6 Colo. Code Regs. § 1015-4-301

Current through Register Vol. 47, No. 24, December 25, 2024

Section 6 CCR 1015-4-301 - Nondesignation and Designation Processes

1. General Provisions

A. Any Colorado facility receiving trauma patients by ambulance or other means shall follow the process for designation or nondesignation 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 or nondesignation agreement 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 statuses are:

(1) Nondesignated facility - A hospital, freestanding emergency department (FSED), community clinic providing emergency services, or other licensed facility that receives and is accountable for injured persons but chooses not to seek trauma center designation.

(2) New facility - A hospital, FSED, community clinic providing emergency services, or other licensed facility that is seeking trauma center designation for the first time or seeking to change to a different level of designation.

(3) 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.

(4) Existing facility renewal - A currently designated trauma center seeking renewal at the same designation level.

B. The specific administrative and clinical criteria for each of the Level I-V and RPTC designations are set forth in Section 303 through Section 307 and Section 309 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. Nondesignated Facilities

A. A facility requesting nondesignation status shall file a nondesignation 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 admit patients with single system injuries that are not threatening to life or limb and whose care is not complicated by co-morbid conditions.

(3) The facility acknowledges and agrees that it shall triage and treat patients according to the following:

Patient Condition	Time Frame	Required Action
Traumatic injury requiring emergent intervention	One hour	Initiate resuscitation and transfer to a trauma center with the resources necessary to meet the patient's emergent needs. Transfer must be initiated but need not be completed within one hour. Transfer shall not be encumbered by restrictions to keep patients within a particular healthcare organization.
Any non-emergent traumatic injury meeting mandatory transfer or consult criteria as described in 6 CCR 1015-4, Chapter Three, Section 305.	Two hours	Initiate resuscitation and transfer to a trauma center with the resources necessary to meet the patient's needs. Transfer must be initiated but need not be completed within two hours.
Any non-emergent trauma patient that has experienced a significant injury or mechanism as defined in 6 CCR 1015-4, Chapter One, prehospital algorithms, or requiring care beyond the resources of the facility.	Two hours	Initiate resuscitation and transfer to a trauma center with the resources necessary to meet the patient's needs. Transfer must be initiated but need not be completed within two hours. Decisions regarding transfer shall include consideration of co-morbid conditions, potential complications, etc.

(4) The facility has identified key resource facilities for adult, pediatric, and specialty care patients.

(5) The facility has established transfer agreements as required by Section 25-3.5-703(4)(a), C.R.S.

(6) Nondesignation agreements shall be renewed on a triennial basis.

B. Upon initiation or renewal of a nondesignation agreement, each nondesignated facility shall contact its RETAC. The communication will be documented and a copy of the documentation shall accompany the signed nondesignation agreement described in Section 301.6.A . The documentation shall demonstrate that the following was discussed:

(1) Key resource facilities identified by the RETAC per CCR 1015-4, Chapter Four, 401.10.

(2) Trauma system resources available for all types of trauma patients, including specialty services such as burns, reimplantation, and pediatric care. Such resources may be located within or outside the RETAC.

(3) Communication systems available within the RETAC, system capabilities, and how to integrate with those systems.

(4) Resources available for prehospital and interfacility transport.

4. 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

(1) Facilities seeking simultaneous verification or consultation by the American College of Surgeons (ACS) shall pay any fees associated with the verification directly to the ACS, and the state fees identified below will be paid to the Department. If the ACS is unable to supply all required team members for the state review, the facility shall pay the state an additional $3,000 per reviewer obtained by the state.

(2) The facility shall submit the non-refundable state designation fee with its application. The new facility designation fee is:

Level I/RPTC:	$17,500
Level II:	$17,500
Level III:	$11,300
Level IV/V:	$8,500

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 Section 303 through Section 307 and Section 309 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 through Section 307 and Section 309 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 301.6.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 301.6.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 301.6.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 and RPTC 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 302.4 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 301.6.A.(2) through (4).

(4) The subsequent site review and designation decision procedures shall follow those described for renewal of existing facilities at 301.6.B. through D.

(5) Designation following the full review will mark the beginning of a full three-year designation cycle.

5. Replacement Facility

A. Application Procedure

(1) A trauma designation review is required when the Department issues a new hospital, FSED, or community clinic providing emergency services 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/RPTC:	$6,500
Level II:	$6,500
Level III:	$1,800
Level IV/V:	$1,800

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 301.6.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 301.6.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 301.6.D of this chapter.

E. Designation Period

Designation following the replacement review will continue until the end of the facility's existing designation cycle.

6. 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) Facilities seeking state designation only:

a. The facility shall submit the required annual designation fee in the manner specified by the Department. The renewal of existing facility designation fee is:

Level I/RPTC:	$12,300
Level II:	$12,300
Level III:	$7,000
Level IV/V: Emergency Department Visits > 15,000 per year	$5,000
Level IV/V: Emergency Department Visits between 5,000 - 15,000 per year	$4,000
Level IV/V: Emergency Department Visits < 5,000 per year	$3,000

(2) Facilities seeking state designation and simultaneous ACS verification must pay each of the following fees separately:

a. Facilities seeking verification by the ACS shall pay any fees associated with the verification by the ACS directly to the ACS and the state fees identified below.

b. Facilities requesting simultaneous verification by the ACS at the time of the Colorado state trauma designation survey shall pay the following annual fee to the Department for the state designation process only:

Level I/RPTC:	$8,100
Level II:	$8,100
Level III:	$5,000
Level IV/V:	N/A

c. If the ACS is unable to supply all required team members for the designation review, the facility shall pay the Department an additional $3,000 per reviewer obtained by the state.

(3) The new fees shall be in effect on July 1, 2017, and the first annual payment shall be due on July 1 of the state fiscal year in which the current state designation expires.

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 or RPTC 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 302.4 of this chapter shall apply.

E. Period of Designation

(1) 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.

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 Branch

ATTN: Branch Chief

CDPHE, HFEMSD

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 2 - General Licensure Standards, Part 2.6.

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 302.4, 302.5, or 302.6 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 Medical 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 Medical 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 findings, and any plan of correction submitted by the facility.

6 CCR 1015-4-301

39 CR 02, January 25, 2016, effective 2/14/2016

40 CR 08, April 25, 2017, effective 5/15/2017

41 CR 22, November 25, 2018, effective 12/15/2018

42 CR 10, May 25, 2019, effective 6/14/2019

43 CR 09, May 10, 2020, effective 6/14/2020

44 CR 10, May 25, 2021, effective 7/1/2021