6 Colo. Code Regs. § 1015-4-302
Current through Register Vol. 47, No. 24, December 25, 2024
Section 6 CCR 1015-4-302 - Enforcement and Disciplinary Process1. Unscheduled or Interim, Focused or Re-ReviewsA. At any time the Department may require and conduct an unscheduled or interim, focused or re-review of a currently designated facility based upon, but not limited to, the following criteria:(1) Recent review results,(3) Monitoring of the EMTS system.2. Plans of CorrectionA. Prior to making a designation decision, or after an unscheduled or interim, focused or re-review, the Department shall require a plan of correction from any facility with review deficiencies and/or met with reservations.B. A plan of correction shall include, but not be limited to, the following:(1) Identification of the problem(s) with the current activity and what the facility will do to correct each deficiency,(2) A description of how the facility will accomplish the corrective action,(3) A description of how the facility will monitor the corrective action to ensure the deficient practice is remedied and will not recur,(4) A timeline with the expected implementation and completion date. Completion date is the date that the facility deems it can achieve compliance.C. Completed plans of correction shall be: (1) Submitted to the Department in the form and manner required by the Department,(2) Submitted within thirty (30) calendar days after the date of the Department's written notice of deficiencies and/or criteria identified as met with reservations when areas of non-compliance with rules pertaining to the designation of trauma centers have been identified, and(3) Signed by the facility administrator and facility trauma director.D. The Department has the discretion to approve, modify, or reject plans of correction. (1) If the plan of correction is accepted, the Department shall notify the facility by issuing a written notice of acceptance within thirty (30) calendar days of receipt of the plan.(2) If the plan of correction is unacceptable, the Department shall notify the facility in writing, and the facility shall re-submit changes to the Department within fifteen (15) calendar days of the date of the written notice.(3) If the facility fails to comply with the requirements or deadlines for submission of a plan or fails to submit requested changes to the plan, the Department may reject the plan of correction and impose disciplinary sanctions as set forth below.(4) If the facility fails to timely implement the actions agreed to in the plan of correction, the Department may impose disciplinary sanctions as set forth below.3. Re-Review Fee Structure A. In the event the Department designates a facility with a required interim, focused, or re-review per Section 302.1.A .(1) above, the facility shall submit the required fee in the manner specified by the Department. The methodology used to determine the re-review fee for an existing facility is: Levels I and II: | 100% of costs of review team, excluding state observer time |
Levels III through V: | 75% of costs of review team, excluding state observer time |
B. These fees shall apply to all on-site trauma re-reviews conducted subsequent to the effective date of these rules.4. Denials A. The Department may deny an application for Level I-V or RPTC designation to a new, replacement, or existing facility for reasons including, but not limited to, the following: (1) The facility does not meet the criteria for designation as set forth in these regulations,(2) The facility's application or accompanying documents contain a false statement of material fact,(3) The facility refuses any part of an on-site review,(4) The facility's failure to comply with or to successfully complete a plan of correction, or(5) The facility is substantially out of compliance with any of the Department's regulations.B. If the facility does not meet the level of designation criteria for which it has applied, the Department may recommend designation at a lesser level. Such action, unless agreed to by the applicant, shall represent a denial of the application.C. If the Department denies an application for designation or waiver, the Department shall provide the facility with a notice explaining the basis for the denial. The notice shall also inform the facility of its right to appeal the denial and the procedure for appealing the denial.D. Appeals of Departmental denials shall be conducted in accordance with the State Administrative Procedure Act, Section 24-4-101, et seq., C.R.S.5. Revocation or Temporary Suspension A. The Department may revoke the designation of a facility if any owner, officer, director, manager, or other employee: (1) Fails or refuses to comply with the provisions of these regulations,(2) Makes a false statement of material fact about facility capabilities or other pertinent circumstances in any record or in a matter under investigation for any purposes connected with this chapter,(3) Prevents, interferes with, or attempts to impede in any way, the work of a representative of the Department in implementing or enforcing these regulations or the statute,(4) Falsely advertises or in any way misrepresents the facility's ability to care for trauma patients based on its designation status,(5) Is substantially out of compliance with these regulations and has not rectified such noncompliance,(6) Fails to provide reports required by the registry or the state in a timely and complete fashion, or(7) Fails to comply with or complete a plan of correction in the time or manner specified.B. If the Department revokes or temporarily suspends a designation or waiver, it shall provide the facility with a notice explaining the basis for the action. The notice shall also inform the facility of its right to appeal and the procedure for appealing the action.C. Appeals of Departmental revocations or suspensions shall be conducted in accordance with the State Administrative Procedure Act, Section 24-4-101, et seq., C.R.S.6. Summary Suspension A. The Department may summarily suspend a designation or waiver if it finds, after investigation, that a facility has engaged in a deliberate and willful violation of these regulations or that the public health, safety, or welfare requires immediate action.B. If the Department summarily suspends a designation or waiver, it shall provide the facility with a notice explaining the basis for the summary suspension. The notice shall also inform the facility of its right to appeal and that it is entitled to a prompt hearing on the matter.C. Appeals of summary suspensions shall be conducted in accordance with the State Administrative Procedure Act, Section 24-4-101, et seq., C.R.S.7. Redesignation at a Lesser Level A. The Department may determine that a facility be redesignated at a lesser level due to the facility's inability to meet the designation criteria at its current level, notwithstanding any waiver previously granted.B. If the Department seeks to redesignate the facility, it shall provide the facility with a notice explaining the basis for its action. The notice shall also inform the facility of its right to appeal and the procedure for appealing the action.C. Appeals of involuntary redesignation shall be conducted in accordance with the State Administrative Procedure Act, Section 24-4-101, et seq., C.R.S.8. Monetary Penalties Any facility, provider, or employee of a facility that falsely misrepresents a facility's designation level or violates any rule adopted by the board shall be subject to a civil penalty of $500 per violation. The fee shall be assessed in accordance with Section 25-3.5-707(2), C.R.S.
39 CR 02, January 25, 2016, effective 2/14/201640 CR 08, April 25, 2017, effective 5/15/201741 CR 22, November 25, 2018, effective 12/15/201842 CR 10, May 25, 2019, effective 6/14/201943 CR 09, May 10, 2020, effective 6/14/202044 CR 10, May 25, 2021, effective 7/1/2021