6 Colo. Code Regs. § 1015-3-4-9
Current through Register Vol. 47, No. 11, June 10, 2024
Section 6 CCR 1015-3-4-9 - Mandatory Incident Reporting Requirements For Licensees9.1 Mandatory incidents shall be reported to the Department as follows: 9.1.1 Upon the ambulance service's discovery that any of the following procedural incidents has occurred, the ambulance service administrator shall notify the Department of the incident as soon as practicable, but no later than seven (7) calendar days following its discovery, in the form and format specified by the Department. Upon notification, the Department may contact the ambulance service as needed. A) Any final agency action against the ambulance service by any federal or state entity related to substandard patient care, health care fraud, or the ambulance service's Drug Enforcement Agency (DEA) license.B) Any civil judgment or criminal conviction in a case brought by federal, state, or local authorities that involves the operation, management, ownership of an ambulance service and contains allegations related to substandard patient care, health care fraud, or moral turpitude. a guilty verdict, a plea of guilty, or a plea of nolo contendere (no contest) accepted by the court is considered a conviction.C) Any instance in which an EMS provider is terminated or suspended by the ambulance service based on the good cause rules set forth in 6 CCR 1015-3, Chapter One.D) Any suspension or revocation of a medical director's license to practice by the Colorado Medical Board.E) The unexpected or untimely separation of a medical director from an ambulance service whether voluntary or involuntary. All other separations or transitions must be reported by the medical director pursuant to 6 CCR 1015-3, Chapter Two.9.1.2 Within 90 days of the ambulance service's discovery that any of the incidents listed within this 9.1.2 may have occurred, the ambulance service and medical director shall review the incident through the ambulance service's quality assurance program to determine if the incident is one or more of the following reportable incidents, and if so, report to the Department no later than the end of the 90-day period, consistent with 9.1.3 below.A) Any incident during response or while providing patient care in which an employee, contractor, or volunteer of the ambulance service knowingly: 1) Commits physical assault against another person pursuant to Article 3 of Title 18, C.R.S.; or2) Commits sexual assault, pursuant to Article 3 of Title 18, C.R.S. As used here, "sexual assault" includes: a) Any improper sexual contact, touching, intrusion, or penetration that an ambulance service employee, contractor, or volunteer inflicts upon another person; orb) Any instance in which an EMS provider, while purporting to offer a medical service, engages in treatment or examination of a patient for other than a bona fide medical purpose or in a manner substantially inconsistent with reasonable medical practices.B) Any incident involving the commission of patient abuse, including the willful infliction of injury, unreasonable confinement, intimidation, or punishment, with resulting physical harm, pain, or mental anguish; or patient neglect, including the failure to provide goods and services necessary to attain and maintain physical and mental well-being by the ambulance service or its employees, contractors, or volunteers.C) Any unauthorized appropriation or possession of medications, supplies, equipment, money, or personal items.D) The response to an incident, or treatment of a patient, by an ambulance service's employees, contractors, or volunteers while impaired by the use of alcohol or drugs.E) Any instance of care provided by someone impersonating a licensed healthcare provider, including someone practicing without a valid certification, license, or privilege to practice.F) The death or injury of an occupant of an ambulance that is licensed and permitted by the Department and is a direct result of a motor vehicle collision occurring during response or transport by the ambulance service.G) Administration of an adulterated or contaminated drug, device, or biologic provided by the ambulance service.H) The following incidents that lead to injury, illness, or death to a patient not ordinarily expected as a result of the patient's condition:1) A medication error or medical act error;2) An invasive procedure performed on the wrong site;3) The use or function of a device in which the device is used in a manner other than as intended or approved by medical direction; or4) The use of physical restraints or chemical restraints; or5) Patient suicide or attempted suicide that occurs during the provision of patient care.9.1.3 Incident Reporting ProcessA) Upon determination through the quality assurance program that an incident is reportable pursuant to Section 9.1.2, the ambulance service shall submit a report to the Department no later than ninety (90) calendar days after discovery of the potential incident that:1) Describes the incident review;2) Identifies whether additional corrective measures are necessary to prevent reoccurrence of the reported incident; and3) Specifies each corrective measure that will be undertaken to prevent reoccurrence of the reported incident.B) An ambulance service may request an extension to the ninety (90) calendar day report deadline in Section 9.1.3.A if more time is required to complete the quality assurance process. The Department may grant extensions not to exceed a total of ninety (90) calendar days.C) The Department may request further supplemental information concerning any mandatory reporting incident if it determines such information is necessary.37 CR 12, June 25, 2014, effective 5/21/201437 CR 12, June 25, 2014, effective 7/15/201437 CR 22, November 25, 2014, effective 12/15/201438 CR 24, December 25, 2015, effective 1/14/201640 CR 10, May 25, 2017, effective 7/1/201740 CR 20, October 25, 2017, effective 1/1/201840 CR 21, November 10, 2017, effective 1/1/201841 CR 23, December 10, 2018, effective 1/14/201943 CR 22, November 25, 2020, effective 1/1/202144 CR 23, December 10, 2021, effective 12/30/202145 CR 10, May 25, 2022, effective 6/14/202247 CR 02, January 25, 2024, effective 2/14/2024