Current through Register Vol. XLI, No. 36, September 6, 2024
Section 64-27-7 - Process of Designation7.1. The chief executive officer of a facility seeking to apply for trauma center designation shall request in writing from the medical director of OEMS an application for initial provisional trauma center designation. The application and other required materials shall be completed and submitted to OEMS with the initial provisional non-refundable designation fee.7.2. Site visits. The following two (2) types of site visits are used in the designation process: 7.2.a. Consultation site visit. A consultation site visit shall be conducted early in the provisional designation process to identify areas of non-compliance and provide specific recommendations to assist facilities in fully meeting the designation requirements. 7.2.a.1. All facilities seeking designation as a level I, II, or III center shall obtain an official American College of Surgeons, Committee on Trauma consultation site visit as outlined in Subdivision 7.3.c. of this rule, except as provided in Subdivision 7.3.i. of this rule. OEMS may waive this consultation site visit if the facility has undergone an official ACS-COT consultation site visit in the past year.7.2.a.2. All facilities seeking designation as a level IV center shall obtain a consultation site visit by a State site visit team as outlined in Subdivision 7.3.C. of this rule.7.2.a.3. The team composition, format, and nature of a level IV consultation shall be determined by OEMS based on discussions and information from the specific facility as to the need for clarification of guidelines and degree of assistance needed to meet the standards and criteria of designation. In certain situations, the consultation may be done by telecommunication or other electronic or written means.7.2.b. Verification site visit. A verification site visit shall be conducted during the provisional designation period or prior to re-certification of a permanently designated facility, in order to verify compliance with trauma center designation requirements. 7.2.b.1. All facilities seeking permanent designation as a level I, II, or III center shall obtain an official American College of Surgeons, Committee on Trauma verification site visit as outlined in Subdivision 7.4.b. of this rule, except as provided in Subdivision 7.3.i. of this rule.7.2.b.2. All facilities seeking designation as a level IV center shall obtain a verification site visit by a West Virginia site visit team as outlined in Subdivision 7.4.c. of this rule.7.3. Initial Provisional Designation. -- After the effective date of this rule, any facility seeking designation as a trauma center shall apply for initial provisional designation status as outlined in this rule. This requirement also includes those trauma centers designated prior to the effective date of this rule. At the discretion of the Commissioner, a facility holding an active trauma center designation prior to the effective date of this rule may maintain that designation for no longer than six (6) months from the effective date of this rule or until the new initial provisional designation is granted or denied, whichever of the three (3) circumstances occur first. The Commissioner may grant provisional status to facilities which meet or substantially meet the requirements as outlined in this rule, and provide evidence of committed progress toward meeting all standards and criteria for permanent designation status. The process for obtaining provisional designation and required activities during the provisional designation are as follows: 7.3.a. Upon receiving a correctly completed application and other required materials, OEMS shall review and evaluate the information provided and make a preliminary assessment as to the facility's ability to meet the requirements of the designation level requested. If, in the opinion of OEMS, the facility appears to substantially meet the requirements and shows evidence of committed progress toward meeting all standards and criteria for permanent status, the facility will be notified in writing of the intent to grant provisional designation status to the facility.7.3.b. If OEMS determines that the facility does not have the ability to substantially meet the requirements for provisional designation at the requested level, OEMS shall deny the application and may recommend that the facility seek provisional designation at a different level and/or suggest to the facility additional modifications before re-applying for provisional designation status.7.3.c. Upon receiving notification from OEMS of the intent to grant provisional status, the facility shall provide to OEMS evidence of the scheduling of a consultation site visit as outlined in Subsection 7.2. of this rule to occur within ninety (90) days of the notification except as outlined in Paragraph 7.2.a.1. of this rule. The cost of the consultation site visit is at the facility's own expense.7.3.d. After receiving written evidence from the facility of the scheduled consultation site visit, the Commissioner shall grant the facility official provisional designation status. The provisional designation letter shall outline any known non-compliance areas discovered during the preliminary review conducted under Subdivision 7.3.a. of this rule. OEMS may establish specific time frames for correction of deficiencies or other activities, including expected progress toward complete compliance. Facilities shall respond to all inquiries and requirements as outlined by OEMS. Provisional status remains valid for no longer than two (2) years, except as outlined in Subdivision 7.3.e. of this rule.7.3.e. The Commissioner may grant a facility a one-time only six (6) month extension of provisional status, upon submission by the facility of a written request for extension, accompanied by a detailed explanation and plan of action to fulfill the requirements for permanent trauma center designation. If, at the end of the six (6) month extension period, the facility has not been designated as a permanent trauma center, the provisional designation expires.7.3.f. Facilities shall use the information provided in the consultation site visit report to assist in correction of non-compliance areas in preparation for the permanent verification site visit. Facilities shall send OEMS a written copy of the consultation report within ten (10) days of receipt of the report by the facility.7.3.g. Provisionally designated facilities seeking permanent designation shall complete the permanent designation process as outlined in Subsection 7.4. of this rule, no sooner than six (6) months nor longer than two (2) years after the date of official provisional designation.7.3.h. If a facility applying for initial provisional designation status has a valid ACS-COT verification certificate issued within the previous two (2) years, OEMS may waive the requirement for a consultation site visit and grant the facility provisional designation status. The facility may then apply for permanent designation status by completing the permanent designation application and materials and paying the appropriate permanent designation fee. If after six (6) months of provisional status the facility continues to meet or exceed all standards and criteria established in this rule, the Commissioner may waive the requirement for a verification site visit, and grant the facility permanent designation as outlined under the permanent designation guidelines in Subsection 7.4. of this rule.7.4. Permanent designation. Provisional centers seeking permanent designation shall complete the following process during their provisional designation period no sooner than six (6) months nor greater than two (2) years after their official date of provisional designation: 7.4.a. All facilities seeking permanent designation shall complete and submit an official permanent designation application and other required materials to OEMS, along with the non-refundable permanent designation fee. This permanent designation application shall be submitted ninety (90) days prior to expiration and prior to the scheduling of the verification site visit.7.4.b. All facilities seeking permanent designation as a level I, II, or III center shall obtain an official American College of Surgeons, Committee on Trauma verification site visit. This visit shall be conducted no later than two (2) years after granting of provisional designation, except as outlined in Subdivision 7.3.h. of this rule. The cost of the ACS-COT verification site visit is at the facility's own expense.7.4.c. All facilities seeking designation as a level IV center shall obtain a verification site visit by a state site visit team. This visit shall be conducted no later than two (2) years after the official provisional designation date. The state verification site visit team shall be appointed by the state EMS medical director from a pool of names developed by the State Trauma Advisory Council (STAC). The site visit team shall consist of a minimum of two (2) persons, one of which is a licensed physician who practices in emergency medicine or trauma surgery and one who is a registered nurse with trauma system care experience. The credentials of this pool shall be developed by the State Trauma Advisory Council.7.4.d. Verification site visit reports shall be sent to the medical director of OEMS. The facilities shall assure that ACS-COT site visit reports are received by OEMS within ten (10) days of receipt of the report by the facility. In extreme situations where a delay in receipt of a report is beyond the control of the facility, OEMS may accept the report if the circumstances for a reasonable delay are explained in writing. State site visit reports shall be sent by the site visit team to the medical director of OEMS in a timely manner.7.4.e. OEMS shall use the information from the verification site visit report and other information, including activities during the facility's provisional status, to determine the permanent designation status of the facility. OEMS may take into account any special situations relating to the state system when rendering a final decision including, but not limited to: the need for trauma or emergency care in a particular geographic area; the number of facilities applying for designation within a particular locale or area; and resources available within a specific area. OEMS may require facilities to develop joint facility designation plans according to specific guidelines established by OEMS in situations where multiple facilities are seeking similar designation status in the same general location. Nothing in this rule shall be interpreted to require OEMS or the Commissioner to designate or not designate a facility based solely on the recommendation of the verification site visit report.7.4.f. OEMS may visit the facility or make further inquiries to confirm information in the application or site visit report in order to determine the final disposition of the facility.7.5. Granting of designation. 7.5.a. The Commissioner shall review the site visit report, application, and any additional materials and, within thirty (30) days after receipt of the site visit report, shall determine the designation status of the facility.7.5.b. The Commissioner shall issue the official designation letter and certification to the facility. The effective date of the permanent designation shall be the date of the official designation letter.7.6. Authority to inspect. Any facility designated or seeking designation may be inspected at any time by OEMS in order to determine compliance with the standards and criteria outlined in this rule. 7.6.a. Facilities shall make available any requested information and cooperate fully with OEMS during a compliance inspection. Failure to cooperate as determined by OEMS shall be grounds for immediate suspension of designation status pending further review and investigation.7.6.b. If information obtained during an inspection visit indicates substantial non-compliance with standards or criteria, OEMS shall provide written notification to the facility of intent to change the designation status of the facility. This written notification shall include detailed descriptions of the areas of non-compliance as well as the proposed action by OEMS concerning the designation status of the facility.7.6.c. If the facility disagrees with the findings outlined in the notification referenced in Subdivision 7.6.b. of this rule, the facility may respond in writing to the state EMS medical director, within ten (10) working days, and present clear and convincing evidence as to why the facility is not subject to the proposed action. Specific steps proposed to correct the deficiencies shall also be included. The Commissioner shall consider this information and make a decision within thirty (30) days of receipt of the facility's written response, and shall send written notification to the facility of the decision regarding the request and the final status of the facility. The facility may then request a contested case hearing pursuant to Section 11 of this rule.7.6.d. If information is obtained by inspection or other means that OEMS concludes is a situation or condition at a facility that could pose an immediate threat to the public health or safety, the OEMS medical director may immediately suspend the designation status of a facility pending further review and evaluation by the Commissioner.7.7. Designation Fees. Pursuant to W. Va. Code § 55-7B-9c(b)(2), OEMS may collect reasonable fees for designation of trauma centers. 7.7.a. Fees for designation: 7.7.a.1. Shall accompany the application for initial provisional designation, the application for permanent designation, and the application for re-certification of permanent designation;7.7.a.2. Shall be the following: initial provisional designation fee per facility, two thousand dollars ($2000.); permanent designation fee, two thousand dollars ($2000.); level I, II, and III re-certification designation fee, five thousand dollars ($5000.); and level IV re-certification designation fee, two thousand five hundred dollars ($2500.); and7.7.a.3. Are non-refundable and shall be deposited in accordance with W. Va. Code § 16-4C-6b and expended in accordance with the duties imposed in this rule.7.8. Re-certification of Designation Status. Permanent designation status is valid for three (3) years from the date of the official permanent designation letter from the Commissioner.7.8.a. Within the last year of certification, all level I, II, and III trauma facilities shall undergo an ACS-COT verification site visit and file the report of that visit with a re-certification application supplied by OEMS. The application and site visit report shall be submitted to OEMS with the appropriate non-refundable designation fee, no less than ninety (90) days prior to the expiration of the designation certification of the facility.7.8.b. Within the last year of certification, all level IV trauma facilities shall undergo a re-verification site visit by a West Virginia site visit team. The facility shall schedule the visit with OEMS so as to ensure its completion no less than ninety (90) days prior to the expiration of the designation certification of the facility. The re-certification application, materials, and appropriate non-refundable designation fee must be received by OEMS prior to scheduling of the state site visit.7.8.c. OEMS may grant an extension of the re-certification time limits of up to one hundred twenty (120) days if the facility submits in writing clear and convincing evidence of extraordinary circumstances which prevent the completion of the re-certification process on schedule.7.9. Probational Designation. The Commissioner may place a permanently designated facility on probational status, if it is determined to be in the best interest of the public health and safety for the facility to remain designated during the time it is in the process of correcting deficiencies identified by OEMS either during the re-certification process or during an inspection of the facility. 7.9.a. In the event that a facility is placed on probational status, OEMS shall provide written notification to the facility outlining the specific deficiencies requiring correction. OEMS may at its discretion establish time frames for correction of deficiencies or other activities.7.9.b. If a facility does not meet the standards and criteria for permanent designation within a reasonable time, but not less than one (1) year, the facility designation may continue on probation, be changed to provisional, be downgraded or revoked.7.9.c. A facility whose designation has been revoked may reapply for designation and complete all the requirements outlined in this rule. Facilities may not reapply sooner than one (1) year after the date of official revocation.7.10. Downgrading, Suspension, or Revocation of Designation. A facility's designation status may be downgraded, placed on probation, suspended, or revoked at any time by the Commissioner for failure of the facility to substantially comply with any of the standards and criteria outlined in this rule. The Commissioner may also downgrade, place on probation, suspend, or revoke the designation status of a facility any time continued designation poses a threat to the public health or safety, as determined by the Commissioner. 7.10.a. In the event a facility's designation is downgraded, suspended, or revoked, OEMS shall provide written notification to the facility outlining the specific reasons for the action.7.10.b. If a facility disagrees with the findings leading to the action taken under Subdivision 7.10.a, of this rule, it may respond as outlined in Subdivision 7.6.C. of this rule.