Raye Z. Litten, Ph.D./ Acting Director, Division of Treatment and Recovery
The National Institute on Alcohol Abuse and Alcoholism (NIAAA) requests approval from the NIAAA Advisory Council to allow Kaiser Permanente of Northern California (KPNC) to submit a contract proposal in response to a sole-source request for proposal.
This acquisition, for other than full and open competition, is conducted under the authority of 41 United States Code (U.S.C.) 3304(a)(1) as set forth in Federal Acquisition Regulation (FAR) 6.302-1.
Under FAR 6.302-1, U.S. Government Contract Law allows federal agencies to award sole source contracts for supplies or services from only once source if the source has submitted an unsolicited research proposal that:
- Demonstrates a unique and innovative concept, or, demonstrates a unique capability of the source to provide the particular research services proposed;
- Offers a concept or services not otherwise available to the Government;
- Does not resemble the substance of a pending competitive acquisition (See 10 U.S.C. 2304(d)(1)(A) and 41 U.S.C. 3304(b)(1).)
A pre-solicitation notice (RFP-NIH-NIAAA-2021-8) was published on February 22nd, 2021, in accordance with FAR Part 5.203, and expired on March 09, 2021. No capability statements were received in response to this notice.
A request for proposal will be made public and issued via beta.SAM.gov along with the NIH-approved justification and approvals for other than full and open competition.
NIAAA's mission is to generate and disseminate fundamental knowledge about the effects of alcohol on health and well-being, and apply that knowledge to improve diagnosis, prevention, and treatment of alcohol-related problems, including alcohol use disorder (AUD), across the lifespan. One high priority area for NIAAA is to increase understanding of recovery from AUD, including factors that affect the likelihood of recovery success, such as quantity of alcohol consumed and the involvement of health and substance abuse comorbidities (NOT-AA-20-22). To meet this mission, NIAAA requires comprehensive, real-world, large-scale, longitudinal data of individuals in recovery from AUD. These individuals would have received treatment for AUD (pharmacotherapy and/or behavioral therapy) in a large health care system. Data should include assessment of alcohol consumption at multiple time points linked to electronic health records.
The proposed contract is to develop a registry of patients with a diagnosis of AUD or confirmed alcohol misuse by leveraging a large comprehensive, proprietary electronic health record (EHR) database provided by KPNC and provide NIAAA-directed analyses. KPNC is an integrated health care system that provides primary and specialty care (including addiction medicine and psychiatry) internally and has a mature, fully developed EHR system, Kaiser Permanente HealthConnect™, that stores data collected throughout the full course of patient care since 2005. Since this time, KPNC’s rich EHR system has been collecting data on AUD diagnosis, alcohol consumption and drinking behavior in conjunction with health outcomes.
The granularity of alcohol consumption data, necessary for relevant drinking outcomes, and the ability to evaluate data collected on the “whole patient” makes this database unique and rare.
Longitudinal, multi-dimensional patient-level data can be obtained from KPNC’s EHR system (including health service utilization, diagnoses, medications, laboratory tests, and responses to health questionnaires), providing a unique opportunity to study the onset and progression of alcohol problems, care provided during all phases (i.e., follow-up, management, continuity of care), and long-term outcomes such as recovery. Using the registry, NIAAA will have the ability to evaluate the full course of alcohol problems, longitudinally and comprehensively, including early identification, initiation and engagement in treatment (including psychiatry, addiction medicine, and pharmacotherapy), and long-term outcomes (e.g., drinking, physical and mental well-being), which are critical to understanding recovery.
This is a unique database and no other organization known to us (or as assessed by the pre-solicitation notice) possesses the volume and numbers of patient records with the required drinking data and repeated long-term healthcare follow-ups as the KPNC EHR system.