-17188.pdf

DEPARTMENT OF VETERANS AFFAIRS

Justification and Approval (J&A) for Other Than Full and Open Competition (>SAT)

Acquisition Plan Action ID: 36C252-19-AP-2666

1. Contracting Activity: Department of Veterans Affairs, VISN 12, William S. Middleton Memorial

Veterans Hospital, Great Lakes Acquisition Center (GLAC), 607-19-3-969-0105.

2. Nature and/or Description of the Action Being Processed: The William S. Middleton Memorial Veterans Hospital is requesting a qualiy assurance system to include software, equipment and standard maintenance agreements for a radiotherapy beam dosimetry system. This is a new requirement to be awarded as a single, new, firm fixed price purchase order. The standard maintenance agreements will include a base plus four option years.

This procurement is in accordance with FAR 13.5 Simplified Procedures for Certain Commercial Items and specifically FAR 13.501 Special Documentation Requirements, where acquisitions conducted under Simplified Acquisition Procedures are exempt from the requirements of FAR Part 6, but still require a justification using the format of FAR 6.303-2.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: This procurement is for the following:

Software/Equipment:

Part Description Qty Unit Price Extended

(With Discount)

1220000- 0Z

ArcCHECK™ 4D Isotropic Arc Delivery QA Cylindrical detector array designed for rotational delivery QA and conventional IMRT QA, with 21cm in diameter and 21cm long. 1386 detectors, active area of 0.64mm², update frequency of 50ms. Includes SNC Patient analysis software (Machine QA features are included, 25 meter power-data cable, USB cable, power supply (110/220 V), case, 1 year of hardware maintenance and 1 year of software maintenance.

See product datasheet for minimum PC requirements.

1220000- 3Z

ArcCHECK® MultiPlug™ (PMMA) ArcCHECK PMMA (Acrylic) insert enabling film measurements and with versatility to take ion chamber measurements in up to 25 unique locations within the ArcCHECK cavity. Includes film cassette, one ion chamber plug (please specify ion chamber model), and additional plugs to create a homogeneous insert.

1220533Z Inner Plug for ArcCHECK Mulit-Plug 2

1220200Z

ArcCHECK Trolley Trolley for moving the ArcCHECK. 18” wide profile. Trolley includes top shelf, handle, two legs with integrated cable channels, cable wrap, and four locking 5" casters. Trolleys for ArcCHECKs purchased before March, 2016 will need the ArcCHECK Cradle Upgrade Kit - 1220801Z.

TRNG-T1

Training Voucher, 1 Day On Site Training Voucher for one day on site product training.

Includes one full day of in depth product training by a qualified Sun Nuclear representative. Refer to Product Training Datasheet (attached) for the number of training units that need to be allocated for each product (one training unit = 1 day). Additional consecutive days can be purchased at a discounted price. Allow 4 weeks minimum for scheduling.

Training for ArcCHECK

1122000- 0Z

IC PROFILER™

A linac radiation beam scanning system providing real-time beam profile data for beam alignment during LINAC factory testing, for field installation and service, and for routine trending of LINAC beam characteristics in clinical site. IC PROFILER uses 251 ionization chambers placed in four linear arrays (X,Y and two diagonals) on a 5mm grid. Measurement range is specified as 32cm on both X and Y axes and 45cm on the diagonals. Comprehensive PC analysis software included.

25 meter power-data cable, USB/serial power data supply, USB cable, Serial cable, 1 year warranty. Includes case. See product datasheet for minimum PC requirements.

1122000-

VZ

Gantry Mounting Fixture Holds IC PROFILER™ at 100cm SDD, fits Varian

1122-AZ

Adapter plate for the GMF (1122000-V and 1122000-E) - Adapter plate for the GMF™ (1122000-V and 1122000-E) to support MapCHECK® 2 (1177000-0), PROFILER™ 2 (1174000-0) and Daily QA™ 3 (1093000-0). Supports device inherent buildup only.

Requires 1122000-V or 1122000-E.

1122606Z

Electron Energy Quad Wedge Plate Quad aluminum wedge plate designed for precise electron energy measurements independent of wedge positioning and suitable for 4MeV to 22MeV. 3mm of acrylic material surrounds each wedge. For use with the IC PROFILER.

1122607Z

Photon Energy Quad Wedge Plate Quad copper wedge plate designed for precise photon energy measurements independent of wedge positioning and suitable for 6MV to 18 MV. Compatible with FFF beams. 3mm of acrylic material surrounds each wedge. For use with the IC PROFILER.

805457 Solid Water HE - 30 x 30 x 0.1 cm 2

805510

Solid Water HE - 40 x 40 x 5.0 cm Solid Water® HE is the next generation of water-mimicking material pioneered by Gammex. Our new patent-pending technology more accurately mimics true water within 0.5% for therapeutic and diagnostic energies. Enhanced uniformity and reduced variation compared to other water-mimicking formulations, more consistent and accurate results.

Includes unique Nanosphere technology that provides high strength and water equivalence. Custom sizes available for unique applications. This product includes a 5-year warranty.

1174111Z Solid Water HE 35.3 x 36.7 x 0.2cm 2

1174113Z Solid Water HE 35.3 x 36.7 x 0.5cm 3

1174114Z Solid Water HE 35.3 x 36.7 x 1.0cm 3

1174115Z Solid Water HE 35.3 x 36.7 x 2.0cm 4

1174115Z Solid Water HE 35.3 x 36.7 x 2.0cm

• Scribed and Drilled for A1SL, A12, and A11

• Please specify drilling orientation A or B

1174116Z Solid Water HE 35.3 x 36.7 x 5.0cm 5

TRNG-T1

Training Voucher, 1 Day On Site Training Voucher for one day on site product training. Includes one full day of in depth product training by a qualified Sun Nuclear representative. Refer to Product Training Datasheet (attached) for the number of training units that need to be allocated for each product (one training unit = 1 day).

Additional consecutive days can be purchased at a discounted price. Allow 4 weeks minimum for scheduling.

Training for IC PROFILER

1093000- 1Z rf-Daily QA™3 Real time wireless data transmission from 13 total ion chambers for daily output, flatness and symmetry, electron & photon energy trending (no buildup or additional attenuation required. 12 total diode detectors for Light : Radiation field coincidence. Real-time air density correction with results displayed on PC Windows software in real time. Includes comprehensive database manager for graphical data presentation and daily therapist guide. 25 meter power-data cable, USB power-data interface, USB cable. 1 year warranty included. See product datasheet for minimum PC requirements.

1254000-

Sun Nuclear QA Phantom Kit Includes kV imaging QA phantom (1250000-0), MV imaging QA phantom (1251000-0), field size QA phantom (1252000-0), and “Winston Lutz” phantom (1253000-0). Kit also includes stand for kV/MV imaging phantom and storage case.

1179000- P

SRS MapCHECK Package Package for SRS delivery QA including: SRS MapCHECK (1179000-0z), StereoPHAN package w/ MRI Support (1255000- 0z). Includes SNC Patient analysis software, 25 meter power-data cable, USB cable, power supply (110/220 V), and 1 year of hardware and 1 year of software maintenance. See product datasheet for minimum PC requirements.

1255231

StereoPHAN Multi-Slice Film Insert Multi-film insert (3 film layers) for StereoPHAN includes titanium fiducial markers. Supports sagittal, coronal and axial measurements.

1220533Z Inner Plug, A1SL Includes scribe lines for off-axis detector positioning. Requires part number 1220000-1

TRNG-T1

Training Voucher, 1 Day On Site Training Voucher for one day on site product training. Includes one full day of in depth product training by a qualified Sun Nuclear representative. Refer to Product Training Datasheet

(attached) for the number of training units that need to be allocated for each product (one training unit = 1 day).

Additional consecutive days can be purchased at a discounted price. Allow 4 weeks minimum for scheduling.

Training for SRS MapCHECK Package

805561

CTDI Phantom - 2 Piece The Gammex CTDI 2-Piece Phantom easily measures absorbed dose and monitors scanner output faster and more easily than ever before. The tongue and groove design provides precise, fast module and insert placement. Includes a custom water-tight, hard case, and wedges for stabilizing the phantom on the couch. This product includes a 5-year warranty.

805810

CBCT Electron Density Phantom for CONE-Beam and Wide Field CT This electron density phantom is used to provide accurate corrections for tissue inhomogeneities and to establish the relationship between the electron density of various tissues and their corresponding CT numbers. This phantom is constructed of CT HE Solid Water, and is 40 cm wide, 30 cm high, and 16.5 cm deep. It includes 16 ports that accommodate 16 interchangeable density inserts. The interchangeable rods include Gammex patent pending rod marker technology. The 20 cm head section is removable and can be used separately.

The phantom base can also be used as a body ring for the 464 ACR CT Phantom. This kit includes a deluxe stand and a wheeled case. This product includes a 5 year warranty.

805779

ROD/ALUMINUM INSERT FOR 1467 PHANTOM

ROD/ ALUMINUM INSERT FOR 1467 PHANTOM, 16.5 cm

805780

ROD/TITANIUM INSERT FOR 1467 PHANTOM ROD/TITANIUM

INSERT FOR 1467 PHANTOM, 16.5 cm

805781

ROD/STAINLESS STEEL INSERT FOR 1467 PHANTOM

ROD/ STAINLESS STEEL INSERT FOR 1467 PHANTOM, 16.5 cm

1299920Z

60R Rack Server (Pass-Through) Specifications and pricing subject to change.

Rack-format base system. Dual Intel Xeon 10-Core 2.2GHz Processors. 128GB RAM. NVIDIA Tesla K80 GPU. Solid-State Drive for Operating System plus 6.0TB available RAID storage space.

1142000-

SNC Routine SNC Routine Comprehensive Daily, Monthly, Annual Machine QA

SunCHECK Platform

- Unified database for all SunCHECK patient and machine QA data

- Browser-based software for access from anywhere with connection to the clinical network

- Integration within the clinical network

SunCHECK Machine Comprehensive Radiation Oncology machine QA test and data management.

- SNC Routine: Complete, customizable templates for TG- 142 daily, monthly, and annual QA of mechanical, safety, accessories, dosimetry, and more. Collection, analysis, review, and trending of data in the SunCHECK database.

Direct connectivity to SNC Daily QA 3 and IC PROFILER devices.

- SNC Machine: Image Analysis software for automated imaging system quality tests, plus image-based Linac MLC and VMAT QA.

License valid for one Linac.

One year of software maintenance included.

Please confirm required server specifications, software environment requirements and third-party system compatibility and pre-requisites with Sun Nuclear.

1142-

15SD

SNC Routine SunDEPLOYS SNC Routine SunDEPLOYS Installation and Implementation Support

- Pre-installation analysis/project management/consultation

- Software installation and server preparation

- System configuration and verification

- On-site SNC device calibration support

- On-site Machine QA plan and QA template creation support

- On-site customer training

- Clinical adoption support

- Priority support through to clinical adoption

Valid for up to 4 Linacs connected to one SunCHECK server, at one clinic/department location.

1217000-

DoseCHECK DoseCHECK Secondary Dose Calculations in a Modern, Integrated, Workflow

SunCHECK Platform

- Unified database for all SunCHECK patient and machine QA data

- Browser-based access from anywhere with connection to the clinical network

- Integration within the clinical network

DoseCHECK:

- Independent Secondary 3D Dose Calculations

License valid for one Linac or TomoTherapy® System. One year of software maintenance included.

Please confirm required server specifications, software environment requirements and third-party system compatibility and pre-requisites with Sun Nuclear.

Total

Standard Maintenance Agreement (SMA) (Base Plus Four, One-Year Options):

Part Description Qty Unit Price

Extended (With

Discount)

1220-

MC

ArcCHECK® Standard Maintenance Agreement

Includes complimentary service loaners (USA only), full hardware warranty extension, software license renewal, full access to all new software releases, telephone and web-based technical support. In addition, the agreement provides access to all updated user manuals and reference guides. Additional charges may apply if the agreement is renewed after the previous coverage period has lapsed. Multiple years may be purchased.

1122-

W

IC PROFILER™ Standard Maintenance Agreement Includes complimentary service loaners (USA only), full hardware warranty extension, software license renewal, full access to all new software releases, and telephone and web-based technical support.

In addition, the agreement provides access to all updated user manuals and reference guides. Additional charges may apply if the agreement is renewed after the previous coverage period has lapsed. Multiple years may be purchased.

1093-

1W rf-Daily QA™3 Standard Maintenance Agreement

Includes complimentary service loaners (USA only), full hardware warranty extension, software license renewal, full access to all new software releases, and telephone and web-based technical support.

In addition, the agreement provides access to all updated user manuals and reference guides. Additional charges may apply if the agreement is renewed after the previous coverage period has lapsed. Multiple years may be purchased.

1142-

SC

SNC Routine Software Maintenance Agreement SNC Routine software maintenance for main Linac licenses. Valid for one main Linac license (1142000-0, 1142000-3, 1142000-6 or

1142000-8).

Includes software license renewal, full access to all new software releases, and telephone and web-based technical support. In addition, the agreement provides access to all updated user manuals and reference guides. Additional charges may apply if the agreement is renewed after the previous coverage period has lapsed. Multiple years may be purchased. Valid for one SNC Routine main license.

Requirement for all SNC Routine licenses to be renewed for renewal to be valid.

1142-

SC2

SNC Routine Software Maintenance Agreement (additional Non-

Linac maintenance)

SNC Routine software maintenance for additional machine licenses.

Valid for one additional machine license (1142000-2). Includes all necessary software upgrades for SNC Routine for a period of one year. This agreement is renewable annually after the first year of ownership. Extra charges may apply if the agreement is renewed after the previous coverage period has lapsed. Requirement for all

SNC Routine vault licenses to be renewed for renewal to be valid.

1179-

MC

SRS MapCHECK Standard Maintenance Agreement

Includes complimentary service loaners (USA only), full hardware warranty extension, software license renewal, full access to all new software releases, and telephone and web-based technical support.

In addition, the agreement provides access to all updated user manuals and reference guides. Additional charges may apply if the agreement is renewed after the previous coverage period has lapsed. Multiple years may be purchased.

1217-

SC

DoseCHECK Software Maintenance Agreement Annual software ONLY agreement. Includes all necessary software upgrades and telephone and web-based technical support. In addition, the agreement provides access to all updated user manuals and reference guides. Additional charges may apply if the agreement is renewed after the previous coverage period has lapsed. Multiple years may be purchased. Valid for one DoseCHECK license.

Total

Total Estimated Value, Software/Equipment and SMA:

Period of Performance (SMA):

Base Year 9/1/2019 – 8/31/2020 Option Year 1 9/1/2020 – 8/31/2021 Option Year 2 9/1/2021 – 8/31/2022 Option Year 3 9/1/2022 – 8/31/2023 Option Year 4 9/1/2023 – 8/31/2024

4. Statutory Authority Permitting Other than Full and Open Competition: The authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. 1901 and is implemented by for restricting competition on this procurement via FAR 13.106-1(b)(2).

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority): This equipment is for Radiation/Oncology Patients that will be receiving radiation therapy in the newly constructed Cancer Treatment Center (CTC) at the William S. Middleton Memorial Veterans Hospital located in Madison, WI. The Quality Assurance (QA) system is used to verify clinical radiation therapy plans. A 3D radiotherapy beam dosimetry QA system intended for the measurement of radiation dose distributions for the purpose of comparison with a simulated dose distribution in the same phantom geometry as calculated by the treatment planning system (TPS) that includes a time element making it 4D when identifying the source of errors.

Quality Management (QM) is the top priority when providing radiation therapy: every patient’s treatment plan is unique, every three-dimensional calculation of radiation dose is unique, and treatment is delivered using an invisible beam of radiation that cannot be “inspected” during use.

Having a robust Quality Management Platform that is independent from the Vendor of the delivery system or planning system, but still able to integrate devices throughout the QA process is key to any successful program. Sun Nuclear Corporation's (manufacturer) Quality Management platform allows all QA pieces to interface together to ensure that all aspects of the clinical planning and delivery system are accurate.

With QA equipment from a single vendor, maximum efficiency can be achieved. For example, a single software database can track and trend results from multiple measurement devices when acquired from a single vendor such as Sun Nuclear. This homogenization results in reduced time required for quality management testing, easier auditing of holistic system performance, and more efficient workflows. Sun Nuclear has the most complete portfolio of QA equipment and software, leading to the most “future-proof” choice for a clinic’s Quality Management Program.

Sun Nuclear’s SunCHECK is an integrated, independent enterprise software solution for radiation therapy that focuses on patient safety. This solution features automation and direct QA device connectivity. SunCHECK is seamless and standardizes machine and patient QA workflows and can support a broad spectrum of Oncology Information Systems. The following other products, along with accessories (not listed) are needed for the robust QM Program and all are from Sun Nuclear.

The QA measurement devices below include a three-dimensional diode array needed for patient-specific routine measurements of radiation plans, a planar array of ion chambers used for routine treatment delivery system quality management, a simple, fast device for comprehensive daily quality assurance, phantoms used to audit the performance of the imaging systems used for patient planning and alignment, and software applications to integrate machine quality management data as well as perform independent “second-checks” of patient dose calculations. The SRS MapCheck is a high-resolution diode array used to measure dose distributions typical for very advanced treatment techniques.

1. ArcCHECK 4D Isotropic Arc Delivery QA

2. IC PROFILER

3. rf-Daily QA3

4. Sun Nuclear QA Phantom Kit

5. CTDI Phantom - 2 Piece

6. CBCT Electron Density Phantom for CONE-Beam and Wide Field CT

7. SNC Routine

8. DoseCHECK

9. SRS MapCheck

As described in section 6 below, a Sources Sought notification (36C25219Q0587) was posted to the Governmentwide Point of Entry (GPE), FBO.gov, to confirm that there are no other equipment manufacturers that can provide the requested supplies and services (according to the Statement of Work) on a Brand Name or Equal basis. Zero results were returned.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable: The Contracting Officer (CO) contacted the facility to determine if this procurement was to be conducted via Brand Name or Equal or Brand Name Only specifications, as the procurement package was unclear as to which strategy the procurement office was to pursue.

The facility responded that it wanted to pursue the equipment/software/services on a Brand Name Only basis for the reasons described in this document. The CO’s limited knowledge of the system prompted him to conduct further market research, including identifying potential sources by posting a Sources Sought notification. Sources Sought notification number 36C25219Q0587 was posted to the GPE from 5/8/2019 through 5/14/2019 requesting any businesses, including VOSBs and

SDVOSBs, that are able to provide quality assurance software and equipment for a radiotherapy beam dosimetry system. As of 6/3/2019, zero responses were received.

An Intent to Sole notification (36C25219Q0628) was posted to the GPE from 5/24/2019 through 5/30/2019 to inform Industry of the Government’s intent to award to Sun Nuclear Corporation. As of 6/3/2019, no responses were received.

7. Determination by the CO that the Anticipated Cost to the Government will be Fair and

Reasonable: Anticipated price to the Government will be determined fair and reasonable IAW FAR 13.106-3(a)(2): (ii) Comparison of the proposed price with prices found reasonable on previous purchases; and (vii) Any other reasonable basis.

The CO was provided previously-quoted and awarded purchase orders from the public and private sectors. Prices were comparable and within tolerances of the adjusted price, post-consumer price index estimated rate of inflation applied.

The manufacturer offers a further discount of when compared to original unit price of equipment/software. This provides further savings to the Government, allowing it to use the funds elsewhere in the support of Veterans.

8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons

Market Research Was Not Conducted: In addition to the market research described above, the

Contracting Officer (CO) conducted a search on VIP VetBiz for the Keyword, “Quality Assurance.”

125 results were returned. A secondary search added NAICS code 334519 (Other Measuring and

Controlling Device Manufacturing). Zero results were returned.

Market research was also conducted on the NAC MedSurg and GSA Advantage! catalogs for the requested equipment. Zero results were revealed.

An examination of acquisition history in FPDS was conducted. The CO e-mailed six other COs/Contract Specialists (CSs) across the country and multiple agencies to request pricing data as well as source lists and/or justificaitons for award decisions. Two responses were received, both for Sun Nuclear QA equipment and services.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition: According to Task Group 100 of the American Association of Physicists in Medicine (AAPM), the collection of quality assurance, quality control, and procedural tasks set into recommendations will help organize the QM increase safety and the quality for treatment for patients (Huq, M. S., Fraass, B. A., Dunscombe, P. B., Gibbons, J. P., Jr, Ibbott, G. S., Mundt, A. J., … Yorke, E. D.) (2016). See file in eCMS Briefcase, “S30 - AAPM Application of Risk Analysis Methods to Radiation Therapy Quality Management.” TG- 100 went further to state that the three key components of the QM program are standardized procedures, adequate training of staff, and clear lines of communication among staff. The clinic will be utilizing providers and physicists that are already trained and familiar with much of this equipment and software. Because of the familiarity, the previous training and knowledge, Sun Nuclear’s QM platform and equipment will meet all three components.

Statement of Work available in eCMS Briefcase.

10. Listing of Sources that Expressed, in Writing, an Interest in the Acquisition:

Sun Nuclear Corporation

11. A Statement of the Actions, if any, the Agency May Take to Remove or Overcome any Barriers to

Competition before Making subsequent acquisitions for the supplies or services required:

Continuous survey of Industry for QA software and equipment for radiotherapy beam dosimetry systems.

12. Requirements Certification: I certify that the requirement outlined in this justification is a Bona Fide Need of the Department of Veterans Affairs and that the supporting data under my cognizance, which are included in the justification, are accurate and complete to the best of my knowledge and belief.

David Pena Date Cancer Treatment Center Activation Project Manager William S. Middleton Memorial Veterans Hospital

13. Approvals in accordance with the VHAPM Part 806.3 OFOC SOP:

a. Contracting Officer or Designee’s Certification (required): I certify that the foregoing justification is accurate and complete to the best of my knowledge and belief.

Jim Hedman Date Contracting Officer Great Lakes Acquisition Center

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $700K): I certify the justification meets requirements for other than full and open competition.

Daniel Rasmussen Date Supervisory Contracting Officer Great Lakes Acquisition Center