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Based on observation, interview and record review, the hospital failed to conspicuously post signs in the Emergency Department (ED) entrance, admission area, waiting room and treatment areas, which specified the rights of individuals under the Emergency Medical Treatment and Active Labor Act (EMTALA), regarding examination and treatment for emergency medical conditions and women in labor (ready to give birth). This failure had the potential for patients and families to be unaware of their rights under EMTALA.

Findings:

During an observation on 8/8/22, at 10:15 AM, with Registered Nurse (RN) Clinical Analyst (RNCA) 1, at the ED security entrance, on the wall, were two small (8.5 inches by 11 inches each) white notices with black printing. One notice was in English and the other notice was in Spanish. The notice indicated, "NOTICE FOR EMERGENCY ROOM IT'S THE LAW! If you have an Emergency Medical Condition or are in Labor ..."

During an observation on 8/8/22, at 10:17 AM, with RNCA 1, in the ED waiting room, RNCA 1 was unable to locate signage for patient rights under EMTALA.

During an observation on 8/8/22, at 10:22 AM, with RNCA 1, in the ED treatment area (back area), RNCA 1 was unable to locate signage for patient rights under EMTALA.

During an interview on 8/8/22, at 10:35 AM, with RN 1, in Zone 4 (mental health treatment area), RN 1 stated, the facility did not have a patient right's poster in Zone 4.

During an interview on 8/8/22, at 10:40 AM, with ED Director, ED Director stated, the back area of the ED would be considered treatment areas. ED Director stated, she was not aware of any signs for patient rights under EMTALA except those in the front of the ED.

During an observation on 8/9/22, at 1:30 PM, with RNCA 1, a couple walked past the EMTALA notices posted in the security screening area without stopping to look at the signs.

During an interview on 8/9/22, at 1:48 PM, in the ED waiting room, with ED Director, ED Director stated, she did not recall any other signage for EMTALA in the ED other than by security.

During a concurrent observation and interview on 8/9/22, at 2:06 PM, with RNCA 1, at the ED Admission area, no signage regarding patient rights under EMTALA was noted. Patient Access 1 stated, she did not give every patient a copy of the Patient Rights and It's the Law. Patient Access 1 stated, she only provided a copy of the rights if patients' asked for it.

During a review of the facility policy and procedure (P&P) titled, "Compliance with EMTALA," dated 1/29/20, the P&P indicated, Signage - The signs posted by [facility name] in its dedicated emergency department(s) and in a place or place(s) likely to be noticed by all individuals entering the dedicated emergency department(s) (including waiting room, admitting area, entrance and treatment areas), that inform individuals of their rights under EMTALA.

Based on interview and record review, the facility failed to ensure:

1. A standardized procedure policy was developed to determine Registered Nurses' (RN) qualification to perform an Obstetric (OB- related to pregnancy, labor, or delivery) Medical Screening Exam (MSE) within the California Board of Registered Nursing (BRN) guidelines.

2. OB MSEs were performed by qualified RNs who met the competency standards and were signed off to perform OB MSEs by an OB medical doctor (MD), for 10 of 17 OB triage (assignment of degrees of urgency to patients seeking emergency care) nurses (RN 2, RN 3, RN 4, RN 5, RN 6, RN 7, RN 8, RN 9, RN 11 and RN 12).

3. Four of five sample patients (Patient 16, Patient 17, Patient 18, and Patient 19) in the Labor & Delivery (L&D) triage unit were assigned an Emergency Severity Index (ESI) score.

These failures had the potential for OB patients to have MSEs performed by unqualified nursing staff and the timeliness of completion of the MSE to be prolonged.

Findings:

1. During an interview on 8/8/22, at 10:29 AM, with Interim Labor & Delivery Nurse Manager (INM), INM stated, the hospital had a core group of L&D staff who had competencies to work in the L&D triage and perform MSEs on patients who presented to L&D triage. A copy of the hospital's standardized procedure (SP- legal mechanism for registered nurses to perform functions which would otherwise be considered the practice of medicine) policy, which guides OB triage nurses to perform an MSE, was requested. INM stated, she was unsure if the hospital had a SP policy.

During an interview on 8/8/22, at 10:38 AM, with RN 10, RN 10 stated, OB triage nurses take an annual exam to maintain competency as an OB triage nurse.

During an interview on 8/8/22, at 1:55 PM, with INM, INM stated, she was unable to find a unit specific SP policy for L&D Triage Unit or a hospital-wide SP policy.

During an interview on 8/9/22, at 8:35 AM, with Director of Maternal/Child Health (DMCH), DMCH stated, there was not an SP policy for nurses conducting MSEs in the OB triage unit. DMCH stated, an OB MD signs off on nursing competency to perform MSEs in OB triage.

2. During an interview on 8/8/22, at 10:29 AM, with INM, INM stated, the hospital had a core group of L&D RNs who had competencies to work in the L&D triage and perform MSEs on patients who present to L&D triage.

During an interview on 8/8/22, at 10:45 AM, with INM, INM stated, an OB MD signs off on each OB triage nurse's competency to perform MSEs in OB triage.

During an interview on 8/9/22, at 8:35 AM, with DMCH, DMCH stated, OB MD signs off on nursing competency to perform MSEs in OB triage.

During a concurrent interview and record review, on 8/8/22, at 2:53 PM, with Risk Management Manager (RMM), RN 2's "Self-Assessment and Verification of Competency Obstetrical Medical Screening Exam Labor and Delivery/OB Triage RN" (SAVC) form, dated 8/6/12, was reviewed. RMM stated, there was no MD signature on the form.

During a concurrent interview and record review, on 8/8/22, at 2:55 PM, with RMM, RN 3's SAVC form, dated 12/11/18, was reviewed. RMM stated, there was no MD signature on the form.

During a concurrent interview and record review, on 8/8/22, at 2:56 PM, with RMM, RN 4's SAVC form, dated 10/2/19, was reviewed. RMM stated, there was no MD signature on the form.

During a concurrent interview and record review, on 8/8/22, at 3:01 PM, with RMM, RN 5's SAVC form, dated 8/6/12, was reviewed. RMM stated, there was no MD signature on the form.

During a concurrent interview and record review, on 8/8/22, at 3:07 PM, with RMM, RN 6's SAVC form, dated 3/20/13, was reviewed. RMM stated, there was no MD signature on the form.

During a concurrent interview and record review, on 8/8/22, at 3:09 PM, with RMM, RN 7's SAVC form, dated 8/5/12, was reviewed. RMM stated, there was no MD signature on the form.

During a concurrent interview and record review, on 8/8/22, at 3:10 PM, with RMM, RN 8's SAVC form, dated 7/21/20, was reviewed. RMM stated, there was no MD signature on the form.

During a concurrent interview and record review, on 8/8/22, at 3:12 PM, with RMM, RN 9's SAVC form, dated 12/8/17, was reviewed. RMM stated, there was no MD signature on the form.

During a concurrent interview and record review, on 8/8/22, at 3:16 PM, with RMM, RN 11's SAVC form, dated 3/23/13, was reviewed. RMM stated, there was no MD signature on the form.

During a concurrent interview and record review, on 8/8/22, at 2:47 PM, with RMM, RN 12's SAVC form, dated 9/8/21, was reviewed. RMM stated, there was no MD signature on the form.

During a review of the hospital's "Medical Staff Rules and Regulations," dated 2/23/22, the Medical Staff Rules and Regulations indicated, "4.3. Standardized Procedures: (a) The Medical Executive Committee and the District's nursing and pharmacy departments must review and approve any standardized procedures that permit treatment to be initiated by an individual (for example, a nurse) without a prior specific order from the attending physician. All standardized procedures will identify well-defined clinical scenarios for when the procedure is to be used. (b) The Medical Executive Committee will confirm that all approved standardized procedures are consistent with nationally recognized and evidence-based guidelines. The Medical Executive Committee will also ensure that such standardized procedures are reviewed periodically. (c) If the use of a standardized procedure has been approved by the Medical Executive Committee, treatment may be initiated for a patient pursuant to the standardized procedure: (1) by a nurse or other authorized individual acting within his or her scope of practice who activates the standardized procedure; or (2) when a nurse enters documentation into the medical record that triggers the standardized procedures. (d) When used, standardized procedures must be dated, timed, and authenticated promptly in the patient's medical record by the individual who activates the procedure or by another responsible practitioner. (e) The attending physician must authenticate the initiation of each standardized procedure after the fact, with the exception of those for influenza and pneumococcal vaccines."

During a review of the California Board of Registered Nursing's guideline titled, "Standardized Procedure Guidelines," dated 1/11, the "Standardized Procedure Guidelines" indicated, "1470. Purpose The Board of Registered Nursing in conjunction with the Division of Allied Health Professions of the Board of Medical Quality Assurance (see the regulations of the Board of Medical Quality Assurance, Article 9.5, Chapter 13, Title 16 of the California Code of Regulations) intends, by adopting the regulations contained in the article, to jointly promulgate guidelines for the development of standardized procedures to be used in organized health care systems which are subject to this rule. The purpose of these guidelines is: (a) To protect consumers by providing evidence that the nurse meets all requirements to practice safely. (b) To provide uniformity in development of standardized procedures. 1474. . . Standardized Procedure Guidelines Following are the standardized procedure guidelines jointly promulgated by the Division of Allied Health Professions of the Board of Medical Quality Assurance and by the Board of Registered Nursing: (a) Standardized procedures shall include a written description of the method used in developing and approving them and any revision thereof. (b) Each standardized procedure shall: (1) Be in writing, dated and signed by the organized health care system personnel authorized to approve it. (2) Specify which standardized procedure functions registered nurses may perform and under what circumstances. (3) State any specific requirements which are to be followed by registered nurses in performing particular standardized procedure functions. (4) Specify any experience, training, and/or education requirements for performance of standardized procedure functions. (5) Establish a method for initial and continuing evaluation of the competence of those registered nurses authorized to perform standardized procedure functions. (6) Provide for a method of maintaining a written record of those persons authorized to perform standardized procedure functions. (7) Specify the scope of supervision required for performance of standardized procedure functions, for example, immediate supervision by a physician. (8) Set forth any specialized circumstances under which the registered nurse is to immediately communicate with a patient's physician concerning the patient's condition. (9) State the limitations on settings, if any, in which standardized procedure functions may be performed. (10) Specify patient record keeping requirements. (11) Provide for a method of periodic review of the standardized procedures."

3. During an interview on 8/8/22, at 10:34 AM, with RN 10, RN 10 stated, there was not an ESI component to the OB triage MSE, as there is in the Emergency Department. RN 10 stated, OB triage nurses determined the severity of a patient's clinical presentation by the nurse's clinical experience.

During an interview on 8/8/22, at 1:55 PM, with INM and RN 10, INM and RN 10 stated, OB triage nurses did not assign an ESI score to patients who presented to the L&D triage.

During an interview on 8/9/22, at 8:35 AM, with DMCH, DMCH stated, no numerical values [ESI score] were assigned to patients during the OB triage process. DMCH stated, "We will have to work on that."

During a concurrent interview and review of Patient 16's medical record on 8/9/22, at 9:30 AM, with Clinical Informaticist (CI) 2, Patient 16 was seen in the OB Triage unit on 2/2/22 at 5:08 PM. Patient 16 was 32 4/7 weeks pregnant with complaints of cramping and left sided pain. CI 2 stated, no ESI was assigned to Patient 16.

During a concurrent interview and review of Patient 17's medical record on 8/9/22, at 9:36 AM, with CI 2, Patient 17 was seen in the OB Triage unit on 4/5/22, at 10:58 AM. Patient 17 was 37 4/7 weeks pregnant and sent from her OB MD's office with complaints of itching. CI 2 stated, no ESI was assigned to Patient 17.

During a concurrent interview and review of Patient 18's medical record on 8/9/22, at 9:47 AM, with CI 1, Patient 18 was seen in the OB Triage unit on 6/23/22, at 4:16 PM. Patient 18 was 26 weeks pregnant with complaints of back pain. CI 1 stated, no ESI was assigned to Patient 18.

During a concurrent interview and review of Patient 19's medical record on 8/9/22, at 10:39 AM, with CI 2, Patient 19 was seen in the OB Triage unit on 5/31/22, at 10:41 AM. Patient 19 was 35 6/7 weeks pregnant and sent to the hospital from her OB MD's office with complaints of decreased amniotic fluid (fluid surrounding fetus in the uterus) and needing a steroid (reduces inflammation) injection. CI 1 stated, no ESI was assigned to Patient 19.

During a concurrent interview and record review, on 8/9/22, at 3:30 PM, with DMCH, the "Emergency Severity Index (ESI Triage) Determining the right acuity for your patients" (ESI Triage) exam was reviewed. DMCH stated, the ESI Triage exam was the annual competency exam used to ensure OB triage nurses remain competent to perform OB MSEs. DMCH stated, the ESI Triage did not contain any reference to OB triage or OB patients. DMCH stated, OB triage nurses did not assign ESI scores to their patients.

During a review of the hospital's policy and procedure (P&P) titled, "Triage of Pregnant Patient Greater Than 20 Weeks Gestation in OB Triage (EMTALA)," dated 7/29/19, the P&P indicated, "All patients requesting services who are greater than 20 weeks gestation will have an Obstetrical Medical Screening (MSE) by a qualified Registered Nurse (RN) who has completed their competencies in OB Triage. The Obstetrical MSE will include assessment of contractions, assessment of cervical dilatation [opening of uterus] and effacement [thinning of opening of uterus] if indicated, assessment of the fetal heart tones, and status of the amniotic sac of fluid. Pregnant patients presenting to Labor and Delivery will have an Obstetrical Medical Assessment Exam in OB triage within 30 minutes."

Based on interview and record review, the hospital failed to:

1. Ensure one of 16 transferred patients (Patient 1) received a risk and benefit statement of transfer from the emergency department (ED) physician while awake and alert.

2. Ensure three of 16 transferred patients (Patient 1, Patient 23, and Patient 25) had a Patient Transfer Acknowledgement signed by either the patient or patient's responsible party.

These failures had the potential for patients' or patients' responsible party to be unable to make informed decisions before consenting to the transfer.

Findings:

1. During a review of Patient 1's "Emergency Documentation," dated 3/5/22, the Emergency Documentation indicated, Patient 1 was a 47-year-old male who presented to the hospital on 3/5/22, at 2:30 AM, via ambulance, with chief complaint of "auto vs (versus) pedestrian, approximately 25 mph (miles per hour), with positive loss of consciousness ([oc], and significant facial trauma. [Patient 1] sustained multiple facial bone fractures, displaced fracture of the zygomatic arch [a break on the bone of the side of the face below the eye], right and left mandibular fractures [break in the jawbone], and lacerations [cut] over left eye and on left cheek." The ED assigned Patient 1 an Emergency Severity Index (ESI) score of 2-emergent (needing prompt care). Hospital 1 transferred Patient 1 to Hospital 2 via Advance Life Support (ALS) ground transport on 3/5/22 at 4:30 PM.

During a concurrent interview and record review on 8/8/22, at 2 PM, with Case Manager (CM) 1 and CM 2, Patient 1's "Physician Certification and Authorization," dated 3/5/22, was reviewed. The "Physician Certification and Authorization" indicated, "Summary of Risks Explained to Patient: Airway; potential for obstruction or need for intubation (airway assistance), Breathing; increased dyspnea (shortness of breath) to possible arrest, Circulation; increased bleeding or loss of blood, Seizure Activity (convulsion), Paralysis (loss of ability to move or feel anything in part or most of the body), Loss of limb or life, MVA (motor-vehicular accident), and Worsening of Condition. Summary of Benefits Explained to Patient: Surgical Specialty Service: OMFS (Oral and maxillofacial surgery - a surgical specialty focusing on reconstructive surgery of the face, oral cavity, head and neck)." CM 1 and CM 2 stated, the "Physician Certification and Authorization" was completed and signed by the ED Physician (MD) 2 at the same time the Patient Acknowledgement was discussed and signed on 3/5/22, at 1:30 PM, when CM 3 documented, "[Patient 1] was not arousable."

During a concurrent interview and record review on 8/8/22, at 3:56 PM, with ED Physician (MD) 1, Patient 1's Emergency Documentation, dated 3/5/22, was reviewed. MD 1 stated, we (physicians) inform the patient if we are transferring the patient out-of-town, especially if we do not provide the service in this hospital. We make the patient aware, he/she needs a definitive (best plan of care for patient) care. MD 1 reviewed MD 2's documentation regarding Patient 1's orientation and alertness and validated Patient 1's "Physician Certification and Authorization" was discussed and signed by MD 2 when the patient was documented as "not arousable."

During a review of the facility's Medical Staff Rules and Regulations, approved 2/23/22, the Rules and Regulations indicated, "EMTALA [Emergency Medical Treatment and Labor Act] Transfers: (a) The transfer of a patient with an emergency medical condition from the Emergency Department to another hospital will be made in accordance with the District's applicable policy and in compliance with all applicable state and federal laws, such as EMTALA. (b) Before any such transfer occurs, a physician must see the patient and enter a certification in the patient's medical record indicating that the medical benefits to be received at another medical facility outweigh the risk to the patient of being transferred. . .(4) provide the following information to the patient whenever the patient is transferred: (i) the reason for the transfer (ii) the risks and benefits of the transfer; and (iii) available alternatives to the transfer."

During a review of the facility's Policy and Procedures (P&P) titled, "Compliance with EMTALA, Attachment B," approved 1/29/20, Attachment B indicated, "Physician's Certification & Authorization. . .Based on this examination, the information available to me at this time, and the reasonable risks and benefits to the patient, I have concluded for the reasons which follow that, as of the time of transfer, the medical benefits reasonably expected from the provision of treatment at another facility outweigh any increased risks to the patient."

During a review of the facility's P&P titled, "Informed Consent for Surgical, Diagnostic, or Therapeutic Procedure," dated 11/23/21, the P&P indicated, "Procedure: In order to obtain informed consent, the provider must first determine whether the patient has decision-making capacity. . .Section lll. B. Witnessing the Signing of the Consent Form and Verification of Consent: Confirm that the patient has been given sufficient information by the provider regarding the procedure. The licensed staff will ask the patient to read the consent form and/or read the consent form to the patient if requested."

2 a. During a concurrent interview and record review, on 8/8/22, at 2:10 PM, with CM 1 and CM 2, Patient 1's Patient Transfer Acknowledgement Form, dated 3/5/22, was reviewed. CM 2 stated, CM 3 documented on 3/5/22, at 1:30 PM, "Patient 1 was not arousable." CM 2 verified two employees signed the form for Patient 1 at 1:30 PM. CM 2 stated, MD 4 documented at 3:13 PM, [Patient 1] was awake, alert, and oriented and could answer questions appropriately. CM 2 stated, she would have returned and made another encounter with the patient to inform him of the transfer and let the patient sign when the patient was alert to understand and sign the form.


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2 b. During a review of Patient 23's "Emergency Documentation," dated 4/13/22, the Emergency Documentation indicated, Patient 23 was a 17- year-old male who presented to the hospital on 4/13/22, at 3:16 PM, via ambulance, with chief complaint of "Intentional overdose of Clonidine tablets (medication used for high blood pressure and Attention Deficit Disorder -ADD). Patient 23 reports of self harm through pill ingestion". Patient 23 was assigned an ESI of 2-emergent. The hospital transferred Patient 23 to Hospital 3 for specialized care (Behavioral Health) via Basic Life Support (BLS) ground transport on 6/14/22 at 12:15 PM.

During a concurrent interview and record review, on 8/9/22, at 10 AM, with Clinical Informaticist (CI - Computer Specialist) 1, Patient 23's "Patient Transfer Request Acknowledgement," dated 4/14/22, was reviewed. The "Patient Transfer Request Acknowledgement" form indicated, "Patient Transfer Acknowledgement signature line for the patient or legal representative, date, and time, and witness signatures were not signed, and the entire section was left blank." CI 1 stated, the patient/legal representative section was not signed.

During a concurrent interview and record review, on 8/9/22, at 10:42 AM, with CI 3, Patient 23's "Patient Transfer Request Acknowledgement," dated 4/14/22, was reviewed. The "Patient Transfer Request Acknowledgement" form indicated, "Patient Transfer Acknowledgement signature line for the patient or legal representative, date, and time, and witness signatures were not signed, and the entire section was left blank." CI 3 stated, the patient/legal representative section was not signed.

During a concurrent interview and record review, on 8/9/22, at 2:30 PM, with Licensed Clinical Social Worker (LCSW) 1, Patient 23's "Patient Transfer Request Acknowledgement," dated 4/14/22, was reviewed. The "Patient Transfer Request Acknowledgement" form indicated, "Patient Transfer Acknowledgement signature line for the patient or legal representative, date and time, and witness signatures were not signed, and the entire section was left blank." LCSW 1 stated, the patient/legal representative section was not signed. LCSW 1 stated, Patient 23 was an involuntary hold (5585- legal hold of a minor patient with intent to harm self) and did not require a signature from patient or responsible party, but instead should have been signed by the LCSW involved in his discharge plan. A facility policy and procedure was requested, none was provided.

2 c. During a review of Patient 25's "Emergency Documentation," dated 6/27/22, the Emergency Documentation indicated, Patient 25 was a 39-year-old male who presented to the hospital on 6/26/22, at 7:50 PM, via ambulance, with chief complaint of a high speed roll over car accident who was ejected from the vehicle and sustained a left ear avulsion (torn away from), multiple rib fractures, and pelvic fracture. The hospital transferred Patient 25 to Hospital 4 for specialized care on 6/27/22 at 12:42 AM.

During a concurrent interview and record review, on 8/9/22, at 11:35 AM, with CI 3, Patient 25's "Patient Transfer Request Acknowledgement," dated 6/27/22, was reviewed. The Patient Transfer Request Acknowledgement Form, indicated, Patient Transfer Acknowledgment was signed by Patient 25. CI 3 stated, Patient 25 signed this section.

During a concurrent interview and record review, on 8/9/22, at 2:45 PM, with CM 2, Patient 25's "Patient Transfer Request Acknowledgement," dated 6/27/22, was reviewed. The Patient Transfer Request Acknowledgement Form indicated, Patient Transfer Acknowledgment was signed by Patient 25. CM 2 stated, Patient 25 received a dose of Fentanyl (narcotic pain medication) 75 mg IV (Intravenous) on 6/26/22 at 8:20 PM, a 2nd dose at 10:16 PM, and a 3rd dose at 11:46 PM. CM 2 stated Patient 25 signed his transfer consent on 6/27/22 at 0042 (12:42 AM). The facility was unable to provide documentation of the patient's decision-making capacity after being administered three doses of Fentanyl.

During a review of the facility's Policy and Procedures (P&P) titled, Informed Consent for Surgical, Diagnostic, or Therapeutic Procedure," dated 11/23/21, the P&P indicated, "Procedure: In order to obtain informed consent, the provider must first determine whether the patient has decision-making capacity."

During a review of the facility's P&P titled, "Compliance with EMTALA, Attachment B," approved 1/29/20, Attachment B indicated, "Patient Transfer Acknowledgement I understand that I have a right to receive...and that I have a right to be informed of the reasons for any transfer...and have been informed of the reasons for my transfer."

During a review of the facility P&P titled "Interfacility: Transfer, Access & Stabilization," approved 1/28/20, the P&P indicated, "Physician Certification of Medical Benefit...physician has signed a certification that, based upon the information available at the time of transfer, the medical benefits reasonably expected from the provision of emergency medical treatment at another facility outweigh the increased risks to the individual. . .the 'Physician Certification' (Form B), will be completed and signed by the physician. . .E. Notice to Patient 1. The patient, or the patient's legal representative if present, must be notified of the transfer and of the reasons for transfer. The individual's acknowledgement of this notification shall be reflected in "Patient Transfer Acknowledgement (Form F)."