Highlighted Items are notes/instructions for CCR publication and are not part of the rules.
Amendments to Rules Pertaining to the Statewide Emergency Medical and Trauma Care System, 6 CCR 1015-4, Chapter Two, sections 202(C)(4) and 202(C)(5), and Chapter Three, adopted by the State Board of Health on July 18, 2007

Amendments to Chapter Two – State Emergency Medical and Trauma Care System Standards
Replace existing sections 202(C)(4) and 202(C)(5), paragraph ID’s 1285718 through 1285721, with the following:

4.	Nondesignated Facilities 
Within two hours of recognition that a patient has experienced a significant injury or mechanism as defined in 6 CCR 1015-4, section 202C, 202D or the prehospital algorithm, the facility shall resuscitate, stabilize and/or initiate transfer of the patient, after consultation with a trauma surgeon or emergency physician at the closest designated trauma center. Transfer shall be to the closest appropriate trauma facility as defined by RETAC protocols and as determined in consultation with the trauma surgeon or emergency physician.  Nondesignated facilities must transfer all trauma patients except those defined in rule 205(C)(5). 
5.	Noncomplicated Trauma Injuries
Interfacility transfer of single system injuries that are not threatening to life or limb and whose care is not complicated by co-morbid conditions shall be made in accordance with RETAC protocols.  RETACs must monitor transport within their regions and report systematic exceptions to the protocols or regulations to the Department.

Amendments to Chapter Three – Designation of Trauma Facilities
Replace existing sections 301 and 302 in their entirety (paragraph IDs 1285905 through 1286045) with the following: 
Section 301.	Designation Process 
1.	General Provisions
A.	Any Colorado facility receiving trauma patients by ambulance or other means shall follow the process for designation or non-designation based upon its operational status as set forth in 301.2.A.
B.	Healthcare facilities shall have state licensure before obtaining designation as a trauma center.
C.	A separate designation is required for each distinct physical location where a facility provides trauma care services. 
2.	Process to be Applied
A.	The current operational status of the facility will determine the designation process to be applied.	 The four types of operational status are:  	
(1)	New facility – a hospital, community clinic and emergency center (CCEC), or other licensed facility that is seeking trauma center designation for the first time or seeking to change to a different level of designation.
(2)	Replacement facility – an existing trauma center requesting designation at the current level for a new physical location and not retaining trauma center status at the old location.
(3)	Existing facility renewal – a currently designated trauma center seeking renewal at the same designation level.
(4)	Non-designated facility – a hospital, CCEC or other licensed facility that receives and is accountable for injured persons, but chooses not to seek trauma center designation.
B.	The specific administrative and clinical criteria for each of the Level I–V designations are set forth in sections 303 and 304 of this chapter.
C.	Applications for designation are public documents.  The facility is responsible for identifying any proprietary information.  Proprietary documents are defined here as those that are protected by copyright, or are used, produced or marketed under exclusive legal right of the facility.
D.	At any time, the department may move to revoke, suspend or otherwise limit a facility’s designation consistent with the enforcement and disciplinary process contained in section 302 of this chapter.
3.	New Facility
A.	Application Procedure
(1)	A new facility shall submit a written notice to the department at least 180 days in advance of either the anticipated date of opening or commencement of operation at a higher designation level.  Facilities moving to a lower level of designation shall provide notice no later than 90 days in advance.  The notice shall state the level of designation the facility is requesting. 
(2)	The facility shall complete a trauma designation application for new facilities on the department’s form and submit it along with the designation fee before the site visit according to the deadline specified by the department.
(3)	After an initial assessment of the application by the department, the facility shall have ten (10) calendar days to respond to written notice of any application deficiency.  
(4)	If a facility does not correct application deficiencies in a timely manner, the department may delay or cancel the review process.  The department may also consider the facility’s failure to respond in a timely manner as grounds for denial of designation.	
B.	Fee Structure
The facility shall submit the non-refundable designation fee with its application.  The new facility designation fee is:

Level I:	$20,000	
Level II:	$19,800	
Level III:	$14,330	
Level IV:	$ 6,800	
Level V:	$ 6,800	
C.	Site Review Procedure	
(1)	Any facility requesting a new Level I through V designation shall undergo an on-site review.  The department will set a review date no more than ninety (90) days before the new facility opens or commencement of operation at the new designation level.
(2)	All equipment and policies for the requested designation level as currently required by sections 303 and 304 of this chapter shall be in place for inspection or evidence of their placement shall be provided to the department before the facility’s opening or commencement of operation at the new designation level.
(3)	All personnel for the requested designation level as currently required by section 303 of this chapter shall be identified and available for interview.
(4)	The department will select the new facility review team according to the following specifications:
a.	Level I–II facilities:
i.	A minimum of one trauma surgeon and one trauma nurse who live and work outside the State of Colorado,
ii.	One state observer,  
iii.	Departmental discretion to designate additional reviewers up to a full team as set forth in 301.5.C(1)a of this section.
b.	Level III facilities:
i.	A minimum of one trauma surgeon and one trauma nurse who live and work outside the facility’s RETAC area,
ii.	One state observer, 
iii.	Departmental discretion to designate additional reviewers up to a full team as set forth in 301.5.C(1)b of this section.
c.	Level IV–V facilities:
i.	A minimum of one emergency physician or trauma surgeon and one trauma nurse who live and work outside the facility’s RETAC area,
ii.	One state observer, 
iii.	Departmental discretion to designate additional reviewers up to a full team as set forth in 301.5.C(1)c of this section.
(5)	All review team members shall also meet the following criteria:
a.	Physician reviewers shall be certified by the American Board of Medical Specialties or the American Board of Osteopathic Medicine,
b.	Physician reviewers shall be board certified in the specialty they are representing, 
c.	Be currently active in trauma care at the level being reviewed or above,
d.	Have no conflict of interest with the facility under review, and
e.	Live and work outside the facility’s RETAC area.
(6)	The department will provide the applicant with the names of the on-site reviewers once they have been selected.
(7)	If the applicant believes that a potential reviewer has a financial, professional or personal bias that may adversely affect the review, the facility shall notify the department, in writing, no later than seven (7) calendar days after the department’s announcement of the proposed team members.  Such notice shall contain all details of any alleged bias along with supporting documentation. The department shall consider such notice and make a decision concerning replacement of the reviewer in question.
(8)	The review may consist of, but is not limited to, consideration of the following:
a.	Review of application,
b.	Equipment check throughout the facility,
c.	Review of all policies and procedures,
d.	Review of quality improvement plans and other quality improvement documentation as may be appropriate,
e.	Physical inspection of facility,
f.	Interviews with staff,
g.	Transfer protocols,
h.	Call schedules,
i.	Credentials of staff,
j.	Review of the facility’s planned interaction with prehospital transport, and
k.	Other documents deemed appropriate by the department.
(9)	The review team shall provide a verbal report of its findings to the applicant before leaving the facility.
D.	Designation Decision Procedure
(1)	The department shall present a summary of the Level I–II results to SEMTAC or a summary of the Level III–V results to the Designation Review Committee (DRC) for a recommendation on the new facility designation.
(2)	The department shall consider all evidence and notify the applicant in writing of its decision within thirty (30) calendar days of receiving the recommendation.   
(3)	The department’s final determination regarding each application shall be based upon consideration of all pertinent factors including, but not limited to, the application, the evaluation and recommendations of the on-site review team, the recommendation from SEMTAC or DRC, the best interests of trauma patients, and any unique attributes or circumstances that make the facility capable of meeting particular or special community needs. 
(4)	If the department denies new facility designation, the provisions of section 302.3 of this chapter shall apply.
E.	Period of Designation
(1)	A new facility designation is a one-time designation valid for 18 months.  
(2)	Once a new facility designation is issued, the facility will coordinate with the department to schedule a full review within 12–14 months.
(3)	Prior to the full review, the facility shall follow the application procedures described in 301.5.A(2) through (4).
(4)	The subsequent site review and designation decision procedures shall follow those described for renewal of existing facilities at 301.5.C and D.
(5)	Designation following the full review will mark the beginning of a full three-year designation cycle.
4.	Replacement Facility
	Any facility that has applied for replacement facility designation before the effective date of these rules and whose site review occurs after the effective date of these rules shall be exempt from section 301.4.A(3) and B.
A.	Application Procedure
(1)	A trauma designation review is required when the department issues a new hospital or CCEC license based upon a change of location. 
(2)	A replacement facility shall submit a written notice to the department at least 180 days in advance of the anticipated date of opening. 
(3)	The facility shall provide the department with a copy of its last renewal application along with updated statistical data and information on any policy changes.  The facility shall submit the application, designation fee and additional information to the department before the site visit according to the specified deadline.
(4)	After an initial assessment of the application and updated information by the department, the facility shall have ten (10) calendar days to respond to written notice of any application deficiency.  
(5)	If a facility does not correct application deficiencies in a timely manner, the department may delay or cancel the review process.  The department may also consider the facility’s failure to respond in a timely manner as grounds for denial of designation.	
(6)	The facility will coordinate with the department to schedule a date for the replacement review to occur no sooner than the move to the replacement physical plant and no later than thirty (30) calendar days after the move.
(7)	The facility’s existing trauma designation continues until a replacement review occurs and the department makes a decision on the replacement facility application.
B. 	Fee Structure
The facility shall submit the non-refundable designation fee with its application.  The replacement facility designation fee is:

Level I: 	$8,700	
Level II:	$8,100	
Level III:	$3,080	
Level IV:	$2,800	
Level V:	$2,800	
C.	Site Review Procedure
(1)	Any facility requesting replacement designation at the same level for a new physical plant shall undergo an on-site review at the new location. 
(2)	All equipment and policies required by the facility’s current designation level shall be in place for inspection at the replacement facility.
(3)	The department will select the site review team for the replacement facility according to the following specifications:
a.	Level I–II  facilities:
i.	A minimum of one trauma surgeon and one trauma nurse who live and work outside the State of Colorado,
ii.	One state observer, 
iii.	Departmental discretion to designate additional reviewers up to a full team as set forth in 301.5.C(1)a. 
b.	Level III–V facilities:
i.	A minimum of one trauma nurse who lives and works outside the facility’s RETAC area,
ii.	One state observer, 
iii.	Departmental discretion to designate additional reviewers up to a full team as set forth in 301.5.C(1)b and c.
(4)	All review team members shall also meet the following criteria:
a.	Physician reviewers shall be certified by the American Board of Medical Specialties or the American Board of Osteopathic Medicine,	
b.	Physician reviewers shall be board certified in the specialty they are representing, 
c.	Be currently active in trauma care at the level being reviewed or above,
d.	Have no conflict of interest with the facility under review, and
e.	Live and work outside the facility’s RETAC area.
(5)	The department will provide the applicant with the names of the on-site reviewers once they have been selected.
(6)	If the applicant believes that a potential reviewer has a financial, professional or personal bias that may adversely affect the review, the facility shall notify the department, in writing, no later than seven (7) calendar days after the department’s announcement of the proposed team members.  Such notice shall contain all details of any alleged bias along with supporting documentation.  The department shall consider such notice and make a decision concerning replacement of the reviewer in question.
(7)	The on-site review may consist of, but is not limited to, consideration of the following:
a.	Equipment check throughout the facility,
b.	Physical inspection of facility,
c.	Review of all policies and procedures,
d.	Interviews with staff,
e.	Review of effects of the facility move on prehospital transport protocols, and
f.	Other documents deemed appropriate by the department.
(8)	The team shall provide a verbal report of its findings to the applicant before leaving the facility.
D.	Designation Decision Procedure  
	The designation decision procedure shall follow the one described for existing facility renewal at section 301.5.D of this chapter.
E.	Designation Period
	Designation following the replacement review will continue until the end of the facility’s existing designation cycle.
5.	Renewal of Existing Facility
A.	Application Procedure
(1)	Existing facilities shall submit a letter of intent to maintain their current trauma level designation to the department no later than 120 days before the current designation expiration date.  
(2)	The facility shall complete a trauma designation application for renewal of existing facilities on the department’s form and submit it to the department before the site visit according to the deadline specified by the department. 
(3)	After an initial assessment of the application by the department, the facility shall have ten (10) calendar days to respond to written notice of any application deficiency.  
(4)	If a facility does not correct application deficiencies in a timely manner, the department may delay or cancel the review process.  The department may also consider the facility’s failure to respond in a timely manner as grounds for denial of designation.	
B.	Fee Structure
(1)	The facility shall submit the required designation fee in the manner specified by the department.  The renewal of existing facility designation fee is:

Level I:	$26,600	
Level II:	$25,900	
Level III:	$16,600	
Level IV:	$6,800	
Level V:	$6,800	
(2)	Fees submitted with the renewal application may be forfeited if the facility does not respond in a timely manner to application deficiencies.
C.	Site Review Procedure
(1)	The department will select the site review members for renewal of an existing facility designation according to the following specifications:
a.	Level I–II facilities – An out-of-state multidisciplinary team consisting of two trauma surgeons, one trauma nurse coordinator or RN involved in trauma program management, one emergency physician, and one state observer.
b.	Level III facilities - A team consisting of one trauma surgeon, one emergency physician, one trauma nurse coordinator or registered nurse involved in trauma program management and one state observer.
c.	Level IV–V facilities - A team consisting of one emergency physician or trauma surgeon, one trauma nurse coordinator or registered nurse involved in trauma program management and one state observer.
(2)	All review team members shall also meet the following criteria:
a.	Physician reviewers shall be certified by the American Board of Medical Specialties or the American Board of Osteopathic Medicine,
b.	Physician reviewers shall be board certified in the specialty they are representing, 
c.	Be currently active in trauma care at the level being reviewed or above,
d.	Have no conflict of interest with the facility under review, and
e.	Live and work outside the facility’s RETAC area.
(3)	The department will provide the applicant with the names of the on-site reviewers once they have been selected.
(4)	If the applicant believes that a potential reviewer has a financial, professional or personal bias that may adversely affect the review, the facility shall notify the department, in writing, no later than seven (7) calendar days after the department’s announcement of the proposed team members.  Such notice shall contain all details of any alleged bias along with supporting documentation.  The department shall consider such notice and make a decision concerning replacement of the reviewer in question.
(5)	The on-site review team shall evaluate the capability of the facility to meet the responsibilities, required equipment and performance criteria appropriate to its designation level as identified in these rules through the following: 	
a.	Review of application, 
b.	Physical inspection of the facility,
c.	Review of trauma patient medical records,
d.	Review of patient discharge summaries,
e.	Review of patient care logs,
f.	Review of quality improvement/management/assurance records and meeting minutes,
g.	Review of rosters, schedules and meeting minutes,
h.	Interviews with appropriate facility personnel and other medical providers, 
i.	Review of research, prevention, and educational programs as applicable, and
j.	Review of other documents as deemed appropriate by the team.
(6)	The review team shall provide a verbal report of its findings to the applicant before leaving the facility.  
D.	Designation Decision Procedure
(1)	The department shall present a summary of the Level I–II results to SEMTAC or a summary of the Level III–V results to the Designation Review Committee (DRC) for a recommendation to the department on the facility designation.
(2)	If the department determines that a plan of correction is appropriate, the facility shall follow the process set forth in section 302.2 of this chapter.
(3)	The department shall notify the applicant in writing of its decision within thirty (30) calendar days of receiving the recommendation.  
(4)	The department’s final determination regarding each application shall be based upon consideration of all pertinent factors, including but not limited to the application, the evaluation and recommendations of the on-site review team, the recommendation from SEMTAC or DRC, compliance history, the best interests of trauma patients, and any unique attributes or circumstances that make the facility capable of meeting particular or special community needs.  
(5)	If the department denies renewal of existing facility designation, the provisions of section 302.3 of this chapter shall apply.
E.	Period of Designation
	Renewal of existing facility designation will be valid for three years from the prior expiration date, unless voluntarily relinquished by the facility, revoked, suspended or otherwise sanctioned pursuant to these rules.
6.	Non-designated Facility
A. 	A facility requesting non-designation status shall file a non-designation agreement that, at a minimum, states the following:
(1)	The facility chooses not to seek such designation.
(2)	The facility acknowledges and agrees that it may only treat patients who have single system injuries that are not threatening to life or limb and whose care is not complicated by co-morbid conditions. 
(3)	The facility has established transfer agreements as required by Section 25-3.5-703(4)(a), C.R.S.
(4)	Within two hours of recognition that a patient has experienced a significant injury or mechanism as defined in 6 CCR 1015-4, section 202.C, 202.D or the prehospital algorithm, the facility shall resuscitate, stabilize and/or initiate transfer of the patient, after consultation with a trauma surgeon or emergency physician at the closest designated trauma center, as required by Section 202.C.4. Transfer shall be to the closest appropriate trauma facility as defined by RETAC protocols and as determined in consultation with the trauma surgeon or emergency physician.
7.	Waivers	
A.	The department may grant a waiver from one or more criteria that are established in this chapter	for Level I–V trauma centers.
B.	Facilities seeking a waiver shall submit a completed waiver application on the department’s form.  The department may require the applicant to provide additional information, and the application will not be considered complete until the required information is provided.
C.	The facility seeking the waiver shall also post notice of the waiver application and a meaningful description of the substance of the request at all public entrances to the facility and in at least one area commonly used by the patients. The notice shall be posted no later than the application’s submission date and shall remain posted for at least thirty (30) calendar days.
D.	The notice shall describe where to send comments within that 30-day period.  Comments should be directed to:
EMTS Section
ATTN:  Section Chief
CDPHE, HFEMSD-A2
4300 Cherry Creek Drive South
Denver, CO  80246
E.	At the same time the notice is posted in the facility, the facility shall also distribute a copy of the notice to prehospital emergency medical service providers active in the community served by the facility.
F.	The completed waiver application shall be submitted to the department at least thirty (30) calendar days before a SEMTAC meeting in order to be placed on the next agenda.  Applications completed less than thirty (30) calendar days in advance will be placed on the subsequent agenda.
G.	The department shall distribute a copy of the public notice of the SEMTAC meeting regarding the waiver to all other designated trauma centers.
H.	SEMTAC shall review the request and make recommendations to the department.  The department shall make a decision and send notice of that decision to the facility administrator within thirty (30) calendar days of the recommendation.
(1)	If the waiver is granted, the department may:
a.	Specify the terms and conditions of the waiver.
b.	Specify the duration of the waiver.  Under no circumstances shall a waiver be granted for a period longer than the designation cycle for that facility.
(2)	The department may require the submission of progress reports from any facility granted a waiver.
(3)	If the waived rule is amended or repealed, obviating the need for the waiver, the waiver shall expire on the effective date of the rule change.
I.	A facility shall notify the department prior to any change of ownership of the facility as defined in 6 CCR 1011-1, Chapter II, Part 2.9.1.	
J.	Facilities wishing to maintain a waiver beyond its expiration shall submit a new waiver application to the department no less than ninety (90) days prior to the expiration of the waiver.
K.	The department may revoke or suspend a waiver if it determines:
(1)	That its continuation jeopardizes the health, safety, and/or welfare of the patients, 
(2)	The applicant has provided false or misleading information in the waiver application,
(3)	The applicant has failed to comply with conditions of the waiver, or
(4)	The department determines that a change in federal or state law prohibits continuation of the waiver.
L.	If the department denies, revokes or suspends a waiver, the pertinent provisions of sections 302.3, 302.4 or 302.5 of this chapter shall apply. 
8.	Designation Review Committee
A.	The Designation Review Committee (DRC) shall make recommendations to the department about the designation of Level III–V facilities and shall report such recommendations to SEMTAC.
B.	The DRC shall be comprised of nine members.  A minimum of five members shall be current SEMTAC members.  The members shall represent the following constituencies and disciplines:
(1)	One healthcare facility administrator,	
(2)	One board-certified general surgeon;
(3)	One board-certified general surgeon with experience as a site reviewer or a trauma service director at a Level III–V facility,
(4)	One physician board-certified in emergency medicine,
(5)	One physician board-certified in emergency medicine with experience as a site reviewer or a trauma service director at a Level III–V facility,
(6)	One trauma program manager or trauma nurse coordinator,
(7)	One trauma program manager or trauma nurse coordinator with experience as a site reviewer or a Level III–V trauma nurse coordinator,
(8)	One member representing the prehospital/EMS community/or public, and
(9)	One member representing a RETAC.
C.	SEMTAC shall make recommendations to the department on the membership of the DRC along with the criteria to be used by the DRC.
D.	The DRC meetings shall be public.
E.	The DRC shall have access to a facility’s application with any proprietary material extracted, a summary of the site review finding, and any plan of correction submitted by the facility.
Section 302.	Enforcement and Disciplinary Process
1.	Unscheduled or Interim Reviews
A.	At any time the department may require and conduct an unscheduled or interim review of a currently designated facility based upon, but not limited to, the following criteria:
(1)	Recent review results,
(2)	A complaint, or
(3)	Monitoring of the EMTS system.
2.	Plans of Correction
A.	Prior to making a designation decision, or after an unscheduled or interim 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.	Denials
A.	The department may deny an application for Level I–V 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.
4.	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.    
5.	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.
6.	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.
7.	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.

Replace existing sections 304, 305 and 306 in their entirety (paragraph IDs 1287173 through 1287317), with the following:
304.   	Trauma Quality Improvement Programs for Designated Trauma Centers Levels III–V
1.	All designated Level III–V trauma centers shall have an organized, trauma quality improvement program that demonstrates a plan, process and accountability for continuous quality improvement in the delivery of trauma care. The program shall include, but not be limited to: 
A.	A plan that shall address the entire spectrum of services necessary to ensure optimal care to the trauma patient, from prehospital to rehabilitative care.  This plan may be parallel to, and interactive with, the hospital-wide quality improvement program as defined in C.R.S. § 25-3-109 but may not be replaced by the facility process.  In Level IV–V clinics or facilities, this plan may be part of the hospital-wide quality improvement program, but must have specific defined trauma-related indicators and components. This plan shall include identification of:
(1)	The trauma center’s organizational structure responsible for the administration of the plan, to include a description of who has the authority to change policies, procedures or protocols related to trauma care;
(2)	The responsibility of the trauma service director, or in Level IV–V centers the physician responsible for coordination of the service in coordination with the trauma nurse coordinator for:
a.	The identification of and responsibility for the oversight of the plan;
b.	Initiation of corrective action as needed;
c.	Conducting a special audit of all trauma deaths with:
i.	Written documentation of the process to include the assessment, any corrective action and resolution; and   
ii.	The deaths shall be identified as:
1.	Preventable,
2.	Potentially preventable, or
3.	Non-preventable, and
iii.	Reporting a summary of the audit findings to the trauma multidisciplinary /*committee;
d.	The facility-defined standards of medical care for the trauma patient;
e.	A process for corrective action, to include problem identification, action plan, resolution or outcome for loop closure;
f.	The method for documentation and maintenance of minutes on site and readily available of special death audits, trauma multidisciplinary committee, or any other committees used in this process;
g.	The process for prehospital trauma care review;
h.	The data sources to support an effective monitoring system, to include but not be limited to retrospective and concurrent medical record review;
I.	A process for the identification and review of facility-defined patient sentinel events, complications and trends;
j.	The development and evidence of on-going reporting and trending of institution specific audit filters to facilitate the quality improvement program to identify at a minimum, but not limited to:
i.	Program structure (systems issues) with:  all trauma transfers in or out, except those with isolated extremity fractures;
ii.	Program process (medical issues) with:  provider response times when the trauma team is activated; and
iii.	Program outcomes with compliance with:  initial resuscitation and stabilization as defined in facility policy;
k.	Institution specific nursing audits with: 
i.	Evidence that nursing performance improvement issues are reviewed as part of the trauma program;
ii.	Clinical filters for nursing documentation; and
iii.	Ongoing monitoring and/or trending.
l.	Methods and process for conducting multidisciplinary peer review to include;
i.	A process of peer review as defined in C.R.S. § 12-36.5-104 et.seq.  This process shall monitor compliance with, or adherence to facility-defined standards of medical care for the trauma patient.  All trauma centers shall have a policy that includes the process and criteria for utilization of a resource outside the facility for peer review.  Documentation of findings and recommendations must be maintained with an identified reporting process for loop closure.  Qualifications of outside peer reviewer must be identified by the facility as defined in C.R.S § 12-36.5-104;
m.	Provision for case presentations of interest for educational purposes to improve overall care to the trauma patient to include:
i.	All aspects and contributing factors of trauma care from prehospital to discharge or death; and
ii.	A review of any event that deviates from an anticipated outcome; and
iii.	Documentation of the review shall include date, reason for review, problem identification, recommendations, resolution and education.
B.	The trauma multidisciplinary committee, as defined in section 303 Level IIII–V of these rules, is responsible for trauma program performance at each trauma center. Membership will be established by the facility and the committee will establish attendance requirements. This includes, but is not limited to:
(1)	The review of all services essential to the care and management of the trauma patient;
(2)	Meeting on a regular basis, but not less than every two months for Level III facilities, and quarterly for Level IV–V clinics or facilities, to assure timely review and corrective action.
(3)	Performance management functions include but are not limited to:
a.	Establishing and enforcing policies and procedures;
b.	Reviewing process issues, e.g., communications; reviewing systems issues, e.g., response times and notification times; and promoting educational offerings; and
c.	Reviewing and analyzing trauma registry data for program evaluation and utilization;
i.	With defined intervals for data collection and analysis;
1.	Level III facilities shall maintain a trauma registry as required by regulation in Chapter 1.
2.	In Level IV–V clinics or facilities shall fulfill the reporting requirement for the submission of data as required by regulation in Chapter 1;
3.	In Level IV–V clinics or facilities with non-participation in the Colorado Hospital Association discharge data set, the trauma registry as defined in Chapter 1 of these rules may, at a minimum, be in the form of a hard-copy abstract approved by the department;
4.	Maintaining a system (such as a log) for tracking patient disposition, and deaths.
305.	Reserved.
306.	Burn Unit Referral Criteria
A burn unit may treat adults or children or both.  The attending surgeon at a burn unit shall be consulted for any of the following burn injuries:
1.	Partial thickness burn greater than 10% total body surface area (TBSA).
2.	Burns that involve the face, hands, feet, genitalia, perineum, or major joints.
3.	Third-degree burns in any age group.
4.	Electrical burns, including lightning injury.
5.	Chemical burns.
6.	Inhalation injury.
7.	Burn injury in patients with pre-existing medical disorders that could complicate management, prolong recovery, or affect mortality.
8.	Any patients with burns and concomitant trauma (such as fractures) in which the burn injury poses the greatest risk of morbidity or mortality.  In such cases, if the trauma poses the greater immediate risk, the patient may be initially stabilized in a trauma center before being transferred to a burn unit.  Physician judgment will be necessary in such situations and should be in concert with the regional medical control plan and triage protocols.
9.	Burned children in hospitals without qualified personnel or equipment for the care of children.
10.	Burn injury in patients who will require special social, emotional, or long-term rehabilitative intervention.