist in bringing Pt 1 back to the ED. Pt 1 was hit by a car and transported via emergent medical evacuation to Hospital B where Pt 1 was diagnosed with multiple trauma injuries including a L5 TP fracture (broken back bone) and a femur fracture (broken leg bone) that required surgery. The cumulative effect of this systemic problem resulted in the hospitals to not ensure the provision of quality healthcare in a safe and responsible manner. (refer to A2407)”

“STABILIZING TREATMENT CFR(s): 489.24(d)(1-3) (1) General. Subject to the provisions of paragraph (d)(2) of this section, if any individual (whether or not eligible for Medicare benefits) comes to a hospital and the hospital determines that the individual has an emergency medical condition, the hospital must provide either- (i) within the capabilities of the staff and facilities available at the hospital, for further medical examination and treatment as required to stabilize the medical condition. (ii) For for transfer of the individual to another medical facility in accordance with paragraph (e) of this section. (2) Exception: Application to inpatients. (i) If a hospital has screened an individual under paragraph (a) of this section and found the individual to have an emergency medical condition, and admits that individual as an inpatient in good faith in order to stabilize the emergency medical condition, the hospital has satisfied its special responsibilities under this section with respect to that individual (ii) This section is not applicable to an inpatient who was admitted for elective (nonemergency) diagnosis or treatment. (iii) A hospital is required by the conditions of participation for hospitals under Part 482 of this chapter to provide care to its inpatients in accordance with those conditions of participation. (3) Refusal to consent to treatment. A hospital meets the requirements of paragraph (d)(1)(i) of this section with respect to an individual if the hospital offers the individual the further medical examination and treatment described in that paragraph and informs the individual (or a person acting on the individual’s behalf) of the risks and benefits to the individual of the examination and treatment, but the individual (or a person acting on the individual’s behalf) does not consent to the examination or treatment. The medical record must contain a description of the examination, treatment, or both if applicable, that was refused by or on behalf of the individual. The hospital must take all reasonable steps to secure the individual’s written informed refusal (or that of the person acting on his or her behalf). The written document should indicate that the person has been informed of the risks and benefits of the examination or treatment, or both. This Standard is not met as evidenced by: 42321 Based on interview and record review, Hospital A failed to stabilize and keep safe one of twenty patients (Patient (Pt) 1) when Pt 1 was brought into the Emergency Department (ED) by ambulance (BIBA) on 11/23/24 on a 5150 hold (a Welfare and Institutions code that allows for the involuntary detention of an adult experiencing a mental health crisis) for suicidal ideation’s (thoughts, fantasies, or contemplations about ending one’s own life) and after being examined by a physician, being placed in a room and monitored by a sitter, Pt 1 ran past staff and left the ED with staff knowledge and staff did not notify security to assist in bringing Pt 1 back to the ED. Pt 1 was hit by a car and transported via emergent medical evacuation to Hospital B where Pt 1 was diagnosed with multiple trauma injuries including a L5 TP fracture (broken back bone) and a femur fracture (broken leg bone) that required surgery. This failure resulted in Pt 1 not being stabilized for a known mental health emergency medical condition (EMC), permitted to leave the ED without providing security personnel the opportunity to bring Pt 1 back into the facility and subsequently experiencing an avoidable accident with injury. Pt 1 was hit by a car and transported via emergent medical evacuation to Hospital B where Pt 1 was diagnosed with multiple trauma injuries including a L5 TP fracture (broken back bone) and a femur fracture (broken leg bone) that required surgery. Findings: During a concurrent interview and record review on 2/25/25 at 2:33 p.m. with the Emergency Department Manager (EDM), Pt 1’s Electronic Health records (EHR) for her ED visit on 11/23/24 were reviewed. Pt 1’s EHR indicated, she was brought in by ambulance to Hospital A’s ED at 1:35 p.m. on a 5150 hold. The EDM stated Pt 1 was seen by medical doctor (MD 1) at 1:39 p.m. to start the medical screening exam (MSE) and place orders. Pt 1 was placed on suicidal precautions (prevention measures). The EDM stated the “ED Physicians Notes” dated 11/23/24 at 7:37 p.m. indicated, “... 18-year-old female presenting for danger to self. Per paramedics and police, she has had history of being placed on hold. She was reportedly walking onto incoming traffic. She stated that she wanted to harm herself. Police witnessed this and placed her on a 5150 hold. She does not give a specific plan at this time as to how she would harm herself. On exam, patient is endorsing SI [suicidal ideation]. Will order labs per protocol. If labs are reassuring, then patient will be cleared for transfer to psychiatric facility ...” The EDM stated at 2:02 p.m. staff in the ED did a safety check on the room Pt 1 was going to be placed in for anything that could be used to harm herself and everything was removed. The EDM stated at 2:10 p.m. Pt 1 was placed in this room, and she changed into the burgundy scrubs and a 1 to 1 sitter (a person that is assigned to observe someone around the clock) was initiated. Pt 1’s EHR indicated, Pt 1 was agitated and at 2:21 p.m. received Geodon (an antipsychotic medication used to treat symptoms of schizophrenia [chronic mental health condition characterized by disruptions in thought processes, perceptions, emotions, and social interactions] and bipolar disorder [a chronic mental health condition characterized by extreme mood swings, alternating between periods of mania [elevated mood] and depression [low mood]) which appeared to be helping, from 3 p.m. to 4:30 p.m. Pt 1 was sleeping, at 4:45 p.m. Pt 1 woke up and became more agitated and was pacing. Pt 1’s EHR indicated MD 1 spoke with Pt 1 at 4:58 p.m. and planned to place further orders when Pt 1 took off running at 4:59 p.m. through the ambulance bay doors. The EDM stated Pt 1 was followed by the sitter and registered nurse (RN 1), “they ran after her [Pt 1]”. The EDM stated staff yelled at Pt 1 encouraging her to return but Pt 1 continued to run and did not come back. The EDM stated the Monitor Tech (MT 1) immediately called the police department at 5:01 p.m. to report Pt 1’s elopement. Pt 1’s EHR indicated no staff documented any attempts to reach out to the patient or family on 11/23/24 and 11/24/24. During an interview on 2/25/25 at 3:34 p.m. with the House Supervisor (HS 1), HS 1 stated she received a call on 11/23/24 from the monitor tech (MT 1) stating that a patient had eloped around 5 p.m. HS 1 stated MT 1 had called PD, and staff were currently looking for the patient. HS 1 stated the normal process when a patient elopes from the hospital “is to make sure security is out looking for the patient on our campus; next need to make sure the primary nurse fills in the RADAR (electronic report that reports the incident to the hospital risk department), and that staff are looking for the patient as well.” HS 1 stated, “we also alert the administration coming on the next shift.” HS 1 stated the responsibility of the hospital is to make sure the policy is being followed, PD is called, call the family and escalate to administration to make sure they are aware. During an interview on 2/25/25, at 3:21 p.m. with Registered Nurse (RN 1), RN 1 stated she came onto her shift at 4 p.m. on 11/23/24 and asked to take over care of Pt 1. RN 1 stated she was sitting at the nurse’s station when a girl (Pt 1) came out of room 6 and she was agitated saying she did not feel good, and something was wrong. RN 1 stated MD 1 showed up and saw Pt 1 and went to speak with her about what was wrong and told her he would get her something to relax. RN 1 stated she worked on getting Pt 1 a dinner tray, “... just as [MD 1] turned left to his office to put the orders in, the patient [Pt1] came back out of her room turned left and ran towards the ambulance doors. She ran out of the doors.” RN 1 stated the MT 1 called PD right away and RN 1 ran after the patient but by the time she turned the corner the patient was already out by the street and “I did not have time to yell at her to come back.” RN 1 stated the sitter was just outside Pt 1 ‘s door monitoring Pt 1 but Pt 1 just ran right past him. RN 1 stated she is not sure if MT 1 called a code green (hospital code called overhead when a patient elopes) nor if security was called, and she did not see security during the elopement. During an interview on 2/25/25 at 3:40 p.m. with MD 1, MD 1 stated Pt 1 was on a 5150 hold, and she eloped and maybe got hit by a car. MD 1 stated since the incident extra security has been placed in the ED and stationed near the ambulance entrance. MD 1 stated we [the hospital] try not to put patients in restraints, so we try to deescalate the situation with the patient. MD 1 stated we don’t want staff to block the patient, we want them to protect themselves as well. MD 1 stated at the time of the incident, he did put in additional orders for Pt 1. MD 1 stated the ED team called the police and did what they were supposed to do for this type of situation. During an interview on 2/26/25 at 9:03 a.m. with the Ambulance Triage Nurse (RN 2), RN 2 stated Pt 1 was BIBA on 11/23/24 and described Pt 1 as younger and has been here before. RN 2 stated Pt 1 came in very upset. RN 2 stated Pt 1 tends to be aggressive but easily calmed. RN 2 stated Pt 1 is familiar with the ED routine, “Pt 1 can start to yell and get upset but she never gets physical with staff”. During an interview on 2/26/25 at 9:16 a.m. with the Monitor Technician (MT 1), MT 1 stated he was working at the nurse’s station when Pt 1 eloped. MT 1 stated he was busy with transfers, but that security and the house supervisor were there. MT 1 stated the hospital had 4 ambulance patients in the hallways, so it was crowded and chaotic. MT 1 stated he remembers Pt 1 coming to her doorway 2 to 3 times, once asking for her phone. MT 1 stated the sitter, and the security guard were right there. MT 1 stated Pt 1 stated she did not want to stay here anymore and asked why we were keeping her here. Staff told her she needed to stay in her room and seconds later she took off. She just ran past the gurneys at the back door, we didn’t have time to stop her. MT 1 stated Pt 1 had been to the ED earlier that day but had eloped, this time Pt 1 was BIBA on a 5150 hold. MT 1 stated when Pt 1 eloped, he did not call a code green but that he did call the police department (PD) right away. MT 1 stated PD took quite a while to come to Hospital A. MT 1 stated he heard on the 911 status net that a young lady had been hit by a car later after the elopement. MT 1 stated the driver of the vehicle was brought in by officers and mentioned that she just darted out in front of his vehicle. MT 1 stated he got off work at 7:30 p.m. that night. When asked if anyone followed Pt 1 outside, MT 1 stated the nurse did and he believed security followed the patient outside as well. During an interview on 2/26/25 at 10:06 a.m. with Security Guard (SG 1), SG 1 stated when a patient elopes staff is supposed to notify security, and we respond. SG1 stated if the patient is still onsite then security will try to talk with the patient, “we do not put hands on the patient and we do not physically block them, we talk to them and try to get them to stay and be safe”. SG 1 stated he worked the day of 11/23/24 and remembers doing his normal patrols and when he went into the ED, he noticed the crisis patient was gone. SG 1 stated he spoke with MT 1 and MT 1 informed him the patient had left already about an hour ago. SG 1 stated MT 1 did not mention that Pt 1 had eloped just that she had left so he figured she was discharged normally. SG 1 stated it wasn’t until later that night that the police department came and started investigating Pt 1’s elopement. SG 1 stated he spoke with ED staff and told them they should have called a code green and let security know that Pt 1 had eloped so security would know to look for the patient. During an interview on 2/26/25 at 3:05 p.m. with the Sitter (SI 1), SI 1 stated he was the sitter for Pt 1 on 11/23/24. SI 1 stated he is a monitor technician for Hospital A and on 11/23/24 he was educated and given instructions on how to be a sitter for Pt 1. SI 1 stated this was the first time he was a sitter for a patient, but he knew he needed to be no less than 10 feet away from the patient with uninterrupted visibility. SI 1 stated as a sitter he was responsible to watch the patient and fill in the form every 15 minutes indicating what the patient was doing i.e. sleeping and fill in the initial paperwork that shows the room was cleared of any hazards and was safe for a suicidal patient. SI 1 stated Pt 1 was very agitated when she came in and it was hard to get her to settle down, “she was antsy in the room and would pace around”. SI 1 stated he is not sure if the nurse gave Pt 1 any medication, but Pt 1 spent most of his shift sleeping. SI 1 stated then Pt 1 jumped out of bed and said her arm, her body hurt. SI 1 stated the nurse and the doctor both spoke with the patient at that time trying to deescalate her, something was said about getting her medication for pain. SI 1 stated we were going to order her a dinner tray when the doctor turned to leave, and Pt 1 literally ran with her yellow socks on out the ambulance bay doors. SI 1 stated he was in front of the nurse’s station sitting and Pt 1 ran right past him and the nurse and him ran after Pt 1. SI 1 stated the nurse was yelling that Pt 1 was on a hold and staff could get her medication and a meal, but Pt 1 did not respond to us she just kept running. SI 1 stated we did follow Pt 1 outside there was an ambulance coming in and by the time we saw her she was already out at the sidewalk and Pt 1 never turned around to look at us. SI 1 stated security was not there at the time Pt 1 eloped, security came afterwards once patient was out of sight. SI 1 stated he believed it was SG 1, but he was not sure if MT 1 called security or if security just showed up. SI 1 stated it was a busy night, there was a transfer of a patient going on. SI 1 stated he is not sure if a code green was called. During an interview on 2/27/25 at 10:45 a.m. with the Security Manager (SM), the SM stated she covers four sites associated with Hospital A. The SM stated the security guards at the hospital patrol the areas outside and inside the hospital, she mentioned there are sensors that security must tap to show they have patrolled all the areas. The SM stated once they tap the sensor, they need to make a comment to what they see. The SM stated the security officer helps with deescalating patients and persuading them to calm down and stay if they are attempting to elope, if not successful the security officer will ask the medical staff what they would like to do next. The SM stated medical staff will either want to give the patient medication or security officer may have to help hold a limb while restraints are being placed on the patient. The SM stated when there is an elopement there is an expectation that the security guard will submit a report to explain what occurred and what was done. The SM stated SG 1 did not submit a report because he stated that he was not informed about the elopement of Pt 1 until later that night. During a review of document titled, “Tour Details,” dated 11/23/24, the document indicated, SG 1 was on duty that night and there was no mention of an elopement nor anything unusual that night. During an interview on 2/27/25 at 11:06 a.m. with the Manager of Risk Management (MRM) and the Director of Quality (DQ), the root cause analysis (a structured process used to identify and address issues that lead to adverse events in healthcare) for Pt 1’s elopement was reviewed. The MRM stated Pt 1’s elopement was investigated, and gaps were found. The MRM and DQ stated a code green was not called and there was some confusion when they interviewed staff as to whether Security was present at the time of the elopement or if they were even informed of Pt 1 eloping at the time. The MRM stated it was later determined that Pt 1 was hit by a car after she eloped. The MRM stated since this event security has been increased and increased their rounding, they now have a security guard always stationed at the back ambulance doors to help with issues in the ED. The MRM stated education has gone out to staff on the elopement policy and to have better communication and “close the loop so that staff and security are on the same page”. During a review of Pt 1’s Hospital B’s electronic health records (EHR) dated 2/27/25, the EHR indicated Pt 1 arrived by air for an inpatient trauma visit on 11/23/24, at 7:27 p.m. Pt 1’s ED Pt (patient) care timeline for Hospital B was reviewed and indicated, “... Chief Complaints Updated pedestrian vs vehicle ... ED Notes Addendum ... Patient came in as a STAT (right now) trauma by [name of air transport]. Per EMS [emergency medical services] patient was an elopement from [Hospital A’s name] in which they were struck by a vehicle at approximately 55 mph (miles per hour) ... Patient on arrival presents with significant road rash to their back, frontal forehead with an associated hematoma (bruise), and an obvious femur deformity. Per [name of air transport] patient’s dorsalis pedis pulse (felt on top of the foot) was absent however after traction patient presents in hare traction (used to reduce patient pain, secure the leg in an appropriate position and restore length to the femur) with a doppler (device used to detect blood flow) pulse. Patient presenting as a Glasgow coma scale 14/15 (GCS- a number between 3 and 15 that measures a person’s level of consciousness. A lower score indicates a lower level of consciousness and a more severe injury.) ... Admit to Inpatient ... Ortho consult ... 11/24/2024 04:30 [4:30 a.m.] ED Notes per [City name] PD [police department] pt was placed on 5150 for DTS [danger to self], and taken to [Hospital A], prior to her eloping and being struck by car. Per PD 5150 is still in effect. Attempting to contact [Hospital A] for copy of 5150 ...” Review of Pt 1’s Acute Care Surgery Service Discharge Summary from Hospital B, dated 11/30/24, indicated, “... Injuries -left midshaft femur fracture - scattered abrasions - grade 3 splenic lacerations (a significant injury to the spleen (small organ that stores and filters blood)-L5 TP fracture (broken back bone). Patient underwent left femur intramedullary nail placement (a metal rod that’s inserted into the femur (thigh bone) to treat fractures) with orthopedic surgery and is medically cleared for discharge. Pending psych recommendations/probable psych placement ...” During a review of Hospital A’s Policy titled, “EMTALA- Medical Screening Examination (MSE) and Stabilization”, dated 11/20/2019, indicated, “... POLICY SUMMARY/INTENT: A. To ensure that all individuals who Come to the Hospital (as defined in the Compliance with EMTALA policy) seeking or in need of Emergency Services and Care receive an appropriate Medical Screening Examination and further examination and Stabilizing treatment in accordance with applicable laws and Hospital policies ... 2. Psychiatric Condition. A Psychiatric Emergency Medical Condition is considered Stabilized when the Treating Physician has determined, within reasonable clinical confidence, that the individual is protected or prevented from injuring or harming himself/herself or others ... 7. Elopement. If an individual leaves the Hospital without notifying Hospital personnel (i.e., elopement), the elopement should be documented by Dedicated Emergency Department staff in accordance with the Patient LWBS/Elopement/AMA/LABS; Dedicated Emergency Department (DED) policy ...” During a review of Hospital A’s Policy titled, “Code Green - Patient Elopement”, dated 5/15/2024, the policy indicated, “... the purpose of this policy is to provide an appropriate response in the event of a missing/eloping patient who is determined to be a danger to himself/herself, or who is identified as a safety risk ... High Risk Patient for Elopement ... A patient who ... on a legal hold (danger to themselves or others); Having active suicidal/homicidal ideation ... On a “patient watch” or has a safety attendant/sitter ... Key Elements A. All reasonable measures will be taken to prevent the elopement of high-risk patients from the hospital ... take all reasonable steps necessary to safely retrieve/locate an eloped patient as quickly as possible ... The hospital’s response will be limited to the hospital campus. The police will be notified for assistance beyond the hospital campus ... Patients have the right to leave the hospital ... against medical advice and the organization must ensure patient safety and therefore a safe discharge ...PROCEDURES: A. Upon Discovery of an Eloped Patient: 1. Staff will notify the PBX operator immediately and provide the following information: a. Patient care unit where the patient eloped from. B. Description of the eloped patient. c. Time and location the patient was last seen. 3. The PBX operator will announce a Code Green via the overhead paging system and ensure notifications are made to the administrator in charge, security and risk management. 4. Staff will notify the charge nurse and security services when a patient who does not meet the criteria is missing from the patient care area to assist with retrieving the patient ... B. Recovery: 1. The Security Officer and police department (if applicable) will determine when the Code Green is concluded and will release the site to resume normal operations. 2. The Security Officer will notify the PBX Operator and page, “Code Green, all clear” three (3) times ... 3. Training and Education: a. Patient care staff should receive appropriate orientation and training relative to working with high-risk elopement patients. B. All staff will be educated about Code Green ...” During a review of Hospital A’s policy titled, “One to One Monitoring, Behavioral Health Patients,” dated 9/20/2023, the policy indicated, “Policy Summary/Intent: A. Ensure patient safety by identifying patients that are a danger to self or to others. B. Identify personnel that may provide 1:1 continuous monitoring/attention. C. Provide a safe and a supportive environment ... 2. The Registered Nurse (RN) must assess every shift and reassess as needed to determine continued need for 1:1 monitoring. 3. The Sitter will have access at all times to nursing staff, such as the primary RN or the Lead RN. 4. The sitter must be in eye to eye contact with the patient at all times. a. NEVER leave the patient alone or unattended at any time. b. When the patient uses the restroom, make every effort to provide same sex staff to attend to the patient’s personal needs and to make sure the patient stays safe ... 6. The duties of the Sitter may include feeding a patient that does not have swallowing restrictions, sitting with the patient, walking with the patient, reading to the patient, praying with the patient, etc. B. Education ... B. Continuous Monitoring: 1 ... Monitor patient continuously in the patient’s room ...” During a review of Hospital A’s policy titled, “Suicide Prevention,” not dated, the policy indicated, “Policy Summary/Intent: The purpose of this policy is to provide guidelines for screening patients, to identify those patients at risk for suicide, and to provide interventions that are appropriate to the risk level identified in hospital settings ... Key Elements A. Screening: Early identification of patients at risk for suicide is crucial. Complete the C-SSRS screening tool (The Columbia Suicide Severity Rating Scale - it rates an individual’s degree of suicidal ideation on a scale by asking questions) for all patients who are being evaluated or treated for a behavioral health condition as their primary reason for care or who may be at risk as determined by the clinician. For patients who are unable to answer or refused, the patient shall be considered as high risk until the screen can be completed ... C. Interventions for non-behavioral health settings: Risk reduction strategies and safety measures should be initiated by the Registered Nurse based upon screening, clinical judgment, and any additional assessments ... 3. Interventions for High Risk: a. Notify the LIP (Licensed Independent Practitioner). b. Document the plan/actions used to mitigate the risk for suicide for the patient to include at minimum: i. PSA (Patient Safety Attendant) for Constant 1:1 observation of the patient. See Attachment F for an example of the minimum information that should be documented including validation at least every 15 minutes that observation has been continuous. I. Line of sight observation of patient continues in the shower/bathroom ... PSA will use an environmental checklist to document risk items removed ... Patients will be placed in burgundy paper scrubs ... 1. Care planning will be initiated, and interventions included ... C-SSRS Frequent Screener tool every shift ...””

“NURSING CARE PLAN CFR(s): 482.23(b)(4) The hospital must ensure that the nursing staff develops, and keeps current, a nursing care plan for each patient that reflects the patient’s goals and the nursing care to be provided to meet the patient’s needs. The nursing care plan may be part of an interdisciplinary care plan. This Standard is not met as evidenced by: 45977 Based on interview and record review the hospital failed to follow their policy and procedure (P&P) titled, “Swing Bed Program” for one of 26 sampled patients (Patient (Pt) 16)) when nurses did not assess and develop a care plan for PTSD [Post traumatic Stress Disorder - a mental health condition that can develop in people who have experience a life-threatening event], and Night Terrors [a sleep disorder in which a person quickly awakens from sleep in a terrified state].. This failure had the potential to result in PTSD symptoms of night terrors to go unaddressed. Findings: During a concurrent interview and record review on 5/29/24, at 10:15 a.m., with the Risk Quality Specialist (RQS) and Clinical Informatics Nurse (CIN), Pt 16’s electronic health record (EHR- digital collection of medical information) was reviewed. Pt 16’s “History and Physical (H&P - the formal document that physicians produce through interview with the patient, physical exam, and the summary of testing either obtained or pending)”, dated 5/21/24, and “Order Plans [Nursing Care Plan]”, undated dated, were reviewed Pt 16’s H&P indicated Pt 16 was brought to the hospital “PMhx [Past Medical History] of HTN [Hypertension - high blood pressure], Atrial Fibrillation [a heart condition that causes an irregular and often rapid heartbeat], PTSD [Post traumatic Stress Disorder - a mental health condition that can develop in people who have experience a life-threatening event], Night Terrors [a sleep disorder in which a person quickly awakens from sleep in a terrified state] who is admitted to Swing Bed for trach [tracheotomy - a opening through the neck into the windpipe to allow air to fill the lungs] care, PEG [percutaneous endoscopic gastrostomy - a tube through the abdomen to the stomach for feeding] tube feeds, and rehabilitation after an acute hospitalization ... after having an accident on his motorcycle which led to Cardiac Arrest, with multiple ... Injuries ... During his hospitalization ... pt suffered a vent [ventilator - breathing machine] associated pneumonia [infection of the lungs] and was not able to be weaned from the Vent and had to have a trach placed. ... He is a Veteran and has a history of PTSD and Night Terror - recommends that staff not try to wake him up in the dark when he is having a terror episode, they should turn on the light and call his name from a distance. Says the Night Terror are worse anytime he is stressed or sleep deprived. ...”. RQS stated, Pt 16’s care plan addressed issues for self-care deficit, skin integrity, pain management, and discharge readiness as the focused care problems for nursing interventions. RQS stated, nothing was included to address his “night terrors” or PTSD. RQS stated, there should have been a nursing care plan that addresses PTSD and “night terrors”. RQS stated, nurses are expected to develop a care plan that matches and guides the care needs of the patient. During a concurrent observation and interview on 5/30/2024, at 10:00 a.m., with Pt 16, in room 15 A, Pt 16 was observed resting in bed, watching television and in no apparent distress. Pt 16 stated, he has a history of PTSD and “night terrors”. Pt 16 stated, he should not have any roommates because he often wakes up in the middle of night yelling out. During a concurrent interview and record review with Registered Nurse (RN) 1 on 5/30/24, at 10:45 a.m. Pt 16’s EHR titled “History and Physical”, dated 5/21/24, and “Order Plans [Nursing Care Plan]”, undated dated, were reviewed.. RN 1 stated, she was not aware of Pt 16’s history of “night terrors”. RN 1 stated, the care plan should have include interventions to address Pt 16’s history of “night terrors”. During a concurrent interview and record review with Medical/Surgical Unit Manager (MSM) on 5/30/24, at 11:05 a.m., Pt 16’s “History and Physical”, dated 5/21/24, and “Order Plans [Nursing Care Plan]”, undated t , were reviewed. MSM stated, Pt 16 should have a focus intervention to address his past history of PTSD and “night terrors”. MSM stated, she expected the nurses to update the care plan to address the needs of the patient. MSM stated, if the care plan is not updated, the care of the patient could suffer. During a concurrent interview and record review with the Assistant Patient Care Executive (APCE), on 5/31/24, at 10:00 a.m., Pt 16’s “Nursing Care Plan” undated, was reviewed. The APCE stated, the nursing care plan should have been updated to address Pt 16’s needs. The APCE stated, the nursing care plan should address the patient’s care needs to provide safe quality care. The APCE stated, nurses are expected to follow the policy to develop. document and updating the care plan to meet the patient’s care needs. During a review of the facility position description titled, “RN [Registered Nurse] Job Summary”, dated 2/3/2024, indicated, “ ... Collects relevant data pertinent to the patient’s health or situation. Analyzes the assessment data in determining diagnosis and care issues. Develops a plan that prescribes interventions to attain outcomes. Implements the plan, coordinates care delivery, and employs strategies to promote health and a safe environment. Evaluates progress toward attaining outcomes. Identifies outcomes for the patient or the patient’s situation ... “ During a review of the facility P&P titled, “Swing Bed Program”, dated 9/21/2021, the P&P indicated, “ ... D. Comprehensive Care Plan: ... 1. The comprehensive care plan is developed by the Interdisciplinary team. ...2. The comprehensive care plan must include measurable objectives and time frames to meet these needs: ... a. Be developed within 7 days after completion of the comprehensive assessment. ... b. Describe services that will be furnished to maintain or help the patient achieve their highest level of functioning. ... “ During a review of a professional reference titled, “Lippincott Manual of Nursing Practice 10th Edition,” dated 2014, page 16-17 indicated, “ Standards of practice General Principles... 1. The practice of professional nursing has standards of practice setting minimum levels of acceptable performance for which its practitioners are accountable ...b. These standards provide patients with a means of measuring the quality of care they receive ...5. A deviation from the protocol should be documented in the patient’s chart with clear, concise statements of the nurse’s decisions, actions, and reasons for the care provided, including any apparent deviation ... Legal claims most commonly made against professional nurses include the following departures from appropriate care: failure to assess the patient properly or in a timely fashion, follow physician orders, follow appropriate nursing measures, communicate information about the patient, adhere to facility policy or procedure, document appropriate information in the medical record ... Failure to formulate or follow the nursing care plan ...””

“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: 45977 Based on interview and record review the hospital failed to follow their policy and procedure (P&P) titled “Pain Management Guidelines” for one of 21 sampled patients (Patient (Pt) 15) when nurses did not attempt interventions to relieve the assessed pain. This failure had the potential to leave patients with uncontrolled pain. Findings: During a review of Pt 15’s,”History & Physical [H&P (H&P -- the formal document that physicians produce through interview with the patient, physical exam, and the summary of testing either obtained or pending)] Examination”, dated 5/14/24, the “H&P Examination” indicated, Pt 15 was admitted on 5/14/24, “ ... with morbid obesity, HTN [hypertension - high blood pressure], A-Fib [Atrial Fibrillation -- a heart condition that causes an irregular and often rapid heartbeat], on Coumadin [Warfarin] [a medication that prevents blood from forming clots], type 2 diabetes mellitus [chronic disease that occurs when the body does not produce enough insulin or cannot effectively use the insulin it produces], HX [history] of CVA [cerebrovascular Accident - brain attack], admitted ... with right-sided facial droop speech [a condition that occurs when the facial muscles are not working properly] difficulty, weakness in the right lower extremity. ... She was accepted to our swing bed for rehab [rehabilitation]. ...” During a concurrent interview and record review on 5/29/24, at 1:22 p.m., with the Risk Quality Specialist (RQS) and Clinical Informatics Nurse (CIN), Pt 15’s electronic health record (EHR- digital collection of medical information), Pt 15’s “H&P Examination”, dated 5/14/24, “Pain Monitoring Flowsheet [PMF]”, and “Medication Administration Records” for 5/14 admission were reviewed. The RQS stated, Pt15 had an order for acetaminophen-hydrocodone (an opioid pain medication) 7.5 mg (unit of measurement- milligrams) every four hours as need for severe pain of 7 out of 10 (Pain management scales utilizing the 0-10 descriptors, will be assessed as a pain rating of 0=no pain, 1-3=mild pain, 4-6=moderate pain and 7-10=severe pain). The PMF indicated, Pt 15 reported pain intensity level of 8 on 5/27/2024 at 9:27 a.m., a level of 8 on 5/28/2024 at 7:44 a.m. and a level of 8 on 5/29/2024 at 8:45 a.m. when vital signs [measurements of the body’s most basic functions] were recorded. The PMF indicated, no interventions for those pain assessments were recorded by the nurse. The RQS validated no pain interventions or medications were documented for those pain assessments. During a concurrent interview and record review on 5/30/24, at 10:45 a.m., with Registered Nurse (RN) 1,Pt 15’s EHR, “H&P Examination”, “Pain Monitoring Flowsheet [PMF]”, and “Medication Administration Records”, for 5/14/2024 admission were reviewed. RN 1 stated, the pain assessments in the record for Pt 15 on 5/27/2024 at 9:27 a.m., 5/28/2024 at 7:44 a.m. and 5/29/2024 at 8:45 a.m. were done when vitals signs were taken by staff helping the Registered Nurse for the patient. RN 1 stated, the reported pain by Pt 15 should have been reported to the nurse for follow up but nothing is documented in the chart as to why the pain was not addressed with interventions or pain medications. During a concurrent interview and record review on 5/30/24, at 11:05 a.m., with Medical/Surgical Unit Manager (MSM). Pt 15’s EHR, “H&P Examination”, “Pain Monitoring Flowsheet [PMF]”, and “Medication Administration Records”, for 5/14/2024 admission, were reviewed MSM stated, nurses should have addressed Pt 15’s pain and charted the follow up in the medical chart. MSM stated, the CNA recorded the pain and there was no follow up charted about the pain interventions used or reassessment of pain by the nurses. . MSM stated, t staff should have reported any concerns the patients have to the nurse and a follow up on those concerns should have occurred in a timely manner. During an interview on 5/31/24, at 10:00 a.m., with the Assistant Patient Care Executive (APCE), . The APCE stated, nurses are expected to treat pain and document the interventions and reassessment in the chart. The APCE stated, the expectation of the CNAs is to report any concerns from the patients to the nurses and the nurses should follow up and make sure patients are treated in a timely manner. During a review of the facility P&P titled, “Pain Assessment & Management”, dated 9/20/2023, the P&P indicated, “ ... Pain is assessed in all patients. The organization will address the appropriateness and effectiveness of pain management. ... It is the responsibility of all clinical staff to assess and periodically reassess the patient for pain and relief from pain including the Intensity and quality (i.e., character, frequency, location and duration of pain), and responses to treatment ... Intensity ratings will be categorized as mild 1-3; moderate 4-6; severe 7-10. Any rating of 5 or greater requires an intervention. ... All patients will undergo reassessment of pain every shift with vital signs, after every pain control mechanism employed by patient care providers, and prn [as needed] ... Documentation: ... a. Initial assessment of patient pain will be documented in the Electronic Health Record (EHR) and electronic Medication Administration system ... Electronic documentation of pain medication administered with pain related comment and reassessment. ...” During a review of the California Board of Registered Nursing Professional Reference titled, “California Code of Regulations” undated, (https://rn.ca.gov) indicated, “... A registered nurse shall directly provide ... Ongoing patient assessments as defined in the Business and Professions Code, Section 2725(d). Such assessments shall be performed, and the findings documented in the patient ’ s medical record, for each shift and upon receipt of the patient when he/she is transferred to another patient care area ... RN is accountable for an ongoing comprehensive assessment that includes data collection, analysis, and drawing conclusions/making judgments in order to ... formulate diagnoses and update diagnoses formulate or change the plan of care ... decide on specific activities to implement the plan of care (immediate and long-term) ... prioritize and coordinate delivery of care delegate to nursing care competent staff to deliver required care ... anticipate discharge planning/teaching needs... advocate for the patient as needed ... RN uses scientific knowledge and experience to make clinical judgments about observed abnormalities and changes based on a series of complex, independent and collaborative decision making activities ... RN is responsible/accountable to see actual and potential patient needs/health problems are addressed and get recorded on the plan of care ... “”

“GOVERNING BODY CFR(s): 482.12 There must be an effective governing body that is legally responsible for the conduct of the hospital. If a hospital does not have an organized governing body, the persons legally responsible for the conduct of the hospital must carry out the functions specified in this part that pertain to the governing body ... This Condition is not met as evidenced by: 40644 Based on observation, interview and record review, the hospital failed to have an effective governing body (GB) that is legally responsible for the conduct of the hospital when: 1. The hospital failed to provide care in a safe setting for Patient 1 when registered nurses (RNs) in Labor & Delivery Unit did not recognize and act on Patient 1’s risk factors that identified the pregnancy as high risk. RNs did not accurately interpret and document fetal heart monitoring and did not recognize and act on Patient 1’s high risk for shoulder dystocia. (Refer to A144) 2. The hospital failed to ensure registered nurses were competent to provide care to meet the patients’ needs when Labor and delivery (L&D) staff did not have current competencies in fetal heart rate interpretation, mandatory simulation training classes for obstetrical emergencies, annual skills fair, and no training or competency on how to complete physical examination and determination of the presence of labor for patients. (Refer to A397) 3. The hospital did not have effective quality assurance and performance improvement (QAPI) program that collected and analyzed data and used the data to implement tracking and monitoring when the facility failed to analyze causes and implement preventive measures following the unexpected death of a newborn, Patient (Pt) 1. The internal investigation conducted by the hospital’s Performance Improvement unit did not include all factors that contributed to the unexpected death of Pt 1. The actions implemented as a result of the incomplete internal investigation did not provide sufficient level of safety for newborns in the hospital and did not identify gaps in nursing competencies and training. (Refer to A 283 and A 286) The cumulative effect of these systemic problems resulted in the hospital’s inability to ensure the provision of quality healthcare in a safe and professional manner.”

“PATIENT RIGHTS CFR(s): 482.13 A hospital must protect and promote each patient’s rights. This Condition is not met as evidenced by: 37529 Based on observation, interview and record review the facility failed to protect and promote each patient’s rights for safety and privacy when: 1. The hospital failed to provide care in a safe setting for Patient 1 when registered nurses (RNs) in Labor & Delivery Unit did not recognize and act on Patient 1’s risk factors that identified the pregnancy as high risk. RNs did not accurately interpret and document fetal heart monitoring and did not recognize and act on Patient 1’s high risk for shoulder dystocia. (Refer to A144) 2. The hospital failed to follow their policy and procedure titled “”Patient-Related Complaint and Grievance Management (CGM)” when resolutions responses were not given within the required time frame for two Patients (Patient 28 and 29) and the written response for Patient (Pt) 28’s mother (PM 28) was not in Spanish the language the patient understood. (Refer to A118 and A123) The cumulative effect of these systemic problems resulted in failure to ensure patients were cared for in a safe manner, and their rights were protected and promoted at all times.”

“QAPI CFR(s): 482.21 The hospital must develop, implement and maintain an effective, ongoing, hospital-wide, data-driven quality assessment and performance improvement program. The hospital’s governing body must ensure that the program reflects the complexity of the hospital’s organization and services; involves all hospital departments and services (including those services furnished under contract or arrangement); and focuses on indicators related to improved health outcomes and the prevention and reduction of medical errors. The hospital must maintain and demonstrate evidence of its QAPI program for review by CMS. This Condition is not met as evidenced by: 40644 Based on interview and record review, the hospital failed to maintain an effective, comprehensive, ongoing, hospital-wide, data-driven quality assessment and performance improvement (QAPI) program when the facility failed to analyze causes and implement preventive measures following the unexpected death of a newborn, Patient (Pt) 1. The internal investigation conducted by the hospital’s Performance Improvement unit did not include all factors that contributed to the unexpected death of Pt 1. The actions implemented as a result of the incomplete internal investigation did not provide sufficient level of safety for newborns in the hospital and did not identify gaps in nursing competencies and training. (Refer to A 283 and A 286) The cumulative effect of these systemic problems resulted in the facility’s inability to ensure the provision of quality patient care in a safe environment.”

“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: 37529 Based on observation, interview and record review, the hospital failed to ensure the safe provision of nursing services when the hospital failed to ensure registered nurses were competent to provide care to meet the patients’ needs when Labor and delivery (L&D) staff did not have current competencies in fetal heart rate interpretation, mandatory simulation training classes for obstetrical emergencies, annual skills fair, and no training or competency on how to complete physical examination and determination of the presence of labor for patients. (Refer to A397) The cumulative effect of these deficient practices resulted in the hospital’s inability to ensure the provision of safe nursing care.”

“PATIENT RIGHTS: GRIEVANCES CFR(s): 482.13(a)(2) The hospital must establish a process for prompt resolution of patient grievances and must inform each patient whom to contact to file a grievance. This Standard is not met as evidenced by: 45929 Based on interviews and record review, the facility failed to follow their policy and procedure on the grievance process when two of two patients (Patient 28 and 29) did not receive resolution responses to their filed grievances within seven days. These failures resulted in Patient (Pt) 28 and Pt 29 not being provided resolutions to their filed grievances for over six months. Findings: During a review of the facility’s “Grievance Log (GL)”, dated 1/1/23 to 12/15/23, the “GL” indicated on 3/1/23 Pt 28’s parents filed a grievance regarding their son’s care in the Emergency Department (ED). The “GL” indicated, “ ... The parents were concerned because they did not feel the ED doctor took them seriously. They said their son was pale, had a fast heart rate and was complaining of abdominal pain. but the doctor didn’t validate their concerns. The doctor was planning to send them home but [Pt 28] started having rectal bleeding at that time and was then given fluids and transferred to a higher level of care ... stated that if they hadn’t spoken up for him he would have been discharged with a serious medical condition ... [Mother] would like a return call so that she knows that the appropriate people are aware of the situation ...”. The “GL” indicated, “ ... ‘3/2 Contact made by phone. Spoke to guardian about situation. Apologies made for dissatisfaction. Staff education implimented [sic]. [ED Director, EDD]’ ... GRV [grievance] letter sent [Senior Risk Analyst {SRA}] 3/9 ...”. The “GL” indicated the resolution date as 3/2/23. During an interview on 12/15/23 at 1:42 p.m. with the mother of Pt 28 (PM 28), PM 28 stated she did not get a resolution to her satisfaction. PM 28 stated she did not receive a call back from the facility after her complaint. PM 28 stated she did not receive a letter nor any communication from the facility. During a review of the facility’s “GL”, the “GL” indicated on 5/3/23 Pt 29 filed a grievance regarding her treatment in the ED by the ED staff and physician. The “GL” indicated, “ ... they did not discuss lab or CT [Computerized Tomography, specialized imaging study] results, pain not controlled. Patient states that the nurse came in and told her that she was going to take out the IV [intravenous, in the vein] and foley catheter [a tube inserted in the bladder to assist in urination] out and she was discharged. Patient states that she wanted to finish the IV fluids and was still in severe pain and was told no she was discharged y the doctor and had to leave. Patient was diagnosed with a Kidney Stone ...” The “GL” indicated, “ ... Service recovery due 5/10. [SRA] ... 5/3Tasked to [Assistant Patient Care Executive {APCE}] and [EDD] to f/u [follow up] with patient. [SRA] 5/5 Grievance letter sent 5/10 [SRA] ...”. The “GL” indicated the issue resolution date was 5/8/23. During an interview on 12/15/23 at 2:00, p.m. with Pt 29, Pt 29 stated she was “ ... kicked out ...” by the physician and no CT or lab results were shared with her. Pt 29 stated the next day she was taken by ambulance to another facility, saw a nephrologist (a doctor specializing in kidneys) and was told she had a leak in her stomach and had fluid and blood removed. Pt 29 stated she never received a phone call or letter or heard from the facility after her complaint. During a concurrent interview and record review on 12/18/23 at 3:43 p.m. with the Risk/Quality Manager (RQM) and the Risk Management Specialist (RMS) reviewed Pt 29’s “CT results”, dated 5/2/23. The RQM stated the CT results indicated, “ ... There is fluid in the peritoneal cavity [space between the abdominal organs] ...” During a concurrent interview and record review on 12/18/23 at 3:49 p.m. with the Risk/Quality Manager (RQM) and the Risk Management Specialist (RMS) reviewed the “GL”. The RMS stated grievances were received by the Risk Management department via email or phone call and then the grievance was forwarded to the director of the involved department to address. The RMS stated sometimes the medical director for the unit completed a chart review. The RMS stated conversations with the complainant, investigations of the grievance, and any actions taken should be documented in the “GL”. The RMS stated the conversations, investigation and actions were not documented in the “GL” for Pt 29’s grievance. The RMS stated the physician peer review task should be in the “GL” for Pt 29 but is not. The RQM and RMS stated they were surprised to learn two of three logged grievance complainants stated they had no contact after grievance was filed. During a review of the facility’s policy titled, “Patient-Related Complaint and Grievance Management (CGM)”, dated 1/27/23, the “CGM” indicated, “ ... DEFINITIONS ... Licensed Independent Practitioner (LIP) - Any practitioner permitted by state law and by the organization to provide care and service, without direction or supervision ... Overview of the grievance process ... When a grievance is received regarding a licensed independent practitioner’s or allied health practitioner’s competence, conduct, or professionalism, the mater will be addressed through the peer review process ... Whenever a grievance involves issues that potentially expose the facility to legal risks, the facility’s risk management department should be consulted at the outset ... responsible risk manager shall determine the best approach for confidentially investigating, resolving, and communicating with the patient or patient’s legal representative. The investigation conducted by Risk Management should be documented ... TIME FRAMES ... Grievances are to be resolved within seven (7) days whenever possible ... GRIEVNACE RESOLUTION ... A grievance is considered resolved when the patient or patient’s legal representative is satisfied with the actions taken on their behalf ... The facility must maintain documentation of its efforts and demonstrate compliance with this policy ...””

“PATIENT RIGHTS: NOTICE OF GRIEVANCE DECISION CFR(s): 482.13(a)(2)(iii) At a minimum: In its resolution of the grievance, the hospital must provide the patient with written notice of its decision that contains the name of the hospital contact person, the steps taken on behalf of the patient to investigate the grievance, the results of the grievance process, and the date of completion. This Standard is not met as evidenced by: 45929 Based on interviews and record review, the facility failed to follow their policy on grievances when, the facility’s written response to Patient (Pt) 28’s mother (PM 28) was in English and not in a language Pt 28 or PM 28 understood and Pt 28 and PM 28 spoke and read in Spanish only. This failure resulted in the hospital not upholding PM 28’s right to a written response describing the resolution to the grievance in a language that PM 28 could understand. Findings: During a review of the facility’s “Grievance Log (GL)”, dated 1/1/23 to 12/15/23, the “GL” indicated on 3/1/23 Pt 28’s parents filed a grievance regarding their son’s care in the Emergency Department (ED). The “GL” indicated, “ ... The parents were concerned because they did not feel the ED doctor took them seriously. They said their son was pale, had a fast heart rate and was complaining of abdominal pain. but the doctor didn’t validate their concerns. The doctor was planning to send them home but [Pt 28] started having rectal bleeding at that time and was then given fluids and transferred to a higher level of care ... stated that if they hadn’t spoken up for him he would have been discharged with a serious medical condition ... [Mother] would like a return call so that she knows that the appropriate people are aware of the situation ...”. During a review of Pt 28’s “Face Sheet (FS, a document with important patient information)”, dated 2/21/23, the “FS” indicated the Pt 28’s spoken and written language were both Spanish. During an interview on 12/15/23 at 1:42 p.m. with the mother of Pt 28 (PM 28), PM 28 stated she speaks and reads in Spanish only. During a concurrent interview and record review on 12/18/23 at 3:45 p.m. with the Risk Management Specialist (RMS) Pt 28’s “Grievance Resolution Letter (GRL)”, dated 3/8/23, was reviewed. The RMS stated the letter was in English and should be in the language the patient or patient’s representative can understand. During a review of the facility’s policy and procedure titled, “Patient-Related Complaint and Grievance Management (CGM)”, dated 1/27/23, the “CGM” indicated, “ ... Overview of the grievance process ... A written notice of the facility’s determination regarding the grievance shall be communicated to the patient or patient’s legal representative in a language and manner that the patient or patient’s legal representative understands ...””

“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: 37529 Based on interview and record review, the hospital failed to provide care in a safe setting for one of four laboring patients (Patient 1), when registered nurses (RNs) in the Labor & Delivery Unit did not accurately interpret and document fetal heart monitoring and did not recognize and act on Patient 1’s high risk for shoulder dystocia. These failures resulted in possible avoidable complications during the birth of the baby for Patient 1. Findings: During a review of Pt 1’s clinical record, the record indicated Pt 1 was admitted by MD 1 to the hospital on 11/17/23 for an induction of labor at 39 weeks 2 days gestation. This was Patient 1’s fifth pregnancy. Pt 1’s obstetrician’s orders and history and physical indicated Pt 1’s labor was being induced due to “Fetal macrosomia (defined as a baby weighing more than 8 pounds, 13 ounces [4,000 grams], regardless of his or her gestational age) in third trimester, History of intrauterine fetal death (IUFD). Active problems include, gestational diabetes mellitus (GDM), Obesity with a Body Mass Index [BMI] of 43 [5 feet tall, weight was 220 pounds], elevated liver function tests, Beta strep positive.” In addition to those pregnancy risk factors, review of Pt 1’s record indicated this was a high risk pregnancy with advanced maternal age (AMA-35 years or older), a history seven years ago of a preterm delivery of a baby at 24 weeks gestation who survived with disabilities, a history of an IUFD at 24 weeks, and two other pregnancy losses at four weeks gestation. Pt 1 received prenatal care with MD 1 and also had several appointments with a perinatologist (doctors who specialize in high-risk pregnancies). Review an ultrasound done on 11/8/23 indicated an estimated fetal weight of 4206 grams and the abdominal circumference measured 393.3 mm (out of range). Review of Pt 1’s labor progress indicated, on 11/17/23 at 12 p.m. Pt 1’s cervix was dilated 4 centimeters (cm; 10 cm is completely dilated) and was 100% effaced (effacement- thinning and shortening of the cervix), and a -3 station (The location of the baby’s presenting part [head] is in relationship to the ischial spines of the pelvis [-3 station is 3 cm above the ischial spines]). Cervix posterior. At 9 p.m. Pt 1 was having occasional mild contractions and the FHR baseline was 130 bpm with variable decelerations. FHR interpretation Category II and RN cannot reach cervix or fetal presenting part in pelvis. Pitocin held. MD 2 examined Pt 1 on 11/18/23 at 12:10 a.m., cervix dilated to 4 cm, 60% effaced, and -3 station, cervical position posterior, Bishop score 5 of a possible 13 (Bishop score- method to rate the readiness of the cervix for induction of labor based on five pelvic exam findings. If the Bishop score is 8 or greater, the chances of having a vaginal delivery are good and the cervix is said to be favorable or “ripe” for induction). Review of the fetal monitor strips on 11/18/23 indicated the presence of early and variable decelerations on and off throughout the day. An epidural was placed at 9:30 a.m. by an anesthesia provider, and at 1 p.m. MD 2 performed and artificial rupture of membranes. Fetal monitor strips reflect recurrent early decelerations. Pt 1 was completely dilated at 3 p.m. and the presenting part was at a 0 station, and Pt 1 began pushing. By 4:40 p.m. Pt 1 was exhausted and stopped pushing for 30 minutes and then resumed pushing. Continued variable decelerations, At 6:35 p.m. a vacuum was applied, and at 6:54 p.m. the baby’s head was delivered, and a tight nuchal cord was reduced. Shoulder dystocia was identified, and nurses notes indicated at 6:54 p.m., “Shoulder dystocia nursing interventions performed-McRoberts, suprapubic pressure, position change, delivery team notified... Provider [MD 2] interventions-Episiotomy, internal rotation. delivery of posterior arm,” and after failed attempts to deliver the body Pt 1 was taken to the operating room to attempt a C-section delivery. The record indicated the monitor strips reflecting the fetal heart rate ended at 7:02 p.m. when Pt 1 was taken to the OR, and the assessment of the FHR after that time is not reflected in the medical record. Efforts to deliver the baby by C/S were unsuccessful., The ED physician was able to deliver the baby vaginally at 7:18 p.m., 24 minutes after the delivery of the head. The baby had no signs of life at delivery and after two hours of attempted resuscitation the baby was pronounced dead. Pt 1 had suffered significant blood loss and also an episiotomy and fourth degree laceration, and after being stabilized Pt 1 was transferred to Hospital B for a higher level of care. The baby’s death record indicated, “brain death due to anoxic brain injury due to shoulder dystocia.” Pt 1’s record indicated there was no documentation on 11/17/23 or 11/18/23 by MD 2. MD 1 arrived to the hospital at 7:52 p.m. and MD 3 arrived at 8: 18 p.m. (Obstetricians called by staff to help). During an interview on 12/13/23 at 10 a.m. with emergency department physician (EDMD 1), EDMD 1 stated he was on duty in the emergency department on 11/18/23 and responded to a call for assistance in labor and delivery. Pt 1 was in the OR and the baby’s head had been delivered vaginally, and Pt 1 also had an abdominal incision and the baby’s legs were sticking out of that incision. EDMD 1 stated MD 2 apparently had attempted to deliver the baby by C-section, but the head was stuck, and MD 2 was unable to get the baby out that way either. EDMD 1 stated he put his hand in Pt 1’s vagina and used his finger to grab the baby’s arm and shoulder and was able to deliver the baby vaginally. EDMD 1 stated he and the RT were working on the baby who had no signs of life, and he also assisted MD 2 with Pt 1. who was bleeding. EDMD 1 stated MD 2 was tired. EDMD 1 stated after other doctors arrived to take over care of both patients, he had to return to the ED because he was the only physician on duty. During an interview on 12/14/23 at 11:15 a.m. with the Director of Maternal-Child Services (DMCS), not do concurrent or retrospective fetal heart monitor strip review to assess consistency of interpretation and documentation as part of RN competency evaluation or annual evaluation of the RNs performance. The DMCS stated she did not review Pt 1’s fetal monitor strips. During a concurrent interview and record review on 12/14/23 at 1:20 p.m. with the OBE, the The OBE stated in 2023, simulation classes were held for the topics of postpartum hemorrhage, hypertensive disorders of pregnancy, vacuum assisted vaginal delivery, umbilical cord prolapse, shoulder dystocia and others. The OBE stated she also teaches fetal heart monitor interpretation, which is required for all obstetric nurses every two years. The OBE stated she is developing a competency for fetal heart monitoring interpretation, and stated that at this time there is no ongoing fetal monitor strip review (retrospective or concurrent) with the staff as a way to validate competency. The OBE stated that the nursing staff are not consistently compliant with their mandatory training including the simulation training provided this year for management of shoulder dystocia and vacuum delivery. She stated she had reported this to the director (DMCS), and it had been discussed in meetings, but does not know what is being done to correct this. The OBE estimated overall staff compliance with required training is “about 50-60%.” The OBE provided copies of the spreadsheet record of staff compliance with attendance at the mandatory classes, annual skills fair, and fetal monitoring class completion. The report indicated for the fetal heart monitor class requirement 27% of the RNs were not compliant. The report indicated 59% of the nursing staff attended the mandatory shoulder dystocia/vacuum assisted delivery simulation training classes held in 2023. Concerning Pt 1’s delivery on 11/18/23, the OBE was asked about her review of Pt 1’s labor and delivery and occurrence of shoulder dystocia and subsequent death of the baby. The OBE stated she was made aware of what had occurred but was not included in the RCA of this case, and was not allowed to review the record including the fetal monitor strips. Fetal monitor strips from different times in Patient 1’s labor were reviewed with the OBE. On 11/18/23 between 8:25 a.m. and 8:43 a.m. the strip indicated minimal and moderate variability, no accelerations, recurrent early decelerations. Review of RN 1’s notes indicated the presence of accelerations 15 x15 (an abrupt increase in FHR above baseline with onset to peak of the acceleration less than 30 seconds. Adequate accelerations are defined as greater than or equal to 15 bpm above baseline for greater than or equal to 15 seconds [15x15]), no decelerations and moderate variability. At 11 am the monitor strip indicated minimal variability, no accelerations, and variable decelerations. RN 1’s notes indicated moderate variability, presence of accelerations 15x15 and variable decelerations. Between 3 p.m. and 4:20 p.m. there were multiple instances where the fetal monitor was not picking up the fetal heart rate well enough to make an assessment of the baseline rate or the characteristics of accelerations or decelerations. RN 1’s notes reflect assessment of the characteristics of the FHR tracing despite the quality of the tracing. The OBE stated the documentation by the nurse doesn’t reflect what is showing on the monitor strips. During a concurrent interview and record review on 12/15/23 at 2:15 p.m. with the OB Educator (OBE), the OBE stated her review of the fetal heart monitor tracings for Pt 1 indicated staff are not always using the accepted, standardized language to describe the characteristics of the fetal heart rate, and there were instances where the nurses notes weren’t consistent with what was reflected on the fetal monitor strip. The OBE stated there is not currently a system in place at the hospital for routine review of fetal monitor strips to assess the accuracy of the labor and delivery RN’s interpretation as part of an ongoing competency assessment or to ensure the standardized language was being used. The OBE stated she planned to use monitor strips as part of her fetal monitoring class and that going forward regular chart review including fetal heart monitor strip review will be part of the ongoing competency assessment of each RN. The OBE provided a copy of the curriculum for the shoulder dystocia training class. The training materials indicated the risk factors for shoulder dystocia include, “Macrosomia 4000-4500 grams, preexisting maternal diabetes or gestational diabetes, maternal obesity [BMI greater than 30], protracted second stage of labor [pushing], maternal short stature, use of vacuum or forceps, previous delivery with shoulder dystocia.” The OBE stated, “She [Pt 1] had almost all of them.” During an interview on 12/15/23 at 3 p.m. with the respiratory therapist (RT)1, RT 1 stated he was in the hospital on 11/18/23 visiting a family member when he was contacted by another RT about Pt 1’s delivery complicated by shoulder dystocia.. RT 1 he went to the operating room to assist and after the baby was delivered with no signs of life, he along with the ED physician started resuscitation measures.. RT 1 stated a neonatologist from Hospital B arrived, participated in the resuscitation efforts and ultimately stopped the resuscitation after there were no signs of life despite lifesaving measures performed for two hours. RT 1 stated EDMD 1 was providing care to both the baby (Pt 2) and the mom (Pt 1), who was bleeding, until another obstetrician arrived. RT 1 stated MD 2 was visibly exhausted and appeared weak. During an interview on 12/19/23 at 10:29 a.m. with the charge nurse (RN 14), RN 14 stated she was the charge nurse working at he time of the shoulder dystocia on 11/18/23. RN 14 stated that day they were short-staffed due to sick calls. RN 14 stated she wasn’t aware of a problem until the head was out. RN 14 stated during Pt 1’s labor, MD 2 “mentioned that she didn’t like the variables [fetal heart rate variable decelerations] she was seeing.” RN 14 stated MD 2 looked tired. RN 14 stated, stated MD 2 did not mention a c-section and, “When I asked [MD 2], what’s your plan with this patient, she said I’m going to do a quick note, then I’m going to push with the patient.” She pushed with the patient for 30-40 minutes. RN 14 stated she was in the room during the delivery after being told that a vacuum was going to be used. An RT was called for the delivery also. RN 14 stated after the head was delivered she heard MD 2 say, “ We have a shoulder.” RN 14 stated, “We didn’t realize how big the baby was. The baby was big - 4200 grams (9.26 pounds).” RN 14 stated an ED physician responded and helped out. RN 14 stated “MD 2 was looking faint and I thought she was going to pass out. I had to act on that very quickly. I called [MD 1] but he didn’t answer because other nurses were calling him, then I called MD 3 and he said it really should be MD 1, and then I called the Chief of OB.” RN 14 stated she intervened on her own, MD 2 did not ask anyone to get help for her. RN 14 stated she has not reviewed the fetal monitor strips. RN 14 stated, “The patient was having variables. The doctor. noticed it, and I noticed it. There was a cord around the neck.” RN 14 stated, “I’ve asked myself, if I should have questioned the use of the vacuum. But MD 2 was pushing for 40 minutes with the patient so she should have noticed if there was turtling effect [Turtle sign-after the fetal head is delivered, it retracts back tightly against the maternal perineum. A sign of shoulder dystocia]. Two physicians should have already established if the pelvis was big enough.” During a review of the professional reference, “American College of Obstetricians and Gynecologists, Practice Bulletin Number 178, Shoulder Dystocia,” dated 5/17, the reference indicated, “...Obstetric simulation is an effective tool in preparing for shoulder dystocia because it is a high acuity/low frequency event...Evidence indicates that introduction of shoulder dystocia simulation and team training protocols at individual institutions may be associated with a reduction in transient brachial plexus injury when shoulder dystocia occurs. After the introduction of a mandatory clinical shoulder dystocia simulation for all personnel on a labor and delivery unit, the frequency of evidence-based management of shoulder dystocia was higher, and the rate of neonatal brachial injury at birth was lower. During a review of the reference titled, “AHRQ Safety Program for Perinatal Care: Monitoring for Perinatal Safety-Electronic Fetal Monitoring, AHRQ Publication No. 17-0003-18-EF, dated 5/17, the reference indicated, “... Use of the standard National Institute for Child Health and Human Development [NICHD] nomenclature for communicating and documenting EFM findings provides a common language for use among providers and staff to decrease variation and provide accurate communication among caregivers. A complete description of an EFM tracing requires a qualitative and quantitative assessment of the following: uterine contractions, baseline FHR, baseline FHR variability, presence of FHR accelerations, periodic or nonperiodic FHR decelerations, and changes in trend over time...Key perinatal safety elements for EFM...Create a mechanism for identifying recurrent nonuse or deviation from the established unit policies or procedures by clinicians. EFM “ strip rounds “ refers to periodic, multidisciplinary review of actual EFM strips from past patients for the purposes of teaching and learning in a team environment. The emphasis of strip rounds is on practicing the use of standardized terminology for describing and communicating the findings from the strip. Strip rounds can be used to practice differentiating Category I, II, and III tracings, and discussion of the standard unit approach for responding to each category of tracing. Regular peer review with feedback for all staff (physicians, midwives, staff nurses) who use and interpret EFM is another strategy that can be used to support use of standard nomenclature. Last, nurse competency assessment and medical staff credentialing and privileging processes specific to EFM use may be another strategy for improving standardization of EFM interpretation and communication...” During a review of the UpToDate article titled, “Shoulder dystocia: Risk factors and planning birth of high-risk pregnancies,” dated 4/7/23, the article indicated,”...Clinicians should be aware of risk factors for shoulder dystocia, so they can discuss the possibility of scheduled cesarean birth with patients at highest risk of occurrence and appropriately manage a prolonged second stage of labor in less high-risk patients...” During a review of internet article, “Shoulder Dystocia-StatPearls-NCBI Bookshelf,” dated 1/23, the article indicated, “...Shoulder dystocia is, by definition, a mechanical problem occurring during a vaginal delivery characterized by one of the following parameters: failure to deliver the fetal shoulders using solely gentle downward traction, requirement of additional delivery maneuvers are needed to successfully deliver the baby, a documented head-to-body interval of greater than 1 minute...Several risk factors for shoulder dystocia have been identified. Fetal macrosomia is the most significant risk factor for shoulder dystocia. Other known risk factors include pregestational and gestational diabetes, prior history of shoulder dystocia, and operative vaginal delivery, particularly with the use of the vacuum...” During a review of the professional reference, “AWHONN position statement: Fetal Heart Monitoring,” dated 11/18, the reference indicated, “...The Association of Women ’ s Health, Obstetric and Neonatal Nurses (AWHONN) maintains that the availability of registered nurses (RNs) and other health care professionals who are skilled in fetal heart monitoring (FHM) techniques, including auscultation and electronic fetal monitoring (EFM), is essential to maternal and fetal well-being during antepartum care, labor, and birth. Fetal heart monitoring requires advanced assessment and clinical judgment skills and should not be delegated to unlicensed assistive personnel or others who do not possess the appropriate licensure, education, and skills validation. Labor is dynamic; therefore, consideration of preferences and identification of risk factors should occur upon admission to the birth setting and should be ongoing throughout labor...” During a review of the Journal of Maternal-Fetal and Neonatal Medicine, Volume 30, Issue 15, article titled, “Fetal macrosomia as a risk factor for shoulder dystocia during vacuum extraction,” dated 5/16, the article reflected the results of a research study of macrosomic babies delivered by vacuum extraction over a 10 year period from 2003 to 2013. The study found, “The risk of shoulder dystocia [SD] was significantly higher in the study group. We found a significant association between SD and vacuum delivery...and the composite adverse neonatal outcome rate was 6.5% in the study group and 1.7% in the control group, respectively...”. During a review of the professional reference titled, “The American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin No. 173- Fetal Macrosomia,” dated 11/16, the reference indicated, “... As birth weight increases, the likelihood of labor abnormalities, shoulder dystocia, birth trauma, and permanent injury to the neonate increases... Regardless of birth weight, infants of women with diabetes have an increased risk of shoulder dystocia, clavicular fracture, and brachial plexus injury...Pregnant women with suspected fetal macrosomia should be provided individualized counseling about the risks and benefits of vaginal and cesarean delivery based on the degree of macrosomia...” During a review of American Journal of Obstetrics and Gynecology (AJOG) article titled, “Association between diabetes in pregnancy and risk of shoulder dystocia by infant birth weight,” dated 1/22, the article indicated, “Diabetes in pregnancy is associated with an increased risk of shoulder dystocia, even at a lower birthweight threshold (4000-4500 grams) than currently recommended for cesarean delivery (>4500 grams).” During a review of the Journal of Clinical Medicine Article titled Vacuum-Assisted Delivery Complication Rates Based on Ultrasound-Estimated Fetal Weight, dated 6/2022, the journal article indicated, a research study was conducted of women with singleton pregnancies at 34-41 weeks gestation, who underwent ultrasonographic pre-labor Estimated Fetal Weight (EFW) and Vacuum Assisted Delivery (VAD) over a six year period. The results of the study indicated, “... After controlling for all potential confounders, higher EFW (greater than or equal to 3700 g), maternal age, and diabetes were found to be independent risk-factors for adverse outcomes. EFW greater than or equal to 3700 grams based on ultrasound was a significant risk factor for shoulder dystocia and clavicular fracture...” During a review of the Sage Journal Women’s Health article titled, “Shoulder dystocia: prediction & management,” dated 2/22/16, the article indicated,”... It is often assumed that shoulder dystocia is an unpredictable and, therefore, unpreventable complication but this fatalism is unwarranted. Although predicting with certainty that shoulder dystocia or BPI will occur in a particular case is rarely possible, our ability to identify cases in which shoulder problems are likely is improving and can help guide clinical decisions. Risk factors can be identified in the patient ’ s history and during prenatal care and labor. Most prominent are a history of prior shoulder dystocia or brachial plexus injury, current fetal macrosomia, maternal obesity, diabetes mellitus, excessive weight gain and dysfunctional labor patterns, especially a long deceleration phase followed by a long second stage. Prediction of this complication is imperfect, but many cases can be avoided by taking multiple risk factors into account and delivering the highest risk cases by preemptive cesarean...” During a review of the reference titled, “AHRQ Safety Program for Perinatal Care: Labor and Delivery Unit Safety- Shoulder Dystocia, AHRQ Publication No. 17-0003-21-EF,” dated 5/17, the reference indicated, ...”Key Perinatal Safety Elements- Have situational awareness. Situational awareness refers to all staff caring for the patient...knowing what the patient’s plan is through briefings and team management, being aware of what is going on and what is likely to happen next...In the context of shoulder dystocia, this includes risk awareness for all patients, timely recognition of a shoulder dystocia diagnosis, awareness and monitoring of time since diagnosis, and discussing next steps if sequential maneuvers are not successful...” key perinatal safety elements related to shoulder dystocia management. Simulation reinforces teamwork and communication related to situational awareness,, ability to get additional help quickly, use of cognitive aids, such as checklists, communication with rapid responders, communication with patient/family, and use of briefings, huddles, and debriefings. Shoulder dystocia simulation training focused on clinical/technical skills may require a mannequin or high-fidelity birthing simulator...””

“QUALITY IMPROVEMENT ACTIVITIES CFR(s): 482.21(b)(2)(ii), (c)(1), (c)(3) (b) Program Data (2) [The hospital must use the data collected to - .....] (ii) Identify opportunities for improvement and changes that will lead to improvement. (c) Program Activities (1) The hospital must set priorities for its performance improvement activities that-- (i) Focus on high-risk, high-volume, or problem-prone areas; (ii) Consider the incidence, prevalence, and severity of problems in those areas; and (iii) Affect health outcomes, patient safety, and quality of care. (3) The hospital must take actions aimed at performance improvement and, after implementing those actions, the hospital must measure its success, and track performance to ensure that improvements are sustained. This Standard is not met as evidenced by: 37529 Based on observation, interview and record review, the hospital failed to set priorities for its performance improvement activities to include high-risk, high volume, or problem-prone areas when the Quality Improvement program did not collect and analyze data related to nursing quality of care in the Perinatal Department, the hospital ’ s busiest unit by patient volume. These failures resulted in the hospital not auditing the charts for women in labor to validate professional nursing practice, and had the potential to result in harm to patients in labor if changes in fetal heart rates go unnoticed. (cross-reference A-397) Findings: A review of the clinical record indicated Pt 1 was admitted to Labor and Delivery on 11/17/23 at 39 weeks and 2 days gestation for an induction of labor with Pitocin for “fetal macrosomia in third trimester, history of intrauterine fetal death.” The record indicated Pt 1 was 35 years old (Advanced Maternal Age- [AMA], age 35 or older) had gestational diabetes and obesity with a body mass index of 43, and an ultrasound on 11/8/23 indicated an estimated fetal weight of 4206 grams (9.27 pounds) and an abdominal circumference of 393.3 mm (out of range). Continuous fetal monitoring was initiated. At 12 p.m. on 11/17/23, an exam indicated Pt 1’s cervix was dilated to 4 centimeters (cm), 100% effaced and -3 station and was having occasional contractions. On 11/18/23 at 1 p.m., MD 2 performed an artificial rupture of membranes, and at 3 p.m. Pt 1 was completely dilated and began pushing. By 4:40 p.m. Pt 1 was exhausted and stopped pushing for 30 minutes and then resumed pushing. At 6:35 p.m. a vacuum was applied, and at 6:54 p.m. the baby’s head was delivered, and a tight nuchal cord was reduced. Shoulder dystocia was identified, and after failed attempts to deliver the body, Pt 1 was taken to the operating room to attempt a C-section delivery which was unsuccessful. The ED physician was able to deliver the body vaginally at 7:18 p.m., 24 minutes after the delivery of the head. The baby had no signs of life at delivery and after two hours of attempted resuscitation the baby was pronounced dead. Pt 1 suffered significant blood loss and after being stabilized Pt 1 was transferred to Hospital B for a higher level of care. The baby’s death record indicated, “brain death due to anoxic brain injury due to shoulder dystocia.” Pt 1’s record indicated there was no documentation on 11/17/23 or 11/18/23 by MD 2. During an interview on 12/14/23 at 11:15 a.m. with the Director of Maternal-Child Services (DMCS), the DMCS stated she does not routinely audit nursing documentation to assess the quality of documentation or quality of care. The DMCS stated she does not do concurrent or retrospective fetal heart monitor strip review to assess consistency of interpretation and documentation as part of RN competency evaluation or annual evaluation of the RNs performance. The DMCS stated she did not review Pt 1’s fetal monitor strips. During an interview on 12/15/23 at 9:30 a.m. with the APCE, the APCE stated they are not doing routine chart reviews or fetal monitor strip reviews as part of their performance improvement activities for obstetrics. During a concurrent interview and record review on 12/15/23 at 2:15 p.m. with the OB Educator (OBE), the OBE stated her review of the fetal heart monitor tracings for Pt 1 indicated staff are not always using the accepted, standardized language to describe the characteristics of the fetal heart rate, and there were instances where the nurses notes weren’t consistent with what was reflected on the fetal monitor strip. The OBE stated there is not currently a system in place at the hospital for routine review of fetal monitor strips to assess the accuracy of the labor and delivery RN’s interpretation as part of an ongoing competency assessment or to ensure the standardized language was being used. The OBE stated she planned to use monitor strips as part of her fetal monitoring class and that going forward regular chart review including fetal heart monitor strip review will be part of the ongoing competency assessment of each RN. During a review of hospital document titled, “ Policy: QAPI Plan “ last revision date 5/25/2023, the document indicated, “ ...Policy Summary/Intent: In support of the Organization’s mission and vision, the purpose of Organizational Quality Assessment and Performance Improvement (QAPI) plan is to ensure that the Governing Body, Medical Staff, clinical and professional services staff deliver safe, effective and optimal patient care and assure a safe environment for patients, visitors and the workforce ...6. Performance Improvement Projects: a. The QC [Quality Committee] shall oversee performance improvement projects (performance improvement teams, focused studies,) the number and scope of which shall be proportional to the scope and complexity of the hospital ’ s services and operations. The QC must also ensure there is documentation of what quality improvement projects are being the rationale behind conducting those projects, and the measurable progress achieved as evidenced on the projects. 7. Follow-up: a. The QC shall assure that steps taken to improve performance and enhance safety are appropriately implemented, measured, and tracked to determine that the steps have achieved and sustained the intended effect. 1. The FOCUS Plan, Do, Check Act (FOCUS PDCA) methodology is utilized to plan, design, measure, assess and improve functions and processes related to patient care and safety throughout the organization. “ During a concurrent interview and record review on 12/18/23 at 1:35 p.m. with RN 15, RN 15 explained the two Performance Improvement Projects that the Perinatal Department was working on. The first document, titled “ Performance Improvement Report Form ...Project: Appointment Scheduling Improvement “ dated 6/12/23 indicated the department was working on improving the patient scheduling process. The report did not include evidence of the FOCUS PDCA methodology. The second document, titled “ Performance Improvement Report Form ...Project: Improve Outpatient Report Handoff “ dated 9/13/22 indicated the department was working on improving the consistency of communication between nurses and physicians. The report did not include evidence of the FOCUS PDCA methodology, and there were no results described on the document to indicate that communication has improved. During an interview on 12/19/23 at 9:10 a.m. in the Birthing Center with Obstetrics Educator (OBE) and the Director of OB, nursing staff were asked if they had been involved in any performance improvement projects on their unit. Monitor Technician 1 stated she had not been involved in any performance improvement projects related to quality of care and could not state any projects that were in progress. RN 14 stated she had never been involved with any projects and was not aware of projects that were in progress. A professional reference from the National Institute of Health retrieved from <https://pubmed.ncbi.nlm.nih.gov/28802345/> indicated, “ ... Implementation of standardized practices in the delivery room fosters a safe environment to ensure that newborn infants are cared for optimally, whether or not they require extensive resuscitation. Quality improvement (QI) is an excellent methodology for implementation of standardized practices due to the multidisciplinary nature of the delivery room, the complexity of the tasks involved, and opportunities to track measurable processes and outcomes ... “ During a review of the reference titled, “AHRQ Safety Program for Perinatal Care: Monitoring for Perinatal Safety-Electronic Fetal Monitoring, AHRQ Publication No. 17-0003-18-EF, dated 5/17, the reference indicated, “... Use of the standard National Institute for Child Health and Human Development [NICHD] nomenclature for communicating and documenting EFM findings provides a common language for use among providers and staff to decrease variation and provide accurate communication among caregivers. A complete description of an EFM tracing requires a qualitative and quantitative assessment of the following: uterine contractions, baseline FHR, baseline FHR variability, presence of FHR accelerations, periodic or nonperiodic FHR decelerations, and changes in trend over time...Key perinatal safety elements for EFM...Create a mechanism for identifying recurrent nonuse or deviation from the established unit policies or procedures by clinicians. EFM “ strip rounds “ refers to periodic, multidisciplinary review of actual EFM strips from past patients for the purposes of teaching and learning in a team environment. The emphasis of strip rounds is on practicing the use of standardized terminology for describing and communicating the findings from the strip. Strip rounds can be used to practice differentiating Category I, II, and III tracings, and discussion of the standard unit approach for responding to each category of tracing. Regular peer review with feedback for all staff (physicians, midwives, staff nurses) who use and interpret EFM is another strategy that can be used to support use of standard nomenclature. Last, nurse competency assessment and medical staff credentialing and privileging processes specific to EFM use may be another strategy for improving standardization of EFM interpretation and communication...” During a review of the World Health Organization’s (WHO) document titled “STANDARDS FOR IMPROVING QUALITY OF MATERNAL AND NEWBORN CARE IN HEALTH FACILITIES,” dated 2016, the document outlined a framework for improving the quality of care for mothers and newborns around the time of childbirth. The document identified standards and quality statements to define the priorities for quality improvement. The document indicated, “Quality Statement 2.1: Every woman and newborn has a complete, accurate, standardized medical record during labor, childbirth and the early postnatal period. Complete, accurate medical recording during labor is important for documenting care, clinical follow-up, accurate hand-over, early detection of complications and health outcomes and provides information for identifying areas for improvement...2.2: Every health facility has a mechanism for data collection, analysis and feedback as part of its activities for monitoring and improving performance around the time of childbirth The purpose of data collection is to provide information that can be analyzed and used appropriately to provide feedback and improve health outcomes...””

“PATIENT SAFETY CFR(s): 482.21(a), (c)(2), (e)(3) (a) Standard: Program Scope (1) The program must include, but not be limited to, an ongoing program that shows measurable improvement in indicators for which there is evidence that it will ... identify and reduce medical errors. (2) The hospital must measure, analyze, and track ...adverse patient events ... (c) Program Activities ..... (2) Performance improvement activities must track medical errors and adverse patient events, analyze their causes, and implement preventive actions and mechanisms that include feedback and learning throughout the hospital. (e) Executive Responsibilities, The hospital’s governing body (or organized group or individual who assumes full legal authority and responsibility for operations of the hospital), medical staff, and administrative officials are responsible and accountable for ensuring the following: ... (3) That clear expectations for safety are established. This Standard is not met as evidenced by: 37529 Based on interview and record review, the facility failed to thoroughly analyze one of one adverse patient event (an event, preventable or nonpreventable, that caused harm to a patient) when the hospital’s internal investigation (root cause analysis (RCA) - process of discovering the root causes of problems in order to identify appropriate solutions) did not identify gaps in nursing competencies and training. This failure interfered with the thorough investigation into the root causes and contributing factors of Patient (Pt) 1’s events that occurred during hospitalization, delayed implementation of the action plan to prevent recurrence, and had potential harm to laboring mothers and their infants. (cross-reference tag - A397). Findings: A review of the clinical record indicated Pt 1 was admitted to Labor and Delivery on 11/17/23 at 39 weeks and 2 days gestation for an induction of labor with Pitocin for “fetal macrosomia in third trimester, history of intrauterine fetal death.” The record indicated Pt 1 was 35 years old (Advanced Maternal Age- [AMA], age 35 or older) had gestational diabetes and obesity with a body mass index of 43, and an ultrasound on 11/8/23 indicated an estimated fetal weight of 4206 grams (9.27 pounds) and an abdominal circumference of 393.3 mm (out of range). Continuous fetal monitoring was initiated. At 12 p.m. on 11/17/23, an exam indicated Pt 1’s cervix was dilated to 4 centimeters (cm), 100% effaced and -3 station and was having occasional contractions. 11/18/23 at 1 p.m. Pt 1 was dilated to 8 cm, 90% effaced and -1 station and MD 2 performed and artificial rupture of membranes. Pt 1 was completely dilated at 3 p.m. and the presenting part was at a 0 station, and Pt 1 began pushing. By 4:40 p.m. Pt 1 was exhausted and requested to stop pushing. After a 30 minute break, exam indicated a +1 station and Pt 1 resumed pushing. Continued to push and at 6:35 p.m. Pt 1 agreed to the use of a vacuum. At 6:54 p.m. the baby’s head was delivered with the vacuum and soon after shoulder dystocia (delivery of head followed by failure to deliver the fetal shoulders using solely gentle downward traction, requirement of additional delivery maneuvers, a documented head-to-body interval of greater than 1 minute) was identified. After failed attempts to deliver the body, Pt 1 was taken to the operating room to attempt C/S delivery which was unsuccessful. An ED physician was able to deliver the body vaginally at 7:18 p.m., 24 minutes after the delivery of the head. The baby had no signs of life at delivery and after two hours of attempted resuscitation the baby was pronounced dead. Pt 1 suffered significant blood loss and after being stabilized Pt 1 was transferred to Hospital B for a higher level of care. The record indicated there was no documentation on 11/17/23 or 11/18/23 by MD 2. During a concurrent interview and record review on 12/14/23 at 2 p.m. with the Risk Management Specialist (RMS), the RMS showed a printed document which she stated was the Root Cause Analysis (RCA) for the investigation of the index case (Patients 1 and 2 [baby of Patient 1]). The RMS stated the RCA occurred on 11/28/23 at 1 p.m., and she attended the meeting. The document showed a timeline of events starting when Pt 1 first arrived in the birthing center and ended with the deceased newborn. The pages of the document titled “ Barriers “ and “ Conclusions “ were blank. There was no evidence of any attempt to determine if the difficult delivery should have been anticipated or if anything could have been done differently while Pt 1 was in labor that might have saved the baby ’ s life. The RMS stated the document was the entire RCA and could not state any conclusions that were reached. During an interview on 12/12/23 at 11 a.m. with the DMCS, Patient (Pt) 1 delivery on 11/18/23 was discussed. The DMCS stated Pt 1 had risk factors for shoulder dystocia since the baby had suspected macrosomia, Pt 1 was diabetic, and was obese. Pt 1 pushed for hours, was exhausted and a vacuum was used. The DMCS stated she had reviewed the record and participated in an RCA of this incident. The DMCS was asked if there was discussion with Pt 1 and/or with MD 2 about a C/S delivery at any time during Pt 1’s labor or during the hours of pushing when Pt 1 was exhausted, and the DMCS stated no. The DMCS stated she did not identify anything during the RCA that she thought could have been done differently. During an interview on 12/14/23 at 1:20 p.m. with the Obstetrics Educator (OBE), the OBE was asked about her review of Pt 1’s labor and delivery and occurrence of shoulder dystocia and subsequent death of the baby. The OBE stated she was made aware of what had occurred but was not included in the RCA of this case, and was not allowed to review the record including the fetal monitor strips. She stated she asked to review the record, but the DMCS told her she could not. The OBE stated she did not know the director’s reasons for not allowing her to review the record, but that “when your director tells you no” then you don’t review it. The OBE stated as the OB educator and instructor of the fetal monitoring classes it is valuable for her to review the record of a serious event including the fetal monitor strips. The OBE stated in 2023 they had a mandatory simulation training class on shoulder dystocia and vacuum assisted delivery, but that there were many staff who had not attended either session. The OBE stated approximately 60% of the nursing staff attended this mandatory training. During an interview on 12/19/23 at 10:29 a.m. with RN 14, RN 14 stated she was the Charge Nurse on the day of the incident, “ I remember that we were short staffed. We had 2 sick calls that day. “ She was asked to attend the RCA on 11/28/23. RN 14 stated the RCA was a review of the timeline of events, and they did not determine what the cause of the baby ’ s death was. RN 14 stated the people leading the RCA “asked if we had done all of the maneuvers, which we had,” and asked if a c-section was considered and if the use of the vacuum was appropriate. They mentioned the simulation training classes, and if they (the nurses) hadn ’ t attended what does the Director do. RN 14 stated the irregularities in the fetal monitoring strips weren ’ t discussed in the RCA, and they didn ’ t review the fetal monitoring strips during the RCA. CN 1 stated, “The patient was having variables [variable heart rate decelerations]. The doctor noticed it, and I noticed it. There was a cord around the neck.” During a concurrent interview and record review on 12/15/23 8:34 a.m. with the APCE, the RQM and the RMS, the RQM presented a document which they stated was developed 12/14/23 in the evening. The document was an action plan to address the need for additional training for nurses in the Labor and Delivery department. The APCE stated this is a new action plan, and it was not created prior to the arrival of the survey team. The Centers for Medicare & Medicaid Services (CMS) Center for Clinical Standards and Quality/Quality, Safety & Oversight Group Ref: QSO-23-09-Hospital indicated, “ ... A hospital with a well-designed and well-maintained QAPI program, fully engaged in hospital-wide continuous assessment and improvement efforts can significantly enhance its ability to provide high quality and safe care to its patients, and thereby reduce the incidence of medical errors and adverse events throughout the hospital ... “ During a review of the reference titled, “AHRQ Safety Program for Perinatal Care: Monitoring for Perinatal Safety-Electronic Fetal Monitoring, AHRQ Publication No. 17-0003-18-EF”, dated 5/17, the reference indicated, ...”Key Safety Element- Learn from Defects: Debrief and analyze near misses and adverse events, and the contribution of Electronic Fetal Monitoring [EFM] use, EFM interpretation, and communication of EFM findings. This allows for understanding of what went well, what could have gone better, and what could be done differently next time. Have a process in place to review severe maternal or neonatal morbidity or mortality events. Share the outcomes and process improvements from the debriefings and from formal analysis with the staff to achieve transparency and enhance organizational learning...” During a review of the reference titled, “AHRQ Safety Program for Perinatal Care: Labor and Delivery Unit Safety- Shoulder Dystocia, AHRQ Publication No. 17-0003-21-EF,” dated 5/17, the reference indicated, ...”Key Perinatal Safety Elements- Debrief and analyze near misses and adverse events related to shoulder dystocia...Share outcomes or process improvements from the informal (debriefing) and formal analysis with staff...Have situational awareness. Situational awareness refers to all staff caring for the patient...knowing what the patient ’ s plan is through briefings and team management, being aware of what is going on and what is likely to happen next...In the context of shoulder dystocia, this includes risk awareness for all patients, timely recognition of a shoulder dystocia diagnosis, awareness and monitoring of time since diagnosis, and discussing next steps if sequential maneuvers are not successful...””

“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: 37529 Based on observation, interview and record review, the hospital failed to ensure registered nurses were competent to provide care to meet the patients’ needs when: Labor and delivery (L&D) staff did not have evidence of current competency in fetal heart rate interpretation, L&D staff did not participate in mandatory simulation training classes for obstetrical emergencies and annual skills fair, and RN staff were performing a physical examination and determination of the presence of labor for patients coming to labor and delivery seeking care without having training or validation of competency. These failures resulted in RNs not accurately interpreting and documenting the fetal heart rate monitoring during Patient 1’s labor and delivery, and potentially not being prepared to recognize Pt 1’s risk factors for shoulder dystocia in order to escalate concerns to the physician. These failures also placed all laboring patients at risk for potential harm if nursing staff are not prepared to respond appropriately to shoulder dystocia and other obstetric emergencies. Findings: During a concurrent observation and interview on 12/12/23 at 10:30 a.m. with the Director of Maternal-Child Services (DMCS), the labor and delivery, postpartum, and newborn units were observed. The DMCS stated the current staffing for the labor and delivery unit was a “lead” registered nurse (RN) plus three additional RNs. The DMCS stated their core (minimum) staffing was a lead RN plus two other RNs and then they add more RNs depending on the census and acuity. The DMCS stated all of the RNs are required to have Basic Life Support (BLS-Cardiopulmonary Resuscitation [CPR]), Advanced Cardiovascular Life Support (ACLS- builds on BLS, includes early recognition and management of resp and cardiac arrest, airway and medication management), Neonatal Resuscitation Program (NRP-evidence-based approach to the evaluation and resuscitation of newborns at birth), Intermediate or Advanced Fetal Monitoring, Annual Skills Fair, and simulation classes scheduled at different times during the year for OB emergencies including umbilical cord prolapse, maternal hemorrhage, hypertensive disorders of pregnancy, shoulder dystocia and vacuum assist. The DMCS stated they have an OB Educator (OBE) who coordinates the classes. The DMCS stated the labor and delivery RNs do perform an examination and evaluation of patients who come to L&D to be assessed for labor, and before discharging the patient the RN is required to call the physician. A list of RNs who were determined to be competent to perform an examination and evaluation of pregnant patients for the presence of labor and/or other pregnancy related issues and have been approved to do so as identified in the medical staff bylaws was requested of the Risk/Quality Manager (RQM) as well as the policy, competency, and standardized procedure guiding the examination and evaluation process. The hospital was not able to provide evidence of training or competency validation for the RNs. During an interview on 12/12/23 at 11 a.m. with the DMCS, Patient (Pt) 1’s delivery on 11/18/23 was discussed. The DMCS stated she was called by the nursing staff and came in after Pt 1 was already in the operating room. The DMCS stated Pt 1 was admitted at 39 weeks and 2 days gestation for induction of labor (stimulation of uterine contractions before the onset of labor) on 11/17/23 due to possible fetal macrosomia (baby weighing more than 8 pounds, 13 ounces [4,000 grams], regardless of his or her gestational age), and previous pregnancy losses. The DMCS stated this was Pt 1’s fifth pregnancy and Pt 1 had three previous pregnancy losses at an early gestational age. The DMCS stated Pt 1 had one living child with disabilities who was born prematurely at 24 weeks gestation and is now seven years old. The DMCS stated Pt 1 had risk factors for shoulder dystocia (delivery of head followed by failure to deliver the fetal shoulders using solely gentle downward traction, requirement of additional delivery maneuvers, a documented head-to-body interval of greater than 1 minute) since the baby had suspected macrosomia, Pt 1 was diabetic, and was obese. Pt 1 pushed for hours, was exhausted and the pushing was not effective. The DMCS stated a vacuum was used, with one pop-off (the vacuum cup becomes disengaged) and with the vacuum assist the head was delivered. The DMCS stated after the head was out the body was stuck and a shoulder dystocia was identified. The DMCS stated the staff tried “all of the maneuvers” to get the baby delivered but they were unsuccessful, so Pt 1 was taken to the OR to do an emergency cesarean section (C/S). The DMCS stated Pt 1 had an extensive episiotomy to the rectum also. The DMCS stated they were not able to deliver the baby by C/S, but the ED physician who responded to the call for assistance was able to deliver the baby vaginally. The DMCS stated there was more than 20 minutes from the delivery of the head until the delivery of the body and the baby had no signs of life, but resuscitation was attempted but the baby did not respond. The DMCS stated she had reviewed the record and participated in a root cause analysis (RCA) of this incident. The DMCS was asked if there was discussion with Pt 1 and/or with MD 2 of having a C/S delivery at any time during Pt 1’s labor or during the hours of pushing when Pt 1 was exhausted, and the DMCS stated no. The DMCS stated she did not identify anything during the RCA that she thought they could have done differently. The DMCS stated the RN (RN 1) who took care of Pt 1 on 11/18/23 was on vacation and would not be available for interview, and the lead RN (RN 13) working on 11/18/23 had just left work due to a personal issue and would be off for several days. During a review of Pt 1’s medical record, the record indicated the following: On 11/17/23 at 6:10 a.m., Pt 1 came to the hospital for an induction of labor. Pt 1 was 35 years old (Advanced Maternal Age) and was spanish-speaking. The baseline Fetal Heart Rate (FHR) was 115 beats per minute (bpm), moderate variability, contractions every 2-3 minutes. At 12 p.m. a vaginal exam indicated Pt 1’s cervix was dilated to 4 centimeters (cm- 10 cm is completely dilated) and was 100% effaced (effacement- thinning and shortening of the cervix), and a -3 station (Where the baby’s presenting part [head] is located in relationship to the ischial spines of the pelvis [-3 station is 3 cm above the ischial spines]). Cervix posterior. Membranes intact. At 12:20 p.m. MD 1 ordered admission for induction of labor at 39 weeks 2 days gestation for “history of fetal demise and possible macrosomia.” Review of MD 1’s admission history and physical (H&P) indicated, “Assessment/plan: “Fetal macrosomia in third trimester. Hx of intrauterine fetal death. Active problems include: gestational diabetes mellitus (GDM), Obesity with a Body Mass Index [BMI] of 43 [5 feet tall, weight was 220 pounds], elevated liver function tests, Beta strep positive.” MD 1 orders included Pitocin induction, blood glucose every 4 hours. Review of nurses notes dated 11/17/23 at 8:30 p.m., indicated RN 2 performed a vaginal exam and was unable to reach the cervix and could not feel the presenting part in the pelvis. At 9 p.m. Pt 1 was having occasional mild contractions and the FHR baseline was 130 bpm with variable decelerations. FHR interpretation Category II. MD 2 notified that RN cannot reach cervix or fetal presenting part in pelvis. Pitocin held. MD 2 examined Pt 1 on 11/18/23 at 12:10 a.m., cervix dilated to 4 cm, 60% effaced, and -3 station, cervical position posterior, Bishop score 5 of a possible 13 (Bishop score- method to rate the readiness of the cervix for induction of labor based on five pelvic exam findings. If the Bishop score is 8 or greater, the chances of having a vaginal delivery are good and the cervix is said to be favorable or “ripe” for induction. If the Bishop score is 6 or less the chances of having a vaginal delivery are low and the cervix is said to be unfavorable or “unripe” for induction.) 11/18/23 9:25- Epidural initiated by the anesthesia provider for pain relief and at 1 p.m. vaginal exam indicated Pt 1’s cervix was dilated to 8 cm, 90% effaced, and -1 station. Artificial rupture of membranes (AROM) by MD 2, clear fluid noted. Fetal monitor strips reflect recurrent early decelerations. 11/18/23 3 p.m. Pt 1 completely dilated, 100% effaced, and at a 0 station (presenting part is at the level of the ischial spines of the pelvis). Started pushing. By 4:40 p.m. Pt 1 was exhausted and asked for a break from pushing. A 30 minute break was given, and the pushing resumed at 5:10 p.m. Exam indicated +1 station. Fetal monitor strip at 5 p.m. indicated baseline fetal heart rate of 160 bpm, with recurrent decelerations. At 6 p.m. MD 2 in room pushing with Pt 1. At 6:25 p.m. Pt 1 agreed to use of a vacuum. At 6:35 the vacuum was applied with a pop-off at 6:38. Vacuum reapplied. At 6:54 p.m. vacuum assisted delivery of the baby’s head occurred and there was a tight nuchal cord (the umbilical cord becomes wrapped around the fetal neck 360 degrees). Shoulder dystocia identified immediately by MD 2. Nurses notes indicated shoulder dystocia nursing interventions performed were McRoberts, suprapubic pressure, position change. Nurses notes indicated Provider interventions by MD 2 were episiotomy, internal rotation. delivery of posterior arm. Other physicians called by staff to help. Efforts to deliver baby vaginally were unsuccessful and at 7 p.m. Pt 1 was taken to the operating room to attempt delivery by emergency C/S. The record indicated recording of the FHR stopped at 7:02 p.m. when Pt 1 was taken to the OR, and the assessment of the FHR after that time is not reflected in the medical record. Efforts to deliver the baby by C/S were unsuccessful. The ED physician who responded to the call for assistance was able to deliver the baby vaginally at 7:18 p.m. (24 minutes after the head was delivered). Apgar scores 0/0/0 at 1, 5, and 10 minutes of life. (Apgar score-assessment of color, heart rate, reflexes, muscle tone, respiration, each of which is given a score of 0, 1, or 2. Assessed at 1 minute and 5 minutes after birth for all infants, and at 5-minute intervals thereafter until 20 minutes for infants with a score less than 7). After attempts to resuscitate the baby for two hours were unsuccessful the baby was pronounced dead. Pt 1 experienced significant blood loss and after receiving ten units of blood and other blood products, she was transferred to Hospital B for a higher level of care. The baby’s death record indicated, “brain death due to anoxic brain injury due to shoulder dystocia.” A review of the physician notes for 11/17/23 and 11/18/23 indicated there was no documentation by MD 2. Review of Pt 1’s prenatal ultrasound reports indicated on 11/8/23, Pt 1 had an ultrasound to assess fetal size. The report indicated the baby’s estimated weight was 4206 grams, and the abdominal circumference of the baby measured 393.3 mm (out of range). During an interview on 12/13/23 at 10 a.m. with emergency department physician (EDMD 1), EDMD 1 stated he was on duty in the emergency department on 11/18/23. EDMD 1 stated he is the only physician on during the shift and responded to the overhead call for assistance in labor and delivery. EDMD 1 stated he took a couple of ED nurses with him. EDMD 1 stated when he arrived in labor and delivery Pt 1 was in the OR and the baby’s head had been delivered vaginally, and Pt 1 also had an abdominal incision and the baby’s legs were sticking out of that incision. EDMD 1 stated there was “blood everywhere.” EDMD 1 stated Pt 1 was asleep, and the anesthesia provider was there. EDMD 1 stated MD 2 apparently had attempted to deliver the baby by C-section, but the head was stuck, and MD 2 was unable to get the baby out that way either. EDMD 1 stated he put his hand in Pt 1’s vagina and used his finger to grab the baby’s arm and shoulder and was able to deliver the baby vaginally. EDMD 1 stated the baby was limp and had no signs of life, and he immediately took the baby to the warmer where the respiratory therapist (RT) was. EDMD 1 stated he and the RT began resuscitation measures and the resuscitation went on for a long time. EDMD 1 stated he also assisted MD 2 with Pt 1. who was bleeding. EDMD 1 stated MD 2 was tired. EDMD 1 stated after other doctors arrived to take over care of both patients, he had to return to the ED because he was the only physician on duty. During an interview on 12/14/23 at 11:15 a.m. with the DMCS, the DMCS stated she had reviewed the record and that her opinion is “everything was fine until it wasn’t.” She stated she had not reviewed the fetal monitor strips, just the nurses notes which reflected the RNs interpretation of the fetal heart rate, documented at intervals during Pt 1’s labor. The DMCS stated she does not do fetal heart rate monitor strip review as part of her annual evaluation of the RNs performance. The DMCS stated there was nothing in the record indicating a C/S had been considered or discussed during Pt 1’s labor or prolonged second stage (Second stage- the period from complete dilation of the cervix [10 cm] until delivery of the baby) which lasted longer than 4 hours (prolonged- defined as more than 2 hours without or 3 hours with epidural analgesia in nulliparous women [women who have not had a previous birth], and 1 hour without, or 2 hours with epidural in women with at least one previous birth). As far as staffing on 11/18/23, the DMCS stated on 11/18/23 there were three RN sick calls which left a lead RN and two other RNs for the labor and delivery unit. The DMCS stated the staffing ended up being “ok; kind of,” and that no one called her during the day to indicate the day was unmanageable. The DMCS stated on 11/17/23 there were also staffing issues which caused a delay in starting Pt 1’s labor induction. During a concurrent interview and record review on 12/14/23 at 1:20 p.m. with the OBE, the OBE stated she has worked for the hospital system for twenty-one years and since 6/22 she has been in the role of educator for the maternal child units. The OBE stated part of her responsibilities included coordinating and teaching an annual skills fair, organizing, and teaching simulation classes for different obstetric emergencies and other content. In 2023, simulation classes were held for the topics of postpartum hemorrhage, hypertensive disorders of pregnancy, vacuum assisted vaginal delivery, umbilical cord prolapse, shoulder dystocia and others. The OBE stated she also teaches intermediate fetal heart monitor interpretation, which is required for all obstetric nurses, and in April 2024 she will also start teaching advanced fetal monitoring classes, which is not required to be taken but is strongly recommended. The OBE stated RNs are required to take fetal monitoring classes every two years. The OBE stated she is developing a competency for fetal heart rate monitoring interpretation, and stated that at this time there is no ongoing fetal monitor strip review (retrospective or concurrent) with the staff as a way to validate competency. The OBE stated that the nursing staff are not consistently compliant with their mandatory training including the training provided this year for management of shoulder dystocia. She stated she reports this to the director (DMCS), and it has been discussed in meetings, but does not know what is being done to correct this. The OBE estimated staff compliance with required training is “about 50-60%.” The OBE provided copies of the curriculum for the OB simulation training classes held during the year as well as the spreadsheet record of staff compliance with attendance at the mandatory classes, annual skills fair, and fetal monitoring class completion. Concerning Pt 1’s delivery on 11/18/23, the OBE was asked about her review of Pt 1’s labor and delivery and occurrence of shoulder dystocia and subsequent death of the baby. The OBE stated she was made aware of what had occurred but was not included in the RCA of this case, and was not allowed to review the record including the fetal monitor strips. She stated she asked to review the record, but the DMCS told her she could not. The OBE stated she did not know the director’s reasons for not allowing her to review the record, but that “when your director tells you no” then you don’t review it. The OBE stated as the OB educator and instructor of the fetal monitoring classes it is valuable for her to review the record including the fetal monitor strips. Fetal monitor strips from different times in Patient 1’s labor were reviewed with the OBE. On 11/18/23 between 8:25 a.m. and 8:43 a.m. the strip indicated minimal and moderate variability, no accelerations, recurrent early decelerations. Review of RN 1’s notes indicated the presence of accelerations 15 x15 (an abrupt increase in FHR above baseline with onset to peak of the acceleration less than 30 seconds. Adequate accelerations are defined as greater than or equal to 15 bpm above baseline for greater than or equal to 15 seconds [15x15]), no decelerations and moderate variability. At 11 am the monitor strip indicated minimal variability, no accelerations, and variable decelerations. RN 1’s notes indicated moderate variability, presence of accelerations 15x15 and variable decelerations. Between 3 p.m. and 4:20 p.m. there were multiple instances where the fetal monitor was not picking up the fetal heart rate well enough to make an assessment of the baseline rate or the characteristics of accelerations or decelerations. RN 1’s notes reflect assessment of the characteristics of the FHR tracing despite the quality of the tracing. The OBE stated the documentation by the nurse doesn’t reflect what is showing on the monitor strips. During a review of the content outline of the class on shoulder dystocia provided by the OBE, the outline indicated the risk factors for shoulder dystocia include, “Macrosomia 4000-4500 grams, preexisting maternal diabetes or gestational diabetes, maternal obesity [BMI greater than 30], protracted second stage of labor [pushing], maternal short stature, use of vacuum or forceps, previous delivery with shoulder dystocia.” During a review of the spreadsheet document provided by the OBE listing staff compliance with fetal heart monitoring education and training, the spreadsheet indicated the hospital was unable to provide evidence that eleven of the forty-one RNs (27%) who were required to take intermediate or advanced fetal monitoring classes every two years, had done so. The classes were held on four different dates in 2023, with additional classes available if needed. During a review of the spreadsheet provided by the OBE listing nursing staff compliance with attendance at mandatory simulation classes and annual skills fair conducted during 2023, the spreadsheet indicated the topic, dates of classes, and staff attendance by name: Postpartum Hemorrhage on 2/22/23 and 2/23/2023, 65% compliance (16 of 41 did not attend); Annual Skill Fair 5/4/23, 67% compliance (21 of 64 did not attend); Hypertensive Disorders of Pregnancy/Eclampsia, Abdominal Prep/Surgical Site Infection Prevention on 6/28/23 and 6/29/23, 49% compliance (22 of 43 did not attend); Shoulder Dystocia/Operative Vaginal Delivery (Vacuum Assist) on 9/13/23 and 9/14/23, 59% compliance (21 of 51 did not attend), and Cord Prolapse/STAT C/S on 11/15/23 and 11/16/23, 62% compliance (20 of 52 did not attend). During an interview on12/14/23 at 3 p.m. with MD 1, MD 1 stated he admitted Pt 1 on 11/17/23 for an induction of labor for possible macrosomia and her history of three pregnancy losses. MD 1 stated since estimates of fetal weight can be inaccurate, scheduling an elective C/S was not indicated. He stated MD 2 was working on 11/18/23 but that a nurse called him when the patient was in the operating room, and he came in. He arrived after the body was delivered. He stated he had not reviewed the fetal heart monitor strips. The interview ended due to MD 1 being called to a delivery. During an interview on 12/15/23 at 9:30 a.m. with the APCE, the APCE stated they are not doing chart reviews or fetal monitor strip reviews as part of their performance improvement activities. During a concurrent interview and record review on 12/15/23 at 2:15 p.m. with the OBE, the OBE stated her review of the fetal heart monitor tracing for Pt 1 indicated staff are not always using the accepted, standardized language to describe the characteristics of the fetal heart rate. The OBE stated is planning to use monitor strips as part of her class and that the staff will be given a test they must pass as part of the competency validation. Going forward regular chart review including fetal heart monitor strip review will be part of the ongoing competency assessment of each RN. During an interview on 12/15/23 at 3 p.m. with the respiratory therapist (RT)1, RT 1 stated he has been a respiratory therapist at the hospital for more than 20 years. RT 1 stated in addition to working as a respiratory therapist in the hospital, he also is an NRP instructor. RT 1 stated he was in the hospital on 11/18/23 visiting a family member when he was contacted by another RT about Pt 1’s delivery complicated by shoulder dystocia. RT 1 stated he went to the birthing center and Pt 1 was in the operating room, with the baby’s head delivered but not the body. RT 1 stated there were a lot of people in the room. RT 1 stated MD 2 was there and an ED physician (EDMD 1). RT 1 stated he prepared the warmer in anticipation of the delivery and when EDMD 1 was able to get the baby out vaginally he brought the baby to RT 1 at the warmer. RT 1 stated the baby was floppy, showed no signs of life and was cyanotic. RT 1 stated he and EDMD 1 began resuscitation measures according to the NRP algorithm, and other staff assisted with the resuscitation efforts. RT 1 stated throughout the code lasting nearly two hours, they were not able to auscultate a heartbeat but did get a pulse showing on the monitor. RT 1 stated a neonatologist from Hospital B arrived, participated in the resuscitation efforts and ultimately stopped the resuscitation after there were no signs of life despite lifesaving measures performed. RT 1 stated during the code, EDMD 1 was providing care to both the baby (Pt 2) and the mom (Pt 1), who was bleeding, until another obstetrician arrived. RT 1 stated MD 2 was visibly exhausted and appeared weak, and EDMD 1 assisted her. During an interview on 12/19/23 at 8 a.m. with the APCE, the APCE stated MD 2 is on vacation and is not working at the hospital again until January. During an interview on 12/19/23 at 8:22 a.m. with the OBE and the Director of OB (DOB) at their sister hospital (covering for the DMCS), the DOB stated, “We didn ’ t have a competency for the medical screening exam process,” but they have developed one and have started training and validating staff competency. During an interview on 12/19/23 at 10:29 a.m. with the charge nurse (RN 14), RN 14 stated she was the charge nurse working at he time of the shoulder dystocia on 11/18/23. RN 14 stated that day they were short-staffed due to sick calls. RN 14 stated she was told that Pt 1 was here for induction of labor for gestational diabetes mellitus (GDM- diabetes not present prior to pregnancy) and there was a delay in starting the induction because of staffing. RN 14 stated she wasn’tt aware of a problem until the head was out. Prior to that Pt 1 was tired and Pt 1’s primary nurse (RN 1) called MD 2 and Pt 1 was given a 30 minute break from pushing. RN 14 stated she saw MD 2 at the bedside a few times and “MD 2 mentioned that she didn’t like the variables [fetal heart rate variable decelerations] she was seeing.” RN 14 stated MD 2 looked tired. RN 14 stated, “When I asked [MD 2], what’s your plan with this patient, she said I’m going to do a quick note, then I’m going to push with the patient.” She pushed with the patient for 30-40 minutes. RN 14 stated she was in the room during the delivery after being told that a vacuum was going to be used. A respiratory therapist was called for the delivery also. RN 14 stated after the head was delivered she heard MD 2 say, “ We have a shoulder.” RN 14 stated, “We didn’t realize how big the baby was. The baby was big - 4200 grams (9.26 pounds).” RN 14 stated MD 2 never discussed a C/S at any time. RN 14 stated an ED physician responded and helped out. RN 14 stated “MD 2 was looking faint and I thought she was going to pass out. I had to act on that very quickly. I called [MD 1] but he didn’t answer because other nurses were calling him, then I called MD 3 and he said it really should be MD 1, and then I called the Chief of OB.” RN 14 stated she intervened on her own, MD 2 did not ask anyone to get help for her. RN 14 stated she has not reviewed the fetal monitor strips. RN 14 stated, “The patient was having variables. The doctor. noticed it, and I noticed it. There was a cord around the neck.” RN 14 stated she was involved in the RCA, and they did not determine what the cause was. RN 14 stated the people leading the RCA “asked if we had done all of the maneuvers which we had,” and asked if a c-section was considered and if the use of the vacuum was appropriate. RN 14 stated the simulation training classes were discussed too, and if they (the nurses) hadn’t attended what does the Director do. RN 14 stated as far as what could have been done differently, “I’ve asked myself, if I should have questioned the use of the vacuum. But MD 2 was pushing for 40 minutes with the patient so she should have noticed if there was turtling effect [Turtle sign-after the fetal head is delivered, it retracts back tightly against the maternal perineum. A sign of shoulder dystocia]. Two physicians should have already established if the pelvis was big enough.” During a review of the professional reference, “American College of Obstetricians and Gynecologists, Practice Bulletin Number 178, Shoulder Dystocia,” dated 5/17, the reference indicated, “...Obstetric simulation is an effective tool in preparing for shoulder dystocia because it is a high acuity/low frequency event...Evidence indicates that introduction of shoulder dystocia simulation and team training protocols at individual institutions may be associated with a reduction in transient brachial plexus injury when shoulder dystocia occurs. After the introduction of a mandatory clinical shoulder dystocia simulation for all personnel on a labor and delivery unit, the frequency of evidence-based management of shoulder dystocia was higher, and the rate of neonatal brachial injury at birth was lower. During a review of the professional reference, “AWHONN position statement: Fetal Heart Monitoring,” dated 11/18, the reference indicated, “...The Association of Women ’ s Health, Obstetric and Neonatal Nurses (AWHONN) maintains that the availability of registered nurses (RNs) and other health care professionals who are skilled in fetal heart monitoring (FHM) techniques, including auscultation and electronic fetal monitoring (EFM), is essential to maternal and fetal well-being during antepartum care, labor, and birth. Fetal heart monitoring requires advanced assessment and clinical judgment skills and should not be delegated to unlicensed assistive personnel or others who do not possess the appropriate licensure, education, and skills validation. Labor is dynamic; therefore, consideration of preferences and identification of risk factors should occur upon admission to the birth setting and should be ongoing throughout labor...” During a review of internet article, “Shoulder Dystocia-StatPearls-NCBI Bookshelf,” dated 1/23, the article indicated, “...Shoulder dystocia is, by definition, a mechanical problem occurring during a vaginal delivery characterized by one of the following parameters: failure to deliver the fetal shoulders using solely gentle downward traction, requirement of additional delivery maneuvers are needed to successfully deliver the baby, a documented head-to-body interval of greater than 1 minute...Several risk factors for shoulder dystocia have been identified. Fetal macrosomia is the most significant risk factor for shoulder dystocia. Other known risk factors include pregestational and gestational diabetes, prior history of shoulder dystocia, and operative vaginal delivery, particularly with the use of the vacuum...” During a review of the UpToDate article titled, “Shoulder dystocia: Risk factors and planning birth of high-risk pregnancies,” dated 4/7/23, the article indicated,”...Clinicians should be aware of risk factors for shoulder dystocia, so they can discuss the possibility of scheduled cesarean birth with patients at highest risk of occurrence and appropriately manage a prolonged second stage of labor in less high-risk patients...” During a review of the Journal of Clinical Medicine Article titled Vacuum-Assisted Delivery Complication Rates Based on Ultrasound-Estimated Fetal Weight, dated 6/2022, the journal article indicated, a research study was conducted of women with singleton pregnancies at 34-41 weeks gestation, who underwent ultrasonographic pre-labor Estimated Fetal Weight (EFW) and Vacuum Assisted Delivery (VAD) over a six year period. The results of the study indicated, “... After controlling for all potential confounders, higher EFW (greater than or equal to 3700 g), maternal age, and diabetes were found to be independent risk-factors for adverse outcomes. EFW greater than or equal to 3700 grams based on ultrasound was a significant risk factor for shoulder dystocia and clavicular fracture...” During a review of the Journal of Maternal-Fetal and Neonatal Medicine, Volume 30, Issue 15, article titled, “Fetal macrosomia as a risk factor for shoulder dystocia during vacuum extraction,” dated 5/16, the article reflected the results of a research study of macrosomic babies delivered by vacuum extraction over a 10 year period from 2003 to 2013. The study found, “The risk of shoulder dystocia [SD] was significantly higher in the study group. We found a significant association between SD and vacuum delivery...and the composite adverse neonatal outcome rate was 6.5% in the study group and 1.7% in the control group, respectively...”. During a review of the professional reference titled, “The American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin No. 173- Fetal Macrosomia,” dated 11/16, the reference indicated, “... As birth weight increases, the likelihood of labor abnormalities, shoulder dystocia, birth trauma, and permanent injury to the neonate increases... Infants who are macrosomic because of maternal glucose intolerance tend to have greater total body fat, greater shoulder and upper-extremity circumferences, greater upper-extremity skin-fold measurements, and smaller head-to-abdominal-circumference ratios compared with macrosomic infants of women without diabetes. It has been suggested that it is this altered fetal body shape that is responsible for the higher incidence of shoulder dystocia seen among infants of women with diabetes. Regardless of birth weight, infants of women with diabetes have an increased risk of shoulder dystocia, clavicular fracture, and brachial plexus injury...Pregnant women with suspected fetal macrosomia should be provided individualized counseling about the risks and benefits of vaginal and cesarean delivery based on the degree of macrosomia...” During a review of the professional reference titled, “The American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin No. 49 on Dystocia and Augmentation of Labor,” dated 11/03, the reference indicated a prolonged second stage is defined as,” more than 2 hours without or 3 hours with epidural analgesia in nulliparous women, and 1 hour without, or 2 hours with epidural in multiparous women.” During a review of the journal article in American Family Physician, Volume 102, Number 2, titled, “Shoulder Dystocia: Managing an Obstetric Emergency,” dated 7/15/20, the article indicated, “...Risk factors for shoulder dystocia include fetal macro¿somia, prior shoulder dystocia, and preexisting or gestational diabetes melli¿tus. Other risk factors include maternal obesity, excessive maternal weight gain during pregnancy, oxytocin (Pitocin) use, prolonged first or second stage labor, and operative vaginal delivery (forceps or vacuum) ... ACOG and the Advanced Life Support in Obstetrics program recommend that labor and delivery teams conduct regular team train¿ing drills that include iden¿tification and management of shoulder dystocia. Training and simulation exer¿cises improve physician and team performance when shoulder dystocia occurs...” During a review of American Journal of Obstetrics and Gynecology (AJOG) article titled, “Association between diabetes in pregnancy and risk of shoulder dystocia by infant birth weight,” dated 1/22, the article indicated, “Diabetes in pregnancy is associated with an increased risk of shoulder dystocia, even at a lower birthweight threshold (4000-4500 grams) than currently recommended for cesarean delivery (>4500 grams).” During a review of the Sage Journal Women’s Health article titled, “Shoulder dystocia: prediction & management,” dated 2/22/16, the article indicated,”... It is often assumed that shoulder dystocia is an unpre¿dictable and, therefore, unpreventable complica¿tion but this fatalism is unwarranted. Although predicting with certainty that shoulder dystocia or BPI will occur in a particular case is rarely possible, our ability to identify cases in which shoulder problems are likely is improving and can help guide clinical decisions. Risk factors can be identified in the patient ’ s history and during prenatal care and labor. Most prominent are a history of prior shoulder dystocia or brachial plexus injury, current fetal macrosomia, maternal obesity, diabetes mellitus, excessive weight gain and dysfunctional labor patterns, especially a long deceleration phase followed by a long second stage. Prediction of this complication is imperfect, but many cases can be avoided by taking multiple risk factors into account and delivering the highest risk cases by preemptive cesarean...” During a review of International Journal of Molecular Sciences article titled, “Diabetes during Pregnancy: A Maternal Disease Complicating the Course of Pregnancy with Long-Term Deleterious Effects on the Offspring. A Clinical Review,” dated 3/15/21, the article indicated, “Fetal macrosomia in diabetic pregnancies is characterized by the larger shoulder and extremity circumferences, a decreased head-to-shoulder ratio, significantly higher body fat, and thicker upper-extremity skin-folds due to the accumulation of subcutaneous fat in the abdominal and interscapular areas. Macrosomia can firstly be diagnosed by ultrasound around week 24 and is generally maintained throughout pregnancy. Fetal macrosomia has been associated with higher perinatal mortality, risk of Erb ’ s palsy, shoulder dystocia, brachial plexus trauma, and neonatal morbidity, and is a cause of severe maternal complications during labor that may be threatening maternal life...” During a review of the reference titled, “AHRQ Safety Program for Perinatal Care: Monitoring for Perinatal Safety-Electronic Fetal Monitoring, AHRQ Publication No. 17-0003-18-EF, dated 5/17, the reference indicated, “... Use of the standard National Institute for Child Health and Human Development [NICHD] nomenclature for communicating and documenting EFM findings provides a common language for use among providers and staff to decrease variation and provide accurate communication among caregivers. A complete description of an EFM tracing requires a qualitative and quantitative assessment of the following: uterine contractions, baseline FHR, baseline FHR variability, presence of FHR accelerations, periodic or nonperiodic FHR decelerations, and changes in trend over time...Key perinatal safety elements for EFM...Create a mechanism for identifying recurrent nonuse or deviation from the established unit policies or procedures by clinicians. EFM “ strip rounds “ refers to periodic, multidisciplinary review of actual EFM strips from past patients for the purposes of teaching and learning in a team environment. The emphasis of strip rounds is on practicing the use of standardized terminology for describing and communicating the findings from the strip. Strip rounds can be used to practice differentiating Category I, II, and III tracings, and discussion of the standard unit approach for responding to each category of tracing. Regular peer review with feedback for all staff (physicians, midwives, staff nurses) who use and interpret EFM is another strategy that can be used to support use of standard nomenclature. Last, nurse competency assessment and medical staff credentialing and privileging processes specific to EFM use may be another strategy for improving standardization of EFM interpretation and communication...” During a review of the professional reference, “Obstetric Care Consensus, American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine-Pregnancy at Age 35 years or Older,” dated 8/22, the reference indicated, “...Advanced Maternal Age...We suggest that pregnancy with anticipated delivery at age 35 years or older be recognized as a risk factor for adverse maternal, fetal, and neonatal outcomes when counseling patients and determining management plans...””

“INFECTION CONTROL SURVEILLANCE, PREVENTION CFR(s): The infection prevention and control program includes surveillance, prevention, and control of HAIs, including maintaining a clean and sanitary environment to avoid sources and transmission of infection, and addresses any infection control issues identified by public health authorities; and This Standard is not met as evidenced by: 40644 45929 Based on observations, interviews and record review, the facility failed to maintain a clean and sanitary environment to avoid sources of transmission of infection when, 1. On 12/12/23 Sterile Processing Technician (SPT) 1 missed a hand washing opportunity and two of three hand sanitizer dispensers in the in the surgical area were empty and were not monitored for the level of sanitizer per facility’s policy. 2. Wet sterile instruments were drying on a towel directly over an open package of sterile (free from bacteria and microorganisms) towels in conflict with sterility professional standards. 3. Two of two anesthetists (medical specialists who administer anesthetics, medication inducing insensitivity to pain) did not have their facial hair covered before and during surgical procedures in the Operating Room (OR) in accordance with the facility’s policy on surgical attire. These failures resulted in a potential for cross contamination and potential for spread of infectious diseases to patients and staff. Findings: 1. During a concurrent observation and interview on 12/12/23 at 11:20 a.m. with SPT 1, the Surgical Services Director (SSD), and the Surgical Services Manager (SSM), SPT 1, the SSD and the SSM exited the Sterile Processing decontamination room (area in which biological debris is removed from used surgical instruments), into the main hallway and into the surgical department to the door of the sterile processing room. SPT 1 and the SSD attempted to use the hand sanitizer dispenser before entering the sterile processing room (where surgical instruments are sterilized (made free from bacteria). The SSD stated the dispenser was empty. The SSD and the SSM attempted to use the next closest hand sanitizer dispenser, outside the OR room. SPT 1 continued into the sterile processing room without performing hand hygiene. The SSD stated the second dispenser was also empty. The SSD went into the Post Anesthesia Care Unit (PACU, recovery area) and located a dispenser with hand sanitizer. The SSD and the SSM used the hand sanitizer to perform hand hygiene. During an interview on 12/12/23 at 11:22 a.m. with the SSD and the SSM, the SSD and the SSM stated Environmental Services (EVS) fills the hand sanitizer dispensers. The SSD and the SSM stated they did not know if EVS staff checks the dispensers or if nursing staff calls EVS when the dispensers are empty. During an interview on 12/12/23 at 2:45 p.m. with the Environmental Services General Manager (EVSM), the EVSM stated EVS staff completed a terminal clean (procedure required to ensure an area has been cleaned/decontaminated following use by a patient to ensure a safe environment for the next patient) in the surgical department after surgery was completed. The EVSM stated hand sanitizer levels in the dispensers were to be checked by the EVS team with a terminal clean and filled if dispensers were empty. During a review of “Surgery Schedule (SS)”, dated 12/12/23, the “SS” indicated only one surgery scheduled for 12/12/23 from 7:00 a.m. to 7:58 p.m. During an interview on 12/18/23 at 1:15 p.m. with the Infection Preventionist (IP), the IP stated EVS was responsible for filling hand sanitizer dispensers, but everyone was responsible for their own hand hygiene and any staff in the area should have called EVS to have dispensers filled. The IP stated someone should have noticed two empty dispensers so close together and this indicated poor hand hygiene practices. The IP stated hand hygiene was the best way to prevent infection. During a review of the facility’s policy titled “Hand Hygiene (HH)”, dated 2/8/22, “HH” indicated, “ ... Use alcohol-based rub or soap and water to routinely decontaminate hands in the following clinical situations ... After contact with medical equipment in patient areas ... after removing gloves ...”. During a review of the facility’s “Seven Step Cleaning Process (SSCP)” (undated), the “SSCP” indicated, “ ... CLEANING IN PATIENT ROOMS ... HOSPITAL CLEAN STANDARDS ... Dispensers are free of dust, soiling and residue and restocked appropriately ... ‘Go Beyond What’s Expected’ ...”. 2. During a concurrent observation and interview on 12/12/23 at 11:25 a.m. in the sterile processing room with SPT 1, surgical instruments were drying on a towel on top of a wire shelf, which was directly over the opening of a bag of sterile towels. SPT 1 stated the drying instruments could drip water onto the sterile towels in the bag and contaminate the towels. SPT 1 stated the bag of towels should have been covered and should be re-sterilized. During an interview on 12/18/23 at 1:19 p.m. with the IP, the IP stated surgical instruments that are washed but not sterilized can drip water and contaminate the bag of sterile towels under the drying rack. The IP stated any water on the towels could cross contaminate and carry microorganisms or bacteria on a sterile package into the OR. During the review of a professional reference titled, “Sterilizing Practices (SP)” from the Centers for disease Control and Prevention (CDC), dated 9/18/16, the “SP” indicated, “ ... Sterile items that become wet are considered contaminated because moisture brings with it microorganisms from the air and surfaces ...”. 3. During an observation on 12/13/23 at 9:15 a.m. in the OR, during the preparation of and the OR for Patient (Pt) 21’s surgery, Certified Registered Nurse Anesthetist (CRNA) 1 was noted to be wearing a face mask which did not cover his beard on the sides of his face and under his chin. Throughout Pt 21’s surgery, CRNA 1 continued to have his facial hair exposed. During an observation on 12/13/23 at 3:30 p.m. in the Birthing OR (operating room in labor and delivery), during the preparation for Pt 22’s Cesarean section (C-section, the surgical delivery of a baby though a cut made in the mother’s abdomen), Anesthesiologist (AN) 1 was noted to be wearing a face mask which did not cover his beard or sideburns. AN 1 was noted to have exposed hair at the nape of his neck, not covered by his surgical cap. AN 1’s nape and facial hair continued to be exposed throughout Pt 22’s C-section. During a concurrent interview and record review on 12/18/23 at 1:17 p.m. with the IP, the facility’s policy titled “Surgical Attire (SA)”, dated 10/2022, was reviewed. The “SA” indicated, “ ... Personnel entering the semi-restricted and restricted areas should cover the head, hair and facial hair ... personnel should wear a clean surgical head cover or hood that covers all visible hair, scalp skin, sideburns, and nape of neck ...”. The IP stated “SA” is a corporate policy and all entities (facilities in the corporation) must follow the “SA”. The IP stated that anesthesiology personnel were not an exception to the “SA”. During a review of a professional reference titled, “Behind the Scenes: patient safety in the operating room and central materiel service during deployments (BTS)” retrieved from https://www.ncbi.nlm.nih.gov/books/NBK20543/pdf/Bookshelf_NBK20543.pdf, the “BTS” indicated, “ ... The semi-restricted area is where scrub attire and hair coverings are worn, the scrub sinks are located, and clean and sterile supplies are stored; it also includes some of the areas used to process surgical instruments. The restricted area includes operating rooms, procedure rooms, and clean-core areas. This is where full surgical attire and masks are worn ...” During a review of a professional reference titled “Statement on Surgical Attire (SSA)” form the American Society of Anesthesiologist, dated 10/26/22, the “SSA” indicated, “ ... Recommendations ... When in a restricted or semi-restricted procedural area, cover facial hair not contained within a mask ... When choosing a facial hair covering material, consider containment of shed particles, comfort and fit ... Healthy human skin and hair is colonized [settled in, establish control over] by bacteria ... and generally are not eliminated by routine bathing and shampooing ... Wearing head gear during surgical procedures is also recommended to prevent dispersion [spreading] of infectious particles shed from the scalp and hair. Hair may entrap and sequester [isolate] shed skin particles, and these may be released into the ambient [surrounding] air ... covering that completely cover the hair would most effectively prevent dispersion [distribution] ...”.”