Special Notice - final.pdf

Title: Risk of New Malignancies Following Breast Cancer: Tissue retrieval for contralateral breast cancer cases

Solicitation Number: 75N91021Q00257

Contract Opportunity Type: Special Notice

Original Published Date: August 25, 2021

Original Response Date: September 1, 2021

Product Service Code: B537 – Special Studies/Analysis- Medical/Health

NAICS: 541990 – All Other Professional, Scientific, and Technical Services

Description:

The Department of Health and Human Services (DHHS), National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) intends to procure technical scientific support services on a sole source basis from Kaiser Permanente 1730 Minor Avenue, Ste. 1600, Seattle, WA 98101.

The response close date of this notice 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 awarded pursuant to the authority in FAR 13.106-1(b)(1) using simplified acquisition procedures. It 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 and the business size standard is $16.5 million.

1.0 BACKGROUND

The National Institutes of Health (NIH), National Cancer Institute (NCI), Division of Cancer Epidemiology and Genetics (DCEG) is engaged in ongoing research with the Kaiser Permanente Washington Health Research Institute (KPWHRI). 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. DCEG is contributing to this growing area of research by studying the risk of new malignancies following breast cancer.

The 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. This cohort is unique because it combines detailed treatment information with risk factor information and sufficient statistical power to study risk of second cancers.

The NCI has also conducted a feasibility sub-study within the Kaiser Breast Cancer Survivors’ Cohort study. Through this study, the NCI retrieved tissues for twenty study participants that were clinically inactive (i.e., either they were deceased by 12/31/2017 or alive but tissues collected prior to 2009) and diagnosed with a contralateral breast cancer (CBC). NCI then pursued a second, follow-on feasibility study. Through this study, NCI obtained approval from the Institutional Review Board (IRB) at KPWHRI for tissue collection from clinically active patients, and retrieving tissues from five participants that were clinically active (i.e., alive with tissues collected after to 2009) and diagnosed with a contralateral breast cancer (CBC).

To support these numerous and varied efforts, KPWHRI developed a database for tissue selection and tracking purposes in 2021. This Research Electronic Data Capture (REDCap) database was necessary for tissue selection and tracking purposes

The NCI is now requesting tissues for all remaining patients existing archival tissues for both index cancer and contralateral breast cancers (N~100) within the Kaiser Breast Cancer Survivors’ Cohort study at KPWHRI with. In order to process these additional samples, the NCI also seeks to modify the REDCap database to optimize the tissue selection, access to tissues and sample manifest preparation for shipment.

2.0 SCOPE

The Contractor shall provide technical scientific services to the NCI DCEG to support ongoing research into the risk of new malignancies following breast cancer diagnosis. Specifically, the Contractor shall facilitate the retrieval and tracking of breast tissue sample blocks between the NCI and KPWHRI. This shall include samples from approximately 100 clinically active and inactive patients who developed CBC stored in the Kaiser Breast Cancer Survivors’ Cohort, and with existing archival tissues for both index cancer and contralateral breast cancers.

The Contractor shall modify and support the ongoing development of a tissue tracking database.

These services shall address limitations identified in previous projects and prepare the database for use in larger studies. These database changes will increase efficiency in redacted pathology report review for NCI and will ensure the greatest efficiency and data quality for the tissue sent to NCI.

3.0 CONTRACT REQUIREMENTS/ AND PERSONNEL QUALIFICATIONS

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 tasks outlined in this section.

The Contractor shall participate in monthly teleconferences with the NCI COR. These conferences shall consist of updates regarding the general progress of the work, as well as any problems encountered by the NCI or the Contractor.

3.1 TASK 1 – RETRIEVE AND TRANSMIT PATHOLOGY REPORTS

The Contractor shall retrieve, and send redacted pathology reports for approximately 100 CBC patients identified for this study by the NCI as having tissues for both index breast cancer and CBC based on the exiting of path reports in the electronic medical records. Redactions shall remove all personally identifiable information (PII) from the reports.

The NCI will review these reports and identify tissues-of-interest for selection and, in available in the Contractor’s tissue repository, shipment to the NCI. Patients may be excluded if tissue blocks from pathology reports cannot be found or the tissues are being used for clinical care.

3.2 TASK 2 – DATABASE UPDATES

The Contractor shall modify the Research Electronic Data Capture (REDCap) database to incorporate changes necessary for this larger study.

The Contractor shall coordinate with the NCI to identify the required updates, including – but not limited to – the following:

• Modifying data input fields in the database so that format corresponds to the format in the Contractor’s tissue repository (e.g. itemized at the block level if possible, 1A, 1B, 1C instead of 1A – 1C).

• A tracking feature that can be used to identify where any tissue specimen is at any time (Contractor’s site, in-transit, the NCI) so that clinical care will not be impacted.

• Export functionality so that input fields in the database can be exported for tissue specimen retrieval and the shipment manifest required by NCI as outlined in this Statement of Work.

3.3 TASK 3 – SAMPLE RETRIEVAL, PREPARATION & SHIPMENT

For tissues selected from the pathology reports by the NCI, the Contractor shall retrieve tissue blocks identified by NCI as potentially of interest for the following categories:

i. Primary breast cancer tumor block – obtained from surgery of the primary breast cancer

ii. Benign adjacent normal tissue block – obtained from surgery of the primary breast cancer

iii. Lymph node tissue block – obtained from surgery of the primary breast cancer – only selected when the woman is negative for lymph node metastatic disease

iv. Contralateral breast cancer tumor block – obtained from surgery of the second primary breast cancer

v. Contralateral breast cancer adjacent normal block – obtained from surgery of the second primary breast cancer

The Government anticipates identifying an average of 8 tissue blocks for blocks i-iii for the index diagnosis and an average of 6 tissue blocs for iv-v for the contralateral diagnosis. The total number of samples will not exceed 50 samples total for all blocks.

The Contractor shall prepare to ship de-identified specimens to the NCI. All samples will need to be deidentified by the Contractor and must comply with the Institutional Review Board (IRB) and the Material Data Transfer Agreement (MDTA) requirements. The Contractor shall mask all identifying information (e.g., name, address, medical record number) present on the block and affix a label containing the patient’s study ID to the masked area.

Once blocks have been identified and prepared for shipment, the Contractor shall transfer tissue blocks for processing to the central repository at NCI, located at the following address:

Tristain Worsey / Wayne Frolich NCI at Frederick Central Repository

4600 Wedgewood Blvd Suite H Loading Dock Frederick, MD 21703 Tel: 301-732-8200 Email: NCIatFrederickCentralRepositoryOperations@mail.nih.gov

Prior to shipment, the Contractor shall contact the NCI repository to inform that they are ready for shipment and wait until the NCI repository responds with an agreement to receive the shipment.

Shipment should be done by an overnight carrier, Monday to Wednesday, and avoiding days with extreme heat conditions.

The Contractor shall prepare and deliver a tissue tracking log as requested by the NCI repository.

This log shall, detail the subject study ID number, tissue date, and tissue specimen that corresponds to each selected tissue block (tumor, normal, node).

The contractor shall process specimens returned from NCI to the Contractor’s clinical system for clinically active cases.

4.0 GOVERNMENT RESPONSIBILITIES

The Government will review the pathology reports delivered under Task 1 and will notify the Contractor of the tissue selections no later than 30 calendar days after delivery of the pathology reports.

The NCI COR will notify the Contractor of any discrepancies between the specimen manifest and specimens received within one month of shipment receipt.

The Government will return specimens from clinically active cases no later than 90 calendar days after receipt of the tissue blocks.

5.0 TYPE OF ORDER

This is a firm fixed price purchase order for non-severable services.

Funds are only available for use for the contract line item (CLIN) to which they are obligated.

Unused funds from one CLIN may not rollover for use in other CLINs or order periods.

6.0 PERIOD OF PERFORMANCE

The period of performance shall be for 12-months from the date of award.

7.0 PLACE OF PERFORMANCE

Services shall be performed at the Contractor’s facilities or facilities authorized by the Contractor.

mailto:NCIatFrederickCentralRepositoryOperations@mail.nih.gov

8.0 REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE

All written deliverable products shall be submitted in electronic copy for review and comment.

Other formats may be submitted after prior approval from the technical point-of-contact (TPOC).

Electronic copies shall be submitted using Microsoft Office file format (e.g. .DOC, .XLSX) unless prior approval for another format has been obtained from the TPOC.

If any data includes geographic or other Personally Identifiable Information, the Contractor shall transfer the data via a secure, encrypted method.

All deliverables shall be submitted per the following deliverable schedule in the table below:

DELIVERABLE DESCRIPTION FORMAT/METHOD

OF DELIVERY

DUE DATE

Redacted pathology reports

Prepare redacted pathology reports from patients in the Breast Cancer Survivors’ Cohort

90 calendar days following effective date of order

Updates on the on-going tasks

Participate in monthly teleconferences with the

NCI COR.

Monthly, with the first call occurring within 30 calendar days following the effective date of the order.

Link access to the initially modified database

Release initial modifications and updates to the electronic database for testing.

90 calendar days following effective date of order

Link access to the final database.

Complete all modifications and testing of the current electronic database

6-months following effective date of order

Confirmation of tissue blocks being received by the NCI repository

Ship specimens and electronic manifest to the NCI Repository

9-months following effective date of order

Confirmation that the Contractor receives the clinically active tissue blocks

Process returned specimens

15-days prior to end of period of performance

9.0 SUBMISSION INSTRUCTIONS

This notice is not a request for competitive quotation; however, if any interested party – especially any small business – believes it can meet this requirement, it may submit a capability statement for the Government to consider. The response and any other information furnished must be in writing and must contain material in sufficient detail to allow NCI to determine if the party can perform the requirement.

Responses must be received in the contracting office no later than 3:00 PM EST Wednesday, September 01, 2021 (09/01/2021). All responses and/or questions must be submitted via e-mail to Renee Jones-Chuang, Contract Specialist, at renee.jones-chuang@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. In order to receive an award, contractors must be registered and have valid certification through SAM.gov and have representations and certifications completed.

Responses should include both the STATEMENT OF CAPABILITY and the BUSINESS SIZE AND SOCIOECONOMIC STATUS information as explained below. This notice is to assist with determining sources only. If a solicitation is issued it will be announced at a later date, and all interested parties must respond to that solicitation announcement separately from the responses to this announcement.

Requested Information:

(1) Statement of Capability: Submit a brief description (10-pages or fewer) that includes product specifications. Include past experience with performing this type of service for Government agencies, or for a private medical facility. Please indicate your address.

(2) Business Size and Socio-Economic Status:

• (a) Indicate whether your organization is a small business or other-than-small business.

• (b) If small, indicate if your firm qualifies as a small, emerging business; or a small disadvantaged business.

• (c) If disadvantaged, specify under which disadvantaged group and if your firm is certified under Section 8(a) of the Small Business Act.

• (d) Indicate if your firm is a certified HUB-Zone firm.

• (e) Indicate if your firm is a woman-owned or operated business.

• (f) Indicate if your firm is a certified Service-Disabled Veteran Owned Small Business

(SDVOSB) or a Veteran Owned Small Business (VOSB).

• (g) Include the DUNS number of your firm.

• (h) State whether your firm is registered in the System for Award Management (SAM).

Reference 75N91021Q00257 on all correspondence.

mailto:renee.jones-chuang@nih.gov