36C10X26R0048 Vendor Questions.pdf

36C10X26R0048 Vendor Questions

Government answers are in red font

• Regarding the requirement for embedded algorithms capable of predicting patient deterioration or hemodynamic instability, can the VA further define the specific clinical outcome or functionality it is seeking?

The VA is seeking a hemodynamic monitoring system with an embedded predictive algorithm designed to proactively identify patients at risk of acute deterioration as evidenced by changes in hemodynamic parameters (e.g., hypotension, hypoperfusion, arrhythmias, sudden changes in cardiac output/stroke volume). The intended clinical outcome is early identification of impending instability, allowing clinicians to intervene ahead of adverse events such as sustained hypotension, shock, or organ dysfunction. The predictive algorithm should offer actionable insights and risk mitigation—ideally at the point of care—to facilitate timely, informed clinical decision-making and enhance patient safety. Functionality may include, but is not limited to, predictive indices/alerts, real-time risk scoring, and integration with existing patient monitoring workflows.

• Please confirm that an offeror may satisfy SC3 through a predictive algorithm or clinical decision-support capability that is integrated with the proposed hemodynamic monitoring solution, including through an integrated software or platform layer, provided the proposed solution delivers the required capability to predict patient deterioration or hemodynamic instability at the point of care.

Yes, an offeror may satisfy SC3 by providing a predictive algorithm and/or clinical decision-support capability that is integrated with the hemodynamic monitoring solution, either as an embedded algorithm within the monitor or through an integrated software or platform layer. The critical requirement is that the predictive capability be functionally and seamlessly available at the point of care, supporting real-time clinical decision-making in the clinical setting. Integration must not impede timely accessibility, reliability, or data accuracy.

• Please clarify the market research and clinical rationale supporting SC3 as currently written.

Specifically, did VA's market research identify and evaluate commercially available hemodynamic monitoring solutions from multiple manufacturers against the clinical capability contemplated by SC3? If so, please confirm whether VA determined that more than one commercially available solution can satisfy SC3 as written. If only one manufacturer's solution was identified as meeting SC3, please clarify the clinical or operational rationale for requiring the predictive capability to be embedded within the monitor rather than permitting alternative technical approaches that achieve the same clinical outcome.

VA’s market research included a broad review of commercially available hemodynamic monitoring solutions and an assessment of both hardware and software offerings, including varying levels of embedded predictive analytics. Solutions from multiple manufacturers were considered, and the current state of the market indicates that more than one FDA-cleared solution incorporates predictive algorithms designed to forecast patient deterioration or hemodynamic instability.

The rationale for requiring the predictive capability to be “embedded” is to ensure real-time, bedside utility, reduce latency or dependence on external interfacing (which may be subject to network or integration failures), and standardize capabilities across care locations. However, VA will consider technically equivalent solutions where predictive/corrective features are provided via an integrated platform layer, provided that end-users experience seamless, uninterrupted access at the point of care. The overriding goal is prompt, actionable data available when and where needed, irrespective of the technical delivery pathway.

• Please confirm whether offerors may propose an alternative CLIN or product configuration when necessary to provide an equal solution that satisfies all minimum salient characteristics. The solicitation provides flexibility for offerors to propose product solutions or configurations meeting the salient characteristics and incorporates the applicable FAR Subpart 4.202 provisions concerning alternative line-item structures. Please also confirm whether ancillary items necessary to complete an offered solution may be identified as separate line items, including at zero quantity where permitted by the solicitation.

Per Attachment D, “Offeror’s may propose any product solution or configuration so long as they meet all the salient characteristics. Products proposed in the technical volume must be captured on the Offeror’s pricing volume (Attachment A, Price Cost Schedule of the solicitation).

Distributors must be authorized distributors as certified by the OEM. Offerors are asked to propose any additional products that may be beneficial; these items must be captured in the vendor’s pricing volume with an estimated quantity of zero.” Offerors may quote any alternative solutions so long as satisfies all Salient Characteristics and location of compliance to the Salient

Characteristics are documented per the Salient Characteristics chart in the Combined

Synopsis/Solicitation document.

• SC 3 requires an embedded algorithm that predicts patient deterioration/hemodynamic instability.

We identified published clinical studies that found HPI-guided monitoring did not significantly reduce intraoperative hypotension and that a standard MAP-based alarm performed comparably to HPI.

With that in mind, would the Government consider broadening SC3 to allow FDA-cleared hemodynamic monitoring solutions that support clinicians in identifying and managing hemodynamic instability, even if the solution does not include an embedded predictive algorithm?

References:

Maheshwari et al., Hypotension Prediction Index for Prevention of Hypotension during

Moderate- to High-risk Noncardiac Surgery, Anesthesiology (2020).

Florax et al., Hypotension Prediction Index versus Mean Arterial Pressure Alarm for Preventing

Intraoperative Hypotension in Elective Non-Cardiac Surgery: A Randomized Controlled Trial, Anesthesiology (2026).

The VA values evidence-based innovation and acknowledges there is an emerging scientific discourse on the efficacy of various predictive indices, such as HPI versus traditional MAP-based approaches (as seen in Maheshwari et al. 2020 and Florax et al. 2026). However, the SC3 requirement reflects a commitment to advancing proactive, rather than solely reactive, patient monitoring. The aim is not only to alert to the presence of instability, but also to anticipate and help prevent it, consistent with national patient safety goals and the VA’s broader quality initiatives.

We continue to welcome input and will consider alternatives that match the spirit and functional goals of SC3—including FDA-cleared, clinically validated solutions that offer demonstrable support for predicting and managing patient deterioration in real time.

• Because hyperlinks are prohibited and evaluation is limited to the submitted information, please confirm that all descriptive literature relied upon for compliance must be embedded in or appended to Volume I, and clarify whether document bookmarks and internal cross-references are permitted.

All descriptive literature relied upon to demonstrate compliance must be contained within the offeror's submission. The prohibition on hyperlinks applies to references to information stored outside the submission; document bookmarks and internal cross-references to material within the offeror's own proposal are permitted

• Can the Government clarify the intended care environment(s) for these systems, such as

Interventional Labs, Intensive Care Unit (ICU), or other clinical settings?

The national contract is intended to service all critical care settings but primarily the OR and ICU.