The COT at 100: Setting the Standard for Quality Programs

Highlights

• Outlines the evolution of COT standards to ensure trauma center quality
• Describes the goals and revision process for each edition of the Resources for Optimal Care of the Injured Patient
• Identifies the role of trauma registries in collecting high-quality data to assess patient outcomes and center performance
• Highlights future goals, including incorporating PROMs into the data collection process, to advance the care of the injured patient

For the past 100 years, the American College of Surgeons (ACS) has led national and global initiatives to improve the quality of patient care in multiple areas, including trauma, cancer, and general surgery. Trauma care efforts have focused on both the development and implementation of standards for the optimal care of the injured patient, development of a trauma center consultation and verification program, and establishment of trauma registries, including the National Trauma Data Bank^® (NTDB^®) and, ultimately, the Trauma Quality Improvement Program^® (TQIP^®).

Initially, quality improvement (QI) in trauma centers focused on developing and supporting adequate structures and processes to ensure care for the injured patient. The ACS Committee on Trauma (COT) first published Optimal Hospital Resources for Care of the Seriously Injured (now Resources for Optimal Care of the Injured Patient) in 1976. Since then, this manual has outlined the equipment, personnel, and infrastructure needed for centers to provide high-quality trauma care and subsequently led to the Verification, Review, and Consultation (VRC) Program. This approach has revolutionized the care of severely injured patients and has become the model for comprehensive QI across the House of Surgery. This seminal work was followed by key efforts to create standardized data registries and to allow for benchmarking and collaborative efforts to improve quality through TQIP.

Establishing Standards for Trauma Center Quality

In 1976, a COT taskforce published an article in the Bulletin, “Optimal Hospital Resources for Care of the Seriously Injured,” which called for hospitals to commit to providing the resources, facilities, and personnel to address the needs of seriously injured patients. Along with requirements for personnel and equipment, it called for regularly scheduled mandatory quality assurance audits and reviews of all professional and nonprofessional services. This taskforce developed an implementation plan based on the hospital resources article. A reporting format was created to ensure the standards were applied appropriately and discretionary interpretation was minimized.

The evolution of the standards document corresponded with the evolution of the philosophy of care by the COT. The initial title, Optimal Hospital Resources for Care of the Injured Patient, has evolved into Resources for Optimal Care of the Injured Patient. This subtle title change underscores a shift in emphasis from optimal hospital resources to optimal care given the available resources, and reflects an important and abiding principle that the needs of injured patients should be addressed both at the point of injury and wherever they receive care.

On April 16, 1980, the Task Force for the Implementation of the Hospital Resources Document developed a Verification Consultation Program for Level I and II hospitals for the COT’s approval. Implementation of this program was hotly debated, with the ACS leadership expressing its views that it was too regulatory in nature and would be cost-prohibitive. The COT was initially allowed to proceed with a consultation process only.

In spring 1986, the National Commission for the Accreditation of Trauma Centers was formed external to the ACS with the intent of carrying out review and formal accreditation of trauma centers. The COT, under Donald D. Trunkey, MD, FACS, then-COT Chair, agreed that while the idea put forth by the national commission was a good one, the COT Executive Committee asserted that this activity should remain the purview of the COT and, certainly, the ACS. After several years of advocating for the ACS to implement such a program, the Board of Regents approved it in October 1986, and implementation began in earnest for a true trauma verification process led by the COT.

The Verification Review Committee Program was formally established in 1987. Frank L. Mitchell Jr., MD, FACS, was appointed as the first Chair of the then-Ad Hoc Committee on Verification/Consultation. The first Level I trauma center, Detroit Receiving Hospital, MI, was verified in 1987, followed in 1988 by the verification of the first Level II trauma center, Ascension Via Christi, Wichita, KS.

Pediatric trauma center criteria then were developed, and the first pediatric trauma center consultation was performed in 1989 at Norton Children’s Hospital, Louisville, KY. The first Resources for Optimal Care of the Injured Patient book was released in 1990. Based on the red cover it became known as the “Red Book,” which started the tradition of referring to subsequent updates to the standards by the color of the book. The first Level III trauma center, Exeter Hospital, NH, was verified in 1990. At present, the ACS has verified 546 trauma centers and conducts more than 227 verification site visits annually (see Table 1).

*Verified Centers as of March 1, 2022
Table 1.

Evolution of the Standards

The 1990 Red Book introduced the “broken man” image on the manual’s cover, which has become synonymous with the ACS COT Resources for the Optimal Care of the Injured Patient manual and the COT as a whole. (see sidebar, page 40).

The 1999 “Gold Book” expanded and replaced the manual’s “Quality of Trauma Care Personnel” chapter with separate, more detailed “Clinical Functions” chapters for general surgery, emergency medicine, neurosurgery, and orthopaedic surgery. With the Gold Book came a change in the nomenclature from quality assurance to performance improvement (PI), providing trauma providers with a new lexicon of key terms such as “opportunities for improvement” and “loop closure.”

A notable change in the 2006 “Green Book” was the incorporation of patient safety into PI. The new acronym, PIPS (Performance Improvement and Patient Safety), was coined to embody the goal of reducing inappropriate variations in care and thereby improving patient safety and outcomes. Regular data submission to the NTDB became a requirement, and today the NTDB houses the largest aggregation of trauma registry data ever assembled and is used extensively in trauma research.

The “Orange Book,” published in 2014, was the sixth edition of Resources for Optimal Care of the Injured Patient and represented a Herculean effort because of extensive changes. In this revision, the principles for developing an inclusive trauma system were further refined. The Orange Book’s PIPS section was more than twice the size of the same section in the Red Book. The operational concepts of the PIPS process now were required to be in a written plan outlining in a formal document the configuration and details of the trauma center’s PI program. The Orange Book introduced a new criterion requiring participation in national risk-adjusted benchmarking, allowing trauma centers to begin comparing their outcomes with other similar centers.

Goals of Revisions to Resources for Optimal Care

The approach to each edition and its subsequent revision process has evolved as the changing landscape of trauma care results in new opportunities and needs. Each edition requires numerous stakeholders volunteering significant time, energy, experience, and knowledge to provide constructive feedback and to draft each new manual (see Figure 1).

Resource Manuals from 1976-2022

• Optimal Hospital Resources for Care of the Seriously Injured—1976
• Hospital Resources for Optimal Care of the Injured Patient and Appendices A through J—1979
• Hospital and Prehospital Resources for Optimal Care of the Injured Patient and Appendices A through J—1983
• Hospital and Prehospital Resources for Optimal Care of the Injured Patient and Appendices A through J—1986/1987
• Resources for Optimal Care of the Injured Patient—1990, “Red Book”
• Resources for Optimal Care of the Injured Patient—1993, “Blue Book”
• Resources for Optimal Care of the Injured Patient—1999, “Gold Book”
• Resources for Optimal Care of the Injured Patient—2006, “Green Book”
• Resources for Optimal Care of the Injured Patient—2014, “Orange Book”
• Resources for Optimal Care of the Injured Patient—2022, “Grey Book”

Future editions of the Resources for Optimal Care of the Injured Patient will continue to build on the ongoing integration of the VRC, PIPS, TQIP, and trauma systems concepts into one seamless program leading to a Trauma Quality Program that is easier and more effective to implement. The primary goal for the revision process continues to be the provision of better definitions of the resources needed to provide optimal care of injured patients within an appropriately designed and funded system of care.

Another goal of the revision process is to use an evidence-based scientific method when data are available. The COT seeks not only to identify and support new potential criteria, but also to apply new research to existing standards and to recommend the elimination of criteria proven to be of limited value.

The goal remains to continue to develop consistent and clear standards that are value-based and patient-centric—that benefit all patients rather than a single institution or program. The latest revision has focused on creating standards that are easier to understand and implement and are more objectively verified during the site visit. The standards also have been consolidated to eliminate redundancy. The next edition represents greater alignment with and standardization of all ACS Quality Programs. The new Resources for the Optimal Care of the Injured Patient was released in April 2022. And while its new cover is a charcoal gray, we plan to begin using the actual name of the book as it more accurately describes to the uninitiated the importance of its contents.

Data-Driven QI

QI relies on high-quality data to assess patient outcomes and trauma center performance. The COT’s continuing focus on providing the best possible care to the injured patient links the efforts of the VRC focused on standardization of resources to the work of creating reliable and usable data through the NTDB and TQIP. These combined efforts to develop standards and improve quality resulted in the creation of the NTDB as a national repository for data collected through trauma registries. In turn, review and use of the data eventually resulted in the development of the National Trauma Data Standard (NTDS)—the standard set of definitions and formats for data collection—and ultimately to the development of TQIP, which, through the reports provided to participating centers, allows the centers to compare their processes and outcomes with their peers.

In the early 1970s, David R. Boyd, MD, FACS, and colleagues described the first hospital trauma registry that was developed to enable research and patient monitoring. Subsequently, the Major Trauma Outcomes Study, developed by Howard R. Champion, MD, FACS, and coordinated through the COT, collected data from trauma centers across the US in 1982−1989. This pioneering work led to the Trauma and Injury Severity Score methodology, which combined the Revised Trauma Score and the Injury Severity Score and established national norms to provide a predicted risk of mortality that could be used to identify patient cases that, when reviewed, would identify QI opportunities.

In 1986, Hospital and Prehospital Resources for Optimal Care of the Injured Patient identified the trauma registry as essential for verification. Registries allowed individual centers to measure processes of care and outcomes that then facilitated the development of institution-specific performance improvement initiatives that led to lower morbidity and mortality.

The NTDB

As COT Chair, Dr. Trunkey appointed the Ad Hoc Committee on Quality Assurance, in 1985, with Frank L. Mitchell Jr., MD, FACS, as the first Chair, followed by Dr. Champion. In 1990, another committee was established to focus on the development of a national trauma registry with Charles L. Rice, MD, FACS, as the first Chair of the Subcommittee on the Trauma Registry.

Also in 1995, David B. Hoyt, MD, FACS, Chair, Subcommittee on the Trauma Registry, and Immediate Past-ACS Executive Director, established a workgroup to develop the NTDB. This panel sought broad stakeholder input, reviewed all relevant existing data sets, and incorporated quality indicators as established by the COT Quality Improvement Subcommittee (formerly the Ad Hoc Committee on Quality Assurance).

Through the leadership of John Fildes, MD, FACS, Chair, Ad Hoc Committee on NTDB, the first NTDB annual report (based on 181,000 records) was published in 2001, with the first pediatric report published in 2003. In 2004, the NTDB reached a milestone by accruing a cumulative total of 1.1 million records, meeting a challenge from the ACS Board of Regents to significantly expand participation through submission of data.

Richard Fantus, MD, FACS, Chair of the Trauma Registry Advisory Ad Hoc Committee from 2006 to 2011, soon began demonstrating the power of the data in a series of 200 consecutive articles in the Bulletin with creative titles ranging from “Hit the road, jacked—road rash injuries” to “Who let the dogs out?” Dr. Fantus’ final column was published in 2019.

Don’t Mess with the Broken Man!

Since its introduction in 1990 on the cover of the Red Book, the COT Broken Man has become a beloved icon, universally representing the injured patient. Everything the COT does, every decision the COT leaders make, is weighed against the questions of whether we are acting in the best interests of the severely injured patient. These principles guide the decisions of the COT, carrying more weight than business imperatives, preferences, or any other considerations. The Broken Man reminds us why we act as a group and why individually we chose trauma as our calling. The patient (Broken Man) is our reason for being. 

Over the years, the Broken Man has gone through some stylistic refreshes, at least one of which was soundly rejected. Ronald M. Stewart, MD, FACS, COT Chair (2014–2018), presided over the most recent refresh a few years ago and had definite thoughts about the suggested changes to its appearance. Suffice it to say that all future designers will be cautioned, “Don’t mess with the Broken Man!” Going forward, our Broken (hu)Man may be refined gently, but it will continue to stand as an enduring reminder of our patients and why we have dedicated ourselves to doing what we do so well. 

TQIP

Although significant progress was made at the individual trauma center level through the aforementioned efforts, the need for a national risk-adjusted benchmarking program in trauma was evident from the NTDB data published. Despite the standardization of structure and processes orchestrated by the VRC, mortality outcomes varied substantially, supporting the need for additional programs and measures beyond structures and processes of care to improve outcomes for injured patients.

The development and implementation of TQIP began with the creation of a TQIP Project Team in 2006, led by H. Gil Cryer, MD, FACS, under the direction of Dr. Fildes, incoming COT Chair. The project team was charged with piloting and launching a program to provide risk-adjusted outcomes to participating trauma centers. In addition to guiding improvement efforts, this information would allow the COT to identify high-performing centers that could share best practices and guidelines with the broader community, thus elevating the care of injured patients. Dr. Nathens, a coauthor of this article, assumed responsibilities for TQIP in 2008, and provided foundational leadership to the development of the program. In 2016, Dr. Nathens was formally hired as the Medical Director for Trauma Quality Programs and continues to serve in that position.

Making Meaningful Comparisons

Although the National Surgical Quality Improvement Program^® (ACS NSQIP^®) could serve as a guide for the development of TQIP, the unique qualities of trauma patients versus general surgery patients required that statistical analytic methodologies be developed specific to trauma patients. Thus, both the data collected and the outcomes reported by TQIP needed to be specific to the trauma population. In addition, TQIP needed to consider which patients would be eligible for inclusion. To ensure that equitable comparisons were made between centers, TQIP based analysis on consistent patient cohorts across hospitals.

The feasibility of TQIP as a QI program was tested in a successful pilot study conducted in 2008−2009 under the leadership of Dr. Nathens and the ACS COT staff. In 2014, Pediatric TQIP launched to provide a similar approach to QI for pediatric trauma patients and risk-adjusted benchmarking for pediatric trauma centers. That year, TQIP Collaboratives also debuted. The goal of collaboratives is to provide a self-identified group of trauma centers, typically defined by state, with assistance in identifying opportunities for improvement across the group that may not otherwise be apparent for each individual center and to help facilitate PI efforts across the collaborative participants. In 2016, the program was expanded to include Level III trauma centers.

As of February 2022, 885 programs were enrolled. Program participants included 526 Level I and II centers, 160 pediatric centers, and 199 Level III centers from all 50 states, Washington, DC, and three countries. Six regional and 15 state collaboratives also were registered. TQIP offers ongoing training and continuing education opportunities for trauma registrars through a variety of mechanisms, including webinars, interactive question-and-answer sessions, and annual course modules.

Patient Outcomes, Processes of Care, Risk-Adjustment, and Center Reports

Outcomes that TQIP measures include mortality and complications. These outcomes, as all aspects of TQIP benchmark reports, have evolved and remain a work in progress as TQIP adapts to the changing needs and priorities of participants and the trauma community at large. Because the structures and processes of care directly affect patient outcomes, TQIP also provides reports on several processes of care that are specific to the trauma population. TQIP uses hierarchical, linear models to create the risk-adjusted outcomes used in TQIP benchmark reports. These models produce odds ratios or, in some cases, risk-adjusted time-to metrics, as measures of hospital performance (see Figure 2).

Process of Care

Figure 2.

Transforming Data into Performance Improvement Efforts

TQIP recognizes that providing centers with data is insufficient to support meaningful changes in patient care. Thus, TQIP offers resources on how to develop and execute performance improvement initiatives. Collaboration between centers is a key means by which TQIP facilitates QI efforts. TQIP always has provided feedback regarding what aspects of data quality or care could benefit from improvement; however, the task of identifying, designing, and implementing an intervention has been dependent on the participating site itself. To address this gap, TQIP is now piloting a program to provide peer coaching for participants under the leadership of Dr. Nathens and Michael C. Chang, MD, FACS, Heidi A. Hotz, RN, and Robbie Dumond, BSN, MHA.

Consistent with the aim of helping to identify and implement interventions, TQIP also launched the TQIP Mortality Reporting System in 2019, through the efforts of Samuel P. Mandell, MD, FACS, and now led by Aaron Jensen, MD, FACS, aimed at collecting structured mortality reviews for use in multi-institutional retrospective analyses.

The ACS TQIP Annual Conference, formerly known as the ACS TQIP Annual Scientific Meeting and Training, plays a key role in educating and supporting centers to help them provide quality care. Under the leadership of Dr. Chang, outgoing Trauma Quality Pillar Chair and TQIP Conference Program Chair, the meeting has drawn a range of attendees including, but not limited to, trauma medical directors, program managers, program coordinators, and registrars from participating and prospective TQIP centers. The 2019 meeting drew nearly 2,000 individuals from more than 730 institutions in the US and around the world. The 2020 program, which took place virtually because of the pandemic, had more than 6,300 participants.

The Future

The VRC Program represents a standard process for trauma center verification that has resulted in improved outcomes. The continued emphasis on quality outcomes only will grow in the future. Although the goal of zero preventable deaths after injury may never be achieved, continuous QI can reduce mortality and morbidity for injured patients. Furthermore, we need to move beyond measuring mortality as the primary outcome to ensure that we are optimizing all dimensions of care for the injured patient.

TQIP continually evolves to respond to the needs of its participating centers and to push the envelope on advancing care for the injured patient. As inhospital mortality rates continue to decline, we recognize the need to focus on strategies to optimize long-term functional outcomes. To address this challenge, TQIP is developing a pilot program to incorporate patient-reported outcome measures (PROMs) into the data collection process. The PROMs Work Group, led by Angela M. Ingraham, MD, FACS, Joseph V. Sakran, MD, MPH, MPA, FACS, and Sarah F. Parker, BSN, RN, TCRN, is exploring the collection of PROMs from trauma survivors and confronting the unique challenges associated with accomplishing this goal.

TQIP supports advances in care through research, and TQIP data have been used to support many studies exploring variations in care and factors associated with improved outcomes. As a core member of the Coalition for National Trauma Research, the COT recently invested in creating a platform to support incremental data collection, which when combined with TQIP data, can serve as infrastructure to support prospective observational and interventional trials.

Conclusion

Over the past 100 years, the COT has focused on quality of care of injured patients—setting standards for resources and care through the work of the VRC, and continually working to improve that care through the Trauma Quality Programs.

TQIP has revolutionized the care of the injured patient through risk-adjusted benchmarking of outcomes between trauma centers. TQIP translates data into action through the critical examination of individual center and collaborative reports as well as the distribution of best practices and lessons learned through the program’s annual meeting and other forums. Through TQIP, centers have identified areas for improvement and implemented changes to reduce variability and complications in trauma care and to improve resource use and patient survival.

Past-Chairs

Ad Hoc Committee on Verification/Consultation; Trauma Center Consultation/Verification Committee

• Frank L. Mitchell Jr., MD, FACS (1987–1995)
• Charles E. Lucas, MD, FACS (1995–2000)
• Robert L. Coscia, MD, FACS (2000–2006)
• Frank L. Mitchell III, MD, FACS (2006–2010)
• Chris Cribari, MD, FACS (2010–2014)
• Rosemary A. Kozar, MD, FACS (2014–2017)
• Todd Maxson, MD, FACS (2017–2018)
• Daniel R. Margulies, MD, FACS (2018–2020)
• William H. Marx, DO, FACS (2020–2022)
• Nilda M. Garcia, MD, FACS (2022– )

Subcommittee on the Trauma Registry (Programs)

• Charles L. Rice, MD, FACS (1990–1993)
• David B. Hoyt, MD, FACS (1994–1997)
• Ronald G. Tompkins, MD, FACS (1997–2004)
• John Fildes, MD, FACS (2004–2006)
• David E. Clark, MD, FACS (2006–2008)
• Avery B. Nathens, MD, PhD, FACS, FRCSC (2008–2009)

Trauma Registry Advisory Ad Hoc Committee

• Richard J. Fantus, MD, FACS (2006–2011)
• Trauma Quality Improvement Program (TQIP) Advisory Committee
• Avery B. Nathens, MD, PhD, FACS, FRCSC (2011–2016)

Ad Hoc Committee on the National Trauma Data Bank/Quality and Data Resources Committee (QDRC)/TQIP Committee

• Wayne Meredith, MD, FACS (1997–2000)
• John Fildes, MD, FACS (2000–2004)
• Avery B. Nathens, MD, PhD, FACS, FRCSC (2009-2011)
• Michael L. Nance, MD, FACS (2011–2016)
• Michael C. Chang, MD, FACS (2016–2022)

Acknowledgements

The authors would like to acknowledge the contributions of William Marx, MD, FACS, Chris Cribari, MD, FACS, Daniel Margulies, MD, FACS, Angela Ingraham, MD, FACS, and Jean Clemency to this article.

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