S02 - 36C25623Q0530_RapidAI Software.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* RAPIDT Software Request for Quote for CT Perfusion/CTA(LVO)ICH/ASPECTS- Software

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 77056-5643

SOLICITATION NUMBER* 36C25623Q0530

RESPONSE DATE/TIME/ZONE 03-20-2023 1:00pm CENTRAL TIME, USA

ARCHIVE 60 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE SBA

PRODUCT SERVICE CODE* 6525

NAICS CODE* 621512

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office 16

5075 Westheimer Road, Suite 750 Houston TX 77056-5643

POINT OF CONTACT*

Contract Specialist Shasta Britt shasta.britt@va.gov

PLACE OF PERFORMANCE

ADDRESS Department of Veterans Affairs Michael E. DeBakey Veterans Affairs Medical

Center

(MEDVAMC)

2002 Holcombe Blvd.

Houston Texas

POSTAL CODE 77030

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL https://www.va.gov URL DESCRIPTION Department of Veterans Affairs AGENCY CONTACT’S EMAIL ADDRESS shasta.britt@va.gov EMAIL DESCRIPTION 36C25623Q0530 - Request for Quote (RFQ)

DESCRIPTION

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Items,” in conjunction with FAR Part 13.5 for Certain Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the solicitation only and a quote is being requested.

This solicitation is issued as a Request for Quotation (RFQ). The solicitation document and incorporated clauses and provisions are those in effect through Federal Acquisition Circular 2023-01, 12-30-2022.

This solicitation is being issued as a Small Business Set-Aside.

The associated North American Industrial Classification System (NAICS) code for this procurement is 621512- Diagnostic Imaging Centers, with a size standard of $16.5 million.

The FSC/PSC is 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary.

Contractor is required to be actively registered in the System for Award Management (SAM).

Vendor quote may be considered non-compliant and rejected if the Contracting Officer is unable to verify active registration status. The Department of Veterans Affairs (VA), Michael E.

DeBakey VA Medical Center (MEDVAMC) located at 2002 Holcombe Blvd; Houston, Texas 77030 is seeking to purchase CT Perfusion/CTA(LVO)ICH/ASPECTS - RAPID™ Software (Brand Name) to the MEDVAMC Neuro-Interventional Radiology Department with four (4)-one

(1) year options for annual subscription software support.

See B.3 Price Cost Schedule / B.5 Statement of Work (SOW) of this document for details of the Government’s requirement.

(End of Description)

36C25623Q0530

Table of Contents

SECTION B - CONTINUATION OF THE TERMS AND CONDITIONS

B.1 CONTRACT ADMINISTRATION DATA

B.2 IT CONTRACT SECURITY

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

B.4 DELIVERY SCHEDULE

B.5 STATEMENT OF WORK (SOW)

SECTION C - CONTRACT CLAUSES

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.2 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

C.3 52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY PRICED LINE

ITEM (MAR 1989)

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) ...19

C.5 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

C.6 VAAR 852.212-71 GRAY MARKET ITEMS (APR 2020)

C.7 VAAR 852.212-72 GRAY MARKET AND COUNTERFEIT ITEMS (MAR 2020)

C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV

2018)

C.9 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020)

C.10 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB

1998)

E.2 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.3 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.4 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.5 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION

(OCT 2018)

E.6 INFORMATION AND COMMUNICATION TECHNOLOGY ACCESSIBILITY

NOTICE (FEB 2023)

E.7 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.8 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (DEC 2022)

SECTION B - CONTINUATION OF THE TERMS AND CONDITIONS

B.1 CONTRACT ADMINISTRATION DATA

(continuation from Standard Form 1449, block 18A.)

1. Contract Administration: All contract administration matters will be handled by the following individual:

a. CONTRACTOR: Company Name:

ATTN/POC Name:

Address:

Phone:

Email:

UEI:

Tax ID:

GSA/FSS, NAC, SEWP Contract# (if applicable):

b. GOVERNMENT: Contracting Officer 36C256

Department of Veterans Affairs Network Contracting Office 16

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

a. 52.232-33 Payment by Electronic Funds Transfer - System for Award

Management through TUNGSTEN

3. INVOICES: Invoices shall be submitted in arrears:

a. Other: Upon receipt and acceptance by the Government

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of

Payment Requests.

a. Include purchase order number (PO# (TBD)) on all invoices, located Standard

Form 1449 block 4.

5. Offeror shall complete the following located in Sections B and E of this solicitation:

a. Section B- CONTRACT ADMINISTRATION DATA, CONTRACTOR contact information.

b. Section B- PRICE/COST SCHEDULE, unit price, amount, and grand total

c. Section E- 52.204-24 REPRESENTATION REGARDING CERTAIN

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR

EQUIPMENT; If applicable.

d. Section E- 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS;

If applicable.

e. Submission of authorized distributor letter.

6. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 IT CONTRACT SECURITY

VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY

1. GENERAL

Contractors, contractor personnel, subcontractors, and subcontractor personnel shall be subject to the same Federal laws, regulations, standards, and VA Directives and Handbooks as VA and VA personnel regarding information and information system security.

2. ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

a. A contractor/subcontractor shall request logical (technical) or physical access to VA information and VA information systems for their employees, subcontractors, and affiliates only to the extent necessary to perform the services specified in the contract, agreement, or task order.

b. All contractors, subcontractors, and third-party servicers and associates working with VA information are subject to the same investigative requirements as those of VA appointees or employees who have access to the same types of information. The level and process of background security investigations for contractors must be in accordance with VA Directive and Handbook 0710, Personnel Suitability and Security Program. The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

c. Contract personnel who require access to national security programs must have a valid security clearance. National Industrial Security Program (NISP) was established by Executive Order 12829 to ensure that cleared U.S. defense industry contract personnel safeguard the classified information in their possession while performing work on contracts, programs, bids, or research and development efforts. The Department of Veterans Affairs does not have a Memorandum of Agreement with Defense Security Service (DSS). Verification of a Security Clearance must be processed through the Special Security Officer located in the Planning and National Security Service within the Office of Operations, Security, and Preparedness.

d. Custom software development and outsourced operations must be located in the U.S. to the maximum extent practical. If such services are proposed to be performed abroad and are not disallowed by other VA policy or mandates, the contractor/subcontractor must state where all non-U.S. services are provided and detail a security plan, deemed to be acceptable by VA, specifically to address mitigation of the resulting problems of communication, control, data protection, and so forth. Location within the U.S. may be an evaluation factor.

e. The contractor or subcontractor must notify the Contracting Officer immediately when an employee working on a VA system or with access to VA information is reassigned or leaves the contractor or subcontractor's employ. The Contracting Officer must also be notified immediately by the contractor or subcontractor prior to an unfriendly termination.

3. VA INFORMATION CUSTODIAL LANGUAGE

a. Information made available to the contractor or subcontractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1).

b. VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor's information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA's information is returned to the VA or destroyed in accordance with VA's sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements.

c. Prior to termination or completion of this contract, contractor/ subcontractor must not destroy information received from VA, or gathered/ created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract.

d. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract.

e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.

f. If VA determines that the contractor has violated any of the information confidentiality, privacy, and security provisions of the contract, it shall be sufficient grounds for VA to withhold payment to the contractor or third party or terminate the contract for default or terminate for cause under Federal Acquisition Regulation (FAR) part 12.

g. If a VHA contract is terminated for cause, the associated BAA must also be terminated and appropriate actions taken in accordance with VHA Handbook 1600.01, Business Associate Agreements. Absent an agreement to use or disclose protected health information, there is no business associate relationship.

h. The contractor/subcontractor must store, transport, or transmit VA sensitive information in an encrypted form, using VA-approved encryption tools that are, at a minimum, FIPS 140-2 validated.

i. The contractor/subcontractor's firewall and Web services security controls, if applicable, shall meet or exceed VA's minimum requirements. VA Configuration Guidelines are available upon request.

j. Except for uses and disclosures of VA information authorized by this contract for performance of the contract, the contractor/subcontractor may use and disclose VA information only in two other situations: (i) in response to a qualifying order of a court of competent jurisdiction, or (ii) with VA's prior written approval. The contractor/subcontractor must refer all requests for, demands for production of, or inquiries about, VA information and information systems to the VA contracting officer for response.

k. Notwithstanding the provision above, the contractor/subcontractor 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 health records pertaining to drug addiction, sickle cell anemia, alcoholism or alcohol abuse, or infection with human immunodeficiency virus. If the contractor/subcontractor is in receipt of a court order or other requests for the above mentioned information, that contractor/subcontractor shall immediately refer such court orders or other requests to the VA contracting officer for response.

l. For service that involves the storage, generating, transmitting, or exchanging of VA sensitive information but does not require C&A or an MOU-ISA for system interconnection, the contractor/subcontractor must complete a Contractor Security Control Assessment (CSCA) on a yearly basis and provide it to the COR.

4. INTENTIONALLY LEFT BLANK

5. INTENTIONALLY LEFT BLANK

6. SECURITY INCIDENT INVESTIGATION

a. The term "security incident" means an event that has, or could have, resulted in unauthorized access to, loss or damage to VA assets, or sensitive information, or an action that breaches VA security procedures. The contractor/ subcontractor shall immediately notify the COR and simultaneously, the designated ISO and Privacy Officer for the contract of any known or suspected security/privacy incidents, or any unauthorized disclosure of sensitive information, including that contained in system(s) to which the contractor/ subcontractor has access.

b. To the extent known by the contractor/subcontractor, the contractor/ subcontractor's notice to VA shall identify the information involved, the circumstances surrounding the incident (including to whom, how, when, and where the VA information or assets were placed at risk or compromised), and any other information that the contractor/subcontractor considers relevant.

c. With respect to unsecured protected health information, the business associate is deemed to have discovered a data breach when the business associate knew or should have known of a breach of such information. Upon discovery, the business associate must notify the covered entity of the breach. Notifications need to be made in accordance with the executed business associate agreement.

d. In instances of theft or break-in or other criminal activity, the contractor/subcontractor must concurrently report the incident to the appropriate law enforcement entity (or entities) of jurisdiction, including the VA OIG and Security and Law Enforcement. The contractor, its employees, and its subcontractors and their employees shall cooperate with VA and any law enforcement authority responsible for the investigation and prosecution of any possible criminal law violation(s) associated with any incident. The contractor/subcontractor shall cooperate with VA in any civil litigation to recover VA information, obtain monetary or other compensation from a third party for damages arising from any incident, or obtain injunctive relief against any third party arising from, or related to, the incident.

7. LIQUIDATED DAMAGES FOR DATA BREACH

a. Consistent with the requirements of 38 U.S.C. 5725, a contract may require access to sensitive personal information. If so, the contractor is liable to VA for liquidated damages in the event of a data breach or privacy incident involving any SPI the contractor/subcontractor processes or maintains under this contract.

b. The contractor/subcontractor shall provide notice to VA of a "security incident" as set forth in the Security Incident Investigation section above. Upon such notification, VA must secure from a non-Department entity or the VA Office of Inspector General an independent risk analysis of the data breach to determine the level of risk associated with the data breach for the potential misuse of any sensitive personal information involved in the data breach. The term 'data breach' means the loss, theft, or other unauthorized access, or any access other than that incidental to the scope of employment, to data containing sensitive personal information, in electronic or printed form, that results in the potential compromise of the confidentiality or integrity of the data. Contractor shall fully cooperate with the entity performing the risk analysis.

Failure to cooperate may be deemed a material breach and grounds for contract termination.

c. Each risk analysis shall address all relevant information concerning the data breach, including the following:

(1) Nature of the event (loss, theft, unauthorized access);

(2) Description of the event, including:

(a) date of occurrence;

(b) data elements involved, including any PII, such as full name, social security number, date of birth, home address, account number, disability code;

(3) Number of individuals affected or potentially affected;

(4) Names of individuals or groups affected or potentially affected;

(5) Ease of logical data access to the lost, stolen or improperly accessed data in light of the degree of protection for the data, e.g., unencrypted, plain text;

(6) Amount of time the data has been out of VA control;

(7) The likelihood that the sensitive personal information will or has been compromised (made accessible to and usable by unauthorized persons);

(8) Known misuses of data containing sensitive personal information, if any;

(9) Assessment of the potential harm to the affected individuals;

(10) Data breach analysis as outlined in 6500.2 Handbook, Management of Security and Privacy Incidents, as appropriate; and

(11) Whether credit protection services may assist record subjects in avoiding or mitigating the results of identity theft based on the sensitive personal information that may have been compromised.

d. Based on the determinations of the independent risk analysis, the contractor shall be responsible for paying to the VA liquidated damages in the amount of $37.50 per affected individual to cover the cost of providing credit protection services to affected individuals consisting of the following:

(1) Notification;

(2) One year of credit monitoring services consisting of automatic daily monitoring of at least 3 relevant credit bureau reports;

(3) Data breach analysis;

(4) Fraud resolution services, including writing dispute letters, initiating fraud alerts and credit freezes, to assist affected individuals to bring matters to resolution;

(5) One year of identity theft insurance with $20,000.00 coverage at $0 deductible; and

(6) Necessary legal expenses the subjects may incur to repair falsified or damaged credit records, histories, or financial affairs.

8. SECURITY CONTROLS COMPLIANCE TESTING

On a periodic basis, VA, including the Office of Inspector General, reserves the right to evaluate any or all of the security controls and privacy practices implemented by the contractor under the clauses contained within the contract. With 10 working-day's notice, at the request of the government, the contractor must fully cooperate and assist in a government-sponsored security controls assessment at each location wherein VA information is processed or stored, or information systems are developed, operated, maintained, or used on behalf of VA, including those initiated by the Office of Inspector General. The government may conduct a security control assessment on shorter notice (to include unannounced assessments) as determined by VA in the event of a security incident or at any other time.

9. TRAINING

Required course(s): Contractor required to complete VA Privacy and Information Security Awareness & Rules of Behavior Training (TMS) COURSE #: 10176 “Privacy and INFOSEC & Rules of Behavior”)

a. All contractor employees and subcontractor personnel requiring access to VA information and VA information systems shall sign and acknowledge (manually) understanding of and responsibilities for compliance within 1 week of the effective date of award of the contract, before being granted access to VA information and its systems; and annually thereafter (if applicable), as required by the following:

(1) Sign and acknowledge (manually) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Appendix E relating to access to VA information and information systems;

(2) Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually (if applicable) complete required security training; and

(3) Successfully complete the appropriate VA Privacy training and annually complete required privacy training.

b. The contractor shall provide to the contracting officer and/or the COR a copy of the training certificates and certification of signing the Contractor Rules of Behavior for each applicable employee within 1 week of the initiation of the contract and annually thereafter, as required.

c. Failure to complete the mandatory annual training and sign the Rules of Behavior annually, within the timeframe required, is grounds for suspension or termination of all physical or electronic access privileges and removal from work on the contract until such time as the training and documents are complete.

(End of VA INFORMATION AND INFORMATION SYSTEM SECURITY/PRIVACY)

B.3 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

1.00

EA

CT Perfusion/CTA(LVO)ICH/ASPECTS - RAPIDT Software Contract Period: Base POP Begin: 05-01-2023 POP End: 04-30-2024 PRINCIPAL NAICS CODE: 621512 - Diagnostic Imaging Centers PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary MANUFACTURER PART NUMBER (MPN): None NATIONAL STOCK NUMBER: None LOCAL STOCK NUMBER: None

CT Perfusion/CTA (LVO)/ICH/ASPECTS - RAPIDT Implementation, Optimization, Training (I/O/T) - One Time Fee Contract Period: Base POP Begin: 05-01-2023 POP End: 04-30-2024 PRINCIPAL NAICS CODE: 621512 - Diagnostic Imaging Centers PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary MANUFACTURER PART NUMBER (MPN): None

Web App - RAPIDT Software 1 USD Contract Period: Base POP Begin: 05-01-2023 POP End: 04-30-2024 PRINCIPAL NAICS CODE: 621512 - Diagnostic Imaging Centers PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary MANUFACTURER PART NUMBER (MPN): None

LOCAL STOCK NUMBER: None

BASE YEAR TOTAL: __________________

Annual Subscription - RAPIDT Software 1 USD Contract Period: Option 1 POP Begin: 05-01-2024 POP End: 04-30-2025 PRINCIPAL NAICS CODE: 621512 - Diagnostic Imaging Centers PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary MANUFACTURER PART NUMBER (MPN): None

Contract Period: Option 2 POP Begin: 05-01-2025 POP End: 04-30-2026 PRINCIPAL NAICS CODE: 621512 - Diagnostic Imaging Centers PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary MANUFACTURER PART NUMBER (MPN): None

Contract Period: Option 3 POP Begin: 05-01-2026 POP End: 04-30-2027 PRINCIPAL NAICS CODE: 621512 - Diagnostic Imaging Centers PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary MANUFACTURER PART NUMBER (MPN): None

Contract Period: Option 4 POP Begin: 05-01-2027 POP End: 04-30-2028 PRINCIPAL NAICS CODE: 621512 - Diagnostic Imaging Centers PRODUCT/SERVICE CODE: 6525 - Imaging Equipment and Supplies: Medical, Dental, Veterinary MANUFACTURER PART NUMBER (MPN): None

GRAND TOTAL __________________

B.4 DELIVERY SCHEDULE

ITEM NUMBER QUANTITY DELIVERY DATE

1.00 5/1/2023-4/30/2024

1.00 5/1/2024-4/30/2025

1.00 5/1/2025-4/30/2026

1.00 5/1/2026-4/30/2027

1.00 5/1/2027-4/30/2028

B.5 STATEMENT OF WORK (SOW)

1. INTRODUCTION

The Michael E. DeBakey VA Medical Center is seeking to procure AI software that delivers automated image processing to identify acute stroke patients who may benefit from an emergency surgery to re-establish blood flow in the brain. This software must be capable of determining the amount of brain tissue affected by the stroke, including distinguishing the amount of tissue that is potentially salvageable versus unsalvageable. The image processing results must be generated within minutes and include automated alerts, thereby reducing delays in treatment and improving patient outcomes. The software and annual subscription are required and a necessary asset in the Interventional Radiology Department in the Diagnostic Therapeutic Careline (MEDVAMC) 2002 Holcombe Blvd. Houston, TX.

77030.

2. BACKGROUND

2.1 The Contract shall provide, transport, install and test all listed software. All products must meet all salient characteristics defined in this section.

2.2 Updated software must meet manufacturers and VA specifications.

2.3 The contractor shall furnish all supplies and services required for delivery and installation of the software.

2.4 The Contractor is responsible for any missing part and components not included in order to carry out the installation.

3. SALIENT CHARACTERISTICS

3.1 Rapid CTA delivers automatic identification of blood vessel density asymmetry in the middle cerebral artery (MCA) territory for more accurate decisions in patient care.

3.1.1 CTA module must auto process images with 3D reconstruction without the need for manual or outsourced post-processing.

3.1.2 CTA module must include a colored overlay that identifies different levels of reduction in blood vessel density to support clinical team in identifying patients with occlusions of the within the middle cerebral or internal carotid artery

3.1.3 CTA module must include a 2d Output that delivers colored overlay maps that identify brain regions with reduced blood vessel density

3.1.4 CTA module blood vessel density maps must contain a color-coded-scale to support simple and readily visualization by the clinical team.

3.1.5 CTA Module must provide severity of blood vessel density reduction compared to the contralateral side

3.1.6 CTA modules must automatically remove bone and non-vascular tissue upon receipt of the scan and generate MIP images of cerebral blood vessels.

3.1.7 CTA Module must include coronal, sagittal, and axial views source images

3.1.8 CTA Module must be able to create 3D vascular reconstructions that can be rotated for optimal viewing of blood vessels in both pitch and yaw rotation.

3.1.9 CTA Module must be independent research validation

3.2 Rapid LVO, in as few as 3 minutes, helps physicians quickly identify suspected large vessel occlusions ( LVOs) involving the distal internal carotid artery (ICA) or the middle cerebral artery (MCA-M1). Rapid LVO helps speed the triage decision making process and facilitates better patient outcomes where every 1.8 seconds results in 1.9 million lost neurons.

3.2.1 LVO Modules must have FDA approved 96% sensitivity and 98% specificity in detecting suspected LVO’s

3.2.2 LVO module must be supported by independent research validation

3.2.3 LVO modules must have the ability to notify the clinical team when suspected LVO has been detected via desktop, email, mobile device and web application

3.2.4 LVO module must have the capability to identify suspected LVO’s involving the ICA terminus through distal M1 segment of the MCA

3.2.5 LVO module must be able to identify suspected intracranial ICA occlusions beginning at the level of the ophthalmic artery and extending to the origin of the MCA

3.3 Rapid CT Perfusion automatically delivers quantitative and color-coded CT perfusion maps that help physicians quickly identify and assess salvageable brain tissue- enabling faster clinical decisions that facilitate improved and better patient outcomes.

3.3.1 CTP Module must be validated large, international, multi centered, randomized clinical trials that contributed to AAH guidelines recommendation changes (such as SWIFT PRIME, DEFUSE 3 and

DAWN, Extend IA)

3.3.2 CTP module must include metrics that identify severity of cerebral blood flow reduction compared to normal brain tissue indicating likelihood of successful reperfusion

3.3.3 CTP module must automatically deliver quantitative perfusion maps

3.3.4 CTP module must deliver color coded CT Perfusion maps

3.3.5 CTP module must be fully automated with an FDA approved option for indication that thrombectomy may be indicated per imaging criteria

3.3.6 CTP Module must automatically deliver a co-registered NCCT study with

HU Multi -threshold map that illustrates the degree of Hounsfield Unit asymmetry

3.3.7 CTP Module must deliver a fully automated CBF-Mismatch Map that provides a comparison between brain regions with substantially reduction in cerebral blood flow regions as well as area with critical hypo-perfusion

(Tmax>6s)

3.3.8 The CTP Module must deliver all of the following three.

3.3.8A Tmax Hypoperfusion map that illustrates the delays in contrast arrive times

3.3.8B The volume of tissue with delays

3.3.8C The Hypoperfusion Intensity Ratio (HIR) which is to be automatically calculated.

3.3.9 The CTP Module must be capable of offering a Co-registered view of the

CT Scan with the CT Perfusion Maps with no thresholds applied and no volumes are calculated to deliver a comparison between CT findings and the perfusion images

3.3.10 The CTP Module must offer a CT AIF and Motions Plots image that display with the AIF plot displays automatically chosen by the software

(for the arterial input function {AIF} and the venous output function {VOF})

3.3.11 The CTP Module must offer a CBV Thresholds and Index image that provides (CBV) cerebral blood volume thresholds. The CBV Thresholds must include a CBV Index

3.3.12 The CTP Module must provide a CBF Thresholds image which includes a

20% “Golden Hour” Threshold to support patients arriving at the hospital within 60 minutes of symptom onset

3.3.13 CTP module must provide a Movement Map that automatically displays the location for BOTH the arterial input function (AIF) and the venous output function (VOV)

3.3.14 CTP Module Movement Map must offer the ability to delete excessive movement frames and change the auto-selected AIF.

3.3.15 CTP module must be clinically validated in at least 6 major multicenter clinical trials

3.4 Rapid ICH and Hyper density leverage the latest technology in artificial intelligence to effectively and efficiently triage non-contrast CT (NCCT) cases by notifying clinicians of possible intracranial hemorrhage (ICH) and then providing identified hyperdense regions of the brain. These RapidAI clinical modules help front line stroke and trauma teams where every second matters, by expediting patient care with a more streamlined assessment decision making workflow. In 3 minutes or less, RapidICH automatically suspects intracranial hemorrhage and immediately notifies the clinical team.

3.4.1 ICH Module must automatically process CT images and assess them for hemorrhage

3.4.2 ICH Module must be capable of screening the following areas:

3.4.2A Intraparenchymal (IP)

3.4.2B Intraventricular (IVH)

3.4.2C Subdural (SDH)

3.4.2D Subarachnoid (SAH)

3.4.2E Epidural (ED)

3.4.3 ICH Module must have a FDA clearance at no less than 97% sensitivity and 99% specificity (or greater) when identifying suspected intracranial hemorrhages

3.4.4 ICH Module (96%) sensitivity and (95%) specificity have independent research validation https://pubmed.ncbi.nlm.nih.gov/33361378/

3.4.5 ICH Module must have an FDA cleared Notification Feature

3.4.6 ICH Module Must be able to process on premise.

3.4.7 ICU Module must be scanner agnostic imaging solution

3.4.8 ICH Module must have Motion Correction embedded in algorithm https://pubmed.ncbi.nlm.nih.gov/33361378/

3.5 Rapid Hyper density analyzes non-contrast CT scans to quickly assess the volume of hyperdense tissue in the brain to support physicians' understanding of the extent of intracerebral hemorrhage.

3.5.1 The Hyper density Module must deliver quick identification and output of hyperdense volumes to improve hemorrhage management capable of being used for head trauma screening and tracking of serial stability ICH scans.

3.5.2 The Hyper density Solution/ Module must automatically identify elevated hyperdense regions > or equal to 1 ml

3.5.3 The Hyper density Module must identify and provide a corresponding volume output

3.5.4 The Hyper density Module must send notifications to PACS, email and the The Rapid Workflow for Stroke mobile and web applications

3.5.5 The Hyper density Module must indicate the acute hyperdense region(s) for easy visualization.

3.6 Rapid ASPECTS implements validated machine learning algorithms to automatically identify regions of the brain with accompanying scores to help physicians quickly assess patient eligibility for thrombectomy. Rapid ASPECTS receives CT scan data, tilt corrects the images, identifies the ASPECTS Regions and provides an automatically generated measure of early ischemic change on non-contrast CT (NCCT) scans which predicts irreversible injury.

3.6.1 ASPECTS Module must be FDA approved.

3.6.2 ASPECTS Module must have independent research validation

3.6.3 ASPECTS Module must automatically identify the ASPECT regions of the brain and generate an ASPECT score to indicate early signs of brain infarction

3.6.4 ASPECTS Module must have FDA CADx classification

3.6.5 ASPECTS Module must have documentation/ validation by MRI

3.6.6 ASPECTS Module must provide standardized ASPECT score to help determine a patient's eligibility for thrombectomy

3.6.7 ASPECTS Module must have a machine learning algorithm validated in clinical research studies

3.6.8 ASPECTS Module must provide slice up and down feature for simple viewing

3.6.9 ASPECTS Module must provide zoom capability for viewing

3.6.10 ASPECTS Module must provide windowing capability for viewing.

3.6.11 ASPECTs Module must have the ability to review and adjust score via vendor web portal

3.6.12 Results must be delivered to PACS, email (Mobile App and Rapid Web

App)

4 SOFTWARE PROJECT IMPLEMENTATION

4.1. Project Kickoff

4.1.1 ISV Team introduction email - Rapid Team

4.1.2 Scheduled Kick off virtual call - Rapid Team

4.1.3 Contract (Sales Order and PO) -customer

4.1.4 Schedule weekly project call - Rapid Team

4.2 Rapid Questionnaire Completion

4.2.1 Provide main contact information - Customer

4.2.2 Provide onsite scanner specifications- Customer

4.2.3 Provide CTP protocol - Customer

4.2.4 Provide IT/ Network/ PACS information - Customer

4.3. Rapid Remote Access

4.3.1 Send documentation for completion- customer

4.3.2 Provide remote access- customer

4.4. Rapid Server

4.4.1 Confirm Virtual or physical server - customer

4.4.2 Confirm if VA uses CentOS- customer

4.4.3 Provide OVF File- Rapid

4.4.4 Spin up server, deploy OVF, configure to Rapid technical specifications-customer

4.4.5 Assign static IP address, hostname, AETitle for the Rapid service-customer

4.4.6 Connect Rapid Server to Customer hospital sub-network-customer

4.4.7 Install and configure RAPID application on server- Rapid

4.5. Modality Setup

4.5.1 Determine if adding nodes to scanners requires external scanner vendors- customer

4.5.2 If external vendor required, schedule external scanner vendor-customer

4.5.3 Provide modality setup instructions- Rapid

4.5.4 Add RAPID to CT scanners (if CT Modules were licensed)

4.4.5 Add RAPID to MR Scanners (if MR Modules were licensed)

4.6. PACS Setup

4.6.1 Provide PACS set up instructions- Rapid

4.6.2 Configure PACS to allow incoming data from Rapid- customer

4.7. Email and Rapid Portal set up

4.7.1 Identify and provide list of email addresses to Rapid- customer

4.7.2 Configure email distribution list for Rapid email notification (per customer request)- customer

4.7.3 Provide list of Admin and Clinical Users for Rapid Reprocessing Portal – customer

4.7.4 Set up clinical/ admin user accounts from customer provided list-Rapid

4.7.5 Schedule Training for the Rapid Portal for the individuals requested by customer -Rapid and Customer

4.8 Testing and Protocol Optimization

4.8.1 Send “dummy” cases from CT and MR scanners to Rapid for testing

4.8,2 Confirm Rapids results display in PACS- customer

4.8.3 Send images to Rapid Image Review Team for protocol review-Rapid

4.8.4 Provide protocol recommendations- Rapid

4.8.5 Review and approve imaging protocols on scanners- customer

4.8.6 If customer adopts ISV protocol recommendation, repeat 8.1 to 8.5 – customer and Rapid

4.9 ISV System Go Live

4.9.1 Send Technical Go Live Email - Rapid

4.10 Clinical Go Live Preparation

4.10.1 Clinical Go Live Email- Rapid

4.11 Rapid/ ISV Training

4.11.1 Rapid U Portal Access-clinical training for physicians- Customer

4.11.2 Rapid U Portal Access- technical training for CT/ MR Techs-customer

4.11.3 Instructor Led clinical training session for physicians (optional)-Rapid

4.11.4 Instructor Led Technologist training session for customer Tech team (opt)

4.12 Testing and Protocol Optimization

4.12.1 Send “dummy” cases from CT and MR scanners to Rapid for testing

4.12.2 Confirm Rapids results display in PACS- customer

4.12.3 Send images to Rapid Image Review Team for protocol review-Rapid

4.13 Post Live Check in

4.13.1 Schedule 1 week post live check in -Rapid

4.13.2 Schedule 1 Month post live check in- Rapid

4.13.3 Schedule 3-month post live check in -Rapid

4.14 Web Desktop App Base Set-up

4.14.1 Confirm Web Desktop app is included in contract -Rapid

4.14.2 Provide site with the Web App Technical Specifications as needed

4.15 Advance Notification Settings

4.15.1 Review advanced notification settings with clinical team -Rapid

4.15.2 Confirm activations- Rapid

5 Industry Security and Compliance Requirements

5.1. On Premise Network system

5.2 USA Designed and Owned Architecture

5.3 HIPPA and GDPR Compliant

5.4 ISO 13485, 27001 and 27701 Certifications

5.5 NIST Cybersecurity Framework

5.6 Encryption of ePHI data at rest and in transit

5.7 Built in de-identification patient data process

(End of SOW)

SECTION C - CONTRACT CLAUSES

ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.1 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a clause may be accessed electronically at this/these address(es):

http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/

FAR

Number

Title Date

52.203-16 PREVENTING PERSONAL CONFLICTS OF INTEREST JUN 2020

52.203-17 CONTRACTOR EMPLOYEE WHISTLEBLOWER RIGHTS

AND REQUIREMENT TO INFORM EMPLOYEES OF

WHISTLEBLOWER RIGHTS

JUN 2020

52.204-4 PRINTED OR COPIED DOUBLE-SIDED ON

POSTCONSUMER FIBER CONTENT PAPER

MAY 2011

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

DEC 2022

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—

COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES

DEC 2022

52.227-19 COMMERCIAL COMPUTER SOFTWARE LICENSE DEC 2007

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

NOV 2021

(End of Clause)

C.2 52.217-6 OPTION FOR INCREASED QUANTITY (MAR 1989)

The Government may increase the quantity of supplies called for in the Schedule at the unit price specified. The Contracting Officer may exercise the option by written notice to the

Contractor within 30 days. Delivery of the added items shall continue at the same rate as the like items called for under the contract, unless the parties otherwise agree.

C.3 52.217-7 OPTION FOR INCREASED QUANTITY—SEPARATELY PRICED

LINE ITEM (MAR 1989)

The Government may require the delivery of the numbered line item, identified in the Schedule as an option item, in the quantity and at the price stated in the Schedule. The Contracting

Officer may exercise the option by written notice to the Contractor within 30 days. Delivery of added items shall continue at the same rate that like items are called for under the contract, unless the parties otherwise agree.

(End of Clause)

C.4 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR

2000)

(a) The Government may extend the term of this contract by written notice to the Contractor within 15 days; provided that the Government gives the Contractor a preliminary written notice of its intent to extend at least 30 days before the contract expires. The preliminary notice does not commit the Government to an extension.

(b) If the Government exercises this option, the extended contract shall be considered to include this option clause.

(c) The total duration of this contract, including the exercise of any options under this clause, shall not exceed five (5) years.

(End of Clause)

C.5 VAAR 852.203-70 COMMERCIAL ADVERTISING (MAY 2018)

The Contractor shall not make reference in its commercial advertising to Department of

Veterans Affairs contracts in a manner that states or implies the Department of Veterans Affairs approves or endorses the Contractor’s products or services or considers the Contractor’s products or services superior to other products or services.

(End of Clause)

C.6 VAAR 852.212-71 GRAY MARKET ITEMS (APR 2020)

(a) No gray market or remanufactured items will be acceptable. Gray market items are Original

Equipment Manufacturers’ (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical equipment only for VA medical facilities.

(b) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the

OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

C.7 VAAR 852.212-72 GRAY MARKET AND COUNTERFEIT ITEMS (MAR

2020)

(a) No used, refurbished, or remanufactured supplies or equipment/parts shall be provided.

This procurement is for new Original Equipment Manufacturer (OEM) items only. No gray market items shall be provided. Gray market items are OEM goods intentionally or unintentionally sold outside an authorized sales territory or sold by non-authorized dealers in an authorized sales territory.

(b) No counterfeit supplies or equipment/parts shall be provided. Counterfeit items include unlawful or unauthorized reproductions, substitutions, or alterations that have been mismarked, misidentified, or otherwise misrepresented to be an authentic, unmodified item from the original manufacturer, or a source with the express written authority of the original manufacturer or current design activity, including an authorized aftermarket manufacturer. Unlawful or unauthorized substitutions include used items represented as new, or the false identification of grade, serial number, lot number, date code, or performance characteristics.

(c) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the

OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

(End of Clause)

C.8 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT

REQUESTS (NOV 2018)

(a) Definitions. As used in this clause—

(1) Contract financing payment has the meaning given in FAR 32.001;

(2) Designated agency office means the office designated by the purchase order, agreement, or contract to first receive and review invoices. This office can be contractually designated as the receiving entity. This office may be different from the office issuing the payment;

(3) Electronic form means an automated system transmitting information electronically according to the accepted electronic data transmission methods and formats identified in paragraph (c) of this clause. Facsimile, email, and scanned documents are not acceptable electronic forms for submission of payment requests;

(4) Invoice payment has the meaning given in FAR 32.001; and

(5) Payment request means any request for contract financing payment or invoice payment submitted by the contractor under this contract.

(b) Electronic payment requests. Except as provided in paragraph (e) of this clause, the contractor shall submit payment requests in electronic form. Purchases paid with a

Government-wide commercial purchase card are considered to be an electronic transaction for purposes of this rule, and therefore no additional electronic invoice submission is required.

(c) Data transmission. A contractor must ensure that the data transmission method and format are through one of the following:

(1) VA’s Electronic Invoice Presentment and Payment System at the current website address provided in the contract.

(2) Any system that conforms to the X12 electronic data interchange (EDI) formats established by the Accredited Standards Center (ASC) and chartered by the American National

Standards Institute (ANSI).

(d) Invoice requirements. Invoices shall comply with FAR 32.905.

(e) Exceptions. If, based on one of the circumstances in this paragraph (e), the Contracting

Officer directs that payment requests be made by mail, the Contractor shall submit payment requests by mail through the United States Postal Service to the designated agency office.

Submission of payment requests by mail may be required for—

(1) Awards made to foreign vendors for work performed outside the United States;

(2) Classified contracts or purchases when electronic submission and processing of payment requests could compromise the safeguarding of classified or privacy information;

(3) Contracts awarded by contracting officers in the conduct of emergency operations, such as responses to national emergencies;

(4) Solicitations or contracts in which the designated agency office is a VA entity other than the VA Financial Services Center in Austin, Texas; or

(5) Solicitations or contracts in which the VA designated agency office does not have electronic invoicing capability as described above.

(End of Clause)

C.9 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT

2020)

The Contracting Officer reserves the right to designate an Administrative Contracting Officer

(ACO) for the purpose of performing certain tasks/duties in the administration of the contract.

Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

C.10 VAAR 852.246-71 REJECTED GOODS (OCT 2018)

(a) Supplies and equipment. Rejected goods will be held subject to Contractor’s order for not more than 15 days, after which the rejected merchandise will be returned to the Contractor’s address at the Contractor’s risk and expense. Expenses incident to the examination and testing of materials or supplies that have been rejected will be charged to the Contractor.

(b) Perishable supplies. The Contractor shall remove rejected perishable supplies within 48 hours after notice of rejection. Supplies determined to be unfit for human consumption will not be removed without permission of the local health authorities. Supplies not removed within the allowed time may be destroyed. The Department of Veterans Affairs will not be responsible for, nor pay for, products rejected. The Contractor will be liable for costs incident to examination of rejected products.

(End of Addendum to 52.212-4)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR

ATTACHMENTS

Intentionally Left Blank

SECTION E - SOLICITATION PROVISIONS

ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

Provisions that are incorporated by reference (by Citation Number, Title, and Date), have the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

The following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

E.1 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY

REFERENCE (FEB 1998)

This solicitation incorporates one or more solicitation…