● A resulting limitation of neurological, physical, or sensory function that 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. ● 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, compared to 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. (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. (d) Was a procedure to remove unplanned foreign objects remaining from a surgical procedure (Florida Legislature, 2012). 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 Legislature, 2012). In addition to reporting any adverse incidents and malpractice actions, Florida hospitals and ambulatory surgical centers also must report to the AHCA any injuries of which they are aware that occurred through any healthcare service, including nursing homes, home health organizations, doctors’ offices, dentists’ offices, or any other purveyor of healthcare service. Florida Statute 641.55 requires similar reporting of patient injury incidents by health maintenance organizations (AHCA, 2014). Two types of reports record patient injury: ● The Annual Report , which includes all adverse incidents (per statutory definition) that occur in the course of a calendar year. These reports are due after the first of each year for the previous year. ● The Code 15 Report , which records in detail each serious patient injury, the facility’s investigation of the injury, and whether the factors causing or resulting in the adverse incident represent a potential risk to other patients. The findings of this investigation must be reported to AHCA within 15 days of the adverse incident (AHCA, 2014). Table 2 depicts the State of Florida Code 15 Sentinel Events.
the Medication Error Reporting System (MERP), which receives thousands of reports of medication errors from healthcare providers and consumers annually. The MERP reporting system is voluntary and confidential. The reporting form is available on the ISMP website ( https://www.ismp.org/ orderforms/reporterrortoismp.asp ). U.S. Food and Drug Administration MedWatch reporting program The FDA’s MedWatch program has three goals: (1) to educate healthcare providers and their patients about the importance of reporting serious adverse events to the FDA, (2) to take the new safety information that results from analysis of these reports and disseminate it to clinicians and their patients in a timely fashion for use at the point of care, and (3) to maintain safety surveillance of medical products (FDA, 2014a). The MedWatch program reviews the results of laboratory, animal, and human testing pre-market. Once products are marketed, the MedWatch program also conducts careful reviews of adverse experiences reported to it. MedWatch monitors drugs (prescription and over-the-counter), medical devices, biologics (except vaccines), and special nutritional products such as dietary supplements, infant formulas, and medical foods, as well as cosmetics. The MedWatch reporting system is voluntary, available to healthcare professionals and consumers, and has an online reporting site ( http://www.fda.gov/Safety/MedWatch/ The National Academy for State Health Policy (NASHP) is an independent academy of state health policy makers dedicated to helping states achieve excellence in health policy and practice. Their electronic Patient Safety Map & Toolkit provides states with tools they can use or modify as they develop or improve adverse event reporting systems. It includes information (policies, practices, forms, reports, methods, and contracts) related to states’ reporting systems, links to other web resources, and fast facts and issues related to patient safety ( http://www.nashp.org/patient-safety-toolkit ). Currently, 26 states and the District of Columbia require hospitals to report adverse events (DHHS, 2008). Variability exists in the state reporting systems. These systems often require different information, employ different reporting criteria, and require different accompanying information. However, most states appear to use the collected data in similar ways to improve patient safety (DHHS, 2008). Florida is an example of a state with such a reporting system for adverse events. Florida Although reporting sentinel events to the Joint Commission is voluntary, Florida law makes reporting of sentinel events mandatory. Florida’s Comprehensive Medical Malpractice Act of 1985 (F.S. 395.0197) mandates that each licensed hospital implement a risk management program with state oversight and an internal incident-reporting system. The State of Florida Agency for Health Care Administration (AHCA) provides oversight. Each licensed facility is required to hire a risk manager who is responsible for the implementation and management of the risk management program (Florida Legislature, 2012). Florida Statute 395.0197 mandates internal reporting of any adverse incident (event) over which healthcare personnel could exercise control, and that 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. HowToReport/default.htm ). State reporting systems
● Brain or spinal damage. ● Permanent disfigurement. ● Fracture or dislocation of bones or joints.
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