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body has oversight and accountability for the quality assessment and performance improvement program to ensure policies and programs are administered to provide quality healthcare in a safe environment.PATIENT GRIEVANCES The analysis of patient grievances that relate to patient care and the quality of medical services is another component of the risk management program requirements.The Medicare Conditions for Coverage now contain significant requirements for a patient grievance program. It requires that the facility develop a time table to address grievances and a communication process. For example, if a patient complains about quality of care and the issue can be addressed and resolved quickly, it may not be considered a grievance. If the complaint cannot be resolved with a quick or immediate response, the complaint escalates into a grievance that now requires time frames for each step. Perhaps the first step is having the patient or staff put the grievance into a written document; the second step may be investigation of the issue that can take up to 10 days; a requirement to communicate findings to the patient within 14 days; if unresolved to the patient’s satisfaction, a second investigation by someone higher in the organizational chart with a time table for communication back to the patient. Surgical centers may elect to keep a grievance notebook that contains the grievance policy and related forms, as well as any grievances filed and processed, to show to surveyors and inspectors the system and its implementation. The state inspectors may also review how patient satisfaction in general is measured and how complaints written on patient satisfaction surveys are investigated and a corrective action plan developed and implemented. INFORMING A PATIENT OF AN ADVERSE INCIDENT Another component of a risk management program is a system for informing a patient or an individual pursuant to s. 765.401 (1) Florida Statutes (FS) that the patient was the subject of an adverse incident, as defined in s. 395.0197 (5) FS. This notice shall be given by an appropriately trained person, designated by the facility, as soon as practicable to minimize damage or injury. The organization must designate an appropriately trained person as responsible for coordinating disclosure communication. The patient, parents of a minor and/or significant others or designated healthcare surrogate must be advised if the patient should experience an adverse event that resulted in serious harm to the patient. The patient or other designee shall receive information as soon as possible in order that he or she may understand what is happening in his or her treatment, why any changes have taken place in that plan, and what to be aware of in the form of reactions or consequences, and what actions the patient can consider in order to minimize the injury. Note: There is also a requirement under s. 456.0575 FS for all licensed health care practitioners to notify patients about adverse incidents that result in serious harm to the patient. There should be documentation that the patient was informed of the incident. Regulation does not require that this documentation occur in the medical record. It can be recorded on the incident investigation form or another document that has restricted access. The development and implementation of an incident reporting system must be in place and include procedures detailed in writing and disseminated to all employees. It is the affirmative duty of all health care providers and all agents and employees of the licensed ASC to report adverse incidents to the risk manager, or to his or her designee, within 3 business days after their occurrence. The incident reports shall be used to develop categories of incidents which identify problem areas. Once identified, procedures shall be adjusted to correct the problem areas. This is another example of how risk management activities become part of the quality improvement activities. An inspector or surveyor may ask to see how trends or frequency of events have resulted in actions such as education of staff, clarification or addition of policies, monitoring changes in process to see if the planned corrective action worked and additional actions taken to monitor and change protocols and practices. The governing body is responsible for the internal risk management program. A Florida licensed ambulatory surgical center must have a Florida licensed health care risk manager to provide oversight and implementation of the internal risk management program. The Florida licensed health care risk manager must have a current license issued by the State of Florida. The licensed health care risk manager can be an employee or can be retained by the ambulatory surgical center. The ambulatory surgical center will also have a risk manager designee to act in the absence of the licensed health care risk manager. Whether the licensed health care risk manager is an employee or contracted, the licensed health care risk manager should work with the Center’s administration to determine which duties may be assigned to the risk manager designee. In order for the designee to review incident reports he/she must be determined to be competent in risk management techniques. A risk manager designee competency check list sample is located in the Appendices. The duties assigned to the risk manager designee are performed under the supervision of the licensed health care risk manager. All risk management duties and functions remain the responsibility of the licensed health care risk manager and the licensed health care risk manager shall maintain responsibility for the oversight and implementation of the internal risk management program. The ambulatory surgical center’s governing body must appoint the licensed health care risk manager and the risk manager designee. This appointment must be documented in writing. Surveyors and inspectors will want to see documentation of these appointments. Documentation should occur in governing body minutes and a job description signed and dated by the licensed health care risk manager, risk manager designee and the governing body chair. The governing body will receive a quarterly report on the facility’s risk management activities from the licensed health care risk manager. This report should be included or attached to governing body minutes. Include discussion of any action taken by the governing body on the quarterly reports. For surgical centers that have a governing body meeting less than once a quarter, document the review of the risk management report by the governing body by having the chair initial and date the report. APPROACHES TO REDUCE FREQUENCY AND SEVERITY OF MEDICAL MALPRACTICE AND PATIENT INJURY CLAIMS 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. The risk management activities may include extending internal risk management programs to providers’ offices. FLORIDA STATUTES GOVERNING THE ESTABLISHMENT OF INTERNAL RISK MANAGEMENT PROGRAM The program must use an incident report. The incident reports are part of the work papers of the attorney defending the licensed facility in litigation relating to the licensed facility and are subject to discovery, but are not admissible as evidence in court. Incident reports must be filed with the individual of responsibility who is employed or retained and competent in risk management techniques. The facility may have an incident report that is separate from the investigation, findings, action plan, and outcome of the incident. Florida Risk Management and Related Regulations :An adverse incident means an event over which health care personnel could