The Orange Book has been in force for a little over half a year. How are trauma centers doing under the new criteria? Recently, Trauma System News interviewed Ronald M. Stewart, MD, FACS, chair of the ACS Committee on Trauma (COT), and Rosemary Ann Kozar, MD, PhD, FACS, chair of the ACS Verification Review Committee of the COT. They talked about trauma centers’ early experience with the new standards—and previewed upcoming changes that will have a big impact on the verification process.

Q. How are trauma centers experiencing the verification process under the Orange Book?

Stewart: I think today we are seeing the same thing that Frank Mitchell, Erwin Thal and Charles Wolferth saw in the early 90s when they wrote about the initial experience of the verification review program. Their overlying theme was that there are a lot of verification criteria, but if surgeons and nurses are committed to becoming a trauma center, and if hospital leadership is also committed to becoming a trauma center, then in general the verification process goes extremely smoothly. In my experience, if those two things are in place—clinical leadership commitment and hospital leadership commitment—the program finds a way to work through any issues with respect to specific criteria.

Kozar: I think that’s correct. Having seen all the reports, I can tell you that we are not having trauma centers fail because of the Orange Book, and I think that’s an important message. For centers that have undergone reverification in the first six months, the overall pass rate was 94% compared to a pass rate of 97% under the Green Book for a comparable period of time.

Q. The Orange Book strengthened PIPS standards. Do you have any recommendations for complying with these criteria?

Stewart: The simple answer is that if trauma program leaders look at Chapter 16, which was totally revised in the Orange Book, it lays down a very good path to performance improvement and patient safety. And similarly, the TOPIC course from our colleagues at the Society of Trauma Nurses lays out the trauma PI process for people who may be new to it. I very much recommend that course.

But with regard to facilitating compliance, I should say here that we are in the middle of a project that in some ways started before the release of the Orange Book. The goal of this project is to more tightly integrate PIPS with the Verification, Review, and Consultation Program and also with the Trauma Quality Improvement Program. The aim of this project is obviously to improve patient care, but also to make the entire process better for the people administering and leading the trauma program, that is the trauma medical director and the trauma program manager and their staff.

Q. What does this new project involve?

Stewart: We’ve realized that to make all those pieces fit together—verification, performance improvement and TQIP—we need standardization of the components themselves. One concrete example is that we’ve realized we need to have standard PIPS definitions that are aligned with the NTDB standard. This is also the main driving force behind the requirement, starting in January 2017, that TQIP participation will be mandatory for ACS-verified centers. We want TQIP to fit seamlessly into the PIPS program and into verification.

Kozar: Another thing that we are working towards is the incorporation of TQIP Best Practice Guidelines into the PIPS process. Until that occurs, centers are encouraged to use the Best Practice Guidelines as part of their performance improvement initiatives. For instance, if a center found that they were having an increased incidence of infections related to open fractures, they can use the Management of Orthopaedic Trauma Best Practices to guide timing, type and duration of antibiotic administration.

Q. What’s the inspiration for this new project?

Stewart: In a way, even though the verification program and PIPS and TQIP all evolved together and are related to each other, they are not integrated as one seamless program. So what we’re trying to do is make certain that all those pieces fit together better and work together better. In the next revision of Resources for the Optimal Care of the Injured Patient, we will see improved integration of those three major components. I am optimistic this will lead to a Quality Program that is easier and more effective to implement.

The analogy I use is that we want those pieces to fit together seamlessly, similar to the pieces of a well-designed automobile. And so if you think about the automobile analogy, PIPS is the quality drivetrain, TQIP is the dashboard, and the verification program is the overall design and maintenance program. That’s the way we look at it.

Q. How will this be better for trauma program leaders?

Kozar: I think what it’s going to do is make the PIPS process much more objective. The review process will also be providing a lot more guidance for centers. This is less related to patient care, but aimed at making the process easier for trauma centers to follow.

Stewart: That’s really our goal, to make it a better PI process that is easier for trauma programs to implement. We are basically trying to standardize the PIPS process and also clarify what we at least think people should be doing. And this standard program will seamlessly integrate with verification review and TQIP.

Q. Will the standardized PIPS process be mandatory for trauma centers?

Stewart: My personal view is that if we had a standard PIPS process that fits into verification and is incorporated with TQIP, I think people would want to use it. But I think if someone wants to use their own PIPS program that is consistent with Chapter 16, that’s fine.

Q. What is the time frame for all of this?

Stewart: We are aiming to have the next revision of Resources for the Optimal Care of the Injured Patient done within the next couple of years. In terms of our goal of improving the integration of all the components, I think this will be in evolution probably over five or ten years minimum and continuing beyond that.