| (n) The surveyor(s) shall provide the facility with a written, signed survey report regarding their evaluation of the facility's compliance with trauma facility criteria. This survey report shall be forwarded to the facility within 30 calendar days of the completion date of the survey. The facility is responsible for forwarding a copy of this report to the office if it intends to continue the designation process. (o) The office shall review the findings of the survey report for compliance with trauma facility criteria. (1) A recommendation for designation shall be made to the commissioner based on compliance with the criteria. (2) If a facility does not meet the criteria for the level of designation deemed appropriate by the office, the office shall notify the facility of the requirements it must meet to achieve the appropriate level of designation. (3) If a facility does not comply with criteria, the office shall notify the facility of deficiencies and recommend corrective action. (A) The facility shall submit to the office a report that outlines the corrective action(s) taken. The office may require a second survey to ensure compliance with the criteria. If the office substantiates action that brings the facility into compliance with the criteria, the Office shall recommend designation to the commissioner. (B) If a facility disagrees with the office's decision regarding its designation application or status, it may request a secondary review by a designation review committee. Membership on a designation review committee will: (i) be voluntary; (ii) be appointed by the office director; (iii) be representative of trauma care providers and appropriate levels of designated trauma facilities; and (iv) include representation from the department and the Trauma Systems Committee of the Governor's EMS and Trauma Advisory Council (GETAC). (C) If a designation review committee disagrees with the office's recommendation for corrective action, the records shall be referred to the assistant commissioner for recommendation to the commissioner. (D) If a facility disagrees with the office's recommendation at the end of the secondary review, the facility has a right to a hearing, in accordance with the department's rules for contested cases, and Government Code, Chapter 2001. (p) The facility shall have the right to withdraw its application at any time prior to being recommended for trauma facility designation by the office. (q) If the commissioner concurs with the recommendation to designate, the facility shall receive a letter and a certificate of designation valid for 3 years. Additional actions, such as a site review or submission of information/reports to maintain designation, may be required by the department. (r) It shall be necessary to repeat the designation process as described in this section prior to expiration of a facility's designation or the designation expires. (s) A designated trauma facility shall: (1) comply with the provisions within these sections; all current state and system standards as described in this chapter; and all policies, protocols, and procedures as set forth in the system plan; (2) continue its commitment to provide the resources, personnel, equipment, and response as required by its designation level; (3) participate in the Texas EMS/Trauma Registry. Data submission requirements for designation purposes are as follows. (A) Initial designation--Six months of data prior to the initial designation survey must be uploaded. Subsequent to initial designation, data should be uploaded to the Texas EMS/Trauma Registry on at least a quarterly basis (with monthly submissions recommended) as indicated in §103.19 of this title (relating to Electronic Reporting). (B) Re-designation--The facility's trauma registry should be current with at least quarterly uploads of data to the Texas EMS/Trauma Registry (monthly submissions recommended) as indicated in §103.19 of this title; (4) notify the office, its RAC plus other affected RACs of all changes that affect air medical access to designated landing sites. (A) Non-emergent changes shall be implemented no earlier than 120 days after a written notification process. (B) Emergency changes related to safety may be implemented immediately along with immediate notification to department, the RAC, and appropriate Air Medical Providers. (C) Conflicts relating to helipad air medical access changes shall be negotiated between the facility and the EMS provider. (D) Any unresolved issues shall be handled utilizing the nonbinding alternative dispute resolution (ADR) process of the RAC in which the helipad is located; (5) within 5 days, notify the office; its RAC plus other affected RACs; and the healthcare facilities to which it customarily transfers-out trauma patients or from which it customarily receives trauma transfers-in if temporarily unable to comply with a designation criterion. If the healthcare facility intends to comply with the criterion and maintain current designation status, it must also submit to the office a plan for corrective action and a request for a temporary exception to criteria within 5 days. (A) If the requested essential criterion exception is not critical to the operations of the healthcare facility's trauma program and the office determines that the facility has intent to comply, a 30-day to 90-day exception period from the onset date of the deficiency may be granted for the facility to achieve compliancy. (B) If the requested essential criterion exception is critical to the operations of the healthcare facility's trauma program and the office determines that the facility has intent to comply, no greater than a 30-day exception period from the onset date of the deficiency may be granted for the facility to achieve compliancy. Essential criteria that are critical include such things as: (i) neurological surgery capabilities (Level I, II); (ii) orthopedic surgery capabilities (Level I, II, III); (iii) general/trauma surgery capabilities (Level I, II, III); (iv) anesthesiology (Levels I, II, III); (v) emergency physicians (all levels); (vi) trauma medical director (all levels); (vii) trauma nurse coordinator/program manager (all levels); and (viii) trauma registry (all levels). (C) If the healthcare facility has not come into compliance at the end of the exception period, the office may at its discretion elect one of the following: (i) allow the facility to request designation at the level appropriate to its revised capabilities; (ii) propose to re-designate the facility at the level appropriate to its revised capabilities; (iii) propose to suspend the facility's designation status. If the facility is amenable to this action, the office will develop a plan for corrective action for the facility and a specific timeline for compliance by the facility; or (iv) propose to extend the facility's temporary exception to criteria for an additional period not to exceed 90 days. The department will develop a plan for corrective action for the facility and a specific timeline for compliance by the facility. (I) Suspensions of a facility's designation status and exceptions to criteria for facilities will be documented on the office website. (II) If the facility disagrees with a proposal by the office, or is unable or unwilling to meet the office-imposed timelines for completion of specific actions plans, it may request a secondary review by a designation review committee as defined in subsection (o)(3)(B) of this section. (III) The office may at its discretion choose to activate a designation review committee at any time to solicit technical advice regarding criteria deficiencies. (IV) If the designation review committee disagrees with the office's recommendation for corrective actions, the case shall be referred to the assistant commissioner for recommendation to the commissioner. (V) If a facility disagrees with the office's recommendation at the end of the secondary review process, the facility has a right to a hearing, in accordance with the department's rules for contested cases and Government Code, Chapter 2001. (VI) Designated trauma facilities seeking exceptions to essential criteria shall have the right to withdraw the request at any time prior to resolution of the final appeal process; (6) notify the office; its RAC plus other affected RACs; and the healthcare facilities to which it customarily transfers-out trauma patients or from which it customarily receives trauma transfers-in, if it no longer provides trauma services commensurate with its designation level. Cont'd... |
