SECTION 157.39. Comprehensive Clinical Management Program Approval

(a) Purpose and Scope. This section establishes eligibility requirements and minimum training standards that a Texas licensed emergency medical services (EMS) provider must have and maintain to receive approval by the department for the provider to conduct a Comprehensive Clinical Management Program for Texas certified or licensed EMS personnel employed by or affiliated with that EMS provider, such that those personnel can become recertified or relicensed pursuant to §157.34(b)(5) of this title (relating to Recertification). The program will assure that EMS personnel affiliated with the EMS provider conducting the program will receive continuing EMS education, quality improvement, intensified individualized monitoring, mentoring, assessment and ongoing professional development as required by the standards outlined in this section.

(b) Definitions.

(1) CCMP--A comprehensive clinical management program is a recertification training program conducted by a licensed EMS provider for EMS personnel employed by or affiliated with the EMS provider such that the EMS personnel can meet recertification or relicensure requirements as outlined in §157.34(b)(5) of this title.

(2) CCMP Coordinator--Person responsible for the administrative functions of the CCMP program. However, the EMS provider, approved to conduct a CCMP, is the person or entity having the ultimate and overall responsibility for continually meeting state requirements for CCMP approval.

(3) Credentialing Process--The process by which an EMS provider continually verifies and assesses the qualifications and competencies of EMS personnel to provide patient care services.

(4) CCMP Survey Organization--A department recognized organization, which manages a CCMP survey team comprised of members as described and referenced in subsection (f) of this section for the purpose of conducting a survey, based upon the standards outlined in this section, of EMS providers seeking CCMP approval.

(5) Preceptor--A person who holds a department EMS personnel certificate or license or other licensed medical professional approved by the medical director and who is employed by or volunteers for an EMS provider to train and evaluate EMS personnel.

(6) Quality Improvement Process--An ongoing system that includes retrospective review, concurrent review, and prospective forecasting of clinical care. Quality improvement also combines a circular response through measurement of identified goals and sentinel events identifying opportunities for improvement, reeducation, process design, and measurement of corrective efforts.

(7) Self Study--A document developed by the EMS provider that outlines its planning, preparation and qualifications to conduct a CCMP and include 6 months of operational data.

(8) Survey--The onsite visit(s) conducted by a department recognized CCMP survey organization that evaluates an EMS provider applying for department approval to conduct a CCMP.

(9) Sentinel Event--An unexpected event that triggers, or has the potential to trigger, an immediate investigation and/or response. This event usually relates to the care of a patient or the well-being of EMS personnel, such that the event causes or has the potential to cause death, serious physical or psychological injury to either the patient or the EMS personnel or the public.

(c) CCMP Eligibility Requirements.

(1) The applicant must hold a current Texas EMS provider license, continuously valid for at least 5 years prior to the date of the application.

(2) The applicant must not have received a department disciplinary sanction as an EMS provider, not including a reprimand or an administrative penalty of $2000 or less, during the 2 years immediately preceding the application filing date.

(3) Any physician who the applicant has employed or contracted with to function as its medical director or as its full-time or part-time consultant, must be in good standing with the Texas Medical Board or predecessor agency to practice medicine in Texas.

(4) A person holding more than one EMS provider license that is applying for department approval to conduct a CCMP shall be required to apply separately for each of its licenses. A CCMP approval will only be allowed per one EMS provider license. A CCMP may not extend beyond one EMS provider license and its affiliated First Responder Organization(s).

(5) Although an EMS provider approved to conduct a CCMP may require the EMS personnel, employed by or affiliated with that provider, to participate in and to meet the objectives of its own CCMP, those personnel may still utilize another option, listed in §157.34(b) of this title, to achieve individual EMS personnel state recertification or relicensure.

(6) The applicant must have submitted no less than two years of required data, prior to the initial CCMP survey, to the Texas EMS/Trauma Registry.

(d) Application Process for CCMP Approval.

(1) A sufficiently complete application shall include:

(A) a full non-refundable CCMP approval application fee payment of $60.00;

(B) department application form with all fields correctly and legibly filled in, dated, and signed with original signatures of the EMS director, CCMP coordinator, and EMS provider's medical director; and

(C) all required documents to include an accurate and complete CCMP self-study. This self-study shall be submitted in an electronic format as required and described by the department and shall sufficiently and accurately address those topics outlined in subsection (h) of this section.

(2) Initial Application Form Review Period. Within 30 days from the date the department receives an initial written application for CCMP approval from an applicant, the department will send to the applicant a written notice that either the application form is complete and accepted for filing, or the application form is incomplete, and noting the application's deficiencies and the additional information required for the application to be accepted for filing.

(3) Continuing Application Form Review Period. Within 14 days from the date that the department receives any written information from the applicant that attempts to respond to an earlier department notice of any application deficiencies and notice of the need for additional information to resolve the deficiencies, the department will send the applicant a written notice that either the application form is finally complete and accepted for filing or that the application form is still incomplete, and specifying any remaining application deficiencies and the additional information required for it to be accepted for filing.

(4) Final Application Form Review Period. Within 14 days from the date that the department receives from the applicant the last item or piece of information to resolve all previously noted deficiencies necessary to complete the application, the department will send written notice to the applicant that the application is finally complete and accepted for filing.

(5) Failure to Correct Application Form Deficiencies. If the department does not receive from an applicant the items or information requested by the department to correct the deficiencies in the application form by the 10th day after the date that the department has sent written notice to the applicant noting that the application form is incomplete for filing and noting the application's deficiencies and the additional information required for it to be accepted for filing, then the application is deemed to be withdrawn and void. The application fee will not be refunded.

(6) Initiation of Survey. After the department notifies applicant that the application form is sufficiently complete and is accepted for filing, the EMS provider can initiate the survey process to be conducted by a department recognized CCMP survey organization.

(7) Final Period for Full Application Review. The final period for full application review will begin on the date that the department timely receives from the applicant's survey organization a true and correct written survey report, the department's review of which will be the last stage of the application review process, and end on the date that the department sends written notice to the applicant that the application for CCMP approval is granted, or that it proposes to deny the application. This period is 60 days.

(8) CCMP Approval Period. The department's grant of approval to an EMS provider to conduct a CCMP will be valid for four years from the date that approval is granted, unless the EMS provider later surrenders its CCMP approval or the department revokes the approval.

(e) Application Process to Renew CCMP Approval.

(1) No later than the 120th day prior to the expiration date of the existing CCMP approval, an EMS provider, who is requesting renewal of CCMP approval, shall:

(A) timely file a sufficiently completed renewal application form according to the application filing process, as described in subsection (d) of this section;

(B) have been timely re-surveyed by a department recognized CCMP survey organization, in advance to allow for report submission described in subparagraph (C) of this paragraph; and

(C) ensure that the CCMP survey organization, that has conducted the survey, has filed with the department and that the department has received from the survey organization a complete survey report.

(2) If a renewal applicant meets the requirements in subsection (1) of this section no later than the 120th day prior to the expiration date of its existing CCMP approval, the existing CCMP approval does not expire until the applicant's eligibility for renewal of its CCMP approval has been finally determined, as described in Texas Government Code, §2001.054. If the department provides the applicant with a written notice proposing the denial of its renewal application or placement of limitations upon the renewal of approval, and if the department timely receives from the applicant a written request for an administrative appeal hearing to contest the proposed denial or limitation, the existing CCMP approval does not expire until the last day for the applicant to seek a state district court judicial review of the agency order or a later date fixed by order of the reviewing court.

(3) If a renewal applicant fails to meet the requirements in subsection (1) of this section, no later than 120 days prior to the expiration date of its existing CCMP approval, the existing CCMP approval expires on its expiration date.

(4) Any EMS personnel that are participating in the applicant's existing CCMP may lose their eligibility to renew their individual EMS certifications or licenses under §157.34(b)(5) of this title, after the expiration date of the existing approved CCMP within which the EMS personnel are participating. If a CCMP approval expires, as set forth in paragraphs (2) or (3) of this subsection, EMS personnel who continue to participate with that CCMP after its expiration date will no longer be allowed credit toward continuing education hours needed for certification or licensure renewal, unless approved by the department.

(f) CCMP Survey.

(1) The applicant shall seek review and approval of its self-study by a department recognized CCMP survey organization.

(2) The applicant shall notify the department of the date the survey will begin, the name of the CCMP survey organization, the composition of the survey team, and the names of the survey team members, no later than the 30th day prior to the date the CCMP survey will begin.

(3) The applicant shall be responsible for any cost and expenses associated with the survey.

(4) The department, at its discretion, may assign a department staff member and/or appoint an observer to accompany the survey team.

(5) The survey team shall contain members that have a multi-disciplinary background to include at a minimum: one EMS medical director, one EMS educator and one EMS administrator. The department may require additional surveyors and surveyors with other professional backgrounds, depending upon, but not limited to, the type of EMS provider, the kind of population it serves, and factors noted in the self-study. If such is required, the department will notify the applicant of the additional required surveyors within 20 days after the date that the department has notified the applicant that its application is complete and accepted for filing.

(6) All members of the survey team, except department staff, shall come from a Trauma Service Area that the applicant is not affiliated with and at least 100 miles from the provider unless otherwise approved by the department at least 20 days before the date the survey is to begin. There shall be no direct business or patient care relationship or any potential conflict of interest between the CCMP survey members, or any of the individual survey members' places of employment or affiliation with a volunteer EMS provider, and the applicant being surveyed. The survey team shall not be composed solely with members from a single EMS provider.

(7) Department recognized survey organization team members at minimum shall:

(A) have at least five years experience in active management and leadership of an EMS system using CCMP principles;

(B) be currently employed with or volunteering for, and be actively managing within an EMS system using CCMP principles;

(C) have adequate direct experience in assisting an EMS provider in preparing for a CCMP survey and in obtaining CCMP approval; and

(D) have completed a department-approved CCMP survey course and/or participation in a survey internship.

(8) The department at its discretion may exempt survey team members from having to meet the requirements noted in paragraph (7)(A), (B) or (C) of this subsection, if the number of qualified survey team members in the applicant's general geographical area is inadequate to form a survey team. The CCMP survey organization must make a written request showing sufficient cause for the department to grant an exemption.

(9) The survey organization with its survey team members shall professionally and accurately evaluate and make written findings of the EMS provider's ability to effectively meet and maintain CCMP standards described in subsection (h) of this section.

(g) Survey Documentation and Reporting Timetable.

(1) The survey organization shall utilize the department's CCMP survey form and shall provide the department and the provider with an accurate and complete written survey report, signed by all survey team members, regarding its evaluation of the applicant's compliance with CCMP standards, no later than 30th calendar day after the completion date of the survey.

(2) The CCMP survey(s), and the resulting survey documentation, and the applicant's CCMP survey organization's submission of the survey report and related documentation to the department shall be completed no later than two years after the date the department sent notice to the applicant that its application was accepted for filing. Failure to timely complete all of the above within two years from the date that the department sent notice to the applicant that its application was accepted for filing will be deemed to be a withdrawal of the EMS provider's application for CCMP approval.

(3) The department reserves the right to request from the applicant, and the applicant shall be obligated to produce no later than the 10th day after having received such request, true and correct copies of any survey reports that the applicant received from its survey organization related to any initial surveys, conducted prior to any final survey.

(4) CCMP Final Survey Report. The survey report, completed by the department recognized CCMP survey organization, shall accurately document the survey organization's findings and its evaluation of the EMS provider's ability to effectively meet the minimum standards required to obtain and to maintain CCMP department approval as outlined in subsection (h) of this section.

(h) CCMP Minimum Standards. To receive and maintain department approval to conduct a CCMP, an EMS provider shall:

(1) assure that an initial assessment of new EMS personnel has been conducted by providing documentation of:

(A) a written assessment of didactic knowledge evaluation, specific to the certification level of the applicant and focusing on the clinical information (evaluation cannot be the department or NREMT exam, and should utilize numeric scoring - not pass/fail - to assess individuals' level of preparedness);

(B) a situation-based practical evaluation;

(C) a background investigation process of EMS personnel, which includes verification of certification/licensure and administrative/disciplinary history through the department, work history and driving record;

(D) a detailed job description; and

(E) a screening process to ensure the minimum requirements are met, and which includes significant medical director involvement.

(2) credential EMS personnel by providing documentation of:

(A) a state certification/licensure verification process;

(B) a process for EMS personnel to demonstrate skills proficiency to the satisfaction of the medical director;

(C) a process for reintegration (i.e. bringing an individual from inactive or administrative status back into active practice in the field);

(D) a process for bi-annual field evaluation by a preceptor (field training officer or similar position) which includes demonstration of adequate patient care and scene control skills, appropriate conduct for EMS personnel, etc.; and

(E) a policy that defines the EMS personnel covered by the CCMP program (only individuals credentialed by the medical director will be eligible for renewal through §157.34(b)(5) of this title).

(3) assure and maintain a preceptor selection, development and training process; developed with the medical director's input and approval.

(4) assure EMS personnel internship by providing documentation of:

(A) a process in which interns ride as a third person until the preceptor establishes the intern has met pre-established competencies as defined by the medical director;

(B) a process in which interns ride as the second person until the preceptor establishes the intern has met prerequisites for independent duty as determined by the medical director;

(C) a process in which the intern must demonstrate proficiency to at least two different preceptors;

(D) a process in which the intern evaluates the internship program; and

(E) a process in which the medical director reviews and ensures that all predetermined competencies are met before being released from internship.

(5) assure and maintain professional development of EMS personnel by maintaining and providing documentation:

(A) of professional development training of EMS personnel in the following amounts per year: EMT-P--24 hours, EMT-I--20 hours, EMT--16 hours, ECA--10 hours;

(B) that other staff (flight nurses and communications personnel) are required to obtain at least the minimum continuing education hours as directed by the appropriate certifying or licensing authority;

(C) that EMS personnel receive continuing education on at least a semiannual or quarterly basis;

(D) that the continuing education instruction spans the three learning domains which include cognitive, affective and psychomotor;

(E) that demonstrates programmatic strengths and performance improvement plans for weaknesses;

(F) that the continuing education clinical content is defined and approved by the medical director;

(G) that 50% of the continuing education is in-person training; and

(H) of consistent instructional delivery by all instructors.

(6) assure and maintain protocol/standard of care management by providing documentation of:

(A) ongoing protocol review, updated according to current literature, practice techniques, executed and approved by the medical director;

(B) a process for assessing the relative benefit from protocol revisions;

(C) a process for protocol knowledge assessment among EMS personnel protocol assessment that reflects the ongoing protocol review and revision, with structure and content defined and approved by the medical director, and a defined remediation process with established timelines;

(D) a process for protocol criteria to be jointly defined by the medical director and EMS provider administration; and

(E) a reassessment/re-education process and timeline that clearly identifies the criteria for identification of weakness and successful completion of re-education; or revocation of credentials if unsuccessful.

(7) assure and maintain a quality improvement program by providing documentation of:

(A) a five component problem-solving process with the following components: assessment, goal setting, plan development, intervention, and progress evaluation;

(B) an assessment of the provider's daily activities;

(C) measurable clinical indicators that are regularly assessed for compliance with established thresholds;

(D) an appropriate, organized and prioritized monitoring and evaluation system for compliance with documentation standards, correct protocol selection and appropriate patient care;

(E) assessment of key performance indicators such as personnel/staffing, response and averaging with correct statistical monitoring, clinical care (skills performance, protocol selection, patient assessment, etc.), customer relations program, education, administrative/operational policies;

(F) a monthly random chart review of all runs (at least 5% or 30, whichever is greater) for compliance with documentation standards, correct protocol selection, and appropriate patient care;

(G) an annual cardiac arrest survival analysis in accordance with current acceptable criteria; and

(H) tracking individual performance of skills (5 minimum), appropriate for that level of certification or licensure, for each EMS personnel.

(8) assure and maintain a complaint resolution process/management by providing documentation of:

(A) a centralized location for receiving complaints;

(B) an established triage process to appropriately direct complaint resolution to potential disciplinary or quality improvement avenues;

(C) a process that ensures the timely reporting of any rule or law violations to appropriate licensing and government authorities; and

(D) a process to track/trend the nature of each complaint and feed data into a quality improvement program.

(9) assure and maintain a system to respond to sentinel event response process/management; by providing documentation of:

(A) a process to appropriately direct the response to emergency problems such as equipment failures, supply deficiency, medication errors, fleet failures, etc.;

(B) appropriate record-keeping and tracking of sentinel events; and

(C) a process to investigate sentinel events which involves the appropriate parties.

(10) assure and maintain an ongoing corrective action process by providing documentation of:

(A) annual documentation of the results of the quality improvement efforts and formal complaint tracking process, including content of continuing education or individual training sessions to resolve identified deficiencies;

(B) evidence to resolve and reassess identified deficiencies;

(C) a process to determine whether deficiencies are individual or system oriented;

(D) a developed reporting structure that includes a public performance report;

(E) a policy and methods regarding privilege/confidentiality;

(F) a process of remediation and improvement strategies which comply with DSHS continuing education requirements, as appropriate; and

(G) evidence of medical director involvement in the process.

(11) assure committee(s) are established and maintained to identify, plan, implement and evaluate opportunities to improve performance in all areas of the EMS system.

(12) assure that the medical director qualifications, experience, involvement and responsibilities are maintained by providing documentation that the medical director:

(A) is registered as the EMS provider's medical director with the department;

(B) meets requirements of 22 TAC, Chapter 197 (relating to Emergency Medical Service) of the Texas Medical Board;

(C) is an active participant in the local Regional Advisory Committee; and

(D) has completed a course in EMS medical direction.

(13) assure that the CCMP coordinator qualifications, experience, involvement and responsibilities are maintained by providing documentation that:

(A) the CCMP coordinator is responsible for the administrative functions of the CCMP program;

(B) the dedication of staff time is sufficient to fulfill the programmatic requirements of the CCMP;

(C) a CCMP organizational chart clearly describes the administrative reporting structure of the CCMP program;

(D) there is evidence to demonstrate that quality improvement experience and/or training is sufficient to implement and maintain CCMP standards; and

(E) shall complete a department approved CCMP workshop of at least 8 hours.

(i) Probation, Suspension, Revocation or Denial of Initial or Renewal CCMP Approval. The department may probate, suspend, revoke, or deny initial or renewal approval for an EMS provider to conduct a CCMP for, but not limited to, the following noted reasons:

(1) the EMS provider fails to meet or maintain the CCMP minimum standards or the eligibility requirements, outlined in this section;

(2) the EMS Provider fails to meet or maintain those responsibilities required or standards, outlined in §157.11 of this title (relating to Requirements for an EMS Provider);

(3) the EMS provider falsifies or makes misrepresentations in any documentations communications regarding its applications seeking department approval to conduct a CCMP;

(4) the provider falsifies or makes misrepresentations in any documentations or communications regarding its conducting a CCMP; or

(5) the EMS provider is found to have committed any of the violations, outlined in §157.16 of this title (relating to Emergency Suspension, Suspension, Probation, Revocation or Denial of a Provider License) that serves as a basis for such department disciplinary actions as: a reprimand, a monetary administrative penalty assessment, EMS provider license suspension, probated suspension of an EMS provider license, revocation of license, emergency suspension of license.

(j) Appeal Procedure for Proposed Denial, Probated Suspension, Suspension, or Revocation of CCMP Approval.

(1) If the department proposes to deny, suspend, or revoke its approval given for an EMS provider to conduct a CCMP, the department will send written notification of such to the EMS provider's last known address as shown in the current records of the department. The notice will state the alleged facts or conduct to warrant the proposed action and state that the EMS provider may request an administrative hearing.

(2) An EMS provider's request for an administrative appeal hearing to contest the proposed action shall be in writing and submitted to the department within 15 days after the date that the department sent written notice to the EMS provider of the department's proposed action. The appeal hearing shall be conducted pursuant to the Administrative Procedure Act, Government Code, Chapter 2001.

(3) If the department does not receive a written notice of its request for an administrative appeal hearing from the EMS provider by the 15th day after the date the department sent written notice to the EMS provider of the department's proposed action, the EMS provider is deemed to have waived the opportunity for a hearing and the department may take the proposed action.

(k) Probation. The department may probate the suspension of approval of a CCMP and specify terms and conditions of any probated suspension accessed.

(l) Surrender of CCMP Approval.

(1) An EMS provider shall use a department approved surrender form to document its surrender to the department of its CCMP approval.

(2) An EMS provider's surrender of a CCMP approval to the department shall not deprive the department of jurisdiction in regard to any disciplinary action against the EMS provider.

(3) In the event that any department proposed disciplinary against the EMS provider is pending or is reasonably imminent, the EMS provider must acknowledge that the surrender of its CCMP approval constitutes a plea of "no contest" to the allegations upon which the proposed disciplinary action is predicated.

(m) Reapplication After Surrender, Denial, or Revocation. An EMS provider, whose EMS provider license or approval to conduct a CCMP has either been surrendered while disciplinary action is pending or is reasonably imminent or which has been denied or revoked, cannot apply for, nor receive, approval to conduct a CCMP until 2 years after the date of the denial, revocation or such surrender of the EMS provider license or CCMP approval. An EMS provider who files an application for CCMP approval at least 2 years after the date of such surrender, denial or revocation of its previous EMS provider license or CCMP approval, shall provide evidence, and have the burden to show, that the reasons for the earlier denial, revocation, or such surrender of its previous EMS provider license or CCMP approval, no longer exists.

(n) Notification of Disposition. A summary of the department's order, outlining the final disposition of any proposed disciplinary action and the basis for such may be placed upon the department's website. A copy of such order may be sent to the licensed EMS provider, and the medical director.

(o) Medical Director Attestation of CCMP Participation. With regard to EMS personnel, employed by or affiliated with an EMS provider having approval to conduct a CCMP, the EMS provider's medical director shall timely provide to such EMS personnel a document, signed and dated by the medical director, attesting to such EMS personnel's participation in that CCMP.

(1) The document shall acknowledge that the EMS personnel is currently participating in the CCMP and shall specify the amount of time, including the beginning date that the EMS personnel participated in the CCMP.

(2) For those personnel who leave the CCMP the medical director within 30 days of their departure (or sooner, if needed) shall provide to the EMS personnel documentation, attesting to such EMS personnel's participation in that CCMP and attesting to the amount of time, including the beginning date and ending date, that the EMS personnel participated in the CCMP.

(3) Those EMS personnel, who have departed from an approved CCMP and who are making application for recertification or relicensure, wholly or partly through §157.34(b)(5) of this title, utilizing a medical director's signed document that attests to the EMS personnel's participation in a CCMP, will be given by the department a prorated continuing education credit, in six month increments, for the amount of time the person was participating in a CCMP.

(4) Those continuing education credit hours, used to satisfy those continuing education requirements of a CCMP by EMS personnel who have departed from that CCMP, cannot be credited or used again to supplement any remaining number of continuing education hours needed by EMS personnel to gain recertification or relicensure. Only continuing education hours gained by EMS personnel that were not used to satisfy a CCMP's requirements can be used to supplement the department's recertification or relicensure requirements.

Source Note: The provisions of this §157.39 adopted to be effective December 27, 2007, 32 TexReg 9632