J1_CIREN_Manual_QC_RFP.pdf

Crash Injury Research and

Engineering Network CIREN Phase IV

Process and Coding Manual

July 2018

Version 3.0.2p version 3.0.2p

0 TABLE OF CONTENTS

0 Table of Contents

1 Introduction

1.1 CIREN Phase Four

1.2 Purpose

1.2.1 Additional References

1.2.2 Formatting standards:

1.3 Workflow and Target Schedule

1.3.1 Case Production Workflow

1.3.2 Case Status Definitions

1.3.3 Target Schedule

1.4 Study Criteria

1.4.1 Motor Vehicle Occupant Inclusion Criteria

1.4.2 Case Equivalent Value

2 Data Collection and Entry

2.1 Overview of CISSweb CIREN

2.1.1 User Roles and Responsibilities

2.1.2 Initiating a Case

2.1.3 Advancing Case through Workflow

2.2 Crash Investigation Elements (Enrolling Center)

2.2.1 CISS Case Form

2.2.2 General Vehicle Tab

2.2.3 Exterior Vehicle Tab

2.2.4 Interior Vehicle Tab

2.2.5 Safety Systems Tab

2.2.6 Occupant Form

2.2.7 Crash Case Photography

2.3 CIREN Elements (Enrolling Center)

2.3.1 CIREN|Crash Tab

2.3.2 CIREN|Admissions

2.3.3 CIREN|EMS

2.3.4 CIREN|Demo/Anthro

2.3.5 CIREN|Clothing

2.3.6 CIREN|Comorbidities

2.3.7 CIREN|Occupant Status

2.3.8 CIREN|Ventilation

2.3.9 CIREN|Radiology

2.3.10 CIREN|Procedures

2.3.11 CIREN|Injury

2.3.12 CIREN|Autopsy

2.3.13 CIREN|QC Review

2.4 Injury Causation Elements (Engineering Center)

2.4.1 BioTab Injury Causation Methodology

2.4.2 BioTab Process

2.4.3 Special Considerations

2.4.4 BioTab Templates

2.4.5 BioTab Data Elements

2.5 Narrative Summaries

2.5.1 Crash Summary (Enrolling Center)

2.5.2 Injury Analysis (Engineering Center)

2.6 Sanitization

3 Joint Case Review

3.1 Scheduling

3.2 Required Participants

3.3 Presentation Types

3.4 Case Review Requirements

4 Quality Control

4.1 CIREN Medical Center Responsibilities

4.2 CIREN Engineering Center Responsibilities

4.3 Quality Control Contractor Responsibilities

4.4 NHTSA HQ Review and Final Publishing

4.5 Process

5 Appendices

5.1 Appendix A: Abbreviations

5.2 Appendix B: IT Accounts

5.2.1 CISSWeb User Account Process

5.2.2 DOT E-mail

5.3 Appendix C: File Naming Conventions

5.4 Appendix D: Style Guide for Narrative Summaries

5.5 Appendix E: BioTab Examples and Additional Information

5.5.1 AIS 2 Injury Codes Requiring Long-form BioTab Completion

5.5.2 Completed Example Templates

5.6 Appendix F: Sample Confidentiality Agreement

Version History

Version Release Date Notes

3.0 7/28/2017 New manual applicable to program starting in 2017

3.0.1 10/26/2017 Minor revisions to BioTab

3.0.2 7/5/2018 Revised file naming convention; miscellaneous clarifications; changes to case value and inclusion criteria; updated BioTab guidelines and attribute lists; glazing;

3.0.2p 7/5/2018 Provisional version for RFP purposes

Note: Prior major versions not documented here

1 INTRODUCTION

The Crash Injury Research and Engineering Network (CIREN) is a field-based data collection and research program led by the Human Injury Research Division of the National Highway Traffic Safety Administration (NHTSA).

Integrating clinicians and engineers to comprehensively study injury causation in motor vehicle crashes, CIREN’s mission is to improve the prevention, treatment, and rehabilitation of motor vehicle crash injuries to reduce deaths, disabilities, and human and economic costs. The CIREN process combines prospective data collection with professional multi-disciplinary analysis of medical and engineering evidence to determine injury causation in every crash investigation conducted. In addition to populating a detailed crash injury database, the CIREN program serves as a sentinel for emerging problems, a catalyst for research, and an injury biomechanics knowledge base.

1.1 CIREN PHASE FOUR

The fourth phase of the CIREN program sees evolutionary change in the overall approach, though is accompanied by a revolutionary change in the supporting electronic data system and data collection protocols. The NHTSA undertook a modernization of its field data collection programs, and the result was a modernized electronic data system along with enhancements to crash investigation methods to better support future agency needs. The basics of CIREN have not changed – the emphasis remains on identifying occupant injury causation and incubating research into emerging motor vehicle occupant protection needs. CIREN will still adhere to the NHTSA crash and scene investigation protocols established by the National Center for Statistics and Analysis (NCSA) for the Crash Injury Sampling System (CISS), and CIREN cases will still be occupant-centric with expanded medical and causation analysis being hallmarks of the CIREN program.

An open competition for new CIREN centers was initiated in July 2016 with a modified network configuration where case enrollment will be performed at CIREN Medical Centers and engineering review of injury causation will be performed at CIREN Engineering Centers without requirements for case enrollment. This revised approach was explored to enable institutions with strong injury biomechanics research programs to support injury causation analysis and generate relevant research without having to rely on association with a high-volume trauma center for case enrollment. The modified configuration also incorporates Integrated Centers, which perform the roles of the Medical and Engineering Centers. Other parties contracted by NHTSA for the CIREN program include the Quality Control (QC) center and the Crash Data Acquisition Network (CDAN) information technology contractor.

1.2 PURPOSE

This process and coding manual is designed as a reference and requirements document for CIREN center personnel. The manual contains information on required data elements, rules, definitions, and guidance for the data entry applications. The requirements contained in this manual are the baseline to which all CIREN motor vehicle occupant cases must adhere. Failure to comply with the guidelines contained in this document shall be considered a failure to comply with contract terms.

While CIREN is an injury-focused research and investigation tool of NHTSA’s Human Injury Research Division, the underlying crash investigation protocols mostly conform to those established by the NCSA. As such, this manual is a CIREN-specific manual that must be referenced in conjunction with the process documents associated with all of NHTSA’s field crash investigation programs.

The authority for technical oversight of the CIREN program is the NHTSA CIREN Program Manager. The NHTSA CIREN Program Manager is responsible for the content of this document and other CIREN-specific process documents, and shall ensure the content provides appropriate guidance. Questions or concerns about the requirements in this document shall be directed to the NHTSA CIREN Program Manager. CIREN personnel shall notify the NHTSA CIREN Program Manager of any errors, inconsistencies, or required clarifications which will be remedied through incremental revisions. The NHTSA CIREN Program Manager is specified in contract documents.

The Contracting Officer’s Representative (COR) also serves as a technical point-of-contact for the CIREN centers.

1.2.1 ADDITIONAL REFERENCES

This manual applies to CIREN cases involving occupants injured in motor vehicle crashes and is meant to be used in conjunction with other process documents pertaining to NHTSA field crash investigations. The following documents are considered to be CIREN process documents and shall be provided by NHTSA to CIREN center contractors:

• NHTSA Field Crash Investigations Vehicle Measurement Techniques manual (applicable to calendar year of crash)

• NHTSA Field Crash Investigations Crash Investigation Coding & Editing Manual (applicable to calendar year of crash)

• NHTSA Field Crash Investigations Digital Photography guide (applicable to calendar year of crash) and CIREN Photo Addendum

• NHTSA Injury Coding Manual using AIS 2015

• Case Review Presentation Templates (Full, Expedited, and In-System)

NHTSA may issue periodic, incremental updates to the process documents, and shall provide the most up-to-date version to CIREN center contractors to ensure compliance with current protocols. Additional documents incorporated by reference shall be maintained by CIREN center contractors, and shall include, at a minimum:

• ANSI D16.1-2007 Manual on Classification of Motor Vehicle Traffic Accidents

• SAE J224 MAR80 Collision Deformation Classification

1.2.2 FORMATTING STANDARDS:

Within this manual, the following formatting standards have been utilized to enhance clarity:

• Bold text in the body is for emphasis; bold text in tables or lists is to delineate sections

• Tab, sub-tab, and pop-up names are italicized

• Variable names are identified with [square brackets] – indicates the database variable name

• Field names and attributes are identified with “quotation marks”

• Relationships between tabs, sub-tabs, and fields are indicated by pipe and colon separators Tab|Sub-Tab:

Field (note that italics and quotation marks are not used in this construct)

• Command buttons are identified with “quotation marks and underline” for text labels and with a pictogram for graphic labels

• Comments marked with a flag, , are intended to draw attention to unique rules or conditions that shall be considered when coding a CIREN case

• Notes marked with a pushpin, , are intended to provide helpful reminders about definitions or procedures

1.3 WORKFLOW AND TARGET SCHEDULE

The CIREN process begins with identification of eligible case subjects through a CIREN Medical Center. After gaining case subject consent within the guidelines of the enrolling institution’s Institutional Review Board (IRB), collection of medical and crash data commences according to the requirements in this manual. Once the crash and medical data have been entered into the data system and an injury list generated, an assigned CIREN Engineering Center shall review the available evidence and establish draft injury causation scenarios for all injuries according to the guidelines in this manual. A case review meeting of relevant CIREN participants is then held to deliberate the evidence and finalize the case subject’s injury causation scenarios. Following the case review meeting, the Engineering Center enters the final causation data and the case is reviewed by a quality control agent. The case then undergoes final review by NHTSA prior to being approved and published to the public case viewer and data files.

1.3.1 CASE PRODUCTION WORKFLOW

Many factors may affect completion of a CIREN case, making it difficult to adhere to a strict workflow or a firm set of deadlines. Consequently, the CIREN case workflow and schedule presented here is a guideline that centers should endeavor to follow. Figure 1 depicts the customary, generalized workflow of a CIREN case. During the normal case production process, the nature of the CIREN program requires frequent interaction among the parties and adaptions to the depicted flow are common and acceptable. When a CIREN center requires a deviation from the standard workflow, the requesting center shall notify the CIREN Program Manager via email.

Figure 1: Generalized CIREN workflow

It should be noted that in CIREN, a CIREN case is based on an occupant. Each enrolled occupant is considered a single case. In CISS, a case is based on an entire crash, which may include multiple occupants in multiple vehicles.

Because a vehicle or crash may lead to multiple CIREN case occupants, it is necessary to clarify the distinction between a CIREN case and a CIREN crash due to the association between CIREN and CISS in the CISSWeb data system. CIREN cases are created as children of a CIREN crash in the CISSWeb data system. In this manual, the term “case” used on its own will refer to a CIREN case. A “crash case” refers to the CISS-equivalent CIREN crash case that contains all of the vehicles involved in the crash.

1.3.2 CASE STATUS DEFINITIONS

Case Processing Status Attribute [STATUS]

MC Active – This is the first status a CIREN case receives upon being created by a CIREN Medical Center. The enrolling Medical Center is entering crash and medical data at this time. This status should not be queried for research.

EC Active – Upon completion of the crash and medical data entry described in Sections 2.2 and 2.3, including the building of the injury code list, the case is ready for biomechanics review at the assigned CIREN Engineering Center.

Prior to being marked EC Active, the CIREN Medical Center shall perform internal quality control to ensure completeness of coding and attachment of supporting evidence to provide the assigned Engineering Center the required crash and medical evidence to develop the injury causation scenarios. This status indicates that the case is undergoing review by a CIREN Engineering Center in preparation for the case review meeting. This status should not be queried for research.

In Review – When the assigned CIREN Engineering Center has completed the draft injury causation scenarios in preparation for the case review, the status should be changed by the Engineering Center to In Review. At this point, the required data fields and case elements should have undergone internal quality control review by the Engineering Center. The case is read-only at this time and this status is acceptable for research queries, though case coding may not be final. (Version 3.0.2 Note: to be retired in an upcoming CISSweb update)

EC Conclusion – Following the case review session, if no further crash or medical revisions are required of the CIREN Medical Center, the CIREN Engineering Center chooses this status to make revisions to the injury causation scenarios and write the Injury Analysis narrative. If, following the case review session, the Medical Center must revise crash or medical data elements, the case status must be reverted to MC Active and then rerouted through the Engineering Center (a follow-up case review session may be required if requested by NHTSA). This status is acceptable for research queries, though case coding may not be final. (Version 3.0.2 Note: to be retired in an upcoming CISSweb update)

QC Review – When the Engineering Center has completed the causation data entry and Injury Analysis narrative, the QC Review status indicates the readiness for review by the third-party quality control (QC) contractor. This status is acceptable for research queries, though case coding may not be final.

QC Incomplete – If the QC contractor determines that the case does not meet completion requirements and/or contains fundamental errors, the case must be sent back to the preparing centers for the shortcomings to be addressed. By default, the case must first go back to the enrolling CIREN Medical Center for repair. The case will have undergone little or no QC review, and the preparing centers must expedite the case back to QC Review status.

This status should not be queried for research purposes.

QC Complete – Once the QC contractor has conducted its review and documented its findings, the case is ready for the preparing centers to address the noted case quality issues. By default, the case must first go back to the enrolling CIREN Medical Center for repair. After the enrolling Medical Center addresses findings for its portion of the case, the assigned Engineering Center shall address findings for its portion of the case. This status is acceptable for research queries, though the case coding may not be final.

MC Complete – The enrolling Medical Center has addressed the QC findings relevant to its portion of the case and the case is ready for completion by the Engineering Center. Further changes to the case may be required if the Engineering Center or NHTSA discover invalid or incomplete elements that affect case consistency or adherence with coding protocols. Shortcomings identified in the subsequent case publishing process (once the case is marked EC Complete) may require reversion to QC Complete status for remediation. This status is acceptable for research queries, though the case coding may not be final.

EC Complete – The assigned Engineering Center has addressed the QC findings relevant to its portion of the case and the case is ready for final review by NHTSA. Further changes to the case may be required if NHTSA discovers invalid or incomplete elements that affect case consistency or adherence with coding protocols. Shortcomings identified in the subsequent case publishing process may require reversion to QC Complete or MC Complete status for remediation. This status is acceptable for research queries.

Dropped – For circumstances where case work must be discontinued after initiation, the enrolling CIREN Medical Center may choose this status to purge all case data except basic case identification fields.

Published – Once reaching EC Complete status, the NHTSA CIREN Program Manager or a designee will review the case and determine whether the case can be released for access by the public. A Medical Center or Engineering Center may be asked to revise portions of a case prior to being published, though the expectation is that the previous quality control steps will have identified and rectified any shortcomings in the case contents. A case must reach Published status in order to count toward the responsible centers’ annual quotas. In the event one or the other responsible center fails to satisfy case publication requirements, credit for the case will only be applied for the center that fulfilled its responsibilities (e.g., if the assigned Engineering Center fails to address documented findings but the Medical Center met the requirements, the Medical Center would receive credit and the Engineering Center would not). This status is acceptable for research queries.

Restricted – This status is reserved for cases that have been identified by the enrolling Medical Center or NHTSA as being unsuitable for access to the public. Compelling reasons must exist for this publication status to be applied and only NHTSA can mark a case as Restricted. A case marked Restricted does count toward center quotas and is otherwise assumed to be complete and in accordance with NHTSA and CIREN case production requirements. A justification explaining the reason for this status must be included with the case.

A schematic of the case flow with status changes is depicted in Figure 2. The schematic delineates the roles of the CIREN centers, the quality control (QC) contractor, and NHTSA. It should be noted that the case review, which is contained within the CIREN center area, does include NHTSA and the QC contractor.

Note: The case status is associated with the CIREN subject’s case. The status of the underlying crash case is assumed based on the status of the most-advanced CIREN case within that crash.

Figure 2: Case status flow (schematic includes In Review and EC Conclusion, which will be eliminated in an upcoming CISSweb update)

1.3.3 TARGET SCHEDULE

In general, a CIREN case shall be complete (marked EC Complete) within six months (26 weeks) after the crash date. While the timeline shall be generally based on the crash date, NHTSA acknowledges that there may be a lag in acquisition of some case occupant-related medical information and has specified some dates relative to the case occupant’s initial discharge date. For circumstances involving long-duration stays prior to initial discharge (generally more than two weeks) of the case occupant, the enrolling Medical Center shall work with NHTSA and the reviewing Engineering Center to adjust the timeline.

The following case production milestones serve as the standard guideline:

• Within eight (8) weeks of the crash date, the CIREN Medical Center shall collect and enter the required vehicle and scene data into the CIREN data system.

• Within eight (8) weeks of the case occupant’s initial discharge date from the enrolling center, the CIREN Medical Center shall collect and enter the required medical documentation, including radiology and a complete injury list, into the CIREN data system (case marked EC Active).

• A CIREN Medical Center shall schedule case review sessions, in collaboration with NHTSA and the assigned CIREN Engineering Center, to occur no later than sixteen (16) weeks after the crash date. The case review session cannot occur earlier than ten (10) weeks after the case occupant’s discharge date from the enrolling center. Case review dates must be scheduled such that the assigned Engineering Center is allowed no less than two (2) weeks to establish injury causation scenarios and prepare case review materials following receipt of all required case elements from the Medical Center. In cases of extended hospital stays, the CIREN Medical Center shall consult with NHTSA regarding scheduling of case reviews to ensure adequate review time by the assigned Engineering Center.

• Following the joint case review session, the CIREN Medical Center shall make any required revisions to crash, scene, and medical data identified in the case review session within one (1) week of the case review session date.

• Following the joint case review session, the CIREN Engineering Center shall finalize the injury causation scenarios and enter the causation data into the CIREN data system within two (2) weeks of the case review session date (case marked QC Review). This two-week period includes any time required by the Medical Center to make revisions identified in the case review session.

• The third-party QC contractor shall return the case with documented findings of required and suggested changes (case marked QC Complete) within four (4) weeks of the case being marked QC Review.

• The enrolling Medical Center shall complete repairs (case marked MC Complete) and document responses to the QC contractor’s findings within two (2) weeks after the case is marked QC Complete.

• The assigned Engineering Center shall complete repairs (case marked EC Complete) and document responses to the QC contractor’s findings within four (4) weeks after the case is marked QC Complete.

• Upon reaching EC Complete status, the NHTSA CIREN Program Manager or designee shall review the case content and provide feedback for any necessary revisions to the responsible CIREN centers within two (2) weeks. When revisions are requested, the responsible CIREN centers shall respond to the NHTSA findings and expedite the case back to EC Complete status.

Whenever special accommodations are required for the case production schedule due to challenges with data access, the responsible CIREN centers shall work with the NHTSA CIREN Program Manager and the QC contractor (if necessary) to adjust the schedule.

1.4 STUDY CRITERIA

CIREN cases are based on persons, sustaining serious injuries in traffic crashes, who are transported to participating enrolling centers or otherwise identified by participating enrolling centers as eligible for inclusion according to Institutional Review Board (IRB) criteria. Individual enrolling center IRB guidelines may stipulate additional requirements beyond the established NHTSA inclusion criteria, but credit for case enrollment in the context of the contractual arrangement between NHTSA and the enrolling CIREN center is governed by the guidelines established in this section.

1.4.1 MOTOR VEHICLE OCCUPANT INCLUSION CRITERIA

The inclusion criteria for injured occupants of CISS-applicable motor vehicles (passenger cars, light trucks, and vans as defined in the NHTSA Field Crash Investigations Coding & Editing Manual) are based on crash type, vehicle age, restraint use, occupant position, occupant age, and occupant injury severity. Different criteria apply for adults compared to children, where adults are defined as occupants thirteen (13) years of age or older. For Phase Four CIREN, NHTSA has established Preferred and Extended inclusion criteria to encourage enrollment of valuable cases while still allowing for centers to meet quotas when admissions meeting Preferred criteria are limited. Inclusion criteria details are presented in Table 1 and Table 2.

Table 1: Adult (13 years and older) case inclusion criteria

Adult Preferred Adult Extended Vehicle criteria

Restraint criteria

Occupant position

Injury severity

Vehicle criteria

Restraint criteria Occupant position

Injury severity

Frontal Crashes – generally 10 o’clock to 2 o’clock impact angle with front plane damage CY-6 (+SC) 3pt belt NGM

+ DFA

Row 1 outboard

AC † DFA (unbelted) † †

MY1998+ 3pt belt NGM Rows 2+ AC n/a MY1998+ 3pt belt NGM

+ DFA

Row 1 outboard

TLS n/a

MY1998+ WCR Any Any n/a Side Crashes – generally 8 o’clock to 10 o’clock or 2 o’clock to 4 o’clock impact angle with side plane damage

CY-6 (+SC) Any Near-side any row

AC MY2005+ Side torso and head bag deployment

MY2005+ 3pt belt NGM Far-side any row

AC Any † † †

MY2005+ WCR Any Any n/a Rear – generally 5 o’clock to 7 o’clock impact angle with rear plane damage n/a CY-6 (+SC) 3pt belt Any AC Rollover Crashes n/a CY-6 (+SC) 3pt belt Any AC Success Cases* – high-energy crashes with minor or no injury to case occupant n/a CY-6 (+SC) 3pt belt Any Any AC=adult conventional, CY=calendar year, DFA=deployed frontal airbag, MY=model year, NGM=no gross misuse (lap and shoulder belt positioned over occupant as designed), SC=sisters and clones, TLS=thoracolumbar spine (requires seat documentation), WCR=wheelchair-seated occupant using adaptive restraint

* requires NHTSA pre-approval, must prove other properly-restrained occupants sustained serious injury (AIS 3+ or 2 AIS 2) † same criterion as in Preferred

Table 2: Child (12 years and younger) case inclusion criteria

Child Preferred Vehicle criteria Restraint criteria Occupant position Injury severity

Frontal Crashes – generally 10 o’clock to 2 o’clock impact angle with front plane damage CY-8 (+SC) 3pt belt or CRS used NGM Any CC MY1998+ 3pt belt NGM Rows 2+ CC MY1998+ WCR Any Any

Side Crashes – generally 8 o’clock to 10 o’clock or 2 o’clock to 4 o’clock impact angle with side plane damage CY-8 (+SC) Any Near-side any row CC MY2005+ 3pt belt NGM Far-side any row CC MY2005+ WCR Any Any

Rear – generally 5 o’clock to 7 o’clock impact angle with rear plane damage MY1998+ CRS used NGM Row 2+ CC

Rollover Crashes CY-8 (+SC) 3pt belt or CRS used NGM Any CC

Success Cases* – high-energy crashes with minor or no injury to case occupant CY-8 (+SC) 3pt belt or CRS used NGM Any Any CC=child conventional, CRS=child restraint system, CY=calendar year, MY=model year, NGM=no gross misuse (appropriate belt/harness positioning and/or CRS installation), SC=sisters and clones, WCR=wheelchair-seated occupant using adaptive restraint

* requires NHTSA pre-approval, must prove other properly-restrained occupants sustained serious injury (AIS 3+ or 2 AIS 2)

In addition to the criteria noted in Table 1 and Table 2, CIREN centers may identify crashes of interest to the NHTSA Special Crash Investigations (SCI) program. Topics of interest to SCI include adaptive vehicles, alternative fuel vehicles, ambulance crashes, guardrail end treatment impacts, and automated driving technology. If a CIREN center consents an injured occupant involved in such a crash, but that occupant and crash do not meet the conventional inclusion criteria, the NHTSA CIREN Program Manager may approve inclusion on a case-by-case basis.

NHTSA may impose special requirements on the investigation and data collection for such cases depending on the applicability of the crash to the SCI program. Once approved for inclusion and completed, such cases will be classified as Preferred.

Furthermore, NHTSA may issue special-interest case inclusion requests in response to changing agency needs or defect investigation efforts. Such cases will be classified as Preferred and the period of eligibility will be determined by the NHTSA CIREN Program Manager. If such circumstances arise, a detailed description of the criteria will be provided to all CIREN Medical Centers.

1.4.1.1 VEHICLE CRITERIA DESCRIPTIONS

CIREN is focused on injury causation in newer vehicles, and has typically based its inclusion criteria on the model year of the case vehicle being a maximum of six or fewer years older than the calendar year at the time of enrollment (CY-6). For example, in calendar year 2018, a 2012 model year vehicle would qualify based on CY-6.

Child cases may be enrolled based on a maximum eight-year age limit (CY-8).

As an extension of the six-year age limit for the CY-6 criterion, NHTSA allows older vehicles to be enrolled if no major chassis and safety technology changes have taken place within a generation of a vehicle make/model that is eligible in its newer model years. NHTSA references the sisters and clones database maintained by Scalia Safety Engineering to make this determination. For example, a 2008 Honda Accord would qualify as a sister/clone (SC) if enrolled in 2018 since that generation runs from 2008 through 2012 model years (cutoff for CY-6 is 2012 model year). All model years of the same make/model with the same Clone ID are considered eligible for inclusion if the most-recent model year in the year/model interchange database is within the eligible time frame. Related vehicles with dissimilar Clone IDs or wheelbase values may be considered on an individual basis when there is uncertainty regarding a restyle or full redesign. Approval by the NHTSA CIREN Program Manager or designee is required for all SC enrollments.

Note: The Scalia Safety Engineering sisters and clones database is a paid subscription service available at http://www.scaliaanderson.com/clones. The NHTSA CIREN Program Manager maintains an active subscription.

Note: Some conditions are eligible for even broader vehicle model year inclusion. These are noted with MY1998+ or MY2005+ for circumstances that allow 1998 and newer or 2005 and newer model year vehicles to be enrolled.

1.4.1.2 INJURY SEVERITY DESCRIPTIONS (USING AIS 2015)

Adult Conventional (AC) – must meet one of the following requirements:

• At least one (1) AIS 3+ injury

• Two (2) AIS 2 injuries (with medical significance) in two different AIS body regions

• At least one (1) AIS 2 injury code of the following types:

http://www.scaliaanderson.com/clones o Brain lesion (e.g., tiny contusion, hemorrhage, subarachnoid hemorrhage; except “NFS; no LOC” codes) o Skull fracture (except “NFS” codes) o Facial fracture (except “NFS” codes) o Two fractured ribs (except “NFS” code) o Vertebral fracture requiring acute operative stabilization (including halo vest), external bracing, TLSO, or cast o Upper extremity long bone fracture meeting one of the following conditions: requiring invasive treatment, partial or complete articular, displacement of more than 25% of shaft width, comminuted, segmental, or with multiple fracture lines o Lower extremity long bone fracture meeting one of the following conditions: requiring invasive treatment, partial or complete articular, displacement of more than 25% of shaft width, comminuted, segmental, or with multiple fracture lines o Talus or calcaneus fracture, or hindfoot fracture-dislocation, with articular involvement or resulting in significant foot deformity o Acetabulum fracture (except “NFS” code) o Pelvic ring fracture (anterior and posterior elements must be documented; except “NFS” code) o Significant external soft tissue trauma (e.g., avulsion, burn, degloving, or complex laceration) requiring reconstruction and/or complex closure

• An AIS 2 concussive injury code in the absence of any other AIS 2+ in all other body regions if the following conditions are also met:

o Well-documented loss of consciousness (LOC) at the time of the crash o No anatomical brain injuries diagnosed during CIREN center admission o CT or MRI performed within 24 hours of initial admission o GCS decreased or occupant is amnestic to event o No illicit drugs or alcohol present at time of crash based on lab tests performed within six (6) hours of crash

Thoracolumbar Spine (TLS) – AIS 2+ vertebral body fracture in T10-L5 region (case occupant’s seat must be properly documented with photographs and measurements as defined in Section 2.2.5)

Child Conventional (CC) – AIS 2+ injury anywhere without restriction

Note: Success cases require documentation of a medical evaluation to substantiate the absence of serious injury. Available documentation may differ, but would likely include a first-responder report (if not transported) or a discharge summary.

1.4.1.3 EXCLUSIONS

Exclusion criteria apply to all case and occupant types

• Case vehicles experiencing catastrophic impacts resulting in occupant compartment intrusions of generally more than 50% of the original distance in any direction (consult with NHTSA CIREN Program Manager or designee when such circumstances arise)

• Non-admitted fatal occupants lacking a complete CT or MRI injury record or complete internal autopsy documentation

• Case vehicles experiencing fire damage to the relevant portion of the occupant compartment

• Child Restraint System (if used) not available for inspection

1.4.2 CASE EQUIVALENT VALUE

In order to better manage fluctuations in eligible motor vehicle trauma admissions experienced by enrolling CIREN centers, a new method to account for cases has been developed for CIREN Phase Four. This approach encourages enrollment of cases better suited to research and reconstruction – occupants in crashes with single significant impacts, fully-restrained occupants in newer vehicles, and cases with very thorough documentation. Instead of all cases contributing the same amount to a center’s quota, an effective case value will allow some cases to contribute more making it easier for a center to satisfy contractual requirements. In this approach, there are two types of cases: Basic and Standard. The two types of cases will have different baseline Case Equivalent Values (CEV), and those values can be increased or decreased based on modifiers. The effective case count, to be determined on an annual basis, is calculated as the sum of each completed case CEV.

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𝑛𝑛 𝑖𝑖=1

Basic: Basic CIREN cases shall meet the Extended inclusion criteria. Cases must include any available digital radiology to substantiate injuries. The CEV for a Basic case is 0.5. There is no limit imposed on the number of Basic cases a center may enroll.

Standard: Standard CIREN cases shall meet the Preferred inclusion criteria. Cases must include any available digital radiology to substantiate injuries and an EDR report acquired from the case vehicle (if supported by latest NHTSA-issued Bosch CDR software/hardware at time of vehicle inspection). The CEV for a Standard case is 1.0.

In addition to the above two categories, the following modifying factors can increase or decrease the CEV for a given case:

Case Modifier Additions

Table 3: Case modifier additions

ID Description Basic Standard A Telematics documentation +0.1 +0.1 B Crash avoidance technology activation +0.1 +0.1 C Exemplar occupant in exemplar vehicles +0.1 +0.1 D Opposing vehicle(s) photos and damage +0.1 +0.1 E Qualifying airbag deployment for case occupant +0.05 +0.05 F EDR report from case vehicle +0.1 n/a G EDR report from case vehicle not supported by Bosch +0.1 +0.1 H EDR report from opposing vehicle(s) +0.05 +0.05 I Initial reports for transferred case subject +0.1 +0.1 J Case subject external photos +0.1 +0.1 K Volumetric DICOM data for at least three body regions +0.1 +0.1 L Single injurious event crash +0.1 +0.1 M Success case injured occupant enrollment +0.1 n/a

A. For crash-involved vehicles equipped with Automatic Crash Notification (ACN) or Advanced Automatic Crash Notification (AACN), documentation from the Public Safety Answering Point (PSAP) of the telematics call attached to case (includes call logs, transcripts, or description of any transmitted data – must indicate notification times)

B. Details about presence and activation of crash avoidance technology in case vehicle (includes confirmation of activation from EDR report)

C. Photos of a similarly-sized occupant (±5% weight and ±2% height) with calibration device (e.g., incremented rod) in a representative seating position of an exemplar vehicle (same generation/make/model as case vehicle) attached to case – position the calibration device(s) in such a manner as to indicate distances between the occupant’s body segments and adjacent interior components along the presumed kinematic directions (e.g., knee to bolster and head to header for frontal crash, head to b-pillar for side impact)

D. Photos and damage assessment from the opposing vehicle(s) (must include CDC and/or crush profile associated with case vehicle’s Rank 1 event)

E. Occupant seating position equipped with deployed knee bolster airbag, seat pan airbag, or inflatable belt F. EDR report acquired from the case vehicle (if supported by latest NHTSA-issued Bosch CDR software/hardware at time of vehicle inspection) for a Basic case G. EDR report acquired from the case vehicle (if supported by retrieval system other than NHTSA-issued

Bosch CDR software/hardware) H. EDR report acquired from the opposing vehicle(s) containing a stored event associated with an impact to the case vehicle I. For case subjects transferred from referring hospital: initial EMS report (scene to initial hospital), ER or trauma bay records from initial hospital, and initial hospital radiology and radiology reports attached to case

J. Photographic evidence of case subject’s external injuries (or lack thereof) attached to case K. Inclusion of volumetric DICOM studies covering at least three of the following body regions for the case subject: head, chest, abdomen, pelvis, thigh, or leg L. Single injurious event crash for case vehicle (based on crash events assigned as Sources of Energy in final injury causation coding) M. Enrollment of qualifying seriously injured occupant in the same vehicle as a Success case (applies only for

Success case)

Case Modifier Subtractions

Table 4: Case modifier subtractions

ID Description Basic Standard A Off-road terrain vertical drop -0.2 -0.2 B Off-road terrain gradient -0.2 -0.2 C Two or more severe impacts for case vehicle -0.1 -0.3 D No EDR report from case vehicle supported by Bosch n/a -0.1 E Incomplete anthropometric measurements -0.1 -0.1 F Incomplete operative and radiology notes -0.1 -0.1

A. Case vehicle experienced off-road terrain vertical drop of more than 240 cm in the event sequence B. Case vehicle experienced an off-road terrain gradient greater than 60% in the event sequence

C. Case vehicle experienced two or more severe impacts, where a severe impact is classified as one of the following:

1. Front plane impact with CDC extent zone greater than 2

2. Side plane impact with more than 15 cm of lateral occupant compartment intrusion

3. Side plane impact with CDC extent zone greater than 2 in front or rear side planes (SHL=F or B; if no occupant compartment involvement)

4. Swiping impact with more than 15 cm of lateral occupant compartment intrusion

5. Rollover top plane impact with CDC extent zone greater than 3 at case occupant’s position

6. Override or underride where hood/trunk and/or top of fenders are involved with more than 25 cm of occupant compartment intrusion

7. Undercarriage impact with crush or bending of vehicle structural components (e.g., frame rails)

8. Rear plane impact with CDC extent zone greater than 3

9. Consult with the NHTSA CIREN Program Manager or designee in the event of uncertainty –

NHTSA shall make the final determination of case eligibility and resultant CEV in the event of unusual multi-event crashes

D. Failure to upload EDR report imaged from case vehicle (if supported by latest NHTSA-issued Bosch CDR software/hardware at time of vehicle inspection)

E. Failure to document all occupant anthropometric measures as described in Section 2.3.4 F. Failure to include complete text of operative notes and radiology reports generated at the enrolling center (complete text should include full dictated report – more than the “Impression” or “Conclusion”)

The enrolling Medical Center shall indicate the proposed case type at the time of the case review session.

Following the case review session, NHTSA shall approve a case’s CEV based on the criteria applicable at the time the crash occurred. The final CEV may not be realized until a case is marked MC Complete and modifiers have been determined. Note that the CEV applies to case quotas for CIREN Medical Centers. Case quotas for Engineering Centers are calculated based on a simple raw count of individual cases reviewed.

2 DATA COLLECTION AND ENTRY

2.1 OVERVIEW OF CISSWEB CIREN

NHTSA data systems have undergone a modernization that has led to updates to the field inspection protocols as well as an overhaul of the electronic data collection system. The CDAN application through which CIREN case data are entered and viewed is called CISSWeb. The CDAN applications, including CISSWeb, must be accessed by registered users of the max.gov web service. Users must log into the Single Sign On (SSO) site using a compatible Internet browser in order to access CDAN applications. For CIREN users, CISSWeb provides a means to access the crash case and the CIREN case, where the CIREN case portion includes the data elements unique to the CIREN program. Within the application and throughout the case production process, different user types will have different levels of access to the case data. In general, the Medical Center users control the crash case and CIREN medical data while the Engineering Center users control the injury causation data. Injury and causation coding are performed in a separate application, VisualAID, which links to the case in CISSWeb.

Note: The CISSWeb application does not save selections or entries on a form until a different form or tab is selected. There is no save button, and the system will not retain selections or entries if a user logs out without first selecting a different form or tab.

The information about the CISSWeb data system presented in this manual differs in scope for the crash case requirements and the CIREN requirements. The crash case requirements, established by NHTSA’s Crash Investigation and Safety Systems Management Divisions and applicable to all NHTSA field crash studies, are presented in other documents with some modifications specific to CIREN provided in Section 2.2 of this manual.

The CIREN-unique elements are described in greater detail in Section 2.3 of this manual, and include usage guidelines and data entry instructions.

2.1.1 USER ROLES AND RESPONSIBILITIES

User accounts for CISSWeb are granted after a multi-stage screening process. Prospective users must first undergo a Department of Transportation (DOT) screening process initiated by the NHTSA CIREN staff. Once cleared, users are assigned accounts on DOT information technology systems. Finally, the CISSWeb Operations and Maintenance (O&M) contractor establishes accounts with appropriate CISSWeb access through the max.gov web services portal.

Access to the CISSWeb data system will be prioritized for those individuals who must enter or review case data for regular CIREN case production. Additional details on the screening process are presented in Appendix B: IT Accounts.

CIREN Technician – The Technician user, also referred to as the Crash Investigator in CIREN, collects and enters vehicle, crash, and scene information into the electronic data system. This user is part of a CIREN Medical Center team and can edit all Medical Center case elements except injury coding.

CIREN Medical – The Medical user collects and enters patient-related information into the electronic data system.

This user is part of a CIREN Medical Center team and can edit occupant information and injury codes.

CIREN Engineering – The Engineering user develops and enters injury causation information into the electronic data system. This user is part of a CIREN Engineering Center team and can edit the injury causation data elements and the Injury Analysis text.

CIREN QC – The QC user conducts a quality control review of all case elements with read-only access of the coded data. This user is part of the third-party CIREN QC contractor team. QC users have write privileges for the QC Findings portion of the crash and CIREN case.

CIREN NHTSA – The NHTSA users are Federal or designated contractor employees at NHTSA HQ or regional sites with read-only access to the coded data. NHTSA users have edit privileges for the Case Equivalent Value data elements as well as the QC Findings portion of the crash and CIREN case.

CDAN Developer – The CDAN Developer users are Federal or designated contractor employees responsible for development, operation, or maintenance of the electronic data system.

Table 5: Roles and rights by case status

Case Status CISSWeb CIREN User Type Technician Medical Engineering QC NHTSA CDAN Developer

Ca se

In -P ro gr es s

MC Active R/W R/W RO RO RO** R/W EC Active RO RO R/W RO RO** R/W In Review RO RO RO* RO RO** RO EC Conclusion RO RO R/W RO RO** R/W QC Review RO RO RO R/W† RO** R/W QC Incomplete R/W R/W RO RO RO** R/W QC Complete R/W R/W RO RO RO** R/W MC Complete RO RO R/W RO RO** R/W EC Complete RO RO RO RO RO** RO Dropped RO RO RO RO RO RO

Published RO RO RO RO RO RO Restricted RO RO RO RO RO RO RO=read only, R/W=read and write

* The Engineering Center users may change the status of the case at this stage, but other data elements are read-only † QC users have write access only for the “Review Note” field ** NHTSA users possess write-access to the Case Value tab contents until the case is published

The publicly-viewable status of a case can only be set to Published if the case status has reached EC Complete.

2.1.2 INITIATING A CASE

Initiating a CIREN case is a two-step process which begins with structuring a crash case in CISSWeb. Once the case occupant has been structured in the case vehicle, a CIREN case can be generated for one of the structured occupants.

2.1.2.1 CRASH CASE

The crash investigator shall generate the crash case in the CISSWeb data system by clicking the “Create CIREN Crash” button on the CISSWeb CIREN case list screen. This crash case serves as the foundation upon which one or more CIREN cases can be created. Each CIREN Medical Center, upon creation of a CIREN crash case, must manually append a three-digit sequential center-specific case number to the default string in the “Case Number” field of the crash case’s Crash tab. The default string that appears in the field upon creation of a CIREN crash case describes the study, center, and case year – this string is unique to each CIREN Medical Center. The sequential case number chosen applies to the entire crash (in the context of a CISS crash) and one or more CIREN occupant cases may be created as a part of this CIREN crash case. Each Medical Center shall number its first enrolled crash case with 001 and increment by 1 for each subsequent crash case. The components of the CIREN crash “Case Number” are described in Table 6. The CISSWeb system automatically generates a “CaseID” unique CIREN-wide case identifier.

Attention: A CIREN crash’s “Case Number” shall indicate the calendar year in which the case was created in CISSWeb.

Table 6: CIREN crash case number format

3-C2-2017-005 3 C2 2017 005

CIREN Center number Case year (indicates year when case is generated)

Center-specific sequential case number

Note: The NHTSA-assigned CIREN center numbers (C1, C2, etc.) shall not be disclosed outside of the CIREN network.

2.1.2.2 CIREN OCCUPANT CASE

To create the CIREN occupant case for the consented occupant once that occupant has been structured into the vehicle, the Medical Center user shall click the green “+” button in the CIREN Case column of the row corresponding to the consented occupant in the Case|Case Summary|Occupants area. Each CIREN Medical Center, upon creation of a CIREN case, must manually enter a unique CIREN case number in the “CIREN Case Number” field of the Create CIREN Case dialog box. Each CIREN Medical Center shall develop its own internal CIREN case numbering scheme. The CISSWeb system automatically generates a “CIRENID” unique CIREN-wide case identifier and sets the initial case status to MC Active.

2.1.3 ADVANCING CASE THROUGH WORKFLOW

Throughout the case production process, the responsible CIREN center must advance the case through the workflow using the “Change Status” function in CISSWeb. The ability to advance the case status depends on the current status and the rights of the user. Table 7 shows the options for advancing a case at various stages of production.

Table 7: Case advancement options (table includes In Review and EC Conclusion, which will be eliminated in an upcoming CISSweb update)

Status [database code] Owner New Case Status Options

Comments

MC Active [22] MC →Dropped →EC Active

MC must select assigned EC when advancing status to EC Active

EC Active [20] EC →In Review In Review [23] EC →Dropped

→EC Conclusion Case content un-editable prior to case review, but EC still in control of case status. Case may be

→MC Active reverted to prior status to continue editing.

EC Conclusion [30] EC →QC Review Avoid advancing case to this status unless the MC has completed any changes required after case review session.

QC Review [27] QC →QC Incomplete →QC Complete

Following QC review process, case returns to MC followed by EC

QC Incomplete [28] MC →EC Active Essentially MC Active status again QC Complete [25] MC →MC Complete - MC Complete [24] EC →EC Complete - EC Complete [26] HQ →QC Complete

→Published →Restricted

NHTSA review of case may require further edits by MC or EC

Dropped [5] System n/a - Published [8] HQ →Restricted

→QC Complete A case may be unpublished by NHTSA for further revision or to be restricted from public access.

Restricted [29] HQ →Published →QC Complete

Cases will be restricted from public access only in unusual circumstances.

EC=Engineering Center, HQ=NHTSA CIREN, MC=Medical Center, QC=Quality control contractor

2.2 CRASH INVESTIGATION ELEMENTS (ENROLLING CENTER)

CIREN crash investigations are required to adhere to the rules and protocols established in the NHTSA Field Crash Investigations Coding & Editing Manual applicable to the date of the crash. Field investigations shall be conducted in accordance with the Coding & Editing Manual except where noted in this section.