Pre-Sol Notice.pdf

Notice Type:

Presolicitation Notice

PSC Code:

AN11 – Health R&D Services; Health Care Services; Basic Research

NAICS Code:

541715 -- Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance:

Baltimore, Maryland Metropolitan Area

The proposed contract action is to provide supplies or services for which the Government intends to solicit and negotiate with only one source, the University of Maryland - Baltimore, under the authority of FAR 6.302-1. Interested persons may identify their interest and capability to respond to the requirement. This notice of intent is not a request for competitive proposals.

However, all proposals received will be considered by the Government. A determination by the Government not to continue with this proposed contract based upon responses to this notice is solely within the discretion of the Government. Information received will normally be considered solely for the purpose of determining whether to conduct a competitive acquisition.

Background:

The Resource for the Collection and Evaluation of Human Tissue, Cells, and Bio-fluids from Donors with an Epidemiologic Profile supports molecular epidemiology studies of human lung, breast, prostate, liver and pancreatic cancer, as well as, the molecular pathogenesis and translational studies of all these diseases. Laboratory of Human Carcinogenesis (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, focus shifted to case-control studies which still included collection of material from cancer patients, and also healthy population-based controls, recruited from online advertisements. 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. Five (5) previous contracts have been awarded competitively. The current contract 75N91020C00007 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 9/21/2020.

This Cost-Reimbursement contract was awarded on a competitive basis for a one (1)-year base period (September 30, 2020- September 29, 2021) and four (4) one-year option periods for a total potential period of performance through September 29, 2025. The total current value of the contract, inclusive of all Options is $7,053,827.

Description:

The Government intends to modify contract number 75N91020C00007, with the University of Maryland, Baltimore, to extend the period of performance for two years, by adding two, one-year option periods, beginning on or about September 30, 2025.

During this two-year extension, the Contractor will be responsible for:

1. Biological Sample Collection

Collect and store all specimens (tissues, paraffin embedded blocks, blood products, urine, nasal swabs, cheek swabs, etc.) from either cases or controls, already enrolled, in plastic vials of appropriate size. Human samples containing or suspected of containing infectious substance shall be packaged and handled in accordance with applicable government regulations.

Deliver frozen biological specimens that have been stored at ‐80°C or paraffin embedded tissue blocks at room temperature to NCI as requested by the COR. Human samples containing or suspected of containing infectious substance shall be packaged and handled in accordance with applicable government regulations.

Characterize and histologically classify both cancerous and non‐cancerous solid tissues delivered to the NCI. Provide the diagnosis, stage, grade, and tumor, node, metastasis status from pathology reports generated by the physician and the pathologist for individual cases as well as other pertinent classifications (i.e. ER status, viral load) where indicated or as specified by the COR. Ensure that the Information delivered to Government personnel is void of any personally identifiable health information on the cases or the controls.

2. Data Requirements

Provide an epidemiology profile from an NCI-developed questionnaire, administered by trained interviewers via informed consent from each participant.

Provide data abstracted from Medical Records of participants, from all hospitals for which volunteers were recruited, as requested by the COR, using the Medical Abstraction form developed by LHC and IRB approved.

Prepare, request, and store data for selected cases in the study for survival searches per the National Death Index as requested by the COR. Merge and appropriately clean Individual patient questionnaire data before transfer (without PHI) to the LHC.

3. Database Migration

Store and maintain the computerized profiles of the participants (without personal identifiers) in a tissue‐donor epidemiology database, secured according to the Privacy Act requirements.

Privacy Act Statement of Record Number (SORN) 09‐25‐0200 is applicable to the requirements of this Statement of Work.

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.

Develop and support relational SQ database, as requested in COA letter, that combines medical records, questionnaire data, patient tissue inventory, survival data and omics data with a platform for reporting. The patient data will be taken from medical records, questionnaires, pathology reports at UMD and other hospitals where volunteers were recruited, National Death Index from the CDC, and omics data from NCI.

Document, as requested, the number of patients accrued for case‐control studies of cancers of the lung, liver, breast and pancreas as well as the number of patients admitted to the studies.

Report all curation and essential contract activities to the managing NCI/LHC investigators in written form, in preparation for and to be discussed verbally during regularly scheduled Conference Calls established by the COR. The contractor's Principal Investigator and the NCI/LHC Principal Investigators may attend the calls as determined by the COR.

4. Ethical and Legal Approvals

Maintain approvals for the accrual of patient data and operation of the project in accordance with the local IRB, Privacy Act, HIPAA regulations, Good Clinical Practices (GCP), FISMA, and laboratory safety with an emphasis on biohazard training.

No other source has been found that possesses all the requisite knowledge, skills, accessibility and locality to perform the services in a way that would satisfy the requirements on the current contract. Award to any other source would result in substantial delays in service delivery and duplication of cost to the Government that is not expected to be recovered through competition.

This is not a request for proposals, proposal abstracts, or quotations and does not commit the Government to any contractual agreement. The original sources sought notice was posted to SAM.gov under Solicitation Number 75N91024R00018. All responsible sources may submit a tailored capability statement addressing the scope of the work noted above, which shall be considered by the agency. The capability statement must be submitted electronically (via email) to Erin Felent, Contracting Officer, at Erin.Felent@nih.gov in MS Word or Adobe Portable Document Format (PDF) by July 15th at 12:00 PM, EST. All responses must be received by the specified due date and time in order to be considered. CAPABILITY STATEMENTS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls or facsimile transmissions will be accepted.