Resource for the Collection of Human Tissues, Cells, Biofluids and Epidemiologic Profiles from Donors

THIS IS A NOTICE OF INTENT, NOT A REQUEST FOR PROPOSAL. A SOLICITATION WILL BE ISSUED ON A LATER DATE.

BACKGROUND:

This contract is the essential resource serving the Center for Cancer Research (CCR), Laboratory of Human Carcinogenesis (LHC) research program. It supports molecular epidemiology studies of human lung, breast, liver and pancreatic cancer; as well as, the molecular pathogenesis and translational studies of all these diseases. LHC studies the induction of cancer directly in human tissues and cells. This requires a reliable source of fresh, professionally obtained human specimens.

The contract initially began as a pilot to obtain tissues for the experimental development of conditions to culture human specimens as organ and cellular tissues. The focus at that time was to obtain case-series cancer and adjacent uninvolved tissues from consented patients as they underwent surgery.  Historically, cancer cases were obtained primarily from the Baltimore Veteran's Administration Hospital, the University of Maryland Medical Center, and Johns Hopkins University Hospital. Beginning in 1996, the focus shifted to case-control studies which still included collection of material from cancer patients, and also healthy population-based controls, recruited from the Maryland Department of Motor Vehicles records. Population controls were recruited based on matching to the cancer cases by geographic location (Baltimore City, Maryland and surrounding selected counties), gender, and race.

In addition to human tissues for research, the resource provides corresponding epidemiology profiles that include occupational histories, personal health history, family health history, smoking information, and exercise information via informed consent. Addition of medical record abstracts and pathological reports complete questionnaires. Personal Identifying Information is excluded when data or samples are delivered to the NIH.  Further, the contract provides histology slides and histopathological interpretations by professionals. Unstained regular, standard and immuno-stained slides are made available for staining and interpretation in LHC.  Four (4) previous contracts have been awarded competitively. The current contract HHSN261201500051C titled “Resource for the Collection and Evaluation of Human Tissues and Cells from Donors with an Epidemiology Profile” was awarded to University of Maryland on 9/28/2015.

REQUIREMENTS:

The LHC, a Clinical Laboratory Improvement Amendment (CLIA) certified laboratory with a record of assays that are designed for clinical application, uses integrative biology and translational research strategies to investigate the molecular epidemiology of human cancer. To that end, the contractor shall be responsible for:

1. Identifying and Recruiting Cancer Cases and Population-Based Controls and Obtain Signed Informed Consent from Potential Participants:

The contractor shall accrue a goal of up to:  100 lung cancer cases per year; 40 benign lung nodules from surgery cases per year; 200 low-dose computed tomography (LDCT) screened candidates per year; 100 primary hepatocellular liver carcinomas (HCC) cases per year; 150 chronic liver disease (CLD) cases per year; 100 primary pancreatic ductal adenocarcinoma cases per year; 50 chronic pancreatitis cases per year; 40 breast cancer patients scheduled for surgery per year; 225 normal population control subjects per year; and accrue cancer patients willing to participate in research but who do not qualify for specific aforementioned studies.

2. Collecting, Storing, Processing and De-identifying Biological Specimens Transferred to the LHC:

The contractor shall administer an NCI-developed interview to each participant for the collection of basic demographic information, smoking history, family history of cancer, medications, occupational history, for use in epidemiological studies. At the time of interview, the contractor shall:  collect and store specimens (tissues, blood products, urine, nasal swabs, cheek swabs, etc.) from either cases or controls; collect when possible, from each case, non-adjacent normal and tumor tissues; prepare paraffin embedded tissues for tumor and non-involved tissue from all cancer cases; collect and process an oral mouthwash rinse for cheek cells if a blood-draw is not possible; collect and process two vacutainers for serum and up to four vacutainers for plasma and lymphocyte preparation from all participants; deliver fresh tissues on wet-ice within 3 hours after receiving the specimen from the pathologist; deliver frozen biological specimens that have been stored at ‐80°C to NCI as a batch bimonthly; characterize and histologically classify both cancerous and non‐cancerous solid tissues delivered to the NCI, and; ensure that the information delivered to Government personnel will be void of any personally identifiable health information.

3. Collecting, Storing, Processing and De-identifying Participant Interview Data:

The contractor shall: provide an epidemiology profile from an NCI-developed questionnaire, administered by trained interviewers via informed consent from each participant; store and maintain the computerized profiles of the participants (without personal identifiers) in a secured tissue‐donor epidemiology database; provide secure storage of completed questionnaires and up‐to‐date security for all electronic data, especially of those data containing personal identifiers in the contractor's facility. Databases must be covered under a Federal Information Security Management Act Authority to Operate (FISMA ATO) Letter, and; prepare, request, and store data for selected cases in the study for survival searches per the National Death Index as required by the LHC investigators.

4. Obtaining and maintaining ethical and legal approvals, including but not limited to Local Institutional Review Board (IRB) approvals.

The Services will be acquired through Full and Open Competition. The Government anticipates that one cost type (1) contract will be awarded with a one (1) year base period plus four (4) one (1) year option periods beginning on or about September 30, 2020. The NAICS Code is 541715.
 

MANDATORY QUALIFICATION CRITERION:

This criterion establishes conditions that must be met at the time of receipt of proposal. The proposals that fail to meet the following criterion will not be considered for award:

The offeror’s proposal must clearly demonstrate the ability to ensure delivery of non-frozen, fresh viable tissues on wet ice to LHC, NIH Campus located at 37 Convent Drive, Building 37, Room 3054, Bethesda, MD within three hours of release from the Offeror’s pathology department.

The RFP will be available electronically on or around February 18, 2020 and may be accessed through the Contract Opportunities at https://beta.sam.gov/. IT IS THE OFFERORS’ RESPONSIBILITY TO MONITOR THE AFOREMENTIONED SITE FOR THE RELEASE OF THE SOLICITATION AND ANY AMENDMENTS. WE ENCOURAGE ALL RESPONSIBLE SOURCES, PARTICULARLY SMALL BUSINESSES, TO SUBMIT A PROPOSAL WHICH WILL BE CONSIDERED BY THE AGENCY. 

This notice does not commit the Government to award a contract. No collect calls will be accepted. No facsimile or email transmissions will be accepted.