36H79725R0002 DRAFT Solicitation.docx

36H79725R0002

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

36H79725R0002

Marissa Wright 708-786-5933

12:00PM

CT

36H797 Department of Veterans Affairs OPAL/ National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines IL 60141

X

334517 1200 Employees

N/A

As indicated on individual delivery orders against this contract.

36H797 Department of Veterans Affairs OPAL/ National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines IL 60141

36H797 Department of Veterans Affairs

CHIEF, FISCAL DIVISION (901A)

HINES SERVICE AND DISTRIBUTION CENTER

PO BOX 7005

HINES IL 60141-7005

FSC Group 6525- Radiation Therapy Systems, Upgrades, and Accessories to include Linear Accelerators, Simulators Therapy Information Systems, After Loading Systems, Water Phantoms, and Installation.

$0.00

See SF 1449 CONTINUATION Page

Table of Contents

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

The Department of Veterans Affairs National Acquisition Center (VA NAC) Radiation Therapy Equipment Program and the Defense Logistics Agency (DLA) Troop Support Solicitation.

This is a Draft RFP for contractor response and input only. The Government will not award a contract in response to the DRAFT RFP.

The Draft RFP is not an authorization to begin performance and in no way obligates the Government for any costs incurred by the contractor for this requirement. The Government will not award a contract in response to the subject DRAFT RFP.

Potential Offerors are requested to respond to the DRAFT solicitation by December 20, 2024, 12 PM Central Time (CT). Offerors should use Attachment # 9 – DRAFT Solicitation Question Matrix to provide any feedback, questions, comments, or concerns. Please submit to Marissa Wright @ marissa.wright@va.gov. After receiving feedback, if deemed appropriate, the Government will update the Solicitation and supporting documents before releasing the official solicitation 36H79725R0002.

STATEMENT OF WORK

I. RADIATION THERAPY SYSTEMS PROGRAM OVERVIEW

The Department of Veterans Affairs, National Acquisition Center (VA NAC) is responsible for the acquisition and management of radiation therapy equipment systems, subsystems, and components along with maintenance services, training, and incidental services related to the supply of the equipment for customers located in the United States and worldwide. The VA NAC Radiation Therapy Equipment Program was established to support the requirements of both VA and the Defense Logistics Agency (DLA).

II. GENERAL REQUIREMENTS

This solicitation provides for the supply of Radiation Therapy equipment systems; including but not limited to - linear accelerators (LINAC), simulator systems, record and verify systems, treatment planning systems, orthovoltage systems, stereotactic radiosurgery systems, high dose rate (HDR) brachytherapy systems, scanning water bath phantoms gamma knife, cyberknife, upgrades and accessories, equipment installation, service/maintenance, training, and incidental services related to the purchase of the equipment.

Incidental services are standard commercial services that the contractor may be asked to perform in connection with supplying a fully functional/ operational system under the scope of the contract. What constitutes an incidental service is fact specific and will be a function of factors such as type of service, existence of a close relationship between the service and the item supplied, and the time required to perform the service. This determination will be made at the ordering level.

III. CONTRACT ADMINISTRATION

The Department of Veterans Affairs National Acquisition Center (VA NAC) is the only organization authorized to administer contracts awarded against this solicitation. After contract award, only the Contracting Officer can authorize any action at the IDIQ contract level, including basic contract modifications.

IV. AUTHORITY TO ISSUE ORDERS

(a.) VA NAC and DLA are the only activities authorized to place delivery orders under this IDIQ contract except as otherwise delegated in writing by the VA NAC. Any delegation may be rescinded unilaterally at any time through written notice to vendors. Both the VA NAC and DLA will issue orders directly against any IDIQ contract under the program. The agency which issues a delivery order will be responsible for all administration functions for the given delivery order.

(b.) Orders may be issued in support of requirements from the Department of Defense (DoD), VA, other Federal Agencies/Organizations, and foreign governments through the DoD foreign military sales programs.

(c.) Individual procuring activities of the VA are hereby delegated authority to place delivery orders for their respective facility, for equipment valued at $50,000 or less under this contract. Also, individual procuring activities of the VA are hereby delegated authority to place task orders for their respective facility, for required maintenance services at any value under this contract. Individual VA procuring activities will obtain pricing and maintenance information for a specific contract holder from the VA NAC at National Contract Service - Home (sharepoint.com). The delegation may be rescinded unilaterally by the VA NAC at any time through written notice to vendors.

V. DELIVERY REQUIREMENTS

(a.) Order delivery locations are located in both the contiguous United States (CONUS), which includes the 48 contiguous States and the District of Columbia as well as areas outside of the contiguous United States (OCONUS).

(b.) Vendors shall support all CONUS locations. Contract pricing should be provided on a F.O.B. Destination basis for all CONUS locations.

(c.) Vendors shall support Alaska, Hawaii, and U.S. Territories. Contract pricing should be provided on a F.O.B. Destination basis for Alaska, Hawaii, and U.S. Territories. Different F.O.B. Destination pricing other than offered for CONUS locations may be offered for Alaska, Hawaii, and/or U.S. Territories if it is consistent with commercial practice and can be determined as fair and reasonable by the Contracting Officer. Delivery dates will be agreed on between the facility and ordering CO at the ordering level. Acceptable price support information shall be provided by the vendor to substantiate different pricing than for CONUS deliveries.

(d.) Delivery dates will be agreed on between the facility and ordering CO at the ordering level.

(e.) Some orders may require delivery to OCONUS locations outside of Alaska, Hawaii, and U.S. Territories. For OCONUS locations outside of Alaska, Hawaii, and U.S. Territories; F.O.B. Destination pricing shall be established prior to order issuance to factor any additional shipping charges.

(f.) The Government reserves the right to issue orders on a F.O.B. Origin basis.

VI. DELIVERY ORDER PLACEMENT PROCEDURES

This solicitation will result in Multiple Award, Indefinite-Delivery/Indefinite-Quantity (IDIQ) contracts pursuant to FAR 16.505(b)(1). All contractors offering the required supplies will be considered for each order. The vendor completed Modality Matrix, Attachment #6, will be used to determine which contractors offer the required supplies and should be considered for an order. The Government will place delivery orders with the contract awardees representing the best value to the Government for that specific ordering requirement in accordance with FAR 16.505(b)(1). Each awardee shall be provided a fair opportunity to be considered for each delivery order in excess of the Micro-Purchase Threshold unless a statutory exception to the fair opportunity process applies as outlined in FAR 16.505(b)(2) - Exceptions to the fair opportunity process.

The evaluation criteria for order selection will be tailored to each requirement. Pricing will always be a factor in order selection.

Agency specific policies and regulations will be applied at the delivery order level by the issuing agency. VA requirements will be subject to VA policies and regulations while DoD requirements will be subject to DLA and DoD policies and regulations.

VII. CONTRACT LIMITATIONS

(a.) Maximum Contract Value A contract maximum shall be established by the Government for each individual contract through analysis of available information that may include analysis of previous sales, commercial sales, or other methods. This single maximum contract value shall apply for life of the contract, including the base year and all option years, if exercised.

(b.) Guaranteed Minimum.

The minimum quantity of supplies that the Government agrees to order during the period of this contract is $4,000. If, at the conclusion of the contract period (10 -year period of performance), the contractor has received orders for less than $4,000, the Government will pay (upon request) the difference between the amount ordered and the $4,000.

(a) Request for payment of any amount due under this section shall be submitted in writing to the Contracting Officer within 30 days after the end of the contract period.

(b) The guaranteed minimum does not apply if the contract is terminated for cause.

VIII. CONTRACT BASE AND OPTION PERIODS

All contracts shall have a two-year base period and four, two-year option periods or one 5-year base and one 5-year option period.

IX. GOVERNMENT INSPECTION, ACCEPTANCE, AND PAYMENT TERMS AND CONDITIONS

(1.) Inspection and Testing The Government shall have the right to inspect and test the equipment within thirty (30) calendar days after receipt of the notice of readiness for inspection (the 30-day period) or thereafter during the warranty period if the Government fails to inspect and test during this “30-day period”. The contractor shall provide the necessary technical and applications personnel to perform the inspection (and any re-inspections).

The Government shall provide notice of acceptance of the equipment or of unsatisfactory inspection/test results to the contractor within 30 calendar days after the date of inspection. The latter notice shall identify to the contractor any deficiencies found during the inspection and whether the deficiencies were significant or not, and will provide the contractor fourteen (14) calendar days to correct such deficiencies. A significant deficiency means any defect or combination of defects that may impede the function of the equipment. Defect means a failure to provide products and/or services in conformance with the Government’s requirement (e.g., technical specifications or SOW).

Non-conforming equipment or services may be conditionally accepted at the sole discretion of the Government. Conditional acceptance means acceptance of supplies or services that do not conform to contract quality requirements, or are otherwise incomplete, that the contractor is required to correct or otherwise complete by a specified date. Contractors shall correct all reported deficiencies at no additional cost to the Government and notify the Contracting Officer when all corrections have been made and the equipment is ready for re-inspection. Re-inspection(s) will be performed by the Government with all costs incurred chargeable to the contractor’s account.

(2.) Final Acceptance Procedures Upon completion of installation and after contractor makes available to the using activity any training (e.g., initial applications and operator training) required by the manufacturer to properly use the equipment, the equipment shall be turned over to the facility for clinical use and the contractor shall furnish a written notice of readiness for inspection to the following Government personnel:

For VA Issued Orders:

NAC, VHA HTM/Biomedical Engineering, VHA Logistics, VA Ordering Facility POC.

For DLA Troop Support Issued Orders:

DLA Troop Support Biomedical Engineer, Service Logistics Agency, Customer, and using WAWF system (see DLA Invoicing Instructions)

Clinical use will be presumed to begin on the day after the notice of readiness for inspection is received by the Government. The using activity must notify the Contracting Officer, contractor, Service Logistics Agency (DLA issued DoD orders), DLA Troop Support Biomedical Engineer (All DLA issued orders) and VHA HTM/Biomedical Engineering (ALL NAC issued orders) if clinical use is not initiated at this time.

Submission of the notice of readiness for inspection, and any other notice required by this section by electronic mail is acceptable, provided that the party giving such notice obtains and preserves electronic evidence of receipt at the email address or addresses of the party or parties who have a right to notice. The Government shall provide appropriate email addresses on the purchasing documentation.

(3.) Warranty Effective Date Any applicable warranty period will commence on the date the notice of readiness for inspection was submitted; if deficiencies are found during the inspection that require the vendor to re-inspect, the warranty period will begin on the day the vendor submits for re-inspect. For systems failing the initial acceptance inspection and accepted after a Government re-inspection (s), the warranty period will commence on the date the notice of readiness for the successful re-inspection was submitted. If the Government determines only minor (i.e., non-significant) deficiencies are found during inspection and clinical use continues, the warranty date will commence on the date the notice of readiness for inspection was submitted.

(4.) Clinical Use Clinical use means the installed equipment as determined by the Government performs the basic intended clinical function of the system in a safe manner for the purpose for which it was designed, with most or all system functionality, allowing the equipment to be used clinically. Clinical use does not include initial patient examinations or procedures during applications training.

If the equipment is put into clinical use by the Government for thirty (30) calendar days after the inspection request, acceptance will occur thereafter as described below. However, if significant deficiencies in the equipment are identified during the 30-day period while it is in clinical use and clinical use ceases, the procedures under this section will be followed.

For systems in clinical use for thirty (30) calendar days without significant deficiencies being identified during inspection (if inspection occurs), the contractor will notify the Government that the system has been in clinical use for this time period, and request acceptance and payment. The Government will confirm with the customer whether or not clinical use has occurred for thirty (30) calendar days, and, upon positive confirmation, the Government will issue a notice of acceptance and authorize an appropriate payment document (WAWF for DoD; inspection report or receiving report for VA) within 30 calendar days after receiving the request. In the event that the Government is notified by the customer that clinical use has not occurred for thirty (30) calendar days, the Government shall so notify the contractor within 30 calendar days after receiving the request for acceptance and payment. Within this notice, the Government will provide rationale for why the equipment was not used.

The failure of the Government to notify the contractor of its intent to dispute clinical use within 30 calendar days after receiving the request for acceptance and payment shall constitute acceptance on the part of the Government. Acceptance under this paragraph shall not preclude the Government from exercising its rights later under any remedy available to the Government by federal law or regulation. In the event the Government has not conducted an inspection of the equipment within thirty (30) calendar days of the date of the notice of readiness for inspection, during the period of clinical use, the Government shall have the right to inspect the equipment during the warranty period. Deficiencies discovered during the inspection shall be presented to the contractor for correction as appropriate under the terms of the warranty.

(5.) No Clinical Use No clinical use means that delivered equipment does not perform the basic intended clinical function in a safe manner for the purpose for which it was designed and that most or all system functionality is not present, preventing the equipment from being used clinically during the 30-day period. If the equipment does not meet the criteria for clinical use, as defined in Section 4 of this section, the system will not be accepted without formal testing under Section 2, and final payment will not be issued until after the equipment satisfactorily completes formal testing.

(6.) Final Acceptance/Rejection Procedures In the event the equipment is not placed in clinical use within thirty (30) days, or is so placed and inspected and significant deficiencies are found, within seventy-five (75) calendar days after receipt of the notice of readiness for inspection, the Government shall:

(i.) accept the equipment; or (ii.) accept the equipment and request that identified defects be remedied under the contract’s warranty provisions; or (iii.) reject and request removal of the equipment.

If equipment is rejected, the contractor shall completely uninstall all equipment items and remove them within 10 calendar days (from Notice of Rejection) from the Government premises at the contractor’s expense.

(7.) Payment Terms

(a.) Prompt Payment terms apply in accordance with FAR 52.212-4(i). Commercial Interim payments are authorized, as appropriate, in accordance with FAR 32.2, Commercial Product and Commercial Service Purchase Financing.

(b.) Delivery Orders Requiring Installation:

a. Delivery orders for equipment/systems requiring extended installation or turnkey will allow a commercial interim payment of 80% of the total price of the equipment/system. The initial 80% interim payment will be authorized after a vendor delivers all the equipment and the receipt of the equipment is confirmed by the Contracting Officer (see specific VA and DLA receiving, acceptance, and payment requirements/procedures discussed above). Upon receipt and approval of the receiving report and the contractor's properly submitted invoice, the 80% interim payment will be processed. The 80% commercial interim payment will be under its own line item.

b. The remaining 20% of the total price of the equipment/system will be paid after extended installation or turnkey has been completed and final inspection and acceptance has occurred. The remaining 20% balance will be under its own line item separate of the commercial interim payment.

Note: VA ISSUED DELIVERY ORDERS:

Separately priced installation services shall be compensated following the completion of installation extended installation or turnkey will allow a commercial interim payment of 80% of the total price of the equipment/system. Accordingly, the remaining 20% of the equipment price and extended installation or turnkey costs shall be compensated after final inspection and acceptance.

(c.) Delivery Orders without Installation: Delivery orders issued for equipment/systems that do not require installation shall be issued with 100% of the total price of the equipment/system being paid after final inspection and acceptance has occurred.

(8.) Final Payment (a.) Payment Office and Invoicing Instructions for VA Orders Only:

The Contractor shall submit invoices through TUNGSTEN@http://www.tungsten-network.com/US/en/veterans-affairs/.

An invoice must include-

a. Name and address of the Contractor.

b. Invoice date and number, the PO order number (use the delivery order)

c. Contract number, line-item number, and a CLIN number

d. Description, quantity, unit of measure, unit price and extended price of the items delivered

e. Remit to address

f. Name and address of official to whom payment is to be sent

g. Vendor code, buyer/supplier TN number

h. Name, title, and phone number of person to notify in event of defective invoice

i. Supplier tax registration number, buyer tax registration number (b.) Payment Office and Invoicing Instructions for DLA Orders Only: Vendors shall use Wide Area Workflow (WAWF) for inspection, acceptance, and invoicing. The following procedures will apply for all delivery orders:

(1.) The vendor shall send an official e-mail Notification of Delivery and Readiness for Inspection Testing (after delivery for orders requiring installation) or Notification of Installation Completion and Readiness for Inspection Testing (after installation or for orders without installation) to e-mail addresses specified in each order and copying the DLA Troop Support Biomedical Engineer. The Government shall have 30 calendar days to complete the Inspection Testing from the date of the e-mail notification. The subject line of this e-mail shall be “Installation Completion – Readiness for Inspection Testing Notification” or “Notification of Delivery” if requesting an initial 80% delivery payment. This e-mail shall include the following as a minimum:

(i.) Complete contract number including delivery order number.

(ii.) Description of the equipment and/or CLINs to be inspected.

(iii.) The Installation Location (Hospital/Facility Name, Room # & Base/City/State).

(iv.) Contractor’s notification POC information: Name, title, telephone # and e-mail address.

(v.) Contractor’s Inspection POC: Name, title, telephone # and e-mail address.

(vi.) Statement requesting customer to:

Attach any applicable documentation such as Proof of Delivery or customer signoffs to e-mail and WAWF receiving report.

An automated WAWF receiving report submission notification is not sufficient for the above notification requirement.

(2.) Concurrently with sending of the official e-mail notification, the contractor shall submit a “Material Inspection and Receiving Report” in the form of an “Other/Other Receiving Report (RR) only” in Wide Area Workflow (WAWF).

Critical WAWF Codes for Other/Other Receiving Report:

Pay Office: SL4701 Issue By = SPE2D1 Admin By = Inspect By = Accept at Other = SPE2D1 Ship to: Provided in each delivery order

Errors in critical WAWF codes will result in delayed inspection of the receiving report and may require correction or resubmission prior to processing.

(3.) The DLA Troop Support engineer shall confirm delivery/inspection with the customer and “Inspect” (digitally sign) the receiving report within 30 calendar days, if no deficiencies are identified.

(4.) The DLA Troop Support Contracting Officer shall “Accept” the receiving report within the same allotted 30 calendar days. The Contracting Officer is the only Government representative who can authorize acceptance in WAWF.

(5.) After the inspection process is completed, the vendor shall create and submit an “Invoice Only” from the receiving report in WAWF. This results in a system generated e-mail stating that the invoice has been processed. Upon receipt of the contractor’s invoice, payment will be made in accordance with contract terms. Submitting an invoice prior to the processing of a receiving report may result in delay of payment.

X. WARRANTY

(a.) OPERATIONAL TIME System or Equipment must be operable and available for use 95% of the normal operational time until expiration of the warranty. Operational time will vary and is site specific. Operational time will be stipulated in each order. Downtime is computed from the time that the Contractor is notified by the Government that equipment is inoperable to the time repair is completed and equipment becomes operable. Scheduled maintenance will be excluded from downtime. Multiple failures to meet this requirement over a three consecutive month period may be grounds for termination for cause under paragraph (m) of clause 52.212-4, "Contract Terms and Conditions -- Commercial Products and Commercial Services.”

(b.) SERVICE DURING WARRANTY The Contractor shall provide a minimum of a one-year warranty at final acceptance that includes all parts, labor, preventive maintenance, and adjustments necessary for normal operation of the equipment.

Maintenance (i.e., Preventive Maintenance) under warranty shall be scheduled with a designated person from the facility at least two weeks ahead of the time frame the scheduled maintenance is due. For example – if the maintenance is due July15th then a date should be agreed upon at least two weeks prior to the due date. Other service under warranty shall be provided within 24 hours of notice by the Government requesting maintenance or service under the warranty period. A service request will be issued upon any failure which degrades system performance but does not disrupt continued patient care.

(c.) EMERGENCY AND ROUTINE SERVICE All service covered by Warranty shall be provided during normal Government work hours as stipulated in the delivery order.

When the Government notifies the Contractor of an emergency service request, the Contractor shall provide a qualified engineer within 4 hours of the Government’s request to perform repairs if the notification is made during normal work hours excluding weekends and federal holidays. Telephone response does not satisfy this requirement. An emergency service request will be issued upon any failure in normal equipment operation which disrupts continued patient care.

Service not covered by Warranty shall only be approved by a Contracting Officer at the local site and be performed under a stand-alone contract issued by the local site.

XI. EQUIPMENT REQUIREMENTS

(a.) AVAILABILITY OF PARTS AND SERVICE The contractor shall ensure servicing and replacement parts are available, and that it is able to provide the parts for a period of ten (10) years after final acceptance.

(b.) OPERATOR TRAINING The Contractor shall provide on-site orientation and training of a minimum of two Government personnel in the use, operation and care of the equipment furnished. This training shall include protocol installation (if needed), and on-site demonstration and operation of the equipment including any adjustments or other actions which may be undertaken by operating personnel in the event of equipment failure, provided that such adjustment or action will in no way jeopardize the Government's rights under contract warranty provisions. This training will be given by qualified contractor personnel upon completion of installation. The contractor shall contact the facility point of contact (POC) referenced in the delivery order to arrange the time for this training.

Training should be equivalent to what the contractor (Original Equipment Manufacturer) field service representatives receive and shall include all prerequisite classes. All service manuals, schematics, diagrams, diagnostic software, other special tools and hardware keys equivalent to what the contractor field service representatives have available to diagnose, troubleshoot, repair and maintain the equipment shall be furnished to the government at no additional cost.

On delivery orders, training shall be listed under its own delivery order line item, unless provided at no additional charge to the Government.

ONLY FOR VA ISSUED ORDERS: Both clinical and technical training shall not expire until 365 days after the equipment warranty expires.

(d.) APPLICATION SOFTWARE AND OPERATING SYSTEM REQUIREMENTS For the purpose of this section, updates are defined as all changes to correct or improve system operation and current functions including known remedies for security vulnerabilities. Updates shall be provided to the Government at no additional cost. Upgrades are defined as providing additional functions and shall be made available for purchase via the contractors’ price book.

Application software (e.g., image acquisition, manipulation, reconstruction, analysis, display, etc.), and any commercial Operating System (OS) necessary for operation and maintenance of the system being purchased shall be provided with all orders as required. The OS must be the latest major release currently available for purchase in the commercial marketplace or no older than one release prior to the latest major release. Older releases may be considered acceptable if authorized in writing by the requesting facility and approved by the Contracting Officer. Application software updates compatible with the offered system's hardware shall be kept current at no additional cost to the Government as long as the equipment is in use.

Updates that are bundled with upgrades shall be provided at no additional cost. The contractor may restrict added upgrade functions if restriction does not limit existing functions.

Modifications of software by the Government shall not be made without prior consent of contractor.

Government shall be able to reinstall vendor application software and OS on new hardware if the software on the original hardware fails.

Software and commercial OS provided must not be self-canceling, which is interpreted to mean the function of the software will not be stopped due to elapsing time or other condition not identified with the original equipment purchase. The prime contractor is responsible to ensure any third-party provided software is included in this restriction. No “renewable” licenses or agreements will be authorized.

The data rights clause found at FAR 52.227-19, Commercial Computer Software License is incorporated by reference into this solicitation and resultant contracts/ for equipment containing commercial computer software. However, the Government shall not have the right to unilaterally modify the commercial computer software if it is embedded in medical equipment.

The Government shall have networking rights for all commercial computer software that it acquires for equipment awarded under this contract. The Government shall be the licensee and all such software acquired shall be for a perpetual duration.

(e.) HARDWARE UPGRADES(1.) All equipment, related peripherals including any underlying software, shall be state-of-the-art technology. "State-of-the-art" is defined as the most recently designed components which are announced for marketing purposes, available, maintained and supported in accordance with requirements specified in the SOW. Components and products with a manufacturer's planned obsolescence are not acceptable. For existing contract items, vendors are required to immediately notify the Contracting Officer and site POC when it is known that an item will become obsolete, provide the estimated obsolescence date, and disclose the obsolescence date in all offers. An alternative to the components or products, which are now obsolete, must be provided.

(2.) If hardware upgrades become available after award of a delivery order, but prior to installation of the equipment, the contractor is required to inform the Contracting Officer.

(3.) The contractor's proposal for such upgrades shall include the following information:

(i) Pricing information, to include both the price of the equipment to be added and the equipment to be deleted.

(ii) Specific awarded items which shall be changed if the proposal is awarded.

(iii) Performance data, including both comparison to the specification requirements and to the equipment on contract.

(iv) A detailed description of the differences between the awarded items and those being proposed, and a specific analysis of the comparative advantages/ disadvantages of the items involved.

(v) An evaluation of the effect proposed changes will have on the life cycle of the equipment and an associated cost impact as it relates to site preparation, installation, maintenance, and operational expense.

(vi) An analysis of the timeframe required to institute the change.

(f.) SERVICE BULLETINS Service bulletins affecting safety, effectiveness, functionality, and/ or maintenance of equipment furnished under this contract shall be emailed to the receiving activity for the entire expected life of the product or a period of ten (10) years from the date of delivery, whichever is longer.

Service bulletins as well as any other special communications, such as, but not limited to, hazard alerts, safety notices, end-of-life notifications, and/or any other manufacturers’ letters shall be emailed to the Contracting Officer for the basic contract and all POC’s on any issued delivery orders. When applicable, this shall occur within FDA established timeframes from the date of a recall. Additionally, the following organizations shall be emailed:

For Center for Engineering & Occupational Safety and Health (CEOSH):

VHAHTMRMDWorkgroup@va.gov

National Center for Patient Safety, Veterans Health Administration, 24 Frank Lloyd Wright Dr, Ste M2100, Ann Arbor, MI 48106: VHANCPS@VA.GOV

(g.) PRODUCT CORRECTION, REMOVAL OR RECALL If any product awarded under this contract requires correction as defined by FDA, is removed or recalled by the contractor or manufacturer due to defects in the product or potential dangers to patients, or if any required correction, removal or recall is suggested or mandated by a regulatory or official agency, the following steps will immediately be taken by the contractor or manufacturer:

a. All the following offices and points of contact should email or mailed a notification:

(1.) Chief, High Tech Medical Equipment, VA National Acquisition Center, P.O. Box 76, Building 37, Hines, IL 60141.

(2.) VA Contracting Officer and Biomedical Engineer cited in the delivery order.

(3.) Manager, Product Recall Office, National Center for Patient Safety, Veterans Health

(4.) Biomedical Engineer, Center for Engineering & Occupational Safety and Health (CEOSH) (138F), Veterans Health Administration, 1 Jefferson Barracks Rd. Bldg. 65, St. Louis, MO 63125 or VHAHTMRMDWorkgroup@va.gov

(5.) Each individual VA Facility that purchased the product.

(6.) DLA Contracting Officer and Biomedical Engineer cited in the delivery order.

(7.) DoD Service Recall POC and all facility POC’s referenced in the DLA delivery order.

b. The following information shall be provided in each individual notification that is forwarded to all above offices and points of contact:

i. Complete item description and/or identification, the contract number and delivery order numbers

ii. Reasons for modifications, removal or recall.

iii. Proposed offers for return for full reimbursement replacement or corrective action shall be forwarded to the facility POC and Contracting Officer, for consideration by the Government.

c. The vendor is responsible for all costs associated with a recall.

d. The following additional information must be provided, in writing, to the above points of contact at the National Center for Patient Safety (NCPS) and the Center for Engineering & Occupational Safety and Health (CEOSH) regarding each individual notification that is forwarded to all above offices and points of contact:

i. Complete listing of ALL VA Facilities who purchased the product and the total number of affected product(s) at each facility.

ii. National summary detailing the status of the actions being taken by the contractor or manufacturer regarding the product correction, removal, or recall at the affected VA Facilities.

iii. Confirmation that all affected products were corrected, removed, or recalled at the affected VA Facilities and all expected actions were completed.

(h.) REPAIR PARTS FOR DEPLOYABLE SYSTEMS The contractor shall guarantee availability of all required repair (spare) parts from the contractor for a minimum of 10 years from the date of final system acceptance. To affect efficient, easy purchase of repair (spare) parts by the Government, it is highly desired that vendors include all such spare parts in their price book.

(i.) OTHER ASSOCIATED TECHNICAL REQUIREMENTS ONLY FOR VA ISSUED ORDERS:

All contractors shall provide service/maintenance/diagnostic software and associated security keys to provide for in-house service of the equipment once appropriate level of training has been completed. Where applicable, the vendor will renew the software license or security key for the duration of the installation at a VA facility. At a minimum, the service software will include system diagnostics down to board or module level, error codes and definitions, and system setup capabilities to include networking, DICOM configuration and peripheral connectivity. The diagnostic/service software will be equivalent to what the manufacturer’s service engineers use.

XII. CONTRACT AND DELIVERY ORDER PRICING REQUIREMENTS

(a.) The primary purpose of this contract is to provide for complete functional systems.

Contract price book item and descriptions for all the components required for the final system, including services and planned maintenance, and service contract . Items which are not separately priced, but included as part of a particular component (i.e., cables, brackets, etc.) shall be referenced in the component descriptions.

(b.) Pricing Support for Price Reasonableness Determinations: The vendor shall provide other than certified cost or pricing data to support the reasonableness of the offered items, as requested by the Contracting Officer.

(1.) The contractor shall be required to submit invoices and/or other documentation to substantiate commercial catalog prices and discounts for offered items. This data will also be used to substantiate that prices are equal to or better prices that are given to the commercial customers within similar purchasing environments. Similar purchasing environment should be considered customers that purchase under the same constraints as the Federal Government, the combination of all VA and DLA orders, with no guaranteed commitment level.

(2.) Vendors shall complete and provide Discount and Pricing Information (DPI) Worksheet (Attachment #3) as part of this initial proposal as well as provide updates as necessary throughout the life of the contract.

(3.) At the discretion of the Contracting Officer, a random sample may be used to limit the number of items for which a vendor has to provide price support information. Summary information should be provided in the price book tab “OFFER-CATALOG,” columns BN through BW (see below for further details on each field) along with actual documents.

At a minimum, vendors shall provide one of the following types of prices supports information in accordance the following order of precedence:

The following price support information order of precedence shall apply at the contracting officer’s discretion. The most recent commercial invoice reflecting the same list price as item(s) to be added or existing group purchasing organization (GPO) pricing for exact items shall be provided for all items requested by the Government. If a vendor does not have any invoices or existing GPO pricing for a given item, then the vendor can provide current or most recent commercial quotes.

Note: If using quotes, the vendor must also supply the accepted customer quote with signature. The Government may request invoices for these items later. This may be through an audit later either as part of option exercise (in addition to normal sample population for option review) or as a separate audit. If the item is new and has not yet been quoted, the vendor may use a similar item and provide information outlining differences/similarities between the items that justify the offered price.

The Government reserves the right to require other pricing information or use other price support procedures during the life of the contract to ensure that all prices are fair and reasonable. Failure to provide adequate supporting information for the Contracting Officer to determine pricing as fair and reasonable shall result in rejection of the offer or addition request.

Notes on other than certified cost or pricing data:

The data provided can be a mix of invoices, quotes with POs, GPOs, and similar items already on contract.

The contractor shall not submit invoices or quotes that are under different buying circumstances such as volume buys or committed customer discounts. These are unusable and shall not count toward satisfying the sample size as the Government can only review invoices for customers buying under the same conditions as the Government.

Pricing support data must clearly indicate the list price of the items as well as net price.

If a GPO that was previously provided to the Government has been updated, the Government reserves the right to re-evaluate the GPO through invoice reviews. In this case, the invoices DO NOT have to include the new items proposed for addition. The number of items reviewed to re-validate the vendor’s GPO is at the Contracting Officer’s discretion. It is NOT the sample size. The sample size is reflective of the items proposed for addition not the GPO.

Invoices must be current (dated within the last12 months); however, the contracting officer may consider older dated invoices at their discretion. Invoice list prices must MATCH offered list prices of added items for review.

The vendor shall provide FDA 510k certification that all items being added have FDA approvals.

(c.) Contract Price Book Format Requirements: The Price Book serves as the contract schedule with all part numbers, item descriptions, pricing, and other mandatory information. Contract pricing consists of the vendor’s list price and contract discount. The Contract Net Price is arrived at by subtracting the contract discount from the vendor’s list price for applicable requirement. An item may have multiple discounts based on configuration. Proposed contract offering and pricing shall be submitted using the excel spreadsheet format in Contract Pricebook Template (Attachment #5) that includes all mandatory data elements. No changes in format are allowable, no formulas are to be embedded into the catalog submission, and no additional tabs are allowed. There shall be a single excel spreadsheet Price Book, with the sole exception of the maintenance offering. The maintenance offering may be provided in a separate spreadsheet if a single spreadsheet becomes too large in size. However, if using a separate spreadsheet, ensure the maintenance offering follows the mandatory Price Book’s spreadsheet format.

(4.) The following columns must be completed for all offered items and item additions after contract award:

Column B - Catalog Number (MANUFACTURER P/N): The actual manufacturer’s part number (p/n) must be provided for all items, even if the vendor is a dealer utilizing its own p/n system.

Column C - Short Description: A short description must be provided for all items.

Column D - Long Description: The long description must be provided and have sufficient detail about the item to allow the Government to clearly understand what the offered item is without relying on any other vendor literature or contacting the vendor for explanation.

Column E – UOM: The unit of measure for the given item.

Column F - List Price: The list price should be the same price as referenced in the vendor’s commercial price list.

Column G through BD – Discount Columns: The vendors discount off the list price should be entered in the column(s) in accordance with vendor’s price structure. Vendors may utilize multiple columns it needed to capture different fixed discounts based on product category, volume, or other considerations.

Column BE - COUNTRY OF ORIGIN: The Country of Origin shall be completed for all offered items. Items that are not being offered for individual ordering, but are part of a TAA compliant higher level end item shall be identified by placing “COMPONENT” in the price book field followed by the country of origin for the item. “COMPONENT” items shall never be offered or purchased on their own. Applying the country of origin from a higher end item or higher system level is not acceptable.

Column BG – MANUFACTURER: The manufacturer name for each item must be provided.

Column BH - DEALER/DISTRIBUTOR P/N: If the vendor is not the manufacturer of a given item and has its own part number system, the vendor should complete this field with their own p/n. The vendor is still required to provide the manufacturer p/n in Column B. If the vendor is a manufacturer, then this column is not applicable.

(5.) The price support information and related columns shall be provided as part of clarifications after the closing date of the solicitation. The same process shall be used for any item additions after contract award. Along with providing actual invoices or quotes, the price book tab “OFFER-CATALOG,” columns BN through BW shall be used to provide summary pricing information requested by the Government. The price book modification/award price support fields are as follows:

Column BN - Invoice Number: Input the invoice number of most recent invoice. Must have been issued within the last 12 months. Actual invoice must also be provided.