641—136.2 (147A) Trauma registry.
	 136.2(1) Adoption by reference.
	  a.   	 “Iowa Trauma Patient Data Dictionary” (July 2005) is incorporated by reference for inclusion criteria and reportable patient data to be reported to the trauma registry or reported to a trauma care facility. For any differences which may occur between the adopted reference and this chapter, the administrative rules shall prevail.
	  b.   	 “Iowa Trauma Patient Data Dictionary” is available through the Iowa Department of Public Health, Bureau of Emergency Medical Services, Lucas State Office Building, Des Moines, Iowa 50319-0075, or the bureau of EMS Web site (www.idph.state.ia.us/ems).
	  c.   	 “Iowa EMS Patient Registry Data Dictionary” (August 2007) is incorporated by reference for inclusion criteria and reportable patient data to be reported to the department. For any differences which may occur between the adopted reference and this chapter, the administrative rules shall prevail.
	  d.   	 “Iowa EMS Patient Registry Data Dictionary” is available through the Iowa Department of Public Health, Bureau of Emergency Medical Services, Lucas State Office Building, Des Moines, Iowa 50319-0075, or bureau of EMS Web site (www.idph.state.ia.us/ems).
	 136.2(2) A verified trauma care facility shall:
	  a.   	 Submit reportable patient data identified in 136.2(1) via electronic transfer or in writing to the department. Data shall be submitted in a format approved by the department.
	  b.   	 Submit reportable patient data identified in 136.2(1) to the department for each calendar quarter. Reportable patient data shall be submitted no later than 90 days after the end of the quarter.
	  c.   	 Submit reportable patient data identified in 136.2(1) to the receiving trauma care facility upon delivery of the injured patient. Data shall be submitted in a format approved by the department.
	 136.2(3) A service program shall:
	  a.   	 Submit reportable patient data identified in 136.2(1) via electronic transfer or in writing. Data shall be submitted in a format approved by the department.
	  b.   	 Submit reportable patient data identified in 136.2(1) to the department for each calendar quarter. Reportable patient data shall be submitted no later than 90 days after the end of the quarter.
	  c.   	 Submit reportable patient data identified in 136.2(1) to the receiving trauma care facility upon delivery of the injured patient. Data shall be submitted in a format approved by the department.
	 136.2(4) Reportable patient data compilations. The department shall prepare compilations for release or dissemination on all reportable patient data entered into the trauma registry during the reporting period. The compilations shall include, but not be limited to, trends and patient care outcomes for local, regional and statewide evaluations. The compilations shall be made available to all providers submitting reportable patient data to the registry.
	 136.2(5) Access and release of reportable patient data and information.
	  a.   	 The data collected by and furnished to the department pursuant to this section are confidential records of the condition, diagnosis, care, or treatment of patients or former patients, including outpatients, pursuant to Iowa Code section 22.7. The compilations prepared for release or dissemination from the data collected are not confidential under Iowa Code section 22.7, subsection 2. However, information which individually identifies patients shall not be disclosed and state and federal law regarding patient confidentiality shall apply.
	  b.   	 The department may approve requests for reportable patient data for special studies and analysis provided:
	 (1) 	 The request has been reviewed and approved by the department with respect to the scientific merit and confidentiality safeguards; and
	 (2) 	 The department has given administrative approval for the proposal.
	 (3) 	 The confidentiality of patients and trauma care facilities is protected pursuant to Iowa Code section 22.7.
	  c.   	 The department may require those requesting the data to pay any or all of the reasonable costs associated with furnishing the reportable patient data.
	 136.2(6) Data collection methods. To the extent possible, activities under this section shall be coordinated with other health data collection methods.
	 136.2(7) Quality assurance.
	  a.   	 For the purpose of ensuring the completeness and quality of reportable patient data, the department or authorized representative may examine all or part of the patient’s medical records as necessary to verify or clarify all reportable patient data submitted by a trauma care facility or a service program.
	  b.   	 Review of a patient’s medical record by the department shall be scheduled in advance with the trauma care facility or service program and completed in a timely manner.
	  c.   	 The director, pursuant to rule, may grant a variance from the requirements of rules adopted under this chapter for any hospital, emergency care facility, or service program provided that the variance is related to undue hardships in complying with this chapter or the rules adopted pursuant to this chapter.