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Based on record review, review of facility quality improvement activity documentation, and staff interviews, the hospital failed to ensure the performance improvement activities of the hospital included timely implementation of actions or measures identified to improve performance of process for obtaining consent for treatment of minors in the Emergency Department (ED), measuring the effect of the actions, and tracking to ensure improvements are sustained. These failures resulted in care provided without parental or guardian consent to 6 of 9 minor children/patients (P17, P18, P21, P22. P23, and P24) reviewed for care in the ED and placed all minor patients at risk to receive treatment without parental or legal guardian consent.


Findings


During a hospital initiated investigation regarding patient rights to refuse treatment and to be free of physical restraint in the Emergency Department, the hospital self-identified concerns with the process for obtaining consent for treatment of who presented to the ED for examination and/or treatment unaccompanied by a parent or legal guardian. Based on the findings of the facility investigation the hospital developed and approved new policies and procedures titled "Treatment of Minors". The purpose of the policy: To ensure proper consent for treatment is obtained when minors are seeking medical care. The scope of the policy: this policy and procedure applies to all departments in the hospital.

An undated hospital document titled "Root Cause Analysis", indicated the facility's Risk Management Committee (RMC) identified an adverse patient event occurred during P17's ED visit on 06/13/19. The RMC determined the facility did not have a policy or process in place for ensuring a parent or legal guardian provided consent for treatment for a minor child. The analysis stated, "No developed process flow for minors in police custody. If a minor child presents to the emergency department and/or hospital and it is identified that the child does not reside with his/her parents there is no specific process for determining guardianship of the minor child." The analysis further indicated, "There is no set process when Child Protection Services (CPS) attempts to have a child seen in the ED/Hospital and/or when CPS instructs the Police Department to bring a minor child to the ED to obtain a medical screening exam and/or urine drug screen."


Review of hospital documents titled, "Quality Assurance/Performance Improvement Plan CY2019," approved on 02/2019, stated, "The QAPI Program addresses the care provided to all patients and is inclusive of all clinical sites of care, functions and processes carried out within the organization." The QAPI plan identified prioritized goals that included "prioritized 100% completion of the informed consent form for all procedures requiring consent."


On 12/11/19 at 9:30 AM, during an interview the Quality Assurance/Risk Manager (QARM) said the RMC discussed the 6/13/19 incident involving P17 and a new hospital policy was developed to ensure facility staff were trained on obtaining the proper consent for treatment prior to rendering services to a minor child. However, the QARM stated there had been no monitoring of the new policy developed as a result of the incident.


The hospital policy titled, "Treatment of Minors," dated 10/2019, stated, "prior to providing medical treatment to a minor IHS medical providers are required to obtain informed consent from the minor's parent or guardian." In addition, the facility's policy stated, "Law enforcement officers cannot mandate that IHS medical providers perform a medical or surgical procedure or treatment that would violate the law or patient rights to provide or withhold their consent. Even when law enforcement officers request that a medical or surgical procedure or treatment be performed on a patient or individual, the IHS must obtain the patient's informed consent, in the case of a minor, the parent or guardian."


Nine minor child/patient emergency department visits were identified by review of the ED log. Six of nine ED cases reviewed: (P17 on 6/13/19, P19 on 8/3/19, P21 on 10/23/19, P22 on 11/14/19, P23 on 11/21/19, and P24 on 10/22/19) did not comply with the new Hospital policies and procedures regarding validation of consent for treatment by responsible parent or court-appointed guardian.


On 12/11/19 at 10:43 AM, an interview was conducted with the Chief Executive Officer (CEO) who said the Hospital governing body approved a new policy related to the treatment of minor children when presenting to the Hospital in October 2019. When informed that six of nine ED records reviewed, 4 of which were after October 22, 2019, did not comply with facility policy regarding consent for treatment of minors. The CEO said the facility had not yet fully implemented the policies approved in October 2019 regarding the consent process for minor patients. The CEO confirmed that the implementation of new policy and procedure was not monitored as part of the hospital's Quality Assurance Performance Improvement (QAPI) activities. The CEO said the hospital administration determined the training regarding implementation of the new policies should be conducted in face-to-face sessions with staff because the CEO said she felt there may be a lot of questions and she wanted to ensure managers were present during training to answer questions and ensure understanding of the new process and policy. The CEO said she began discussions with law enforcement agencies about the requirements for parental or legal guardian consent for treatment of minors in the ED. The CEO concurred the hospital did not implement the corrective actions identified by the facility in a timely manner.