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Trauma Registry Release of Data Guidelines

Trauma Registry Release of Data Guidelines - Clinical Hub, References, Level I Adult Trauma Center Manual, Operational Guidelines, Trauma Registry

Focus

Purpose Statement

The purpose of this policy is to maintain adequate control of the release of trauma registry data in accordance with the rules set forth by the American College of Surgeons. This policy helps ensure that appropriate measures are in place to meet the confidentiality requirements of the data. This policy is also used to protect against threats, hazards, and unauthorized uses or disclosures of these data.

Objectives

  1. Provide timely access to complete information
  2. Constantly strive to improve the quality and accuracy of information
  3. Use of aggregate data, along with other databases, external and internal, to compare data and pursue opportunities for improvement.

Defintions

  1. Scope of registry data
    1. The University Hospital Trauma Registry includes all injured patients whose injury is severe enough to result in trauma activation, hospital admission, or death.
  2. Criteria for trauma registry inclusion:
    1. Any patient admitted to the hospital because of an acute injury/trauma, where the ICD‐10‐CM discharge diagnosis code is between:
      1. S00-S99 with 7th character modifiers of A, B, or C only ( injuries to specific body parts- initial encounter)
      2. T07 (unspecified multiple injuries)
      3. T14 ( injury of unspecified body region)
      4. T20- T32 with 7th character modifier of A only ( burns by specific body p[arts- initial encounter)
      5. T79.A1- T79.A9 with 7th character modifier of A ONLY ( Traumatic Compartment Syndrome- initial encounter)
      6. Excluding S00, S10, S20, S30, S40, S50, S60, S79, S80, S90
      7. Excluding late effects codes which are represented using the same range of injury diagnosis codes but with the 7th digit modifier code D through S
    2. Any patient transferred via EMS from one acute care facility to another because of acute injury/trauma (from ED or inpatient settings). This will include injuries sustained after a same level fall.
    3. Any patient who dies as a result of injury/trauma that was brought to the hospital.
  3. Registry purpose
    1. The primary purpose of the UH Trauma Registry is the assessment of the quality of care. It is the principle tool for the systematic audit of the quality of care provided to the injured patient during all phases of trauma care from the pre‐hospital response thorough inpatient hospital admission.
    2. The UH Trauma Registry is the information source for trauma related Institutional Research Projects involving the UH, internal quality/process improvement initiatives, and the Trauma Program Process Improvement/Patient Safety (PIPS) program.
    3. Data is analyzed and displayed to demonstrate the trends reflecting epidemiology of injury, system performance, and health care delivery outcomes for the injured patient.
  4. Intent of Sharing Trauma Registry data
    1. Requests for use of the Trauma Registry data will be balanced with the proper level of security versus ease of access.
    2. The decision to participate in any project using Trauma Registry Data is contingent upon the legal and ethical requirements for maintaining the confidentiality and privacy of patients.
    3. Requests for participation in data collection, research projects, and reporting programs will be reviewed by the Trauma Medical Directors and the Trauma Program Coordinators with the input of the Trauma Registrars who will make recommendations regarding the adequacy of resources for participation.

Guidelines

  1. Responsibilities of data requesters
    1. Requests for access to data for the purpose of analysis will be by written permission of the Trauma Program Manager or Trauma Program Medical Director. The procedure for request of data must be followed.
    2. Data requesters must use the Trauma Registry data for the stated purpose only and may not be employed for personal use or transferred to any third party.
    3. The UH Trauma Registry is to be clearly acknowledged as the data source for any and all written or oral presentation of this information.
    4. All manuscripts utilizing data from the UWHC/AFCH Trauma Registry must be reviewed and approved by the Trauma Program Medical Director prior to submission for publication. Final approval sign‐off will be the responsibility of the Trauma Program Medical Director. Copies of the published manuscripts are to be forwarded to the Trauma Program Manager to be included in the Trauma Program Project Files.
    5. Abstracts of presentations pertaining to data obtained from the UH Trauma Registry must be reviewed and approved by the Trauma Program Medical Director prior to submission for publication. Final approval sign‐off will be the responsibility of the Trauma Program Medical Director. Copies of the published manuscripts are to be forwarded to the Trauma Program Manager to be included in the Trauma Program Project Files.
    6. Requests of trauma registry data will be held to the standards of the trauma program and/or IRB, when applicable. Any unapproved use of data will be reported to the Trauma Executive Committee and/or IRB when warranted.
  2. Procedure for requesting data
    1. Discuss request with the Trauma Program Manager or Trauma Medical Director.
    2. Complete the Trauma Registry Information Request Form (TRIR). Submit to the appropriate Trauma Program Manager.
    3.  If requesting aggregate data (no individual patients with identifiers) simply complete the Trauma Registry Information Request Form.  All other responsibilities of Data Requesters apply.
    4. Apply for IRB approval when non‐aggregate data is requested and/or publication is desired.
    5. The IRB office will review the request and determine if exemption from review criteria is met.
    6. If request is exempt, submit the signed exemption form to the appropriate Trauma Program Manager for review. 
    7. If exemption from review criteria is not met, requestor will need to submit the approved IRB proposal to the appropriate Trauma Program Manager.
    8. The Trauma Medical Director and Trauma Program Manager will review the request
    9. All requests will be verified prior to the generation/distribution of registry data.
    10. Copies of all reports will be kept on fil in eh Trauma Dept.

See Appendix: Trauma Registry Request Form

Resources