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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. results in the following injuries: 5. A resulting limitation of neurological, physical, or sensory function which continues after dis-charge from the facility; 6. Any condition that required specialized medical attention or surgical intervention resulting from nonemergency medical intervention, other than an emergency medical condition, to which the patient has not given his or her informed con-sent; or 7. 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 condi-tion prior to the adverse incident; b. 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; c. the need to perform 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. a procedure performed to remove unplanned foreign objects remaining from a surgical procedure.The ambulatory surgical center may include other items for internal reporting program. Near misses, staff noted opportunities for improvement, system problems that could negatively impact patient care, audits of compliance to nationally recognized standards and other events may be part of the risk management program and/or part of the quality assurance and performance improvement program. The surgical center may elect to have the same or different reporting systems that bring attention to the potential for adverse outcomes or events. Only those adverse events that must be reported to the state would be reported, but other events or indicators may be reported internally to provide options for quality improvement activities and risk reduction. Incidents, as previously defined, that have been filed in the facility between January 1 and December 31 must be summarized on an annual reporting form provided by the Agency for Health Care Administration and submitted to the Agency by April 1 of the following year. A “Code 15” Report must be filed with the agency within 15 calendar days of the occurrence of any of the following adverse incidents: (a)Death; (b) Brain or spinal damage; (c) the performance of a surgical procedure on the wrong patient; (d) a wrong-site surgical procedure; (e) a wrong surgical procedure; (f) performance of a surgical procedure that is medically unnecessary or otherwise unrelated to the patient’s diagnosis or medical condition; (g) 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 (h) the procedure to remove unplanned foreign objects remaining from a surgical procedure. The report form and instructions for completion are available on the AHCA at http://ahca.myflorid a.com/ SCHS/Risk Mg tPub Safety/RiskManagement.shtml. Each licensed facility shall annually report to the Agency for Health Care Administration and the Department of Health the name and judgments entered against each health care practitioner for which it assumes liability. Per ss 458.337 FS and 459.016 FS, any disciplinary action taken shall be reported to the Department of Health within 30 working days after its initial occurrence, regardless of whether the physician is appealing the disciplinary action or not. The notification shall identify the disciplined physician, the action taken, and the reason for such action. s. 395.0191 FS, which address medical staff appointments and privileging, also requires in s. 395.0191 (6) FS that the denial of staff membership or clinical privileges to any applicant be reported in writing to the applicant’s respective licensing board. 6 - Florida Risk Management and Related Regulations | The internal risk manager must investigate an allegation of sexual misconduct which is made against a member of the facility’s personnel who has direct patient contact, when the allegation is that the sexual misconduct occurred to a patient at the facility or on the grounds of the facility. Any person who witnessed or who possesses actual knowledge of the act that is the basis of an allegation of sexual abuse shall notify the local police and notify the risk manager and the administrator. The internal risk manager must report every allegation of sexual misconduct to the administrator; notify the family or guardian of the victim, if a minor, that an allegation of sexual misconduct has been made and that an investigation is being conducted, and report to the Department of Health every allegation of sexual misconduct, as defined in Chapter 456 FAC and the respective practice act, by a licensed health care professional that involves a patient. “Sexual abuse” means acts of a sexual nature committed for the sexual gratification of anyone upon, or in the presence of, a vulnerable adult, without the vulnerable adult’s informed consent, or a minor. “Sexual abuse” includes, but is not limited to, the acts defined in s. 794.011 (1) (h) FS, fondling, exposure of a vulnerable adult’s or minor’s sexual organs, or the use of the vulnerable adult or minor to solicit or engage in prostitution or sexual performance. “Sexual abuse” does not include any act intended for a valid medical purpose or any act which may reasonably be construed to be a normal care-giving action. Other forms of abuse: Health care professionals or personnel who know or have a reasonable cause to suspect that an aged person, disabled adult, or child is an abused, neglected, or exploited person shall immediately report such knowledge or suspicion to the central abuse registry and tracking system on the single statewide toll- free telephone number of 1-800-962-2873. A follow-up written report confirming the initial report must be submitted within 48 hours to the local State office. Regulations about reporting and about an online reporting system can be located at http://www.myflfamilies.com/service-programs/abuse-hotline/reportine-online. Each facility must have a patient safety officer and a patient safety committee. At least one member of the committee must be a person who is neither employed by nor practicing in the facility. There must be a patient safety plan, similar to what Medicare requires in 42 CFR 416.43. See the appendices for s 395.1012 FS. The plan of Quality Assurance and Performance Improvement as outlined in the 42 CFR 416.43, which is part of the Medicare Conditions for Coverage for ambulatory surgical centers, requires in part that the ASC conduct an ongoing, comprehensive self-assessment of the quality of care provided, including medical necessity of procedures performed and appropriateness of care. The purpose of the patient safety committee is to: (1) promote the health and safety of patients; (2) review and evaluate the quality of patient safety measures used by the facility and (3) to assist in the implementation of the facility safety plan. This regulation and its integration with other sections of the regulations that must be followed for a surgical center to participate as a Medicare provider have been extensively rewritten. While the