RULES, RULES, RULES

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RULES, RULES, RULES!

• Changes to the Designation Rules and Level IV
  Essential
• Criterion

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Rule Making Process
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Rules are opened every four years for review
with stake holder input.
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• Prior to being posted to the Texas Registrar
  proposed rules must have the blessings of
• GETAC
• the DSHS Council and
• HHSC

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• Publication in the Texas Register is usually for
  30 days.
• Allows for final stakeholder comment
• Each comment must be appropriately addressed.
• Send all comments to Steve Janda
  (steve.janda_at_dshs.state.tx.us)
• The final rule packet is drafted and includes
  responses to all comments.
• If there are many comments or complex issues, the
  rule packet may go back to the stakeholder group
  to review changes/issues.

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• Draft of final rule packet is forwarded to HHSC
  requesting adoption/publication of the final
  rule.
• Usually about 20 days for adoption
• The final rule must be adopted within 6 months of
  proposal or the proposal expires!!!
• There will be an implementation phase

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Big Changes to 157.125

• Format has been revised
• Easier flow of subject matter
• Difficult to compare to current rule
• Contact OEMS/TS staff with questions
• Changes Level III facilities from General to
  Advanced Trauma Facilities

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157.125

• Defines a health care facility in relationship to
  multiple campuses
• Each campus is considered separately in regards
  to resources and level of designation
• When applying for designation all campuses
  sharing a single license number must apply

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157.125

• Outlines a process for the assessment of
  capability
• Appropriate level of designation is based on, but
  not limited to
• The facilitys resources/ capabilities
• Evidence of 24/7 physician services
• Substantial compliance 90 of the time
• Resources of the Trauma Service Area
• Ability of the facility to meet the essential
  criterion

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157.125

• Appeals process for under-designation issues
• Appeal in writing within 60 days to the Director
  of the Office
• Must include a signed letter from the facilitys
  governing board
• May include letter of support from the
• Executive board of the RAC
• Individual healthcare facilities ( lead
  facilities)
• EMS providers in the TSA
• OEMS/TS must respond within 30 days
• Secondary appeal to Assistant Commissioner

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157.125

• Outlines a process for requesting exceptions to
  criterion and reporting deficiencies
• Allows for a separate organization to conduct
  trauma designation surveys for Level III and IV
  facilities
• Additional requirements for Level I II above
  ACS criterion

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157.125

• ATLS standards for physicians boarded in
  Emergency Medicine
• Must have successfully completed the course once.
  
• Do not have to maintain current ATLS unless
  required by hospital credentialing
• All non-EM boarded physicians must maintain
  current ATLS certification

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157.125

• Defines a timely and sufficient application.
• Avoids lapse in designation
• Requires application for re-designation to be
  submitted to the OEMS/TS 1 year prior to
  expiration
• Complete survey report must be submitted 60 days
  prior to expiration
• Prevents loss of funding due to lapse in
  designation.

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157.125

• Deletes the need for approval of the application
  before surveying
• Allows a facility to schedule a survey early in
  the process
• In the best interest of the facility to have the
  application reviewed
• Input regarding the program and areas of concern
• Ensures a complete application for the survey team

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Level IV Essential Criteria
A Whole New Look
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Level IV Essential Criteria

• Trauma Medical Director
• Identifies a TMD
• Provides definition for the TMD job description
• SHALL participate in a leadership role in the
  hospital, community, and emergency management
  (disaster) response committee
• SHOULD participate in the development of the
  regional trauma systems plan

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Level IV Essential Criteria

• Trauma Nurse Coordinator
• Adds educational requirements of TNCC/ATCN or
  approved equivalent and PALS or ENPC
• Re-enforces the ability of the TNC to make change
  within the institution
• Authority/responsibility to monitor trauma
  patient care through out the continuum
• SHALL participate in a leadership role in the
  hospital, community and regional emergency
  management (disaster) response committee

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Level IV Essential Criteria

• TNC Role contd
• SHOULD have a minimum of .8 FTE dedicated to the
  TNC/TPM position
• SHOULD complete a course such as TOPIC or TCCC
• Registrar
• Can still be the TNC
• Training in Injury Severity Scoring
• Suggest 1 FTE per 500 patients annually

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Level IV Essential Criteria

• Physician Services Emergency Medicine
• Physicians boarded in emergency medicine must
  have successfully completed ATLS once
• A representative from the ED must participate in
  gt 50 of trauma committee meeting (PI, Peer
  review)

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Level IV Essential Criteria

• Nursing Services
• All in-patient units caring for trauma patients
• Clinical competencies/trauma specific
  orientation/ continuing education
• Written plan for additional staffing (written
  disaster plan)

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Level IV Essential Criteria

• Emergency Department
• Clarifies the role of the mid-level vs. physician
  in the care of trauma patients
• Activation criteria expanded to include patients
  arriving by private vehicle
• Acuity based staffing in the initial
  resuscitation area

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Level IV Essential Criteria

• Change in the educational requirements for
  initial designations
• At least one member of the RN staff responding to
  trauma team activation holds current ACLS/Pals or
  ENPC/ TNCC or ATCN
• 100 nurses credentialed ACLS/ATCN/
  TNCC/PALS/ENPC 18m of hire or designation
• Nursing documentation tool must include the
  essential components needed for registry upload.

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Level IV Essential Criteria

• Emergency Department Equipment
• Adds verbiage for all ages
• Addition of
• Supraglottic airway management devices / LMA
• the words large bore intravenous catheters
• Suggested sterile surgical sets
• Drugs and supplies necessary for emergency care
  crash cart and ACLS drugs

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Level IV Essential Criteria

• ED Equipment Contd
• Length based body weight tracheal tube size
  evaluation system and age/dose appropriate
  resuscitation medications equipment
• Pelvic stabilization device
• Not specific for type of device
• Qualitative end CO2 monitor

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Level IV Essential Criteria

• Clinical Lab Services
• Call back with 30 minute response.
• Response time monitored in the PI process
• Changes the verbiage regarding the immediate
  release of blood products
• Adds the capability for coagulation studies to
  the essential criterion

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Level IV Essential Criteria

• Radiological Capabilities
• Call back with 30 minute response time
• Response time must be monitored in the PI program

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Level IV Essential Criteria

• Performance Improvement
• Defines a track record for initial designation
• 6 months of completed PI audits/ loop closure
• Defines a track record for re-designation
• Continuous PI activities throughout designation
  and a rolling three year period of data available
  for review.

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Level IV Essential Criteria

• Defines Minimal Inclusion Criteria
• All trauma team activation
• Including those discharged from the hospital
• Trauma deaths
• Dead on arrival
• All major and severe trauma admissions
• Transfers In / Transfers Out
• Re-admissions within 48 hours after discharge

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Level IV Essential Criteria

• Components of the PI program
• Chart audit for appropriateness/quality of care
• Documented evidence of identification of all
  deviations from standard of care, with in-depth
  critical review
• Documentation of actions taken to address all
  identified issues
• Documented evidence of participation by the
  trauma medical director

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Level IV Essential Criteria

• PI components contd
• Morbidity and mortality review including
  decisions by the TMD as to whether or not
  standard of care was met
• Assign preventability
• Documented resolutions / Loop Closure of all
  identified issues to prevent recurrence
• Special audit for all trauma deaths and other
  specified cases, including complications,
  utilizing age specific criteria

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Level IV Essential Criteria

• PI components contd
• Multidisciplinary hospital trauma PI committee
  structure in place
• May be incorporated into pre-existing hospital PI
  committee

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Level IV Essential Criteria

• Feedback regarding major/severe trauma
  transfers-out
• Monthly statistical/outcomes review
• Participation in RAC PI programs
• Critical review of all diversion hours

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Level IV Essential Criteria

• Transfers
• Requires a process to expedite the transfer of
  major/severe trauma patients to include such
  things as
• Written protocols
• Written transfer agreements
• Regional trauma system transfer plan

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Level IV Audit Filters

• Additions
• Absence of documented temperature on arrival,
  discharge and when indicated
• A comatose patient (GCSlt 8) leaving the ED before
  a definitive airway is established
• All delays in identification of injuries
• Patients admitted to the hospital and then
  transferred to a higher level of care

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Level IV Audit Filters

• Additions contd
• Major/severe (hemodynamically unstable) trauma
  patients transferred-out when a general surgeon
  was on-call to the ED
• Denial of acceptance by a higher level of care.
• Changes
• Diversion of major/severe trauma patients
  (greater than 8 hours in any month)

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Level IV Standards

• Additions by number
• 4. Age specific policies and process
• 6. Notification of the region when usually
  provided services
  are not available
• 7. Use of the general surgeon for life/limb
  saving procedures
• 9. Trauma specific education and skill for staff
  throughout the continuum of care
• 13. Participation by all disciplines involved in
  the care of trauma patients

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Level IV Standards

• Additions contd
• 15. Data extraction shall be no longer than 45
  days from the date of discharge
• 17. Participation in RAC PI as well as other
  RACs as requested
• 18. Appropriateness of transferring patients when
  a general surgeon is on-call to the facility.

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Level IV Standards

• Changes
• 3. Pre-transfer dialogue with lead facilities
• 8. Adds educational requirements for other
  physicians participating in trauma
  resuscitations
• 10. Recognizes ATCN and ENPC as additions to
  trauma management guidelines
• 12. Verbiage change regarding major and severe
  patients retained gt 2 hrs.

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Level IV Standards

• Changes contd
• 14. Medical record review of major and severe
  trauma patients should include autopsy results
  when available
• 16. Verbiage change Texas Hospital Standard Data
  Set essential items shall be uploaded at least
  quarterly

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Thank You

• Questions?