● Hemolytic blood transfusion reaction caused by use of the wrong blood group. ● The wrong invasive procedure, or an invasive procedure on the wrong patient or the wrong site. ● A foreign object left inside a patient after a surgical or any invasive procedure. ● Severe neonatal hyperbilirubinemia. ● Too much radiation or radiation to the wrong part of the body. ● Fire, flame, unanticipated smoke, heat, or flashes during direct patient care caused by equipment operated and used by the hospital. ● Any maternal death that occurs during the birth process. ● Severe maternal morbidity (a patient safety event that occurs from the intrapartum period through the immediate postpartum period requiring transfusion of four or more units of packed red blood cells and/or admission to the intensive care unit). (TJC, 2023b) (c) Required the surgical repair of damage resulting to a patient from a planned surgical procedure, where the damage was not a recognized specific risk as disclosed to the patient and documented through the informed- consent process; or (d) Was a procedure to remove unplanned foreign objects remaining from a surgical procedure (Florida Legislature, 2021). The risk-management reporting system must include the following: (a) The investigation and analysis of the frequency and causes of general categories and specific types of adverse incidents to patients. (b) The development of appropriate measures to minimize the risk of adverse incidents to patients. (c) The analysis of patient grievances that relate to patient care and the quality of medical services. (d) A system for informing a patient or an individual identified pursuant to section 765.401(1) that the patient was the subject of an adverse incident, as defined in subsection (5). Such notice shall be given by an appropriately trained person designated by the licensed facility as soon as practicable to allow the patient an opportunity to minimize damage or injury. (e) The development and implementation of an incident reporting system based upon the affirmative duty of all healthcare providers and all agents and employees of the licensed healthcare facility to report adverse incidents to the risk manager, or to his or her designee, within three business days after their occurrence. (Florida Statutes, 2021) In addition to reporting internally any adverse incidents and malpractice actions, hospitals and ambulatory surgical centers in the state of Florida must also report to AHCA any injuries of which they are aware that occurred through any healthcare service in their organizations, including events that occurred to patients while they were patients in nursing homes, home health organizations, physician offices, dental offices, or any other source of healthcare service. Florida Statutes sections 429.23, 400.147, and 641.55 require similar reporting of patient injury incidents at assisted living facilities (Florida Statutes, 2022), nursing homes (Florida Statutes, 2018) and health care service programs (Florida Statutes, 2019), respectively. Patient injury incidents are reported through two different types of reports:
noted that not all sentinel events are the result of an error and that not all errors result in a sentinel event (TJC, 2023b). The following sentinel events require the completion of a root cause analysis (RCA), which will be discussed next in this course: ● Suicide that takes place within a facility that is fully staffed around the clock, or suicide that takes place within 72 hours of discharge, including from the hospital’s emergency department. ● Unexpected death of a full-term infant. ● Abduction of a patient. ● Any elopement (unauthorized departure) of a patient from a facility staffed around the clock leading to death, permanent harm, or severe temporary harm. ● An infant being sent home with the wrong family. ● On-site rape, assault, or homicide of a patient, staff member, visitor, or vendor. Mandates within the State of Florida Regulation Alert for the Florida Healthcare Professional! In the State of Florida, as part of continuing education requirements for licensure renewal, all healthcare professionals must obtain a minimum of at least two (2) hours of approved training on Prevention of Medical Errors. Although reporting sentinel events to TJC is voluntary, Florida law makes reporting of sentinel events mandatory. Florida’s Comprehensive Medical Malpractice Act of 1985 (F.S. 395.0917) mandates that each licensed hospital must implement a risk management program with state oversight and an internal incident-reporting system. Oversight is provided by the State of Florida Agency for Health Care Administration (AHCA). Each licensed hospital is required to hire a risk manager who is responsible for the implementation and management of the risk management program (Florida Statutes, 2021). Florida Statute 395.0197 mandates internal reporting of any adverse incident (event): over which healthcare personnel could exercise control, and which is associated in whole or in part with medical intervention, rather than the condition for which such intervention occurred, and which: (a) Resulted in one of the following injuries: ○ Death; ○ Brain or spinal damage; ○ Permanent disfigurement; ○ Fracture or dislocation of bones or joints; ○ A limitation of neurological, physical, or sensory function which continues after discharge from the facility; ○ Any condition that required specialized medical attention or surgical intervention resulting from non-emergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed consent; or ○ Any condition that required the transfer of the patient, within or outside the facility, to a unit providing a more acute level of care due to the adverse incident, rather than the patient’s condition prior to the adverse incident; (b) Was the performance of a surgical procedure on the wrong patient, a wrong surgical procedure, a wrong-site surgical procedure, or a surgical procedure otherwise unrelated to the patient’s diagnosis or medical condition;
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Book Code: MFL1225
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