P03 BNJ_Redacted.pdf

VHAPG Part 813.5 Simplified Acquisition Procedures for Certain Commercial Items Attachment 1: Request for Sole Source Justification Template >SAT-$7.5M under FAR13.5

Effective Date: 02/01/2022 Page 1 of 5

DEPARTMENT OF VETERANS AFFAIRS

BRAND NAME JUSTIFICATION

SOLE SOURCE JUSTIFICATION UNDER SIMPLIFIED PROCEDURES FOR CERTAIN COMMERCIAL

ITEMS IN ACCORDANCE WITH FAR 13.5

Acquisition Plan Action ID: 36C262-24-AP-1312

1. Contracting Activity: Department of Veterans Affairs, VISN 22, VA Long Beach Healthcare System for Purchase Request# 600-24-2-114-0036

2. Nature and/or Description of the Action Being Processed: This procurement is to establish a Firm- Fixed-Price Contract to lease a GE brand Mobile PET/CT Trailer for VA Long Beach Healthcare System Radiology Services temporarily for maximum 8-months period while the construction gets completed for a new PET/CT facility. The contractor shall be responsible for transporation (drop-off for installation, and pick-up once contract is completed), and also provide a minimum of 3-days for application training, and initial supplies necessary to perform PET/CT examinations, maintenance, and repair of all contractor furnished equipment.

3. Description of Supplies/Services Required to Meet the Agency’s Needs: VA Long Beach Radiology

Service is requesting a GE brand Mobile PET/CT system such as model# GE Discovery MI Gen2 PET/CT system that is a full body PET/CT scanner system with dose calibrator. The system must have ability to perform a wide range of exams to include: PET/CT FDG SBTT, PET/CT FDG WB, PET/CT PSMA PYLARIFY VERTEX TO MID THIGH, PET/CT DOTATATE NETSPOT VERTEX TO MID THIGH, PET/CT FDG BRAIN, PET/CT NAF BONE WB, CT ABDOMEN/PELVIS WITH & W/O IVCM, CT ABDOMEN WITH PO WITH & W/O IVCM, CT ABDOMEN/PELVIS WITH PO WITH & W/O IVCM, CT HEAD WITH & W/O

IVCM, CT THORAX WITH & W/O IVCM, CT PELVIS WITH & W/O IVCM.

Mobile PET/CT trailer unit must have following capabilities:

a. Hardware and software necessary to permit interpretation of PET/CT Images at the site where images are obtained.

b. Dose calibrator

c. Ability to create, store and export Digital Imaging and Communications in Medicine

(DICOM), Joint Photographic Experts Group (JPEG) and Moving Picture Experts Group (MPEG) file formats.

d. The mobile unit shall be equipped with Compact Disk-Recordable CD-R/DVD-R burning capabilities as a backup to network transfer if available.

e. The mobile unit shall be equipped with a phantom for daily quality assurance (QA) checks.

f. The mobile unit shall be equipped with an Intravenous (IV) contrast injector (Medrad

Stellant CT contrast injector).

g. The mobile unit shall be equipped with a programmable injector with pressure monitor having the following capabilities (Medrad Stellant Double Syringe Injector):

1. Scan delay

2. Multiphase option

3. Protocol storing

4. Pause hold functionality

h. Minimum security requirements:

1. Up-to-date Microsoft (MS) patches and anti-virus software at the vendor mobile unit.

2. Up-to-date MS patches and anti-virus software at the vendor workstation.

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3. Workstation configuration must be compatible with VA supplied anti-virus (currently McAfee Enterprise).

4. No patient identifiers such as name and Social Security Number shall reside on the mobile unit and images shall have an identifier which does not disclose Personally Identifiable Information (PII).

i. Trailer shall be complied with American with Disabilities Act (ADA) requirements for access.

j. The PET/CT shall provide images with consistently high technical quality to be approved by

VA employed experts. Poor image quality will be considered non-performance under this contract and must be remedied within 30 days of notification or incurred default.

k. The PET/CT should be capable of acquiring and post-processing of 3-dimensional and/or time of flight data.

l. The PET/CT Unit shall have a minimum of a 64 -slice detector and be capable of acquiring the transmission images within one breath hold.

m. The PET/CT shall be capable of acquiring data for anatomic localization and attenuation correction.

n. The PET/CT system shall have attenuation correction algorithm(s) that are designed to use non-contrast enhanced CT data.

o. The PET/CT system shall have attenuation correction algorithm(s) that are designed to use CT data with intravenous contrast enhancement.

p. The PET/CT system shall have attenuation correction algorithm(s) that are designed to use CT data with oral contrast enhancement with positive contrast (iodinated contrast).

q. The PET/CT system shall have attenuation correction algorithm(s) that are designed to use CT data with oral contrast enhancement with negative contrast (water).

r. The Mobile PET/CT unit shall have a patient injection/incubation room.

s. The Mobile PET/CT unit shall maintain a temperature to assure proper operation of the scanner without frequent calibration and provide for patient comfort.

t. The PET/CT unit shall meet all federal, state and local fire and safety requirements.

u. The mobile unit shall provide a patient injection room, and patient restroom if possible.

v. Telecommunications: The mobile unit shall be equipped with outlet jack’s connections capable of transmitting data and voice through Government provided category five (5) cable and dual pair phone cable. The Government will provide the connection required for the transmission of images, data and voice.

w. Equipment maintenance shall be provided by the contractor for the preventive maintenance, emergency and general repairs, safety, cleaning, and upkeep of all equipment furnished by the Contractor, which to include 24/7 telepone technical support.

The anticipated period of performance is to start the lease on 1/15/24 through 9/30/24, 8-months or less, until the construction gets completed. The estimated cost of this requirement is

4. Statutory Authority Permitting Restricted Competition:

FAR 13.5 Simplified Procedures for Certain Commercial Items. The statutory authority for applying the Simplified Procedures for Commercial Items of FAR 13.5 is 41 U.S.C. § 1901 and is implemented by FAR 13.106-1(b)(2) for restricting competition on this procurement. Competition is restricted on this procurement for the reason below:

(X) Only One Responsible Source and No Other Supplies or Services Will Satisfy Agency Requirements

( ) Unusual and Compelling Urgency

Effective Date: 02/01/2022 Page 3 of 5

( ) Industrial Mobilization, Engineering, Developmental or Research Capability or Expert Services

( ) International Agreement ( ) Authorized or Required by Statute ( ) National Security ( ) Public Interest

5. Demonstration that the Contractor’s Unique Qualifications or Nature of the Acquisition Requires the Use of the Authority Cited Above (applicability of authority):

VA Long Beach Healthcare System Radiology Service is currently utilizing GE brand name PET/CT system. Hence all of its users including radiology technicians and doctors are familiar with operating GE brand PET/CT system. The requesting service only temporarily needs this mobile PET/CT trailer for less than eight-months until the PET/CT facility gets renovated by September 2024. A new GE PET/CT system is already purchased and scheduled to be installed in June 2024.

PET/CT Scanner is a complex system, hence if a different brand name PET/CT is procured, in-depth and longer training will be required for users, which will cost more money and time to the VA. The using service urges that it will take more than three weeks for training and to enforce a new standardization throughout its facility. Radiology Service is already experiencing backed looged in PET/CT, so further down time will cause additional delays in veterans care as there will be a delay in much needed imaging that will ultimately delay the course of patients’ treatments.

Also, VA Long Beach Radiology has already purchased GE’s proprietary licenses, servers, and workstation called AW workstation. AW workstation is used to allow images taken on GE equipment to be processed, quantify data, and make save-screens of significant findings that users are able to correlate their previous study in real time. The workstation allows technicians and doctors to pull up all previous and current studies simultaneously without having to utilize multiple integrated platforms. If a different brand name is procured, additional proprietary licnese, servers, and workstation will need to be purchased, which will cost more money to the VA.

Since VA Long Beach Radiology Service has already purchased the GE brand PET/CT systems, it is in the Government’s best interest to lease a GE brand mobile PET/CT trailer temporarily to avoid additional spending in money and time on trainings and proprietary items for a different brand’s PET/CT system that will only last in usage for eight-months time frame.

6. Description of Efforts Made to ensure that offers are solicited from as many potential sources as deemed practicable:

Small Business Administration (SBA)’s VetCert was utilized to survey potential SDVOSB and VOSB under NAICS code 621512 – Diagnostic Imaging Centers. SAM.gov and FPDS were utilized to study the similar past prourements and its procurement methods. VA National Acquisition Center MedSurg Catalog and VA Supply Chain Master Catalog was also reviewed to check if there are any mandatory contracts for requested supplies/services. Detailed of conducted market research findings are described under 8.

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

Reasonable:

Contracting will solicit this requirement as a brand name requirement in the open market to promote competition and determine fair and reasonable pricing.

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8. Description of the Market Research Conducted and the Results, or a Statement of the Reasons Market Research Was Not Conducted:

SBA’s VetCert identified 186 verified SD/VOSB under NAICS code 621512 – Diagnostic Imaging Centers.

SAM.gov and FPDS were utilized to study similar past procurements and its procurement methods.

Notice ID# , a special notice, was identified, which included a limited source justification (LSJ) that VISN 16 intends to award a short-term firm fixed price BPA contract under the statutory authority implemendted by FAR 8.405-6(b)(3) to the incumbent contractor named Abbot Labaratories, Inc. Another solicitation # was identified, which was issued by NCO 22 for VA Loma Linda Healthcare System that was set aside for SDVOSB as a brand name or equal requirement. The contract# was awarded to Brigade Medical Services, Inc. in the amount of $ on 12/7/2021.

Mobile PET/CT Trailer is considered a medical equipment, therefore, VA National Acquistion Center MedSurg Catalog was searched by the key-term ‘Mobile PET/CT Trailer’. But there was no active items available.

VA Supply Chain Master Catalog (SCMC) was used to study if there are any established BPA/IDIQ contract within VISN 22; however, there was no active contracts. Identified contracts were for VISN 4 and 12. IDIQ contract# was procured by NCO 12 for Mobile PET/CT Services for Jesse Brown VAMC. Period of performance was to start 12/18/22 through 12/17/27 with option years. Total contract value is $ Based on FPDS record, this acquisition was competed in the open market unrestricted, and the award was made to a large business named Shared Medical Services, Inc. Another contract# was identified, which was procured by NCO 4 for VA Philadelphia’s Mobile CT/PET Trailer. This procurement was set aside to SDVOSB in the open market, and the award was made to Salvadorini Consulting, LLC for the period of performance of 3/16/23 through 3/15/25. Total contract value was $ based on FPDS.

A sources sought notice was posted on SAM.gov. Four SDOVSB expressed interest in this acquisition.

Their SDVOSB statuses have been verified through SBA VetCert.

9. Any Other Facts Supporting the Use of Other than Full and Open Competition:

This acquisition request is to lease a mobile PET/CT trailer temporarily for maximum eight-months period until the PET/CT facility gets renovated. The requesting service has already procured and purchased GE brand PET/CT scanner system for its use in the future. Hence leasing a different brand that ultimately would cost more money and time in training and its proprietary items is not in best interest for the Government.

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

Following is the list of verified Service-Disabled Veteran-Owned Small Businesses that expressed interest to this procurement:

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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:

No actions are planned as this requirement is to lease temporarily for maximum eight-months until the remodel/construction is completed for a new PET/CT facility.

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.

Chief Technologist VA Long Beach Healthcare System

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.

Contracting Officer

NCO 22

b. One Level Above the Contracting Officer (Required over SAT but not exceeding $750K): I certify the justification meets requirements for other than full and open competition.

Division Chief

NCO 22