Special Notice 75N91020Q00109.pdf

Title: Development and Testing of REDCap Database & Study Workflow for DCEG Mammographic Density Study using Kaiser/DCEG Breast Cancer Survivors’ Cohort data

Document Type: Special Notice

Solicitation Number: 75N91020Q00109

Posted Date: 06/24/2020

Response Date: 07/2/2020

Classification Code: B537 – Special Studies/Analysis- Medical/Health NAICS Code: 541990 – All Other Professional, Scientific, and Technical Services

Contracting Office Address:

Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E136, Bethesda, MD

20892, UNITED STATES.

Description:

The Division of Cancer Epidemiology & Genetics (DCEG), at the U.S. Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), is engaged in ongoing research with the Kaiser Permanente Washington Health Research Institute (KPWHRI). Together, DCEG and KPWHRI developed the Kaiser/DCEG Breast Cancer Survivors’ Cohort, a comprehensive source of HIPAA-compliant data. The DCEG Mammographic Density Study relies on data from the Breast Cancer Survivors’ Cohort. DCEG is studying contralateral breast cancer (CBC) through the examination of pathological characteristics and molecular features of index and contralateral tumors. KPWHRI controls access to the data from the Breast Cancer Survivors’ Cohort. DCEG’s ongoing Mammographic Density Study is built upon data from the Breast Cancer Survivors’ Cohort. Due to the complexities of tissue selection and access to tissues, it is necessary to develop infrastructure, in the form of a Research Electronic Data Capture (REDCap) database, for tissue selection and tracking purposes, and to test the developed database and study workflow, in order to inform the feasibility of a larger tissue retrieval effort for breast cancer patients within the Kaiser/DCEG Breast Cancer Survivors’ Cohort study.

The Office of Acquisitions (OA) plans to procure, on a sole source basis, support services to develop and test a REDCap database and study workflow for the DCEG Mammographic Density Study from the Kaiser Permanente Washington Health Research Institute (KPWHRI – 1730 Minor Ave. Ste. 1600 Seattle, WA 98101).

The response close date of this notice for this requirement is in accordance with FAR 5.203(a)(1). This acquisition will be processed under FAR Part 12 – Acquisition for Commercial Items and will be made pursuant to the authority in FAR 13.106-1(b)(1) using simplified acquisition procedures for commercial acquisitions and is exempt from the requirements of FAR Part 6. The North American Industry Classification System code is 541990 – All Other Professional, Scientific, and Technical Services.

One award will be issued under this solicitation. This will be awarded as a non-severable firm fixed price type contract.

BACKGROUND

Substantial improvements in breast cancer survival, combined with increasing incidence rates have resulted in an increased number of breast cancer survivors in the US. The long-term health of these women is a clinical and public health concern, with an estimated 10% developing a second cancer by ten years after diagnosis. The National Cancer Institute (NCI) and Kaiser Permanente Washington Health Research Institute (KPWHRI) developed the Kaiser/DCEG Breast Cancer Survivors’ Cohort to evaluate relationships between breast cancer treatment and other risk factors and the development of second malignancies and cardiovascular disease. The Kaiser/DCEG Breast Cancer Survivors’ Cohort is unique among similar cohorts because of the level of detailed treatment information combined with risk factor information and sufficient statistical power to study risk of second cancers.

SCOPE

Over the course of the contract, KPWHRI shall use their access to the data to develop and test a REDCap database and study workflow infrastructure in order to inform the feasibility of a larger tissue retrieval effort for breast cancer patients within the Breast Cancer Survivors’ Cohort for use by the DCEG Mammographic Density Study. KPWHRI shall also secure local Institutional Review Board (IRB) clearance allowing access to breast tissue specimens from all patients in the Breast Cancer Survivors’ Cohort. In order to demonstrate the functionality of the database and study workflow infrastructure, KPWHRI shall ship five (5) clinically active patient samples to

NCI.

CONTRACT REQUIREMNETS

Independently, and not as an agent of the Government, the Contractor shall furnish all necessary labor, materials, supplies, equipment, and services not otherwise provided by the Government to perform the following tasks:

1. Prepare redacted pathology reports from patients in the Breast Cancer Survivors’ Cohort for sharing with NCI to select tissue blocks for research.

2. Build a REDCap (Research Electronic Data Capture) based database that shall be shared between KPWHRI and NCI with the following specifications:

i. For Kaiser Breast Cancer Survivors’ Cohort members with available breast pathology reports at KPWHRI, the following data elements shall be captured: the patient’s study ID, breast laterality of the index cancer, and the dates of the index cancer and, if the patient develops a CBC, the date for the CBC.

ii. Each record shall include menus to select sub-records in the database that correspond to each pathology report available from the biopsies and surgeries that led to the diagnosis of the index breast cancer and from the pathology report associated with the CBC-related surgery (if the patient develops a CBC). Each sub-record will display information detailing the date and type of the procedure performed from the associated pathology report.

iii. In addition, each sub-record shall have clickable data fields to facilitate selection by NCI of the tissues blocks of interest, if any, from each pathology report. Upon clicking the data fields, open text data fields shall allow for specification of the selection of the index tumor tissue block, index adjacent normal tissue block, index negative notes, CBC tumor tissue block and CBC adjacent normal tissue block. Each of these data elements shall also capture corresponding open text comment fields.

iv. The REDCap database capture shall have demonstrated capability for generating reports for tissue specimen retrieval and tracking.

3. Test the developed REDCap database and study workflow for tissue block selection and retrieval.

4. Secure local IRB clearance to be able to obtain breast tissue specimens for all patients in the Breast Cancer Survivors’ Cohort at KPWHRI.

5. Ship up to 5 clinically active patients in the Kaiser Breast Cancer Survivors’ Cohort to the NCI.

DELIVERABLES AND DELIVERY SCHEDULE

Deliverables:

Deliverable Description Due Date 1 Prepare redacted pathology reports from patients in the Breast Cancer Survivors’ Cohort 60 days After Receipt of Order (ARO)

2 Build REDcap-based database 90 days ARO 3 Test the REDcap database 120 days ARO 4 Submission of IRB and approval sent to NCI 90 days ARO 5 Ship clinically active specimens 150 days ARO

TYPE OF ORDER

This will be a Non-Severable Firm Fixed-Price Purchase Order.

PERIOD OF PERFORMANCE

The period of performance shall be for six (6) months from the date of award, as follows:

Base Period: 6 months from the date of award

PLACE OF PERFORMANCE

Service shall be performed at the following location:

Kaiser Permanente Washington Health Research Institute (KPWHRI) 1730 Minor Avenue, Suite 1600 Seattle, WA 98101

The Kaiser Permanente Washington Health Research Institute (KPWHRI) and National Cancer Institute (NCI), developed the Kaiser/DCEG Breast Cancer Survivors’ Cohort to evaluate relationships between breast cancer treatment and other risk factors and the development of second malignancies and cardiovascular disease. For NCI, KPWHRI is the only known organization with access to, and the necessary experience managing the requested data from the Kaiser/DCEG Breast Cancer Survivors’ Cohort.

As the data collaborator in the Kaiser/DCEG Breast Cancer Survivors’ Cohort, KPWHRI has the unique and specific qualifications for performing the work requested by NCI. No other organization meets these requirements to NCI’s knowledge. KPWHRI controls access to the data from the Breast Cancer Survivors’ Cohort. Therefore, relying on any other organization without access to the Breast Cancer Survivors’ Cohort data would result in inaccurate infrastructure feasibility for the DCEG Mammographic Density Study.

This notice is not a request for competitive quotation. However, if any interested party, especially small businesses, believes it can meet the above requirement, it may submit a capability statement, proposal, or quotation, which shall be considered by the agency. The statement of capabilities and any other information furnished must be in writing and must contain material in sufficient detail to allow the NCI to determine if the party can perform the requirement. Responses must be received no later than 3:00PM EST, July 2, 2020. All responses and questions must be in writing and emailed to Lena Lee, Contract Specialist, via electronic mail at lena.lee@nih.gov. A determination by the Government not to compete this proposed requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. No collect calls will be accepted. In order to receive an award, Contractors must be registered and have valid, current Entity Record, including current Representations and Certifications, in the System for Award Management (SAM) through SAM.gov. Reference: 75N91020Q00109 on all correspondence.

mailto:lena.lee@nih.gov