26-006633 - Sole Source Justification.pdf

May 28, 2026

To: Office of Procurement and Contracts

From: Head, Clinical Epidemiology Section, Critical Care Medicine Department

Re: Sole Source Justification for Data Management Service Contract with

Commonwealth Informatics Inc., Waltham, MA.

Commonwealth Informatics Inc. (CII; Waltham, MA) is the only known informatics company with over five years of experience working with the Cerner Healthfacts database, a large multi-hospital electronic health record-based database with granular information on patient physiologic, laboratory, pharmacy and administrative data. The Critical Care Medicine Department (CCMD) at NIH/CC previously collaborated with Harvard’s Department of Population Medicine on a study that used Cerner Healthfacts as the data source and CII for data management and analysis, which provided an estimate of the prevalence of sepsis in the US and was published in JAMA in 2017.

Similarly, CCMD has collaborated with NIAID DIR, which has contracted with CII in the past on projects that involved use of this same data source Cerner Healthfacts, through which several analytical macros and predictive models were established that CII has gained familiarity with, a familiarity that would greatly benefit the epidemiologic studies at CCMD proposed for 2026-2027 to be expedited as well.

Furthermore, CII generated the deliverables requested by NIAID DIR on that previous contract in a timely and efficient manner. Given their experience with Cerner data, their services can be elicited for data curation of other similar datasets such as the Premier Healthcare dataset.

The objective of planned study for which CII’s services are currently sought is to Find ways to improve outcomes of patients with life threatening infections such as target trial emulations to identify therapies that can be potentially lifesaving but for which traditional clinical trials are not feasible or practical and may never occur. Findings are likely to inform clinical practice as well as national healthcare policy, but the studies require expeditious conduct while maintaining high quality. If we use another contractor, there is likely to be a large time lag associated with their learning curve using data and pre-defined algorithms with which CII analysts have now gained a high degree of familiarity. Furthermore, CII’s work on a recent CCMD study on COVID-19 prediction models will act as a foundation on which future studies planned for 2026-2027 will be designed and conducted.

The high utility and time sensitive nature of this work necessitates we take every step to ensure expeditious data file generation and analysis, which we feel is more likely if we are able to use CII’s services again.

Jing Feng, MS, COR Date

NATIONAL INSTITUTES OF HEALTH CLINICAL CENTER

Public Health Service

Warren G. Magnuson Clinical Center Mark O. Hatfield Clinical Research Center

Building 10, Room 6-2551 10 Center Drive, MSC 1504 Bethesda, Maryland 20892 clinicalcenter.nih.gov

Sameer Kadri, MD, MS Date Staff Clinician, CCMD

Contracting Officer Date