Wyo. Code R. 048-0056-2
Trauma Program, Wyoming
Chapter 2: Designation Process
Effective Date: 11/20/2008 to Current
Rule Type: Current Rules & Regulations
Reference Number: 048.0056.2.11202008
Section 1. General Procedure.
(a) Trauma Care Facilities - Designation Process.
(i) The facility designation categories are as follows:
(A) Regional Trauma Centers (RTCs); (B) Area Trauma Hospitals (ATHs); (C) Community Trauma Hospitals (CTHs); and (D) Trauma Receiving Facilities (TRFs).
(ii) The designation process shall consist of:
(A) Each facility providing information to the OEMS regarding that facility's capabilities as a trauma facility;
(B) A site survey as specified in Chapter 2, Section 1, (c);
(C) Identification of facility requirements that are not met by the facility. The OEMS shall provide advice and education to assist the facility in meeting these identified requirements; and
(D) Upon meeting the facility requirements, the OEMS shall assign a specific designation for a period of three (3) years.
(iii) The OEMS may provide consultation, advice, and/or technical assistance to facilities who request assistance in any aspect of this process. Telephone the OEMS Trauma Program Coordinator at (307) 777-7955.
(iv) The OEMS shall develop a designation criteria form for facilities seeking designation or renewal of designation as trauma care facilities. The form shall include:
(A) System standards for facility level and category of designation sought;
(B) Designation criteria form requirements;
(C) Evaluation criteria;
(D) Goals and objectives of the facility; (E) Capability to provide trauma care; (F) Commitment to serve the trauma care needs of the state-wide system; (G) Compliance with goals of the state trauma plan; and (H) Geographic area for which the facility proposes to provide trauma care coverage.
(v) The OEMS's analysis of the submitted designation criteria form shall include a review of:
(A) The evidence of participation in system planning; (B) The completeness of the form materials submitted; and (C) The facility's self-study for comparison with the criteria.
(vi) The facility shall:
(A) Submit designation criteria form to OEMS within ninety (90) working days of receiving the these materials from the OEMS;
(B) Within thirty (30) working days of receipt of a form from the facility, the OEMS shall review the designation criteria form for completeness and notify the facility of the result of that review;
(I) If the form is complete, the facility shall be notified in writing;
(II) If the form is incomplete, the facility shall be notified in writing of omissions or errors. The facility may refile the form when complete; and
(vii) The OEMS may grant provisional designation, for a period not exceeding one (1) year, to facilities that are currently unable to meet the standards of this Chapter of these rules, in order to ensure adequate trauma care.
(viii) The OEMS shall:
(A) Conduct a site survey of each facility in accordance with this Chapter, Section 1 (b) (ii) (B) and Section 1 (c); and (B) Consider applications for designation, if and when applications are received, from facilities located and licensed in adjacent states in the same manner as applications received from facilities located and licensed in Wyoming.
(ix) After an evaluation to determine the current capability of each facility to meet or exceed the requirements of this Chapter for the applicable level of designation applied for, the OEMS shall designate the health care facility, based on the following guidelines:
(A) Evaluation of the designation criteria form submitted;
(B) Recommendations from the on site survey team;
(C) For facilities that have been previously designated, outcomes of trauma patients during the previous designation period;
(D) Quality of care provided to patients residing in that area;
(E) Ability of each facility to comply with goals of the state and regional plan; and
(F) Compliance with these rules during the previous designation period.
(x) The OEMS shall:
(A) Notify the facility in writing of designation or denial of designation. This notification shall include a written report of the site survey; and
(B) Notify the OEMS and RACs of the name, location, level, and category of service of facilities that have been designated.
(xi) The OEMS shall issue a renewal designation criteria form as described in this section, for all interested health care facilities, including those currently designated, no later than one hundred twenty (120) working days prior to the expiration of each facility’s current designation.
(b) Site survey for designation. The OEMS shall perform a site survey of all facilities prior to designation.
(i) The OEMS shall establish multi disciplinary on site survey teams composed of individuals knowledgeable in trauma care appropriate to the level of designation requested. On site survey team members may include:
(A) Trauma surgeons;
(B) Emergency physicians; (C) Trauma nurse coordinators; (D) Physicians knowledgeable in pediatric trauma; (E) Family physicians; (F) Hospital or medical administrators; (G) OEMS personnel; and/or (H) Other specialties as needed for the level and category
applied for.
(ii) On site survey teams for Regional Trauma Centers and Area Trauma Hospitals will, consist of a general surgeon who is an out-of-state surveyor, an emergency physician, and a trauma nurse coordinator with experience in similar trauma systems.
(iii) On site survey teams for Community Trauma Hospitals and Trauma Receiving Facilities may be composed of in state surveyors, including a general surgeon, an emergency physician, and a trauma nurse coordinator.
(iv) The on site survey team shall evaluate the appropriateness and capabilities of the facility to provide high quality trauma care services, and validate the facility's ability to meet the responsibilities, equipment, and performance standards for the level of designation sought. The evaluation shall include, but not necessarily be limited to:
(A) Reviewing medical records, staff rosters, and schedules, quality assurance committee meeting minutes, and other documents relevant to trauma care;
(B) Reviewing equipment and the physical plant; and
(C) Conducting interviews with the appropriate hospital personnel.
(v) The on site survey team shall:
(A) Make a verbal report of findings to the facility prior to leaving the facility; and
(B) Make written recommendations to the OEMS in the format prescribed by the OEMS.
(vi) The OEMS shall review the report and recommendations to determine if the facility is substantially in compliance with the criteria. If the facility does not meet the criteria for the level of designation for which it applied, the OEMS, at its sole discretion, shall discuss designation at a lower level with the facility.
(vii) In the event there is an area in which the facility does not comply with the criteria, the OEMS shall within thirty (30) working days notify the facility, in writing, of deficiencies and recommend corrective action. The facility may submit to the OEMS a report which outlines the educational and corrective action taken. Before approving the designation, the OEMS may, at its sole discretion, elect to perform an on site inspection to confirm that the action taken brings the facility into compliance with all relevant criteria. If the OEMS elects not to perform an on site inspection and if the report substantiates action which brings the facility into compliance with all relevant criteria, the OEMS may approve the designation. If the facility disagrees that there is a need for corrective action, the facility may file a grievance according to Section 4 of these rules.
(viii) The OEMS shall require and maintain confidentiality of information, records, and reports developed pursuant to site surveys to the extent allowed by law. Members of the on site survey team shall not divulge any information obtained or included in reports submitted to the OEMS relating to the site survey, unless ordered to do so by a court of competent jurisdiction.
(ix) The facility may submit to the OEMS written objections to the report or recommendations or concerns regarding conflicts of interest pertaining to any member of the on site survey team.
(x) Applications from facilities located and licensed in adjacent states shall be treated in same manner as applications received from Wyoming facilities.
(c) A designated trauma facility shall:
(i) Notify those facilities necessary for appropriate transfer of trauma patients as soon as possible before the applicable situation, if it anticipates being unable to comply with designation standards for twenty-four (24) hours or more¹;
(ii) Immediately notify the OEMS, the WTC, and the RAC if it chooses to cease providing trauma services commensurate with its designation level. If the facility chooses to apply for a lower level of designation, it may do so at any time. This may be accomplished by initiating a new designation process as described in Section 1 of Chapter 2 of these rules. There shall be a paper review by the OEMS to determine if a full survey shall be required. This does not apply to temporary re-designation as described in Section 1 (d) (i) above.
(iii) Comply with the provisions within these sections, all current state and system standards as described in this Chapter, and all policies, protocols, and procedures set forth in the system plan;
(iv) Continue its commitment to provide the resources, personnel, equipment, and response as required by its designation level;
(v) Participate in the state trauma registry as described in Section 1 of Chapter 3 of these rules; and
(vi) Have a written transfer agreement with a receiving trauma facility2 (as appropriate) for the transfer of severely injured trauma patients. This transfer agreement shall include written guidelines for determining the basis for seeking consultation and arranging the transport of trauma patients. Trauma transport protocols must comply with current EMTALA and COBRA/OBRA regulations and shall include the following:
(A) The physician in the initial receiving facility shall be responsible for a decision to transfer a patient to another facility. Unless circumstances make such contact impossible, a physician or a physician-supervised mid-level practitioner in the initial receiving facility shall have direct contact with the physician at the accepting hospital before the transfer occurs;
(B) Once the decision to transfer has been made, it should be accomplished as soon as it is feasible. Resuscitation and stabilization should begin at the referring hospital, realizing that the patient’s problems may be such that true stabilization may only be possible at another facility3. Transport decisions must comply with current EMTALA and COBRA/OBRA regulations;
(C) The mode of transportation used for transfer shall be determined based on time, medical interventions necessary for ongoing life support during transfer, and availability of resources. The referring and accepting physicians shall agree, prior to initiating transfer, who will assume responsibility for on-line medical control during transfer;
(D) All designated trauma services shall have written transfer agreements for the identification and transfer of patients with special care needs who meet interhospital transfer criteria; and
(E) Transfer agreements shall include the responsibility of the transferring hospital and of the receiving hospital and determine the method of assigning medical control during interhospital transfer.
(d) The OEMS may at any time review, inspect, evaluate, and audit all trauma patient records, trauma quality assurance committee minutes, and other documents relevant to trauma care in any designated facility at any time to verify compliance with criteria. The OEMS shall maintain confidentiality of such records as required by federal and state statutes and rules. Such inspection shall be scheduled by the OEMS when appropriate.
(e) When a health care facility is designated or loses its designation as a trauma care facility, such information is not confidential and is considered public information.
(f) Whereby the OEMS may grant a waiver from designation to hospitals and medical facilities that do not maintain an emergency department or advertise to care for trauma patients.
Section 2. Plan Development.
(a) Facilities shall have a trauma plan that is consistent with the Wyoming Trauma Plan and these rules and shall include the following:
(b) Regional Advisory Councils:
(i) The RAC shall develop a system plan based on standard guidelines for comprehensive system development. The system plan is subject to approval by the OEMS. The OEMS shall review the plan to assure that:
(A) All counties within the region have been included unless a specific county, or portion thereof, has been included within an adjacent system;
(B) All health care entities and interested speciality centers have been given an opportunity to participate in the planning process; and
(C) The following have been addressed:
(I) Access to the system; (II) Communications; (III) Medical oversight; (IV) Prehospital triage criteria; (V) Diversion protocols; (VI) Bypass protocols; (VII) Regional medical control; (VIII) Facility triage criteria; (IX) Inter-hospital transfers; and
(X) A quality improvement program that evaluates the outcome from a system perspective.
(ii) The RACs shall:
(A) Advise the OEMS concerning the statewide trauma system; and (B) Establish trauma education and injury prevention programs.
(iii) The RAC is an entity which functions without the expectation of state or federal funding.
(iv) The RACs may request technical assistance from the OEMS.
(v) The RACs shall not require changes to referral or transport patterns for individual facilities.
(vi) The RAC shall provide a report by December 31 each year to the OEMS. This report shall describe the progress toward system development and include evidence that members of the RAC are currently involved in trauma care.
(c) Confidentiality.
(i) Data and reports concerning peer review, quality improvement, or the quality of the trauma care provided by a health care facility or a health care provider that are produced by a RAC or the WTC or provided by a health care facility to a RAC or the WTC as well as the proceedings of those committees concerning peer review and quality improvement shall be confidential, as required by applicable federal and state laws and regulations.
(ii) A statistical report on trauma and trauma care developed by the OEMS that does not identify specific health care facilities, health care providers, or patients is not confidential and is considered public information.
Section 3. Policy Development. Health care facilities planning to implement a trauma system shall develop policies which, at a minimum, address the following:
(p) Assuring the availability of trauma team personnel.
(a) OEMS shall deny an application for designation if it finds in the course of the designation process, that the applying facility:
(i) Is unable to meet the requirements of Chapter 4 of these rules for the level of designation sought;
(ii) Made a false statement of a material fact in its application for designation;
(iii) Refuses to allow representatives of the OEMS to inspect any part of the facility, records, documentation, or files;
(iv) Is unable to meet or comply with the requirements of the approved trauma plan;
(v) Refuses to submit data to the state trauma registry as described in Chapter 3, Section 1 of these rules; or
(vi) Has engaged in unauthorized disclosure of medical or other confidential information.
(b) OEMS shall revoke or suspend designation if any owner, officer, director, or managing employee of a designated facility:
(i) Fails to comply with Section 5 (e) of the State of Wyoming Department of Health Standards, Rules, and Regulations for Hospitals and Related Facilities;
(ii) Fails or refuses to comply with the provisions of this Chapter or Chapter 4 of these rules;
(iii) Fails to provide data to the trauma registry;
(iv) Makes a false statement of a material fact in the application for designation or in any record required by this Chapter or in a matter under investigation;
(v) Prevents, interferes with, or attempts to impede in any way, the work of a representative of the OEMS in the lawful enforcement of this Chapter;
(vi) Misrepresents or is fraudulent in any aspect of conducting business, or has been unable or refuses to comply with OEMS requirements; or
(vii) Is substantially out of compliance with the requirements of this Chapter and Chapter 4 of these rules, and has been unable to or refused to comply with OEMS requirements.
(c) The OEMS shall notify a facility in writing of denial, revocation, or suspension of designation. Such notice shall include:
(i) The reasons for the action; and
(ii) Rights of the facility, which include a right to hearing, and may also include the opportunity to submit a plan of correction.
(A) The designated facility found out of compliance with Chapter 4 and this Chapter of these rules shall within thirty (30) working days, submit a plan of correction to the OEMS. The plan shall include steps the facility is to take to correct deficiencies. The OEMS shall provide assistance to the facilities that are out of compliance in order to bring the facility into compliance with these rules.
(B) When the facility submits a plan of correction, the OEMS shall approve or disapprove the plan within thirty (30) working days, unless the OEMS, at its sole discretion, elects to perform a site survey of the facility, in which case the OEMS shall approve or disapprove the plan within sixty (60) working days.
(C) Upon notification that the plan of correction is approved by OEMS, the facility shall implement that plan immediately.
(D) Upon the receipt of satisfactory evidence of correction, which may include a site survey, the OEMS may, at its sole discretion, reinstate designation status.
(E) The facility may appeal decisions of denial, suspension, or revocation of designation. Appeals will be addressed to the OEMS, Department of Health, Hathaway Building, Cheyenne, WY, 82002. Any appeal of the OEMS' decision shall be conducted in accordance with the Wyoming Administrative Procedure Act (W.S. 16-3-101 through W.S. 16-3-115).
(d) Designation shall, unless earlier evoked or suspended, expire three (3) years after the date of award unless the designee has made a timely and sufficient request for renewal of the designation.
(e) OEMS shall conduct a site survey to inspect the facilities of all applicants, during the initial designation of the trauma facility and the renewing verification of such designation, for compliance of this part and Chapter 4 of these rules. A report of inspection shall be provided to the OEMS within thirty (30) working days after the site survey. Within thirty (30) working days of receipt of the inspection report, the OEMS may accept or reject the plan for designation based upon the findings and recommendations of such reports.
Section 5: Superseding Effect. This Chapter supersedes all prior rules or policy statements issued by the Department including manuals, bulletins, and policy statements, which are inconsistent with this Chapter.