Current through Register Vol. 48, No. 9, September 27, 2024
A. The licensee shall report a record of each accident and/or incident occurring at the facility to the Department within five (5) days of occurrence. Reports submitted to the Department shall contain only: facility name, license number, type of accident/incident, date of accident/incident occurred, number of patients directly injured or affected, patient medical record identification number, patient age and sex, number of staff directly injured or affected, number of visitors directly injured or affected, witness(es) name(s), identified cause of accident/incident, internal investigation results if cause unknown, a brief description of the accident/incident including location where occurred, and treatment of injuries. The report retained by the facility, in addition to the minimum reported to the Department, shall contain: names of patient(s), staff, and/or visitor(s), the injuries and treatment associated with each patient, staff, and/or visitor. Records of all accidents and incidents shall be retained by the facility for ten (10) years after the patient stops receiving services at the facility.
B. The licensee shall report each accident and/or incident resulting in unexpected death or serious injury to the next of kin or party responsible for each affected individual at the earliest practicable hour, not exceeding twenty-four (24) hours. The licensee shall notify the Department immediately, not to exceed twenty-four (24) hours, via telephone, email or facsimile. The licensee shall submit a report of the licensee's investigation of the accident and/or incident to the Department within five (5) days. Accidents and/or incidents requiring reporting include, but are not limited to,:
1. Surgical or Invasive Procedure Events
a. Surgery or other invasive procedure performed on the wrong site;
b. Surgery or other invasive procedure performed on the wrong patient;
c. Wrong surgical or other invasive procedure performed on a patient;
d. Unintended retention of a foreign object in a patient after surgery or other invasive procedure; and
e. Intraoperative or immediately/postprocedure death.
2. Product or Device Events
a. Patient death or serious injury associated with the use of contaminated drugs, devices, or biologics provided by the Facility;
b. Patient death or serious injury associated with the use or function of a device in patient care, in which the device is used or functions other than as intended; and
c. Patient death or serious injury associated with intravascular air embolism that occurs while being cared for in the Facility.
3. Patient Protection Events
a. Discharge or release of a patient of any age, who is unable to make decisions, to other than an authorized person;
b. Patient death or serious injury associated with patient elopement; and
c. Patient suicide, attempted suicide, or self-harm that results in serious injury while being cared for in the Facility.
4. Care Management Events
a. Patient death or serious injury associated with a medication error (e.g., errors involving the wrong drug, wrong dose, wrong patient, wrong time, wrong rate, wrong preparation, or wrong route of administration);
b. Patient death or serious injury associated with unsafe administration of blood products;
c. Patient death or serious injury associated with a fall while being cared for in the Facility;
d. Patient death or serious injury resulting from failure to follow up or communicate laboratory, pathology, or radiology test results.
5. Environmental Events
a. Patient or staff death or serious injury associated with an electric shock in the course of a patient care process in the Facility;
b. Any incident in which systems designated for oxygen or other gas to be delivered to a patient contains no gas, the wrong gas, or are contaminated by toxic substances;
c. Patient or staff death or serious injury associated with a burn incurred from any source in the course of a patient care process in the Facility; and
d. Patient death or serious injury associated with the use of physical restraints or bedrails while being cared for in the Facility.
6. Potential Criminal Events
a. Any instance of care ordered by or provided by someone impersonating a physician, nurse, pharmacist, or other licensed healthcare provider;
b. Abduction of any patient of any age;
c. Sexual abuse/assault on a patient or staff member within or on the grounds of the Facility; and
d. Death or serious injury of a patient or staff member resulting from a physical assault (i.e., battery) that occurs within or on the grounds of the Facility.
