The College of American Pathologists (CAP) appreciates the opportunity to comment on the newly-released USCDI+ Quality initiative. As the world’s largest organization of board-certified pathologists, the CAP advocates for excellence in pathology and laboratory medicine, and fosters collaboration to improve diagnostic medicine for patients and the public.

The USCDI is important to establish a foundation of standards to build interoperable electronic health information that supports patient care across health systems. The CAP supports the idea of USCDI+ Quality to adapt this framework specifically for quality measurement by centering the data elements that are critical for measure development. In addition to CAP’s previous specific comments on USCDI v4 that are relevant to USCDI+ Quality, we offer the following input:

First, the overall process of establishing USCDI+ Quality should follow the transparent regulatory process needed for such an important framework and should maintain the ongoing iterative development of USCDI. In the current iteration, the selection of data elements is unclear. The ONC has stated that the data element set was put together with input from external stakeholders, but that process is unclear, and some data elements appear to be generated by internal crosswalks. Furthermore, featuring data elements from proprietary initiatives such as mCode does not contribute to a spirit of dialogue nor is conducive to a sense of transparency. Thus the choice of final elements remains opaque and somewhat problematic. This subregulatory process, including rapid comment period, does not allow appropriate stakeholder input and will produce a set of data elements that do not have full buy-in at best, and will have unintended consequences at worst. Given the potential payment implications of USCDI+ Quality and its role in quality measure development, the CAP strongly encourages the ONC to roll out the USCDI+ Quality through a proper regulatory process rather than a subregulatory mechanism.

The CAP also emphasizes the need for an in-depth analysis of the current state of data prior to codifying these data elements. As has been identified in USCDI laboratory and pathology data elements, some of the proposed USCDI+ Quality data elements have significant underlying issues of clinical interoperability. This is relevant not just for pathologist measures of quality, but also for many other specialties’ measures that include laboratory data elements. As articulated by the ongoing SHIELD initiative, there are many instances in which a numerical laboratory value from one platform/location/laboratory cannot be compared to the value from another platform/location/laboratory. The SHIELD initiative is seeking to ensure that numerical laboratory values have the same clinical meaning across settings and time. Thus, careful consideration must be given when considering additional laboratory or pathology data elements in USCDI+ Quality. We suggest that projects such as SHIELD and ONC’s Laboratory Interoperability work should also inform USCDI+ Quality.

Therefore, we suggest additional strategic thought around interoperability, stakeholder input, and transparency in the process of creating the USCDI+ Quality data element list as well as vetting through a regulatory process. Although we appreciate the inclusion of Laboratory data elements in USCDI+ Quality to acknowledge the critical role played by laboratories, there are serious issues in the current state of laboratory and pathology data interoperability that preclude their effective use in USCDI+ Quality.

The CAP also encourages ONC and the Centers for Medicare and Medicaid Services (CMS) to be more explicit as to the intent of USCDI+ Quality. It is difficult to comment on a data set if its intent is not clear. Specifically, is this set of data elements meant to capture and harmonize what is already being used in existing quality measures, as suggested by the inclusion of data elements from current eCQMs? Or is the intent to start from scratch and establish a new standard set of data elements independent of what is being currently used? If it is the former—harmonizing what is already being used—CAP encourages a more thorough evaluation of data elements currently in use in quality measures, expanding beyond the limited set of eCQMs. While eCQMs represent one kind of digital quality metric, many other measures can be captured electronically. Indeed, CMS has established a digital quality measure roadmap that acknowledges an expanded set of data sources for quality measures outside of eCQMs.

If the intent of USCDI+ Quality is instead to create a new set of data elements irrespective of what is currently being used in quality measures, we suggest that a more thorough rationale is needed for this effort. The current data elements used in quality measures are based on extensive testing by measure developers and should not be superseded without due cause. The CAP appreciates all attempts to reduce burden on clinicians participating in quality measurement but establishing a new set of data elements may not accomplish this. We suggest that additional clarification of the intent of USCDI+ Quality may be helpful.

CMS has emphasized the necessity of a parsimonious set of freestanding quality measures for each specialty to be considered digital quality measures in the future to be of maximum utility, meaning the data element building blocks of such measures must be thoroughly vetted. Understanding the opportunities for improvement in data collection and the limitations of current data element sets will be key. The CAP looks forward to engaging with ONC to provide input on future iterations of USCDI+ Quality.