Inspection and Revocation of Designation

Section 515 Section 515.2020  Inspection and Revocation of Designation a) The Department shall have the authority to inspect designated trauma centers to assure compliance with the provisions of the Act and this Part. Information received by the Department through filed reports, inspection or as otherwise authorized under the Act shall not be disclosed publicly in such a manner as to identify individuals or hospitals, except in a proceeding involving the denial, suspension or revocation of a trauma center designation or imposition of a fine on a trauma center. (Section 3.90(b)(6) of the Act) b) The Department shall have the authority to take the following action, as appropriate, after determining that a trauma center is in violation of the Act or this Part: 1) If the Director determines that the violation presents a substantial probability that death or serious physical harm will result and if the trauma center fails to eliminate the violation immediately or within a fixed period of time, not exceeding 10 days, as determined by the Director, the Director may immediately revoke the trauma center designation.  The trauma center may appeal the revocation within 15 days after receiving the Director's revocation order, by requesting a hearing as provided by Section 3.135 of the Act.  The Director shall notify the chair of the Region's Trauma Center Medical Directors Committee and EMS Medical Directors for the appropriate EMS Systems of such a trauma center designation revocation. 2) If the Director determines that the violation does not present a substantial probability that death or serious physical harm will result, the Director shall issue a notice of violation and request a plan of correction which shall be subject to the Department's approval.  The trauma center shall have 10 days after the receipt of the notice of violation in which to submit a plan of correction.  The Department may extend this period for up to 30 days. (Section 3.90(b)(10)(B) of the Act) A)        The Department will consider the following factors in determining whether or not to extend the period for submission of the plan of correction to a maximum of 30 days:  whether a substantial probability that death or serious physical harm will result still exists, and whether the delay could lead to physical harm. B) The plan shall include a fixed time period not in excess of 90 days within which violations are to be corrected. The plan of correction and the status of its implementation by the trauma center shall be provided, as appropriate, to the EMS Medical Directors for the appropriate EMS Systems.  If the Department rejects a plan of correction, it shall send notice of the rejection and the reason for the rejection to the trauma center.  The trauma center shall have 10 days after receipt of the notice of rejection in which to submit a modified plan.  If the modified plan is not timely submitted, or if the modified plan is rejected, the trauma center shall follow an approved plan of correction imposed by the Department.  If, after notice and opportunity for hearing, the Director determines that a trauma center has failed to comply with an approved plan of correction, the Director may revoke the trauma center designation. The trauma center shall have 15 days after receiving the Director's notice in which to request a hearing.  Such hearing shall conform to the provisions of Section 3.135 of the Act. (Section 3.90(b)(10)(B) of the Act) C)        Each plan of correction shall be based on an assessment by the facility of the conditions or occurrences which are the basis of the violation and an evaluation of the practices, policies, and procedures which have caused or contributed to the conditions or occurrences.  Evidence of such assessment and evaluation shall be maintained by the facility.  Each plan shall include: i)          A description of the specific corrective action the facility is taking, or plans to take, to abate, eliminate, or correct the violation cited in the notice; ii)         A description of the steps that will be taken to avoid future occurrences of the same or similar violations. D)        The Department shall review each plan of correction to ensure that it provides for the abatement, elimination, or correction of the violation.  The Department shall reject a submitted plan if it finds any of the following deficiencies: i)          The plan does not address the conditions or occurrences that are the basis of the violation and an evaluation of the practices, policies, and procedures that have caused or contributed to the conditions or occurrences. ii)         The plan is not specific or does not provide measures to indicate the actual actions the facility will be taking to abate, eliminate, or correct the violation(s). iii)        The plan does not provide steps that will avoid future occurrences of the same and similar violations. iv)        The plan does not provide for timely completion of the corrective action, considering the seriousness of the violation, any possible harm to patients, and the extent and complexity of the corrective action. E)        The Department shall verify the completion of the corrective action: i)          By requiring the trauma center to submit monthly reports to the Department for up to one year, which consists of current hospital trauma plan (first month only); trauma quality monitoring plan and indicators (first month only); minutes of all meetings pertaining to trauma, including but not limited to Trauma Service Committee, Department of Surgery, and Morbidity and Mortality Review Committee; a list of all Category I and II trauma patients treated in the previous month, which includes but is not limited to medical record number, date and time of arrival at the trauma center, sex, mechanism of injury, trauma category classification and time; trauma surgeon and surgical specialty; time of notification and arrival time; and ii)         Through subsequent investigations, surveys and evaluations of the trauma center.