Florida Administrative Code § 64B8-9.001

“Physician office incident reporting under the Department of Health regulations”

An adverse incident is an act by a physician which results in the following patient injuries:

• The death of a patient;
• Brain or spinal damage to a patient;
• The performance of a surgical procedure on the wrong patient;
• The performance of a wrong-site surgical procedure, a wrong surgical procedure, or the surgical repair of damage to a patient resulting from a planned surgical procedure where the damage is not a recognized specific risk as disclosed to the patient and documented through the informed-consent process;
• A procedure to remove unplanned foreign objects remaining from a surgical procedure; or
• Any condition that required the transfer of a patient to a hospital from any facility or office maintained by a physician.

Each physician’s office must establish an incident reporting system. The system must noify the Department of Health of an adverse incident within 15 days. The physician is responsible for the regular and systematic review of all incident reports and implementing corrective actions. The physician’s office must maintain copies of incident reports.

Related laws:

Florida Statutes § 458.309

Florida Statutes § 458.351