DRAFT 36C24125R0116 24 Sept 2025 version.pdf

PAGE 1 OF 1. REQUISITION NO.

2. CONTRACT NO. 3. AWARD/EFFECTIVE DATE 4. ORDER NO. 5. SOLICITATION NUMBER 6. SOLICITATION ISSUE DATE

a. NAME b. TELEPHONE NO. (No Collect Calls) 8. OFFER DUE DATE/LOCAL

TIME

9. ISSUED BY CODE 10. THIS ACQUISITION IS UNRESTRICTED OR SET ASIDE: % FOR:

SMALL BUSINESS

HUBZONE SMALL

BUSINESS

SERVICE-DISABLED

VETERAN-OWNED

SMALL BUSINESS

WOMEN-OWNED SMALL BUSINESS

(WOSB) ELIGIBLE UNDER THE WOMEN-OWNED

SMALL BUSINESS PROGRAM

EDWOSB

8(A)

NAICS:

SIZE STANDARD:

11. DELIVERY FOR FOB DESTINA-

TION UNLESS BLOCK IS

MARKED

SEE SCHEDULE

12. DISCOUNT TERMS

13a. THIS CONTRACT IS A

RATED ORDER UNDER

DPAS (15 CFR 700)

13b. RATING

14. METHOD OF SOLICITATION

RFQ IFB RFP

15. DELIVER TO CODE 16. ADMINISTERED BY CODE

17a. CONTRACTOR/OFFEROR CODE FACILITY CODE 18a. PAYMENT WILL BE MADE BY CODE

TELEPHONE NO. UEI: EFT:

PHONE: FAX:

17b. CHECK IF REMITTANCE IS DIFFERENT AND PUT SUCH ADDRESS IN OFFER

18b. SUBMIT INVOICES TO ADDRESS SHOWN IN BLOCK 18a UNLESS BLOCK BELOW IS CHECKED

SEE ADDENDUM

19. 20. 21. 22. 23. 24.

ITEM NO. SCHEDULE OF SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

(Use Reverse and/or Attach Additional Sheets as Necessary)

25. ACCOUNTING AND APPROPRIATION DATA 26. TOTAL AWARD AMOUNT (For Govt. Use Only)

27a. SOLICITATION INCORPORATES BY REFERENCE FAR 52.212-1, 52.212-4. FAR 52.212-3 AND 52.212-5 ARE ATTACHED. ADDENDA ARE ARE NOT ATTACHED.

27b. CONTRACT/PURCHASE ORDER INCORPORATES BY REFERENCE FAR 52.212-4. FAR 52.212-5 IS ATTACHED. ADDENDA ARE ARE NOT ATTACHED

28. CONTRACTOR IS REQUIRED TO SIGN THIS DOCUMENT AND RETURN _______________ 29. AWARD OF CONTRACT: REF. ___________________________________ OFFER COPIES TO ISSUING OFFICE. CONTRACTOR AGREES TO FURNISH AND DATED ________________________________. YOUR OFFER ON SOLICITATION DELIVER ALL ITEMS SET FORTH OR OTHERWISE IDENTIFIED ABOVE AND ON ANY (BLOCK 5), INCLUDING ANY ADDITIONS OR CHANGES WHICH ARE ADDITIONAL SHEETS SUBJECT TO THE TERMS AND CONDITIONS SPECIFIED SET FORTH HEREIN IS ACCEPTED AS TO ITEMS:

30a. SIGNATURE OF OFFEROR/CONTRACTOR 31a. UNITED STATES OF AMERICA (SIGNATURE OF CONTRACTING OFFICER)

30b. NAME AND TITLE OF SIGNER (TYPE OR PRINT) 30c. DATE SIGNED 31b. NAME OF CONTRACTING OFFICER (TYPE OR PRINT) 31c. DATE SIGNED

AUTHORIZED FOR LOCAL REPRODUCTION (REV. NOV 2021)

PREVIOUS EDITION IS NOT USABLE Prescribed by GSA - FAR (48 CFR) 53.212

7. FOR SOLICITATION

INFORMATION CALL:

STANDARD FORM 1449

SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30

36C24125R0116

Melanie Stockman 480-466-7938

16:00 CST

Department of Veterans Affairs Network Contracting Office 1 (NCO 1) Contracting Officer (90C) 1 VA Center Augusta ME 04330

X

339112

1000 Employees

N/A

Department of Veteran Affairs VA Connecticut 950 Campbell Avenue

West Haven CT 06516

Network Contracting Office 1 (NCO 1) Contracting Officer (90C)

Financial Services Center http://www.fsc.va.gov/einvoice.asp See VAAR 852.232-72 Austin TX 78714-9971

See CONTINUATION Page

See CONTINUATION Page

Table of Contents

SECTION A

A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

Statement of Work (SOW) for Anesthesia Units

B.2 IT CONTRACT SECURITY

SECTION C - CONTRACT CLAUSES

C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL PRODUCTS

AND COMMERCIAL SERVICES (NOV 2023)

C.2 52.216-18 ORDERING (AUG 2020)

C.3 52.216-19 ORDER LIMITATIONS (OCT 1995)

C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995)

C.5 52.216-32 TASK-ORDER AND DELIVERY-ORDER OMBUDSMAN (SEP 2019) ... 38

C.6 52.232-19 AVAILABILITY OF FUNDS FOR THE NEXT FISCAL YEAR (APR

1984)

C.7 52.252-6 AUTHORIZED DEVIATIONS IN CLAUSES (NOV 2020)

C.8 SUPPLEMENTAL INSURANCE REQUIREMENTS

C.9 VAAR 852.211-76 LIQUIDATED DAMAGES - REIMBURSEMENT FOR DATA

BREACH COSTS (FEB 2023)

C.10 VAAR 852.219-76 VA NOTICE OF LIMITATIONS ON SUBCONTRACTING—

CERTIFICATE OF COMPLIANCE FOR SUPPLIES AND PRODUCTS (NOV 2022)

C.11 VAAR 852.222-71 COMPLIANCE WITH EXECUTIVE ORDER 13899

(DEVIATION)(APR 2025)

C.12 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS

(NOV 2018)

C.13 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT 2020) . 44

C.14 VAAR 852.247-73 PACKING FOR DOMESTIC SHIPMENT (OCT 2018)

C.15 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998)

C.16 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT

STATUTES OR EXECUTIVE ORDERS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (JAN 2025) (DEVIATION FEB 2025)

C.17 MANDATORY WRITTEN DISCLOSURES

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS

SECTION E - SOLICITATION PROVISIONS

E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (SEP 2023)

E.2 52.201-1 ACQUISITION 360: VOLUNTARY SURVEY (SEP 2023)

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN TELECOMMUNICATIONS

AND VIDEO SURVEILLANCE SERVICES OR EQUIPMENT (NOV 2021)

E.4 52.204-29 FEDERAL ACQUISITION SUPPLY CHAIN SECURITY ACT

ORDERS—REPRESENTATION AND DISCLOSURES (DEC 2023)

E.5 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018)

E.6 52.216-1 TYPE OF CONTRACT (APR 1984)

E.7 52.225-6 TRADE AGREEMENTS CERTIFICATE (FEB 2021)

E.8 52.233-2 SERVICE OF PROTEST (SEP 2006)

E.9 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018)

E.10 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE

(FEB 1998)

E.11 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (NOV 2021)

E.12 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2024) (DEVIATION

FEB 2025)

SECTION B - CONTINUATION OF SF 1449 BLOCKS

Request for Quote (RFQ) 36C24125R0116

B.1 CONTRACT ADMINISTRATION DATA

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

a. CONTRACTOR:

b. GOVERNMENT: Contracting Officer 36C241 Sarah Scott sarah.scott1@va.gov 267-581-6318

Department of Veterans Affairs Network Contracting Office 1 (NCO 1) Contracting Officer (90C)

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

[X] 52.232-33, Payment by Electronic Funds Transfer—System For Award Management, or

[] 52.232-36, Payment by Third Party

3. INVOICES: Invoices shall be submitted in arrears:

a. Quarterly []

b. Semi-Annually []

c. Other [X] Invoicing instructions will be included with delivery orders

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.

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

AMENDMENT NO DATE

mailto:sarah.scott1@va.gov

Description for solicitation# 36C24125R0116

This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in the Federal Acquisition Regulation (FAR) subpart 12.6, “Streamlined Procedures for Evaluation and Solicitation for Commercial Products and Commercial Services” as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Proposals are being requested, and a written solicitation document will not be issued.

The solicitation number 36C24125R0116 is issued as a “Request for Proposals” (RFP). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular 2025-05 (effective 08/07/2025).

This solicitation is unrestricted and the associated North American Industrial Classification System (NAICS) code for this procurement is 339112, with a small business size standard of 1,000 employees. The Product Service Code (PSC) is 6515.

The objective of this acquisition is to establish a multiple award IDIQ contract with Firm Fixed Price (FFP) orders for a period of ten years. (Period of performance will be a five-year base period with a five-year option period). The VA intends to award contracts capable of providing one or more of the equipment, services, and consumables specified in the RFP and Statement of Work (SOW). Contractors must identify the specific Anesthesia System requirements they intend to satisfy. The scope of work consists of providing Anesthesia Systems, Associated Maintenance Services, and Consumables to any VA site throughout the United States including Alaska, Hawaii and Puerto Rico that provides Anesthesia treatment to Veterans. The capability to furnish multiple systems is preferred but not required.

All interested companies shall submit proposals in accordance with instructions to offerors in Section E.1 of this solicitation by the time and date specified on the cover page of this solicitation.

Delivery shall be provided as agreed to in any resultant order placed as specified in the Statement of Work. Delivery shall be F.O.B. Destination.

The provisions at FAR 52.212-1, Instructions to Offerors-Commercial Products and and Commercial Services, FAR 52.212-2, Evaluation-Commercial Products and Commercial Services, and at FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services, apply to this acquisition and addenda are attached in SECTION E, as applicable.

Offerors shall include a completed copy of the provision at FAR 52.212-3, Offeror Representations and Certifications-Commercial Products and Commercial Services with their offer.

The clauses at FAR 52.212-4-Contract Terms and Conditions-Commercial Products and Commercial Services, and at FAR 52.212-5-Contract Terms and Conditions Required to Implement Statutes or Executive Orders-Commercial Products and Commercial Services, apply to this acquisition and addenda are attached in SECTION C, as applicable.

Interested companies may submit questions pertaining to the solicitation via email only to melanie.stockman@va.gov and sarah.scott1@va.gov by 10AM CST on ___________________. All questions will be answered and posted via an amendment.

B.2 Statement of Work (SOW) for Anesthesia Units

1.0 SCOPE

This statement of work ("SOW") details the Government's requirement relative to the purchase, delivery, installation, maintenance, and testing of Anesthesia Units. This requirement includes the purchase of required anesthesia units, accessories, installation, training, consumables, and supplementary maintenance service agreements. Each Anesthesia System shall come with a minimum 12-month manufacturer's warranty and shall be FDA approved.

2.0 BACKGROUND

The VA is responsible for providing high-quality and timely medical and surgical procedures to our Veterans and their families. Providing the best possible medical equipment and associated service support is the goal of the Veterans Health Administration ("VHA"). The anesthesia units/equipment being procured by the VA is localized regarding facility requirements across VHA. This procurement is to seek efficiencies and consistency in overall life-cycle costs across all Veterans Affairs Medical Centers (VAMCs).

The Veterans Health Administration (VHA) surgeons seek to and provide our Veterans advanced surgical techniques that are comparable to state-of the-art commercial surgical and anesthetic solutions in the private sector.

3.0 APPLICABLE DOCUMENTS

In the performance of the tasks associated with this Statement of Work (SOW), the Contractor shall comply with the following directives and handbooks:

a. VA Directive 6500 Information Security Program

b. VA Directive 0710 Personnel Suitability and Security Program.

c. VA Directive 6550 Pre-Procurement Assessment for Medical Devices

d. VHA DIRECTIVE 1080.01(1) “Data Use Agreements”

e. 36 C.F.R. Part 1194 "Electronic and Information Technology Accessibility Standards," July 1, 2003

4.0 REQUIREMENTS

mailto:melanie.stockman@va.gov mailto:sarah.scott1@va.gov

The Contractor, their personnel, and any subcontractors shall be subject to the Federal laws, regulations, standards, and VA Directives and Handbooks regarding information and information system security as delineated in this contract.

The Contractor shall deliver, install, and test Anesthesia Units and all related equipment, accessories, consumables, training and warranty to the VAMC locations in the quantities, locations and configurations as specified in the individual Delivery/Task Order locations. Locations include Continental United States (CONUS) or Outside Continental United States (OCONUS). In addition, the Contractor shall provide the associated accessories, training and maintenance services as specified in individual Delivery/Task Order(s) for anesthesia units that are currently installed at VAMCs. Contractor shall provide services, instruments, and accessories under the terms of this contract for Systems previously procured (if applicable) to ensure the continuity of care.

Anesthesia Units are devices that continuously or intermittently administer a mixture of gases (oxygen, nitrous oxide, and the vapor of a volatile liquid such as halogenated hydrocarbon), varying the proportion of gases in order to control the patient's level of consciousness. These devices are also designed to facilitate spontaneous, controlled, or assisted ventilation with these gas mixtures. An anesthesia system is typically comprised of four basic subsystems: a gas supply and control circuit, a breathing and ventilation circuit, a scavenging system, and a set of system function and breathing circuit monitors (e.g., inspired oxygen concentration, breathing circuit integrity). Also included in some anesthesia systems are a number of monitors and alarms that indicate levels and variations of several physiologic variables and parameters associated with cardiopulmonary function and/or gas and agent concentrations in breathed-gas mixtures. Some anesthesia machines are designed specifically for use in magnetic resonance imaging (MRI).

5.0 SYSTEM COMPONENTS AND ACCESSORIES

High‐performance Anesthesia Systems are distinguished largely by their ability to serve a wide range of patients and to operate with little or no supplemental equipment. Features that make this possible include ventilator modes and tidal volume ranges suitable for neonates and adults, as well as integrated gas and sometimes physiologic monitoring capabilities. The Contractor shall deliver Anesthesia Systems, system related documentation and any accessories, training or maintenance services to the delivery points specified in the specific associated Delivery/Task Orders.

Minimum safety features are essential for all anesthesia systems. Among these features are O2 fail‐safe and hypoxic mixture fail‐safe systems, gas cylinder yokes for O2 tanks if central supplies fail, and an internal battery (for units with automatic ventilators) capable of powering the unit for at least 30 minutes.

All anesthesia systems must be able to measure O2 concentrations, airway pressures, and lung volumes. Continuous monitoring of End‐tidal CO2 (ETCO2) levels on all intubated patients is required. This can be accomplished via an integrated ETCO2 monitor in the anesthesia system or with a separate, standalone monitoring device (e.g., capnograph, multi-gas monitor).

6.0 SYSTEM DOCUMENT AND SITE SURVEY

Upon receipt of a Delivery/Task Order, the Contractor shall provide to the Contracting Officer's Representative (COR) designated in the Delivery/Task Order a pre-installation checklist with technical and clinical specifications that include installation requirements (e.g., power, space and floor plan and facility requirements), System specifications and requirements, and data pertinent to the installation, operation, and use of the System.

Within 30 days of receipt of a Delivery/Task Order the Contractor shall provide a field site survey for each site to the VA designated representative as designated in the Delivery/Task Order. This documentation shall include the installation test plan and procedures that the Contractor shall follow to conduct an initial pre-acceptance test.

The Contractor shall document and deliver all necessary information, including any and all manuals to operate and maintain the System by the end users including on-site handling as well as service call events and indications. The documentation shall include all procedures for the handling and sterilization of the System to be performed by the end users as well as procedures for the use of the System.

The Contractor shall provide manuals for operation of the System (two per System) as applicable to the System and its components. Digital documentation is acceptable. The Contractor shall provide all documentation to the VA designated representative prior to the delivery of each System.

7.0 FDA REQUIREMENT

The Anesthesia System shall be compliant with the FDA requirement to market and deliver medical products for use in the United States. Any System must be approved for use in the United States by the FDA's Center for Devices and Radiological Health (CDRH), the federal agency responsible for regulating firms who manufacture, repackage, re-label, and/or import medical devices sold in the United States. According to 21 Code of Federal Regulations (CFR) Part 807 Subpart E, a manufacturer cannot commercially distribute medical devices in the United States until the FDA authorizes them to do so. The contractor shall provide proof that all Systems, instruments, and accessories delivered under this contract have FDA clearance.

8.0 REMOTE MONITORING, VA NETWORK CONNECTIVITY, AND CLOUD

USAGE

Systems with remote monitoring capability shall meet the following requirements to connect to the VA network and transmit patient and device data to a cloud for remote monitoring. The contractor shall be responsible for all costs associated with meeting the following requirements.

- Shall meet VA Information and Information System Security and Privacy Requirements

- Shall be capable of bi-directional communication with VA’s electronic health care record systems and anesthesia recordkeeping software

- Shall meet Digital Imaging and Communications in Medicine (DICOM) Conformance Standards requirements and validated via VistA Imaging (as applicable)

- The Contractor shall not release any data without the consent of VA in writing. All requests for release must be submitted in writing to the Contracting Officer’s Representative (COR) and/or Contracting Officer (CO)

- The contractor shall work with VA Healthcare Technology Management (HTM)/Biomedical Engineering to provide the following documents/material in compliance with the VA Enterprise Risk Assessment (ERA) (cybersecurity risk assessment) process (as applicable)

- 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) within 30 days of contract approval and on a yearly basis and provide it to the COTR in accordance with all requirements outlined in Appendix B in VA HANDBOOK 6500.6

a. VA Form 6550 Appendix A

b. Manufacturer Disclosure Statement for Medical Device Security (MDS2)

c. Ports, Protocols, and Services (PPS)

d. Software/Device Inventory

e. Data Flow Topological Diagram

9.0 PERFORMANCE DETAILS

It is anticipated that the solicitation shall result in a Firm Fixed Price (FFP) FAR Part 15 single-award IDIQ per original equipment manufacturer (OEM). This requirement includes the purchase of required anesthesia units, accessories, installation, training, consumables, and supplementary maintenance service agreements and are considered commercial off-the-shelf (COTS). The anticipated procurement will be awarded to a manufacturer or an authorized distributor for Anesthesia Systems. Any authorized distributor must provide an authorized distribution letter (ADL) on OEM letterhead. Each VAMC will utilize this contract vehicle for the purchase of the Anesthesia System with warranties and any instruments, accessories, training, and maintenance services for that vendor. Ordering Officers ("OO") shall be appointed for the purpose of procuring supply items and other deliverables. All OOs shall be registered in eCERT and shall follow the policies as established in eCERT and follow-on guidance for OOs. Contingent upon Onsite connectivity, the Contractor shall supply up-to-date statistics and other detailed information relative to each VAMC's system inventory, consumable and attachment usage, and surgical procedures performed so the VA can utilize this information to maximize and optimize its Return on Investment ("ROI"). The CLIN structure breaks down all supply items which can be purchased via this contract.

9.1 PERFORMANCE PERIOD

The ordering period for the subject Anesthesia Systems awards shall be one five-year base year period with one five-year option year period.

Upon acceptance of each individual System order, the Contractor shall provide the warranty as described in Section 8.0, on-site clinical support as described in Section 5.1, and off- site training services as described in Section 5.2 during the warranty period. All deliveries shall be made within 60 days of award of the Delivery/Task Order unless otherwise specified.

Expedited shipping and delivery of units may be requested; charges for expedited Shipping will be indicated using a separate CLIN.

9.2 HOURS OF OPERATION

Normal hours of operation at VA are Monday through Friday, 7:00 AM to 4:30 PM excluding Federal Holidays. All services shall be performed during normal hours of operation.

9.3 FEDERAL HOLIDAYS

Any scheduled work at the Government site shall not take place on Federal holidays or weekends unless directed by the Contracting Officer (CO). VA follows all Federal holidays that are set by law (USC Title 5 Section 6103).

9.4 PLACE OF PERFORMANCE

The Contractor shall deliver the specified Anesthesia System(s), accessories, and services to VAMCs identified in each Delivery/Task Order. Such locations may include both CONUS and OCONUS VAMC locations.

10.0 TRAVEL

The Government will not pay for any Contractor travel under this requirement.

Any VA personnel requiring off-site training will follow local applicable travel policies.

11.0 TRAINING

11.1 On-site (VA Medical Center site) Clinical and Support Staff Training

If specified in the applicable Delivery/Task Order, the Contractor shall provide clinical training onsite and shall be responsible for training and staff education for all clinical users on their application and use.

Education curriculum must include, but is not limited to the following:

a. Operations and set‐up

b. User maintenance

c. Safety

d. User troubleshooting

e. Negotiating and understanding machine profiles to better serve the patient and staff

Biomedical Engineering Training/Test Equipment Requirements: The Offeror shall offer the training of in-house service biomedical engineering technicians.

This training shall be equal to the training provided by the manufacturer for their service personnel and will train the designated in-house personnel on the calibration, maintenance, and repair of the entire system purchased. This training will occur at the location of the Offeror’s training facility and shall include associated travel and lodging expenses. This training shall be provided prior to expiration of the warranty period.

a. The Offeror shall include all necessary biomedical testing and preventative maintenance equipment necessary for the system.

b. Training should, at a minimum, address the following topics:

i. Theory of Operation

ii. Use of schematics and circuit diagrams

iii. Use of Technical Service Mode

iv. Commissioning and Preventative Maintenance

v. Calibration procedures

vi. Troubleshooting

vii. Interpreting and correcting alarm conditions

viii. Spare parts

12.0 DELIVERY AND ACCEPTANCE

12.1 Delivery

Upon the Contractor's receipt of a Delivery/Task Order from a VAMC, the Contractor and the VA-designated representative from the ordering VAMC will coordinate the delivery and installation date. To avoid delays or wasted effort, the subject VAMC and Contractor shall mutually determine a date certain for delivery and shall memorialize those logistical and planning events to avoid wasted trips or System delays.

12.2 Special Delivery Instructions

Prior to shipping, the Contractor shall notify the local Point of Contact (POC) by phone, followed by e-mail of all incoming deliveries, including line-by-line details of all Contract Line-Item Numbers (CLINs) being shipped. The Contractor must coordinate deliveries with Site POCs cited on the Delivery/Task Order before shipment of any equipment and accessories to ensure sites have adequate storage space. All shipments, either single or multiple container deliveries, will bear the VA Purchase Order (PO) number on external shipping labels and associated manifests or packing lists. In the case of multiple container deliveries, a statement readable near the VA PO number will indicate a total number of containers for the complete shipment (ex. Package of 2") clearly readable on manifests and external shipping labels.

Shipping terms is FOB Destination. Any Order received by the Contractor from the Government that does not have the FOB specified or is incorrectly designated as FOB Origin is deemed superseded, as stated herein. Freight fees are included in the pricing of systems; title transfers to the Government when the Government has provided Acceptance to the Contractor.

12.3 Testing and Certification

Upon completing delivery and installation, the Contractor shall pre-test the entire System to verify that the System meets the manufacturer's technical specifications and performance capabilities as set forth in the operator manuals, and passes all internal diagnostics tests and VA requirements as set forth in this SOW. After successful pre testing, the Contractor shall notify the VA designated representative, the Biomedical representative at the delivery site, in writing that the System meets all requirements, passed the pre-test and that the System is ready for Government testing and final acceptance by VA. Submission of this notification of System readiness shall be accomplished by the Contractor prior to beginning the Government acceptance test. This shall be accomplished pre delivery in the event that installation is not required.

12.4 Government Acceptance Testing

In the presence of the VA designated representative, the site Biomedical representative, and designated VA site medical professionals, the Contractor shall test each System using established procedures to ensure that the System meets all System specifications and conforms to System documentation and passes all internal diagnostics testing to fully prove System performance and meets VA requirements as set forth in this SOW. The Contractor shall provide final acceptance test results and a summary signature page indicating completion by the Contractor. The Contractor shall provide Contractor's Standard Form (Acceptance Letter) to the VA designated representative for approval. The written approval by the VA designated representative will indicate Government acceptance of the System and the beginning of the warranty period for that System. In the event the System does not pass the Government acceptance testing, the Contractor shall return the Anesthesia System delivered and deliver a new system at no additional cost to the Government. Testing will then be performed on the new system delivered. Payments to the Contractor will be made based on final written acceptance of each System by the VA designated representative.

13.0 SOFTWARE LICENSES AND RESTRICTIONS

The Contractor grants to VA non-exclusive, non-transferrable licenses to use Anesthesia Systems and all associated accessories and software, including any documentation, for Systems intended purposes.

14.0 SYSTEM WARRANTY

The Contractor shall provide a warranty that includes product support for the delivered Anesthesia System to ensure the System is operating at optimum performance levels and in conformance with product documentation, specifications and demonstrated claims, and is free from all defects. The warranty shall include support, all parts, labor, and travel as well as all software updates and upgrades at no additional cost to the VA for the duration of the warranty period. The Contractor shall provide a warranty on all repairs and service and certify that the System is fully operational after such repair or service. The VA designated representative is the Contractor's reporting and contact official for all service calls. The Contractor shall contact the designated VA designated representative at the facility to schedule service Anesthesia Systems. At completion of any service or repair, the Contractor shall provide all documentation for System configuration and updates as well as all service reports to the VA designated representative and Biomedical Engineer.

14.1 System Service and Maintenance

Post Warranty Maintenance: For maintenance service after the warranty period, the Contractor shall provide service agreement CLINS addressing, at minimum, the following items:

i. Guaranteed period of availability of replacement parts

ii. Delivery time for replacement parts upon receipt of order

iii. Normal service hours for field service

iv. Qualified service personnel should be available to respond onsite to issues within (2-4) hours from notification to the site.

a. Periodic software maintenance updates to the original software investment;

b. Installation and configuration for the software maintenance updates;

c. Software diagnostics and troubleshooting

d. Updates to any documentation such as operation and maintenance manuals;

e. Preventive maintenance service and inspections in accordance with the manufacturer's specifications

f. Test/adjust/calibrate parts on the Anesthesia System as required;

g. Replace defective or malfunctioning parts

h. Repair operational malfunctions

i. Replace and install software, hardware, and mechanical equipment for safety and reliability

j. Perform System preventative maintenance inspections as necessary to maintain factory specifications.

14.2 Software Updates

During the warranty period, the Contractor shall provide and install any and all software updates that become available for the device.

The Contractor shall coordinate the installation of any software upgrades with the VA designated representative and Biomedical engineer. The VA designated representative and Biomedical engineer will notify and include the Information Security Officer (ISO) as required.

14.3 Response

The Contractor shall maintain the Systems in accordance with the warranty and service requirements as set forth in 8.0, 8.1 and 8.2 of this SOW. Response time for repair services during both the Warranty and Maintenance periods is as set forth herein. The Contractor shall provide telephone operational and technical support (Customer Service Department) twenty-four (24) hours per day, seven (7) days per week (24/7). The Customer Service Department assistance shall be via a toll-free service and shall be operated by service personnel who are qualified to operate, maintain, troubleshoot, and repair the Anesthesia System. The Contractor shall respond within two (2) hours for emergency service requests via notification to the Customer Service Department to be provided to each site VA designated representative. If the problem cannot be corrected by phone, or via remote access, the Contractor shall commence work with on site, physical response within 24 hours of receipt of the first notification or as approved by the VA designated representative. All required repairs shall commence without undue delay with the System corrected to include replacing malfunctioning parts and retesting the System within 48 hours. The vendor agrees and understands that before any connection to these devices using vendor-supplied equipment (laptop or USB drive devices), those devices must be scanned for malicious code or other malware by the Biomedical engineer or ISO.

15.0 PRODUCT MODIFICATION, REMOVAL OR RECALL

If any product awarded under this solicitation requires modification, is removed, or recalled by the Contractor or manufacturer, or if any required modification, removal, or recall is suggested or mandated by a regulatory or official agency, the following steps shall immediately be taken by the Contractor or manufacturer:

1) The Contractor shall notify the CO, in writing, in the most expeditious manner possible. The Contractor shall provide two copies of the notification which shall include, but not be limited to the following:

a. Complete item description and/or identification,

b. Order numbers from customers and the contract number assigned as a result of an award on this solicitation;

c. Reasons for modifications, removal, or recall; and

d. necessary instructions for return for credit, replacement, or corrective action.

The Contractor shall provide the above information to the VA-designated representative at all VAMCs and facilities that purchased the product. The Contractor shall provide the CO a copy of the notification and a list of all agencies and/or VA facilities notified.

A copy of the notification will be provided to:

Manager, Product Recall Office National Center for Patient Safety Veterans Health Administration 24 Frank Lloyd Wright Drive, Lobby M Ann Arbor, MI 48106

Contractor shall be responsible for all costs associated with the above.

16.0 COMPLIANCE WITH GENERAL SAFETY REGULATIONS

All Contractors performing services for the Government shall comply with all Occupational Safety and Health Administration (OSHA), State, County, and Municipal Safety and Occupational Health Standards and any other applicable rules and regulations. Also, all Contractors shall be held responsible for the safety of their employees and any unsafe acts or conditions that may cause injury or damage to any persons or property within and around the work site area under this contract.

17.0 ACCESS TO VA INFORMATION AND VA INFORMATION SYSTEMS

As necessary, the Contractor 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.

The contractor and associates working with VA information may be 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 Security and Suitability Program.

The Office for Operations, Security, and Preparedness is responsible for these policies and procedures.

In the event that VA denies facility access to any Contractor personnel because such personnel has not met the VA's Security Requirements, the Contractor shall provide a fully trained substitute. The Contractor employee access to VA facilities will be denied until such time as the individual meets VA Security Requirements.

The Contractor shall ensure that any individual performing work has successfully completed a formalized training program in providing the type of service(s) expected.

The Contractor agrees that none of its officers or employees shall use or reveal any research, statistical, medical, or security information obtained in the performance of the work required pursuant to this SOW without the written consent of the Contracting Officer.

The Contractor agrees that the appropriate Data Use Agreements (DUAs) in accordance with the Health Insurance Portability and Accountability Act (HIPAA) and with VHA privacy policy as outlined in VHA DIRECTIVE 1080.01(1).

The Contractor shall be professional at all times and shall take all necessary precautions to maintain a safe environment for the occupants. The Contractor shall minimize noise to the fullest extent possible while working in all buildings.

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.

18.0 CONFORMANCE STANDARDS

All work shall be performed, and equipment shall function in conformance with all VA safety standards, manufacturer's/industry standards, the latest published edition of NFPA-99, FDA, U.L., and other applicable state, local, national, and industry standards. Equipment shall meet EMC (Electromagnetic Compatibility) for IEC 60601-1-2 CE, CSA, and ETL Approved to U.L. 2601-1, second edition.

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.

Within 10 working days' 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.

19.0 CONTRACT SECURITY

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 the 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. 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.

Security Incident Investigation

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 VA designated representative 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.

Training

All Contractor employees and subcontractor employees requiring access to VA information and VA information systems shall complete the following before being granted access to VA information and its systems:

Sign and acknowledge (either manually or electronically) understanding of and responsibilities for compliance with the Contractor Rules of Behavior, Attachment A, relating to access to VA information and information systems

Successfully complete the VA Cyber Security Awareness and Rules of Behavior training and annually complete required security training

Successfully complete the appropriate VA privacy training and annually complete required privacy training; and

Successfully complete any additional cyber security or privacy training, as required for VA personnel with equivalent information system access to be defined by the VA program official and provided to the contracting officer for inclusion in the solicitation document.

The Contractor shall provide to the contracting officer and/or the VA designated representative 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.

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.

20.0 QUARTERLY REPORTING

The Contractor shall accurately report the dollar value, in U.S. dollars and rounded to the nearest whole dollar, of all sales under this contract by fiscal quarter (October 1- December 31, January 1-March 31, April 1-June 30, and July 1-September 30). The dollar value of a sale is the price paid by the Delivery/Task Order user for supplies/services on a Delivery/Task Order. The Contractor shall maintain a consistent accounting method of sales reporting, based on the Contractor's established commercial accounting practice.

All Delivery/Task Orders issued shall be reported to the Contracting Officer and Contracting Officer’s Representative within thirty (30) calendar days following the completion of each reporting quarter. The Contractor shall continue to furnish quarterly reports through physical completion of the last outstanding order of the contract.

The Contractor shall provide the quarterly dollar value of sales.

21.0 SYSTEM TRADE-IN

In the event the Government requests to trade in a previously purchased System as part of a purchase transaction for a new System, and the Contractor agrees to take such trade, the Contractor and Government will determine fair and reasonableness of the Trade-in Value prior to the issuance of the Task Order. The Contractor shall remove and dispose of any existing Anesthesia Systems identified in the Delivery/Task Order under the Contract Line-Item Number (CLIN) "Consideration for Trade-in."

The Government will trade in the Trade-in System to the vendor and receive the agreed Trade in Credit which will be applied toward the System price of System purchased under the applicable Order. Title to the Trade-In System passes to Contractor on Acceptance of the System purchased under the applicable Order. Within thirty (30) days after Acceptance, the Government will provide access to the Trade-in System at the Government's site to enable Contractor to disconnect and remove the Trade-in System. The Government is, and remains, responsible for costs related to the loss or damage to the Trade-In System until it is removed by Contractor from the Government's site. The Contracting Officer must approve all Trade-ins unless trade-in values are pre-priced.

22.0 DEFINITIONS/ACRONYMS

Acceptance Signature

VA employee who is authorized to sign-off on the ESR which indicates that the PM has been concluded or is still pending completion, or that the Emergency Repair has been accomplished or is still in a pending status.

AHIMA American Health Information Management Association

CDRH Center for Devices and Radiological Health

CFR Code of Federal Regulations CO Contracting Officer

COR Contracting Officer's Representative

EMC Electromagnetic Compatibility ESR (Vendor) Engineering Service

Report Documentation of the services rendered for each incidence of work performance under the terms and conditions of this contract

ETL Originally a mark of ETL Testing Laboratories, now a mark of Intertek Testing Services

FAR Federal Acquisition Regulation FDA US Food and Drug Administration FSE Field Service Engineer - A person who is authorized, certified, and trained by the Contractor to perform maintenance (corrective and/or preventive) services on the VA premises

HIPPA Health Insurance Portability and Accountability Act

ISO Information Security Officer OAO Office of Acquisition Operations OSHA Occupational Safety and Health

Administration PHI Public Health Information SOW Statement of Work UL Underwriters Laboratory USC United States Code VA Department of Veterans Affairs

B.3 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…