Statement of Need_SITUATE CONSOLE X.docx

STATEMENT OF NEED (SON)

VISN 8 Situate Detection System

PROGRAM REQUESTOR/MANAGER).

1. Background. VISN 8 currently does not utilize a lap sponge detection system other than manual sponge counts conducted by surgical staff. The absence of an automated detection solution increases the risk of human error and retained surgical items, which can compromise patient safety and lead to adverse events.

2. Scope. The Situate Console X System is a low Radio Frequency‑based surgical safety device designed to detect tagged laparotomy sponges during operative procedures, reducing the risk of retained surgical items. It includes the Body Scanner Lite, Room Scanner X and the Complete Care Service Plan. The system uses a low‑energy body scanner pad and handheld scanner to identify sponges within the patient or surgical environment in real time. The system enhances accuracy beyond manual sponge counts and supports safer, more efficient surgical workflows. It serves as an adjunct to established surgical counting protocols to strengthen patient safety.

3. Specific Tasks. The Government requires an integrated retained surgical item (RSI) detection system that serves as an adjunct to established manual sponge counting procedures. The purpose of the system is to provide an independent method of detecting retained radiofrequency (RF)-tagged laparotomy sponges during operative procedures in order to enhance patient safety and reduce the potential for retained surgical items.

The Government's minimum operational requirements include:

• Automated non-handheld RF scanning beneath the patient capable of detecting RF-tagged surgical sponges during operative procedures.

• A handheld environmental scanner capable of locating RF-tagged sponges within the operating room, including linens, waste containers, prep areas, and surrounding equipment.

• Workflow guidance that provides standardized prompts supporting consistent use of the system across multiple VISN 8 medical centers.

• Verification of completed scans prior to surgical closure.

• Documentation supporting incorporation of scan results into the patient's medical record.

• Manufacturer-supported software updates, preventive maintenance, technical support, and replacement parts throughout the contract period.

These capabilities are required to provide a standardized retained surgical item prevention process throughout VISN 8 and to supplement, rather than replace, manual sponge counting procedures.

Based upon the Government's market research conducted prior to this acquisition, the Government did not identify another commercially available retained surgical item detection system that simultaneously satisfies all of the Government's minimum operational requirements without requiring revision of those requirements.

Accordingly, the Government has determined that the Medtronic Situate Detection System X is the only commercially available system identified during market research that satisfies the Government's documented minimum clinical, operational, and support requirements.

4. Performance Monitoring Period of Performance Beginning at contract award and continuing through substantial completion. Delivery and installation shall occur as soon as possible. All deliveries must be scheduled during standard working hours, Monday through Friday, 0700–1630. The system shall be delivered to the facilities listed in the contract.

Deliverables

• Ensure timely delivery of the Medtronic Situate Laparoscopic Detection System, all accessories, and all required documentation to the locations listed below.

• Deliver comprehensive user training for surgeons, nursing staff, and perioperative personnel covering system operation, lap detection workflow, safety protocols, and troubleshooting.

• Provide hands‑on training sessions to ensure all staff members demonstrate proficiency in using the Situate system according to manufacturer guidelines.

• Train biomedical engineering and technical support staff in routine maintenance, system checks, calibration, and troubleshooting procedures.

• Issue certifications for all personnel who successfully complete training requirements, confirming competency in system operation and maintenance.

• Provide on‑site clinical support during the initial phase of system use to ensure proper workflow adoption and real‑time guidance.

• Deliver ongoing clinical and technical support as needed throughout the early implementation period.

• Conduct preventive maintenance in accordance with manufacturer standards to ensure continued accuracy and system performance.

• Supply required parts, consumables, and maintenance materials in accordance with the service agreement.

• Provide 24/7 technical support via phone, email, or online portal for operational questions, system alerts, or software‑related issues.• Ensure timely on‑site repair services for issues not resolvable remotely, within the agreed response window.

• Maintain the system with all required software updates, upgrades, and firmware revisions to ensure compliance with current standards and optimize functionality.

• Provide a comprehensive warranty covering system components, accessories, software, and workmanship for the agreed‑upon warranty period.

• Clearly outline warranty terms, including repair, replacement, response times, and any conditions or exclusions.

Site Delivery Locations:

Bay Pines VAMC 10000 Bay Pines Blvd Bay Pines, FL 33744

Bay Pines VAMC 10000 Bay Pines Blvd Bay Pines, FL 33744

2489 Diplomat Parkway East Cape Coral, FL 33909-5422

Gainesville FL 32608

619 S. Marion Ave. Lake City, FL 32025-5808

James Holm Angel Gonzalez-Gonzalez Clifton Perkins Mike Simmons Jorge Perez

13800 Veterans Way, Orlando, FL 32827

1536 North Jefferson Street Jacksonville, FL 32209-6525

7305 N. Military Trail West Palm Beach FL 33410-6400

James Holm Angel Gonzalez-Gonzalez Clifton Perkins Mike Simmons Jorge Perez

13800 Veterans Way, Orlando, FL 32827

13000 Bruce B. Downs Boulevard Tampa FL 33612

Eric Wilhelm Jowel.Linton@va.gov eric.wilhelm@va.gov Miami VAMC 6725 NW 36th Street Suite 695 Miami, FL 33166

5. Security Requirements

VA INFORMATION CUSTODIAL LANGUAGE

a. The Government shall receive unlimited rights to data/intellectual property first produced and delivered in the performance of this contract or order (hereinafter “contract”) unless expressly stated otherwise in this contract. This includes all rights to source code and all documentation created in support thereof. The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General. The primary clause used to define computer software license (not data/intellectual property first produced under this contractor or order) is FAR 52.227-19, Commercial Computer Software License.

b. Information made available to the contractor by VA for the performance or administration of this contract will be used only for the purposes specified in the service agreement, SOW, PWS, PD, and/or contract. The contractor shall not use VA information in any other manner without prior written approval from a VA Contracting Officer (CO). The primary clause used to define Government and Contractor data rights is FAR 52.227-14 Rights in Data – General.

c. VA information will not be co-mingled with any other data on the contractor’s information systems or media storage systems. The contractor shall ensure compliance with Federal and VA requirements related to data protection, data encryption, physical data segregation, logical data segregation, classification requirements and media sanitization.

d. VA reserves the right to conduct scheduled or unscheduled audits, assessments, or investigations of contractor Information Technology (IT) resources to ensure information security is compliant with Federal and VA requirements. The contractor shall provide all necessary access to records (including electronic and documentary materials related to the contracts and subcontracts) and support (including access to contractor and subcontractor staff associated with the contract) to VA, VA's Office Inspector General (OIG), and/or Government Accountability Office (GAO) staff during periodic control assessments, audits, or investigations.

e. The contractor may only use VA information within the terms of the contract and applicable Federal law, regulations, and VA policies. If new Federal information security laws, regulations or VA policies become applicable after execution of the contract, the parties agree to negotiate contract modification and adjustment necessary to implement the new laws, regulations, and/or policies.

f. The contractor shall not make copies of VA information except as specifically authorized and necessary to perform the terms of the contract. If copies are made for restoration purposes, after the restoration is complete, the copies shall be destroyed in accordance with VA Directive 6500, VA Cybersecurity Program and VA Information Security Knowledge Service.

g. If a Veterans Health Administration (VHA) contract is terminated for default or cause with a business associate, the related local Business Associate Agreement (BAA) shall also be terminated and actions taken in accordance with VHA Directive 1605.05, Business Associate Agreements. If there is an executed national BAA associated with the contract, VA will determine what actions are appropriate and notify the contactor.

h. The contractor shall store and transmit VA sensitive information in an encrypted form, using VA-approved encryption tools which are, at a minimum, Federal Information Processing Standards (FIPS) 140-2, Security Requirements for Cryptographic Modules (or its successor) validated and in conformance with VA Information Security Knowledge Service requirements. The contractor shall transmit VA sensitive information using VA approved Transport Layer Security (TLS) configured with FIPS based cipher suites in conformance with National Institute of Standards and Technology (NIST) 800-52, Guidelines for the Selection, Configuration and Use of Transport Layer Security (TLS) Implementations.

i. The contractor’s firewall and web services security controls, as applicable, shall meet or exceed VA’s minimum requirements.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor may use and disclose VA information only in two situations: (i) in response to a qualifying order of a court of competent jurisdiction after notification to VA CO (ii) with written approval from the VA CO. The contractor shall refer all requests for, demands for production of or inquiries about, VA information and information systems to the VA CO for response.

k. Notwithstanding the provision above, the contractor shall not release VA records protected by Title 38 U.S.C. § 5705, Confidentiality of medical quality assurance records and/or Title 38 U.S.C. § 7332, Confidentiality of certain medical records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse or infection with Human Immunodeficiency Virus (HIV). If the contractor is in receipt of a court order or other requests for the above mentioned information, the contractor shall immediately refer such court order or other requests to the VA CO for response.

l. Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor in performance or administration of the contract will be protected and secured in accordance with VA Directive 6500 and Identity and Access Management (IAM) Security processes specified in the VA Information Security Knowledge Service.

m. Any data destruction done on behalf of VA by a contractor shall be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management, VA Handbook 6300.1, Records Management Procedures, and applicable VA Records Control Schedules.

n. The contractor shall provide its plan for destruction of all VA data in its possession according to VA Directive 6500 and NIST 800-88, Guidelines for Media Sanitization prior to termination or completion of this contract. If directed by the COR/CO, the contractor shall return all Federal Records to VA for disposition.

o. Any media, such as paper, magnetic tape, magnetic disks, solid state devices or optical discs that is used to store, process, or access VA information that cannot be destroyed shall be returned to VA.The contractor shall hold the appropriate material until otherwise directed by the Contracting Officer’s Representative (COR) or CO. Items shall be returned securely via VA-approved methods. VA sensitive information must be transmitted utilizing VA-approved encryption tools which are validated under FIPS 140-2 (or its successor) and NIST 800-52. If mailed, the contractor shall send via a trackable method (USPS, UPS, FedEx, etc.) and immediately provide the COR/CO with the tracking information. Self-certification by the contractor that the data destruction requirements above have been met shall be sent to the COR/CO within 30 business days of termination of the contract.

p. All electronic storage media (hard drives, optical disks, CDs, back-up tapes, etc.) used to store, process or access VA information will not be returned to the contractor at the end of lease, loan, or trade-in. Exceptions to this paragraph will only be granted with the written approval of the VA CO.