NCSS PCA-NHLBI-04751.pdf

NON-COMPETITIVE COMBINED SYNOPSIS / SOLICITATION

Title: INOVA/NHLBI Biobanking in Hospitalized Patients

(i) This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; proposals are being requested, and a separate written solicitation will not be issued.

(ii) The solicitation number is PCA-NHLBI-04751. This solicitation is issued as a Notice of Intent (NOI) for a non-competitive combined synopsis/solicitation to award a contract or purchase order without providing for full and open competition (including brand-name, if applicable).

This acquisition is conducted under the authority of FAR 12.603, Streamlined Solicitation for Commercial Products or Commercial Services, and is not expected to exceed the simplified acquisition threshold. Additional authority includes 41 U.S.C. 1901 and FAR 6.302-3(a)(2)(ii).

The National Institutes of Health (NIH), Office of the Director, Office of Acquisitions, intends to negotiate and award a firm-fixed-price purchase order on a non-competitive basis to Inova Health Care Services, 8095 Innovation Park Dr, Fairfax, VA 22031-4868, for the provision of access to patient samples and associated clinical data in support of the NHLBI Critical Care Research Program. Inova Fairfax Hospital is a local community hospital in close proximity to the NIH with an established infrastructure to consent, enroll, collect samples, and transfer samples to the NIH within 48 hours of patient admission, and this requirement is a renewal of an existing contract where pausing sample collection to establish equivalent infrastructure elsewhere would be detrimental to the program.

(iii) The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2026-01, effective 03/13/2026.

(iv) The associated NAICS code is 622110, General Medical and Surgical Hospitals, and the small business size standard is $47 million in average annual receipts. This requirement is not set aside for small business.

(v) Description of Requirement: The Contractor shall provide access to patient samples and associated clinical and laboratory data for patients hospitalized at Inova Fairfax Hospital that are of interest to investigators at the NHLBI, in support of the NHLBI Critical Care Research Program and the Critical Care Medicine and Pulmonary Branch. Services required include: (1) identification of subjects according to the specifications outlined in the research protocol; (2) consenting of patients; (3) enrollment in the research study protocol; (4) collection of a detailed medical history of the patient; (5) sample collection according to the primary investigator's request; (6) scheduling of sample pickup from Inova and delivery to NIH; and (7) open correspondence regarding clinical data from patients. The Contractor shall also provide general support of NHLBI clinical protocols, expert and clinical guidance, patient recruitment, credentialing and space for NHLBI personnel, and a qualified team (Principal Investigator/Project Director, Clinical/Research Investigators, and Clinical Research Coordinators) as further described in the Statement of Work.

(vi) Delivery/Performance Location: Inova Fairfax Hospital and the National Heart, Lung, and Blood Institute. Period of Performance: 11/18/2026 – 11/17/2027.

(vii) [Reserved]

(viii) FAR 52.204-7, System for Award Management, applies to this acquisition.

(ix) The provision at FAR 52.212-1, Instructions to Offerors—Commercial Items, applies to this acquisition.

(x) The provision at FAR 52.212-2, Evaluation—Commercial Items, applies to this acquisition.

(a) A written notice of award or acceptance of an offer, issued to the successful offeror within the time specified in the offer, shall result in a binding contract without further action by either party. The Government reserves the right to accept any offer (or part of an offer) before the expiration date, whether or not discussions are conducted, unless a written notice of withdrawal is received prior to award.

(xi) FAR 52.212-4, Contract Terms and Conditions—Commercial Items, applies to this acquisition.

(xii) Additional contract requirements or terms and conditions, as determined necessary by the Contracting Officer and consistent with customary commercial practices: None.

(xiii) The Defense Priorities and Allocations System (DPAS) is not applicable to this requirement.

(xiv) Submission Requirements: Responses must include sufficient information to demonstrate the respondent's capability to provide the required product or service. Price quotations shall include, at a minimum: unit price, list price, shipping and handling costs, delivery timeframe after award, delivery terms, prompt payment discount terms, F.O.B.

point (destination or origin), product or catalog numbers, product descriptions, and any other relevant information.

Evaluation factors may include, but are not limited to: past performance, technical capability, special features, trade-in considerations, expected lifecycle, warranty, maintenance availability, and environmental or energy efficiency considerations.

Respondents claiming to be manufacturers or authorized resellers of a specified brand-name product must provide: (a) Product, catalog, model, and/or part number(s); (b) Product description; (c) Documentation demonstrating that the offered item meets all required salient characteristics; (d) Quantity; (e) Estimated price or cost; (f) Shipping, handling, and/or installation charges; and (g) Delivery timeframe after receipt of order.

Responses must also include the Unique Entity Identifier (UEI), Taxpayer Identification Number (TIN), and business size certification. All offerors must be actively registered in the System for Award Management (SAM) at www.sam.gov.

All responses must be received by October 20, 2026, 1:00 PM EDT and must reference solicitation number PCA-NHLBI-04751. Responses may be submitted electronically to nicholas.capobianco@nih.gov.

(xv) Point of Contact: Nicholas Capobianco, Contracting Specialist, National Institutes of Health. Email: nicholas.capobianco@nih.gov

Statement of Work (SOW)

1. Project Title: INOVA/NHLBI Biobanking in Hospitalized Patients

2. Introduction and Background: The National Heart, Lung, and Blood Institute (NHLBI) has a world-class Critical Care Research Program dedicated to the study of patients with various forms of critical illness.

After nearly 15 years, the Program continues to provide exceptional opportunities for critical care research.

3. Statement of Need and Objectives: The Program facilitates the on-going collaboration between NHLBI and Contractor by providing each institution unique access to the expertise and resources of the other. It is expected that the Program will continue to benefit not only research and medical personnel associated with the Program but also their patients. The NHLBI benefits from this program by gaining access expertise and to patient samples with associated clinical information for patients hospitalized at INOVA Fairfax Hospital to benefit the research occurring in the NIH Critical Care Medicine and Pulmonary Branch.

4. Product Specifications/Features/Salient Characteristics

Contractor will provide access to patient samples and associated clinical data.

5. General Contractor Responsibilities

5.1 Contractor Requirements:

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

5.1.1 Contractor shall provide general support of NHLBI

clinical protocols on an as needed basis as directed by

NHLBI.

5.1.2 Contractor shall act as a strategic partner in the

continued development of the Program. Specifically, Contractor shall provide expert guidance pertaining to any activity associated with the Program when called upon by

NHLBI.

5.1.3 Contractor shall provide clinical guidance in the

management of NHLBI patients suffering from pulmonary hypertension and other advanced lung diseases on an as needed basis in both in-patient and out-patient settings.

5.1.4 Contractor personnel shall attend and actively

participate in meetings/conferences relating to NHLBI research as requested by NHLBI.

5.1.5 Contractor shall recruit patients with pulmonary

diseases including, but not limited to, asthma, sarcoidosis, bronchiectasis and lymphangioleiomyomatosis to NHLBI clinical protocols in accordance with the requirements of each protocol.

5.1.6 Contractor shall allow NHLBI pulmonary physicians, nurse practitioners and nurses to contact all patients evaluated by the Contractor for possible enrollment in NHLBI clinical trials.

5.1.7 Contractor shall provide expedited credentialing of

NHLBI personnel for work at its facilities.

5.1.8 Contractor shall provide space at its facilities to

house/accommodate any NHLBI equipment and personnel required to conduct onsite research/clinical activities.

Contractor shall expand its space allocation for the Program as the Program grows and additional space is needed, as determined by NHLBI.

5.1.9 Contractor shall assemble a highly-qualified team

consisting of a Principle Investigator/Project Director (PI), Clinical/Research Investigators, and Clinical Research Coordinators to support the Program. Each position’s responsibilities are outlined below:

5.1.10 Contractor shall provide access to blood samples and

associated clinical and laboratory data for patients hospitalized at INOVA Fairfax that are of interest to investigators at the NHLBI.

5.1.10.1 Principle Investigator/Project Director

• Oversee Program activities at Contractor’s facilities

• See patients at NHLBI as mutually agreed to by Contractor and NHLBI

• Take part in providing round-the-clock (24/7), on-call coverage, and availability for all patients associated with the Program

• Lead in generating new research ideas, scrutinizing study results and the preparation of presentations and manuscripts pertaining to research findings pertaining to the Program

5.1.10.2 Clinical/Research Investigators

• Identify and recruit potential study participants

• Perform routine medical management of patients, prior to, during, and after patients’ enrollment in clinical trials

• Take part in providing round-the-clock (24/7), on-call coverage and availability for all patients associated with the Program

• Generate new research ideas, scrutinize study results, and the prepare presentations and manuscripts pertaining to research under the Program

• One Clinical/Research Investigator shall manage NHLBI/Contractor clinical research trials and cohort generation for current and future NHLBI clinical research studies. He/she shall spend two days per week working at NHLBI’s facilities and two days per week working at Contractor’s facilities

5.1.10.3 Clinical Research Coordinators

• Assist investigators in identification and recruitment of potential study participants

• Assist with preparation of materials for study implementation

• Shepherd studies through the IRB approval process

• Compile/store documentation pertaining to studies

• Care for specimens collected during studies

• Assist as needed in the routine medical management of patients, both prior to, during, and after patients’ enrollment in clinical trials

5.1.11 The Contractor shall ensure personnel acquire and

maintain any/all required credentials/qualifications to perform their assigned duties under the Program according to industry standards and NIH/NHLBI policies.

5.2 Assumptions

The work referenced in this document is based on the following assumptions:

5.2.1 Protocols involving patients to be seen at both institutions should be reviewed and approved by NHLBIs Laboratory of Critical Illness Pathogenesis and Therapeutics (LCIPT) Chief and Contractor’s PI prior to submission to their respective IRBs. The LCIPT Chief shall have full control of any collaborative basic and translational research studies implemented at NHLBI as part of the Program.

5.2.2 Patients referred directly to the Contractor shall be seen and evaluated at the Contractor’s facilities initially. They will be given the option of enrollment in one or more of the clinical trials that are available through the Program including trials offered by NHLBI. Should the patients consent to a trial offered by NHLBI, they will be seen at the NHLBI facilities for further evaluation.

NHLBI physician and nursing staff may work at Inova on selected days of the week to ensure a cohesive interaction between programs.

5.2.3 Patients referred directly to NHLBI shall be seen and evaluated at NHLBI facilities. This evaluation may be performed by Contractor personnel working at NHLBI. In addition to being offered the option of enrollment in available studies at the NHLBI, patients will have the option of ongoing disease management through the Contractor. Should the patients agree to ongoing disease management through the Contractor, then they will be referred to the Contractor for on-going follow-up. If the patients do not enrolled in a treatment trial through the NHLBI, then they may be eligible for available pharmaceutical therapeutic trials offered by the Contractor.

6 Delivery or Performance Location

INOVA Fairfax Hospital and National Heart, Lung and Blood Institute.

7 Period of Performance

11/18/2026 – 11/17/2027

8 Inspection and Acceptance:

All work performed under the contract will be reviewed for acceptance. Acceptance will be based on completeness, accuracy, consulting performance, and review of Contractor’s reports by the

COR.

https://www.ipp.gov/ mailto:NHLBIContractsBranchB@mail.nih.gov https://www.ipp.gov/