Trauma registry—updates for clarification, 136.1, 136.2
PUBLIC HEALTH DEPARTMENT
Notice of Intended Action
Proposing rule making related to trauma registry
and providing an opportunity for public comment
The Department of Public Health hereby proposes to amend Chapter 136, "Trauma Registry," Iowa Administrative Code.
Legal Authority for Rule Making
This rule making is proposed under the authority provided in Iowa Code section 147A.27.
State or Federal Law Implemented
This rule making implements, in whole or in part, Iowa Code section 147A.26.
Purpose and Summary
The purpose of the amendments is to provide clarification. The proposed amendments make the following changes:
●Remove the definition of "ICD10."
●Add a definition for "health care providers."
●Update the definition of "trauma patient."
●Add a definition for "trauma survey team."
●Update references to the Iowa Trauma Patient Data Dictionary (January 2017).
●Update the website address for the Iowa Trauma Patient Data Dictionary (January 2017).
●Remove the word "elements" from the phrase "data elements."
●Clarify who is authorized to review reported data for quality assurance.
This rule making has no fiscal impact to the State of Iowa.
After analysis and review of this rule making, no impact on jobs has been found.
Any person who believes that the application of the discretionary provisions of this rule making would result in hardship or injustice to that person may petition the Department for a waiver of the discretionary provisions, if any, pursuant to the Department's variance and waiver provisions contained in 641—Chapter 178.
Any interested person may submit written comments concerning this proposed rule making. Written comments in response to this rule making must be received by the Department no later than 4:30 p.m.on April 17, 2018. Comments should be directed to:
Department of Public Health
Lucas State Office Building
321 East 12th Street
Des Moines, Iowa 50319
No public hearing is scheduled at this time. As provided in Iowa Code section 17A.4(1)"b," an oral presentation regarding this rule making may be demanded by 25 interested persons, a governmental subdivision, the Administrative Rules Review Committee, an agency, or an association having 25 or more members.
Review by Administrative Rules Review Committee
The Administrative Rules Review Committee, a bipartisan legislative committee which oversees rule making by executive branch agencies, may, on its own motion or on written request by any individual or group, review this rule making at its regular monthly meeting or at a special meeting. The Committee's meetings are open to the public, and interested persons may be heard as provided in Iowa Code section 17A.8(6).
The following rule-making actions are proposed:
Item 1. Amend rule 641—136.1(147A) as follows:
641—136.1(147A) Definitions. For the purposes of these rules, the following definitions shall apply:
"Cases" means trauma patients that meet the trauma registry inclusion criteria.
"Department" means the Iowa department of public health.
"Director" means the director of the Iowa department of public health.
"Health care providers" for the purpose of this chapter includes licensed physicians, nurse practitioners, physician assistants, and registered nurses.
"ICD10" means International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM).
"Inclusion criteria" means criteria determined by the department and adopted by reference to determine which trauma patients are to be included in the trauma registry.
"Reportable patient data" means data elements and definitions determined by the department and adopted by reference to be reported to the trauma registry on trauma patients meeting the inclusion criteria.
"Trauma care facility" means a hospital or emergency care facility which provides trauma care and has been verified by the department as having Level I, Level II, Level III or Level IV care capabilities and has been issued a certificate of verification pursuant to Iowa Code section 147A.23(2)"c."
"Trauma patient" means a victim of an external cause of injury that results in major or minor tissue damage or destruction caused by intentional or unintentional exposure to thermal, mechanical, electrical or chemical energy, or by the absence of heat or oxygen . as defined in the "Iowa Trauma Patient Data Dictionary" as established in 136.2(1)"a."
"Trauma registry" means the data repository operated by the department to collect and analyze reportable patient data on the incidence, severity, and causes of trauma, including the central registry for brain and spinal cord injuries ( IAC rule 641—21.1(135)) and farm-related injuries.
"Trauma survey team" means a group of health care providers contracted by the department to assist in verifying trauma care facilities' compliance with trauma criteria adopted by reference in 641—subrule 134.2(3).
Item 2. Amend rule 641—136.2(147A) as follows:
641—136.2(147A) Trauma registry.
136.2(1) Adoption by reference.
a. "Iowa Trauma Patient Data Dictionary" (January 2017) is incorporated by reference for inclusion criteria and reportable patient data to be reported to the trauma registry. For any differences which may occur between the adopted reference and this chapter, the administrative rules shall prevail.
b. "Iowa Trauma Patient Data Dictionary" (January 2017) is available through the Iowa Department of Public Health, Bureau of Emergency and Trauma Services (BETS), Lucas State Office Building, Des Moines, Iowa 50319-0075, or the BETS Web site (http://idph.iowa.gov/BETS) website idph.iowa.gov/Portals/1/userfiles/43/Trauma%20Registry%20Data%20Dictionary%20Jan_%202017.pdf.
136.2(2) A trauma care facility shall report data as follows:
a. Trauma care facilities shall submit reportable patient data identified in 136.2(1) electronically to the department. Data shall be submitted in a format approved by the department.
b. Trauma care facilities that enter required trauma data elements identified in 136.2(1) 136.2(1)"a" directly into the state registry shall, at a minimum, enter 80 percent of cases within 60 days of a patient's discharge. Within 120 days of a patient's discharge, 100 percent of cases shall be entered into the registry.
c. Trauma care facilities that submit required trauma data elements identified in 136.2(1) 136.2(1)"a" via upload shall, at a minimum, submit 80 percent of cases discharged within the previous 60 days of the first business day of every even-numbered calendar month. Within 120 days of a patient's discharge or next scheduled data upload, 100 percent of cases shall be entered into the registry.
136.2(3) to 136.2(5) No change.
136.2(6) Quality assurance of reported data.
a. For the purpose of ensuring the completeness and quality of reportable patient data, the department or authorized representative its designated trauma survey team may examine all or part of the patient's medical records as necessary to verify or clarify all reportable patient to validate the accuracy of data submitted by a trauma care facility.
b. Review of a patient's medical record records by the department or its designated trauma survey team shall be scheduled in advance with the trauma care facility and completed in a timely manner.
c. The director, pursuant to 641—Chapter 178, may grant a variance from the requirements of rules adopted under this chapter for a trauma care facility that meets the requirements of this chapter.