36H79719R0007-0006037.docx
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- Next Gen 2019 Rad Therapy Systems and Accessories Federal contract opportunity
- Solicitation number
- 36H79719R0007
About this file
This solicitation is for radiation therapy systems and accessories. It will be issued on April 23, 2019 by the Department of Veterans Affairs National Acquisition Center, with responses due 30 days later. Multiple awards are anticipated under the single base year plus four option years contract period. Products required include linear accelerators, simulators, record and verify systems, treatment planning systems, brachytherapy equipment, and related accessories. Set-asides are indicated for small businesses. Pricing is to be offered as discounts from commercial price lists. Installation, training, manuals, and IT requirements are outlined. The solicitation also specifies quality, regulatory compliance, product support, and information security terms.
36H79719R0007 0006 RAD Therapy Amended Solicitation.docx
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36H79719R0007
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.
DUNS:
DUNS+4:
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. 2/2012)
PREVIOUS EDITION IS NOT USABLE
Prescribed by GSA - FAR (48 CFR) 53.212
7. FOR SOLICITATION
INFORMATION CALL:
STANDARD FORM 1449
OFFEROR TO COMPLETE BLOCKS 12, 17, 23, 24, & 30
SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS
36H79719R0007 04-23-2019 Hasael Roman 708-786-5243
NA
Department of Veterans Affairs OPAL/National Acquisition Center Building 37, 003B6C1 1st Ave, One Block North of Cermak Hines IL 60141
334517 1000 Employees
N/A
X
As indicated on individual delivery orders against this contract.
OPAL/ National Acquisition Center Building 37 1st Avenue, One Block North of Cermak Hines IL 60141
CHIEF, FISCAL DIVISION (901A)
HINES SERVICE AND DISTRIBUTION CENTER
PO BOX 7005
HINES IL 60141-7005
See CONTINUATION Page
FSC Group 6525- Radiation Therapy Systems, Upgrades, and Accessories to include Linear Accelerators, Simulators Therapy Information Systems, After Loading Systems, Water Phantoms, and Installation.
See CONTINUATION Page
X
Table of Contents
| SECTION A | 1 |
| A.1 SF 1449 SOLICITATION/CONTRACT/ORDER FOR COMMERCIAL ITEMS | 1 |
| SECTION B - CONTINUATION OF SF 1449 BLOCKS | 4 |
| B.1 CONTRACT ADMINISTRATION DATA | 4 |
| B.2 SCHEDULE OF SUPPLIES & DELIVERY | 5 |
| B.3 STATEMENT OF WORK (SOW) | 10 |
| PART ONE – GENERAL REQUIREMENTS | 10 |
| PART TWO - INSTALLATION | 24 |
| PART THREE - TRAINING | 34 |
| PART FOUR – MANUALS / COMPLIANCE | 35 |
| PART FIVE – INFORMATION TECHNOLOGY REQUIREMENTS | 38 |
| SECTION C - CONTRACT CLAUSES | 48 |
| C.1 52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL ITEMS (OCT 2018) | 48 |
| C.2 52.216-18 ORDERING (OCT 1995) | 53 |
| C.3 52.216-19 ORDER LIMITATIONS (OCT 1995) | 53 |
| C.4 52.216-22 INDEFINITE QUANTITY (OCT 1995) | 54 |
| C.5 52.217-9 OPTION TO EXTEND THE TERM OF THE CONTRACT (MAR 2000) | 54 |
| C.6 VAAR 852.215-71 EVALUATION FACTOR COMMITMENTS (DEC 2009) | 55 |
| C.7 VAAR 852.219-9 VA SMALL BUSINESS SUBCONTRACTING PLAN MINIMUM REQUIREMENTS (DEC 2009) | 55 |
| C.8 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING AND COMPLIANCE (JUL 2018) | 56 |
| C.9 VAAR 852.219-76 SUBCONTRACTING PLANS MONITORING AND COMPLIANCE (JUL 2018) | 56 |
| C.10 VAAR 852.219-71 VA MENTOR-PROTÉGÉ PROGRAM (DEC 2009) | 57 |
| C.11 VAAR 852.232-72 ELECTRONIC SUBMISSION OF PAYMENT REQUESTS (NOV 2018) | 57 |
| C.12 VAAR 852.237-70 CONTRACTOR RESPONSIBILITIES (APR 1984) | 58 |
| C.13 52.252-2 CLAUSES INCORPORATED BY REFERENCE (FEB 1998) | 59 |
| C.14 52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO IMPLEMENT STATUTES OR EXECUTIVE ORDERS—COMMERCIAL ITEMS (JAN 2019) | 59 |
| SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR ATTACHMENTS | 66 |
| SECTION E - SOLICITATION PROVISIONS | 68 |
| E.1 52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL ITEMS (OCT 2018) | 68 |
| E.2 52.212-2 EVALUATION – COMMERCIAL ITEMS (OCT 2014) | 74 |
| E.3 52.209-7 INFORMATION REGARDING RESPONSIBILITY MATTERS (OCT 2018) | 76 |
| E.4 52.216-1 TYPE OF CONTRACT (APR 1984) | 77 |
| E.5 52.233-2 SERVICE OF PROTEST (SEP 2006) | 77 |
| E.6 52.252-1 SOLICITATION PROVISIONS INCORPORATED BY REFERENCE (FEB 1998) | 78 |
| E.7 VAAR 852.215-70 SERVICE-DISABLED VETERAN-OWNED AND VETERAN-OWNED SMALL BUSINESS EVALUATION FACTORS (JUL 2016)(DEVIATION) | 79 |
| E.8 VAAR 852.233-70 PROTEST CONTENT/ALTERNATIVE DISPUTE RESOLUTION (OCT 2018) | 79 |
| E.9 VAAR 852.233-71 ALTERNATE PROTEST PROCEDURE (OCT 2018) | 80 |
| E.10 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—COMMERCIAL ITEMS (OCT 2018) | 80 |
SECTION B - CONTINUATION OF SF 1449 BLOCKS
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 36N797
OPAL/National Acquisition Center Building 37, 003B6C1 1st Ave, One Block North of Cermak Hines IL 60141
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] VA Contractors may request an 80% commercial interim payment once written approval of the interim storage is received from the contracting officer. Payment will be authorized as of the scheduled delivery date. For DLA Contractors, see 1-11. |
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.
Department of Veterans Affairs
CHIEF, FISCAL DIVISION (901A)
HINES SERVICE AND DISTRIBUTION CENTER
PO BOX 7005
HINES IL 60141-7005
ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:
| AMENDMENT NO |
| DATE |
B.2 SCHEDULE OF SUPPLIES & DELIVERY
This is a multiple ward Indefinite Delivery/Indefinite Quantity (ID/IQ) solicitation. Contracts resulting from this solicitation shall cover the base contract period of one year, beginning on the date of award, up to one year later (beginning September 1, 2019 through August 31, 2020), with the Government’s option to renew for up to four additional one-year periods. This will include Radiation Therapy Systems, upgrades, and accessories (to include training and installation). No contract will extend beyond the 12-month base with four one-year options.
This section is to be completed and submitted with your proposal, annotating the discount percentage offered for each item proposed, along with the associated page number in the Contractor’s Price Book.
1. LINEAR ACCELERATOR SYSTEMS. Base system shall include operator console, patient couch, table accessories, gantry, collimator assembly, patient positioning lasers, Digital Imaging and Communications in Medicine (DICOM) compliance, connectivity to treatment planning system (TPS) and record and verify system (R&V), and training. (Also See I-3, Networking/Interfacing) HIGH Energy Base: Photon energy levels shall be 6 and 18 MV and should have at least 5 selectable electron treatment beam energies, with nominal energies of 4-21 MeV.
LOW Energy Base: Photon energy level shall be 4 or 6 MV and electron energies are optional.
(ADD All Relevant Items in Contractor Price Book)
| Discount Percentage Offered |
| Contractor’s Price Book Page Reference |
01A. High (Dual) Energy Base System Components
01B. Low Energy Base System Components
01C. System Options. Identify available system options with pricing data.
01D. Accessories. Provide listing of available accessories with pricing data.
01E. Upgrades. Identify available upgrades with pricing data.
01F. Portal Imaging System
02. SIMULATOR SYSTEMS. Base system shall include operator console, patient couch, gantry, X-ray generator and tube, collimator assembly, DICOM compliance, connectivity to treatment planning system (TPS) and record and verify system (R&V), and training.
Discount Percentage Offered
Pricing Page Reference
02A. Radiation Simulator Base System Components
02B. System Options:
02C. Accessories:
02D Upgrades:
03. RECORD AND VERIFY SYSTEMS. Base system shall include network gateway to interface with hospital information system, computer workstation, station and interface for one linear accelerator and one simulator, interface with treatment planning system, printer, and training.
03A. Base System Components.
03B. Optional Software Modules. Provide listing of other available software modules with pricing data.
03C. System Options
03D. Additional Workstations. Identify available workstations, including hardware and software, with pricing data
03E. Accessories
03F. Upgrades
| 04. TREATMENT PLANNING SYSTEMS. Shall include computer workstation, printer, film digitizer and/or interface with Computerized Tomography (CT) scanner and training. |
| Discount Percentage Offered |
| Pricing Page Reference |
04A. Base System Components
04B. Optional Software Modules
04C. System Options
04D. Accessories
04E. Upgrades
04F. Digitizers. Identify available film digitizers with pricing data
| 05. ORTHOVOLTAGE SYSTEMS AND ACCESSORIES. Shall include control console, treatment couch, applicator cones and filters, variable collimator and training. |
| Discount Percentage Offered |
| Pricing Page Reference |
Orthovoltage Systems and Accessories
06. STEREOTACTIC RADIOSURGERY SYSTEMS AND ACCESSORIES. Shall include computer controller, operator console and chair, treatment couch, head frame for surgery and treatment, accessories, collimator, planning capabilities, phantom pointer and training.
Stereotactic Radiosurgery Systems and Accessories
07. HIGH DOSE RATE (HDR) BRACHYTHERAPY SYSTEMS AND ACCESSORIES. Shall include treatment unit, control unit, radiation sources, applicators, accessories, integration with treatment planning system and training.
High Dose Rate Brachytherapy Systems and Accessories
08. SCANNING WATER BATH PHANTOMS AND ACCESSORIES: Identify the scanning water bath phantoms used in the radiation oncology department. Identify the various options and accessories.
Scanning Water Bath Phantoms and Accessories
09. GAMMA KNIFE: Shall include but not limited to treatment unit, helmets, collimators, accessories, integration with treatment planning system, and training.
GAMMA KNIFE
10. CYBERKNIFE: Shall include but not be limited to robotic manipulator, linear accelerator, image detectors, variable aperture collimator, integration with treatment planning system, and training.
CYBER KNIFE.
11. OTHER RADIATION THERAPY SYSTEMS AND ACCESSORIES.
Identify the other systems used in the radiation oncology department. Identify the various options and accessories.
Discount Percentage Offered
OTHER RADIATION THERAPY SYSTEMS AND ACCESSORIES.
12. TRAINING. Commercially available training options, both operator and maintenance, shall be provided as options to the users in addition to the minimum training requirements of this contract.
12A. Operator/User Training
12B. Advanced User Training
12C. Maintenance Training
The information below must be completed to display the percentage discount for the option years.
Option Year Pricing/Discount Description Offerors hereby offers for the option years shown below the same or better percentage discount, deducted from its published commercial price list as cited above for the Base Year.
| Discount Percentage Offered | |||
| Option Year One: September 1, 2020 through August 31, 2021 | _________ | ||
| Option Year Two: September 1, 2021 through August 31, 2022 | _________ | ||
| Option Year Three: September 1, 2022 through August 31, 2023 | _________ | ||
| Option Year Four: September 1, 2023 through August 31, 2024 | _________ |
ESTIMATED QUANTITIES
This is a type of contract that provides for an indefinite quantity of supplies or services during a fixed period of time. Therefore, it is impossible to determine the exact quantities that will be required during the contract term. Each offeror whose offer is accepted will be required to deliver all supplies or services as needed.
Previous sales for the last Fiscal Year (October 1, 2017, through September 30, 2018) for Radiation Therapy Systems, Upgrades, and Accessories, Including Installation for the VA and DLA Troop Support were approximately $23M. The Government anticipates a similar total for the base year and each additional option year of awards from this solicitation.
Offerors shall provide the systems identified herein with discounts from the offeror’s published commercial price list. The published commercial price list shall be made a part of the ultimate contract, Offerors shall indicate “No Bid” if a certain type product/system is not offered.
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, 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.
B.3 STATEMENT OF WORK (SOW)
36H79719R0007
PART ONE – GENERAL REQUIREMENTS
This solicitation provides for the normal supply of Radiation Therapy Systems, upgrades and accessories, linear accelerators, simulators, therapy information systems, therapy planning systems, after loading systems, water phantoms, and equipment installation for the Department of Veterans Affairs, Department of Defense, and other Federal Agencies. Upon request for delivery, the contractor shall deliver radiation therapy equipment Free On Board (FOB) destination within consignee premises to the Department of Veterans Affairs and other Federal Agencies. The VA and Federal Agencies shall receive radiation therapy equipment within the 50 states, Washington, D.C., (CONUS), and Puerto Rico. DLA Troop Support may issue orders for non-US (OCONUS) locations.
Federal Activities functioning in OCONUS locations and sales to foreign governments are subject under the Foreign Military Sales (FMS) Program (DFAR 252.225-7027). The resultant contracts will be used as sources for the articles or services listed herein. Articles or services will be ordered from time to time in such quantities as may be needed to fill any requirement determined in accordance with currently applicable procurement and supply procedures.
1.1 ITEMS OFFERED
(a) Items offered are to be contractor's standard commercial product line and as such shall conform to the specifications within the contractor’s product and technical data. In addition, the items offered shall conform to the Government’s minimum purchase description to be eligible for initial award. The Government’s minimum purchase descriptions are contained in the Schedule of Supplies (B.2).
(b) All equipment and related peripherals contracted for shall be of state-of-the-art technology. For the purposes of this solicitation, "State-of-the-art" is defined as the most recently designed components that are announced for marketing purposes, available, maintained and supported in accordance with mandatory requirements specified in the solicitation. Components and products with a manufacturer's planned obsolescence within the first year of contract award are not acceptable.
(c) Should equipment delivered under this contract fail to meet the requirements of paragraph (a) above, the contractor shall be responsible for all costs associated with the upgrading or replacement of equipment to meet the requirements specified.
(e) Proof of FDA 510(k) premarket notification, for all offered products that require this certification, must be provided with offer. Alternatively, the offeror may represent that all required certifications are available and may be produced individually on demand.
1-2 DELIVERY ORDER PRICING STRUCTURE
The purpose of this section is to explain the requirement for complete functional systems. A particular item(s) may be combined with a compatible component(s) to develop a unique system. Therefore, prices quoted for each item shall be listed in Attachment 5 (Contract Price Book) and shall include the price of all components, such as mounting hardware, electrical cable, adapting parts, etc., required to form a complete operational system when an item is installed with compatible items (offered under this solicitation) in the development of a system. System (or item) descriptions, both long and short, shall be listed in the Contract Price Book. These descriptions shall clearly identify component parts included in the unit price quoted. When more than one component is required to make up an item or system, all model and/or catalog numbers are to be shown and properly identified.
In addition to the costs of the equipment, the prices shown in the Contract Price Book (Attachment 5) shall include charges for site visits, drawings, transportation, rigging, packing, unpacking with disposal of packing material, installation, applications training/instruction(s) and warranty for delivery within the 50 states and Washington, DC (CONUS) and Puerto Rico.
When delivery is for outside the 50 states, Washington, DC, or Puerto Rico (OCONUS), or when the items/services on contract are not required, the percentages shown in Section B.2 (Schedule of Supplies) may be deducted at the discretion of the Contracting Officer from the prices shown on the Contract Price Book (Attachment 5). Further negotiation will be conducted on an individual delivery order basis to include these services and costs, or any other services required, for overseas orders or existing system upgrades, interfaces or add-ons.
Pricing shall reflect F.O.B. Destination within the consignee’s premises, within the 50 states, Washington, D.C., and Puerto Rico. Offerors are not required to provide OCONUS pricing but may be asked to provide OCONUS (Non- U.S.) pricing on a per delivery order basis.
*NOTE - Contractors may voluntarily reduce contract prices at any time during the contract period. Reductions may be offered on an individual order basis or for all orders under the contract for a specified time.
1-3 MARKET ACCEPTABILITY AND DELIVERY CRITERIA
Items offered shall be a standard commercial product offered for sale by the contractor in the commercial marketplace. Items offered should have been in clinical use for not less than three (3) months in at least one (1) clinical site. If an item offered does not meet this requirement, an award for that item may still be executed at the discretion of the Contracting Officer.
(a) Delivery shall be made within 120 calendar days after receipt of delivery order (ARO). The required delivery date will be annotated on each individual delivery order. Should the delivery date require a change, the contracting officer will advise the contractor of the new delivery date at least 45 days prior to the original or adjusted delivery dates.
(b) In the event that the government is unable to accept delivery as scheduled and the contracting officer fails to notify the contractor of a new delivery date within 45 calendar days prior to the scheduled delivery date, interim storage may be authorized by the contracting officer.
(c) Contractors shall request interim storage in writing to the contracting officer. Each request shall include the following:
(1) The catalog and serial numbers of all major components of the system to be placed in interim storage.
(2) Identification of the warehouse and address where the items will be stored.
(d) Contractors may request an 80% commercial interim payment once written approval of the interim storage is received from the contracting officer. Payment will be authorized as of the scheduled delivery date.
(e) The government reserves the right to inspect the warehouse where the government’s orders have been placed in storage.
In general, all components of a given system shall be offered with a common, standard delivery time for that system. In the event a specific item offered cannot be delivered within the delivery time for the general system with which it was purchased, the contractor shall notify the Government to determine if an extended delivery is applicable. So long as the item is afforded an extended delivery time and meets the established requirements, the item may be placed on contract and be available for purchase.
1-4 SERVICE AIDS
Service Aids include but are not limited to: Service access hardware, software keys, testing apparatus, calibration devices, and phantoms routinely used by service personnel. All Service Aids must be provided with the equipment at no additional charge, unless otherwise stated in the contract. If they will not be provided with the equipment, the offeror must identify the Service Aids in their proposal; submit the commercial price list for these items; and state the discounts offered to the Government.
1-5 NETWORKING/INTERFACING
(a). Networking/Interfacing of Existing Equipment. Networking/interfacing of existing equipment shall be quoted on a site-specific basis. Upon receipt of a comprehensive listing of existing systems, subsystems and networking, the contractor shall supply a site-specific quote describing the network/interface requirements per the clinical needs of a given site. The networking/interfacing quote shall include all equipment, materials and labor required to fully install and make operational the system intended to meet the clinical needs of a given site.
(b). Networking/Interfacing of New Equipment. Networking/interfacing of new equipment shall be quoted on a site-specific basis. Upon receipt of a comprehensive listing of new systems, subsystems and networking, the contractor shall supply a site-specific quote describing the network/interface requirements per the clinical needs of a given site. The networking/interfacing quote shall include all equipment, materials and labor required to fully install and make operational the system intended to meet the clinical needs of the given site.
(c). Networking/Interfacing of New Equipment to Existing Equipment. Networking/interfacing of new and existing equipment shall be quoted on a site-specific basis. Upon receipt of a comprehensive listing of new and existing systems, subsystems and networking, the contractor shall supply a site-specific quote describing the network/interface requirements per the clinical needs of a given site. The networking/ interfacing quote shall include all equipment, materials and labor required to fully install and make operational the system intended to meet the clinical needs of the given site.
(d). Accessories. Upon receipt of a comprehensive listing of accessories, the contractor shall supply a site-specific quote describing the accessory requirements per the clinical needs of a given site. Prices shall be at discounts equal to or greater than discounts awarded under this contract.
1-6 HARDWARE UPGRADES
(a). As hardware upgrades become available, , the contractor is required to inform the Contracting Officer.
(b). The contractor's proposal for such upgrades shall include the following information:
(1) Pricing information, to include both the price of the equipment to be added and the equipment to be deleted.
(2) Specific awarded items that shall be changed.
(3) Performance data, including both comparison to the specification requirements and to the equipment on contract.
(4) A detailed description of the differences between the original awarded items and those being upgraded, and a specific analysis of the comparative advantages/disadvantages of the items involved.
(5) 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.
(6) An analysis of the timeframe required to institute the change.
1-7 TRADE-INS
(a) DISCOUNT/CREDIT
Upon receipt of a comprehensive listing of systems and subsystems, as specified for each individual location, the contractor shall supply a site-specific quote describing the terms and conditions of the trade-in value or upgradability (discount/credit) afforded to existing hospital oncology equipment and subsystems to be used towards the purchase of the new equipment. Upon initiation of the installation, the Government equipment items slated for trade-in shall be de-installed by the contractor, effecting formal transfer of ownership from the Government. The room shall be left broom clean by the contractor after de-installation. Trade-in credit shall be quoted on a site-specific basis.
(b). SANITIZATION OF SENSITIVE DATA FOR TRADE-IN EQUIPMENT All medical equipment provided for trade-in containing electronic Protected Health Information (ePHI) will be sanitized by VA according to VA guidelines, and DoD according to DoD guidelines, prior to release to the vendor. The media sanitization process will be as minimally destructive as possible to preserve functioning of the equipment. Whenever possible, the operating system OS and application software will be preserved. If the Operating System (OS) and/or application software cannot be preserved, VA and DoD will elect to use one of the following trade-in options:
(1) Trade-in Option 1 - In instances where sanitization of ePHI compromises the OS and/or application software, or requires the removal of internal storage media, the vendor accepts the equipment "as is." The government does not guarantee preservation of the operating system.
(2) Trade-in Option 2 - In instances where sanitization of ePHI compromises the OS and/or application software, the operating system and application software will be reloaded by VA or a vendor contracted by VA on the native system drive post sanitization. Verification of system operation is the responsibility of the vendor.
1-8 APPLICATION SOFTWARE AND OPERATING SYSTEM REQUIREMENTS
Application software (e.g. physiological data and image acquisition, manipulation, reconstruction, analysis, display, etc.), and any Off the Shelf commercial Operating System (OS) necessary for operation and maintenance of the system being purchased, are to be provided by the contractor. 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 in accordance with the warranty. Updates are defined as all modifications to correct or improve system operation and current functions including known remedies for security vulnerabilities and shall be provided to the Government at no additional cost. Upgrades are defined as providing additional functions and shall be made available for purchase at the Government’s election.
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 will not be made without prior consent of contractor. Except for Pharmacy Automation Equipment, the Government shall be able to reinstall vendor application software and OS on new hardware if the original hardware on which such software was installed fails. Software and commercial OS provided must not be self-canceling, which is interpreted to mean that 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. Except for Pharmacy Automation Equipment, no “renewable” licenses or agreements will be entered into by either the Contracting Officer or the using facility.
Additionally, the Government shall have networking rights for all commercial computer software that it acquires through contracts and orders for equipment awarded under this solicitation. The Government shall be the licensee. Except for Pharmacy Automation Equipment, all such software acquired shall be for a perpetual duration. Pharmacy Automation Equipment shall include extended descriptions so that customers can easily identify software that is renewable via maintenance or is maintained at no cost with the initial purchase of the equipment (perpetual duration).
1-9 SERVICE PRIOR TO AND DURING WARRANTY PERIOD
Service may be required on equipment prior to the start of the warranty period. All services will be performed at no charge to the Government during this period. The one-year warranty after acceptance inspection will include all parts, labor, preventive maintenance and adjustments necessary for operation of the equipment at a level meeting all requirements of the purchase description/salient characteristics/specifications.
1-10 SERVICE AND MAINTENANCE UNDER WARRANTY
Maintenance and routine service under warranty shall be provided within 24 hours of notice from the POC specified on the delivery order. A routine service request will be issued upon any failure which degrades system performance but does not prevent continuation of patient care.
Emergency service by a qualified engineer must be provided within 4 hours of notification to the vendor during normal business hours. This excludes weekends and federal holidays. Telephone response does not satisfy this requirement. An emergency service request will be issued upon any failure which prevents systems operation and disrupts continued patient care.
Contractor service personnel (Field Service Techs) shall be English speaking (fluent) and required to show documentation of professional formal training on the equipment and at least annual continuing education, per Joint Commission on the Accreditation of Healthcare Organizations (JCAHO). OCONUS service personnel shall be a US citizen or National of Host Country.
1-11 OPTIONAL SERVICE AND MAINTENANCE AGREEMENTS
If offerors have optional service/maintenance agreements, they may be offered to the facility using separate contract methods with the facility, but not under this solicitation. These agreements may be purchased by the local using facility after expiration of the initial warranty.
NOTE: Service agreements cannot be invoiced until the service period has ended (i.e. billed in arrears). For delivery orders issued by DLA Troop Support, the vendor will be paid quarterly. The vendor can request payment after the last day of each quarter.
1-12 AVAILABILITY OF PARTS AND SERVICE
The contractor guarantees availability of servicing and replacement parts for a period of five (5) years.
1-13 OPERATIONAL UPTIME
(a) Unit must be operable and available for use 97% of the normal operational time until expiration of the warranty period. Operational time is considered 7:00 am - 10:00 p.m. Repairs are to be made during normal work hours. Downtime will be computed from the notification by the government during normal work hours until equipment is available for normal service (Normal work hours are 8:00 am - 5:00 p.m., Monday through Friday, excluding national holidays). Scheduled maintenance will be excluded from downtime. If at anytime the operability of the unit falls below 97%, the Government, may seek a claim under paragraph (o) of clause 52.212-4, "Contract Terms and Conditions -- Commercial Items".
(b) Refusal of access to the equipment indicates that the unit is up and running and time will not be considered when determining downtime. Refusal of access to the equipment voids the service request.
1-14 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, Ordering Division Contracting Officer listed on the delivery order and VHA Customer.
For DLA Troop Support Issued Orders: See Completion of Installation in Section 2-3, paragraph b.5 (b)..
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 and Service Logistics Agency for DoD if clinical use is not initiated at this time.
Submission of the notice of readiness for inspection, and any other notice required 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 under this clause. The Government shall provide appropriate email addresses on the purchasing documentation.
(a) 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 as noted below. 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 ten (10) 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. It is the contractor’s responsibility to correct reported deficiencies and to advise 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.
(b) Warranty Effective Date The warranty period will commence on the date the final inspection is completed and the unit is “accepted.”
(c) Clinical Use For the purpose of this solicitation, Clinical Use is when the delivered equipment is able to perform 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 scanning of patients 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. 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 requirement for 30 calendar days of Clinical Use will not be considered met and procedures under “No Clinical Use” will be followed. It is understood that Clinical Use is incompatible with and cannot continue in the event significant deficiencies are identified.
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 (Receiving Report in WAWF for DoD, inspection report or receiving report for VA) within ten (10) 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 ten (10) 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 ten (10) 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 negate the right on the part of the Government to later exercise its rights under any remedy available to the Government by federal law or regulation.
In the event the Government has not conducted an acceptance 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.
(d) No Clinical Use No Clinical Use means that delivered equipment is not able to 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 (c) above, the system will not be accepted without formal testing and final payment will not be issued until after the equipment satisfactorily completes formal testing.
(e) Final Acceptance/Rejection Procedures In the event the equipment is not placed in Clinical Use for 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:
(1) Accept the equipment; or
(2) Accept the equipment and request that identified defects be remedied under the contract’s warranty; or
(3) Request the contractor propose an equitable offset in lieu of correcting defects or rejection; or
(4) Reject and request removal of the equipment.
When requested, the contractor shall propose offsets within five (5) calendar days. If agreement is not reached with the Government on such offsets within five (5) calendar days thereafter, additional discussion on offsets may continue at the mutual agreement of the contractor and Government, or, at the request of either party, the Government will cease any clinical use, reject and request removal of the equipment. In cases of an offset, where the equipment is accepted by the Government, the commencement of the warranty period will be established by the Contracting Officer.
If equipment is rejected and the contractor is requested to remove such equipment, the contractor shall completely de-install all equipment items and remove them within ten (10) calendar days from the Government premises at the contractor’s expense.
(f) Final Payment Final payment is due in 30 calendar days after formal inspection acceptance. In cases where the Government accepts an offset proposal, final payment (if any is owed) is due within 30 calendar days of the Government’s formal inspection acceptance of the proposal.
1-14 ACTIVITY AUTHORIZED TO ISSUE ORDERS
THE VA NATIONAL ACQUISITION CENTER, NATIONAL CONTRACTS SERVICE (003B6C1) AND DEFENSE LOGISTICS AGENCY-TROOP SUPPORT (DLA Troop Support), 700 Robbins Avenue, Philadelphia, PA 19111-5092 ARE THE ONLY ACTIVITIES AUTHORIZED TO PLACE DELIVERY ORDERS UNDER THIS CONTRACT EXCEPT AS OTHERWISE DELEGATED IN WRITING. Individual facilities of the Department of Veterans Affairs and other non-Department of Defense Federal Agencies are hereby delegated authority to place delivery orders valued at $50,000 or less for equipment under this contract.
1-15 DLA TROOP SUPPORT ORDERS
(a) Final Payment Payment Office and Invoicing Instructions: 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 Contract Line Item Numbers (CLIN)s to be inspected.
(iii.) The Installation Location (Hospital/Facility Name, Room # & Base) (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: | |
| (aa) Confirm delivery | |
| (bb) Inspect equipment | |
| (cc) Relay results to DLA within 30 calendar days. |
(2) 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.
(3) 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 (WAWF). Critical WAWF Codes for Other/Other Receiving Report include:
Pay Office: SL4701 Issue By = SPE2D1 Admin By = SPE2D1 Inspect By = SPE2D1 Accept By = SPE2D1
(4) Ship to: Provided in each delivery order
(5) Errors in critical WAWF codes will result in delayed inspection of the receiving report and may require correction or resubmission prior to processing.
(6) 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.
(7) The DLA Troop Support Contracting Officer shall “Accept” the receiving report within the same allotted 30 calendar days. A Contracting Officer is the only Government representative who can authorize acceptance in WAWF.
(8) 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.
1-16 PRESERVATION, PACKAGING, PACKING, LABELING AND MARKING (PPPL&M)
(a) PPPL&M requirements are described in Attachment 4 (Medical Marking Standard NO.1C). In addition to Attachment 4, the below requirements apply:
(1) Packaging and packing shall be commercial, as specified herein.
(2) Each complete unit shall be properly packaged in suitable sealed unit container. When required, unit containers shall contain internal fittings, wrappings, cushions, etc. capable of protecting the contents from damage and/or breakage. Units shall be packed in suitable commercial exterior (shipping) containers (export when necessary), which shall ensure acceptance and safe delivery common or other carrier, at the lowest rate, to the point of delivery called for in the contract or delivery order. Palletization shall be in accordance with MIL-STD-147. Unitized loads shall be used whenever total quantity for shipment to one destination exceeds 250 lbs (excluding the pallet) or 20 cubic feet. Loads shall be unitized on Type IV or Type V 4-way entry pallets. Pallet shall have a length of 40 inches and a width of 48 inches, pallet load, including the pallet, shall not exceed 54 inches in height, 43 inches in length and 52 inches in width.
(3) Quantity for shipment to one destination of less than 250 lbs or 20 cubic feet need not be palletized.
(4) If a properly palletized load of a single item (equipment item and pallet) exceeds 54 inches in height, height limitation need not be adhered to.
(5) If a single item exceeds the maximum pallet load dimensions, length and width need not be adhered to, contact the Contracting Officer for additional guidance. As an alternate, commercial unitization may be supplied.
(6) Material shall be labeled and marked in accordance with commercial practice and as specified herein.
(7) Marking on each unit shall include the National Stock Number (NSN) and Government quantity and unit of issue. However, exceptions are currently applicable to NSNs in Federal Supply Codes (FSCs) 6505 and 6509.
(8) Additional markings shall be supplied in accordance with all applicable regulatory requirements for all items requiring special handling, i.e. controlled, perishable and hazardous items.
(9) As an alternate, for shipments directly to medical facilities of all items except perishable items and hazardous material required, markings may be supplied on the DD Form 250 or packing list accompanying the shipment (applicable to all shipments, except shipments to DLA distribution locations).
(10) MIL-STD-147 is available online at http://quicksearch.dla.mil/
1-17 PRODUCT MODIFICATION, REMOVAL OR RECALL
If any product awarded under this solicitation requires modification, is removed or recalled by the contractor or manufacturer due to defects in the product or potential dangers to patients, or if any required modification, 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. Notify the Contracting Officer, National Contracts Service (003B6C1), VA National Acquisition Center, P.O. Box 76, Building 37, Hines, IL 60141, in writing, by the most expeditious manner possible. Provide two copies of the notification which shall include, but not be limited to the following:
| (1) Complete item description and/or identification, order numbers from customers, and the contract number assigned as a result of an award on this solicitation. |
| (2) Reasons for modifications, removal or recall. |
| (3) Necessary instructions for return for credit, replacement or corrective action. |
b. A copy of the notification in a. above shall be provided to:
| Manager, Product Recall Office |
| National Center for Patient Safety |
| Veterans Health Administration |
| 24 Frank Lloyd Wright Dr Ste M2100 |
| Ann Arbor, MI 48106 |
c. Provide the information in a. above to all agencies applicable to this solicitation, who purchased the product.
d. The National Contracts Service (003B6C1) shall be provided a copy of the notification in c. above, and a list of all agencies and/or VA facilities notified.
e. The vendor will be responsible for all costs associated with a recall.
PART TWO - INSTALLATION
2-1 EXTENDED INSTALLATION
Extended Installation is applicable to this solicitation. It is defined as simple installation or alteration at a public building or public work that is incidental to furnishing supplies or equipment under a supply contract; however, if a substantial and segregable amount of construction, alteration, or repair is required, such as for installation of heavy generators or large refrigerator systems or for plant modification or rearrangement, the requirements of the construction section shall apply. However, it shall not apply if the construction work is so merged with non-construction work or so fragmented in terms of the locations or time spans in which it is to be performed, that it is not capable of being segregated as a separate contractual requirement per FAR Part 22.402 (2)(b)(i).
(a) The Government may require extended installation services, in addition to those required in Section 2-2 (CONTRACTOR'S RESPONSIBILITY IN CONNECTION WITH INSTALLATION) of this solicitation. The costs of extended installation services are not included in the price of the equipment and shall be individually negotiated. Extended Installation costs shall be quoted on a site-specific basis. A site visit is required to appropriately determine the requirements of the extended installation.
(b) Extended installation shall, as a minimum, include: connecting with existing utilities, furnishing and installing support structures for the equipment.
(c) Extended installation may include, but is not limited to: power transformers, step-up or step-down transformers, power runs, disconnects, conduit, wiring, structural support, shielding, and Heating Ventilation and Air…
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